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SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub- stance formulation (NFCSF).

Subpart A—General Provisions Subpart E—Generally Recognized as Safe Sec. (GRAS) Notice 170.3 Definitions. 170.203 Definitions. 170.6 Opinion letters on food additive sta- 170.205 Opportunity to submit a GRAS no- tus. tice. 170.10 Food additives in standardized foods. 170.210 How to send your GRAS notice to 170.15 Adoption of regulation on initiative FDA. of Commissioner. 170.215 Incorporation into a GRAS notice. 170.17 Exemption for investigational use 170.220 General requirements applicable to a and procedure for obtaining authoriza- GRAS notice. tion to market edible products from ex- 170.225 Part 1 of a GRAS notice: Signed perimental animals. statements and certification. 170.18 Tolerances for related food additives. 170.230 Part 2 of a GRAS notice: Identity, 170.19 Pesticide chemicals in processed method of manufacture, specifications, foods. and physical or technical effect. Subpart B—Food Additive Safety 170.235 Part 3 of a GRAS notice: Dietary ex- posure. 170.20 General principles for evaluating the 170.240 Part 4 of a GRAS notice: Self-lim- safety of food additives. iting levels of use. 170.22 Safety factors to be considered. 170.245 Part 5 of a GRAS notice: Experience 170.30 Eligibility for classification as gen- based on common use in food before 1958. erally recognized as safe (GRAS). 170.250 Part 6 of a GRAS notice: Narrative. 170.35 Affirmation of generally recognized 170.255 Part 7 of a GRAS notice: List of sup- as safe (GRAS) status. porting data and information in your 170.38 Determination of food additive sta- GRAS notice. tus. 170.260 Steps you may take before FDA re- 170.39 Threshold of regulation for sub- sponds to your GRAS notice. stances used in food-contact articles. 170.265 What FDA will do with a GRAS no- tice. Subpart C—Specific Administrative Rulings 170.270 Procedures that apply when the in- and Decisions tended conditions of use of a notified substance include use in a product or 170.45 Fluorine-containing compounds. products subject to regulation by the 170.50 Glycine (aminoacetic acid) in food for Food Safety and Inspection Service human consumption. (FSIS) of the United States Department 170.60 Nitrites and/or nitrates in curing pre- of Agriculture. mixes. 170.275 Public disclosure of a GRAS notice. 170.280 Submission of a supplement. Subpart D—Premarket Notifications 170.285 Disposition of pending GRAS affir- mation petitions. 170.100 Submission of a premarket notifica- tion for a food contact substance (FCN) AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, to the Food and Drug Administration 371. (FDA). SOURCE: 42 FR 14483, Mar. 15, 1977, unless 170.101 Information in a premarket notifica- otherwise noted. tion for a food contact substance (FCN). 170.102 Confidentiality of information in a EDITORIAL NOTE: Nomenclature changes to premarket notification for a food contact part 170 appear at 66 FR 56035, Nov. 6, 2001 substance (FCN). and 69 FR 13717, Mar. 24, 2004. 170.103 Withdrawal without prejudice of a premarket notification for a food contact Subpart A—General Provisions substance (FCN). 170.104 Action on a premarket notification § 170.3 Definitions. for a food contact substance (FCN). 170.105 The Food and Drug Administration’s For the purposes of this subchapter, (FDA’s) determination that a premarket the following definitions apply: notification for a food contact substance (a) Secretary means the Secretary of (FCN) is no longer effective. Health and Human Services.

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(b) Department means the Department substance for food use by a significant of Health and Human Services. number of consumers. (c) Commissioner means the Commis- (g) The word substance in the defini- sioner of Food and Drugs. tion of the term ‘‘food additive’’ in- (d) As used in this part, the term act cludes a food or food component con- means the Federal Food, Drug, and sisting of one or more ingredients. Cosmetic Act approved June 25, 1936, 52 (h) Scientific procedures include the Stat. 1040 et seq., as amended (21 U.S.C. application of scientific data (includ- 301–392). ing, as appropriate, data from human, (e)(1) Food additives includes all sub- animal, analytical, or other scientific stances not exempted by section 201(s) studies), information, and methods, of the act, the intended use of which whether published or unpublished, as results or may reasonably be expected well as the application of scientific to result, directly or indirectly, either principles, appropriate to establish the in their becoming a component of food or otherwise affecting the characteris- safety of a substance under the condi- tics of food. A material used in the pro- tions of its intended use. duction of containers and packages is (i) Safe or safety means that there is subject to the definition if it may rea- a reasonable certainty in the minds of sonably be expected to become a com- competent scientists that the sub- ponent, or to affect the characteristics, stance is not harmful under the condi- directly or indirectly, of food packed in tions of its intended use. It is impos- the container. ‘‘Affecting the charac- sible in the present state of scientific teristics of food’’ does not include such knowledge to establish with complete physical effects, as protecting contents certainty the absolute harmlessness of of packages, preserving shape, and pre- the use of any substance. Safety may venting moisture loss. If there is no be determined by scientific procedures migration of a packaging component or by general recognition of safety. In from the package to the food, it does determining safety, the following fac- not become a component of the food tors shall be considered: and thus is not a food additive. A sub- (1) The probable consumption of the stance that does not become a compo- substance and of any substance formed nent of food, but that is used, for exam- in or on food because of its use. ple, in preparing an ingredient of the (2) The cumulative effect of the sub- food to give a different flavor, texture, stance in the diet, taking into account or other characteristic in the food, any chemically or pharmacologically may be a food additive. related substance or substances in such (2) Uses of food additives not requiring diet. a listing regulation. Use of a substance (3) Safety factors which, in the opin- in a food contact article (e.g., food- ion of experts qualified by scientific packaging or food-processing equip- training and experience to evaluate the ment) whereby the substance migrates, safety of food and food ingredients, are or may reasonably be expected to mi- generally recognized as appropriate. grate, into food at such levels that the use has been exempted from regulation (j) The term nonperishable processed as a food additive under § 170.39, and food means any processed food not sub- food contact substances used in accord- ject to rapid decay or deterioration ance with a notification submitted that would render it unfit for consump- under section 409(h) of the act that is tion. Examples are flour, sugar, cere- effective. als, packaged cookies, and crackers. (3) A food contact substance is any sub- Not included are hermetically sealed stance that is intended for use as a foods or manufactured dairy products component of materials used in manu- and other processed foods requiring re- facturing, packing, packaging, trans- frigeration. porting, or holding food if such use is (k) General recognition of safety shall not intended to have any technical ef- be in accordance with § 170.30. fect in such food. (l) Prior sanction means an explicit (f) Common use in food means a sub- approval granted with respect to use of stantial history of consumption of a a substance in food prior to September

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6, 1958, by the Food and Drug Adminis- (8) Condiments and relishes, includ- tration or the United States Depart- ing plain seasoning sauces and spreads, ment of Agriculture pursuant to the olives, pickles, and relishes, but not Federal Food, Drug, and Cosmetic Act, or herbs. the Poultry Products Inspection Act, (9) Confections and frostings, includ- or the Meat Inspection Act. ing candy and flavored frostings, (m) Food includes human food, sub- marshmallows, baking chocolate, and stances migrating to food from food- brown, lump, rock, maple, powdered, contact articles, pet food, and animal and raw sugars. feed. (10) Dairy product analogs, including (n) The following general food cat- nondairy milk, frozen or liquid cream- egories are established to spe- ers, coffee whiteners, toppings, and cific related foods together for the pur- other nondairy products. pose of establishing tolerances or limi- (11) Egg products, including liquid, tations for the use of direct human frozen, or dried eggs, and egg dishes food ingredients. Individual food prod- made therefrom, i.e., egg roll, egg foo ucts will be included within these cat- young, egg salad, and frozen multi- egories according to the detailed clas- course egg meals, but not fresh eggs. sifications lists contained in Exhibit (12) Fats and oils, including mar- 33B of the report of the National Acad- garine, dressings for salads, butter, emy of Sciences/National Research salad oils, shortenings and cooking Council report, ‘‘A Comprehensive Sur- oils. vey of Industry on the Use of Food (13) Fish products, including all pre- Chemicals Generally Recognized as pared main dishes, salads, appetizers, Safe’’ (September 1972), which is incor- frozen multicourse meals, and spreads porated by reference. Copies are avail- containing fish, shellfish, and other able from the National Technical Infor- aquatic animals, but not fresh fish. mation Service (NTIS), 5285 Port Royal (14) Fresh eggs, including cooked Rd., Springfield, VA 22161, or at the Na- eggs and egg dishes made only from tional Archives and Records Adminis- fresh shell eggs. tration (NARA). For information on (15) Fresh fish, including only fresh the availability of this material at and frozen fish, shellfish, and other NARA, call 202–741–6030, or go to: http:// aquatic animals. www.archives.gov/federallregister/ (16) Fresh fruits and fruit juices, in- codeloflfederallregulations/ cluding only raw fruits, citrus, melons, ibrllocations.html. and , and home-prepared ‘‘ades’’ and punches made therefrom. (1) Baked goods and baking mixes, in- (17) Fresh meats, including only fresh cluding all ready-to-eat and ready-to- or home-frozen beef or veal, pork, lamb bake products, flours, and mixes re- or mutton and home-prepared fresh quiring preparation before serving. meat-containing dishes, salads, appe- (2) Beverages, alcoholic, including tizers, or sandwich spreads made there- malt beverages, wines, distilled liq- from. uors, and cocktail mix. (18) Fresh poultry, including only (3) Beverages and beverage bases, fresh or home-frozen poultry and nonalcoholic, including only special or birds and home-prepared fresh poultry- spiced teas, soft drinks, coffee sub- containing dishes, salads, appetizers, or stitutes, and fruit and vegetable fla- sandwich spreads made therefrom. vored gelatin drinks. (19) Fresh vegetables, tomatoes, and (4) Breakfast cereals, including potatoes, including only fresh and ready-to-eat and instant and regular home-prepared vegetables. hot cereals. (20) Frozen dairy desserts and mixes, (5) Cheeses, including curd and whey including ice cream, ice milks, sher- cheeses, cream, natural, grating, proc- bets, and other frozen dairy desserts essed, spread, dip, and miscellaneous and specialties. cheeses. (21) Fruit and water ices, including (6) , including all forms. all frozen fruit and water ices. (7) Coffee and tea, including regular, (22) Gelatins, puddings, and fillings, decaffeinated, and instant types. including flavored gelatin desserts,

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puddings, custards, parfaits, pie fill- centrates, dilutions, ‘‘ades’’, and drink ings, and gelatin base salads. substitutes made therefrom. (23) Grain products and pastas, in- (36) Processed vegetables and vege- cluding macaroni and noodle products, table juices, including all commer- rice dishes, and frozen multicourse cially processed vegetables, vegetable meals, without meat or vegetables. dishes, frozen multicourse vegetable (24) Gravies and sauces, including all meals, and vegetable juices and blends. meat sauces and gravies, and tomato, (37) Snack foods, including chips, milk, buttery, and specialty sauces. pretzels, and other novelty snacks. (25) Hard candy and cough drops, in- (38) Soft candy, including candy bars, cluding all hard type candies. chocolates, fudge, mints, and other (26) Herbs, seeds, spices, seasonings, chewy or nougat candies. blends, extracts, and flavorings, includ- (39) Soups, home-prepared, including ing all natural and artificial spices, meat, fish, poultry, vegetable, and blends, and flavors. combination home-prepared soups. (27) Jams and jellies, home-prepared, (40) Soups and soup mixes, including including only home-prepared jams, commercially prepared meat, fish, jellies, fruit butters, preserves, and poultry, vegetable, and combination sweet spreads. soups and soup mixes. (28) Jams and jellies, commercial, in- (41) Sugar, white, granulated, includ- cluding only commercially processed ing only white granulated sugar. jams, jellies, fruit butters, preserves, (42) Sugar substitutes, including and sweet spreads. granulated, liquid, and tablet sugar (29) Meat products, including all substitutes. meats and meat containing dishes, sal- (43) Sweet sauces, toppings, and syr- ads, appetizers, frozen multicourse ups, including chocolate, , fruit, meat meals, and sandwich ingredients corn syrup, and maple sweet sauces and prepared by commercial processing or toppings. using commercially processed meats (o) The following terms describe the with home preparation. physical or technical functional effects (30) Milk, whole and skim, including for which direct human food ingredi- only whole, lowfat, and skim fluid ents may be added to foods. They are milks. adopted from the National Academy of (31) Milk products, including flavored Sciences/National Research Council na- milks and milk drinks, dry milks, top- tional survey of food industries, re- pings, snack dips, spreads, weight con- ported to the Food and Drug Adminis- trol milk beverages, and other milk or- tration under the contract title ‘‘A igin products. Comprehensive Survey of Industry on (32) Nuts and products, including the Use of Food Chemicals Generally whole or shelled tree nuts, peanuts, co- Recognized as Safe’’ (September 1972), conut, and nut and peanut spreads. which is incorporated by reference. (33) protein products, including Copies are available from the National the National Academy of Sciences/Na- Technical Information Service (NTIS), tional Research Council ‘‘reconstituted 5285 Port Royal Rd., Springfield, VA vegetable protein’’ category, and meat, 22161, or at the National Archives and poultry, and fish substitutes, analogs, Records Administration (NARA). For and extender products made from plant information on the availability of this proteins. material at NARA, call 202–741–6030, or (34) Poultry products, including all go to: http://www.archives.gov/ poultry and poultry-containing dishes, federallregister/ salads, appetizers, frozen multicourse codeloflfederallregulations/ poultry meals, and sandwich ingredi- ibrllocations.html. ents prepared by commercial proc- (1) Anticaking agents and free-flow essing or using commercially processed agents: Substances added to finely pow- poultry with home preparation. dered or crystalline food products to (35) Processed fruits and fruit juices, prevent caking, lumping, or agglomer- including all commercially processed ation. fruits, citrus, berries, and mixtures; (2) Antimicrobial agents: Substances salads, juices and juice punches, con- used to preserve food by preventing

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growth of microorganisms and subse- carriers, binders, fillers, plasticizers, quent spoilage, including fungistats, film-formers, and tableting aids, etc. mold and rope inhibitors, and the ef- (15) Fumigants: Volatile substances fects listed by the National Academy of used for controlling insects or pests. Sciences/National Research Council (16) Humectants: Hygroscopic sub- under ‘‘preservatives.’’ stances incorporated in food to pro- (3) Antioxidants: Substances used to mote retention of moisture, including preserve food by retarding deteriora- moisture-retention agents and anti- tion, rancidity, or discoloration due to dusting agents. oxidation. (17) Leavening agents: Substances (4) Colors and coloring adjuncts: Sub- used to produce or stimulate produc- stances used to impart, preserve, or en- tion of dioxide in baked goods hance the color or shading of a food, in- to impart a light texture, including cluding color stabilizers, color fixa- yeast, yeast foods, and salts tives, color-retention agents, etc. listed by the National Academy of (5) Curing and agents: Sub- Sciences/National Research Council stances imparting a unique flavor and/ under ‘‘dough conditioners.’’ or color to a food, usually producing an (18) Lubricants and release agents: Sub- increase in shelf life stability. stances added to food contact surfaces (6) Dough strengtheners: Substances to prevent ingredients and finished used to modify starch and gluten, products from sticking to them. thereby producing a more stable dough, (19) Non-nutritive sweeteners: Sub- including the applicable effects listed stances having less than 2 percent of by the National Academy of Sciences/ the caloric value of sucrose per equiva- National Research Council under lent unit of sweetening capacity. ‘‘dough conditioner.’’ (20) Nutrient supplements: Substances (7) Drying agents: Substances with which are necessary for the body’s nu- moisture-absorbing ability, used to tritional and metabolic processes. maintain an environment of low mois- (21) Nutritive sweeteners: Substances ture. having greater than 2 percent of the ca- (8) Emulsifiers and emulsifier salts: loric value of sucrose per equivalent Substances which modify surface ten- unit of sweetening capacity. sion in the component of an (22) Oxidizing and reducing agents: emulsion to establish a uniform disper- Substances which chemically oxidize sion or emulsion. or reduce another food ingredient, (9) Enzymes: Enzymes used to im- thereby producing a more stable prod- prove food processing and the quality uct, including the applicable effect list- of the finished food. ed by the National Academy of (10) Firming agents: Substances added Sciences/National Research Council to precipitate residual pectin, thus under ‘‘dough conditioners.’’ strengthening the supporting tissue (23) pH control agents: Substances and preventing its collapse during added to change or maintain active processing. acidity or basicity, including buffers, (11) Flavor enhancers: Substances acids, alkalies, and neutralizing added to supplement, enhance, or mod- agents. ify the original taste and/or aroma of a (24) Processing aids: Substances used food, without imparting a char- as manufacturing aids to enhance the acteristic taste or aroma of its own. appeal or utility of a food or food com- (12) Flavoring agents and adjuvants: ponent, including clarifying agents, Substances added to impart or help im- clouding agents, catalysts, flocculents, part a taste or aroma in food. filter aids, and crystallization inhibi- (13) Flour treating agents: Substances tors, etc. added to milled flour, at the mill, to (25) Propellants, aerating agents, and improve its color and/or baking quali- : Gases used to supply force to ties, including bleaching and maturing expel a product or used to reduce the agents. amount of in contact with the (14) Formulation aids: Substances used food in packaging. to promote or produce a desired phys- (26) Sequestrants: Substances which ical state or texture in food, including combine with polyvalent ions to

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form a soluble metal complex, to im- (b) Since enactment of the Food Ad- prove the quality and stability of prod- ditives Amendment, the Food and Drug ucts. Administration has advised such in- (27) Solvents and vehicles: Substances quirers that an article: used to extract or dissolve another sub- (1) Is a food additive within the stance. meaning of section 201(s) of the act; or (28) Stabilizers and thickeners: Sub- (2) Is generally recognized as safe stances used to produce viscous solu- (GRAS); or tions or dispersions, to impart body, (3) Has prior sanction or approval improve consistency, or stabilize emul- under that amendment; or sions, including suspending and body- (4) Is not a food additive under the ing agents, setting agents, jellying conditions of intended use. agents, and bulking agents, etc. (c) In the interest of the public (29) Surface-active agents: Substances health, such articles which have been used to modify surface properties of considered in the past by the Food and liquid food components for a variety of Drug Administration to be safe under effects, other than emulsifiers, but in- the provisions of section 402(a)(1), or to cluding solubilizing agents, be generally recognized as safe for dispersants, detergents, wetting their intended use, or to have prior agents, rehydration enhancers, whip- sanction or approval, or not to be food ping agents, foaming agents, and de- additives under the conditions of in- foaming agents, etc. tended use, must be reexamined in the (30) Surface-finishing agents: Sub- light of current scientific information stances used to increase palatability, and current principles for evaluating preserve gloss, and inhibit discolora- the safety of food additives if their use tion of foods, including glazes, polishes, is to be continued. , and protective coatings. (d) Because of the time span in- (31) Synergists: Substances used to act volved, copies of many of the letters in or react with another food ingredient which the Food and Drug Administra- to produce a total effect different or tion has expressed an informal opinion greater than the sum of the effects pro- concerning the status of such articles duced by the individual ingredients. may no longer be in the file of the Food (32) Texturizers: Substances which af- and Drug Administration. In the ab- fect the appearance or feel of the food. sence of information concerning the names and uses made of all the articles [42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, referred to in such letters, their safety 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, of use cannot be reexamined. For this July 17, 1995; 67 FR 35729, May 21, 2002; 81 FR reason all food additive status opinions 55047, Aug. 17, 2016] of the kind described in paragraph (c) of this section given by the Food and § 170.6 Opinion letters on food addi- Drug Administration are hereby re- tive status. voked. (a) Over the years the Food and Drug (e) The prior opinions of the kind de- Administration has given informal scribed in paragraph (c) of this section written opinions to inquiries as to the will be replaced by qualified and cur- safety of articles intended for use as rent opinions if the recipient of each components of, or in contact with, such letter forwards a copy of each to food. Prior to the enactment of the the Department of Health and Human Food Additives Amendment of 1958 Services, Food and Drug Administra- (Pub. L. 85–929; Sept. 6, 1958), these tion, Center for Food Safety and Ap- opinions were given pursuant to sec- plied , 5001 Campus Dr., Col- tion 402(a)(1) of the Federal Food, lege Park, MD 20740, along with a copy Drug, and Cosmetic Act, which reads in of his letter of inquiry, on or before part: ‘‘A food shall be deemed to be July 23, 1970. adulterated if it bears or contains any (f) This section does not apply to food poisonous or deleterious substance additive status opinion letters per- which may render it injurious to taining to articles that were considered health’’. by the Food and Drug Administration

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to be food additives nor to articles in- additive regulation will be conditioned cluded in regulations in parts 170 on such compliance and will expire through 189 of this chapter if the arti- with the expiration of the temporary cles are used in accordance with the re- permit. quirements of such regulations. [42 FR 14483, Mar. 15, 1977, as amended at 54 § 170.15 Adoption of regulation on ini- FR 24896, June 12, 1989; 81 FR 49896, July 29, tiative of Commissioner. 2016] (a) The Commissioner upon his own initiative may propose the issuance of § 170.10 Food additives in standard- a regulation prescribing, with respect ized foods. to any particular use of a food additive, (a) The inclusion of food ingredients the conditions under which such addi- in parts 170 through 189 of this chapter tive may be safely used. Notice of such does not imply that these ingredients proposal shall be published in the FED- may be used in standardized foods un- ERAL REGISTER and shall state the rea- less they are recognized as optional in- sons for the proposal. gredients in applicable food standards. (b) Action upon a proposal made by Where a petition is received for the the Commissioner shall proceed as pro- issuance or amendment of a regulation vided in part 10 of this chapter. establishing a definition and standard of identity for a food under section 401 [42 FR 14486, Mar. 15, 1977, as amended at 42 of the Act, which proposes the inclu- FR 15673, Mar. 22, 1977] sion of a food additive in such defini- tion and standard of identity, the pro- § 170.17 Exemption for investigational visions of the regulations in this part use and procedure for obtaining au- shall apply with respect to the infor- thorization to market edible prod- ucts from experimental animals. mation that must be submitted with respect to the food additive. Since sec- A food additive or food containing a tion 409(b)(5) of the Act requires that food additive intended for investiga- the Secretary publish notice of a peti- tional use by qualified experts shall be tion for the establishment of a food-ad- exempt from the requirements of sec- ditive regulation within 30 days after tion 409 of the Act under the following filing, notice of a petition relating to a conditions: definition and standard of identity (a) If intended for investigational use shall also be published within that in vitro or in laboratory research ani- time limitation if it includes a request, mals, it bears a label which states so designated, for the establishment of prominently, in addition to the other a regulation pertaining to a food addi- information required by the act, the tive. warning: (b) If a petition for a definition and standard of identity contains a pro- Caution. Contains a new food additive for investigational use only in laboratory re- posal for a food-additive regulation, search animals or for tests in vitro. Not for and the petitioner fails to designate it use in humans. as such, the Commissioner, upon deter- mining that the petition includes a (b) If intended for use in animals proposal for a food-additive regulation, other than laboratory research animals shall so notify the petitioner and shall and if the edible products of the ani- thereafter proceed in accordance with mals are to be marketed as food, per- the regulations in this part. mission for the marketing of the edible (c) A regulation will not be issued al- products as food has been requested by lowing the use of a food additive in a the sponsor, and authorization has food for which a definition and stand- been granted by the Food and Drug Ad- ard of identity is established, unless its ministration in accordance with § 511.1 issuance is in conformity with section of this chapter or by the Department of 401 of the Act or with the terms of a Agriculture in accordance with 9 CFR temporary permit issued under § 130.17 309.17, and it bears a label which states of this chapter. When the contemplated prominently, in addition to the other use of such additive complies with the information required by the Act, the terms of a temporary permit, the food warning:

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Caution. Contains a new food additive for (2) Divide the quantity of each res- use only in investigational animals. Not for idue by the tolerance that would apply use in humans. if it occurred alone, and multiply by Edible products of investigational animals are not to be used for food unless authoriza- 100 to determine the percentage of the tion has been granted by the U.S. Food and permitted amount of residue present. Drug Administration or by the U.S. Depart- (3) Add the percentages so obtained ment of Agriculture. for all residues present. (c) If intended for nonclinical labora- (4) The sum of the percentage shall tory studies in food-producing animals, not exceed 100 percent. the study is conducted in compliance with the regulations set forth in part 58 § 170.19 Pesticide chemicals in proc- of this chapter. essed foods. [42 FR 14483, Mar. 15, 1977, as amended at 43 When pesticide chemical residues FR 60021, Dec. 22, 1978] occur in processed foods due to the use of raw agricultural commodities that § 170.18 Tolerances for related food ad- bore or contained a pesticide chemical ditives. in conformity with an exemption (a) Food additives that cause similar granted or a tolerance prescribed under or related pharmacological effects will section 408 of the Act, the processed be regarded as a class, and in the ab- food will not be regarded as adulter- sence of evidence to the contrary, as ated so long as good manufacturing having additive toxic effects and will practice has been followed in removing be considered as related food additives. any residue from the raw agricultural (b) Tolerances established for such commodity in the processing (such as related food additives may limit the by peeling or washing) and so long as amount of a common component that the concentration of the residue in the may be present, or may limit the processed food when ready to eat is not amount of biological activity (such as greater than the tolerance prescribed cholinesterase inhibition) that may be for the raw agricultural commodity. present or may limit the total amount But when the concentration of residue of related food additives that may be in the processed food when ready to eat present. is higher than the tolerance prescribed (c) Where food additives from two or more chemicals in the same class are for the raw agricultural commodity, present in or on a food, the tolerance the processed food is adulterated unless for the total of such additives shall be the higher concentration is permitted the same as that for the additive hav- by a tolerance obtained under section ing the lowest numerical tolerance in 409 of the Act. For example, if fruit this class, unless there are available bearing a residue of 7 parts per million methods that permit quantitative de- of DDT permitted on the raw agricul- termination of the amount of each food tural commodity is dried and a residue additive present or unless it is shown in excess of 7 parts per million of DDT that a higher tolerance is reasonably results on the dried fruit, the dehy- required for the combined additives to drated fruit is adulterated unless the accomplish the physical or technical higher tolerance for DDT is authorized effect for which such combined addi- by the regulations in this part. Food tives are intended and that the higher that is itself ready to eat, and which tolerance will be safe. contains a higher residue than allowed (d) Where residues from two or more for the raw agricultural commodity, additives in the same class are present may not be legalized by blending or in or on a food and there are available mixing with other foods to reduce the methods that permit quantitative de- residue in the mixed food below the tol- termination of each residue, the quan- erance prescribed for the raw agricul- tity of combined residues that are tural commodity. within the tolerance may be deter- mined as follows: (1) Determine the quantity of each residue present.

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Subpart B—Food Additive Safety tation data to man of 100 to 1, will be used; that is, a food additive for use by § 170.20 General principles for evalu- man will not be granted a tolerance ating the safety of food additives. that will exceed 1⁄100th of the maximum (a) In reaching a decision on any pe- amount demonstrated to be without tition filed under section 409 of the harm to experimental animals. Act, the Commissioner will give full consideration to the specific biological § 170.30 Eligibility for classification as properties of the compound and the generally recognized as safe adequacy of the methods employed to (GRAS). demonstrate safety for the proposed (a) General recognition of safety may use, and the Commissioner will be be based only on the views of experts guided by the principles and procedures qualified by scientific training and ex- for establishing the safety of food addi- perience to evaluate the safety of sub- tives stated in current publications of stances directly or indirectly added to the National Academy of Sciences-Na- food. The basis of such views may be ei- tional Research Council. A petition ther (1) scientific procedures or (2) in will not be denied, however, by reason the case of a substance used in food of the petitioner’s having followed pro- prior to January 1, 1958, through expe- cedures other than those outlined in rience based on common use in food. the publications of the National Acad- General recognition of safety requires emy of Sciences-National Research common knowledge throughout the sci- Council if, from available evidence, the entific community knowledgeable Commissioner finds that the proce- about the safety of substances directly dures used give results as reliable as, or indirectly added to food that there or more reliable than, those reasonably is reasonable certainty that the sub- to be expected from the use of the out- stance is not harmful under the condi- lined procedures. In reaching a deci- tions of its intended use (see § 170.3(i)). sion, the Commissioner will give due (b) General recognition of safety weight to the anticipated levels and based upon scientific procedures shall patterns of consumption of the additive specified or reasonably inferrable. For require the same quantity and quality the purposes of this section, the prin- of scientific evidence as is required to ciples for evaluating safety of additives obtain approval of a food additive. Gen- set forth in the abovementioned publi- eral recognition of safety through sci- cations will apply to any substance entific procedures shall be based upon that may properly be classified as a the application of generally available food additive as defined in section and accepted scientific data, informa- 201(s) of the Act. tion, or methods, which ordinarily are (b) Upon written request describing published, as well as the application of the proposed use of an additive and the scientific principles, and may be cor- proposed experiments to determine its roborated by the application of unpub- safety, the Commissioner will advise a lished scientific data, information, or person who wishes to establish the methods. safety of a food additive whether he be- (c)(1) General recognition of safety lieves the experiments planned will through experience based on common yield data adequate for an evaluation use in food prior to January 1, 1958, of the safety of the additive. may be achieved without the quantity or quality of scientific procedures re- § 170.22 Safety factors to be consid- quired for approval of a food additive. ered. General recognition of safety through In accordance with section experience based on common use in 409(c)(5)(C) of the Act, the following food prior to January 1, 1958, shall be safety factors will be applied in deter- based solely on food use of the sub- mining whether the proposed use of a stance prior to January 1, 1958, and food additive will be safe: Except where shall ordinarily be based upon gen- evidence is submitted which justifies erally available data and information. use of a different safety factor, a safety An ingredient not in common use in factor in applying animal experimen- food prior to January 1, 1958, may

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achieve general recognition of safety GRAS without specific inclusion in only through scientific procedures. part 182, part 184 or part 186 of this (2) A substance used in food prior to chapter. January 1, 1958, may be generally rec- (e) Food ingredients were listed as ognized as safe through experience GRAS in part 182 of this chapter during based on its common use in food when 1958–1962 without a detailed scientific that use occurred exclusively or pri- review of all available data and infor- marily outside of the United States if mation relating to their safety. Begin- the information about the experience ning in 1969, the Food and Drug Admin- establishes that the substance is safe istration has undertaken a systematic under the conditions of its intended use review of the status of all ingredients within the meaning of section 201(u) of used in food based on the view that the Federal Food, Drug, and Cosmetic they are GRAS under the conditions of Act (see also § 170.3(i)). Common use in their intended use or subject to a prior food prior to January 1, 1958, that oc- sanction. All affirmations of GRAS sta- curred outside of the United States tus or determinations of food additive shall be documented by published or status or prior sanction status pursu- other information and shall be corrobo- ant to this review shall be handled pur- rated by information from a second, suant to §§ 170.35, 170.38, and 180.1 of independent source that confirms the this chapter. Affirmation of GRAS sta- history and circumstances of use of the tus shall be announced in part 184 or substance. The information used to part 186 of this chapter. document and to corroborate the his- (f) [Reserved] tory and circumstances of use of the (h) A food ingredient that is listed as substance must be generally available; GRAS in part 182 of this chapter or af- that is, it must be widely available in firmed as GRAS in part 184 or part 186 the country in which the history of use of this chapter shall be regarded as has occurred and readily available to GRAS only if, in addition to all the re- interested qualified experts in the quirements in the applicable regula- United States. A person who concludes that a use of a substance is GRAS tion, it also meets all of the following through experience based on its com- requirements: mon use in food outside of the United (1) It complies with any applicable States should notify FDA of that view food grade specifications of the Food in accordance with subpart E of this Chemicals Codex, 2d Ed. (1972), or, if part. specifically indicated in the GRAS af- (d) The food ingredients listed as firmation regulation, the Food Chemi- GRAS in part 182 of this chapter or af- cals Codex, 3d Ed. (1981), which are in- firmed as GRAS in part 184 or part 186 corporated by reference, except that of this chapter do not include all sub- any substance used as a component of stances that are generally recognized articles that contact food and affirmed as safe for their intended use in food. as GRAS in part 186 of this chapter Because of the large number of sub- shall comply with the specifications stances the intended use of which re- therein, or in the absence of such speci- sults or may reasonably be expected to fications, shall be of a purity suitable result, directly or indirectly, in their for its intended use. Copies may be ob- becoming a component or otherwise af- tained from the National Academy fecting the characteristics of food, it is Press, 2101 Constitution Ave. NW., impracticable to list all such sub- Washington, DC 20418, or at the Na- stances that are GRAS. A food ingre- tional Archives and Records Adminis- dient of natural biological origin that tration (NARA). For information on has been widely consumed for its nutri- the availability of this material at ent properties in the United States NARA, call 202–741–6030, or go to: http:// prior to January 1, 1958, without known www.archives.gov/federallregister/ detrimental effects, which is subject codeloflfederallregulations/ only to conventional processing as ibrllocations.html. practiced prior to January 1, 1958, and (2) It performs an appropriate func- for which no known safety hazard ex- tion in the food or food-contact article ists, will ordinarily be regarded as in which it is used.

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(3) It is used at a level no higher than § 170.35 Affirmation of generally recog- necessary to achieve its intended pur- nized as safe (GRAS) status. pose in that food or, if used as a compo- (a) The Commissioner, on his own nent of a food-contact article, at a initiative, may affirm that a substance level no higher than necessary to that directly or indirectly becomes a achieve its intended purpose in that ar- component of food is GRAS under the ticle. conditions of its intended use. (i) If a substance is affirmed as GRAS (b)(1) If the Commissioner proposes in part 184 or part 186 of this chapter on his own initiative that a substance with no limitation other than good is entitled to affirmation as GRAS manufacturing practice, it shall be re- under the conditions of its intended garded as GRAS if its conditions of use use, he will place all of the data and in- are not significantly different from formation on which he relies on public those reported in the regulation as the file in the office of the Division of basis on which the GRAS status of the Dockets Management and will publish substance was affirmed. If the condi- in the FEDERAL REGISTER a notice giv- tions of use are significantly different, ing the name of the substance, its pro- such use of the substance may not be posed uses, and any limitations pro- GRAS. In such a case a manufacturer posed for purposes other than safety. may not rely on the regulation as au- (2) The FEDERAL REGISTER notice will thorizing the use but must independ- allow a of 60 days during which ently establish that the use is GRAS or any interested person may review the must use the substance in accordance data and information and/or file com- with a food additive regulation. ments with the Division of Dockets (j) If an ingredient is affirmed as Management. Copies of all comments GRAS in part 184 or part 186 of this received shall be made available for ex- chapter with specific limitation(s), it amination in the Division of Dockets may be used in food only within such Management’s office. limitation(s) (including the category of (3) The Commissioner will evaluate food(s), the functional use(s) of the in- all comments received. If he concludes gredient, and the level(s) of use). Any that there is convincing evidence that use of such an ingredient not in full the substance is GRAS under the con- compliance with each such established ditions of its intended use as described limitation shall require a food additive in § 170.30, he will publish a notice in regulation. the FEDERAL REGISTER listing the (k) Pursuant to § 170.35, a food ingre- GRAS conditions of use of the sub- dient may be affirmed as GRAS in part stance in part 184 or part 186 of this 184 or part 186 of this chapter for a spe- chapter, as appropriate. cific use(s) without a general evalua- (4) If, after evaluation of the com- tion of use of the ingredient. In addi- ments, the Commissioner concludes tion to the use(s) specified in the regu- that there is a lack of convincing evi- lation, other uses of such an ingredient dence that a substance is GRAS under may also be GRAS. Any affirmation of the conditions of its intended use and GRAS status for a specific use(s), with- that it should be considered a food ad- out a general evaluation of use of the ditive subject to section 409 of the Fed- ingredient, is subject to reconsider- eral Food, Drug, and Cosmetic Act, he ation upon such evaluation. shall publish a notice thereof in the (l) New information may at any time FEDERAL REGISTER in accordance with require reconsideration of the GRAS § 170.38. status of a food ingredient. Any change to the GRAS status of a food ingre- (Information collection requirements were approved by the Office of Management and dient in parts 182, 184, or 186 of this Budget under control number 0910–0132) chapter shall be accomplished pursuant to § 170.38. [42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, [42 FR 14483, Mar. 15, 1977, as amended at 49 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 81 FR 1988; 81 FR 55047, Aug. 17, 2016] 55048, Aug. 17, 2016]

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§ 170.38 Determination of food addi- (2) It may promulgate an interim tive status. food additive regulation governing use (a) The Commissioner may, in ac- of the additive. cordance with § 170.35(b)(4), publish a (3) It may require discontinuation of notice in the FEDERAL REGISTER deter- the use of the additive. mining that a substance is not GRAS (4) It may adopt any combination of under the conditions of its intended use the above three approaches for dif- and is a food additive subject to section ferent uses or levels of use of the addi- 409 of the Federal Food, Drug, and Cos- tive. metic Act. (d) If the Commissioner of Food and (b)(1) The Commissioner, on his own Drugs is aware of any prior sanction initiative or on the petition of any in- for use of the substance, he will con- terested person, pursuant to part 10 of currently propose a separate regulation this chapter, may issue a notice in the covering such use of the ingredient FEDERAL REGISTER proposing to deter- under part 181 of this chapter. If the mine that a substance is not GRAS and Commissioner is unaware of any such is a food additive subject to section 409 applicable prior sanction, the proposed of the Act. Any petition shall include regulation will so state and will re- all relevant data and information of quire any person who intends to assert the type described in § 171.130(b). The or rely on such sanction to submit Commissioner will place all of the data proof of its existence. Any regulation and information on which he relies on promulgated pursuant to this section public file in the office of the Division constitutes a determination that ex- of Dockets Management and will in- cluded uses would result in adultera- clude in the FEDERAL REGISTER notice tion of the food in violation of section the name of the substance, its known 402 of the Act, and the failure of any uses, and a summary of the basis for person to come forward with proof of the determination. such an applicable prior sanction in re- (2) The FEDERAL REGISTER notice will sponse to the proposal will constitute a allow a period of 60 days during which waiver of the right to assert or rely on any interested person may review the such sanction at any later time. The data and information and/or file com- notice will also constitute a proposal ments with the Division of Dockets to establish a regulation under part 181 Management. Copies of all comments of this chapter, incorporating the same shall be made available for examina- provisions, in the event that such a tion in the Division of Dockets Man- regulation is determined to be appro- agement’s office. priate as a result of submission of proof (3) The Commissioner will evaluate of such an applicable prior sanction in all comments received. If he concludes response to the proposal. that there is a lack of convincing evi- dence that the substance is GRAS or is [42 FR 14488, Mar. 15, 1977, as amended at 42 otherwise exempt from the definition FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, of a food additive in section 201(s) of 1989; 81 FR 55048, Aug. 17, 2016] the Act, he will publish a notice there- of in the FEDERAL REGISTER. If he con- § 170.39 Threshold of regulation for cludes that there is convincing evi- substances used in food-contact ar- ticles. dence that the substance is GRAS, he will publish an order in the FEDERAL (a) A substance used in a food-con- REGISTER listing the substance as tact article (e.g., food-packaging or GRAS in part 182, part 184, or part 186 food-processing equipment) that mi- of this chapter, as appropriate. grates, or that may be expected to mi- (c) A FEDERAL REGISTER notice deter- grate, into food will be exempted from mining that a substance is a food addi- regulation as a food additive because it tive shall provide for the use of the ad- becomes a component of food at levels ditive in food or food contact surfaces that are below the threshold of regula- as follows: tion if: (1) It may promulgate a food additive (1) The substance has not been shown regulation governing use of the addi- to be a carcinogen in humans or ani- tive. mals, and there is no reason, based on

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the chemical structure of the sub- substance from regulation as a food ad- stance, to suspect that the substance is ditive shall include three copies of the a carcinogen. The substance must also following information (If part of the not contain a carcinogenic impurity or, submitted material is in a foreign lan- if it does, must not contain a carcino- guage, it must be accompanied by an genic impurity with a TD50 value based English translation verified to be com- on chronic feeding studies reported in plete and accurate in accordance with the scientific literature or otherwise § 10.20(c)(2) of this chapter): available to the Food and Drug Admin- (1) The chemical composition of the istration of less than 6.25 milligrams substance for which the request is per kilogram bodyweight per day (The made, including, whenever possible, TD50, for the purposes of this section, is the name of the chemical in accord- the feeding dose that causes cancer in ance with current Chemical Abstract 50 percent of the test animals when Service (CAS) nomenclature guidelines corrected for tumors found in control and a CAS registry number, if avail- animals. If more than one TD50 value able; has been reported in the scientific lit- (2) Detailed information on the con- erature for a substance, the Food and ditions of use of the substance (e.g., Drug Administration will use the low- temperature, type of food with which est appropriate TD50 value in its re- the substance will come into contact, view.); the duration of the contact, and wheth- (2) The substance presents no other er the food-contact article will be for health or safety concerns because: repeated or single use applications); (i) The use in question has been (3) A clear statement as to whether shown to result in or may be expected the request for exemption from regula- to result in dietary concentrations at tion as a food additive is based on the or below 0.5 parts per billion, cor- fact that the use of the substance in responding to dietary exposure levels the food-contact article results in a di- at or below 1.5 micrograms/person/day etary concentration at or below 0.5 (based on a diet of 1,500 grams of parts per billion, or on the fact that it food and 1,500 grams of liquid food per involves the use of a regulated direct person per day); or food additive for which the dietary ex- (ii) The substance is currently regu- posure is at or below 1 percent of the lated for direct addition into food, and acceptable dietary intake (ADI); the dietary exposure to the substance (4) Data that will enable the Food resulting from the proposed use is at or and Drug Administration to estimate below 1 percent of the acceptable daily the daily dietary concentration result- intake as determined by safety data in ing from the proposed use of the sub- the Food and Drug Administration’s stance. These data should be in the files or from other appropriate sources; form of: (3) The substance has no technical ef- (i) Validated migration data obtained fect in or on the food to which it mi- under worst-case (time/temperature) grates; and intended use conditions utilizing ap- (4) The substance use has no signifi- propriate food simulating solvents; cant adverse impact on the environ- (ii) Information on the amount of the ment. substance used in the manufacture of (b) Notwithstanding paragraph (a) of the food-contact article; or this section, the Food and Drug Admin- (iii) Information on the residual level istration reserves the right to decline of the substance in the food-contact ar- to grant an exemption in those cases in ticle. For repeat-use articles, an esti- which available information estab- mate of the amount of food that con- lishes that the proposed use may pose a tacts a specific unit of surface area public health risk. The reasons for the over the lifetime of the article should agency’s decision to decline to grant an also be provided. (In cases where data exemption will be explained in the are provided only in the form of manu- Food and Drug Administration’s re- facturing use levels or residual levels sponse to the requestor. of the substance present in the food- (c) A request for the Food and Drug contact article, the Food and Drug Ad- Administration to exempt a use of a ministration will calculate a worst-

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case dietary concentration level as- Administration will maintain a list of suming 100 percent migration.) A de- substances exempted from regulation tailed description of the analytical as food additives under this section on method used to quantify the substance display at the Division of Dockets should also be submitted along with Management. This list will include the data used to validate the detection name of the company that made the re- limit. quest, the chemical name of the sub- (iv) In cases where there is no detect- stance, the specific use for which it has able migration into food or food received an exemption from regulation simulants, or when no residual level of as a food additive, and any appropriate a substance is detected in the food-con- limitations on its use. The list will not tact article by a suitable analytical include any trade names. This list will method, the Food and Drug Adminis- enable interested persons to see the tration will, for the purposes of esti- types of uses of food-contact materials mating the dietary concentration, con- being exempted under the regulation. sider the validated detection limit of Interested persons may also obtain a the method used to analyze for the sub- copy of the list of exempted substances stance. by contacting the Food and Drug Ad- (5) The results of an analysis of exist- ministration’s Office of Premarket Ap- ing toxicological information on the proval (HFS–200), 5001 Campus Dr., Col- substance and its impurities. This in- lege Park, MD 20740. For actions re- formation on the substance is needed quiring an environmental assessment, to show whether an animal carcinogen the agency’s finding of no significant bioassay has been carried out, or impact and the evidence supporting whether there is some other basis for that finding, contained in the peti- suspecting that the substance is a car- tioner’s environmental assessment, cinogen or potent toxin. This type of also will be available for public inspec- information on the impurities is need- tion at the Division of Dockets Man- ed to show whether any of them are agement in accordance with § 25.51(b)(2) carcinogenic, and, if carcinogenic, of this chapter. Requests for copies of whether their TD50 values are greater releasable information contained in than 6.25 milligrams per kilogram submissions requesting exemptions bodyweight per day in accordance with from the food additive regulations will paragraph (a)(1) of this section. be handled in accordance with the Food (6) Information on the environmental and Drug Administration’s Freedom of impact that would result from the pro- Information Act procedures, as de- posed use of the substance. The request scribed in part 20 of this chapter. In should contain either a claim for cat- particular, data and information that egorical exclusion as specified in § 25.32 fall within the definitions of a trade se- of this chapter or an environmental as- cret or confidential commercial or fi- sessment as specified in § 25.40 of this nancial information are not available chapter. for public disclosure in accordance (d) Data to be reviewed under this with § 20.61(c) of this chapter. section shall be submitted to the Food (f) If the request for an exemption and Drug Administration’s Office of from regulation as a food additive is Premarket Approval (HFS–200), 5001 not granted, the requestor may submit Campus Dr., College Park, MD 20740. a petition to the Food and Drug Ad- (e) The Food and Drug Administra- ministration for reconsideration of the tion will inform the requestor by letter decision in accordance with the provi- whether the specific food-contact ap- sions of § 10.33 of this chapter. plication is exempt from regulation as (g) If the Food and Drug Administra- a food additive or not. Although a sub- tion receives significant new informa- stance that migrates to food at a level tion that raises questions about the di- that results in a dietary concentration etary concentration or the safety of a at or below the threshold of regulation substance that the agency has exempt- will not be the subject of a regulation ed from regulation, the Food and Drug published in the FEDERAL REGISTER Administration may reevaluate the and will not appear in the Code of Fed- substance. If the Food and Drug Ad- eral Regulations, the Food and Drug ministration tentatively concludes

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that the information that is available in the Food and Drug Administration’s about the substance no longer supports guidance documents. an exemption for the use of the food- [60 FR 36595, July 17, 1995, as amended at 62 contact material from the food addi- FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, tive regulations, the agency will notify 2000; 81 FR 49896, July 29, 2016] any persons that requested an exemp- tion for the substance of its tentative Subpart C—Specific Administra- decision. The requestors will be given tive Rulings and Decisions an opportunity to show why the use of the substance should not be regulated § 170.45 Fluorine-containing com- under the food additive provisions of pounds. the act. If the requestors fail to ade- The Commissioner of Food and Drugs quately respond to the new evidence, has concluded that it is in the interest the agency will notify them that - of the public health to limit the addi- ther use of the substance in question tion of to foods (a) for the particular use will require a to that resulting from the fluoridation food additive regulation. This notifica- of public water supplies, (b) to that re- tion will be placed on public display at sulting from the fluoridation of bottled the Division of Dockets Management water within the limitation established as part of the file of uses of substances in § 165.110(d) of this chapter, and (c) to that authorized by regulations (40 CFR exempted from regulation as food addi- part 180) under section 408 of the Act. tives. The Food and Drug Administra- tion recognizes that manufacturers [42 FR 14483, Mar. 15, 1977, as amended at 72 other than those that actually made a FR 10357 Mar. 8, 2007] request for exemption may also be § 170.50 Glycine (aminoacetic acid) in using exempted substances in food-con- food for human consumption. tact articles under conditions of use (a) Heretofore, the Food and Drug (e.g., use levels, temperature, type of Administration has expressed the opin- food contacted, etc.) that are similar to ion in trade correspondence that gly- those for which the exemption was cine is generally recognized as safe for issued. Because only requestors will be certain technical effects in human food notified as part of the revocation proc- when used in accordance with good ess described in this section, the Food manufacturing practice; however: and Drug Administration plans to no- (1) Reports in scientific literature in- tify other manufacturers by means of a dicate that adverse effects were found notice published in the FEDERAL REG- in cases where high levels of glycine ISTER of its decision to revoke an ex- were administered in diets of experi- emption issued for a specific use of a mental animals. substance in a food contact article. (2) Current usage information indi- (h) Guidance documents to assist re- cates that the daily dietary intake of questors in the preparation of submis- glycine by humans may be substan- sions seeking exemptions from the food tially increasing due to changing use additive regulations are available from patterns in food technology. the Food and Drug Administration’s Therefore, the Food and Drug Adminis- Office of Premarket Approval (HFS– tration no longer regards glycine and 200), 5001 Campus Dr., College Park, its salts as generally recognized as safe MD 20740. Interested persons are en- for use in human food and all out- couraged to obtain specific guidance standing letters expressing sanction for from the Food and Drug Administra- such use are rescinded. tion on the appropriate protocols to be (b) The Commissioner of Food and used for obtaining migration data, on Drugs concludes that by May 8, 1971, the validation of the analytical meth- manufacturers: ods used to quantify migration levels, (1) Shall reformulate food products on the procedures used to relate migra- for human use to eliminate added gly- tion data to dietary exposures, and on cine and its salts; or (2) Shall bring such products into any other issue not specifically covered compliance with an authorizing food

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additive regulation. A food additive pe- Subpart D—Premarket tition supported by toxicity data is re- Notifications quired to show that any proposed level of glycine or its salts added to foods for SOURCE: 67 FR 35729, May 21, 2002, unless human consumption will be safe. otherwise noted. (c) The status of glycine as generally recognized as safe for use in animal § 170.100 Submission of a premarket feed, as prescribed in § 582.5049 of this notification for a food contact sub- chapter, remains unchanged because stance (FCN) to the Food and Drug Administration (FDA). the additive is considered an essential nutrient in certain animal feeds and is (a) An FCN is effective for the food safe for such use under conditions of contact substance manufactured or good feeding practice. prepared by the manufacturer or sup- plier identified in the FCN submission. § 170.60 Nitrites and/or nitrates in cur- If another manufacturer or supplier ing premixes. wishes to market the same food con- tact substance for the same use, that (a) Nitrites and/or nitrates are food manufacturer or supplier must also additives when combined in curing pre- submit an FCN to FDA. mixes with spices and/or other fla- (1) An FCN must contain all of the voring or seasoning ingredients that information described in § 170.101. contain or constitute a source of sec- (2) An FCN may incorporate by ref- ondary or tertiary amines, including erence any information in FDA’s files but not limited to essential oils, diso- provided that the manufacturer or sup- dium inosinate, disodium guanylate, plier is authorized to reference the in- hydrolysates of animal or plant origin formation. The FCN must include in- (such as hydrolyzed vegetable protein), formation establishing that the manu- oleoresins of spices, soy products, and facturer or supplier is authorized to extractives. Such food additives reference information in FDA’s files. may be used only after the establish- (3) Any material submitted in or ref- ment of an authorizing food additive erenced by an FCN that is in a foreign regulation. A food additive petition language must be accompanied by an submitted pursuant to §§ 171.1 and English translation verified to be com- 171.100 of this chapter, supported by plete and accurate. data demonstrating that nitrosamines (b) FDA may choose not to accept an are not formed in curing premixes con- FCN for either of the following: taining such food additives, is required (1) A use of a food contact substance to establish safety. that is the subject of a regulation in (b) Nitrites and/or nitrates, when parts 173 through 189 of this chapter; or packaged separately from flavoring (2) A use of a food contact substance that is the subject of an exemption and seasoning in curing premixes, may under the threshold of regulation proc- continue to be used under prior sanc- ess described in § 170.39. tions in the commercial curing of meat (c) A petition must be submitted and meat products and poultry prod- under § 171.1 of this chapter to author- ucts and in accordance with the provi- ize the safe use of a food contact sub- sions of §§ 172.170 and 172.175 of this stance in either of the following cir- chapter that apply to meat curing cumstances, unless FDA agrees to ac- preparations for the home curing of cept an FCN for the proposed use. meat and meat products, including (1) The use of the food contact sub- poultry and wild game. To assure safe stance increases the cumulative die- use of such ingredients the labeling of tary concentration to a certain level. the premixes shall bear instructions to For a substance that is a biocide (e.g., the user that such separately packaged it is intended to exert microbial tox- ingredients are not to be combined icity), this level is equal to or greater until just prior to use. Encapsulating than 200 parts per billion in the daily or coating some or all of the ingredi- diet (0.6 milligram (mg)/person/day). ents does not constitute separate pack- For a substance that is not a biocide, aging. this level is equal to or greater than 1

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part per million in the daily diet (3 mg/ and Drug Administration (FDA), and person/day); or the report and signed certification of (2) There exists a bioassay on the the validating party must be submitted food contact substance, FDA has not as part of the notification. reviewed the bioassay, and the bio- (d) Information to address FDA’s re- assay is not clearly negative for car- sponsibility under the National Envi- cinogenic effects. ronmental Policy Act, in the form of (d) A manufacturer or supplier for either: which a notification is effective must (1) A claim of categorical exclusion keep a current address on file with under § 25.30 or § 25.32 of this chapter; or FDA. (2) An environmental assessment (1) The current address may be either complying with § 25.40 of this chapter. the manufacturer’s (or supplier’s) ad- (e) A completed and signed FDA dress or the address of the manufactur- Form No. 3480. er’s (or supplier’s) agent. (2) FDA will deliver correspondence § 170.102 Confidentiality of informa- to the manufacturer’s or supplier’s cur- tion in a premarket notification for rent address. a food contact substance (FCN). (a) During the 120-day period of the § 170.101 Information in a premarket Food and Drug Administration (FDA) notification for a food contact sub- review of an FCN, FDA will not dis- stance (FCN). close publicly any information in that An FCN must contain the following: FCN. (a) A comprehensive discussion of the (b) FDA will not disclose publicly the basis for the manufacturer’s or sup- information in an FCN that is with- plier’s determination that the use of drawn prior to the completion of FDA’s the food contact substance is safe. This review. discussion must: (c) Once FDA completes its review of (1) Discuss all information and data an FCN, the agency will make its con- submitted in the notification; and clusion about the FCN publicly avail- (2) Address any information and data able. For example, if FDA objects to a that may appear to be inconsistent notification 90 days after the date of with the determination that the pro- receipt, the agency would make avail- posed use of the food contact substance able its objection at that time. is safe. (d) By submitting an FCN to FDA, (b) All data and other information the manufacturer or supplier waives that form the basis of the determina- any claim to confidentiality of the in- tion that the food contact substance is formation required to adequately de- safe under the intended conditions of scribe the food contact substance and use. Data must include primary bio- the intended conditions of use that are logical data and chemical data. the subject of that FCN. (c) A good laboratory practice state- (e) The following data and informa- ment for each nonclinical laboratory tion in an FCN are available for public study, as defined under § 58.3(d) of this disclosure, unless extraordinary cir- chapter, that is submitted as part of cumstances are shown, on the 121st day the FCN, in the form of either: after receipt of the notification by (1) A signed statement that the study FDA, except that no data or informa- was conducted in compliance with the tion are available for public disclosure good laboratory practice regulations if the FCN is withdrawn under § 170.103. under part 58 of this chapter; or (1) All safety and functionality data (2) A brief signed statement listing and information submitted with or in- the reason(s) that the study was not corporated by reference into the notifi- conducted in compliance with part 58 cation. Safety and functionality data of this chapter. include all studies and tests of a food (3) Data from any study conducted contact substance on animals and hu- after 1978 but not conducted in compli- mans and all studies and tests on a ance with part 58 of this chapter must food contact substance for establishing be validated by an independent third identity, stability, purity, potency, party prior to submission to the Food performance, and usefulness.

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(2) A protocol for a test or study, un- (2) If FDA accepts an FCN, then FDA less it is exempt from disclosure under will acknowledge in writing its receipt § 20.61 of this chapter. of that FCN. (3) A list of all ingredients contained (c) Objection to an FCN: in a food contact substance, excluding (1) If FDA objects to an FCN, then information that is exempt from dis- FDA will send an FCN objection letter. closure under § 20.61 of this chapter. The date of the letter will be the date Where applicable, an ingredient list of FDA’s objection for purposes of sec- will be identified as incomplete. tion 409(h)(2)(A) of the act. (2) If FDA objects to an FCN within (4) An assay method or other analyt- the 120-day period for FDA review, the ical method, unless it serves no regu- FCN will not become effective. latory or compliance purpose and is ex- (3) FDA may object to an FCN if any empt from disclosure under § 20.61 of part of FDA’s 120-day review occurs this chapter. during a period when this program is (5) All correspondence and written not funded as required in section summaries of oral discussions relating 409(h)(5) of the act. to the notification, except information (d) If FDA and a manufacturer or that is exempt for disclosure under supplier agree that the notifier may § 20.61 of this chapter. submit a food additive petition pro- (6) All other information not subject posing the approval of the food contact to an exemption from disclosure under substance for the use in the manufac- subpart D of part 20 of this chapter. turer’s or supplier’s FCN, FDA will consider that FCN to be withdrawn by § 170.103 Withdrawal without preju- the manufacturer or supplier on the dice of a premarket notification for date the petition is received by FDA. a food contact substance (FCN). § 170.105 The Food and Drug Adminis- A manufacturer or supplier may tration’s (FDA’s) determination that withdraw an FCN without prejudice to a premarket notification for a food a future submission to the Food and contact substance (FCN) is no Drug Administration (FDA) if FDA has longer effective. not completed review of the FCN. For (a) If data or other information avail- the purpose of this section, FDA’s re- able to FDA, including data not sub- view is completed when FDA has al- mitted by the manufacturer or sup- lowed 120 days to pass without object- plier, demonstrate that the intended ing to the FCN or FDA has issued an use of the food contact substance is no objection letter. longer safe, FDA may determine that the authorizing FCN is no longer effec- § 170.104 Action on a premarket notifi- tive. cation for a food contact substance (b) If FDA determines that an FCN is (FCN). no longer effective, FDA will inform (a) If the Food and Drug Administra- the manufacturer or supplier in writing tion (FDA) does not object to an FCN of the basis for that determination. FDA will give the manufacturer or sup- within the 120-day period for FDA re- plier an opportunity to show why the view, the FCN becomes effective. FCN should continue to be effective (b) If an FCN is complete when re- and will specify the time that the man- ceived, the 120-day review period begins ufacturer or supplier will have to re- on the date FDA receives the FCN. spond. (1) If any element required under (c) If the manufacturer or supplier § 170.101 is missing from an FCN, then fails to respond adequately to the safe- FDA will not accept that FCN and FDA ty concerns regarding the notified use, will send an FCN nonacceptance letter FDA will publish a notice of its deter- to the manufacturer or supplier. If the mination that the FCN is no longer ef- manufacturer or supplier submits the fective. FDA will publish this notice in missing information before FDA sends the FEDERAL REGISTER, stating that a an FCN nonacceptance letter, the 120- detailed summary of the basis for day review period begins on the date of FDA’s determination that the FCN is receipt of the missing information. no longer effective has been placed on

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public display and that copies are your conclusion that the substance is available upon request. The date that GRAS under the conditions of its in- the notice publishes in the FEDERAL tended use in accordance with § 170.30. REGISTER is the date on which the noti- Notified substance means the sub- fication is no longer effective. stance that is the subject of your (d) FDA’s determination that an FCN GRAS notice. is no longer effective is final agency Notifier means the person (e.g., an in- action subject to judicial review. dividual, partnership, corporation, as- § 170.106 Notification for a food con- sociation, or other legal entity) who is tact substance formulation responsible for the GRAS notice, even (NFCSF). if another person (such as an attorney, (a) In order for the Food and Drug agent, or qualified expert) prepares or Administration (FDA) to accept an submits the notice or provides an opin- NFCSF, any food additive that is a ion about the basis for a conclusion of component of the formulation must be GRAS status. authorized for its intended use in that Qualified expert means an individual NFCSF. who is qualified by scientific training (b) FDA may publish a notice in the and experience to evaluate the safety FEDERAL REGISTER stating that the of substances under the conditions of agency has insufficient resources to re- their intended use in food. view NFCSFs. From the date that this Supplement means any data and infor- notice publishes in the FEDERAL REG- mation that you submit regarding a ISTER, FDA will no longer accept filed GRAS notice after we respond to NFCSFs. your notice by letter in accordance (c) An NFCSF must contain the fol- with § 170.265(b)(1) or cease to evaluate lowing: your notice in accordance with (1) A completed and signed FDA § 170.265(b)(3). Form No. 3479; and We, our, and us refer to the United (2) Any additional documentation re- States Food and Drug Administration quired to establish that each compo- (FDA). nent of the formulation already may be You and your refer to a notifier. marketed legally for its intended use. § 170.205 Opportunity to submit a Subpart E—Generally Recognized GRAS notice. as Safe (GRAS) Notice Any person may notify FDA of a view that a substance is not subject to the SOURCE: 81 FR 55048, Aug. 17, 2016, unless premarket approval requirements of otherwise noted. section 409 of the Federal Food, Drug, § 170.203 Definitions. and Cosmetic Act based on that per- son’s conclusion that the substance is The definitions and interpretations GRAS under the conditions of its in- of terms in § 170.3 apply to such terms tended use. when used in this subpart. The fol- lowing definitions also apply: § 170.210 How to send your GRAS no- Amendment means any data and infor- tice to FDA. mation that you submit regarding a filed GRAS notice before we respond to (a) Send your GRAS notice to the Of- your notice by letter in accordance fice of Food Additive Safety (HFS–200), with § 170.265(b)(1) or cease to evaluate Center for Food Safety and Applied Nu- your notice in accordance with trition, Food and Drug Administration, § 170.265(b)(3). 5001 Campus Dr., College Park, MD GRAS means generally recognized as 20740. safe. (b) When you submit your GRAS no- GRAS notice means a submission that tice, you may do so either in an elec- informs us of your view that a sub- tronic format that is accessible for our stance is not subject to the premarket evaluation or on paper. If you send approval requirements of the Federal your GRAS notice on paper, a single Food, Drug, and Cosmetic Act based on paper copy is sufficient.

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§ 170.215 Incorporation into a GRAS population expected to consume the notice. notified substance; You may incorporate into your (5) Inform us of the statutory basis GRAS notice either specifically identi- for your conclusion of GRAS status fied data and information that you pre- (i.e., through scientific procedures in viously submitted to the Center for accordance with § 170.30(a) and (b) or Food Safety and Applied Nutrition through experience based on common (CFSAN), or specifically identified pub- use in food in accordance with licly available data and information § 170.30(a) and (c)); submitted by another party, when such (6) State your view that the notified data and information remain in substance is not subject to the pre- CFSAN’s records, such as data and in- market approval requirements of the formation contained in a previous Federal Food, Drug, and Cosmetic Act GRAS notice or a food additive peti- based on your conclusion that the noti- tion. fied substance is GRAS under the con- ditions of its intended use; § 170.220 General requirements appli- (7) State that, if we ask to see the cable to a GRAS notice. data and information that are the basis (a) A GRAS notice has seven parts as for your conclusion of GRAS status, ei- required by §§ 170.225 through 170.255. ther during or after our evaluation of You must submit the data and infor- your notice, you will: mation specified in each of these parts (i) Agree to make the data and infor- on separate pages or sets of pages. mation available to us; and (b) You must include each of the (ii) Agree to both of the following seven parts in your GRAS notice. If procedures for making the data and in- you do not include a part, you must in- formation available to us: clude with your GRAS notice an expla- (A) Upon our request, you will allow nation of why that part does not apply us to review and copy the data and in- to your GRAS notice. formation during customary business hours at the address you specify for § 170.225 Part 1 of a GRAS notice: where these data and information will Signed statements and certification. be available to us; and (a) Part 1 of your GRAS notice must (B) Upon our request, you will pro- be dated and signed by a responsible of- vide us with a complete copy of the ficial of your organization, or by your data and information either in an elec- attorney or agent. tronic format that is accessible for our (b) Except as required by paragraph evaluation or on paper; (c)(8) of this section, you must not in- (8) State your view as to whether any clude any information that is trade se- of the data and information in Parts 2 cret or confidential commercial infor- through 7 of your GRAS notice are ex- mation in Part 1 of your GRAS notice. empt from disclosure under the Free- (c) In Part 1 of your GRAS notice, dom of Information Act, 5 U.S.C. 552 you must: (e.g., as trade secret or as commercial (1) Inform us that you are submitting or financial information that is privi- a GRAS notice in accordance with this leged or confidential). subpart; (9) Certify that, to the best of your (2) Provide the name and address of knowledge, your GRAS notice is a com- your organization; plete, representative, and balanced (3) Provide the name of the notified submission that includes unfavorable substance, using an appropriately de- information, as well as favorable infor- scriptive term; mation, known to you and pertinent to (4) Describe the intended conditions the evaluation of the safety and GRAS of use of the notified substance, includ- status of the use of the substance; ing the foods in which the substance (10) State both the name and position will be used, the levels of use in such or title of the person who signs the foods, and the purposes for which the GRAS notice; and substance will be used, including, when (11) When applicable, state as re- appropriate, a description of a sub- quired by § 170.270 whether you:

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(i) Authorize us to send any trade se- whether your conclusion of GRAS sta- crets to the Food Safety and Inspection tus is through scientific procedures or Service (FSIS) of the U.S. Department through experience based on common of Agriculture; or use in food, as follows: (ii) Ask us to exclude any trade se- (a) You must provide an estimate of crets from the copy of the GRAS notice dietary exposure to the notified sub- that we will send to FSIS. stance that includes exposure from its § 170.230 Part 2 of a GRAS notice: intended use and all sources in the Identity, method of manufacture, diet; and specifications, and physical or tech- (b) When applicable, you must pro- nical effect. vide an estimate of dietary exposure to In Part 2 of your GRAS notice, you any other substance that is expected to must include: be formed in or on food because of the (a) Scientific data and information use of the notified substance (e.g., that identifies the notified substance. hydrolytic products or reaction prod- (1) Examples of appropriate data and ucts); information include the chemical (c) When applicable, you must pro- name, applicable registry numbers vide an estimate of dietary exposure to (such as a Chemical Abstracts Service any other substance that is present (CAS) registry number or an Enzyme with the notified substance either nat- Commission (EC) number), empirical urally or due to its manufacture (e.g., formula, structural formula, quan- contaminants or by-products); titative composition, and char- (d) You must describe the source of acteristic properties. any food consumption data that you (2) When the source of a notified sub- stance is a biological material, you use to estimate dietary exposure in ac- must include data and information suf- cordance with paragraphs (a) through ficient to identify: (c) of this section; and (i) The taxonomic source (e.g., genus, (e) You must explain any assump- species) including, as applicable, data tions you made to estimate dietary ex- and information at the sub-species posure in accordance with paragraphs level (e.g., variety, strain); (a) through (c) of this section. (ii) The part of any plant or animal used as the source; and § 170.240 Part 4 of a GRAS notice: Self- (iii) Any known toxicants that could limiting levels of use. be in the source; In circumstances where the amount (b) A description of the method of of the notified substance that can be manufacture of the notified substance added to food is limited because food in sufficient detail to evaluate the containing levels of the notified sub- safety of the notified substance as stance above a particular level would manufactured; become unpalatable or technologically (c) Specifications for food-grade ma- impractical, in Part 4 of your GRAS terial; and notice you must include data and infor- (d) When necessary to demonstrate mation on such self-limiting levels of safety, relevant data and information bearing on the physical or other tech- use. nical effect the notified substance is § 170.245 Part 5 of a GRAS notice: Ex- intended to produce, including the perience based on common use in quantity of the notified substance re- food before 1958. quired to produce such effect. If the statutory basis for your con- § 170.235 Part 3 of a GRAS notice: Die- clusion of GRAS status is through ex- tary exposure. perience based on common use in food, In part 3 of your GRAS notice, you in Part 5 of your GRAS notice you must provide data and information must include evidence of a substantial about dietary exposure (i.e., the history of consumption of the notified amount of relevant substances that substance for food use by a significant consumers are likely to eat or drink as number of consumers prior to January part of a total diet), regardless of 1, 1958.

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§ 170.250 Part 6 of a GRAS notice: Nar- basis for a conclusion of GRAS status rative. if qualified experts do not have access In Part 6 of your GRAS notice, you to such data and information. must include a narrative that provides the basis for your conclusion of GRAS § 170.255 Part 7 of a GRAS notice: List status, in which: of supporting data and information in your GRAS notice. (a)(1) You must explain why the data and information in your notice provide (a) In part 7 of your GRAS notice, a basis for your view that the notified you must include a list of all of the substance is safe under the conditions data and information that you discuss of its intended use. In your expla- in Part 6 of your GRAS notice to pro- nation, you must address the safety of vide a basis for your view that the no- the notified substance, considering all tified substance is safe under the condi- dietary sources and taking into ac- tions of its intended use as described in count any chemically or pharmacologi- accordance with § 170.250(a)(1). cally related substances in such diet; (b) You must specify which data and (2) In your explanation, you must information that you list in accordance identify what specific data and infor- with paragraph (a) of this section are mation that you discuss in accordance generally available, and which data with paragraph (a)(1) of this section are and information are not generally generally available, and what specific available. data and information that you discuss in accordance with paragraph (a)(1) of § 170.260 Steps you may take before this section are not generally avail- FDA responds to your GRAS notice. able, by providing citations to the list (a) You may submit a timely amend- of data and information that you in- ment to your filed GRAS notice, to up- clude in Part 7 of your GRAS notice in date your GRAS notice or in response accordance with § 170.255; to a question from us, before we re- (b) You must explain how the gen- spond to your notice by letter in ac- erally available data and information cordance with § 170.265(b)(1) or cease to that you rely on to establish safety in evaluate your notice in accordance accordance with paragraph (a) of this with § 170.265(b)(3). section provide a basis for your conclu- (b) At any time before we respond to sion that the notified substance is gen- your GRAS notice in accordance with erally recognized, among qualified ex- § 170.265(b)(1), you may request in writ- perts, to be safe under the conditions of ing that we cease to evaluate your its intended use; (c) You must either: GRAS notice. Your request does not (1) Identify, discuss, and place in con- preclude you from submitting a future text, data and information that are, or GRAS notice in accordance with this may appear to be, inconsistent with subpart with respect to the notified your conclusion of GRAS status, re- substance. gardless of whether those data and in- § 170.265 What FDA will do with a formation are generally available; or GRAS notice. (2) State that you have reviewed the available data and information and are (a)(1) We will conduct an initial eval- not aware of any data and information uation of your submission to determine that are, or may appear to be, incon- whether to file it as a GRAS notice for sistent with your conclusion of GRAS evaluation of your view that the noti- status; fied substance is GRAS under the con- (d) If you view any of the data and in- ditions of its intended use. formation in your notice as exempt (2) If we file your submission as a from disclosure under the Freedom of GRAS notice, we will send you a letter Information Act, you must identify the that informs you of the date of filing. specific data and information; and (3) If we do not file your submission (e) For non-public, safety-related as a GRAS notice, we will send you a data and information considered in letter that informs you of that fact and reaching a conclusion of GRAS status, provides our reasons for not filing the you must explain how there could be a submission as a GRAS notice.

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(4) We will consider any timely in accordance with paragraph (a)(1) of amendment that you submit to a filed this section; and GRAS notice, to update your GRAS no- (c) We will ask FSIS to advise wheth- tice or in response to a question from er the intended conditions of use com- us, before we respond to you by letter ply with applicable statutes and regu- in accordance with paragraph (b)(1) of lations, or, if not, whether the use of this section, if we deem that doing so is the substance would be permitted in feasible within the timeframes estab- products under FSIS’ jurisdiction lished in paragraph (b) of this section. under specified conditions or restric- If we deem that considering your tions. amendment is not feasible within the timeframes established in paragraph (d) As appropriate, we will inform (b) of this section or if we have granted you of the advice we receive from FSIS your request to cease to evaluate your in the letter we send you in accordance notice, we will inform you that we are with § 170.265(b)(1). not considering your amendment. (b)(1) Within 180 days of filing, we § 170.275 Public disclosure of a GRAS will respond to you by letter based on notice. our evaluation of your notice. We may (a) The data and information in a extend the 180 day timeframe by 90 GRAS notice (including data and infor- days on an as needed basis. mation submitted in any amendment (2) If we extend the timeframe, we or supplement to your GRAS notice or will inform you in writing of the exten- incorporated into your GRAS notice) sion as soon as practicable but no later are: than within 180 days of filing. (1) Considered a mandatory, rather (3) If you ask us to cease to evaluate than voluntary, submission for pur- your GRAS notice in accordance with poses of their status under the Free- § 170.260(b), we will send you a letter in- dom of Information Act and our public forming you of our decision regarding information requirements in part 20 of your request. (c) If circumstances warrant, we will this chapter; and send you a subsequent letter about the (2) Available for public disclosure in notice. accordance with part 20 of this chapter as of the date that we receive your § 170.270 Procedures that apply when GRAS notice. the intended conditions of use of a (b) We will make the following read- notified substance include use in a ily accessible to the public: product or products subject to reg- ulation by the Food Safety and In- (1) A list of filed GRAS notices, in- spection Service (FSIS) of the cluding the information described in United States Department of Agri- § 170.225(c)(2) through (c)(5); culture. (2) The text of any letter that we If the intended conditions of use of issue under § 170.265(b)(1) or (c); and the notified substance include use in a (3) The text of any letter that we product or products subject to regula- issue under § 170.265(b)(3) if we grant tion by FSIS under statutes that it ad- your request that we cease to evaluate ministers: your notice. (a) When applicable, you must in- (c) We will disclose all remaining clude in your GRAS notice a statement data and information that are not ex- as to whether you: empt from public disclosure in accord- (1) Authorize us to send any trade se- ance with part 20 of this chapter. crets to FSIS; or (2) Ask us to exclude any trade se- § 170.280 Submission of a supplement. crets from the copy of the GRAS notice that we will send to FSIS. If circumstances warrant, you may (b)(1) We will forward a copy of a submit a supplement to a filed GRAS GRAS notice or relevant portions notice after we respond to your notice thereof to FSIS; by letter in accordance with (2) We will exclude any trade secrets § 170.265(b)(1) or cease to evaluate your unless you have authorized us to do so notice in accordance with § 170.265(b)(3).

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§ 170.285 Disposition of pending GRAS petition shall state petitioner’s post of- affirmation petitions. fice address to which published notices Because the procedure to submit a or orders issued or objections filed pur- GRAS notice is replacing the former suant to section 409 of the Act may be process to submit a GRAS affirmation sent. petition, the following will happen to a (b) Pertinent information may be in- filed GRAS affirmation petition that is corporated in, and will be considered as pending on October 17, 2016. part of, a petition on the basis of spe- (a) On October 17, 2016, we will close cific reference to such information sub- the docket for any GRAS affirmation mitted to and retained in the files of petition that is still pending as of Oc- the Food and Drug Administration. tober 17, 2016. However, any reference to unpublished (b) Any person who submitted a information furnished by a person GRAS affirmation petition described in other than the applicant will not be this section may submit a GRAS notice considered unless use of such informa- as described in this subpart and request tion is authorized in a written state- that we incorporate the GRAS affirma- ment signed by the person who sub- tion petition as described in § 170.215. mitted it. Any reference to published information offered in support of a food additive petition should be accom- PART 171—FOOD ADDITIVE panied by reprints or photostatic cop- PETITIONS ies of such references. (c) Petitions shall include the fol- Subpart A—General Provisions lowing data and be submitted in the Sec. following form: 171.1 Petitions. (Date) 171.6 Amendment of petition. Name of petitioner lllllllllllll 171.7 Withdrawal of petition without preju- Post-office address lllllllllllll dice. Date lllllllllllllllllllll 171.8 Threshold of regulation for substances Name of food additive and proposed use ll used in food-contact articles. llllllllllllllllllllllll Subpart B—Administrative Actions on Office of Food Additive Safety (HFS–200), Applications Center for Food Safety and Applied Nutri- tion, Food and Drug Administration, 5001 171.100 Regulation based on petition. Campus Dr., College Park, MD 20740. 171.102 Effective date of regulation. DEAR SIRS: 171.110 Procedure for objections and hear- The undersigned, lllll submits this ings. petition pursuant to section 409(b)(1) of the 171.130 Procedure for amending and repeal- Federal Food, Drug, and Cosmetic Act with ing tolerances or exemptions from toler- respect to lllll ances. (Name of the food additive and proposed use) AUTHORITY: 21 U.S.C. 321, 342, 348, 371. Attached hereto, in triplicate (quadru- SOURCE: 42 FR 14489, Mar. 15, 1977, unless plicate, if intended uses include use in meat, otherwise noted. meat food product, or poultry product), and constituting a part of this petition are the Subpart A—General Provisions following: A. The name and all pertinent information § 171.1 Petitions. concerning the food additive, including chemical identity and composition of the (a) Petitions to be filed with the food additive, its physical, chemical, and bi- Commissioner under the provisions of ological properties, and specifications pre- section 409(b) of the Federal Food, scribing the minimum content of the desired Drug, and Cosmetic Act (the act) shall component(s) and identifying and limiting be submitted in triplicate (quadru- the reaction byproducts and other impuri- plicate, if intended uses include use in ties. Where such information is not avail- meat, meat food product, or poultry able, a statement as to the reasons why it is not should be submitted. product). If any part of the material When the chemical identity and composi- submitted is in a foreign language, it tion of the food additive is not known, the shall be accompanied by an accurate petition shall contain information in suffi- and complete English translation. The cient detail to permit evaluation regarding

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the method of manufacture and the analyt- technical effect or that it may reasonably be ical controls used during the various stages expected to become a component, or to affect of manufacturing, processing, or packing of the characteristics, directly or indirectly, of the food additive which are relied upon to es- food and the amount necessary to accom- tablish that it is a substance of reproducible plish this. These data should include infor- composition. Alternative methods and con- mation in sufficient detail to permit evalua- trols and variations in methods and controls tion with control data. within reasonable limits that do not affect D. A description of practicable methods to the characteristics of the substance or the determine the amount of the food additive in reliability of the controls may be specified. the raw, processed, and/or finished food and If the food additive is a mixture of chemi- of any substance formed in or on such food cals, the petition shall supply a list of all because of its use. The test proposed shall be substances used in the synthesis, extraction, one that can be used for food-control pur- or other method of preparation, regardless of poses and that can be applied with consistent whether they undergo chemical change in results by any properly equipped and trained the process. Each substance should be identi- laboratory personnel. fied by its common English name and com- E. Full reports of investigations made with plete chemical name, using structural for- respect to the safety of the food additive. mulas when necessary for specific identifica- (A petition may be regarded as incomplete tion. If any proprietary preparation is used unless it includes full reports of adequate as a component, the proprietary name should tests reasonably applicable to show whether be followed by a complete quantitative or not the food additive will be safe for its statement of composition. Reasonable alter- intended use. The reports ordinarily should natives for any listed substance may be spec- include detailed data derived from appro- ified. priate animal and other biological experi- If the petitioner does not himself perform ments in which the methods used and the re- all the manufacturing, processing, and pack- sults obtained are clearly set forth. The peti- ing operations for a food additive, the peti- tion shall not omit without explanation any tion shall identify each person who will per- reports of investigations that would bias an form a part of such operations and designate evaluation of the safety of the food additive.) the part. F. Proposed tolerances for the food addi- The petition shall include stability data, tive, if tolerances are required in order to in- and, if the data indicate that it is needed to sure its safety. A petitioner may include a insure the identity, strength, quality, or pu- proposed regulation. rity of the additive, the expiration date that G. If submitting petition to modify an ex- will be employed. isting regulation issued pursuant to section B. The amount of the food additive pro- 409(c)(1)(A) of the Act, full information on posed for use and the purposes for which it is each proposed change that is to be made in proposed, together with all directions, rec- the original regulation must be submitted. ommendations, and suggestions regarding The petition may omit statements made in the proposed use, as well as specimens of the the original petition concerning which no labeling proposed for the food additive and change is proposed. A supplemental petition any labeling that will be required by applica- must be submitted for any change beyond ble provisions of the Federal Food, Drug, and the variations provided for in the original Cosmetic Act on the finished food by reason petition and the regulation issued on the of the use of the food additive. If the additive basis of the original petition. results or may reasonably be expected to re- H. The petitioner is required to submit ei- sult from the use of packaging material, the ther a claim for categorical exclusion under petitioner shall show how this may occur § 25.30 or 25.32 of this chapter or an environ- and what residues may reasonably be antici- mental assessment under § 25.40 of this chap- pated. ter. (Typewritten or other draft-labeling copy Yours very truly, will be accepted for consideration of the pe- Petitioner llllllllllllllllll tition, provided a statement is made that By llllllllllllllllllllll final printed labeling identical in content to (Indicate authority) the draft copy will be submitted as soon as available and prior to the marketing of the (d) The petitioner will be notified of food additive.) the date on which his petition is filed; (If the food additive is one for which a tol- and an incomplete petition, or one that erance limitation is required to assure its has not been submitted in triplicate, safety, the level of use proposed should be no will usually be retained but not filed as higher than the amount reasonably required a petition under section 409 of the Act. to accomplish the intended physical or other technical effect, even though the safety data The petitioner will be notified in what may support a higher tolerance.) respects his petition is incomplete. C. Data establishing that the food additive (e) The petition must be signed by will have the intended physical or other the petitioner or by his attorney or

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agent, or (if a corporation) by an au- dients shall be deleted from any such thorized official. list prior to public disclosure if it is (f) The data specified under the sev- shown to fall within the exemption es- eral lettered headings should be sub- tablished in § 20.61 of this chapter, and mitted on separate sheets or sets of a notation shall be made that any such sheets, suitably identified. If such data ingredient list is incomplete. have already been submitted with an (v) An assay method or other analyt- earlier application, the present peti- ical method, unless it serves no regu- tion may incorporate it by specific ref- latory or compliance purpose and is erence to the earlier. If part of the data shown to fall within the exemption es- have been submitted by the manufac- tablished in § 20.61 of this chapter. turer of the food additive as a master (2) The following data and informa- file, the petitioner may refer to the tion in a food additive petition are not master file if and to the extent he ob- available for public disclosure unless tains the manufacturer’s written per- they have been previously disclosed to mission to do so. The manufacturer the public as defined in § 20.81 of this may authorize specific reference to the chapter or they relate to a product or data without disclosure to the peti- ingredient that has been abandoned tioner. Nothing herein shall prevent and they no longer represent a trade reference to published data. secret or confidential commercial or fi- (g) A petition shall be retained but nancial information as defined in § 20.61 shall not be filed if any of the data pre- of this chapter: scribed by section 409(b) of the Act are (i) Manufacturing methods or proc- lacking or are not set forth so as to be esses, including quality control proce- readily understood. dures. (h)(1) The following data and infor- (ii) Production, sales, distribution, mation in a food additive petition are and similar data and information, ex- available for public disclosure, unless cept that any compilation of such data extraordinary circumstances are and information aggregated and pre- shown, after the notice of filing of the pared in a way that does not reveal petition is published in the FEDERAL data or information which is not avail- REGISTER or, if the petition is not able for public disclosure under this promptly filed because of deficiencies provision is available for public disclo- in it, after the petitioner is informed sure. that it will not be filed because of the (iii) Quantitative or semiquantita- deficiencies involved: tive formulas. (i) All safety and functionality data (3) All correspondence and written and information submitted with or in- summaries of oral discussions relating corporated by reference in the petition. to a food additive petition are avail- (ii) A protocol for a test or study, un- able for public disclosure in accordance less it is shown to fall within the ex- with the provisions of part 20 of this emption established for trade secrets chapter when the food additive regula- and confidential commercial informa- tion is published in the FEDERAL REG- tion in § 20.61 of this chapter. ISTER. (iii) Adverse reaction reports, prod- (4) For purposes of this regulation, uct experience reports, consumer com- safety and functionality data include plaints, and other similar data and in- all studies and tests of a food additive formation, after deletion of: on animals and humans and all studies (a) Names and any information that and tests on a food additive for iden- would identify the person using the tity, stability, purity, potency, per- product. formance, and usefulness. (b) Names and any information that (i)(1)(i) Within 15 days after receipt, would identify any third party involved the Food and Drug Administration will with the report, such as a physician or notify the petitioner of the acceptance hospital or other institution. or nonacceptance of a petition, and if (iv) A list of all ingredients contained not accepted, the reasons therefor. If in a food additive, whether or not it is accepted, the petitioner will be sent a in descending order of predominance. A letter stating this and the date of the particular ingredient or group of ingre- letter shall become the date of filing

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for the purposes of section 409(b)(5) of food in which the additive is proposed the act. In cases in which the Food and to be used, at any time while a petition Drug Administration agrees that a pre- is under consideration. The Commis- market notification for a food contact sioner shall specify in the request for a substance (Food Contact Notification sample of the food additive, or articles (FCN)) submitted under section 409(h) used as components thereof, or of the of the act may be converted to a peti- food in or on which the additive is pro- tion, the withdrawal date for the FCN posed to be used, a quantity deemed will be deemed the date of receipt for adequate to permit tests of analytical the petition. methods to determine quantities of the (ii) If the petitioner desires, he may food additive present in foods for which supplement a deficient petition after it is intended to be used or adequate being notified regarding deficiencies. If for any study or investigation reason- the supplementary material or expla- ably required with respect to the safety nation of the petition is deemed ac- of the food additive or the physical or ceptable, the petitioner shall be noti- technical effect it produces. The date fied. The date of such notification be- used for computing the 90-day limit for comes the date of filing. If the peti- the purposes of section 409(c)(2) of the tioner does not wish to supplement or Act shall be moved forward 1 day for explain the petition and requests in each day after the mailing date of the writing that it be filed as submitted, request taken by the petitioner to sub- the petition shall be filed and the peti- mit the sample. If the information or tioner so notified. sample is requested a reasonable time (iii) Notwithstanding paragraph in advance of the 180 days, but is not (i)(1)(ii) of this section, the petition submitted within such 180 days after shall not be filed if the Food and Drug filing of the petition, the petition will Administration determines that the be considered withdrawn without prej- use identified in the petition should be udice. the subject of an FCN under section (k) If nonclinical laboratory studies 409(h) of the act rather than a petition. are involved, petitions filed with the (2) The Commissioner will publish in Commissioner under section 409(b) of the FEDERAL REGISTER within 30 days the act shall include, with respect to from the date of filing of such petition, each nonclinical study contained in the a notice of the filing, the name of the petition, either a statement that the petitioner, and a brief description of study has been, or will be, conducted in the proposal in general terms. In the compliance with the good laboratory case of a food additive which becomes a practice regulations as set forth in part component of food by migration from 58 of this chapter, or, if any such study packaging material, the notice shall was not conducted in compliance with include the name of the migratory sub- such regulations, a brief statement of stance, and where it is different from the reason for the noncompliance. that of one of the original components, (l) [Reserved] the name of the parent component, the (m) If clinical investigations involv- maximum quantity of the migratory ing human subjects are involved, peti- substance that is proposed for use in tions filed with the Commissioner food, and the physical or other tech- under section 409(b) of the Act shall in- nical effect which the migratory sub- clude statements regarding each such stance or its parent component is in- clinical investigation relied upon in tended to have in the packaging mate- the petition that it either was con- rial. A copy of the notice will be ducted in compliance with the require- mailed to the petitioner when the ments for institutional review set forth original is forwarded to the FEDERAL in part 56 of this chapter, or was not REGISTER for publication. subject to such requirements in accord- (j) The Commissioner may request a ance with § 56.104 or § 56.105, and that it full description of the methods used in, was conducted in compliance with the and the facilities and controls used for, requirements for informed consent set the production of the food additive, or forth in part 50 of this chapter. a sample of the food additive, articles (n)(1) If intended uses of the food ad- used as components thereof, or of the ditive include uses in meat, meat food

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product, or poultry product subject to quested by petitioner. This may be due regulation by the U.S. Department of to the fact that the data are not suffi- Agriculture (USDA) under the Poultry ciently clear or complete. In such Products Inspection Act (PPIA) (21 cases, the petitioner may withdraw the U.S.C. 451 et seq.) or the Federal Meat petition pending its clarification or the Inspection Act (FMIA) (21 U.S.C. 601 et obtaining of additional data. This with- seq.), FDA shall, upon filing of the peti- drawal will be without prejudice to a tion, forward a copy of the petition or future filing. Upon refiling, the time relevant portions thereof to the Food limitation will begin to run anew from Safety and Inspection Service, USDA, the date of refiling. for simultaneous review under the (b) At any time before the order pro- PPIA and FMIA. vided for in § 171.100(a) has been for- (2) FDA will ask USDA to advise warded to the FEDERAL REGISTER for whether the proposed meat and poultry publication, the petitioner may with- uses comply with the FMIA and PPIA, draw the petition without prejudice to or if not, whether use of the substance a future filing. Upon refiling the time would be permitted in products under limitation will begin to run anew. USDA jurisdiction under specified con- (c) Any petitioner who has a food ad- ditions or restrictions. ditive petition pending before the agen- [42 FR 14489, Mar. 15, 1977, as amended at 42 cy and who subsequently submits a FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, premarket notification for a food con- 1981; 50 FR 7492, Feb. 22, 1985; 50 FR 16668, tact substance (FCN) for a use or uses Apr. 26, 1985; 62 FR 40599, July 29, 1997; 65 FR described in such petition shall be 51763, Aug. 25, 2000; 67 FR 35731, May 21, 2002; deemed to have withdrawn the petition 72 FR 10357, Mar. 8, 2007; 81 FR 49896, July 29, for such use or uses without prejudice 2016] to a future filing on the date the FCN is received by the Food and Drug Ad- § 171.6 Amendment of petition. ministration. After a petition has been filed, the petitioner may submit additional in- [42 FR 14489, Mar. 15, 1977, as amended at 67 formation or data in support thereof. FR 35731, May 21, 2002] In such cases, if the Commissioner de- § 171.8 Threshold of regulation for termines that the additional informa- substances used in food-contact ar- tion or data amount to a substantive ticles. amendment, the petition as amended Substances used in food-contact arti- will be given a new filing date, and the cles (e.g., food-packaging or food-proc- time limitation will begin to run anew. essing equipment) that migrate or that If nonclinical laboratory studies are in- may be expected to migrate into food volved, additional information and at negligible levels may be reviewed data submitted in support of filed peti- under § 170.39 of this chapter. The Food tions shall include, with respect to and Drug Administration will exempt each nonclinical study, either a state- substances whose uses it determines ment that the study was conducted in meet the criteria in § 170.39 of this compliance with the requirements set chapter from regulation as food addi- forth in part 58 of this chapter, or, if tives and, therefore, a food additive pe- the study was not conducted in compli- tition will not be required for the ex- ance with such regulations, a brief empted use. statement of the reason for the non- compliance. [60 FR 36596, July 17, 1995] [50 FR 7492, Feb. 22, 1985, as amended at 50 FR 16668, Apr. 26, 1985] Subpart B—Administrative Actions on Applications § 171.7 Withdrawal of petition without prejudice. § 171.100 Regulation based on petition. (a) In some cases the Commissioner (a) The Commissioner will forward will notify the petitioner that the peti- for publication in the FEDERAL REG- tion, while technically complete, is in- ISTER, within 90 days after filing of the adequate to justify the establishment petition (or within 180 days if the time of a regulation or the regulation re- is extended as provided for in section

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409(c)(2) of the Act), a regulation pre- § 171.130 Procedure for amending and scribing the conditions under which repealing tolerances or exemptions the food additive may be safely used from tolerances. (including, but not limited to, speci- (a) The Commissioner, on his own fications as to the particular food or initiative or on the petition of any in- classes of food in or on which such ad- terested person, pursuant to part 10 of ditive may be used, the maximum this chapter, may propose the issuance quantity that may be used or per- of a regulation amending or repealing a mitted to remain in or on such food, regulation pertaining to a food additive the manner in which such additive may or granting or repealing an exception be added to or used in or on such food, for such additive. and any directions or other labeling or (b) Any such petition shall include an packaging requirements for such addi- assertion of facts, supported by data, tive deemed necessary by him to assure showing that new information exists the safety of such use), and prior to the with respect to the food additive or that new uses have been developed or forwarding of the order to the FEDERAL old uses abandoned, that new data are REGISTER for publication shall notify available as to toxicity of the chem- the petitioner of such order and the ical, or that experience with the exist- reasons for such action; or by order ing regulation or exemption may jus- deny the petition, and shall notify the tify its amendment or repeal. New data petitioner of such order and of the rea- shall be furnished in the form specified sons for such action. in §§ 171.1 and 171.100 for submitting pe- (b) The regulation shall describe the titions. conditions under which the substance [42 FR 14491, Mar. 15, 1977, as amended at 42 may be safely used in any meat prod- FR 15674, Mar. 22, 1977] uct, meat food product, or poultry product subject to the Federal Meat In- PART 172—FOOD ADDITIVES PER- spection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspec- MITTED FOR DIRECT ADDITION TO tion Act (PPIA) (21 U.S.C. 451 et seq.). FOOD FOR HUMAN CONSUMP- (c) If the Commissioner determines TION that additional time is needed to study Subpart A—General Provisions and investigate the petition, he shall by written notice to the petitioner ex- Sec. tend the 90-day period for not more 172.5 General provisions for direct food ad- than 180 days after the filing of the pe- ditives. tition. Subpart B—Food Preservatives [42 FR 14489, Mar. 15, 1977, as amended at 65 172.105 Anoxomer. FR 51763, Aug. 25, 2000] 172.110 BHA. 172.115 BHT. § 171.102 Effective date of regulation. 172.120 Calcium disodium EDTA. A regulation published in accordance 172.130 Dehydroacetic acid. 172.133 Dimethyl dicarbonate. with § 171.100(a) shall become effective 172.135 Disodium EDTA. upon publication in the FEDERAL REG- 172.140 Ethoxyquin. ISTER. 172.145 Heptylparaben. 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- § 171.110 Procedure for objections and phenol. hearings. 172.155 Natamycin (pimaricin). 172.160 nitrate. Objections and hearings relating to 172.165 Quaternary ammonium chloride food additive regulations under section combination. 409 (c), (d), or (h) of the Act shall be 172.167 nitrate and peroxide governed by part 12 of this chapter. solution. 172.170 nitrate. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.175 Sodium nitrite. FR 15674, Mar. 22, 1977] 172.177 Sodium nitrite used in processing smoked chub. 172.180 Stannous chloride.

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172.185 TBHQ. 172.575 . 172.190 THBP. 172.580 Safrole-free extract of . 172.585 Sugar beet extract flavor base. Subpart C—Coatings, Films and Related 172.590 Yeast-malt sprout extract. Substances Subpart G—Gums, Chewing Gum Bases 172.210 Coatings on fresh citrus fruit. and Related Substances 172.215 Coumarone-indene . 172.225 Methyl and ethyl esters of fatty 172.610 Arabinogalactan. acids produced from edible fats and oils. 172.615 Chewing . 172.230 Microcapsules for flavoring sub- 172.620 Carrageenan. stances. 172.623 Carrageenan with polysorbate 80. 172.235 Morpholine. 172.626 Salts of carrageenan. 172.250 Petroleum naphtha. 172.655 Furcelleran. 172.255 Polyacrylamide. 172.660 Salts of furcelleran. 172.260 Oxidized . 172.665 Gellan gum. 172.270 Sulfated butyl oleate. 172.695 Xanthan gum. 172.275 Synthetic paraffin and succinic de- rivatives. Subpart H—Other Specific Usage Additives 172.280 Terpene resin. 172.710 Adjuvants for pesticide use dilu- Subpart D—Special Dietary and Nutritional tions. Additives 172.712 1,3–Butylene glycol. 172.715 Calcium lignosulfonate. 172.310 Aluminum nicotinate. 172.720 Calcium lactobionate. 172.315 Nicotinamide-ascorbic acid complex. 172.723 Epoxidized soybean oil. 172.320 Amino acids. 172.725 Gibberellic acid and its potassium 172.325 Bakers yeast protein. salt. 172.330 Calcium pantothenate, calcium chlo- 172.730 Potassium bromate. ride double salt. 172.735 Glycerol ester of . 172.335 D-Pantothenamide. 172.736 Glycerides and polyglycides of hy- 172.340 Fish protein isolate. drogenated vegetable oils. 172.345 Folic acid (folacin). 172.755 Stearyl monoglyceridyl citrate. 172.350 Fumaric acid and salts of fumaric 172.765 Succistearin (stearoyl propylene gly- acid. col hydrogen succinate). 172.365 Kelp. 172.770 Ethylene polymer. 172.370 - citrate complex. 172.775 Methacrylic acid-divinylbenzene co- 172.372 N-Acetyl-L-methionine. polymer. 172.375 Potassium iodide. 172.780 Acacia (). 172.379 D2. 172.785 Listeria-specific bacteriophage prepa- 172.380 Vitamin D3. ration. 172.381 Vitamin D2 bakers yeast. 172.385 Whole fish protein concentrate. Subpart I—Multipurpose Additives 172.395 Xylitol. 172.399 methionine sulfate. 172.800 Acesulfame potassium. 172.802 Acetone peroxides. Subpart E—Anticaking Agents 172.803 Advantame. 172.804 Aspartame. 172.410 Calcium . 172.806 Azodicarbonamide. 172.430 Iron ammonium citrate. 172.808 Copolymer condensates of ethylene 172.480 dioxide. oxide and propylene oxide. 172.490 prussiate of soda. 172.809 Curdlan. 172.810 Dioctyl sodium sulfosuccinate. Subpart F—Flavoring Agents and Related 172.811 Glyceryl tristearate. Substances 172.812 Glycine. 172.814 Hydroxylated . 172.510 Natural flavoring substances and 172.816 Methyl glucoside- oil ester. natural substances used in conjunction 172.818 Oxystearin. with flavors. 172.820 Polyethylene gylcol (mean molec- 172.515 Synthetic flavoring substances and ular weight 200–9,500). adjuvants. 172.822 Sodium lauryl sulfate. 172.520 Cocoa with dioctyl sodium sulfo- 172.824 Sodium mono- and dimethyl naph- succinate for manufacturing. thalene sulfonates. 172.530 Disodium guanylate. 172.826 Sodium stearyl fumarate. 172.535 Disodium inosinate. 172.828 Acetylated monoglycerides. 172.540 DL-Alanine. 172.829 Neotame. 172.560 Modified hop extract. 172.830 Succinylated monoglycerides.

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172.831 Sucralose. Subpart A—General Provisions 172.832 Monoglyceride citrate. 172.833 Sucrose acetate isobutyrate (SAIB). § 172.5 General provisions for direct 172.834 Ethoxylated mono- and diglycerides. food additives. 172.836 Polysorbate 60. (a) Regulations prescribing condi- 172.838 Polysorbate 65. 172.840 Polysorbate 80. tions under which food additive sub- 172.841 Polydextrose. stances may be safely used predicate 172.842 monostearate. usage under conditions of good manu- 172.844 Calcium stearoyl-2-lactylate. facturing practice. For the purposes of 172.846 Sodium stearoyl lactylate. this part, good manufacturing practice 172.848 Lactylic esters of fatty acids. shall be defined to include the fol- 172.850 Lactylated esters of glyc- lowing restrictions. erol and propylene glycol. (1) The quantity of the substance 172.852 Glyceryl-lacto esters of fatty acids. added to food does not exceed the 172.854 Polyglycerol esters of fatty acids. amount reasonably required to accom- 172.856 Propylene glycol mono- and diesters plish its intended physical, nutritive, of fats and fatty acids. or other technical effect in food. 172.858 Propylene glycol alginate. (2) Any substance intended for use in 172.859 Sucrose fatty acid esters. or on food is of appropriate food grade 172.860 Fatty acids. and is prepared and handled as a food 172.861 substitute from coco- ingredient. nut oil, , or both oils. (b) The existence of a regulation pre- 172.862 Oleic acid derived from tall oil fatty acids. scribing safe conditions of use for a 172.863 Salts of fatty acids. food additive shall not be construed to 172.864 Synthetic fatty alcohols. relieve the use of the substance from 172.866 Synthetic glycerin produced by the compliance with any other provision of hydrogenolysis of carbohydrates. the Act. 172.867 Olestra. (c) The existence of any regulation 172.868 Ethyl cellulose. prescribing safe conditions of use for a 172.869 Sucrose oligoesters. nutrient substance does not constitute 172.870 Hydroxypropyl cellulose. a finding that the substance is useful 172.872 Methyl ethyl cellulose. or required as a supplement to the diet 172.874 Hydroxypropyl methylcellulose. of humans. 172.876 Castor oil. 172.878 White oil. Subpart B—Food Preservatives 172.880 Petrolatum. 172.882 Synthetic isoparaffinic petroleum § 172.105 Anoxomer. . 172.884 Odorless light petroleum hydro- Anoxomer as identified in this sec- . tion may be safely used in accordance 172.886 Petroleum . with the following conditions: 172.888 Synthetic petroleum wax. (a) Anoxomer is 1,4-benzenediol, 2- 172.890 Rice bran wax. (1,1-dimethylethyl)-polymer with 172.892 Food starch-modified. diethenylbenzene, 4-(1,1-dimethyl- 172.894 Modified cottonseed products in- ethyl)phenol, 4- methoxyphenol, 4,4′-(1- tended for human consumption. methylethylidene)bis(phenol) and 4- 172.896 Dried yeasts. methylphenol (CAS Reg. No. 60837–57–2) 172.898 Bakers yeast glycan. prepared by condensation polymeriza- AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, tion of divinylbenzene (m- and p-) with 379e. tert-butylhydroquinone, tert-butyl- phenol, hydroxyanisole, p-cresol and SOURCE: 42 FR 14491, Mar. 15, 1977, unless ′ otherwise noted. 4,4 -isopropylidenediphenol. (b) The polymeric antioxidant meets EDITORIAL NOTE: Nomenclature changes to the following specifications: part 172 appear at 61 FR 14482, Apr. 2, 1996, 66 (1) Polymer, not less than 98.0 per- FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880, cent as determined by an July 15, 2005, 70 FR 67651, Nov. 8, 2005, 70 FR method entitled ‘‘Ultraviolet Assay, 72074, Dec. 1, 2005, and 81 FR 49896, July 29, ‘‘1982, which is incorporated by ref- 2016. erence. Copies are available from the

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Center for Food Safety and Applied Nu- § 172.110 BHA. trition (HFS–200), Food and Drug Ad- The food additive BHA (butylated hy- ministration, 5001 Campus Dr., College droxyanisole) alone or in combination Park, MD 20740, or at the National Ar- with other antioxidants permitted in chives and Records Administration food for human consumption in this (NARA). For information on the avail- subpart B may be safely used in or on ability of this material at NARA, call specified foods, as follows: 202–741–6030, or go to: http:// (a) The BHA meets the following www.archives.gov/federallregister/ specification: codeloflfederallregulations/ ibrllocations.html. Assay (total BHA), 98.5 percent minimum. ° (2) Molecular weight: Total mono- 48 C minimum. mers, dimers and trimers below 500 not (b) The BHA is used alone or in com- more than 1 percent as determined by a bination with BHT, as an antioxidant method entitled ‘‘Low Molecular in foods, as follows: Weight Anoxomer Analysis,’’ 1982, Limitations which is incorporated by reference. (total BHA Copies are available from the Center Food and BHT) parts per for Food Safety and Applied Nutrition million (HFS–200), Food and Drug Administra- tion, 5001 Campus Dr., College Park, Dehydrated potato shreds ...... 50 MD 20740, or at the National Archives Active dry yeast ...... 1 1,000 Beverages and desserts prepared from dry and Records Administration (NARA). mixes ...... 1 2 For information on the availability of Dry breakfast cereals ...... 50 this material at NARA, call 202–741– Dry diced glazed fruit ...... 1 32 6030, or go to: http://www.archives.gov/ Dry mixes for beverages and desserts ...... 1 90 Emulsion stabilizers for shortenings ...... 200 federallregister/ Potato flakes ...... 50 codeloflfederallregulations/ Potato granules ...... 10 ibrllocations.html. Sweet potato flakes ...... 50 (3) Phenol content: Not less than 3.2 1 BHA only. milliequivalent/gram and not more than 3.8 milliequivalent/gram as deter- (c) To assure safe use of the additive: mined by a method entitled ‘‘Total (1) The label of any market package Phenols,’’ 1982, which is incorporated of the additive shall bear, in addition by reference. Copies are available from to the other information required by the Center for Food Safety and Applied the Act, the name of the additive. Nutrition (HFS–200), Food and Drug (2) When the additive is marketed in Administration, 5001 Campus Dr., Col- a suitable carrier, in addition to meet- lege Park, MD 20740, or at the National ing the requirement of paragraph (c)(1) of this section, the label shall declare Archives and Records Administration the percentage of the additive in the (NARA). For information on the avail- mixture. ability of this material at NARA, call (3) The label or labeling of dry mixes 202–741–6030, or go to: http:// for beverages and desserts shall bear www.archives.gov/federallregister/ adequate directions for use to provide codeloflfederallregulations/ that beverages and desserts prepared ibrllocations.html. from the dry mixes contain no more (4) Heavy as (as Pb), not than 2 parts per million BHA. more than 10 parts per million. Arsenic (as As), not more than 3 parts per mil- § 172.115 BHT. lion. Mercury (as Hg), not more than 1 The food additive BHT (butylated hy- part per million. droxytoluene), alone or in combination (c) Anoxomer may be safely used as with other antioxidants permitted in an antioxidant in food at a level of not this subpart B may be safely used in or more than 5,000 parts per million based on specified foods, as follows: on fat and oil content of the food. (a) The BHT meets the following [48 FR 18798, Apr. 26, 1983, as amended at 54 specification: Assay (total BHT) 99 per- FR 24896, June 12, 1989] cent minimum.

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(b) The BHT is used alone or in com- Limita- bination with BHA, as an antioxidant tion Food (parts Use in foods, as follows: per mil- lion) Limitations (total BHA Dressings, nonstandard- 75 Preservative. Food and BHT) ized. parts per Dried lima beans 310 Promote color retention. million (cooked canned). Egg product that is 1 200 Preservative. Dehydrated potato shreds ...... 50 hard-cooked and con- Dry breakfast cereals ...... 50 sists, in a cylindrical Emulsion stabilizers for shortenings ...... 200 shape, of egg white Potato flakes ...... 50 with an inner core of Potato granules ...... 10 egg yolk. Sweetpotato flakes ...... 50 Fermented malt bev- 25 Antigushing agent. erages. (c) To assure safe use of the additive: French dressing ...... 75 Preservative. Legumes (all cooked 365 Promote color retention. (1) The label of any market package canned, other than of the additive shall bear, in addition dried lima beans, pink to the other information required by beans, and red the Act, the name of the additive. beans). Mayonnaise ...... 75 Do. (2) When the additive is marketed in (cooked 200 Promote color retention. a suitable carrier, in addition to meet- canned). ing the requirement of paragraph (c)(1) Oleomargarine ...... 75 Preservative. Pecan pie filling ...... 100 Promote color retention. of this section, the label shall declare Pink beans (cooked 165 Promote color retention. the percentage of the additive in the canned). mixture. Potato salad ...... 100 Preservative. Processed dry pinto 800 Promote color retention. beans. § 172.120 Calcium disodium EDTA. Red beans (cooked 165 Promote color retention. The food additive calcium disodium canned). Salad dressing ...... 75 Preservative. EDTA (calcium disodium ethylene- Sandwich spread ...... 100 Do. diaminetetraacetate) may be safely Sauces ...... 75 Do. used in designated foods for the pur- Shrimp (cooked 250 Retard struvite forma- canned). tion; promote color poses and in accordance with the condi- retention. tions prescribed, as follows: Spice extractives in 60 Promote color and fla- (a) The additive contains a minimum soluble carriers. vor retention. of 99 percent by weight of either the di- Spreads, artificially col- 100 Promote color retention. ored and lemon-fla- hydrate C10H12O8N2CaNa2·2H2O or the vored or orange-fla- trihydrate C10H12O8N2CaNa2·3H2O, or vored. any mixture of the two. 1 By weight of egg yolk portion. (b) It is used or intended for use as (2) With disodium EDTA (disodium follows: ethylenediaminetetraacetate) in the (1) Alone, in the following foods at following foods at not to exceed, in not to exceed the levels prescribed, cal- combination, the levels prescribed, cal- culated as the anhydrous compound: culated as anhydrous C10H12O8N2CaNa2: Limita- tion Limita- Food (parts Use tion per mil- Food (parts Use lion) per mil- lion) Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. Dressings, nonstandardized .... 75 Preservative. French dressing ...... 75 Do. Canned carbonated soft 33 Promote flavor reten- Mayonnaise ...... 75 Do. drinks. tion. Salad dressing ...... 75 Do. Canned white potatoes 110 Promote color retention. Sandwich spread ...... 100 Do. Clams (cooked canned) 340 Promote color retention. Sauces ...... 75 Do. Crabmeat (cooked 275 Retard struvite forma- canned). tion; promote color retention. (c) To assure safe use of the additive: Cucumbers pickled ...... 220 Promote color, flavor, (1) The label and labeling of the addi- and texture retention. tive container shall bear, in addition to Distilled alcoholic bev- 25 Promote stability of erages. color, flavor, and/or the other information required by the product clarity. Act, the name of the additive.

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(2) The label or labeling of the addi- 25-mL Pipette tive container shall bear adequate use 10-mL Burette (automatic, eg., Metrohm bu- directions to provide a final food prod- rette) uct that complies with the limitations Stirrer provided in paragraph (b) of this sec- Device for potentiometric titration tion. Reference electrode (d) In the standardized foods listed in electrode paragraph (b) of this section, the addi- REAGENTS tives are used only in compliance with the applicable standards of identity for Acetone, analytical-grade such foods. Solution of 1 N diisobutylamine in chloro- benzene, distilled [42 FR 14491, Mar. 15, 1977, as amended at 48 1 N FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, PROCEDURE Aug. 8, 2000] Accurately weigh in about 2 grams of the § 172.130 Dehydroacetic acid. sample (W) and dissolve in 100 mL acetone. Add accurately 25 mL of the 1 N diisobutyl- The food additive dehydroacetic acid amine solution by pipette and allow to stand and/or its sodium salt may be safely for 5 minutes. Subsequently, titrate the re- used in accordance with the following action mixture potentiometrically with 1 N prescribed conditions: hydrochloric acid (consumption=a mL) while (a) The food additive meets the fol- stirring. For determining the blank con- lowing specifications: sumption, carry out the analysis without a sample (consumption=b mL). Dehydroacetic acid: Melting point, 109 °C–111 ° C; assay, minimum 98 percent (dry basis). CALCULATION Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry basis). ()ba− ×13. 4 (b) It is used or intended for use as a = % DMDC preservative for cut or peeled squash, W and is so used that no more than 65 NOTE: For adding the diisobutylamine so- parts per million expressed as dehydro- lution, always use the same pipette and wait acetic acid remains in or on the pre- for a further three drops to fall when the pared squash. flow has stopped. (c) The label or labeling of any pack- (2) The additive contains not more age of the additive intended for use in than 2,000 ppm (0.2 percent) dimethyl food shall bear adequate directions for carbonate as determined by a method use to insure compliance with this sec- entitled ‘‘ Chromatography Method tion. for Dimethyl Carbonate Impurity in § 172.133 Dimethyl dicarbonate. Dimethyl Dicarbonate,’’ which is incor- porated by reference in accordance Dimethyl dicarbonate (CAS Reg. No. with 5 U.S.C. 552(a). Copies are avail- 4525–33–1) may be safely used in food in accordance with the following pre- able from the Center for Food Safety scribed conditions: and Applied Nutrition (HFS–200), 5001 (a) The additive meets the following Campus Dr., College Park, MD 20740, or specifications: at the National Archives and Records (1) The additive has a purity of not Administration (NARA). For informa- less than 99.8 percent as determined by tion on the availability of this mate- the following titration method: rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ PRINCIPLES OF METHOD federallregister/ Dimethyl dicarbonate (DMDC) is mixed codeloflfederallregulations/ with excess diisobutylamine with which it ibrllocations.html. reacts quantitatively. The excess amine is backtitrated with acid. (b) The additive is used or intended for use as a microbial control agent in APPARATUS the following beverages under normal 250-milliliter (mL) Beaker circumstances of bottling, canning, or 100-mL Graduate cylinder other forms of final packaging, where

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the viable microbial load has been re- culated as anhydrous calcium disodium duced to 500 microorganisms per milli- EDTA: liter or less by current good manufac- Limita- turing practices such as heat treat- tion ment, , or other technologies Food (parts Use per mil- prior to the use of dimethyl dicar- lion) bonate: (1) In wine, dealcoholized wine, and Aqueous prep- 150 With iron salts as a arations. stabilizer for vita- low alcohol wine in an amount not to min B 12 in liquid exceed 200 parts per million. multivitamin prep- (2) In ready-to-drink teas in an arations. amount not to exceed 250 parts per mil- Canned black-eyed peas .... 145 Promote color re- tention. lion. Canned kidney beans ...... 165 Preservative. (3) In carbonated or noncarbonated, Canned strawberry pie filling 500 Promote color re- nonjuice-containing (less than or equal tention. to 1 percent juice), flavored or Cooked sausage ...... 36 As a cure accel- erator with so- unflavored beverages containing added dium ascorbate (5–20 milliequivalents/liter or ascorbic acid. sodium ion (Na + ) and 3–7 milli- Dressings, nonstandardized 75 Preservative. equivalents/liter potassium ion (K + )) French dressing ...... 75 Do. Frozen white potatoes in- 100 Promote color re- in an amount not to exceed 250 parts cluding cut potatoes. tention. per million. Gefilte fish balls or patties in 1 50 Inhibit discoloration. (4) In carbonated, dilute beverages packing medium. Legumes (all cooked 165 Promote color re- containing juice, fruit flavor, or both, canned, other than black- tention. with juice content not to exceed 50 per- eyed peas). cent, in an amount not to exceed 250 Mayonnaise ...... 75 Preservative. parts per million. Ready-to-eat cereal prod- 2 315 Promote color re- ucts containing dried ba- tention. (c) To ensure the safe use of the food nanas. additive, the label of the package con- Salad dressing ...... 75 Preservative. taining the additive shall bear, in addi- Sandwich spread ...... 100 Do. tion to other information required by Sauces ...... 75 Do. the Federal Food, Drug, and Cosmetic 1 Based on total weight of finished product including packing Act: medium. 2 In dried banana component of cereal product. (1) The name of the additive ‘‘di- methyl dicarbonate.’’ (2) With calcium disodium EDTA (2) The intended use of the additive. (calcium disodium ethylenediamine- (3) Adequate directions for use to en- tetraacetate; calcium disodium sure compliance with this section. (ethylenedinitrilo) tetraacetate), in the following foods at not to exceed, in [53 FR 41329, Oct. 21, 1988, as amended at 58 combination, the levels prescribed, cal- FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; culated as anhydrous C10H12O8N2CaNa2: 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, 1996; 66 FR 13653, Mar. 7, 2001] Limita- tion Food (parts Use § 172.135 Disodium EDTA. per mil- The food additive disodium EDTA lion) (disodium ethylenediaminetetraace- Dressings, nonstandardized 75 Preservative. tate) may be safely used in designated French dressing ...... 75 Do. foods for the purposes and in accord- Mayonnaise ...... 75 Do. ance with the following prescribed con- Salad dressing ...... 75 Do. Sandwich spread ...... 100 Do. ditions: Sauces ...... 75 Do. (a) The additive contains a minimum of 99 percent disodium ethylenedia- (3) Alone, as a sequestrant in the minetetraacetate dihydrate nonnutritive sweeteners that are listed (C10H14O8N2Na2·2H2O). in § 180.37 of this chapter and that, in (b) It is used or intended for use as addition, are designed for aqueous solu- follows: tion: Provided, That the amount of the (1) Alone, in the following foods at additive, calculated as anhydrous cal- not to exceed the levels prescribed, cal- cium disodium EDTA, does not exceed

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0.1 percent by weight of the dry non- section 401 of the Act (21 U.S.C. 341) do nutritive sweetener. not preclude such use. (c) To assure the safe use of the addi- tive: § 172.150 4-Hydroxymethyl-2,6-di-tert- (1) The label and labeling of the addi- butylphenol. tive container shall bear, in addition to The food additive 4-hydroxymethyl- the other information required by the 2,6-di-tert-butylphenol may be safely act, the name of the additive. used in food in accordance with the fol- (2) The label or labeling of the addi- lowing prescribed conditions: tive container shall bear adequate use (a) The additive has a solidification directions to provide a final food prod- point of 140 °C–141 °C. uct that complies with the limitations (b) The additive is used as an anti- provided in paragraph (b) of this sec- oxidant alone or in combination with tion. other permitted antioxidants. (d) In the standardized foods listed in (c) The total amount of all anti- paragraphs (b) (1) and (2) of this section oxidants added to such food shall not the additives are used only in compli- exceed 0.02 percent of the oil or fat con- ance with the applicable standards of tent of the food, including the essential identity for such foods. (volatile) oil content of the food. [42 FR 14491, Mar. 15, 1977, as amended at 65 § 172.155 Natamycin (pimaricin). FR 48379, Aug. 8, 2000] (a) Natamycin (CAS Reg. No. 7681–93– § 172.140 Ethoxyquin. 8), also known as pimaricin, is a pol- yene macrolide antimycotic substance (a) Ethoxyquin (1,2-dihydro-6-ethoxy- possessing an empirical formula of 2,2,4-trimethylquinoline) may be safely C33H47NO13 and a molecular weight of used as an antioxidant for preservation 665.7. of color in the production of chili pow- (b) The additive shall conform to the der, paprika, and ground chili at levels following specifications: not in excess of 100 parts per million. (b) In order to provide for the safe Purity: 97 percent ±2 percent on an anhy- use of the additive in feed prepared in drous basis. accordance with §§ 573.380 and 573.400 of Arsenic: Not more than 1 part per million. (as Pb): Not more than 20 parts this chapter, tolerances are established per million. for residues of ethoxyquin in or on edi- ble products of animals as follows: (c) The additive may be applied on cheese, as an antimycotic, in amounts 5 parts per million in or on the uncooked fat not to exceed 20 milligrams per kilo- of meat from animals except poultry. gram (20 parts per million) in the fin- 3 parts per million in or on the uncooked liver and fat of poultry. ished product as determined by Inter- 0.5 part per million in or on the uncooked national Dairy Federation (IDF) Stand- muscle meat of animals. ard 140A:1992, ‘‘Cheese and Cheese 0.5 part per million in poultry eggs. Rind-Determination of Natamycin Con- Zero in milk. tent-Method by Molecular Absorption Spectrometry and by High-Perform- § 172.145 Heptylparaben. ance Liquid Chromatography,’’ which (a) The food additive heptylparaben is incorporated by reference. The Di- is the chemical n-heptyl p-hydroxy- rector of the Office of the Federal Reg- benzoate. ister approves this incorporation by (b) It may be safely used to inhibit reference in accordance with 5 U.S.C. microbiological spoilage in accordance 552(a) and 1 CFR part 51. Copies are with the following prescribed condi- available from the Division of Product tions: Policy (HFS–206), Center for Food Safe- (1) In fermented malt beverages in ty and Applied Nutrition, Food and amounts not to exceed 12 parts per mil- Drug Administration, 5001 Campus Dr., lion. College Park, MD 20740, or may be ex- (2) In noncarbonated soft drinks and amined at the Food and Drug Adminis- fruit-based beverages in amounts not tration’s Main Library, 10903 New to exceed 20 parts per million, when Hampshire Ave., Bldg. 2, Third Floor, standards of identity established under Silver Spring, MD 20993, 301–796–2039, or

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at the National Archives and Records Component Parts per Administration (NARA). For informa- million tion on the availability of this mate- n-Hexadecyl dimethyl benzyl ammonium chlo- rial at NARA, call 202–741–6030, or go ride ...... 1.5–6.0 to: http://www.archives.gov/ n-Octadecyl dimethyl benzyl ammonium chlo- federal register/ ride ...... 0.25–1.0 l n-Tetradecyl dimethyl benzyl ammonium chlo- codeloflfederallregulations/ ride ...... 3.0–12.0 ibrllocations.html. n-Tetradecyl dimethyl ethylbenzyl ammonium chloride ...... 1.6–6.5 [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb. [50 FR 3890, Jan. 29, 1985] 3, 2016] § 172.167 Silver nitrate and hydrogen § 172.160 Potassium nitrate. peroxide solution. The food additive potassium nitrate An aqueous solution containing a may be safely used as a curing agent in mixture of silver nitrate and hydrogen the processing of cod roe, in an amount peroxide may be safely used in accord- not to exceed 200 parts per million of ance with the following prescribed con- the finished roe. ditions: (a) The additive is used as an anti- § 172.165 Quaternary ammonium chlo- microbial agent in bottled water. ride combination. (b) meets the The food additive, quaternary ammo- specifications of the Food Chemicals nium chloride combination, may be Codex, 7th ed. (2010), pp. 496–497, which safely used in food in accordance with is incorporated by reference. The Di- the following conditions: rector of the Office of the Federal Reg- (a) The additive contains the fol- ister approves this incorporation by lowing compounds: n-dodecyl dimethyl reference in accordance with 5 U.S.C. benzyl ammonium chloride (CAS Reg. 552(a) and 1 CFR part 51. You may ob- No. 139–07–1); n-dodecyl dimethyl ethyl- tain copies from the United States benzyl ammonium chloride (CAS Reg. Pharmacopeial Convention, 12601 No. 27479–28–3); n-hexadecyl dimethyl Twinbrook Pkwy., Rockville, MD 20852 benzyl ammonium chloride (CAS Reg. (Internet address http://www.usp.org). No. 122–18–9); n-octadecyl dimethyl Copies may be examined at the Food benzyl ammonium chloride (CAS Reg. and Drug Administration’s Main Li- No. 122–19–0); n-tetradecyl dimethyl brary, 10903 New Hampshire Ave., Bldg. benzyl ammonium chloride (CAS Reg. 2, Third Floor, Silver Spring, MD 20993, No. 139–08–2); n-tetradecyl dimethyl 301–796–2039, or at the National Ar- ethylbenzyl ammonium chloride (CAS chives and Records Administration Reg. No. 27479–29–4). (NARA). For information on the avail- (b) The additive meets the following ability of this material at NARA, call specifications: pH (5 percent active so- 202–741–6030 or go to: http:// lution) 7.0–8.0; total amines, maximum www.archives.gov/federal-register/cfr/ibr- 1 percent as combined free amines and locations.html. amine hydrochlorides. (c) The amount of silver added will (c) The additive is used as an anti- not exceed 17 micrograms per kilogram microbial agent, as defined in in the treated bottled water, and the § 170.3(o)(2) of this chapter, in raw sugar amount of hydrogen peroxide will not cane juice. It is added prior to clari- exceed 23 milligrams per kilogram in fication when further processing of the the treated bottled water. Analyses for sugar cane juice must be delayed. silver and hydrogen peroxide shall be (d) The additive is applied to the conducted on samples of treated bot- sugar juice in the following quantities, tled water at the site of bottling, using based on the weight of the raw cane: samples of the water intended for treatment for the blank determination. Parts per Component million (d)(1) The amount of silver in the treated bottled water is determined n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 n-Dodecyl dimethyl ethylbenzyl ammonium using the method for silver designated chloride ...... 3.4–13.5 in 21 CFR 165.110(b)(4)(iii)(G)(2)(i).

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(2) The amount of hydrogen peroxide that the level of sodium nitrate does in the treated bottled water is deter- not exceed 500 parts per million and the mined using a Hydrogen Peroxide Test level of sodium nitrite does not exceed Kit from the HACH Co., or equivalent. 200 parts per million in the finished The manual from the Hydrogen Per- product. oxide Test Kit, Model HYP–1, Catalog (2) As a preservative and color fixa- Number 22917–00, 1991, is incorporated tive, with or without sodium nitrite, in by reference. The Director of the Fed- meat-curing preparations for the home eral Register approves this incorpora- curing of meat and meat products (in- tion by reference in accordance with 5 cluding poultry and wild game), with U.S.C. 552(a) and 1 CFR part 51. You directions for use which limit the may obtain copies of the test kit man- amount of sodium nitrate to not more ual from the HACH Co., P.O. Box 389, than 500 parts per million in the fin- Loveland CO, 80359 (1–800–227–4224), ished meat product and the amount of Model HYP–1, Catalog Number 22917–00. sodium nitrite to not more than 200 Copies may be examined at the Food parts per million in the finished meat and Drug Administration’s Main Li- product. brary, 10903 New Hampshire Ave., Bldg. (b) To assure safe use of the additive, 2, Third Floor, Silver Spring, MD 20993, in addition to the other information re- 301–796–2039, 301–436–2163, or at the Na- quired by the Act: tional Archives and Records Adminis- (1) The label of the additive or of a tration (NARA). For information on mixture containing the additive shall the availability of this material at bear: NARA, call 202–741–6030 or go to: http:// (i) The name of the additive. www.archives.gov/federallregister/ (ii) A statement of the concentration codeloflfederallregulations/ of the additive in any mixture. ibrllocations.html. (2) If in a retail package intended for (e) Substances generally recognized household use, the label and labeling of as safe in or on food may be used to the additive, or of a mixture con- stabilize the additive to ensure that taining the additive, shall bear ade- the additive will perform its intended quate directions for use to provide a technical effect. final food product that complies with (f) The additive may not be added to the limitations prescribed in paragraph bottled water that has been filtered or (a) of this section. is intended to be filtered through a sil- (3) If in a retail package intended for ver-containing water filter. household use, the label of the additive (g) Bottled water must meet the or of a mixture containing the addi- quality standards for bottled water in tive, shall bear the statement ‘‘Keep § 165.110(b)(2) through (b)(5) of this out of the reach of children’’. chapter, including the limits specified for total silver and nitrate, unless the § 172.175 Sodium nitrite. water bears a label statement of sub- The food additive sodium nitrite may standard quality, as provided for under be safely used in or on specified foods § 165.110(c) of this chapter. in accordance with the following pre- [74 FR 11478, Mar. 18, 2009, as amended at 78 scribed conditions: FR 71461, Nov. 29, 2013; 81 FR 5591, Feb. 3, (a) It is used or intended for use as 2016] follows: (1) As a color fixative in smoked § 172.170 Sodium nitrate. cured tunafish products so that the The food additive sodium nitrate level of sodium nitrite does not exceed may be safely used in or on specified 10 parts per million (0.001 percent) in foods in accordance with the following the finished product. prescribed conditions: (2) As a preservative and color fixa- (a) It is used or intended for use as tive, with or without sodium nitrate, follows: in smoked, cured sablefish, smoked, (1) As a preservative and color fixa- cured salmon, and smoked, cured shad tive, with or without sodium nitrite, in so that the level of sodium nitrite does smoked, cured sablefish, smoked, cured not exceed 200 parts per million and the salmon, and smoked, cured shad, so level of sodium nitrate does not exceed

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500 parts per million in the finished of the edible portion of the finished product. smoked product is not less than 100 (3) As a preservative and color fixa- parts per million and not greater than tive, with sodium nitrate, in meat-cur- 200 parts per million, as measured in ing preparations for the home curing of the loin muscle. meat and meat products (including (c) Smoked chub shall be heated by a poultry and wild game), with directions controlled heat process which provides for use which limit the amount of so- a monitoring system positioned in as dium nitrite to not more than 200 parts many strategic locations in the smoke- per million in the finished meat prod- house as necessary to assure a contin- uct, and the amount of sodium nitrate uous temperature throughout each fish to not more than 500 parts per million of at least 160 °F for a minimum of 30 in the finished meat product. minutes. (b) To assure safe use of the additive, (d) The finished product shall be in addition to the other information re- cooled to a temperature of 50 °F or quired by the Act: below within 3 hours after smoking and (1) The label of the additive or of a further cooled to a temperature of 38 °F mixture containing the additive shall or below within 12 hours after smoking. bear: A temperature of 38 °F or below shall (i) The name of the additive. be maintained during all subsequent (ii) A statement of the concentration storage and distribution. All shipping of the additive in any mixture. containers, retail packages, and ship- (2) If in a retail package intended for ping records shall indicate with appro- household use, the label and labeling of priate notice the perishable nature of the additive, or of a mixture con- the product and specify that the prod- taining the additive, shall bear ade- uct shall be held under refrigeration (38 quate directions for use to provide a °F or below) until consumed. final food product which complies with (e) To assure safe use of the additive: the limitations prescribed in paragraph (1) The label and labeling of the addi- (a) of this section. tive container shall bear, in addition to (3) If in a retail package intended for the other information required by the household use, the label of the addi- Act, the name of the additive. tive, or of a mixture containing the ad- (2) The label or labeling of the addi- ditive, shall bear the statement ‘‘Keep tive container shall bear adequate di- out of the reach of children’’. rections to assure use in compliance with the provisions of this section. § 172.177 Sodium nitrite used in proc- essing smoked chub. § 172.180 Stannous chloride. The food additive sodium nitrite may The food additive stannous chloride be safely used in combination with salt may be safely used for color retention (NaCl) to aid in inhibiting the out- in asparagus packed in glass, with lids growth and toxin formation from Clos- lined with an inert material, in an tridium botulinum type E in the com- amount not to exceed 20 parts per mil- mercial processing of smoked chub in lion calculated as tin (Sn). accordance with the following pre- scribed conditions: § 172.185 TBHQ. (a) All fish in smoking establish- The food additive TBHQ, which is the ments shall be clean and wholesome chemical 2-(1,1-dimethylethyl)-1,4-benz- and shall be expeditiously processed, enediol (Chemical Abstracts Service packed, and stored under adequate san- Registry Number 1948–33–0), also known itary conditions in accordance with as tertiary butylhydroquinone, may be good manufacturing practice. safely used in food in accordance with (b) The brining procedure is con- the following prescribed conditions: trolled in such a manner that the (a) The food additive has a melting water phase portion of the edible por- point of not less than 126.5 °C. tion of the finished smoked product has (b) The percentage of TBHQ in the a salt (NaCl) content of not less than food additive is not less than 99.0 per- 3.5 percent, as measured in the loin cent when tested by the assay de- muscle, and the sodium nitrite content scribed in the Food Chemicals Codex,

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9th ed. (2014), pp. 1192–1194, which is in- used in food in accordance with the fol- corporated by reference, or an equiva- lowing prescribed conditions: lent method. The Director of the Office (a) The food additive has a melting of the Federal Register approves this point of 149 °C–153 °C. incorporation by reference in accord- (b) It is used as an antioxidant alone ance with 5 U.S.C. 552(a) and 1 CFR or in combination with other permitted part 51. You may obtain copies from antioxidants. the United States Pharmacopeial Con- (c) The total antioxidant content of a vention, 12601 Twinbrook Pkwy., Rock- ville, MD 20852 (Internet address: http:// food containing the additive will not www.usp.org). Copies may be examined exceed 0.02 percent of the oil or fat con- at the Food and Drug Administration’s tent of the food, including the essential Main Library, 10903 New Hampshire (volatile) oil content of the food. Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the Subpart C—Coatings, Films and National Archives and Records Admin- Related Substances istration (NARA). For information on the availability of this material at § 172.210 Coatings on fresh citrus fruit. NARA, call 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr- Coatings may be applied to fresh cit- locations.html. rus fruit for protection of the fruit in (c) It is used as an antioxidant alone accordance with the following condi- or in combination with BHA and/or tions: BHT. (a) The coating is applied in the min- (d) The total antioxidant content of a imum amount required to accomplish food containing the additive will not the intended effect. exceed 0.02 percent of the oil or fat con- (b) The coating may be formulated tent of the food, including the essential from the following components, each (volatile) oil content of the food. used in the minimum quantity required [42 FR 14491, Mar. 15, 1977, as amended at 80 to accomplish the intended effect: FR 34276, June 16, 2015] (1) Substances generally recognized as safe for the purpose or previously § 172.190 THBP. sanctioned for the purpose. The food additive THBP (2,4,5-tri- (2) One or more of the following: hydroxybutyrophenone) may be safely

Component Limitations

Fatty acids ...... Complying with § 172.860. Oleic acid derived from tall oil fatty acids ...... Complying with § 172.862. Partially hydrogenated rosin ...... Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C. Color of WG or paler. Pentaerythritol ester of maleic anhydride-modi- Acid number of 134–145; drop-softening point of 127 °C–173 °C; saponifica- fied wood rosin. tion number of less than 280; and a color of M or paler. Do ...... Acid number of 176–186; drop-softening point of 110 °C–118 °C; saponifica- tion number of less than 280; and a color of M or paler. Polyethylene glycol ...... Complying with § 172.820. As a defoamer and dispersing adjuvant. Polyhydric alcohol diesters of oxidatively refined Complying with § 178.3770 of this chapter and having a dropping point of 77 (Gersthofen process) montan wax acids. to 83 °C (170.6 to 181.4 °F), as determined by ASTM Method D566–76 (Reapproved 1982), ‘‘Standard Test Method for Dropping Point of Lubri- cating Grease,’’ which is incorporated by reference (Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or at the National Ar- chives and Records Administration (NARA). For information on the avail- ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/codeloflfederallregulations/ ibrllocations.html.) using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio. Sodium lauryl sulfate ...... Complying with § 172.822. As a film former. Wood rosin ...... Color of K or paler.

(3) In lieu of the components listed in the following copolymer and one or paragraph (b) (2) and (4) of this section, more of the listed adjuvants.

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Component Limitations

Vinyl chloride-vinylidene chloride copolymer ...... As an aqueous dispersion containing a minimum of 75 percent water when applied. Polyethylene glycol ...... Complying with § 172.820. As a defoamer and dispersing adjuvant. Polyvinylpyrrolidone ...... As an adjuvant. ...... Do. Propylene glycol alginate ...... Do. Sodium decylbenzenesulfonate ...... Do.

(4) In lieu of the components listed in the following rosin derivative and ei- paragraph (b) (2) and (3) of this section, ther or both of the listed adjuvants:

Component Limitations

Calcium salt of partially dimerized rosin ...... Having a maximum drop-softening point of 197 °C and a color of H or paler. It is prepared by reaction with not more than 7 parts hydrated lime per 100 parts of partially dimerized rosin. The partially dimerized rosin is rosin that has been dimerized by catalyst to a drop-softening point of 95 °C to 105 °C and a color of WG or paler. Petroleum naphtha ...... As adjuvant. Complying with § 172.250. Sperm oil ...... As adjuvant.

[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996]

§ 172.215 Coumarone-indene resin. federallregister/ codeloflfederallregulations/ The food additive coumarone-indene ibrllocations.html. resin may be safely used on grapefruit, 25 lemons, limes, oranges, tangelos, and (2) Refractive index (n /D) 1.63–1.64. tangerines in accordance with the fol- (c) It is used or intended for use as a lowing prescribed conditions: protective coating for grapefruit, lem- (a) The food additive is manufactured ons, limes, oranges, tangelos, and tan- by the of a crude, gerines whereby the maximum amount heavy coal-tar solvent naphtha meet- of the resin remaining on the fruit does ing the following specifications: not exceed 200 parts per million on a fresh-weight basis. (1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and (d) To assure safe use of the additive: related compounds. (1) The label of the market package (2) It contains no more than 0.25 per- or any intermediate premix of the ad- cent tar bases. ditive shall bear, in addition to the (3) 95 percent distills in the range 167 other information required by the act: °C–184 °C. (i) The name of the additive, cou- (b) The food additive meets the fol- marone-indene resin. lowing specifications: (ii) A statement of the concentration (1) Softening point, ring and ball: 126 of the additive therein. °C minimum as determined by ASTM (2) The label or accompanying label- method E28–67 (Reapproved 1982), ing shall bear adequate directions that, ‘‘Standard Test Method for Softening if followed, will result in a finished Point by Ring-and-Ball Apparatus,’’ food not in conflict with the require- which is incorporated by reference. ments of this section. Copies may be obtained from the Amer- [42 FR 14491, Mar. 15, 1977, as amended at 49 ican Society for Testing Materials, 100 FR 10103, Mar. 19, 1984] Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be § 172.225 Methyl and ethyl esters of examined at the National Archives and fatty acids produced from edible Records Administration (NARA). For fats and oils. information on the availability of this Methyl esters and ethyl esters of material at NARA, call 202–741–6030, or fatty acids produced from edible fats go to: http://www.archives.gov/ and oils may be safely used in food,

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subject to the following prescribed con- (4) In lieu of the components listed in ditions: paragraphs (a)(2) and (3) of this section, (a) The additive consists of a mixture the following component: of either methyl or ethyl esters of fatty acids produced from edible fats COMPONENT AND LIMITATIONS and oils and meets the following speci- Petroleum wax—Complying with § 172.886. fications: Not to exceed 50 percent by combined (1) Not less than 90 percent methyl or weight of the microcapsule and spice-fla- ethyl esters of fatty acids. voring substance. (2) Not more than 1.5 percent unsa- (b) The microcapsules produced from ponifiable matter. the components listed in paragraphs (a) (b) The additive is used or intended (1), (2), and (3) of this section may be for use at the level not to exceed 3 per- used for encapsulating authorized fla- cent by weight in an aqueous emulsion voring oils for use, in accordance with in dehydrating grapes to produce rai- good manufacturing practice, in foods sins, whereby the residue of the addi- for which standards of identity estab- tive on the raisins does not exceed 200 lished under section 401 of the Act do parts per million. not preclude such use, except that [57 FR 12711, Apr. 13, 1992] microcapsules formulated from compo- nents listed in paragraph (a)(2) of this § 172.230 Microcapsules for flavoring section may be used only for encap- substances. sulating lemon oil, distilled lime oil, orange oil, peppermint oil, and spear- Microcapsules may be safely used for mint oil for use in dry mixes for pud- encapsulating discrete particles of fla- dings and gelatin desserts. voring substances that are generally (c) The microcapsules produced from recognized as safe for their intended the components listed in paragraphs (a) use or are regulated under this part, in (1) and (4) of this section may be used accordance with the following condi- only for encapsulating authorized tions: spice-flavoring substances for use, in (a) The microcapsules may be formu- accordance with good manufacturing lated from the following components, practice, in frozen pizzas which are to each used in the minimum quantity re- be further processed by heat. Such piz- quired to accomplish the intended ef- zas shall bear labels or labeling includ- fect: ing adequate directions for use to en- (1) Substances generally recognized sure heating to temperatures which as safe for the purpose. will melt the wax to release the spice- (2) One or more of the following com- flavoring substances. ponents: [45 FR 48123, July 18, 1980] COMPONENT AND LIMITATIONS § 172.235 Morpholine. Succinylated gelatin—Not to exceed 15 per- cent by combined weight of the microcap- Morpholine may be safely used as a sule and flavoring oil. Succinic acid con- component of food, subject to the fol- tent of the gelatin is 4.5 to 5.5 percent. lowing restrictions. Arabinogalactan—Complying with § 172.610; (a) It is used as the salt(s) of one or as adjuvant. more of the fatty acids meeting the re- —Complying with § 172.480; as quirements of § 172.860, as a component adjuvant. of protective coatings applied to fresh (3) In lieu of the components listed in fruits and vegetables. paragraph (a)(2) of this section, the fol- (b) It is used at a level not in excess lowing components: of that reasonably required to produce its intended effect. COMPONENT AND LIMITATIONS § 172.250 Petroleum naphtha. Glutaraldehyde—As cross-linking agent for insolubilizing a coacervate of gum arabic Petroleum naphtha may be safely and gelatin. used in food in accordance with the fol- n-Octyl alcohol—As a defoamer. lowing conditions:

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(a) The additive is a mixture of liquid ±0.005 centimeter. With distilled water in the hydrocarbons, essentially paraffinic cells, determine any absorbance difference. and naphthenic in nature obtained Spectrophotometer. Spectral range 250–400 μ μ from petroleum, m with spectral slit width of 2 m or less; under instrument operating conditions for (b) The additive is refined to meet these absorbance measurements, the spectro- the following specifications when sub- photometer shall also meet the following jected to the procedures described in performance requirements: this paragraph. ± ° ° Absorbance repeatability, 0.01 at 0.4 absorb- (1) Boiling-point range: 175 F–300 F. ance. (2) Nonvolatile residue: 0.002 gram Absorbance accuracy, 1 ±0.05 at 0.4 absorb- per 100 milliliters maximum. ance. (3) Ultraviolet absorbance limits, as Wavelength repeatability, ±0.2 millimicron. follows: Wavelength accuracy, ±1.0 millimicron. Ultraviolet lamp. Long wavelength (3400– Maximum absorb- 3800A°). Wavelength (milli-microns) ance per centimeter REAGENTS optical pathlength Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-milliliter Erlenmeyer 280–289 ...... 0.15 flask, add 1 milliliter of purified n-hexa- 290–299 ...... 13 300–359 ...... 08 decane, insert the head assembly, allow ni- 360–400 ...... 02 trogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and vacuum line in such a way as to prevent any ANALYTICAL SPECIFICATION FOR PETROLEUM back flow of condensate into the flask. The NAPHTHA contents of the flask are evaporated on a GENERAL INSTRUCTIONS steam bath until 1 milliliter of residue re- mains. Dissolve the 1 milliliter of hexa- All glassware should be scrupulously decane residue in isooctane and make up to cleaned to remove all organic matter such as 25 milliliters. Determine the absorbance in a oil, grease, detergent residues, etc. Examine 5-centimeter path length cell compared to all glassware, including stoppers and stop- isooctane as reference. The absorbance cocks, under ultraviolet light to detect any should not exceed 0.01 per centimeter path residual fluorescent contamination. As a pre- length between 280–400 mμ. If necessary, iso- cautionary measure, it is recommended prac- octane may be purified by passage through a tice to rinse all glassware with purified iso- column of activated (Grade 12, Da- octane immediately before use. No grease is vidson Chemical Co., Baltimore, Md., or to be used on stopcocks or joints. Great care equivalent) or by distillation. to avoid contamination of petroleum naph- Methyl alcohol, A.C.S. reagent grade. Use 10 tha samples in handling and to assure ab- milliliters and proceed as with isooctane. sence of any extraneous material arising The absorbance per centimeter of path from inadequate packaging is essential. Be- μ cause some of the polynuclear hydrocarbons length should be 0.00 between 280–400 m . sought in this test are very susceptible to Methyl alcohol may be purified by simple photo-oxidation, the entire procedure is to be carried out under subdued light. 1 As determined by procedure using potas- sium chromate for reference standard and APPARATUS described in National Bureau of Standards Separatory funnels. 250-milliliter, and 2,000- Circular 484, Spectrophotometry, U.S. De- milliliter capacity, equipped with tetra- partment of Commerce, (1949). The accuracy fluoroethylene polymer stopcocks. is to be determined by comparison with the Erlenmeyer flask. 125-milliliter with 24/40 standard values at 290, 345, and 400 milli- standard taper neck. microns. The procedure is incorporated by Evaporation flask. 250-milliliter capacity reference. Copies of the material incor- all-glass flask equipped with 24/40 standard porated by reference are available from the taper stopper having inlet and outlet tubes Center for Food Safety and Applied Nutri- to permit passage of across the sur- tion (HFS–200), Food and Drug Administra- face of the container liquid to be evaporated. tion, 5001 Campus Dr., College Park, MD Condenser. 24/40 joints, fitted with drying 20740, or available for inspection at the Na- tube, length optional. tional Archives and Records Administration Spectrophotometric cells. Fused quartz cells, (NARA). For information on the availability optical path length in the range of 5,000 cen- of this material at NARA, call 202–741–6030, timeters ±0.005 centimeter; also for checking or go to: http://www.archives.gov/ spectrophotometer performance only, optical federallregister/codeloflfederallregulations/ path length in the range 1,000 centimeter ibrllocations.html.

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distillation or by refluxing in the presence of tion of the layers, draw off the aqueous layer potassium (10 grams/2 liters) and into a second 250-milliliter separatory fun- zinc dust (25 grams/2 liters) for 3 hours fol- nel. Transfer the layer in the lowed by distillation. first funnel to a 25-milliliter volumetric n-Hexadecane, 99 percent olefin-free. Dilute flask. 1.0 milliliter of n-hexadecane to 25 milliliters Carefully wash the Erlenmeyer flask with with isooctane and determine the absorbance an additional 6 milliliters of isooctane, swirl, in a 5-centimeter cell compared to isooctane and transfer to the second separatory funnel. as reference between 280–400 mμ. The absorb- Shake the funnel for 1 minute. After separa- ance per centimeter path length shall not ex- tion of the layers, draw off the aqueous layer ceed 0.00 in this range. Purify, if necessary, into the first separatory funnel. Transfer the by percolation through activated silica gel isooctane in the second funnel to the volu- or by distillation. metric flask. Again wash the Erlenmeyer Sodium borohydride. 98 percent. flask with an additional 6 milliliters of iso- Water. All distilled water must be ex- octane, swirl, and transfer to the first sepa- tracted with isooctane before use. A series of ratory funnel. Shake the funnel for 1 minute. three successive extracts of 1.5 liters of dis- After separation of the layers, draw off the tilled water with 100-milliliter portions of aqueous layer and discard. Transfer the iso- isooctane is satisfactory. octane layer to the volumetric flask and ad- just the volume to 25 milliliters of isooctane. PROCEDURE Mix the contents well, then transfer to the Determination of ultraviolet absorbance. Add first separatory funnel and wash twice with a 25-milliliter aliquot of the hydrocarbon 50-milliliter portions of distilled water. Dis- solvent together with 1 milliliter of hexa- card the aqueous layers after each wash. decane to the 125-milliliter Erlenmeyer Determine the ultraviolet absorbance of flask. While flushing with nitrogen, evapo- the isooctane extract in 5-centimeter path rate to 1 milliliter on a steam bath. Nitrogen length cells compared to isooctane as ref- is admitted through a 8±1-milliliter outer-di- erence between 280–400 mμ. Determine a rea- ameter tube, drawn out into a 2±1-centimeter gent blank concurrently with the sample, long and 1±0.5-millimeter inner-diameter using 25 milliliters of purified isooctane in- capillary tip. This is positioned so that the stead of a solvent sample and measuring the capillary tip extends 4 centimeters into the ultraviolet absorbance of the blank between flask. The nitrogen flow rate is such that the 280–400mμ. surface of the liquid is barely disturbed. The reagent blank absorbance should not After the volume is reduced to that of the 1 exceed 0.04 per centimeter path length be- milliliter of hexadecane, the flask is left on tween 280–289 mμ; 0.020 between 290–359 mμ; the steam bath for 10 more minutes before and 0.010 between 360–400 mμ. removing. Add 10 milliliters of purified iso- Determination of boiling-point range. Use octane to the flask and reevaporate the solu- ASTM method D86–82, ‘‘Standard Method for tion to a 1-milliliter volume in the same Distillation of Petroleum Products,’’ which manner as described above, except do not is incorporated by reference. Copies may be heat for an added 10 minutes. Repeat this op- obtained from the American Society for eration twice more. Let the flask cool. Testing Materials, 100 Barr Harbor Dr., West Add 10 milliliters of methyl alcohol and Conshohocken, Philadelphia, PA 19428-2959, about 0.3 gram of sodium borohydride. (Mini- or may be examined at the National Ar- mize exposure of the borohydride to the at- chives and Records Administration (NARA). mosphere; a measuring dipper may be used.) For information on the availability of this Immediately fit a water-cooled condenser material at NARA, call 202–741–6030, or go to: equipped with a 24/40 joint and with a drying http://www.archives.gov/federallregister/ tube into the flask, mix until the sodium codeloflfederallregulations/ borohydride is dissolved, and allow to stand ibrllocations.html. for 30 minutes at room temperature, with Determination of nonvolatile residue. For hy- intermittent swirling. At the end of this drocarbons boiling below 121 °C, determine time, disconnect the flask and evaporate the the nonvolatile residue by ASTM method methyl alcohol on the steam bath under ni- D1353–78, ‘‘Standard Test Method for Non- trogen until sodium borohydride begins to volatile Matter in Volatile Solvents for Use drop out of solution. Remove the flask and in Paint, , , and Related let it cool. Products;’’ for those boiling above 121 °C, use Add 6 milliliters of isooctane to the flask ASTM method D381–80, ‘‘Standard Test and swirl to wash the crystalline slurry. Method for Existent Gum in Fuels by Jet Carefully transfer the isooctane extract to a Evaporation,’’ which methods are incor- 250-milliliter separatory funnel. Dissolve the porated by reference. Copies may be obtained crystals in the flask with about 25 milliliters from the American Society for Testing Ma- of distilled water and pour this also into the terials, 100 Barr Harbor Dr., West separatory funnel. Adjust the water volume Conshohocken, Philadelphia, PA 19428-2959, in the separatory funnel to about 100 milli- or may be examined at the National Ar- liters and shake for 1 minute. After separa- chives and Records Administration (NARA).

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For information on the availability of this apple, plantain, pumpkin, rutabaga, material at NARA, call 202–741–6030, or go to: squash (acorn), sweetpotatoes, tan- http://www.archives.gov/federallregister/ gerines, turnips, watermelon, Brazil codeloflfederallregulations/ nuts, chestnuts, filberts, , pe- ibrllocations.html. cans, and walnuts (all nuts in shells). (c) Petroleum naphtha containing (c) The additive is used in accordance antioxidants shall meet the specified with good manufacturing practice and ultraviolet absorbance limits after cor- in an amount not to exceed that re- rection for any absorbance due to the quired to produce the intended effect. antioxidants. Petroleum naphtha may contain antioxidants authorized for use § 172.270 Sulfated butyl oleate. in food in an amount not to exceed Sulfate butyl oleate may be safely that reasonably required to accomplish used in food, subject to the following the intended effect or to exceed any prescribed conditions: prescribed limitations. (d) Petroleum naphtha is used or in- (a) The additive is prepared by sul- tended for use as a solvent in protec- fation, using concentrated sulfuric tive coatings on fresh citrus fruit in acid, of a mixture of butyl esters pro- compliance with § 172.210. duced by transesterification of an edi- ble using 1-butanol. Fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing sulfation, the reaction mixture FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, is washed with water and neutralized 1984; 54 FR 24896, June 12, 1989] with aqueous sodium or potassium hy- § 172.255 Polyacrylamide. droxide. Prior to sulfation, the butyl oleate reaction mixture meets the fol- Polyacrylamide containing not more lowing specifications: than 0.2 percent of acrylamide mon- (1) Not less than 90 percent butyl ole- omer may be safely used as a film ate. former in the imprinting of soft-shell (2) Not more than 1.5 percent unsa- gelatin capsules when the amount used ponifiable matter. is not in excess of the minimum re- (b) The additive is used or intended quired to produce the intended effect. for use at a level not to exceed 2 per- § 172.260 Oxidized polyethylene. cent by weight in an aqueous emulsion in dehydrating grapes to produce rai- Oxidized polyethylene may be safely sins, whereby the residue of the addi- used as a component of food, subject to tive on the raisins does not exceed 100 the following restrictions: parts per million. (a) Oxidized polyethylene is the basic resin produced by the mild air oxida- [57 FR 12711, Apr. 13, 1992] tion of polyethylene. The polyethylene used in the oxidation process conforms § 172.275 Synthetic paraffin and suc- to the , maximum n-hexane ex- cinic derivatives. tractable fraction, and maximum xy- Synthetic paraffin and succinic de- lene soluble fraction specifications pre- rivatives identified in this section may scribed in item 2.3 of the table in be safely used as a component of food, § 177.1520(c) of this chapter. The subject to the following restrictions: oxidized polyethylene has a minimum (a) The additive is prepared with 50 number average molecular weight of percent Fischer-Tropsch process syn- 1,200, as determined by high tempera- thetic paraffin, meeting the definition ture vapor pressure osmometry; con- and specifications of § 172.615, and 50 tains a maximum of 5 percent by percent of such synthetic paraffin to weight of total oxygen; and has an acid which is bonded succinic anhydride and value of 9 to 19. succinic acid derivatives of isopropyl (b) The additive is used or intended alcohol, polyethylene glycol, and poly- for use as a protective coating or com- propylene glycol. It consists of a mix- ponent of protective coatings for fresh ture of the Fischer-Tropsch process avocados, bananas, beets, , paraffin (), alkyl succinic anhy- eggplant, garlic, grapefruit, lemons, dride, alkyl succinic anhydride iso- limes, mango, muskmelons, onions, or- propyl half ester, dialkyl succinic an- anges, papaya, peas (in pods), pine- hydride polyethylene glycol half ester,

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and dialkyl succinic anhydride poly- Subpart D—Special Dietary and propylene glycol half ester, where the Nutritional Additives alkane (alkyl) has a chain length of 30– 70 carbon atoms and the polyethylene § 172.310 Aluminum nicotinate. and polypropylene glycols have molec- Aluminum nicotinate may be safely ular weights of 600 and 260, respec- used as a source of niacin in foods for tively. special dietary use. A statement of the (b) The additive meets the following concentration of the additive, ex- specifications: Molecular weight, 880– pressed as niacin, shall appear on the ° ° 930; melting point, 215 –217 F; acid label of the food additive container or number, 43–47; and saponification num- on that of any intermediate premix ber, 75–78. prepared therefrom. (c) It is used or intended for use as a protective coating or component of § 172.315 Nicotinamide-ascorbic acid protective coatings for fresh grape- complex. fruit, lemons, limes, muskmelons, or- Nicotinamide-ascorbic acid complex anges, sweetpotatoes, and tangerines. may be safely used in accordance with (d) It is used in an amount not to ex- the following prescribed conditions: ceed that required to produce the in- (a) The additive is the product of the tended effect. controlled reaction between ascorbic acid and nicotinamide, melting in the § 172.280 Terpene resin. range 141 °C to 145 °C. The food additive terpene resin may (b) It is used as a source of ascorbic be safely used in accordance with the acid and nicotinamide in multivitamin following prescribed conditions: preparations. (a) The food additive is the beta- pinene polymer obtained by polym- § 172.320 Amino acids. erizing terpene hydrocarbons derived The food additive amino acids may from wood. It has a softening point of be safely used as nutrients added to 112 °C–118 °C, as determined by ASTM foods in accordance with the following method E28–67 (Reapproved 1982), conditions: ‘‘Standard Test Method for Softening (a) The food additive consists of one Point By Ring-and-Ball Apparatus,’’ or more of the following individual which is incorporated by reference. amino acids in the free, hydrated, or Copies may be obtained from the Amer- anhydrous form, or as the hydro- ican Society for Testing Materials, 100 chloride, sodium, or potassium salts: Barr Harbor Dr., West Conshohocken, (1) L-Alanine Philadelphia, PA 19428-2959, or may be (2) L-Arginine examined at the National Archives and (3) L-Asparagine Records Administration (NARA). For (4) L-Aspartic acid information on the availability of this (5) L-Cysteine material at NARA, call 202–741–6030, or (6) L-Cystine go to: http://www.archives.gov/ (7) L-Glutamic acid federallregister/ (8) L- codeloflfederallregulations/ (9) Aminoacetic acid (glycine) ibrllocations.html. (10) L-Histidine (b) It is used or intended for use as (11) L-Isoleucine follows: (12) L-Leucine (13) L-Lysine (1) As a moisture barrier on soft gela- (14) DL-Methionine (not for infant tin capsules in an amount not to ex- foods) ceed 0.07 percent of the weight of the (15) L-Methionine capsule. (16) L-Phenylalanine (2) As a moisture barrier on powders (17) L- of ascorbic acid or its salts in an (18) L-Serine amount not to exceed 7 percent of the (19) L-Threonine weight of the powder. (20) L-Tryptophan [42 FR 14491, Mar. 15, 1977, as amended at 49 (21) L-Tyrosine FR 10104, Mar. 19, 1984] (22) L-Valine

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(b) The food additive meets the fol- a food containing naturally occurring lowing specifications: primarily intact protein that is consid- (1) As found in Food Chemicals ered a significant dietary protein Codex: source, provided that: (i) L-Alanine, pages 28 and 29. (1) A reasonable daily adult intake of (ii) L-Arginine, pages 69 and 70. the finished food furnishes at least 6.5 (iii) L-Arginine Monohydrochloride, grams of naturally occurring primarily pages 70 and 71. intact protein (based upon 10 percent of (iv) L-Cysteine Monohydrochloride, the daily allowance for the ‘‘reference’’ pages 269 and 270. adult male recommended by the Na- (v) L-Cystine, pages 270 and 271. tional Academy of Sciences in ‘‘Rec- (vi) Aminoacetic acid (glycine), pages ommended Dietary Allowances,’’ NAS 457 and 458. Publication No. 1694. (vii) L-Leucine, pages 577 and 578. (2) The additive(s) results in a pro- (viii) DL-Methionine, pages 641 and 642. tein efficiency ratio (PER) of protein (ix) L-Methionine, pages 642 and 643. in the finished ready-to-eat food equiv- (x) L-Tryptophan, pages 1060 and 1061. alent to casein as determined by the (xi) L-Phenylalanine, pages 794 and 795. method specified in paragraph (d) of (xii) L-Proline, pages 864 and 865. this section. (xiii) L-Serine, pages 915 and 916. (3) Each amino acid (or combination (xiv) L-Threonine, pages 1031 and 1032. of the minimum number necessary to (xv) L-Glutamic Acid Hydrochloride, achieve a statistically significant in- page 440. crease) added results in a statistically (xvi) L-Isoleucine, pages 544 and 545. significant increase in the PER as de- (xvii) L-Lysine Monohydrochloride, termined by the method described in pages 598 and 599. paragraph (d) of this section. The min- (xviii) Monopotassium L-glutamate, imum amount of the amino acid(s) to pages 697 and 698. achieve the desired effect must be used (xix) L-Tyrosine, page 1061. and the increase in PER over the pri- (xx) L-Valine, pages 1072. marily intact naturally occurring pro- (2) As found in ‘‘Specifications and tein in the food must be substantiated Criteria for Biochemical Compounds,’’ as a statistically significant difference NAS/NRC Publication, for the fol- with at least a probability (P) value of lowing: less than 0.05. (i) L-Asparagine (4) The amount of the additive added (ii) L-Aspartic acid for nutritive purposes plus the amount (iii) L-Glutamine naturally present in free and combined (iv) L-Histidine (as protein) form does not exceed the (c) The additive(s) is used or intended following levels of amino acids ex- for use to significantly improve the bi- pressed as percent by weight of the ological quality of the total protein in total protein of the finished food:

Percent by weight of total protein (expressed as free amino acid)

L-Alanine ...... 6.1 L-Arginine ...... 6.6 L-Aspartic acid (including L-asparagine) ...... 7.0 L-Cystine (including L-cysteine) ...... 2.3 L-Glutamic acid (including L-glutamine) ...... 12.4 Aminoacetic acid (glycine) ...... 3.5 L-Histidine ...... 2.4 L-Isoleucine ...... 6.6 L-Leucine ...... 8.8 L-Lysine ...... 6.4 L- and DL-Methionine ...... 3.1 L-Phenylalanine ...... 5.8 L-Proline ...... 4.2 L-Serine ...... 8.4 L-Threonine ...... 5.0 L-Tryptophan ...... 1.6 L-Tyrosine ...... 4.3 L-Valine ...... 7.4

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(d) Compliance with the limitations and Drug Administration’s Main Li- concerning PER under paragraph (c) of brary, 10903 New Hampshire Ave., Bldg. this section shall be determined by the 2, Third Floor, Silver Spring, MD 20993, method described in sections 43.212– 301–796–2039, or at the National Ar- 43.216, ‘‘Official Methods of Analysis of chives and Records Administration the Association of Official Analytical (NARA). For information on the avail- Chemists.’’ Each manufacturer or per- ability of this material at NARA, call son employing the additive(s) under 202–741–6030 or go to: http:// the provisions of this section shall www.archives.gov/federal-register/cfr/ibr- keep and maintain throughout the pe- locations.html. riod of his use of the additive(s) and for (1) AOAC INTERNATIONAL, 481 a minimum of 3 years thereafter, North Frederick Ave., suite 500, Gai- records of the tests required by this thersburg, MD 20877: paragraph and other records required (i) Sections 43.212–43.216, ‘‘Official to assure effectiveness and compliance Methods of Analysis of the Association with this regulation and shall make of Official Analytical Chemists,’’ 13th such records available upon request at Ed. (1980). all reasonable hours by any officer or (ii) [Reserved] employee of the Food and Drug Admin- (2) National Academy of Sciences, istration, or any other officer or em- available from the FDA Main Library, ployee acting on behalf of the Sec- 10903 New Hampshire Ave., Silver retary of Health and Human Services Spring, MD 20993: and shall permit such officer or em- (i) ‘‘Recommended Dietary Allow- ployee to conduct such inventories of ances,’’ NAS Publication No. 1694, 7th raw and finished materials on hand as Ed. (1968). he deems necessary and otherwise to check the correctness of such records. (ii) ‘‘Specifications and Criteria for (e) To assure safe use of the additive, Biochemical Compounds,’’ NAS/NRC the label and labeling of the additive Publication, 3rd Ed. (1972). and any premix thereof shall bear, in (3) United States Pharmacopeial Con- addition to the other information re- vention, 12601 Twinbrook Pkwy., Rock- quired by the Act, the following: ville, MD 20852 (Internet address http:// (1) The name of the amino acid(s) www.usp.org): contained therein including the spe- (i) Food Chemicals Codex, 7th ed. cific optical and chemical form. (2010), pages 28, 29, 69, 70, 71, 269, 270, (2) The amounts of each amino acid 271, 440, 457, 458, 544, 545, 577, 578, 598, contained in any mixture. 599, 641, 642, 643, 697, 698, 794, 795, 864, (3) Adequate directions for use to 865, 915, 916, 1031, 1032, 1060, 1061, and provide a finished food meeting the 1072. limitations prescribed by paragraph (c) (ii) [Reserved] of this section. [78 FR 71461, Nov. 29, 2013] (f) The food additive amino acids added as nutrients to special dietary § 172.325 Bakers yeast protein. foods that are intended for use solely under medical supervision to meet nu- Bakers yeast protein may be safely tritional requirements in specific med- used in food in accordance with the fol- ical conditions and comply with the re- lowing conditions: quirements of part 105 of this chapter (a) Bakers yeast protein is the insol- are exempt from the limitations in uble proteinaceous material remaining paragraphs (c) and (d) of this section after the mechanical rupture of yeast and may be used in such foods at levels cells of Saccharomyces cerevisiae and re- not to exceed good manufacturing moval of whole cell walls by cen- practices. trifugation and separation of soluble (g) The standards required in this cellular materials. section are incorporated by reference (b) The additive meets the following into this section with the approval of specifications on a dry weight basis: the Director of the Federal Register (1) Zinc salts less than 500 parts per under 5 U.S.C. 552(a) and 1 CFR part 51. million (ppm) as zinc. Copies may be examined at the Food (2) Nucleic acid less than 2 percent.

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(3) Less than 0.3 ppm arsenic, 0.1 ppm (1) The additive shall consist prin- cadmium, 0.4 ppm lead, 0.05 ppm mer- cipally of dried fish protein prepared cury, and 0.3 ppm . from the edible portions of fish after (c) The viable microbial content of removal of the heads, fins, tails, bones, the finished ingredient is: scales, viscera, and intestinal contents. (1) Less than 10,000 organisms/gram (2) The additive shall be derived only by aerobic plate count. from species of bony fish that are gen- (2) Less than 10 yeasts and molds/ erally recognized by qualified sci- gram. entists as safe for human consumption (3) Negative for Salmonella, E. coli, and that can be processed as prescribed coagulase positive Staphylococci, Clos- to meet the required specifications. tridium perfringens, Clostridium botu- (3) Only wholesome fresh fish other- linum, or any other recognized micro- wise suitable for human consumption bial pathogen or any harmful microbial may be used. The fish shall be handled toxin. expeditiously under sanitary condi- (d) The ingredient is used in food as tions. These conditions shall be in ac- a nutrient supplement as defined in cordance with recognized good manu- § 170.3(o)(20) of this chapter. facturing practice for fish to be used as human food. § 172.330 Calcium pantothenate, cal- (4) The additive shall be prepared by cium chloride double salt. extraction with hexane and food-grade ethanol to remove fat and moisture. The food additive Solvent residues shall be reduced by double salt of calcium pantothenate drying. may be safely used in foods for special (b) The food additive meets the fol- dietary uses in accordance with good lowing specifications: (Where methods manufacturing practice and under the of determination are specified, they are following prescribed conditions: Association of Official Analytical (a) The food additive is of the d (dex- Chemists Methods, 13th ed., 1980, which trorotatory) or the dl (racemic) form. are incorporated by reference). 1 (b) To assure safe use of the additive, (1) Protein content, as N × 6.25, shall the label and labeling of the food addi- not be less than 90 percent by weight of tive container, or that of any inter- the final product, as determined by the mediate premixes prepared therefrom, method described in section 2.057, Im- shall bear, in addition to the other in- proved Kjeldahl Method for Nitrate- formation required by the Act, the fol- Free Samples (20)—Official Final Ac- lowing: tion. (1) The name of the additive ‘‘cal- (2) Moisture content shall not be cium chloride double salt of d-calcium more than 10 percent by weight of the pantothenate’’ or ‘‘calcium chloride final product, as determined by the double salt of dl-calcium panto- method described in section 24.003, Air thenate’’, whichever is appropriate. Drying (1)—Official First Action. (2) A statement of the appropriate (3) Fat content shall not be more concentration of the additive, ex- than 0.5 percent by weight of the final pressed as . product, as determined by the method described in section 24.005, Crude Fat § 172.335 D-Pantothenamide. or Extract—Official Final Ac- The food additive D-pantothenamide tion. as a source of pantothenic acid activ- (4) Solvent residues in the final prod- ity, may be safely used in foods for spe- uct shall not be more than 5 parts per cial dietary use in an amount not in excess of that reasonably required to 1 Copies are available from: AOAC INTER- produce its intended effect. NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or examined at § 172.340 Fish protein isolate. the National Archives and Records Adminis- tration (NARA). For information on the (a) The food additive fish protein iso- availability of this material at NARA, call late may be safely used as a food sup- 202–741–6030, or go to: http://www.archives.gov/ plement in accordance with the fol- federallregister/codeloflfederallregulations/ lowing prescribed conditions: ibrllocations.html.

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million of hexane and 3.5 percent eth- which are codified in § 107.100 of this anol by weight. chapter. (f) Folic acid may be added to a med- [46 FR 38072, July 24, 1981, as amended at 47 ical food, as defined in section 5(b)(3) of FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, 1989] the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to exceed the § 172.345 Folic acid (folacin). amount necessary to meet the distinc- tive nutritional requirements of the Folic acid (CAS Reg. No. 59–30–3), disease or condition for which the food also known as folacin or , may be is formulated. safely used in food as a nutrient in ac- (g) Folic acid may be added to food cordance with the following prescribed for special dietary use at levels not to conditions: exceed the amount necessary to meet (a) Folic acid is the chemical N-[4- the special dietary needs for which the [[(2-amino-1,4-dihydro-4-oxo-6-pteri- food is formulated. dinyl)methyl]amino]benzoyl]-L-glu- (h) Folic acid may be added to foods tamic acid. represented as meal-replacement prod- (b) Folic acid meets the specifica- ucts, in amounts not to exceed: tions of the Food Chemicals Codex, 9th (1) Four hundred μg per serving if the ed., updated through Third Supple- food is a meal-replacement that is rep- ment, effective December 1, 2015, pp. resented for use once per day; or 495–496, which is incorporated by ref- (2) Two hundred μg per serving if the erence. The Director of the Office of food is a meal-replacement that is rep- the Federal Register approves this in- resented for use more than once per corporation by reference in accordance day. with 5 U.S.C. 552(a) and 1 CFR part 51. (i) Folic acid may be added to corn You may obtain copies from the United masa flour at a level not to exceed 0.7 States Pharmacopeial Convention, milligrams of folic acid per pound of 12601 Twinbrook Pkwy., Rockville, MD corn masa flour. 20852 (Internet address http:// www.usp.org). Copies may be examined [61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999; 78 at the Food and Drug Administration’s FR 71463, Nov. 29, 2013; 81 FR 22183, Apr. 15, Main Library, 10903 New Hampshire 2016] Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the § 172.350 Fumaric acid and salts of fu- National Archives and Records Admin- maric acid. istration (NARA). For information on Fumaric acid and its calcium, fer- the availability of this material at rous, , potassium, and so- NARA, call 202–741–6030 or go to: http:// dium salts may be safely used in food www.archives.gov/federal-register/cfr/ibr- in accordance with the following pre- locations.html. scribed conditions: (c) Folic acid may be added to foods (a) The additives meet the following subject to a standard of identity estab- specifications: lished under section 401 of the Federal (1) Fumaric acid contains a minimum Food, Drug, and Cosmetic Act (the act) of 99.5 percent by weight of fumaric when the standard of identity specifi- acid, calculated on the anhydrous cally provides for the addition of folic basis. acid. (2) The calcium, magnesium, potas- (d) Folic acid may be added, at levels sium, and sodium salts contain a min- not to exceed 400 micrograms (μg) per imum of 99 percent by weight of the re- serving, to breakfast cereals, as defined spective salt, calculated on the anhy- under § 170.3(n)(4) of this chapter, and drous basis. Ferrous fumarate contains to corn grits at a level such that each a minimum of 31.3 percent total iron pound of corn grits contains not more and not more than 2 percent ferric than 1.0 milligram of folic acid. iron. (e) Folic acid may be added to infant (b) With the exception of ferrous fu- formula in accordance with section marate, fumaric acid and the named 412(i)(1) of the act or with regulations salts are used singly or in combination issued under section 412(i)(2) of the act in food at a level not in excess of the

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amount reasonably required to accom- (1) Purity assay, on a dry basis: Min- plish the intended effect. imum 99 percent. (c) Ferrous fumarate is used as a (2) Residue on ignition: Maximum 0.1 source of iron in foods for special die- percent. tary use, when the use is consistent (3) Specific optical rotation 20 with good nutrition practice. [alpha] D: Between ¥19° and ¥23°. (4) The additive may contain residues § 172.365 Kelp. of not more than 500 ppm ethyl ace- Kelp may be safely added to a food as tate; 50 ppm ethyl alcohol; 10 ppm a source of the essential mineral io- methyl alcohol; and 10 ppm acetone, dine, provided the maximum intake of when used as processing solvents. the food as may be consumed during a (c) The additive is used or intended period of one day, or as directed for use for use as a source of L-methionine to in the case of a , improve significantly the biological will not result in daily ingestion of the quality of the total protein in a food additive so as to provide a total containing naturally occurring pri- amount of in excess of 225 marily intact vegetable protein that is micrograms for foods labeled without considered a significant dietary protein reference to age or physiological state; source, provided that: and when age or the conditions of preg- (1) A reasonable daily adult intake of nancy or lactation are specified, in ex- the finished food furnishes at least 6.5 cess of 45 micrograms for infants, 105 grams of naturally occurring primarily micrograms for children under 4 years intact vegetable protein. of age, 225 micrograms for adults and (2) The additive results in a protein children 4 or more years of age, and 300 efficiency ratio (PER) of protein in the micrograms for pregnant or lactating finished ready-to-eat food equivalent women. The food additive kelp is the to casein as determined by the method dehydrated, ground product prepared specified in paragraph (d) of this sec- from Macrocystis pyrifera, Laminaria tion. digitata, Laminaria saccharina, and Lam- (3) The use of the additive results in inaria cloustoni. a statistically significant increase in the PER as determined by the method § 172.370 Iron-choline citrate complex. described in paragraph (d) of this sec- tion. The minimum amount of the ad- Iron-choline citrate complex made by ditive to achieve the desired effect reacting approximately equimolecular must be used, and the increase in PER quantities of ferric hydroxide, choline, over the primarily intact naturally oc- and citric acid may be safely used as a curring vegetable protein in the food source of iron in foods for special die- must be substantiated as a statis- tary use. tically significant difference with at least a probability (P) value of less § 172.372 N-Acetyl-L-methionine. than 0.05. The food additive N-acetyl-L-methio- (4) The amount of the additive added nine may be safely added to food (ex- for nutritive purpose shall not exceed cept infant foods and foods containing the level that will provide a total of 3.1 added nitrites/nitrates) as a source of percent L- and DL-methionine (ex- L-methionine for use as a nutrient in pressed as the free amino acid) by accordance with the following condi- weight of the total protein of the fin- tions: ished food, including the amount natu- (a) N-Acetyl-L-methionine (Chemical rally present in free and combined (as Abstracts Service Registry No. 65–82–7) protein) form. is the derivative of the amino acid me- (5) The additive shall not be added to thionine formed by addition of an ace- infant foods or to foods containing tyl group to the alpha-amino group of added nitrites/nitrates. methionine. It may be in the free, hy- (d) Compliance with the limitations drated or anhydrous form, or as the so- concerning PER under paragraph (c) of dium or potassium salts. the section shall be determined by the (b) The additive meets the following method described in sections 43.212– specifications: 43.216, ‘‘Official Methods of Analysis of

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the Association of Official Analytical not to exceed good manufacturing Chemists,’’ 13th Ed. (1980), which is in- practices. corporated by reference. Copies may be [43 FR 27784, June 27, 1978, as amended at 46 obtained from the AOAC INTER- FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, NATIONAL, 481 North Frederick Ave., 1984; 54 FR 24897, June 12, 1989] suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar- § 172.375 Potassium iodide. chives and Records Administration The food additive potassium iodide (NARA). For information on the avail- may be safely used in accordance with ability of this material at NARA, call the following prescribed conditions: 202–741–6030, or go to: http:// (a) Potassium iodide may be safely www.archives.gov/federallregister/ added to a food as a source of the es- codeloflfederallregulations/ sential mineral iodine, provided the ibrllocations.html. Each manufacturer maximum intake of the food as may be consumed during a period of one day, or person employing the additive under or as directed for use in the case of a the provisions of this section shall dietary supplement, will not result in keep and maintain throughout the pe- daily ingestion of the additive so as to riod of use of the additive and for a provide a total amount of iodine in ex- minimum of 3 years thereafter, records cess of 225 micrograms for foods labeled of the tests required by this paragraph without reference to age or physio- and other records required to assure ef- logical state; and when age or the con- fectiveness and compliance with this ditions of pregnancy or lactation are regulation. Those records shall be specified, in excess of 45 micrograms made available upon request at all rea- for infants, 105 micrograms for children sonable hours by any officer or em- under 4 years of age, 225 micrograms ployee acting on behalf of the Sec- for adults and children 4 or more years retary of Health and Human Services. of age, and 300 micrograms for preg- Those officers or employees shall be nant or lactating women. permitted to conduct inventories of (b) To assure safe use of the additive, raw and finished materials on hand as in addition to the other information re- are deemed necessary to verify the quired by the Act, the label of the addi- records. tive shall bear: (1) The name of the additive. (e) To assure safe use of the additive, (2) A statement of the concentration the label and labeling of the additive of the additive in any mixture. and any premix thereof shall bear, in

addition to the other information re- § 172.379 2. quired by the Act, the following: Vitamin D2 may be used safely in (1) The name of the additive con- foods as a nutrient supplement defined tained therein. under § 170.3(o)(20) of this chapter in ac- (2) The amounts of additive and each cordance with the following prescribed amino acid contained in any mixture. conditions: (3) Adequate directions for use to (a) Vitamin D2, also known as provide a finished food meeting the ergocalciferol, is the chemical 9,10- limitations prescribed by paragraph (c) seco(5Z,7E,22E)-5,7,10(19),22- of this section. ergostatetraen-3-ol. Vitamin D2 is pro- (f) When the food additive is added as duced by ultraviolet irradiation of er- a nutrient to special dietary foods that gosterol isolated from yeast and is pu- are intended for use solely under med- rified by crystallization. ical supervision to meet nutritional re- (b) Vitamin D2 meets the specifica- quirements in specific medical condi- tions of the 2015 Food Chemical Codex, 9th edition (through Third Supple- tions and these foods comply with the ment), effective December 1, 2015, pp. requirements of part 105 of this chap- 1260–1261, which is incorporated by ref- ter, the food additive is exempt from erence. The Director of the Office of the limitations in paragraphs (c)(1) the Federal Register approves this in- through (4) and (d) of this section and corporation by reference in accordance may be used in those foods at levels with 5 U.S.C. 552(a) and 1 CFR part 51.

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You may obtain copies from the United National Archives and Records Admin- States Pharmacopeial Convention, istration (NARA). For information on 12601 Twinbrook Pkwy., Rockville, MD the availability of this material at 20852 (Internet address http:// NARA, call 202–741–6030 or go to: http:// www.usp.org). Copies may be examined www.archives.gov/federal-register/cfr/ibr- at the Food and Drug Administration’s locations.html. Main Library, 10903 New Hampshire (c) The additive may be used as fol- Ave., Bldg. 2, Third Floor, Silver lows: Spring, MD 20993, 301–796–2039, or at the

Category of Food Maximum Levels in Food (as Served)

Edible plant-based beverages intended as milk alternatives 84 IU/100 g.

Edible plant-based yogurt alternatives 89 IU/100 g.

Soy beverage products 89 IU/100 g

Soy-based butter substitute spreads 330 IU/100 g

Soy-based cheese substitutes and soy-based cheese substitute 270 IU/100 g products

[74 FR 11022, Mar. 16, 2009, as amended at 78 the availability of this material at FR 71463, Nov. 29, 2013; 81 FR 46581, July 18, NARA, call 202–741–6030, or go to: http:// 2016] www.archives.gov/federallregister/ codeloflfederallregulations/ § 172.380 Vitamin D . 3 ibrllocations.html. Vitamin D3 may be used safely in (c) The additive may be used as fol- foods as a nutrient supplement defined lows: under § 170.3(o)(20) of this chapter in ac- (1) At levels not to exceed 100 Inter- cordance with the following prescribed national Units (IU) per 240 milliliters conditions: (mL) in 100 percent fruit juices (as de- (a) Vitamin D3, also known as chole- fined under § 170.3(n)(35) of this chapter) calciferol, is the chemical 9,10- that are fortified with greater than or seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. equal to 33 percent of the reference Vitamin D3 occurs in and is isolated daily intake (RDI) of calcium per 240 from fish liver oils. It also is manufac- mL, excluding fruit juices that are spe- tured by ultraviolet irradiation of 7-de- cially formulated or processed for in- hydrocholesterol produced from choles- fants. terol and is purified by crystallization. (2) At levels not to exceed 100 IU per (b) Vitamin D3 meets the specifica- 240 mL in fruit juice drinks (as defined tions of the 2015 Food Chemical Codex, under § 170.3(n)(35) of this chapter) that 9th edition (through Third Supple- are fortified with greater than or equal ment), effective December 1, 2015, pp. to 10 percent of the RDI of calcium per 1261–1262, which is incorporated by ref- 240 mL, excluding fruit juice drinks erence. The Director of the Office of that are specially formulated or proc- the Federal Register approves this in- essed for infants. corporation by reference in accordance (3) At levels not to exceed 140 IU per with 5 U.S.C. 552(a) and 1 CFR part 51. 240 mL (prepared beverage) in soy-pro- You may obtain copies from the United tein based meal replacement beverages States Pharmacopeial Convention, (powder or liquid) that are represented 12601 Twinbrook Pkwy., Rockville, MD for special dietary use in reducing or 20852 (Internet address http:// maintaining body weight in accordance www.usp.org). Copies may be examined with § 105.66 of this chapter. at the Food and Drug Administration’s (4) At levels not to exceed 100 IU per Main Library, 10903 New Hampshire 40 grams in meal replacement bars or Ave., Bldg. 2, Third Floor, Silver other-type bars that are represented Spring, MD 20993, 301–796–2039, or at the for special dietary use in reducing or National Archives and Records Admin- maintaining body weight in accordance istration (NARA). For information on with § 105.66 of this chapter.

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(5) At levels not to exceed 81 IU per 30 national Units of vitamin D2 per 100 grams in cheese and cheese products as grams in the finished food. defined under § 170.3(n)(5) of this chap- (d) To assure safe use of the additive, ter, excluding cottage cheese, ricotta the label or labeling of the food addi- cheese, and hard grating cheeses such tive container shall bear, in addition to as Parmesan and Romano as defined in the other information required by the §§ 133.165 and 133.183 of this chapter, and Federal Food, Drug, and Cosmetic Act, those defined by standard of identity in adequate directions for use to provide a § 133.148 of this chapter. final product that complies with the (6) At levels not to exceed 500 IU per limitations prescribed in paragraph (c) 240 mL (prepared beverage) in meal re- of this section. placement beverages that are not in- (e) Labels of manufactured food prod- tended for special dietary use in reduc- ucts containing the additive shall bear, ing or maintaining body weight and in the ingredient statement, the name that are represented for use such that of the additive, ‘‘vitamin D2 bakers the total amount of Vitamin D3 pro- yeast,’’ in the proper order of decreas- vided by the product does not exceed ing predominance in the finished food. 1,000 IU per day. (7) At levels not to exceed 1.0 IU per [77 FR 52231, Aug. 29, 2012] kilocalorie in foods represented for use as a sole source of nutrition for enteral § 172.385 Whole fish protein con- centrate. feeding. (8) At levels not to exceed 84 IU per The food additive whole fish protein 100 g (800 IU/quart) in milk that con- concentrate may be safely used as a tains more than 42 IU vitamin D per 100 food supplement in accordance with g (400 IU/quart) and that meets the re- the following prescribed conditions: quirements for foods named by use of a (a) The additive is derived from nutrient content claim and a standard- whole, wholesome hake and hakelike ized term in accordance with § 130.10 of fish, herring of the genera Clupea, men- this chapter. haden, and anchovy of the species En- graulis mordax, handled expeditiously [68 FR 9003, Feb. 27, 2003, as amended at 70 and under sanitary conditions in ac- FR 36025, June 22, 2005; 70 FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005; 78 FR 71463, cordance with good manufacturing Nov. 29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR practices recognized as proper for fish 46582, July 18, 2016] that are used in other forms for human food. § 172.381 Vitamin D 2 bakers yeast. (b) The additive consists essentially

Vitamin D2 bakers yeast may be used of a dried fish protein processed from safely in foods as a source of vitamin the whole fish without removal of D2 and as a leavening agent in accord- heads, fins, tails, viscera, or intestinal ance with the following prescribed con- contents. It is prepared by solvent ex- ditions: traction of fat and moisture with iso- (a) Vitamin D2 bakers yeast is the propyl alcohol or with ethylene dichlo- substance produced by exposing bakers ride followed by isopropyl alcohol, ex- yeast (Saccharomyces cerevisiae) to ul- cept that the additive derived from traviolet light, resulting in the photo- herring, menhaden and anchovy is pre- chemical conversion of endogenous er- pared by solvent extraction with iso- gosterol in bakers yeast to vitamin D2 propyl alcohol alone. Solvent residues (also known as ergocalciferol or (9,10- are reduced by conventional heat dry- seco(5Z,7E,22E)-5,7,10(19),22- ing and/or microwave radiation and ergostatetraen-3-ol)). there is a partial removal of bone. (b) Vitamin D2 bakers yeast may be (c) The food additive meets the fol- used alone as an active dry yeast con- lowing specifications: centrate or in combination with con- (1) Protein content (N × 6.25) shall ventional bakers yeast. not be less than 75 percent by weight of (c) The additive may be used in the final product, as determined by the yeast-leavened baked goods and baking method described in section 2.057 in mixes and yeast-leavened baked snack ‘‘Official Methods of Analysis of the foods at levels not to exceed 400 Inter- Association of Official Analytical

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Chemists’’ (AOAC), 13th Ed. (1980). Pro- per day (about one heaping table- tein quality shall not be less than 100, spoon). as determined by the method described (e) When the additive is used as a in sections 43.212–43.216 of the AOAC. protein supplement in manufactured The 13th Ed. is incorporated by ref- food, the total content (ex- erence, and copies may be obtained pressed as F) of the finished food shall from the AOAC INTERNATIONAL, 481 not exceed 8 ppm based on the dry North Frederick Ave., suite 500, Gai- weight of the food product. thersburg, MD 20877, or may be exam- (f) To assure safe use of the additive, ined at the National Archives and in addition to the other information re- Records Administration (NARA). For quired by the Act: information on the availability of this (1) The label of consumer-sized or material at NARA, call 202–741–6030, or bulk containers of the additive shall go to: http://www.archives.gov/ bear the name ‘‘whole fish protein con- federallregister/ centrate’’. codeloflfederallregulations/ (2) The label or labeling of containers ibrllocations.html. of the additive shall bear adequate di- (2) Moisture content shall not exceed rections for use to comply with the 10 percent by weight of the final prod- limitations prescribed by paragraphs uct, as determined by the method de- (d) and (e) of this section. scribed in section 24.003 of the AOAC. (3) Labels of manufactured foods con- See paragraph (c)(1) of this section for taining the additive shall bear, in the availability of the material incor- ingredient statement, the name of the porated by reference. additive, ‘‘whole fish protein con- (3) Fat content shall not exceed 0.5 centrate’’ in the proper order of de- percent by weight of the final product, creasing predominance in the finished as determined by the method described food. in section 24.005 of the AOAC. See para- graph (c)(1) of the this section for [42 FR 14491, Mar. 15, 1977, as amended at 49 availability of the material incor- FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989] porated by reference. (4) The additive may contain residues § 172.395 Xylitol. of isopropyl alcohol and ethylene di- chloride not in excess of 250 parts per Xylitol may be safely used in foods million and 5 parts per million, respec- for special dietary uses, provided the tively, when used as solvents in the ex- amount used is not greater than that traction process. required to produce its intended effect. (5) Microwave radiation meeting the § 172.399 Zinc methionine sulfate. requirements of § 179.30 of this chapter may be used to reduce residues of the Zinc methionine sulfate, CAS Reg. solvents used in the extraction process. No. 56329–42–1, may be safely used in (6) The additive shall contain not in accordance with the following pre- excess of 100 parts per million scribed conditions: (expressed as F). (a) The additive is the product of the (7) The additive shall be free of Esch- reaction between equimolar amounts of erichia coli and pathogenic organisms, zinc sulfate and DL-methionine in puri- including Salmonella, and shall have a fied water. total bacterial plate count of not more (b) The additive meets the following than 10,000 per gram. specifications: (8) The additive shall have no more Zinc content—19 to 22 percent. than a faint characteristic fish odor C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- and taste. cent. (d) When the additive is used or in- Cadmium—not more than 0.05 part per mil- tended for use in the household as a lion. protein supplement in food for regular (c) The additive is used in tablet form consumption by children up to 8 years as a source of dietary zinc. of age, the amount of the additive from this source shall not exceed 20 grams [46 FR 58297, Dec. 1, 1981]

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Subpart E—Anticaking Agents (c) It is used or intended for use as a stabilizer in the production of beer, and § 172.410 Calcium silicate. is removed from the beer by filtration Calcium silicate, including synthetic prior to final processing. calcium silicate, may be safely used in (d) It is used or intended for use as an food in accordance with the following adsorbent for dl-a-tocopheryl acetate prescribed conditions: and pantothenyl alcohol in tableted (a) It is used as an anticaking agent foods for special dietary use, in an in food in an amount not in excess of amount not greater than that required that reasonably required to produce its to accomplish the intended physical or intended effect. technical effect. (b) It will not exceed 2 percent by weight of the food, except that it may § 172.490 Yellow prussiate of soda. be present up to 5 percent by weight of (a) The food additive yellow prussiate baking powder. of soda (sodium ferrocyanide decahy- drate; Na Fe(CN) ·10H O contains a § 172.430 Iron ammonium citrate. 4 6 2 minimum of 99 percent by weight of so- Iron ammonium citrate may be safe- dium ferrocyanide decahydrate. ly used in food in accordance with the (b) The additive is used or intended following prescribed conditions: for use as an anticaking agent in salt (a) The additive is the chemical and as an adjuvant in the production of green ferric ammonium citrate. dendritic crystals of salt in an amount (b) The additive is used, or intended needed to produce its intended effect for use as an anticaking agent in salt for human consumption so that the but not in excess of 13 parts per million level of iron ammonium citrate does calculated as anhydrous sodium ferro- not exceed 25 parts per million (0.0025 cyanide. percent) in the finished salt. [42 FR 14491, Mar. 15, 1977, as amended at 58 (c) To assure safe use of the additive FR 17098, Apr. 1, 1993] the label or labeling of the additive shall bear, in addition to the other in- Subpart F—Flavoring Agents and formation required by the Act: (1) The name of the additive. Related Substances (2) Adequate directions to provide a § 172.510 Natural flavoring substances final product that complies with the and natural substances used in con- limitations prescribed in paragraph (b) junction with flavors. of this section. Natural flavoring substances and § 172.480 Silicon dioxide. natural adjuvants may be safely used The food additive silicon dioxide may in food in accordance with the fol- be safely used in food in accordance lowing conditions. with the following conditions: (a) They are used in the minimum (a) The food additive is manufactured quantity required to produce their in- by vapor phase hydrolysis or by other tended physical or technical effect and means whereby the particle size is such in accordance with all the principles of as to accomplish the intended effect. good manufacturing practice. (b) It is used as an anticaking agent, (b) In the appropriate forms (plant subject to the following conditions: parts, fluid and solid extracts, con- (1) It is used in only those foods in centrates, absolutes, oils, gums, bal- which the additive has been dem- sams, , oleoresins, waxes, and dis- onstrated to have an anticaking effect. tillates) they consist of one or more of (2) It is used in an amount not in ex- the following, used alone or in com- cess of that reasonably required to bination with flavoring substances and produce its intended effect. adjuvants generally recognized as safe (3) [Reserved] in food, previously sanctioned for such (4) It is used in an amount not to ex- use, or regulated in any section of this ceed 2 percent by weight of the food. part.

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Common name Scientific name Limitations

Aloe ...... Aloe perryi Baker, A. barbadensis Mill., A. ferox Mill., and hybrids of this sp. with A. africana Mill. and A. spicata Baker. Althea and flowers ...... Althea officinalis L. Amyris (West Indian sandalwood) ...... Amyris balsamifera L. Angola weed ...... Roccella fuciformis Ach ...... In alcoholic beverages only Arnica flowers ...... Arnica montana L., A. fulgens Pursh, A. sororia Do. Greene, or A. cordifolia Hooker. Artemisia (wormwood) ...... Artemisia spp ...... Finished food thujone free 1 Artichoke leaves ...... Cynara scolymus L ...... In alcoholic beverages only resin ...... Styrax benzoin Dryander, S. paralleloneurus Per- kins, S. tonkinensis (Pierre) Craib ex Hartwich, or other spp. of the Section Anthostyrax of the genus Styrax. Blackberry bark ...... Rubus, Section Eubatus. Boldus (boldo) leaves ...... Peumus boldus Mol ...... Do. Boronia flowers ...... Boronia megastigma Nees. Bryonia root ...... Bryonia alba L., or B. diocia Jacq ...... Do. Buchu leaves ...... Barosma betulina Bartl. et Wendl., B. crenulata (L.) Hook. or B. serratifolia Willd. Buckbean leaves ...... Menyanthes trifoliata L ...... Do. Cajeput ...... Melaleuca leucadendron L. and other Melaleuca spp. Calumba root ...... Jateorhiza palmata (Lam.) Miers ...... Do. tree ...... Cinnamomum camphora (L.) Nees et Eberm ...... Safrole free Cascara sagrada ...... Rhamnus purshiana DC. Cassie flowers ...... Acacia farnesiana (L.) Willd. Castor oil ...... Ricinus communis L. Catechu, black ...... Acacia catechu Willd. Cedar, white (aborvitae), leaves and twigs ... Thuja occidentalis L ...... Finished food thujone free 1 Centuary ...... Centaurium umbellatum Gilib ...... In alcoholic beverages only Cherry pits ...... Prunus avium L. or P. cerasus L ...... Not to exceed 25 p.p.m. prussic acid Cherry-laurel leaves ...... Prunus laurocerasus L ...... Do. Chestnut leaves ...... Castanea dentata (Marsh.) Borkh. Chirata ...... Swertia chirata Buch.-Ham ...... In alcoholic beverages only Cinchona, red, bark ...... Cinchona succirubra Pav. or its hybrids ...... In beverages only; not more than 83 p.p.m. total cinchona alkaloids in finished beverage Cinchona, yellow, bark ...... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do. hybrids of these with other spp. of Cinchona.. Copaiba ...... South American spp. of Copaifera L. , oak ...... Quercus suber L., or Q. occidentalis F. Gay ...... In alcoholic beverages only Costmary ...... Chrysanthemum balsamita L ...... Do. Costus root ...... Saussurea lappa Clarke. Cubeb ...... Piper cubeba L. f. Currant, black, buds and leaves ...... Ribes nigrum L. Damiana leaves ...... Turnera diffusa Willd. Davana ...... Artemisia pallens Wall. Dill, Indian ...... Anethum sowa Roxb. (Peucedanum graveolens Benth et Hook., Anethum graveolens L.). Dittany (fraxinella) ...... Dictamnus albus L ...... Do. Dittany of Crete ...... Origanum dictamnus L. Dragon’s blood (dracorubin) ...... Daemonorops spp. Elder tree leaves ...... Sambucus nigra L ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Elecampane rhizome and roots ...... Inula helenium L ...... In alcoholic beverages only Elemi ...... Canarium commune L. or C. luzonicum Miq. Erigeron ...... Erigeron canadensis L. Eucalyptus globulus leaves ...... Eucalyptus globulus Labill. Fir (‘‘pine’’) needles and twigs ...... Abies sibirica Ledeb., A. alba Mill., A. sachalinesis Masters or A. mayriana Miyabe et Kudo. Fir, balsam, needles and twigs ...... Abies balsamea (L.) Mill. Galanga, greater ...... Alpinia galanga Willd ...... Do.

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Common name Scientific name Limitations

Galbanum ...... Ferula galbaniflua Boiss. et Buhse and other Ferula spp. Gambir (catechu, pale) ...... gambir Roxb. Genet flowers ...... Spartium junceum L. Gentian rhizome and roots ...... Gentiana lutea L. Gentian, stemless ...... Gentiana acaulis L ...... Do. Germander, chamaedrys ...... Teucrium chamaedrys L ...... Do. Germander, golden ...... Teucrium polium L ...... Do. Guaiac ...... Guaiacum officinale L., G. santum L., Bulnesia sarmienti Lor. ...... Paullinia cupana HBK. Haw, black, bark ...... Viburnum prunifolium L. Hemlock needles and twigs ...... Tsuga canadensis (L.) Carr. or T. heterophylla (Raf.) Sarg. Hyacinth flowers ...... Hyacinthus orientalis L. Iceland moss ...... Cetraria islandica Ach ...... Do. Imperatoria ...... Peucedanum ostruthium (L.). Koch (Imperatoria ostruthium L.). Iva ...... Achillea moschata Jacq ...... Do. Labdanum ...... Cistus spp. Lemon-verbena ...... Lippia citriodora HBK ...... Do. Linaloe wood ...... Bursera delpechiana Poiss. and other Bursera spp. Linden leaves ...... Tillia spp ...... Do. Lovage ...... Levisticum officinale Koch. Lungmoss (lungwort) ...... Sticta pulmonacea Ach. Maidenhair ...... Adiantum capillus-veneris L ...... Do. Maple, mountain ...... Acer spicatum Lam. Mimosa (black wattle) flowers ...... Acacia decurrens Willd. var. dealbata. Mullein flowers ...... Verbascum phlomoides L. or V. thapsiforme Schrad Do. ...... Commiphora molmol Engl., C. abyssinica (Berg) Engl., or other Commiphora spp. Myrtle leaves ...... Myrtus communis L ...... Do. Oak, English, wood ...... Quercus robur L ...... Do. Oak, white, chips ...... Quercus alba L. Oak moss ...... Evernia prunastri (L.) Ach., E. furfuracea (L.) Mann, Finished food thujone and other lichens. free 1 Olibanum ...... Boswellia carteri Birdw. and other Boswellia spp. Opopanax (bisabolmyrrh) ...... Opopanax chironium Koch (true opopanax) of Commiphora erythraea Engl. var. Llabrescens. Orris root ...... Iris germanica L. (including its variety florentina Dykes) and I. pallida Lam. Pansy ...... Viola tricolor L ...... In alcoholic beverages only Passion flower ...... Passiflora incarnata L. Patchouly ...... Pogostemon cablin Benth. and P. heyneanus Benth. Peach leaves ...... Prunus persica (L.) Batsch ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Pennyroyal, American ...... Hedeoma pulegioides (L.) Pers. Pennyroyal, European ...... Mentha pulegium L. Pine, dwarf, needles and twigs ...... Pinus mugo Turra var. pumilio (Haenke) Zenari. Pine, Scotch, needles and twigs ...... Pinus sylvestris L. Pine, white, bark ...... Pinus strobus L ...... In alcoholic beverages only Pine, white oil ...... Pinus palustris Mill., and other Pinus spp. Poplar buds ...... Populus balsamifera L. (P. tacamahacca Mill.), P. Do. candicans Ait., or P. nigra L. Quassia ...... Picrasma excelsa (Sw.) Planch, or Quassia amara L. Quebracho bark ...... Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii (Quebrachia lorentzii (Griseb)). (Griseb.) Engl. Quillaia (soapbark) ...... Quillaja saponaria Mol. Red saunders (red sandalwood) ...... Pterocarpus san alinus L ...... In alcoholic beverages only Rhatany root ...... Krameria triandra Ruiz et Pav. or K. argentea Mart. Rhubarb, garden root ...... Rheum rhaponticum L ...... Do. Rhubarb root ...... Rheum officinale Baill., R. palmatum L., or other spp. (excepting R. rhaponticum L.) or hybrids of Rheum grown in China. Roselle ...... Hibiscus sabdariffa L ...... Do. Rosin (colophony) ...... Pinus palustris Mill., and other Pinus spp ...... Do. St. Johnswort leaves, flowers, and caulis ...... L ...... Hypericin-free alcohol dis- tillate form only; in alco- holic beverages only

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Common name Scientific name Limitations

Sandalwood, white (yellow, or East Indian) ... Santalum album L. Sandarac ...... Tetraclinis articulata (Vahl.), Mast ...... In alcoholic beverages only Sarsaparilla ...... Smilax aristolochiaefolia Mill., (Mexican sarsaparilla), S. regelii Killip et Morton (Honduras sarsaparilla), S. febrifuga Kunth (Ecuadorean sarsaparilla), or undetermined Smilax spp. (Ecuadorean or Central American sarsaparilla). Sassafras leaves ...... Sassafras albidum (Nutt.) Nees ...... Safrole free Senna, Alexandria ...... Cassia acutifolia Delile. Serpentaria (Virginia snakeroot) ...... Aristolochia serpentaria L ...... In alcoholic beverages only Simaruba bark ...... Simaruba amara Aubl ...... Do. Snakeroot, Canadian (wild ginger) ...... Asarum canadense L. Spruce needles and twigs ...... Picea glauca (Moench) Voss or P. mariana (Mill.) BSP. Storax (styrax) ...... Liquidambar orientalis Mill. or L. styraciflua L. Tagetes (marigold) ...... Tagetes patula L., T. erecta L., or T. minuta L. (T. As oil only glandulifera Schrank). Tansy ...... Tanacetum vulgare L ...... In alcoholic beverages only; finished alcoholic beverage thujone free 1 Thistle, blessed (holy thistle) ...... Onicus benedictus L ...... In alcoholic beverages only Thymus capitatus (Spanish ‘‘origanum’’) ...... Thymus capitatus Hoffmg. et Link. Tolu ...... Myroxylon balsamum (L.) Harms. ...... Pinus palustris Mill. and other Pinus spp. which yield terpene oils exclusively. Valerian rhizome and roots ...... Valeriana officinalis L. Veronica ...... Veronica officinalis L ...... Do. Vervain, European ...... Verbena officinalis L ...... Do. Vetiver ...... Vetiveria zizanioides Stapf ...... Do. Violet, Swiss ...... Viola calcarata L. Walnut husks (hulls), leaves, and green nuts Juglans nigra L. or J. regia L. Woodruff, sweet ...... Asperula odorata L ...... In alcoholic beverages only Yarrow ...... Achillea millefolium L ...... In beverages only; fin- ished beverage thujone free 1 Yerba santa ...... Eriodictyon californicum (Hook, et Arn.) Torr. Yucca, Joshua-tree ...... Yucca brevifolia Engelm. Yucca, Mohave ...... Yucca schidigera Roezl ex Ortgies (Y. mohavensis Sarg.). 1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by ref- erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ ibrllocations.html.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 69 FR 24511, May 4, 2004; 72 FR 10357, Mar. 8, 2007]

§ 172.515 Synthetic flavoring sub- vants generally recognized as safe in stances and adjuvants. food, prior-sanctioned for such use, or Synthetic flavoring substances and regulated by an appropriate section in adjuvants may be safely used in food in this part. accordance with the following condi- Acetal; acetaldehyde diethyl acetal. tions. Acetaldehyde phenethyl propyl acetal. (a) They are used in the minimum Acetanisole; 4′-methoxyacetophenone. quantity required to produce their in- Acetophenone; methyl phenyl ketone. tended effect, and otherwise in accord- Allyl anthranilate. Allyl butyrate. ance with all the principles of good Allyl cinnamate. manufacturing practice. Allyl cyclohexaneacetate. (b) They consist of one or more of the Allyl cyclohexanebutyrate. following, used alone or in combination Allyl cyclohexanehexanoate. with flavoring substances and adju- Allyl cyclohexaneproprionate.

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Allyl cyclohexanevalerate. Benzyl methoxyethyl acetal; acetaldehyde Allyl disulfide. benzyl b-methoxyethyl acetal. Allyl 2-ethylbutyrate. Benzyl phenylacetate. Allyl hexanoate; allyl caproate. Benzyl propionate. Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- Benzyl salicylate. ene-1-yl)-1,6-heptadiene-3-one. oil. ; mustard oil. Borneol; d-camphanol. Allyl isovalerate. Bornyl acetate. Allyl mercaptan; 2-propene-1-thiol. Bornyl formate. Allyl nonanoate. Bornyl isovalerate. Allyl octanoate. Bornyl valerate. Allyl phenoxyacetate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca- Allyl phenylacetate. hydro-la-isopropyl-3aa-methyl-6-meth- Allyl propionate. ylene-cyclobuta [1,2:3,4] dicyclopentene. Allyl sorbate; allyl 2,4-hexadienoate. 2-Butanol. Allyl sulfide. 2-Butanone; methyl ethyl ketone. Allyl tiglate; allyl trans-2-methyl-2- Butter acids. butenoate. Butter esters. Allyl 10-undecenoate. Butyl acetate. Ammonium isovalerate. Butyl acetoacetate. Ammonium sulfide. Butyl alcohol; 1-butanol. Butyl anthranilate. Amyl alcohol; pentyl alcohol. Butyl butyrate. Amyl butyrate. Butyl butyryllactate; lactic acid, butyl -Amylcinnamaldehyde. a ester, butyrate. a-Amylcinnamaldehyde dimethyl acetal. a-Butylcinnamaldehyde. -Amylcinnamyl acetate. a Butyl cinnamate. a-Amylcinnamyl alcohol. Butyl 2-decenoate. a-Amylcinnamyl formate. Butyl ethyl malonate. a-Amylcinnamyl isovalerate. Butyl formate. Amyl formate. Butyl heptanoate. Amyl heptanoate. Butyl hexanoate. Amyl hexanoate. Butyl p-hydroxybenzoate. Amyl octanoate. Butyl isobutyrate. Anisole; methoxybenzene. Butyl isovalerate. Anisyl acetate. Butyl lactate. Anisyl alcohol; p-methoxybenzyl alcohol. Butyl laurate. Anisyl butyrate Butyl levulinate. Anisyl formate. Butyl phenylacetate. Anisyl phenylacetate. Butyl propionate. Anisyl propionate. Butyl stearate. Beechwood . Butyl sulfide. dimethyl acetal. Butyl 10-undecenoate. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- Butyl valerate. oxan-5-ol. Butyraldehyde. Benzaldehyde propylene glycol acetal; 4- Cadinene. methyl-2-phenyl-m-dioxolane. Camphene; 2,2-dimethyl-3-methylene- Benzenethiol; thiophenol. norbornane. Benzoin; 2-hydroxy-2-phenylacetophenone. d-Camphor. Benzophenone; diphenylketone. ; 2-p-cymenol. Benzyl acetate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Benzyl acetoacetate. Carveol; p-mentha-6,8-dien-2-ol. Benzyl alcohol. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Benzyl benzoate. terpinenol. Benzyl butyl ether. cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- Benzyl butyrate. one. Benzyl cinnamate. Carvyl acetate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Carvyl propionate. tiglate. b-Caryophyllene. Benzyl disulfide; dibenzyl disulfide. Caryophyllene alcohol. Benzyl ethyl ether. Caryophyllene alcohol acetate. Benzyl formate. b-Caryophyllene oxide; 4-12,12-trimethyl-9- 3-Benzyl-4-heptanone; benzyl dipropyl ke- methylene-5-oxatricylo [8.2.0.0 46] dode- tone. cane. Benzyl isobutyrate. Cedarwood oil alcohols. Benzyl isovalerate. Cedarwood oil terpenes. Benzyl mercaptan; a-toluenethiol. 1,4-Cineole. 64

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Cinnamaldehyde ethylene glycol acetal. p-Dimethoxybenzene; dimethyl hydro- Cinnamic acid. quinone. Cinnamyl acetate. 2,4-Dimethylacetophenone. Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. a,a-Dimethylbenzyl isobutyrate; phenyldi- Cinnamyl benzoate. methylcarbinyl isobutyrate. Cinnamyl butyrate. 2,6-Dimethyl-5-heptenal. Cinnamyl cinnamate. 2,6-Dimethyl octanal; isodecylaldehyde. Cinnamyl formate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Cinnamyl isobutyrate. a,a-Dimethylphenethyl acetate; benzyl- Cinnamyl isovalerate. propyl acetate; benzyldimethylcarbinyl ac- Cinnamyl phenylacetate. etate. Cinnamyl propionate. a,a-Dimethylphenethyl alcohol; dimethyl- Citral diethyl acetal; 3,7-dimethyl-2,6-octa- benzyl carbinol. dienal diethyl acetal. a,a-Dimethylphenethyl butyrate; benzyl- Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- dimethylcarbinyl butyrate. dienal dimethyl acetal. a,a-Dimethylphenethyl formate; benzyldi- Citral propylene glycol acetal. methylcarbinyl formate. Citronellal; 3,7-dimethyl-6-octenal; rhodinal. Dimethyl succinate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- 1,3-Diphenyl-2-propanone; dibenzyl ketone. ronellol. delta-Dodecalactone; 5-hydroxydodecanoic Citronelloxyacetaldehyde. acid, deltalactone. Citronellyl acetate. g-Dodecalactone; 4-hydroxydodecanoic acid g- Citronellyl butyrate. lactone. Citronellyl formate. 2-Dodecenal. Citronellyl isobutyrate. Estragole. Citronellyl phenylacetate. r-Ethoxybenzaldehyde. Citronellyl propionate. Ethyl acetoacetate. Citronellyl valerate. Ethyl 2-acetyl-3-phenylpropionate; ethyl- p-Cresol. benzyl acetoacetate. Cuminaldehyde; cuminal; p-isopropyl benz- Ethyl aconitate, mixed esters. aldehyde. Ethyl acrylate. Cyclohexaneacetic acid. Ethyl r-anisate. Cyclohexaneethyl acetate. Ethyl anthranilate. Cyclohexyl acetate. Ethyl benzoate. Cyclohexyl anthranilate. Ethyl benzoylacetate. Cyclohexyl butyrate. a-Ethylbenzyl butyrate; a-phenylpropyl bu- Cyclohexyl cinnamate. tyrate. Cyclohexyl formate. Ethyl brassylate; tridecanedioic acid cyclic Cyclohexyl isovalerate. ethylene glycol diester; cyclo 1,13-ethyl- Cyclohexyl propionate. enedioxytridecan-1,13-dione. p-Cymene. 2-Ethylbutyl acetate. g-Decalactone; 4-hydroxy-decanoic acid, g- 2-Ethylbutyraldehyde. lactone. 2-Ethylbutyric acid. g-Decalactone; 5-hydroxy-decanoic acid, d- Ethyl cinnamate. lactone. Ethyl crotonate; trans-2-butenoic acid ethyl- Decanal dimethyl acetal. ester. 1-Decanol; decylic alcohol. Ethyl cyclohexanepropionate. 2-Decenal. Ethyl decanoate. 3-Decen-2-one; heptylidene acetone. 2-Ethylfuran. Decyl actate. Ethyl 2-furanpropionate. Decyl butyrate. 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. Decyl propionate. Ethyl heptanoate. Dibenzyl ether. 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy- Ethyl hexanoate. droxy-butyric acid, g-lactone. Ethyl isobutyrate. Dibutyl sebacate. Ethyl isovalerate. Diethyl malate. Ethyl lactate. Diethyl malonate; ethyl malonate. Ethyl laurate. Diethyl sebacate. Ethyl levulinate. Diethyl succinate. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- Diethyl tartrate. one. 2,5-Diethyltetrahydrofuran. Ethyl 2-methylbutyrate. Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl- Ethyl myristate. 3-isopropenylcyclohexanol. Ethyl nitrite. Dihydrocarvone. Ethyl nonanoate. Dihydrocarvyl acetate. Ethyl 2-nonynoate; ethyl octyne carbonate. m-Dimethoxybenzene. Ethyl octanoate.

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Ethyl oleate. Heptyl isobutyrate. Ethyl phenylacetate. Heptyl octanoate. Ethyl 4-phenylbutyrate. 1-Hexadecanol; cetyl alcohol. Ethyl 3-phenylglycidate. w-6-Hexadecenlactone; 16-hydroxy-6- Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, w-lactone; cinnamate. ambrettolide. Ethyl propionate. g-Hexalactone; 4-hydroxyhexanoic acid, g-lac- Ethyl pyruvate. tone; tonkalide. Ethyl salicylate. Hexanal; caproic aldehyde. Ethyl sorbate; ethyl 2,4-hexadienoate. 2,3-Hexanedione; acetyl butyryl. Ethyl tiglate; ethyl trans-2-methyl-2- Hexanoic acid; caproic acid. butenoate. 2-Hexenal. Ethyl undecanoate. 2-Hexen-1-ol. Ethyl 10-undecenoate. 3-Hexen-1-ol; leaf alcohol. Ethyl valerate. 2-Hexen-1-yl acetate. ; 1,8-epoxy-p-menthane; cineole. 3-Hexenyl isovalerate. Eugenyl acetate. 3-Hexenyl 2-methylbutyrate. Eugenyl benzoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen- Eugenyl formate. ylacetate. Eugenyl methyl ether; 4-allylveratrole; Hexyl acetate. methyl . 2-Hexyl-4-acetoxytetrahydrofuran. Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- Hexyl alcohol. 1-ol. Hexyl butyrate. d-Fenchone; d-1,3,3-trimethyl-2-nor- a-Hexylcinnamaldehyde. bornanone. Hexyl formate. Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Hexyl hexanoate. bornanol. 2-Hexylidene cyclopentanone. Formic acid (2-Furyl)-2-propanone; furyl acetone. Hexyl isovalerate. 1-Furyl-2-propanone; furyl acetone. Hexyl 2-methylbutyrate. Fusel oil, refined (mixed amyl alcohols). Hexyl octanoate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Hexyl phenylacetate; n-hexyl phenylacetate. octadien-1-yl acetoacetate. Hexyl propionate. Geranyl acetone; 6,10-dimethyl-5,9- ; 3,7-dimethyl-7-hydroxy- undecadien-2-one. octanal. Geranyl benzoate. Hydroxycitronellal diethyl acetal. Geranyl butyrate. Hydroxycitronellal dimethyl acetal. Geranyl formate. Hydroxycitronellol; 3,7-dimethyl-1,7- Geranyl hexanoate octanediol. Geranyl isobutyrate. N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Geranyl isovalerate. pelargonyl vanillylamide. Geranyl phenylacetate. 5-Hydroxy-4-octanone; butyroin. Geranyl propionate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Glucose pentaacetate. benzyl acetone. Guaiacol; μ-methoxyphenol. Indole. Guaiacyl acetate; μ-methoxyphenyl acetate. a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Guaiacyl phenylacetate. yl)-3-buten-2-one. Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10- b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- octahydroazulene. yl)-3-buten-2-one. Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy- a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- isopropyl)-d9,10-octahydroazulene acetate. 1-yl)-3-buten-2-one; 6-methylionone. g-Heptalactone; 4-hydroxyheptanoic acid, g- Isoamyl acetate. lactone. Isoamyl acetoacetate. Heptanal; enanthaldehyde. Isoamyl alcohol; isopentyl alcohol; 3-methyl- Heptanal dimethyl acetal. 1-butanol. Heptanal 1,2-glyceryl acetal. Isoamyl benzoate. 2,3-Heptanedione; acetyl valeryl. Isoamyl butyrate. 3-Heptanol. Isoamyl cinnamate. 2-Heptanone; methyl amyl ketone. Isoamyl formate. 3-Heptanone; ethyl butyl ketone. Isoamyl 2-furanbutyrate; a-isoamyl furfuryl- 4-Heptanone; dipropyl ketone. propionate. cis-4-Heptenal; cis-4-hepten-1-al. Isoamyl 2-furanpropionate; a-isoamyl fur- Heptyl acetate. furylacetate. Heptyl alcohol; enanthic alcohol. Isoamyl hexanoate. Heptyl butyrate. Isoamyl isobutyrate. Heptyl cinnamate. Isoamyl isovalerate. Heptyl formate. Isoamyl laurate.

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Isoamyl-2-methylbutyrate; isopentyl-2- Isopropyl propionate. methylbutyrate. Isopulegol; p-menth-8-en-3-ol. Isoamyl nonanoate. Isopulegone; p-menth-8-en-3-one. Isoamyl octanoate. Isopulegyl acetate. Isoamyl phenylacetate. Isoquinoline. Isoamyl propionate. Isovaleric acid. Isoamyl pyruvate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- Isoamyl salicylate. penten-1-one. Isoborneol. Lauric aldehyde; dodecanal. Isobornyl acetate. Lauryl acetate. Isobornyl formate. Lauryl alcohol; 1-dodecanol. Isobornyl isovalerate. Lepidine; 4-methylquinoline. Isobornyl propionate. Levulinic acid. Isobutyl acetate. oxide; cis- and trans-2-vinyl-2-meth- Isobutyl acetoacetate. yl-5-(1′-hydroxy-1′-methylethyl) tetra- Isobutyl alcohol. hydrofuran. Isobutyl angelate; isobutyl cis-2-methyl-2- Linalyl anthranilate; 3,7-dimethyl-1,6- butenoate. octadien-3-yl anthranilate. Isobutyl anthranilate. Linalyl benzoate. Isobutyl benzoate. Linalyl butyrate. Isobutyl butyrate. Linalyl cinnamate. Isobutyl cinnamate. Linalyl formate. Isobutyl formate. Linalyl hexanoate. Isobutyl 2-furanpropionate. Linalyl isobutyrate. Isobutyl heptanoate. Linalyl isovalerate. Isobutyl hexanoate. Linalyl octanoate. Isobutyl isobutyrate. Linalyl propionate. a-Isobutylphenethyl alcohol; isobutyl benzyl Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. carbinol; 4-methyl-1-phenyl-2-pentanol. Menthadienol; p-mentha-1,8(10)-dien-9-ol. Isobutyl phenylacetate. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Isobutyl propionate. Menthadienyl acetate; p-mentha-1,8(10)-dien- Isobutyl salicylate. 9-yl acetate. 2-Isobutylthiazole. p-Menth-3-en-1-ol. Isobutyraldehyde. 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl Isobutyric acid. acetate. Isoeugenol; 2-methoxy-4-propenylphenol. ; 2-isopropyl-5-methylcyclohexanol. Isoeugenyl acetate. Menthone; p-menthan-3-one. Isoeugenyl benzyl ether; benzyl isoeugenol. Menthyl acetate; p-menth-3-yl acetate. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- Menthyl isovalerate; p-menth-3-yl iso- anisole; ethyl isoeugenol. valerate. Isoeugenyl formate. o-Methoxybenzaldehyde. Isoeugenyl methyl ether; 4-propenyl- p-Methoxybenzaldehyde; p-anisaldehyde. veratrole; methyl isoeugenol. o-Methoxycinnamaldehyde. Isoeugenyl phenylacetate. 2-Methoxy-4-methylphenol; 4-methyl- Isojasmone; mixture of 2-hexylidenecyclo- guaiacol; 2-methoxy-p-cresol. pentanone and 2-hexyl-2-cyclopenten-1-one. 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- a-Isomethylionone; 4-(2,6,6-trimethyl-2- tone. cyclohexen-1-yl)-3-methyl-3-buten-2-one; 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- methyl g-ionone. one; methoxystyryl isopropyl ketone. Isopropyl acetate. 1-(p-Methoxyphenyl)-1-penten-3-one; a- r-Isopropylacetophenone. methylanisylidene acetone; ethone. Isopropyl alcohol; isopropanol. 1-(p-Methoxyphenyl)-2-propanone; Isopropyl benzoate. anisylmethyl ketone; anisic ketone. r-Isopropylbenzyl alcohol; cuminic alcohol; 2-Methoxy-4-vinylphenol; p-vinylguaiacol. r-cymen-7-ol. Methyl acetate. Isopropyl butyrate. 4′-Methylacetophenone; p-methylaceto- Isopropyl cinnamate. phenone; methyl p-tolyl ketone. Isopropyl formate. 2-Methylallyl butyrate; 2-methyl-2-propenl- Isopropyl hexanoate. yl butyrate. Isopropyl isobutyrate. Methyl anisate. Isopropyl isovalerate. o-Methylanisole; o-cresyl methyl ether. r-Isopropylphenylacetaldehyde; r-cymen-7- p-Methylanisole; p-cresyl methyl ether; p- carboxaldehyde. methoxytoluene. Isopropyl phenylacetate. Methyl benzoate. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso- Methylbenzyl acetate, mixed o-,m-,p-. propylhydrocinnamaldehyde; cuminyl ac- a-Methylbenzyl acetate; styralyl acetate. etaldehyde. a-Methylbenzyl alcohol; styralyl alcohol. 67

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a-Methylbenzyl butyrate; styralyl butyrate. b-Methylphenethyl alcohol; hydratropyl al- a-Methylbenzyl isobutyrate; styralyl iso- cohol. butyrate. Methyl phenylacetate. a-Methylbenzyl formate; styralyl formate. 3-Methyl-4-phenyl-3-butene-2-one. a-Methylbenzyl propionate; styralyl propio- 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- nate. phenylethyl carbinyl acetate. 2-Methyl-3-buten-2-ol. 2-Methyl-4-phenyl-2-butyl isobutyrate; 2-Methylbutyl isovalerate. dimethylphenyl ethylcarbinyl isobutyrate. Methyl p-tert-butylphenylacetate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl 2-Methylbutyraldehyde; methyl ethyl acetal- phenylacetaldehyde. dehyde. Methyl 4-phenylbutyrate. 3-Methylbutyraldehyde; isovaleraldehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- Methyl butyrate. butyl ketone. 2-Methylbutyric acid. Methyl 3-phenylpropionate; methyl hydro- a-Methylcinnamaldehyde. cinnamate. p-Methylcinnamaldehyde. Methyl propionate. Methyl cinnamate. 3-Methyl-5-propyl-2-cyclohexen-1-one. 2-Methyl-1,3-cyclohexadiene. Methyl sulfide. Methylcyclopentenolone; 3-methylcyclopen- 3-Methylthiopropionaldehyde; methional. tane-1,2-dione. 2-Methyl-3-tolylpropionaldehyde, mixed o-, Methyl disulfide; dimethyl disulfide. m-, p-. Methyl ester of rosin, partially hydrogenated 2-Methylundecanal; methyl nonyl acetal- (as defined in § 172.615); methyl dehyde. dihydroabietate. Methyl 9-undecenoate. Methyl heptanoate. Methyl 2-undecynoate; methyl decyne car- bonate. 2-Methylheptanoic acid. Methyl valerate. 6-Methyl-3,5-heptadien-2-one. 2-Methylvaleric acid. Methyl-5-hepten-2-ol. Myrcene; 7-methyl-3-methylene-1,6-octa- 6-Methyl-5-hepten-2-one. diene. Methyl hexanoate. Myristaldehyde; tetradecanal. Methyl 2-hexanoate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Methyl p-hydroxybenzoate; methylparaben. hexanol. Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclo- Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. hexen-1-yl)-4-penten-3-one. Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo- 3-ol. hexen-1-yl)-4-penten-3-one. Neryl acetate. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo- Neryl butyrate. hexen-1-yl-)-4-penten-3-one. Neryl formate. Methyl isobutyrate. Neryl isobutyrate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- Neryl isovalerate. hyde; a-methyl-p-isopropylhydro- Neryl propionate. cinnamal- dehyde; cyclamen aldehyde. 2,6-Nonadien-1-ol. Methyl isovalerate. g-Nonalactone; 4-hydroxynonanoic acid, g- Methyl laurate. lactone; aldehyde C–18. Methyl mercaptan; methanethiol. Nonanal; pelargonic aldehyde. Methyl o-methoxybenzoate. 1,3-Nonanediol acetate, mixed esters. Methyl N-methylanthranilate; dimethyl an- Nonanoic acid; pelargonic acid. thranilate. 2-Nonanone; methylheptyl ketone. Methyl 2-methylbutyrate. 3-Nonanon-1-yl acetate; 1-hydroxy-3- Methyl-3-methylthiopropionate. nonanone acetate. Methyl 4-methylvalerate. Nonyl acetate. Methyl myristate. Nonyl alcohol; 1-nonanol. Methyl b-naphthyl ketone; 2′-acetonaph- Nonyl octanoate. thone. Nonyl isovalerate. Methyl nonanoate. Nootkatone; 5,6-dimethyl-8-isopropenyl- Methyl 2-nonenoate. bicyclo[4,4,0]-dec-1-en-3-one. Methyl 2-nonynoate; methyloctyne car- Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- bonate. octatriene. 2-Methyloctanal; methyl hexyl acetaldehyde. g-Octalactone; 4-hydroxyoctanoic acid, g-lac- Methyl octanoate. tone. Methyl 2-octynoate; methyl heptine car- Octanal; caprylaldehyde. bonate. Octanal dimethyl acetal. 4-Methyl-2,3-pentanedione; acetyl iso- 1-Octanol; octyl alcohol. butyryl. 2-Octanol. 4-Methyl-2-pentanone; methyl isobutyl ke- 3-Octanol. tone. 2-Octanone; methyl hexyl ketone.

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3-Octanone; ethyl amyl ketone. 3-Phenylpropionic acid; hydrocinnamic acid. 3-Octanon-1-ol. 3-Phenylpropyl acetate. 1-Octen-3-ol; amyl vinyl carbinol. 2-Phenylpropyl butyrate. 1-Octen-3-yl acetate. 3-Phenylpropyl cinnamate. Octyl acetate. 3-Phenylpropyl formate. 3-Octyl acetate. 3-Phenylpropyl hexanoate. Octyl butyrate. 2-Phenylpropyl isobutyrate. Octyl formate. 3-Phenylpropyl isobutyrate. Octyl heptanoate. 3-Phenylpropyl isovalerate. Octyl isobutyrate. 3-Phenylpropyl propionate. Octyl isovalerate. 2-(3-Phenylpropyl)-tetrahydrofuran. Octyl octanoate. a-Pinene; 2-pinene. Octyl phenylacetate. b-Pinene; 2(10)-pinene. Octyl propionate. oil. w-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, w-lactone; pentadecanolide; an- Piperidine. gelica lactone. . 2,3-Pentanedione; acetyl propionyl. d-Piperitone; p-menth-1-en-3-one. 2-Pentanone; methyl propyl ketone. Piperitenone; p-mentha-1,4(8)-dien-3-one. 4-Pentenoic acid. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)- 1-Penten-3-ol. en-3-one. Perillaldehyde; 4-isopropenyl-1-cyclohexene- Piperonyl acetate; heliotropyl acetate. 1-carboxaldehyde;p-mentha-1,8-dien-7-al. Piperonyl isobutyrate. Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Polylimonene. tate. Polysorbate 20; polyoxyethylene (20) sorbitan a-Phellandrene; r-mentha-1,5-diene. monolaurate. Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan Phenethyl alcohol; b-phenylethyl alcohol. monostereate. Phenethyl anthranilate. Polysorbate 80; polyoxyethylene (20) sorbitan Phenethyl benzoate. monooleate. Phenethyl butyrate. Potassium acetate. Phenethyl cinnamate. Propenylguaethol; 6-ethoxy-m-anol. Phenethyl formate. Propionaldehyde. Phenethyl isobutyrate. Propyl acetate. Phenethyl isovalerate. Propyl alcohol; 1-propanol. Phenethyl 2-methylbutyrate. p-Propyl anisole; dihydroanethole. Phenethyl phenylacetate. Propyl benzoate. Phenethyl propionate. Propyl butyrate. Phenethyl salicylate. Propyl cinnamate. Phenethyl senecioate; phenethyl 3,3-di- Propyl disulfide. methylacrylate. Propyl formate. Phenethyl tiglate. Propyl 2-furanacrylate. Phenoxyacetic acid. Propyl heptanoate. 2-Phenoxyethyl isobutyrate. Propyl hexanoate. Phenylacetaldehyde; a-toluic aldehyde. Propyl p-hydroxybenzoate; propylparaben. Phenylacetaldehyde 2,3-butylene glycol ace- 3-Propylidenephthalide. tal. Propyl isobutyrate. Phenylacetaldehyde dimethyl acetal. Propyl isovalerate. Phenylacetaldehyde glyceryl acetal. Propyl mercaptan. Phenylacetic acid; a-toluic acid. a-Propylphenethyl alcohol. 4-Phenyl-2-butanol; phenylethyl methyl car- Propyl phenylacetate. binol. Propyl propionate. 4-Phenyl-3-buten-2-ol; methyl styryl car- Pulegone; p-menth-4(8)-en-3-one. binol. Pyridine. 4-Phenyl-3-buten-2-one. Pyroligneous acid extract. 4-Phenyl-2-butyl acetate; phenylethyl meth- Pyruvaldehyde. yl carbinyl acetate. Pyruvic acid. 1-Phenyl-3-methyl-3-pentanol; phenylethyl Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- methyl ethyl carbinol. citronellol. 1-Phenyl-1-propanol; phenylethyl carbinol. Rhodinyl acetate. 3-Phenyl-1-propanol; hydrocinnamyl alcohol. Rhodinyl butyrate. 2-Phenylpropionaldehyde; hydratropalde- Rhodinyl formate. hyde. Rhodinyl isobutyrate. 3-Phenylpropionaldehyde; hydrocinnamal- Rhodinyl isovalerate. dehyde. Rhodinyl phenylacetate. 2-Phenylpropionalde-hyde dimethyl acetal; Rhodinyl propionate. hydratropic aldehyde dimethyl acetal. Rum ether; ethyl oxyhydrate.

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Salicylaldehyde. in combination in oleomargarine are Santalol, a and b. used at levels not to exceed 10 parts per Santalyl acetate. million and 20 parts per million, re- Santalyl phenylacetate. Skatole. spectively, in accordance with § 166.110 Sorbitan monostearate. of this chapter. Styrene. (d) BHA (butylated hydroxyanisole) Sucrose octaacetate. may be used as an antioxidant in fla- a-Terpinene. voring substances whereby the additive g-Terpinene. does not exceed 0.5 percent of the es- a-Terpineol; p-menth-1-en-8-ol. sential (volatile) oil content of the fla- b-Terpineol. Terpinolene; p-menth-1,4(8)-diene. voring substance. Terpinyl acetate. [42 FR 14491, Mar. 15, 1977, as amended at 42 Terpinyl anthranilate. FR 23148, May 6, 1977; 43 FR 19843, May 9, Terpinyl butyrate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, Terpinyl cinnamate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR Terpinyl formate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; Terpinyl isobutyrate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, Terpinyl isovalerate. 1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511, Terpinyl propionate. May 4, 2004] Tetrahydrofurfuryl acetate. Tetrahydrofurfuryl alcohol. Tetrahydrofurfuryl butyrate. § 172.520 Cocoa with dioctyl sodium Tetrahydrofurfuryl propionate. sulfosuccinate for manufacturing. Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- The food additive ‘‘cocoa with dioctyl undecen-2-one. sodium sulfosuccinate for manufac- Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. turing,’’ conforming to § 163.117 of this Tetramethyl ethylcyclohexenone; mixture of 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- chapter and § 172.810, is used or in- one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- tended for use as a flavoring substance hexen-1-one. in dry beverage mixes whereby the 2-Thienyl mercaptan; 2-thienylthiol. amount of dioctyl sodium sulfo- . succinate does not exceed 75 parts per Tolualdehyde glyceryl acetal, mixed o, m, p. million of the finished beverage. The Tolualdehydes, mixed o, m, p. labeling of the dry beverage mix shall p-Tolylacetaldehyde. o-Tolyl acetate; o-cresyl acetate. bear adequate directions to assure use p-Tolyl acetate; p-cresyl acetate. in compliance with this section. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- tone. § 172.530 Disodium guanylate. p-Tolyl isobutyrate. Disodium guanylate may be safely p-Tolyl laurate. used as a flavor enhancer in foods, at a p-Tolyl phenylacetate. 2-(p-Tolyl)-propionaldehyde; p-methylhydra- level not in excess of that reasonably tropic aldehyde. required to produce the intended effect. Tributyl acetylcitrate. 2-Tridecenal. § 172.535 Disodium inosinate. 2,3-Undecadione; acetyl nonyryl. The food additive disodium inosinate g-Undecalactone; 4-hydroxyundecanoic acid may be safely used in food in accord- g-lactone; peach aldehyde; aldehyde C–14. Undecenal. ance with the following prescribed con- 2-Undecanone; methyl nonyl ketone. ditions: 9-Undecenal; undecenoic aldehyde. (a) The food additive is the disodium 10-Undecenal. salt of inosinic acid, manufactured and Undecen-1-ol; undecylenic alcohol. purified so as to contain no more than 10-Undecen-1-yl acetate. 150 parts per million of soluble barium Undecyl alcohol. in the compound disodium inosinate Valeraldehyde; pentanal. Valeric acid; pentanoic acid. with seven and one-half of acetate; acetyl vanillin. water of crystallization. Veratraldehyde. (b) The food additive is used as a fla- Verbenol; 2-pinen-4-ol. voring adjuvant in food. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2- butanone. § 172.540 DL-Alanine. (c) D-Decalactone and D- DL-Alanine (a racemic mixture of D- dodecalactone when used separately or and L-alanine; CAS Reg. No. 302–72–7)

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may be safely used as a flavor enhancer the range for light petro- for sweeteners in pickling mixtures at leum spirits is 150 °F–300 °F. a level not to exceed 1 percent of the (3) The additive is manufactured pickling spice that is added to the from hops by a sequence of extractions pickling brine. and fractionations, using methylene chloride, hexane, and methyl alcohol as [56 FR 6968, Feb. 21, 1991] solvents, followed by isomerization by § 172.560 Modified hop extract. treatment. Residues of the solvents in the modified hop ex- The food additive modified hop ex- tract shall not exceed 5 parts per mil- tract may be safely used in beer in ac- lion of methylene chloride, 25 parts per cordance with the following prescribed million of hexane, and 100 parts per conditions: million of methyl alcohol. (a) The food additive is used or in- (4) The additive is manufactured tended for use as a flavoring agent in from hops by a sequence of extractions the brewing of beer. and fractionations, using benzene, light (b) The food additive is manufactured petroleum spirits, methyl alcohol, n- by one of the following processes: butyl alcohol, and ethyl acetate as sol- (1) The additive is manufactured vents, followed by isomerization by po- from a hexane extract of hops by si- tassium carbonate treatment. Residues multaneous isomerization and selec- of solvents in the modified hop extract tive reduction in an alkaline aqueous shall not exceed 1.0 part per million of medium with sodium borohydride, benzene, 1.0 part per million of light whereby the additive meets the fol- petroleum spirits, 50 parts per million lowing specifications: of methyl alcohol, 50 parts per million (i) A solution of the food additive sol- of n-butyl alcohol, and 1 part per mil- ids is made up in approximately 0.012 n lion of ethyl acetate. The light petro- alkaline methyl alcohol (6 milliliters leum spirits and benzene solvents shall of 1 n sodium hydroxide diluted to 500 comply with the specifications in milliliters with methyl alcohol) to § 172.250 except that the boiling point show an absorbance at 253 millimicrons range for light petroleum spirits is 150 of 0.6 to 0.9 per centimeter. (This ab- °F to 300 °F. sorbance is obtained by approximately (5) The additive is manufactured 0.03 milligram permilliliter.) The from hops by an initial extraction and ultraviolet absorption spectrum of this fractionation using one or more of the solution exhibits the following charac- following solvents: Ethylene dichlo- teristics: An absorption peak at 253 ride, hexane, isopropyl alcohol, methyl millimicrons; no absorption peak at 325 alcohol, methylene chloride, trichloro- to 330 millimicrons; the absorbance at ethylene, and water; followed by 268 millimicrons does not exceed the isomerization by calcium chloride or absorbance at 272 millimicrons. treatment in (ii) The boron content of the food ad- ethylene dichloride, methylene chlo- ditive does not exceed 310 parts per ride, or trichloroethylene and a further million (0.0310 percent), calculated as sequence of extractions and fraction- boron. ations using one or more of the sol- (2) The additive is manufactured vents set forth in this paragraph. Resi- from hops by a sequence of extractions dues of the solvents in the modified and fractionations, using benzene, light hop extract shall not exceed 125 parts petroleum spirits, and methyl alcohol per million of hexane; 150 parts per mil- as solvents, followed by isomerization lion of ethylene dichloride, methylene by potassium carbonate treatment. chloride, or trichloroethylene; or 250 Residues of solvents in the modified parts per million of isopropyl alcohol hop extract shall not exceed 1.0 part or methyl alcohol. per million of benzene, 1.0 part per mil- (6) The additive is manufactured lion of light petroleum spirits, and 250 from hops by an initial extraction and parts per million of methyl alcohol. fractionation using one or more of the The light petroleum spirits and ben- solvents listed in paragraph (b)(5) of zene solvents shall comply with the this section followed by: Hydro- specifications in § 172.250 except that genation using palladium as a catalyst

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in methyl alcohol, ethyl alcohol, or § 172.580 Safrole-free extract of sas- isopropyl alcohol acidified with hydro- safras. chloric or sulfuric acid; oxidation with The food additive safrole-free extract peracetic acid; isomerization by cal- of sassafras may be safely used in ac- cium chloride or magnesium chloride cordance with the following prescribed treatment in ethylene dichloride, conditions: methylene chloride, or trichloro- (a) The additive is the aqueous ex- ethylene (alternatively, the hydro- tract obtained from the root bark of genation and isomerization steps may the plant Sassafras albidum (Nuttall) be performed in reverse order); and a Nees (Fam. Lauraceae). further sequence of extractions and (b) It is obtained by extracting the fractionations using one or more of the bark with dilute alcohol, first concen- solvents listed in paragraph (b)(5) of trating the alcoholic solution by vacu- this section. The additive shall meet um distillation, then diluting the con- the residue limitations as prescribed in centrate with water and discarding the paragraph (b)(5) of this section. oily fraction. (7) The additive is manufactured (c) The purified aqueous extract is from hops as set forth in paragraph safrole-free. (b)(6) of this section followed by reduc- (d) It is used as a flavoring in food. tion with sodium borohydride in aque- ous alkaline methyl alcohol, and a se- § 172.585 Sugar beet extract flavor quence of extractions and fraction- base. ations using one or more of the sol- Sugar beet extract flavor base may vents listed in paragraph (b)(5) of this be safely used in food in accordance section. The additive shall meet the with the provisions of this section. residue limitations as prescribed in paragraph (b)(5) of this section, and a (a) Sugar beet extract flavor base is boron content level not in excess of 300 the concentrated residue of soluble parts per million (0.0300 percent), cal- sugar beet extractives from which culated as boron. sugar and glutamic acid have been re- covered, and which has been subjected (8) The additive is manufactured to ion exchange to minimize the con- from hops as a nonisomerizable non- centration of naturally occurring trace volatile hop resin by an initial extrac- minerals. tion and fractionation using one or more of the solvents listed in para- (b) It is used as a flavor in food. graph (b)(5) of this section followed by § 172.590 Yeast-malt sprout extract. a sequence of aqueous extractions and removal of nonaqueous solvents to less Yeast-malt sprout extract, as de- than 0.5 percent. The additive is added scribed in this section, may be safely to the wort before or during cooking in used in food in accordance with the fol- the manufacture of beer. lowing prescribed conditions: (a) The additive is produced by par- § 172.575 Quinine. tial hydrolysis of yeast extract (de- Quinine, as the hydrochloride salt or rived from Saccharomyces cereviseae, sulfate salt, may be safely used in food Saccharomyces fragilis, or Candida utilis) in accordance with the following condi- using the sprout portion of malt barley tions: as the source of enzymes. The additive contains a maximum of 6 percent 5′ nu- Uses Limitations cleotides by weight. (b) The additive may be used as a fla- In carbonated bev- Not to exceed 83 parts per million, as erages as a flavor. quinine. Label shall bear a promi- vor enhancer in food at a level not in nent declaration of the presence of excess of that reasonably required to quinine either by the use of the produce the intended effect. word ‘‘quinine’’ in the name of the article or through a separate dec- laration.

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Subpart G—Gums, Chewing Gum agent: Essential oils, nonnutritive Bases and Related Substances sweeteners, flavor bases, nonstandard- ized dressings, and pudding mixes. § 172.610 Arabinogalactan. § 172.615 Chewing gum base. Arabinogalactan may be safely used in food in accordance with the fol- The food additive chewing gum base lowing conditions: may be safely used in the manufacture (a) Arabinogalactan is a poly- of chewing gum in accordance with the saccharide extracted by water from following prescribed conditions: Western larch wood, having galactose (a) The food additive consists of one units and arabinose units in the ap- or more of the following substances proximate ratio of six to one. that meet the specifications and limi- (b) It is used in the following foods in tations prescribed in this paragraph, the minimum quantity required to used in amounts not to exceed those re- produce its intended effect as an emul- quired to produce the intended physical sifier, stabilizer, binder, or bodying or other technical effect.

MASTICATORY SUBSTANCES NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Sapotaceae: Chicle ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Chiquibul ...... Manilkara zapotilla Gilly. Crown gum ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Gutta hang kang ...... Palaquium leiocarpum Boerl. and Palaquium oblongifolium Burck. Massaranduba balata (and the solvent-free Manilkara huberi (Ducke) Chevalier. resin extract of Massaranduba balata). Massaranduba chocolate ...... Manilkara solimoesensis Gilly. Nispero ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Rosidinha (rosadinha) ...... Micropholis (also known as Sideroxylon) spp. Venezuelan chicle ...... Manilkara williamsii Standley and related spp. Apocynaceae: Jelutong ...... Dyera costulata Hook, F. and Dyera lowii Hook, F. Leche caspi (sorva) ...... Couma macrocarpa Barb. Rodr. Pendare ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Perillo ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Moraceae: Leche de vaca ...... Brosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi (Woodson), Monachino (Apocynaceae). Niger gutta ...... Ficus platyphylla Del. Tunu (tuno) ...... Castilla fallax Cook. Euphorbiaceae: Chilte ...... Cnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus tepiquensis (Cost. and Gall.) McVaugh. (smoked sheet and sol- Hevea brasiliensis. ids).

Synthetic Specifications

Butadiene-styrene rubber ...... Basic polymer. Isobutylene-isoprene copolymer (butyl rub- Do. ber).

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MASTICATORY SUBSTANCES—Continued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Paraffin ...... Synthesized by Fischer-Tropsch process from carbon monoxide and hydro- gen which are catalytically converted to a mixture of paraffin hydrocarbon. Lower molecular weight fractions are removed by distillation. The residue is hydrogenated and further treated by percolation through activated charcoal. The product has a congealing point of 93°–99 °C as determined by ASTM method D938–71 (Reapproved 1981), ‘‘Standard Test Method for Con- gealing Point of Petroleum Waxes, Including Petrolatum,’’ a maximum oil content of 0.5 percent as determined by ASTM method D721–56T, ‘‘Ten- tative Method of Test for Oil Content of Petroleum Waxes,’’ and an absorp- tivity of less than 0.01 at 290 millimicrons in decahydronaphthalene at 88 °C as determined by ASTM method D2008–80, ‘‘Standard Test Method for Ultraviolet Absorbance and Absorptivity of Petroleum Products,’’ which are incorporated by reference. Copies may be obtained from the American So- ciety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Ar- chives and Records Administration (NARA). For information on the avail- ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/codeloflfederallregulations/ ibrllocations.html. Petroleum wax ...... Complying with § 172.886. Petroleum wax synthetic ...... Complying with § 172.888. Polyethylene ...... Molecular weight 2,000–21,000. Polyisobutylene ...... Minimum molecular weight 37,000 (Flory). Polyvinyl acetate ...... Molecular weight, minimum 2,000.

PLASTICIZING MATERIALS (SOFTENERS)

Glycerol ester of partially dimerized rosin ...... Having an acid number of 3–8, a minimum drop-softening point of 109 °C, and a color of M or paler. Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a minimum drop-softening point of 79 °C, wood rosin. and a color of N or paler. Glycerol ester of polymerized rosin ...... Having an acid number of 3–12, a minimum melting-point of 80 °C, and a color of M or paler. Glycerol ester of gum rosin ...... Having an acid number of 5–9, a minimum drop-softening point of 88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of tall oil rosin ...... Having an acid number of 2–12, a softening point (ring and ball) of 80°–88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of wood rosin ...... Having an acid number of 3–9, a drop-softening point of 88 °C–96 °C, and a color of N or paler. The ester is purified by steam stripping. Lanolin ...... Methyl ester of rosin, partially hydrogenated ...... Having an acid number of 4–8, a refractive index of 1.5170–1.5205 at 20 °C, and a of 23–66 poises at 25 °C. The ester is purified by steam stripping. Pentaerythritol ester of partially hydrogenated Having an acid number of 7–18, a minimum drop-softening point of 102 °C, gum or wood rosin. and a color of K or paler. Pentaerythritol ester of gum or wood rosin ...... Having an acid number of 6–16, a minimum drop-softening point of 109 °C, and a color of M or paler. Rice bran wax ...... Complying with § 172.890. ...... Complying with § 172.860. Sodium and potassium stearates ...... Complying with § 172.863.

TERPENE RESINS

Synthetic resin ...... Consisting of polymers of apinene, bpinene, and/or dipentene; acid value less than 5, saponification number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirit solution. Natural resin ...... Consisting of polymers of a-pinene; softening point minimum 155 °C, deter- mined by U.S.P. closed-capillary method, United States Pharmacopeia XX (1980) (page 961).

ANTIOXIDANTS

Butylated hydroxyanisole ...... Not to exceed antioxidant content of 0.1% when used alone or in any com- bination. Butylated hydroxytoluene ...... Do. Propyl gallate ...... Do.

MISCELLANEOUS

Sodium sulfate ...... Sodium sulfide ...... Reaction-control agent in synthetic polymer production.

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(b) In addition to the substances list- § 172.623 Carrageenan with poly- ed in paragraph (a) of this section, sorbate 80. chewing gum base may also include Carrageenan otherwise meeting the substances generally recognized as safe definition and specifications of § 172.620 in food. (a) and (b) and salts of carrageenan (c) To assure safe use of the additive, otherwise meeting the definition of in addition to the other information re- § 172.626(a) may be safely produced with quired by the act, the label and label- the use of polysorbate 80 meeting the ing of the food additive shall bear the specifications and requirements of name of the additive, ‘‘chewing gum § 172.840 (a) and (b) in accordance with base.’’ As used in this paragraph, the the following prescribed conditions: term ‘‘chewing gum base’’ means the (a) The polysorbate 80 is used only to manufactured or partially manufac- facilitate separation of sheeted carra- tured nonnutritive masticatory sub- geenan and salts of carrageenan from stance comprised of one or more of the drying rolls. ingredients named and so defined in (b) The carrageenan and salts of car- paragraph (a) of this section. rageenan contain not more than 5 per- [42 FR 14491, Mar. 15, 1977, as amended at 45 cent by weight of polysorbate 80, and FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, the final food containing the additives 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, contains polysorbate 80 in an amount July 23, 2001; 66 FR 53711, Oct. 24, 2001] not to exceed 500 parts per million. § 172.620 Carrageenan. (c) The carrageenan and salts of car- rageenan so produced are used only in The food additive carrageenan may producing foods in gel form and only be safely used in food in accordance for the purposes defined in §§ 172.620(c) with the following prescribed condi- and 172.626(b), respectively. tions: (d) The carrageenan and salts of car- (a) The food additive is the refined rageenan so produced are not used in hydrocolloid prepared by aqueous ex- foods for which standards of identity traction from the following members of exist unless the standards provide for the families Gigartinaceae and Solier- the use of carrageenan, or salts of car- iaceae of the class Rodophyceae (red rageenan, combined with polysorbate seaweed): 80. Chondrus crispus. (e) The carrageenan and salts of car- Chondrus ocellatus. rageenan produced in accordance with Eucheuma cottonii. this section, and foods containing the Eucheuma spinosum. Gigartina acicularis. same, in addition to the other require- Gigartina pistillata. ments of the Act, are labeled to show Gigartina radula. the presence of polysorbate 80, and the Gigartina stellata. label or labeling of the carrageenan (b) The food additive conforms to the and salts of carrageenan so produced following conditions: bear adequate directions for use. (1) It is a sulfated polysaccharide the § 172.626 Salts of carrageenan. dominant hexose units of which are ga- lactose and anhydrogalactose. The food additive salts of carra- (2) Range of sulfate content: 20 per- geenan may be safely used in food in cent to 40 percent on a dry-weight accordance with the following pre- basis. scribed conditions: (c) The food additive is used or in- (a) The food additive consists of car- tended for use in the amount necessary rageenan, meeting the provisions of for an emulsifier, stabilizer, or thick- § 172.620, modified by increasing the ener in foods, except for those stand- concentration of one of the naturally ardized foods that do not provide for occurring salts (ammonium, calcium, such use. potassium, or sodium) of carrageenan (d) To assure safe use of the additive, to the level that it is the dominant salt the label and labeling of the additive in the additive. shall bear the name of the additive, (b) The food additive is used or in- carrageenan. tended for use in the amount necessary

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for an emulsifier, stabilizer, or thick- (c) To assure safe use of the additive, ener in foods, except for those stand- the label and labeling of the additive ardized foods that do not provide for shall bear the name of the salt of fur- such use. celleran that dominates the mixture by (c) To assure safe use of the additive, reason of the modification, e.g., ‘‘so- the label and labeling of the additive dium furcelleran’’, ‘‘potassium furcel- shall bear the name of the salt of car- leran’’, etc. rageenan that dominates the mixture by reason of the modification, e.g., § 172.665 Gellan gum. ‘‘sodium carrageenan’’, ‘‘potassium The food additive gellan gum may be carrageenan’’, etc. safely used in food in accordance with the following prescribed conditions: § 172.655 Furcelleran. (a) The additive is a high molecular The food additive furcelleran may be weight polysaccharide gum produced safely used in food in accordance with from Pseudomonas elodea by a pure cul- the following prescribed conditions: ture fermentation process and purified (a) The food additive is the refined by recovery with isopropyl alcohol. It hydrocolloid prepared by aqueous ex- is composed of tetrasaccharide repeat traction of furcellaria fastigiata of the units, each containing one of class Rodophyceae (red seaweed). rhamnose and glucuronic acid, and two (b) The food additive conforms to the molecules of glucose. The glucuronic following: acid is neutralized to a mixed potas- (1) It is a sulfated polysaccharide the sium, sodium, calcium, and magnesium dominant hexose units of which are ga- salt. The polysaccharide may contain lactose and anhydrogalactose. acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. (2) Range of sulfate content: 8 per- (b) The strain of P. elodea is non- cent to 19 percent, on a dry-weight pathogenic and nontoxic in man and basis. animals. (c) The food additive is used or in- (c) The additive is produced by a tended for use in the amount necessary process that renders it free of viable for an emulsifier, stabilizer, or thick- cells of P. elodea. ener in foods, except for those stand- (d) The additive meets the following ardized foods that do not provide for specifications: such use. (1) Positive for gellan gum when sub- (d) To assure safe use of the additive, jected to the following identification the label and labeling of the additive tests: shall bear the name of the additive, (i) A 1-percent solution is made by furcelleran. hydrating 1 gram of gellan gum in 99 milliliters of distilled water. The mix- § 172.660 Salts of furcelleran. ture is stirred for about 2 hours, using The food additive salts of furcelleran a motorized stirrer and a propeller- may be safely used in food in accord- type stirring blade. A small amount of ance with the following prescribed con- the above solution is drawn into a wide ditions: bore pipet and transferred into a solu- (a) The food additive consists of fur- tion of 10-percent calcium chloride. A celleran, meeting the provisions of tough worm-like gel will form in- § 172.655, modified by increasing the stantly. concentration of one of the naturally (ii) To the 1-percent distilled water occurring salts (ammonium, calcium, solution prepared for identification potassium, or sodium) of furcelleran to test (i), 0.50 gram of sodium chloride is the level that it is the dominant salt in added. The solution is heated to 80 °C the additive. with stirring, held at 80 °C for 1 (b) The food additive is used or in- minute, and allowed to cool to room tended for use in the amount necessary temperature without stirring. A firm for an emulsifier, stabilizer, or thick- gel will form. ener in foods, except for those stand- (2) Residual isopropyl alcohol (IPA) ardized foods that do not provide for not to exceed 0.075 percent as deter- such use. mined by the procedure described in

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the ‘‘Gellan gum’’ monograph in the (b) The strain of Xanthomonas Food Chemicals Codex, 7th ed. (2010), campestris is nonpathogenic and pp. 425–426, which is incorporated by nontoxic in man or other animals. reference. The Director of the Office of (c) The additive is produced by a the Federal Register approves this in- process that renders it free of viable corporation by reference in accordance cells of Xanthomonas campestris. with 5 U.S.C. 552(a) and 1 CFR part 51. (d) The additive meets the following You may obtain copies from the United specifications: States Pharmacopeial Convention, (1) Residual isopropyl alcohol not to 12601 Twinbrook Pkwy., Rockville, MD exceed 750 parts per million. 20852 (Internet address http:// www.usp.org). Copies may be examined (2) An aqueous solution containing 1 at the Food and Drug Administration’s percent of the additive and 1 percent of Main Library, 10903 New Hampshire stirred for 2 hours Ave., Bldg. 2, Third Floor, Silver has a minimum viscosity of 600 centi- Spring, MD 20993, 301–796–2039, or at the poises at 75 °F, as determined by National Archives and Records Admin- Brookfield Viscometer, Model LVF (or istration (NARA). For information on equivalent), using a No. 3 spindle at 60 the availability of this material at r.p.m., and the ratio of at 75 NARA, call 202–741–6030 or go to: http:// °F and 150 °F is in the range of 1.02 to www.archives.gov/federal-register/cfr/ibr- 1.45. locations.html. (3) Positive for xanthan gum when (e) The additive is used or intended subjected to the following procedure: for use in accordance with current good manufacturing practice as a stabilizer LOCUST BEAN GUM GEL TEST and thickener as defined in § 170.3(o)(28) Blend on a weighing paper or in a weighing of this chapter. The additive may be pan 1.0 gram of powdered locust bean gum used in foods where standards of iden- with 1.0 gram of the powdered polysaccharide tity established under section 401 of to be tested. Add the blend slowly (approxi- the Federal Food, Drug, and Cosmetic mately 1⁄2 minute) at the point of maximum Act do not preclude such use. agitation to a stirred solution of 200 milli- (f) To assure safe use of the additive: liters of distilled water previously heated to (1) The label of its container shall 80 °C in a 400-milliliter beaker. Continue me- bear, in addition to other information chanical stirring until the mixture is in solu- required by the Federal Food, Drug, tion, but stir for a minimum time of 30 min- and Cosmetic Act, the name of the ad- utes. Do not allow the water temperature to ° ditive and the designation ‘‘food drop below 60 C. grade’’. Set the beaker and its contents aside to cool in the absence of agitation. Allow a (2) The label or labeling of the food minimum time of 2 hours for cooling. Exam- additive container shall bear adequate ine the cooled beaker contents for a firm directions for use. rubbery gel formation after the temperature ° [55 FR 39614, Sept. 28, 1990, as amended at 57 drops below 40 C. FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, In the event that a gel is obtained, make 1999; 78 FR 71463, Nov. 29, 2013] up a 1 percent solution of the polysaccharide to be tested in 200 milliliters of distilled § 172.695 Xanthan gum. water previously heated to 80 °C (omit the lo- cust bean gum). Allow the solution to cool The food additive xanthan gum may without agitation as before. Formation of a be safely used in food in accordance gel on cooling indicates that the sample is a with the following prescribed condi- gelling polysaccharide and not xanthan gum. tions: Record the sample as ‘‘positive’’ for xan- (a) The additive is a polysaccharide than gum if a firm, rubbery gel forms in the gum derived from Xanthomonas presence of locust bean gum but not in its campestris by a pure-culture fermenta- absence. Record the sample as ‘‘negative’’ for tion process and purified by recovery xanthan gum if no gel forms or if a soft or with isopropyl alcohol. It contains D- brittle gel forms both with locust bean gum glucose, D-mannose, and D-glucuronic and in a 1 percent solution of the sample (containing no locust bean gum). acid as the dominant hexose units and is manufactured as the sodium, potas- (4) Positive for xanthan gum when sium, or calcium salt. subjected to the following procedure:

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PYRUVIC ACID TEST Subpart H—Other Specific Usage Pipet 10 milliliters of an 0.6 percent solu- Additives tion of the polysaccharide in distilled water (60 milligrams of water-soluble gum) into a § 172.710 Adjuvants for pesticide use 50-milliliter flask equipped with a standard dilutions. taper glass joint. Pipet in 20 milliliters of 1N The following and related hydrochloric acid. Weigh the flask. Reflux adjuvants may be safely added to pes- the mixture for 3 hours. Take precautions to ticide use dilutions by a grower or ap- avoid loss of vapor during the refluxing. Cool plicant prior to application to the the solution to room temperature. Add dis- growing crop: tilled water to make up any weight loss from

the flask contents. n-Alkyl (C8-C18) amine acetate, where the Pipet 1 milliliter of a 2,4-dinitrophenyl- alkyl groups (C8-C18) are derived from coco- hydrazine reagent (0.5 percent in 2N hydro- nut oil, as a in emulsifier blends chloric acid) into a 30-milliliter separatory at levels not in excess of 5 percent by weight funnel followed by a 2-milliliter aliquot (4 of the emulsifier blends that are added to milligrams of water-soluble gum) of the for application to corn and sor- polysaccharide hydrolyzate. Mix and allow ghum. Di-n-alkyl (C -C ) dimethyl ammonium the reaction mixture to stand at room tem- 8 18 chloride, where the alkyl groups (C8-C18) are perature for 5 minutes. Extract the mixture derived from coconut oil, as surfactants in with 5 milliliters of ethyl acetate. Discard emulsifier blends at levels not in excess of 5 the aqueous layer. percent by weight of emulsifier blends that Extract the hydrazone from the ethyl ace- are added to herbicides for application to tate with three 5 milliliter portions of 10 per- corn or sorghum. cent sodium carbonate solution. Dilute the Diethanolamide condensate based on a combined sodium carbonate extracts to 100 mixture of saturated and unsaturated soy- milliliters with additional 10 percent sodium bean oil fatty acids (C16-C18) as a surfactant carbonate in a 10-milliliter volumetric flask. in emulsifier blends that are added to the Measure the optical density of the sodium atrazine for application to corn. carbonate solution at 375 millimicrons. Diethanolamide condensate based on Compare the results with a curve of the op- stripped coconut fatty acids (C10 C18) as a surfactant in emulsifier blends that are tical density versus concentration of an au- added to the herbicide atrazine for applica- thentic sample of pyruvic acid that has been tion to corn. run through the procedure starting with the a-(p-Dodecylphenyl)-omega-hydroxypoly preparation of the hydrazone. (oxyethylene) produced by the condensation Record the percent by weight of pyruvic of 1 mole of dodecylphenol (dodecyl group is acid in the test polysaccharide. Note ‘‘posi- a proplyene tetramer isomer) with an aver- tive’’ for xanthan gum if the sample contains age of 4–14 or 30–70 moles of ethylene oxide; more than 1.5 percent of pyruvic acid and if a blend of products is used, the average ‘‘negative’’ for xanthan gum if the sample number of moles of ethylene oxide reacted to contains less than 1.5 percent of pyruvic acid produce any product that is a component of by weight. the blend shall be in the range of 4–14 or 30– 70. (e) The additive is used or intended Ethylene dichloride. for use in accordance with good manu- Polyglyceryl phthalate ester of coconut oil facturing practice as a stabilizer, emul- fatty acids. sifier, thickener, suspending agent, a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- omega-hydroxypoly(oxyethylene) produced bodying agent, or foam enhancer in by the condensation of 1 mole of p-(1,1,3,3- foods for which standards of identity tetramethylbutyl) phenol with an average of established under section 401 of the Act 4–14 or 30–70 moles of ethylene oxide; if a do not preclude such use. blend of products is used, the average num- (f) To assure safe use of the additive: ber of moles of ethylene oxide reacted to produce any product that is a component of (1) The label of its container shall the blend shall be in the range of 4–14 or 30– bear, in addition to other information 70. required by the Act, the name of the a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- additive and the designation ‘‘food omega-hydroxypoly(oxyethylene) produced grade’’. by the condensation of 1 mole of p-(1,1,3,3- tetramethylbutyl) phenol with 1 mole of (2) The label or labeling of the food ethylene oxide. additive container shall bear adequate Sodium acrylate and acrylamide copoly- directions for use. mer with a minimum average molecular weight of 10,000,000 in which 30 percent of the

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polymer is comprised of acrylate units and 70 preharvest or postharvest application percent acrylamide units, for use as a drift to bananas. control agent in herbicide formulations ap- plied to crops at a level not to exceed 0.5 § 172.720 Calcium lactobionate. ounces of the additive per acre. The food additive calcium § 172.712 1,3-Butylene glycol. lactobionate may be safely used in food in accordance with the following pre- The food additive 1,3-butylene glycol scribed conditions: (CAS Reg. No. 107–88–0) may be safely (a) The food additive is the calcium used in food in accordance with the fol- salt of lactobionic acid (4-(b,D- lowing prescribed conditions: galactosido)-D-gluconic acid) produced (a) It is prepared by the aldol con- by the oxidation of lactose. densation of acetaldehyde followed by (b) It is used or intended for use as a catalytic hydrogenation. firming agent in dry pudding mixes at (b) The food additive shall conform a level not greater than that required to the identity and specifications of to accomplish the intended effect. the Food Chemicals Codex, 7th ed. (2010), p. 126, which is incorporated by § 172.723 Epoxidized soybean oil. reference. The Director of the Office of Epoxidized soybean oil may be safely the Federal Register approves this in- used in accordance with the following corporation by reference in accordance prescribed conditions: with 5 U.S.C. 552(a) and 1 CFR part 51. (a) The additive is prepared by react- You may obtain copies from the United ing soybean oil in toluene with hydro- States Pharmacopeial Convention, gen peroxide and formic acid. 12601 Twinbrook Pkwy., Rockville, MD (b) It meets the following specifica- 20852 (Internet address http:// tions: www.usp.org). Copies may be examined (1) Epoxidized soybean oil contains at the Food and Drug Administration’s oxirane oxygen, between 7.0 and 8.0 per- Main Library, 10903 New Hampshire cent, as determined by the American Ave., Bldg. 2, Third Floor, Silver Oil Chemists’ Society (A.O.C.S.) meth- Spring, MD 20993, 301–796–2039, or at the od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- National Archives and Records Admin- approved 1989, which is incorporated by istration (NARA). For information on reference in accordance with 5 U.S.C the availability of this material at 552(a) and 1 CFR part 51. Copies are NARA, call 202–741–6030 or go to: http:// available from the American Oil Chem- www.archives.gov/federal-register/cfr/ibr- ists’ Society, P. O. Box 3489, Cham- locations.html. paign, IL 61826–3489, or may be exam- (c) It is used in the manufacture of ined at the Office of Food Additive sausage casings as a formulation aid as Safety (HFS–200), Center for Food Safe- defined in § 170.3(o)(14) of this chapter ty and Applied Nutrition, Food and and as a processing aid as defined in Drug Administration, 5001 Campus Dr., § 170.3(o)(24) of this chapter. College Park, MD 20740, 240–402–1200, or at the National Archives and Records [62 FR 26228, May 13, 1997, as amended at 78 Administration (NARA). For informa- FR 14664, Mar. 7, 2013; 78 FR 71463, Nov. 29, tion on the availability of this mate- 2013] rial at NARA, call 202–741–6030, or go § 172.715 Calcium lignosulfonate. to: http://www.archives.gov/ federallregister/ Calcium lignosulfonate may be safely codeloflfederallregulations/ used in or on food, subject to the provi- ibrllocations.html. sions of this section. (2) The maximum iodine value is 3.0, (a) Calcium lignosulfonate consists of as determined by A.O.C.S. method Cd sulfonated lignin, primarily as calcium 1–25, ‘‘Iodine Value of Fats and Oils and sodium salts. Wijs Method,’’ revised 1993, which is in- (b) It is used in an amount not to ex- corporated by reference in accordance ceed that reasonably required to ac- with 5 U.S.C. 552(a) and 1 CFR part 51. complish the intended physical or tech- The availability of this incorporation nical effect when added as a dispersing by reference is given in paragraph agent and stabilizer in pesticides for (b)(1) of this section.

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(3) The heavy metals (as Pb) content foods or with salts of fatty acids con- cannot be more than 10 parts per mil- forming to § 172.863. lion, as determined by the ‘‘Heavy Met- (b) They are used or intended for use als Test,’’ of the ‘‘Food Chemicals in the malting of barley under condi- Codex,’’ 4th ed. (1996), pp. 760–761, Meth- tions whereby the amount of either or od II (with a 2-gram sample and 20 both additives present in the malt is microgram of lead ion in the control), not in excess of 2 parts per million ex- which is incorporated by reference in pressed as gibberellic acid, and the accordance with 5 U.S.C. 552(a) and 1 treated malt is to be used in the pro- CFR part 51. Copies are available from duction of fermented malt beverages or the National Academy Press, Box 285, distilled spirits only, whereby the fin- 2101 Constitution Ave. NW., Wash- ished distilled spirits contain none and ington, DC 20055 (Internet address the finished malt beverage contains http://www.nap.edu), or may be exam- not more than 0.5 part per million of ined at the Food and Drug Administra- gibberellic acid. tion’s Main Library, 10903 New Hamp- (c) To insure the safe use of the food shire Ave., Bldg. 2, Third Floor, Silver additives the label of the package shall Spring, MD 20993, 301–796–2039, or at the bear, in addition to the other informa- National Archives and Records Admin- tion required by the Act: istration (NARA). For information on (1) The name of the additive, the availability of this material at ‘‘gibberellic acid’’ or ‘‘potassium NARA, call 202–741–6030, or go to: http:// gibberellate’’, whichever is appro- www.archives.gov/federallregister/ priate. codeloflfederallregulations/ (2) An accurate statement of the con- ibrllocations.html. centration of the additive contained in (c) The additive is used as a the package. stabilizer in brominated soybean oil at (3) Adequate use directions to provide a level not to exceed 1 percent. not more than 2 parts per million of gibberellic acid in the finished malt. [60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999; 78 FR 14665, Mar. 7, (4) Adequate labeling directions to 2013; 81 FR 5591, Feb. 3, 2016] provide that the final malt is properly labeled as described in paragraph (d) of § 172.725 Gibberellic acid and its po- this section. tassium salt. (d) To insure the safe use of the addi- The food additives gibberellic acid tive the label of the treated malt shall and its potassium salt may be used in bear, in addition to the other informa- the malting of barley in accordance tion required by the Act, the state- with the following prescribed condi- ments: tions: (1) ‘‘Contains not more than 2 parts (a) The additives meet the following per million lll’’, the blank being specifications: filled in with the words ‘‘gibberellic (1) The gibberellic acid is produced acid’’ or ‘‘potassium gibberellate’’, by deep-culture fermentation of a suit- whichever is appropriate; and able nutrient medium by a strain of (2) ‘‘Brewer’s malt—To be used in the Fusarium moniliforme or a selection of production of fermented malt bev- this culture. erages only’’ or ‘‘Distiller’s malt—To (2) The gibberellic acid produced is of be used in the production of distilled 80 percent purity or better. spirits only’’, whichever is appropriate. (3) The empirical formula of gibberellic acid is represented by § 172.730 Potassium bromate. C19H22O6. The food additive potassium bromate (4) Potassium gibberellate is the po- may be safely used in the malting of tassium salt of the specified gibberellic barley under the following prescribed acid. conditions: (5) The potassium gibberellate is of 80 (a)(1) It is used or intended for use in percent purity or better. the malting of barley under conditions (6) The gibberellic acid or potassium whereby the amount of the additive gibberellate may be diluted with sub- present in the malt from the treatment stances generally recognized as safe in does not exceed 75 parts per million of

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bromate (calculated as Br), and the § 172.736 Glycerides and polyglycides treated malt is used only in the pro- of hydrogenated vegetable oils. duction of fermented malt beverages or The food additive glycerides and distilled spirits. polyglycides of hydrogenated vegetable (2) The total residue of inorganic bro- oils may be safely used in food in ac- mides in fermented malt beverages, re- cordance with the following prescribed sulting from the use of the treated conditions: malt plus additional residues of inor- (a) The additive is manufactured by ganic bromides that may be present heating a mixture of hydrogenated oils from uses in accordance with other reg- of vegetable origin and polyethylene ulations in this chapter promulgated glycol in the presence of an alkaline under sections 408 and/or 409 of the act, catalyst followed by neutralization does not exceed 25 parts per million of with any acid that is approved or is generally recognized as safe for this bromide (calculated as Br). No toler- use to yield the finished product. ance is established for bromide in dis- (b) The additive consists of a mixture tilled spirits because there is evidence of mono-, di- and tri-glycerides and that inorganic bromides do not pass polyethylene glycol mono- and di- over in the distillation process. esters of fatty acids (polyglycides) of (b) To assure safe use of the additive, hydrogenated vegetable oils and meets the label or labeling of the food addi- the following specifications: tive shall bear, in addition to the other (1) Total ester content, greater than information required by the Act, the 90 percent as determined by a method following: entitled ‘‘Determination of Esterified (1) The name of the additive. Glycerides and Polyoxyethylene (2) Adequate directions for use. Glycols,’’ approved November 16, 2001, (c) To assure safe use of the additive, printed by Gattefosse S.A.S., and in- the label or labeling of the treated corporated by reference. The Director malt shall bear, in addition to other in- of the Office of the Federal Register formation required by the Act, the approves this incorporation by ref- erence in accordance with 5 U.S.C. statement, ‘‘Brewer’s Malt—To be used 552(a) and 1 CFR part 51. You may ob- in the production of fermented malt tain a copy from the Office of Food Ad- beverages only’’, or ‘‘Distiller’s Malt— ditive Safety, 5001 Campus Dr., College To be used in the production of dis- Park, MD 20740 or you may examine a tilled spirits only’’, whichever is the copy at the Food and Drug Administra- case. tion’s Main Library, 10903 New Hamp- shire Ave., Bldg. 2, Third Floor, Silver § 172.735 Glycerol ester of rosin. Spring, MD 20993, 301–796–2039, or at the Glycerol ester of wood rosin, gum National Archives and Records Admin- rosin, or tall oil rosin may be safely istration (NARA). For information on used in food in accordance with the fol- the availability of this material at lowing prescribed conditions: NARA, call 202–741–6030, or go to http:// (a) It has an acid number of 3 to 9, a www.archives.gov/federallregister/ drop-softening point of 88 to 96 °C; and codeloflfederallregulations/ a color of N or paler as determined in ibrllocations.html. accordance with Official Naval Stores (2) Acid value, not greater than 2, Standards of the United States. It is and hydroxyl value, not greater than purified by countercurrent steam dis- 56, as determined by the methods enti- tillation or steam stripping. tled ‘‘Acid Value,’’ p. 1220 and ‘‘Hydroxyl Value,’’ p. 1223, respec- (b) It is used to adjust the density of tively, in the Food Chemicals Codex, citrus oils used in the preparation of 7th ed. (2010), which is incorporated by beverages whereby the amount of the reference. The Director of the Office of additive does not exceed 100 parts per the Federal Register approves this in- million of the finished beverage. corporation by reference in accordance [42 FR 14491, Mar. 15, 1977, as amended at 70 with 5 U.S.C. 552(a) and 1 CFR part 51. FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22, You may obtain copies from the United 2007] States Pharmacopeial Convention,

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12601 Twinbrook Pkwy., Rockville, MD drops or similar small units of meas- 20852 (Internet address http:// ure. www.usp.org). Copies may be examined [71 FR 12620, Mar. 13, 2006, as amended at 78 at the Food and Drug Administration’s FR 71463, Nov. 29, 2013; 81 FR 5591, Feb. 3, Main Library, 10903 New Hampshire 2016] Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the § 172.755 Stearyl monoglyceridyl cit- rate. National Archives and Records Admin- istration (NARA). For information on The food additive stearyl the availability of this material at monoglyceridyl citrate may be safely NARA, call 202–741–6030 or go to: http:// used in food in accordance with the fol- www.archives.gov/federal-register/cfr/ibr- lowing provisions: (a) The additive is prepared by con- locations.html. trolled chemical reaction of the fol- (3) Lead, not greater than 0.1 mg/kg lowing: as determined by the American Oil Chemists’ Society (A.O.C.S.) method Reactant Limitations Ca 18c–91, ‘‘Determination of Lead by Citric acid ...... Direct Graphite Furnace Atomic Ab- Monoglycerides of fatty Prepared by the glycerolysis of ed- sorption Spectrophotometry,’’ updated acids. ible fats and oils or derived from fatty acids conforming with 1995, and incorporated by reference in § 172.860. accordance with 5 U.S.C. 552(a) and 1 Stearyl alcohol...... Derived from fatty acids con- CFR part 51. Copies are available from forming with § 172.860, or de- rived synthetically in conformity American Oil Chemists’ Society, P. O. with § 172.864. Box 3489, Champaign, IL 61826–3489, or may be examined at the Food and Drug (b) The additive stearyl Administration’s Main Library, 10903 monoglyceridyl citrate, produced as New Hampshire Ave., Bldg. 2, Third described under paragraph (a) of this Floor, Silver Spring, MD 20993, 301–796– section, meets the following specifica- 2039, or at the National Archives and tions: Records Administration (NARA). For Acid number 40 to 52. information on the availability of this Total citric acid 15 to 18 percent. material at NARA, call 202–741–6030, or Saponification number 215–255. go to http://www.archives.gov/ (c) The additive is used or intended federallregister/ for use as an emulsion stabilizer in or codeloflfederallregulations/ with shortenings containing emulsi- ibrllocations.html. fiers. (4) 1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/kg), and § 172.765 Succistearin (stearoyl pro- pylene glycol hydrogen succinate). ethylene oxide, not greater than 1 mg/ kg, as determined by a gas The food additive succistearin (ste- chromatographic method entitled aroyl propylene glycol hydrogen succi- ‘‘Determination of Ethylene Oxide and nate) may be safely used in food in ac- 1,4-Dioxane by Headspace Gas Chroma- cordance with the following prescribed conditions: tography,’’ approved November 5, 1998, (a) The additive is the reaction prod- printed by Gattefosse S.A.S., and in- uct of succinic anhydride, fully hydro- corporated by reference in accordance genated vegetable oil (predominantly with 5 U.S.C. 552(a) and 1 CFR part 51; C16 or C18 fatty acid chain length), and see paragraph (b)(1) of this section for propylene glycol. availability of the incorporation by (b) The additive meets the following reference. specifications: (c) The additive is used or intended Acid number 50–150. for use as an excipient in dietary sup- Hydroxyl number 15–50. plement tablets, capsules, and liquid Succinated ester content 45–75 percent. formulations that are intended for in- (c) The additive is used or intended gestion in daily quantities measured in for use as an emulsifier in or with shortenings and edible oils intended for

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use in cakes, cake mixes, fillings, (c) The additive is used as a carrier of icings, pastries, and toppings, in ac- vitamin B12 in foods for special dietary cordance with good manufacturing use. practice. § 172.780 Acacia (gum arabic). § 172.770 Ethylene oxide polymer. The food additive may be safely used The polymer of ethylene oxide may in food in accordance with the fol- be safely used as a foam stabilizer in lowing prescribed conditions: fermented malt beverages in accord- (a) Acacia (gum arabic) is the dried ance with the following conditions. gummy exudate from stems and branches of trees of various species of (a) It is the polymer of ethylene the genus Acacia, family Leguminosae. oxide having a minimum viscosity of (b) The ingredient meets the speci- 1,500 centipoises in a 1 percent aqueous fications of the Food Chemicals Codex, ° solution at 25 C. 8th ed. (2012), p. 516, which is incor- (b) It is used at a level not to exceed porated by reference. The Director of 300 parts per million by weight of the the Office of the Federal Register ap- fermented malt beverage. proves this incorporation by reference (c) The label of the additive bears di- in accordance with 5 U.S.C. 552(a) and 1 rections for use to insure compliance CFR part 51. You may obtain copies with paragraph (b) of this section. from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., § 172.775 Methacrylic acid- Rockville, MD 20852 (Internet address: divinylbenzene copolymer. http://www.usp.org). Copies may be ex- Methacrylic acid-divinylbenzene co- amined at the Food and Drug Adminis- polymer may be safely used in food in tration’s Main Library, 10903 New accordance with the following pre- Hampshire Ave., Bldg. 2, 3d Floor, Sil- scribed conditions: ver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Ad- (a) The additive is produced by the ministration (NARA). For information polymerization of methacrylic acid and on the availability of this material at divinylbenzene. The divinylbenzene NARA, call 202–741–6030, or go to: http:// functions as a cross-linking agent and www.archives.gov/federal-register/cfr/ibr- constitutes a minimum of 4 percent of locations.html. the polymer. (c) The ingredient is used in food in (b) Aqueous extractives from the ad- accordance with good manufacturing ditive do not exceed 2 percent (dry practices under the following condi- basis) after 24 hours at 25 °C. tions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages, alcoholic ...... 20.0 ...... Thickener, emulsifier, or stabilizer. Breakfast cereals, § 170.3(n)(4) of this chapter ..... 6.0 ...... ; emulsifier and emulsifier salt; fla- voring agent and adjuvant; formulation aid; processing aid; stabilizer and thickener; sur- face-finishing agent; texturizer. Cakes, brownies, pastries, biscuits, muffins, and 3.0 ...... Do. cookies. Grain-based bars (e.g., breakfast bars, granola 35.0 ...... Do. bars, rice cereal bars). Soups and soup mixes, § 170.3(n)(40) of this 2.5 ...... Do. chapter, except for soups and soup mixes con- taining meat or poultry that are subject to regu- lation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act. Food categories listed in § 184.1330 of this chap- Levels prescribed in Dietary fiber. ter, except for meat, poultry, and foods for § 184.1330 of this which standards of identity established under chapter. section 401 of the Federal Food, Drug, and Cosmetic Act preclude the use of acacia.

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[70 FR 8034, Feb. 17, 2005, as amended at 78 (2) The mean phage titer of each FR 71464, Nov. 29, 2013; 78 FR 73437, Dec. 6, monophage in the additive is 1 × 109 2013] plaque forming units (PFU)/ml. The an- alytical method for determining phage § 172.785 Listeria-specific bacteriophage preparation. titer entitled ‘‘Method to Determine Lytic Activity/Phage Titer,’’ dated No- The additive may be safely used as an vember 6, 2001, and printed by antimicrobial agent specific for Listeria Intralytix, Inc., is incorporated by ref- monocytogenes (L. monocytogenes) in ac- erence. Copies are available at loca- cordance with the following conditions: tions cited in paragraph (b)(1) of this (a) Identity. (1) The additive consists section. of a mixture of equal proportions of six (3) The phages present in the prepara- different individually purified lytic- tion must not contain a functional por- type (lacking lysogenic activity) tion of any of the toxin-encoding se- bacteriophages (phages) specific quences described in 40 CFR 725.421(d). against L. monocytogenes. No sequences derived from genes en- (2) Each phage is deposited at, and coding bacterial 16S ribosomal RNA assigned an identifying code by, a sci- are present in the complete genomic entifically-recognized culture collec- sequence of the phages. tion center, and is made available to (4) L. monocytogenes toxin, FDA upon request. listeriolysin O (LLO), is not greater (3) The additive is produced from one than 5 hemolytic units (HU)/ml. The or more cell cultures of L. analytical method for determining monocytogenes in a safe and suitable nu- LLO entitled ‘‘Quantitation of trient medium. Listeriolysin O Levels in LMP–102 TM,’’ (b) Specifications. (1) The additive dated September 27, 2004, and printed achieves a positive lytic result (OD600 by Intralytix, Inc., is incorporated by ≤0.06) when tested against any of the reference. Copies are available at loca- following L. monocytogenes isolates tions cited in paragraph (b)(1) of this available from American Type Culture section. Collection (ATCC): ATCC 35152 (5) The additive is negative for L. (serogroup 1/2a), ATCC 19118 (serogroup monocytogenes. The modified version of 4b), and ATCC 15313 (serogroup 1/2b). the U.S. Department of Agriculture’s The analytical method for determining method for determining L. the potency of the additive entitled monocytogenes entitled ‘‘LMP–102 TM ‘‘Determination of Potency of LMP– Listeria monocytogenes Sterility Test- 102 TM,’’ dated October 9, 2003, and ing,’’ dated May 24, 2004, and printed by printed by Intralytix, Inc., is incor- Intralytix, Inc., is incorporated by ref- porated by reference. The Director of erence. Copies are available at loca- the Office of the Federal Register ap- tions cited in paragraph (b)(1) of this proves this incorporation by reference section. in accordance with 5 U.S.C. 552(a) and 1 (6) The additive is negative for gram- CFR part 51. You may obtain a copy positive and gram-negative bacteria from the Office of Food Additive Safety capable of growing in commonly used (HFS–200), Food and Drug Administra- microbiological media (e.g., Luria- tion’s Main Library, 10903 New Hamp- Bertani (LB) medium), including Esch- shire Ave., Bldg. 2, Third Floor, Silver erichia coli, Salmonella species and Spring, MD 20993, 301–796–2039, or you coagulase-positive Staphylococci, as de- may examine a copy at the Center for termined by the ‘‘Method to Determine Food Safety and Applied Nutrition’s Microbial Contamination,’’ dated July Library, 5001 Campus Dr., College 11, 2003, and printed by Intralytix, Inc., Park, MD 20740, or at the National Ar- is incorporated by reference. Copies are chives and Records Administration available at locations cited in para- (NARA). For information on the avail- graph (b)(1) of this section. ability of this material at NARA, call (7) Total organic carbon (TOC) is less 202–741–6030, or go to: http:// than or equal to 36 mg/kg. The analyt- www.archives.gov/federallregister/ ical method for determining TOC enti- codeloflfederallregulations/ tled ‘‘Determination of Total Organic ibrllocations.html. Carbon by Automated Analyzer,’’ dated

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March 30, 2001, and printed by (2) Fluoride content is not more than Intralytix, Inc., is incorporated by ref- 30 milligrams per kilogram, as deter- erence. Copies are available at loca- mined by method III of the Fluoride tions cited in paragraph (b)(1) of this Limit Test of the Food Chemicals section. Codex, 7th ed. (2010), p. 1151, which is (c) Conditions of use. The additive is incorporated by reference. The Direc- used in accordance with current good tor of the Office of the Federal Register manufacturing practice to control L. approves this incorporation by ref- monocytogenes by direct application to erence in accordance with 5 U.S.C. meat and poultry products that comply 552(a) and 1 CFR part 51. You may ob- with the ready-to-eat definition in 9 tain copies from the United States CFR 430.1. Current good manufacturing Pharmacopeial Convention, 12601 practice is consistent with direct spray Twinbrook Pkwy., Rockville, MD 20852 application of the additive at a rate of (Internet address http://www.usp.org). approximately 1 mL of the additive per Copies may be examined at the Food 500 cm2 product surface area. and Drug Administration’s Main Li- [71 FR 47731, Aug. 18, 2006, as amended at 81 brary, 10903 New Hampshire Ave., Bldg. FR v5591, Feb. 3, 2016] 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar- Subpart I—Multipurpose Additives chives and Records Administration (NARA). For information on the avail- § 172.800 Acesulfame potassium. ability of this material at NARA, call 202–741–6030 or go to: http:// Acesulfame potassium (CAS Reg. No. www.archives.gov/federal-register/cfr/ibr- 55589–62–3), also known as acesulfame locations.html. K, may be safely used as a general-pur- (c) If the food containing the additive pose sweetener and flavor enhancer in is represented to be for special dietary foods generally, except in meat and uses, it shall be labeled in compliance poultry, in accordance with current with part 105 of this chapter. good manufacturing practice and in an amount not to exceed that reasonably [53 FR 28382, July 28, 1988, as amended at 57 required to accomplish the intended FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, technical effect in foods for which Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR standards of identity established under 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003; section 401 of the Federal Food, Drug, 78 FR 71464, Nov. 29, 2013] and Cosmetic Act do not preclude such § 172.802 Acetone peroxides. use, under the following conditions: (a) Acesulfame potassium is the po- The food additive acetone peroxides tassium salt of 6-methyl-1,2,3- may be safely used in flour, and in oxathiazine-4(3H)-one-2,2-dioxide. bread and rolls where standards of (b) The additive meets the following identity do not preclude its use, in ac- specifications: cordance with the following prescribed (1) Purity is not less than 99 percent conditions: on a dry basis. The purity shall be de- (a) The additive is a mixture of termined by a method titled monomeric and linear dimeric acetone ‘‘Acesulfame Potassium Assay,’’ which peroxide, with minor proportions of is incorporated by reference. Copies are higher polymers, manufactured by re- available from the Center for Food action of hydrogen peroxide and ace- Safety and Applied Nutrition (HFS– tone. 200), Food and Drug Administration, (b) The additive may be mixed with 5001 Campus Dr., College Park, MD an edible carrier to give a concentra- 20740, or available for inspection at the tion of: (1) 3 grams to 10 grams of hy- National Archives and Records Admin- drogen peroxide equivalent per 100 istration (NARA). For information on grams of the additive, plus carrier, for the availability of this material at use in flour maturing and bleaching; or NARA, call 202–741–6030, or go to: http:// (2) approximately 0.75 gram of hydro- www.archives.gov/federallregister/ gen peroxide equivalent per 100 grams codeloflfederallregulations/ of the additive, plus carrier, for use in ibrllocations.html. dough conditioning.

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(c) It is used or intended for use: (1) (1) Assay for advantame, not less In maturing and bleaching of flour in a than 97.0 percent and not more than quantity not more than sufficient for 102.0 percent on a dry basis. such effect; and (2) as a dough-condi- (2) Free N-[N-[3-(3-hydroxy-4- tioning agent in bread and roll produc- methoxyphenyl)propyl]-a-aspartyl]-L- tion at not to exceed the quantity of phenylalanine, not more than 1.0 per- hydrogen peroxide equivalent nec- cent. essary for the artificial maturing ef- (3) Total other related substances, fect. not more than 1.5 percent. (d) To insure safe use of the additive, (4) Lead, not more than 1.0 milligram the label of the food additive container per kilogram. and any intermediate premix thereof (5) Water, not more than 5.0 percent. shall bear, in addition to the other in- (6) Residue on ignition, not more formation required by the act: than 0.2 percent. (1) The name of the additive, ‘‘ace- (7) Specific rotation, determined at20 tone peroxides’’. °C [a]D: ¥45.0 to ¥38.0° calculated on a (2) The concentration of the additive dry basis. expressed in hydrogen peroxide equiva- (c) The food additive advantame may lents per 100 grams. be safely used as a sweetening agent (3) Adequate use directions to provide and flavor enhancer in foods generally, a final product that complies with the except in meat and poultry, in accord- limitations prescribed in paragraph (c) ance with current good manufacturing of this section. practice, in an amount not to exceed that reasonably required to achieve the § 172.803 Advantame. intended technical effect, in foods for (a) Advantame is the chemical N-[N- which standards of identity established [3-(3-hydroxy-4- under section 401 of the Federal Food, Drug, and Cosmetic Act do not pre- methoxyphenyl)propyl]-a-aspartyl]-L- phenylalanine 1-methyl ester, clude such use. monohydrate (CAS Reg. No. 714229–20– (d) If the food containing the additive 6). purports to be or is represented to be (b) Advantame meets the following for special dietary use, it must be la- beled in compliance with part 105 of specifications when it is tested accord- this chapter. ing to the methods described or ref- erenced in the document entitled [79 FR 29085, May 21, 2014] ‘‘Specifications and Analytical Meth- ods for Advantame’’ dated April 1, 2009, § 172.804 Aspartame. by the Ajinomoto Co. Inc., Sweetener The food additive aspartame may be Department 15–1, Kyobashi 1-chome, safely used in food in accordance with Chuo-ku, Tokyo 104–8315, Japan. The good manufacturing practice as a Director of the Office of the Federal sweetening agent and a flavor enhancer Register approves this incorporation in foods for which standards of identity by reference in accordance with 5 established under section 401 of the act U.S.C. 552(a) and 1 CFR part 51. Copies do not preclude such use under the fol- are available from the Office of Food lowing conditions: Additive Safety (HFS–200), Center for (a) Aspartame is the chemical 1- Food Safety and Applied Nutrition, methyl N-L-a-aspartyl-L-phenylalanine 5001 Campus Dr., College Park, MD (C14H18N2O5). 20740. Copies may be examined at the (b) The additive meets the specifica- Food and Drug Administration’s Main tions of the Food Chemicals Codex, 7th Library, 10903 New Hampshire Ave., ed. (2010), pp. 73–74, which is incor- Bldg. 2, Third Floor, Silver Spring, MD porated by reference. The Director of 20993, 301–796–2039, or at the National the Office of the Federal Register ap- Archives and Records Administration proves this incorporation by reference (NARA). For information on the avail- in accordance with 5 U.S.C. 552(a) and 1 ability of this material at NARA, call CFR part 51. You may obtain copies 202–741–6030 or go to: http:// from the United States Pharmacopeial www.archives.gov/federal-register/cfr/ibr- Convention, 12601 Twinbrook Pkwy., locations.html. Rockville, MD 20852 (Internet address

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http://www.usp.org). Copies may be ex- statement of the concentration of the amined at the Food and Drug Adminis- additive contained therein; tration’s Main Library, 10903 New (2) The label of any food containing Hampshire Ave., Bldg. 2, Third Floor, the additive shall bear, either on the Silver Spring, MD 20993, 301–796–2039, or principal display panel or on the infor- at the National Archives and Records mation panel, the following statement: Administration (NARA). For informa- tion on the availability of this mate- PHENYLKETONURICS: CONTAINS rial at NARA, call 202–741–6030 or go to: PHENYLALANINE http://www.archives.gov/federal-register/ cfr/ibr-locations.html. The statement shall appear in the la- (c)(1) When aspartame is used as a beling prominently and conspicuously sugar substitute tablet for sweetening as compared to other words, state- hot beverages, including coffee and tea, ments, designs or devices and in bold L-leucine may be used as a lubricant in type and on clear contrasting back- the manufacture of such tablets at a ground in order to render it likely to level not to exceed 3.5 percent of the be read and understood by the ordinary weight of the tablet. individual under customary conditions (2) When aspartame is used in baked of purchase and use. goods and baking mixes, the amount of (3) When the additive is used in a the additive is not to exceed 0.5 percent sugar substitute for table use, its label by weight of ready-to-bake products or shall bear instructions not to use in of finished formulations prior to bak- cooking or baking. ing. Generally recognized as safe (4) Packages of the dry, free-flowing (GRAS) ingredients or food additives additive shall prominently display the approved for use in baked goods shall sweetening equivalence in teaspoons of be used in combination with aspartame sugar. to ensure its functionality as a sweet- (e) If the food containing the additive ener in the final baked product. The purports to be or is represented for spe- level of aspartame used in these prod- cial dietary uses, it shall be labeled in ucts is determined by an analytical compliance with part 105 of this chap- method entitled ‘‘Analytical Method ter. for the Determination of Aspartame [39 FR 27319, July 26, 1974] and Diketopiperazine in Baked Goods and Baking Mixes,’’ October 8, 1992, EDITORIAL NOTE: For FEDERAL REGISTER ci- which was developed by the Nutrasweet tations affecting § 172.804, see the List of CFR Co. Copies are available from the Office Sections Affected, which appears in the Finding Aids section of the printed volume of Premarket Approval (HFS–200), Food and at www.fdsys.gov. and Drug Administration’s Main Li- brary, 10903 New Hampshire Ave., Bldg. § 172.806 Azodicarbonamide. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or are available for inspec- The food additive azodicarbonamide tion at the Center for Food Safety and may be safely used in food in accord- Applied Nutrition’s Library, Food and ance with the following prescribed con- Drug Administration, 5001 Campus Dr., ditions: College Park, MD 20740, and at the Na- (a) It is used or intended for use: tional Archives and Records Adminis- (1) As an aging and bleaching ingre- tration (NARA). For information on dient in cereal flour in an amount not the availability of this material at to exceed 2.05 grams per 100 pounds of NARA, call 202–741–6030, or go to: http:// flour (0.0045 percent; 45 parts per mil- www.archives.gov/federallregister/ lion). codeloflfederallregulations/ (2) As a dough conditioner in bread ibrllocations.html. baking in a total amount not to exceed (d) To assure safe use of the additive, 0.0045 percent (45 parts per million) by in addition to the other information re- weight of the flour used, including any quired by the Act: quantity of azodicarbonamide added to (1) The principal display panel of any flour in accordance with paragraph intermediate mix of the additive for (a)(1) of this section. manufacturing purposes shall bear a (b) To assure safe use of the additive:

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(1) The label and labeling of the addi- tive does not exceed the weight of the tive and any intermediate premix pre- flavoring oils in the flavor concentrate. pared therefrom shall bear, in addition (2) The additive identified in para- to the other information required by graph (a)(2) of this section is used as a the Act, the following: processing aid and wetting agent in (i) The name of the additive. combination with dioctyl sodium sulfo- (ii) A statement of the concentration succinate for fumaric acid as pre- or the strength of the additive in any scribed in § 172.810. intermediate premixes. (3) The additive identified in para- (2) The label or labeling of the food graph (a)(3) of this section is used: additive shall also bear adequate direc- (i) As a surfactant and defoaming tions for use. agent, at levels not to exceed 0.05 per- cent by weight, in scald baths for poul- § 172.808 Copolymer condensates of try defeathering, followed by potable ethylene oxide and propylene oxide. water rinse. The temperatures of the scald baths shall be not less than 125 Copolymer condensates of ethylene °F. oxide and propylene oxide may be safe- (ii) As a foam control and rinse adju- ly used in food under the following pre- vant in hog dehairing machines at a scribed conditions: use level of not more than 5 grams per (a) The additive consists of one of the hog. following: (4) The additive identified in para- (1) a-Hydro-omega-hydroxy-poly (oxy- graph (a)(4) of this section is used as a ethylene) poly(oxypropylene)-(55–61 dough conditioner in yeast-leavened moles)poly(oxyethylene) copoly- bakery products for which standards of mer, having a molecular weight range identity established under section 401 of 9,760–13,200 and a cloud point above of the Act do not preclude such use, 100 °C in 1 percent aqueous solution. provided that the amount of the addi- (2) a-Hydro-omega-hydroxy-poly (oxy- tive dose not exceed 0.5 percent by ethylene)poly(oxypropylene)-(53–59 weight of the flour used. moles)poly(oxyethylene)(14–16 moles) [42 FR 14491, Mar. 15, 1977, as amended at 46 block copolymer, having a molecular FR 57476, Nov. 24, 1981] weight range of 3,500–4,125 and a cloud point of 9 °C–12 °C in 10 percent aqueous § 172.809 Curdlan. solution. Curdlan may be safely used in ac- (3) a-Hydro-omega-hydroxy-poly(ox- cordance with the following conditions: yethylene)/poly(oxypropylene) (min- (a) Curdlan is a high molecular imum 15 moles)/poly(oxyethylene) weight polymer of glucose (b-1,3- block copolymer, having a minimum glucan; CAS Reg. No. 54724–00–4) pro- average molecular weight of 1900 and a duced by pure culture fermentation minimum cloud point of 9 °C–12 °C in 10 from the nonpathogenic and percent aqueous solution. nontoxicogenic bacterium Alcaligenes (4) a-Hydro-omega-hydroxy-poly(ox- faecalis var. myxogenes. yethylene) poly (oxypropylene)-(51–57 (b) Curdlan meets the following spec- moles) poly(oxyethylene) block copoly- ifications when it is tested according mer, having an average molecular to the methods described or referenced weight of 14,000 and a cloud point above in the document entitled ‘‘Analytical 100 °C in 1 percent aqueous solution. Methods for Specification Tests for (b) The additive is used or intended Curdlan,’’ by Takeda Chemical Indus- for use as follows: tries, Ltd., 12–10 Nihonbashi, 2–Chome, (1) The additive identified in para- Chuo-ku, Tokyo, 103, Japan, 1996, which graph (a)(1) of this section is used in is incorporated by reference in accord- practice as a solubilizing and stabi- ance with 5 U.S.C. 552(a) and 1 CFR lizing agent in flavor concentrates part 51. Copies are available from the (containing authorized flavoring oils) Office of Food Additive Safety (HFS– for use in foods for which standards of 200), Food and Drug Administration’s identity established under section 401 Main Library, 10903 New Hampshire of the Act do not preclude such use, Ave., Bldg. 2, Third Floor, Silver provided that the weight of the addi- Spring, MD 20993, 301–796–2039, 240–402–

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1200, or may be examined at the Center http://www.usp.org). Copies may be ex- for Food Safety and Applied Nutri- amined at the Food and Drug Adminis- tion’s Library, Food and Drug Admin- tration’s Main Library, 10903 New istration, 5001 Campus Dr., College Hampshire Ave., Bldg. 2, Third Floor, Park, MD 20740, or at the National Ar- Silver Spring, MD 20993, 301–796–2039, or chives and Records Administration at the National Archives and Records (NARA). For information on the avail- Administration (NARA). For informa- ability of this material at NARA, call tion on the availability of this mate- 202–741–6030, or go to: http:// rial at NARA, call 202–741–6030 or go to: www.archives.gov/federallregister/ http://www.archives.gov/federal-register/ codeloflfederallregulations/ cfr/ibr-locations.html). The food additive, ibrllocations.html. dioctyl sodium sulfosuccinate, may be (1) Positive for curdlan. safely used in food in accordance with (2) Assay for curdlan (calculated as the following prescribed conditions: anhydrous glucose), not less than 80 (a) As a wetting agent in the fol- percent. lowing fumaric acid-acidulated foods: (3) pH of 1 percent aqueous suspen- Dry gelatin dessert, dry beverage base, sion, 6.0–7.5. and fruit juice drinks, when standards (4) Lead, not more than 0.5 mg/kg. of identity do not preclude such use. (5) Heavy metals (as Pb), not more The labeling of the dry gelatin dessert than 0.002 percent. and dry beverage base shall bear ade- (6) Total nitrogen, not more than 0.2 quate directions for use, and the addi- percent. tive shall be used in such an amount (7) Loss on drying, not more than 10 that the finished gelatin dessert will percent. contain not in excess of 15 parts per (8) Residue on ignition, not more million of the additive and the finished than 6 percent. (9) Gel strength of 2 percent aqueous beverage or fruit juice drink will con- suspension, not less than 600 × 103 dyne tain not in excess of 10 parts per mil- per square centimeter. lion of the additive. (10) Aerobic plate count, not more (b) As a processing aid in sugar fac- than 103 per gram. tories in the production of unrefined (11) Coliform bacteria, not more than cane sugar, in an amount not in excess 3 per gram. of 0.5 part per million of the additive (c) Curdlan is used or intended for per percentage point of sucrose in the use in accordance with good manufac- juice, syrup, or massecuite being proc- turing practice as a formulation aid, essed, and so used that the final molas- processing aid, stabilizer and thick- ses will contain no more than 25 parts ener, and texturizer in foods for which per million of the additive. standards of identity established under (c) As a solubilizing agent on gums section 401 of the act do not preclude and hydrophilic colloids to be used in such use. food as stabilizing and thickening agents, when standards of identity do [61 FR 65941, Dec. 16, 1996, as amended at 78 FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016] not preclude such use. The additive is used in an amount not to exceed 0.5 § 172.810 Dioctyl sodium sulfo- percent by weight of the gums or hy- succinate. drophilic colloids. The food additive, dioctyl sodium (d) As an emulsifying agent for cocoa sulfosuccinate, meets the specifica- fat in noncarbonated beverages con- tions of the Food Chemicals Codex, 7th taining cocoa, whereby the amount of ed. (2010), pp. 313–314, which is incor- the additive does not exceed 25 parts porated by reference. The Director of per million of the finished beverage. the Office of the Federal Register ap- (e) As a dispersing agent in ‘‘cocoa proves this incorporation by reference with dioctyl sodium sulfosuccinate for in accordance with 5 U.S.C. 552(a) and 1 manufacturing’’ that conforms to the CFR part 51. You may obtain copies provisions of § 163.117 of this chapter from the United States Pharmacopeial and the use limitations prescribed in Convention, 12601 Twinbrook Pkwy., § 172.520, in an amount not to exceed 0.4 Rockville, MD 20852 (Internet address percent by weight thereof.

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(f) As a processing aid and wetting Uses Limitations agent in combination with a-hydro- 2. As a formulation aid as de- Not to exceed 0.5 percent. omega -hydroxy - poly(oxyethylene) - fined in § 170.3(o)(14) of this poly-(oxypropylene) (53–59 moles) chapter, lubricant and release poly(oxyethylene) (14–16 moles) block agent as defined in § 170.3(o)(18) of this chapter, copolymer, having a molecular weight and surface-finishing agent as range of 3,500–4,125 and a cloud point of defined in § 170.3(o)(30) of 9 °C–12 °C in 10 percent aqueous solu- this chapter in food. 3. As a formulation aid as de- Not to exceed 3.0 percent tion, for fumaric acid used in fumaric fined in § 170.3(o)(14) of this of the combined weight acid-acidulated dry beverage base and chapter in confections. of the formulation. in fumaric acid-acidulated fruit juice 4. As a formulation aid as de- Not to exceed 1.0 percent fined in § 170.3(o)(14) of this of the combined weight drinks, when standards of identity do chapter in fats and oils as de- of the formulation. not preclude such use. The labeling of fined in § 170.3 (n)(12) of this the dry beverage base shall bear ade- chapter. quate directions for use, and the addi- 5. As a winterization and frac- Not to exceed 0.5 percent tionation aid in fat and oil by weight of the proc- tives shall be used in such an amount processing. essed fat or oil. that the finished beverage or fruit juice drink will contain not in excess of a (d) To assure safe use of the additive: total of 10 parts per million of the (1) In addition to the other informa- dioctyl sodium sulfosuccinate-block tion required by the act, the label or copolymer combination. labeling of the additive shall bear the name of the additive. [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, (2) The label of the additive shall 2013] bear adequate directions to provide a final product that complies with the § 172.811 Glyceryl tristearate. limitations prescribed in paragraph (c) of this section. The food additive glyceryl tristearate may be safely used in food in accord- [53 FR 21632, June 9, 1988, as amended at 59 ance with the following prescribed con- FR 24924, May 13, 1994] ditions: (a) The food additive (CAS Reg. No. § 172.812 Glycine. 555–43–1) is prepared by reacting stearic The food additive glycine may be acid with glycerol in the presence of a safely used for technological purposes suitable catalyst. in food in accordance with the fol- (b) The food additive meets the fol- lowing prescribed conditions: lowing specifications: (a) The additive meets the specifica- tions of the Food Chemicals Codex, 7th Acid number: Not to exceed 1.0. ed. (2010), pp. 457–458, which is incor- Iodine number: Not to exceed 1.0. porated by reference. The Director of Saponification number: 186–192. the Office of the Federal Register ap- Hydroxyl number: Not to exceed 5.0. proves this incorporation by reference Free glycerol content: Not to exceed 0.5 per- in accordance with 5 U.S.C. 552(a) and 1 cent. CFR part 51. You may obtain copies Unsaponifiable matter: Not to exceed 0.5 per- cent. from the United States Pharmacopeial Melting point (Class II): 69 °C–73 °C. Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address (c) The additive is used or intended http://www.usp.org). Copies may be ex- for use as follows when standards of amined at the Food and Drug Adminis- identity established under section 401 tration’s Main Library, 10903 New of the Act do not preclude such use: Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or Uses Limitations at the National Archives and Records 1. As a crystallization accel- Not to exceed 1 percent of Administration (NARA). For informa- erator in cocoa products, in the combined weight of tion on the availability of this mate- imitation chocolate, and in the formulation. rial at NARA, call 202–741–6030 or go to: compound coatings. http://www.archives.gov/federal-register/ cfr/ibr-locations.html.

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(b) The additive is used or intended § 172.816 Methyl glucoside-coconut oil for use as follows: ester. Methyl glucoside-coconut oil ester Uses Limitations may be safely used in food in accord- As a masking agent for the Not to exceed 0.2 percent in ance with the following conditions: bitter aftertaste of sac- the finished beverage. (a) It is the methyl glucoside-coconut charin used in manufac- tured beverages and bev- oil ester having the following specifica- erage bases. tions: As a stabilizer in mono- and Not to exceed 0.02 percent of diglycerides prepared by the mono- and Acid number: 10–20 the glycerolysis of edible diglycerides. Hydroxyl number: 200–300 fats or oils. pH (5% aqueous): 4.8–5.0 Saponification number: 178–190 (c) To assure safe use of the additive, (b) It is used or intended for use as in addition to the other information re- follows: quired by the Act: (1) As an aid in crystallization of su- (1) The labeling of the additive shall crose and dextrose at a level not to ex- bear adequate directions for use of the ceed the minimum quantity required to additive in compliance with the provi- produce its intended effect. sions of this section. (2) As a surfactant in molasses at a (2) The labeling of beverage bases level not to exceed 320 parts per million containing the additive shall bear ade- in the molasses. quate directions for use to provide that beverages prepared therefrom shall § 172.818 Oxystearin. contain no more than 0.2 percent gly- The food additive oxystearin may be cine. safely used in foods, when such use is [42 FR 14491, Mar. 15, 1977, as amended at 49 not precluded by standards of identity FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, in accordance with the following condi- 2013] tions: (a) The additive is a mixture of the § 172.814 Hydroxylated lecithin. glycerides of partially oxidized stearic and other fatty acids obtained by heat- The food additive hydroxylated ing hydrogenated cottonseed or soy- lecithin may be safely used as an emul- bean oil under controlled conditions, in sifier in foods in accordance with the the presence of air and a suitable cata- following conditions: lyst which is not a food additive as so (a) The additive is obtained by the defined. The resultant product meets treatment of lecithin in one of the fol- the following specifications: lowing ways, under controlled condi- tions whereby the separated fatty acid Acid number: Maximum 15. fraction of the resultant product has Iodine number: Maximum 15. an acetyl value of 30 to 38: Saponification number: 225–240. Hydroxyl number: 30–45. (1) With hydrogen peroxide, benzoyl Unsaponifiable material: Maximum 0.8 per- peroxide, lactic acid, and sodium hy- cent. droxide. Refractive index (butyro): 60±1 at 48 °C. (2) With hydrogen peroxide, acetic (b) It is used or intended for use as a acid, and sodium hydroxide. crystallization inhibitor in vegetable (b) It is used or intended for use, in oils and as a release agent in vegetable accordance with good manufacturing oils and vegetable shortenings, where- practice, as an emulsifier in foods, ex- by the additive does not exceed 0.125 cept for those standardized foods that percent of the combined weight of the do not provide for such use. oil or shortening. (c) To assure safe use of the additive, (c) To insure safe use of the additive, the label of the food additive container the label and labeling of the additive shall bear, in addition to the other in- container shall bear, in addition to the formation required by the Act: other information required by the Act: (1) The name of the additive, (1) The name of the additive. ‘‘hydroxylated lecithin’’. (2) Adequate directions to provide an (2) Adequate directions for its use. oil or shortening that complies with

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the limitations prescribed in paragraph SX850, or equivalent) 12 percent in H2O by (b) of this section. weight on 60–80 mesh nonacid washed diato- maceous earth (Chromosorb W. Johns-Man- § 172.820 Polyethylene glycol (mean ville, or equivalent). molecular weight 200–9,500). REAGENTS AND MATERIALS Polyethylene glycol identified in this Carrier gas, nitrogen: Commercial grade in section may be safely used in food in cylinder equipped with reducing regulator to accordance with the following pre- provide 50 p.s.i.g. to the gas chromatograph. scribed conditions: Ethylene glycol: Commercial grade. Purify (a) Identity. (1) The additive is an ad- if necessary, by distillation. dition polymer of ethylene oxide and Diethylene glycol: Commercial grade. Pu- water with a mean molecular weight of rify, if necessary, by distillation. 200 to 9,500. Glycol standards: Prepare (2) It contains no more than 0.2 per- chromatographic standards by dissolving known amounts of ethylene glycol and cent total by weight of ethylene and diethylene glycol in water. Suitable con- diethylene glycols when tested by the centrations for standardization range from 1 analytical methods prescribed in para- to 6 milligrams of each component per milli- graph (b) of this section. liter (for example 10 milligrams diluted to (b) Analytical method. (1) The analyt- volume in a 10-milliliter volumetric flask is ical method prescribed in the National equivalent to 1 milligram per milliliter). Formulary XV (1980), page 1244, for pol- STANDARDIZATION yethylene glycol 400 shall be used to determine the total ethylene and Inject a 2-microliter aliquot of the glycol diethylene glycol content of poly- standard into the gas chromatograph em- ploying the conditions described above. ethylene glycols having mean molec- Measure the net peak heights for the ethyl- ular weights of 450 or higher. ene glycol and for the diethylene glycol. (2) The following analytical method Record the values as follows: shall be used to determine the total A = Peak height in millimeters of the ethylene and diethylene glycol content ethylene glycol peak. of polyethylene glycols having mean B = milligrams of ethylene glycol per mil- molecular weights below 450. liliter of standard solution. C = Peak height in millimeters of the diethylene glycol peak. ANALYTICAL METHOD D = Milligrams of diethylene glycol per milliliter of standard solution. ETHYLENE GLYCOL AND DIETHYLENE GLYCOL CONTENT OF POLYETHYLENE GLYCOLS PROCEDURE The analytical method for determining Weigh approximately 4 grams of poly- ethylene glycol and diethylene glycol is as ethylene glycol sample accurately into a 10- follows: milliliter volumetric flask. Dilute to volume with water. Mix the solution thoroughly and APPARATUS inject a 2-microliter aliquot into the gas Gas chromatograph with hydrogen chromatograph. Measure the heights, in mil- ionization detector (Varian Aerograph 600 D limeters, of the ethylene glycol peak and of or equivalent). The following conditions the diethylene glycol peak and record as E shall be employed with the Varian and F, respectively. Aerograph 600 D gas chromatograph: × × Column temperature: 165 °C. Percent ethylene glycol = (E B) / (A sam- Inlet temperature: 260 °C. ple weight in grams) Carrier gas (nitrogen) flow rate: 70 milli- Percent diethylene glycol = (F × D) / (C × liters per minute. sample weight in grams) Hydrogen and air flow to burner: Optimize to give maximum sensitivity. (c) Uses. It may be used, except in Sample size: 2 microliters. milk or preparations intended for addi- Elution time: Ethylene glycol: 2.0 minutes. tion to milk, as follows: Diethylene glycol: 6.5 minutes. (1) As a coating, binder, plasticizing Recorder: ¥0.5 to + 1.05 millivolt, full span, agent, and/or lubricant in tablets used 1 second full response time. for food. Syringe: 10-microliter (Hamilton 710 N or equivalent). (2) As an adjuvant to improve flavor Chromatograph column: 5 feet × 1⁄8 inch. and as a bodying agent in nonnutritive I.D. stainless steel tube packed with sweeteners identified in § 180.37 of this (Mathieson-Coleman-Bell 2768 Sorbitol chapter.

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(3) As an adjuvant in dispersing vita- step is followed by a conventional re- min and/or mineral preparations. fining process that includes alkali neu- (4) As a coating on sodium nitrite to tralization and deodorization of the inhibit hygroscopic properties. fats and oils. (d) Limitations. (1) It is used in an (c) To insure the safe use of the addi- amount not greater than that required tive, the label of the food additive con- to produce the intended physical or tainer shall bear, in addition to the technical effect. other information required by the Act: (2) A tolerance of zero is established (1) The name of the additive, sodium for residues of polyethylene glycol in lauryl sulfate. milk. (2) Adequate use directions to provide [42 FR 14491, Mar. 15, 1977, as amended at 49 a final product that complies with the FR 10105, Mar. 19, 1984] limitations prescribed in paragraph (b) of this section. § 172.822 Sodium lauryl sulfate. The food additive sodium lauryl sul- [42 FR 14491, Mar. 15, 1977, as amended at 43 fate may be safely used in food in ac- FR 18668, May 2, 1978] cordance with the following conditions: (a) The additive meets the following § 172.824 Sodium mono- and dimethyl naphthalene sulfonates. specifications: (1) It is a mixture of sodium alkyl The food additive sodium mono- and sulfates consisting chiefly of sodium dimethyl naphthalene sulfonates may lauryl sulfate [CH2(CH2)10CH2OSO2Na]. be safely used in accordance with the (2) It has a minimum content of 90 following prescribed conditions: percent sodium alkyl sulfates. (a) The additive has a molecular (b) It is used or intended for use: weight range of 245–260. (1) As an emulsifier in or with egg (b) The additive is used or intended whites whereby the additive does not for use: exceed the following limits: (1) In the crystallization of sodium Egg white solids, 1,000 parts per million. carbonate in an amount not to exceed Frozen egg whites, 125 parts per million. 250 parts per million of the sodium car- Liquid egg whites, 125 parts per million. bonate. Such sodium carbonate is used (2) As a whipping agent at a level not or intended for use in potable water to exceed 0.5 percent by weight of gela- systems to reduce hardness and aid in tine used in the preparation of marsh- sedimentation and coagulation by rais- mallows. ing the pH for the efficient utilization (3) As a surfactant in: of other coagulation materials. (i) Fumaric acid-acidulated dry bev- (2) As an anticaking agent in sodium erage base whereby the additive does nitrite at a level not in excess of 0.1 not exceed 25 parts per million of the percent by weight thereof for author- finished beverage and such beverage ized uses in cured fish and meat. base is not for use in a food for which (c) In addition to the general labeling a standard of identity established requirements of the Act: under section 401 of the Act precludes (1) Sodium carbonate produced in ac- such use. cordance with paragraph (b)(1) of this (ii) Fumaric acid-acidulated fruit section shall be labeled to show the juice drinks whereby the additive does presence of the additive and its label or not exceed 25 parts per million of the labeling shall bear adequate directions finished fruit juice drink and it is not for use. used in a fruit juice drink for which a (2) Sodium nitrite produced in ac- standard of identity established under cordance with paragraph (b)(2) of this section 401 of the Act precludes such section shall bear the labeling required use. by § 172.175 and a statement declaring (4) As a wetting agent at a level not the presence of sodium mono- and di- to exceed 10 parts per million in the partition of high and low melting frac- methyl naphthalene sulfonates. tions of crude vegetable oils and ani- [42 FR 14491, Mar. 15, 1977, as amended at 63 mal fats, provided that the partition FR 7069, Feb. 12, 1998]

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§ 172.826 Sodium stearyl fumarate. essing, food-packing, or food-storage Sodium stearyl fumarate may be equipment. safely used in food in accordance with [42 FR 14491, Mar. 15, 1977, as amended at 50 the following conditions: FR 3508, Jan. 25, 1985] (a) It contains not less than 99 per- cent sodium stearyl fumarate cal- § 172.829 Neotame. culated on the anhydrous basis, and (a) Neotame is the chemical N-[N- not more than 0.25 percent sodium ste- (3,3-dimethylbutyl)-L-a-aspartyl]-L- aryl maleate. phenylalanine-1-methyl ester (CAS (b) The additive is used or intended Reg. No. 165450–17–9). for use: (b) Neotame meets the following (1) As a dough conditioner in yeast- specifications when it is tested accord- leavened bakery products in an amount ing to the methods described or ref- not to exceed 0.5 percent by weight of erenced in the document entitled the flour used. ‘‘Specifications and Analytical Meth- (2) As a conditioning agent in dehy- ods for Neotame’’ dated April 3, 2001, drated potatoes in an amount not to by the NutraSweet Co., 699 North exceed 1 percent by weight thereof. Wheeling Rd., Mount Prospect, IL (3) As a stabilizing agent in 60056. The Director of the Office of the nonyeast-leavened bakery products in Federal Register has approved the in- an amount not to exceed 1 percent by corporation by reference of this mate- weight of the flour used. rial in accordance with 5 U.S.C. 552(a) (4) As a conditioning agent in proc- and 1 CFR part 51. Copies are available essed cereals for cooking in an amount from the Office of Food Additive Safety not to exceed 1 percent by weight of the dry cereal, except for foods for (HFS–200), Food and Drug Administra- which standards of identity preclude tion’s Main Library, 10903 New Hamp- such use. shire Ave., Bldg. 2, Third Floor, Silver (5) As a conditioning agent in starch- Spring, MD 20993, 301–796–2039. Copies thickened or flour-thickened foods in may be examined at the Center for an amount not to exceed 0.2 percent by Food Safety and Applied Nutrition’s weight of the food. Library, 5001 Campus Dr., rm. 1C–100, College Park, MD 20740, or at the Na- § 172.828 Acetylated monoglycerides. tional Archives and Records Adminis- tration (NARA). For information on The food additive acetylated the availability of this material at monoglycerides may be safely used in NARA, call 202–741–6030, or go to: http:// or on food in accordance with the fol- www.archives.gov/federallregister/ lowing prescribed conditions: (a) The additive is manufactured by: codeloflfederallregulations/ (1) The interesterification of edible ibrllocations.html. fats with triacetin and in the presence (1) Assay for neotame, not less than of catalytic agents that are not food 97.0 percent and not more than 102.0 additives or are authorized by regula- percent on a dry basis. tion, followed by a molecular distilla- (2) Free dipeptide acid (N-[N-(3,3- tion or by steam stripping; or dimethylbutyl)-L-a-aspartyl]-L- (2) The direct acetylation of edible phenylalanine), not more than 1.5 per- monoglycerides with acetic anhydride cent. without the use of catalyst or molec- (3) Other related substances, not ular distillation, and with the removal more than 2.0 percent. by vacuum distillation, if necessary, of (4) Lead, not more than 2.0 milli- the acetic acid, acetic anhydride, and grams per kilogram. triacetin. (5) Water, not more than 5.0 percent. (b) The food additive has a Reichert- (6) Residue on ignition, not more Meissl value of 75–200 and an acid value than 0.2 percent of less than 6. (7) Specific rotation, determined at (c) The food additive is used at a 20 °C [a]D: ¥40.0° to 43.4° calculated on level not in excess of the amount rea- a dry basis. sonably required to produce its in- (c) The food additive neotame may be tended effect in food, or in food-proc- safely used as a sweetening agent and

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flavor enhancer in foods generally, ex- galactopyranoside (CAS Reg. No. 56038– cept in meat and poultry, in accord- 13–2). ance with current good manufacturing (b) The additive meets the specifica- practice, in an amount not to exceed tions of the Food Chemicals Codex, 7th that reasonably required to accomplish ed. (2010), pp. 993–995, which is incor- the intended technical effect, in foods porated by reference. The Director of for which standards of identity estab- the Office of the Federal Register ap- lished under section 401 of the Federal proves this incorporation by reference Food, Drug, and Cosmetic Act do not in accordance with 5 U.S.C. 552(a) and 1 preclude such use. CFR part 51. You may obtain copies (d) When neotame is used as a sugar from the United States Pharmacopeial substitute tablet, L-leucine may be Convention, 12601 Twinbrook Pkwy., used as a lubricant in the manufacture Rockville, MD 20852 (Internet address of tablets at a level not to exceed 3.5 http://www.usp.org). Copies may be ex- percent of the weight of the tablet. amined at the Food and Drug Adminis- (e) If the food containing the additive tration’s Main Library, 10903 New purports to be or is represented to be Hampshire Ave., Bldg. 2, Third Floor, for special dietary use, it shall be la- Silver Spring, MD 20993, 301–796–2039, or beled in compliance with part 105 of at the National Archives and Records this chapter. Administration (NARA). For informa- tion on the availability of this mate- [67 FR 45310, July 9, 2002, as amended at 81 rial at NARA, call 202–741–6030 or go to: FR 5591, Feb. 3, 2016] http://www.archives.gov/federal-register/ § 172.830 Succinylated monoglycerides. cfr/ibr-locations.html. (c) The additive may be used as a The food additive succinylated sweetener in foods generally, in accord- monoglycerides may be safely used in ance with current good manufacturing food in accordance with the following practice in an amount not to exceed prescribed conditions: that reasonably required to accomplish (a) The additive is a mixture of semi- the intended effect. and neutral succinic acid esters of (d) If the food containing the additive mono- and diglycerides produced by the purports to be or is represented to be succinylation of a product obtained by for special dietary use, it shall be la- the glycerolysis of edible fats and oils, beled in compliance with part 105 of or by the direct esterification of glyc- this chapter. erol with edible fat-forming fatty acids. [63 FR 16433, Apr. 3, 1998, as amended at 64 FR 43909, Aug. 12, 1999; 78 FR 14665, Mar. 7, (b) The additive meets the following 2013; 78 FR 71464, Nov. 29, 2013] specifications: Succinic acid content: 14.8%–25.6% § 172.832 Monoglyceride citrate. Melting point: 50 °C–60 °C. A food additive that is a mixture of Acid number: 70–120 glyceryl monooleate and its citric acid (c) The additive is used or intended monoester manufactured by the reac- for use in the following foods: tion of glyceryl monooleate with citric (1) As an emulsifier in liquid and acid under controlled conditions may plastic shortenings at a level not to ex- be safely used as a synergist and solu- ceed 3 percent by weight of the short- bilizer for antioxidants in oils and fats, ening. when used in accordance with the con- ditions prescribed in this section. (2) As a dough conditioner in bread (a) The food additive meets the fol- baking, when such use is permitted by lowing specifications: an appropriate food standard, at a level not to exceed 0.5 percent by weight of Acid number, 70–100. the flour used. Total citric acid (free and combined), 14 per- cent–17 percent. § 172.831 Sucralose. (b) It is used, or intended for use, in (a) Sucralose is the chemical 1,6- antioxidant formulations for addition dichloro-1,6-dideoxy-b-D- to oils and fats whereby the additive fructofuranosyl-4-chloro-4-deoxy-a-D- does not exceed 200 parts per million of 95

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the combined weight of the oil or fat 202–741–6030, or go to: http:// and the additive. www.archives.gov/federallregister/ (c) To assure safe use of the additive: codeloflfederallregulations/ (1) The container label shall bear, in ibrllocations.html. addition to the other information re- (3) Acid value: Not to exceed 0.20 de- quired by the Act, the name of the ad- termined using 50 grams of sample by ditive. the ‘‘Guide to Specifications for Gen- (2) The label or accompanying label- eral Notices, General Analytical Tech- ing shall bear adequate directions for niques, Identification Tests, Test Solu- the use of the additive which, if fol- tions, and Other Reference Materials,’’ lowed, will result in a food that com- in the ‘‘Compendium of Food Additive plies with the requirements of this sec- Specifications, Addendum 4, FAO Food tion. and Nutrition Paper 5, Revision 2,’’ p. § 172.833 Sucrose acetate isobutyrate 189 (1991), which is incorporated by ref- (SAIB). erence; see paragraph (b)(2) of this sec- tion for availability of the incorpora- Sucrose acetate isobutyrate may be tion by reference. safely used in foods in accordance with the following prescribed conditions: (4) Lead: Not to exceed 1.0 milli- (a) Sucrose acetate isobutyrate (CAS grams/kilogram determined by the Reg. No. 27216–37–1), or SAIB, is the ‘‘Atomic Absorption chemical alpha-D-glucopyranoside, O- Spectrophotometric Graphite Furnace acetyl-tris-O-(2-methyl-1-oxopropyl)- Method, Method I,’’ in the ‘‘Food beta-D-fructofuranosyl, acetate tris(2- Chemicals Codex,’’ 4th ed. (1996), pp. 763 methyl propanoate). and 764, with an attached modification (b) SAIB, a pale, straw-colored liquid, to the sample digestion section in Ap- meets the following specifications: (1) pendix III.B (July 1996), which is incor- Assay: Not less than 98.8 percent and porated by reference. Copies are avail- not more than 101.9 percent, based on able from the National Academy Press, the following formula: 2101 Constitution Ave. NW., Box 285, Washington, DC 20055 (Internet http:// Assay = ((SV 0.10586) ÷ 56.1) × 100 www.nap.edu), or may be examined at Where SV = Saponification value the Food and Drug Administration’s (2) Saponification value: 524–540 de- Main Library, 10903 New Hampshire termined using 1 gram of sample by the Ave., Bldg. 2, Third Floor, Silver ‘‘Guide to Specifications for General Spring, MD 20993, 301–796–2039, or at the Notices, General Analytical Tech- National Archives and Records Admin- niques, Identification Tests, Test Solu- istration (NARA). For information on tions, and Other Reference Materials,’’ the availability of this material at in the ‘‘Compendium of Food Additive NARA, call 202–741–6030, or go to: http:// Specifications, Addendum 4, Food and www.archives.gov/federallregister/ Agriculture Organization of the United codeloflfederallregulations/ Nations (FAO), Food and Nutrition ibrllocations.html. Paper 5, Revision 2’’ (1991), pp. 203 and (5) Triacetin: Not to exceed 0.10 per- 204, which is incorporated by reference, cent determined by gas chroma- in accordance with 5 U.S.C. 552(a) and 1 tography as described in the ‘‘Guide to CFR part 51. Copies are available from Specifications for General Notices, the Office of Food Additive Safety General Analytical Techniques, Identi- (HFS–200), Food and Drug Administra- fication Tests, Test Solutions, and tion’s Main Library, 10903 New Hamp- Other Reference Materials,’’ in the shire Ave., Bldg. 2, Third Floor, Silver ‘‘Compendium of Food Additive Speci- Spring, MD 20993, 301–796–2039, 240–402– fications, Addendum 4, FAO Food and 1200, or may be examined at the Center Nutrition Paper 5, Revision 2,’’ (1991), for Food Safety and Applied Nutri- pp. 13–26, which is incorporated by ref- tion’s Library, 5001 Campus Dr., Col- erence; see paragraph (b)(2) of this sec- lege Park, MD 20740, or at the National tion for availability of the incorpora- Archives and Records Administration tion by reference. (NARA). For information on the avail- (c) The food additive is used as a sta- ability of this material at NARA, call bilizer (as defined in § 170.3(o)(28) of this

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chapter) of emulsions of flavoring oils Use Limitations in nonalcoholic beverages. 6. As an emulsifier in edible Not to exceed 0.4 percent by (d) The total SAIB content of a bev- vegetable fat-water emul- weight of the finished vege- erage containing the additive does not sions intended for use as table fat-water emulsions. exceed 300 milligrams/kilogram of the substitutes for milk or finished beverage. cream in beverage coffee. [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, (d) When the name ‘‘polyglycerate 1999, as amended at 78 FR 14665, Mar. 7, 2013; 60’’ is used in labeling it shall be fol- 81 FR 5591, Feb. 3, 2016] lowed by either ‘‘polyoxyethylene (20) mono-and diglycerides of fatty acids’’ § 172.834 Ethoxylated mono- and or ‘‘ethoxylated mono- and diglycerides. diglycerides’’ in parentheses. The food additive ethoxylated mono- and diglycerides (polyoxyethylene (20) [42 FR 14491, Mar. 15, 1977, as amended at 42 mono- and diglycerides of fatty acids) FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, 1985] (polyglycerate 60) may be safely used in food in accordance with the fol- § 172.836 Polysorbate 60. lowing prescribed conditions: The food additive polysorbate 60 (a) The food additive is manufactured (polyoxyethylene (20) sorbitan mono- by: stearate) which is a mixture of (1) Glycerolysis of edible fats pri- polyoxyethylene of mixed par- marily composed of stearic, palmitic, tial stearic and palmitic acid esters of and myristic acids; or sorbitol anhydrides and related com- (2) Direct esterification of glycerol pounds, may be safely used in food in with a mixture of primarily stearic, accordance with the following pre- palmitic, and myristic acids; scribed conditions: to yield a product with less than 0.3 (a) The food additive is manufactured acid number and less than 0.2 percent by reacting stearic acid (usually con- water, which is then reacted with taining associated fatty acids, chiefly ethylene oxide. palmitic) with sorbitol to yield a prod- (b) The additive meets the following uct with a maximum acid number of 10 specifications: and a maximum water content of 0.2 percent, which is then reacted with Saponification number, 65–75. Acid number, 0–2. ethylene oxide. Hydroxyl number, 65–80. (b) The food additive meets the fol- Oxyethylene content, 60.5–65.0 percent. lowing specifications: (c) The additive is used or intended Saponification number 45–55. for use in the following foods when Acid number 0–2. standards of identity established under Hydroxyl number 81–96. Oxyethylene content 65 percent–69.5 percent. section 401 of the Act do not preclude such use: (c) It is used or intended for use as follows: Use Limitations (1) As an emulsifier in whipped edible 1. As an emulsifier in pan-re- Not to exceed levels required oil topping with or without one or a lease agents for and as a to produce the intended ef- combination of the following: dough conditioner in yeast- fects, total not to exceed (i) Sorbitan monostearate; leavened bakery products. 0.5 percent by weight of the flour used. (ii) Polysorbate 65; 2. As an emulsifier in cakes Not to exceed 0.5 percent by (iii) Polysorbate 80; and cake mixes. weight of the dry ingredi- ents. whereby the maximum amount of the 3. As an emulsifier in Not to exceed 0.45 percent additive or additives used does not ex- whipped vegetable oil top- by weight of the finished ceed 0.4 percent of the weight of the pings and topping mixes. whipped vegetable oil top- pings. finished whipped edible oil topping; ex- 4. As an emulsifier in icings Not to exceed 0.5 percent by cept that a combination of the additive and icing mixes. weight of the finished with sorbitan monostearate may be icings. used in excess of 0.4 percent, provided 5. As an emulsifier in frozen Not to exceed 0.2 percent by desserts. weight of the finished fro- that the amount of the additive does zen desserts. not exceed 0.77 percent and the amount

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of sorbitan monostearate does not ex- shall exceed 1 percent of the weight of ceed 0.27 percent of the weight of the the cake icing or cake filling. finished whipped edible oil topping. (6) To impart greater opacity to (2) As an emulsifier in cakes and cake sugar-type confection coatings where- mixes, with or without one or a com- by the maximum amount of the addi- bination of the following: tive does not exceed 0.2 percent of the (i) Polysorbate 65. weight of the finished sugar coating. (ii) Sorbitan monostearate. (7) As an emulsifier in nonstandard- When used alone, the maximum ized dressings whereby the maximum amount of polysorbate 60 shall not ex- amount of the additive does not exceed ceed 0.46 percent of the cake or cake 0.3 percent of the weight of the finished mix, on a dry-weight basis. When used dressings. with polysorbate 65 and/or sorbitan (8) As an emulsifier, alone or in com- monostearate, it shall not exceed 0.46 bination with polysorbate 80, in percent, nor shall the polysorbate 65 shortenings and edible oils intended for exceed 0.32 percent or the sorbitan use in foods as follows, when standards monostearate exceed 0.61 percent, and of identity established under section no combination of these emulsifiers 401 of the act do not preclude such use: shall exceed 0.66 percent of the cake or (i) It is used alone in an amount not cake mix, all calculated on a dry- to exceed 1 percent of the weight of the weight basis. finished shortening or oil. (3) As an emulsifier, alone or in com- (ii) It is used with polysorbate 80 in bination with sorbitan monostearate, any combination providing no more in nonstandardized confectionery coat- than 1 percent of polysorbate 60 and no ings and standardized cacao products more than 1 percent of polysorbate 80, specified in §§ 163.123, 163.130, 163.135, provided that the total combination 163.140, 163.145, and 163.150 of this chap- does not exceed 1 percent of the fin- ter, as follows: ished shortening or oil. (i) It is used alone in an amount not (iii) The 1–percent limitation speci- to exceed 0.5 percent of the weight of fied in paragraph (c)(8) (i) and (ii) of the finished nonstandardized confec- this section may be exceeded in premix tionery coating or standardized cacao concentrates of shortening or edible oil product. if the labeling complies with the re- (ii) It is used with sorbitan mono- quirements of paragraph (d) of this sec- stearate in any combination of up to tion. 0.5 percent of polysorbate 60 and up to (9) As an emulsifier in solid-state, ed- 1 percent of sorbitan monostearate: ible vegetable fat-water emulsions in- Provided, That the total combination tended for use as substitutes for milk does not exceed 1 percent of the weight or cream in beverage coffee, with or of the finished nonstandardized confec- without one or a combination of the tionery coating or standardized cacao following: product. (i) Polysorbate 65. (4) [Reserved] (5) As an emulsifier in cake icings (ii) Sorbitan monostearate. and cake fillings, with or without one The maximum amount of the additive or a combination of the following: or additives shall not exceed 0.4 per- (i) Polysorbate 65. cent by weight of the finished edible (ii) Sorbitan monostearate. vegetable fat-water emulsion. When used alone, the maximum (10) As a foaming agent in non- amount of polysorbate 60 shall not ex- alcoholic mixes, to be added to alco- ceed 0.46 percent of the weight of the holic beverages in the preparation of cake icings and cake fillings. When mixed alcoholic drinks, at a level not used with polysorbate 65 and/or sorbi- to exceed 4.5 percent by weight of the tan monostearate, it shall not exceed nonalcoholic mix. 0.46 percent, nor shall the polysorbate (11) As a dough conditioner in yeast- 65 exceed 0.32 percent or the sorbitan leavened bakery products in an amount monostearate exceed 0.7 percent, and not to exceed 0.5 percent by weight of no combination of these emulsifiers the flour used.

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(12) As an emulsifier, alone or in tions prescribed in paragraph (c) of this combination with sorbitan monostea- section. rate, in the minimum quantity re- [42 FR 14491, Mar. 15, 1977, as amended at 43 quired to accomplish the intended ef- FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, fect, in formulations of white mineral 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, oil conforming with § 172.878 and/or pe- Oct. 28, 1999] troleum wax conforming with § 172.886 for use as protective coatings on raw § 172.838 Polysorbate 65. fruits and vegetables. The food additive polysorbate 65 (13) As a dispersing agent in artifi- (polyoxyethylene (20) sorbitan cially sweetened gelatin desserts and in tristearate), which is a mixture of artificially sweetened gelatin dessert polyoxyethylene ethers of mixed ste- mixes, whereby the amount of the addi- aric acid esters of sorbitol anhydrides tive does not exceed 0.5 percent on a and related compounds, may be safely dry-weight basis. used in food in accordance with the fol- (14) As an emulsifier in chocolate fla- lowing prescribed conditions: vored syrups, whereby the maximum (a) The food additive is manufactured amount of the additive does not exceed by reacting stearic acid (usually con- 0.05 percent in the finished product. taining associated fatty acids, chiefly (15) As a surfactant and wetting palmitic) with sorbitol to yield a prod- agent for natural and artificial colors uct with a maximum acid number of 15 in food as follows: and a maximum water content of 0.2 (i) In powdered soft drink mixes in an percent, which is then reacted with amount not to exceed 4.5 percent by ethylene oxide. weight of the mix. (b) The food additive meets the fol- (ii) In sugar-based gelatin dessert lowing specifications: mixes in an amount not to exceed 0.5 Saponification number 88–98. percent by weight of the mix. Acid number 0–2. (iii) In artificially sweetened gelatin Hydroxyl number 44–60. dessert mixes in an amount not to ex- Oxyethylene content 46 percent–50 percent. ceed 3.6 percent by weight of the mix. (c) The additive is used, or intended (iv) In sugar-based pudding mixes in for use, as follows: an amount not to exceed 0.5 percent by (1) As an emulsifier in ice cream, fro- weight of the mix. zen custard, ice milk, fruit sherbet and (v) In artificially sweetened pudding nonstandardized frozen desserts when mixes in an amount not to exceed 0.5 used alone or in combination with percent by weight of the mix. polysorbate 80, whereby the maximum (16) As an emulsifier in ice cream, amount of the additives, alone or in frozen custard, fruit sherbet, and non- combination, does not exceed 0.1 per- standardized frozen desserts when used cent of the finished frozen dessert. alone or in combination with poly- (2) As an emulsifier in cakes and cake sorbate 65 and/or polysorbate 80, where- mixes, with or without one or a com- by the maximum amount of the addi- bination of the following: tives, alone or in combination, does not (i) Sorbitan monostearate. exceed 0.1 percent of the finished frozen (ii) Polysorbate 60. dessert. When used alone, the maximum (d) To assure safe use of the additive, amount of polysorbate 65 shall not ex- in addition to the other information re- ceed 0.32 percent of the cake or cake quired by the Act: mix, on a dry-weight basis. When used (1) The label of the additive and any with sorbitan monostearate and/or intermediate premixes shall bear: polysorbate 60, it shall not exceed 0.32 (i) The name of the additive. percent, nor shall the sorbitan mono- (ii) A statement of the concentration stearate exceed 0.61 percent or the or strength of the additive in any in- polysorbate 60 exceed 0.46 percent, and termediate premixes. no combination of these emulsifiers (2) The label or labeling shall bear shall exceed 0.66 percent of the cake or adequate directions to provide a final cake mix, all calculated on a dry- product that complies with the limita- weight basis.

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(3) As an emulsifier in whipped edible § 172.840 Polysorbate 80. oil topping with or without one or a The food additive polysorbate 80 combination of the following: (polyoxyethylene (20) sorbitan (i) Sorbitan monostearate; monooleate), which is a mixture of (ii) Polysorbate 60; polyoxyethylene ethers of mixed par- (iii) Polysorbate 80; tial oleic acid esters of sorbitol anhy- whereby the maximum amount of the drides and related compounds, may be additive or additives used does not ex- safely used in food in accordance with ceed 0.4 percent of the weight of the the following prescribed conditions: (a) The food additive is manufactured finished whipped edible oil topping. by reacting oleic acid (usually con- (4) As an emulsifier in solid-state, ed- taining associated fatty acids) with ible vegetable fat-water emulsions in- sorbitol to yield a product with a max- tended for use as substitutes for milk imum acid number of 7.5 and a max- or cream in beverage coffee, with or imum water content of 0.5 percent, without one or a combination of the which is then reacted with ethylene following: oxide. (i) Sorbitan monostearate. (b) The food additive meets the fol- (ii) Polysorbate 60. lowing specifications: The maximum amount of the additive Saponification number 45–55. or additives shall not exceed 0.4 per- Acid number 0–2. cent by weight of the finished edible Hydroxyl number 65–80. vegetable fat-water emulsion. Oxyethylene content 65 percent–69.5 percent. (5) As an emulsifier in cake icings (c) The additive is used or intended and cake fillings, with or without one for use as follows: or a combination of the following: (1) An emulsifier in ice cream, frozen (i) Sorbitan monostearate. custard, ice milk, fruit sherbet, and (ii) Polysorbate 60. nonstandardized frozen desserts, when used alone or in combination with When used alone, the maximum polysorbate 65 whereby the maximum amount of polysorbate 65 shall not ex- amount of the additives, alone or in ceed 0.32 percent of the weight of the combination, does not exceed 0.1 per- cake icing or cake filling. When used cent of the finished frozen dessert. with sorbitan monostearate and/or (2) In yeast-defoamer formulations polysorbate 60, it shall not exceed 0.32 whereby the maximum amount of the percent, nor shall the sorbitan mono- additive does not exceed 4 percent of stearate exceed 0.7 percent or the poly- the finished yeast defoamer and the sorbate 60 exceed 0.46 percent, and no maximum amount of the additive in combination of these emulsifiers shall the yeast from such use does not ex- exceed 1 percent of the weight of the ceed 4 parts per million. cake icing or cake filling. (3) As a solubilizing and dispersing (d) To assure safe use of the additive, agent in pickles and pickle products, in addition to the other information re- whereby the maximum amount of the quired by the Act: additive does not exceed 500 parts per (1) The label of the additive and any million. intermediate premixes shall bear: (4) As a solubilizing and dispersing (i) The name of the additive. agent in: (ii) A statement of the concentration (i) Vitamin-mineral preparations or strength of the additive in any in- containing calcium caseinate in the ab- termediate premixes. sence of fat-soluble , whereby the maximum intake of polysorbate 80 (2) The label or labeling shall bear shall not exceed 175 milligrams from adequate directions to provide a final the recommended daily dose of the product that complies with the limita- preparations. tions prescribed in paragraph (c) of this (ii) Fat-soluble vitamins in vitamin section. and vitamin-mineral preparations con- [42 FR 14491, Mar. 15, 1977, as amended at 43 taining no calcium caseinate, whereby FR 2871, Jan. 20, 1978] the maximum intake of polysorbate 80

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shall not exceed 300 milligrams from (10) It is used as a wetting agent in the recommended daily dose of the scald water for poultry defeathering, preparations. followed by potable water rinse. The (iii) In vitamin-mineral preparations concentration of the additive in the containing both calcium caseinate and scald water does not exceed 0.0175 per- fat-soluble vitamins, whereby the max- cent. imum intake of polysorbate 80 shall (11) As a dispersing agent in gelatin not exceed 475 milligrams from the rec- desserts and in gelatin dessert mixes, ommended daily dose of the prepara- whereby the amount of the additive tions. does not exceed 0.082 percent on a dry- (5) As a surfactant in the production weight basis. of coarse crystal sodium chloride (12) As an adjuvant added to herbi- whereby the maximum amount of the cide use and plant-growth regulator additive in the finished sodium chlo- use dilutions by a grower or applicator ride does not exceed 10 parts per mil- prior to application of such dilutions to lion. the growing crop. Residues resulting (6) In special dietary foods, as an from such use are exempt from the re- emulsifier for edible fats and oils, with quirement of a tolerance. When so used directions for use which provide for the or intended for use, the additive shall ingestion of not more than 360 milli- be exempt from the requirements of grams of polysorbate 80 per day. paragraph (d)(1) of this section. (7) As a solubilizing and dispersing (13) As a defoaming agent in the prep- agent for dill oil in canned spiced green aration of the creaming mixture for beans, not to exceed 30 parts per mil- cottage cheese and lowfat cottage lion. cheese, as identified in §§ 133.128 and (8) As an emulsifier, alone or in com- 133.131 of this chapter, respectively, bination with polysorbate 60, in whereby the amount of the additive shortenings and edible oils intended for does not exceed .008 percent by weight use in foods as follows, when standards of the finished products. of identity established under section (14) As a surfactant and wetting 401 of the act do not preclude such use: agent for natural and artificial colors (i) It is used alone in an amount not for use in barbecue sauce where the to exceed 1 percent of the weight of the level of the additive does not exceed finished shortening or oil. 0.005 percent by weight of the barbecue (ii) It is used with polysorbate 60 in sauce. any combination providing no more (d) To assure safe use of the additive, than 1 percent of polysorbate 80 and no in addition to the other information re- more than 1 percent of polysorbate 60, quired by the Act: provided that the total combination (1) The label of the additive and any does not exceed 1 percent of the fin- intermediate premixes shall bear: ished shortening or oil. (i) The name of the additive. (iii) The 1–percent limitation speci- (ii) A statement of the concentration fied in paragraph (c)(8) (i) and (ii) of or strength of the additive in any in- this section may be exceeded in premix termediate premixes. concentrates of shortening or edible oil (2) The label or labeling shall bear if the labeling complies with the re- adequate directions to provide a final quirements of paragraph (d) of this sec- product that complies with the limita- tion. tions prescribed in paragraph (c) of this (9) As an emulsifier in whipped edible section. oil topping with or without one or a combination of the following: [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, (i) Sorbitan monostearate; 1980; 46 FR 8466, Jan. 27, 1981] (ii) Polysorbate 60; (iii) Polysorbate 65; § 172.841 Polydextrose. whereby the maximum amount of the Polydextrose as identified in this sec- additive or additives used does not ex- tion may be safely used in food in ac- ceed 0.4 percent of the weight of the cordance with the following prescribed finished whipped edible oil topping. conditions:

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(a)(1) Polydextrose (CAS Reg. No. laxative effect from excessive con- 68424–04–4) is a partially metabolizable sumption of this product’’. water-soluble polymer prepared by the [46 FR 30081, June 5, 1981, as amended at 59 condensation of a melt which consists FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, either of approximately 89 percent D- 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, glucose, 10 percent sorbitol, and 1 per- June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR cent citric acid or of approximately 90 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; percent D-glucose, 10 percent sorbitol, 72 FR 46564, Aug. 21, 2007; 78 FR 71464, Nov. 29, 2013] and 0.1 percent phosphoric acid, on a weight basis. § 172.842 Sorbitan monostearate. (2) Polydextrose may be partially The food additive sorbitan monostea- neutralized with potassium hydroxide, rate, which is a mixture of partial ste- or partially reduced by transition aric and palmitic acid esters of sorbitol metal catalytic hydrogenation in aque- anhydrides, may be safely used in or on ous solution. food in accordance with the following (b) The additive meets the specifica- prescribed conditions: tions of the Food Chemicals Codex, 7th (a) The food additive is manufactured ed. (2010), pp. 811–814, which is incor- by reacting stearic acid (usually con- porated by reference. The Director of taining associated fatty acids, chiefly the Office of the Federal Register ap- palmitic) with sorbitol to yield essen- proves this incorporation by reference tially a mixture of esters. in accordance with 5 U.S.C. 552(a) and 1 (b) The food additive meets the fol- CFR part 51. You may obtain copies lowing specifications: from the United States Pharmacopeial Saponification number, 147–157 Convention, 12601 Twinbrook Pkwy., Acid number, 5–10 Rockville, MD 20852 (Internet address Hydroxyl number, 235–260 http://www.usp.org). Copies may be ex- amined at the Food and Drug Adminis- (c) It is used or intended for use, alone or in combination with poly- tration’s Main Library, 10903 New sorbate 60 as follows: Hampshire Ave., Bldg. 2, Third Floor, (1) As an emulsifier in whipped edible Silver Spring, MD 20993, 301–796–2039, or oil topping with or without one or a at the National Archives and Records combination of the following: Administration (NARA). For informa- (i) Polysorbate 60; tion on the availability of this mate- (ii) Polysorbate 65; rial at NARA, call 202–741–6030 or go to: (iii) Polysorbate 80; http://www.archives.gov/federal-register/ cfr/ibr-locations.html. whereby the maximum amount of the (c) When standards of identity estab- additive or additives used does not ex- lished under section 401 of the act do ceed 0.4 percent of the weight of the not preclude such use, polydextrose finished whipped edible oil topping; ex- may be used in accordance with cur- cept that a combination of the additive with polysorbate 60 may be used in ex- rent good manufacturing practices as a cess of 0.4 percent: Provided, That the bulking agent, formulation aid, humec- amount of the additive does not exceed tant, and texturizer in all foods, except 0.27 percent and the amount of poly- meat and poultry, baby food, and in- sorbate 60 does not exceed 0.77 percent fant formula. of the weight of the finished whipped (d) If the food containing the additive edible oil topping. purports to be or is represented for spe- (2) As an emulsifier in cakes and cake cial dietary uses, it shall be labeled in mixes, with or without one or a com- compliance with part 105 of this chap- bination of the following: ter. (i) Polysorbate 65. (e) The label and labeling of food a (ii) Polysorbate 60. single serving of which would be ex- When used alone, the maximum pected to exceed 15 grams of the addi- amount of sorbitan monostearate shall tive shall bear the statement: ‘‘Sen- not exceed 0.61 percent of the cake or sitive individuals may experience a cake mix, on a dry-weight basis. When

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used with polysorbate 65 and/or poly- (6) It is used alone as a rehydration sorbate 60, it shall not exceed 0.61 per- aid in the production of active dry cent, nor shall the polysorbate 65 ex- yeast in an amount not to exceed 1 per- ceed 0.32 percent or the polysorbate 60 cent by weight of the dry yeast. exceed 0.46 percent, and no combina- (7) As an emulsifier, alone or in com- tion of the emulsifiers shall exceed 0.66 bination with polysorbate 60, in the percent of the weight of the cake or minimum quantity required to accom- cake mix, calculated on a dry-weight plish the intended effect, in formula- basis. tions of white mineral oil conforming (3) As an emulsifier, alone or in com- with § 172.878 and/or petroleum wax bination with polysorbate 60 in non- conforming with § 172.886 for use as pro- standardized confectionery coatings tective coatings on raw fruits and vege- and standardized cacao products speci- tables. fied in §§ 163.123, 163.130, 163.135, 163.140, (d) To assure safe use of the additive, 163.145, and 163.150 of this chapter, as in addition to the other information re- follows: quired by the Act: (i) It is used alone in an amount not (1) The label of the additive and any to exceed 1 percent of the weight of the intermediate premixes shall bear: finished nonstandardized confectionery (i) The name of the additive. coating or standardized cacao product. (ii) A statement of the concentration (ii) It is used with polysorbate 60 in or strength of the additive in any in- any combination of up to 1 percent sor- termediate premixes. bitan monostearate and up to 0.5 per- (2) The label or labeling shall bear cent polysorbate 60 provided that the adequate directions to provide a final total combination does not exceed 1 product that complies with the limita- percent of the weight of the finished tions prescribed in paragraph (c) of this nonstandardized confectionery coating section. or standardized cacao product. [42 FR 14491, Mar. 15, 1977, as amended at 43 (4) As an emulsifier in cake icings FR 2871, Jan. 20, 1978] and cake fillings, with or without one or a combination of the following: § 172.844 Calcium stearoyl-2-lactylate. (i) Polysorbate 65. The food additive calcium stearoyl-2- (ii) Polysorbate 60. lactylate may be safely used in or on When used alone, the maximum food in accordance with the following amount of sorbitan monostearate shall prescribed conditions: not exceed 0.7 percent of the weight of (a) The additive, which is a mixture the cake icing or cake filling. When of calcium salts of stearoyl lactylic used with polysorbate 65 and/or poly- acids and minor proportions of other sorbate 60, it shall not exceed 0.7 per- calcium salts of related acids, is manu- cent, nor shall the polysorbate 65 ex- factured by the reaction of stearic acid ceed 0.32 percent or the polysorbate 60 and lactic acid and conversion to the exceed 0.46 percent, and no combina- calcium salts. tion of these emulsifiers shall exceed 1 (b) The additive meets the following percent of the weight of the cake icing specifications: or cake filling. Acid number, 50–86. (5) As an emulsifier in solid-state, ed- Calcium content, 4.2–5.2 percent. ible vegetable fat-water emulsions in- Lactic acid content, 32–38 percent. tended for use as substitutes for milk Ester number, 125–164. or cream in beverage coffee, with or without one or a combination of the (c) It is used or intended for use as following: follows: (i) Polysorbate 60. (1) As a dough conditioner in yeast- leavened bakery products and prepared (ii) Polysorbate 65. mixes for yeast-leavened bakery prod- The maximum amount of the additive ucts in an amount not to exceed 0.5 or additives shall not exceed 0.4 per- part for each 100 parts by weight of cent by weight of the finished edible flour used. vegetable fat-water emulsion. (2) As a whipping agent in:

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(i) Liquid and frozen egg white at a (1) As a dough strengthener, emulsi- level not to exceed 0.05 percent. fier, or processing aid in baked prod- (ii) Dried egg white at a level not to ucts, pancakes, and waffles, in an exceed 0.5 percent. amount not to exceed 0.5 part for each (iii) Whipped vegetable oil topping at 100 parts by weight of flour used. a level not to exceed 0.3 percent of the (2) As a surface-active agent, emulsi- weight of the finished whipped vege- fier, or stabilizer in icings, fillings, table oil topping. puddings, and toppings, at a level not (3) As a conditioning agent in dehy- to exceed 0.2 percent by weight of the drated potatoes in an amount not to finished food. exceed 0.5 percent by weight thereof. (3) As an emulsifier or stabilizer in (d) To assure safe use of the additive: liquid and solid edible fat-water emul- (1) The label and labeling of the food sions intended for use as substitutes additive and any intermediate premix for milk or cream in beverage coffee, at prepared therefrom shall bear, in addi- a level not to exceed 0.3 percent by tion to the other information required weight of the finished edible fat-water by the act, the following: emulsion. (i) The name of the additive. (4) As a formulation aid, processing (ii) A statement of the concentration aid, or surface-active agent in dehy- or strength of the additive in any in- drated potatoes, in an amount not to termediate premixes. exceed 0.5 percent of the dry weight of (2) The label or labeling of the food the food. additive shall also bear adequate direc- (5) As an emulsifier, stabilizer, or tions of use to provide a finished food texturizer in snack dips, at a level not that complies with the limitations pre- to exceed 0.2 percent by weight of the scribed in paragraph (c) of this section. finished product. § 172.846 Sodium stearoyl lactylate. (6) As an emulsifier, stabilizer, or texturizer in cheese substitutes and The food additive sodium stearoyl imitations and cheese product sub- lactylate (CAS Reg. No. 25–383–997) may stitutes and imitations, at a level not be safely used in food in accordance to exceed 0.2 percent by weight of the with the following prescribed condi- finished food. tions: (7) As an emulsifier, stabilizer, or (a) The additive, which is a mixture texturizer in sauces or gravies, and the of sodium salts of stearoyl lactylic products containing the same, in an acids and minor proportions of sodium amount not to exceed 0.25 percent by salts of related acids, is manufactured weight of the finished food. by the reaction of stearic acid and lac- (8) In prepared mixes for each of the tic acid and conversion to the sodium foods listed in paragraphs (c) (1) salts. through (7) of this section, provided the (b) The additive meets the specifica- additive is used only as specified in tions of the ‘‘Food Chemicals Codex,’’ each of those paragraphs. 3d Ed. (1981), pp. 300–301, which is incor- (9) As an emulsifier, stabilizer, or porated by reference. Copies may be texturizer in cream liqueur drinks, at a obtained from the National Academy level not to exceed 0.5 percent by Press, 2101 Constitution Ave. NW., weight of the finished product. Washington, DC 20418, or may be exam- ined at the National Archives and [45 FR 51767, Aug. 5, 1980, as amended at 49 Records Administration (NARA). For FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, information on the availability of this 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. material at NARA, call 202–741–6030, or 27, 1986; 65 FR 60859, Oct. 13, 2000] go to: http://www.archives.gov/ federallregister/ § 172.848 Lactylic esters of fatty acids. codeloflfederallregulations/ Lactylic esters of fatty acids may be ibrllocations.html. safely used in food in accordance with (c) It is used or intended for use as the following prescribed conditions: follows when standards of identity es- (a) They are prepared from lactic tablished under section 401 of the Act acid and fatty acids meeting the re- do not preclude such use: quirements of § 172.860(b) and/or oleic

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acid derived from tall oil fatty acids derived from tall oil fatty acids con- meeting the requirements of § 172.862. forming with § 172.862 and/or edible fats (b) They are used as emulsifiers, plas- and oils. ticizers, or surface-active agents in the (b) They are used in amounts not in following foods, when standards of excess of those reasonably required to identity do not preclude their use: accomplish their intended physical or Foods Limitations technical effect as emulsifiers and plas- ticizers in food. Bakery mixes ...... Baked products ...... Cake icings, fillings, and toppings § 172.854 Polyglycerol esters of fatty Dehydrated fruits and vegetables acids. Dehydrated fruit and vegetable juices. Polyglycerol esters of fatty acids, up Edible vegetable fat-water emul- As substitutes for milk or to and including the decaglycerol sions. cream in beverage cof- esters, may be safely used in food in ac- fee. Frozen desserts ...... cordance with the following prescribed Liquid shortening ...... For household use. conditions: Pancake mixes ...... (a) They are prepared from corn oil, Precooked instant rice ...... Pudding mixes ...... cottonseed oil, lard, from fruit, peanut oil, safflower oil, sesame (c) They are used in an amount not oil, soybean oil, and tallow and the greater than required to produce the fatty acids derived from these sub- intended physical or technical effect, stances (hydrogenated and nonhydro- and they may be used with shortening genated) meeting the requirements of and edible fats and oils when such are § 172.860(b) and/or oleic acid derived required in the foods identified in para- from tall oil fatty acids meeting the graph (b) of this section. requirements of § 172.862. (b) They are used as emulsifiers in § 172.850 Lactylated fatty acid esters of glycerol and propylene glycol. food, in amounts not greater than that required to produce the intended phys- The food additive lactylated fatty ical or technical effect. acid esters of glycerol and propylene glycol may be safely used in food in ac- (c) Polyglycerol esters of a mixture cordance with the following prescribed of stearic, oleic, and coconut fatty conditions: acids are used as a cloud inhibitor in (a) The additive is a mixture of esters vegetable and salad oils when use is produced by the lactylation of a prod- not precluded by standards of identity. uct obtained by reacting edible fats or The fatty acids used in the production oils with propylene glycol. of the polyglycerol esters meet the re- (b) The additive meets the following quirements of § 172.860(b), and the specifications: Water insoluble com- polyglycerol esters are used at a level bined lactic acid, 14–18 percent; and not in excess of the amount required to acid number, 12 maximum. perform its cloud-inhibiting effect. (c) It is used in amounts not in excess Oleic acid derived from tall oil fatty of that reasonably required to produce acids conforming with § 172.862 may be the intended physical effect as an used as a substitute for or together emulsifier, plasticizer, or surface-ac- with the oleic acid permitted by this tive agent in food. paragraph. (d) Polyglycerol esters of butter oil § 172.852 Glyceryl-lacto esters of fatty acids. fatty acids are used as emulsifiers in combination with other approved emul- Glyceryl-lacto esters of fatty acids sifiers in dry, whipped topping base. (the lactic acid esters of mono- and The fatty acids used in the production diglycerides) may be safely used in food in accordance with the following of the polyglycerol esters meet the re- prescribed conditions: quirements of § 172.860(b), and the (a) They are manufactured from glyc- polyglycerol esters are used at a level erin, lactic acid, and fatty acids con- not in excess of the amount required to forming with § 172.860 and/or oleic acid perform their emulsifying effect.

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§ 172.856 Propylene glycol mono- and exceed 0.9 percent by weight of the fin- diesters of fats and fatty acids. ished product. Propylene glycol mono- and diesters (4) As an emulsifier, stabilizer, or of fats and fatty acids may be safely thickener in fats and oils at a level not to exceed 1.1 percent by weight of the used in food, subject to the following finished product. prescribed conditions: (5) As an emulsifier, stabilizer, or (a) They are produced from edible thickener in gelatins and puddings at a fats and/or fatty acids in compliance level not to exceed 0.6 percent by with § 172.860 and/or oleic acid derived weight of the finished product. from tall oil fatty acids in compliance (6) As a stabilizer or thickener in gra- with § 172.862. vies and in sweet sauces at a level not (b) They are used in food in amounts to exceed 0.5 percent by weight of the not in excess of that reasonably re- finished product. quired to produce their intended effect. (7) As a stabilizer in jams and jellies at a level not to exceed 0.4 percent by § 172.858 Propylene glycol alginate. weight of the finished product. The food additive propylene glycol (8) As an emulsifier, stabilizer, or alginate (CAS Reg. No. 9005–37–2) may thickener in condiments and relishes be used as an emulsifier, flavoring ad- at a level not to exceed 0.6 percent by juvant, formulation aid, stabilizer, sur- weight of the finished product. factant, or thickener in foods in ac- (9) As a flavoring adjunct or adjuvant cordance with the following prescribed in seasonings and flavors at a level not conditions: to exceed 1.7 percent by weight of the (a) The additive meets the specifica- finished product. tions of the Food Chemicals Codex, 3d (10) As an emulsifier, flavoring adju- Ed. (1981), p. 256, which is incorporated vant, formulation aid, stabilizer or by reference (Copies are available from thickener, or surface active agent in the National Academy Press, 2101 Con- other foods, where applicable, at a stitution Ave. NW., Washington, DC level not to exceed 0.3 percent by 20418, or available for inspection at the weight of the finished product. National Archives and Records Admin- (c) To ensure safe use of the additive, istration (NARA). For information on the label of the food additive container the availability of this material at shall bear, in addition to the other in- NARA, call 202–741–6030, or go to: http:// formation required by the act: www.archives.gov/federallregister/ (1) The name of the additive, ‘‘pro- codeloflfederallregulations/ pylene glycol alginate’’ or ‘‘propylene ibrllocations.html.), and the additional glycol ester of alginic acid’’. specification that it shall have up to 85 (2) Adequate directions for use. percent of the groups [47 FR 29950, July 9, 1982] esterified with the remaining groups either free or neutralized. § 172.859 Sucrose fatty acid esters. (b) The additive is used or intended Sucrose fatty acid esters identified in for use in the following foods as defined this section may be safely used in ac- in § 170.3(n) of this chapter, when stand- cordance with the following prescribed ards of identity established under sec- conditions: tion 401 of the act do not preclude such (a) Sucrose fatty acid esters are the use: mono-, di-, and tri-esters of sucrose (1) As a stabilizer in frozen dairy des- with fatty acids and are derived from serts, in fruit and water ices, and in sucrose and edible tallow or hydro- confections and frostings at a level not genated edible tallow or edible vege- to exceed 0.5 percent by weight of the table oils. The only solvents which finished product. may be used in the preparation of su- (2) As an emulsifier, flavoring adju- crose fatty acid esters are those gen- vant, stabilizer, or thickener in baked erally recognized as safe in food or reg- goods at a level not to exceed 0.5 per- ulated for such use by an appropriate cent by weight of the finished product. section in this part. Ethyl acetate or (3) As an emulsifier, stabilizer, or methyl ethyl ketone or dimethyl sulf- thickener in cheeses at a level not to oxide and isobutyl alcohol (2-methyl-1-

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propanol) may be used in the prepara- mined by a method titled ‘‘Methyl tion of sucrose fatty acid esters. Ethyl Ketone Test; Methyl Alcohol (b) Sucrose fatty acid esters meet the Test,’’ which is incorporated by ref- following specifications: erence. Copies are available from the (1) The total content of mono-, di-, Center for Food Safety and Applied Nu- and tri-esters is not less than 80 per- trition (HFS–200), Food and Drug Ad- cent as determined by a method title ministration, 5001 Campus Dr., College ‘‘Sucrose Fatty Acid Esters, Method of Park, MD 20740, or available for inspec- Assay,’’ which is incorporated by ref- tion at the National Archives and erence. Copies are available from the Records Administration (NARA). For Center for Food Safety and Applied Nu- information on the availability of this trition (HFS–200), Food and Drug Ad- material at NARA, call 202–741–6030, or ministration, 5001 Campus Dr., College go to: http://www.archives.gov/ Park, MD 20740, or available for inspec- federallregister/ tion at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this material at NARA, call 202–741–6030, or (10) The total dimethyl sulfoxide con- go to: http://www.archives.gov/ tent is not more than 2 parts per mil- federallregister/ lion as determined by a method enti- codeloflfederallregulations/ tled ‘‘Determination of Dimethyl Sulf- ibrllocations.html. oxide,’’ which is incorporated by ref- (2) The free sucrose content is not erence. Copies are available from the more than 5 percent as determined by Center for Food Safety and Applied Nu- Test S.2 in the method titled ‘‘Sucrose trition (HFS–200), Food and Drug Ad- Fatty Acid Esters, Method of Assay,’’ ministration, 5001 Campus Dr., College which is incorporated by reference. The Park, MD 20740, or available for inspec- availability of this incorporation by tion at the National Archives and reference is given in paragraph (b)(1) of Records Administration (NARA). For this section. information on the availability of this (3) The acid value is not more than 6. material at NARA, call 202–741–6030, or (4) The residue on ignition (sulfated go to: http://www.archives.gov/ ash) is not more than 2 percent. federallregister/ (5) The total ethyl acetate content is codeloflfederallregulations/ not more than 350 parts per million as ibrllocations.html. determined by a method titled ‘‘Deter- (11) The total isobuytl alcohol (2- mination of Ethyl Acetate,’’ which is methyl-1-propanol) content is not more incorporated by reference. Copies are than 10 parts per million as determined available from the Center for Food by a method entitled ‘‘Determination Safety and Applied Nutrition (HFS– of Isobutyl Alcohol,’’ which is incor- 200), Food and Drug Administration, porated by reference. Copies are avail- 5001 Campus Dr., College Park, MD able from the Center for Food Safety 20740, or available for inspection at the and Applied Nutrition (HFS–200), Food National Archives and Records Admin- and Drug Administration, 5001 Campus istration (NARA). For information on Dr., College Park, MD 20740, or avail- the availability of this material at NARA, call 202–741–6030, or go to: http:// able for inspection at the National Ar- www.archives.gov/federallregister/ chives and Records Administration codeloflfederallregulations/ (NARA). For information on the avail- ibrllocations.html. ability of this material at NARA, call (6) Arsenic is not more than 3 parts 202–741–6030, or go to: http:// per million. www.archives.gov/federallregister/ (7) Total heavy metal content (as Pb) codeloflfederallregulations/ is not more than 50 parts per million. ibrllocations.html. (8) Lead is not more than 10 parts per (c) Sucrose fatty acid esters may be million. used as follows when standards of iden- (9) The total content of methyl ethyl tity established under section 401 of ketone or of methanol shall not be the Federal Food, Drug, and Cosmetic more than 10 parts per million as deter- Act do not preclude such use:

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(1) As emulsifiers as defined in (2) It is free of chick-edema factor: § 170.3(o)(8) of this chapter, or as stabi- (i) As evidenced during the bioassay lizers as defined in § 170.3(o)(28) of this method for determining the chick- chapter, in baked goods and baking edema factor as prescribed in para- mixes as defined in § 170.3(n)(1) of this graph (c)(2) of this section; or chapter, in chewing gum as defined in (ii) As evidenced by the absence of § 170.3(n)(6) of this chapter, in coffee chromatographic peaks with a reten- and tea beverages with added dairy in- tion time relative to aldrin (RA) be- gredients and/or dairy product ana- tween 10 and 25, using the gas logues, in confections and frostings as chromatographic- defined in § 170.3(n)(9) of this chapter, method prescribed in paragraph (c)(3) in dairy product analogues as defined of this section. If chromatographic in § 170.3(n)(10) of this chapter, in frozen peaks are found with RA values be- dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, and in tween 10 and 25, the food additive shall whipped milk products. meet the requirements of the bioassay (2) As texturizers as defined in method prescribed in paragraph (c)(2) § 170.3(o)(32) of this chapter in biscuit of this section for determining chick- mixes, in chewing gum as defined in edema factor. § 170.3(n)(6) of this chapter, in confec- (c) For the purposes of this section: tions and frostings as defined in (1) Unsaponifiable matter shall be de- § 170.3(n)(9) of this chapter, and in termined by the method described in surimi-based fabricated seafood prod- the 13th Ed. (1980) of the ‘‘Official ucts. Methods of Analysis of the Association (3) As components of protective coat- of Official Analytical Chemists,’’ which ings applied to fresh apples, avocados, is incorporated by reference. Copies are bananas, banana plantains, limes, mel- available from the AOAC INTER- ons (honeydew and cantaloupe), pa- NATIONAL, 481 North Frederick Ave., paya, peaches, pears, pineapples, and suite 500, Gaithersburg, MD 20877, or plums to retard ripening and spoiling. available for inspection at the National (d) Sucrose fatty acid esters are used Archives and Records Administration in accordance with current good manu- (NARA). For information on the avail- facturing practice and in an amount ability of this material at NARA, call not to exceed that reasonably required 202–741–6030, or go to: http:// to accomplish the intended effect. www.archives.gov/federallregister/ [47 FR 55475, Dec. 10, 1982, as amended at 48 codeloflfederallregulations/ FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, ibrllocations.html. 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR (2) Chick-edema factor shall be deter- 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] mined by the bioassay method de- § 172.860 Fatty acids. scribed in ‘‘Official Methods of Anal- ysis of the Association of Official Ana- The food additive fatty acids may be lytical Chemists,’’ 13th Ed. (1980), sec- safely used in food and in the manufac- tions 28.127–28.130, which is incor- ture of food components in accordance with the following prescribed condi- porated by reference. Copies may be tions: obtained from the AOAC INTER- (a) The food additive consists of one NATIONAL, 481 North Frederick Ave., or any mixture of the following suite 500, Gaithersburg, MD 20877, or straight-chain monobasic carboxylic may be examined at the National Ar- acids and their associated fatty acids chives and Records Administration manufactured from fats and oils de- (NARA). For information on the avail- rived from edible sources: Capric acid, ability of this material at NARA, call caprylic acid, lauric acid, myristic 202–741–6030, or go to: http:// acid, oleic acid, palmitic acid, and ste- www.archives.gov/federallregister/ aric acid. codeloflfederallregulations/ (b) The food additive meets the fol- ibrllocations.html. lowing specifications: (3) The gas chromatographic-electron (1) Unsaponifiable matter does not capture method for testing fatty acids exceed 2 percent. for chick-edema shall be the method

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described in the ‘‘Journal of the Asso- (1) As coating material for sugar, ciation of Official Analytical Chem- table salt, vitamins, citric acid, suc- ists,’’ Volume 50 (No. 1), pages 216–218 cinic acid, and spices; and (1967), or the modified method using a (2) In compound coatings, cocoa sulfuric acid clean-up procedure, as de- creams, cocoa-based sweets, toffees, scribed in the ‘‘Journal of the Associa- caramel masses, and chewing sweets as tion of the Offical Analytical Chem- defined in § 170.3 (n)(9) and (n)(38) of ists,’’ Volume 51 (No. 2), pages 489–490 this chapter, except that the ingredient (1968), which are incorporated by ref- may not be used in a standardized food erence. See paragraph (c)(2) of this sec- unless permitted by the standard of tion for availability of these ref- identity. erences. (d) The ingredient is used in accord- (d) It is used or intended for use as ance with current good manufacturing follows: practice and in an amount not to ex- (1) In foods as a lubricant, binder, ceed that reasonably required to ac- and as a defoaming agent in accordance complish the intended effect. with good manufacturing practice. [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, (2) As a component in the manufac- 1992] ture of other food-grade additives. (e) To assure safe use of the additive, § 172.862 Oleic acid derived from tall the label and labeling of the additive oil fatty acids. and any premix thereof shall bear, in The food additive oleic acid derived addition to the other information re- from tall oil fatty acids may be safely quired by the act, the following: used in food and as a component in the (1) The common or usual name of the manufacture of food-grade additives in acid or acids contained therein. accordance with the following pre- (2) The words ‘‘food grade,’’ in jux- scribed conditions: taposition with and equally as promi- (a) The additive consists of purified nent as the name of the acid. oleic acid separated from refined tall [42 FR 14491, Mar. 15, 1977, as amended at 47 oil fatty acids. FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, (b) The additive meets the following 1984; 54 FR 24897, June 12, 1989] specifications: (1) Specifications for oleic acid pre- § 172.861 Cocoa butter substitute from scribed in the Food Chemicals Codex, coconut oil, palm kernel oil, or both 7th ed. (2010), pp. 743–744, which is in- oils. corporated by reference, except that The food additive, cocoa butter sub- titer (solidification point) shall not ex- stitute from coconut oil, palm kernel ceed 13.5 °C and unsaponifiable matter oil, or both oils, may be safely used in shall not exceed 0.5 percent. The Direc- food in accordance with the following tor of the Office of the Federal Register conditions: approves this incorporation by ref- (a) Cocoa butter substitute from co- erence in accordance with 5 U.S.C. conut oil, palm kernel oil (CAS Reg. 552(a) and 1 CFR part 51. You may ob- No. 85665–33–4), or both oils is a mixture tain copies from the United States of triglycerides. It is manufactured by Pharmacopeial Convention, 12601 esterification of glycerol with food- Twinbrook Pkwy., Rockville, MD 20852 grade fatty acids (complying with (Internet address http://www.usp.org). § 172.860) derived from edible coconut Copies may be examined at the Food oil, edible palm kernel oil, or both oils. and Drug Administration’s Main Li- (b) The ingredient meets the fol- brary, 10903 New Hampshire Ave., Bldg. lowing specifications: 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar- Acid number: Not to exceed 0.5. chives and Records Administration Saponification number: 220 to 260. (NARA). For information on the avail- Iodine number: Not to exceed 3. ability of this material at NARA, call Melting range: 30 to 44 °C. 202–741–6030 or go to: http:// (c) The ingredient is used or intended www.archives.gov/federal-register/cfr/ibr- for use as follows: locations.html.

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(2) The resin acid content does not (c) To assure safe use of the additive, exceed 0.01 as determined by ASTM the label and labeling of the additive method D1240–82, ‘‘Standard Test Meth- and any premix thereof shall bear, in od for Rosin Acids in Fatty Acids,’’ addition to the other information re- which is incorporated by reference. quired by the Act, the following: Copies may be obtained from the Amer- (1) The common or usual name of the ican Society for Testing Materials, 100 fatty acid salt or salts contained there- Barr Harbor Dr., West Conshohocken, in. Philadelphia, PA 19428-2959, or may be (2) The words ‘‘food grade,’’ in jux- examined at the National Archives and taposition with and equally as promi- Records Administration (NARA). For nent as the name of the salt. information on the availability of this material at NARA, call 202–741–6030, or § 172.864 Synthetic fatty alcohols. go to: http://www.archives.gov/ Synthetic fatty alcohols may be safe- federallregister/ ly used in food and in the synthesis of codeloflfederallregulations/ food components in accordance with ibrllocations.html. the following prescribed conditions: (3) The requirements for absence of (a) The food additive consists of any chick-edema factor as prescribed in one of the following fatty alcohols: § 172.860. (1) Hexyl, octyl, decyl, lauryl, (c) It is used or intended for use as myristyl, cetyl, and stearyl; manufac- follows: tured by fractional distillation of alco- (1) In foods as a lubricant, binder, hols obtained by a sequence of oxida- and defoaming agent in accordance tion and hydrolysis of organo-alu- with good manufacturing practice. minums generated by the controlled re- (2) As a component in the manufac- action of low molecular weight ture of other food-grade additives. trialkylaluminum with purified ethyl- (d) To assure safe use of the additive, ene (minimum 99 percent by volume the label and labeling of the additive C2H4), and utilizing the hydrocarbon and any premix thereof shall bear, in solvent as defined in paragraph (b) of addition to the other information re- this section, such that: quired by the Act, the following: (i) Hexyl, octyl, decyl, lauryl, and (1) The common or usual name of the myristyl alcohols contain not less than acid. 99 percent of total alcohols and not less (2) The words ‘‘food grade’’ in jux- than 96 percent of straight chain alco- taposition with and equally as promi- hols. Any nonalcoholic impurities are nent as the name of the acid. primarily paraffins. [42 FR 14491, Mar. 15, 1977, as amended at 49 (ii) Cetyl and stearyl alcohols con- FR 10105, Mar. 19, 1984; 78 FR 71465, Nov. 29, tain not less than 98 percent of total 2013] alcohols and not less than 94 percent of straight chain alcohols. Any non- § 172.863 Salts of fatty acids. alcoholic impurities are primarily The food additive salts of fatty acids paraffins. may be safely used in food and in the (iii) The synthetic fatty alcohols con- manufacture of food components in ac- tain no more than 0.1 weight percent of cordance with the following prescribed total diols as determined by a method conditions: available upon request from the Com- (a) The additive consists of one or missioner of Food and Drugs. any mixture of two or more of the alu- (2) Hexyl, octyl, and decyl; manufac- minum, calcium, magnesium, potas- tured by fractional distillation of alco- sium, and sodium salts of the fatty hols obtained by a sequence of oxida- acids conforming with § 172.860 and/or tion, hydrolysis, and catalytic hydro- oleic acid derived from tall oil fatty genation (catalyst consists of , acids conforming with § 172.862. , and nickel) of organo-alu- (b) The food additive is used or in- minums generated by the controlled re- tended for use as a binder, emulsifier, action of low molecular weight and anticaking agent in food in accord- trialkylaluminum with purified ethyl- ance with good manufacturing prac- ene (minimum 99 percent by volume tice. C2H4), and utilizing an external coolant 110

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such that these alcohols meet the spec- boiling point range. Copies of the ma- ifications prescribed in paragraph (a)(1) terial incorporated by reference may (i) and (iii) of this section. be obtained from the American Society (3) n-Octyl; manufactured by the for Testing Materials, 100 Barr Harbor hydrodimerization of 1,3-butadiene, fol- Dr., West Conshohocken, Philadelphia, lowed by catalytic hydrogenation of PA 19428-2959, or may be examined at the resulting dienol, and distillation to the National Archives and Records Ad- produce n-octyl alcohol with a min- ministration (NARA). For information imum purity of 99 percent. The analyt- on the availability of this material at ical method for n-octyl alcohol entitled NARA, call 202–741–6030, or go to: http:// ‘‘Test Method [Normal-octanol]’’ dated www.archives.gov/federallregister/ October 2003, and printed by Kuraray codeloflfederallregulations/ Co., Ltd., is incorporated by reference. ibrllocations.html. The Director of the Office of the Fed- (3) The analytical method for deter- eral Register approves this incorpora- mining ultraviolet absorbance limits is tion by reference in accordance with 5 as follows: U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of GENERAL INSTRUCTIONS Food Additive Safety, 5001 Campus Dr., All glassware should be scrupulously College Park, MD 20740, or you may ex- cleaned to remove all organic matter such as amine a copy at the Food and Drug Ad- oil, grease, detergent residues, etc. Examine ministration’s Main Library, 10903 New all glassware, including stoppers and stop- Hampshire Ave., Bldg. 2, Third Floor, cocks, under ultraviolet light to detect any Silver Spring, MD 20993, 301–796–2039, or residual fluorescent contamination. As a pre- at the National Archives and Records cautionary measure, it is recommended prac- Administration (NARA). For informa- tice to rinse all glassware with purified iso- octane immediately before use. No grease is tion on the availability of this mate- to be used on stopcocks or joints. Great care rial at NARA, call 202–741–6030, or go to to avoid contamination of hydrocarbon sol- http://www.archives.gov/federallregister/ vent samples in handling and to assure ab- codeloflfederallregulations/ sence of any extraneous material arising ibrllocations.html. from inadequate packaging is essential. Be- (b) The hydrocarbon solvent used in cause some of the polynuclear hydrocarbons the process described in paragraph sought in this test are very susceptible to (a)(1) of this section is a mixture of liq- photo-oxidation, the entire procedure is to be carried out under subdued light. uid hydrocarbons essentially paraffinic in nature, derived from petroleum and APPARATUS refined to meet the specifications de- Chromatographic tube. 450 millimeters in scribed in paragraph (b)(1) of this sec- length (packing section), inside diameter 19 tion when subjected to the procedures millimeters ±1 millimeter, equipped with a described in paragraph (b) (2) and (3) of wad of clean Pyrex brand filtering wool (Cor- this section. ning Glass Works Catalog No. 3950 or equiva- (1) The hydrocarbon solvent meets lent). The tube shall contain a 250-milliliter the following specifications: reservoir and a 2-millimeter tetrafluoro- (i) Boiling-point range: 175 °C–275 °C. ethylene polymer stopcock at the opposite end. Overall length of the tube is 670 milli- (ii) Ultraviolet absorbance limits as meters. follows: Stainless steel rod. 2 feet in length, 2 to 4 millimeters in diameter. Maximum absorb- Vacuum oven. Similar to Labline No. 3610 but modified as follows: A copper tube one- Wavelength (millicrons) ance per centimeter fourth inch in diameter and 13 inches in optical path length length is bent to a right angle at the 4-inch point and plugged at the opposite end; eight 280–289 ...... 0.15 copper tubes one-eighth inch in diameter and 290–299 ...... 12 5 inches in length are silver soldered in 300–359 ...... 05 drilled holes (one-eighth inch in diameter) to 360–400 ...... 02 the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and 12.5-inch points; the one- (2) Use ASTM method D86–82, eighth-inch copper tubes are bent to conform ‘‘Standard Method for Distillation of with the inner periphery of the oven. Petroleum Products,’’ which is incor- Beakers. 250-milliliter and 500-milliliter ca- porated by reference, to determine pacity.

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Graduated cylinders. 25-milliliter, 50-milli- Dissolve the 1 milliliter of hexadecane res- liter, and 150-milliliter capacity. idue in isooctane and make to 5 milliliters Tuberculin syringe. 1-milliliter capacity, volume. Determine the absorbance in the 1- with 3-inch, 22-gauge needle. centimeter path length cells compared to Volumetric flask. 5-milliliter capacity. isooctane as reference. The absorbance of the Spectrophotometric cells. Fused quartz solution of the solvent residue shall not ex- ground glass stoppered cells, optical path ceed 0.02 per centimeter path length between length in the range of 1.000 centimeter ±0.005 280 and 300 mμ and shall not exceed 0.01 per centimeter. With distilled water in the cells, centimeter path length between 300 and 400 determine any absorbance difference. mμ. Spectrophotometer. Spectral range 250 milli- Isooctane (2,2,4-trimethylpentane). Use 10 microns—400 millimicrons with spectral slit milliliters for the test described in the pre- width of 2 millimicrons or less: under instru- ceding paragraph. If necessary, isooctane ment operating conditions for these absorb- may be purified by passage through a column ance measurements, the spectrophotometer of activated silica gel (Grade 12, Davison shall also meet the following performance Chemical Co., Baltimore, Md., or equiva- requirements: lent). Absorbance repeatability, ±0.01 at 0.4 ab- Benzene, spectro grade (Burdick and Jackson sorbance. Laboratories, Inc., Muskegon, Mich., or equiva- Absorbance accuracy, 1 ±0.05 at 0.4 absorb- lent). Use 80 milliliters for the test. If nec- ance. essary, benzene may be purified by distilla- Wavelength repeatability, ±0.2 milli- tion or otherwise. micron. Hexane, spectro grade (Burdick and Jackson Wavelength accuracy, ±1.0 millimicron. Laboratories, Inc., Muskegon, Mich., or equiva- Nitrogen cylinder. Water-pumped or equiva- lent). Use 650 milliliters for the test. If nec- lent purity nitrogen in cylinder equipped essary, hexane may be purified by distilla- with regulator and valve to control flow at 5 tion or otherwise. p.s.i.g. 1,2-Dichloroethane, spectro grade (Matheson, Coleman, and Bell, East Rutherford, N.J., or REAGENTS AND MATERIALS equivalent). Use 20 milliliters for test. If nec- Organic solvents. All solvents used through- essary, 1,2-dichloroethane may be purified by out the procedure shall meet the specifica- distillation. tions and tests described in this specifica- Eluting mixtures: 1. 10 percent 1,2-dichloroethane in hexane. tion. The isooctane, benzene, hexane, and 1,2- Pipet 100 milliliters of 1,2-dichloroethane dichloroethane designated in the list fol- into a 1-liter glass-stoppered volumetric lowing this paragraph shall pass the fol- flask and adjust to volume with hexane, with lowing test: mixing. To the specified quantity of solvent in a 2. 40 percent benzene in hexane. Pipet 400 250-milliliter beaker, add 1 milliliter of puri- milliliters of benzene into a 1-liter glass- fied n-hexadecane and evaporate in the vacu- stoppered volumetric flask and adjust to vol- um oven under a stream of nitrogen. Dis- ume with hexane, with mixing. continue evaporation when not over 1 milli- n-Hexadecane, 99 percent olefin-free. Dilute liter of residue remains. (To the residue from 1.0 milliliter of n-hexadecane to 5 milliliters benzene add a 5-milliliter portion of purified with isooctane and determine the absorbance isooctane, reevaporate, and repeat once to in a 1-centimeter cell compared to isooctane insure complete removal of benzene.) as reference between 280 mμ-400mμ. The ab- sorbance per centimeter path length shall 1 As determined by using potassium chro- not exceed 0.00 in this range. If necessary, n- mate for reference standard and described in hexadecane may be purified by percolation National Bureau of Standards Circular 484, through activated silica gel or by distilla- Spectrophotometry, U.S. Department of tion. Commerce, (1949). The accuracy is to be de- Silica gel, 28–200 mesh (Grade 12, Davison termined by comparison with the standard Chemical Co., Baltimore, Md., or equivalent). values at 290, 345, and 400 millimicrons. Cir- Activate as follows: Weigh about 900 grams cular 484 is incorporated by reference. Copies into a 1-gallon bottle, add 100 milliliters of are available from the Center for Food Safe- de-ionized water, seal the bottle and shake ty and Applied Nutrition (HFS–200), Food and roll at intervals for 1 hour. Allow to and Drug Administration, 5001 Campus Dr., equilibrate overnight in the sealed bottle. College Park, MD 20740, or available for in- Activate the gel at 150 °C for 16 hours, in a spection at the National Archives and 2-inch × 7-inch × 12-inch porcelain pan loose- Records Administration (NARA). For infor- ly covered with aluminum foil, cool in a mation on the availability of this material dessicator, transfer to a bottle and seal. at NARA, call 202–741–6030, or go to: http:// PROCEDURE www.archives.gov/federallregister/ codeloflfederallregulations/ Determination of ultraviolet absorbance. Be- ibrllocations.html. fore proceeding with the analysis of a sample

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determine the absorbance in a 1-centimeter cover with aluminum foil (previously rinsed path cell for the reagent blank by carrying with hexane) until cool. out the procedure without a sample. Record Quantitatively transfer the hexadecane the absorbance in the wavelength range of residue to a 5-milliliter volumetric flask and 280 to 400 millimicrons. Typical reagent dilute to volume with isooctane. Determine blank absorbance in this range should not the absorbance of the solution in 1-centi- exceed 0.04 in the 280 to 299 millimicron meter path length cells between 280 and 400 range, 0.02 in the 300 to 359 millimicron millimicrons using isooctane as a reference. range, and 0.01 in the 360 to 400 millimicron Correct the absorbance values for any ab- range. If the characteristic benzene peaks in sorbance derived from reagents as deter- the 250 to 260 millimicron region are present, mined by carrying out the procedure without remove the benzene by the procedure de- a sample. If the corrected absorbance does scribed above under ‘‘Reagents and Mate- not exceed the limits prescribed in para- rials,’’ ‘‘Organic Solvents,’’ and record ab- graph (b)(1)(ii) of this section, the sample sorbance again. meets the ultraviolet absorbance specifica- tions for hydrocarbon solvent. Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. (c) Synthetic fatty alcohols may be Raise and drop the column on a semisoft, used as follows: clean surface for about 1 minute to settle the (1) As substitutes for the cor- gel. Pour 100 milliliters of hexane into the responding naturally derived fatty al- column with the stopcock open and allow to drain to about one-half inch above the gel. cohols permitted in food by existing Turn off the stopcock and allow the column regulations in this part or part 173 of to cool for 30 minutes. After cooling, vibrate this chapter provided that the use is in the column to eliminate air and stir the top compliance with any prescribed limita- 1 to 2 inches with a small diameter stainless tions. steel rod. Take care not to get the gel above (2) As substitutes for the cor- the liquid and onto the sides of the column. responding naturally derived fatty al- Weigh out 40 grams ±0.1 gram of the hydro- cohols used as intermediates in the carbon solvent sample into a 250-milliliter synthesis of food additives and other beaker, add 50 milliliters of hexane, and pour substances permitted in food. the solution into the column. Rinse the beaker with 50 milliliters of hexane and add [42 FR 14491, Mar. 15, 1977, as amended at 47 this to the column. Allow the hexane sample FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, solution to elute into a 500-milliliter beaker 1984; 54 FR 24897, June 12, 1989; 70 FR 72908, until the solution is about one-half inch Dec. 8, 2005; 81 FR 5591, Feb. 3, 2016] above the gel. Rinse the column three times with 50-milliliter portions of hexane. Allow § 172.866 Synthetic glycerin produced each hexane rinse to separately elute to by the hydrogenolysis of carbo- about one-half inch above the gel. Replace hydrates. the eluate beaker (discard the hexane eluate) Synthetic glycerin produced by the with a 250-milliliter beaker. Add two sepa- rate 25-milliliter portions of 10 percent 1,2- hydrogenolysis of carbohydrates may dichloroethane and allow each to separately be safely used in food, subject to the elute as before. Finally, add 150 milliliters of provisions of this section: 10 percent 1,2-dichloroethane for a total of (a) It shall contain not in excess of 200 milliliters. When the final 10 percent 1,2- 0.2 percent by weight of a mixture of dichloroethane fraction is about one-half butanetriols. inch above the top of the gel bed, replace the (b) It is used or intended for use in an receiving beaker (discard the 1,2- amount not to exceed that reasonably dichloroethane eluate) with a 250-milliliter required to produce its intended effect. beaker containing 1 milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters § 172.867 Olestra. per minute, add two 25-milliliter portions of 40 percent benzene and allow each to sepa- Olestra, as identified in this section, rately elute as before to within about one- may be safely used in accordance with half inch of the gel bed. Finally, add 150 mil- the following conditions: liliters of 40 percent benzene for a total of 200 (a) Olestra is a mixture of octa-, milliliters. Evaporate the benzene in the hepta-, and hexa-esters of sucrose with oven with vacuum and sufficient nitrogen fatty acids derived from edible fats and flow to just ripple the top of the benzene so- lution. When the benzene is removed (as de- oils or fatty acid sources that are gen- termined by a constant volume of hexa- erally recognized as safe or approved decane) add 5 milliliters of isooctane and for use as food ingredients. The chain evaporate. Repeat once to insure complete lengths of the fatty acids are no less removal of benzene. Remove the beaker and than 12 carbon atoms.

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(b) Olestra meets the specifications prominently and conspicuously as spec- of the Food Chemicals Codex, 7th ed. ified in § 101.2(c) of this chapter; (2010), pp. 744–746, which is incorporated (2) Olestra shall not be considered as by reference. The Director of the Office a source of fat or calories for purposes of the Federal Register approves this of §§ 101.9 and 101.13 of this chapter. incorporation by reference in accord- [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, ance with 5 U.S.C. 552(a) and 1 CFR 1996, as amended at 68 FR 46402, Aug. 5, 2003; part 51. You may obtain copies from 69 FR 29432, May 24, 2004; 78 FR 71465, Nov. 29, the United States Pharmacopeial Con- 2013] vention, 12601 Twinbrook Pkwy., Rock- ville, MD 20852 (Internet address http:// § 172.868 Ethyl cellulose. www.usp.org). Copies may be examined The food additive ethyl cellulose may at the Food and Drug Administration’s be safely used in food in accordance Main Library, 10903 New Hampshire with the following prescribed condi- Ave., Bldg. 2, Third Floor, Silver tions: Spring, MD 20993, 301–796–2039, or at the (a) The food additive is a cellulose National Archives and Records Admin- ether containing ethoxy (OC2H5) groups istration (NARA). For information on attached by an ether linkage and con- the availability of this material at taining on an anhydrous basis not more NARA, call 202–741–6030 or go to: http:// than 2.6 ethoxy groups per www.archives.gov/federal-register/cfr/ibr- anhydroglucose unit. locations.html. (b) It is used or intended for use as (c) Olestra may be used in place of follows: fats and oils in prepackaged ready-to- (1) As a binder and filler in dry vita- eat savory (i.e., salty or piquant but min preparations. not sweet) snacks and prepackaged, (2) As a component of protective unpopped popcorn kernels that are coatings for vitamin and mineral tab- ready-to-heat. In such foods, the addi- lets. tive may be used in place of fats and (3) As a fixative in flavoring com- oils for frying or baking, in dough con- pounds. ditioners, in sprays, in filling ingredi- § 172.869 Sucrose oligoesters. ents, or in flavors. Sucrose oligoesters, as identified in (d) To compensate for any inter- this section, may be safely used in ac- ference with absorption of fat soluble cordance with the following conditions: vitamins, the following vitamins shall (a) Sucrose oligoesters consist of be added to foods containing olestra: mixtures of sucrose fatty acid esters 1.9 milligrams alpha-tocopherol equiva- with an average degree of lents per gram olestra; 51 retinol esterification ranging from four to equivalents per gram olestra (as seven. It is produced by retinyl acetate or retinyl palmitate); 12 μ interesterification of sucrose with IU vitamin D per gram olestra; and 8 g methyl esters of fatty acids derived vitamin K1 per gram olestra. from edible fats and oils (including hy- (e)(1) Vitamins A, D, E, and K present drogenated fats and oils). The only sol- in foods as a result of the requirement vents which may be used in the prepa- in paragraph (d) of this section shall be ration of sucrose oligoesters are di- declared in the listing of ingredients. methyl sulfoxide, isobutyl alcohol, and Such vitamins shall not be considered those solvents generally recognized as in determining nutrient content for the safe in food. nutritional label or for any nutrient (b) Sucrose oligoesters meet the spec- claims, express or implied. ifications in the methods listed in the (i) An asterisk shall follow vitamins table in this paragraph. The methods A, D, E, and K in the listing of ingredi- for determining compliance with each ents; specification are incorporated by ref- (ii) The asterisk shall appear as a su- erence. The Director of the Office of perscript following each vitamin; the Federal Register approves this in- (iii) Immediately following the ingre- corporation by reference in accordance dient list an asterisk and statement, with 5 U.S.C. 552(a) and 1 CFR part 51. ‘‘Dietarily insignificant’’ shall appear Copies may be examined at the Food

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and Drug Administration’s Main Li- ability of this material at NARA, call brary, 10903 New Hampshire Ave., Bldg. 202–741–6030 or go to: http:// 2, Third Floor, Silver Spring, MD 20993, www.archives.gov/federal-register/cfr/ibr- 301–796–2039, or at the National Ar- locations.html. Copies of the methods chives and Records Administration are available from the sources listed in (NARA). For information on the avail- the table in this paragraph:

Specification Limit Method Cited Source for Obtaining Method

(1) Sucrose esters ...... Not less than 90% ...... ‘‘Method for Analyzing the Pu- Office of Food Additive Safe- rity of Sucrose Fatty Acid ty, Center for Food Safety Esters,’’ issued by and Applied Nutrition (HFS– Mitsubishi Chemical Corp., 200), Food and Drug Ad- June 17, 1998. ministration, 5001 Campus Dr., College Park, MD 20740.

(2) Mono-, di-, and tri-esters ... Not more than 45% ...... ‘‘Method for Measuring the Do. Ester Distribution of Su- crose Oligoesters,’’ issued by Mitsubishi Chemical Corp., June 17, 1998.

(3) Tetra-, penta-, hexa-, and Not less than 50% ...... Do. Do. hepta-esters.

(4) Octa-esters ...... Not more than 40% ...... Do. Do.

(5) Free Sucrose ...... Not more than 0.5% ...... ‘‘Free Sucrose Method,’’ Do. issued by Mitsubishi Chem- ical Corp., June 17, 1998.

(6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, United States Pharmacopeial Method I (Commercial Fatty Convention, 12601 Acids), in the Food Chemi- Twinbrook Pkwy., Rockville, cals Codex, 7th ed. (2010), MD 20852 (Internet address p. 1220. http://www.usp.org)

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition,’’ Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 7th ed. (2010), pp. 1141–1142 (using a 1-gram sample).

(8) Residual Methanol ...... Not more than 10 milligrams/ Method listed in the mono- Do kilogram. graph for ‘‘Sucrose Fatty Acid Esters’’ in the Food Chemicals Codex, 7th ed. (2010), pp. 998–1000.

(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ ...... do Do. oxide. kilogram.

(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ ...... do Do. kilogram.

(11) Lead ...... Not more than 1.0 milligram/ ‘‘Atomic Absorption Do. kilogram. Spectrophometric Graphite Furnace Method,’’ Method I in the Food Chemicals Codex, 7th ed. (2010), p. 1154–1155

(c) The additive is used as an emulsi- in a standardized food unless permitted fier (as defined in § 170.3(o)(8) of this by the standard of identity. chapter) or stabilizer (as defined in [68 FR 50072, Aug. 20, 2003, as amended at 78 § 170.3(o)(28) of this chapter) in choco- FR 71465, Nov. 29, 2013] late and in butter-substitute spreads, at a level not to exceed 2.0 percent; ex- cept that the additive may not be used

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§ 172.870 Hydroxypropyl cellulose. [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is the number of methyl groups and y is The food additive hydroxypropyl cel- the number of ethyl groups. The aver- lulose may be safely used in food, ex- age value of x is 0.3 and the average cept standardized foods that do not value of y is 0.7. provide for such use, in accordance with the following prescribed condi- (b) The additive meets the following tions: specifications: (a) The additive consists of one of the (1) The methoxy content shall be not following: less than 3.5 percent and not more than (1) A cellulose ether containing pro- 6.5 percent, calculated as OCH3, and the pylene glycol groups attached by an ethoxy content shall be not less than ether linkage that contains, on an an- 14.5 percent and not more than 19 per- hydrous basis, not more than 4.6 cent, calculated as OC2H5, both meas- hydroxypropyl groups per ured on the dry sample. anhydroglucose unit. The additive has (2) The viscosity of an aqueous solu- a minimum viscosity of 10 centipoises tion, 2.5 grams of the material in 100 ° for a 10 percent by weight aqueous so- milliliters of water, at 20 C, is 20 to 60 lution at 25 degrees C. centipoises. (2) A cellulose ether containing pro- (3) The ash content on a dry basis has pylene glycol groups attached by an a maximum of 0.6 percent. ether linkage having a hydroxypropoxy (c) The food additive is used as an aerating, emulsifying, and foaming (OC3H6OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous agent, in an amount not in excess of basis, i.e., 0.1 to 0.4 hydroxypropyl that reasonably required to produce its groups per anhydroglucose unit. The intended effect. common name for this form of the ad- ditive is low substituted hydroxypropyl § 172.874 Hydroxypropyl methylcellulose. cellulose. (b) The additive is used or intended The food additive hydroxypropyl for use as follows: methylcellulose (CAS Reg. No. 9004–65– (1) The additive identified in para- 3) may be safely used in food, except in graph (a)(1) of this section is used or standardized foods which do not pro- intended for use as an emulsifier, film vide for such use if: former, protective colloid, stabilizer, (a) The additive complies with the suspending agent, or thickener in food, definition and specifications prescribed in accordance with good manufacturing in the National Formulary, 12th edi- practice. The additive also may be used tion. as a binder in dietary supplements, in (b) It is used or intended for use as an accordance with good manufacturing emulsifier, film former, protective col- practice. loid, stabilizer, suspending agent, or (2) The additive identified in para- thickener, in accordance with good graph (a)(2) of this section is used or manufacturing practice. intended for use as a binder and dis- (c) To insure safe use of the additive, integrator in tablets or wafers con- the container of the additive, in addi- taining dietary supplements of vita- tion to being labeled as required by the mins and/or minerals. The additive is general provisions of the act, shall be used in accordance with good manufac- accompanied by labeling which con- turing practice. tains adequate directions for use to provide a final product that complies [46 FR 50065, Oct. 9, 1981, as amended at 76 FR with the limitations prescribed in para- 41689, July 15, 2011] graph (b) of this section. § 172.872 Methyl ethyl cellulose. [42 FR 14491, Mar. 15, 1977, as amended at 47 The food additive methyl ethyl cel- FR 38273, Aug. 31, 1982] lulose may be safely used in food in ac- cordance with the following prescribed § 172.876 Castor oil. conditions. The food additive castor oil may be (a) The additive is a cellulose ether safely used in accordance with the fol- having the general formula lowing conditions:

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(a) The additive meets the specifica- (3) It meets the specifications pre- tions of the United States Pharma- scribed in the ‘‘Journal of the Associa- copeia XX (1980). tion of Official Analytical Chemists,’’ (b) The additive is used or intended Volume 45, page 66 (1962), which is in- for use as follows: corporated by reference, after correc- Use and Limitations tion of the ultraviolet absorbance for any absorbance due to added anti- Hard candy production—As a release agent and antisticking agent, not to exceed 500 oxidants. Copies of the material incor- parts per million in hard candy. porated by reference are available from Vitamin and mineral tablets—As a compo- the Center for Food Safety and Applied nent of protective coatings. Nutrition (HFS–200), Food and Drug [42 FR 14491, Mar. 15, 1977, as amended at 49 Administration, 5001 Campus Dr., Col- FR 10105, Mar. 19, 1984] lege Park, MD 20740, or available for in- spection at the National Archives and § 172.878 White mineral oil. Records Administration (NARA). For White mineral oil may be safely used information on the availability of this in food in accordance with the fol- material at NARA, call 202–741–6030, or lowing conditions: go to: http://www.archives.gov/ (a) White mineral oil is a mixture of federallregister/ liquid hydrocarbons, essentially par- codeloflfederallregulations/ affinic and naphthenic in nature ob- ibrllocations.html. tained from petroleum. It is refined to (b) White mineral oil may contain meet the following specifications: (1) It meets the test requirements of any antioxidant permitted in food by the United States Pharmacopeia XX regulations issued in accordance with (1980) for readily carbonizable sub- section 409 of the Act, in an amount stances (page 532). not greater than that required to (2) It meets the test requirements of produce its intended effect. U.S.P. XVII for compounds (page (c) White mineral oil is used or in- 400). tended for use as follows:

Limitation (inclusive of all petroleum hydro- Use carbons that may be used in combination with white mineral oil)

1. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining concentrates of flavoring, spices, condiments, and nutrients intended for let. addition to food, excluding confectionery. 2. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining food for special dietary use. let. 3. As a float on fermentation fluids in the manufacture of vinegar and wine to pre- In an amount not to exceed good manu- vent or retard access of air, evaporation, and wild yeast contamination during facturing practice. fermentation. 4. As a defoamer in food ...... In accordance with § 173.340 of this chap- ter. 5. In bakery products, as a release agent and lubricant ...... Not to exceed 0.15% of bakery products. 6. In dehydrated fruits and vegetables, as a release agent ...... Not to exceed 0.02% of dehydrated fruits and vegetables. 7. In egg white solids, as a release agent ...... Not to exceed 0.1% of egg white solids. 8. On raw fruits and vegetables, as a protective coating ...... In an amount not to exceed good manu- facturing practice. 9. In frozen meat, as a component of hot-melt coating ...... Not to exceed 0.095% of meat. 10. As a protective float on brine used in the curing of pickles ...... In an amount not to exceed good manu- facturing practice. 11. In molding starch used in the manufacture of confectionery ...... Not to exceed 0.3 percent in the molding starch. 12. As a release agent, binder, and lubricant in the manufacture of yeast ...... Not to exceed 0.15 percent of yeast. 13. As an antidusting agent in sorbic acid for food use ...... Not to exceed 0.25 percent in the sorbic acid. 14. As release agent and as sealing and polishing agent in the manufacture of Not to exceed 0.2 percent of confectionery. confectionery. 15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and Applied at a level of no more than 0.02 sorghum. percent by weight of grain.

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Limitation (inclusive of all petroleum hydro- Use carbons that may be used in combination with white mineral oil)

16. As a dust control agent for rice ...... ISO 100 oil viscosity (100 centistokes (cSt) at 100 °F) applied at a level of no more than 0.08 percent by weight of the rice grain.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998]

§ 172.880 Petrolatum. subjected to the analytical procedure described in § 172.886(b): Petrolatum may be safely used in food, subject to the provisions of this Ultraviolet absorbance per centimeter section. path length: (a) Petrolatum complies with the Millimicrons Maximum specifications set forth in the United States Pharmacopeia XX (1980) for 280–289 ...... 0.25 290–299 ...... 20 white petrolatum or in the National 300–359 ...... 14 Formulary XV (1980) for petrolatum. 360–400 ...... 04 (b) Petrolatum meets the following ultraviolet absorbance limits when (c) Petrolatum is used or intended for use as follows:

Limitation (inclusive of all petroleum hydrocarbons Use that may be used in combination with petrolatum)

In bakery products; as release agent and lubricant ...... With white mineral oil, not to exceed 0.15 percent of bakery product. In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery. In dehydrated fruits and vegetables; as release agent ...... Not to exceed 0.02 percent of dehydrated fruits and vegetables. In egg white solids; as release agent ...... Not to exceed 0.1 percent of egg white solids. On raw fruits and vegetables; as protective coating ...... In an amount not to exceed good manufacturing prac- tice. In beet sugar and yeast; as defoaming agent ...... As prescribed in § 173.340 of this chapter.

(d) Petrolatum may contain any Distillation of Petroleum Products,’’ which antioxidant permitted in food by regu- is incorporated by reference. Copies may be lations issued in accordance with sec- obtained from the American Society for tion 409 of the Act, in an amount not Testing Materials, 100 Barr Harbor Dr., West greater than that required to produce Conshohocken, Philadelphia, PA 19428-2959, its intended effect. or may be examined at the National Ar- chives and Records Administration (NARA). [42 FR 14491, Mar. 15, 1977, as amended at 49 For information on the availability of this FR 10105, Mar. 19, 1984] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ § 172.882 Synthetic isoparaffinic petro- codeloflfederallregulations/ leum hydrocarbons. ibrllocations.html. Synthetic isoparaffinic petroleum Ultraviolet absorbance: hydrocarbons may be safely used in 260–319 millimicrons—1.5 maximum. food, in accordance with the following 320–329 millimicrons—0.08 maximum. conditions: 330–350 millimicrons—0.05 maximum. (a) They are produced by synthesis Nonvolatile residual: 0.002 gram per 100 milliliters maximum. from petroleum gases and consist of a Synthetic isoparaffinic petroleum hydro- mixture of liquid hydrocarbons meet- carbons containing antioxidants shall meet ing the following specifications: the specified ultraviolet absorbance limits Boiling point 93–260 °C as determined by after correction for any absorbance due to ASTM method D86–82, ‘‘Standard Method for the antioxidants. The ultraviolet absorbance

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shall be determined by the procedure de- Uses Limitations scribed for application of mineral oil, dis- regarding the last sentence of the procedure, 5. As a float on fermentation Do. under ‘‘Specifications’’ on page 66 of the fluids in the manufacture of vin- egar and wine and on brine ‘‘Journal of the Association of Official Ana- used in curing pickles, to pre- lytical Chemists,’’ Volume 45 (February vent or retard access of air, 1962), which is incorporated by reference. evaporation, and contamination Copies are available from the Center for with wild organisms during fer- Food Safety and Applied Nutrition (HFS– mentation. 200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or [42 FR 14491, Mar. 15, 1977, as amended at 47 available for inspection at the National Ar- FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, chives and Records Administration (NARA). 1984; 54 FR 24897, June 12, 1989] For information on the availability of this material at NARA, call 202–741–6030, or go to: § 172.884 Odorless light petroleum hy- http://www.archives.gov/federallregister/ drocarbons. codeloflfederallregulations/ Odorless light petroleum hydro- ibrllocations.html. For hydrocarbons boiling carbons may be safely used in food, in below 250 °F, the nonvolatile residue shall be accordance with the following pre- determined by ASTM method D1353–78, scribed conditions: ‘‘Standard Test Method for Nonvolatile Mat- (a) The additive is a mixture of liquid ter in Volatile Solvents for Use in Paint, hydrocarbons derived from petroleum Varnish, Lacquer, and Related Products;’’ for those boiling above 121 °C, ASTM method or synthesized from petroleum gases. D381–80, ‘‘Standard Test Method for Existent The additive is chiefly paraffinic, Gum in Fuels by Jet Evaporation’’ shall be isoparaffinic, or naphthenic in nature. used. These methods are incorporated by ref- (b) The additive meets the following erence. Copies may be obtained from the specifications: American Society for Testing Materials, 100 (1) Odor is faint and not kerosenic. Barr Harbor Dr., West Conshohocken, Phila- (2) Initial boiling point is 300 °F min- delphia, PA 19428-2959, or may be examined imum. at the National Archives and Records Ad- (3) Final boiling point is 650 °F max- ministration (NARA). For information on imum. the availability of this material at NARA, (4) Ultraviolet absorbance limits de- call 202–741–6030, or go to: http:// termined by method specified in www.archives.gov/federallregister/ § 178.3620(b)(1)(ii) of this chapter, as fol- codeloflfederallregulations/ ibrllocations.html. lows: (b) Isoparaffinic petroleum hydro- Maximum absorb- carbons may contain antioxidants au- μ ance per Wavelength m centimeter thorized for use in food in an amount optical not to exceed that reasonably required pathlength to accomplish the intended technical 280–289 ...... 4.0 effect nor to exceed any prescribed lim- 290–299 ...... 3.3 itations. 300–329 ...... 2.3 (c) Synthetic isoparaffinic petroleum 330–360 ...... 8 hydrocarbons are used or intended for (c) The additive is used as follows: use as follows: Use Limitations Uses Limitations As a coating on shell eggs ...... In an amount not to ex- 1. In the froth-flotation cleaning of In an amount not to ex- ceed good manufac- vegetables. ceed good manufac- turing practice. turing practice. As a defoamer in processing beet Complying with 2. As a component of Do. sugar and yeast. § 173.340 of this chap- formulations for use on proc- ter. essed foods. As a float on fermentation fluids in In an amount not to ex- 3. As a component of coatings on Do. the manufacture of vinegar and ceed good manufac- fruits and vegetables. wine to prevent or retard ac- turing practice. 4. As a coating on shell eggs ...... Do. cess of air, evaporation, and wild yeast contamination during fermentation. In the froth-flotation cleaning of Do. vegetables.

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Use Limitations the bottom and a suitable ball-joint at the top for connecting to the nitrogen supply. As a component of insecticide for- Do. The male fitting should be equipped with mulations used in compliance glass hooks. with regulations issued in parts Chromatographic tube. 180 millimeters in 170 through 189 of this chapter. length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, frit- § 172.886 Petroleum wax. ted-glass disc, a polymer stopcock, and a female 24/40 standard tapered Petroleum wax may be safely used in fitting at the opposite end. (Overall length of or on food, in accordance with the fol- the column with the female joint is 235 milli- lowing conditions: meters.) The female fitting should be (a) Petroleum wax is a mixture of equipped with glass hooks. solid hydrocarbons, paraffinic in na- Disc. Tetrafluoroethylene polymer 2–inch ture, derived from petroleum, and re- diameter disc approximately 3⁄16–inch thick fined to meet the specifications pre- with a hole bored in the center to closely fit the stem of the chromatographic tube. scribed by this section. Heating jacket. Conical, for 500–milliliter (b) Petroleum wax meets the fol- separatory funnel. (Used with variable trans- lowing ultraviolet absorbance limits former heat control.) when subjected to the analytical proce- Suction flask. 250–milliliter or 500–milliliter dure described in this paragraph. filter flask. Condenser. 24/40 joints, fitted with a drying Maximum tube, length optional. ultraviolet Evaporation flask (optional). 250–milliliter absorb- ance per or 500–milliliter capacity all-glass flask centimeter equipped with standard taper stopper having path length inlet and outlet tubes to permit passage of nitrogen across the surface of contained liq- 280–289 millimicrons ...... 0.15 290–299 millimicrons ...... 0.12 uid to be evaporated. 300–359 millimicrons ...... 0.08 Vacuum distillation assembly. All glass (for 360–400 millimicrons ...... 0.02 purification of dimethyl sulfoxide); 2–liter distillation flask with heating mantle; ANALYTICAL SPECIFICATION FOR PETROLEUM Vigreaux vacuum-jacketed condenser (or WAX equivalent) about 45 centimeters in length and distilling head with separable cold finger GENERAL INSTRUCTIONS condenser. Use of tetrafluoroethylene poly- mer sleeves on the glass joints will prevent Because of the sensitivity of the test, the freezing. Do not use grease on stopcocks or possibility of errors arising from contamina- joints. tion is great. It is of the greatest importance Spectrophotometric cells. Fused quartz cells, that all glassware be scrupulously cleaned to optical path length in the range of 5.000 cen- remove all organic matter such as oil, timeters ±0.005 centimeter; also for checking grease, detergent residues, etc. Examine all spectrophotometer performance only, optical glassware, including stoppers and stopcocks, path length in the range 1.000 centimeter under ultraviolet light to detect any residual ±0.005 centimeter. With distilled water in the fluorescent contamination. As a pre- cells, determine any absorbance differences. cautionary measure it is recommended prac- Spectrophotometer. Spectral range 250 milli- tice to rinse all glassware with purified iso- microns–400 millimicrons with spectral slit octane immediately before use. No grease is width of 2 millimicrons or less, under instru- to be used on stopcocks or joints. Great care ment operating conditions for these absorb- to avoid contamination of wax samples in ance measurements, the spectrophotometer handling and to assure absence of any extra- shall also meet the following performance neous material arising from inadequate requirements: packaging is essential. Because some of the Absorbance repeatability, ±0.01 at 0.4 ab- polynuclear hydrocarbons sought in this test sorbance. are very susceptible to photo-oxidation, the Absorbance accuracy, 1 ±0.05 at 0.4 absorb- entire procedure is to be carried out under ance. subdued light. 1 APPARATUS As determined by using potassium chro- mate for reference standard and described in Separatory funnels. 250–milliliter, 500–milli- National Bureau of Standards Circular 484, liter, 1,000–milliliter, and preferably 2,000– Spectrophotometry, U.S. Department of milliliter capacity, equipped with tetra- Commerce, (1949). The accuracy is to be de- fluoroethylene polymer stopcocks. termined by comparison with the standard Reservoir. 500–milliliter capacity, equipped values at 290, 345, and 400 millimicrons. Cir- with a 24/40 standard taper male fitting at cular 484 is incorporated by reference. Copies

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Wavelength repeatability, ±0.2 milli- centimeters in length and 5 centimeters to 8 micron. centimeters in diameter. Wavelength accuracy, ±1.0 millimicron. Benzene, A.C.S. reagent grade. Use 150 milli- Nitrogen cylinder. Water-pumped or equiva- liters for the test. Purify, if necessary, by lent purity nitrogen in cylinder equipped distillation or otherwise. with regulator and valve to control flow at 5 Acetone, A.C.S. reagent grade. Use 200 milli- p.s.i.g. liters for the test. Purify, if necessary, by distillation. REAGENTS AND MATERIALS Eluting mixtures: 1. 10 percent benzene in isooctane. Pipet 50 Organic solvents. All solvents used through- milliliters of benzene into a 500–milliliter out the procedure shall meet the specifica- glass-stoppered volumetric flask and adjust tions and tests described in this specifica- to volume with isooctane, with mixing. tion. The isooctane, benzene, acetone, and 2. 20 percent benzene in isooctane. Pipet 50 methyl alcohol designated in the list fol- milliliters of benzene into a 250–milliliter lowing this paragraph shall pass the fol- glass-stoppered volumetric flask, and adjust lowing test: to volume with isooctane, with mixing. To the specified quantity of solvent in a 3. Acetone-benzene-water mixture. Add 20 250–milliliter Erlenmeyer flask, add 1 milli- milliliters of water to 380 milliliters of ace- liter of purified n-hexadecane and evaporate tone and 200 milliliters of benzene, and mix. on the steam bath under a stream of nitro- n-Hexadecane, 99 percent olefin-free. Dilute gen (a) loose aluminum foil jacket around 1.0 milliliter of n-hexadecane to 25 milliliters the flask will speed evaporation). Dis- with isooctane and determine the absorbance continue evaporation when not over 1 milli- in a 5–centimeter cell compared to isooctane liter of residue remains. (To the residue from as reference point between 280 mμ–400 mμ. benzene add a 10–milliliter portion of puri- The absorbance per centimeter path length fied isooctane, reevaporate, and repeat once shall not exceed 0.00 in this range. Purify, if to insure complete removal of benzene.) necessary, by percolation through activated Alternatively, the evaporation time can be silica gel or by distillation. reduced by using the optional evaporation Methyl alcohol, A.C.S. reagent grade. Use flask. In this case the solvent and n-hexa- 10.0 milliliters of methyl alcohol. Purify, if decane are placed in the flask on the steam necessary, by distillation. bath, the tube assembly is inserted, and a Dimethyl sulfoxide. Pure grade, clear, stream of nitrogen is fed through the inlet water-white, m.p. 18° minimum. Dilute 120 tube while the outlet tube is connected to a milliliters of dimethyl sulfoxide with 240 solvent trap and vacuum line in such a way milliliters of distilled water in a 500–milli- as to prevent any flow-back of condensate liter separatory funnel, mix and allow to into the flask. cool for 5–10 minutes. Add 40 milliliters of Dissolve the 1 milliliter of hexadecane res- isooctane to the solution and extract by idue in isooctane and make to 25 milliliters shaking the funnel vigorously for 2 minutes. volume. Determine the absorbance in the 5– Draw off the lower aqueous layer into a sec- centimeter path length cells compared to ond 500–milliliter separatory funnel and re- isooctane as reference. The absorbance of the the extraction with 40 milliliters of iso- solution of the solvent residue (except for octane. Draw off and discard the aqueous methyl alcohol) shall not exceed 0.01 per cen- layer. Wash each of the 40–milliliter extrac- timeter path length between 280 and 400 mμ. tives three times with 50–milliliter portions For methyl alcohol this absorbance value of distilled water. Shaking time for each shall be 0.00. wash is 1 minute. Discard the aqueous lay- Isooctane (2,2,4–trimethylpentane). Use 180 ers. Filter the first extractive through anhy- milliliters for the test described in the pre- drous sodium sulfate prewashed with iso- ceding paragraph. Purify, if necessary, by octane (see Sodium sulfate under ‘‘Reagents passage through a column of activated silica and Materials’’ for preparation of filter), into gel (Grade 12, Davison Chemical Company, a 250–milliliter Erlenmeyer flask, or option- Baltimore, Maryland, or equivalent) about 90 ally into the evaporating flask. Wash the first separatory funnel with the second 40– milliliter isooctane extractive, and pass are available from the Center for Food Safe- through the sodium sulfate into the flask. ty and Applied Nutrition (HFS–200), Food Then wash the second and first separatory and Drug Administration, 5001 Campus Dr., funnels successively with a 10–milliliter por- College Park, MD 20740, or available for in- tion of isooctane, and pass the solvent spection at the National Archives and through the sodium sulfate into the flask. Records Administration (NARA). For infor- Add 1 milliliter of n-hexadecane and evapo- mation on the availability of this material rate the isooctane on the steam bath under at NARA, call 202–741–6030, or go to: http:// nitrogen. Discontinue evaporation when not www.archives.gov/federallregister/ over 1 milliliter of residue remains. To the codeloflfederallregulations/ residue, add a 10–milliliter portion of iso- ibrllocations.html. octane and reevaporate to 1 milliliter of

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hexadecane. Again, add 10 milliliters of iso- trough lined with aluminum foil (free from octane to the residue and evaporate to 1 mil- rolling oil). Break up the magnesia with a liliter of hexadecane to insure complete re- clean spatula and spread out the absorbent moval of all volatile materials. Dissolve the on the aluminum foil in a layer about 1 cen- 1 milliliter of hexadecane in isooctane and timeter to 2 centimeters thick. Dry for 24 make to 25–milliliter volume. Determine the hours at 160 °C ±1 °C. Pulverize the magnesia reference. The absorbance of the solution with mortar and pestle. Sieve the pulverized should not exceed 0.02 per centimeter path absorbent between 60–180 mesh. Use the mag- length in the 280 mμ–400 mμ range. (NOTE. nesia retained on the 180–mesh sieve. Difficulty in meeting this absorbance speci- Celite 545. Johns-Manville Company, diato- fication may be due to organic impurities in maceous earth, or equivalent. the distilled water. Repetition of the test Magnesium oxide-Celite 545 mixture (2 + 1) by omitting the dimethyl sulfoxide will disclose weight. Place the magnesium oxide (60–180 their presence. If necessary to meet the spec- mesh) and the Celite 545 in 2 to 1 propor- ification, purify the water by redistillation, tions, respectively, by weight in a glass- passage through an ion-exchange resin, or stoppered flask large enough for adequate otherwise.) mixing. Shake vigorously for 10 minutes. Purify, if necessary, by the following pro- Transfer the mixture to a glass trough lined cedure: To 1,500 milliliters of dimethyl sulf- with aluminum foil (free from rolling oil) oxide in a 2–liter glass-stoppered flask, add and spread it out on a layer about 1 centi- 6.0 milliliters of phosphoric acid and 50 meter to 2 centimeters thick. Reheat the grams of Norit A (decolorizing carbon, alka- mixture at 160 °C ±1 °C for 2 hours, and store line) or equivalent. Stopper the flask, and in a tightly closed flask. with the use of a magnetic stirrer (tetra- Sodium sulfate, anhydrous, A.C.S. reagent fluoroethylene polymer coated bar) stir the grade, preferably in granular form. For each solvent for 15 minutes. Filter the dimethyl bottle of sodium sulfate reagent used, estab- sulfoxide through four thicknesses of fluted lish as follows the necessary sodium sulfate paper (18.5 centimeters, Schleicher & prewash to provide such filters required in Schuell, No. 597, or equivalent). If the initial the method: Place approximately 35 grams of filtrate contains carbon fines, refilter anhydrous sodium sulfate in a 30–milliliter through the same filter until a clear filtrate coarse, fritted-glass funnel or in a 65–milli- is obtained. Protect the sulfoxide from air meter filter funnel with glass wool plug; and moisture during this operation by cov- wash with successive 15–milliliter portions of ering the solvent in the funnel and collection the indicated solvent until a 15–milliliter flask with a layer of isooctane. Transfer the portion of the wash shows 0.00 absorbance filtrate to a 2–liter separatory funnel and per centimeter path length between 280 mμ draw off the dimethyl sulfoxide into the 2– and 400 mμ when tested as prescribed under liter distillation flask of the vacuum dis- ‘‘Organic solvents.’’ Usually three portions tillation assembly and distill at approxi- of wash solvent are sufficient. mately 3–millimeter Hg pressure or less. Dis- Before proceeding with analysis of a sam- card the first 200–milliliter fraction of the ple, determine the absorbance in a 5–centi- distillate and replace the distillate collec- meter path cell between 250 mμ and 400 mμ tion flask with a clean one. Continue the dis- for the reagent blank by carrying out the tillation until approximately 1 liter of the procedure, without a wax sample, at room sulfoxide has been collected. temperature, recording the spectra after the At completion of the distillation, the rea- extraction stage and after the complete pro- gent should be stored in glass-stoppered bot- cedure as prescribed. The absorbance per tles since it is very hygroscopic and will centimeter path length following the extrac- react with some metal containers in the tion stage should not exceed 0.040 in the presence of air. wavelength range from 280 mμ to 400 mμ; the Phosphoric acid. 85 percent A.C.S. reagent absorbance per centimeter path length fol- grade. lowing the complete procedure should not Sodium borohydride. 98 percent. exceed 0.070 in the wavelength range from 280 Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 299 mμ, inclusive, nor 0.045 in the ery Company, Westvaco Division, distributed by wavelength range from 300 mμ to 400 mμ. If in chemical supply firms, or equivalent). Place 100 either spectrum the characteristic benzene grams of the magnesium oxide in a large peaks in the 250 mμ–260 mμ region are beaker, add 700 milliliters of distilled water present, remove the benzene by the proce- to make a thin slurry, and heat on a steam dure under ‘‘Organic solvents’’ and record bath for 30 minutes with intermittent stir- absorbance again. ring. Stir well initially to insure that all the Place 300 milliliters of dimethyl sulfoxide absorbent is completely wetted. Using a in a 1–liter separatory funnel and add 75 mil- Buchner funnel and a filter paper (Schleicher liliters of phosphoric acid. Mix the contents & Schuell No. 597, or equivalent) of suitable of the funnel and allow to stand for 10 min- diameter, filter with suction. Continue suc- utes. (The reaction between the sulfoxide tion until water no longer drips from the and the acid is exothermic. Release pressure funnel. Transfer the absorbent to a glass after mixing, then keep funnel stoppered.)

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Add 150 milliliters of isooctane and shake to lower aqueous layer into a second separatory preequilibrate the solvents. Draw off the in- funnel (preferably 2–liter) and repeat the ex- dividual layers and store in glass-stoppered traction with 80 milliliters of isooctane. flasks. Draw off and discard the aqueous layer. Place a representative 1–kilogram sample Wash each of the 80–milliliter extractives of wax, or if this amount is not available, the three times with 100–milliliter portions of entire sample, in a beaker of a capacity distilled water. Shaking time for each wash about three times the volume of the sample is 1 minute. Discard the aqueous layers. Fil- and heat with occasional stirring on a steam ter the first extractive through anhydrous bath until the wax is completely melted and sodium sulfate prewashed with isooctane (see homogeneous. Weigh four 25–gram ±0.2 gram Sodium Sulfate under ‘‘Reagents and Mate- portions of the melted wax in separate 100– rials’’ for preparation of filter) into a 250– milliliter beakers. Reserve three of the por- milliliter Erlenmeyer flask (or optionally tions for later replicate analyses as nec- into the evaporation flask). Wash the first essary. Pour one weighed portion imme- separatory funnel with the second 80–milli- diately after remelting (on the steam bath) liter isooctane extractive and pass through into a 500–milliliter separatory funnel con- the sodium sulfate. Then wash the second taining 100 milliliters of the preequilibrated and first separatory funnels successively sulfoxide-phosphoric acid mixture that has with a 20–milliliter portion of isooctane and been heated in the heating jacket at a tem- pass the solvent through the sodium sulfate perature just high enough to keep the wax into the flask. Add 1 milliliter of n-hexa- melted. (NOTE: In preheating the sulfoxide- decane and evaporate the isooctane on the acid mixture, remove the stopper of the sepa- steam bath under nitrogen. Discontinue ratory funnel at intervals to release the evaporation when not over 1 milliliter of res- pressure.) idue remains. To the residue, add a 10–milli- Promptly complete the transfer of the liter portion of isooctane, reevaporate to 1 sample to the funnel in the jacket with por- milliliter of hexadecane, and repeat this op- tions of the preequilibrated isooctane, warm- eration once. ing the beaker, if necessary, and using a Quantitatively transfer the residue with total volume of just 50 milliliters of the sol- isooctane to a 25–milliliter volumetric flask, vent. If the wax comes out of solution during make to volume, and mix. Determine the ab- these operations, let the stoppered funnel re- sorbance of the solution in the 5–centimeter main in the jacket until the wax redissolves. path length cells compared to isooctane as (Remove stopper from the funnel at intervals reference between 280 mμ–400 mμ (take care to release pressure.) When the wax is in solu- to lose none of the solution in filling the tion, remove the funnel from the jacket and sample cell). Correct the absorbance values shake it vigorously for 2 minutes. Set up for any absorbance derived from reagents as three 250–milliliter separatory funnels with determined by carrying out the procedure each containing 30 milliliters of without a wax sample. If the corrected ab- preequilibrated isooctane. After separation sorbance does not exceed the limits pre- of the liquid phases, allow to cool until the scribed in this paragraph (b), the wax meets main portion of the wax-isooctane solution the ultraviolet absorbance specifications. If begins to show a precipitate. Gently swirl the corrected absorbance per centimeter the funnel when precipitation first occurs on path length exceeds the limits prescribed in the inside surface of the funnel to accelerate this paragraph (b), proceed as follows: this process. Carefully draw off the lower Quantitatively transfer the isooctane solu- layer, filter it slowly through a thin layer of tion to a 125–milliliter flask equipped with glass wool fitted loosely in a filter funnel 24/40 joint and evaporate the isooctane on into the first 250–milliliter separatory fun- the steam bath under a stream of nitrogen to nel, and wash in tandem with the 30–milli- a volume of 1 milliliter of hexadecane. Add liter portions of isooctane contained in the 10 milliliters of methyl alcohol and approxi- 250–milliliter separatory funnels. Shaking mately 0.3 gram of sodium borohydride. time for each wash is 1 minute. Repeat the (Minimize exposure of the borohydride to the extraction operation with two additional atmosphere. A measuring dipper may be portions of the sulfoxide-acid mixture, re- used.) Immediately fit a water-cooled con- placing the funnel in the jacket after each denser equipped with a 24/40 joint and with a extraction to keep the wax in solution and drying tube into the flask, mix until the washing each extractive in tandem through borohydride is dissolved, and allow to stand the same three portions of isooctane. for 30 minutes at room temperature, with Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe- liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the erably 2–liter), containing 480 milliliters of methyl alcohol on the steam bath under ni- distilled water, mix, and allow to cool for a trogen until the sodium borohydride begins few minutes after the last extractive has to come out of the solution. Then add 10 mil- been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol- the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10 nel vigorously for 2 minutes. Draw off the milliliters of isooctane and concentrate to a

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volume of approximately 5 milliliters. Swirl until most of the solvent mixture is re- the flask repeatedly to assure adequate moved. Wash the eluate three times with washing of the sodium borohydride residues. 300–milliliter portions of distilled water, Fit the tetrafluoroethylene polymer disc shaking well for each wash. (The addition of on the upper part of the stem of the small amounts of sodium chloride facilitates chromatographic tube, then place the tube separation.) Discard the aqueous layer after with the disc on the suction flask and apply each wash. After the final separation, filter the vacuum (approximately 135 millimeters the residual benzene through anhydrous so- Hg pressure). Weight out 14 grams of the 2:1 dium sulfate prewashed with benzene (see So- magnesium oxide-Celite 545 mixture and dium sulfate under ‘‘Reagents and Materials’’ pour the adsorbent mixture into the for preparation of filter) into a 250–milliliter chromatographic tube in approximately 3– Erlenmeyer flask (or optionally into the centimeter layers. After the addition of each evaporation flask). Wash the separatory fun- layer, level off the top of the adsorbent with nel with two additional 20–milliliter portions a flat glass rod or metal plunger by pressing of benzene which are also filtered through down firmly until the adsorbent is well the sodium sulfate. Add 1 milliliter of n- packed. Loosen the topmost few millimeters hexadecane and completely remove the ben- of each adsorbent layer with the end of a zene by evaporation under nitrogen, using metal rod before the addition of the next the special procedure to eliminate benzene layer. Continue packing in this manner until as previously described under ‘‘Organic Sol- all the 14 grams of the adsorbent is added to vents.’’ Quantitatively transfer the residue the tube. Level off the top of the adsorbent with isooctane to a 25–milliliter volumetric by pressing down firmly with a flat glass rod flask and adjust to volume. Determine the or metal plunger to make the depth of the absorbance of the solution in the 5–centi- adsorbent bed approximately 12.5 centi- meter path length cells compared to iso- meters in depth. Turn off the vacuum and re- octane as reference between 250 mμ–400 mμ. move the suction flask. Fit the 500–milliliter Correct for any absorbance derived from the reservoir onto the top of the reagents as determined by carrying out the chromatographic column and prewet the col- procedure without a wax sample. If either umn by passing 100 milliliters of isooctane spectrum shows the characteristic benzene through the column. Adjust the nitrogen peaks in the 250 mμ–260 mμ region, evaporate pressure so that the rate of descent of the the solution to remove benzene by the proce- isooctane coming off of the column is be- dure under ‘‘Organic Solvents.’’ Dissolve the tween 2–3 milliliters per minute. Discontinue residue, transfer quantitatively, and adjust pressure just before the last of the isooctane to volume in isooctane in a 25–milliliter vol- reaches the level of the adsorbent. (CAUTION: umetric flask. Record the absorbance again. Do not allow the liquid level to recede below If the corrected absorbance does not exceed the adsorbent level at any time.) Remove the the limits prescribed in this paragraph (b), reservoir and decant the 5–milliliter iso- the wax meets the ultraviolet absorbance octane concentrate solution onto the column specifications. and with slight pressure again allow the liq- uid level to recede to barely above the ad- (c) Petroleum wax may contain one sorbent level. Rapidly complete the transfer or more of the following adjuvants in similarly with two 5–milliliter portions of amounts not greater than that re- isooctane, swirling the flask repeatedly each time to assure adequate washing of the res- quired to produce their intended effect: idue. Just before the final 5–milliliter wash (1) Antioxidants permitted in food by reaches the top of the adsorbent, add 100 mil- regulations issued in accordance with liliters of isooctane to the reservoir and con- section 409 of the act. tinue the percolation at the 2–3 milliliter per (2) Poly(alkylacrylate) (CAS Reg. No. minute rate. Just before the last of the iso- 27029–57–8), made from long chain (C16- octane reaches the adsorbent level, add 100 C22) alcohols and acrylic acid, or milliliters of 10 percent benzene in isooctane poly(alkylmethacrylate) (CAS Reg. No. to the reservoir and continue the percolation at the aforementioned rate. Just before the 179529–36–3), made from long chain (C18- solvent mixture reaches adsorbent level, add C22) methacrylate esters, having: 25 milliliters of 20 percent benzene in iso- (i) A number average molecular octane to the reservoir and continue the per- weight between 40,000 and 100,000; colation at 2–3 milliliters per minute until (ii) A weight average molecular all this solvent mixture has been removed weight (MWw) to number average mo- from the column. Discard all the elution sol- lecular weight (MWn) ratio (MWw/MWn) vents collected up to this point. Add 300 mil- of not less than 3; and liliters of the acetone-benzene-water mixture to the reservoir and percolate through the (iii) Unreacted alkylacrylate or column to elute the polynuclear compounds. alkylmethacrylate monomer content Collect the eluate in a clean 1–liter sepa- not in excess of 14 percent, as deter- ratory funnel. Allow the column to drain mined by a method entitled ‘‘Method

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for Determining Weight-Average and (a) Synthetic petroleum wax is a Number-Average Molecular Weight and mixture of solid hydrocarbons, par- for Determining Alkylacrylate Mon- affinic in nature, prepared by either omer Content of Poly(alkylacrylate) catalytic polymerization of ethylene or used as Processing Aid in Manufacture copolymerization of ethylene with lin- of Petroleum Wax,’’ which is incor- ear (C3 to C12) alpha-olefins, and refined porated by reference in accordance to meet the specifications prescribed in with 5 U.S.C. 552(a) and 1 CFR part 51. this section. Copies are available from the Office of (b) Synthetic petroleum wax meets Food Additive Safety (HFS–200), Center the ultraviolet absorbance limits of for Food Safety and Applied Nutrition, § 172.886(b) when subjected to the ana- Food and Drug Administration, 5001 lytical procedure described therein. Campus Dr., College Park, MD 20740, (c) Synthetic petroleum wax has a 240–402–1200, or may be examined at the number average molecular weight of Food and Drug Administration’s Main not less than 500 nor greater than 1,200 Library, 10903 New Hampshire Ave., as determined by vapor pressure os- Bldg. 2, Third Floor, Silver Spring, MD mometry. 20993, 301–796–2039 or at the National (d) Synthetic petroleum wax may Archives and Records Administration contain any antioxidant permitted in (NARA). For information on the avail- food by regulations issued in accord- ability of this material at NARA, call ance with section 409 of the act, in an 202–741–6030, or go to: http:// amount not greater than that required www.archives.gov/federallregister/ to produce its intended effect. codeloflfederallregulations/ (e) Synthetic petroleum wax is used ibrllocations.html. Petroleum wax shall or intended for use as follows: contain not more than 1,050 parts per million of poly(alkylacrylate) or Use Limitations poly(alkylmethacrylate) residues as In chewing gum base, as a In accordance with § 172.615 determined by a method entitled masticatory substance. in an amount not to exceed ‘‘Method for Determining Residual good manufacturing prac- Level of Poly(alkylacrylate) in Petro- tice. On cheese and raw fruits and In an amount not to exceed leum Wax,’’ which is incorporated by vegetables as a protective good manufacturing prac- reference. Copies are available from coating. tice. the addresses cited in this paragraph. As a defoamer in food ...... In accordance with § 173.340 (d) Petroleum wax is used or intended of this chapter. for use as follows: [42 FR 14491, Mar. 15, 1977, as amended at 59 Use Limitations FR 10986, Mar. 9, 1994] In chewing gum base, as a mas- In an amount not to ex- ticatory substance. ceed good manufac- § 172.890 Rice bran wax. turing practice. Rice bran wax may be safely used in On cheese and raw fruits and Do. vegetables as a protective coat- food in accordance with the following ing. conditions: As a defoamer in food ...... In accordance with (a) It is the refined wax obtained § 173.340 of this chap- ter. from rice bran and meets the following As a component of microcapsules In accordance with specifications: for spice-flavoring substances. § 172.230 of this chap- ter. Melting point 75 °C to 80 °C. Free fatty acids, maximum 10 percent. Iodine number, maximum 20. [42 FR 14491, Mar. 15, 1977, as amended at 45 Saponification number 75 to 120. FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, (b) It is used or intended for use as May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR follows: 44122, Aug. 13, 1999; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016] Food Limitation in food Use

§ 172.888 Synthetic petroleum wax. Candy ...... 50 p.p.m ...... Coating. Fresh fruits and fresh ...... do ...... Do. Synthetic petroleum wax may be vegetables. safely used in or on foods in accordance Chewing gum ...... 21⁄2 pct ...... Plasticizing with the following conditions: material.

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§ 172.892 Food starch-modified. Limitations Food starch-modified as described in Monosodium orthophosphate ...... Residual phosphate in this section may be safely used in food. food starch-modified not to exceed 0.4 per- The quantity of any substance em- cent calculated as ployed to effect such modification shall . not exceed the amount reasonably re- 1–Octenyl succinic anhydride, not quired to accomplish the intended to exceed 3 percent. 1–Octenyl succinic anhydride, not physical or technical effect, nor exceed to exceed 2 percent, and alu- any limitation prescribed. To insure minum sulfate, not to exceed 2 safe use of the food starch-modified, percent. 1-Octenyl succinic anhydride, not Limited to use as a sta- the label of the food additive container to exceed 3 percent, followed bilizer or emulsifier in shall bear the name of the additive by treatment with a beta-amy- beverages and bev- ‘‘food starch-modified’’ in addition to lase enzyme that is either an erage bases as de- other information required by the Act. approved food additive of is fined in § 170.3(n)(3) of generally recognized as safe. this chapter. Food starch may be modified by treat- Phosphorus oxychloride, not to ment prescribed as follows: exceed 0.1 percent. (a) Food starch may be acid-modified Phosphorus oxychloride, not to Acetyl groups in food exceed 0.1 percent, followed by starch-modified not to by treatment with hydrochloric acid or either acetic anhydride, not to exceed 2.5 percent. sulfuric acid or both. exceed 8 percent, or vinyl ace- (b) Food starch may be bleached by tate, not to exceed 7.5 percent. treatment with one or more of the fol- Sodium trimetaphosphate ...... Residual phosphate in food starch-modified lowing: not to exceed 0.04 percent, calculated as Limitations phosphorus. Sodium tripolyphosphate and so- Residual phosphate in Active oxygen obtained from hy- dium trimetaphosphate. food starch-modified drogen peroxide and/or per- not to exceed 0.4 per- acetic acid, not to exceed 0.45 cent calculated as percent of active oxygen. phosphorus. Ammonium persulfate, not to ex- Succinic anhydride, not to exceed ceed 0.075 percent and sulfur 4 percent. dioxide, not to exceed 0.05 per- Vinyl acetate ...... Acetyl groups in food cent. starch-modified not to , as calcium hypochlorite, The finished food starch- exceed 2.5 percent. not to exceed 0.036 percent of modified is limited to dry starch. use only as a compo- nent of batter for com- (e) Food starch may be etherified by mercially processed treatment with one of the following: foods. Chlorine, as sodium hypochlorite, Limitations not to exceed 0.0082 pound of chlorine per pound of dry starch. , not to exceed 0.6 per- Potassium permanganate, not to Residual cent. exceed 0.2 percent. (calculated as Mn), not Epichlorohydrin, not to exceed to exceed 50 parts per 0.3 percent. million in food starch- Epichlorohydrin, not to exceed Residual propylene modified. 0.1 percent, and propylene chlorohydrin not more Sodium chlorite, not to exceed 0.5 oxide, not to exceed 10 per- than 5 parts per million percent. cent, added in combination or in food starch-modified. in any sequence. (c) Food starch may be oxidized by Epichlorohydrin, not to exceed Do. 0.1 percent, followed by pro- treatment with chlorine, as sodium hy- pylene oxide, not to exceed 25 pochlorite, not to exceed 0.055 pound of percent. chlorine per pound of dry starch. Propylene oxide, not to exceed Do. 25 percent. (d) Food starch may be esterified by treatment with one of the following: (f) Food starch may be esterified and Limitations etherified by treatment with one of the following: Acetic anhydride ...... Acetyl groups in food starch-modified not to Limitations exceed 2.5 percent. Adipic anhydride, not to exceed Do. Acrolein, not to exceed 0.6 per- Acetyl groups in food 0.12 percent, and acetic anhy- cent and vinyl acetate, not to starch-modified not to dride. exceed 7.5 percent. exceed 2.5 percent.

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Limitations (1) Decorticated, partially defatted, cooked, ground cottonseed kernels; or Epichlorohydrin, not to exceed 0.3 Acetyl groups in food percent, and acetic anhydride. starch-modified not to (2) Decorticated, ground cottonseed exceed 2.5 percent. kernels, in a process that utilizes n- Epichlorohydrin, not to exceed 0.3 hexane as an extracting solvent in such percent, and succinic anhy- a way that no more than 60 parts per dride, not to exceed 4 percent. Phosphorus oxychloride, not to Residual propylene million of n-hexane residues and less exceed 0.1 percent, and pro- chlorohydrin not more than 1 percent fat by weight remain in pylene oxide, not to exceed 10 than 5 parts per million the finished product; or percent. in food starch-modi- (3) Glandless cottonseed kernels fied. roasted to attain a temperature of not (g) Food starch may be modified by less than 250 °F in the kernel for not treatment with one of the following: less than 5 minutes for use as a snack food, or in baked goods, or in soft Limitations candy; or (4) Raw glandless cottonseed kernels Chlorine, as sodium hypochlorite, Residual propylene not to exceed 0.055 pound of chlorohydrin not more may be used in hard candy where the chlorine per pound of dry than 5 parts per million kernel temperature during cooking starch; 0.45 percent of active in food starch-modi- will exceed 250 °F for not less than 5 oxygen obtained from hydrogen fied. peroxide; and propylene oxide, minutes. not to exceed 25 percent. (b) The additive is prepared to meet Sodium hydroxide, not to exceed the following specifications: 1 percent. (1) Free gossypol content not to ex- ceed 450 parts per million. (h) Food starch may be modified by a (2) It contains no added arsenic com- combination of the treatments pre- pound and therefore may not exceed a scribed by paragraphs (a), (b), and/or (i) maximum natural background level of of this section and any one of the 0.2 part per million total arsenic, cal- treatments prescribed by paragraph (c), culated as As. (d), (e), (f), or (g) of this section, sub- (c) To assure safe use of the additive, ject to any limitations prescribed by the label of the food additive container the paragraphs named. shall bear, in addition to other infor- (i) Food starch may be modified by mation required by the act, the name treatment with the following enzymes: of the additive as follows: Enzyme Limitations (1) The additive identified in para- graph (a)(1) of this section as ‘‘par- Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be tially defatted, cooked cottonseed generally recognized as safe or approved as flour’’. a food additive for this (2) The additive identified in para- purpose. The resulting graph (a)(2) of this section as ‘‘defatted nonsweet nutritive sac- charide polymer has a cottonseed flour’’. dextrose equivalent of (3) The additive identified in para- less than 20. graph (a)(3) of this section as ‘‘roasted Beta-amylase (E.C. 3.2.1.2). glandless cottonseed kernels’’. Glucoamylase (E.C. 3.2.1.3). Isoamylase (E.C. 3.2.1.68). (4) The additive identified in para- Pullulanase (E.C. 3.2.1.41). graph (a)(4) of this section as ‘‘raw glandless cottonseed kernels for use in [42 FR 14491, Mar. 15, 1977, as amended at 43 cooked hard candy’’. FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, (d) The Food and Drug Administra- 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, tion and the Environmental Protection Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001] Agency have determined that glandless cottonseed kernels permitted for use § 172.894 Modified cottonseed products by this section are a distinct com- intended for human consumption. modity from glanded cottonseed. The food additive modified cotton- seed products may be used for human § 172.896 Dried yeasts. consumption in accordance with the Dried yeast (Saccharomyces cerevisiae following prescribed conditions: and Saccharomyces fragilis) and dried (a) The additive is derived from: torula yeast (Candida utilis) may be

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safely used in food provided the total Use Limitations folic acid content of the yeast does not (4) In cheese spread analogs as Do. exceed 0.04 milligram per gram of yeast a stabilizer and thickener as de- (approximately 0.008 milligram of fined in § 170.3(o)(28) of this pteroyglutamic acid per gram of chapter, or texturizer as defined yeast). in § 170.3(o)(32) of this chapter. (5) In cheese-flavored and sour Do. cream-flavored snack dips as a § 172.898 Bakers yeast glycan. stabilizer and thickener as de- Bakers yeast glycan may be safely fined in § 170.3(o)(28) of this chapter, or texturizer as defined used in food in accordance with the fol- in § 170.3(o)(32) of this chapter. lowing conditions: (a) Bakers yeast glycan is the (e) The label and labeling of the in- comminuted, washed, pasteurized, and gredient shall bear adequate directions dried cell walls of the yeast, Saccharo- to assure that use of the ingredient myces cerevisiae. It is composed prin- complies with this regulation. cipally of long chain carbohydrates, not less than 85 percent on a dry solids [42 FR 14491, Mar. 15, 1977, as amended at 45 basis. The carbohydrate is composed of FR 58836, Sept. 5, 1980] glycan and mannan units in approxi- mately a 2:1 ratio. PART 173—SECONDARY DIRECT (b) The additive meets the following FOOD ADDITIVES PERMITTED IN specifications on a dry weight basis: FOOD FOR HUMAN CONSUMP- Less than 0.4 part per million (ppm) ar- TION senic, 0.13 ppm cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, Subpart A—Polymer Substances and and 10 ppm zinc. Polymer Adjuvants for Food Treatment (c) The viable microbial content of the finished ingredient is: Sec. 173.5 Acrylate-acrylamide resins. (1) Less than 10,000 organisms/gram 173.10 Modified polyacrylamide resin. by aerobic plate count. 173.20 Ion-exchange membranes. (2) Less than 10 yeasts and molds/ 173.21 Perfluorinated ion exchange mem- gram. branes. (3) Negative for Salmonella, E. coli, 173.25 Ion-exchange resins. coagulase positive Staphylococci, Clos- 173.40 Molecular sieve resins. tridium perfringens, Clostridium botu- 173.45 Polymaleic acid and its sodium salt. 173.50 Polyvinylpolypyrrolidone. linum, or any other recognized micro- 173.55 Polyvinylpyrrolidone. bial pathogen or any harmful microbial 173.60 Dimethylamine-epichlorohydrin co- toxin. polymer. (d) The additive is used or intended 173.65 Divinylbenzene copolymer. for use in the following foods when 173.70 Chloromethylated aminated styrene- standards of identity established under divinylbenzene resin. section 401 of the Act do not preclude 173.73 Sodium polyacrylate. 173.75 Sorbitan monooleate. such use:

Use Limitations Subpart B—Enzyme Preparations and Microorganisms (1) In salad dressings as an emul- Not to exceed a con- sifier and emulsifier salt as de- centration of 5 percent 173.110 Amyloglucosidase derived from fined in § 170.3(o)(8) of this of the finished salad Rhizopus niveus. chapter, stabilizer and thickener dressing. 173.115 Alpha-acetolactate decarboxylase (a- as defined in § 170.3(o)(28) of ALDC) enzyme preparation derived from this chapter, or texturizer as de- a recombinant Bacillus subtilis. fined in § 170.3(o)(32) of this chapter. 173.120 Carbohydrase and cellulase derived (2) In frozen dessert analogs as a In an amount not to ex- from Aspergillus niger. stabilizer and thickener as de- ceed good manufac- 173.130 Carbohydrase derived from Rhizopus fined in § 170.3(o)(28) of this turing practice. oryzae. chapter, or texturizer as defined 173.135 Catalase derived from Microccocus in § 170.3(o)(32) of this chapter. lysodeikticus. (3) In sour cream analogs as a Do. 173.140 Esterase-lipase derived from Mucor stabilizer and thickener as de- fined in § 170.3(o)(28) of this miehei. chapter, or texturizer as defined 173.145 Alpha-Galactosidase derived from in § 170.3(o)(32) of this chapter. Mortierella vinaceae var. raffinoseutilizer.

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173.150 Milk-clotting enzymes, microbial. Subpart A—Polymer Substances 173.160 Candida guilliermondii. and Polymer Adjuvants for 173.165 Candida lipolytica. 173.170 Aminoglycoside 3′-phospho Food Treatment transferase II. § 173.5 Acrylate-acrylamide resins. Subpart C—Solvents, Lubricants, Release Acrylate-acrylamide resins may be Agents and Related Substances safely used in food under the following 173.210 Acetone. prescribed conditions: 173.220 1,3–Butylene glycol. (a) The additive consists of one of the 173.228 Ethyl acetate. following: 173.230 Ethylene dichloride. (1) Acrylamide-acrylic acid resin 173.240 Isopropyl alcohol. (hydrolyzed polyacrylamide) is pro- 173.250 Methyl alcohol residues. duced by the polymerization of acryl- 173.255 Methylene chloride. amide with partial hydrolysis, or by 173.270 Hexane. copolymerization of acrylamide and 173.275 Hydrogenated sperm oil. acrylic acid, with the greater part of 173.280 Solvent extraction process for citric the polymer being composed of acryl- acid. amide units. 173.290 Trichloroethylene. (2) Sodium polyacrylate-acrylamide Subpart D—Specific Usage Additives resin is produced by the polymerization and subsequent hydrolysis of acrylo- 173.300 Chlorine dioxide. nitrile in a sodium silicate-sodium hy- 173.310 Boiler water additives. droxide aqueous solution, with the 173.315 Chemicals used in washing or to as- greater part of the polymer being com- sist in the peeling of fruits and vegeta- posed of acrylate units. bles. (b) The additive contains not more 173.320 Chemicals for controlling micro- than 0.05 percent of residual monomer organisms in cane-sugar and beet-sugar mills. calculated as acrylamide. 173.322 Chemicals used in delinting cotton- (c) The additive is used or intended seed. for use as follows: 173.325 Acidified sodium chlorite solutions. (1) The additive identified in para- 173.340 Defoaming agents. graph (a) (1) of this section is used as a 173.342 113 and flocculent in the clarification of beet . sugar juice and liquor or cane sugar 173.345 Chloropentafluoroethane. juice and liquor or corn starch 173.350 product gas. hydrolyzate in an amount not to ex- 173.355 . ceed 5 parts per million by weight of 173.356 Hydrogen peroxide. the juice or 10 parts per million by 173.357 Materials used as fixing agents in weight of the liquor or the corn starch the immobilization of enzyme prepara- tions. hydrolyzate. 173.360 Octafluorocyclobutane. (2) The additive identified in para- 173.368 Ozone. graph (a)(2) of this section is used to 173.370 Peroxyacids. control organic and mineral scale in 173.375 Cetylpyridinium chloride. beet sugar juice and liquor or cane 173.385 Sodium methyl sulfate. sugar juice and liquor in an amount 173.395 Trifluoromethane . not to exceed 2.5 parts per million by 173.400 Dimethyldialkylammonium chlo- weight of the juice or liquor. ride. 173.405 Sodium dodecylbenzenesulfonate. [42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981] AUTHORITY: 21 U.S.C. 321, 342, 348.

SOURCE: 42 FR 14526, Mar. 15, 1977, unless § 173.10 Modified polyacrylamide otherwise noted. resin. Modified polyacrylamide resin may EDITORIAL NOTE: Nomenclature changes to part 173 appear at 61 FR 14482, Apr. 2, 1996, 66 be safely used in food in accordance FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, with the following prescribed condi- 2001, 81 FR 49896, July 29, 2016. tions:

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(a) The modified polyacrylamide § 173.21 Perfluorinated ion exchange resin is produced by the copolymeriza- membranes. tion of acrylamide with not more than Substances identified in paragraph 5–mole percent b-methacrylyloxyethy- (a) of this section may be safely used as ltrimethylammonium methyl sulfate. ion exchange membranes intended for (b) The modified polyacrylamide use in the treatment of bulk quantities resin contains not more than 0.05 per- of liquid food under the following pre- cent residual acrylamide. scribed conditions: (c) The modified polyacrylamide (a) Identity. The membrane is a co- resin is used as a flocculent in the clar- polymer of ethanesulfonyl fluoride, 2- ification of beet or cane sugar juice in [1-[difluoro-[(trifluoro- an amount not exceeding 5 parts per ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- million by weight of the juice. ethoxy]-1,1,2,2,-tetrafluoro-, with tetra- (d) To assure safe use of the additive, fluoroethylene that has been subse- the label and labeling of the additive quently treated to hydrolyze the shall bear, in addition to the other in- sulfonyl fluoride group to the sulfonic formation required by the act, ade- acid. The Chemical Abstracts Service quate directions to assure use in com- name of this polymer is ethanesulfonic pliance with paragraph (c) of this sec- acid, 2-[1-[difluoro-[(trifluoro- tion. ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- ethoxy]-1,1,2,2,-tetrafluoro-, polymer § 173.20 Ion-exchange membranes. with tetrafluoroethane (CAS Reg. No. 31175–20–9). Ion-exchange membranes may be (b) Optional adjuvant substances. The safely used in the processing of food basic polymer identified in paragraph under the following prescribed condi- (a) of this section may contain optional tions: adjuvant substances required in the (a) The ion-exchange membrane is production of such basic polymer. prepared by subjecting a polyethylene These optional adjuvant substances base conforming to § 177.1520 of this may include substances used in accord- chapter to polymerization with styrene ance with § 174.5 of this chapter. until the polystyrene phase of the base (c) Conditions of use. (1) is not less than 16 percent nor more Perfluorinated ion exchange mem- than 30 percent by weight. The base is branes described in paragraph (a) of then modified by reaction with this section may be used in contact chloromethyl methyl ether, and by with all types of liquid foods at tem- subsequent amination with trimethyl- peratures not exceeding 70° (158 °F). amine, dimethylamine, diethylene- (2) Maximum thickness of the copoly- triamine, or . mer membrane is 0.007 inch (0.017 centi- (b) The ion-exchange membrane is meter). manufactured so as to comply with the (3) Perfluorinated ion exchange mem- following extraction limitations when branes shall be maintained in a sani- subjected to the described procedure: tary manner in accordance with cur- Separate square-foot samples of mem- rent good manufacturing practice so as brane weighing approximately 14 grams to prevent microbial adulteration of each are cut into small pieces and food. refluxed for 4 hours in 150 cubic centi- (4) To assure their safe use, meters of the following solvents: Dis- perfluorinated membranes tilled water, 5 percent acetic acid, and shall be thoroughly cleaned prior to 50 percent alcohol. Extraction from their first use in accordance with cur- each sample will not exceed 0.4 percent rent good manufacturing practice. by weight of sample. [59 FR 15623, Apr. 4, 1994] (c) The ion-exchange membrane will be used in the production of grapefruit § 173.25 Ion-exchange resins. juice to adjust the ratio of citric acid Ion-exchange resins may be safely to total solids of the grapefruit juice used in the treatment of food under the produced. following prescribed conditions:

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(a) The ion-exchange resins are pre- aminolyzed with dimethylaminopro- pared in appropriate physical form, and pylamine. consist of one or more of the following: (14) Epichlorohydrin cross-linked (1) Sulfonated copolymer of styrene with ammonia. and divinylbenzene. (15) Sulfonated tetrapolymer of sty- (2) Sulfonated anthracite coal meet- rene, divinylbenzene, acrylonitrile, and ing the requirements of ASTM method methyl acrylate derived from a mix- D388–38, Class I, Group 2, ‘‘Standard ture of monomers containing not more Specifications for Classification of Coal than a total of 2 percent by weight of by Rank,’’ which is incorporated by acrylonitrile and methyl acrylate. reference. Copies are available from (16) Methyl acrylate-divinylbenzene- University Microfilms International, diethylene glycol divinyl ether 300 N. Zeeb Rd., Ann Arbor, MI 48106, or terpolymer containing not less than 3.5 available for inspection at the National percent by weight of divinylbenzene Archives and Records Administration and not more than 0.6 percent by (NARA). For information on the avail- weight of diethylene glycol divinyl ability of this material at NARA, call ether, aminolyzed with dimethyl- 202–741–6030, or go to: http:// aminopropylamine. www.archives.gov/federallregister/ (17) Styrene-divinylbenzene cross- codeloflfederallregulations/ linked copolymer, first ibrllocations.html. chloromethylated then aminated with (3) Sulfite-modified cross-linked phe- dimethylamine and oxidized with hy- nol-, with modification drogen peroxide whereby the resin con- resulting in sulfonic acid groups on tains not more than 15 percent by side chains. weight of vinyl N,N-dimethylbenzyl- (4) Methacrylic acid-divinylbenzene amine-N-oxide and not more than 6.5 copolymer. percent by weight of nitrogen. (5) Cross-linked polystyrene, first (18) Methyl acrylate-divinylbenzene- chloromethylated then aminated with diethylene glycol divinyl ether trimethylamine, dimethylamine, di- terpolymer containing not less than 7 ethylenetriamine, or dimethylethanol- percent by weight of divinylbenzene amine. and not more than 2.3 percent by (6) Diethylenetriamine, triethylene- weight of diethylene glycol divinyl tetramine, or tetraethylenepentamine ether, aminolyzed with dimethyl- cross-linked with epichlorohydrin. aminopropylamine and quaternized (7) Cross-linked phenol-formaldehyde with methyl chloride. activated with one or both of the fol- (19) Epichlorohydrin cross-linked lowing: Triethylene tetramine and with ammonia and then quaternized tetraethylenepentamine. with methyl chloride to contain not (8) Reaction resin of formaldehyde, more than 18 percent strong base ca- acetone, and tetraethylenepentamine. pacity by weight of total exchange ca- (9) Completely hydrolyzed copoly- pacity [Chemical Abstracts Service mers of methyl acrylate and name: Oxirane (chloromethyl)-, poly- divinylbenzene. mer with ammonia, reaction product (10) Completely hydrolyzed with chloromethane; CAS Reg. No. terpolymers of methyl acrylate, 68036–99–7]. divinylbenzene, and acrylonitrile. (20) Regenerated cellulose, cross- (11) Sulfonated terpolymers of sty- linked and alkylated with epichloro- rene, divinylbenzene, and acrylonitrile hydrin and propylene oxide, then sulfo- or methyl acrylate. nated whereby the amount of epi- (12) Methyl acrylate-divinylbenzene chlorohydrin plus propylene oxide em- copolymer containing not less than 2 ployed does not exceed 250 percent by percent by weight of divinylbenzene, weight of the starting quantity of cel- aminolyzed with dimethylaminopro- lulose. pylamine. (b) Ion-exchange resins are used in (13) Methyl acrylate-divinylbenzene the purification of foods, including po- copolymer containing not less than 3.5 table water, to remove undesirable ions percent by weight of divinylbenzene, or to replace less desirable ions with

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one or more of the following: bicarbon- section are exempted from the require- ate, calcium, carbonate, chloride, hy- ments of paragraph (c)(4) of this sec- drogen, hydroxyl, magnesium, potas- tion, but the strongly acidic cation-ex- sium, sodium, and sulfate except that: change resins referred to in paragraphs The ion-exchange resin identified in (b)(1) (i) and (ii) of this section used in paragraph (a)(12) of this section is used the process meet the requirements of only in accordance with paragraph paragraph (c)(4) of this section, except (b)(1) of this section, the ion-exchange for the exemption described in para- resin identified in paragraph (a)(13) of graph (d) of this section. this section is used only in accordance (2) The ion-exchange resins identified with paragraph (b)(2) of this section, in paragraphs (a) (13) and (16) of this the resin identified in paragraph (a)(16) section are used to treat water and of this section is used only in accord- aqueous food only of the types identi- ance with paragraph (b)(1) or (b)(2) of fied under Categories I, II, and VI-B in this section, the ion-exchange resin table 1 of § 176.170(c) of this chapter: identified in paragraph (a)(17) of this Provided, That the temperature of the section is used only in accordance with water or food passing through the resin paragraph (b)(3) of this section, the beds is maintained at 50 °C or less and ion-exchange resin identified in para- the flow rate of the water or food pass- graph (a)(18) of this section is used only ing through the beds is not less than 0.5 in accordance with paragraph (b)(4) of gallon per cubic foot per minute. this section, and the ion-exchange (i) The ion-exchange resin identified resin identified in paragraph (a)(20) of in paragraph (a)(13) of this section is this section is used only in accordance used to treat water and aqueous food with paragraphs (b)(5) and (d) of this only of the types identified under cat- section. egories I, II, and VI-B in Table 1 of (1) The ion-exchange resins identified § 176.170(c) of this chapter: Provided, in paragraphs (a) (12) and (16) of this That the temperature of the water or section are used to treat water for use food passing through the resin bed is in the manufacture of distilled alco- maintained at 50 °C or less and the flow holic beverages, subject to the fol- rate of the water or food passing lowing conditions: through the bed is not less than 0.5 gal- (i) The water is subjected to treat- lon per cubic foot per minute. ment through a mixed bed consisting of (ii) The ion-exchange resin identified one of the resins identified in para- in paragraph (a)(16) of this section is graph (a) (12) or (16) of this section and used to treat water and aqueous food one of the strongly acidic cation-ex- only of the types identified under cat- change resins in the hydrogen form egories I, II, and VI-B in Table 1 of identified in paragraphs (a) (1), (2), and § 176.170(c) of this chapter, Provided, (11) of this section; or that either: (ii) The water is first subjected to (A) The temperature of the water or one of the resins identified in para- food passing through the resin bed is graph (a) (12) or (16) of this section and maintained at 50 °C or less and the flow is subsequently subjected to treatment rate of the water or food passing through a bed of or through the bed is not less than 0.5 gal- one of the strongly acidic cation-ex- lon per cubic foot per minute; or change resins in the hydrogen form (B) Extracts of the resin will be found identified in paragraphs (a) (1), (2), and to contain no more than 1 milligram/ (11) of this section. kilogram dimethylaminopropylamine (iii) The temperature of the water in each of the food simulants, distilled passing through the resin beds identi- water and 10 percent ethanol, when, fied in paragraphs (b)(1) (i) and (ii) of following washing and pretreatment of this section is maintained at 30 °C or the resin in accordance with less, and the flow rate of the water § 173.25(c)(1), the resin is subjected to passing through the beds is not less the following test under conditions than 2 gallons per cubic foot per simulating the actual temperature and minute. flow rate of use: ‘‘The Determination of (iv) The ion-exchange resins identi- 3-Dimethylaminopropylamine in Food fied in paragraph (a) (12) or (16) of this Simulating Extracts of Ion Exchange

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Resins,’’ February 4, 1998, which is in- this section, the pH range for the resin corporated by reference in accordance shall be no less than 2 and no more with 5 U.S.C. 552(a) and 1 CFR part 51. than 10, and the temperatures of water Copies are available from the Office of and food passing through the resin Food Additive Safety (HFS–200), Center shall not exceed 50 °C. for Food Safety and Applied Nutrition, (c) To insure safe use of ion-exchange Food and Drug Administration, 5001 resins, each ion-exchange resin will be: Campus Dr., College Park, MD 20740, (1) Subjected to pre-use treatment by 240–402–1200, or may be examined at the the manufacturer and/or the user in ac- Food and Drug Administration’s Main cordance with the manufacturer’s di- Library, 10903 New Hampshire Ave., rections prescribed on the label or la- Bldg. 2, Third Floor, Silver Spring, MD beling accompanying the resins, to 20993, 301–796–2039, or at the National guarantee a food-grade purity of ion- Archives and Records Administration exchange resins, in accordance with (NARA). For information on the avail- good manufacturing practice. ability of this material at NARA, call (2) Accompanied by label or labeling 202–741–6030, or go to: http:// to include directions for use consistent www.archives.gov/federallregister/ with the intended functional purpose of codeloflfederallregulations/ the resin. ibrllocations.html. (3) Used in compliance with the label (3) The ion-exchange resin identified or labeling required by paragraph (c)(2) in paragraph (a)(17) of this section is of this section. used only for industrial application to (4) Found to result in no more than 1 treat bulk quantities of aqueous food, part per million of organic extractives including potable water, or for treat- obtained with each of the named sol- ment of municipal water supplies, sub- vents, distilled water, 15 percent alco- ject to the condition that the tempera- hol, and 5 percent acetic acid when, ture of the food or water passing having been washed and otherwise through the resin bed is maintained at treated in accordance with the manu- 25 °C or less and the flow rate of the facturer’s directions for preparing food or water passing through the bed them for use with food, the ion-ex- is not less than 2 gallons per cubic foot change resin is subjected to the fol- per minute. lowing test: Using a separate ion-ex- (4) The ion-exchange resin identified change column for each solvent, pre- in paragraph (a)(18) of this section is pare columns using 50 milliliters of the used to treat aqueous sugar solutions ready to use ion-exchange resin that is subject to the condition that the tem- to be tested. While maintaining the perature of the sugar solution passing highest temperature that will be en- through the resin bed is maintained at countered in use pass through these 82 °C (179.6 °F) or less and the flow rate beds at the rate of 350–450 milliliters of the sugar solution passing through per hour the three test solvents dis- the bed is not less than 46.8 liters per tilled water, 15 percent (by volume) cubic meter (0.35 gallon per cubic foot) ethyl alcohol, and 5 percent (by weight) of resin bed volume per minute. acetic acid. The first liter of effluent (5) The ion-exchange resin identified from each solvent is discarded, then in paragraph (a)(20) of this section is the next 2 liters are used to determine limited to use in aqueous process organic extractives. The 2-liter sample streams for the isolation and purifi- is carefully evaporated to constant cation of protein concentrates and iso- weight at 105 °C; this is total extrac- lates under the following conditions: tives. This residue is fired in a muffle (i) For resins that comply with the furnace at 850 °C to constant weight; requirements in paragraph (d)(2)(i) of this is ash. Total extractives, minus this section, the pH range for the resin ash equals the organic extractives. If shall be no less than 3.5 and no more the organic extractives are greater than 9, and the temperatures of water than 1 part per million of the solvent and food passing through the resin bed used, a blank should be run on the sol- shall not exceed 25 °C. vent and a correction should be made (ii) For resins that comply with the by subtracting the total extractives ob- requirements in paragraph (d)(2)(ii) of tained with the blank from the total

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extractives obtained in the resin test. acid. The resin shall be found to result The solvents used are to be made as in no more than 25 parts per million of follows: organic extractives obtained with each Distilled water (de-ionized water is distilled). of the following solvents: Distilled 15 percent ethyl alcohol made by mixing 15 water; 15 percent alcohol; and hydro- volumes of absolute ethyl alcohol A.C.S. chloric acid, pH 2. Blanks should be run reagent grade, with 85 volumes of distilled for each of the solvents, and correc- de-ionized water. tions should be made by subtracting 5 percent acetic acid made by mixing 5 parts the total extractives obtained with the by weight of A.C.S. reagent grade glacial blank from the total extractives ob- acetic acid with 95 parts by weight of dis- tilled de-ionized water. tained in the resin test. (e) Acrylonitrile copolymers identi- In addition to the organic extractives fied in this section shall comply with limitation prescribed in this para- the provisions of § 180.22 of this chap- graph, the ion-exchange resin identi- ter. fied in paragraph (a)(17) of this section, when extracted with each of the named [42 FR 14526, Mar. 15, 1977, as amended at 46 solvents, distilled water, 50 percent al- FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, cohol, and 5 percent acetic acid, will be Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR found to result in not more than 7 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999; parts per million of nitrogen extrac- 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, tives (calculated as nitrogen) when the 2016] resin in the free-base form is subjected to the following test immediately be- § 173.40 Molecular sieve resins. fore each use: Using a separate 1–inch Molecular sieve resins may be safely diameter glass ion-exchange column used in the processing of food under the for each solvent, prepare each column following prescribed conditions: using 100 milliliters of ready to use ion- (a) The molecular sieve resins consist exchange resin that is to be tested. of purified dextran having an average With the bottom outlet closed, fill each molecular weight of 40,000, cross-linked ion-exchange column with one of the with epichlorohydrin in a ratio of 1 three solvents at a temperature of 25 °C part of dextran to 10 parts of until the solvent level is even with the epichlorohydrin, to give a stable three top of the resin bed. Seal each column dimensional structure. The resins have at the top and bottom and store in a vertical position at a temperature of 25 a pore size of 2.0 to 3.0 milliliters per °C. After 96 hours, open the top of each gram of dry resin (expressed in terms column, drain the solvent into a collec- of water regain), and a particle size of tion vessel, and analyze each drained 10 to 300 microns. solvent and a solvent blank for nitro- (b) The molecular sieve resins are gen by a standard micro-Kjeldahl thoroughly washed with potable water method. prior to their first use in contact with (d)(1) The ion-exchange resins identi- food. fied in paragraphs (a)(1), (a)(2), (a)(11), (c) Molecular sieve resins are used as and (a)(15) of this section are exempted the gel filtration media in the final pu- from the acetic acid extraction re- rification of partially delactosed whey. quirement of paragraph (c)(4) of this The gel bed shall be maintained in a section. sanitary manner in accordance with (2) The ion-exchange resin identified good manufacturing practice so as to in paragraph (a)(20) of this section prevent microbial build-up on the bed shall comply either with: and adulteration of the product. (i) The extraction requirement in paragraph (c)(4) of this section by using § 173.45 Polymaleic acid and its so- dilute sulfuric acid, pH 3.5 as a sub- dium salt. stitute for acetic acid; or Polymaleic acid (CAS Reg. No. 26099– (ii) The extraction requirement in 09–2) and its sodium salt (CAS Reg. No. paragraph (c)(4) of this section by using 70247–90–4) may be safely used in food reagent grade hydrochloric acid, di- in accordance with the following pre- luted to pH 2, as a substitute for acetic scribed conditions:

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(a) The additives have a weight-aver- § 173.50 Polyvinylpolypyrrolidone. age molecular weight in the range of 540 to 850 and a number-average molec- The food additive polyvinylpoly- ular weight in the range of 520 to 650, pyrrolidone may be safely used in ac- calculated as the acid. Molecular cordance with the following prescribed weights shall be determined by a meth- conditions: od entitled ‘‘Determination of Molec- (a) The additive is a homopolymer of ular Weight Distribution of purified vinylpyrrolidone catalytically Poly(Maleic) Acid,’’ March 17, 1992, pro- produced under conditions producing duced by Ciba-Geigy, Inc., Seven Sky- polymerization and cross-linking such line Dr., Hawthorne, NY 10532–2188, that an insoluble polymer is produced. which is incorporated by reference in (b) The food additive is so processed accordance with 5 U.S.C. 552(a) and 1 that when the finished polymer is CFR part 51. Copies are available from refluxed for 3 hours with water, 5 per- the Office of Food Additive Safety cent acetic acid, and 50 percent alco- (HFS–200), Center for Food Safety and hol, no more than 50 parts per million Applied Nutrition, Food and Drug Ad- of extractables is obtained with each ministration, 5001 Campus Dr., College solvent. Park, MD 20740, 240–402–1200, or are available for inspection at the Food (c) It is used or intended for use as a and Drug Administration’s Main Li- clarifying agent in beverages and vin- brary, 10903 New Hampshire Ave., Bldg. egar, followed by removal with filtra- 2, Third Floor, Silver Spring, MD 20993, tion. 301–796–2039, or at the National Ar- chives and Records Administration § 173.55 Polyvinylpyrrolidone. (NARA). For information on the avail- The food additive polyvinylpyrroli- ability of this material at NARA, call done may be safely used in accordance 202–741–6030, or go to: http:// with the following prescribed condi- www.archives.gov/federallregister/ tions: codeloflfederallregulations/ (a) The additive is a polymer of puri- ibrllocations.html. fied vinylpyrrolidone catalytically pro- (b) The additives may be used, indi- duced, having an average molecular vidually or together, in the processing weight of 40,000 and a maximum of beet sugar juice and liquor or of cane sugar juice and liquor to control min- unsaturation of 1 percent, calculated as eral scale. the monomer, except that the (c) The additives are to be used so polyvinylpyrrolidone used in beer is that the amount of either or both addi- that having an average molecular tives does not exceed 4 parts per mil- weight of 360,000 and a maximum lion (calculated as the acid) by weight unsaturation of 1 percent, calculated as of the beet or cane sugar juice or liquor the monomer. process stream. (b) The additive is used or intended [51 FR 5315, Feb. 13, 1986, as amended at 61 for use in foods as follows: FR 386, Jan. 5, 1996; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016]

Food Limitations

Beer ...... As a clarifying agent, at a residual level not to exceed 10 parts per million. Flavor concentrates in tablet form ...... As a tableting adjuvent in an amount not to exceed good manufacturing practice. Nonnutritive sweeteners in concentrated liquid As a stabilizer, bodying agent, and dispersant, in an amount not to exceed form. good manufacturing practice. Nonnutritive sweeteners in tablet form ...... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in liquid form .... As a stabilizer, bodying agent, and dispersant, in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in tablet form .... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vinegar ...... As a clarifying agent, at a residual level not to exceed 40 parts per million. Wine ...... As a clarifying agent, at a residual level not to exceed 60 parts per million.

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§ 173.60 Dimethylamine- liquor refining at a concentration not epichlorohydrin copolymer. to exceed 150 parts per million of co- Dimethylamine-epichlorohydrin co- polymer by weight of sugar solids. polymer (CAS Reg. No. 25988–97–0) may (d) To assure safe use of the additive, be safely used in food in accordance the label and labeling of the additive with the following prescribed condi- shall bear, in addition to other infor- tions: mation required by the Act, adequate (a) The food additive is produced by directions to assure use in compliance copolymerization of dimethylamine with paragraph (c) of this section. and epichlorohydrin in which not more [48 FR 37614, Aug. 19, 1983, as amended at 54 than 5 mole-percent of dimethylamine FR 24897, June 12, 1989] may be replaced by an equimolar amount of ethylenediamine, and in § 173.65 Divinylbenzene copolymer. which the mole ratio of total amine to epichlorohydrin is approximately 1:1. Divinylbenzene copolymer may be (b) The additive meets the following used for the removal of organic sub- specifications: stances from aqueous foods under the (1) The nitrogen content of the co- following prescribed conditions: polymer is 9.4 to 10.8 weight percent on (a) The copolymer is prepared in ap- a dry basis. propriate physical form and is derived (2) A 50-percent-by-weight aqueous by the polymerization of a grade of solution of the copolymer has a min- divinylbenzene which comprises at imum viscosity of 175 centipoises at 25 least 79 weight-percent divinylbenzene, °C as determined by LVT-series Brook- 15 to 20 weight-percent ethylvinyl- field viscometer using a No. 2 spindle benzene, and no more than 4 weight- at 60 RPM (or by another equivalent percent nonpolymerizable impurities. method). (b) In accordance with the manufac- (3) The additive contains not more turer’s directions, the copolymer de- than 1,000 parts per million of 1,3- scribed in paragraph (a) of this section dichloro-2-propanol and not more than is subjected to pre-use extraction with 10 parts per million epichlorohydrin. a water soluble alcohol until the level The epichlorohydrin and 1,3-dichloro-2- of divinylbenzene in the extract is less propanol content is determined by an than 50 parts per billion as determined analytical method entitled ‘‘The Deter- by a method titled, ‘‘The Determina- mination of Epichlorohydrin and 1,3- tion of Divinylbenzene in Alcohol Ex- Dichloro-2-Propanol in Dimethyl- tracts of Amberlite XAD–4,’’ which is amine-Epichlorohydrin Copolymer,’’ incorporated by reference. Copies of which is incorporated by reference. this method are available from the Copies are available from the Center Center for Food Safety and Applied Nu- for Food Safety and Applied Nutrition trition (HFS–200), Food and Drug Ad- (HFS–200), Food and Drug Administra- ministration, 5001 Campus Dr., College tion, 5001 Campus Dr., College Park, Park, MD 20740, or available for inspec- MD 20740, or available for inspection at tion at the National Archives and the National Archives and Records Ad- Records Administration (NARA). For ministration (NARA). For information information on the availability of this on the availability of this material at material at NARA, call 202–741–6030, or NARA, call 202–741–6030, or go to: http:// go to: http://www.archives.gov/ www.archives.gov/federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. The copolymer is (4) Heavy metals (as Pb), 2 parts per then treated with water according to million maximum. the manufacturer’s recommendation to (5) Arsenic (as As), 2 parts per million remove the extraction solvent to guar- maximum. antee a food-grade purity of the resin (c) The food additive is used as a de- at the time of use, in accordance with colorizing agent and/or flocculant in current good manufacturing practice. the clarification of refinery sugar liq- (c) The temperature of the aqueous uors and juices. It is added only at the food stream contacting the polymer is defecation/clarification stage of sugar maintained at 79.4 °C (175 °F) or less.

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(d) The copolymer may be used in entitled ‘‘Determination of Weight Av- contact with food only of Types I, II, erage and Number Average Molecular and VI-B (excluding carbonated bev- Weight of Sodium Polyacrylate,’’ erages) described in table 1 of para- which is incorporated by reference in graph (c) of § 176.170 of this chapter. accordance with 5 U.S.C. 552(a), the ad- ditive has— [50 FR 61, Jan. 2, 1985] (1) A weight average molecular § 173.70 Chloromethylated aminated weight of 2,000 to 2,300; and styrene-divinylbenzene resin. (2) A weight average molecular Chloromethylated aminated styrene- weight to number average molecular divinylbenzene copolymer (CAS Reg. weight ratio of not more than 1.3. Cop- No. 60177–39–1) may be safely used in ies of the method are available from food in accordance with the following the Center for Food Safety and Applied prescribed conditions: Nutrition (HFS–200), Food and Drug (a) The additive is an aqueous disper- Administration, 5001 Campus Dr., Col- sion of styrene-divinylbenzene copoly- lege Park, MD 20740, or available for in- mers, first chloromethylated then spection at the National Archives and aminated with trimethylamine, having Records Administration (NARA). For an average particle size of not more information on the availability of this than 2.0 microns. material at NARA, call 202–741–6030, or (b) The additive shall contain no go to: http://www.archives.gov/ more than 3.0 percent nonvolatile, federallregister/ soluble extractives when tested as fol- codeloflfederallregulations/ lows: One hundred grams of the addi- ibrllocations.html. tive is centrifuged at 17,000 r/min for 2 (b) The additive is used to control hours. The resulting clear supernatant mineral scale during the evaporation of is removed from the compacted solids beet sugar juice or cane sugar juice in and concentrated to approximately 10 the production of sugar in an amount grams on a steam bath. The 10-gram not to exceed 3.6 parts per million by sample is again centrifuged at 17,000 r/ weight of the raw juice. min for 2 hours to remove any residual [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, insoluble material. The supernatant 1988] from the second centrifugation is then removed from any compacted solids § 173.75 Sorbitan monooleate. and dried to constant residual weight Sorbitan monooleate may be safely using a steam bath. The percent non- used in accordance with the following volatile solubles is obtained by divid- prescribed conditions: ing the weight of the dried residue by the weight of the solids in the original (a) The additive is produced by the resin dispersion. esterification of sorbitol with commer- (c) The additive is used as a decol- cial oleic acid. orizing and clarification agent for (b) It meets the following specifica- treatment of refinery sugar liquors and tions: juices at levels not to exceed 500 parts (1) Saponification number, 145–160. of additive solids per million parts of (2) Hydroxyl number, 193–210. sugar solids. (c) The additive is used or intended for use as follows: [50 FR 29209, July 18, 1985] (1) As an emulsifier in polymer dis- § 173.73 Sodium polyacrylate. persions that are used in the clarifica- tion of cane or beet sugar juice or liq- Sodium polyacrylate (CAS Reg. No. uor in an amount not to exceed 7.5 per- 9003–04–7) may be safely used in food in cent by weight in the final polymer dis- accordance with the following pre- persion. scribed conditions: (2) The additive is used in an amount (a) The additive is produced by the not to exceed 0.70 part per million in polymerization of acrylic acid and sub- sugar juice and 1.4 parts per million in sequent hydrolysis of the polyacrylic sugar liquor. acid with an aqueous sodium hydroxide solution. As determined by a method [51 FR 11720, Apr. 7, 1986]

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Subpart B—Enzyme Preparations the Federal Register approves this in- and Microorganisms corporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. § 173.110 Amyloglucosidase derived Copies may be obtained from the Na- from Rhizopus niveus. tional Academy Press, 2101 Constitu- Amyloglucosidase enzyme product, tion Ave. NW., Washington, DC 20055, consisting of enzyme derived from or may be examined at the Center for Rhizopus niveus, and diatomaceous sili- Food Safety and Applied Nutrition, ca as a carrier, may be safely used in 5001 Campus Dr., College Park, MD food in accordance with the following 20740, or at the National Archives and conditions: Records Administration (NARA). For (a) Rhizopus niveus is classified as fol- information on the availability of this lows: Class, Phycomycetes; order, material at NARA, call 202–741–6030, or go to: Mucorales; family, Mucoraceae; genus, http://www.archives.gov/ federal register/ Rhizopus; species, niveus. l code of federal regulations/ (b) The strain of Rhizopus niveus is l l l nonpathogenic and nontoxic in man or ibrllocations.html. (c) The additive is used in an amount other animals. not in excess of the minimum required (c) The enzyme is produced by a proc- to produce its intended effect as a proc- ess which completely removes the or- essing aid in the production of alco- ganism Rhizopus niveus from the holic malt beverages and distilled liq- amyloglucosidase. uors. (d) The additive is used or intended for use for degrading gelatinized starch [66 FR 27022, May 16, 2001] into constituent sugars, in the produc- tion of distilled spirits and vinegar. § 173.120 Carbohydrase and cellulase (e) The additive is used at a level not derived from Aspergillus niger. to exceed 0.1 percent by weight of the Carbohydrase and cellulase enzyme gelatinized starch. preparation derived from Aspergillus niger may be safely used in food in ac- § 173.115 Alpha-acetolactate cordance with the following prescribed decarboxylase (α-ALDC) enzyme conditions: preparation derived from a recom- (a) Aspergillus niger is classified as binant Bacillus subtilis. follows: Class, Deuteromycetes; order, The food additive alpha-acetolactate Moniliales; family, Moniliaceae; genus, decarboxylase (a-ALDC) enzyme prepa- Aspergillus; species, niger. ration, may be safely used in accord- (b) The strain of Aspergillus niger is ance with the following conditions: nonpathogenic and nontoxic in man or (a) The food additive is the enzyme other animals. preparation derived from a modified (c) The additive is produced by a Bacillus subtilis strain that contains the process that completely removes the gene coding for a-ALDC from Bacillus organism Aspergillus niger from the brevis. carbohydrase and cellulase enzyme (b)(1) The manufacturer produces the product. additive from a pure culture fermenta- (d) The additive is used or intended tion of a strain of Bacillus subtilis that for use as follows: is nonpathogenic and nontoxigenic in (1) For removal of visceral mass (bel- man or other animals. lies) in clam processing. (2) The manufacturer may stabilize (2) As an aid in the removal of the the enzyme preparation with shell from the edible tissue in shrimp glutaraldehyde or with other suitable processing. approved food additives or generally (e) The additive is used in an amount recognized as safe substances. not in excess of the minimum required (3) The enzyme preparation must to produce its intended effect. meet the general and additional re- quirements for enzyme preparations in § 173.130 Carbohydrase derived from the Food Chemicals Codex, 4th ed., 1996, Rhizopus oryzae. pp. 133–134, which is incorporated by Carbohydrase from Rhizopus oryzae reference. The Director of the Office of may be safely used in the production of

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dextrose from starch in accordance genus, Mucor; species, miehei; variety with the following prescribed condi- Cooney et Emerson. tions: (b) The strain of Mucor miehei var. (a) Rhizopus oryzae is classified as fol- Cooney et Emerson is nonpathogenic and lows: Class, Phycomycetes; order, nontoxic in man or other animals. Mucorales; family, Mucoraceae; genus, (c) The enzyme is produced by a proc- Rhizopus; species, Rhizopus oryzae. ess which completely removes the or- (b) The strain of Rhizopus oryzae is ganism Mucor miehei var. Cooney et nonpathogenic and nontoxic. Emerson from the esterase-lipase. (c) The carbohydrase is produced (d) The enzyme is used as a flavor under controlled conditions to main- enhancer as defined in § 170.3(o)(12). tain nonpathogenicity and nontoxicity, (e) The enzyme is used at levels not including the absence of aflatoxin. to exceed current good manufacturing practice in the following food cat- (d) The carbohydrase is produced by a egories: cheeses as defined in process which completely removes the § 170.3(n)(5) of this chapter; fat and oils organism Rhizopus oryzae from the as defined in § 170.(3)(n)(12) of this chap- carbohydrase product. ter; and milk products as defined in (e) The carbohydrase is maintained § 170.(3)(n)(31) of this chapter. Use of under refrigeration from production to this food ingredient is limited to use and is labeled to include the neces- nonstandarized foods and those foods sity of refrigerated storage. for which the relevant standards of identity permit such use. § 173.135 Catalase derived from Micro- coccus lysodeikticus. (f) The enzyme is used in the min- imum amount required to produce its Bacterial catalase derived from limited technical effect. Micrococcus lysodeikticus by a pure cul- ture fermentation process may be safe- [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, ly used in destroying and removing hy- 1983] drogen peroxide used in the manufac- § 173.145 Alpha-Galactosidase derived ture of cheese, in accordance with the from Mortierella vinaceae var. following conditions. raffinoseutilizer. (a) The organism Micrococcus The food additive alpha-galactosidase lysodeikticus from which the bacterial and parent mycelial microorganism catalase is to be derived is dem- Mortierella vinaceae var. raffinoseutilizer onstrated to be nontoxic and nonpatho- may be safely used in food in accord- genic. ance with the following conditions: (b) The organism Micrococcus (a) The food additive is the enzyme lysodeikticus is removed from the bac- alpha-galactosidase and the mycelia of terial catalase prior to use of the bac- the microorganism Mortierella vinaceae terial catalase. var. raffinoseutilizer which produces the (c) The bacterial catalase is used in enzyme. an amount not in excess of the min- (b) The nonpathogenic microorga- imum required to produce its intended nism matches American Type Culture effect. Collection (ATCC) No. 20034, 1 and is classified as follows: § 173.140 Esterase-lipase derived from Mucor miehei. Class: Phycomycetes. Order: Mucorales. Esterase-lipase enzyme, consisting of Family: Mortierellaceae. enzyme derived from Mucor miehei var. Genus: Mortierella. Cooney et Emerson by a pure culture fer- Species: vinaceae. mentation process, with maltodextrin Variety: raffinoseutilizer. or sweet whey as a carrier, may be (c) The additive is used or intended safely used in food in accordance with for use in the production of sugar (su- the following conditions: crose) from sugar beets by addition as (a) Mucor miehei var. Cooney et Emer- son is classified as follows: Class, 1 Available from: American Type Culture Phycomycetes; subclass, Zygomycetes; Collection, 12301 Parklawn Drive, Rockville, order, Mucorales; family, Mucoraceae; MD 20852.

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mycelial pellets to the molasses to in- (d) The additive is used in an amount crease the yield of sucrose, followed by not in excess of the minimum required removal of the spent mycelial pellets to produce its intended effect in the by filtration. production of those cheeses for which (d) The enzyme removal is such that it is permitted by standards of identity there are no enzyme or mycelial resi- established pursuant to section 401 of dues remaining in the finished sucrose. the Act. [42 FR 14526, Mar. 15, 1977, as amended at 54 [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. FR 24897, June 12, 1989] 28, 1977, as amended at 62 FR 59284, Nov. 3, 1997] § 173.150 Milk-clotting enzymes, micro- bial. § 173.160 Candida guilliermondii. Milk-clotting enzyme produced by The food additive Candida pure-culture fermentation process may guilliermondii may be safely used as the be safely used in the production of organism for fermentation production cheese in accordance with the fol- of citric acid in accordance with the lowing prescribed conditions: following conditions: (a) Milk-clotting enzyme is derived (a) The food additive is the enzyme from one of the following organisms by system of the viable organism Candida a pure-culture fermentation process: guilliermondii and its concomitant me- (1) Endothia parasitica classified as tabolites produced during the fer- follows: Class, Ascomycetes; order, mentation process. Sphaeriales; family, Diaporthacesae; (b)(1) The nonpathogenic and genus, Endothia; species, parasitica. nontoxicogenic organism descending (2) Bacillus cereus classified as fol- from strain, American Type Culture lows: Class, Schizomycetes; order, Collection (ATCC) No. 20474, 1 is classi- Eubacteriales; family, Bacillaceae; fied as follows: genus, Bacillus; species, cereus (Frankland and Frankland). Class: Deuteromycetes. (3) Mucor pusillus Lindt classified as Order: Moniliales. follows: Class, Phycomycetes; subclass, Family: Cryptococcaceae. Zygomycetes; order, Mucorales; fam- Genus: Candida. Species: guilliermondii. ily, Mucoraceae; genus, Mucor; species, Variety: guilliermondii. pusillus; variety, Lindt. (4) Mucor miehei Cooney et Emerson (2) The toxonomic characteristics of classified as follows: Class, the reference culture strain ATCC No. Phycomycetes; subclass, Zygomycetes; 20474 agree in the essentials with the order, Mucorales; family, Mucoraceae; standard description for Candida genus, Mucor; species, miehei; variety, guilliermondii variety guilliermondii list- Cooney et Emerson. ed in ‘‘The Yeasts—A Toxonomic (5) Aspergillus oryzae modified by re- Study;’’ 2d Ed. (1970), by Jacomina combinant deoxyribonucleic (DNA) Lodder, which is incorporated by ref- techniques to contain the gene coding erence. Copies are available from the for aspartic proteinase from Center for Food Safety and Applied Nu- Rhizomucor miehei var. Cooney et Emer- trition (HFS–200), Food and Drug Ad- son as defined in paragraph (a)(4) of ministration, 5001 Campus Dr., College this section, and classified as follows: Park, MD 20740, or available for inspec- Class, Blastodeuteromycetes tion at the National Archives and (Hyphomycetes); order, Phialidales Records Administration (NARA). For (Moniliales); genus, Aspergillus; species information on the availability of this oryzae. material at NARA, call 202–741–6030, or (b) The strains of organism identified go to: http://www.archives.gov/ in paragraph (a) of this section are federallregister/ nonpathogenic and nontoxic in man or codeloflfederallregulations/ other animals. ibrllocations.html. (c) The additive is produced by a process that completely removes the 1 Available from: American Type Culture generating organism from the milk- Collection, 12301 Parklawn Drive, Rockville, clotting enzyme product. MD 20852.

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(c)(1) The additive is used or intended standard description for Candida for use as a pure culture in the fer- lipolytica variety lipolytica listed in mentation process for the production ‘‘The Yeasts—A Toxonomic Study,’’ 2d of citric acid using an acceptable aque- Ed. (1970), by Jacomina Lodder, which ous carbohydrate substrate. is incorporated by reference. Copies are (2) The organism Candida available from the Center for Food quilliermondii is made nonviable and is Safety and Applied Nutrition (HFS– completely removed from the citric 200), Food and Drug Administration, acid during the recovery and purifi- 5001 Campus Dr., College Park, MD cation process. 20740, or available for inspection at the (d) The additive is so used that the citric acid produced conforms to the National Archives and Records Admin- specifications of the Food Chemicals istration (NARA). For information on Codex, 7th ed. (2010), pp. 226–227, which the availability of this material at is incorporated by reference. The Di- NARA, call 202–741–6030, or go to: http:// rector of the Office of the Federal Reg- www.archives.gov/federallregister/ ister approves this incorporation by codeloflfederallregulations/ reference in accordance with 5 U.S.C. ibrllocations.html. 552(a) and 1 CFR part 51. You may ob- (c) The additive is used or intended tain copies from the United States for use as a pure culture in the fer- Pharmacopeial Convention, 12601 mentation process for the production Twinbrook Pkwy., Rockville, MD 20852 of citric acid from purified normal (Internet address http://www.usp.org). . Copies may be examined at the Food (d) The additive is so used that the and Drug Administration’s Main Li- citric acid produced conforms to the brary, 10903 New Hampshire Ave., Bldg. specifications of the Food Chemicals 2, Third Floor, Silver Spring, MD 20993, Codex, 7th ed. (2010), pp. 226–227, which 301–796–2039, or at the National Ar- chives and Records Administration is incorporated by reference. The Di- (NARA). For information on the avail- rector of the Office of the Federal Reg- ability of this material at NARA, call ister approves this incorporation by 202–741–6030 or go to: http:// reference in accordance with 5 U.S.C. www.archives.gov/federal-register/cfr/ibr- 552(a) and 1 CFR part 51. You may ob- locations.html. tain copies from the United States Pharmacopeial Convention, 12601 [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, Twinbrook Pkwy., Rockville, MD 20852 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, (Internet address http://www.usp.org). Nov. 29, 2013] Copies may be examined at the Food and Drug Administration’s Main Li- § 173.165 Candida lipolytica. brary, 10903 New Hampshire Ave., Bldg. The food additive Candida lipolytica 2, Third Floor, Silver Spring, MD 20993, may be safely used as the organism for 301–796–2039, or at the National Ar- fermentation production of citric acid chives and Records Administration in accordance with the following condi- (NARA). For information on the avail- tions: ability of this material at NARA, call (a) The food additive is the enzyme 202–741–6030 or go to: http:// system of the organism Candida www.archives.gov/federal-register/cfr/ibr- lipolytica and its concimitant metabo- locations.html. The additive meets the lites produced during the fermentation following ultraviolet absorbance limits process. when subjected to the analytical proce- (b)(1) The nonpathogenic organism is dure described in this paragraph: classified as follows:

Class: Deuteromycetes. Ultraviolet absorbance per centimeter path Maximum Order: Moniliales. length Family: Cryptococcaceae. 280 to 289 millimicrons ...... 0.25 Genus: Candida. 290 to 299 millimicrons ...... 0.20 Species: lipolytica. 300 to 359 millimicrons ...... 0.13 (2) The taxonomic characteristics of 360 to 400 millimicrons ...... 0.03 the culture agree in essential with the

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ANALYTICAL PROCEDURE FOR CITRIC ACID taining 0.5 milliliter of purified n-hexa- decane and evaporated on the rotary evapo- GENERAL INSTRUCTIONS rator at 45 °C to constant volume. Six milli- Because of the sensitivity of the test, the liters of purified isooctane are added to this possibility of errors arising from contamina- residue and evaporated under the same con- tion is great. It is of the greatest importance ditions as above for 5 minutes. Determine that all glassware be scrupulously cleaned to the absorbance of the residue compared to remove all organic matter such as oil, purified n-hexadecane as reference. The ab- grease, detergent residues, etc. Examine all sorbance of the solution of the solvent res- glassware including stoppers and stopcocks, idue shall not exceed 0.03 per centimeter under ultraviolet light to detect any residual path length between 280 and 299 nanometers fluorescent contamination. As a pre- and 0.01 per centimeter path length between cautionary measure it is recommended prac- 300 and 400 nanometers. tice to rinse all glassware with purified iso- Methyl alcohol, A.C.S. reagent grade. Use 100 octane immediately before use. No grease is milliliters for the test described in the pre- to be used on stopcocks or joints. Great care ceding paragraph. If necessary, methyl alco- to avoid contamination of citric acid sam- hol may be purified by distillation through a ples in handling is essential to assure ab- Virgreaux column discarding the first and sence of any extraneous material arising last ten percent of the distillate or other- from inadequate packaging. Because some of wise. the polynuclear hydrocarbons sought in this Benzene, spectrograde (Burdick and Jackson test are very susceptible to photo-oxidation, Laboratories, Inc., Muskegon, Mich., or equiva- the entire procedure is to be carried out lent). Use 80 milliliters for the test. If nec- under subdued light. essary, benzene may be purified by distilla- tion or otherwise. APPARATUS Isooctane (2,2,4-trimethylpentane). Use 100 1. Aluminum foil, oil free. milliliters for the test. If necessary, iso- 2. Separatory funnels, 500-milliliter capac- octane may be purified by passage through a ity, equipped with tetrafluoroethylene poly- column of activated silica gel, distillation or mer stopcocks. otherwise. 3. Chromatographic tubes: (a) 80-milli- Hexane, spectrograde (Burdick and Jackson meter ID × 900-millimeter length equipped Laboratories, Inc., Muskegon, Mich., or equiva- with tetrafluoroethylene polymer stopcock lent). Use 100 milliliters for the test. If nec- and course fritted disk; (b) 18-millimeter ID essary, hexane may be purified by distilla- × 300-millimeter length equipped with tetra- tion or otherwise. fluoroethylene polymer stopcock. 1,2-Dichloroethane, spectrograde (Matheson, 4. Rotary vacuum evaporator, Buchi or Coleman and Bell, East Rutherford, N.J., or equivalent. equivalent). Use 100 milliliters for the test. If 5. Spectrophotometer—Spectral range 250– necessary, 1,2-dichloroethane may be puri- 400 nanometers with spectral slit width of 2 fied by distillation or otherwise. nanometers or less; under instrument oper- ELUTING MIXTURES ating conditions for these absorbance meas- urements, the spectrophotometer shall also 1. 10 percent 1,2-dichloroethane in hexane. meet the following performance require- Prepare by mixing the purified solvents in ments: the volume ratio of 1 part of 1,2- Absorbance repeatability, ±0.01 at 0.4 ab- dichloroethane to 9 parts of hexane. sorbance. 2. 40 percent benzene in hexane. Prepare by Wavelength repeatability, ±0.2 nanometer. mixing the purified solvents in the volume Wavelength accuracy, ±1.0 nanometer. ratio of 4 parts of benzene to 6 parts of The spectrophotometer is equipped with hexane. matched 1 centimeter path length quartz n-Hexadecane, 99 percent olefin-free. Deter- microcuvettes with 0.5-milliliter volume ca- mine the absorbance compared to isooctane pacity. as reference. The absorbance per centimeter 6. Vacuum oven, minimum inside dimen- path length shall not exceed 0.00 in the range sions: 200 mm × 200 mm × 300 mm deep. of 280–400 nanometers. If necessary, n-hexa- decane may be purified by percolation REAGENTS AND MATERIALS through activated silica gel, distillation or Organic solvents. All solvents used through- otherwise. out the procedure shall meet the specifica- Silica gel, 28–200 mesh (Grade 12, Davison tions and tests described in this specifica- Chemical Co., Baltimore, MD, or equivalent). tion. The methyl alcohol, isooctane, benzene, Activate as follows: Slurry 900 grams of sili- hexane and 1,2-dichloroethane designated in ca gel reagent with 2 liters of purified water the list following this paragraph shall pass in a 3-liter beaker. Cool the mixture and the following test: pour into a 80 × 900 chromatographic column The specified quantity of solvent is added with coarse fritted disc. Drain the water, to a 250-milliliter round bottom flask con- wash with an additional 6 liters of purified

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water and wash with 3,600 milliliters of puri- gel into the column. Tap the column ap- fied methyl alcohol at a relatively slow rate. proximately 20 times on a semisoft, clean Drain all of the solvents and transfer the surface to settle the silica gel. Carefully silica gel to an aluminum foil-lined drying pour 3 grams of anhydrous sodium sulfate dish. Place foil over the top of the dish. Acti- onto the top of the silica gel in the column. vate in a vacuum oven at low vacuum (ap- Carefully drain the isooctane extract of proximately 750 millimeters Mercury or 27 the citric acid solution into the column in a inches of Mercury below atmospheric pres- series of additions while the isooctane is ° ° sure) at 173 to 177 C for at least 20 hours. draining from the column at an elution rate Cool under vacuum and store in an amber of approximately 3 milliliters per minute. bottle. Rinse the separatory funnel with 10 milli- Sodium sulfate, anhydrous, A.C.S. reagent liters of isooctane after the last portion of grade. This reagent should be washed with the extract has been applied to the column purified isooctane. Check the purity of this reagent as described in § 172.886 of this chap- and add this rinse to the column. After all of ter. the extract has been applied to the column Water, purified. All water used must meet and the solvent layer reaches the top of the the specifications of the following test: sulfate bed, rinse the column with 25 milli- Extract 600 milliliters of water with 50 mil- liters of isooctane followed by 10 milliliters liliters of purified isooctane. Add 1 milliliter of a 10-percent dichloroethane in hexane so- of purified n-hexadecane to the isooctane ex- lution. For each rinse solution, drain the col- tract and evaporate the resulting solution to umn until the solvent layer reaches the top 1 milliliter. The absorbance of this residue of the sodium sulfate bed. Discard the rinse shall not exceed 0.02 per centimeter path solvents. Place a 250-milliliter round bottom length between 300–400 nanometers and 0.03 flask containing 0.5 milliliter of purified n- per centimeter path length between 280–299 hexadecane under the column. Elute the nanometers. If necessary, water may be puri- polynuclear aromatic hydrocarbons from the fied by distillation, extraction with purified column with 30 milliliters of 40-percent ben- organic solvents, treatment with an absorb- zene in hexane solution. Drain the eluate ent (e.g., activated carbon) followed by fil- until the 40-percent benzene in the hexane tration of the absorbent or otherwise. solvent reaches the top of the sodium sulfate bed. PROCEDURE Evaporate the 40-percent benzene in Separate portions of 200 milliliters of puri- hexane eluate on the rotary vacuum evapo- fied water are taken through the procedure rator at 45 °C until only the n-hexadecane for use as control blanks. Each citric acid residue of 0.5 milliliter remains. Treat the n- sample is processed as follows: Weigh 200 hexadecane residue twice with the following grams of anhydrous citric acid into a 500 mil- wash step: Add 6 milliliters of purified iso- liliter flask and dissolve in 200 milliliters of octane and remove the solvents by vacuum ° pure water. Heat the solution to 60 C and evaporation at 45 °C to constant volume, i.e., transfer to a 500 milliliter separatory funnel. 0.5 milliliter. Cool the n-hexadecane residue Rinse the flask with 50 milliliters of iso- and transfer the solution to an 0.5-milliliter octane and add the isooctane to the sepa- microcuvette. Determine the absorbance of ratory funnel. Gently shake the mixture 90 this solution compared to purified n-hexa- times (caution: vigorous shaking will cause emulsions) with periodic release of the pres- decane as reference. Correct the absorbance sure caused by shaking. values for any absorbance derived from the Allow the phases to separate for at least 5 control reagent blank. If the corrected ab- minutes. Draw off the lower aqueous layer sorbance does not exceed the limits pre- into a second 500-milliliter separatory funnel scribed, the samples meet the ultraviolet ab- and repeat the extraction with a second ali- sorbance specifications. quot of 50 milliliters of isooctane. After sep- The reagent blank is prepared by using 200 aration of the layers, draw off and discard milliliters of purified water in place of the the water layer. Combine both isooctane ex- citric acid solution and carrying the water tracts in the funnel containing the first ex- sample through the procedure. The typical tract. Rinse the funnel which contained the control reagent blank should not exceed 0.03 second extract with 10 milliliters of iso- absorbance per centimeter path length be- octane and add this portion to the combined tween 280 and 299 nanometers, 0.02 absorb- isooctane extract. ance per centimeter path length between 300 A chromatographic column containing 5.5 and 359 nanometers, and 0.01 absorbance per grams of silica gel and 3 grams of anhydrous centimeter path length between 360 and 400 sodium sulfate is prepared for each citric nanometers. acid sample as follows: Fit 18 × 300 column with a small glass wool plug. Rinse the in- [42 FR 14491, Mar. 15, 1977, as amended at 47 side of the column with 10 milliliters of puri- FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, fied isooctane. Drain the isooctane from the 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, column. Pour 5.5 grams of activated silica Nov. 29, 2013]

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§ 173.170 Aminoglycoside 3′-phospho- § 173.228 Ethyl acetate. transferase II. Ethyl acetate (CAS Reg. No. 141–78–6) The food additive aminoglycoside 3′- may be safely used in food in accord- phosphotransferase II may be safely ance with the following conditions: used in the development of genetically (a) The additive meets the specifica- modified cotton, oilseed rape, and to- tions of the Food Chemicals Codex, 7th matoes in accordance with the fol- ed. (2010), pp. 343–344, which is incor- lowing prescribed conditions: porated by reference. The Director of (a) The food additive is the enzyme the Office of the Federal Register ap- aminoglycoside 3′-phosphotransferase proves this incorporation by reference II (CAS Reg. No. 58943–39–8) which cata- in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies lyzes the phosphorylation of certain from the United States Pharmacopeial aminoglycoside antibiotics, including Convention, 12601 Twinbrook Pkwy., kanamycin, neomycin, and gentamicin. Rockville, MD 20852 (Internet address ′ (b) Aminoglycoside 3 -phosphotrans- http://www.usp.org). Copies may be ex- ferase II is encoded by the kanr gene amined at the Food and Drug Adminis- originally isolated from transposon Tn5 tration’s Main Library, 10903 New of the bacterium Escherichia coli. Hampshire Ave., Bldg. 2, Third Floor, (c) The level of the additive does not Silver Spring, MD 20993, 301–796–2039, or exceed the amount reasonably required at the National Archives and Records for selection of plant cells carrying the Administration (NARA). For informa- kanr gene along with the genetic mate- tion on the availability of this mate- rial of interest. rial at NARA, call 202–741–6030 or go to: http://www.archives.gov/federal-register/ [59 FR 26711, May 23, 1994] cfr/ibr-locations.html. (b) The additive is used in accordance Subpart C—Solvents, Lubricants, with current good manufacturing prac- Release Agents and Related tice as a solvent in the decaffeination Substances of coffee and tea. [47 FR 146, Jan. 5, 1982, as amended at 49 FR § 173.210 Acetone. 28548, July 13, 1984; 78 FR 71466, Nov. 29, 2013] A tolerance of 30 parts per million is established for acetone in spice § 173.230 Ethylene dichloride. oleoresins when present therein as a A tolerance of 30 parts per million is residue from the extraction of spice. established for ethylene dichloride in spice oleoresins when present therein § 173.220 1,3-Butylene glycol. as a residue from the extraction of spice; Provided, however, That if resi- 1,3-Butylene glycol (1,3-butanediol) dues of other chlorinated solvents are may be safely used in food in accord- also present the total of all residues of ance with the following prescribed con- such solvents shall not exceed 30 parts ditions: per million. (a) The substance meets the fol- lowing specifications: § 173.240 Isopropyl alcohol. (1) 1,3-Butylene glycol content: Not Isopropyl alcohol may be present in less than 99 percent. the following foods under the condi- (2) Specific gravity at 20/20 °C: 1.004 tions specified: to 1.006. (a) In spice oleoresins as a residue (3) Distillation range: 200°–215 °C. from the extraction of spice, at a level (b) It is used in the minimum amount not to exceed 50 parts per million. required to perform its intended effect. (b) In lemon oil as a residue in pro- (c) It is used as a solvent for natural duction of the oil, at a level not to ex- and synthetic flavoring substances ex- ceed 6 parts per million. cept where standards of identity issued (c) In hops extract as a residue from under section 401 of the act preclude the extraction of hops at a level not to such use. exceed 2.0 percent by weight: Provided, That,

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(1) The hops extract is added to the § 173.270 Hexane. wort before or during cooking in the Hexane may be present in the fol- manufacture of beer. lowing foods under the conditions spec- (2) The label of the hops extract ified: specifies the presence of the isopropyl (a) In spice oleoresins as a residue alcohol and provides for the use of the from the extraction of spice, at a level hops extract only as prescribed by not to exceed 25 parts per million. paragraph (c)(1) of this section. (b) In hops extract as a residue from the extraction of hops, at a level not to § 173.250 Methyl alcohol residues. exceed 2.2 percent by weight; Provided, Methyl alcohol may be present in the That: following foods under the conditions (1) The hops extract is added to the specified: wort before or during cooking in the (a) In spice oleoresins as a residue manufacture of beer. from the extraction of spice, at a level (2) The label of the hops extract not to exceed 50 parts per million. specifies the presence of the hexane (b) In hops extract as a residue from and provides for the use of the hops ex- the extraction of hops, at a level not to tract only as prescribed by paragraph exceed 2.2 percent by weight; Provided, (b)(1) of this section. That: § 173.275 Hydrogenated sperm oil. (1) The hops extract is added to the wort before or during cooking in the The food additive hydrogenated manufacture of beer. sperm oil may be safely used in accord- (2) The label of the hops extract ance with the following prescribed con- specifies the presence of methyl alco- ditions: hol and provides for the use of the hops (a) The sperm oil is derived from ren- extract only as prescribed by para- dering the fatty tissue of the sperm graph (b)(1) of this section. whale or is prepared by synthesis of fatty acids and fatty alcohols derived § 173.255 Methylene chloride. from the sperm whale. The sperm oil obtained by rendering is refined. The Methylene chloride may be present in oil is hydrogenated. food under the following conditions: (b) It is used alone or as a component (a) In spice oleoresins as a residue of a release agent or lubricant in bak- from the extraction of spice, at a level ery pans. not to exceed 30 parts per million; Pro- (c) The amount used does not exceed vided, That, if residues of other that reasonably required to accomplish chlorinated solvents are also present, the intended lubricating effect. the total of all residues of such sol- vents shall not exceed 30 parts per mil- § 173.280 Solvent extraction process lion. for citric acid. (b) In hops extract as a residue from A solvent extraction process for re- the extraction of hops, at a level not to covery of citric acid from conventional exceed 2.2 percent, Provided, That: Aspergillus niger fermentation liquor (1) The hops extract is added to the may be safely used to produce food- wort before or during cooking in the grade citric acid in accordance with manufacture of beer. the following conditions: (2) The label of the hops extract iden- (a) The solvent used in the process tifies the presence of the methylene consists of a mixture of n-octyl alcohol chloride and provides for the use of the meeting the requirements of § 172.864 of hops extract only as prescribed by this chapter, synthetic isoparaffinic paragraph (b)(1) of this section. petroleum hydrocarbons meeting the (c) In coffee as a residue from its use requirements of § 172.882 of this chap- as a solvent in the extraction of caf- ter, and tridodecyl amine. feine from green coffee beans, at a level (b) The component substances are not to exceed 10 parts per million (0.001 used solely as a solvent mixture and in percent) in decaffeinated roasted coffee a manner that does not result in for- and in decaffeinated soluble coffee ex- mation of products not present in con- tract (instant coffee). ventionally produced citric acid.

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(c) The citric acid so produced meets Subpart D—Specific Usage the polynuclear aromatic hydrocarbon Additives specifications of § 173.165 and the speci- fications of the Food Chemicals Codex, § 173.300 Chlorine dioxide. 7th ed. (2010), pp. 226–227, which is in- Chlorine dioxide (CAS Reg. No. 10049– corporated by reference. The Director 04–4) may be safely used in food in ac- of the Office of the Federal Register cordance with the following prescribed approves this incorporation by ref- conditions: erence in accordance with 5 U.S.C. (a)(1) The additive is generated by 552(a) and 1 CFR part 51. You may ob- one of the following methods: tain copies from the United States (i) Treating an aqueous solution of Pharmacopeial Convention, 12601 sodium chlorite with either chlorine Twinbrook Pkwy., Rockville, MD 20852 gas or a mixture of sodium hypo- (Internet address http://www.usp.org). chlorite and hydrochloric acid. Copies may be examined at the Food (ii) Treating an aqueous solution of and Drug Administration’s Main Li- sodium chlorate with hydrogen per- oxide in the presence of sulfuric acid. brary, 10903 New Hampshire Ave., Bldg. (iii) Treating an aqueous solution of 2, Third Floor, Silver Spring, MD 20993, sodium chlorite by . 301–796–2039, or at the National Ar- (2) The generator effluent contains at chives and Records Administration least 90 percent (by weight) of chlorine (NARA). For information on the avail- dioxide with respect to all chlorine spe- ability of this material at NARA, call cies as determined by Method 4500–ClO2 202–741–6030 or go to: http:// E in the ‘‘Standard Methods for the Ex- www.archives.gov/federal-register/cfr/ibr- amination of Water and Wastewater,’’ locations.html. 20th ed., 1998, or an equivalent method. (d) Residues of n-octyl alcohol and Method 4500–ClO2 E (‘‘Amperometric synthetic isoparaffinic petroleum hy- Method II’’) is incorporated by ref- drocarbons are removed in accordance erence in accordance with 5 U.S.C. with good manufacturing practice. Cur- 552(a) and 1 CFR part 51. You may ob- rent good manufacturing practice re- tain a copy from the Office of Food Ad- sults in residues not exceeding 16 parts ditive Safety (HFS–200), Center for per million (ppm) n-octyl alcohol and Food Safety and Applied Nutrition, 0.47 ppm synthetic isoparaffinic petro- Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or leum hydrocarbons in citric acid. the American Public Health Associa- (e) Tridodecyl amine may be present tion, 800 I St. NW., Washington, DC as a residue in citric acid at a level not 20001–3750. You may inspect a copy at to exceed 100 parts per billion. the Food and Drug Administration’s [42 FR 14491, Mar. 15, 1977, as amended at 49 Main Library, 10903 New Hampshire FR 10106, Mar. 19, 1984; 78 FR 71466, Nov. 29, Ave., Bldg. 2, Third Floor, Silver 2013] Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin- § 173.290 Trichloroethylene. istration (NARA). For information on Tolerances are established for resi- the availability of this material at dues of trichloroethylene resulting NARA, call 202–741–6030, or go to: http:// from its use as a solvent in the manu- www.archives.gov/federallregister/ codeloflfederallregulations/ facture of foods as follows: ibrllocations.html. Decaffeinated ground coffee 25 parts per million. (b)(1) The additive may be used as an Decaffeinated soluble (in- 10 parts per million. antimicrobial agent in water used in stant) coffee extract. poultry processing in an amount not to Spice oleoresins ...... 30 parts per million (provided exceed 3 parts per million (ppm) resid- that if residues of other chlorinated solvents are ual chlorine dioxide as determined by also present, the total of all Method 4500–ClO2 E, referenced in para- residues of such solvents graph (a)(2) of this section, or an equiv- in spice oleoresins shall alent method. not exceed 30 parts per million). (2) The additive may be used as an antimicrobial agent in water used to

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wash fruits and vegetables that are not § 173.310 Boiler water additives. raw agricultural commodities in an Boiler water additives may be safely amount not to exceed 3 ppm residual used in the preparation of steam that chlorine dioxide as determined by will contact food, under the following Method 4500–ClO2 E, referenced in para- conditions: graph (a)(2) of this section, or an equiv- (a) The amount of additive is not in alent method. Treatment of the fruits excess of that required for its func- and vegetables with chlorine dioxide tional purpose, and the amount of shall be followed by a potable water steam in contact with food does not ex- rinse or by blanching, cooking, or can- ceed that required to produce the in- ning. tended effect in or on the food. [60 FR 11900, Mar. 3, 1995. Redesignated at 61 (b) The compounds are prepared from FR 14245, Apr. 1, 1996, as amended at 61 FR substances identified in paragraphs (c) 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; and (d) of this section, and are subject 65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14, to the limitations, if any, prescribed: 2005; 81 FR 5592, Feb. 3, 2016] (c) List of substances:

Substances Limitations

Acrylamide-sodium acrylate resin ...... Contains not more than 0.05 percent by weight of acrylamide monomer. Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copoly- Total not to exceed 20 parts per million (active) in boiler mer having a minimum weight average molecular weight of feedwater. 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled ‘‘Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS’’. Ammonium alginate. sulfate (as catalyst). 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809–21–4) and its sodium and potassium salts. Lignosulfonic acid. Monobutyl ethers of polyethylene-polypropylene glycol produced Minimum mol. wt. 1,500. by random condensation of a 1:1 mixture by weight of ethyl- ene oxide and propylene oxide with butanol. Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. Total not to exceed 1.5 parts per million in boiler feed water. 71050–62–9), produced from a 4:1 to a 16:1 mixture by Copolymer contains not more than 0.5 percent by weight of weight of acrylic acid and sodium hypophosphite. acrylic acid monomer (dry weight basis). Polyethylene glycol ...... As defined in § 172.820 of this chapter. Polymaleic acid [CAS Reg. No. 26099–09–2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal- salt. [CAS Reg. No. 30915–61–8 or CAS Reg. No. 70247– culated as the acid). 90–4]. Polyoxypropylene glycol ...... Minimum mol. wt. 1,000. Potassium carbonate. Potassium tripolyphosphate. Sodium acetate. Sodium alginate. Sodium aluminate. Sodium carbonate. Sodium carboxymethylcellulose...... Contains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with max- imum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25 °C; by the ‘‘Viscosity of Cellulose Gum’’ method prescribed in the Food Chemicals Codex, pp. 1128–1129. Sodium glucoheptonate...... Less than 1 part per million cyanide in the sodium glucoheptonate. Sodium hexametaphosphate. Sodium humate. Sodium hydroxide. Sodium lignosulfonate. Sodium metabisulfite. Sodium metasilicate. Sodium nitrate. Sodium phosphate (mono-, di-, tri-). Sodium polyacrylate. Sodium polymethacrylate. Sodium silicate. Sodium sulfate. Sodium sulfite (neutral or alkaline).

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Substances Limitations

Sodium tripolyphosphate. Sorbitol anhydride esters: A mixture consisting of sorbitan The mixture is used as an anticorrosive agent in steam boiler monostearate as defined in § 172.842 of this chapter; poly- distribution systems, with each component not to exceed 15 sorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as milligrams per kilogram in the steam. defined in § 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) )), meeting the specifications of the Food Chemicals Codex, pp. 825–827.. (including quebracho extract). Tetrasodium EDTA. Tetrasodium pyrophosphate.

(d) Substances used alone or in com- bination with substances in paragraph (c) of this section:

Substances Limitations

Cyclohexylamine ...... Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Diethylaminoethanol ...... Not to exceed 15 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Hydrazine ...... Zero in steam. Morpholine ...... Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Octadecylamine ...... Not to exceed 3 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Trisodium nitrilotriacetate ...... Not to exceed 5 parts per million in boiler feedwater; not to be used where steam will be in contact with milk and milk products.

(e) To assure safe use of the additive, Weight of 60/40 AA/AMPS’’ (October 23, in addition to the other information re- 1987). quired by the Act, the label or labeling (ii) [Reserved] shall bear: (2) United States Pharmacopeial Con- (1) The common or chemical name or vention, 12601 Twinbrook Pkwy., Rock- names of the additive or additives. ville, MD 20852 (Internet address http:// (2) Adequate directions for use to as- www.usp.org): sure compliance with all the provisions (i) Food Chemicals Codex, 7th ed. of this section. (2010), pp. 1128–1129. (f) The standards required in this sec- (ii) Food Chemicals Codex, 7th ed. tion are incorporated by reference into (2010), pp. 825–827. this section with the approval of the Director of the Federal Register under [42 FR 14526, Mar. 15, 1977, as amended at 45 5 U.S.C. 552(a) and 1 CFR part 51. Cop- FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. ies may be examined at the Food and 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Drug Administration’s Main Library, Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 10903 New Hampshire Ave., Bldg. 2, 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; Third Floor, Silver Spring, MD 20993, 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 301–796–2039, or at the National Ar- 1999; 64 FR 29227, June 1, 1999; 78 FR 71466, chives and Records Administration Nov. 29, 2013] (NARA). For information on the avail- ability of this material at NARA, call § 173.315 Chemicals used in washing 202–741–6030 or go to: http:// or to assist in the peeling of fruits www.archives.gov/federal-register/cfr/ibr- and vegetables. locations.html. Chemicals may be safely used to (1) FDA Main Library, 10903 New wash or to assist in the peeling of Hampshire Ave., Silver Spring, MD fruits and vegetables in accordance 20993: with the following conditions: (i) ‘‘Determination of Weight Aver- (a) The chemicals consist of one or age and Number Average Molecular more of the following:

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(1) Substances generally recognized (2) Substances identified in this sub- as safe in food or covered by prior sanc- paragraph and subject to such limita- tions for use in washing fruits and tions as are provided: vegetables.

Substances Limitations

A mixture of alkylene oxide adducts of alkyl alcohols and phosphate May be used at a level not to exceed 0.2 percent in esters of alkylene oxide adducts of alkyl alcohols consisting of: a-alkyl lye-peeling solution to assist in the lye peeling of (C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5–8.5 moles)/poly fruit and vegetables. (oxypropylene) block copolymer having an average molecular weight of 810; a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3–3.7 moles) polymer having an average molecular weight of 380, and sub- sequently esterified with 1.25 moles phosphoric anhydride; and a-alkyl (C10-C12)-omega-hydroxypoly (oxyethylene) (11.9–12.9 moles)/poly (oxypropylene) copolymer, having an average molecular weight of 810, and subsequently esterified with 1.25 moles phosphoric anhy- dride. Aliphatic acid mixture consisting of valeric, caproic, enanthic, caprylic, May be used at a level not to exceed 1 percent in lye and pelargonic acids. peeling solution to assist in the lye peeling of fruits and vegetables. Polyacrylamide ...... Not to exceed 10 parts per million in wash water. Contains not more than 0.2 percent acrylamide monomer. May be used in the washing of fruits and vegetables. Potassium bromide ...... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 Not to exceed 0.2 percent in wash water. May be and not less than 95 percent C10 to C16). used in washing or to assist in the lye peeling of fruits and vegetables. Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and Do. not less than 95% C10 to C16). Sodium 2 ethyl-hexyl sulfate ...... Do. Sodium hypochlorite ...... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245–260) Not to exceed 0.2 percent in wash water. May be used in the washing or to assist in the lye peeling of fruits and vegetables.

(3) Sodium mono- and dimethyl naph- Substance Limitations thalene sulfonates (mol. wt. 245–260) Oleic acid conforming with Do. may be used in the steam/scald vacuum § 172.860 of this chapter. peeling of tomatoes at a level not to Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. exceed 0.2 percent in the condensate or Monoethanolamine ...... Do. scald water. Ethylene dichloride ...... Not to exceed 0.2 ppm. Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. (4) Substances identified in this para- tetraacetate. graph (a)(4) for use in flume water for washing sugar beets prior to the slicing (5) Substances identified in this para- operation and subject to the limita- graph (a)(5) for use on fruits and vege- tions as are provided for the level of tables that are not raw agricultural the substances in the flume water: commodities and subject to the limita- tions provided: Substance Limitations Substances Limitations a-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. ethylene) produced by con- Hydrogen peroxide ...... Used in combination with acetic densation of 1 mole of C11- acid to form peroxyacetic acid. C486315 straight chain ran- Not to exceed 59 ppm in wash domly substituted secondary al- water. cohols with an average of 9 1-Hydroxyethylidene-1,1- May be used only with peroxy- moles of ethylene oxide. diphosphonic acid. acetic acid. Not to exceed 4.8 Linear undecylbenzenesulfonic Do. ppm in wash water. acid. Peroxyacetic acid ...... Prepared by reacting acetic acid Dialkanolamide produced by con- Not to exceed 2 ppm. with hydrogen peroxide. Not to densing 1 mole of methyl lau- exceed 80 ppm in wash water. rate with 1.05 moles of diethanolamine. Triethanolamine ...... Do. (b) The chemicals are used in Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. amounts not in excess of the minimum

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required to accomplish their intended (3) Combinations for cane-sugar mills effect. and beet-sugar mills: (c) The use of the chemicals listed Parts under paragraphs (a)(1), (a)(2), and per mil- (a)(4) is followed by rinsing with pota- lion ble water to remove, to the extent pos- (i) Disodium ethylenebisdithiocarbamate ...... 3.0 sible, residues of the chemicals. Ethylenediamine ...... 2.0 (d) To assure safe use of the additive: Sodium dimethyldithiocarbamate ...... 3.0 (1) The label and labeling of the addi- (ii) Disodium cyanodithioimidocarbonate ...... 2.9 tive container shall bear, in addition to Potassium N-methyldithiocarbamate ...... 4.1 the other information required by the act, the name of the additive or a (4) Single additive for cane-sugar statement of its composition. mills and beet-sugar mills. (2) The label or labeling of the addi- Parts per million tive container shall bear adequate use directions to assure use in compliance 2,2-Dibromo-3-nitrilopropionamide (CAS Not more than with all provisions of this section. Reg. No. 10222–01–2). Limitations: By- 10.0 and not product molasses, bagasse, and pulp less than 2.0. [42 FR 14526, Mar. 15, 1977, as amended at 42 containing residues of 2,2-dibromo-3- FR 29856, June 10, 1977; 42 FR 32229, June 24, nitrilopropionamide are not authorized for use in animal feed. 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 1999] (5) Combination for cane-sugar mills: Parts per mil- § 173.320 Chemicals for controlling lion microorganisms in cane-sugar and beet-sugar mills. n-Dodecyl dimethyl benzyl ammonium chlo- ride ...... 0.05±0.005 Agents for controlling microorga- n-Dodecyl dimethyl ethylbenzyl ammonium nisms in cane-sugar and beet-sugar chloride ...... 0.68±0.068 mills may be safely used in accordance n-Hexadecyl dimethyl benzyl ammonium chloride ...... 0.30±0.030 with the following conditions: n-Octadecyl dimethyl benzyl ammonium (a) They are used in the control of chloride ...... 0.05±0.005 microorganisms in cane-sugar and/or n-Tetradecyl dimethyl benzyl ammonium beet-sugar mills as specified in para- chloride ...... 0.60±0.060 n-Tetradecyl dimethyl ethylbenzyl ammo- graph (b) of this section. nium chloride ...... 0.32±0.032 (b) They are applied to the sugar mill grinding, crusher, and/or diffuser sys- Limitations. Byproduct molasses, ba- tems in one of the combinations listed gasse, and pulp containing residues of in paragraph (b) (1), (2), (3), or (5) of these quaternary ammonium salts are this section or as a single agent listed not authorized for use in animal feed. in paragraph (b) (4) or (6) of this sec- (6) Single additive for beet-sugar tion. Quantities of the individual addi- mills: tives in parts per million are expressed in terms of the weight of the raw cane Parts per million or raw beets. Glutaraldehyde (CAS Reg. No. Not more than 250. (1) Combination for cane-sugar mills: 111–30–8). Parts per mil- (c) To assure safe use of the addi- lion tives, their label and labeling shall Disodium cyanodithioimidocarbonate ...... 2.5 conform to that registered with the Ethylenediamine ...... 1.0 Environmental Protection Agency. Potassium N-methyldithiocarbamate ...... 3.5 [42 FR 14526, Mar. 15, 1977, as amended at 47 (2) Combination for cane-sugar mills: FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, 1985; 57 FR 8065, Mar. 6, 1992] Parts per mil- § 173.322 Chemicals used in delinting lion cottonseed. Disodium ethylenebisdithiocarbamate ...... 3.0 Chemicals may be safely used to as- Sodium dimethyldithiocarbamate ...... 3.0 sist in the delinting of cottonseed in

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accordance with the following condi- plied to poultry meat, organs, or re- tions: lated parts or trim. (a) The chemicals consist of one or (2) When used in a spray or dip solu- more of the following: tion, the additive is used at levels that (1) Substances generally recognized result in sodium chlorite concentra- as safe for direct addition to food. tions between 500 and 1,200 parts per (2) Substances identified in this para- million (ppm), in combination with any graph and subject to such limitations GRAS acid at a level sufficient to as are provided: achieve a solution pH of 2.3 to 2.9. Substances Limitations (3) When used in a prechiller or chill- er solution, the additive is used at lev- alpha-Alkyl-omega- May be used at an applica- hydroxypoly-(oxyethylene) tion rate not to exceed 0.3 els that result in sodium chlorite con- produced by condensation percent by weight of cot- centrations between 50 and 150 ppm, in of a linear primary alcohol tonseeds to enhance combination with any GRAS acid at containing an average delinting of cottonseeds in- chain length of 10 carbons tended for the production levels sufficient to achieve a solution with poly(oxyethylene) hav- of cottonseed oil. Byprod- pH of 2.8 to 3.2. ing an average of 5 ethyl- ucts including lint, hulls, (c) The additive is used as an anti- ene oxide units. and meal may be used in animal feed. microbial agent in accordance with An alkanomide produced by May be used at an applica- current industry practice in the proc- condensation of coconut oil tion rate not to exceed 0.2 essing of red meat, red meat parts, and fatty acids and dietha- percent by weight of cot- nolamine, CAS Reg. No. tonseeds to enhance organs as a component of a spray or in 068603–42–9. delinting of cottonseeds in- the processing of red meat parts and tended for the production organs as a component of a dip. Applied of cottonseed oil. Byprod- ucts including lint, hulls, as a dip or spray, the additive is used and meal may be used in at levels that result in sodium chlorite animal feed. concentrations between 500 and 1,200 ppm in combination with any GRAS [47 FR 8346, Feb. 26, 1982] acid at levels sufficient to achieve a so- lution pH of 2.5 to 2.9. § 173.325 Acidified sodium chlorite so- (d)(1) The additive is used as an anti- lutions. microbial agent in water and ice that Acidified sodium chlorite solutions are used to rinse, wash, thaw, trans- may be safely used in accordance with port, or store seafood in accordance the following prescribed conditions: with current industry standards of (a) The additive is produced by mix- good manufacturing practice. The addi- ing an aqueous solution of sodium chlo- tive is produced by mixing an aqueous rite (CAS Reg. No. 7758–19–2) with any solution of sodium chlorite with any generally recognized as safe (GRAS) GRAS acid to achieve a pH in the range acid. of 2.5 to 2.9 and diluting this solution (b)(1) The additive is used as an anti- with water to achieve an actual use microbial agent in poultry processing water in accordance with current in- concentration of 40 to 50 parts per mil- dustry practice under the following lion (ppm) sodium chlorite. Any sea- conditions: food that is intended to be consumed (i) As a component of a carcass spray raw shall be subjected to a potable or dip solution prior to immersion of water rinse prior to consumption. the intact carcass in a prechiller or (2) The additive is used as a single ap- chiller tank; plication in processing facilities as an (ii) In a prechiller or chiller solution antimicrobial agent to reduce patho- for application to the intact carcass; genic bacteria due to cross-contamina- (iii) As a component of a spray or dip tion during the harvesting, handling, solution for application to poultry car- heading, evisceration, butchering, stor- cass parts; ing, holding, packing, or packaging of (iv) In a prechiller or chiller solution finfish and crustaceans; or following for application to poultry carcass the filleting of finfish; in accordance parts; or with current industry standards of (v) As a component of a post-chill good manufacturing practice. Applied carcass spray or dip solution when ap- as a dip or spray, the additive is used

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at levels that result in a sodium chlo- [Cole] family, application must be by rite concentration of 1,200 ppm, in com- dip treatment only, and must be pre- bination with any GRAS acid at levels ceded by a potable water rinse and fol- sufficient to achieve a pH of 2.3 to 2.9. lowed by a potable water rinse and a Treated seafood shall be cooked prior 24-hour holding period prior to con- to consumption. sumption. When used in a spray or dip (e) The additive is used as an anti- solution, the additive is used at levels microbial agent on raw agricultural that result in sodium chlorite con- commodities in the preparing, packing, centrations between 500 and 1,200 ppm, or holding of the food for commercial in combination with any GRAS acid at purposes, consistent with section a level sufficient to achieve a solution 201(q)(1)(B)(i) of the act, and not ap- pH of 2.3 to 2.9. plied for use under section (h) The concentration of sodium chlo- 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or rite is determined by a method entitled (q)(1)(B)(i)(III) of the act, in accordance ‘‘Determination of Sodium Chlorite: 50 with current industry standards of ppm to 1500 ppm Concentration,’’ Sep- good manufacturing practice. Applied tember 13, 1995, developed by Alcide as a dip or a spray, the additive is used Corp., Redmond, WA, which is incor- at levels that result in chlorite con- porated by reference in accordance centrations of 500 to 1200 parts per mil- with 5 U.S.C. 552(a) and 1 CFR part 51. lion (ppm), in combination with any Copies are available from the Office of GRAS acid at levels sufficient to Food Additive Safety (HFS–200), Center achieve a pH of 2.3 to 2.9. Treatment of for Food Safety and Applied Nutrition, the raw agricultural commodities with Food and Drug Administration, 5001 acidified sodium chlorite solutions Campus Dr., College Park, MD 20740, shall be followed by a potable water 240–402–1200, or may be examined at the rinse, or by blanching, cooking, or can- Food and Drug Administration’s Main ning. Library, 10903 New Hampshire Ave., (f) The additive is used as an anti- Bldg. 2, Third Floor, Silver Spring, MD microbial agent on processed, 20993, 301–796–2039, or at the National comminuted or formed meat food prod- Archives and Records Administration ucts (unless precluded by standards of (NARA). For information on the avail- identity in 9 CFR part 319) prior to ability of this material at NARA, call packaging of the food for commercial 202–741–6030, or go to: http:// purposes, in accordance with current www.archives.gov/federallregister/ industry standards of good manufac- codeloflfederallregulations/ turing practice. Applied as a dip or ibrllocations.html. spray, the additive is used at levels that result in sodium chlorite con- [61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, centrations of 500 to 1200 ppm, in com- 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, bination with any GRAS acid at levels Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR sufficient to achieve a pH of 2.5 to 2.9. 22922, May 7, 2001; 66 FR 31841, June 13, 2001; (g) The additive is used as an anti- 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30, microbial agent in the water applied to 2004; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. processed fruits and processed root, 3, 2016] tuber, bulb, legume, fruiting (i.e., egg- plant, groundcherry, pepino, pepper, § 173.340 Defoaming agents. tomatillo, and tomato), and cucurbit Defoaming agents may be safely used vegetables in accordance with current in processing foods, in accordance with industry standards of good manufac- the following conditions: turing practices, as a component of a (a) They consist of one or more of the spray or dip solution, provided that following: such application be followed by a pota- (1) Substances generally recognized ble water rinse and a 24-hour holding by qualified experts as safe in food or period prior to consumption. However, covered by prior sanctions for the use for processed leafy vegetables (i.e., prescribed by this section. vegetables other than root, tuber, bulb, (2) Substances listed in this para- legume, fruiting, and cucurbit vegeta- graph (a)(2) of this section, subject to bles) and vegetables in the Brassica any limitations imposed:

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Substances Limitations

Dimethylpolysiloxane (substantially free from hydrolyzable chlo- 10 parts per million in food, or at such level in a concentrated ride and alkoxy groups; no more than 18 percent loss in food that when prepared as directed on the labels, the food weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 in its ready-for-consumption state will have not more than centistokes at 25 °C; refractive index 1.400–1.404 at 25 °C). 10 parts per million except as follows: Zero in milk; 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food. Formaldehyde ...... As a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 per- cent of the dimethylpolysiloxane content. a-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) For use as prescribed in § 172.808(b)(3) of this chapter. (minimum 15 moles)/poly(oxyethylene) block copolymer (CAS Reg. No. 9003–11–6) as defined in § 172.808(a)(3) of this chapter. Polyacrylic acid, sodium salt ...... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect. Polyethylene glycol ...... As defined in § 172.820 of this chapter. Polyoxyethylene 40 monostearate ...... As defined in U.S.P. XVI. Polysorbate 60 ...... As defined in § 172.836 of this chapter. Polysorbate 65 ...... As defined in § 172.838 of this chapter. Propylene glycol alginate ...... As defined in § 172.858 of this chapter. Silicon dioxide ...... As defined in § 172.480 of this chapter. Sorbitan monostearate ...... As defined in § 172.842 of this chapter. White mineral oil: Conforming with §172.878 of this chapter ...... As a component of defoaming agents for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water.

(3) Substances listed in this para- use in processing beet sugar and yeast, graph (a)(3), provided they are compo- and subject to any limitations im- nents of defoaming agents limited to posed:

Substances Limitations

Aluminum stearate ...... As defined in § 172.863 of this chapter. Butyl stearate. BHA ...... As an antioxidant, not to exceed 0.1 percent by weight of defoamer. BHT ...... Do. Calcium stearate ...... As defined in § 172.863 of this chapter. Fatty acids ...... As defined in § 172.860 of this chapter. Formaldehyde ...... As a preservative. Hydroxylated lecithin ...... As defined in § 172.814 of this chapter. Isopropyl alcohol. Magnesium stearate ...... As defined in § 172.863 of this chapter. Mineral oil: Conforming with § 172.878 of this chapter ...... Not more than 150 p.p.m. in yeast, measured as hy- drocarbons. Odorless light petroleum hydrocarbons: Conforming with § 172.884 of this chapter. Petrolatum: Conforming with § 172.880 of this chapter ...... Petroleum wax: Conforming with § 172.886 of this chapter. Petroleum wax, synthetic. Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of As an emulsifier not to exceed 10 percent by weight this chapter and providing the oleic acid used in the production of this of defoamer formulation. substance complies with § 172.860 or § 172.862 of this chapter. Synthetic isoparaffinic petroleum hydrocarbons: Conforming with § 172.882 of this chapter. Oleic acid derived from tall oil fatty acids ...... Complying with § 172.862 of this chapter. Oxystearin ...... As defined in § 172.818 of this chapter. Polyoxyethylene (600) dioleate. Polyoxyethylene (600) monoricinoleate. Polypropylene glycol ...... Molecular weight range, 1,200–3,000. Polysorbate 80 ...... As defined in § 172.840 of this chapter. Potassium stearate ...... As defined in § 172.863 of this chapter. Propylene glycol mono- and diesters of fats and fatty acids ...... As defined in § 172.856 of this chapter. Soybean oil fatty acids, hydroxylated. Tallow, hydrogenated, oxidized or sulfated. Tallow alcohol, hydrogenated.

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(4) The substances listed in this para- § 173.342 Chlorofluorocarbon 113 and graph (a)(4), provided they are compo- perfluorohexane. nents of defoaming agents limited to A mixture of 99 percent use in processing beet sugar only, and chlorofluorocarbon 113 (1,1,2-trichloro- subject to the limitations imposed: 1,2,2-trifluoroethane) (CAS Reg. No. 76– 13–1, also known as 113, Substances Limitations CFC 113 and FC 113) and 1 percent n-Butoxypoly(oxyethylene)- Viscosity range, 4,850–5,350 perfluorohexane (CAS Reg. No. 355–42– poly(oxypropylene)glycol. Saybolt Universal Seconds 0) may be safely used in accordance (SUS) at 37.8 °C (100 °F). with the following prescribed condi- The viscosity range is de- termined by the method tions: ‘‘Viscosity Determination of (a) The additive chlorofluorocarbon n-butoxypoly(oxyethylene)- 113 has a purity of not less than 99.99 poly(oxypropylene) glycol’’ dated April 26, 1995, de- percent. veloped by Union Carbide (b) The additive mixture is intended Corp., P.O. Box 670, for use to quickly cool or crust-freeze Bound Brook, NJ 08805, chickens sealed in intact bags com- which is incorporated by reference in accordance posed of substances regulated in parts with 5 U.S.C. 552(a) and 1 174, 175, 177, 178, and § 179.45 of this CFR part 51. Copies of the chapter and conforming to any limita- material incorporated by reference are available tions or specifications in such regula- from the Office of Food Ad- tions. ditive Safety (HFS–200), Center for Food Safety and [55 FR 8913, Mar. 9, 1990] Applied Nutrition, Food and Drug Administration, 5001 § 173.345 Chloropentafluoroethane. Campus Dr., College Park, MD 20740, and may be ex- The food additive amined at the Food and chloropentafluoroethane may be safely Drug Administration’s Main used in food in accordance with the fol- Library, 10903 New Hamp- shire Ave., Bldg. 2, Third lowing prescribed conditions: Floor, Silver Spring, MD (a) The food additive has a purity of 20993, 301–796–2039, or not less than 99.97 percent, and con- at the National Archives and Records Administration tains not more than 200 parts per mil- (NARA). For information on lion saturated fluoro compounds and 10 the availability of this mate- parts per million unsaturated fluoro rial at NARA, call 202– compounds as impurities. 741–6030, or go to: http:// www.archives.gov/ (b) The additive is used or intended federallregister/ for use alone or with one or more of the codeloflfederal following substances: , lregulations/ibrlloca- tions.html. nitrous oxide, propane, and Monoester of alpha-hydro- octafluorocyclobutane complying with omega-hydroxy- § 173.360, as an aerating agent for poly(oxyethylene) foamed or sprayed food products, with poly(oxypropylene) poly(oxyethylene) (15 mole any propellant effect being incidental minimum) blocked copoly- and no more than is minimally nec- mer derived from low eru- essary to achieve the aerating func- cic acid rapeseed oil. tion, except that use is not permitted for those standardized foods that do (b) They are added in an amount not not provide for such use. in excess of that reasonably required to (c) To assure safe use of the additive inhibit foaming. (1) The label of the food additive con- [42 FR 14526, Mar. 15, 1977, as amended at 43 tainer shall bear, in addition to the FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, other information required by the act, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, the following: Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR (i) The name of the additive, 29134, May 28, 1998; 81 FR 5592, Feb. 3, 2016] chloropentafluoroethane. (ii) The percentage of the additive present in the case of a mixture. (iii) The designation ‘‘food grade’’.

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(2) The label or labeling of the food microns to 310 millimicrons, under the same additive container shall bear adequate instrumental conditions. The standard ref- directions for use. erence absorbance is the absorbance at 275 millimicrons of a standard reference solution [42 FR 14526, Mar. 15, 1977, as amended at 43 of naphthalene (National Bureau of Stand- FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, ards Material No. 577 or equivalent in purity) 1978] containing a concentration of 1.4 milligrams per liter in purified isooctane, measured § 173.350 Combustion product gas. against isooctane of the same spectral purity The food additive combustion prod- in 5-centimeter cells. (This absorbance will be approximately 0.30.) uct gas may be safely used in the proc- Solvent. The solvent used is pure grade iso- essing and packaging of the foods des- octane having an ultraviolet absorbance not ignated in paragraph (c) of this section to exceed 0.05 measured against distilled for the purpose of removing and dis- water as a reference. Upon passage of puri- placing oxygen in accordance with the fied inert gas through some isooctane under following prescribed conditions: the identical conditions of the test, a low- (a) The food additive is manufactured ering of the absorbance value has been ob- by the controlled combustion in air of served. The absorbance of isooctane to be used in this procedure shall not be more than butane, propane, or natural gas. The 0.02 lower in the range 255 millimicrons to combustion equipment shall be pro- 310 millimicrons, inclusive, than that of the vided with an absorption-type filter ca- untreated solvent as measured in a 5-centi- pable of removing possible toxic impu- meter cell. If necessary to obtain the pre- rities, through which all gas used in scribed purities, the isooctane may be passed the treatment of food shall pass; and through activated silica gel. with suitable controls to insure that Apparatus. To assure reproducible results, the additive is passed into the isooctane so- any combustion products failing to lution through a gas-absorption train con- meet the specifications provided in this sisting of the following components and nec- section will be prevented from reaching essary connections: the food being treated. 1. A gas flow meter with a range up to 30 (b) The food additive meets the fol- liters per hour provided with a constant dif- lowing specifications: ferential relay or other device to maintain a (1) Carbon monoxide content not to constant flow rate independent of the input exceed 4.5 percent by volume. pressure. 2. An absorption apparatus consisting of an (2) The ultraviolet absorbance in iso- inlet gas dispersion tube inserted to the bot- octane solution in the range 255 milli- tom of a covered cylindrical vessel with a microns to 310 millimicrons not to ex- suitable outlet on the vessel for effluent gas. ceed one-third of the standard ref- The dimensions and arrangement of tube and erence absorbance when tested as de- vessel are such that the inlet tube introduces scribed in paragraph (e) of this section. the gas at a point not above 51⁄4 inches below (c) It is used or intended for use to the surface of the solvent through a sintered displace or remove oxygen in the proc- glass outlet. The dimensions of the vessel are such, and both inlet and vessel are so de- essing, storage, or packaging of bev- signed, that the gas can be bubbled through erage products and other food, except 60 milliliters of isooctane solvent at a rate fresh meats. up to 30 liters per hour without mechanical (d) To assure safe use of the additive loss of solvent. The level corresponding to 60 in addition to the other information re- milliliters should be marked on the vessel. quired by the act, the label or labeling 3. A cooling bath containing crushed ice of the combustion device shall bear and water to permit immersion of the ab- adequate directions for use to provide a sorption vessel at least to the solvent level mark. combustion product gas that complies Caution. The various parts of the absorp- with the limitations prescribed in para- tion train must be connected by gas-tight graph (b) of this section, including in- tubing and joints composed of materials structions to assure proper filtration. which will neither remove components from (e) The food additive is tested for nor add components to the gas stream. The compliance with paragraph (b)(2) by gas source is connected in series to the flow- the following empirical method: rate device, the flow meter, and the absorp- tion apparatus in that order. Ventilation Spectrophotometric measurements. All meas- should be provided for the effluent gases urements are made in an ultraviolet spectro- which may contain carbon monoxide. photometer in optical cells of 5 centimeters Sampling procedure. Immerse the gas-ab- in length, and in the range of 255 milli- sorption apparatus containing 60 milliliters

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of isooctane in the coolant bath so that the ed. (2010), pp. 496 and 497, which is in- solvent is completely immersed. Cool for at corporated by reference. The Director least 15 minutes and then pass 120 liters of of the Federal Register approves this the test gas through the absorption train at incorporation by reference in accord- a rate of 30 liters per hour or less. Maintain the coolant bath at 0 °C throughout. Remove ance with 5 U.S.C. 552(a) and 1 CFR the absorption vessel from the bath, dis- part 51. You may obtain copies from connect, and warm to room temperature. the United States Pharmacopeial Con- Add isooctane to bring the contents of the vention, 12601 Twinbrook Pkwy., Rock- absorption vessel to 60 milliliters, and mix. ville, MD 20852 (Internet address http:// Determine the absorbance of the solution in www.usp.org). Copies may be examined the 5-centimeter cell in the range 255 milli- at the Food and Drug Administration’s microns to 310 millimicrons, inclusive, com- Main Library, 10903 New Hampshire pared to isooctane. The absorbance of the so- lution of combustion product gas shall not Ave., Bldg. 2, Third Floor, Silver exceed that of the isooctane solvent at any Spring, MD 20993, 301–796–2039, or at the wavelength in the specified range by more National Archives and Records Admin- than one-third of the standard reference ab- istration (NARA). For information on sorbance. the availability of this material at NARA, call 202–741–6030, or go to: http:// § 173.355 Dichlorodifluoromethane. www.archives.gov/federallregister/ The food additive dichlorodi- codeloflfederallregulations/ may be safely used in ibrllocations.html. food in accordance with the following (b) The additive is used as an anti- prescribed conditions: microbial agent in the production of (a) The additive has a purity of not modified whey (including, but not lim- less than 99.97 percent. ited to, whey protein concentrates and (b) It is used or intended for use, in whey protein isolates) by accordance with good manufacturing ultrafiltration methods, at a level not practice, as a direct-contact freezing to exceed 0.001 percent by weight of the agent for foods. whey, providing that residual hydrogen (c) To assure safe use of the additive: peroxide is removed by appropriate (1) The label of its container shall chemical or physical means during the bear, in addition to the other informa- processing of the modified whey. tion required by the act, the following: [76 FR 11330, Mar. 2, 2011, as amended at 81 (i) The name of the additive, dichlo- FR 5592, Feb. 3, 2016] rodifluoromethane, with or without the parenthetical name ‘‘Food Freezant § 173.357 Materials used as fixing 12’’. agents in the immobilization of en- (ii) The designation ‘‘food grade’’. zyme preparations. (2) The label or labeling of the food Fixing agents may be safely used in additive container shall bear adequate the immobilization of enzyme prepara- directions for use. tions in accordance with the following conditions: § 173.356 Hydrogen peroxide. (a) The materials consist of one or Hydrogen peroxide (CAS Reg. No. more of the following: 7722–84–1) may be safely used to treat (1) Substances generally recognized food in accordance with the following as safe in food. conditions: (2) Substances identified in this sub- (a) The additive meets the specifica- paragraph and subject to such limita- tions of the Food Chemicals Codex, 7th tions as are provided:

Substances Limitations

Acrylamide-acrylic acid resin: Complying May be used as a fixing material in the immobilization of glucose isomerase en- with § 173.5(a)(1) and (b) of this chapter. zyme preparations for use in the manufacture of high fructose corn syrup, in ac- cordance with § 184.1372 of this chapter. Cellulose triacetate ...... May be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk. Diethylaminoethyl-cellulose ...... May be used as a fixing material in the immobilization of glucose isomerase en- zyme preparations for use in the manufacture of high fructose corn syrup, in ac- cordance with § 184.1372 of this chapter.

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Substances Limitations

Dimethylamine-epichlorohydrin resin: May be used as a fixing material in the immobilization of glucose isomerase en- Complying with § 173.60(a) and (b) of zyme preparations for use in the manufacture of high fructose corn syrup, in ac- this chapter. cordance with § 184.1372 of this chapter. Glutaraldehyde ...... Do. Periodic acid (CAS Reg. No. 10450–60– 9).. Polyethylenimine reaction product with May be used as a fixing material in the immobilization of glucoamylase enzyme 1,2-dichloroethane (CAS Reg. No. preparations from Aspergillus niger for use in the manufacture of beer. 68130–97–2) is the reaction product of May be used as a fixing material in the immobilization of: homopolymerization of ethylenimine in 1. Glucose isomerase enzyme preparations for use in the manufacture of high fruc- aqueous hydrochloric acid at 100 °C tose corn syrup, in accordance with § 184.1372 of this chapter. and of cross-linking with 1,2- 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manu- dichloroethane. The finished polymer facture of beer. Residual ethylenimine in the finished polyethylenimine polymer has an average molecular weight of will be less than 1 part per million as determined by gas chromatography-mass 50,000 to 70,000 as determined by gel spectrometry. The residual ethylenimine is determined by an analytical method permeation chromatography. The analyt- entitled ‘‘Methodology for Ethylenimine Detection in Polyethylenimine,’’ which is ical method is entitled ‘‘Methodology for incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Molecular Weight Detection of Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less Polyethylenimine,’’ which is incorporated than 1 part per million as determined by gas chromatography. The residual 1,2- by reference in accordance with 5 dichloroethane is determined by an analytical method entitled, ‘‘Methodology for U.S.C. 552(a) and 1 CFR part 51. Cop- Ethylenedichloride Detection in Polyethylenimine,’’ which is incorporated by ref- ies may be obtained from the Office of erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be Food Additive Safety (HFS–200), Center obtained from the Office of Food Additive Safety (HFS–200), Center for Food for Food Safety and Applied Nutrition, Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, or may 5001 Campus Dr., College Park, MD be examined at the Food and Drug Administration’s Main Library, 10903 New 20740, and may be examined at the Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, Food and Drug Administration’s Main Li- or at the National Archives and Records Administration (NARA). For information brary, 10903 New Hampshire Ave., on the availability of this material at NARA, call 202–741–6030, or go to: http:// Bldg. 2, Third Floor, Silver Spring, MD www.archives.gov/federallregister/codeloflfederallregulations/ 20993, 301–796–2039, or at the Na- ibrllocations.html. tional Archives and Records Administra- tion (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.

(b) The fixed enzyme preparation is sprayed food products, except for those washed to remove residues of the fixing standardized foods that do not provide materials. for such use. [48 FR 5716, Feb. 8, 1983, as amended at 52 FR (c) To assure safe use of the additive: 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; (1) The label of the food additive con- 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, tainer shall bear, in addition to the 1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, other information required by the act, June 25, 2002; 81 FR 5592, Feb. 3, 2016] the following: (i) The name of the additive, § 173.360 Octafluorocyclobutane. octafluorocyclobutane. The food additive octafluorocyclo-bu- (ii) The percentage of the additive tane may be safely used as a propellant present in the case of a mixture. and aerating agent in foamed or (iii) The designation ‘‘food grade’’. sprayed food products in accordance (2) The label or labeling of the food with the following conditions: additive container shall bear adequate (a) The food additive meets the fol- directions for use. lowing specifications: 99.99 percent octafluorocyclobutane. § 173.368 Ozone. Less than 0.1 part per million fluoroolefins, Ozone (CAS Reg. No. 10028–15–6) may calculated as perfluoroisobutylene. be safely used in the treatment, stor- (b) The additive is used or intended age, and processing of foods, including for use alone or with one or more of the meat and poultry (unless such use is following substances: Carbon dioxide, precluded by standards of identity in 9 nitrous oxide, and propane, as a propel- CFR part 319), in accordance with the lant and aerating agent for foamed or following prescribed conditions:

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(a) The additive is an unstable, color- hydroxyethylidene-1,1-diphosphonic less gas with a pungent, characteristic acid. odor, which occurs freely in nature. It (b)(1) The additive is used as an anti- is produced commercially by passing microbial agent on meat carcasses, electrical discharges or ionizing radi- parts, trim, and organs in accordance ation through air or oxygen. with current industry practice where (b) The additive is used as an anti- the maximum concentration of microbial agent as defined in peroxyacids is 220 parts per million § 170.3(o)(2) of this chapter. (ppm) as peroxyacetic acid, and the (c) The additive meets the specifica- maximum concentration of hydrogen tions for ozone in the Food Chemicals peroxide is 75 ppm. Codex, 7th ed. (2010), pp. 754–755, which (2) The additive is used as an anti- is incorporated by reference. The Di- microbial agent on poultry carcasses, rector of the Office of the Federal Reg- poultry parts, and organs in accord- ister approves this incorporation by ance with current industry standards reference in accordance with 5 U.S.C. of good manufacturing practice (unless 552(a) and 1 CFR part 51. You may ob- precluded by the U.S. Department of tain copies from the United States Agriculture’s standards of identity in 9 Pharmacopeial Convention, 12601 CFR part 381, subpart P) where the Twinbrook Pkwy., Rockville, MD 20852 maximum concentration of (Internet address http://www.usp.org). peroxyacids is 220 parts per million Copies may be examined at the Food (ppm) as peroxyacetic acid, the max- and Drug Administration’s Main Li- imum concentration of hydrogen per- brary, 10903 New Hampshire Ave., Bldg. oxide is 110 ppm, and the maximum 2, Third Floor, Silver Spring, MD 20993, concentration of 1-hydroxyethylidene- 301–796–2039, or at the National Ar- 1,1-diphosphonic acid (HEDP) is 13 ppm. chives and Records Administration (c) The concentrations of peroxyacids (NARA). For information on the avail- and hydrogen peroxide in the additive ability of this material at NARA, call are determined by a method entitled 202–741–6030 or go to: http:// ‘‘Hydrogen Peroxide and Peracid (as www.archives.gov/federal-register/cfr/ibr- Peracetic Acid) Content,’’ July 26, 2000, locations.html. developed by Ecolab, Inc., St. Paul, (d) The additive is used in contact MN, which is incorporated by ref- with food, including meat and poultry erence. The concentration of 1- (unless such use is precluded by stand- hydroxyethylidene-1,1-diphosphonic ards of identity in 9 CFR part 319 or 9 acid is determined by a method enti- CFR part 381, subpart P), in the gas- tled ‘‘Determination of 1- eous or aqueous phase in accordance hydroxyethylidene-1,1-diphosphonic with current industry standards of acid (HEDP) Peroxyacid/Peroxide-Con- good manufacturing practice. taining Solutions,’’ August 21, 2001, de- (e) When used on raw agricultural veloped by Ecolab, Inc., St. Paul, MN, commodities, the use is consistent with which is incorporated by reference. The section 201(q)(1)(B)(i) of the Federal Director of the Office of the Federal Food, Drug, and Cosmetic Act (the act) Register approves these incorporations and not applied for use under section by reference in accordance with 5 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or U.S.C. 552(a) and 1 CFR part 51. You (q)(1)(B)(i)(III) of the act. may obtain copies of these methods [66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, from the Division of Petition Review, 2002, as amended at 78 FR 14665, Mar. 7, 2013; Center for Food Safety and Applied Nu- 78 FR 71467, Nov. 29, 2013] trition, Food and Drug Administration, 5001 Campus Dr., College Park, MD § 173.370 Peroxyacids. 20740, or you may examine a copy at Peroxyacids may be safely used in ac- the Food and Drug Administration’s cordance with the following prescribed Main Library, 10903 New Hampshire conditions: Ave., Bldg. 2, Third Floor, Silver (a) The additive is a mixture of per- Spring, MD 20993, 301–796–2039, or at the oxyacetic acid, octanoic acid, acetic National Archives and Records Admin- acid, hydrogen peroxide, istration (NARA). For information on peroxyoctanoic acid, and 1- the availability of this material at

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NARA, call 202–741–6030, or go to: http:// (2) As a liquid aqueous solution ap- www.archives.gov/federallregister/ plied to raw poultry carcasses either codeloflfederallregulations/ prior to or after chilling at an amount ibrllocations.html. not to exceed 5 gallons of solution per [65 FR 70660, Nov. 27, 2000, as amended at 66 carcass, provided that the additive is FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, used in systems that recapture at least 2002; 81 FR 5593, Feb. 3, 2016] 99 percent of the solution that is ap- plied to the poultry carcasses. The con- § 173.375 Cetylpyridinium chloride. centration of cetylpyridinium chloride Cetylpyridinium chloride (CAS Reg. in the solution applied to the carcasses No. 123–93–5) may be safely used in food shall not exceed 0.8 percent by weight. in accordance with the following condi- When application of the additive is not tions: followed by immersion in a chiller, the (a) The additive meets the specifica- treatment will be followed by a potable tions of the United States Pharma- water rinse of the carcass. copeia (USP)/National Formulary (NF) [72 FR 67576, Nov. 29, 2007, as amended at 76 described in USP 30/NF 25, May 1, 2007, FR 59248, Sept. 26, 2011; 81 FR 5593, Feb. 3, pp. 1700–1701, which is incorporated by 2016] reference. The Director of the Office of the Federal Register approves this in- § 173.385 Sodium methyl sulfate. corporation by reference in accordance Sodium methyl sulfate may be with 5 U.S.C. 552(a) and 1 CFR part 51. present in pectin in accordance with You may obtain copies from the United the following conditions. States Pharmacopeial Convention, (a) It is present as the result of Inc., 12601 Twinbrook Pkwy., Rock- methylation of pectin by sulfuric acid ville, MD 20852, or you may examine a and methyl alcohol and subsequent copy at the Food and Drug Administra- treatment with sodium bicarbonate. tion’s Main Library, 10903 New Hamp- (b) It does not exceed 0.1 percent by shire Ave., Bldg. 2, Third Floor, Silver weight of the pectin. Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin- § 173.395 Trifluoromethane sulfonic istration (NARA). For information on acid. the availability of this material at Trifluoromethane sulfonic acid has NARA, call 202–741–6030, or go to: http:// the empirical formula CF3SO3H (CAS www.archives.gov/federal-register/cfr/ibr- Reg. No. 1493–13–6). The catalyst locations.html. (Trifluoromethane sulfonic acid) may (b) The additive is used in food as an safely be used in the production of antimicrobial agent as defined in cocoa butter substitute from palm oil § 170.3(o)(2) of this chapter to treat the (1-palmitoyl-2-oleoyl-3-stearin) (see surface of raw poultry carcasses. The § 184.1259 of this chapter) in accordance solution in which the additive is used with the following conditions: to treat raw poultry carcasses shall (a) The catalyst meets the following also contain propylene glycol (CAS specifications: Reg. No. 57–55–6) complying with Appearance, Clear liquid. § 184.1666 of this chapter, at a con- Color, Colorless to amber. centration of 1.5 times that of Neutralization equivalent, 147–151. cetylpyridinium chloride. Water, 1 percent maximum. (c) The additive is used as follows: Fluoride ion, 0.03 percent maximum. (1) As a fine mist spray of an ambient Heavy metals (as Pb), 30 parts per million temperature aqueous solution applied maximum. to raw poultry carcasses prior to im- Arsenic (as As), 3 parts per million max- mersion in a chiller, at a level not to imum. exceed 0.3 gram cetylpyridinium chlo- (b) It is used at levels not to exceed ride per pound of raw poultry carcass, 0.2 percent of the reaction mixture to provided that the additive is used in catalyze the directed esterification. systems that collect and recycle solu- (c) The esterification reaction is tion that is not carried out of the sys- quenched with steam and water and tem with the treated poultry carcasses; the catalyst is removed with the aque- or ous phase. Final traces of catalyst are

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removed by washing batches of the (b) The food additive described in product three times with an aqueous paragraph (a)(1) of this section con- solution of 0.5 percent sodium bicar- tains not more than a total of 2 percent bonate. by weight of free amine and amine hy- (d) No residual catalyst may remain drochloride. The food additive de- in the product at a detection limit of scribed in paragraph (a)(2) of this sec- 0.2 part per million fluoride as deter- tion contains not more than 3 percent mined by the method described in ‘‘Of- by weight, each, of free amine and ficial Methods of Analysis of the Asso- amine hydrochloride as determined by ciation of Official Analytical Chem- A.O.C.S. method Te 3a–64, ‘‘Acid Value ists,’’ sections 25.049–25.055, 13th Ed. and Free Amine Value of Fatty Quater- (1980), which is incorporated by ref- nary Ammonium Chlorides,’’ 2d print- erence. Copies may be obtained from ing including additions and revisions the AOAC INTERNATIONAL, 481 North 1990, which is incorporated by reference Frederick Ave., suite 500, Gaithersburg, in accordance with 5 U.S.C. 552(a) and 1 MD 20877, or may be examined at the CFR part 51. Copies are available from National Archives and Records Admin- the Center for Food Safety and Applied istration (NARA). For information on Nutrition (HFS–200), Food and Drug the availability of this material at Administration, 5001 Campus Dr., Col- NARA, call 202–741–6030, or go to: http:// lege Park, MD 20740, and from the www.archives.gov/federallregister/ American Oil Chemists’ Society, P.O. codeloflfederallregulations/ Box 5037, Station A, Champaign, IL ibrllocations.html. 61820, or available for inspection at the [43 FR 54237, Nov. 11, 1978, as amended at 49 National Archives and Records Admin- FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, istration (NARA). For information on 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, the availability of this material at Nov. 8, 2005] NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 173.400 Dimethyldialkylammonium codeloflfederallregulations/ chloride. ibrllocations.html. Dimethyldialkylammonium chloride (c) The food additive is used as a de- may be safely used in food in accord- colorizing agent in the clarification of ance with the following prescribed con- refinery sugar liquors under the fol- ditions: lowing limitations: (a) The food additive is produced by (1) The food additive described in one of the following methods: paragraph (a)(1) of this section is added (1) Ammonolysis of natural tallow only at the defecation/clarification fatty acids to form amines that are stage of sugar liquor refining in an subsequently reacted with methyl chlo- amount not to exceed 700 parts per mil- ride to form the quaternary ammonium lion by weight of sugar solids. compounds consisting primarily of (2) The food additive described in dimethyldioctadecylammonium chlo- paragraph (a)(2) of this section is used ride and dimethyldihexadecyl- under the following conditions: ammonium chloride. The additive may (i) The additive is adsorbed onto a contain residues of isopropyl alcohol support column composed of suitable not in excess of 18 percent by weight polymers that are regulated for con- when used as a processing solvent. tact with aqueous food. Excess non- (2) Ammonolysis of natural tallow adsorbed additive shall be rinsed away fatty acids to form amines that are with potable water prior to passage of then reacted with 2-ethylhexanal, re- sugar liquor through the column. duced, methylated, and subsequently (ii) The residue of the additive in the reacted with methyl chloride to form decolorized sugar liquor prior to crys- the quaternary ammonium compound tallization shall not exceed 1 part per known as dimethyl(2-ethylhexyl) hy- million of sugar as determined by a drogenated tallow ammonium chloride method entitled ‘‘Colorimetric Deter- and consisting primarily of dimethyl(2- mination of Residual Quaternary Am- ethylhexyl)octadecylammonium chlo- monium Compounds (Arquad HTL8) in ride and dimethyl(2-ethyl- Sugar and Sugar Solutions,’’ June 13, hexyl)hexadecylammonium chloride. 1990, which is incorporated by reference

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in accordance with 5 U.S.C. 552(a) and 1 PART 174—INDIRECT FOOD CFR part 51. Copies are available from ADDITIVES: GENERAL the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Sec. Administration, 5001 Campus Dr., Col- 174.5 General provisions applicable to indi- lege Park, MD 20740, or available for in- rect food additives. spection at the National Archives and 174.6 Threshold of regulation for substances Records Administration (NARA). For used in food-contact articles. information on the availability of this AUTHORITY: 21 U.S.C. 321, 342, 348, 371. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 174.5 General provisions applicable federallregister/ to indirect food additives. codeloflfederallregulations/ (a) Regulations prescribing condi- ibrllocations.html. tions under which food additive sub- (d) To assure safe use of the additive, stances may be safely used predicate the label and labeling of the additive usage under conditions of good manu- shall bear, in addition to other infor- facturing practice. For the purpose of mation required by the Federal Food, this part and parts 175, 176, and 177 of Drug, and Cosmetic Act, adequate di- this chapter, good manufacturing prac- rections to assure use in compliance tice shall be defined to include the fol- with paragraph (c) of this section. lowing restrictions: [56 FR 42686, Aug. 29, 1991] (1) The quantity of any food additive substance that may be added to food as § 173.405 Sodium a result of use in articles that contact dodecylbenzenesulfonate. food shall not exceed, where no limits are specified, that which results from Sodium dodecylbenzenesulfonate use of the substance in an amount not (CAS No. 25155–30–0) may be safely used more than reasonably required to ac- in accordance with the following pre- complish the intended physical or tech- scribed conditions: nical effect in the food-contact article; (a) The additive is an antimicrobial shall not exceed any prescribed limita- agent used in wash water for fruits and tions; and shall not be intended to ac- vegetables. The additive may be used complish any physical or technical ef- at a level not to exceed 111 milligrams fect in the food itself, except as such per kilogram in the wash water. Fruits may be permitted by regulations in and vegetables treated by the additive parts 170 through 189 of this chapter. do not require a potable water rinse. (2) Any substance used as a compo- (b) The additive is limited to use in nent of articles that contact food shall commissaries, cafeterias, restaurants, be of a purity suitable for its intended retail food establishments, nonprofit use. food establishments, and other food (b) The existence in the subchapter B service operations in which food is pre- of a regulation prescribing safe condi- pared for or served directly to the con- tions for the use of a substance as an sumer. article or component of articles that (c) To assure safe use of the additive, contact food shall not be construed to the label or labeling of the additive relieve such use of the substance or ar- container shall bear, in addition to the ticle from compliance with any other other information required by the Fed- provision of the Federal Food, Drug, eral Food, Drug, and Cosmetic Act, and Cosmetic Act. For example, if a adequate directions to assure use in regulated food-packaging material compliance with the provisions of this were found on appropriate test to im- section. part odor or taste to a specific food product such as to render it unfit with- [77 FR 71697, Dec. 4, 2012] in the meaning of section 402(a)(3) of the Act, the regulation would not be construed to relieve such use from compliance with section 402(a)(3).

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(c) The existence in this subchapter B Subpart B—Substances for Use Only as of a regulation prescribing safe condi- Components of Adhesives tions for the use of a substance as an Sec. article or component of articles that 175.105 Adhesives. contact food shall not be construed as 175.125 Pressure-sensitive adhesives. implying that such substance may be safely used as a direct additive in food. Subpart C—Substances for Use as (d) Substances that under conditions Components of Coatings of good manufacturing practice may be 175.210 Acrylate ester copolymer coating. safely used as components of articles 175.230 Hot-melt strippable food coatings. that contact food include the fol- 175.250 Paraffin (synthetic). lowing, subject to any prescribed limi- 175.260 Partial phosphoric acid esters of pol- yester resins. tations: 175.270 Poly(vinyl fluoride) resins. (1) Substances generally recognized 175.300 Resinous and polymeric coatings. as safe in or on food. 175.320 Resinous and polymeric coatings for (2) Substances generally recognized polyolefin films. as safe for their intended use in food 175.350 Vinyl acetate/crotonic acid copoly- mer. packaging. 175.360 Vinylidene chloride copolymer coat- (3) Substances used in accordance ings for nylon film. with a prior sanction or approval. 175.365 Vinylidene chloride copolymer coat- (4) Substances permitted for use by ings for polycarbonate film. 175.380 Xylene-formaldehyde resins con- regulations in this part and parts 175, densed with 4,4′-isopropylidenediphenol- 176, 177, 178 and § 179.45 of this chapter. epichlorohydrin epoxy resins. (5) Food contact substances used in 175.390 Zinc-silicon dioxide matrix coatings. accordance with an effective pre- AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. market notification for a food contact SOURCE: 42 FR 14534, Mar. 15, 1977, unless substance (FCN) submitted under sec- otherwise noted. tion 409(h) of the act. EDITORIAL NOTE: Nomenclature changes to [42 FR 14534, Mar. 15, 1977, as amended at 67 part 175 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 35731, May 21, 2002] FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. § 174.6 Threshold of regulation for substances used in food-contact ar- Subpart A [Reserved] ticles. Substances used in food-contact arti- Subpart B—Substances for Use cles (e.g., food-packaging or food-proc- Only as Components of Adhesives essing equipment) that migrate, or that may be expected to migrate, into § 175.105 Adhesives. food at negligible levels may be re- (a) Adhesives may be safely used as viewed under § 170.39 of this chapter. components of articles intended for use The Food and Drug Administration in packaging, transporting, or holding will exempt substances whose uses it food in accordance with the following determines meet the criteria in § 170.39 prescribed conditions: of this chapter from regulation as food (1) The adhesive is prepared from one additives and, therefore, a food addi- or more of the optional substances tive petition will not be required for named in paragraph (c) of this section, subject to any prescribed limitations. the exempted use. (2) The adhesive is either separated [60 FR 36596, July 17, 1995] from the food by a functional barrier or used subject to the following additional PART 175—INDIRECT FOOD ADDI- limitations: (i) In dry foods. The quantity of adhe- TIVES: ADHESIVES AND COMPO- sive that contacts packaged dry food NENTS OF COATINGS shall not exceed the limits of good manufacturing practice. Subpart A [Reserved] (ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts

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packaged fatty and aqueous foods shall (1) Substances generally recognized not exceed the trace amount at seams as safe for use in food or food pack- and at the edge exposure between pack- aging. aging laminates that may occur within (2) Substances permitted for use in the limits of good manufacturing prac- adhesives by prior sanction or approval tice. and employed under the specific condi- (b) Under normal conditions of use tions of use prescribed by such sanc- the packaging seams or laminates will tion or approval. remain firmly bonded without visible (3) Flavoring substances permitted for use in food by regulations in this separation. part, provided that such flavoring sub- (b) To assure safe usage of adhesives, stances are volatilized from the adhe- the label of the finished adhesive con- sives during the packaging fabrication tainer shall bear the statement ‘‘food- process. packaging adhesive’’. (4) Color additives approved for use in (c) Subject to any limitation pre- food. scribed in this section and in any other (5) Substances permitted for use in regulation promulgated under section adhesives by other regulations in this 409 of the Act which prescribes safe subchapter and substances named in conditions of use for substances that this subparagraph: Provided, however, may be employed as constituents of ad- That any substance named in this hesives, the optional substances used paragraph and covered by a specific in the formulation of adhesives may in- regulation in this subchapter, must clude the following: meet any specifications in such regula- tion.

Substances Limitations

Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4). Acetone-urea-formaldehyde resin. N-Acetyl ethanolamine. Acetyl tributyl citrate. Acetyl triethyl citrate. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt (CAS Reg. No. 35641–59–9). Albumin, blood. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983–55–0). 4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6-C18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols. Alkyl (C7-C12) benzene. Alkyl (C10-C20) dimethylbenzyl ammonium chloride. n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium For use as preservative only. cyclohexylsulfamate. Alkyl ketene dimers as described in § 176.120 of this chapter. Alkyl (C7-C12) naphthalene. alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, po- tassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111–41–1). 3-Aminopropanediol ...... For use only in the preparation of polyurethane res- ins. Aluminum. Aluminum acetate. Aluminum di(2-ethylhexoate). Aluminum potassium silicate. N-b-Aminoethyl-gamma-aminopropyl trimethoxysilane. 3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine. Aminomethylpropanol. Ammonium benzoate ...... For use as preservative only. Ammonium ...... For use only as bonding agent for aluminum foil, sta- bilizer or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium borate.

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Substances Limitations

Ammonium citrate. Ammonium persulfate. Ammonium polyacrylate. Ammonium potassium hydrogen phosphate. Ammonium silico-fluoride ...... For use only as bonding agent for aluminum foil, sta- bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium sulfamate. Ammonium thiocyanate. Ammonium thiosulfate. Amyl acetate. Anhydroenneaheptitol. Animal glue as described in § 178.3120 of this chapter. 2-Anthraquinone sulfonic acid, sodium salt ...... For use only as polymerization-control agent. Antimony oxide. . Asphalt, paraffinic and naphthenic. Azelaic acid. Azo-bis-isobutyronitrile. Balata rubber. Barium acetate. Barium peroxide. Barium sulfate. Bentonite. Benzene (benzol). 1,4-Benzenedicarboxylic acid, bis[2-(1,1-dimethylethyl)-6-[[3-(1,1- For use as a stabilizer. dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methyl-phenyl]ester (CAS Reg. No. 57569–40–1). 1,2–Benzisothiazolin–3–one (CAS Registry No. 2634–33–5) ...... For use as preservative only. Benzothiazyldisulfide. p-Benzoxyphenol ...... For use as preservative only. Benzoyl peroxide. Benzyl alcohol. Benzyl benzoate. Benzyl bromoacetate ...... For use as preservative only. p-Benzyloxyphenol ...... Do. BHA (butylated hydroxyanisole). BHT (butylated hydroxytoluene). Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate. 2-Biphenyl diphenyl phosphate. Bis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442–85–1) For use only as a reactant in the preparation of poly- ester resins. 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hy-drazine (CAS Reg. For use at a level not to exceed 2 percent by weight No. 32687–78–8). of the adhesive. 1,3-Bis(2-benzothiazolylmercaptomethyl) urea. 4,4′-Bis(a,a-dimethylbenzyl)diphenylamine. 2,6-Bis(1,1-dimethylethyl)-4-(1-methylpropyl)phenol (CAS Reg. No. For use as an antioxidant and/or stabilizer only. 17540–75–9). 2,6-Bis (1-methylheptadecyl)-p-cresol. 4-[[4, 6-Bis(octylthio)6-Bis(octylthio)6-Bis(octylthio)-s-triazin-2-yl]amino]- 2,6-di-tert-butylphenol (CAS Reg. No. 991–84–4). Bis(tri-n-butyltin) oxide ...... For use as preservative only. Bis(trichloromethyl)sulfone C.A. Registry No. 3064–70–8 ...... Do. Borax. Boric acid. 2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52–51–7) ...... For use only as an antibacterial preservative. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also For use as a surface active agent in adhesives. known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093–88–9]).. 1,3-Butanediol. 1,4-Butanediol. 1,4-Butanediol modified with adipic acid. Butoxy polyethylene polyproplyene glycol (molecular weight 900–4,200). Butyl acetate. Butyl acetyl ricinoleate. Butyl alcohol. Butylated reaction product of p-cresol and dicyclopentadiene ...... As identified in § 178.2010(b) of this chapter. Butylated, styrenated cresols identified in § 178.2010(b) of this chapter. Butyl benzoate. Butyl benzyl phthalate. Butyldecyl phthalate ...... 1,3-Butylene glycoldiglycolic acid copolymer. tert-Butyl hydroperoxide.

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Substances Limitations

4,4′-Butylidenebis(6-tert-butyl-m-cresol). Butyl lactate. Butyloctyl phthalate. p-tert-Butylphenyl salicylate. Butyl phthalate butyl glycolate. p-tert-Butylpyrocatechol ...... For use only as polymerization-control agent. Butyl ricinoleate. Butyl rubber polymer. Butyl stearate. Butyl titanate, polymerized. Butyraldehyde. Calcium ethyl acetoacetate. Calcium nitrate. Calcium metasilicate. Camphor. Camphor fatty acid esters. Candelilla wax. epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer. , channel process. Carbon disulfide-1,1′-methylenedipiperidine reaction product. . Carboxymethylcellulose. Castor oil, polyoxyethylated (4–84 moles ethylene oxide). Cellulose acetate butyrate. Cellulose acetate propionate. Ceresin wax (ozocerite). Cetyl alcohol. Chloracetamide. Chloral hydrate. Chlorinated liquid n-paraffins with chain lengths of C10-C17, containing 40–70 percent chlorine by weight. Chlorinated pyridine mixture with active ingredients consisting of 2,3,5,6- For use as preservative only. tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4- (methylsulfinyl) pyridine and pentachloropyridine. Chlorinated rubber polymer (natural rubber polymer containing approxi- mately 67 percent chlorine). 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... For use as preservative only. Chlorobenzene. 4-Chloro-3,5-dimethylphenol (p-chloro-m-xylenol) ...... For use as preservative only. 4-Chloro-3-methylphenol ...... Do. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4) and For use only as an antimicrobial agent in polymer 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture at a latex emulsions. ratio of 3 parts to 1 part, manufactured from methyl-3- mercaptopropionate (CAS Reg. No. 2935–90–2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377–60–3) at a con- centration equivalent to the isothiazolone active ingredients (weight/ weight). Chloroform. Chloroprene. Chromium caseinate. Chromium nitrate. Chromium potassium sulfate. Cobaltous acetate. Coconut fatty acid amine salt of tetrachlorophenol ...... For use as preservative only. Copal. Copper 8-quinolinolate ...... For use as preservative only. Coumarone-indene resin. Cresyl diphenyl phosphate. hydroperoxide. Cyanoguanidine. Cyclized rubber as identified in § 176.170(b)(2) of this chapter. Cyclohexane. 1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541–81–2). Cyclohexanol. Cyclohexanone resin. Cyclohexanone-formaldehyde condensate. N-Cyclohexyl p-toluene sulfonamide. (h5-Cyclopentadienyl)-(h6-isopropylbenzene)iron(II) hexafluorophosphate For use only as a photoinitiator. (CAS Reg. No. 32760–80–8). Damar. Defoaming agents as described in § 176.210 of this chapter. Dehydroacetic acid ...... Diacetone alcohol. Diacetyl peroxide.

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Substances Limitations

N,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl groups are derived from marine fatty acids (C12-C24). 2,5-Di-tert-amylhydroquinone. Diamines derived from dimerized vegetable oil acids. Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl. 1,2–Dibromo–2,4–dicyanobutane (CAS Registry No. 3569–65–7) ...... For use as a preservative only. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222–01–2)...... For use as a preservative only. Di(butoxyethyl) phthalate. 2,5-Di-tert-butylhydroquinone. Dibutyl maleate. 2,6-Di-tert-butyl-4-methylphenol ...... For use as preservative only. Di(C7, C9-alkyl)adipate. Dibutyl phthalate. Dibutyl sebacate. Dibutyltin dilaurate for use only as a catalyst for polyurethane resins. 1,2-Dichloroethylene (mixed isomers). Dicumyl peroxide. Dicyclohexyl phthalate. Diethanolamine. Diethanolamine condensed with animal or vegetable fatty acids. Diethylamine. Diethylene glycol. Diethylene glycol adipic acid copolymer. Diethylene glycol dibenzoate. Diethylene glycol hydrogenated tallowate monoester. Diethylene glycol laurate. Diethylene glycol monobutyl ether. Diethylene glycol monobutyl ether acetate. Diethylene glycol monoethyl ether. Diethylene glycol monoethyl ether acetate. Diethylene glycol monomethyl ether. Diethylene glycol monooleate. Diethylene glycol monophenyl ether. Diethylene glycol copolymer of adipic acid and phthalic anhydride. Di(2-ethylhexyl) adipate. Di(2-ethylhexyl)hexahydrophthalate. Di(2-ethylhexyl)phthalate. Diethyl oxalate. Diethyl phthalate. Dihexyl phthalate. Dihydroabietylphthalate. Di(2-hydroxy-5-tert-butylphenyl) sulfide. 2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene). 4,5-Dihydroxy-2-imidazolidinone. 4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018–09–01 ...... For use as an antifungal preservative only. Diisobutyl adipate. Diisobutyl ketone. Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride. Diisobutyl phthalate. Diisodecyl adipate. Diisodecyl phthalate. Diisooctyl phthalate. Diisopropylbenzene hydroperoxide. N,N-Dimethylcyclohexylamine dibutyldithiocarbamate. Dimethyl formamide. Dimethyl hexynol. 2,2-Dimethyl-1,3-propanediol dibenzoate. Dimethyl octynediol. N-(1,1-dimethyl-3-oxobutyl) acrylamide. Dimethyl phthalate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione ...... For use as preservative only. Di-b-naphthyl-p-phenylenediamine. 4,6-Dinonyl-o-cresol. Dinonylphenol. Di-n-octyldecyl adipate. Dioctyldiphenylamine. Dioctylphthalate. Dioctylsebacate. Dioxane. Dipentaerythritol pentastearate. Dipentamethylene-thiuram-tetrasulfide. Dipentene ...... Dipentene resins.

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Substances Limitations

Dipentene-beta-pinene-styrene resins. Dipentene-styrene resin (CAS Registry No. 64536–06–7). Diphenyl-2-ethylhexyl phosphate. Diphenyl, hydrogen ated. N,N′-Diphenyl-p-phenylenediamine. Diphenyl phthalate. 1,3-Diphenyl-2-thiourea. Dipropylene glycol. Dipropylene glycol dibenzoate. Dipropylene glycol monomethyl ether. Dipropylene glycol copolymer of adipic acid and phthalic anhydride. Disodium cyanodithioimidocarbonate. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49–8). N,N′-Distearoylethylenediamine. Distearyl thiodipropionate. 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only. droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione. 4,4′-Dithiodimorpholine. n-Dodecylmercaptan. tert-Dodecylmercaptan. Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts. Elemi gum. Epichlorohydrin-4,4′-isopropylidenediphenol resin. Epichlorohydrin-4,4′-sec-butylidenediphenol resin. Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin. Epichlorohydrin-phenolformaldehyde resin. Erucamide (erucylamide). Ethanolamine. Ethoxylated primary linear alcohols of greater than 10 percent ethylene oxide by weight having molecular weights of 390 to 7,000 (CAS Reg. No. 97953–22–5). Ethoxypropanol butyl ether. Ethyl alcohol (ethanol). 5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336–82–0). Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756–27–9). Ethylene-acrylic acid copolymer, partial sodium salt containing no more than 20 percent acrylic acid by weight, and no more than 16 percent of the acrylic acid as the sodium salt (CAS Reg. No. 25750–82–7). Ethylenediamine. Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium salts, single or mixed. Ethylene dichloride. Ethylene glycol. Ethylene glycol monobutyl ether. Ethylene glycol monobutyl ether acetate. Ethylene glycol monoethyl ether. Ethylene glycol monoethyl ether acetate. Ethylene glycol monoethyl ether ricinoleate. Ethylene glycol monomethyl ether. Ethylene glycol monophenyl ether. Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052–62–4) con- taining not more than 30 weight percent of the units derived from car- bon monoxide. Ethylene-maleic anhydride copolymer, ammonium or potassium salt. Ethylene-methacrylic acid copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zinc. Ethylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammo- nium, calcium, magnesium, sodium, and/or zinc. Ethylene-octene-1 copolymers containing not less than 70 weight per- cent ethylene (CAS Reg. No. 26221–73–8). Ethylene-propylene-dicyclopentadiene copolymer rubber. Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer. Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337–35–9) containing not more than 15 weight percent of units de- rived from carbon monoxide. 2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958–30–6). Ethyl-p-hydroxybenzoate ...... For use as preservative only. Ethyl hydroxyethylcellulose. Ethyl lactate. 2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. For use as an antioxidant and/or stabilizer only. No. 118337–09–0). Ethyl phthalyl ethyl glycolate.

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Substances Limitations

Ethyl-p-toluene sulfonamide ...... Fats and oils derived from animal or vegetable sources, and the hydro- genated, sulfated, or sulfonated forms of such fats and oils. Fatty acids derived from animal or vegetable fats and oils; and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Ferric chloride. Fluosilicic acid (hydrofluosilicic acid) ...... For use only as bonding agent for aluminum foil, sta- bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Formaldehyde. Formaldehyde o- and p-toluene sulfonamide. Formamide. Fumaratochromium (III) nitrate. Furfural. Furfuryl alcohol. Fumaric acid. gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822–56–5). Glutaraldehyde. Glycerides, di- and monoesters. Glycerol polyoxypropylene triol, minimum average molecular weight 250 For use only in the preparation of polyester and poly- (CAS Reg. No. 25791–96–2). urethane resins in adhesives. Glyceryl borate (glycol boriborate resin). Glyceryl ester of damar, copal, elemi, and sandarac. Glyceryl monobutyl ricinoleate. Glyceryl monohydroxy stearate. Glyceryl monohydroxy tallowate. Glyceryl polyoxypropylene triol (average molecular weight 1,000). Glyceryl tribenzoate. Glycol diacetate. Glyoxal. Heptane. Hexamethylenetetramine. Hexane. Hexanetriols. Hexylene glycol. Hydroabietyl alcohol. Hydrocarbon resins (produced by polymerization of mixtures of mono- and di-unsaturated hydrocarbons of the aliphatic, alicyclic, and monobenzenoid type derived both from cracked petroleum and ter- pene stocks) (CAS Reg. No. 68239–99–6). Hydrocarbon resins (produced by the polymerization of styrene and alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441–37–2). ...... For use only as bonding agent for aluminum foil, sta- bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Hydrogen peroxide. Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2). Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168–36–9). Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168–37–0). a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...... For use only in the preparation of polyurethane res- ins. Hydroquinone. Hydroquinone monobenzyl ether. Hydroquinone monoethyl ether. 2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole. Hydroxyacetic acid. 7-Hydroxycoumarin. Hydroxyethylcellulose. 2–Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex- Reg. No. 106797–53–9). ceed 5 percent by weight of the adhesive. 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6-C17) imidazolinium chlo- ride. Hydroxyethyldiethylenetriamine.

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Substances Limitations

b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. Hydroxyethyl starch. Hydroxyethylurea ...... Hydroxylamine sulfate. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5- For use only as an antibacterial preservative. hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly- [methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixture. Hydroxypropyl methylcellulose. 2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate. 2-Imidazolidinone. 3–Iodo–2–propynyl-N-butyl carbamate (CAS Reg. No. 55406–53–6) ...... For use only as an antifungal preservative. Iodoform ...... For use only as polymerization-control agent. Isoascorbic acid. Isobutyl alcohol (isobutanol). Isobutylene-isoprene copolymer. Isodecyl benzoate (CAS Reg. No. 131298–44–7). Isophorone. Isopropanolamine (mono-, di-, tri-). Isopropyl acetate. Isopropyl alcohol (isopropanol). Isopropyl-m- and p-cresol (thymol derived). 4,4′-Isopropylidenediphenol. 4,4′-Isopropylidenediphenol, polybutylated mixture ...... For use as preservative only. Isopropyl peroxydicarbonate. p-Isopropoxy diphenylamine. 4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanol. Itaconic acid. . Kerosene. Lauroyl peroxide. Lauroyl sulfate salts: Ammonium. Magnesium. Potassium. Sodium. Lauryl alcohol. Lauryl pyridinium 5-chloro-2-mercaptobenzothiazole. Lignin calcium sulfonate. Lignin sodium sulfonate. Linoleamide (linoleic acid amide). Magnesium fluoride ...... For use only as bonding agent for aluminum foil, sta- bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesives. Magnesium glycerophosphate. Maleic acid. Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt. Manganese acetate. Marine oil fatty acid soaps, hydrogenated. Melamine. Melamine-formaldehyde copolymer. 2-Mercaptobenzothiazole. 2-Mercaptobenzothiazole and dimethyl dithiocarbamic acid mixture, so- For use as preservative only. dium salt. 2-Mercaptobenzothiazole, sodium or zinc salt ...... For use as preservative only. Methacrylate-chromic chloride complex, ethyl or methyl ester. p-Menthane hydroperoxide. Methyl acetate. Methyl acetyl ricinoleate. Methyl alcohol (methanol). Methylcellulose. Methylene chloride. 4,4′-Methylenebis(2,6-di-tert-butylphenol). 2,2-Methylenebis (4-ethyl-6-tert-butylphenol). 2,2-Methylenebis (4-methyl-6-nonylphenol). 2,2-Methylenebis (4-methyl-6-tert-butylphenol). Methyl ethyl ketone. Methyl ethyl ketone-formaldehyde condensate. 2-Methylhexane. 1-Methyl-2-hydroxy-4-isopropyl benzene. Methyl isobutyl ketone. Methyl oleate. Methyl oleate-palmitate mixture. Methyl phthalyl ethyl glycolate.

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Substances Limitations

Methyl ricinoleate. . a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a methylstyrene to 3 vinyltoluene). Methyl tallowate. Mineral oil. Monochloracetic acid. Monooctyldiphenylamine. Montan wax. Morpholine. Myristic acid-chromic chloride complex. Myristyl alcohol. Naphtha. Naphthalene, monosulfonated. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. a-Naphthylamine. a,a′,a″,a″′-Neopentane tetrayltetrakis [omega-hydroxypoly (oxypropylene) (1–2 moles)], average molecular weight 400. Nitric acid. μ-Nitrobiphenyl. Nitrocellulose. 2-Nitropropane. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydro- gen phosphate and monohydrogen phosphate esters; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content aver- ages 6–9 moles or 50 moles. a(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of p-nonylphenol (nonyl group is a propylene trimer isomer) with an average of 1–40 moles of ethylene oxide. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium salt: the nonyl group is a propylene trimer isomer and the poly (oxy- ethylene) content averages 9 or 30 moles. endo-cis-5-Norbornene-2,3-dicarboxylic anhydride. a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 moles. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate. Octyl alcohol. Octyldecyl phthalate. Octylphenol. Octylphenoxyethanols. Octylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide and propylene oxide). Odorless light petroleum hydrocarbons. Oleamide (oleic acid amide). Oleic acid, sulfated. 2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] (CAS Reg. No. 70331–94–1). Oxazoline. a-(oxiranylmethyl)-w-(oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], For use as a reactant in the preparation of epoxy- (alternative name: epichlorohydrin-polypropylene glycol) (CAS Reg. based resins. No. 26142–30–3). 2,2′-[oxybis[(methyl-2,1-ethanediyl)-oxymethylene]]bisoxirane, (alternative For use as a reactant in the preparation of epoxy- name: epichlorohydrin-dipropylene glycol) (CAS Reg. No. 41638–13– based resins. 5). n-Oxydiethylene-benzothiazole. Palmitamide (palmitic acid amide). Paraffin (C12-C20) sulfonate. Paraformaldehyde. Pentachlorophenol. Pentaerythritol ester of maleic anhydride. Pentaerythritol monostearate ...... For use as preservative only. Pentaerythritol tetrabenzoate [CAS Registry No. 4196–86–5]. Pentaerythritol tetrastearate. 2,4-Pentanedione. Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140–01–2). Perchloroethylene. Petrolatum. Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated. Petroleum hydrocarbon resin (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks).

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Substances Limitations

Petroleum hydrocarbon resins (produced by the homo-and copolymeriza- tion of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene types from distillates of cracked petroleum stocks). Phenol ...... For use as preservative only. Phenol-coumarone-indene resin. Phenolic resins as described in § 175.300(b)(3)(vi). Phenothiazine ...... For use only as polymerization-control agent. Phenyl-b-naphthylamine (free of b-naphthylamine). o-Phenylphenol ...... For use as preservative only. o-Phthalic acid. Pimaric acid ...... Pine oil. Piperazine. Piperidinium pentamethylenedithiocarbamate. Poly(acrylamide-[2-acrylamide-2-methylpropylsulfonate]-dimethylidiallyl ammonium chloride) sodium salt (CAS Reg. No. 72275-68-4). Polyamides derived from reaction of one or more of the following acids with one or more of the following amines: Acids: Azelaic acid. Dimerized vegetable oil acids. Amines: Bis(hexamethylene) triamine and higher homologues. Diethylenetriamine. Diphenylamine. Ethylenediamine. Hexamethylenediamine. Poly(oxypropylene)diamine (weight average molecular weight 2010) (CAS Reg. No. 9046–10–0). Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046–10–0). Tetraethylenepentamine. Triethylenetetramine. Polybutene, hydrogenated. Polybutylene glycol (molecular weight 1,000). Poly [2(diethylamino) ethyl methacrylate] phosphate. Polyester of adipic acid, phthalic acid, and propylene glycol, terminated with butyl alcohol. Polyester of diglycolic acid and propylene glycol containing ethylene gly- col monobutyl ether as a chain stopper. Polyester resins (including alkyd type), as the basic polymer, formed as esters when one or more of the following acids are made to react with one or more of the following alcohols: Acids: Azelaic acid. Dimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No. 94–60–0). Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975–82–1) and/or its sodium salt (CAS Reg. No. 3965–55–7). Polybasic and monobasic acids identified in § 175.300(b)(3)(vii)(a) and (b). 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362–79–4). Tetrahydrophthalic acid. Alcohols: 1,4-Cyclohexanedimethanol. 2,2-Dimethyl-1,3-propanediol. 1,6-Hexanediol (CAS Reg. No. 629–11–8). Polyhydric and monohydric alcohols identified in § 175.300(b)(3)(vii)(c) and (d). Polyethyleneadipate modified with ethanolamine with the molar ratio of For use only in the preparation of polyurethan resins. the amine to the adipic acid less than 0.1 to 1. Polyethylene glycol (molecular weight 200–6,000). Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413–26–6). Polyethyleneglycol alkyl(C10-C12)ether sulfosuccinate, disodium salt (CAS Reg. No. 68954–91–6). Polyethylene, oxidized. Polyethylene resins, carboxyl modified, identified in § 177.1600 of this chapter. Polyethylenimine. Polyethylenimine-epichlorohydrin resins.

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Substances Limitations

Poly(ethyloxazoline) (CAS Reg. No. 25805-17-8). Polyisoprene. Polymeric esters of polyhydric alcohols and polycarboxylic acids pre- pared from glycerin and phthalic anhydride and modified with benzoic acid, castor oil, coconut oil, , rosin, soybean oil, styrene, and vinyl toluene. Polymers: Homopolymers and copolymers of the following monomers:. Acrylamide. Acrylic acid. Acrylonitrile. Allylmethacrylate (CAS Reg. No. 00096–05–09). Butadiene. Butene. N-tert-Butylacrylamide. Butyl acrylate. 1,3-Butylene glycol dimethacrylate. Butyl methacrylate. Crotonic acid. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dimethyl-a-methylstyrene. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethyl acrylate. Ethylene. Ethylene cyanohydrin. 2-Ethylhexyl acrylate. Ethyl methacrylate. Fatty acids, C10-13-branched, vinyl esters (CAS Reg. No. 184785– 38–4). Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl, heptyl and octyl esters. Glycidyl methacrylate. 1–Hexene (CAS Reg. No. 592–41–6). 2-Hydroxyethyl acrylate. 2-Hydroxyethyl methacrylate. 2-Hydroxypropyl methacrylate. Isobutyl acrylate. Isobutylene. Itaconic acid. Maleic acid, diester with 2-hydroxyethanesulfonic acid, sodium salt. Maleic anhydride. Methacrylic acid. Methyl acrylate. N,N′-Methylenebisacrylamide. Methyl methacrylate. N-Methylolacrylamide. Methyl styrene. -Methyl styrene. Monoethyl maleate. Monomethyl maleate. Mono (2-ethylhexyl) maleate. 5-Norbornene-2 3-dicarboxylic acid, mono-n-butyl ester. 1-Octene (CAS Reg. No. 111–66–0). Propyl acrylate. Propylene. Styrene. Triallyl cyanurate. Vinyl acetate. Vinyl alcohol (from alcoholysis or hydrolysis of vinyl acetate units). Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl ethyl ether. Vinyl hexoate. Vinylidene chloride. Vinyl methyl ether.

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Substances Limitations

Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Polyoxyalkylated-phenolic resin (phenolic resin obtained from formalde- hyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide and/or propylene oxide). Poly(oxycaproyl) diols and triols (minimum molecular weight 500). Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt. Polyoxyethylene (20 mol)—anhydrous lanolin adduct. Polyoxyethylene (molecular weight 200) dibenzoate. Polyoxyethylene (molecular weight 200–600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil). Polyoxyethylene (15 moles) ester of rosin. Polyoxyethylene (4–5 moles) ether of phenol. Polyoxyethylene (25 moles)—glycerol adduct. Polyoxyethylene (40 moles) stearate. Polyoxyethylene (5–15 moles) tridecyl alcohol. Polyoxypropylene (3 moles) tridecyl alcohol sulfate. Polyoxypropylene (20 moles) butyl ether. Polyoxypropylene (40 moles) butyl ether. Polyoxypropylene (20 moles) oleate butyl ether. Polyoxypropylene-polyoxyethylene condensate (minimum molecular weight 1,900). Polypropylene glycol (minimum molecular weight 150). Polypropylene glycol (3–4 moles) triether with 2-ethyl-2-(hydroxymethyl)- 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245–46–6) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Polypropylene, noncrystalline. Polysiloxanes: Diethyl polysiloxane. Dihydrogen polysiloxane. Dimethyl polysiloxane. Diphenyl polysiloxane. Ethyl hydrogen polysiloxane. Ethyl phenyl polysiloxane. Methyl ethyl polysiloxane. Methyl hydrogen polysiloxane. Methyl phenyl polysiloxane. Phenyl hydrogen polysiloxane. Polysorbate 60. Polysorbate 80. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate). Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate). Poly[styrene-co-disodium maleate-co-a-(p-nonyl-phenyl)-omega-(p-vinyl- benzyl)poly(oxyethylene)] terpolymer. .. Polyurethane resins produced by: (1) reacting diisocyanates with one or more of the polyols or polyesters named in this paragraph, or (2) re- acting the chloroformate derivatives of one or more of the polyols or polyesters named in this paragraph with one or more of the polyamines named in this paragraph, or (3) reacting toluene diisocyanate or 4,4′ methylenebis(cyclohexylisocyanate) (CAS Reg. No. 5124–30–1) with: (i) one or more of the polyols or polyesters named in this paragraph and with either N-methyldiethanolamine (CAS Reg. No. 105–59–9) and dimethyl sulfate (CAS Reg. No. 77–78–1) or dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine (CAS Reg. No. 121–44–8), or (ii) a fumaric acid-modified poly- propylene glycol or fumaric acid-modified tripropylene glycol), triethylamine (CAS Reg. No. 107–15–3), and ethylenediamine (CAS Reg. No. 121–44–8), or (4) reacting meta-tetramethylxylene diisocyanate (CAS Reg. No. 2778–42–9) with one or more of the polyols and polyesters listed in this paragraph and with dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine (CAS Reg. No. 121–44–8), N-methyldiethanolamine (CAS Reg. No. 105–59–9), 2–dimethylaminoethanol (CAS Reg. No. 108–01–0), 2– dimethylamino–2–methyl–1–propanol (CAS Reg. No. 7005–47–2), and/or 2–amino–2–methyl–1–propanol (CAS Reg. No. 124–68–5). Polyvinyl alcohol modified so as to contain not more than 3 weight per- cent of comonomer units derived from 1-alkenes having 12 to 20 car- bon atoms. Polyvinyl butyral. Polyvinyl formal.

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Substances Limitations

Potassium ferricyanide ...... For use only as polymerization-control agent. Potassium N-methyldithiocarbamate. Potassium pentachlorophenate ...... For use as preservative only. Potassium permanganate. Potassium persulfate. Potassium phosphates (mono-, di-, tribasic). Potassium tripolyphosphate. a, a′, a″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly (oxypropylene) (24 moles)]. b-Propiolactone. Propyl alcohol (propanol). Propylene carbonate. Propylene glycol and p-p′-isopropylidenediphenol diether. Propylene glycol dibenzoate (CAS Reg. No. 19224–26–1) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Propylene glycol esters of coconut fatty acids. Propylene glycol monolaurate. Propylene glycol monomethyl ether. Propylene glycol monostearate. a, a′, a″-[Propylidynetris (methylene)] tris [omega-hydroxypoly (oxypropylene) (1.5 moles minimum)], minimum molecular weight 400. Quaternary ammonium chloride (hexadecyl, octadecyl derivative) ...... For use as preservative only. Rosin (wood, gum, and tall oil rosin), rosin dimers, decarboxylated rosin (including rosin oil, disproportionated rosin, and these substances as modified by one or more of the following reactants:. Alkyl (C1-C9) phenolformaldehyde. Ammonia. Ammonium caseinate-p-Cyclohexylphenolformaldehyde. Diethylene glycol. Dipentaerythritol. Ethylene glycol. Formaldehyde. Fumaric acid. Glycerin. Hydrogen. Isophthalic acid. 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy). 4,4′-Isopropylidenediphenol-formaldehyde. Maleic anhydride. Methyl alcohol. Pentaerythritol. Phthalic anhydride. Polyethylene glycol. Phenol-formaldehyde. Phenyl μ-cresol-formaldehyde. p-Phenylphenol-formaldehyde. Sulfuric acid. Triethylene glycol. Xylenol-formaldehyde. Rosin salts (salts of wood, gum, and tall oil rosin, and the dimers there- of, decarboxylated rosin disproportionated rosin, hydrogenated rosin): Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Rosin, gasoline-insoluble fraction. Rubber hydrochloride polymer. Rubber latex, natural. Salicylic acid ...... For use as preservative only. Sandarac. Sebacic acid. . Silicon dioxide as defined in § 172.480(a) of this chapter. Sodium alkyl (C2-C13.5 aliphatic) benezenesulfonate. Sodium aluminum pyrophosphate. Sodium aluminum sulfate. Sodium bisulfate. Sodium calcium silicate. Sodium capryl polyphosphate. Sodium carboxymethylcellulose. Sodium chlorate.

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Substances Limitations

Sodium chlorite. Sodium chromate. Sodium decylsulfate. Sodium dehydroacetate ...... For use as preservative only. Sodium di-(2-ethylhexoate). Sodium di-(2-ethylhexyl) pyrophosphate. Sodium dihexylsulfosuccinate. Sodium dissobutylphenoxydiethoxyethyl sulfonate. Sodium diisobutylphenoxymonoethoxyethyl sulfonate. Sodium diisopropyl- and triisopropylnaphthalenesulfonate. Sodium dimethyldithiocarbamate. Sodium dioctylsulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate. Sodium ethylene ether of nonylphenol sulfate. Sodium 2-ethylhexyl sulfate. ...... For use only as bonding agent for aluminum foil, sta- bilizer, or preservative. Total fluoride for all sources not to exceed 1 percent by weight of the finished adhesive. Sodium formaldehyde sulfoxylate. Sodium formate. Sodium heptadecylsulfate. Sodium hypochlorite. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate. Sodium N-lauroyl sarcosinate. Sodium metaborate. Sodium a-naphthalene sulfonate. Sodium nitrate. Sodium nitrite. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ...... For use as preservative only. Sodium perborate. Sodium persulfate. Sodium μ-phenylphenate ...... For use as preservative only. Sodium polyacrylate. Sodium polymethacrylate. Sodium polystyrene sulfonate. Sodium salicylate ...... For use as preservative only. Sodium salt of 1-hydroxy 2(1H)-pyridine thione ...... Do. Sodium tetradecylsulfate. Sodium thiocyanate. Sodium bis-tridecylsulfosuccinate. Sodium xylene sulfonate. Sorbitan monooleate. Sorbitan monostearate. Soybean oil, epoxidized. Spermaceti wax. Sperm oil wax. Stannous 2-ethylhexanoate ...... For use only as a catalyst for polyurethane resins. Stannous stearate. Starch hydrolysates. Starch or starch modified by one or more of the treatments described in §§ 172.892 and 178.3520 of this chapter. Starch, reacted with a urea-formaldehyde resin. Starch, reacted with formaldehyde. Stearamide (stearic acid amide). Stearic acid. Stearic acid-chromic chloride complex. Stearyl-cetyl alcohol, technical grade, approximately 65 percent–80 per- cent stearyl and 20 percent–35 percent cetyl. Strontium salicylate. Styrenated phenol. Styrene block polymers with 1,3-butadiene. Styrene-maleic anhydride copolymer, ammonium or potassium salt. Styrene-maleic anhydride copolymer (partially methylated) sodium salt. Styrene-methacrylic acid copolymer, potassium salt. Sucrose acetate isobutyrate. Sucrose benzoate. Sucrose octaacetate. 2–sulfoethyl methacrylate (CAS Registry No. 10595–80–9) ...... For use at levels not to exceed 2 percent by weight of the dry adhesive. a-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium salt. Sulfonated octadecylene (sodium form).

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Substances Limitations

Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether diso- dium salt (alcohol moiety produced by condensation of 1 mole of n- dodecyl alcohol and an average of 5–6 moles of ethylene oxide, Chemical Abstracts Service Registry No. 039354–45–5). Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, di- sodium salt (alcohol moiety produced by condensation of 1 mole of nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS Reg. No. 9040–38–4). Sulfur. Synthetic primary linear aliphatic alcohols whose weight average molec- ular weight is greater than 400 (CAS Reg. No. 71750–71–5). Synthetic wax polymer as described in § 176.170(a)(5) of this chapter. Tall oil. Tall oil fatty acids, linoleic and oleic. Tall oil fatty acid methyl ester. Tall oil, methyl ester. Tall oil . Tall oil soaps. Tallow alcohol (hydrogenated). Tallow amine, secondary (hexadecyl, octadecyl), of hard tallow. Tallow, blown (oxidized). Tallow, propylene glycol ester. Terpene resins (a-and b-pinene) homopolymers, copolymers, and con- densates with phenol, formaldehyde, coumarone, and/or indene. Terphenyl. Terphenyl, hydrogenated. Terpineol. Tetraethylene pentamine. Tetraethylthiuram disulfide. Tetrahydrofuran. Tetrahydrofurfuryl alcohol. Tetra-isopropyl titanate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] meth- ane. A[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly-(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 1–40 moles of ethylene oxide. A-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxy-poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles. Tetramethyl decanediol. Tetramethyl decynediol. Tetramethyl decynediol plus 1–30 moles of ethylene oxide. Tetramethylthiuram monosulfide. Tetrasodium N-(1,2-dicarboxyethyl)N-octadecylsulfosuccinamate. 4,4′-Thiobis-6-tert-butyl-m-cresol. Thiodiethylene-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate). 2,2′-(2,5-Thiophenediyl) bis[5-tert-butylbenzoxazole]. Thiram. Thymol ...... For use as preservative only. dioxide. Titanium dioxide-barium sulfate. Titanium dioxide-calcium sulfate. Titanium dioxide-magnesium silicate. Toluene. Toluene 2,4-diisocyanate. Toluene 2,6-diisocyanate. o- and p-Toluene ethyl sulfonamide. o- and p-Toluene sulfonamide. p-Toluene sulfonic acid. p-(p′-Toluene-sulfonylamide)-diphenylamide. Triazine-formaldehyde resins as described in § 175.300(b)(3)(xiii). Tributoxyethyl phosphate. Tributylcitrate. Tri-tert-butyl-p-phenyl phenol ...... For use as preservative only. Tributyl phosphate. Tributyltin chloride complex of ethylene oxide condensate of For use as preservative only. dehydroabietylamine. Tri-n-butyltin acetate ...... For use as preservative only. Tri-n-butyltin neodecanoate ...... Do. 1,1,1-Trichloroethane. 1,1,2-Trichloroethane. Trichloroethylene.

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Substances Limitations

Tri-b-chloroethylphosphate. Tridecyl alcohol. Triethanolamine. 3-(Triethoxysilyl) propylamine. Triethylene glycol. Triethylene glycol dibenzoate. Triethylene glycol di(2-ethylhexoate). Triethylene glycol polyester of benzoic acid and phthalic acid. Triethylhexyl phosphate. Triethylphosphate. 2,4,5-Trihydroxy butyrophenone. Triisopropanolamine. Trimethylol propane. 2,2,4-Trimethylpentanediol-1,3-diisobutyrate. Trimeric aromatic amine resin from diphenylamine and acetone of mo- lecular weight approximately 500. Tri(nonylphenyl) phosphite-formaldehyde resins ...... As identified in § 177.2600(c)(4)(iii) of this chapter. For use only as a stabilizer. Triphenylphosphate. Tripropylene glycol monomethyl ether. 1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H)- trione. Tris (p-tertiary butyl phenyl) phosphate. Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane. Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139– 89–9). Turpentine. Urea-formaldehyde resins as described in § 175.300(b)(3)(xii). Vegetable oil, sulfonated or sulfated, potassium salt. Vinyl acetate-maleic anhydride copolymer, sodium salt. Waxes, petroleum. Wax, petroleum, chlorinated (40% to 70% chlorine). Waxes, synthetic paraffin (Fischer-Tropsch process). 3-(2-Xenolyl)-1,2-epoxypropane. Xylene. Xylene (or toluene) alkylated with dicyclopentadiene. Zein. Zinc acetate. Zinc ammonium chloride. Zinc dibenzyl dithiocarbamate. Zinc dibutyldithiocarbamate. Zinc diethyldithiocarbamate. Zinc di(2-ethylhexoate). Zinc formaldehyde sulfoxylate. Zinc naphthenate and dehydroabietylamine mixture. Zinc nitrate. Zinc orthophosphate. Zinc resinate. Zinc sulfide. Zineb (zinc ethylenebis-dithiocarbamate). Ziram (zinc dimethyldithiocarbamate).

[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 175.105, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 175.125 Pressure-sensitive adhesives. tact surface of labels and/or tapes ap- Pressure-sensitive adhesives may be plied to poultry, dry food, and proc- safely used as the food-contact surface essed, frozen, dried, or partially dehy- of labels and/or tapes applied to food, drated fruits or vegetables. in accordance with the following pre- (1) Substances generally recognized scribed conditions: as safe in food. (a) Pressure-sensitive adhesives pre- (2) Substances used in accordance pared from one or a mixture of two or with a prior sanction or approval. more of the substances listed in this paragraph may be used as the food-con-

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(3) Color additives listed for use in or cresol and dicyclopentadiene in an approxi- on food in parts 73 and 74 of this chap- mate mole ratio of 1.5 to 1.0, respectively, ter. followed by alkylation with isobutylene so (4) Substances identified in § 172.615 of that the butyl content of the final product is not less than 18 percent, for use at levels this chapter other than substances not to exceed 1.0 percent by weight of the used in accordance with paragraph adhesive formulation. (a)(2) of this section. Chlorinated natural rubber. (5) Polyethylene, oxidized; complying Isobutylene-styrene copolymer. with the identity prescribed in Petrolatum. § 177.1620(a) of this chapter. Polybutene-1. (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2- Polybutene, hydrogenated; complying with yl]amino]-2,6-di-tert-butylphenol (CAS the identity prescribed under § 178.3740(b) of Reg. No. 991–84–4) as an antioxidant/ this chapter. Polyisobutylene. stabilizer at a level not to exceed 1.5 cis-1,4-Polyisoprene. percent by weight of the finished pres- Polystyrene. sure-sensitive adhesive. Propyl gallate. (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert- Rapeseed oil, vulcanized. butylbenzoxazole) (CAS Reg. No. 7128– and rosin derivatives as provided in 64–5) as an optical brightener at a level § 178.3870 of this chapter. not to exceed 0.05 percent by weight of Rubber hydrochloride. the finished pressure-sensitive adhe- Rubber (natural latex solids or crepe, smoked or unsmoked). sive. Terpene resins (a- and b-pinene), (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) homopolymers, copolymers, and conden- phenyl]-2-methyl-1-propanone (CAS sates with phenol, formaldehyde, cou- Reg. No. 106797–53–9) as a photoinitiator marone, and/or indene. at a level not to exceed 5 percent by Tetrasodium ethylenediaminetetraacetate. weight of the pressure-sensitive adhe- Tri(mixed mono- and dinonylphenyl) sive. phosphite (which may contain not more (9) Butanedioic acid, sulfo-1,4-di-(C - than 1 percent by weight of 9 triisopropanolamine). C11 alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4- (c) Acrylonitrile copolymers identi- diisodecyl ester, ammonium salt [CAS fied in this section shall comply with Reg. No. 144093–88–9]) as a surface ac- the provisions of § 180.22 of this chap- tive agent at a level not to exceed 3.0 ter. percent by weight of the finished pres- [42 FR 14534, Mar. 15, 1977, as amended at 42 sure-sensitive adhesive. FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, (b) Pressure-sensitive adhesives pre- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, pared from one or a mixture of two or Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] more of the substances listed in this paragraph may be used as the food-con- Subpart C—Substances for Use as tact surface of labels and/or tapes ap- Components of Coatings plied to raw fruit and raw vegetables. (1) Substances listed in paragraphs § 175.210 Acrylate ester copolymer (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), coating. (a)(8), and (a)(9) of this section, and Acrylate ester copolymer coating those substances prescribed by para- may safely be used as a food-contact graph (a)(4) of this section that are not surface of articles intended for pack- identified in paragraph (b)(2) of this aging and holding food, including heat- section. ing of prepared food, subject to the pro- (2) Substances identified in this sub- visions of this section: paragraph and subject to the limita- (a) The acrylate ester copolymer is a tions provided: fully polymerized copolymer of ethyl BHA. acrylate, methyl methacrylate, and BHT. methacrylic acid applied in emulsion Butadiene-acrylonitrile copolymer. form to molded virgin fiber and heat- Butadiene-acrylonitrile-styrene copolymer. Butadiene-styrene copolymer. cured to an insoluble resin. Butyl rubber. (b) Optional substances used in the Butylated reaction product of p-cresol and preparation of the polymer and in the dicyclopentadiene produced by reacting p- preparation and application of the

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emulsion may include substances List of substances Limitations named in this paragraph, in an amount not to exceed that required to accom- Cellulose acetate propionate. Mineral oil, white ...... For use only as a com- plish the desired technical effect and ponent of hot-melt subject to any limitation prescribed: strippable food coat- Provided, however, That any substance ings applied to frozen meats and complying named in this paragraph and covered with § 172.878 of this by a specific regulation in subchapter chapter. B of this chapter must meet any speci- fications in such regulation. § 175.250 Paraffin (synthetic). List of substances Limitations Synthetic paraffin may be safely Aluminum stearate. used as an impregnant in, coating on, Ammonium lauryl sulfate. or component of coatings on articles Borax ...... Not to exceed the used in producing, manufacturing, amount required as a preservative in emul- packing, processing, preparing, treat- sion defoamer. ing, packaging, transporting, or hold- Disodium hydrogen phosphate ..... Do. ing food in accordance with the fol- Formaldehyde. Glyceryl monostearate. lowing prescribed conditions: Methyl cellulose. (a) The additive is synthesized by the Mineral oil. Fischer-Tropsch process from carbon . Potassium hydroxide. monoxide and hydrogen, which are cat- Potassium persulfate. alytically converted to a mixture of Tallow. paraffin hydrocarbons. Lower molec- Tetrasodium pyrophosphate. Titanium dioxide. ular-weight fractions are removed by distillation. The residue is hydro- (c) The coating in the form in which genated and may be further treated by it contacts food meets the following percolation through activated char- tests: coal. This mixture can be fractionated (1) An appropriate sample when ex- into its components by a solvent sepa- posed to distilled water at 212 °F for 30 ration method, using synthetic minutes shall yield total chloroform- isoparaffinic petroleum hydrocarbons soluble extractables not to exceed 0.5 complying with § 178.3530 of this chap- milligram per square inch. ter. (2) An appropriate sample when ex- (b) Synthetic paraffin shall conform posed to n-heptane at 120 °F for 30 min- to the following specifications: utes shall yield total chloroform-solu- (1) Congealing point. There is no speci- ble extractables not to exceed 0.5 milli- fication for the congealing point of gram per square inch. synthetic paraffin components, except those components that have a con- § 175.230 Hot-melt strippable food ° coatings. gealing point below 50 C when used in contact with food Types III, IVA, V, Hot-melt strippable food coatings VIIA, and IX identified in table 1 of may be safely applied to food, subject § 176.170(c) of this chapter and under to the provisions of this section. conditions of use E, F, and G described (a) The coatings are applied to and in table 2 of § 176.170(c) of this chapter used as removable coatings for food. shall be limited to a concentration not (b) The coatings may be prepared, as exceeding 15 percent by weight of the mixtures, from the following sub- finished coating. The congealing point stances: shall be determined by ASTM method (1) Substances generally recognized D938–71 (Reapproved 1981), ‘‘Standard as safe in food. Test Method for Congealing Point of (2) Substances identified in this sub- paragraph. Petroleum Waxes, Including Petro- latum,’’ which is incorporated by ref- List of substances Limitations erence. Copies may be obtained from the American Society for Testing Ma- Acetylated monoglycerides ...... Complying with 172.828 of this chapter. terials, 100 Barr Harbor Dr., West Cellulose acetate butyrate. Conshohocken, Philadelphia, PA 19428-

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2959, or may be examined at the Na- (c) The finished food-contact coating, tional Archives and Records Adminis- when extracted with the solvent or sol- tration (NARA). For information on vents characterizing the type of food the availability of this material at and under the conditions of time and NARA, call 202–741–6030, or go to: http:// temperature characterizing the condi- www.archives.gov/federallregister/ tions of its intended use, as determined codeloflfederallregulations/ from tables 1 and 2 of § 175.300(d), yields ibrllocations.html. total extractives in each extracting (2) Oil content. The substance has an solvent not to exceed 0.3 milligrams oil content not exceeding 2.5 percent as per square inch of food-contact surface, determined by ASTM method D721–56T, as determined by the methods de- ‘‘Tentative Method of Test for Oil Con- scribed in § 175.300(e), and the coating tent of Petroleum Waxes’’ (Revised yields 2,2-dimethyl-1,3-propanediol in 1956), which is incorporated by ref- each extracting solvent not to exceed erence. See paragraph (b)(1) of this sec- 0.3 micrograms per square inch of food- tion for availability of the incorpora- contact surface. In testing the finished tion by reference. food-contact articles, a separate test (3) Absorptivity. The substance has an sample is to be used for each required absorptivity at 290 millimicrons in extracting solvent. decahydronaphthalene at 88 °C not ex- ceeding 0.01 as determined by ASTM § 175.270 Poly(vinyl fluoride) resins. method E131–81a, ‘‘Standard Defini- Poly(vinyl fluoride) resins identified tions of Terms and Symbols Relating in this section may be safely used as to Molecular-Spectroscopy,’’ which is components of food-contact coatings incorporated by reference. See para- for containers having a capacity of not graph (b)(1) of this section for avail- less than 5 gallons, subject to the pro- ability of the incorporation by ref- visions of this section. erence. (a) For the purpose of this section, (c) The provisions of this section are poly(vinyl fluoride) resins consist of not applicable to synthetic paraffin basic resins produced by the polym- used in food-packaging adhesives com- erization of vinyl fluoride. plying with § 175.105. (b) The poly(vinyl fluoride) basic res- [42 FR 14534, Mar. 15, 1977, as amended at 47 ins have an intrinsic viscosity of not FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, less than 0.75 deciliter per gram as de- 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, termined by ASTM method D1243–79, Aug. 3, 1995] ‘‘Standard Test Method for Dilute So- lution Viscosity of Vinyl Chloride § 175.260 Partial phosphoric acid Polymers,’’ which is incorporated by esters of polyester resins. reference. Copies may be obtained from Partial phosphoric acid esters of pol- the American Society for Testing Ma- yester resins identified in this section terials, 100 Barr Harbor Dr., West and applied on aluminum may be safely Conshohocken, Philadelphia, PA 19428- used as food-contact coatings, in ac- 2959, or may be examined at the Na- cordance with the following prescribed tional Archives and Records Adminis- conditions: tration (NARA). For information on (a) For the purpose of this section, the availability of this material at partial phosphoric acid esters of poly- NARA, call 202–741–6030, or go to: http:// ester resins are prepared by the reac- www.archives.gov/federallregister/ tion of trimellitic anhydride with 2,2- codeloflfederallregulations/ dimethyl-1,3-propanediol followed by ibrllocations.html. reaction of the resin thus produced (1) Solvent. N,N-Dimethylacetamide, with phosphoric acid anhydride to technical grade. produce a resin having an acid number (2) Solution. Powdered resin and sol- of 81 to 98 and a phosphorus content of vent are heated at 120 °C until the resin 4.05 to 4.65 percent by weight. is dissolved. (b) The coating is chemically bonded (3) Temperature. Flow times of the to the metal and cured at temperatures solvent and solution are determined at exceeding 450 °F. 110 °C.

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(4) Viscometer. Cannon-Ubbelohde size (1) Substances generally recognized 50 semimicro dilution viscometer (or as safe in food. equivalent). (2) Substances the use of which is (5) Calculation. The calculation meth- permitted by regulations in this part od used is that described in appendix X or which are permitted by prior sanc- 1.3 (ASTM method D1243–79, ‘‘Standard tion or approval and employed under Test Method for Dilute Solution Vis- the specific conditions, if any, of the cosity of Vinyl Chloride Polymers,’’ prior sanction or approval. which is incorporated by reference; see (3) Any substance employed in the paragraph (b) of this section for avail- production of resinous and polymeric ability of the incorporation by ref- coatings that is the subject of a regula- erence) with the reduced viscosity de- tion in subchapter B of this chapter termined for three concentration levels and conforms with any specification in not greater than 0.5 gram per deciliter such regulation. Substances named in and extrapolated to zero concentration this paragraph (b)(3) and further identi- for intrinsic viscosity. The following fied as required: formula is used for determining re- (i) Drying oils, including the duced viscosity: triglycerides or fatty acids derived therefrom: tto− Reduced viscosity in terms = Beechnut. of deciliters per gram to× c Candlenut. where: Castor (including dehydrated). Chinawood (tung). t = Solution efflux time. Coconut. to = Solvent efflux time. Corn. c = Concentration of solution in terms of Cottonseed. grams per deciliter. Fish (refined). [42 FR 14534, Mar. 15, 1977, as amended at 47 Hempseed. FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, Linseed. 1984] Oiticica. Perilla. § 175.300 Resinous and polymeric coat- Poppyseed. ings. Pumpkinseed. Safflower. Resinous and polymeric coatings Sesame. may be safely used as the food-contact Soybean. surface of articles intended for use in Sunflower. producing, manufacturing, packing, Tall oil. processing, preparing, treating, pack- Walnut. aging, transporting, or holding food, in The oils may be raw, heat-bodied, or accordance with the following pre- blown. They may be refined by filtra- scribed conditions: tion, degumming, acid or alkali wash- (a) The coating is applied as a contin- ing, bleaching, distillation, partial de- uous film or enamel over a metal sub- hydration, partial polymerization, or strate, or the coating is intended for solvent extraction, or modified by com- repeated food-contact use and is ap- bination with maleic anhydride. plied to any suitable substrate as a (ii) Reconstituted oils from continuous film or enamel that serves triglycerides or fatty acids derived as a functional barrier between the from the oils listed in paragraph food and the substrate. The coating is (b)(3)(i) of this section to form esters characterized by one or more of the fol- with: lowing descriptions: (1) Coatings cured by oxidation. Butylene glycol. (2) Coatings cured by polymerization, Ethylene glycol. condensation, and/or cross-linking Pentaerythritol. without oxidation. Polyethylene glycol. Polypropylene glycol. (3) Coatings prepared from prepoly- Propylene glycol. merized substances. Sorbitol. (b) The coatings are formulated from Trimethylol ethane. optional substances that may include: Trimethylol propane.

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(iii) Synthetic drying oils, as the Alkylated (methyl, ethyl, propyl, isopropyl, basic polymer: butyl) phenols. p-tert-Amylphenol. Butadiene and methylstyrene copolymer. 4,4′-sec-Butylidenediphenol. Butadiene and styrene copolymer, blown or p-tert-Butylphenol. unblown. o-, m-, and p-Cresol. Maleic anhydride adduct of butadiene sty- p-Cyclohexylphenol. rene. 4,4′-Isopropylidenediphenol. Polybutadiene. p-Nonylphenol. p-Octylphenol. (iv) Natural fossil resins, as the basic 3-Pentadecyl phenol mixture obtained from resin: cashew nut shell liquid. Copal. Phenol. Damar. Phenyl o-cresol. Elemi. p-Phenylphenol. Gilsonite. Xylenol. Glycerol ester of damar, copal, elemi, and (b) Adjunct for phenolic resins: Alu- sandarac. minum butylate. Sandarac. Shellac. (vii) Polyester resins (including Utah coal resin. alkyd-type), as the basic polymers, formed as esters of acids listed in para- (v) Rosins and rosin derivatives, with graph (b)(3)(vii) (a) and (b) of this sec- or without modification by polymeriza- tion by reaction with alcohols in para- tion, isomerization, incidental graph (b)(3)(vii) (c) and (d) of this sec- decarboxylation, and/or hydrogenation, tion. as follows: (a) Polybasic acids: (a) Rosins, refined to color grade of K or paler: Adipic. 1,4-cyclohexanedicarboxylic (CAS Reg. No. Gum rosin. 1076–97–7). Tall oil rosin. Dimerized fatty acids derived from oils listed Wood rosin. in paragraph (b)(3)(i) of this section. (b) Rosin esters formed by reacting Fumaric. Isophthalic. rosin (paragraph (b)(3)(v)(a) of this sec- Maleic. tion) with: 2,6-Naphthalenedicarboxylic. 4,4′-sec-Butylidenediphenol-epichlorohydrin 2,6-Naphthalenedicarboxylic, dimethyl ester. (epoxy). Orthophthalic. Sebacic. Diethylene glycol. Terephthalic. Ethylene glycol. Terpene-maleic acid adduct. Glycerol. Trimellitic. 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy). (b) Monobasic acids: Methyl alcohol. Pentaerythritol. Benzoic acid. 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. (c) Rosin esters (paragraph (b)(3)(v)(b) tert-Butyl benzoic acid. of this section) modified by reaction Fatty acids derived from oils listed in para- with: graph (b)(3)(i) of this section. Rosins listed in paragraph (b)(3)(v)(a) of this Maleic anhydride. section, for use only as reactants in oil- o-, m-, and p-substituted phenol-formalde- based or fatty acid-based alkyd resins. hydes listed in paragraph (b)(3)(vi) of this section. (c) Polyhydric alcohols: Phenol-formaldehyde. Butylene glycol. (d) Rosin salts: Diethylene glycol. 2,2-Dimethyl-1,3-propanediol for use only in Calcium resinate (limed rosin). forming polyester resins for coatings in- Zinc resinate. tended for use in contact with non-alco- (vi) Phenolic resins as the basic poly- holic foods. Ethylene glycol. mer formed by reaction of phenols with Glycerol. formaldehyde: Mannitol. (a) Phenolic resins formed by reac- a-Methyl glucoside. tion of formaldehyde with: Pentaerythritol.

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Propylene glycol. or fatty acids listed in paragraph (b)(3)(i) Sorbitol. of this section. Triethylene glycol, for use as a component in 4,4′-Isopropylidenediphenol-epichlorohydrin polyester resins for coatings not exceeding chemically treated with one or more of a coating weight of 4 milligrams per square the following substances: inch and that are intended for contact Allyl ether of mono-, di-, or trimethylol under conditions of use D, E, F or G de- phenol. scribed in table 2 of paragraph (d) of this 4,4′-sec-Butylidenediphenol-formaldehyde. section with alcoholic beverages con- 4,4′-Isopropylidenediphenol-formaldehyde. taining less than 8 percent alcohol. Melamine-formaldehyde. Trimethylol ethane. 2,2′-[(1-methylethylidene)bis[4,1- Trimethylol propane. phenyleneoxy[1-(butoxymethyl)-2,1- ethanediyl]oxymethylene]]bisoxirane, (d) Monohydric alcohols: CAS Reg. No. 71033–08–4, for use only in Cetyl alcohol. coatings intended for contact with bulk ° Decyl alcohol. dry foods at temperatures below 100 F. Lauryl alcohol. Phenol-formaldehyde. Myristyl alcohol. Urea-formaldehyde. Octyl alcohol. (b) Catalysts and cross-linking agents Stearyl alcohol. for epoxy resins: (e) Catalysts: 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- Dibutyltin oxide (CAS Reg. No. 818–08–6), not amine reacted with phenol and formalde- to exceed 0.2 percent of the polyester resin. hyde in a ratio of 2.6:1.0:2.0, for use only in Hydroxybutyltin oxide (CAS Reg. No. 2273– coatings intended for repeated use in con- 43–0), not to exceed 0.2 percent of the poly- tact with foods only of the types identified ester resin. in paragraph (d) of this section, table 1, Monobutyltin tris(2-ethylhexoate) (CAS Reg. under Category I and Category VIII, at ° ° No. 23850–94–4), not to exceed 0.2 percent of temperatures not exceeding 88 C (190 F). the polyester resin. N-Beta-(aminoethyl)-gamma-aminopropyltri- methoxysilane (CAS Reg. No. 1760–24–3), for (viii) Epoxy resins, catalysts, and ad- use only in coatings at a level not to ex- juncts: ceed 1.3 percent by weight of the resin (a) Epoxy resins, as the basic poly- when such coatings are intended for re- mer: peated use in contact with foods only of the types identified in paragraph (d) of this (Alkoxy C10-C16)-2,3-epoxypropane, in which section, table 1, under Types I, II, and III, the alkyl groups are even numbered and under conditions of use C, D, E, or F as de- consist of a maximum of 1 percent C10 car- scribed in table 2 of paragraph (d) of this bon atoms and a minimum of 48 percent C12 section; or when such coatings are in- carbon atoms and a minimum of 18 percent tended for repeated use in contact with C14 carbon atoms, for use only in coatings foods of the types identified in paragraph that are intended for contact with dry bulk (d) of this section, table 1, under Types V, foods at room temperature. VI, VII, and VIII, under conditions of use E 4,4′-sec-Butylidenediphenol-epichlorohydrin. or F as described in table 2 of paragraph (d) 4,4′-sec-Butylidenediphenol-epichlorohydrin of this section. Use shall be limited to reacted with one or more of the drying oils coatings for tanks of capacity greater than or fatty acids listed in paragraph (b)(3)(i) 530,000 gallons. of this section. Benzyl alcohol (CAS Reg. No. 100–51–6), for 4,4′-sec-Butylidenediphenol-epichlorohydrin use only in coatings at a level not to ex- chemically treated with one or more of ceed 4 percent by weight of the resin when the following substances: such coatings are intended for repeated use Allyl ether of mono-, di-, or trimethylol in contact with foods only of the types phenol. identified in paragraph (d) of this section, 4,4′-sec-Butylidenediphenol-formaldehyde. table 1, under Types I, II, and III, under 4,4′-Isopropylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described Melamine-formaldehyde. in table 2 of paragraph (d) of this section; Phenol-formaldehyde. or when such coatings are intended for re- Urea-formaldehyde. peated use in contact with foods of the Epoxidized polybutadiene. types identified in paragraph (d) of this Glycidyl ethers formed by reacting section, table 1, under Types V, VI, VII, phenolnovolak resins with and VIII, under conditions of use E or F as epichlorohydrin. described in table 2 of paragraph (d) of this 4,4′-Isopropylidenediphenol-epichlorohydrin. section. Use shall be limited to coatings 4,4′-Isopropylidenediphenol-epichlorohydrin for tanks of capacity greater than 530,000 reacted with one or more of the drying oils gallons.

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Catalysts and cross-linking agents for epoxy coholic beverages containing up to 8 per- resins: cent of alcohol by volume. 3-Aminomethyl-3,5,5- Salicylic acid (CAS Reg. No. 69–72–7), for use trimethylcyclohexylamine (CAS Reg. No. only in coatings at a level not to exceed 2855–0913–092). 0.35 percent by weight of the resin when Cyanoguanidine. such coatings are intended for repeated use Dibutyl phthalate, for use only in coatings in contact with foods only of the types for containers having a capacity of 1,000 identified in paragraph (d) of this section, gallons or more when such containers are table 1, under Types I, II, and III, under intended for repeated use in contact with conditions of use C, D, E, or F as described alcoholic beverages containing up to 8 per- in table 2 of paragraph (d) of this section; cent of alcohol by volume. or when such coatings are intended for re- 3-Diethylaminopropylamine (CAS Reg. No. peated use in contact with foods of the 104–78–9), for use in coatings at a level not types identified in paragraph (d) of this to exceed 6 percent by weight of the resin section, table 1, under Types V, VI, VII, when such coatings are intended for re- and VIII, under conditions of use E or F as peated use in contact with foods only of described in table 2 of paragraph (d) of this the types identified in paragraph (d) of this section. Use shall be limited to coatings section, table 1, under Types I, II, and III, for tanks of capacity greater than 530,000 under conditions of use C, D, E, or F as de- gallons. scribed in table 2 of paragraph (d) of this Stannous 2-ethylhexanoate for use only as a section; or when such coatings are in- catalyst at a level not to exceed 1 percent tended for repeated use in contact with by weight of the resin used in coatings that foods of the types identified in paragraph are intended for contact with food under conditions of use D, E, F, and G described (d) of this section, table 1, under Types V, in table 2 of paragraph (d) of this section. VI, VII, and VIII, under conditions of use E Styrene oxide, for use only in coatings for or F as described in table 2 of paragraph (d) containers having a capacity of 1,000 gal- of this section. Use shall be limited to lons or more when such containers are in- coatings for tanks of capacity greater than tended for repeated use in contact with al- 530,000 gallons. coholic beverages containing up to 8 per- Diethylenetriamine. cent of alcohol by volume. Diphenylamine. Tetraethylenepentamine. Ethylenediamine. Tetraethylenepentamine reacted with Isophthalyl dihydrazide for use only in coat- equimolar quantities of fatty acids. ings subject to the provisions of paragraph Tri(dimethylaminomethyl) phenol and its (c) (3) or (4) of this section. salts prepared from the fatty acid moieties 4,4′-Methylenedianiline, for use only in coat- of the salts listed in paragraph ings for containers having a capacity of (b)(3)(xxii)(b) of this section, for use only 1,000 gallons or more when such containers in coatings subject to the provisions of are intended for repeated use in contact paragraph (c) (3) or (4) of this section. with alcoholic beverages containing up to 8 Triethylenetetramine. percent of alcohol by volume. Trimellitic anhydride (CAS Reg. No. 552–30– N-Oleyl-1,3-propanediamine with not more 7) for use only as a cross-linking agent at than 10 percent by weight of a level not to exceed 15 percent by weight diethylaminoethanol. of the resin in contact with food under all 3-Pentadecenyl phenol mixture (obtained conditions of use, except that resins in- from cashew nutshell liquid) reacted with tended for use with foods containing more formaldehyde and ethylenediamine in a than 8 percent alcohol must contact such ratio of 1:2:2 (CAS Reg. No. 68413–28–5). food only under conditions of use D, E, F, Polyamine produced when 1 mole of the and G described in table 2 of paragraph (d) chlorohydrin diether of polyethylene gly- of this section. col 400 is made to react under Trimellitic anhydride adducts of ethylene dehydrohalogenating conditions with 2 glycol and glycerol, prepared by the reac- moles of N-octadecyltrimethylenediamine tion of 1 mole of trimellitic anhydride with for use only in coatings that are subject to 0.4–0.6 mole of ethylene glycol and 0.04–0.12 the provisions of paragraph (c) (3) or (4) of mole of glycerol, for use only as a cross- this section and that contact food at tem- linking agent at a level not to exceed 10 peratures not to exceed room temperature. percent by weight of the cured coating, Polyethylenepolyamine (CAS Reg. No. 68131– provided that the cured coating only con- 73–7), for use only in coatings intended for tacts food containing not more than 8 per- repeated use in contact with food, at tem- cent alcohol. peratures not to exceed 180 °F (82 °C). Meta-Xylylenediamine (1,3-benzenedi- Salicylic acid, for use only in coatings for methanamine, CAS Reg. No. 1477–55–0), for containers having a capacity of 1,000 gal- use only in coatings at a level not to ex- lons or more when such containers are in- ceed 3 percent by weight of the resin when tended for repeated use in contact with al- such coatings are intended for repeated use

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in contact with foods only of the types (ix) Coumarone-indene resin, as the identified in paragraph (d) of this section, basic polymer. table 1, under Types I, II, and III, under (x) Petroleum hydrocarbon resin conditions of use C, D, E or F as described (cyclopentadiene type), as the basic in table 2 of paragraph (d) of this section; polymer. or when such coatings are intended for re- peated use in contact with foods of the (xi) Terpene resins, as the basic poly- types identified in paragraph (d) of this mer, from one or more of the following: section, table 1, under Types V, VI, VII, Dipentene. and VIII, under conditions of use E or F as Hydrogenated dipentene resin (CAS Reg. No. described in table 2 of paragraph (d) of this 106168–39–2). For use only with coatings in section. Use shall be limited to coatings contact with acidic and aqueous foods. for tanks of capacity greater than 530,000 Hydrogenated-beta-pinene-alpha-pinene- gallons. dipentene copolymer resin (CAS Reg. No. Para-Xylylenediamine (1,4 benzenedimethan- 106168–37–0). For use only with coatings in amine, CAS Reg. No. 539–48–0), for use only contact with acidic and aqueous foods. in coatings at a level not to exceed 0.6 per- a-Pinene. cent by weight of the resin when such coat- b-Pinene. ings are intended for repeated use in con- tact with foods only of the types identified (xii) Urea-formaldehyde, resins and in paragraph (d) of this section, table 1, their curing catalyst: under Types I, II, III, under conditions of (a) Urea-formaldehyde resins, as the use C, D, E, or F as described in table 2 of basic polymer: paragraph (d) of this section; or when such Urea-formaldehyde. coatings are intended for repeated use in Urea-formaldehyde chemically modified with contact with foods of the types identified methyl, ethyl, propyl, isopropyl, butyl, or in paragraph (d) of this section, table 1, isobutyl alcohol. under Types V, VI, VII, and VIII, under Urea-formaldehyde chemically modified with conditions of use E and F as described in one or more of the amine catalysts listed table 2 of paragraph (d) of this section. Use in paragraph (b)(3)(viii)(b) of this section. shall be limited to coatings for tanks of ca- pacity greater than 530,000 gallons. (b) Curing (cross-linking) catalyst for urea-formaldehyde resins: (c) Adjuncts for epoxy resins: Dodecyl benzenesulfonic acid (C.A. Registry Aluminum butylate. No. 27176–87–0). Benzoic acid, for use as a component in epoxy resins for coatings not exceeding a (xiii) Triazine-formaldehyde resins coating weight of 4 milligrams per square and their curing catalyst: inch and that are intended for contact (a) Triazine-formaldehyde resins, as under conditions of use D, E, F or G de- the basic polymer: scribed in table 2 of paragraph (d) of this section with alcoholic beverages con- Benzoguanamine-formaldehyde. taining less than 8 percent alcohol. Melamine-formaldehyde. Melamine-formaldehyde chemically modified Polyamides from dimerized vegetable oils with one or more of the following amine and the amine catalysts listed in para- catalysts: graph (b)(3)(viii)(b) of this section, as the Amine catalysts listed in paragraph basic polymer. (b)(3)(viii)(b) of this section. Silane coupled silica, prepared from the re- Dimethylamine-2-methyl-1-propanol. action of microcrystalline quartz with N- Methylpropanolamine. beta-(N-vinylbenzylamino) ethyl-gamma- Triethanolamine. aminopropyltrimethoxy silane, mono- Melamine-formaldehyde chemically modified , for use only in coatings with methyl, ethyl, propyl, isopropyl, intended for repeated use in contact with butyl, or isobutyl alcohol. foods only of the types identified in para- graph (d) of this section, table 1, under (b) Curing (cross-linking) catalyst for Category I and Category VIII, at tempera- triazine-formaldehyde resins: tures not exceeding 88 °C (190 °F). Dodecyl benzenesulfonic acid (C.A. Registry Succinic anhydride, for use as a component No. 27176–87–0). in epoxy resins for coatings not exceeding a coating weight of 4 milligrams per square (xiv) Modifiers (for oils and alkyds, inch, and that are intended for contact including polyesters), as the basic poly- under conditions of use D, E, F or G de- mer: scribed in table 2 of paragraph (d) of this section with alcoholic beverages con- Butyl methacrylate. taining less than 8 percent alcohol. Cyclopentadiene.

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Methyl, ethyl, butyl, or octyl esters of acryl- (xvi) Cellulosics, as the basic poly- ic acid. mer: Methyl methacrylate. Styrene. Carboxymethylcellulose. Vinyl toluene. Cellulose acetate. Cellulose acetate-butyrate. (xv) Vinyl resinous substance, as the Cellulose acetate-propionate. basic polymers: Ethylcellulose. Polyvinyl acetate. Ethyl hydroxyethylcellulose. Polyvinyl alcohol. Hydroxyethylcellulose. Polyvinyl butyral. Hydroxypropyl methylcellulose. Polyvinyl chloride. Methylcellulose. Polyvinyl formal. Nitrocellulose. Polyvinylidene chloride. (xvii) Styrene polymers, as the basic Polyvinyl pyrrolidone. polymer: Polyvinyl stearate. Vinyl chloride-acetate-2,3-epoxypropyl meth- Polystyrene. acrylate copolymers containing not more a-Methyl styrene polymer. than 10 weight percent of total polymer Styrene copolymerized with one or more of units derived from 2,3-epoxypropyl meth- the following: acrylate and not more than 0.1 weight per- Acrylonitrile. cent of unreacted 2,3-epoxypropyl meth- a-Methylstyrene. acrylate monomer for use in coatings for containers. (xviii) Polyethylene and its copoly- Vinyl chloride-acetate, hydroxyl-modified mers as the basic polymer: copolymer. Vinyl chloride-acetate, hydroxyl-modified Ethylene-ethyl acrylate copolymer. copolymer, reacted with trimellitic anhy- Ethylene-isobutyl acrylate copolymers con- dride. taining no more than 35 weight percent of Vinyl chloride copolymerized with acryl- total polymer units derived from isobutyl amide and ethylene in such a manner that acrylate. the finished copolymers have a minimum Ethylene-vinyl acetate copolymer. weight average molecular weight of 30,000 Polyethylene. and contain not more than 3.5 weight per- cent of total polymer units derived from (xix) Polypropylene as the basic poly- acrylamide; the acrylamide portion may or mer: may not be subsequently partially Polypropylene. hydrolyzed. Maleic anhydride adduct of polypropylene Vinyl chloride copolymerized with one or The polypropylene used in the manufac- more of the following substances: ture of the adduct complies with Acrylonitrile. § 177.1520(c), item 1.1; and the adduct has a Fumaric acid and/or its methyl, ethyl, maximum combined maleic anhydride con- propyl, butyl, amyl, hexyl, heptyl, or octyl tent of 0.8 percent and a minimum intrin- esters. sic viscosity of 0.9, determined at 135 °C on Maleic acid and/or its methyl, ethyl, propyl, a 0.1 percent solution of the modified poly- butyl, amyl, hexyl, heptyl, or octyl esters. propylene in decahydronaphthalene as de- 5-Norbornene-2,3-dicarboxylic acid, mono-n- termined by a method titled ‘‘Method for butyl ester; for use such that the finished Determination of Intrinsic Viscosity of vinyl chloride copolymers contain not Maleic Anhydride Adduct of Poly- more than 4 weight percent of total poly- propylene,’’ which is incorporated by ref- mer units derived from this comonomer. erence. Copies are available from the Cen- Vinyl acetate. ter for Food Safety and Applied Nutrition Vinylidene chloride. (HFS–200), Food and Drug Administration, Vinyl chloride-vinylidene chloride-2,3- 5001 Campus Dr., College Park, MD 20740, epoxypropyl methacrylate copolymers con- or available for inspection at the National taining not more than 10 weight percent of Archives and Records Administration total polymer units derived from 2,3- (NARA). For information on the avail- epoxypropyl methacrylate and not more ability of this material at NARA, call 202– than 0.05 weight percent of unreacted 2,3- 741–6030, or go to: http://www.archives.gov/ epoxypropyl methacrylate monomer based federallregister/ on polymer solids for use only in coatings codeloflfederallregulations/ for containers intended for contact with ibrllocations.html. foods under conditions B, C, D, E, F, G, or H described in table 2 of paragraph (d) of (xx) Acrylics and their copolymers, this section. as the basic polymer:

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Acrylamide with ethylacrylate and/or sty- containing no more than 2 weight percent rene and/or methacrylic acid, subsequently of total polymer units derived from meth- reacted with formaldehyde and butanol. acrylic acid and containing no more than Acrylic acid and the following esters thereof: 9.5 weight percent of total polymer units Ethyl. derived from hydroxyethyl methacrylate; Methyl. for use only in coatings in contact with dry Butyl acrylate-styrene-methacrylic acid-hy- food (food type VIII in table 1 of paragraph droxyethyl methacrylate copolymers con- (d) of this section). 2-(Dimethylamino) eth- taining no more than 20 weight percent of anol (C.A.S. Registry No. 108–01–0) may be total polymer units derived from meth- employed as an optional adjuvant sub- acrylic acid and containing no more than 7 stance limited to no more than 2 weight weight percent of total polymer units de- percent based on polymer solids in the rived from hydroxyethyl methacrylate; for coating emulsion. use only in coatings that are applied by Styrene polymers made by the polymeriza- electrodeposition to metal substrates. tion of any combination of styrene or Butyl acrylate-styrene-methacrylic acid- alpha methyl styrene with acrylic acid, hydroxypropyl methacrylate copolymers methacrylic acid, 2-ethyl hexyl acrylate, containing no more than 20 weight percent methyl methacrylate, and butyl acrylate. of total polymer units derived from meth- The styrene and alpha methyl styrene, in- acrylic acid and containing no more than 7 dividually, may constitute from 0 to 80 weight percent of total polymer units de- weight percent of the polymer. The other rived from hydroxypropyl methacrylate; monomers, individually, may be from 0 to for use only in coatings that are applied by 40 weight percent of the polymer. The poly- electrodeposition to metal substrates and mer number average molecular weight (Mn) that are intended for contact, under condi- shall be at least 2,000 (as determined by gel tion of use D, E, F, or G described in table permeation chromatography). The acid 2 of paragraph (d) of this section, with food number of the polymer shall be less than containing no more than 8 percent of alco- 250. The monomer content shall be less hol. than 0.5 percent. The polymers are for use Ethyl acrylate-styrene-methacrylic acid co- only in contact with food of Types IV-A, V, polymers for use only as modifiers for VII in table 1 of paragraph (d) of this sec- epoxy resins listed in paragraph tion, under use conditions E through G in (b)(3)(viii)(a) of this section. table 2 of paragraph (d), and with food of Ethyl acrylate-methyl methacrylate-sty- Type VIII without use temperature restric- rene-methacrylic acid copolymers for use tion. only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this section. (xxi) Elastomers, as the basic poly- 2-Ethylhexyl acrylate-ethyl acrylate copoly- mer: mers prepared by copolymerization of 2- Butadiene-acrylonitrile copolymer. ethylhexyl acrylate and ethyl acrylate in a Butadiene-acrylonitrile-styrene copolymer. 7/3 weight ratio and having a number aver- Butadiene-styrene copolymer. age molecular weight range of 5,800 to 6,500 Butyl rubber. ° and a refractive index, nD25 (40 percent in Chlorinated rubber. 2,2,4-trimethyl pentane) of 1.4130–1.4190; for 2-Chloro-1,3-butadiene (neoprene). use as a modifier for nylon resins com- Natural rubber (natural latex or natural plying with § 177.1500 of this chapter and for latex solids, smoked or unsmoked). phenolic and epoxy resins listed in para- Polyisobutylene. graph (b)(3) (vi) and (viii) of this section, Rubber hydrochloride. respectively, at a level not to exceed 1.5 Styrene-isobutylene copolymer. percent of the coating. 2-Ethylhexyl acrylate-methyl methacrylate- (xxii) Driers made by reaction of a acrylic acid copolymers for use only as metal from paragraph (b)(3)(xxii)(a) of modifiers for epoxy resins listed in para- this section with acid, to form the salt graph (b)(3)(viii) of this section. listed in paragraph (b)(3)(xxii)(b) of this Methacrylic acid and the following esters section: thereof: (a) Metals: Butyl. Ethyl. Aluminum. Methyl. Calcium. Methacrylic acid or its ethyl and methyl Cerium. esters copolymerized with one or more of Cobalt. the following: Iron. Acrylic acid. Lithium. Ethyl acrylate. Magnesium. Methyl acrylate. Manganese. n-Butyl acrylate-styrene-methacrylic acid- Zinc. hydroxyethyl methacrylate copolymers .

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(b) Salts: Petrolatum. Polyethylene wax. Caprate. Polyoxyethylene glycol monooleate (mol. Caprylate. wt. of the polyoxyethylene glycol moiety Isodecanoate. greater than 300). Linoleate. Polytetrafluoroethylene. Naphthenate. Silicones (not less than 300 centistokes vis- Neodecanoate. cosity): Dimethylpolysiloxanes and/or Octoate (2-ethylhexoate). methylphenylpolysiloxanes. The methyl- Oleate. phenylpolysiloxanes contain not more than Palmitate. 2.0 percent by weight of cyclosiloxanes Resinate. having up to and including 4 siloxy units. Ricinoleate. Silicones (not less than 100 centistokes vis- Soyate. cosity): Dimethylpolysiloxanes and/or Stearate. methylphenylpolysiloxanes limited to use Tallate. only on metal substrates. The (xxiii) Waxes: methylphenylpolysiloxanes contain not more than 2.0 percent by weight of Paraffin, Type I. cyclosiloxanes having up to and including 4 Paraffin, Type II. siloxy units. Polyethylene. Sperm oil. (xxvi) Colorants used in accordance Spermaceti. with § 178.3297 of this chapter. (xxiv) Plasticizers: (xxvii) Surface lubricants: Acetyl tributyl citrate. Cottonseed oil and other edible oils. Acetyl triethyl citrate. Dibutyl sebacate. Butyl phthalyl butyl glycolate. Dioctyl sebacate. Butyl stearate. Glyceryl monostearate. p-tert-Butyl phenyl salicylate. Lanolin. Dibutyl sebacate. Mineral oil, white. Diethyl phthalate. Palm oil. Diisobutyl adipate. Paraffin, Type I. Diisooctyl phthalate. Paraffin, Type II. Epoxidized soybean oil (iodine number max- Petrolatum. imum 14; oxirane oxygen content 6% min- Stearic acid. imum), as the basic polymer. (xxviii) Silicones and their curing Ethyl phthalyl ethyl glycolate. catalysts: 2-Ethylhexyl diphenyl phosphate. di-2-Ethylhexyl phthalate. (a) Silicones as the basic polymer: Glycerol. Siloxane resins originating from methyl hy- Glyceryl monooleate. drogen polysiloxane, dimethyl Glyceryl triacetate. polysiloxane, and methylphenyl Monoisopropyl citrate. polysiloxane. Propylene glycol. Siloxane resins originating from the plat- Sorbitol. inum-catalyzed reaction product of vinyl- Mono-, di-, and tristearyl citrate. containing dimethylpolysiloxane (CAS Triethyl citrate. Reg. No. 68083–18–1 and CAS Reg. No. 68083– Triethylene glycol. 19–2) with methylhydrogen polysiloxane 3-(2-Xenolyl)-1,2-epoxypropane. (CAS Reg. No. 63148–57–2) and (xxv) Release agents, as the basic dimethylmethylhydrogen polysiloxane polymer, when applicable: (CAS Reg. No. 68037–59–2), where the plat- inum content does not exceed 150 parts per N,N′-Dioleoylethylenediamine (CAS Reg. No. million. The following substances may be 110–31–6) for use only in ionomeric resins used as optional polymerization inhibitors: complying with § 177.1330 of this chapter 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. and in ethylene vinyl acetate copolymers 107–54–0), at a level not to exceed 0.53 complying with § 177.1350 of this chapter at weight-percent; a level not to exceed 0.0085 milligram per 1-Ethynylcyclohexene (CAS Reg. No. 931–49– square centimeter (0.055 milligram per 7), at a level not to exceed 0.64 weight-per- square inch) in the finished food-contact cent; article. Bis(methoxymethyl)ethyl maleate (CAS Reg. N,N′-Distearoyl ethylenediamine. No. 102054–10–4), at a level not to exceed 1.0 Linoleic acid amide. weight-percent; Oleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No. Palmitic acid amide. 68082–23–5); and

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Tetramethyltetravinylcyclotetrasiloxane Butadiene-styrene-divinylbenzene copolymer (CAS Reg. No. 2554–06–5). (CAS Reg. No. 26471–45–4) for use only at levels not to exceed 23.8 percent by weight (b) Curing (cross-linking) catalysts of the cement solids in can end cements. for silicones (the maximum amount of Butadiene-styrene-fumaric acid copolymer. tin catalyst used shall be that required 4,4′-Butylidenebis (6-tert-butyl-m-cresol). to effect optimum cure but shall not Dibenzamido phenyl disulfide. exceed 1 part of tin per 100 parts of si- Di-b-naphthyl phenylenediamine. loxane resins solids): Dipentamethylene thiuram tetrasulfide. Isobutylene-isoprene-divinylbenzene copoly- Dibutyltin dilaurate. mers for use only at levels not to exceed 15 Stannous oleate. percent by weight of the dry cement com- Tetrabutyl titanate. position. (xxix) Surface active agents: Naphthalene sulfonic acid-formaldehyde con- densate, sodium salt, for use only at levels Ethylene oxide adduct of 2,4,7,9-tetramethyl- not to exceed 0.6 percent by weight of the 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). cement solids in can end cements for con- Poly[2-(diethylamino) ethyl methacrylate] tainers having a capacity of not less than phosphate (minimum intrinsic viscosity in 5 gallons. water at 25 °C is not less than 9.0 deciliters Sodium decylbenzene sulfonate. per gram as determined by ASTM method Sodium nitrite for use only at levels not to D1243–79, ‘‘Standard Test Method for Dilute exceed 0.3 percent by weight of the cement Solution Viscosity of Vinyl Chloride Poly- solids in can end cements for containers mers,’’ which is incorporated by reference having a capacity of not less than 5 gal- (Copies may be obtained from the Amer- lons. ican Society for Testing Materials, 100 Sodium pentachlorophenate for use as a pre- Barr Harbor Dr., West Conshohocken, servative at 0.1 percent by weight in can- Philadelphia, PA 19428-2959, or may be ex- sealing compounds on containers having a amined at the National Archives and capacity of 5 gallons or more. Records Administration (NARA). For in- Sodium phenylphenate. formation on the availability of this mate- Styrene-maleic anhydride resin, partial rial at NARA, call 202–741–6030, or go to: methyl and butyl (sec- or iso-) esters, for http://www.archives.gov/federallregister/ use only at levels not in excess of 3 percent codeloflfederallregulations/ of the cement solids in can end cement for- ibrllocations.html.), for use only as a sus- mulations. pending agent in the manufacture of vinyl Tetrasodium EDTA (tetrasodium ethylene- chloride copolymers and limited to use at diaminetetraacetate). levels not to exceed 0.1 percent by weight Tri (mixed mono- and dinonylphenyl) of the copolymers. phosphite. Sodium dioctyl sulfosuccinate. Zinc dibutyldithiocarbamate. Sodium dodecylbenzenesulfonate Sodium lauryl sulfate. (xxxii) Side seam cements: In addi- 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. tion to the substances listed in para- Reg. No. 126-86-3), for use only in can coat- graph (b)(3) (i) to (xxx), inclusive, of ings which are subsequently dried and this section, the following may be used. cured at temperatures of at least 193 °C (380 °F) for 4 minutes. p-tert-Butyl perbenzoate as a catalyst for epoxy resin. (xxx) Antioxidants: epsilon-Caprolactam-(ethylene-ethyl acry- late) graft polymer. Butylated hydroxyanisole. Dicumyl peroxide for use only as polymeriza- Butylated hydroxytoluene. tion catalyst. Gum guaiac. 4–(Diiodomethylsulfonyl) toluene (CAS Reg. Dilauryl thiodipropionate. No. 20018–09–1) for use as a preservative at Nordihydroguaiaretic acid. a level not to exceed 0.3 percent by weight Propyl gallate. in can-sealing cements. Distearyl thiodipropionate. Diisodecyl phthalate for use only as plasti- Thiodipropionic acid. cizer in side seam cements for containers 2,4,5-Trihydroxybutyrophenone. intended for use in contact with food only (xxxi) Can end cements (sealing com- of the types identified in paragraph (d) of this section, table 1, under Categories I, II, pounds used for sealing can ends only): and VI. In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl- paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081– listed in § 177.1210(b)(5) of this chapter, 67–1. the following may be used: Ethyl toluene sulfonamide.

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N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- Calcium, sodium, and potassium oleates. hydroxyhydrocinnamide), CAS Reg. No. Calcium, sodium, and potassium 23128–74–7. ricinoleates. Polyamides consisting of the following: Calcium, sodium, and potassium stearates. Copolymer of omega-laurolactam and Castor oil, hydrogenated. espilon-caprolactam, CAS Reg. No. 25191– Castor oil, hydrogenated polymer with ethyl- 04–2 (Nylon 12/6). enediamine, 12-hydroxyoctadecanoic acid Homopolymer of omega-aminododecanoic and sebacic acid (CAS Reg. No. 68604–06–8). acid, CAS Reg. No. 24937–16–4. The condensation product formed by the Homopolymer of omega-laurolactam, CAS reaction of hydrogenated castor oil with Reg. No. 25038–74–8 (Nylon 12). polyamide derived from ethylenediamine, Polyamides derived from the following acids sebacic acid and 12-hydroxystearic acid, for and amines: use only in coatings at a level not to ex- Acids: ceed 3.2 percent by weight of the resin Adipic. when such coatings are intended for re- Azelaic. peated use in contact with foods only of Sebacic. the types identified in paragraph (d) of this Vegetable oil acids (with or without section, table 1, under Types I, II, and III, dimerization). under conditions of use C, D, E, or F as de- Amines: scribed in table 2 of paragraph (d) of this Diethylenetriamine. section; or when such coatings are in- Diphenylamine. tended for repeated use in contact with Ethylenediamine. foods of the types identified in paragraph Hexamethylenediamine. (d) of this section, table 1, under Types V, Tetraethylenepentamine. VI, VII, and VIII, under conditions of use E Triethylenetetramine. or F as described in table 2 of paragraph (d) Polypropylene glycol CAS Reg. No. 25322–69– of this section. Use shall be limited to 4. coatings for tanks of capacity greater than Sodium pentachlorophenate for use as a pre- 530,000 gallons. servative at 0.1 percent by weight in can- Castor oil, sulfated, sodium salt (CAS Reg. sealing compounds on containers having a No. 68187–76–8), for use only in coatings for capacity of 5 gallons or more. containers intended for repeated use. Tetrakis [methylene(3,5-di-tert-butyl-4- Cetyl alcohol. hydroxyhydrocinnamate)], CAS 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 6683–19–8. Reg. No. 26172–55–4) and 2-methyl-4- Toluene sulfonamide formaldehyde resin isothiazolin-3-one (CAS Reg. No. 2682–20–4) (basic polymer). mixture, at a ratio of 3 parts to 1 part, re- Triethylene glycol methacrylate for use only spectively, manufactured from methyl-3- as polymerization cross-linking agent in mercaptopropionate (CAS Reg. No. 2935–90– side seam cements for containers intended 2) and optionally containing magnesium for use in contact with food only of the nitrate (CAS Reg. No. 10377–60–3) at a con- types identified in paragraph (d) of this centration equivalent to the isothiazolone section, table 1, under Categories I, II, and active ingredients (weight/weight). For use VI. only as an antimicrobial agent in emul- Urea. sion-based silicone coatings at a level not (xxxiii) Miscellaneous materials: to exceed 50 milligrams per kilogram (based on isothiazolone active ingredient) Ammonium citrate. in the coating formulations. Ammonium potassium phosphate. Cyclohexanone-formaldehyde resin produced Bentonite, modified by reaction with benzyl when 1 mole of cyclohexanone is made to dimethyl alkyl ammonium chloride, where react with 1.65 moles of formaldehyde such the alkyl groups are derived from hydro- that the finished resin has an average mo- genated tallow (CAS Reg. No. 71011–24–0). lecular weight of 600–610 as determined by For use only as a rheological agent in coat- ASTM method D2503–82, ‘‘Standard Test ings intended to contact food under re- Method for Molecular Weight (Relative peated use conditions. Molecular Mass) of Hydrocarbons by Ther- Bentonite, modified by reaction with sodium moelectric Measurement of Vapor Pres- stearate and benzyl dimethyl alkyl ammo- sure,’’ which is incorporated by reference. nium chloride, where the alkyl groups are Copies may be obtained from the American derived from hydrogenated tallow (CAS Society for Testing Materials, 100 Barr Reg. No. 121888–68–4). For use as a Harbor Dr., West Conshohocken, Philadel- rheological agent only in coatings in- phia, PA 19428-2959, or may be examined at tended to contact dry food under repeated- the National Archives and Records Admin- use conditions. istration (NARA). For information on the Calcium acetate. availability of this material at NARA, call Calcium ethyl acetoacetate. 202–741–6030, or go to: http:// Calcium glycerophosphate. www.archives.gov/federallregister/

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codeloflfederallregulations/ Tridecyl alcohol produced from ibrllocations.html. For use only in contact tetrapropylene by the oxo process, for use with nonalcoholic and nonfatty foods only as a processing aid in polyvinyl chlo- under conditions of use E, F, and G, de- ride resins. scribed in table 2 of paragraph (d) this sec- Trimethylolpropane (CAS Reg. No. 77–99–6). tion. For use as a pigment dispersant at levels Decyl alcohol. not to exceed 0.45 percent by weight of the 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. pigment. 35691–65–7). For use as an antimicrobial Vinyl acetate-dibutyl maleate copolymers agent at levels not to exceed 500 milli- produced when vinyl acetate and dibutyl grams per kilogram in emulsion-based sili- maleate are copolymerized with or without cone coatings. one of the monomers: Acrylic acid or Disodium hydrogen phosphate. glycidyl methacrylate. For use only in Ethyl acetoacetate. coatings for metal foil used in contact with Hectorite, modified by reaction with a mix- foods that are dry solids with the surface ture of benzyl methyl dialkyl ammonium containing no free fat or oil. The finished chloride and dimethyl dialkyl ammonium copolymers shall contain at least 50 chloride, where the alkyl groups are de- weight-percent of polymer units derived rived from hydrogenated tallow (CAS Reg. from vinyl acetate and shall contain no No. 121888–67–3). For use as a rheological more than 5 weight-percent of total poly- agent only in coatings intended to contact mer units derived from acrylic acid or dry food under repeated-use conditions. glycidyl methacrylate. Lauryl alcohol. (xxxiv) Polyamide resins derived Lecithin. Magnesium, sodium, and . from dimerized vegetable oil acids Magnesium glycerophosphate. (containing not more than 20 percent of Magnesium stearate. monomer acids) and ethylenediamine, Mono-, di-, and tricalcium phosphate. as the basic resin, for use only in coat- Monodibutylamine pyrophosphate as ings that contact food at temperatures sequestrant for iron. not to exceed room temperature. Mono-, di-, and trimagnesium phosphate. (xxxv) Polyamide resins having a Myristyl alcohol. maximum acid value of 5 and a max- Octyl alcohol. imum amine value of 8.5 derived from Phosphoric acid. Polybutene, hydrogenated; complying with dimerized vegetable oil acids (con- the identity and limitations prescribed by taining not more than 10 percent of § 178.3740 of this chapter. monomer acids), ethylenediamine, and Poly(ethylene oxide). 4,4-bis (4-hydroxyphenyl) pentanoic Siloxanes and silicones, dimethyl, 3- acid (in an amount not to exceed 10 hydroxypropyl group-terminated, diesters percent by weight of said polyamide with poly(2-oxepanone), diacetates (CAS resins); as the basic resin, for use only Reg. No. 116810–47–0) at a level not to ex- in coatings that contact food at tem- ceed 0.025 weight percent of the finished coating having no greater than a 0.5 mil peratures not to exceed room tempera- thickness for use as a component of poly- ture provided that the concentration of ester, epoxy, and acrylic coatings com- the polyamide resins in the finished plying with paragraphs (b)(3)(vii), (viii), food-contact coating does not exceed 5 and (xx) of this section, respectively. milligrams per square inch of food-con- Silver chloride-coated titanium dioxide for tact surface. use only as a preservative in latex emul- (xxxvi) Methacrylonitrile grafted sions at a level not to exceed 2.2 parts per polybutadiene copolymers containing million (based on silver ion concentration) in the dry coating. no more than 41 weight percent of total Sodium pyrophosphate. polymer units derived from Stannous chloride. methacrylonitrile; for use only in coat- Stannous stearate. ings that are intended for contact, Stannous sulfate. under conditions of use D, E, F, or G Stearyl alcohol. described in table 2 of paragraph (d) of 2-Sulfoethyl methacrylate, sodium salt (CAS this section, with food containing no Reg. No. 1804–87–1). For use only in copoly- more than 8 percent of alcohol. mer coatings on metal under conditions of (xxxvii) Polymeric resin as a coating use E, F, and G described in table 2 of para- graph (d) of this section, and limited to use component prepared from terephthalic at a level not to exceed 2.0 percent by acid, isophthalic acid, succinic anhy- weight of the dry copolymer coating. dride, ethylene glycol, diethylene gly- Tetrasodium pyrophosphate. col, and 2,2-dimethyl-1,3-propanediol

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for use in contact with aqueous foods inch nor to exceed that amount as mil- and alcoholic foods containing not ligrams per square inch that would more than 20 percent (by volume) of al- equal 0.005 percent of the water capac- cohol under conditions of use D, E, F, ity of the container in milligrams, di- and G described in table 2 of § 176.170 of vided by the area of the food-contact this chapter. The resin shall contain no surface of the container in square more than 30 weight percent of 2,2-di- inches. methyl-1,3-propanediol. (3) From a coating intended for or (c) The coating in the finished form employed as a component of a con- in which it is to contact food, when ex- tainer for repeated use, not to exceed tracted with the solvent or solvents 18 milligrams per square inch nor to characterizing the type of food, and exceed that amount as milligrams per under conditions of time and tempera- square inch that would equal 0.005 per- ture characterizing the conditions of cent of the water capacity of the con- its intended use as determined from ta- tainer in milligrams, divided by the bles 1 and 2 of paragraph (d) of this sec- area of the food-contact surface of the tion, shall yield chloroform-soluble ex- container in square inches. tractives, corrected for zinc extractives (4) From coating intended for re- as zinc oleate, not to exceed the fol- peated use, and employed other than as lowing: a component of a container, not to ex- (1) From a coating intended for or ceed 18 milligrams per square inch of employed as a component of a con- coated surface. tainer not to exceed 1 gallon and in- (d) Tables: tended for one-time use, not to exceed 0.5 milligram per square inch nor to ex- TABLE 1—TYPES OF FOOD ceed that amount as milligrams per I. Nonacid (pH above 5.0), aqueous products; square inch that would equal 0.005 per- may contain salt or sugar or both, and in- cent of the water capacity of the con- cluding oil-in-water emulsions of low- or tainer, in milligrams, divided by the high-fat content. area of the food-contact surface of the II. Acidic (pH 5.0 or below), aqueous prod- container in square inches. From a fab- ucts; may contain salt or sugar or both, and including oil-in-water emulsions of ricated container conforming with the low- or high-fat content. description in this paragraph (c)(1), the III. Aqueous, acid or nonacid products con- extractives shall not exceed 0.5 milli- taining free oil or fat; may contain salt, gram per square inch of food-contact and including water-in-oil emulsions of surface nor exceed 50 parts per million low- or high-fat content. of the water capacity of the container IV. Dairy products and modifications: as determined by the methods provided A. Water-in-oil emulsion, high- or low-fat. in paragraph (e) of this section. B. Oil-in-water emulsion, high- or low-fat. V. Low moisture fats and oils. (2) From a coating intended for or VI. Beverages: employed as a component of a con- A. Containing alcohol. tainer having a capacity in excess of 1 B. Nonalcoholic. gallon and intended for one-time use, VII. Bakery products. not to exceed 1.8 milligrams per square VIII. Dry solids (no end test required).

TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Extractant Condition of use Types of food (see Table 1) Water Heptane12 8% alcohol (time and temperature) (time and temperature) (time and temperature)

A. High temperature I, IV–B ...... 250 °F, 2 hr ...... heat-sterilized (e.g., over 212 °F). III, IV–A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water-sterilized II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteur- II, IV–B ...... Fill boiling, cool to 100 . ized above 150 °F. °F. III, IV–A ...... do ...... 120 °F, 15 min. V ...... do.

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TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Contin- ued

Extractant Condition of use Types of food (see Table 1) Water Heptane12 8% alcohol (time and temperature) (time and temperature) (time and temperature)

D. Hot filled or pasteur- II, IV–B, VI–B ...... 150 °F, 2 hr ...... ized below 150 °F. III, IV–A ...... do ...... 100 °F, 30 min. V ...... do. VI–A ...... 150 °F, 2 hr. E. Room temperature II, IV–B, VI–B ...... 120 °F, 24 hr ...... filled and stored (no thermal treatment in the container). III, IV–A ...... do ...... 70 °F, 30 min. V, VII ...... do. VI–A ...... 120 °F, 24 hr. F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ...... (no thermal treatment VI–B,VII. in the container). VI–A ...... 70 °F, 48 hr. G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ...... thermal treatment in the container). H. Frozen storage: Ready-prepared foods intended to be re- heated in container at time of use: 1. Aqueous or oil in I, II, IV–B ...... 212 °F, 30 min ...... water emulsion of high or low fat. 2. Aqueous, high or III, IV–A, VII ...... do ...... 120 °F, 30 min. low free oil or fat. 1 Heptane extractant not to be used on wax-lined containers. 2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.

(e) Analytical methods—(1) Selection of only the heptane extractability. Alco- extractability conditions. First ascertain holic beverages (type VI-A) require the type of food product (table 1, para- only the 8 percent alcohol extractant. graph (d) of this section) that is being Having selected the appropriate ex- packed commercially in the test con- tractant or extractants simulating var- tainer and the normal conditions of ious types of foods and beverages and thermal treatment used in packaging the time-temperature exaggerations the type of food involved. Using table 2 over normal use, follow the applicable (paragraph (d) of this section), select extraction procedure. Adapt the proce- the food-simulating solvent or solvents dure, when necessary, for containers (demineralized distilled water, having a capacity of over 1 gallon. heptane, and/or 8 percent ethyl alcohol) (2) Selection of coated-container sam- and the time-temperature exaggera- ples. For consumer-sized containers up tions of the container-use conditions. to 1 gallon, quadruplicate samples of Aqueous products (Types I, II, IV-B, representative containers (using for and VI-B) require only a water- each replicate sample the number of extractability test at the temperature containers nearest to an area of 180 and time conditions shown for the square inches) should be selected from most severe ‘‘conditions of use.’’ Aque- the lot to be examined. ous products with free oil or fat, and (3) Cleaning procedure preliminary to water-oil emulsions (types III, IV-A, determining the amount of extractables and VII) will require determinations of from coated containers. Quadruplicate both water extractability and heptane samples of representative containers extractability. Low-moisture fats and should be selected from the lot to be oils (type V with no free water) require examined and must be carefully rinsed

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to remove extraneous material prior to beaker. Proceed with the determina- the actual extraction procedure. Soda tion of the amount of extractives by fountain pressure-type hot water rins- the method described in paragraph ing equipment, consisting in its sim- (e)(5) of this section. plest form of a 1⁄8-inch–1⁄4-inch internal (iii) Water (from boiling to 100 °F), sim- diameter metal tube attached to a hot ulating hot fill or pasteurization above 150 water line and bent so as to direct a °F. Fill the container within 1⁄4-inch of stream of water upward, may be used. the top with a measured volume of Be sure hot water has reached a tem- boiling, demineralized distilled water. perature of 190 °F–200 °F before starting Insert a thermometer in the water and to rinse the container. Invert the con- allow the uncovered container to stand tainer over the top of the fountain and in a room at 70 °F–85 °F. When the tem- direct a strong stream of hot water perature reads 100 °F, composite the against the bottom and all sides for 1 water from each replicate immediately minute, drain, and allow to dry. in a clean Pyrex flask or beaker. Pro- (4) Exposure conditions—(i) Water (250 ceed with the determination of the °F for 2 hours), simulating high-tempera- amount of extractives by the method ture heat sterilization. Fill the container described in paragraph (e)(5) of this within 1⁄4-inch of the top with a meas- section. ured volume of demineralized distilled (iv) Water (150° for 2 hours), simulating water. Cover the container with clean hot fill or pasteurization below 150 °F. aluminum foil and place the container Preheat demineralized distilled water on a rack in a pressure cooker. Add a to 150 °F in a clean Pyrex flask. Fill small amount of demineralized dis- the container within 1⁄4-inch of the top tilled water to the pressure cooker, but with a measured volume of the 150 °F do not allow the water to touch the water and cover with clean aluminum bottom of the container. Close the foil. Place the test container in an cooker securely and start to heat over oven maintained at 150 °F. After 2 a suitable burner. When a steady hours, remove the test container from stream of steam emerges from the the oven and immediately composite vent, close the vent and allow the pres- the water of each replicate in a clean sure to rise to 15 pounds per square Pyrex flask or beaker. Proceed with inch (250 °F) and continue to maintain the determination of the amount of ex- this pressure for 2 hours. Slowly re- tractives by the method described in lease the pressure, open the pressure paragraph (e)(5) of this section. cooker when the pressure reads zero, (v) Water (120 °F for 24 hours), simu- and composite the water of each rep- lating room temperature filling and stor- licate immediately in a clean Pyrex age. Preheat demineralized distilled flask or beaker. Proceed with the de- water to 120 °F in a clean Pyrex flask. termination of the amount of extrac- Fill the container within 1⁄4-inch of the tives by the method described in para- top with a measured volume of the 120 graph (e)(5) of this section. °F water and cover with clean alu- (ii) Water (212 °F for 30 minutes), simu- minum foil. Place the test container in lating boiling water sterilization. Fill the an incubator or oven maintained at 120 container within 1⁄4-inch of the top °F. After 24 hours, remove the test con- with a measured volume of boiling, tainer from the incubator and imme- demineralized distilled water. Cover diately composite the water of each the container with clean aluminum foil replicate in a clean Pyrex flask or and place the container on a rack in a beaker. Proceed with the determina- pressure cooker in which a small tion of the amount of extractives by amount of demineralized distilled the method described in paragraph water is boiling. Do not close the pres- (e)(5) of this section. sure vent, but operate at atmospheric (vi) Water (70 °F for 48 hours), simu- pressure so that there is a continuous lating refrigerated storage. Bring escape of a small amount of steam. demineralized distilled water to 70 °F Continue to heat for 30 minutes, then in a clean Pyrex flask. Fill the con- remove the test container and com- tainer within 1⁄4-inch of the top with a posite the contents of each replicate measured volume of the 70 °F water, immediately in a clean Pyrex flask or and cover with clean aluminum foil.

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Place the test container in a suitable measured volume of the 150 °F heptane room maintained at 70 °F. After 48 and cover with clean aluminum foil. hours, immediately composite the Place the test container in the water of each replicate in a clean preheated pressure cooker and then put Pyrex flask or beaker. Proceed with the assembly into a 150 °F incubator. the determination of the amount of ex- After 2 hours, remove the pressure tractives by the method described in cooker from the incubator, open the as- paragraph (e)(5) of this section. sembly, and immediately composite (vii) Water (70 °F for 24 hours), simu- the heptane of each replicate in a clean lating frozen storage. Bring Pyrex flask or beaker. Proceed with demineralized distilled water to 70 °F the determination of the amount of ex- in a clean Pyrex flask. Fill the con- tractives by the method described in tainer within 1⁄4-inch of the top with a paragraph (e)(5) of this section. measured volume of the 70 °F water (x) Heptane (120 °F for 30 minutes), sim- and cover with clean aluminum foil. ulating boiling water sterilization of fatty Place the container in a suitable room foods only. Preheat redistilled reagent- maintained at 70 °F. After 24 hours, im- grade heptane (boiling point 208 °F) mediately composite the water of each carefully in a clean Pyrex flask on a replicate in a clean Pyrex flask or water bath or nonsparking hot plate in beaker. Proceed with the determina- a well-ventilated hood to 120 °F. At the tion of the amount of extractives by same time, preheat a pressure cooker the method described in paragraph or equivalent to 120 °F in an incubator. (e)(5) of this section. This pressure cooker is to serve only as (viii) Water (212 °F for 30 minutes), sim- a vented container for the heptane-con- ulating frozen foods reheated in the con- taining test package inside the incu- tainer. Fill the container to within 1⁄4- bator in order to minimize the danger inch of the top with a measured volume of explosion. Fill the test container of boiling, demineralized distilled within 1⁄4-inch of the top with a meas- water. Cover the container with clean ured volume of the 120 °F heptane and aluminum foil and place the container cover with clean aluminum foil. Place on a rack in a pressure cooker in which the test container in the preheated a small amount of demineralized dis- pressure cooker and then put the as- tilled water is boiling. Do not close the sembly into a 120 °F incubator. After 30 pressure vent, but operate at atmos- minutes, remove the pressure cooker pheric pressure so that there is a con- from the incubator, open the assembly, tinuous escape of a small amount of and immediately composite the steam. Continue to heat for 30 minutes, heptane of each replicate in a clean then remove the test container and Pyrex flask or beaker. Proceed with composite the contents of each rep- the determination of the amount of ex- licate immediately in a clean Pyrex tractives by the method described in flask or beaker. Proceed with the de- paragraph (e)(5) of this section. termination of the amount of extrac- (xi) Heptane (120 °F for 15 minutes), tives by the method described in para- simulating hot fill or pasteurization above graph (e)(5) of this section. 150 °F for fatty foods only. Preheat re- (ix) Heptane (150 °F for 2 hours) simu- distilled reagent-grade heptane (boiling lating high-temperature heat sterilization point 208 °F) carefully in a clean Pyrex for fatty foods only. Preheat redistilled flask on a water bath or nonsparking reagent-grade heptane (boiling point hot plate in a well-ventilated hood to 208 °F) carefully in a clean Pyrex flask 120 °F. At the same time, preheat a on a water bath or nonsparking hot pressure cooker or equivalent to 120 °F plate in a well-ventilated hood to 150 in an incubator. This pressure cooker °F. At the same time preheat a pres- is to serve only as a container for the sure cooker or equivalent to 150 °F in heptane-containing test package inside an incubator. This pressure cooker is the incubator in order to minimize the to serve only as a container for the danger of explosion. Fill the test con- heptane-containing test package inside tainer within 1⁄4-inch of the top with a the incubator in order to minimize the measured volume of the 120 °F heptane danger of explosion. Fill the test con- and cover with clean aluminum foil. tainer within 1⁄4-inch of the top with a Place the test container in the

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preheated pressure cooker and then put time, preheat a pressure cooker to 120 the assembly into a 120 °F incubator. °F in an incubator. This pressure cook- After 15 minutes, remove the pressure er is to serve only as a container for cooker from the incubator, open the as- the heptane-containing test package sembly, and immediately composite inside the incubator in order to mini- the heptane of each replicate in a clean mize the danger of explosion. Fill the Pyrex flask or beaker. Proceed with test container within 1⁄4-inch of the top the determination of the amount of ex- with a measured volume of the 120 °F tractives by the method described in heptane and cover with clean alu- paragraph (e)(5) of this section. minum foil. Place the test container in (xii) Heptane (100 °F for 30 minutes), the preheated pressure cooker and then simulating hot fill or pasteurization below put the assembly into a 120 °F incu- 150 °F for fatty foods only. Preheat re- bator. After 30 minutes, remove the distilled reagent-grade heptane (boiling pressure cooker from the incubator, point 208 °F) carefully in a clean Pyrex open the assembly and immediately flask on a water bath or nonsparking composite the heptane from each rep- hot plate in a well-ventilated hood to licate into a clean Pyrex flask. Proceed 100 °F. At the same time, preheat a with the determination of the amount pressure cooker or equivalent to 100 °F of extractives by the method described in an incubator. This pressure cooker in paragraph (e)(5) of this section. is to serve only as a container for the (xv) Alcohol—8 percent (150 °F for 2 heptane-containing test package inside hours), simulating alcoholic beverages hot the incubator in order to minimize the filled or pasteurized below 150 °F. Pre- danger of explosion. Fill the test con- heat 8 percent (by volume) ethyl alco- tainer within 1⁄4-inch of the top with a hol in demineralized distilled water to measured volume of the 100 °F heptane 150 °F in a clean Pyrex flask. Fill the and cover with clean aluminum foil. test container with within 1⁄4-inch of Place the test container in the the top with a measured volume of the preheated pressure cooker and then put 8 percent alcohol. Cover the container the assembly into a 100 °F incubator. with clean aluminum foil and place in After 30 minutes, remove the pressure an oven maintained at 150 °F. After 2 cooker from the incubator, open the as- hours, remove the container from the sembly and immediately composite the oven and immediately composite the heptane of each replicate in a clean alcohol from each replicate in a clean Pyrex flask or beaker. Proceed with Pyrex flask. Proceed with the deter- the determination of the amount of ex- mination of the amount of extractives tractives by the method described in by the method described in paragraph paragraph (e)(5) of this section. (e)(5) of this section. (xiii) Heptane (70 °F for 30 minutes), (xvi) Alcohol—8 percent (120 °F for 24 simulating room temperature filling and hours), simulating alcoholic beverages storage of fatty foods only. Fill the test room-temperature filled and stored. Pre- container within 1⁄4-inch of the top heat 8 percent (by volume) ethyl alco- with a measured volume of the 70 °F hol in demineralized distilled water to heptane and cover with clean alu- 120 °F in a clean Pyrex flask. Fill the minum foil. Place the test container in test container within 1⁄4-inch of the top a suitable room maintained at 70 °F. with a measured volume of the 8 per- After 30 minutes, composite the cent alcohol, cover the container with heptane of each replicate in a clean clean aluminum foil and place in an Pyrex flask or beaker. Proceed with oven or incubator maintained at 120 °F. the determination of the amount of ex- After 24 hours, remove the container tractives by the method described in from the oven or incubator and imme- paragraph (e)(5) of this section. diately composite the alcohol from (xiv) Heptane (120 °F for 30 minutes), each replicate into a clean Pyrex flask. simulating frozen fatty foods reheated in Proceed with the determination of the the container. Preheat redistilled rea- amount of extractives by the method gent-grade heptane (boiling point 208 described in paragraph (e)(5) of this °F) carefully in a clean Pyrex flask on section. a water bath or hot plate in a well-ven- (xvii) Alcohol—8 percent (70 °F for 48 tilated hood to 120 °F. At the same hours), simulating alcoholic beverages in

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refrigerated storage. Bring 8 percent (by Ex= e a volume) ethyl alcohol in demineralized = ( )( )(1000) ° Extractives residue distilled water to 70 F in a clean Pyrex ()()()csF flask. Fill the test container within 1⁄4- inch of the top with a measured volume where: of the 8 percent alcohol. Cover the con- Ex = Extractives residue in ppm for any con- tainer size. tainer with clean aluminum foil. Place e = Milligrams extractives per sample tested. the test container in a suitable room a = Total coated area, including closure in maintained at 70 °F. After 48 hours, im- square inches. mediately composite the alcohol from c = Water capacity of container, in grams. each replicate into a clean Pyrex flask. s = Surface of coated area tested, in square inches. Proceed with the determination of the F = Five, the ratio of the amount of extrac- amount of extractives by the method tives removed from a coated container by described in paragraph (e)(5) of this heptane under exaggerated time-tempera- section. ture test conditions compared to the amount extracted by a fat or oil from a NOTE: The tests specified in paragraph container tested under exaggerated condi- (e)(4) (i) through (xvii) of this section are ap- tions of thermal sterilization and use. plicable to flexible packages consisting of e′ = Chloroform-soluble extractives residue. coated metal contacting food, in which case ee′ = Zinc corrected chloroform-soluble ex- the closure end is double-folded and clamped tractive residue. with metal spring clips by which the package e′ or ee′ is substituted for e in the above equa- can be suspended. tions when necessary. (5) Determination of amount of extrac- If when calculated by the equations in tives—(i) Total residues. Evaporate the paragraph (e)(5)(i) (a) and (b) of this food-simulating solvents from para- section, the concentration of extrac- graph (e)(4) (i) to (xvii), inclusive, of tives residue (Ex) exceeds 50 parts per this section to about 100 milliliters in million or the extractives in milli- grams per square inch exceed the limi- the Pyrex flask and transfer to a clean, tations prescribed in paragraph (c) of tared platinum dish, washing the flask this section for the particular con- three times with the solvent used in tainer size, proceed to paragraph the extraction procedure, and evapo- (e)(5)(ii) of this section (method for de- rate to a few milliliters on a non- termining the amount of chloroform- sparking low-temperature hotplate. soluble extractives residue). The last few milliliters should be evap- (ii) Chloroform-soluble extractives res- orated in an oven maintained at a tem- idue. Add 50 milliliters of chloroform perature of 212 °F. Cool the platinum (freshly distilled reagent grade or a dish in a desiccator for 30 minutes and grade having an established consist- weigh the residue to the nearest 0.1 ently low blank) to the dried and milligram (e). Calculate the extractives weighed residue, (e), in the platinum in milligrams per square inch and in dish, obtained in paragraph (e)(5)(i) of parts per million for the particular size this section. Warm carefully, and filter of container being tested and for the through Whatman No. 41 filter paper in specific food-simulating solvent used. a Pyrex funnel, collecting the filtrate (a) Water and 8-percent alcohol. in a clean, tared platinum dish. Repeat the chloroform extraction, washing the Milligrams extractives e filter paper with this second portion of = chloroform. Add this filtrate to the per square inch s original filtrate and evaporate the Ex= ( e )( a )(1000) total down to a few milliliters on a Extractives residue = low-temperature hotplate. The last few ()()cs milliliters should be evaporated in an oven maintained at 212 °F. Cool the (b) Heptane. platinum dish in a desiccator for 30 minutes and weigh to the nearest 0.1 e Milligrams extractives = milligram to get the chloroform-solu- per square inch ble extractives residue (e′). This e′ is ()()sF substituted for e in the equations in

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paragraph (e)(5)(i) (a) and (b) of this Hot plate, nonsparking (explosion proof), section. If the concentration of extrac- top 12″ × 20″, 2,500 watts, with temperature tives (Ex) still exceeds 50 parts per mil- control. Platinum dish, 100-milliliter capacity min- lion or the extractives in milligrams imum. per square inch exceed the limitations All glass, Pyrex or equivalent. prescribed in paragraph (c) of this sec- tion for the particular container size, (2) Reagents. proceed as follows to correct for zinc Water, all water used in extraction proce- extractives (‘‘C’’ enamels only): Ash dure should be freshly demineralized (deion- the residue in the platinum dish by ized) distilled water. heating gently over a Meeker-type Heptane, reagent grade, freshly redistilled before use, using only material boiling at 208 burner to destroy organic matter and °F. hold at red heat for about 1 minute. Alcohol, 8 percent (by volume), prepared Cool in the air for 3 minutes, and place from undenatured 95 percent ethyl alcohol the platinum dish in the desiccator for diluted with demineralized or distilled 30 minutes and weigh to the nearest 0.1 water. milligram. Analyze this ash for zinc by Chloroform, reagent grade, freshly redis- standard Association of Official Agri- tilled before use, or a grade having an estab- lished, consistently low blank. cultural Chemists methods or equiva- Filter paper, Whatman No. 41 or equiva- lent. Calculate the zinc in the ash as lent. zinc oleate, and subtract from the weight of chloroform-soluble extrac- (g) In accordance with good manufac- tives residue (e′) to obtain the zinc-cor- turing practice, finished coatings in- rected chloroform-soluble extractives tended for repeated food-contact use shall be thoroughly cleansed prior to residue (ee′). This ee′ is substituted for their first use in contact with food. e in the formulas in paragraph (e)(5)(i) (h) Acrylonitrile copolymers identi- (a) and (b) of this section. To comply fied in this section shall comply with with the limitations in paragraph (c) of the provisions of § 180.22 of this chap- this section, the chloroform-soluble ex- ter. tractives residue (but after correction (i) Epoxy resins derived by the reac- for the zinc extractives in case of ‘‘C’’ tion of 4,4′-isopropylidenediphenol and enamels) must not exceed 50 parts per epichlorohydrin, as described in para- million and must not exceed in milli- graph (b)(3)(viii)(a) of this section, may grams per square inch the limitations be used in accordance with this section for the particular article as prescribed except as coatings in packaging for in paragraph (c) of this section. powdered and liquid infant formula. (f) Equipment and reagent require- ments—(1) Equipment. [42 FR 14534, Mar. 15, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci- Rinsing equipment, soda fountain pressure- tations affecting § 175.300, see the List of CFR type hot water, consisting in simplest form Sections Affected, which appears in the of a 1⁄8-inch–1⁄4-inch inside diameter metal Finding Aids section of the printed volume tube attached to a hot water line delivering and at www.fdsys.gov. 190 °F–200 °F water and bent so as to direct a stream of water upward. § 175.320 Resinous and polymeric coat- Pressure cooker, 21-quart capacity with ings for polyolefin films. pressure gage, safety release, and removable rack, 12.5 inches inside diameter × 11 inches Resinous and polymeric coatings inside height, 20 pounds per square inch safe may be safely used as the food-contact operating pressure. surface of articles intended for use in Oven, mechanical convection, range to in- producing, manufacturing, packing, clude 120 °F–212 °F explosion-proof, inside di- processing, preparing, treating, pack- mensions (minimum), 19″ × 19″ × 19″, constant aging, transporting, or holding food, in ± ° temperature to 2 F (water bath may be accordance with the following pre- substituted). scribed conditions: Incubator, inside dimensions (minimum) 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion (a) The coating is applied as a contin- proof (water bath may be substituted). uous film over one or both sides of a Constant-temperature room or chamber 70 base film produced from one or more of °F±2 °F minimum inside dimensions 19″ × 19″ the basic olefin polymers complying × 19″. with § 177.1520 of this chapter. The base

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polyolefin film may contain optional (2) Substances the use of which is adjuvant substances permitted for use permitted under applicable regulations in polyolefin film by applicable regula- in parts 170 through 189 of this chapter, tions in parts 170 through 189 of this by prior sanctions, or approvals. chapter. (3) Substances identified in this para- (b) The coatings are formulated from graph (b)(3) and subject to such limita- optional substances which are: tions as are provided: (1) Substances generally recognized as safe for use in or on food.

List of substances Limitations

(i) Resins and polymers: Acrylic acid polymer and its ethyl or methyl esters. Acrylamide copolymerized with ethyl acrylate and/or sty- rene and/or methacrylic acid, and the copolymer subse- quently reacted with formaldehyde and butanol. Butadiene-acrylonitrile copolymer. Butadiene-acrylonitrile-styrene terpolymer. Butyl rubber. N,N′-Diphenyl-p-phenylenediamine ...... For use only as a polymerization inhibitor in 2-sulfoethyl meth- acrylate, sodium salt. 2-Ethylhexyl acrylate copolymerized with one or more of the following: Acrylonitrile. Itaconic acid. Methacrylonitrile. Methyl acrylate. Methyl methacrylate. 4,4′-Isopropylidenediphenolepichlorohydrin average molec- ular weight 900. Melamine-formaldehyde as the basic polymer or chemi- cally modified with methyl alcohol. Methacrylic acid and its ethyl or methyl esters copolym- erized with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. a-Methyl styrene polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio For use only in coatings that contact food under conditions of 1 a-methylstyrene to 3 vinyltoluene). use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, provided that the concentration of a-methylstyrene- vinyltoluene copolymer resins in the finished food-contact coating does not exceed 1.0 milligram per square inch of food-contact surface. Petroleum alicyclic hydrocarbon resins ...... As defined in § 176.170 of this chapter. Blended with butyl rub- ber for use as a component of coatings on polyolefin fabric for bulk packaging of raw fruits and vegetables and used at a level not to exceed 30 percent by weight of the total coat- ing solids. Polyamide resins (CAS Reg. No. 68139–70–8), as the For use only in coatings for polypropylene films that contact basic resin, derived from: food at temperatures not to exceed room temperature. Dimerized vegetable oil or tall oil acids containing not more than 20 percent of monomer acids. Azelaic acid (CAS Reg. No. 123–99–9) in an amount not to exceed 3.7 percent by weight of the poly- amide resin. Ethylenediamine (CAS Reg. No. 107–15–3). Piperazine (CAS Reg. No. 110–85–0) in an amount not to exceed 6.4 percent by weight of the poly- amide resin. Polyamide resins, derived from dimerized vegetable oil For use only in coatings for polyolefin films that contact food at acids (containing not more than 20% of monomer acids) temperatures not to exceed room temperature. and ethylenediamine, as the basic resin. Polyamide resins having a maximum acid value of 5 and a For use only in coatings that contact food at temperatures not maximum amine value of 8.5 derived from dimerized to exceed room temperature provided that the concentration vegetable oil acids (containing not more than 10 percent of the polyamide resins in the finished food-contact coating of monomer acids), ethylenediamine, and 4,4-bis (4- does not exceed 5 milligrams per square inch of food-con- hydroxyphenyl) pentanoic acids (in an amount not to ex- tact surface. ceed 10 percent by weight of said polyamide resins); as the basic resin.

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List of substances Limitations

Polyester resins formed by reaction of one or more of the following polybasic acids and monobasic acids with one or more of the following polyhydric alcohols: Polybasic acids: Adipic. Azelaic ...... For use in forming polyester resins intended for use in coatings that contact food only of the type identified in § 176.170(c) of this chapter, table 1, under Category VIII, and under condi- tions of use E, F, or G, described in table 2 of § 176.170(c) of this chapter. Dimerized fatty acids derived from: Animal, marine or vegetable fats and oils. Tall oil. Fumaric. Isophthalic. Maleic. o-Phthalic. Sebacic. Terephthalic. Trimellitic. Monobasic acids: Fatty acids derived from: Animal, marine, or vegetable fats and oils. Gum rosin ...... As defined in § 178.3870 of this chapter. For use in forming polyester resins intended for use in coatings that contact food only of the type identified in § 176.170(c) of this chap- ter, table 1, under Category VIII, and under conditions of use E, F, or G described in table 2 of § 176.170(c) of this chap- ter. Polyhydric alcohols: 1,3-Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. Mannitol. a-Methyl glucoside. Pentaerythritol. Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. Polyethylenimine ...... For use only as a primer subcoat to anchor epoxy surface coatings to the base sheet. Polystyrene. Polyvinyl acetate. Polyvinyl chloride ...... Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million. vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083– 18–1 and CAS Reg. No. 68083–19–2) with methylhydrogen polysiloxane (CAS Reg. No. 63148–57–2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037– 59–2). The following substances may be used as optional polymerization inhibitors:. 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107–54–0), at a level not to exceed 0.53 weight percent;. 1-Ethynylcyclohexene (CAS Reg. No. 931–49–7), at a level not to exceed 0.64 weight percent;. Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054–10–4), at a level not to exceed 1.0 weight percent;. Methylvinyl cyclosiloxane (CAS Reg. No. 68082–23–5); and. Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554–06–5)..

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List of substances Limitations

Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a surface coating under the following conditions: 68083–19–2 and 68083–18–1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate food only of the types identified in § 176.170(c) of this chap- (CAS Reg. No. 624–48–6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VII-B when used under 108–05–4) may be used as optional polymerization inhibitors. conditions of use E, F, and G described in table 2 in § 176.170(c) of this chapter. 2. In coatings for olefin polymers provided the coating contacts food only of the types identified in § 176.170(c) of this chap- ter, table 1, under Types III, IV, V, VII-A, VIII, and IX when used under conditions of use A through H described in table 2 in § 176.170(c) of this chapter. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives. 68083–19–2 and 68083–18–1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate (CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No. 108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and diallyl maleate (CAS Reg. No. 999–21–3) may be used as optional polymerization inhibitors. The polymer may also contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a control release agent. Styrene copolymerized with one or more of the following: Acrylonitrile. a-Methyl styrene. Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IV-A, V, and VII in bination of styrene or alpha methyl styrene with acrylic table 1 of § 176.170(c) of this chapter, under use conditions acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl E through G in table 2 of § 176.170(c), and with foods of methacrylate, and butyl acrylate. The styrene and alpha Types VIII and IX without use temperature restriction. methyl styrene, individually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, in- dividually, may be from 0 to 40 weight percent of the polymer. The polymer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel per- meation chromatography). The acid number of the poly- mer shall be less than 250. The monomer content shall be less than 0.5 percent. Styrene-isobutylene copolymer. Terpene resins consisting of polymers of a-pinene, b-pi- nene, and/or dipentene; acid value less than 5, saponi- fication number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution. 2-Sulfoethyl methacrylate, sodium salt Chemical Abstracts For use only in copolymer coatings under conditions of use E, Service No. 1804–87–1]. F, and G described in table 2 of § 176.170(c) of this chapter and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. Vinyl chloride-acetate, hydroxyl-modified copolymer or ma- leic acid-modified copolymer. Vinyl chloride copolymerized with one or more of the fol- lowing: Acrvlonitrile. Vinyl acetate. Vinylidene chloride. Vinylidene chloride copolymerized with one or more of the following: Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Acrylonitrile. Itaconic acid. Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Methacrylonitrile. Vinyl chloride. (ii) Plasticizers: Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl phthalyl butyl glycolate. Butyl stearate. Dibutyl sebacate. Diethyl phthalate. 2-Ethylhexyl diphenyl phosphate. Ethyl phthalyl ethyl glycolate. Glycerol monooleate ......

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List of substances Limitations

Glycerol triacetate. Triethyl citrate. (iii) Adjuvants (release agents, waxes, and dispersants): Acetone. Amides (unsubstituted) of fatty acids from vegetable or animal oils. n-Butyl acetate. n-Butyl alcohol. Candelilla wax. . 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only as an antimicrobial agent in emulsion-based sili- 55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. cone coatings at a level not to exceed 50 milligrams per kilo- 2682–20–4) mixture, at a ratio of 3 parts to 1 part, respec- gram (based on isothiazolone active ingredient) in the coat- tively, manufactured from methyl-3-mercaptopropionate (CAS ing formulation. Reg. No. 2935–90–2) and optionally containing magnesium nitrate (CAS Reg. No. 10377–60–3) at a concentration equivalent to the isothiazolone active ingredients (weight/ weight).. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65– For use as an antimicrobial agent at levels not to exceed 500 7). milligrams per kilogram in emulsion-based silicone coating. Ethyl acetate. Fatty acids from vegetable or animal oils and their alu- minum, ammonium, calcium, magnesium, and sodium salts. Hexane. Methyl ethyl ketone. N,N′-Dioleoylethylenediamine (CAS Reg. No. 110–31–6) ... For use only in ionomeric resins complying with § 177.1330 of this chapter and in ethylene vinyl acetate copolymers com- plying with § 177.1350 of this chapter at a level not to ex- ceed 0.0085 milligram per square centimeter (0.055 milli- gram per square inch) in the finished food-contact article. Petroleum waxes conforming to specifications included in a regulation in subchapter B of this chapter. Polyvinyl alcohol, minimum viscosity of 4% aqueous solu- For use only as a dispersing agent at levels not to exceed 6% tion at 20 °C of 4 centipoises and percent alcoholysis of of total coating weight in coatings for pol-yolefin films pro- 87–100. vided the finished polyolefin films contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VIII, and IX. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauryl sulfate. Sorbitan and sorbitol esters of fatty acids from vegetable or animal oils. Spermaceti wax. Tetrahydrofuran. Toluene. (iv) Preservatives: Silver chloride-coated titanium dioxide ...... For use only as a preservative in latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion con- centration) in the dry coating.

(c) The coating in the finished form the provisions of § 180.22 of this chap- in which it is to contact food, when ex- ter. tracted with the solvent or solvents [42 FR 14534, Mar. 15, 1977, as amended at 43 characterizing the type of food, and FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, under conditions of time and tempera- 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, ture characterizing the conditions of Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR its intended use as determined from ta- 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 bles 1 and 2 of § 176.170(c) of this chap- FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, ter, shall yield net chloroform-soluble 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000] extractives not to exceed 0.5 milligram per square inch of coated surface. § 175.350 Vinyl acetate/crotonic acid (d) Acrylonitrile copolymers identi- copolymer. fied in this section shall comply with A copolymer of vinyl acetate and crotonic acid may be safely used as a coating or as a component of a coating

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which is the food-contact surface of § 175.360 Vinylidene chloride copoly- polyolefin films intended for packaging mer coatings for nylon film. food, subject to the provisions of this Vinylidene chloride copolymer coat- section. ings identified in this section and ap- (a) The copolymer may contain added plied on nylon film may be safely used optional substances to impart desired as food-contact surfaces, in accordance properties. with the following prescribed condi- (b) The quantity of any optional sub- tions: stance does not exceed the amount rea- (a) The coating is applied as a contin- sonably required to accomplish the in- uous film over one or both sides of a tended physical or technical effect nor base film produced from nylon resins any limitations further provided. complying with § 177.1500 of this chap- (c) Any optional substance that is ter. the subject of a regulation in parts 174, 175, 176, 177, 178, and § 179.45 of this (b) The coatings are prepared from chapter conforms with any specifica- vinylidene chloride copolymers pro- tions in such regulation. duced by copolymerizing vinylidene chloride with one or more of the mono- (d) Optional substances as provided in paragraph (a) of this section include: mers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid, methyl ac- (1) Substances generally recognized rylate, methyl methacrylate (CAS Reg. as safe in food. No. 80–62–6; maximum use level 6 (2) Substances subject to prior sanc- weight percent) and 2-sulfoethyl meth- tion or approval for uses with a copoly- acrylate (CAS Reg. No. 10595–80–9; max- mer of vinyl acetate and crotonic acid imum use level 1 weight percent). The and used in accordance with such sanc- finished copolymers contain at least 50 tion or approval. weight percent of polymer units de- (3) Substances identified in this sub- rived from vinylidene chloride. The fin- paragraph and subject to such limita- ished coating produced from vinylidene tions as are provided: chloride copolymers produced by co- List of substances Limitations polymerizing vinylidene chloride with methyl methacrylate and/or 2- Silica. sulfoethyl methacrylate, or with meth- Japan wax. yl methacrylate and/or 2-sulfoethyl (e) Copolymer of vinyl acetate and methacrylate together with one or crotonic acid used as a coating or as a more of the other monomers from this component of a coating conforming section, is restricted to use at or below with the specifications of paragraph room temperature. (e)(1) of this section are used as pro- (c) Optional adjuvant substances em- vided in paragraph (e)(2) of this sec- ployed in the production of the coat- tion. ings or added thereto to impart desired (1) Specifications. (i) The chloroform- properties may include sodium soluble portion of the water extractives dodecylbenzenesulfonate. of the coated film obtained with dis- (d) The coating in the finished form tilled water at 120 °F for 24 hours does in which it is to contact food, when ex- not exceed 0.5 milligram per square tracted with the solvent or solvents inch of coated surface. characterizing the type of food, and (ii) The chloroform-soluble portion of under conditions of time and tempera- the n-heptane extractives of the coated ture characterizing the conditions of film obtained with n-heptane at 70 °F its intended use as determined from ta- for 30 minutes does not exceed 0.5 milli- bles 1 and 2 of § 176.170(c) of this chap- gram per square inch of coated surface. ter, shall yield net chloroform-soluble (2) Conditions of use. The copolymer extractives not to exceed 0.5 milligram of vinyl acetate and crotonic acid is per square inch of coated surface when used as a coating or as a component of tested by the methods described in a coating for polyolefin films for pack- § 176.170(d) of this chapter. aging bakery products and confec- (e) Acrylonitrile copolymers identi- tionery. fied in this section shall comply with

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the provisions of § 180.22 of this chap- § 175.380 Xylene-formaldehyde resins ter. condensed with 4,4′- isopropylidenediphenol- [42 FR 14534, Mar. 15, 1977, as amended at 43 epichlorohydrin epoxy resins. FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, 1980; 47 FR 54430, Dec. 3, 1982] The resins identified in paragraph (a) of this section may be safely used as a § 175.365 Vinylidene chloride copoly- food-contact coating for articles in- mer coatings for polycarbonate tended for use in contact with food, in film. accordance with the following pre- Vinylidene chloride copolymer coat- scribed conditions. ings identified in this section and ap- (a) The resins are produced by the plied on polycarbonate film may be condensation of xylene-formaldehyde ′ safely used as food-contact surfaces, in resin and 4,4 -isopropylidenediphenol- accordance with the following pre- epichlorohydrin epoxy resins, to which scribed conditions: may have been added certain optional adjuvant substances required in the (a) The coating is applied as a contin- production of the resins or added to im- uous film over one or both sides of a part desired physical and technical base film produced from polycarbonate properties. The optional adjuvant sub- resins complying with § 177.1580 of this stances may include resins produced by chapter. the condensation of allyl ether of (b) The coatings are prepared from mono-, di-, or trimethylol phenol and vinylidene chloride copolymers pro- capryl alcohol and also may include duced by copolymerizing vinylidene substances identified in § 175.300(b)(3), chloride with acrylonitrile, methyl ac- with the exception of paragraph (b)(3) rylate, and acrylic acid. The finished (xxxi) and (xxxii) of that section. copolymers contain at least 50 weight- (b) The resins identified in paragraph percent of polymer units derived from (a) of this section may be used as a vinyldene chloride. food-contact coating for articles in- (c) Optional adjuvant substances em- tended for contact at temperatures not ployed in the production of the coat- to exceed 160 °F with food of Types I, ings or added thereto to impart desired II, VI-A and B, and VIII described in properties may include sodium table 1 of § 176.170(c) of this chapter dodecylbenzenesulfonate in addition to provided that the coating in the fin- substances described in § 174.5(d) of this ished form in which it is to contact chapter. food meets the following extractives (d) The coating in the finished form limitations when tested by the meth- in which it is to contact food, when ex- ods provided in § 175.300(e): tracted with the solvent or solvents (1) The coating when extracted with characterizing the type of food, and distilled water at 180 °F for 24 hours under the conditions of time and tem- yields total extractives not to exceed perature characterizing the conditions 0.05 milligram per square inch of food- of its intended use as determined from contact surface. tables 1 and 2 of § 176.170(c) of this chap- (2) The coating when extracted with 8 ter, shall yield net chloroform-soluble percent (by volume) ethyl alcohol in ° extractives in each extracting solvent distilled water at 160 F for 4 hours yields total extractives not to exceed not to exceed 0.5 milligram per square 0.05 milligram per square inch of food- inch of coated surface as determined by contact surface. the methods described in § 176.170(d) of (c) The resins identified in paragraph this chapter. In testing the finished (a) of this section may be used as a food-contact articles, a separate test food-contact coating for articles in- sample is to be used for each required tended for contact at temperatures not extracting solvent. to exceed room temperature with food (e) Acrylonitrile copolymers identi- of Type VI-C described in table 1 of fied in this section shall comply with § 176.170(c) of this chapter provided the the provisons of § 180.22 of this chapter. coating in the finished form in which it is to contact food meets the following

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extractives limitations when tested by tractives not to exceed 0.025 milligram the methods provided in § 175.300(e): per square inch of surface; and chro- (1) The coating when extracted with mium extractives not to exceed 0.05 distilled water at 180 °F for 24 hours microgram per square inch of surface. yields total extractives not to exceed (e) The coatings are used as food-con- 0.05 milligram per square inch of food- tact surfaces for bulk reusable con- contact surface. tainers intended for storing, handling, (2) The coating when extracted with and transporting food. 50 percent (by volume) ethyl alcohol in distilled water at 180 °F for 24 hours PART 176—INDIRECT FOOD ADDI- yields total extractives not to exceed TIVES: PAPER AND PAPERBOARD 0.05 milligram per square inch. COMPONENTS § 175.390 Zinc-silicon dioxide matrix coatings. Subpart A [Reserved] Zinc-silicon dioxide matrix coatings Subpart B—Substances for Use Only as may be safely used as the food-contact Components of Paper and Paperboard surface of articles intended for use in producing, manufacturing, packing, Sec. processing, preparing, treating, pack- 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. aging, transporting, or holding food, 176.130 Anti-offset substances. subject to the provisions of this sec- 176.150 Chelating agents used in the manu- tion; facture of paper and paperboard. (a) The coating is applied to a metal 176.160 Chromium (Cr III) complex of N- surface, cured, and washed with water ethyl-N-heptadecylfluoro-octane sulfonyl to remove soluble substances. glycine. (b) The coatings are formulated from 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. optional substances which include: 176.180 Components of paper and paperboard (1) Substances generally recognized in contact with dry food. as safe. 176.200 Defoaming agents used in coatings. (2) Substances for which safe condi- 176.210 Defoaming agents used in the manu- tions of use have been prescribed in facture of paper and paperboard. § 175.300. 176.230 3,5-Dimethyl-1,3,5,2H- (3) Substances identified in para- tetrahydrothiadiazine-2-thione. graph (c) of this section, subject to the 176.250 Poly-1,4,7,10,13-pentaaza-15- hydroxyhexadecane. limitations prescribed. 176.260 Pulp from reclaimed fiber. (c) The optional substances per- 176.300 Slimicides. mitted are as follows: 176.320 Sodium nitrate-urea complex. 176.350 seed kernel powder. List of substances Limitations AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. Ethylene glycol ...... As a solvent removed by water washing. SOURCE: 42 FR 14554, Mar. 15, 1977, unless Iron oxide. otherwise noted. Lithium hydroxide ...... Removed by water washing. Methyl orange ...... As an acid-base indicator. EDITORIAL NOTE: Nomenclature changes to Potassium dichromate ...... Removed by water washing. part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 Silica gel. FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. Sodium silicate. 1, 2005. Zinc, as particulate metal.

(d) The coating in the finished form Subpart A [Reserved] in which it is to contact food, when ex- tracted with the solvent or solvents Subpart B—Substances for Use characterizing the type of food, and Only as Components of Paper under the conditions of its intended use and Paperboard as shown in table 1 and 2 of § 175.300(d) (using 20 percent alcohol as the solvent § 176.110 Acrylamide-acrylic acid res- when the type of food contains approxi- ins. mately 20 percent alcohol) shall yield Acrylamide-acrylic acid resins may total extractives not to exceed those be safely used as components of arti- prescribed in § 175.300(c)(3); lithium ex- cles intended for use in producing,

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manufacturing, packing, processing, (b) Anti-offset powders are prepared preparing, treating, packaging, trans- from substances that are generally rec- porting, or holding food, subject to the ognized as safe in food, substances for provisions of this section. which prior sanctions or approvals (a) Acrylamide-acrylic acid resins are were granted and which are used in ac- produced by the polymerization of ac- cordance with the specific provisions of rylamide with partial hydrolysis or by such sanction or approval, and sub- the copolymerization of acrylamide stances named in paragraph (c) of this and acrylic acid. section. (b) The acrylamide-acrylic acid res- (c) The substances permitted are as ins contain less than 0.2 percent resid- follows: ual monomer. (c) The resins are used as adjuvants Substances Limitations in the manufacture of paper and paper- Carbon tetrachloride. board in amounts not to exceed that Methyl hydrogen polysiloxanes. necessary to accomplish the technical Industrial starch—modified .... Complying with § 178.3520 of effect and not to exceed 2 percent by this chapter. weight of the paper or paperboard. Stannous oleate. Zinc-2-ethyl hexoate. § 176.120 Alkyl ketene dimers. Alkyl ketene dimers may be safely § 176.150 Chelating agents used in the used as a component of articles in- manufacture of paper and paper- board. tended for use in producing, manufac- turing, packing, processing, preparing, The substances named in paragraph treating, packaging, transporting, or (a) of this section may be safely used in holding food, subject to the provisions the manufacture of paper and paper- of this section. board, in accordance with the condi- (a) The alkyl ketene dimers are man- tions prescribed in paragraphs (b) and ufactured by the dehydrohalogenation (c) of this section: of the acyl halides derived from the (a) Chelating agents: fatty acids of animal or vegetable fats List of substances Limitations and oils. (b) The alkyl ketene dimers are used Ammonium fructoheptonate. Ammonium glucoheptonate. as an adjuvant in the manufacture of Disodium ethylenediamine tetraacetate. paper and paperboard under such condi- Pentasodium salt of diethylenetriamine tions that the alkyl ketene dimers and pentaacetate. Sodium fructoheptonate. their hydrolysis products dialkyl Sodium glucoheptonate. ketones do not exceed 0.4 percent by Tetrasodium ethylenediamine tetra- weight of the paper or paperboard. acetate. (c) The alkyl ketene dimers may be Trisodium N-hydroxyethyl ethylene- diamine triacetate. used in the form of an aqueous emul- sion which may contain sodium (b) Any one or any combination of lignosulfonate as a dispersant. the substances named is used or in- tended for use as chelating agents. § 176.130 Anti-offset substances. (c) The substances are added in an Substances named in paragraphs (b) amount not greater than that required and (c) of this section may be safely to accomplish the intended technical used to prevent the transfer of inks effect nor greater than any specific employed in printing and decorating limitation, where such is provided. paper and paperboard used for food packaging in accordance with the pro- § 176.160 Chromium (Cr III) complex visions of this section: of N-ethyl-N-heptadecylfluoro-oc- (a) The substances are applied to the tane sulfonyl glycine. nonfood contact, printed side of the The chromium (Cr III) complex of N- paper or paperboard in an amount not ethyl - N -heptadecylfluoro-octane greater than that required to accom- sulfonyl glycine containing up to 20 plish the technical effect nor greater percent by weight of the chromium (Cr than any specific limitations, where III) complex of heptadecylfluoro-octane such are provided. sulfonic acid may be safely used as a

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component of paper for packaging dry 1 in paragraph (c) of this section are food when used in accordance with the subject to the provisions of § 176.180. following prescribed conditions. (a) Substances identified in para- (a) The food additive is used as a graph (a) (1) through (5) of this section component of paper in an amount not may be used as components of the food- to exceed 0.5 percent by weight of the contact surface of paper and paper- paper. board. Paper and paperboard products (b)(1) The food-contact surface of the shall be exempted from compliance paper is overcoated with a polymeric or with the extractives limitations pre- scribed in paragraph (c) of this section: resinous coating at least 1⁄3-mil in thickness, that meets the provision of Provided, That the components of the § 176.170; or food-contact surface consist entirely of one or more of the substances identi- (2) The treated paper forms one or fied in this paragraph: And provided fur- more plies of a paper in a multiwall ther, That if the paper or paperboard bag and is separated from the food by when extracted under the conditions at least one ply of packaging films or prescribed in paragraph (c) of this sec- grease-resistant papers which serves as tion exceeds the limitations on extrac- a functional barrier between the food tives contained in paragraph (c) of this additive and the food. Such packaging section, information shall be available films or grease-resistant papers con- from manufacturing records from form with appropriate food additive which it is possible to determine that regulations. only substances identified in this para- (c) The labeling of the food additive graph (a) are present in the food-con- shall contain adequate directions for tact surface of such paper or paper- its use to insure compliance with the board. requirements of paragraphs (a) and (b) (1) Substances generally recognized of this section. as safe in food. (2) Substances generally recognized § 176.170 Components of paper and pa- as safe for their intended use in paper perboard in contact with aqueous and paperboard products used in food and fatty foods. packaging. Substances identified in this section (3) Substances used in accordance may be safely used as components of with a prior sanction or approval. the uncoated or coated food-contact (4) Substances that by regulation in surface of paper and paperboard in- parts 170 through 189 of this chapter tended for use in producing, manufac- may be safely used without extractives turing, packaging, processing, pre- limitations as components of the paring, treating, packing, transporting, uncoated or coated food-contact sur- or holding aqueous and fatty foods, face of paper and paperboard in contact subject to the provisions of this sec- with aqueous or fatty food, subject to tion. Components of paper and paper- the provisions of such regulation. board in contact with dry food of the (5) Substances identified in this para- type identified under Type VIII of table graph, as follows:

List of Substances Limitations

Acetyl peroxide ...... For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet- taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper- monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper- percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and termined by LVG-series Brookfield viscometer (or equivalent) paperboard. using a No. 2 spindle at 30 r.p.m. Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl For use only as a retention aid and flocculant employed prior sulfate copolymer resins containing not more than 10 molar to the sheet-forming operation in the manufacture of paper percent of b-methacrylyloxyethyltrimethylammonium methyl and paperboard. sulfate and containing less than 0.2% of residual acrylamide monomer. Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl For use only in paper mill boilers. ether (CAS Reg. No. 86830–15–1).

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List of Substances Limitations

Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul- For use only as a scale inhibitor prior to the sheet-forming op- fonic acid (CAS Reg. No. 40623–75–4) and/or its ammo- eration in the manufacture of paper and paperboard and nium/ mixed salts. The copolymer is produced by used at a level not to exceed 1.0 kilogram (2.2 pounds) of poly-merization of acrylic acid and 2-acrylamido-2- copolymer per 907 kilograms (1 ton) of dry paper and paper- methylpropane-sulfonic acid in a weight ratio of 60/40, such board fibers. that a 28 percent by weight aqueous solution of the polymer has a viscosity of 75–150 centipoises at 25 °C as deter- mined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 60 r.p.m. Acrylonitrile polymer, reaction product with ethylenediamine For use only as a size promoter and retention aid at a level not sulfate having a nitrogen content of 22.5–25.0 percent (Kjel- to exceed 0.5 percent by weight of the dry paper and paper- dahl dry basis) and containing no more than 0.075 percent board. monomer as ethylenediamine. The finished resin in a 24 per- cent by weight aqueous solution has a viscosity of 1,000– 2,000 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or by other equivalent method). Acrylonitrile polymer with styrene, reaction product with ethyl- 1. For use only as a sizing material applied after the sheet- enediamine acetate, having a nitrogen content of 7.4–8.3 forming operation in the manufacture of paper and paper- percent (Kjeldahl dry basis) and containing no more than board in such amount that the paper and paperboard will 0.25 percent monomer as ethylenediamine. contain the additive at a level not in excess of 0.25 percent by weight of the dry paper and paperboard. 2. For use only as a sizing material applied prior to the sheet- forming operation in the manufacture of paper and paper- board in such amount that the paper and paperboard will contain the additive at a level not in excess of 1.0 percent by weight of the dry paper and paperboard.

1-Alkenyl olefins, containing not less than 72 percent of C30 For use only under the following conditions: and higher olefins. 1. In coatings for paper and paperboard with food of Types I, II, IV-B, and VII-B described in table 1 of paragraph (c) of this section under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2. In coatings for paper and paperboard with food of Type VIII described in table I of paragraph (c) of this section under conditions of use A through H described in table 2 of para- graph (c) of this section. (2-Alkenyl) succinic anhydrides mixture, in which the alkenyl For use only as a sizing agent employed prior to the sheet- groups are derived from olefins which contain not less than forming operation in the manufacture of paper and paper- 95 percent of C15-C21 groups. board and limited to use at a level not to exceed 1 percent by weight of the finished dry paper and paperboard fibers.

Alkyl(C12-C20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheet-forming Reg. No. 27401–06–5). operation in the manufacture of paper and paperboard.

tert-Alkyl(C8-C16)mercaptans ...... For use only as polymerization-control agent. Aluminum acetate. 2-Amino-2-methyl-1-propanol (CAS Reg. No. 124–68–5) ...... For use as a dispersant for pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The suspen- sion is used as a component of coatings for paper and pa- perboard under conditions of use described in paragraph (c) of this section, table 2, conditions of use E through G. Ammonium persulfate. Ammonium thiosulfate. Ammonium zirconium carbonate (CAS Reg. No. 32535–84–5) For use only as an insolubilizer for binders used in coatings for and its tartaric acid adduct. paper and paperboard, and limited to use at a level not to exceed 2.5 percent by weight of coating solids. Ammonium zirconium citrate (CAS Reg. No. 149564–62–5), For use as insolubilizers with protein binders in coatings for ammonium zirconium lactate-citrate (CAS Reg. No. 149564– paper and paperboard, at a level not to exceed 1.4 percent 64–7), ammonium zirconium lactate (CAS Reg. No. 149564– by weight of coating solids. 63–6). Anionic polyurethane, produced by reacting the preliminary For use only as a surface sizing agent at a level not to exceed adduct formed from the reaction of glyceryl monostearate 0.1 percent by weight of dry paper and paperboard. and 2,4-toluenediisocyanate with not more than 10 mole per- cent N-methyldiethanolamine and not less than 90 mole per- cent dimethylolpropionic acid. The final product is a 15 to 20 percent by weight aqueous solution, having a Brookfield vis- cosity of 25 to 100 centipoises at 24 °C (75 °F). 9,10–Anthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of 84–65–1) which has a purity of not less than 98 percent. lignocellulosic material at levels not to exceed 0.1 percent by weight of the raw lignocellulosic material.

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List of Substances Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as modifiers in wax polymer blend coatings for Reg. No. 88526–47–0), produced by the catalytic polym- paper and paperboard at a level not to exceed 50 weight- erization of aromatic substituted olefins from low boiling dis- percent of the coating solids under conditions of use E, F, tillates of cracked petroleum stocks with a boiling point no and G identified in table 2 of paragraph (c) of this section. greater than 220 °C (428 °F), and the subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. The resin meets the following specifications: softening point 85 °C (185 °F) minimum, as determined by ASTM Method E 28–67 (Reapproved 1982), ‘‘Standard Test Meth- od for Softening Point by Ring-and-Ball Apparatus,’’ and ani- line point 70 °C (158 °F) minimum, as determined by ASTM Method D 611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydro- carbon Solvents,’’ which are incorporated by reference in ac- cordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Phila- delphia, PA 19428-2959, or may be examined at the Na- tional Archives and Records Administration (NARA). For in- formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Azo-bisisobutyronitrile ...... For use only as polymerization catalyst. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ...... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.01 mg/in2 (0.0016 mg/cm2) of the finished paper and paperboard. Benzoyl peroxide ...... Do. N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet forming operation. Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions: resins having a 5.8–6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op- No. 68412–27–1). eration in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not in excess of 1.6 percent by weight of the finished dry paper and paperboard fibers. 2. The finished paper and paperboard will be used in contact with nonalcoholic foods only. 3. As a water repellant employed after the sheet-forming oper- ation in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not to exceed 1.6 percent by weight of the finished dry paper and paperboard fibers. The finished paper and paperboard will be used only in contact with food of Types I, II, IV-B, VI, VII-B, and VIII described in table 1 of paragraph (c) of this section. 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52–51–7) ...... For use only as an antimicrobial/preservative in fillers, pigment slurries, starch sizing solutions, and latex coatings at levels not to exceed 0.01 percent by weight of those components. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink. ester, ammonium salt [CAS Reg. No. 144093–88–9]).. tert-Butyl hydroperoxide ...... For use only as polymerization catalyst. tert-Butyl peroxide ...... Do. Calcium isostearate ...... For use only with n-decyl alcohol as a stabilizing material for aqueous calcium stearate dispersions intended for use as components of coatings for paper and paperboard. Carrageenan and salts of carrageenan as described in §§ 172.620 and 172.626 of this chapter. Castor oil, hydrogenated. Castor oil, sulfated, ammonium, potassium, or sodium salt. Cellulose, regenerated. Chloracetamide ...... For use only as polymerization-control agent. Cobaltous acetate ...... For use only as polymerization catalyst. Cumene hydroperoxide ...... Do. Cyanoguanidine ...... For use only: 1. As a modifier for amino resins. 2. As a fluidizing agent in starch and protein coatings for paper and paperboard. n-Decyl alcohol ...... For use only with calcium isostearate as a stabilizing material for aqueous calcium stearate dispersions intended for use as components of coatings for paper and paperboard.

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List of Substances Limitations

Dialdehyde guar gum ...... For use only as a wet-strength agent employed prior to the sheet-forming operation in the manufacture of paper and pa- perboard and used at a level not to exceed 1% by weight of the finished dry paper and paperboard fibers. Dialdehyde locust bean gum ...... Do.

Dialkyl(C16-C18)carbamoyl chloride (CAS Reg. No. 41319–54– For use as a sizing agent at a level not to exceed 0.2 percent 4) manufactured by the reaction of secondary amines de- by weight of the dry fiber. rived from fatty acids of animal or vegetable sources with phosgene. Diallyldimethyl ammonium chloride polymer with acrylamide For use only as a retention and/or drainage aid employed prior and potassium acrylate, produced by copolymerizing either to the sheet-forming operations in the manufacture of paper (1) diallyldimethyl ammonium chloride and acrylamide in a and paperboard and limited to use at a level not to exceed weight ratio of 50/50, with 4.4 percent of the acrylamide sub- 0.05 percent by weight of the finished paper and paper- sequently hydrolyzed to potassium acrylate or (2) polym- board. erized diallyldimethyl ammonium chloride, acrylamide and potassium acrylate (as acrylic acid) in a weight ratio of 50/ 47.8/2.2, respectively, so that the finished resin in a 1 per- cent by weight aqueous solution (active polymer) has a vis- cosity of more than 22 centipoises at 22 °C (72 °F) as deter- mined by LVF series, Brookfield Viscometer using No. 1 spindle at 60 RPM (or by other equivalent method) (CAS Reg. No. 25136–75–8). Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior No. 26590–05–6). The copolymer is produced by copolym- to the sheet-forming operation in the manufacture of paper erizing diallyldimethylammonium chloride with acrylamide in and paperboard and limited to use at a level not to exceed a weight ratio of 50–50 so that the finished resin in a 1 per- 0.05 percent by weight of the finished paper and paper- cent by weight aqueous solution (active polymer) has a vis- board. cosity of more than 22 centipoises at 22 °C (71.6 °F), as de- termined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). Diallyldiethylammonium chloride polymer with acrylamide, and diallyldimethylammonium chloride, produced by copolym- erizing acrylamide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride, respectively, in the fol- lowing weight ratios and having viscosities determined at 22 °C, by LVF-series Brookfield viscometer using a No. 1 spin- dle at 60 r.p.m. (or by other equivalent method), as follows:. 1. Weight ratio: 50–2.5–47.5. The finished resin in a 1 per- For use only as a retention aid employed prior to the sheet- cent by weight aqueous solution has a minimum vis- forming operation in the manufacture of paper and paper- cosity of 22 centipoises. board and limited to use at a level not to exceed 0.05 per- cent by weight of the finished paper and paperboard. 2. Weight ratio: 25–2.5–72.5. The finished resin in a 0.20 For use only as a drainage and/or retention aid employed prior percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper cosity of 20 centipoises. and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paper- board. 3. Weight ratio: 80–2.5–17.5. The finished resin in a 0.30 For use only as a drainage and/or retention aid employed prior percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper cosity of 50 centipoises. and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paper- board. Diallyldiethylammonium chloride polymer with acrylamide, po- For use only as a retention aid employed prior to the sheet- tassium acrylate, and diallyldimethylammonium chloride. The forming operation in the manufacture of paper and paper- polymer is produced by copolymerizing either: (1) acryl- board and limited to use at a level not to exceed 0.05 per- amide, diallyldiethylammonium chloride, and cent by weight of the finished paper and paperboard. diallyldimethylammonium chloride in a weight ratio of 50– 2.5–47.5, respectively, with 4.4 percent of the acrylamide subsequently hydrolyzed to potassium acrylate, or (2) acryl- amide, potassium acrylate (as acrylic acid), diallyldiethylammonium chloride, and diallyldimethylammonium chloride in a weight ratio of 47.8– 2.2–2.5–47.5, so that the finished resin in a 1 percent by weight aqueous solution has a minimum viscosity of 22 cen- tipoises at 22 °C, as determined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).

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List of Substances Limitations

Diallyldimethylammonium chloride polymer with acrylamide, re- For use only as a dry and wet strength agent employed prior action product with glyoxal, produced by copolymerizing not to the sheet-forming operation in the manufacture of paper less than 90 weight percent of acrylamide and not more than and paperboard in such an amount that the finished paper 10 weight percent of diallyldimethylammonium chloride, and paperboard will contain the additive at a level not in ex- which is then cross-linked with not more than 30 weight per- cess of 2 percent by weight of the dry fibers in the finished cent of glyoxal, such that a 10 percent aqueous solution has paper and paperboard. a minimum viscosity of 25 centipoises at 25 °C as deter- mined by Brookfield viscometer Model RVF, using a No. 1 spindle at 100 r.p.m. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222–01–2). For use as a preservative at a level not to exceed 100 parts per million in coating formulations and in component slurries and emulsions, used in the production of paper and paper- board and coatings for paper and paperboard. 2,5-Di-tert-butyl hydroquinone ...... For use only as an antioxidant for fatty based coating adju- vants provided it is used at a level not to exceed 0.005% by weight of coating solids. Diethanolamine ...... For use only: 1. As an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. 2.In paper mill boilers. Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry- For use only as a retention aid and drainage aid employed late, polymer with acrylamide, chemical abstract service reg- prior to the sheet-forming operation in the manufacture of istry No. [26796–75–8] having 90–95 mole pct. acrylamide, a paper and paperboard at a level not to exceed 0.15 pct. by nitrogen content of not more than 19.7 pct. (Kjeldahl, dry weight of finished dry paper and paperboard fibers. basis), and a residual acrylamide monomer content of not more than 0.1 pct. The finished polymer in a 1 pct. by weight aqueous solution has a minimum viscosity of 900 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by equivalent method). Diethylenetriamine ...... For use only as a modifier for amino resins. N,N-Diisopropanolamide of tallow fatty acids ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Dimethylamine-epichlorohydrin copolymer in which not more For use only: than 5 mole-percent of dimethylamine may be replaced by 1. As a retention aid employed before the sheet-forming oper- an equimolar amount of ethylenediamine and in which the ation in the manufacture of paper and paperboard and lim- ratio of total amine to epichlorohydrin does not exceed 1:1. ited to use at a level not to exceed 1 percent by weight of The nitrogen content of the copolymer shall be 9.4 to 10.8 the finished paper and paperboard. weight percent on a dry basis and a 10 percent by weight 2. At the size press at a level not to exceed 0.017 percent by aqueous solution of the final product has a minimum vis- weight of the finished paper and paperboard. cosity of 5.0 centipoises at 25 °C, as determined by LVT-se- ries Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). N-[(Dimethylamino)methyl]-acrylamide polymer with acrylamide For use only as a dry-strength agent employed prior to the and styrene having a nitrogen content of not more than 16.9 sheet-forming operation in the manufacture of paper and pa- percent and a residual acrylamide monomer content of not perboard and used at a level not to exceed 1 percent by more than 0.2 percent on a dry basis. weight of finished dry paper or paperboard fibers. N,N′-Dioleoylethylenediamine. Diphenylamine ...... For use only as an antioxidant for fatty based coating adju- vants provided it is used at a level not to exceed 0.005% by weight of coating solids. Dipropylene glycol. Disodium salt of 1,4-dihydro-9,10-dihydroxyanthracene (CAS For use only as a catalyst in the alkaline pulping of Reg. No. 73347–80–5). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N′-Distearoylethylenediamine. n-Dodecylguanidine acetate ...... For use only as an antimicrobial agent in paper and paper- board under the following conditions: 1. For contact only with nonalcoholic food having a pH above 5 and provided it is used at a level not to exceed 0.4 percent by weight of the paper and paperboard. 2. For use in the outer ply of multiwall paper bags for contact with dry food of Type VIII described in table I of paragraph (c) of this section and provided it is used at a level of 0.8 percent by weight of the paper.

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List of Substances Limitations

n-Dodecylguanidine hydrochloride ...... For use only as an antimicrobial agent in paper and paper- board under the following conditions: 1. For contact only with nonalcoholic food having a pH above 5 and provided it is used at a level not to exceed 0.4 percent by weight of the paper and paperboard. 2. For use in the outer ply of multiwall paper bags for contact with dry food of Type VIII described in table I of paragraph (c) of this section and provided it is used at a level of 0.8 percent by weight of the paper. Fatty acids derived from animal and vegetable fats and oils and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Ferric chloride. Ferrous ammonium sulfate. , hydrogenated. Fish oil, hydrogenated, potassium salt. Furcelleran and salts of furcelleran as described in §§ 172.655 and 172.660 of this chapter. Glutaraldehyde (CAS Reg. No. 111–30–8) ...... For use only as an antimicrobial agent in pigment and filler slurries used in the manufacture of paper and paperboard at levels not to exceed 300 parts per million by weight of the slurry solids. Glyceryl lactostearate. Glyceryl mono-1,2-hydroxystearate. Glyceryl monoricinoleate. Guar gum modified by treatment with b-diethylamino- ethyl For use only as a retention aid and/or drainage aid employed chloride hydrochloride. prior to the sheet-forming operation in the manufacture of paper and paperboard. Guar gum modified by treatment with not more than 25 weight For use only as a retention aid and/or internal size employed percent of 2,3-epoxypropyltri-methylammonium chloride such prior to the sheet-forming operation in the manufacture of that the finished product has a maximum chlorine content of paper and paperboard, and limited to use at a level: (1) Not 4.5 percent, a maximum nitrogen content of 3.0 percent, and to exceed 0.15 percent by weight of the finished dry paper a minimum viscosity in 1-percent-by-weight aqueous solution and paperboard fibers intended for use in contact with all of 1,000 centipoises at 77 °F, as determined by RV-series types of foods, except (2) not to exceed 0.30 pct. by weight Brookfield viscometer (or equivalent) using a No. 3 spindle at of the finished dried paper and paperboard fibers for use 20 r.p.m. with nonalcoholic and nonfatty food of types identified under Types I, II, IV-B, VI-B, VII-B, and VIII of table I in par. (c) of this section. N,N,N′,N′,N″,N″-Hexakis (methoxymethyl)-1,3,5-triazine-2,4,6- For use only as a water-repellent applied to the surface of triamine polymer with stearyl alcohol, a-octadecenyl-omega- paper and paperboard at levels not to exceed 1 percent by hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20 + ) alcohols weight of the finished dry paperboard fibers. The finished (CAS Reg. No. 130328–24–4). paper and paperboard will be used in contact with aqueous foods under conditions of use B through G as described in table 2 of paragraph (c) of this section. Hexamethylenetetramine ...... For use only as polymerization cross-linking agent for protein, including casein. Hydroquinone and the monomethyl or monoethyl ethers of hy- For use only as an inhibitor for monomers. droquinone. Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636– For use only as a preservative in clay-type fillers at a level not 82–4), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms dimethylhydantoin (CAS Reg. No. 6440–58–0). hydroxymethyl-5,5-dimethylhydantoin and 1,3- bis(hydroxymethyl)-5,5-dimethylhydantoin in the filler. Hydroxypropyl guar gum having a minimum viscosity of 5,000 For use only as a dry strength and formation aid agent em- centipoises at 25 °C., as determined by RV-series Brookfield ployed prior to the sheet-forming operation in the manufac- viscometer using a No. 4 spindle at 20 r.p.m. (or other suit- ture of paper and paperboard and used at a level not to ex- able method) and using a test sample prepared by dissolving ceed 1.5 percent by weight of finished dry paper or paper- 5 grams of moisture-free hydroxypropyl guar gum in 495 mil- board fibers. liliters of a 70 percent by weight aqueous propylene glycol solution. 12-Hydroxystearic acid-polyethylene glycol block copolymers For use only as a surfactant for dispersions of polyacrylamide (CAS Reg. No. 70142–34–6) produced by the reaction of retention and drainage aids employed prior to the sheet polyethylene glycol (minimum molecular weight 200) with 12- forming operation in the manufacture of paper and paper- hydroxystearic acid. board. Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at a level not to exceed 0.5 percent by weight of [2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749–55–4)..

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List of Substances Limitations

Isopropyl m- and p-cresols (thymol derived) ...... For use only as an antioxidant for fatty based coating adju- vants provided it is used as a level not to exceed 0.005% by weight of coating solids. Isopropyl peroxydicarbonate ...... For use only as polymerization catalyst. Japan wax. Lanolin. Lauryl peroxide ...... For use only as polymerization catalyst. Lauryl sulfate salts: Ammonium. Magnesium. Potassium. Sodium. Lecithin, hydroxylated. Lignin sulfonate and its calcium, potassium, and sodium salts. Maleic anhydride, polymer with ethyl acrylate and vinyl acetate, For use only as a deposit control additive prior to the sheet hydrolyzed (CAS Reg. No. 113221–69–5) and/or its ammo- forming operation to prevent scale buildup in the manufac- nium, potassium, and sodium salts. ture of paper and paperboard in contact with food, at a level not to exceed 0.075 percent (as the acid) by weight of the dry paper and paperboard. Methacrylic acid-acrylic acid copolymer (CAS Reg. No. 25751– For use only as a boiler water additive at a level not to exceed 21–7). 50 parts per million in the boiler water. N-methyldiallylamine hydrochloride polymer with For use only as a retention aid, flocculating agent, and wet- epichlorohydrin having a nitrogen content of 4.8 to 5.9 per- strength agent employed in the manufacture of paper and cent (Kjeldahl dry basis) such that a 20 percent by weight paperboard prior to the sheet-forming operation and limited aqueous solution has a minimum viscosity of 30 centipoises to use at a level not to exceed 1.5 percent by weight of the and maximum viscosity of 100 centipoises at 25 °C, as de- dry paper and paperboard. termined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method). Methyl naphthalene sulfonic acid-formaldehyde condensate, For use only as an adjuvant to control pulp absorbency and sodium salt. pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. N-methyl-N-(tall oil acyl) , sodium salt (CAS Reg. No. For use only to control scale formation in the manufacture of 61791–41–1). paper and paperboard prior to the sheetforming operation at a level not to exceed 0.015 percent by weight of the dry paper and paperboard. Mineral oil, white. Mono-, di-, tri-(1-methyl-1-phenylethyl)-phenol, ethoxylated, For use only as an emulsifier for rosin based sizing at a level sulfated, ammonium salt with an average of 12 to 16 moles not to exceed 0.03 percent by weight of the finished dry of ethylene oxide (CAS Reg. No. 68130–71–2). paper and paperboard. Monoglyceride citrate. Monoisopropanolamine (CAS Reg. No. 78–96–6) ...... For use as a dispersant for titanium dioxide suspensions at a level not to exceed 0.68 percent by weight of titanium diox- ide. The finished paper and paperboard will be used in con- tact with all food types under conditions of use E through G described in table 2 of paragraph (c) of this section. Mustardseed oil, sulfated, ammonium, potassium, or sodium salt. Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only as an adjuvant to control pulp absorbency and salt. pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Nitrocellulose, 10.9–12.2% nitrogen. Oleic acid, sulfated, ammonium, potassium, or sodium salt. N-Oleoyl-N′-stearoylethylenediamine. Oxystearin. Paraformaldehyde ...... For use only as setting agent for protein. Petrolatum ...... Complying with § 178.3700 of this chapter. Petroleum asphalt, steam and vacuum refined to meet the fol- For use only as a component of internal sizing of paper and lowing specifications: Softening point 88 °C to 93 °C, as de- paperboard intended for use in contact only with raw fruits, termined by ASTM method D36–76, ‘‘Standard Test Method raw vegetables, and dry food of the type identified under for Softening Point of Bitumen (Ring-and-Ball Apparatus);’’ Type VIII of table 1 in paragraph (c) of this section, and pro- penetration at 25 °C not to exceed 0.3 mm, as determined vided that the asphalt is used at a level not to exceed 5% by by ASTM method D5–73 (Reapproved 1978), ‘‘Standard weight of the finished dry paper and paperboard fibers. Test Method for Penetration of Bituminous Materials,’’ which are incorporated by reference (Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Ad- ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.); and maximum weight loss not to exceed 3% when distilled to 371 °C, nor to exceed an additional 1.1% when further distilled between 371 °C and thermal decomposition.

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List of Substances Limitations

Petroleum wax, synthetic ...... Complying with § 178.3720 of this chapter. Phenothiazine ...... For use only as antioxidant in dry rosin size. Phenyl acid phosphate ...... For use only as polymerization catalyst in melamine-formalde- hyde modified alkyd coatings and limited to use at a level not to exceed 2% by weight of the coating solids. Phenyl-b-naphthylamine ...... For use only as antioxidant in dry rosin size and limited to use at a level not to exceed 0.4% by weight of the dry rosin size. Phosphoric acid esters and polyesters (and their sodium salts) For use as an adjuvant prior to the sheet forming operation to of triethanolamine formed by the reaction of triethanolamine control pitch and scale formation in the manufacture of paper with polyphosphoric acid to produce a mixture of esters hav- and paperboard intended for use in contact with food only of ing an average nitrogen content of 1.5 percent and an aver- the types identified in paragraph (c) of this section, table 1, age phosphorus content of 32 percent (as PO4). under Types I, IV, V, VII, VIII, and IX, and used at a level not to exceed 0.075 percent by weight of dry paper or pa- perboard fibers. Poly[acrylamide-acrylic acid-N-(dimethyl-aminomethyl)acryl- For use only as a drainage aid and retention aid employed amide], produced by reacting 2.40 to 3.12 parts by weight of prior to the sheet-forming operation in the manufacture of polyacrylamide with 1.55 parts dimethylamine and 1 part paper and paperboard for use in contact with fatty foods formaldehyde, and containing no more than 0.2 percent under conditions of use described in paragraph (c) of this monomer as acrylamide. section, table 2, conditions of use E, F, and G. Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) For use only as a retention and drainage aid employed prior to produced when one mole of hydroxypropyl acrylate and the sheet-forming operation in the manufacture of paper and three moles of acrylic acid are reacted with three moles of paperboard at a level not to exceed 0.2 percent by weight of ethylenimine and three moles of nitric acid, such that a 35 dry paper or paperboard fiber. percent by weight aqueous solution has a minimum viscosity of 150 centipoises at 72 °F., as determined by RVF-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 20 r.p.m. Polyacrolein (1 part) -sodium bisulfite (0.7 part) adduct, con- For use only as an agent in modifying starches and starch taining excess bisulfite (ratio of excess bisulfite to adduct not gums used in the production of paper and paperboard and to exceed 1.5 to 1). limited to use at a level not to exceed 0.09 mg/in2 of the fin- ished paper and paperboard. Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl- For use only as a drainage aid, retention aid, or dry-strength amide] (C.A. Registry No. 53800–41–2), produced by react- agent employed prior to the sheet-forming operation in the ing 9.6–16.4 parts by weight of polyacrylamide with 1.6 parts manufacture of paper and paperboard at a level not to ex- dimethylamine and 1 part formaldehyde, and containing no ceed 0.25 percent by weight of finished dry paper and pa- more than 0.2% monomer as acrylamide, such that a 20% perboard fibers, when such paper or paperboard is used in aqueous solution has a minimum viscosity of 4,000 cP at 25 contact with fatty foods under conditions of use described in °C., as determined by Brookfield viscometer model RVT, paragraph (c) of this section, table 2, conditions of use E, F, using a No. 5 spindle at 20 r/min (or equivalent method). and G. Polyamide-epichlorohydrin modified resin produced by reacting For use only as a retention aid and flocculant employed prior adipic acid with diethylene triamine to produce a basic poly- to the sheet-forming operation in the manufacture of paper amide which is modified by reaction with formic acid and and paperboard and used at a level not to exceed 0.2 per- formaldehyde and further reacted with epichlorohydrin in the cent dry resin by weight of finished dry paper or paperboard presence of ammonium hydroxide to form a water-soluble fibers. cationic resin having a nitrogen content of 13–16 percent (Kjeldahl, dry basis) such that a 35 percent by weight aque- ous solution has a minimum viscosity of 75 centipoises at 25 °C, as determined by Brookfield viscometer using a No. 1 spindle at 12 r.p.m. Polyamide-epichlorohydrin water-soluble thermosetting resins For use only under the following conditions: [CAS Reg. No. 68583–79–9] prepared by reacting adipic 1. As a retention aid employed prior to the sheet-forming oper- acid with diethylenetriamine to form a basic polyamide and ation in the manufacture of paper and paperboard and lim- further reacting the polyamide with an epichlorohydrin and ited to use at a level not to exceed 0.12 percent by weight of dimethylamine mixture such that the finished resins have a dry paper or paperboard. nitrogen content of 17.0 to 18.0 percent of a dry basis, and 2. The finished paper or paperboard will be used in contact that a 30-percent-by-weight aqueous solution has a minimum with food only of the types identified in paragraph (c) of this viscosity of 350 centipoises at 20 °C, as determined by a section, table 1, under types I and IV-B and under conditions Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or of use described in paragraph (c) of this section, table 2, equivalent method). conditions of use F and G. Polyamide-epichlorohydrin water-soluble thermosetting resin For use only as a wet strength agent and/or retention aid em- (CAS Reg. No. 96387–48–3) prepared by reacting N-methyl- ployed prior to the sheet-forming operation in the manufac- bis(3-aminopropyl) amine with oxalic acid and urea to form a ture of paper and paperboard and used at a level not to ex- basic polyamide and further reacting the polyamide with ceed 1.5 percent by weight of dry paper and paperboard fi- epichlorohydrin. bers.

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List of Substances Limitations

Polyamide-epichlorohydrin water-soluble thermosetting resins For use only in the manufacture of paper and paperboard prepared by reacting adipic acid, isophthalic acid, itaconic under conditions such that the resins do not exceed 1.5 per- acid or dimethyl glutarate with diethylenetriamine to form a cent by weight of the paper or paperboard. basic polyamide and further reacting the polyamide with one of the following: Epichlorohydrin. Epichlorohydrin and ammonia mixture. Epichlorohydrin and sodium hydrosulfite mixture. Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared For use only as a retention aid employed prior to the sheet- by reacting hexanedioic acid, N-(2-aminoethyl)-1,2- forming operation in the manufacture of paper and paper- ethanediamine, (chloromethyl)oxirane, ethyleneimine board at a level not to exceed 0.12 percent resin by weight (aziridine), and polyethylene glycol, partly neutralized with of the finished dry paper or paperboard. sulfuric acid (CAS Reg. No. 167678–45–7). Polyamidol-epichlorohydrin modified resin produced by reacting For use only as a wet strength agent employed prior to the glutaric acid dimethyl ester with diethylene-triamine to sheet-forming operation in the manufacture of paper and pa- produce a basic polyamide which is modified by reaction perboard, and used at a level not to exceed 2.5 percent by with formaldehyde and further reacted with epicholorohydrin weight of dry paper and paperboard fibers when such paper to form a water soluble cationic resin having a nitrogen con- or paperboard is used in contact with food under conditions tent of 10.9–11.9 percent and a chlorine content of 13.8– of use E through G described in table 2 of paragraph (c) of 14.8 percent, on a dry basis, and a minimum viscosity, in this section. 12.5 percent by weight aqueous solution, of 10 centipoises at 25 °C, as determined by a Brookfield Model LVF viscom- eter using a No. 1 spindle at 60 r.p.m. (or equivalent meth- od). Polyamine-epichlorohydrin resin produced by the reaction of For use only as a flocculant, drainage aid, formation aid, reten- epichlorohydrin with monomethylamine to form a prepolymer tion aid, or strength additive employed prior to the sheet- and further reaction of this prepolymer with N,N,N′,N′- forming operation in the manufacture of paper and paper- tetramethylethylenediamine such that the finished resin hav- board, and used at a level not to exceed 0.12 percent by ing a nitrogen content of 11.6 to 14.8 percent and a chlorine weight of dry paper and paperboard fibers. content of 20.8 to 26.4 percent and a minimum viscosity, in 25 percent by weight aqueous solution, of 500 centipoises at 25 °C, as determined by LV-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by other equivalent method). Polyamine-epichlorohydrin resin produced by the reaction of For use only as a clarifier in the treatment of influent water to N,N-dimethyl-1,3-propanediamine with epichlorohydrin and be used in the manufacture of paper and paperboard, and further reacted with sulfuric acid, Chemical Abstracts Service used at a level not to exceed 20 parts per million of the influ- Registry Number [27029–41–0], such that the finished resin ent water. has a maximum nitrogen content of 14.4 percent (dry basis) and a minimum viscosity in 30 percent by weight aqueous solution (pH 4–6) of 50 centipoises at 25 °C, as determined by Brookfield LVT model viscometer, using a No. 1 spindle at 12 r.p.m. (or equivalent method). Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wetstrength agent and/or retention aid em- produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac- comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex- diamines and/or their self-condensation products, and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi- prepolymers produced by reacting 1,2-dichloroethane with bers. the polyamines in (i). The finished resin has a nitrogen con- tent of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0 percent on a dry basis, and a minimum viscosity, in a 25 percent by weight aqueous solution, of 50 centipoises at 20 °C (68 °F), as determined by Brookfield HAT model viscom- eter using a No. 1H spindle at 50 r.p.m. (or equivlent meth- od). Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em- produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac- comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex- diamines and/or their seIf-condensation products and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi- hexamethylenediamine, and/or (iii) bis(hexamethylene) tri- bers. amine and higher homologues, and/or (iv) prepolymers pro- duced by reacting 1,2-dichloroethane with the polyamines in (i) and/or (ii) and/or (iii). The finished resin has a nitrogen content of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0 percent on a dry basis, and a minimum viscosity, in a 25 percent by weight aqueous solution, of 50 centipoises at 20 °C (68 °F), as determined by Brookfield HAT model vis- cometer using a No. 1H spindle at 50 r.p.m. (or equivalent method).

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List of Substances Limitations

Polyamine-epichlorohydrin water soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em- prepared by reacting hexamethylenediamine with 1,2-di- ployed prior to the sheet-forming operation in the manufac- chloroethane to form a prepolymer and further reacting this ture of paper and paperboard, and used at a level not to ex- prepolymer with epichlorohydrin. This resin is then reacted ceed 1 percent by weight of dry paper and paperboard fi- with nitrilotris (methylene-phosphonic acid), pentasodium bers. salt, such that the finished resin has a nitrogen content of 5.0–5.3 percent; a chlorine content of 29.7–31.3 percent; and a phosphorus content of 2.0–2.2 percent, on a dry basis, and a minimum viscosity, in 25 percent by weight aqueous solution, of 50 centipoises at 25 °C., as determined on a Brookfield HAT model viscometer using a No. 1H spin- dle at 50 r.p.m. (or equivalent method). Polyamine resin produced by the reaction of 1,2-dichloroethane For use only as a retention aid and/or flocculent employed with bis(hexamethylene)triamine and higher homologues prior to the sheet-forming operation in the manufacture of such that the finished resin has a nitrogen content of 13.0– paper and paperboard and used at a level not to exceed 0.1 15.0 percent on a dry basis, and a minimum viscosity in 25- percent by weight of dry paper or paperboard fibers. percent-by-weight aqueous solution of 75 centipoises at 25 °C., as determined by Brookfield HAT model viscometer using a No. 1 spindle at 50 r.p.m. (or equivalent method). Polyaminoamide-epichlorohydrin modified resin produced by For use only as a wet-strength agent and/or retention aid em- reacting adipic acid with diethylenetriamine to produce a pol- ployed prior to the sheet-forming operation in the manufac- yamide which is modified by reaction with ture of paper and paperboard, and used at a level not to ex- diethylaminopropylamine and further reacted with dichlor- ceed 0.5 percent by weight of the finished dry paper and pa- oethyl ether to form a polyamide intermediate. This poly- perboard. amide intermediate is then reacted with epichlorohydrin such that the finished resins have a nitrogen content of 10.9–12.4 percent (Kjeldahl, dry basis) and a minimum viscosity in 40 percent-by-weight aqueous solution of 250 centipoises at 22 °C, as determined by a Brookfield Model LVT viscometer using a No. 2 spindle at 30 r.p.m. (or equivalent method). Polybutene, hydrogenated; complying with the identity pre- For use only as provided in §§ 175.300, 178.3740 and scribed under § 178.3740(b) of this chapter. 178.3860 of this chapter. Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062– For use only: 79–3) produced by the polymerization of 1. As a pigment dispersant and/or retention aid prior to the (diallyldimethylammonium chloride) so that the finished resin sheet-forming operation in the manufacture of paper and pa- has a nitrogen content of 8.66±0.4 percent on a dry weight perboard, and used at a level not to exceed 10 pounds of basis and a minimum viscosity in a 40 percent by weight active polymer per ton of finished paper and paperboard. aqueous solution of 1,000 centipoises at 25 °C (77 °F), de- 2. As a pigment dispersant in coatings at a level not to exceed termined by LVF Model Brookfield Viscometer using a No. 3 3.5 pounds of active polymer per ton of finished paper and spindle at 30 r.p.m. (or equivalent method). The level of re- paperboard. sidual monomer is not to exceed 1 percent by weight of the polymer (dry basis). Poly (diallyldimethylammonium chloride) (CAS Reg. No. For use only as a flocculant employed prior to the sheet-form- 26062–79–3) produced by the polymerization of ing operation in the manufacture of paper and paperboard, diallyldimethylammonium chloride so that the finished resin and used at a level not to exceed 10 mg/L (10 parts per mil- has a nitrogen content of 8.66±0.4 percent on a dry basis lion) of influent water. and a minimum viscosity in a 15 weight-percent aqueous so- lution of 10 centipoises at 25 °C (77 °F), as determined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r/min (or equivalent method). The level of residual monomer is not to exceed 1 weight-percent of the polymer (dry basis). Poly(1,2-dimethyl-5-vinylpyridinium methyl sulfate) having a ni- For use only as an adjuvant employed in the manufacture of trogen content of 5.7 to 7.3 percent and a sulfur content of paper and paperboard prior to the sheet-forming operation. 11.7 to 13.3 percent by weight on a dry basis and having a minimum viscosity in 30-percent-by-weight aqueous solution of 2,000 centipoises at 25 °C., as determined by LV-series Brookfield viscometer (or equivalent) using a No. 4 spindle at 60 r.p.m. Polyester resin produced by reacting dimethylolpropionic acid For use only as a surface-sizing compound applied after the (CAS Registry No. 4767–03–7) as a comonomer, at no more sheet-forming operation in the manufacture of paper and pa- than 30 percent by weight of total polymer solids in reaction perboard and limited to use at levels not to exceed 0.1 per- with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and cent by weight of finished dry paper or paperboard. isophthalic acid, such that the polyester resin has a viscosity of 200–600 centipoises at 80 °F as determined by a Brook- field RVT viscometer using a number 3 spindle at 50 rpm (or equivalent method). Polyethylene, oxidized; complying with the identity prescribed For use only as component of coatings that contact food only in § 177.1620(a) of this chapter. of the type identified under Type VII-B of table 1 in para- graph (c) of this section, and limited to use at a level not to exceed 50 percent by weight of the coating solids.

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List of Substances Limitations

Polyethyleneamine mixture produced when 1 mole of ethylene For use only as a retention aid employed prior to the sheet- dichloride, 1.05 moles of ammonia, and 2 moles of sodium forming operation in the manufacture of paper and paper- hydroxide are made to react so that a 10 percent aqueous board. solution has a minimum viscosity of 40 centipoises at 77 °F, as determined by Brookfield viscometer using a No. 1 spin- dle at 60 r.p.m. Polyethylene glycol (200) dilaurate ...... For use only as an adjuvant employed in the manufacture of paper and paperboard prior to the sheet-forming operation. Polyethylene glycol (400) dioleate. Polyethylene glycol (400) esters of coconut oil fatty acids. Polyethylene glycol (600) esters of tall oil fatty acids. Polyethylene glycol (400) monolaurate. Polyethylene glycol (600) monolaurate. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (400) monostearate. Polyethylene glycol (600) monostearate. Polyethylene glycol (3,000) monostearate. Polyethylenimine, produced by the polymerization of For use only as an adjuvant employed prior to sheet formation ethylenimine. in paper-making systems operated at a pH of 4.5 or higher, and limited to use at a level not to exceed 5% by weight of finished dry paper or paperboard fibers. Poly(isobutene)/maleic anhydride adduct, diethanolamine reac- For use only as a surfactant for dispersions of polyacrylamide tion product. The mole ratio of poly(isobutene)/maleic retention and drainage aids employed prior to the sheet for- anydride adduct to diethanolamine is 1:1. mation operation in the manufacture of paper and paper- board. Polymethacrylic acid, sodium salt, having a viscosity in 30-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 125–325 centipoises at when used at a level not to exceed 0.3% by weight of coat- 25 °C as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 60 r.p.m. Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 400–700 centipoises at when used at a level not to exceed 0.1% by weight of coat- 25 °C, as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 30 r.p.m. Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro- For use only as a retention aid employed prior to the sheet- duced by reaction of 1:1 molar ratio of methylamine and forming operation in such an amount that finished paper and epichlorohydrin so that a 31-percent aqueous solution at 25 paperboard will contain the additive at a level not in excess °C has a Stokes viscosity range of 2.5-4.0 as determined by of 1 percent by weight of the dry paper and paperboard. ASTM method D1545–76 (Reapproved; 1981), ‘‘Standard Test Method for Viscosity of Transparent Liquids by Bubble Time Method,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma- terials, 100 Barr Harbor Dr., West Conshohocken, Philadel- phia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For informa- tion on the availability of this material at NARA, call 202– 741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) For use only to improve dry-strength of paper and paperboard ethylene dichloride] produced by reacting equimolar quan- and as a retention and drainage aid employed prior to the tities of N,N,N,N-tetramethylethylene-diamine and sheet-forming operation in the manufacture of paper and pa- dichlorethyl ether to yield a solution of the solid polymer in perboard and limited to use at a level not to exceed 0.1 per- distilled water at 25 °C with a reduced viscosity of not less cent by weight of the finished dry paper and paperboard fi- than 0.15 deciliter per gram as determined by ASTM method bers. D1243–79, ‘‘Standard Test Method for -Dilute Solution Vis- cosity of Vinyl Chloride Polymers,’’ which is incorporated by reference. Copies may be obtained from the American Soci- ety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be ex- amined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.). The following formula is used for deter- mining reduced viscosity:. Reduced viscosity in terms of deciliters per gram = (t ¥ t0) / (t ¥ C), where: t = Solution efflux time to = Water efflux time C = Concentration of solution in terms of grams per deci- liter Polypropylene glycol (minimum molecular weight 1,000).

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List of Substances Limitations

Potassium persulfate. 2-Propenoic acid, telomer with sodium 2-methyl-2-[(1-oxo-2- For use only as a deposit control additive employed prior to propenyl)amino]-1-propane sulfonate and sodium phos- the sheet forming operation in the manufacture of paper and phinate (CAS Reg. No. 110224–99–2). paperboard and at a level not to exceed 0.15 percent by weight of the dry paper and paperboard. Propylene glycol alginate. Protein hydrolysate from animal hides or soybean protein con- densed with oleic and/or stearic acid. Rapeseed oil, sulfated ammonium, potassium, or sodium salt. Ricebran oil, sulfated ammonium, potassium, or sodium salt. Rosin and rosin derivatives ...... As provided in § 178.3870 of this chapter. Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1- For use only as a component of polyolefin coatings with methyl-C9-49-alkyl (CAS Reg. No. 144635–08–5). § 177.1520 of this chapter at a level not to exceed 3 percent by weight. The finished coating will be used only for paper and paperboard that contact food of types VI-A and VI-B of table 1 in paragraph (c) of this section, and under conditions of use C, D, and E, as described in table 2 in paragraph (c) of this section, with a maximum hot fill temperature of 200 °F (94 °C). Silver chloride-coated titanium dioxide ...... For use only as a preservative in polymer latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion concentration) in the dry coating. Sodium carboxymethyl guar gum having a minimum viscosity For use only as a dry-strength and formation-aid agent em- of 2,700 centipoises at 25 °C after 24 hours as determined ployed prior to the sheet-forming operation in the manufac- by RV-series Brookfield viscometer (or equivalent) using a ture of paper and paperboard and used at a level not to ex- No. 4 spindle at 20 r.p.m. and using a test sample prepared ceed 1% by weight of finished dry paper or paperboard fi- by dissolving 8 grams of sodium carboxymethyl guar gum in bers. 392 milliliters of 0.2-percent-by-weight aqueous sodium o- phenylphenate solution. Sodium dioctyl sulfosuccinate. Sodium formaldehyde sulfoxylate ...... For use only as polymerization catalyst. Sodium hypochlorite. Sodium N-methyl-N-oleyltaurate ...... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Sodium nitrite ...... For use only: 1. At levels not to exceed 0.2% by weight of lubricants or re- lease agents applied at levels not to exceed 1 lb. per ton of finished paper or paperboard. 2. As an anticorrosion agent at levels not to exceed 0.2% by weight of wax emulsions used as internal sizing in the manu- facture of paper and paperboard prior to the sheet-forming operation. Sodium persulfate. Sodium polyacrylate ...... For use only: 1. As a thickening agent for natural rubber latex coatings, pro- vided it is used at a level not to exceed 2 percent by weight of coating solids. 2. As a pigment dispersant in coatings at a level not to exceed 0.25 percent by weight of pigment. Sodium poly(isopropenylphosphonate) (CAS Reg. No. 118632– For use only in paper mill boilers. 18–1). Sodium zinc potassium polyphosphate (CAS Reg. No. 65997– For use only as a pigment dispersant in coatings at a level not 17–3). to exceed 1 percent by weight of pigment. Sperm oil, sulfated, ammonium, potassium, or sodium salt. Stannous oleate. Stearyl-2-lactylic acid and its calcium salt. Styrene-butadiene copolymers produced by copolymerizing sty- rene-butadiene with one or more of the monomers: acryl- amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, methacrylic acid, and N-methylolacrylamide (CAS Reg. No. 53504–31–7). The finished copolymers shall contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid, and shall con- tain not more than 3 weight percent of total polymer units derived from N-methylolacrylamide, and shall contain not more than 2 weight percent of polymer units derived from acrylamide.. Styrene-maleic anhydride copolymer, amidated, ammonium so- For use only as a surface size at a level not to exceed 1 per- dium salt; having, in a 25 percent by weight aqueous solu- cent by weight of paper or paperboard substrate. tion at pH 8.8, a minimum viscosity of 600 centipoises at 25 °C as determined by Brookfield model LVT viscometer using a No. 3 spindle at 60 r.p.m. (or equivalent method).

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List of Substances Limitations

Styrene-maleic anhydride copolymer, sodium salt (minimum For use only: molecular weight 30,000). 1. As a coating thickening agent at a level not to exceed 1% by weight of coating solids. 2. As surface size at a level not to exceed 1% by weight of paper or paperboard substrate. Styrene-methacrylic acid copolymer, potassium salt (minimum For use only as a coating thickening agent at a level not to ex- molecular weight 30,000). ceed 1% by weight of coating solids. Synthetic wax polymer prepared by the catalytic polymerization For use only as a component of petroleum wax and/or syn- of alpha olefins such that the polymer has a maximum iodine thetic petroleum wax complying with § 178.3710 or number of 18 and a minimum number average molecular § 178.3720 of this chapter at levels not to exceed 5 percent weight of 2,400. by weight of the wax: 1. Under conditions of use F and G described in table 2 of paragraph (c) of this section for all foods. 2. Under conditions of use E described in table 2 of paragraph (c) of this section for food Types I, II, IV-B, VI, VII-B and VIII as described in table 1 of paragraph (c) of this section. Tallow. Tallow alcohol. Tallow alcohol, hydrogenated. Tallow fatty acid, hydrogenated. Tallow hydrogenated. Tallow sulfated, ammonium, potassium, or sodium salt. Tetraethylenepentamine ...... For use only as a modifier for amino resins. 1,4,4a,9a-Tetrahydro-9, 10-anthracenedione (CAS Reg. No. For use only as a catalyst in the alkaline pulping of 56136–14–2). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N,N′, N′-Tetramethylethylenediamine polymer with bis-(2- For use only as a flocculent, drainage aid or retention aid em- chloroethyl) ether, first reacted with not more than 5 percent ployed prior to the sheet forming operation in the manufac- by weight 1-chloro-2,3-epoxypropane and then reacted with ture of paper and paperboard and limited to use at a level not more than 5 percent by weight poly (acrylic acid) such not to exceed 0.2 percent by weight of the finished dry paper that a 50 percent by weight aqueous solution of the product and paperboard fibers. has a nitrogen content of 4.7–4.9 percent and viscosity of 350–700 centipoises at 25 °C as determined by LV series Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or by other equivalent method). Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo-suc- For use only as an emulsifier in aqueous dispersions of rosin cinamate. sizes complying with § 178.3870(a)(4) of this chapter and limited to use prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to ex- ceed 0.02 pct by weight of finished paper and paperboard. Triethanolamine ...... For use only to adjust pH during the manufacture of amino res- ins permitted for use as components of paper and paper- board. Triethylene glycol adipic acid monoester produced by reacting For use only as a curl-control agent at a level not to exceed equimolar quantities of triethylene glycol and adipic acid. 2% by weight of coated or uncoated paper and paperboard. Triethylenetetramine ...... For use only as a modifier for amino resins. 1,3,5-Triethylhexahydro-1,3,5-triazine (CAS Registry No. 7779– For use only as an antimicrobial agent for coating, binder, pig- 27–3). ment, filler, sizing, and similar formulations added prior to the heat drying step in the manufacture of paper and paper- board and limited to use at a level between 0.05 and 0.15 percent by weight of the formulation. Undecafluorocyclohexanemethanol ester mixture of dihydrogen For use only as an oil repellent at a level not to exceed 0.087 phosphate, compound with 2,2′ iminodiethanol (1:1); hydro- lb (0.046 lb of fluorine) per 1,000 ft2 of treated paper or pa- gen phosphate, compound with 2,2′-iminodiethanol (1:1); and perboard, as determined by analysis for total fluorine in the P,P′-dihydrogen pyrophosphate, compound with 2,2′- treated paper or paperboard without correction for any fluo- iminodiethanol (1:2); where the ester mixture has a fluorine rine which might be present in the untreated paper or paper- content of 48.3 pct to 53.1 pct as determined on a solids board, when such paper or paperboard is used in contact basis. with food only of the types identified in paragraph (c) of this section, table 1, under Types IVA, V, VIIA, VIII, and IX, and under the conditions of use B through G described in table 2 of paragraph (c) of this section. Viscose rayon fibers. Wax, petroleum ...... Complying with § 178.3710 of this chapter. Xanthan gum, conforming to the identity and specifications pre- For use only at a maximum level of 0.125 percent by weight of scribed in § 172.695 of this chapter, except that the residual finished paper as a suspension aid or stabilizer for aqueous isopropyl alcohol shall not exceed 6,000 parts per million. pigment slurries employed in the manufacture of paper and paperboard. Xylene sulfonic acid-formaldehyde condensate, sodium salt ..... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. Zeolite Na-A (CAS Reg. No. 68989–22–0) ...... For use as a pigment extender at levels not to exceed 5.4 per- cent by weight of the finished paper and paperboard. Zinc formaldehyde sulfoxylate ...... For use only as polymerization catalyst. Zinc octoate.

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List of Substances Limitations

Zirconium oxide ...... For use only as a component of waterproof coatings where the zirconium oxide is present at a level not to exceed 1 percent by weight of the dry paper or paperboard fiber and where the zirconium oxide is produced by hydrolysis of zirconium acetate.

(b) Substances identified in para- (1) Substances identified in graphs (b) (1) and (2) of this section § 175.300(b)(3) of this chapter with the may be used as components of the food- exception of those identified in para- contact surface of paper and paper- graphs (b)(3) (v), (xv), (xx), (xxvi), board, provided that the food-contact (xxxi), and (xxxii) of that section and surface of the paper or paperboard com- paragraph (a) of this section. plies with the extractives limitations (2) Substances identified in this para- prescribed in paragraph (c) of this sec- graph (b)(2) follow: tion.

List of substances Limitations

Acrylamide copolymerized with ethyl acrylate and/or stryene and/or methacrylic acid, subsequently reacted with formalde- hyde and butyl alcohol. Acrylamide copolymerized with ethylene and vinyl chloride in For use only as coatings or components of coatings. such a manner that the finished copolymers have a minimum weight average molecular weight of 30,000 and contain not more than 3.5 weight percent of total polymer units derived from acrylamide, and in such a manner that the acrylamide portion may or may not be subsequently partially hydrolyzed. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, so- For use only in coatings at a level not to exceed 0.01 mg/in2 dium salt (CAS Reg. No. 35641–59–9). Acrylic and modified acrylic polymers ...... Complying with § 177.1010 of this chapter. Acrylic copolymers produced by copolymerizing 2 or more of the acrylate monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acrylate, methyl methacrylate, and n- propyl methacrylate, or produced by copolymerizing one or more of such acrylate monomers together with one or more of the monomers acrylic acid, acrylonitrile, butadiene, 2- ethyl-hexyl acrylate, fumaric acid, glycidyl methacrylate, n- hexyl-methacrylate, itaconic acid, methacrylic acid, styrene, vinyl acetate, vinyl chloride, and vinylidene chloride. The fin- ished copolymers shall contain at least 50 weight percent of polymer units derived from one or more of the monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acry- late, methyl methacrylate, and n-propyl methacrylate; and shall contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, glycidyl meth- acrylate, n-hexyl methacrylate, itaconic acid, and methacrylic acid. The provision limiting the finished acrylic copolymers to not more than 5 units derived from acrylic acid, fumaric acid, glycidyl methacrylate, n-hexyl methacrylate, itaconic acid, and methacrylic acid is not applicable to finished acrylic co- polymers used as coating adjuvants at a level not exceeding 2 weight percent of total coating solids. Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10-C18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings cent C14-C16).. and limited to use at levels not to exceed 2 percent by weight of the coating solids. 2. As emulsifiers for vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished poly- mer contacts food only of types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX and under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2-Bromo-4′-hydroxyacetophenone ...... For use only as a preservative for coating formulations, bind- ers, pigment slurries, and sizing solutions at a level not to exceed 0.006 percent by weight of the coating, solution, slur- ry or emulsion.

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List of substances Limitations

Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink. ester, ammonium salt [CAS Reg. No. 144093–88–9]).. Butylbenzyl phthalate ...... Complying with § 178.3740 of this chapter. Butyl oleate, sulfated, ammonium, potassium, or sodium salt. Butyraldehyde. Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2- For use only as a mold- and mildew-proofing agent in coatings dicarboximide). intended for use in contact with food only of the types identi- fied in paragraph (c) of this section, table 1, under Type I, II, VI-B, and VIII. Castor Oil, polyoxyethylated (42 moles ethylene oxide) ...... For use only as an emulsifier in nitrocellulose coatings for paper and paperboard intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Types IV A, V, VII A, VIII, and IX; and limited to use at a level not to exceed 8 percent by weight of the coating solids. 1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only: (CAS Reg. No. 4080–31–3). 1. As a preservative at a level of 0.3 weight percent in latexes used as pigment binders in paper and paperboard intended for use in contact with nonacidic, nonalcoholic food and under the conditions of use described in para- graph (c) of this section, table 2, conditions of use E, F, and G. 2. As a preservative at a level not to exceed 0.07 weight percent in latexes and 0.05 weight percent in pigment slurries used as components of coatings for paper and pa- perboard intended for use in contact with food. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only: 55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in 2682–20–4) mixture at a ratio of 3 parts to 1 part, manufac- paper coatings at a level not to exceed 50 parts per mil- tured from methyl-3-mercaptopropionate (CAS Reg. No. lion (based on isothiazolone active ingredients) in the 2935–90–2). The mixture may contain magnesium nitrate coating formulation. (CAS Reg. No. 10377–60–3) at a concentration equivalent to 2. As an antimicrobial agent for finished coating formulations the isothiazolone active ingredients (weight/weight). and for additives used in the manufacture of paper and paperboard including fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 25 parts per mil- lion (based on isothiazolone active ingredients) in the coating formulations and additives. Copper 8-quinolinolate ...... For use only as preservative for coating formulations. Cyclized rubber produced when natural pale crepe rubber dis- For use only in coatings for paper and paperboard intended for solved in phenol is catalytically cyclized so that the finished use in contact with food only of the types identified in para- cyclized rubber has a melting point of 145 °C to 155 °C as graph (c) of this section, table 1, under Types VIII and IX. determined by ASTM method E28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ which is incorporated by reference (Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.), and contains no more than 4000 ppm of residual-free phenol as determined by a gas liquid chromatographic procedure titled ‘‘Determination of Free Phenol in Cyclized Rubber Resin,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5001 Campus Dr., Col- lege Park, MD 20740, or available for inspection at the Na- tional Archives and Records Administration (NARA). For in- formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. For use only as a preservative at levels not more than 0.05 weight percent and not less than 0.01 weight percent: in latexes used as pigment binders in coatings; in pigment slurries used in coatings; and/or in coatings themselves. The total level of the preservative in the finished coating shall not exceed 0.04 weight percent of the finished coating solids. Dibutyl phthalate. Dibutyl sebacate. Di(C7,C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter. Dicyclohexyl phthalate.

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List of substances Limitations

Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ...... For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use E, F, and G. Diethylene glycol ester of the adduct of terpene and maleic an- hydride. Dihydroxy dichlorodiphenyl methane ...... For use only as preservative for coating formulations. Dimethylpolysiloxane, 100 centistokes viscosity. Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane co- polymer (2:1), 200 to 400 centistokes viscosity. N,N′-Diphenyl-p-phenylenediamine ...... For use only as polymerization inhibitor in 2-sulfoethyl meth- acrylate, sodium salt. Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating sol- ids under conditions described in paragraph (c) of this sec- tion, table 2, condition of use E. 2. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 10 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use F and G. Disodium N-octadecylsulfosuccinamate ...... For use only as an emulsifier in resin latex coatings and limited to use at a level not to exceed 0.05% by weight of the coat- ing solids. EDTA (ethylenediaminetetraacetic acid) and its sodium and/or calcium salts. Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- For use only as an insolubilizer for starch-based coatings and 2(1H)pyrimidinone, propoxylated (CAS Reg. No. 118299-90- limited to use at a level not to exceed 5.0 percent by weight 4). of the coating. Ethylene-acrylic acid copolymers produced by the copolym- erization of ethylene and acrylic acid and/or their partial am- monium salts. The finished copolymer shall contain no more than 25 weight percent of polymer units derived from acrylic acid and no more than 0.35 weight percent of residual monomeric acrylic acid, and have a melt index not to exceed 350 as determined by ASTM method D1238–82, ‘‘Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma- terials, 100 Barr Harbor Dr., West Conshohocken, Philadel- phia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For informa- tion on the availability of this material at NARA, call 202– 741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Formaldehyde ...... For use only as preservative for coating formulations. Glyoxal ...... For use only as an insolubilizing agent in starch- and protein- based coatings that contact nonalcoholic foods, and limited to use at a level not to exceed 6 percent by weight of the starch or protein fraction of the coating solids. Glyceryl monobutyl ricinoleate. Hydroxymethyl derivatives (mixture of mono and poly) of [N-(1, For use only as a comonomer in polyvinyl acetate latex coat- 1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 ings and limited to use at a level not to exceed 1 percent by mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 weight of dry polymer solids. moles of formaldehyde such that the finished product has a maximum nitrogen content of 6.2 percent and a maximum hydroxyl content of 15 percent by weight on a dry basis. Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt. Maleic anhydride adduct of butadiene-styrene copolymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a- methylstyrene to 3 vinyltoluene). Modified kaolin clay (CAS Reg. No. 1344–00–9) is produced For use only as a component of coatings in paper and paper- by the reaction of sodium silicate (CAS Reg. No. 1344–09– board products at a level not to exceed 9 percent by weight 8) and kaolinite clay (CAS Reg. No. 1332–58–7) under hy- of the coating intended for use in contact with food of Types drothermal conditions. The reaction product has a molecular I through IX described in table 1 of paragraph (c) of this sec- weight between 246 and 365 and consists of 46 to 55 per- tion under conditions of use C through H described in table cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide 2 of paragraph (c) of this section. (A1203), and 2 to 7 percent of sodium oxide (Na20). The re- action product will not consist of more than 70 percent modi- fied kaolin clay. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. Oleyl alcohol.

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List of substances Limitations

Oxazolidinylethylmethacrylate (CAS Registry No. 46236–15–1) For use only as a binder for pigment coatings as a binder level copolymer with ethyl acrylate and methyl methacrylate, and not to exceed 4.0 percent by weight of dry paper or paper- containing not more than 6 percent by weight of board. oxazolidinylethylmethacrylate. Maximum nitrogen content shall be 0.5 percent and number average molecular weight of that portion of the copolymer soluble in tetrahydrofuran shall be not less than 50,000. Pentaerythritol tetrastearate. Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use only as modifiers in waxpolymer blend coatings for product thereof, meeting the following specifications: Soft- corrugated paperboard intended for use in bulk packaging or ening point 97 °C minimum, as determined by ASTM method raw fruits, raw vegetables, iced meat, iced fish, and iced E28–67 (Reapproved 1982), ‘‘Standard Test Method for Soft- poultry; and limited to use at a level not to exceed 30 ening Point by Ring and Ball Apparatus;’’ aniline point 120 weight-percent of the coating solids. °C minimum, as determined by ASTM method D611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,’’ which are incorporated by reference (Copies may be ob- tained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.). Specific gravity 0.96–0.99 (20 °C/20 °C). Such petroleum hydro- carbon resins are produced by the catalytic polymerization of dienes and olefins from low-boiling distillates of cracked pe- troleum stocks that contain no material boiling over 200 °C and that meet the ultraviolet absorbance limits prescribed in § 172.880(b) of this chapter when subjected to the analytical procedure described in § 172.886(b) of this chapter, modified as follows: Treat the product as in the first paragraph under ‘‘Procedure’’ in § 172.250(b)(3) of this chapter. Then proceed with § 172.886(b) of this chapter, starting with the paragraph commencing with ‘‘Promptly complete transfer of the sample * * *’’. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride and ethylene gly- col, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C–92 °C., and a color of K or paler. Polyester resin produced by reacting the acid groups in montan wax with ethylene glycol. Polyethylene, oxidized ...... Complying with § 177.1620 of this chapter. Polyethylene reacted with maleic anhydride such that the modi- fied polyethylene has a saponification number not in excess of 6 after Soxhlet extraction for 24 hours with anhydrous ethyl alcohol. Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt Not to exceed 300 p.p.m. in finished coated paper or paper- board. Polyoxypropylene-polyoxyethylene block polymers (minimum molecular weight 6,800). Polyvinyl acetate. Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at 20 °C. of 4 centipoises). Polyvinyl butyral. Polyvinyl formal. Polyvinylidene chloride. Polyvinyl pyrrolidone. Polyvinyl stearate. Propylene glycol mono- and diesters of fats and fatty acids. Siloxanes and silicones; platinum-catalyzed reaction product of For use only as a surface coating. Platinum content not to ex- vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. ceed 200 parts per million. 68083–19–2 and 68083–18–1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating polysiloxane (CAS Reg. No. 63148–57–2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of yl hydrogen) polysiloxane (CAS Reg. No. 68037–59–2). this section, table 1, under Types I, II, VI, and VII-B when Diallyl maleate (CAS Reg No. 999–21–3), dimethyl maleate used under conditions of use E, F, and G described in table (CAS Reg. No. 624–48–6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section. Reg. No. 78–27–3) and vinyl acetate (CAS Reg. No. 108– 2. In coatings for paper and paperboard provided the coating 05–4) may be used as optional polymerization inhibitors. contacts food only of the types identified in paragraph (c) of this section, table 1, under Types III, IV, V, VII-A, VIII, and IX when used under conditions of use A through H de- scribed in table 2 of paragraph (c) of this section.

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List of substances Limitations

Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives. 68083–19–2 and 68083–18–1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate (CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No. 108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and diallyl maleate (CAS Reg. No. 999–21–3) may be used as optional polymerization inhibitors. The polymer may also contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a control release agent. Sodium decylbenzenesulfonate. Sodium dihexyl sulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium For use only as an emulsifier in coatings that contact food only isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. of the types identified in paragraph (c) of this section, table 1, under Types IV-A, V, VII, VIII, and IX; and limited to use at levels not to exceed 0.75 percent by weight of the coating solids. Sodium 2-ethylhexyl sulfate. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ...... For use only as preservative for coating formulations. Sodium o-phenylphenate ...... Do. Sodium vinyl sulfonate polymerized. Sodium xylenesulfonate (CAS Reg. No. 1300–72–7) ...... For use only in paper and paperboard coatings at levels not to exceed 0.01 percent by weight of the finished paper and pa- perboard. Styrene copolymers produced by copolymerizing styrene with For use only as a coating or component of coatings and limited maleic anhydride and its methyl and butyl (sec- or iso-) to use at a level not to exceed 1% by weight of paper or pa- esters. Such copolymers may contain b-nitrostyrene as a po- perboard substrate. lymerization chain terminator. Styrene polymers made by the polymerization of any combina- For use only in contact with foods of Types IV-A, V, and VII in tion of styrene or alpha methyl styrene with acrylic acid, table 1 of paragraph (c) of this section, under use conditions methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, E through G in table 2 of paragraph (c), and with foods of and butyl acrylate. The styrene and alpha methyl styrene, in- Types VIII and IX without use temperature restriction. dividually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, individually, may be from 0 to 40 weight percent of the polymer. The polymer number aver- age molecular weight (Mn) shall be at least 2,000 (as deter- mined by gel permeation chromatography). The acid number of the polymer shall be less than 250. The monomer content shall be less than 0.5 percent. Styrene-acrylic copolymers (CAS Reg. No. 25950–40–7 pro- For use only as a component of coatings and limited to use at duced by polymerizing 77 to 83 parts by weight of styrene a level not to exceed 20 percent by weight of the coating with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of solids. butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and 0.1 to 0.3 part of butyl acrylate such that the finished copoly- mers have a minimum number average molecular weight greater than 100,000 and a level of residual styrene mon- omer in the polymer not to exceed 0.1 percent by weight. Styrene-butadiene copolymers produced by copolymerizing sty- rene-butadiene with one or more of the monomer: acryl- amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid. The finished copolymers shall contain not more than 10 weight percent of total poly- mer units derived from acrylic acid, fumaric acid, 2-hydroxy- ethyl acrylate, itaconic acid and methacrylic acid, and shall contain not more than 2 weight percent of polymer units de- rived from acrylamide. Styrene-butadiene copolymers with 2-hydroxyethyl acrylate and acrylic acid containing not more than 15 weight percent acrylic acid and no more than 20 weight percent of a com- bination of 2-hydroxyethyl acrylate and acrylic acid. Styrene-butadiene-vinylidene chloride copolymers containing For use only as coatings or components of coatings. not more than 40 weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 10 weight percent of total polymer units de- rived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and/or methacrylic acid.

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List of substances Limitations

Styrene-dimethylstyrene-a-methylstyrene copolymers produced For use only in coatings for paper and paperboard intended for by polymerizing equimolar ratios of the three comonomers use in contact with nonfatty food and limited to use at a level such that the finished copolymers have a minimum average not to exceed 50% by weight of the coating solids. molecular weight of 835 as determined by ASTM method D2503–82, ‘‘Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermo- electric Measurement of Vapor Pressure,’’ which is incor- porated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Adminis- tration (NARA). For information on the availability of this ma- terial at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. Styrene-isobutylene copolymers (weight average molecular For use only in coatings for paper and paperboard intended for weight not less than 6,300). use in contact under conditions of use D G described in table 2 of paragraph (c) of this section, with food of Types I, II, IV-B, VI-B, VII-B, and VIII described in table 1 of para- graph (c) of this section; and limited to use at a level not to exceed 40 percent by weight of the coating solids. Styrene-maleic anhydride copolymers ...... For use only as a coating or component of coatings and limited for use at a level not to exceed 2 percent by weight of paper or paperboard substrate. Styrene-methacrylic acid copolymers containing no more than 5 weight percent of polymer units derived from methacrylic acid. Styrene-vinylidene chloride copolymers containing not more For use only as coatings or components of coatings. than 40 weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, itaconic acid, and/or methacrylic acid. 2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts For use only in copolymer coatings under conditions of use E, Service No. 1804–87–1]. F, and G described in paragraph (c) of this section, table 2, and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly (oxy- For use only as a surface-active agent at levels not to exceed ethylene) hydrogen sulfate, sodium salt mixture with a-[p- 3 percent by weight of vinyl acetate polymer with ethylene (1,1,3,3-tetramethylbutyl)-phenyl]-omega-hydroxypoly (oxy- and N-(hydroxymethyl) acrylamide intended for use in coat- ethylene) with both substances having a poly(oxyethylene) ings for paper and paperboard intended for use in contact content averaging 3 moles. with foods: 1. Of the types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, VI-B, and VII, and under the con- ditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. Of the types identified in paragraph (c) of this section, table 1, under Types V, VIII and IX and under the conditions of use described in paragraph (c) of this section, table 2, condi- tions of use C, D, E, F, and G. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfo-succina- For use only as an emulsifier in resin latex coatings, and lim- mate. ited to use at a level not to exceed 0.05% by weight of the coating solids. Toluenesulfonamide-formaldehyde resins.

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List of substances Limitations

Vinyl acetate copolymers produced by copolymerizing vinyl ac- etate with one or more of the monomers acrylamide, acrylic acid, acrylonitrile, bicyclo-[2.2.1]hept-2-ene-6-methylacrylate, butyl acrylate, crotonic acid, decyl acrylate, diallyl fumarate, diallyl maleate, diallyl phthalate, dibutyl fumarate, dibutyl itaconate, dibutylmaleate, di(2-ethylhexyl) maleate, divinyl benzene, ethyl acrylate, 2-ethyl-hexyl acrylate, fumaric acid, itaconic acid, maleic acid, methacrylic acid, methyl acrylate, methyl methacrylate, mono(2-ethylhexyl) maleate, monoethyl maleate, styrene, vinyl butyrate, vinyl crotonate, vinyl hexoate, vinylidene chloride, vinyl pelargonate, vinyl propio- nate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight per- cent of polymer units derived from vinyl acetate and shall contain no more than 5 weight percent of total polymer units derived from acrylamide, acrylic acid, crotonic acid, decyl ac- rylate, dibutyl itaconate, di(2-ethylhexyl) maleate, fumaric acid, itaconic acid, maleic acid, methacrylic acid, mono(2- ethylhexyl) maleate, monoethyl maleate, vinyl butyrate, vinyl hexoate, vinyl pelargonate, vinyl propionate, vinyl stearate, and vinyl sulfonic acid. Vinyl acetate polymer with ethylene and N-(hydroxymethyl) ac- For use only in coatings for paper and paperboard intended for rylamide containing not more than 6 weight percent of total use in contact with foods: polymer units derived from N-(hydroxymethyl) acrylamide. 1. Of the types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, VI B, and VII and under the con- ditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. Of the types identified in paragraph (c) of this section, table 1, under Types V, VIII, and IX and under the conditions of use described in paragraph (c) of this section, table 2, condi- tions of use C, D, E, F, and G. Vinyl chloride copolymers produced by copolymerizing vinyl chloride with one or more of the monomers acrylonitrile; fu- maric acid and its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic acid and its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic an- hydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl ester; vinyl acetate-and vinylidene chloride. The finished co- polymers shall contain at least 50 weight percent of polymer units derived from vinyl chloride: shall contain no more than 5 weight percent of total polymer units derived from fumaric and/or maleic acid and/or their methyl, ethyl, propyl, butyl, amyl, heptyl, or octyl monoesters or from maleic anhydride or from mono-n-butyl ester of 5-norbornene-2, 3-dicarboxylic acid (however, in any case the finished copolymers shall contain no more than 4 weight percent of total polymer units derived from mono-n-butyl ester of 5-norbornene-2,3- dicarboxylic acid). Vinyl chloride-vinyl acetate hydroxyl-modified copolymers. Vinyl chloride-vinyl acetate hydroxyl-modified copolymers re- acted with trimellitic anhydride. Vinylidene chloride copolymers produced by copolymerizing vi- nylidene chloride with one or more of the monomers acryl- amide acrylic acid, acrylonitrile, butyl acrylate, butyl meth- acrylate ethyl acrylate, ethyl methacrylate, fumaric acid, itaconic acid, methacrylic acid, methyl acrylate, methyl meth- acrylate, octadecyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride and vinyl sulfonic acid. The fin- ished copolymers shall contain at least 50 weight percent of polymer units derived from vinylidene chloride; and shall contain no more than 5 weight percent of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sul- fonic acid. Colorants:. Aluminum ...... For use as a colorant only. Aluminum hydrate ...... Do. Aluminum and potassium silicate (mica) ...... Do. Aluminum mono-, di-, and tristearate ...... Do. Aluminum silicate (China clay) ...... Do. Barium sulfate ...... Do. Bentonite ...... Do. Bentonite, modified with dimethyldioctadecylammonium ion Do. Burnt umber ...... Do.

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List of substances Limitations

Calcium carbonate ...... Do. Calcium silicate ...... Do. Calcium sulfate ...... Do. Carbon black (channel process) ...... Do. Cobalt aluminate ...... Do. Diatomaceous earth ...... Do. Iron ...... Do. Magnesium oxide ...... Do. Magnesium silicate (talc) ...... Do. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, Do. 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14– 8). Raw sienna ...... Do. Silica ...... Do. Tartrazine lake (certified FD&C Yellow No. 5 only) ...... Do. Titanium dioxide ...... Do. Titanium dioxide-barium sulfate ...... Do. Titanium dioxide-magnesium ...... Do. silicate. Zinc carbonate ...... Do. Zinc oxide ...... Do.

(c) The food-contact surface of the II. Acid, aqueous products; may contain salt paper and paperboard in the finished or sugar or both, and including oil-in-water form in which it is to contact food, emulsions of low- or high-fat content. III. Aqueous, acid or nonacid products con- when extracted with the solvent or sol- taining free oil or fat; may contain salt, vents characterizing the type of food, and including water-in-oil emulsions of and under conditions of time and tem- low- or high-fat content. perature characterizing the conditions IV. Dairy products and modifications: of its intended use as determined from A. Water-in-oil emulsions, high- or low-fat. tables 1 and 2 of this paragraph, shall B. Oil-in-water emulsions, high- or low-fat. V. Low-moisture fats and oil. yield net chloroform-soluble extrac- VI. Beverages: tives (corrected for wax, petrolatum, A. Containing up to 8 percent of alcohol. mineral oil and zinc extractives as zinc B. Nonalcoholic. oleate) not to exceed 0.5 milligram per C. Containing more than 8 percent alcohol. square inch of food-contact surface as VII. Bakery products other than those in- cluded under Types VIII or IX of this table: determined by the methods described A. Moist bakery products with surface con- in paragraph (d) of this section. taining free fat or oil. B. Moist bakery products with surface con- TABLE 1—TYPES OF RAW AND PROCESSED taining no free fat or oil. FOODS VIII. Dry solids with the surface containing I. Nonacid, aqueous products; may contain no free fat or oil (no end test required). salt or sugar or both (pH above 5.0). IX. Dry solids with the surface containing free fat or oil.

TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER- BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Food-simulating solvents 8 percent al- 50 percent al- Types of food Water Heptane 1 Condition of use (see table 1) cohol cohol Time and Time and Time and Time and tem- temperature temperature temperature perature

A. High temperature heat-sterilized (e.g., I, IV-B, VII-B ...... 250 °F, 2 hr ...... over 212 °F). III, IV-A, VII-A ...... do ...... 150 °F, 2 hr ...... B. Boiling water sterilized ...... II, VII-B ...... 212 °F, 30 min. III, VII-A ...... do ...... 120 °F, 30 ...... min.

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TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER- BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Continued

Food-simulating solvents 8 percent al- 50 percent al- Types of food Water Heptane 1 Condition of use (see table 1) cohol cohol Time and Time and Time and Time and tem- temperature temperature temperature perature

C. Hot filled or pasteurized above 150 °F .... II, IV-B, VII-B ..... Fill boiling, ...... cool to 100 °F. III, IV-A, VII-A ...... do ...... 120 °F, 15 ...... min. V, IX ...... do ...... D. Hot filled or pasteurized below 150 °F ..... II, IV-B, VI-B, ...... VII-B ...... 150 °F, 2 hr ...... III, IV-A, VII-A ...... do ...... 100 °F, 30 ...... min. V, IX ...... do ...... VI-A ...... 150 °F, 2 hr ...... VI-C ...... 150 °F, 2 hr. E. Room temperature filled and stored (no I, II, IV-B, VI-B, 120 °F, 24 hr ...... thermal treatment in the container). VII-B. III, IV-A, VII-A ...... do ...... 70 °F, 30 ...... min. V, IX ...... do ...... VI-A ...... 120 °F, 24 hr ...... VI-C ...... 120 °F, 24 hr. F. Refrigerated storage (no thermal treat- III, IV-A, VII-A .... 70 °F, 48 hr 70 °F, 30 ...... ment in the container). min. I, II, IV-B, VI-B, ...... do ...... VII-B. VI-A ...... 70 °F, 48 hr ...... VI-C ...... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in I, II, IV-B, VII-B .. 70 °F, 24 hr ...... the container). III, VII-A ...... do ...... 70 °F, 30 ...... min. H. Frozen or refrigerated storage: Ready- prepared foods intended to be reheated in container at time of use: 1. Aqueous or oil-in-water emulsion of I, II, IV-B, VII-B .. 212 °F, 30 ...... high- or low-fat. min. 2. Aqueous, high- or low-free oil or fat .. III, IV-A, VII-A, IX ...... do ...... 120 °F, 30 ...... min. 1 Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.

(d) Analytical methods—(1) Selection of aggeration over normal use, follow the extractability conditions. First ascertain applicable extraction procedure. the type of food product (table 1, para- (2) Reagents—(i) Water. All water used graph (c) of this section) that is being in extraction procedures should be packed commercially in the paper or freshly demineralized (deionized) dis- paperboard and the normal conditions tilled water. of thermal treatment used in pack- (ii) n-Heptane. Reagent grade, freshly aging the type of food involved. Using redistilled before use, using only mate- table 2, paragraph (c) of this section, rial boiling at 208 °F. select the food-simulating solvent or (iii) Alcohol. 8 or 50 percent (by vol- solvents and the time-temperature ex- ume), prepared from undenatured 95 aggerations of the paper or paperboard percent ethyl alcohol diluted with use conditions. Having selected the ap- demineralized (deionized) distilled propriate food-simulating solvent or water. solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh- ly redistilled before use, or a grade

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having an established consistently low holding at least one 800-milliliter beak- blank. er partially submersed in bath. (3) Selection of test method. Paper or (b) Analytical balance sensitive to 0.1 paperboard ready for use in packaging milligram with an approximate capac- shall be tested by use of the extraction ity of 100 grams. cell described in ‘‘Official Methods of (c) Tongs. Analysis of the Association of Official (d) Hood and hot-plate facilities. Analytical Chemists,’’ 13th Ed. (1980), (e) Forced draft oven. sections 21.010–21.015, under ‘‘Exposing For each extraction, the following ad- Flexible Barrier Materials for Extrac- ditional apparatus is necessary: tion,’’ which is incorporated by ref- (f) One No. 2 paper clip. erence (Copies may be obtained from (g) One 800-milliliter beaker with the AOAC INTERNATIONAL, 481 North watch-glass cover. Frederick Ave., suite 500, Gaithersburg, (h) One 250-milliliter beaker. MD 20877, or may be examined at the (i) Five 21⁄2-inch-square aluminum National Archives and Records Admin- screens (standard aluminum window istration (NARA). For information on screening is acceptable). the availability of this material at (j) One wire capable of supporting NARA, call 202–741–6030, or go to: http:// sample stack. www.archives.gov/federallregister/ (ii) Procedure. (a) For each extrac- codeloflfederallregulations/ tion, accurately cut eight 21⁄2-inch- ibrllocations.html.); also described in square samples from the formed paper ASTM method F34–76 (Reapproved or paperboard product to be tested. 1980), ‘‘Standard Test Method for Liq- (b) Carefully stack the eight 21⁄2-inch- uid Extraction of Flexible Barrier Ma- square samples and the five 21⁄2-inch- terials,’’ which is incorporated by ref- square aluminum screens in sandwich erence (copies may be obtained from form such that the food-contact side of the American Society for Testing Ma- each sample is always next to an alu- terials, 100 Barr Harbor Dr., West minum screen, as follows: Screen, sam- Conshohocken, Philadelphia, PA 19428- ple, sample, screen, sample, sample, 2959, or may be examined at the Na- screen, etc. Clip the sandwich together tional Archives and Records Adminis- carefully with a No. 2 paper clip, leav- tration (NARA). For information on ing just enough space at the top to slip the availability of this material at a wire through. NARA, call 202–741–6030, or go to: http:// (c) Place an 800-milliliter beaker con- www.archives.gov/federallregister/ taining 100-milliliters of the appro- codeloflfederallregulations/ priate food-simulating solvent into the ibrllocations.html.), except that formed constant temperature bath, cover with paper and paperboard products may be a watch glass and condition at the de- tested in the container by adapting the sired temperature. in-container methods described in (d) After conditioning, carefully § 175.300(e) of this chapter. Formed lower the sample sandwich with tongs paper and paperboard products such as into the beaker. containers and lids, that cannot be (e) At the end of the extraction pe- tested satisfactorily by any of the riod, using the tongs, carefully lift out above methods may be tested in spe- the sample sandwich and hang it over cially designed extraction equipment, the beaker with the wire. usually consisting of clamping devices (f) After draining, pour the food-sim- that fit the closure or container so ulating solvent solution into a tared that the food-contact surface can be 250-milliliter beaker. Rinse the 800-mil- tested, or, if flat samples can be cut liliter beaker three times, using a total from the formed paper or paperboard of not more than 50 milliliters of the products without destroying the integ- required solvent. rity of the food-contact surface, they (g) Determine total nonvolatile ex- may be tested by adapting the fol- tractives in accordance with paragraph lowing ‘‘sandwich’’ method: (d)(5) of this section. (i) Apparatus. (a) Thermostated (±1.0 (4) Selection of samples. Quadruplicate °F) water bath, variable between 70 °F samples should be tested, using for and 120 °F water bath cover capable of each replicate sample the number of

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cups, containers, or preformed or con- (freshly distilled reagent grade or a verted products nearest to an area of grade having an established consist- 100 square inches. ently low blank) to the dried and (5) Determination of amount of extrac- weighed residue, (e), in the evaporating tives—(i) Total residues. At the end of dish obtained in paragraph (d)(5)(i) of the exposure period, remove the test this section. Warm carefully, and filter container or test cell from the oven through Whatman No. 41 filter paper and combine the solvent for each rep- (or equivalent) in a Pyrex (or equiva- licate in a clean Pyrex (or equivalent) lent) funnel, collecting the filtrate in a flask or beaker being sure to rinse the clean, tared evaporating dish (platinum test container or cell with a small or Pyrex). Repeat the chloroform ex- quantity of clean solvent. Evaporate traction, washing the filter paper with the food-simulating solvents to about this second portion of chloroform. Add 100 milliliters in the flask or beaker, this filtrate to the original filtrate and and transfer to a clean, tared evaporate the total down to a few mil- evaporating dish (platinum or Pyrex), liliters on a low-temperature hotplate. washing the flask three times with The last few milliliters should be evap- small portions of solvent used in the extraction procedure, and evaporate to orated in an oven maintained at ap- ° a few milliliters on a nonsparking, low- proximately 221 F. Cool the temperature hotplate. The last few evaporating dish in a desiccator for 30 milliliters should be evaporated in an minutes and weigh to the nearest 0.1 oven maintained at a temperature of milligram to get the chloroform-solu- approximately 221 °F. Cool the ble extractives residue (′). This ′ is sub- evaporating dish in a desiccator for 30 stituted for e in the equations in para- minutes and weigh the residue to the graph (d)(5)(i) (a) and (b) of this sec- nearest 0.1 milligram, (e). Calculate the tion. If the chloroform-soluble extrac- extractives in milligrams per square tives in milligrams per square inch inch of the container or sheeted paper still exceeds the limitation prescribed or paperboard surface. in paragraph (c) of this section, proceed (a) Water and 8- and 50-percent alcohol. to paragraph (d)(5)(iii) of this section Milligrams extractives per square inch (method for determining corrected = (e)/(s). chloroform-soluble extractives res- (b) Heptane. Milligrams extractives idue). per square inch=(e)/(s)(F) (iii) Corrected chloroform-soluble ex- where: tractives residue—(a) Correction for zinc e = Milligrams extractives per sample tested. extractives. Ash the residue in the s = Surface area tested, in square inches. evaporating dish by heating gently F = Five, the ratio of the amount of extrac- over a Meker-type burner to destroy tives removed by heptane under exagger- organic matter and hold at red heat for ated time-temperature test conditions about 1 minute. Cool in the air for 3 compared to the amount extracted by a fat or oil under exaggerated conditions of minutes, and place the evaporating thermal sterilization and use. dish in the desiccator for 30 minutes e′ = Chloroform-soluble extractives residue. and weigh to the nearest 0.1 milligram. ee′ = Corrected chloroform-soluble extrac- Analyze this ash for zinc by standard tives residue. Association of Official Agricultural e′ or ee′ is substituted for e in the above equa- Chemists methods or equivalent. Cal- tions when necessary. culate the zinc in the ash as zinc ole- If when calculated by the equations in ate, and subtract from the weight of paragraph (d)(5)(i) (a) and (b) of this chloroform-soluble extractives residue section, the extractives in milligrams (′) to obtain the zinc-corrected chloro- per square inch exceeds the limitations form-soluble extractives residue (e′). prescribed in paragraph (c) of this sec- This e′ is substituted for e in the equa- tion, proceed to paragraph (d)(5)(ii) of tions in paragraph (d)(5)(i) (a) and (b) of this section (method for determining this section. the amount of chloroform-soluble ex- (b) Correction for wax, petrolatum, and tractives residues). mineral oil—(1) Apparatus. Standard 10 (ii) Chloroform-soluble extractives res- millimeter inside diameter × 60 centi- idue. Add 50 milliliters of chloroform meter chromatographic column (or

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standard 50-milliliter buret with an in- through the column into a clean, tared side diameter of 10–11 millimeters) evaporating dish (platinum or Pyrex) with a stopcock of glass, at a dropwise rate of about 2 milliliters perfluorocarbon resin, or equivalent per minute until the liquid surface material. The column (or buret) may reaches the top glass wool plug; then be optionally equipped with an integral close the stopcock temporarily. Rinse coarse, fritted glass disc and the top of the Pyrex flask which contained the the column (or buret) may be option- filtrate with an additional 10–15 milli- ally fitted with a 100-millimeter sol- liters of heptane and add to the col- vent reservoir. umn. Wash (elute) the column with (2) Preparation of column. Place a more heptane collecting about 100 mil- snug pledget of fine glass wool in the liliters of total eluate including that bottom of the column (or buret) if the already collected in the evaporating column (or buret) is not equipped with dish. Evaporate the combined eluate in integral coarse, fritted glass disc. Over- the evaporating dish to dryness on a lay the glass wool pledget (or fritted steam bath. Dry the residue for 15 min- glass disc) with a 15–20 millimeter deep utes in an oven maintained at a tem- layer of fine sand. Measure in a grad- perature of approximately 221 °F. Cool uated cylinder 15 milliliters of the evaporating dish in a desiccator for chromatographic grade aluminum 30 minutes and weigh the residue to the oxide (80–200 mesh) that has been tight- nearest 0.1 milligram. Subtract the ly settled by tapping the cylinder. weight of the residue from the weight Transfer the aluminum oxide to the of chloroform-soluble extractives res- chromatographic tube, tapping the idue (′) to obtain the wax-, petrolatum- tube during and after the transfer so as , and mineral oil-corrected chloroform- to tightly settle the aluminum oxide. soluble extractives residue (e′). This e′ Overlay the layer of aluminum oxide is substituted for e in the equations in with a 1.0–1.5 centimeter deep layer of paragraph (d)(5)(i) (a) and (b) of this anhydrous sodium sulfate and on top of section. this place an 8–10 millimeter thick plug (ii) For chloroform residues weighing of fine glass wool. Next carefully add more than 0.5 gram. Redissolve the about 25 milliliters of heptane to the dried and weighed chloroform-soluble column with stopcock open, and allow extract residue as described in para- the heptane to pass through the col- graph (d)(5)(iii)(b)(3)(i) of this section umn until the top level of the liquid using proportionately larger quantities just passes into the top glass wool plug of heptane. Transfer the heptane solu- in the column, and close stopcock. tion to an appropriate-sized volumetric (3) Chromatographing of sample ex- flask (i.e., a 250-milliliter flask for tract—(i) For chloroform residues weigh- about 2.5 grams of residue) and adjust ing 0.5 gram or less. To the dried and to volume with additional heptane. Pi- weighed chloroform-soluble extract pette out an aliquot (about 50 milli- residue in the evaporating dish, ob- liters) calculated to contain 0.1–0.5 tained in paragraph (d)(5)(ii) of this gram of the chloroform-soluble extract section, add 20 milliliters of heptane residue and analyze and stir. If necessary, heat carefully to chromatographically as described in dissolve the residue. Additional paragraph (d)(5)(iii)(b)(3)(i) of this sec- heptane not to exceed a total volume of tion. In this case the weight of the 50 milliliters may be used if necessary dried residue from the heptane eluate to complete dissolving. Cool to room must be multiplied by the dilution fac- temperature. (If solution becomes tor to obtain the weight of wax, petro- cloudy, use the procedure in paragraph latum, and mineral oil residue to be (d)(5)(iii)(b)(3)(ii) of this section to ob- subtracted from the weight of chloro- tain an aliquot of heptane solution cal- form-soluble extractives residue (′) to culated to contain 0.1–0.5 gram of chlo- obtain the wax-, petrolatum-, and min- roform-soluble extract residue.) Trans- eral oil-corrected chloroform-soluble fer the clear liquid solution to the col- extractives residue (e′). This e′ is sub- umn (or buret). Rinse the dish with 10 stituted for e in the equations in para- millimeters of additional heptane and graph (d)(5)(i) (a) and (b) of this sec- add to column. Allow the liquid to pass tion. (Note: In the case of chloroform-

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soluble extracts which contain high surface of paper and paperboard in- melting waxes (melting point greater tended for use in producing, manufac- than 170 °F), it may be necessary to di- turing, packing, processing, preparing, lute the heptane solution further so treating, packaging, transporting, or that a 50-milliliter aliquot will contain holding dry food of the type identified only 0.1–0.2 gram of the chloroform- in § 176.170(c), table 1, under Type VIII, soluble extract residue.) subject to the provisions of this sec- (e) Acrylonitrile copolymers identi- tion. fied in this section shall comply with (a) The substances are used in the provisions of § 180.22 of this chap- amounts not to exceed that required to ter, except where the copolymers are accomplish their intended physical or restricted to use in contact with food technical effect, and are so used as to only of the type identified in paragraph accomplish no effect in food other than (c), table 1 under Category VIII. that ordinarily accomplished by pack- [42 FR 14554, Mar. 15, 1977] aging. (b) The substances permitted to be EDITORIAL NOTE: For FEDERAL REGISTER ci- used include the following: tations affecting § 176.170, see the List of CFR Sections Affected, which appears in the (1) Substances that by § 176.170 and Finding Aids section of the printed volume other applicable regulations in parts and at www.fdsys.gov. 170 through 189 of this chapter may be safely used as components of the § 176.180 Components of paper and pa- uncoated or coated food-contact sur- perboard in contact with dry food. face of paper and paperboard, subject The substances listed in this section to the provisions of such regulation. may be safely used as components of (2) Substances identified in the fol- the uncoated or coated food-contact lowing list:

List of substances Limitations

Acrylamide polymer with sodium 2-acrylamido-2- For use at a level not to exceed 0.015 weight percent of dry methylpropane-sulfonate (CAS Reg. No. 38193–60–1). fiber. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983–55–0).. 4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) ethoxy]ethyl]disodium sulfo- For use as a polymerization emulsifier and latex emulsion sta- succinate. bilizer at levels not to exceed 5 percent by weight of total emulsion solids. Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 per- cent C14-C16).. Aluminum and calcium salts of FD & C dyes on a substrate of Colorant. alumina. Ammonium nitrate.. Amylose.. Barium metaborate ...... For use as preservative in coatings and sizings. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ...... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.02 mg/in2 (0.0031 mg/cm2) of finished paper and paperboard. N,N′-Bis(hydroxyethyl)lauramide. Bis(trichloromethyl) sulfone C.A. Registry No. 3064–70–8 ...... For use only as a preservative in coatings. Borax ...... For use as preservative in coatings. Boric acid ...... Do. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink. ester, ammonium salt [CAS Reg. No. 144093–88–9]).. sec-Butyl alcohol.. Butyl benzyl phthalate.. Candelilla wax.. Carbon tetrachloride.. Castor oil, polyoxyethylated (42 moles ethylene oxide).. Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate For use only as a coating adhesive, pigment structuring agent, modified by treatment with 3-chloro-2-hydroxypropyl- and fiber retention aid. trimethylammonium chloride). Cationic soy protein (soy protein isolate modified by treatment For use only as a coating adhesive, pigment structuring agent, with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). and fiber retention aid. Chloral hydrate ...... Polymerization reaction-control agent. N-Cyclohexyl-p-toluene sulfonamide.. 2,5-Di-tert-butyl hydroquinone.

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List of substances Limitations

Diethanolamine.. Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ...... For use only as a plasticizer in polymeric substances. Diethylene glycol monobutyl ether.. Diethylene glycol monoethyl ether.. Diethylenetriamine.. N,N-Diisopropanolamide of tallow fatty acids.. N-[(dimethylamino)methyl]acrylamide polymer with acrylamide and styrene.. N,N-Dioleoylethylenediamine, N,N-dilinoeoyl-ethylenediamine, and N-oleoyl-N-linoleoyl-ethylenediamine mixture produced when tall oil fatty acids are made to react with ethylene- diamine such that the finished mixture has a melting point of 212°–228 °F, as determined by ASTM method D127–60, and an acid value of 10 maximum. ASTM Method D127–60 ‘‘Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax’’ (Revised 1960) is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. Diphenylamine.. Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... For use only as plasticizer in polymeric substances. Disodium N-octadecylsulfosuccinamate.. tert-Dodecyl thioether of polyethylene glycol.. Erucamide (erucylamide).. Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- 2(1H)pyrimidinone, propoxylated.. Ethylene oxide ...... Fumigant in sizing. Ethylene oxide adduct of mono-(2-ethylhexyl) o-phosphate.. Fatty acid (C12-C18) diethanolamide.. Fish oil fatty acids, hydrogenated, potassium salt.. Formaldehyde.. Glyceryl monocaprate.. Glyceryl tribenzoate (CAS Reg. No. 614–33–5) ...... For use only as a plasticizer in polymeric coatings. Glyoxal.. Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013– For use as an insolubilizer for starch in coatings. 01–0) formed by reaction in the molar ratio of approximately 47:33:15, respectively. The reaction product has a number average molecular weight of 278±14 as determined by a suitable method. Glyoxal-urea polymer (CAS Reg. No. 53037–34–6) ...... For use as an insolubilizer for starch. Hexamethylenetetramine ...... Polymerization crosslinking agent for protein, including casein. As neutralizing agent with myristochromic chloride complex and stearato-chromic chloride complex. Hexylene glycol (2-methyl-2,4-pentanediol).. Hydroabietyl alcohol.. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0] octane, For use only as an antibacterial preservative. 5-hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5- hydroxypoly-[methyleneoxy]methyl-1-aza-3,7- dioxabicyclo[3.3.0] octane mixture. Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at levels not to exceed 0.5 percent by weight of [2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749–55–4).. Isopropanolamine hydrochloride.. Isopropyl m- and p-cresol (thymol derived).. Itaconic acid.. Maleic anhydride-diisobutylene copolymer, ammonium or so- dium salt.. Melamine-formaldehyde modified with: Basic polymer. Alcohols (ethyl, butyl, isobutyl, propyl, or isopropyl). Diethylenetriamine. Imino-bis-butylamine. Imino-bis-ethyleneimine. Imino-bis-propylamine. Polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane. Sulfanilic acid. Tetraethylenepentamine. Triethylenetetramine. Methyl alcohol.. Methyl ethers of mono-, di-, and tripropylene glycol..

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List of substances Limitations

Methyl naphthalene sulfonic acid-formaldehyde condensate, sodium salt.. Methylated poly(N-1,2-dihydroxyethylene-1,3-imidazolidin-2- For use only only as an in solubilizer for starch. one). Modified polyacrylamide resulting from an epichlorohydrin addi- For use only as a dry strength and pigment retention aid agent tion to a condensate of formaldehyde-dicyandiamide- employed prior to the sheetforming operation in the manu- diethylene triamine and which product is then reacted with facture of paper and paperboard and used at a level not to polyacrylamide and urea to produce a resin having a nitro- exceed 1 percent by weight of dry fibers. gen content of 5.6 to 6.3 percent and having a minimum vis- cosity in 56 percent-by-weight aqueous solution of 200 centi- poises at 25 °C, as determined by LVT-series Brookfield vis- cometer using a No. 4 spindle at 60 r.p.m. (or equivalent method). Mono- and di(2-alkenyl)succinyl esters of polyethylene glycol For use only as an emulsifier. containing not less than 90 percent of the diester product and in which the alkenyl groups are derived from olefins that contain not less than 95 percent of C15-C21 groups. Monoglyceride citrate.. Myristo chromic chloride complex.. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.. Nickel.. b-Nitrostyrene ...... Basic polymer. Octadecanoic acid, reaction products with 2-[(2- For use prior to sheet forming at levels not to exceed 12 aminoethyl)amino]ethanol and urea (CAS Reg. No. 68412– pounds per ton of paper. 14–6), and the acetate salts thereof (CAS Reg. No. 68784– 21–4), which may be emulsified with ethoxylated tallow alkyl amines (CAS Reg. No. 61791–26–2). a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly(oxyethylene) content averages not less than 20 moles.. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium salt; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 9 or 30 moles..

Oleic acid reacted with N-alkyl-(C16-C18) trimethylenediamine.. Oxidized soy isolate having 50 to 70 percent of its cystine resi- For use as a binder adhesive component of coatings. dues oxidized to cysteic acid. Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use as modifiers at levels up to 30 weight-percent of the product thereof, complying with the identity prescribed in solids content of wax-polymer blend coatings. § 176.170(b)(2). Petroleum hydrocarbon resins (produced by the catalytic po- lymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked pe- troleum stocks).. Petroleum hydrocarbons, light and odorless.. o-Phthalic acid modified hydrolyzed soy protein isolate.. Pine oil.. Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) complying with the identity described in § 176.170(a).. Polyamide-epichloro hydrin modified resins resulting from the reaction of the initial caprolactam-itaconic acid product with diethylenetriamine and then condensing this prepolymer with epichlorohydrin to form a cationic resin having a nitrogen content of 11–15 percent and chlorine level of 20–23 percent on a dry basis.. Polyamide-ethyleneimine-epichlorohydrin resin is prepared by reacting equimolar amounts of adipic acid and three amines (21 mole percent of 1,2-ethanediamine, 51 mole percent of N-(2-aminoethyl)-1,3-propanediamine, and 28 mole percent of N, N′-1,2-ethanediylbis(1,3-propanediamine)) to form a basic polyamidoamine which is modified by reaction with ethyleneimine (5.5:1.0 ethyleneimine:polyamidoamine). The modified polyamidoamine is reacted with a crosslinking agent made by condensing approximately 34 ethylene glycol units with (chloromethyl)oxirane, followed by pH adjustment with formic acid or sulfuric acid to provide a finished product as a formate (CAS Reg. No. 114133–44–7) or a sulfate (CAS Reg. No. 167678–43–5), having a weight-average mo- lecular weight of 1,300,000 and a number-average molecular weight of 16,000..

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List of substances Limitations

Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No. 115340–77–7), prepared by reacting equimolar amounts of adipic acid and N-(2-aminoethyl)-1,2-ethanediamine to form a basic polyamidoamine which is modified by reaction with ethyleneimine, and further reacted with formic acid and (chloromethyl)oxirane-a-hydro-omega-hydroxypoly(oxy-1,2- ethanediyl).. Polybutene, hydrogenated; complying with the identity pre- scribed under § 178.3740(b) of this chapter.. Poly [2-(diethylamino) ethyl methacrylate] phosphate.. Polyethylene glycol (200) dilaurate.. Polyethylene glycol monoisotridecyl ether sulfate, sodium salt For use only as a surfactant at levels not to exceed 3 percent (CAS Reg. No. 150413–26–6). in latex formulations used in pigment binders for paper and paperboard. Polymers: Homopolymers and copolymers of the following Basic polymer. monomers: Acrylamide. Acrylic acid and its methyl, ethyl, butyl, propyl, or octyl esters. Acrylonitrile. Butadiene. Crotonic acid. Cyclol acrylate. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethylene. 2-Ethylhexyl acrylate. Fumaric acid. Glycidyl methacrylate. 2-Hydroxyethyl acrylate. N-(Hydroxymethyl) acrylamide. Isobutyl acrylate. Isobutylene. Isoprene. Itaconic acid. Maleic anhydride and its methyl or butyl esters. Methacrylic acid and its methyl, ethyl, butyl, or propyl esters. Methylstyrene. Mono(2-ethylhexyl) maleate. Monoethyl maleate. 5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester. Styrene. Vinyl acetate. Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl hexoate. Vinylidene chloride. Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Vinyl sulfonic acid. Polymer prepared from urea, ethanedial, formaldehyde, and For use only as a starch and protein reactant in paper and pa- propionaldehyde (CAS Reg. No. 106569–82–8). perboard coatings. Polyoxyethylene (minimum 12 moles) ester of tall oil (30%– 40% rosin acids).. Polyoxypropylene-polyoxyethylene glycol (minimum molecular weight 1,900).. Polyvinyl alcohol.. Potassium titanate fibers produced by calcining titanium diox- ide, potassium chloride, and potassium carbonate, such that the finished crystalline fibers have a nominal diameter of 0.20–0.25 micron, a length-to-diameter ratio of approximately 25:1 or greater, and consist principally of K2Ti4O9 and K2Ti 6O13..

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List of substances Limitations

Sodium diisobutylphenoxy diethoxyethyl sulfonate.. Sodium diisobutylphenoxy monoethoxy ethylsulfonate.. Sodium n-dodecylpolyethoxy (50 moles) sulfate.. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate.. Sodium N-methyl-N-oleyl taurate.. Sodium methyl siliconate.. Sodium nitrite.. Sodium polyacrylate.. Sodium bis-tridecylsulfosuccinate.. Sodium xylene sulfonate.. Stearato chromic chloride complex.. Styrene-allyl alcohol copolymers.. Styrene-methacrylic acid copolymer, potassium salt.. Tetraethylenepentamine ...... Polymerization cross-linking agent. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, po- tassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles.. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl or p-nonylphenyl]-omega- hydroxypoly (oxyethylene) where nonyl group is a propylene trimer isomer.. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl sulfosuccinamate.. Toluene.. Triethanolamine.. Triethylenetetramine ...... Polymerization cross-linking agent. Triethylenetetramine monoacetate, partially stearoylated.. Urea-formaldehyde chemically modified with: Alcohol (methyl, ethyl, butyl, isobutyl, propyl, or isopropyl). Aminomethylsulfonic acid. Diaminobutane. Diaminopropane. Diethylenetriamine. N,N′-Dioleoylethylenediamine. Diphenylamine. N,N′-Distearoylethylenediamine. Ethylenediamine. Guanidine. Imino-bis-butylamine. Imino-bis-ethylamine. Imino-bis-propylamine. N-Oleoyl-N′-stearoylethylenediamine. Polyamines made by reacting ethylenediamine or triethylenediamine with dichloroethane or dichloropropane. Tetraethylenepentamine. Triethylenetetramine. Xylene.. Xylene sulfonic acid-formaldehyde condensate, sodium salt.. Zinc stearate..

[42 FR 14554, Mar. 15, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 176.180, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 176.200 Defoaming agents used in (a) The defoaming agents are pre- coatings. pared as mixtures of substances de- The defoaming agents described in scribed in paragraph (d) of this section. this section may be safely used as com- (b) The quantity of any substance ponents of articles intended for use in employed in the formulation of de- producing, manufacturing, packing, foaming agents does not exceed the processing, preparing, treating, pack- amount reasonably required to accom- aging, transporting, or holding food, plish the intended physical or technical subject to the provisions of this sec- effect in the defoaming agents or any tion. limitation further provided.

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(c) Any substance employed in the (1) Substances generally recognized production of defoaming agents and as safe in food. which is the subject of a regulation in (2) Substances subject to prior sanc- parts 174, 175, 176, 177, 178 and § 179.45 of tion or approval for use in defoaming this chapter conforms with any speci- agents and used in accordance with fication in such regulation. such sanction or approval. (d) Substances employed in the for- (3) Substances identified in this para- mulation of defoaming agents include: graph (d)(3) and subject to such limita- tions as are provided:

List of substances Limitations

n-Butyl alcohol. tert-Butyl alcohol. Butyl stearate. Castor oil, sulfated, ammonium, potassium, or sodium salt. Cetyl alcohol. Cyclohexane. Cyclohexanol. Diethylene glycol monolaurate. Diethylene glycol monostearate. Dimers and trimers of unsaturated C18 fatty acids derived from: For use only at levels not to exceed 0.1% by weight of total coating solids. Animal and vegetable fats and oils. Tall oil. Dimethylpolysiloxane. a-(Dinonylphenyl)-w-hydroxy-poly(oxy-1,2-ethanediyl), con- For use only in defoaming agents for the production of styrene- taining 7 to 24 moles of ethylene oxide per mole of butadiene coatings at a level not to exceed 0.05 percent by dinonylphenol (CAS Reg. No. 9014–93–1). weight of the finished coating. Dipropylene glycol. Ethyl alcohol. Fats and oils derived from animal, marine, or vegetable sources: Fatty acids derived from animal, marine, or vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum.. Ammonium.. Calcium.. Magnesium.. Potassium.. Sodium.. Zinc.. Formaldehyde ...... For use as preservative of defoamer only. Glyceryl mono-12-hydroxystearate. Glyceryl monostearate. Hexane. Hexylene glycol (2-methyl-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Lecithin hydroxylated. Methyl alcohol. Methylcellulose. Methyl esters of fatty acids derived from animal, marine, or vegetable fats and oils. Methyl oleate. Methyl palmitate. Mineral oil. Mustardseed oil, sulfated, ammonium, potassium, or sodium salt. Myristyl alcohol. Naphtha. b-Naphthol ...... For use as preservative of defoamer only. Nonylphenol. Odorless light petroleum hydrocarbons ...... As defined in § 178.3650 of this chapter. Oleic acid, sulfated, ammonium, potassium, or sodium salt. Parachlorometacresol ...... For use as preservative of defoamer only. Peanut oil, sulfated, ammonium, potassium, or sodium salt. Petrolatum. Pine oil. Polyacrylic acid, sodium salt ...... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane. Polyethylene.

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List of substances Limitations

Polyethylene, oxidized. Polyethylene glycol (200) dilaurate. Polyethylene glycol (400) dioleate. Polyethylene glycol (600) dioleate. Polyethylene glycol (400) esters of coconut oil fatty acids. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (600) monoricinoleate. Polyethylene glycol (400) monostearate. Polyoxybutylene-polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 3,700). Polyoxyethylated (min. 3 mols) cetyl alcohol. Polyoxyethylated (min. 5 mols) oleyl alcohol. Polyoxyethylated (min. 1.5 mols) tridecyl alcohol. Polyoxyethylene (min. 15 mols) ester of rosin. Polyoxyethylene (min. 8 mols) monooleate. Polyoxyethylene (40) stearate. Polyoxypropylated (min. 20 mols) butyl alcohol. Polyoxypropylene glycol (min. mol. wt. 200). Polyoxypropylene (min. 20 mols) oleate butyl ether. Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900). Polyoxypropylene (min. 40 mols) stearate butyl ether. Potassium pentachlorophenate ...... For use as preservative of defoamer only. Potassium trichlorophenate ...... Do. Propylene glycol monoester of soybean oil fatty acids. Propylene glycol monoester of tallow fatty acids. Ricebran oil, sulfated, ammonium, potassium, or sodium salt. Rosins and rosin derivatives ...... As provided in § 178.3870 of this chapter. Silica. Sodium 2-mercaptobenzothiazole ...... For use as preservative of defoamer only. Sodium pentachlorophenate ...... Do. Sodium trichlorophenate ...... Do. Sperm oil, sulfated, ammonium, potassium, or sodium salt. Stearyl alcohol. Tall oil fatty acids. Tallow fatty acids, hydrogenated or sulfated. Tallow, sulfated, ammonium, potassium, or sodium salt. Triethanolamine. Triisopropanolamine. Waxes, petroleum.

(e) The defoaming agents are used as (a) The defoaming agents are pre- follows: pared from one or more of the sub- (1) The quantity of defoaming agent stances named in paragraph (d) of this or agents used shall not exceed the section, subject to any prescribed limi- amount reasonably required to accom- tations. plish the intended effect, which is to (b) The defoaming agents are used to prevent or control the formation of prevent or control the formation of foam. foam during the manufacture of paper (2) The defoaming agents are used in and paperboard prior to and during the the preparation and application of sheet-forming process. coatings for paper and paperboard. (c) The quantity of defoaming agent or agents added during the manufac- [42 FR 14554, Mar. 15, 1977, as amended at 62 turing process shall not exceed the FR 39772, July 24, 1997] amount necessary to accomplish the intended technical effect. § 176.210 Defoaming agents used in the (d) Substances permitted to be used manufacture of paper and paper- in the formulation of defoaming agents board. include substances subject to prior Defoaming agents may be safely used sanctions or approval for such use and in the manufacture of paper and paper- employed subject to the conditions of board intended for use in packaging, such sanctions or approvals, substances transporting, or holding food in accord- generally recognized as safe for use in ance with the following prescribed con- food, substances generally recognized ditions: as safe for use in paper and paperboard,

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and substances listed in this para- Triethanolamine (amides and soaps). graph, subject to the limitations, if Triisopropanolamine (amides and soaps). any, prescribed. Trimethylolethane (esters). Zinc hydroxide (soaps). (1) Fatty triglycerides, and the fatty acids, alcohols, and dimers derived (3) Miscellaneous: therefrom: Alcohols and ketone alcohols mixture (still- Beef tallow. bottom product from C12-C18 alcohol manu- Castor oil. facturing process). Coconut oil. Amyl alcohol. Corn oil. Butoxy polyethylene polypropylene glycol Cottonseed oil. molecular weight 900–4,200. Fish oil. Butoxy-polyoxypropylene molecular weight Lard oil. 1,000–2,500. Linseed oil. Butylated hydroxyanisole. Mustardseed oil. Butylated hydroxytoluene. Palm oil. Calcium lignin sulfonate. Peanut oil. Capryl alcohol. p-Chlorometacresol. Rapeseed oil. Cyclohexanol. Ricebran oil. Diacetyltartaric acid ester of tallow mono- Soybean oil. glyceride. Sperm oil. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. Tall oil. 35691–65–7), for use as a preservative at a (2) Fatty triglycerides, and marine level not to exceed 0.05 weight-percent of oils, and the fatty acids and alcohols the defoaming agent. derived therefrom (paragraph (d)(1) of Diethanolamine. Diethylene triamine. this section) reacted with one or more Di-(2-ethylhexyl) phthalate. of the following, with or without dehy- 2,6-Dimethyl heptanol-4 (nonyl alcohol). dration, to form chemicals of the cat- Dimethylpolysiloxane. egory indicated in parentheses: Di-tert-butyl hydroquinone. Dodecylbenzene sulfonic acids. Aluminum hydroxide (soaps). Ethanol. Ammonia (amides). 2-Ethylhexanol. Butanol (esters). Ethylenediamine tetraacetic acid tetra- Butoxy-polyoxypropylene, molecular weight sodium salt. 1,000–2,500 (esters). Formaldehyde. Butylene glycol (esters). Heavy oxo-fraction (a still-bottom product of Calcium hydroxide (soaps). iso-octyl alcohol manufacture, of approxi- Diethanolamine (amides). mate composition: Octyl alcohol 5 percent Diethylene glycol (esters). nonyl alcohol 10 percent, decyl and higher Ethylene glycol (esters). alcohols 35 percent, esters 45 percent, and Ethylene oxide (esters and ethers). soaps 5 percent). Glycerin (mono- and diglycerides). 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2- Hydrogen (hydrogenated compounds). oxazoline. Hydrogen (amines). Hexylene glycol (2-methyl-2-4-pentanediol). Isobutanol (esters). 12-Hydroxystearic acid. Isopropanol (esters). Isobutanol. Magnesium hydroxide (soaps). Isopropanol. Methanol (esters). Isopropylamine salt of dodecylbenzene sul- Morpholine (soaps). fonic acid. Oxygen (air-blown oils). Kerosine. Pentaerythritol (esters). Lanolin. Polyoxyethylene, molecular weights 200, 300, Methanol. 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 Methyl 12-hydroxystearate. (esters). Methyl taurine-oleic acid condensate, molec- Polyoxypropylene, molecular weight 200– ular weight 486. 2,000 (esters). a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu- Potassium hydroxide (soaps). tyl)-o-phenylene]]bis[omega-hydroxypoly Propanol (esters). (oxyethylene)] having 6–7.5 moles of ethyl- Propylene glycol (esters). ene oxide per hydroxyl group. Propylene oxide (esters). Mineral oil. Sodium hydroxide (soaps). Mono-, di-, and triisopropanolamine. Sorbitol (esters). Mono- and diisopropanolamine stearate. Sulfuric acid (sulfated and sulfonated com- Monobutyl ether of ethylene glycol. pounds). Monoethanolamine.

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Morpholine. a-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p- Myristyl alcohol. nonylphenyl-, or p-dodecylphenyl]-omega- Naphtha. hydroxypoly(oxyethylene) produced by the b-Naphthol. condensation of 1 mole of p-alkylphenol Nonylphenol. (alkyl group is 1,1,3,3-tetramethylbutyl, a Odorless light petroleum hydrocarbons. propylene trimer isomer, or a propylene Oleyl alcohol. tetramer isomer) with an average of 1.5–15 Petrolatum. moles of ethylene oxide. o-Phenylphenol. Tetrahydrofurfuryl alcohol. Pine oil. Tributoxyethyl phosphate. Polybutene, hydrogenated; complying with Tributyl phosphate. the identity prescribed under § 178.3740(b) of Tridecyl alcohol. this chapter. Triethanolamine. Polyethylene. Triethylene glycol di(2-ethyl hexanoate). Polyethylene, oxidized (air-blown). Tri-(2-ethylhexyl) phosphate. Polymer derived from N-vinyl pyrrolidone Tristearyl phosphate. and copolymers derived from the mixed Wax, petroleum, Type I and Type II. alkyl (C12-C15, C16, C18, C20, and C22) meth- Wax, petroleum (oxidized). acrylate esters, butyl methacrylate (CAS Wax (montan). Reg. No. 97–88–1), isobutyl methacrylate [42 FR 14554, Mar. 15, 1977, as amended at 47 (CAS Reg. No. 97–86–9) and methyl meth- FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, acrylate (CAS Reg. No. 80–62–6); the com- 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, bined polymer contains no more than 5 June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR weight percent of polymer units derived 14246, Apr. 1, 1996] from N-vinyl pyrrolidone and is present at a level not to exceed 7 parts per million by weight of the finished dry paper and paper- § 176.230 3,5-Dimethyl-1,3,5,2H- board fibers. tetrahydrothiadiazine-2-thione. Polyoxyethylene (4 mols) decyl phosphate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothi- Polyoxyethylene (4 mols) di(2-ethyl hexano- adiazine-2-thione may safely be used as ate). a preservative in the manufacture and Polyoxyethylene (15 mols) ester of rosin. coating of paper and paperboard in- Polyoxyethylene (3–15 mols) tridecyl alcohol. tended for use in contact with food in Polyoxypropylene, molecular weight 200– 2,000. accordance with the following pre- Polyoxypropylene-polyoxethylene conden- scribed conditions: sate, minimum molecular weight 950. (a) It is used as follows: Polyoxypropylene-ethylene oxide condensate (1) In the manufacture of paper and of ethylene diamine, molecular weight paperboard as a preservative for sub- 1,700–3,800. stances added to the pulp suspension Polyvinyl pyrrolidone, molecular weight prior to the sheet-forming operation 40,000. provided that the preservative is vola- Potassium distearyl phosphate. Potassium pentachlorophenate. tilized by heat in the drying and fin- Potassium trichlorophenate. ishing of the paper and paperboard. Rosins and rosin derivatives identified in (2) As a preservative for coatings for § 175.105(c)(5) of this chapter. paper and paperboard, Provided, That Silica. the preservative is volatilized by heat Siloxanes and silicones, dimethyl, methylhy- in the drying and finishing of the coat- drogen, reaction products with poly- ed paper or paperboard. ethylene-polypropylene glycol monoallyl (b) The quantity used shall not ex- ether (CAS Reg. No. 71965–38–3). ceed the least amount reasonably re- Sodium alkyl (C9-C15) benzene-sulfonate. Sodium dioctyl sulfosuccinate. quired to accomplish the intended Sodium distearyl phosphate. technical effect and shall not be in- Sodium lauryl sulfate. tended to nor, in fact, accomplish any Sodium lignin sulfonate. physical or technical effect in the food Sodium 2-mercaptobenzothiazole. itself. Sodium naphthalenesulfonic acid (3 mols) (c) The use of a preservative in any condensed with formaldehyde (2 mols). substance or article subject to any reg- Sodium orthophenylphenate. ulation in parts 174, 175, 176, 177, 178 Sodium pentachlorophenate. Sodium petroleum sulfonate, molecular and § 179.45 of this chapter must comply weight 440–450. with any specifications and limitations Sodium trichlorophenate. prescribed by such regulation for the Stearyl alcohol. substance or article.

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§ 176.250 Poly-1,4,7,10,13-pentaaza-15- or contains any poisonous or delete- hydroxyhexadecane. rious substance which is retained in Poly-1,4,7,10,13-pentaaza-15-hydrox- the recovered pulp and that migrates yhexadecane may be safely used as a to the food, except as provided in regu- retention aid employed prior to the lations promulgated under sections 406 sheet-forming operation in the manu- and 409 of the act or (ii) has been used facture of paper and paperboard in- for shipping or handling any such sub- tended for use in contact with food in stance. an amount not to exceed that nec- essary to accomplish the intended § 176.300 Slimicides. physical or technical effect and not to (a) Slimicides may be safely used in exceed 6 pounds per ton of finished the manufacture of paper and paper- paper or paperboard. board that contact food, in accordance with the following prescribed condi- § 176.260 Pulp from reclaimed fiber. tions: (a) Pulp from reclaimed fiber may be (1) Slimicides are used as anti- safely used as a component of articles microbial agents to control slime in used in producing, manufacturing, the manufacture of paper and paper- packing, processing, preparing, treat- board. ing, packaging, transporting, or hold- (2) Subject to any prescribed limita- ing food, subject to the provisions of tions, slimicides are prepared from one paragraph (b) of this section. or more of the slime-control substances (b) Pulp from reclaimed fiber is pre- named in paragraph (c) of this section pared from the paper and paperboard to which may be added optional adju- products described in paragraphs (b) (1) vant substances as provided for under and (2) of this section, by repulping with water to recover the fiber with paragraph (d) of this section. the least possible amount of nonfibrous (3) Slimicides are added to the proc- substances. ess water used in the production of (1) Industrial waste from the manu- paper or paperboard, and the quantity facture of paper and paperboard prod- added shall not exceed the amount nec- ucts excluding that which bears or con- essary to accomplish the intended tains any poisonous or deleterious sub- technical effect. stance which is retained in the recov- (b) To insure safe usage, the label or ered pulp and that migrates to the labeling of slimicides shall bear ade- food, except as provided in regulations quate directions for use. promulgated under sections 406 and 409 (c) Slime-control substances per- of the Federal Food, Drug, and Cos- mitted for use in the preparation of metic Act. slimicides include substances subject (2) Salvage from used paper and pa- to prior sanction or approval for such perboard excluding that which (i) bears use and the following:

List of substances Limitations

Acrolein. Alkenyl (C16-C18) dimethylethyl-ammonium bromide. n-Alkyl (C12-C18) dimethyl benzyl ammonium chloride. 1,2-Benzisothiazolin-3-one ...... At a level of 0.06 pound per ton of dry weight fiber. Bis(1,4-bromoacetoxy)-2-butene. 5,5-Bis(bromoacetoxymethyl) m-dioxane. 2,6-Bis(dimethylaminomethyl) cyclohexanone. 1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785–34–0] At a maximum level of 0.10 pound per ton of dry weight fiber. Bis(trichloromethyl)sulfone. 4-Bromoacetoxymethyl-m-dioxolane. 2-Bromo-4′-hydroxyacetophenone. 2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52–51–7) ...... At a maximum level of 0.6 pound per ton of dry weight fiber. b-Bromo-b-nitrostyrene ...... At a maximum level of 1 pound per ton of dry weight fiber. Chloroethylenebisthiocyanate. 5-Chloro-2 - methyl - 4 - isothiazolin-3-one calcium chloride At a level of 2.5 pounds per ton of dry weight fiber. and 2-methyl-4-isothiazolin-3-one calcium chloride mixture at a ratio of 3 parts to 1 part. Chlorinated levulinic acids. Chloromethyl butanethiolsulfonate. Cupric nitrate.

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List of substances Limitations

n-Dialkyl (C12-C18) benzylmethylammonium chloride. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. At a maximum level of 0.005% of dry weight fiber. 2,2-Dibromo-3-nitrilopropionamide ...... At a maximum level of 0.1 lb/ton of dry weight fiber. 2,3-Dibromopropionaldehyde. 4,5-dichloro-1, 2-dithiol-3-one (CAS Reg. No. 1192–52–5) ...... For use only at levels not to exceed 10 milligrams per kilogram in the pulp slurry. 1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry may be and/or chlorine) that may contain no more weight fiber. than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/or chlo- rine).. 4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–1). At a maximum level of 0.2 pound per ton (100 grams/1,000 kilograms) of dry weight fiber. 3,5-Dimethyl 1,3,5,2H-tetrahydrothiadiazine-2-thione. Dipotassium and disodium ethylenebis(dithiocarba-mate). Disodium cyanodithioimidocarbonate. n-Dodecylguanidine hydrochloride ...... At a maximum level of 0.20 pound per ton of dry weight fiber. Glutaraldehyde (CAS Reg. No. 111-30-8). 2-(p-hydroxyphenyl) glyoxylohydroximoyl chloride (CAS Reg- At a level of 0.02 pound per ton of dry weight fiber. istry No. 34911–46–1). 2-Hydroxypropyl methanethiol sulfonate. 2-Mercaptobenzothiazole. Methylenebisbutanethiolsulfonate. Methylenebisthiocyanate. 2-Nitrobutyl bromoacetate [CA Reg. No. 32815–96–6] ...... At a maximum level of 0.15 pound per ton of dry weight fiber. N-[a-(Nitroethyl)benzyl] ethylenediamine. Potassium 2-mercaptobenzothiazole. Potassium N-hydroxymethyl-N-methyldithiocarba-mate. Potassium N-methyldithiocarbamate. Potassium pentachlorophenate. Potassium trichlorophenate. Silver fluoride ...... Limit of addition to process water not to exceed 0.024 pound, calculated as silver fluoride, per ton of paper produced. Silver nitrate. Sodium dimethyldithiocarbamate. Sodium 2-mercaptobenzothiazole. Sodium pentachlorophenate. Sodium trichlorophenate. 1,3,6,8-Tetraazatricyclo[6.2.1.13,6] dodecane. 3,3,4,4-Tetrachlorotetrahydrothiophene-1,1-dioxide. Tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. Maximum use level of 84 mg/kg in the pulp slurry. The additive 55566–30–8). may also be added to water, which when introduced into the pulp slurry, results in a concentration in the pulp slurry not to exceed 84 mg/kg. 2-(Thiocyanomethylthio) benzothiazole. Vinylene bisthiocyanate.

(d) Adjuvant substances permitted to a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl- be used in the preparation of slimicides butyl)-o-phenylene]] bis[omega-hydroxypoly include substances generally recog- (oxyethylene)] having 6–7.5 moles of ethyl- nized as safe for use in food, substances ene oxide per hydroxyl group. generally recognized as safe for use in Monomethyl ethers of mono-, di-, and tri- paper and paperboard, substances per- propylene glycol. mitted to be used in paper and paper- Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide. board by other regulations in this Octylphenol reaction product with 25 mol- chapter, and the following: ecules of propylene oxide and 40 molecules Acetone. of ethylene oxide. Butlylene oxide. [42 FR 14554, Mar. 15, 1977, as amended at 42 Dibutyl phthalate. Didecyl phthalate. FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21, N,N-Dimethylformamide. 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Dodecyl phthalate. Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR Ethanolamine. 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989; Ethylene glycol. 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24, Ethylenediamine. 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, N-methyl-2-pyrrolidone (CAS Reg. No. 872– June 30, 2000; 65 FR 70790, Nov. 28, 2000; 69 FR 50–4). 24512, May 4, 2004]

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§ 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer. 177.1050 Acrylonitrile/styrene copolymer Sodium nitrate-urea complex may be modified with butadiene/styrene elas- safely used as a component of articles tomer. intended for use in producing, manu- 177.1060 n-Alkylglutarimide/acrylic copoly- facturing, packing, processing, pre- mers. paring, treating, packaging, trans- 177.1200 Cellophane. porting, or holding food, subject to the 177.1210 Closures with sealing gaskets for provisions of this section. food containers. 177.1211 Cross-linked polyacrylate copoly- (a) Sodium nitrate-urea complex is a mers. clathrate of approximately two parts 177.1240 1,4-Cyclohexylene dimethylene urea and one part sodium nitrate. terephthalate and 1,4-cyclohexylene (b) Sodium nitrate-urea complex con- dimethylene isophthalate copolymer. forming to the limitations prescribed 177.1310 Ethylene-acrylic acid copolymers. in paragraph (b)(1) of this section is 177.1312 Ethylene-carbon monoxide copoly- used as provided in paragraph (b)(2) of mers. 177.1315 Ethylene-1,4-cyclohexylene this section. dimethylene terephthalate copolymers. (1) Limitations. (i) It is used as a plas- 177.1320 Ethylene-ethyl acrylate copoly- ticizer in glassine and greaseproof mers. paper. 177.1330 Ionomeric resins. (ii) The amount used does not exceed 177.1340 Ethylene-methyl acrylate copoly- that required to accomplish its in- mer resins. tended technical effect or exceed 15 177.1345 Ethylene/1,3-phenylene oxyethylene percent by weight of the finished paper. isophthalate/terephthalate copolymer. 177.1350 Ethylene-vinyl acetate copolymers. (2) Conditions of use. The glassine and 177.1360 Ethylene-vinyl acetate-vinyl alco- greaseproof papers are used for pack- hol copolymers. aging dry food or as the food-contact 177.1380 Fluorocarbon resins. surface for dry food. 177.1390 Laminate structures for use at tem- peratures of 250 °F and above. § 176.350 Tamarind seed kernel pow- 177.1395 Laminate structures for use at tem- der. peratures between 120 °F and 250 °F. Tamarind seed kernel powder may be 177.1400 Hydroxyethyl cellulose film, water- insoluble. safely used as a component of articles 177.1420 Isobutylene polymers. intended for use in producing, manu- 177.1430 Isobutylene-butene copolymers. facturing, packing, processing, pre- 177.1440 4,4′-Isopropylidenediphenol- paring, treating, packaging, trans- epichlorohydrin resins minimum molec- porting, or holding food, subject to the ular weight 10,000. provisions of this section. 177.1460 Melamine-formaldehyde resins in (a) Tamarind seed kernel powder is molded articles. the ground kernel of tamarind seed 177.1480 Nitrile rubber modified acrylo- nitrile-methyl acrylate copolymers. (Tamarindus indica L.) after removal of 177.1500 Nylon resins. the seed coat. 177.1520 Olefin polymers. (b) It is used in the manufacture of 177.1550 Perfluorocarbon resins. paper and paperboard. 177.1555 Polyarylate resins. 177.1556 Polyaryletherketone resins. 177.1560 Polyarylsulfone resins. PART 177—INDIRECT FOOD 177.1570 Poly-1-butene resins and butene/ ADDITIVES: POLYMERS ethylene copolymers. 177.1580 Polycarbonate resins. Subpart A [Reserved] 177.1585 Polyestercarbonate resins. 177.1590 Polyester elastomers. Subpart B—Substances for Use as Basic 177.1595 Polyetherimide resin. Components of Single and Repeated 177.1600 Polyethylene resins, carboxyl modi- Use Food Contact Surfaces fied. 177.1610 Polyethylene, chlorinated. Sec. 177.1615 Polyethylene, fluorinated. 177.1010 Acrylic and modified acrylic plas- 177.1620 Polyethylene, oxidized. tics, semirigid and rigid. 177.1630 Polyethylene phthalate polymers. 177.1020 Acrylonitrile/butadiene/styrene co- 177.1632 Poly(phenyleneterephthalamide) polymer. resins. 177.1030 Acrylonitrile/butadiene/styrene/ 177.1635 Poly(p-methylstyrene) and rubber- methyl methacrylate copolymer. modified poly(p-methylstyrene).

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177.1637 Poly(oxy-1,2- 177.2800 Textiles and textile fibers. ethanediyloxycarbonyl-2,6- 177.2910 Ultra-filtration membranes. naphthalenediylcarbonyl) resins. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. 177.1640 Polystyrene and rubber-modified polystyrene. SOURCE: 42 FR 14572, Mar. 15, 1977, unless 177.1650 Polysulfide polymer-polyepoxy res- otherwise noted. ins. 177.1655 Polysulfone resins. EDITORIAL NOTE: Nomenclature changes to 177.1660 Poly(tetramethylene part 177 appear at 61 FR 14482, Apr. 2, 1996, 66 terephthalate). FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 177.1670 Polyvinyl alcohol film. 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 72074, 177.1680 Polyurethane resins. Dec. 1, 2005, 81 FR 49896, July 29, 2016. 177.1810 Styrene block polymers. 177.1820 Styrene-maleic anhydride copoly- Subpart A [Reserved] mers. 177.1830 Styrene-methyl methacrylate co- polymers. Subpart B—Substances for Use as 177.1850 Textryls. Basic Components of Single 177.1900 Urea-formaldehyde resins in molded and Repeated Use Food Con- articles. 177.1950 Vinyl chloride-ethylene copoly- tact Surfaces mers. 177.1960 Vinyl chloride-hexene-1 copoly- § 177.1010 Acrylic and modified acrylic mers. plastics, semirigid and rigid. 177.1970 Vinyl chloride-lauryl vinyl ether Semirigid and rigid acrylic and modi- copolymers. fied acrylic plastics may be safely used 177.1980 Vinyl chloride-propylene copoly- as articles intended for use in contact mers. with food, in accordance with the fol- 177.1990 Vinylidene chloride/methyl acry- late copolymers. lowing prescribed conditions. The 177.2000 Vinylidene chloride/methyl acry- acrylic and modified acrylic polymers late/methyl methacrylate polymers. or plastics described in this section also may be safely used as components Subpart C—Substances for Use Only as of articles intended for use in contact Components of Articles Intended for with food. Repeated Use (a) The optional substances that may be used in the formulation of the 177.2210 Ethylene polymer, chlorosulfonated. semirigid and rigid acrylic and modi- 177.2250 Filters, microporous polymeric. fied acrylic plastics, or in the formula- 177.2260 Filters, resin-bonded. tion of acrylic and modified acrylic 177.2280 4,4′-Isopropylidenediphenol- components of articles, include sub- epichlorohydrin thermosetting epoxy stances generally recognized as safe in resins. food, substances used in accordance 177.2355 Mineral reinforced nylon resins. with a prior sanction or approval, sub- 177.2400 Perfluorocarbon cured elastomers. 177.2410 Phenolic resins in molded articles. stances permitted for use in such plas- 177.2415 Poly(aryletherketone) resins. tics by regulations in parts 170 through 177.2420 Polyester resins, cross-linked. 189 of this chapter, and substances 177.2430 Polyether resins, chlorinated. identified in this paragraph. At least 50 177.2440 Polyethersulfone resins. weight-percent of the polymer content 177.2450 Polyamide-imide resins. of the acrylic and modified acrylic ma- 177.2460 Poly(2,6-dimethyl-1,4-phenylene) terials used as finished articles or as oxide resins. components of articles shall consist of 177.2465 Polymethylmethacrylate/poly(tri methoxysilylpropyl) methacrylate co- polymer units derived from one or polymers. more of the acrylic or methacrylic 177.2470 Polyoxymethylene copolymer. monomers listed in paragraph (a)(1) of 177.2480 Polyoxymethylene homopolymer. this section. 177.2490 Polyphenylene sulfide resins. (1) Homopolymers and copolymers of 177.2500 Polyphenylene sulfone resins. the following monomers: 177.2510 resins. 177.2550 Reverse osmosis membranes. n-Butyl acrylate. 177.2600 Rubber articles intended for re- n-Butyl methacrylate. peated use. Ethyl acrylate. 177.2710 Styrene-divinylbenzene resins, 2-Ethylhexyl acrylate. cross-linked. Ethyl methacrylate.

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Methyl acrylate. Methacryloxyacetamidoethylethylene urea. Methyl methacrylate. Methacryloxyacetic acid. n-Propyl methacrylate. (2) Copolymers produced by copolym- 3,5,5-Trimethylcyclohexyl methacrylate. erizing one or more of the monomers listed in paragraph (a)(1) of this section (4) Polymers identified in paragraphs with one or more of the following (a)(1), (2), and (3) of this section are monomers: mixed together and/or with the fol- lowing polymers, provided that no Acrylonitrile. chemical reactions, other than addi- Methacrylonitrile. tion reactions, occur when they are a-Methylstyrene. Styrene. mixed: Vinyl chloride. Butadiene-acrylonitrile copolymers. Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers. (3) Polymers identified in paragraphs Butadiene-acrylonitrile-styrene-methyl (a)(1) and (2) of this section containing methacrylic copolymers. Butadiene-styrene copolymers. no more than 5 weight-percent of total Butyl rubber. polymer units derived by copolym- Natural rubber. erization with one or more of the Polybutadiene. monomers listed in paragraph (a)(3)(i) Poly (3-chloro-1,3-butadiene). and (ii) of this section. Monomers list- Polyester identified in § 175.300(b)(3)(vii) of ed in paragraph (a)(3)(ii) of this section this chapter. are limited to use only in plastic arti- Polyvinyl chloride. cles intended for repeated use in con- Vinyl chloride copolymers complying with § 177.1980. tact with food. Vinyl chloride-vinyl acetate copolymers. (i) List of minor monomers: (5) Antioxidants and stabilizers iden- Acrylamide. tified in § 175.300(b)(3)(xxx) of this chap- Acrylic acid ter and the following: 1,3-Butylene glycol dimethacrylate. 1,4-Butylene glycol dimethacrylate. Di-tert-butyl-p-cresol. Diethylene glycol dimethacrylate. 2-Hydroxy-4-methoxybenzophenone. Diproplylene glycol dimethacrylate. 2-Hydroxy-4-methoxy-2- Divinylbenzene. carboxybenzophenone. Ethylene glycol dimethacrylate. 3-Hydroxyphenyl benzoate. Itaconic acid. p-Methoxyphenol. Methacrylic acid. Methyl salicylate. N-Methylolacrylamide. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro- N-Methylolmethacrylamide. cinnamate (CAS Reg. No. 2082–79–3): For 4-Methyl-1,4-pentanediol dimethacrylate. use only: (1) At levels not exceeding 0.2 Propylene glycol dimethacrylate. percent by weight in semirigid and rigid Trivinylbenzene. acrylic and modified acrylic plastics, (ii) List of minor monomers limited where the finished articles contact foods to use only in plastic articles intended containing not more than 15 percent alco- hol; and (2) at levels not exceeding 0.01 per- for repeated use in contact with food: cent by weight in semirigid and rigid Allyl methacrylate [Chemical Abstracts acrylic and modified acrylic plastics in- Service Registry No. 96–05–9] tended for repeated food-contact use where tert-Butyl acrylate. the finished article may be used for foods tert-Butylaminoethyl methacrylate. containing more than 15 percent alcohol. sec-Butyl methacrylate. Phenyl salicylate. tert-Butyl methacrylate. (6) Release agents: Fatty acids de- Cyclohexyl methacrylate. Dimethylaminoethyl methacrylate. rived from animal and vegetable fats 2-Ethylhexyl methacrylate. and oils, and fatty alcohols derived Hydroxyethyl methacrylate. from such acids. Hydroxyethyl vinyl sulfide. (7) Surface active agent: Sodium Hydroxypropyl methacrylate. dodecylbenzenesulfonate. Isobornyl methacrylate. (8) Miscellaneous materials: Isobutyl methacrylate. Isopropyl acrylate. Di(2-ethylhexyl) phthalate, for use only as a Isopropyl methacrylate. flow promoter at a level not to exceed 3 Methacrylamide. weight-percent based on the monomers. Methacrylamidoethylene urea. Dimethyl phthalate.

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Oxalic acid, for use only as a polymerization prepared in a still using a block tin catalyst aid. condenser. The 8 and 50 percent (by vol- Tetraethylenepentamine, for use only as a ume) alcohol solvents shall be prepared catalyst activator at a level not to exceed 0.5 weight-percent based on the monomers. from ethyl alcohol meeting the speci- Toluene. fications of the United States Pharma- Xylene. copeia XX and diluted with double-dis- tilled water that has been prepared in a (b) The semirigid and rigid acrylic still using a tin block condenser. The and modified acrylic plastics, in the n-heptane shall be spectrophotometric finished form in which they are to con- grade. Adequate precautions must be tact food, when extracted with the sol- taken to keep all solvents dust-free. vent or solvents characterizing the (4) Blank values on solvents. (i) Dupli- type of food and under the conditions cate determinations of residual solids of time and temperature as determined shall be run on samples of each solvent from tables 1 and 2 of § 176.170(c) of this that have been exposed to the tempera- chapter, shall yield extractives not to ture-time conditions of the extraction exceed the following, when tested by the methods prescribed in paragraph test without the plastic sample. Sixty (c) of this section. The acrylic and milliliters of exposed solvent is modified acrylic polymers or plastics pipetted into a clean, weighed plat- intended to be used as components of inum dish, evaporated to 2–5 milliliters articles also shall yield extractives not on a nonsparking, low-temperature hot ° to exceed the following limitations plate and dried in 212 F oven for 30 when prepared as strips as described in minutes. The residue for each solvent paragraph (c)(2) of this section: shall be determined by weight and the (1) Total nonvolatile extractives not average residue weight used as the to exceed 0.3 milligram per square inch blank value in the total solids deter- of surface tested. mination set out in paragraph (c)(6) of (2) Potassium permanganate oxidiz- this section. The residue for an accept- able distilled water and 8 and 50 per- able solvent sample shall not exceed 0.5 cent alcohol extractives not to exceed milligram per 60 milliliters. an absorbance of 0.15. (ii) For acceptability in the ultra- (3) Ultraviolet-absorbing distilled violet absorbers test, a sample of each water and 8 and 50 percent alcohol ex- solvent shall be scanned in an ultra- tractives not to exceed an absorbance violet spectrophotometer in 5-centi- of 0.30. meter silica spectrophotometric ab- (4) Ultraviolet-absorbing n-heptane sorption cells. The absorbance of the extractives not to exceed an absorb- distilled water when measured versus ance of 0.10. air in the reference cell shall not ex- (c) Analytical methods—(1) Selection of ceed 0.03 at any point in the wave- extractability conditions. These are to be length region of 245 to 310 mμ. The ab- chosen as provided in § 176.170(c) of this sorbance of the 8 percent alcohol when chapter. measured versus distilled water in the (2) Preparation of samples. Sufficient reference cell shall not exceed 0.01 at samples to allow duplicates of all ap- any point in the wavelength region of plicable tests shall be cut from the ar- 245 to 310 mμ. The absorbance of the 50 ticles or formed from the plastic com- percent alcohol when measured versus position under tests, as strips about 2.5 distilled water in the reference cell inches by about 0.85-inch wide by about shall not exceed 0.05 at any point in the 0.125-inch thick. The total exposed sur- wavelength region of 245 to 310 mμ. The face should be 5 square inches ±0.5- absorbance of the heptane when meas- square inch. The samples, after prepa- ured versus distilled water in the ref- ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245, brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any running hot tapwater (140 °F min- point in the wavelength region of 280 to imum), rinsed with distilled water, and 310 mμ. air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de- iccator. terminations shall be run on samples of (3) Preparation of solvents. The water each solvent that has been exposed to used shall be double-distilled water, the temperature-time conditions of the

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extraction test without the plastic tents to room temperature if nec- sample. An aliquot of the exposed sol- essary. vent shall be measured versus the un- (6) Determination of total nonvolatile exposed solvent in the reference cell. extractives. Remove the plastic strip The average difference in the from the solvent with a pair of clean absorbances at any wavelength in the forceps and wash the strip with 5 milli- region of 245 to 310 mμ shall be used as liters of the appropriate solvent, add- a blank correction for the ultraviolet ing the washings to the contents of the absorbers measured at the same wave- test tube. Pour the contents of the test length according to paragraph (c)(8)(ii) tube into a clean, weighed platinum of this section. dish. Wash the tube with 5 milliliters (iv) The acceptability of the solvents of the appropriate solvent and add the for use in the permanganate test shall solvent to the platinum dish. Evapo- be determined by preparing duplicate rate the solvent to 2–5 milliliters on a permanganate test blanks according to nonsparking, low-temperature paragraph (c)(7)(iv) of this section. For hotplate. Complete the evaporation in this test, the directions referring to a 212 °F oven for 30 minutes. Cool the the sample extract shall be dis- dish in a desiccator for 30 minutes and regarded. The blanks shall be scanned weigh to the nearest 0.1 milligram. Cal- in 5-centimeter silica culate the total nonvolatile extractives spectrophotometric cells in the spec- as follows: trophotometer versus the appropriate eb− solvent as reference. The absorbance in Milligrams extractives = distilled water in the wavelength re- per square inch gion of 544 to 552 mμ should be 1.16 but s must not be less than 1.05 nor more Extractives in parts eb than 1.25. The absorbance in the 8 and =×100 50 percent alcohol must not be less per million s than 0.85 nor more than 1.15. where: (v) Duplicate permanganate test de- e = Total increase in weight of the dish, in terminations shall be run on samples of milligrams. distilled water and 8 and 50 percent al- b = Blank value of the solvent in milligrams, cohol solvents that have been exposed as determined in paragraph (c)(4)(i) of to the temperature-time conditions of this section. the extraction test without the plastic s = Total surface of the plastic sample in sample. The procedure shall be as de- square inches. scribed in paragraph (c)(7)(iv) of this (7) Determination of potassium per- section, except that the appropriate ex- manganate oxidizable extractives. (i) Pi- posed solvent shall be substituted pette 25 milliliters of distilled water where the directions call for sample ex- into a clean 125-milliliter Erlenmeyer tract. The average difference in the flask that has been rinsed several absorbances in the region of 544 to 552 times with aliquots of distilled water. mμ shall be used as a blank correction This is the blank. Prepare a distilled for the determination of permanganate water solution containing 1.0 part per oxidizable extractives according to million of p-methoxyphenol (melting paragraph (c)(7)(iv) of this section. point 54–56 °C, Eastman grade or equiv- (5) Extraction procedure. For each ex- alent). Pipette 25 milliliters of this p- traction, place a plastic sample in a methoxyphenol solution into a rinsed clean 25 millimeters × 200 millimeters Erlenmeyer flask. Pipette exactly 3.0 hard-glass test tube and add solvent milliliters of 154 parts per million equal to 10 milliliters of solvent per aqueous potassium permanganate solu- square inch of plastic surface. This tion into the p-methoxyphenol and ex- amount will be between 45 milliliters actly 3.0 milliliters into the blank, in and 55 milliliters. The solvent must be that order. Swirl both flasks to mix the preequilibrated to the temperature of contents and then transfer aliquots the extraction test. Close the test tube from each flask into matched 5-centi- with a ground-glass stopper and expose meter spectrophotometric absorption to the specified temperature for the cells. The cells are placed in the spec- specified time. Cool the tube and con- trophotometer cell compartment with

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the p-methoxyphenol solution in the pose of ascertaining compliance with reference beam. Spectrophotometric the limitations in paragraph (b)(2) of measurement is conducted as in para- this section, the absorbance measure- graph (c)(7)(iv) of this section. The ab- ments obtained on the distilled water sorbance reading in the region 544–552 extracts according to paragraph mμ should be 0.24 but must be not less (c)(7)(iv) of this section shall be multi- than 0.12 nor more than 0.36. This test plied by a correction factor, calculated shall be run in duplicate. For the pur- as follows:

024. = Correction factor for water extracts. Average of duplicate ρ -methoxyphenol absorbance determinations according to this paragraph (c)(7)(i) of this section

(ii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 8 percent alcohol. The absorb- ments obtained on the 8 percent alco- ance in the region 544–552 mμ should be hol extracts according to paragraph 0.26 but must be not less than 0.13 nor (c)(7)(iv) of this section shall be multi- more than 0.39. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:

026. = Correction factor for aqueous Average of duplicate ρ -methoxyphenol 8 percent alcohol extracts. absorbance determination according to this paragraph (c)(7)(ii) of this section

(iii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco- ance in the region 544–552 mμ should be hol extracts according to paragraph 0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi- more than 0.38. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:

025. = Correction factor for 50 percent Average of duplicate ρ -methoxyphenol aqueous alcohol extracts. absorbance determinations according to paragraph (c)(7)(ii) of this section

(iv) Water and 8 and 50 percent alcohol the same solvent. This is the blank. extracts. Pipette 25 milliliters of the ap- Into another similarly rinsed flask, pi- propriate solvent into a clean, 125-mil- pette 25 milliliters of the sample ex- liliter Erlenmeyer flask that has been tract that has been exposed under the rinsed several times with aliquots of conditions specified in paragraph (c)(5)

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of this section. Pipette exactly 3.0 mil- propriate correction factor determined liliters of 154 parts per million aqueous according to paragraph (c)(7) (i), (ii), potassium permanganate solution into and (iii) of this section. This test shall the sample and exactly 3.0 milliliters be run in duplicate and the two results into the blank, in that order. Before averaged. use, the potassium permanganate solu- (8) Determination of ultraviolet-absorb- tion shall be checked as in paragraph ing extractives. (i) A distilled water so- (c)(7)(i) of this section. Both flasks are lution containing 1.0 part per million swirled to mix the contents, and then of p-methoxyphenol (melting point 54 aliquots from each flask are trans- °C–56 °C. Eastman grade or equivalent) ferred to matched 5-centimeter shall be scanned in the region 360 to 220 spectrophotometric absorption cells. mμ in 5-centimeter silica spectrophoto- Both cells are placed in the spectro- photometer cell compartment with the metric absorption cells versus a dis- sample solution in the reference beam. tilled water reference. The absorbance The spectrophotometer is adjusted for at the wavelength of maximum absorb- 0 and 100 percent transmittance at 700 ance (should be about 285 mμ) is about mμ. The spectrum is scanned on the ab- 0.11 but must be not less than 0.08 nor sorbance scale from 700 mμ to 500 mμ in more than 0.14. This test shall be run in such a way that the region 544 mμ to duplicate. For the purpose of 552 mμ is scanned within 5 minutes to ascertaining compliance with the limi- 10 minutes of the time that permanga- tations prescribed in paragraph (b) (3) nate was added to the solutions. The and (4) of this section, the absorbance height of the absorbance peak shall be obtained on the extracts according to measured, corrected for the blank as paragraph (c)(8)(ii) of this section shall determined in paragraph (c)(4)(v) of be multiplied by a correction factor, this section, and multiplied by the ap- calculated as follows:

011. = Correction factor for ultraviolet Average of duplicate ρ -methoxyphenol absorbers test. absorbance determinations according to this paragraph (c)(8)(i) of this section

(ii) An aliquot of the extract that has (e) Acrylonitrile copolymers identi- been exposed under the conditions fied in this section shall comply with specified in paragraph (c)(5) of this sec- the provisions of § 180.22 of this chap- tion is scanned in the wavelength re- ter. gion 360 to 220 mμ versus the appro- (f) The acrylic and modified acrylic priate solvent reference in matched 5- polymers identified in and complying centimeter silica spectrophotometric with this section, when used as compo- absorption cells. The height of any ab- nents of the food-contact surface of an sorption peak shall be measured, cor- article that is the subject of a regula- rected for the blank as determined in tion in this part and in parts 174, 175, paragraph (c)(4)(iii) of this section, and 176, and 178 of this chapter, shall com- multiplied by the correction factor de- ply with any specifications and limita- termined according to paragraph tions prescribed by such regulation for (c)(8)(i) of this section. the article in the finished form in (d) In accordance with current good which it is to contact food. manufacturing practice, finished semirigid and rigid acrylic and modi- [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. fied acrylic plastics, and articles con- 28, 1977, as amended at 43 FR 54927, Nov. 24, taining these polymers, intended for 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR repeated use in contact with food shall 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985] be thoroughly cleansed prior to their first use in contact with food.

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§ 177.1020 Acrylonitrile/butadiene/sty- (2) Residual acrylonitrile monomer rene co-polymer. content of the finished copolymer arti- Acrylonitrile/butadiene/styrene co- cles is not more than 11 parts per mil- polymer identified in this section may lion as determined by a gas be safely used as an article or compo- chromatographic method titled ‘‘De- nent of articles intended for use with termination of Residual Acrylonitrile all foods, except those containing alco- and Styrene Monomers-Gas hol, under conditions of use E, F, and G Chromatographic Internal Standard described in table 2 of § 176.170(c) of this Method,’’ which is incorporated by ref- chapter. erence. Copies are available from the (a) Identity. For the purpose of this Center for Food Safety and Applied Nu- section, the acrylonitrile/butadiene/ trition (HFS–200), Food and Drug Ad- styrene copolymer consists of: ministration, 5001 Campus Dr., College (1) Eighty-four to eighty-nine parts Park, MD 20740, or available for inspec- by weight of a matrix polymer con- tion at the National Archives and taining 73 to 78 parts by weight of acry- Records Administration (NARA). For lonitrile and 22 to 27 parts by weight of information on the availability of this styrene; and material at NARA, call 202–741–6030, or (2) Eleven to sixteen parts by weight go to: http://www.archives.gov/ of a grafted rubber consisting of (i) 8 to federallregister/ 13 parts of butadiene/styrene elastomer codeloflfederallregulations/ containing 72 to 77 parts by weight of ibrllocations.html. butadiene and 23 to 28 parts by weight (d) Extractive limitations. (1) Total of styrene and (ii) 3 to 8 parts by nonvolatile extractives not to exceed weight of a graft polymer having the same composition range as the matrix 0.0005 milligram per square inch sur- polymer. face area when the finished food con- (b) Adjuvants. The copolymer identi- tact article is exposed to distilled fied in paragraph (a) of this section water, 3 percent acetic acid, or n- may contain adjuvant substances re- heptane for 8 days at 120 °F. quired in its production. Such adju- (2) The finished food-contact article vants may include substances gen- shall yield not more than 0.0015 milli- erally recognized as safe in food, sub- gram per square inch of acrylonitrile stances used in accordance with prior monomer when exposed to distilled sanction, substances permitted in this water and 3 percent acetic acid at 150 part, and the following: °F for 15 days when analyzed by a po- larographic method titled ‘‘Extracted Substance Limitations Acrylonitrile by Differential Pulse Po- 2-Mercapto- ethanol The finished copolymer shall contain larography,’’ which is incorporated by not more than 100 ppm 2- reference. Copies are available from mercaptoethanol acrylonitrile adduct as determined by a method titled the Center for Food Safety and Applied ‘‘Analysis of Cycopac Resin for Re- Nutrition (HFS–200), Food and Drug sidual b-(2-Hydroxyethylmercapto) Administration, 5001 Campus Dr., Col- propionitrile,’’ which is incorporated by reference. Copies are available lege Park, MD 20740, or available for in- from the Bureau of Foods (HFS– spection at the National Archives and 200), Food and Drug Administra- Records Administration (NARA). For tion, 5001 Campus Dr., College Park, MD 20740, or available for in- information on the availability of this spection at the National Archives material at NARA, call 202–741–6030, or and Records Administration go to: http://www.archives.gov/ (NARA). For information on the availability of this material at NARA, federallregister/ call 202–741–6030, or go to: http:// codeloflfederallregulations/ www.archives.gov/federallregister/ ibrllocations.html. codeloflfederallregulations/ ibrllocations.html. (e) Acrylonitrile copolymers identi- fied in this section shall comply with (c) Specifications. (1) Nitrogen content the provisions of § 180.22 of this chap- of the copolymer is in the range of 16 ter. to 18.5 percent as determined by Micro- (f) Acrylonitrile copolymers identi- Kjeldahl analysis. fied in this section are not authorized

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to be used to fabricate beverage con- Substances Limitations tainers. 2–Mercaptoethanol .. The finished copolymer shall contain [42 FR 14572, Mar. 15, 1977, as amended at 42 not more than 800 ppm 2– FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, mercaptoethanol acrylonitrile adduct as determined by a method titled 1982; 54 FR 24897, June 12, 1989] ‘‘Analysis of Cycopac Resin for Re- sidual b–(2–Hydroxyethylmercapto) § 177.1030 Acrylonitrile/butadiene/sty- propionitrile,’’ which is incorporated rene/methyl methacrylate copoly- by reference. Copies are available mer. from the Bureau of Foods (HFS– 200), Food and Drug Administra- Acrylonitrile/butadiene/styrene/ tion, 5001 Campus Dr., College Park, MD 20740, or available for in- methyl methacrylate copolymer iden- spection at the National Archives tified in this section may be safely and Records Administration used as an article or component of arti- (NARA). For information on the availability of this material at NARA, cles intended for use with food identi- call 202–741–6030, or go to: http:// fied in table 1 of § 176.170(c) of this www.archives.gov/federallregister/ chapter as Type I, II, III, IVA, IVB, V, codeloflfederallregulations/ l VIB, (except bottles intended to hold ibr locations.html. carbonated beverages), VIIA, VIIB, VIII (c) Specifications. (1) Nitrogen content and IX, under conditions of use C, D, E, of the copolymer is in the range of 13.0 F, and G described in table 2 of to 16.0 percent as determined by Micro- § 176.170(c) of this chapter with a high Kjeldahl analysis. temperature limitation of 190 °F. (2) Residual acrylonitrile monomer (a) Identity. For the purpose of this content of the finished copolymer arti- section, acrylonitrile/butadiene/sty- cles is not more than 11 parts per mil- rene/methyl methacrylate copolymer lion as determined by a gas consists of: (1) 73 to 79 parts by weight chromatographic method titled ‘‘De- of a matrix polymer containing 64 to 69 termination of Residual Acrylonitrile parts by weight of acrylonitrile, 25 to and Styrene Monomers-Gas 30 parts by weight of styrene and 4 to Chromatographic Internal Standard 6 parts by weight of methyl methacry- Method,’’ which is incorporated by ref- late; and (2) 21 to 27 parts by weight of erence. Copies are available from the a grafted rubber consisting of (i) 16 to Center for Food Safety and Applied Nu- 20 parts of butadiene/styrene/elastomer trition (HFS–200), Food and Drug Ad- containing 72 to 77 parts by weight of ministration, 5001 Campus Dr., College butadiene and 23 to 28 parts by weight Park, MD 20740, or available for inspec- of styrene and (ii) 5 to 10 parts by tion at the National Archives and weight of a graft polymer having the Records Administration (NARA). For same composition range as the matrix information on the availability of this polymer. material at NARA, call 202–741–6030, or (b) Adjuvants. The copolymer identi- go to: http://www.archives.gov/ fied in paragraph (a) of this section federallregister/ may contain adjuvant substances re- codeloflfederallregulations/ quired in its production. Such adju- ibrllocations.html. vants may include substances gen- (d) Extractive limitations. (1) Total erally recognized as safe in food, sub- nonvolatile extractives not to exceed stances used in accordance with prior 0.0005 milligram per square inch sur- sanction, substances permitted under face area of the food-contact article applicable regulations in this part, and when exposed to distilled water, 3 per- the following: cent acetic acid, 50 percent ethanol, and n-heptane for 10 days at 120 °F. (2) The finished food-contact article shall yield not more than 0.0025 milli- gram per square inch of acrylonitrile monomer when exposed to distilled water, 3 percent acetic acid and n- heptane at 190 °F for 2 hours, cooled to

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120 °F (80 to 90 minutes) and main- used as a component of packaging ma- tained at 120 °F for 10 days when ana- terials subject to the provisions of this lyzed by a polarographic method titled section. ‘‘Extracted Acrylonitrile by Differen- (a) Identity. For the purposes of this tial Pulse Polarography,’’ which is in- section acrylonitrile/styrene copoly- corporated by reference. Copies are mers are basic copolymers meeting the available from the Center for Food specifications prescribed in paragraph Safety and Applied Nutrition (HFS– (c) of this section. 200), Food and Drug Administration, (b) Adjuvants. (1) The copolymers 5001 Campus Dr., College Park, MD identified in paragraph (c) of this sec- 20740, or available for inspection at the tion may contain adjuvant substances National Archives and Records Admin- required in their production, with the istration (NARA). For information on exception that they shall not contain the availability of this material at NARA, call 202–741–6030, or go to: http:// mercaptans or other substances which www.archives.gov/federallregister/ form reversible complexes with acryl- codeloflfederallregulations/ onitrile monomer. Permissible adju- ibrllocations.html. vants may include substances gen- (e) Acrylonitrile copolymers identi- erally recognized as safe in food, sub- fied in this section shall comply with stances used in accordance with prior the provisions of § 180.22 of this chap- sanction, substances permitted under ter. applicable regulations in this part, and (f) Acrylonitrile copolymers identi- those authorized in paragraph (b)(2) of fied in this section are not authorized this section. to be used to fabricate beverage con- (2) The optional adjuvants for the ac- tainers. rylonitrile/styrene copolymer identi- [42 FR 14572, Mar. 15, 1977, as amended at 42 fied in paragraphs (c) (1) and (3) of this FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, section are as follows: 1982; 54 FR 24898, June 12, 1989] Substances Limitation

§ 177.1040 Acrylonitrile/styrene copoly- Condensation polymer of toluene 0.15 pct maximum. mer. sulfonamide and formaldehyde. Acrylonitrile/styrene copolymers identified in this section may be safely (c) Specifications.

Maximum re- sidual acrylo- nitrile mon- Nitrogen con- Maximum extractable fractions at Conformance with Acrylonitrile/styrene copolymers omer content tent of co- specified temperatures and times certain specifications of finished polymer article

1. Acrylonitrile/styrene copolymer 80 ppm1 ...... 17.4 to 19 Total nonvolatile extractives not to Minimum number av- consisting of the copolymer pro- pct. exceed 0.01 mg/in 2 surface erage molecular duced by polymerization of 66– area of the food contact article weight is 30,000. 1 72 parts by weight of acrylo- when exposed to distilled water nitrile and 28–34 parts by weight and 3 pct acetic acid for 10 d at of styrene; for use with food of 66 °C (150 °F). Type VI-B identified in table 1 of The extracted copolymer shall not § 176.170(c) of this chapter exceed 0.001 mg/in 2 surface under conditions of use C, D, E, area of the food contact article F, G described in table 2 of when exposed to distilled water § 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at 66 °C (150 °F) 1. 2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu- consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25 duced by polymerization of 45– heptane extract obtained when °C (77 °F) is 65 parts by weight of acrylo- 100 g sample of the basic co- 10cP. 1 nitrile and 35–55 parts by weigth polymer in the form of particles of styrene; for use with food of of a size that will pass through a Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and bottles), VII, VIII, and IX identi- that will be held on a U.S. fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex- this chapter under conditions B tracted with 250 mil of deionized (not to exceed 93 °C (200 °F)), water or reagent grade n- C, D, E, F, G described in table heptane at reflux temperature 2 of § 176.170(c) of this chapter. for 2 h.1

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Maximum re- sidual acrylo- nitrile mon- Nitrogen con- Maximum extractable fractions at Conformance with Acrylonitrile/styrene copolymers omer content tent of co- specified temperatures and times certain specifications of finished polymer article

3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di- consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability duced by polymerization of 66– on the area of the food contact article at 23 °C (73 °F) for 72 parts by weight of acrylo- basis of when exposed to distilled water the finished article nitrile and 28–34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer. 3 of styrene; for use with food of of the ac- 66 °C (150 °F). Types VI-A and VI-B identified in rylonitrile The extracted copolymer shall not table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface chapter under conditions of use resin in the area of the food contact article C, D, E, F, G described in table finished ar- when exposed to distilled water 2 of § 176.170(c) of this chapter. ticles). 2 and 3 pct acetic acid for 10 d at 66 °C (150 °F). 1. 1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average mo- lecular weight, and solution viscosity, titled: ‘‘Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method’’; ‘‘Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210 Resin Pellets’’; ‘‘Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,’’ and ‘‘Analytical Method for 10% Solution Viscosity of Tyril,’’ which are incorproated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar- chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html. 2 As determined by the method titled ‘‘Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylo- nitrile in Acrylonitrile Copolyemr Solutions,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar- chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html. 3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction by ASTM method D–1434–82, ‘‘Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, and the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ibrllocations.html.

(d) Interim listing. Acrylonitrile co- mer modified with butadiene/styrene polymers identified in this section elastomer consists of a blend of: shall comply with the provisions of (1) 82–88 parts by weight of a matrix § 180.22 of this chapter. copolymer produced by polymerization (e) Acrylonitrile copolymer identified of 77–82 parts by weight of acrylonitrile in this section may be used to fabricate and 18–23 parts of styrene; and beverage containers only if they com- (2) 12–18 parts by weight of a grafted ply with the specifications of item 3 in rubber consisting of (i) 8–12 parts of bu- paragraph (c) of this section. tadiene/styrene elastomer containing [42 FR 14572, Mar. 15, 1977, as amended at 42 77–82 parts by weight of butadiene and FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 18–23 parts by weight of styrene and (ii) 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 4–6 parts by weight of a graft copoly- Sept. 8, 1987] mer consisting of 70–77 parts by weight of acrylonitrile and 23–30 parts by § 177.1050 Acrylonitrile/styrene copoly- weight of styrene. mer modified with butadiene/sty- rene elastomer. (b) Adjuvants. The modified copoly- mer identified in paragraph (a) of this Acrylonitrile/styrene copolymer section may contain adjuvant sub- modified with butadiene/styrene elas- stances required in its production. tomer identified in this section may be Such adjuvants may include substances safely used as a component of bottles generally recognized as safe in food, intended for use with foods identified substances used in accordance with in table I of § 176.170(c) of this chapter prior sanction, substances permitted as Type VI-B under conditions for use under applicable regulations in this E, F, or G described in table 2 of part, and the following: § 176.170(c) of this chapter. (a) Identity. For the purpose of this section, acrylonitrile/styrene copoly-

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Substances Limitations go to: http://www.archives.gov/ federallregister/ n-Dodecylmercaptan The finished copolymer shall contain not more than 500 parts per million codeloflfederallregulations/ (ppm) dodecylmercaptan as ibrllocations.html. dodecylmercapto-propionitrile as de- (d) Extractives limitations. The fol- termined by the method titled, ‘‘De- lowing extractives limitations are de- termination of b-Dodecyl- mercaptopropionitrile in NR–16 termined by an infrared spectrophoto- Polymer,’’ which is incorporated by metric method titled ‘‘Infrared reference. Copies are available Spectrophotometric Determination of from the Center for Food Safety ® and Applied Nutrition (HFS–200), Polymer Extracted from Borex 210 Food and Drug Administration, 5001 Resin Pellets,’’ which is incorporated Campus Dr., College Park, MD by reference. Copies are available from 20740, or available for inspection at the Center for Food Safety and Applied the National Archives and Records Administration (NARA). For informa- Nutrition (HFS–200), Food and Drug tion on the availability of this mate- Administration, 5001 Campus Dr., Col- rial at NARA, call 202–741–6030, or lege Park, MD 20740, or available for in- go to: http://www.archives.gov/ federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this material at NARA, call 202–741–6030, or (c) Specifications. (1) Nitrogen content go to: http://www.archives.gov/ of the modified copolymer is in the federallregister/ range of 17.7–19.8 percent. codeloflfederallregulations/ (2) Intrinsic viscosity of the matrix ibrllocations.html. Copies are applica- copolymer in butyrolactone is not less ble to the modified copolymers in the than 0.5 deciliter/gram at 35 °C, as de- form of particles of a size that will pass termined by the method titled ‘‘Molec- through a U.S. Standard Sieve No. 6 ular Weight of Matrix Copolymer by and that will be held on a U.S. Stand- Solution Viscosity,’’ which is incor- ard Sieve No. 10: porated by reference. Copies are avail- (1) The extracted copolymer shall not able from the Center for Food Safety exceed 2.0 ppm in aqueous extract ob- and Applied Nutrition (HFS–200), Food tained when a 100-gram sample of co- and Drug Administration, 5001 Campus polymer is extracted with 250 milli- Dr., College Park, MD 20740, or avail- liters of freshly distilled water at able for inspection at the National Ar- reflux temperature for 2 hours. chives and Records Administration (2) The extracted copolymer shall not (NARA). For information on the avail- exceed 0.5 ppm in n-heptane when a 100- ability of this material at NARA, call gram sample of the basic copol-ymer is 202–741–6030, or go to: http:// extracted with 250 milliliters spectral www.archives.gov/federallregister/ grade n-heptane at reflux temperature codeloflfederallregulations/ for 2 hours. ibrllocations.html. (e) Accelerated extraction end test. The (3) Residual acrylonitrile monomer modified copolymer shall yield acrylo- content of the modified copolymer ar- nitrile monomer not in excess of 0.4 ticles is not more than 11 ppm as deter- ppm when tested as follows: mined by a gas chromatographic meth- (1) The modified copolymer shall be od titled ‘‘Determination of Residual in the form of eight strips 1⁄2 inch by 4 Acrylonitrile and Styrene Monomers- inches by .03 inch. Gas Chromatographic Internal Stand- (2) The modified copolymer strips ard Method,’’ which is incorporated by shall be immersed in 225 milliliters of 3 reference. Copies are available from percent acetic acid in a Pyrex glass the Center for Food Safety and Applied pressure bottle. Nutrition (HFS–200), Food and Drug (3) The pyrex glass pressure bottle is Administration, 5001 Campus Dr., Col- then sealed and heated to 150 °F in ei- lege Park, MD 20740, or available for in- ther a circulating air oven or a thermo- spection at the National Archives and stat controlled bath for a period of 8 Records Administration (NARA). For days. information on the availability of this (4) The Pyrex glass pressure bottle is material at NARA, call 202–741–6030, or then removed from the oven or bath

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and cooled to room temperature. A such use by applicable regulations, as sample of the extracting solvent is set forth in part 174 of this chapter. then withdrawn and analyzed for acry- (c) Specifications. Maximum nitrogen lonitrile monomer by a gas content of the copolymer determined chromatographic method titled ‘‘Gas- by micro-Kjeldahl analysis, shall not Solid Chromatographic Procedure for exceed 8 percent. Determining Acrylonitrile Monomer in (d) Limitations. (1) The n-alkylglutar- Acrylonitrile-Containing Polymers and imide/acrylic copolymers in the fin- Food Simulating Solvents,’’ which is ished form in which they shall contact incorporated by reference. Copies, are food, when extracted with the solvent available from the Center for Food or solvents characterizing the type of Safety and Applied Nutrition (HFS– food and under the conditions of time 200), Food and Drug Administration, and temperature described in tables 1 5001 Campus Dr., College Park, MD and 2 of § 176.170(c) of this chapter, 20740, or available for inspection at the shall yield extractives not to exceed National Archives and Records Admin- the limitations of § 177.1010(b) of this istration (NARA). For information on chapter, when prepared as strips, as de- the availability of this material at scribed in § 177.1010(c)(2) of this chapter. NARA, call 202–741–6030, or go to: http:// (2) The n-alkylglutarimide/acrylic co- polymers shall not be used as polymer www.archives.gov/federallregister/ modifiers in vinyl chloride homo- or codeloflfederallregulations/ copolymers. ibrllocations.html. (e) Conditions of use. The n- (f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers fied in this section shall comply with are used as articles or components of the provisions of § 180.22 of this chap- articles (other than articles composed ter. of vinyl chloride homo- or copolymers) (g) Acrylonitrile copolymers identi- intended for use in contact with all fied in this section are not authorized foods except beverages containing to be used to fabricate beverage con- more than 8 percent alcohol under con- tainers. ditions of use D, E, F, and G as de- [42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter. 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, [54 FR 20382, May 11, 1989, as amended at 58 June 12, 1989] FR 17098, Apr. 1, 1993]

§ 177.1060 n-Alkylglutarimide/acrylic § 177.1200 Cellophane. copolymers. Cellophane may be safely used for n-Alkylglutarimide/acrylic copoly- packaging food in accordance with the mers identified in this section may be following prescribed conditions: safely used as articles or components (a) Cellophane consists of a base of articles intended for use in contact sheet made from regenerated cellulose with food subject to provisions of this to which have been added certain op- section and part 174 of this chapter. tional substances of a grade of purity (a) Identity. For the purpose of this suitable for use in food packaging as section, n-alkylglutarimide/acrylic co- constituents of the base sheet or as polymers are copolymers obtained by coatings applied to impart desired reaction of substances permitted by technological properties. § 177.1010(a) (1), (2), and (3) with the fol- (b) Subject to any limitations pre- lowing substance: Monomethylamine scribed in this part, the optional sub- (CAS Reg. No. 74–89–5), to form n- stances used in the base sheet and methylglutarimide/acrylic copolymers. coating may include: (b) Adjuvants. The copolymers identi- (1) Substances generally recognized fied in paragraph (a) of this section as safe in food. may contain adjuvant substances re- (2) Substances for which prior ap- quired in their production. The op- proval or sanctions permit their use in tional adjuvant substances required in cellophane, under conditions specified the production of the basic polymer in such sanctions and substances listed may include substances permitted for in § 181.22 of this chapter.

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(3) Substances that by any regulation (4) Substances named in this section promulgated under section 409 of the and further identified as required. act may be safely used as components (c) List of substances: of cellophane.

Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

Acrylonitrile-butadiene copolymer resins ...... As the basic polymer. Acrylonitrile-butadiene-styrene copolymer resins ...... Do. Acrylonitrile-styrene copolymer resins ...... Do. Acrylonitrile-vinyl chloride copolymer resins ...... Do. N-Acyl sarcosines where the acyl group is lauroyl or stearoyl ... For use only as release agents in coatings at levels not to ex- ceed a total of 0.3 percent by weight of the finished pack- aging cellophane. Alkyl ketene dimers identified in § 176.120 of this chapter. Aluminum hydroxide. Aluminum silicate. Ammonium persulfate. Ammonium sulfate. Behenamide. Butadiene-styrene copolymer ...... As the basic polymer. 1,3-Butanediol. n-Butyl acetate ...... 0.1 percent. n-Butyl alcohol ...... Do. Calcium ethyl acetoacetate. Calcium stearoyl-2-lactylate identified in § 172.844 of this chap- Not to exceed 0.5 percent weight of cellophane. ter. Carboxymethyl hydroxyethylcellulose polymer. Castor oil, hydrogenated. Castor oil phthalate with adipic acid and fumaric acid-diethyl- As the basic polymer. ene glycol polyester. Castor oil phthalate, hydrogenated ...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Castor oil, sulfonated, sodium salt. Cellulose acetate butyrate. Cellulose acetate propionate. Cetyl alcohol. Clay, natural.

Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of fatty acid (C12-C18) diethanolamine soap, and diethanolamine cellulose pulp used in the manufacture of cellophane base mixture having total alkali (calculated as potassium hydrox- sheet. ide) of 16–18% and having an acid number of 25–35. Copal resin, heat processed ...... As basic resin. Damar resin. Defoaming agents identified in § 176.200 of this chapter. Dialkyl ketones where the alkyl groups are lauryl or stearyl ...... Not to exceed a total of 0.35 percent. Dibutylphthalate ...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Dicyclohexyl phthalate ...... Do. Diethylene glycol ester of the adduct of terpene and maleic an- hydride. Di(2-ethylhexyl) adipate. Di(2-ethylhexyl) phthalate...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Diisobutyl phthalate ...... Do. Dimethylcyclohexyl phthalate ...... Do.

Dimethyldialkyl (C8-C18) ammonium chloride ...... 0.005 percent for use only as a flocculant for slip agents. Di-n-ocyltin bis (2-ethylhexyl maleate) ...... For use only as a stabilizer at a level not to exceed 0.55 per- cent by weight of the coating solids in vinylidene chloride co- polymer waterproof coatings prepared from vinylidene chlo- ride copolymers identified in this paragraph, provided that such vinylidene chloride copolymers contain not less than 90 percent by weight of polymer units derived from vinylidene chloride.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent. and N-oleoyl-N′linoleoylethylene-diamine mixture produced when tall oil fatty acids are made to react with ethylene- diamine such that the finished mixture has a melting point of 212°–228 °F., as determined by ASTM method D127–60 (‘‘Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax’’ (Revised 1960), which is incor- porated by reference; copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.), and an acid value of 10 maximum. N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide). Disodium EDTA. Distearic acid ester of di(hydroxyethyl) diethylenetriamine 0.06 percent. monoacetate. N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide). Epoxidized polybutadiene ...... For use only as a primer subcoat to anchor surface coatings to the base sheet. Erucamide. Ethyl acetate. Ethylene-vinyl acetate copolymers complying with § 177.1350. 2-Ethylhexyl alcohol ...... 0.1 percent for use only as lubricant. Fatty acids derived from animal and vegetable fats and oils, and the following salts of such acids, single or mixed: Alu- minum, ammonium, calcium, magnesium, potassium, sodium. Ferrous ammonium sulfate. Fumaric acid. Glycerin-maleic anhydride ...... As the basic polymer. Glycerol diacetate. Glycerol monoacetate. Hydroxyethyl cellulose, water-insoluble. Hydroxypropyl cellulose identified in § 172.870 of this chapter. Isopropyl acetate ...... Residue limit 0.1 percent Isopropyl alcohol ...... Do. Itaconic acid. Lanolin. Lauryl alcohol. Lauryl sulfate salts: ammonium, magnesium, potassium, so- dium. Maleic acid ...... 1 percent. Maleic acid adduct of butadienestyrene copolymer. Melamine formaldehyde ...... As the basic polymer. Melamine-formaldehyde modified with one or more of the fol- As the basic polymer, and used as a resin to anchor coatings lowing: Butyl alcohol, diaminopropane, diethylenetriamine, to substrate. ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-eth- ylamine, imino-bis-propylamine, methyl alcohol, polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane, sulfanilic acid, tetraethylenepentamine, triethanolamine, triethylenetetra- mine. Methyl ethyl ketone ...... Residue limit 0.1 percent Methyl hydrogen siloxane ...... 0.1 percent as the basic polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a- methylstyrene to 3 vinyltoluene). Mineral oil, white. Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS For use only as a release agent at a level not to exceed 0.6 Reg. No. 62362–49–6). percent by weight of coatings for cellophane. Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier. salt. Nitrocellulose, 10.9 percent–12.2 percent nitrogen. Nylon resins complying with § 177.1500. n-Octyl alcohol ...... For use only as a defoaming agent in the manufacture of cello- phane base sheet. Olefin copolymers complying with § 177.1520. Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16 to C18). Oleic acid, sulfonated, sodium salt. Oleyl palmitamide.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl- aminoethyl)oleamide). Paraffin, synthetic, complying with § 175.250 of this chapter. Pentaerythritol tetrastearate ...... 0.1 percent. Polyamide resins derived from dimerized vegetable oil acids For use only in cellophane coatings that contact food at tem- (containing not more than 20 percent of monomer acids) and peratures not to exceed room temperature. ethylenediamine as the basic resin. Polyamide resins having a maximum acid value of 5 and a As the basic resin, for use only in coatings that contact food at maximum amine value of 8.5 derived from dimerized vege- temperatures not to exceed room temperature provided that table oil acids (containing not more than 10 percent mon- the concentration of the polyamido resins in the finished omer acids), ethylenediamine, and 4,4-bis(4- food-contact coating does not exceed 5 milligrams per hydroxyphenyl)pentanoic acid (in an amount not to exceed square inch of food-contact surface. 10 percent by weight of said polyamide resins). Polybutadiene resin (molecular weight range 2,000–10,200; For use only as an adjuvant in vinylidene chloride copolymer bromine number range 210–320). coatings. Polycarbonate resins complying with § 177.1580. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride, and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C–92 °C, and a color of K or paler. Polyethylene. Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent. aric acid is made to react with equal parts of diethylenetriamine and triethylenetetramine and the reaction product is quaternized with diethyl sulfate. Polyethylene glycol (400) monolaurate. Polyethylene glycol (600) monolaurate. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (400) monostearate. Polyethylene glycol (600) monostearate. Polyethylene, oxidized: complying with the identity prescribed in § 177.1620(a). Polyethylenimine ...... As the basic polymer, for use as a resin to anchor coatings to the substrate and for use as an impregnant in the food-con- tact surface of regenerated cellulose sheet in an amount not to exceed that required to improve heat-sealable bonding between coated and uncoated sides of cellophane. Polyisobutylene complying with § 177.1420. Polyoxypropylene-polyoxyethylene block polymers (molecular For use as an adjuvant employed during the processing of cel- weight 1,900–9,000). lulose pulp used in the manufacture of cellophane base sheet. Polypropylene complying with § 177.1520. Polystyrene ...... As the basic polymer. Polyvinyl acetate ...... Do. Polyvinyl alcohol (minimum viscosity of 4 percent aqueous so- lution at 20 °C of 4 centipoises). Polyvinyl chloride ...... As the basic polymer. Polyvinyl stearate ...... Do. n-Propyl acetate ...... Residue limit 0.1 percent. n-Propyl alcohol ...... Do. Rapeseed oil, blown. Rosins and rosin derivatives as provided in § 178.3870 of this chapter. Rubber, natural (natural latex solids). Silica. Silicic acid. Sodium m-bisulfite. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauroyl sarcosinate ...... 0.35 percent; for use only in vinylidene chloride copolymer coatings. Sodium oleyl sulfate-sodium cetyl sulfate mixture ...... For use only as an emulsifier for coatings; limit 0.005 percent where coating is applied to one side only and 0.01 percent where coating is applied to both sides. Sodium silicate. Sodium stearoyl-2-lactylate identified in § 172.846 of this chap- Not to exceed 0.5 percent weight of cellophane. ter. Sodium sulfate. Sodium sulfite. Spermaceti wax. Stannous oleate.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

2-Stearamido-ethyl stearate. Stearyl alcohol. Styrene-maleic anhydride resins ...... As the basic polymer. Terpene resins identified in § 172.615 of this chapter. Tetrahydrofuran ...... Residue limit of 0.1 percent. Titanium dioxide. Toluene ...... Residue limit of 0.1 percent. Toluene sulfonamide formaldehyde ...... 0.6 percent as the basic polymer. Triethylene glycol. Triethylene glycol diacetate, prepared from triethylene glycol containing not more than 0.1 percent of diethylene glycol. 2,2,4-Trimethyl-1,3 pentanediol diisobutyrate ...... For use only in cellophane coatings and limited to use at a level not to exceed 10 percent by weight of the coating sol- ids except when used as provided in § 178.3740 of this chapter Urea (carbamide). Urea formaldehyde ...... As the basic polymer. Urea formaldehyde modified with methanol, ethanol, butanol As the basic polymer, and used as a resin to anchor coatings diethylenetriamine, triethylenetetramine, tetraethylenepenta- to the substrate. mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-eth- ylamine, imino-bis-propylamine, imino-bis-butylamine, diaminopropane, diaminobutane, aminomethylsulfonic acid, polyamines made by reacting ethylenediamine or trimethylenediamine with dichlorethane or dichloropropane. Vinyl acetate-vinyl chloride copolymer resins ...... As the basic polymer. Vinyl acetate-vinyl chloride-maleic acid copolymer resins ...... Do. Vinylidene chloride copolymerized with one or more of the fol- Do. lowing: Acrylic acid, acrylonitrile, butyl acrylate, butyl meth- acrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, ethyl methacrylate, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride. Vinylidene chloride-methacrylate decyloctyl copolymer ...... Do. Wax, petroleum, complying with § 178.3710 of this chapter.

(d) Any optional component listed in in parts 174, 175, 176, 177, 178 and § 179.45 this section covered by a specific food of this chapter; and closure-sealing additive regulation must meet any gaskets, as further prescribed in this specifications in that regulation. section. (e) Acrylonitrile copolymers identi- (b) Closure-sealing gaskets and over- fied in this section shall comply with all discs are formulated from sub- the provisions of § 180.22 of this chap- stances identified in § 175.300(b) of this ter. chapter, with the exception of para- graph (b)(3) (v), (xxxi), and (xxxii) of [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, that section, and from other optional 1999] substances, including the following: (1) Substances generally recognized § 177.1210 Closures with sealing gas- as safe in food. kets for food containers. (2) Substances used in accordance Closures with sealing gaskets may be with the provisions of a prior sanction safely used on containers intended for or approval within the meaning of sec- use in producing, manufacturing, pack- tion 201(s) of the act. ing, processing, preparing, treating, (3) Substances that are the subject of packaging, transporting, or holding regulations in parts 174, 175, 176, 177, 178 food in accordance with the following and § 179.45 of this chapter and used in prescribed conditions: accordance with the conditions pre- (a) Closures for food containers are scribed. manufactured from substances gen- (4) Substances identified in para- erally recognized as safe for contact graph (b)(5) of this section, used in with food; substances that are subject amounts not to exceed those required to the provisions of prior sanctions; to accomplish the intended physical or substances authorized by regulations technical effect and in conformance

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with any limitation provided; and fur- conforms with the identity or speci- ther provided that any substance em- fications prescribed. ployed in the production of closure- (5) Substances that may be employed sealing gasket compositions that is the in the manufacture of closure-sealing subject of a regulation in parts 174, 175, gaskets include: 176, 177, 178 and § 179.45 of this chapter

TABLE 1

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Arachidy-l-behenyl amide (C20-C22fatty acid amides) ...... 5 percent. Azodicarbonamide ...... 1. 2 percent. 2. 5 percent; for use only in the manufacture of polyethylene complying with item 2.1 in § 177.1520(c) of this chapter. Balata rubber. Benzyl alcohol ...... 1 percent. Brominated isobutylene-isoprene copolymers, produced when isobutylene-isoprene copolymers complying with § 177.1420(a)(2) are modified by bromination with not more than 2.3 weight-percent of bromine and having a Mooney Viscosity (ML 1 + 8 (125 °C)) of 27 or higher. The viscosity is determined by the American Society for Testing and Mate- rials (ASTM) method D 1646–81, ‘‘Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Moon- ey Viscometer),’’ which is incorporated by reference in ac- cordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504 and the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5001 Campus Dr., Col- lege Park, MD 20740, or available for inspection at the Na- tional Archives and Records Administration (NARA). For in- formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. 1,3-Butanediol. Calcium tin stearate ...... 2 percent. Calcium zinc stearate ...... Do. Carbon, activated ...... 1 percent. Castor oil, hydrogenated ...... 2 percent. Chlorinated isobutylene-isoprene copolymers complying with § 177.1420. Coco amide (coconut oil fatty acids amides) ...... 2 percent. Cork (cleaned, granulated). Diebenzamide phenyl disulfide ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Di(C7, C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter; except that, there is no limitation on polymer thickness. Di-2-ethylhexyl adipate. Di-2-ethylhexyl sebacate ...... 2 percent. Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per hundred by weight of permitted vinyl chloride homo- and/or copolymer resins used in contact with food of Types I, II, IV- B, VI-A, VI-B, VI-C (up to 15 percent alcohol by volume), VII- B, and VIII described in § 176.170(c) of this chapter, table 1, and under conditions of use A through H described in § 176.170 (c) of this chapter, table 2. Dihexyl ester of sodium sulfosuccinate ...... 1 percent. Diisodecyl phthalate ...... No limitation on amount used but for use only in closure-seal- ing gasket compositions used in contact with non-fatty foods containing no more than 8 percent of alcohol. Di-b-naphthyl-p-phenylenediamine ...... 1 percent. Dipentamethylenethiurametetrasulfide ...... 0.4 percent; for use only in vulcanized natural or synthetic rub- ber gasket compositions. Eicosane (technical grade) (water-white mixture of predomi- nantly straight-chain paraffin hydrocarbons averaging 20 car- bon atoms per molecule). Epoxidized linseed oil. Epoxidized linseed oil modified with trimellitic anhydride. Epoxidized safflower oil. Epoxidized safflower oil modified with trimellitic anhydride. Epoxidized soybean oil modified with trimellitic anhydride.

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TABLE 1—Continued

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Erucylamide ...... 5 percent. Ethylene-propylene copolymer. Ethylene-propylene modified copolymer elastomers produced when ethylene and propylene are copolymerized with 5- methylene-2-norbornene and/or 5-ethylidine-2-norbornene. The finished copolymer elastomers so produced shall con- tain not more than 5 weight-percent of total polymer units derived from 5-methylene-2-norbornene and/or 5-ethylidine- 2-norbornene, and shall have a minimum viscosity average molecular weight of 120,000 as determined by the method described in § 177.1520(d)(5), and a minimum Mooney vis- cosity of 35 as determined by the method described in § 177.1520(d)(6). Ethylene-vinyl acetate copolymer. Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent. ricinoleate). Gutta-percha. Hexamethylenetetramine ...... 1 percent. Hexylene glycol ...... 0.5 percent. Isobutylene-isoprene copolymers complying with § 177.1420. Maleic anhydride-polyethylene copolymer ...... 5 percent. Maleic anhydride-styrene copolymer ...... Do. 2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ...... 1 percent. Mixed octylated diphenylamine (CAS Reg. No. 68411–46–1) ... 0.1 percent in isobutylene-isoprene and chlorinated isobutylene-isoprene copolymers complying with § 177.1420, and brominated isobutylene-isoprene copolymers complying with this section. Naphthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent. salt. Natural rubber (crepe, latex, mechanical dispersions). a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the 0.5 percent. octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 moles. Oleyl alcohol ...... 1 percent. 4,4′-Oxybis (benzene sulfonyl hydrazide) ...... 0.5 percent. Paraformaldehyde ...... 1 percent. Polybutadiene. Poly-p-dinitroso benzene (activator for butyl rubber) ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Polyethylene glycol 400 esters of fatty acids derived from ani- 1 percent. mal and vegetable fats and oils. Polyisobutylene complying with § 177.1420. Polyoxypropylene-polyoxyethylene condensate, average mol. 0.05 percent. wt. 2750–3000. Polyurethane resins manufactured from diphenylmethane For use only: diisocyanate, 1,4-butanediol, and adipic acid (CAS Reg. No. No limitation on amount used, but for use only in closure 26375–23–5).. gasket compositions used in contact with food types VI-A and VI-C (up to 15 percent alcohol) under conditions of use D, E, F, and G, as described in § 176.170(c) of this chapter, tables 1 and 2, respectively. Potassium benzoate ...... 1 percent. Potassium perchlorate ...... Do. Potassium propionate ...... 2 percent. Potassium and sodium persulfate ...... 1 percent. Resorcinol ...... 0.24 percent; for use only as a reactive adjuvant substance employed in the production of gelatin-bonded cord composi- tions for use in lining crown closures. The gelatin so used shall be technical grade or better. Rosins and rosin derivatives as defined in § 175.300(b)(3)(v) of this chapter for use only in resinous and polymeric coatings on metal substrates; for all other uses as defined in § 178.3870 of this chapter. Sodium cetyl sulfate ...... 1 percent. Sodium decylbenzenesulfonate ...... Do. Sodium decyl sulfate ...... Do. Sodium formaldehyde sulfoxylate ...... 0.05 percent. Sodium lauryl sulfate ...... 1 percent. Sodium lignin sulfonate ...... 0.2 percent. Sodium myristyl sulfate (sodium tetradecyl sulfate) ...... 0.6 percent.

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TABLE 1—Continued

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Sodium nitrite ...... 0.2 percent; for use only in annular ring gaskets applied in aqueous dispersions to closures for containers having a ca- pacity of not less than 5 gallons. Sodium o-phenylphenate ...... 0.05 percent. Sodium polyacrylate ...... 5 percent. Sodium and potassium pentachlorophenate ...... 0.05 percent. Sodium salt of trisopropyl naphthalenesulfonic acid ...... 0.2 percent. Sodium tridecylsulfate ...... 0.6 percent. Stearic acid amide ...... 5 percent. Sulfur ...... For use only as a vulcanizing agent in vulcanized natural or synthetic rubber gasket compositions at a level not to ex- ceed 4 percent by weight of the elastomer content of the rubber gasket composition. Tallow, sulfated ...... 1 percent. Tin-zinc stearate ...... 2 percent. Tri(mixed mono- and dinonylphenyl) phosphite ...... 1 percent. Vinyl chloride-vinyl stearate copolymer. Zinc dibutyldithiocarbamate ...... 0.8 percent; for use only in vulcanized natural or synthetic rub- ber gasket compositions.

TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES cork, or glass that forms a part of the [In parts per million] food-contact surface of the assembly, when extracted on a suitable glass con- Chloro- Chloro- Chloro- tainer with a solvent or solvents char- form form form Type of closure-sealing gas- fraction fraction fraction acterizing the type of foods, and under ket composition of water of of alco- conditions of time and temperature extrac- heptane hol ex- tives extrac- tractives characterizing the conditions of its use tives as determined from tables 3 and 4 shall 1. Plasticized polymers, in- yield net chloroform-soluble extrac- cluding unvulcanized or tives (corrected for zinc as zinc oleate) vulcanized or otherwise not to exceed the tolerances specified cured natural and syn- thetic rubber formed in in table 2, calculated on the basis of place as overall discs or the water capacity of the container on annular rings from a hot which the closure is to be used. Employ melt, solution, plastisol, the analytical method described in organisol, mechanical dis- persion, or latex ...... 50 500 50 § 175.300 of this chapter, adapting the 2. Preformed overall discs procedural details to make the method or annular rings of plasti- applicable to closures; such as, for ex- cized polymers, including unvulcanized natural or ample, placing the closed glass con- synthetic rubber ...... 50 250 50 tainer on its side to assure contact of 3. Preformed overall discs the closure’s food-contacting surface or annular rings of vulcan- with the solvent. ized plasticized polymers, including natural or syn- TABLE 3—TYPES OF FOOD thetic rubber ...... 50 50 50 4. Preformed overall discs I. Nonacid (pH above 5.0), aqueous products; or annular rings of poly- may contain salt or sugar or both, and in- meric or resinous-coated cluding oil-in-water emulsions of low- or paper, paperboard, plas- high-fat content. tic, or metal foil substrates 50 250 50 5. Closures with sealing II. Acidic (pH 5.0 or below), aqueous prod- gaskets or sealing com- ucts; may contain salt or sugar or both, positions as described in and including oil-in-water emulsions of 1, 2, 3, and 4, and includ- low- or high-fat content. ing paper, paperboard, III. Aqueous, acid or nonacid products con- and glassine used for dry taining free oil or fat; may contain salt, 1 1 1 foods only ...... ( ) ( ) ( ) and including water-in-oil emulsions of 1 Extractability tests not applicable. low- or high-fat content. IV. Dairy products and modifications: (c) The closure assembly to include A. Water-in-oil emulsions, high- or low-fat. the sealing gasket or sealing com- B. Oil-in-water emulsions, high- or low-fat. pound, together with any polymeric or V. Low-moisture fats and oils. resinous coating, film, foil, natural VI. Beverages:

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A. Containing alcohol. VII. Bakery products. B. Nonalcoholic. VIII. Dry solids (no end-test required).

TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Extractant Conditions of use Types of food (see Table 3) Water (time and tem- Heptane1 (time and 8% alcohol perature) temperature) (time and temperature)

A. High temperature I, IV–B ...... 250 °F, 2 hr ...... heat-sterilized (e.g., over 212 °F). III, IV–A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water-sterilized II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteur- II, IV–B ...... Fill boiling, cool to 100 . ized above 150 °F. °F. III, IV–A ...... do ...... 120 °F, 15 min. V ...... do. D. Hot filled or pasteur- II, IV–B, VI–B ...... 150 °F, 2 hr ...... ized below 150 °F. III, IV–A ...... do ...... 100 °F, 30 min. V ...... do. VI–A ...... 150 °F, 2 hr. E. Room temperature II, IV–B, VI–B ...... 120 °F, 24 hr ...... filled and stored (no thermal treatment in the container). III, IV–A ...... do ...... 70 °F, 30 min. V ...... do. VI–A ...... 120 °F, 24 hr. F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ...... 70 °F, 30 min. (no thermal treatment). VI–B,VII. VI–A ...... 70 °F, 48 hr. G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ...... thermal treatment in the container). 1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.

[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May 9, 2000; 65 FR 52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 2011; 78 FR 14665, Mar. 7, 2013]

§ 177.1211 Cross-linked polyacrylate (2) 2-propenoic acid, polymer with 2- copolymers. ethyl-2-(((1-oxo-2-pro- penyl)oxy)methyl)-1,3-propanediyl di-2- Cross-linked polyacrylate copoly- propenoate and sodium 2-propenoate mers identified in paragraph (a) of this (CAS Reg. No. 76774–25–9). section may be safely used as articles (b) Adjuvants. The copolymers identi- or components of articles intended for fied in paragraph (a) of this section use in contact with food in accordance may contain optional adjuvant sub- with the following prescribed condi- stances required in the production of tions: such copolymers. The optional adju- (a) Identity. For the purpose of this vant substances may include sub- section, the cross-linked polyacrylate stances permitted for such use by regu- copolymers consist of: lations in parts 170 through 179 of this (1) The grafted copolymer of cross- chapter, substances generally recog- linked sodium polyacrylate identified nized as safe in food, and substances as 2-propenoic acid, polymers with N,N- used in accordance with a prior sanc- di-2-propenyl-2-propen-1-amine and tion or approval. hydrolyzed polyvinyl acetate, sodium (c) Extractives limitations. The copoly- salts, graft (CAS Reg. No. 166164–74–5); mers identified in paragraph (a) of this or section, in the finished form in which

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they will contact food, must yield low (b) The quantity of any optional sub- molecular weight (less than 1,000 Dal- stance employed in the production of tons) extractives of no more than 0.15 the copolymer does not exceed the percent by weight of the total polymer amount reasonably required to accom- when extracted with 0.2 percent by plish the intended physical or technical weight of aqueous sodium chloride so- effect or any limitation further pro- lution at 20 °C for 24 hours. The low vided. molecular weight extractives shall be (c) Any substance employed in the determined using size exclusion chro- production of the copolymer that is the matography or an equivalent method. subject of a regulation in parts 174, 175, When conducting the extraction test, 176, 177, 178 and § 179.45 of this chapter the copolymer, with no other absorp- conforms with any specification in tive media, shall be confined either in such regulation. a finished absorbent pad or in any suit- (d) Substances employed in the pro- able flexible porous article, (such as a duction of the copolymer include: ‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized pressure of 0.15 pounds per square inch as safe in food. (for example, a 4 × 6 inch square pad is (2) Substances subject to prior sanc- subjected to a 1.6 kilograms applied tion or approval for use in the copoly- mass). The solvent used shall be at mer and used in accordance with such least 60 milliliters aqueous sodium sanction or approval. chloride solution per gram of copoly- (3) Substances which by regulation in mer. parts 174, 175, 176, 177, 178 and § 179.45 of (d) Conditions of use. The copolymers this chapter may be safely used as identified in paragraph (a)(1) of this components of resinous or polymeric section are limited to use as a fluid ab- coatings and film used as food-contact sorbent in food-contact materials used surfaces, subject to the provisions of in the packaging of frozen or refrig- such regulation. erated poultry. The copolymers identi- (e) The copolymer conforms with the fied in paragraph (a)(2) of this section following specifications: are limited to use as a fluid absorbent (1) The copolymer, when extracted in food-contact materials used in the with distilled water at reflux tempera- packaging of frozen or refrigerated ture for 2 hours, yields total extrac- meat and poultry. tives not to exceed 0.05 percent. (2) The copolymer, when extracted [64 FR 28098, May 25, 1999, as amended at 65 with ethyl acetate at reflux tempera- FR 16817, Mar. 30, 2000] ture for 2 hours, yields total extrac- § 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent. dimethylene terephthalate and 1,4- (3) The copolymer, when extracted cyclohexylene dimethylene with n-hexane at reflux temperature isophthalate copolymer. for 2 hours, yields total extractives not Copolymer of 1,4-cyclohexylene to exceed 0.05 percent. dimethylene terephthalate and 1,4- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, cyclohexylene dimethylene isophtha- 1984, as amended at 55 FR 34555, Aug. 23, 1990] late may be safely used as an article or component of articles used in pro- § 177.1310 Ethylene-acrylic acid co- ducing, manufacturing, packing, proc- polymers. essing, preparing, treating, packaging, The ethylene-acrylic acid copolymers transporting, or holding food, subject identified in paragraph (a) of this sec- to the provisions of this section: tion may be safely used as components (a) The copolymer is a basic poly- of articles intended for use in contact ester produced by the catalytic con- with food subject to the provisions of densation of dimethyl terephthalate this section. and dimethyl isophthalate with 1,4- (a) The ethylene-acrylic acid copoly- cyclohexanedimethanol, to which may mers consist of basic copolymers pro- have been added certain optional sub- duced by the copolymerization of stances required in its production or ethylene and acrylic acid such that the added to impart desired physical and finished basic copolymers contain no technical properties. more than:

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(1) 10 weight-percent of total polymer hesives complying with § 175.105 of this units derived from acrylic acid when chapter. used in accordance with paragraph (b) of this section; and [42 FR 14572, Mar. 15, 1977, as amended at 51 FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, (2) 25 weight-percent of total polymer 1988] units derived from acrylic acid when used in accordance with paragraph (c) § 177.1312 Ethylene-carbon monoxide of this section. copolymers. (b) The finished food-contact articles made with no more than 10 percent The ethylene-carbon monoxide co- total polymer units derived from acryl- polymers identified in paragraph (a) of ic acid, when extracted with the sol- this section may be safely used as com- vent or solvents characterizing the ponents of articles intended for use in type of food and under the conditions contact with food subject to the provi- of its intended use as determined from sions of this section. tables 1 and 2 of § 176.170(c) of this chap- (a) Identity. For the purposes of this ter, yield net acidified chloroform-solu- section, ethylene-carbon monoxide co- ble extractives not to exceed 0.5 milli- polymers (CAS Reg. No. 25052–62–4) con- gram per square inch of food-contact sist of the basic polymers produced by surface when tested by the methods the copolymerization of ethylene and prescribed in § 177.1330(e)(1), (3)(i) carbon monoxide such that the copoly- through (iv), (4), (5), and (6), except mers contain not more than 30 weight- that percent of polymer units derived from (1) The total residue method using 3 carbon monoxide. percent acetic acid, as prescribed in (b) Conditions of use. (1) The polymers § 177.1330(e)(6)(i)(a), does not apply, and may be safely used as components of (2) The net acidified chloroform-solu- the food-contact or interior core layer ble extractives from paper and paper- of multilaminate food-contact articles. board complying with § 176.170 of this (2) The polymers may be safely used chapter may be corrected for wax, pet- as food-contact materials at tempera- rolatum, and mineral oil as provided in tures not to exceed 121 °C (250 °F). § 176.170(d)(5)(iii)(b) of this chapter. (c) Specifications. (1) Food-contact If the finished food-contact article is layers formed from the basic copoly- itself the subject of a regulation in mer identified in paragraph (a) of this parts 174, 175, 176, 177, 178, and § 179.45 of section shall be limited to a thickness this chapter, it shall also comply with of not more than 0.01 centimeter (0.004 any specifications and limitations pre- inch). scribed for it by that regulation. (2) The copolymers identified in para- (c) The finished food-contact layer graph (a) of this section shall have a made with basic copolymers containing melt index not greater than 500 as de- more than 10 weight-percent but no termined by ASTM method D1238–82, more than 25 weight-percent of total condition E ‘‘Standard Test Method for polymer units derived from acrylic Flow Rates of Thermoplastics by Ex- acid and with a maximum thickness of trusion Plastometer,’’ which is incor- 0.0025 inch (2.5 mils) may be used in porated by reference in accordance contact with food types I, II, IVB, VIA, with 5 U.S.C. 552(a) and 1 CFR part 51. VIB, VIIB, and VIII identified in table Copies may be obtained from the Amer- 1 of § 176.170(c) of the chapter under ican Society for Testing Materials, 100 conditions of use B through H as de- Barr Harbor Dr., West Conshohocken, scribed in table 2 of § 176.170(c) of this Philadelphia, PA 19428-2959, or may be chapter, and in contact with food types examined at the Center for Food Safety III, IVA, V, VIIA, and IX identified in and Applied Nutrition (HFS–200), Food table 1 of § 176.170(c) of this chapter and Drug Administration, 5001 Campus under conditions of use E through G as Dr., College Park, MD 20740, or at the described in table 2 of § 176.170(c) of this National Archives and Records Admin- chapter. istration (NARA). For information on (d) The provisions of this section are the availability of this material at not applicable to ethylene-acrylic acid NARA, call 202–741–6030, or go to: http:// copolymers used in food-packaging ad- www.archives.gov/federallregister/

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codeloflfederallregulations/ may be safely used as articles or com- ibrllocations.html. ponents of articles intended for use in (3) The basic copolymer identified in contact with food subject to provisions paragraph (a) of this section, when ex- of this section and of part 174 of this tracted with the solvent or solvents chapter. characterizing the type of food and (a) Identity. For the purposes of this under the conditions of time and tem- section, ethylene-1,4-cyclohexylene perature characterizing the conditions dimethylene terephthalate copolymers of its intended use, as determined from (1,4-benzene dicarboxylic acid, di- tables 1 and 2 of § 176.170(c) of this chap- ter, yields net chloroform-soluble ex- methyl ester, polymerized with 1,4- tractives in each extracting solvent cyclohexanedimethanol and 1,2- not to exceed 0.5 milligram per square ethanediol) (CAS Reg. No. 25640–14–6) or inch of food-contact surface when test- (1,4-benzenedicarboxylic acid, polym- ed by methods described in § 176.170(d) erized with 1,4-cyclohexanedimethanol of this chapter. and 1,2-ethanediol) (CAS Reg. No. (4) The provisions of this section are 25038–91–9) are basic copolymers meet- not applicable to ethylene-carbon mon- ing the specifications prescribed in oxide copolymers complying with paragraph (b) of this section, to which § 175.105 of this chapter. may have been added certain optional [57 FR 32422, July 22, 1992] substances required in their production or added to impart desired physical or § 177.1315 Ethylene-1, 4-cyclohexylene technical properties. dimethylene terephthalate copoly- (b) Specifications: mers. Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer

Maximum extractable fractions of the copolymer in the fin- Ethylene-1,4- ished form at specified tem- cyclohexylene peratures and times (ex- Test for dimethylene Inherent viscosity pressed in micrograms of the orientability Conditions of use terephthalate copolymers terephthaloyl moletles/square centimeter of food-contact sur- face)

1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in- ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con- dimethylene cent solution of per square inch) of food-con- taining not more than terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol- mer is the reaction phenol- with water added at 82.2 °C ume) aqueous alcohol, product of dimethyl tetrachloroetha- (180 °F) and allowed to cool excluding carbonated terephthalate or ter- ne (60:40 ratio to 48.9 °C (120 °F) in con- beverages and beer. ephthalic acid with a wt/wt) solvent is tact with the food-contact ar- Conditions of hot fill mixture containing 99 not less than ticle. not to exceed 82.2 °C to 66 mole percent of 0.669 as deter- (180 °F), storage at ethylene glycol and 1 mined by using temperatures not in to 34 mole percent of a Wagner vis- excess of 48.9 °C 1,4-cyclo- cometer (or (120 °F). No thermal hexanedimethanol (70 equivalent) and treatment in the con- percent trans isomer, calculated from tainer. 30 percent cls isomer). the following equation: Inher- ent viscosity = (Natural loga- rithm of (Nr)/(c) where: Nr = Ratio of flow time of the poly- mer solution to that of the sol- vent, and c = concentration of the test solution expressed in grams per 100 milliliters.

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Maximum extractable fractions of the copolymer in the fin- Ethylene-1,4- ished form at specified tem- cyclohexylene peratures and times (ex- Test for dimethylene Inherent viscosity pressed in micrograms of the orientability Conditions of use terephthalate copolymers terephthaloyl moletles/square centimeter of food-contact sur- face)

...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-con- tact surface when extracted with 3 percent (by volume) aqueous acetic acid added at 82.2 °C (180 °F) and al- lowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-con- tact surface when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5...... do ...... (4) 0.16 microgram per square ...... do ...... Do. centimeter (1.0 microgram per square inch) of food-con- tact surface when extracted for 24 hours with 25 percent (by volume) aqueous ethanol at 48.9 °C (120 °F). 2. Oriented ethylene-1,4- ...... do ...... (1) 0.23 microgram per square When extracted In contact with non- cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ- dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev- terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor- terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9 mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther- to 85 mole percent ticle. meter (0.60 mal treatment in the ethylene glycol and 1 microgram per container. to 15 mole percent of square inch) of 1,4-cyclohexane-di- food-contact methanol (70 percent surface. trans isomer, 30 per- cent cls isomer)...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-con- tact surface of oriented co- polymer when extracted with 3 percent (by volume) aque- ous acetic acid added at 87.8 °C (190 °F) and al- lowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-con- tact surface of oriented co- polymer when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5.

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Maximum extractable fractions of the copolymer in the fin- Ethylene-1,4- ished form at specified tem- cyclohexylene peratures and times (ex- Test for dimethylene Inherent viscosity pressed in micrograms of the orientability Conditions of use terephthalate copolymers terephthaloyl moletles/square centimeter of food-contact sur- face)

...... do ...... (4) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 20 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of thermal 20 percent (by volume) treatment in the con- aqueous ethanol heated to tainer not exceeding 65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for utes and allowed to cool to 20 minutes. Storage at 48.9 °C (120 °F) in contact temperatures not in with the food-contact article. excess of 48.9 °C (120 °F)...... do ...... (5) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 50 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of fill and stor- 50 percent (by volume) age not exceeding aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No (120 °F) for 24 hours. thermal treatment in the container. 3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding cyclohexylene tion of use, must meet speci- specification, may be dimethylene fications described in used as a base sheet terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in mer is the reaction accordance with con- product of dimethyl ditions of use de- terephthalate or ter- scribed in ephthalic acid with a § 177.1630(f), (g), (h), mixture containing 99 or (j). to 95 mole percent of ethylene glycol and 1 to 5 mole percent of 1,4- cyclohexanedimethan- ol (70 percent trans isomer, 30 percent cis isomer).

(c) Analytical method for determination standards prepared in 95:5 percent (v/v) of extractability. The total extracted heptane: tetrahydrofuran. terephthaloyl moieties can be deter- [45 FR 39252, June 10, 1980, as amended at 47 mined in the extracts, without evapo- FR 24288, June 4, 1982; 49 FR 25629, June 22, ration of the solvent, by measuring the 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, ultraviolet (UV) absorbance at 240 Nov. 24, 1995] nanometers. The spectrophotometer (Varian 635–D, or equivalent) is zeroed § 177.1320 Ethylene-ethyl acrylate co- with a sample of the solvent taken polymers. from the same lot used in the extrac- Ethylene-ethyl acrylate copolymers tion tests. The concentration of the may be safely used to produce pack- total terephthaloyl moieties in water, 3 aging materials, containers, and equip- percent acetic acid, and in 8 percent ment intended for use in producing, aqueous alcohol is calculated as bis(2- manufacturing, packing, processing, hydroxyethyl terephthalate) by ref- preparing, treating, packaging, trans- erence to standards prepared in the ap- porting, or holding food, in accordance propriate solvent. Concentration of the with the following prescribed condi- terephthaloyl moieties in heptane is tions: calculated as cyclic trimer (a) Ethylene-ethyl acrylate copoly- (C6H4CO2C2H4CO2)3, by reference to mers consist of basic resins produced 268

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by the catalytic copolymerization of Plastics by the Density-Gradient Tech- ethylene and ethyl acrylate, to which nique,’’ which is incorporated by ref- may have been added certain optional erence. Copies may be obtained from substances to impart desired techno- the American Society for Testing Ma- logical properties to the resin. Subject terials, 100 Barr Harbor Dr., West to any limitations prescribed in this Conshohocken, Philadelphia, PA 19428- section, the optional substances may 2959, or may be examined at the Na- include: tional Archives and Records Adminis- (1) Substances generally recognized tration (NARA). For information on as safe in food and food packaging. the availability of this material at (2) Substances the use of which is NARA, call 202–741–6030, or go to: http:// permitted under applicable regulations www.archives.gov/federallregister/ in parts 170 through 189 of this chapter, codeloflfederallregulations/ prior sanction, or approvals. ibrllocations.html. (b) The ethyl acrylate content of the (2) Limitations. Ethylene-ethyl acry- copolymer does not exceed 8 percent by late copolymers or the blend may be weight unless it is blended with poly- used in contact with food except as a ethylene or with one or more olefin co- component of articles used for pack- polymers complying with § 177.1520 or aging or holding food during cooking with a mixture of polyethylene and one provided they meet the following or more olefin copolymers, in such pro- extractability limits: portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3 tent of the blend does not exceed 8 per- percent in xylene after refluxing and cent by weight, or unless it is used in subsequent cooling to 25 °C. a coating complying with § 175.300 or (ii) Maximum extractable fraction of § 176.170 of this chapter, in such propor- 5.5 percent when extracted with n- ° tions that the ethyl acrylate content hexane at 50 C. does not exceed 8 percent by weight of (d) The provisions of paragraphs (b) the finished coating. and (c)(2) of this section are not appli- (c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co- mers or the blend shall conform to the polymers used in the formulation of ad- specifications prescribed in paragraph hesives complying with § 175.105 of this (c)(1) of this section and shall meet the chapter. ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49 scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984] and the extractability limits pre- scribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins. tion, when tested by the methods pre- Ionomeric resins manufactured from scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co- (1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal- fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium, polymers can be identified by their and/or zinc partial salts), ethylene- characteristic infrared spectra. methacrylic acid-vinyl acetate copoly- (ii) Quantitative determination of ethyl mers (and/or their ammonium, cal- acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium, be determined by the infrared spectra. and/or zinc partial salts,), or meth- Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po- at 11.6 microns and divide by the tassium, sodium and/or zinc partial plaque thickness to obtain absorbance salts) may be safely used as articles or per mil. From a previously prepared components of articles intended for use calibration curve, obtain the amount of in contact with food, in accordance ethyl acrylate present. with the following prescribed condi- (iii) Specific gravity. Ethylene-ethyl tions: acrylate copolymers have a specific (a) For the purpose of this section, gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly- than 0.935, as determined by ASTM mers consist of basic copolymers pro- method D1505–68 (Reapproved 1979), duced by the copolymerization of ‘‘Standard Test Method for Density of ethylene and methacrylic acid such

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that the copolymers contain no more determined from table I of paragraph than 20 weight percent of polymer (f) of this section, shall yield net acidi- units derived from methacrylic acid, fied chloroform-soluble extractives as and the ethylene-methacrylic acid- follows: vinyl acetate copolymers consist of (1) For fatty food use. (i) For films of basic copolymers produced by the co- 2 mil (0.002 inches) thickness or less, polymerization of ethylene, meth- extractives shall not exceed 0.70 milli- acrylic acid, and vinyl acetate such gram/square inch 1 (0.109 milligram/ that the copolymers contain no more square centimeter) of food-contact sur- than 15 weight percent of polymer face (n-heptane extractions) when ex- units derived from methacrylic acid. tracted by the abbreviated method (b) For the purpose of this section, cited in paragraph (e)(2)(i) of this sec- the methacrylic acid copolymers with tion. ethylene and isobutyl acrylate consist (ii) For films of greater than 2 mils of basic copolymers produced by the (0.002 inch) thickness, extractives shall copolymerization of methacrylic acid, not exceed 0.40 milligram/square inch 1 ethylene, and isobutyl acrylate such (0.062 milligram/square centimeter) of that the copolymers contain no less food-contact surface (n-heptane extrac- than 70 weight percent of polymer tions) when extracted by the abbre- units derived from ethylene, no more viated method cited in paragraph than 15 weight percent of polymer (e)(2)(i) of this section, or units derived from methacrylic acid, (iii) Alternatively, for films of great- and no more than 20 weight percent of er than 2 mils thickness, extractives polymer units derived from isobutyl shall not exceed 0.70 milligram/square acrylate. From 20 percent to 70 percent inch 1 (0.109 milligram/square centi- of the carboxylic acid groups may op- meter) of food-contact surface (n- tionally be neutralized to form sodium heptane extractions) when extracted by or zinc salts. the equilibrium method cited in para- (c) The finished food-contact article graph (e)(2)(ii) of this section. described in paragraph (a) of this sec- (2) For aqueous foods. (i) The net tion, when extracted with the solvent acidified chloroform-soluble extrac- or solvents characterizing the type of tives shall not exceed 0.02 milligram/ food and under the conditions of time square inch 2(0.003 milligram/square and temperature characterizing the centimeter) of food-contact surface conditions of its intended use as deter- (water, acetic acid, or ethanol/water mined from tables 1 and 2 of § 176.170(c) extractions) when extracted by the ab- of this chapter, yields net acidified breviated method cited in paragraph chloroform-soluble extractives in each (e)(2)(i) of this section. extracting solvent not to exceed 0.5 (ii) Alternatively, the net acidified milligram per square inch of food-con- chloroform-soluble extractives shall tact surface when tested by the meth- not exceed 0.05 milligram/square inch 3 ods described in paragraph (e)(1) of this (0.078 mg/square centimeter) of food- section, and if the finished food-con- contact surface (water, acetic acid, or tact article is itself the subject of a ethanol/water extractions) when ex- regulation in parts 174, 175, 176, 177, 178 tracted by the equilibrium method and § 179.45 of this chapter, it shall also cited in paragraph (e)(2)(ii) of this sec- comply with any specifications and tion. If when exposed to n-heptane, a limitations prescribed for it by that particular film splits along die lines, regulation. thus permitting exposure of both sides NOTE: In testing the finished food-contact of the film to the extracting solvent, article, use a separate test sample for each required extracting solvent. (d) The finished food-contact article 1 Average of four separate values, no single described in paragraph (b) of this sec- value of which differs from the average of ± tion, when extracted according to the those values by more then 10 percent. 2 Average of four separate values, no single methods listed in paragraph (e)(2) of value of which differs from the average of this section and referenced in this those values by more than ±50 percent. paragraph (d), using the solvent or sol- 3 See footnote 2 to paragraph (d)(2)(i) of vents characterizing the type of food as this section.

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the results for that film sample are in- lating solvent is to contact the food- valid and the test must be repeated for contact film at a temperature of 120 °F that sample until no splitting by the until equilibrium is demonstrated. solvent occurs. If the finished food-con- tact article is itself the subject of a Minimum extraction regulation in parts 174, 175, 176, 177, 178 Solvent times and § 179.45 of this chapter, it shall also (hours) comply with any specifications and n-Heptane ...... 8, 10, 12 limitations prescribed for it by that Water, 3% acetic acid, or 8%/50% ethanol ...... 72, 96, regulation. 120 NOTE: In testing the finished food-contact article, use a separate test sample for each The results from a series of extraction required extracting solvent. times demonstrate equilibrium when (e) Analytical methods—(1) Selection of the net chloroform-soluble extractives extractability conditions for ionomeric res- are unchanging within experimental ins. First ascertain the type of food error appropriate to the method as de- (table 1 of § 176.170(c) of this chapter) scribed in paragraphs (d) (1)(i) and (2)(i) that is being packed or used in contact of this section. Should equilibrium not with the finished food-contact article be demonstrated over the above time described in paragraph (a) of this sec- series, extraction times must be ex- tion, and also ascertain the normal tended until three successive unchang- conditions of thermal treatment used ing values for extractives are obtained. in packaging or contacting the type of In the case where intended uses involve food involved. Using table 2 of § 176.170 temporary food contact above 120 °F, (c) of this chapter, select the food-sim- the food-simulating solvent is to be ulating solvent or solvents and the contacted with the food-contact article time-temperature test conditions that under conditions of time and tempera- correspond to the intended use of the ture that duplicate the actual condi- finished food-contact article. Having selected the appropriate food-simu- tions in the intended use. Subsequently lating solvent or solvents and time- the extraction is to be continued for temperature exaggeration over normal the time period and under the condi- use, follow the applicable extraction tions specified in the above table. procedure. (3) Reagents—(i) Water. All water used (2) Selection of extractability conditions in extraction procedures should be for ionomeric resins. Using table I of freshly demineralized (deionized) dis- paragraph (f) of this section ascertain tilled water. the type of food that is being packed or (ii) n-Heptane. Reagent grade, freshly used in contact with the finished food- redistilled before use, using only mate- contact article described in paragraph rial boiling at 208 °F (97.8 °C). (b) of this section, and also ascertain (iii) Alcohol. 8 or 50 percent (by vol- the food-simulating solvent or solvents ume), prepared from undenatured 95 that correspond to the intended use of percent ethyl alcohol diluted with the finished food-contact article. demineralized (deionized), distilled (i) Abbreviated test. For intended use water. involving food contact at or below 120 (iv) Chloroform. Reagent grade, fresh- °F (49 °C), the appropriate food-simu- ly redistilled before use, or a grade lating solvent is to contact the food- having an established, consistently low contact film for the time and tempera- blank. tures as follows: (v) Acetic acid. 3 percent (by weight), prepared from glacial acetic acid di- Solvent Time Temperature luted with demineralized (deionized), n-Heptane ...... 1 2 120 °F (49 °C). distilled water. 1 ° ° Water, 3% acetic acid, or 8%/ 48 120 F (49 C). (4) Selection of test method. The fin- 50% ethanol. ished food-contact articles shall be 1 Hours tested either by the extraction cell de- (ii) Equilibrium test. For intended use scribed in the Journal of the Association involving food contact at or below 120 of Official Agricultural Chemists, Vol. 47, °F (49 °C), the appropriate food-simu- No. 1, p. 177–179 (February 1964), also

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described in ASTM method F34–76 (Re- where: approved 1980), ‘‘Standard Test Method e = Milligrams extractives per sample tested. for Liquid Extraction of Flexible Bar- s = Surface area tested, in square inches. rier Materials,’’ which are incorporated F = Five, the ratio of the amount of extrac- by reference, or by adapting the in-con- tives removed by heptane under exagger- tainer methods described in § 175.300(e) ated time-temperature test conditions of this chapter. Copies of the material compared to the amount extracted by a incorporated by reference are available fat or oil under exaggerated conditions of from the Center for Food Safety and thermal sterilization and use. e′ = Acidified chloroform-soluble extractives Applied Nutrition (HFS–200), Food and residue. e′ is substituted for e in the Drug Administration, 5001 Campus Dr., above equations when necessary (See College Park, MD 20740, and the Amer- paragraph (e)(6)(ii) of this section for ican Society for Testing Materials, 100 method to obtain e′). Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, respec- If when calculated by the equations in tively, or may be examined at the Na- paragraphs (e)(6)(i) (a) and (b) of this tional Archives and Records Adminis- section, the extractives in milligrams tration (NARA). For information on per square inch exceed the limitations the availability of this material at prescribed in paragraphs (c) or (d) of NARA, call 202–741–6030, or go to: http:// this section, proceed to paragraph www.archives.gov/federallregister/ (e)(6)(ii) of this section (method for de- codeloflfederallregulations/ termining the amount of acidified chlo- ibrllocations.html. roform-soluble extractives residue). (5) Selection of samples. Quadruplicate (ii) Acidified chloroform-soluble extrac- samples should be tested, using for tives residue. Add 3 milliliters of 37 per- each replicate sample the number of cent ACS reagent grade hydrochloric finished articles with a food-contact acid and 3 milliliters of distilled water surface nearest to 100 square inches. to the evaporating dish containing the (6) Determination of amount of extrac- dried and weighed residue, e, obtained tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section. the exposure period, remove the test Mix well so every portion of the residue container or test cell from the oven, if is wetted with the hydrochloric acid any, and combine the solvent for each solution. Then add 50 milliliters of replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter lent) flask or beaker, being sure to through Whatman No. 41 filter paper rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva- small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a rate the food-simulating solvents to clean separatory funnel. Shake for 1 about 100 milliliters in the flask, and minute, then draw off the chloroform transfer to a clean, tared evaporating layer into a clean tared evaporating dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the flask three times with small portions chloroform extraction, washing the of solvent used in the extraction proce- dish, the filter paper, and the sepa- dure, and evaporate to a few milliliters ratory funnel with this second portion on a nonsparking, low-temperature of chloroform. Add this filtrate to the hotplate. The last few milliliters original filtrate and evaporate the should be evaporated in an oven main- total down to a few milliliters on a tained at a temperature of 221 °F (105 low-temperature hotplate. The last few °C). Cool the evaporating dish in a des- milliliters should be evaporated in an iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30 Calculate the extractives in milligrams minutes and weigh to the nearest 0.1 per square inch of the container or ma- milligram to get the acidified chloro- terial surface. form-soluble extractives residue, e′. (a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa- percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i) (a) and (b) grams extractives per square inch=e/s. of this section. (b) Heptane. Milligrams extractives (f) The types of food and appropriate per square inch=(e)/(s)(F) solvents are as follows:

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TABLE 1 temperature characterizing the condi- tions of its intended use as determined Types of food Appropriate solvent from tables 1 and 2 of § 176.170(c) of this 1. Nonacid (pH above 5.0), aque- Water, n-heptane. chapter, yields net chloroform-soluble ous products; may contain salt extractives (corrected for zinc extrac- or sugar or both, and including tives as zinc oleate) in each extracting oil-in-water emulsions of low- or high-fat content. solvent not to exceed 0.5 milligram per 2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% square inch of food-contact surface ous products; may contain salt acetic acid. when tested by the methods described or sugar or both, and including in § 176.170(d) of this chapter. If the fin- oil-in-water emulsions of low- or high-fat content. ished food-contact article is itself the 3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% subject of a regulation in parts 174, 175, ucts containing free oil or fat; acetic acid. 176, 177, 178 and § 179.45 of this chapter, may contain salt, and including water-in-oil emulsions of low- or it shall also comply with any specifica- high-fat content. tions and limitations prescribed for it 4. Dairy products and modifica- by that regulation. tions: NOTE: In testing the finished food-contact Water, n-heptane. i. Water-in-oil emulsions, high article, use a separate test sample for each or low fat. required extracting solvent. ii. Oil-in-water emulsions, high (c) The provisions of this section are or low fat. not applicable to ethylene-methyl ac- 5. Low moisture fats and oils ...... n-heptane. 6. Beverages: rylate copolymer resins used in food- i. Containing up to 8% alcohol 8% ethanol/water. packaging adhesives complying with ii. Nonalcoholic ...... 3% acetic acid. § 175.105 of this chapter. iii. Containing more than 8% 50% ethanol/water. alcohol. § 177.1345 Ethylene/1,3–phenylene oxy- 7. Bakery products ...... Water, n-heptane. 8. Dry solids (without free fat or No extraction test re- ethylene isophthalate/ oil). quired. terephthalate copolymer. 9. Dry solids (with free fat or oil) .. n-heptane. Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (g) The provisions of paragraphs (c) (CAS Reg. No. 87365–98–8) identified in and (d) of this section are not applica- paragraph (a) of this section may be ble to the ionomeric resins that are safely used, subject to the provisions of used in food-packaging adhesives com- this section, as the non-food-contact plying with § 175.105 of this chapter. layer of laminate structures subject to [45 FR 22916, Apr. 4, 1980, as amended at 49 the provisions of § 177.1395, and in FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, blends with polyethylene terephthalate 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, polymers complying with § 177.1630. June 12, 1989] (a) Identity. For the purpose of this section, ethylene/1,3-phenylene oxy- § 177.1340 Ethylene-methyl acrylate co- ethylene isophthalate/terephthalate polymer resins. copolymer consists of the basic copoly- Ethylene-methyl acrylate copolymer mer produced by the catalytic resins may be safely used as articles or polycondensation of isophthalic acid components of articles intended for use and terephthalic acid with ethylene in contact with food, in accordance glycol and 1,3-bis(2- with the following prescribed condi- hydroxyethoxy)benzene such that the tions: finished resin contains between 42 and (a) For the purpose of this section, 48 mole-percent of isophthalic the ethylene-methyl acrylate copoly- moieties, between 2 and 8 mole-percent mer resins consist of basic copolymers of terephthalic moieties, and not more produced by the copolymerization of than 10 mole-percent of 1,3-bis(2- ethylene and methyl acrylate such hydroxyethoxy)benzene moieties. that the copolymers contain no more (b) Specifications—(1) Density. Ethyl- than 25 weight percent of polymer ene/1,3-phenylene oxyethylene units derived from methyl acrylate. isophthalate/terephthalate copolymer (b) The finished food-contact article, identified in paragraph (a) of this sec- when extracted with the solvent or sol- tion has a density of 1.33±0.02 grams per vents characterizing the type of food cubic centimeter measured by ASTM and under the conditions of time and Method D 1505–85 (Reapproved 1990),

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‘‘Standard Test Method for Density of of use C at temperatures not to exceed Plastics by the Density-Gradient Tech- 160 °F (71 °C). nique,’’ which is incorporated by ref- [57 FR 43399, Sept. 21, 1992, as amended at 59 erence in accordance with 5 U.S.C. FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, 552(a) and 1 CFR part 51. Copies may be 1996; 62 FR 34628, June 27, 1997; 81 FR 5593, obtained from the American Society Feb. 3, 2016] for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Phila- § 177.1350 Ethylene-vinyl acetate co- delphia, PA 19428-2959, or may be exam- polymers. ined at the Food and Drug Administra- Ethylene-vinyl acetate copolymers tion’s Main Library, 10903 New Hamp- may be safely used as articles or com- shire Ave., Bldg. 2, Third Floor, Silver ponents of articles intended for use in Spring, MD 20993, 301–796–2039, and at producing, manufacturing, packing, the National Archives and Records Ad- processing, preparing, treating, pack- ministration (NARA). For information aging, transporting, or holding food in on the availability of this material at accordance with the following pre- NARA, call 202–741–6030, or go to: http:// scribed conditions: www.archives.gov/federallregister/ (a)(1) Ethylene-vinyl acetate copoly- codeloflfederallregulations/ mers consist of basic resins produced ibrllocations.html. by the catalytic copolymerization of ethylene and vinyl acetate to which (2) Softening point. Ethylene/1,3–phen- may have been added certain optional ylene oxyethylene isophthalate/ substances to impart desired techno- terephthalate copolymer identified in logical or physical properties to the paragraph (a) of this section has a soft- resin. Subject to any limitations pre- ± ° ening point of 63 5 C as measured by scribed in this section, the optional ASTM Method D 1525–87, ‘‘Standard substances may include: Test Method for VICAT Softening Tem- (i) Substances generally recognized perature of Plastics,’’ which is incor- as safe in food and food packaging. porated by reference in accordance (ii) Substances the use of which is with 5 U.S.C. 552(a) and 1 CFR part 51. permitted under applicable regulations The availability of this material is pro- in parts 170 through 189 of this chapter, vided in paragraph (b)(1) of this sec- prior sanction, or approvals. tion. (iii) Substances identified in (c) Optional adjuvant substances. § 175.300(b)(3) (xxv), (xxvii), (xxx), and Ethylene/1,3–phenylene oxyethylene (xxxiii) of this chapter, and colorants isophthalate/terephthalate copolymer, used in accordance with § 178.3297 of identified in paragraph (a) of this sec- this chapter. tion, may contain optional adjuvant (iv) Erucamide as identified in substances required in their produc- § 178.3860 of this chapter. tion. The optional adjuvants may in- (v) Xanthan gum as identified in clude substances used in accordance § 172.695 for use as a thickening agent with § 174.5 of this chapter. at a level not to exceed 1 percent by (d) Limitations. Copolymer blends de- weight of coating solids in aqueous dis- scribed above shall not exceed 30 per- persions of ethylene-vinyl acetate co- cent by weight of ethylene/1,3-phen- polymers, where such copolymers are ylene oxyethylene isophthalate/ used only as coatings or a component terephthalate copolymer. The finished of coatings. blend may be used in contact with food (vi) The copolymer of vinylidene flu- only under conditions of use C through oride and hexafluoropropene (CAS Reg. G, as described in table 2 of § 176.170(c) No. 9011–17–0), containing 65 to 71 per- of this chapter, except that with food cent fluorine and having a Mooney Vis- cosity of at least 28, for use as a proc- identified as Type III, IV-A, V, VII-A, essing aid at a level not to exceed 0.2 and IX in § 176.170(c), table 1, the co- percent by weight of ethylene-vinyl ac- polymer may be used under condition etate copolymers. (2) Maleic anhydride-grafted ethyl- ene-vinyl acetate copolymers (CAS

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Reg. No. 28064–24–6) consist of basic res- National Archives and Records Admin- ins produced by the catalytic copolym- istration (NARA). For information on erization of ethylene and vinyl acetate, the availability of this material at followed by reaction with maleic anhy- NARA, call 202–741–6030, or go to: http:// dride. Such polymers shall contain not www.archives.gov/federallregister/ more than 11 percent of polymer units codeloflfederallregulations/ derived from vinyl acetate by weight of ibrllocations.html. Compliance of the total polymer prior to reaction with melt flow index specification shall be maleic anhydride, and not more than 2 determined using conditions and proce- percent of grafted maleic anhydride by dures corresponding to those described weight of the finished polymer. Op- in the method as Condition E, Proce- tional adjuvant substances that may be dure A). The copolymers shall be used added to the copolymers include sub- in blends with other polymers at levels stances generally recognized as safe in not to exceed 17 percent by weight of food and food packaging, substances total polymer, subject to the limita- the use of which is permitted under ap- tion that when contacting food of types plicable regulations in parts 170 III, IV-A, V, VI-C, VII-A, and IX, iden- through 189 of this chapter, and sub- tified in § 176.170(c) of this chapter, stances identified in § 175.300(b)(3)(xxv), Table 1, the polymers shall be used (xxvii), (xxxiii), and (xxx) of this chap- only under conditions of use C, D, E, F, ter and colorants for polymers used in and G, described in § 176.170(c) of this accordance with the provisions of chapter, Table 2. § 178.3297 of this chapter. (c) The provisions of paragraph (b) of (b)(1) Ethylene-vinyl acetate copoly- this section are not applicable to ethyl- mers, with or without the optional sub- ene-vinyl acetate copolymers used in stances described in paragraph (a) of food-packaging adhesives complying this section, when extracted with the with § 175.105 of this chapter. solvent or solvents characterizing the (d) Ethylene-vinyl acetate copoly- type of food, and under conditions of mers may be irradiated under the fol- time and temperature characterizing lowing conditions to produce molecular the conditions of their intended use as crosslinking of the polymers to impart determined from tables 1 and 2 of desired properties such as increased § 176.170(c) of this chapter, shall yield strength and increased ability to net chloroform-soluble extractives cor- shrink when exposed to heat: rected for zinc as zinc oleate not to ex- ceed 0.5 milligram per square inch of an (1) Electron beam source of ionizing appropriate sample. radiation at a maximum energy of 3 (2) Maleic anhydride grafted ethyl- million electron volts: Maximum ab- ene-vinyl acetate copolymers shall sorbed dose not to exceed 150 kiloGray have a melt flow index not to exceed 2.1 (15 megarads). grams per 10 minutes as determined by (2) The finished food-contact film ASTM method D 1238–82, ‘‘Standard shall meet the extractives limitations Test Method for Flow Rates of Thermo- prescribed in paragraph (e)(2) of this plastics by Extrusion Plastometer,’’ section. which is incorporated by reference in (3) The ethylene-vinyl acetate co- accordance with 5 U.S.C. 552(a). Copies polymer films may be further irradi- may be obtained from the American ated in accordance with the provisions Society for Testing Materials, 100 Barr of paragraph (e)(1) of this section: Pro- Harbor Dr., West Conshohocken, Phila- vided, That the total accumulated radi- delphia, PA 19428-2959, or at the Office ation dose from both electron beam of Food Additive Safety (HFS–200), and gamma ray radiation does not ex- Center for Food Safety and Applied Nu- ceed 150 kiloGray (15 megarads). trition, Food and Drug Administration, (e) Ethylene-vinyl acetate copolymer 5001 Campus Dr., College Park, MD films intended for contact with food 20740, 240–402–1200, or may be examined may be irradiated to control the at the Food and Drug Administration’s growth of microorganisms under the Main Library, 10903 New Hampshire following conditions: Ave., Bldg. 2, Third Floor, Silver (1) Gamma photons emitted from a Spring, MD 20993, 301–796–2039, or at the cobalt–60 sealed source in the dose

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range of 5–50 kiloGray (0.5–5.0 F34–76 (Reapproved 1980), ‘‘Standard megarads). Test Method for Liquid Extraction of (2) The irradiated ethylene-vinyl ace- Flexible Barrier Materials,’’ which is tate copolymer films, when extracted incorporated by reference. Copies may with reagent grade n-heptane (freshly be obtained from the American Society redistilled before use) according to for Testing Materials, 100 Barr Harbor methods described under § 176.170(d)(3) Dr., West Conshohocken, Philadelphia, of this chapter, at 75 °F for 30 minutes PA 19428-2959, or may be examined at shall yield total extractives not to ex- the National Archives and Records Ad- ceed 4.5 percent by weight of the film. ministration (NARA). For information on the availability of this material at [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, NARA, call 202–741–6030, or go to: http:// 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, www.archives.gov/federallregister/ Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999; 78 FR codeloflfederallregulations/ 14665, Mar. 7, 2013; 81 FR 5593, Feb. 3, 2016] ibrllocations.html. (1) The film when extracted with dis- § 177.1360 Ethylene-vinyl acetate-vinyl tilled water at 21 °C (70 °F) for 48 hours alcohol copolymers. yields total extractives not to exceed Ethylene-vinyl acetate-vinyl alcohol 0.0047 milligram per square centimeter copolymers (CAS Reg. No. 26221–27–2) (0.03 milligram per square inch) of may be safely used as articles or com- food-contact surface. ponents of articles intended for use in (2) The film when extracted with 50 contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for the following prescribed conditions: 48 hours yields total extractives not to (a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen- hol copolymers are produced by the timeter (0.04 milligram per square partial or complete alcoholysis or hy- inch) of food-contact surface. drolysis of those ethylene-vinyl acetate (c) The finished food-contact article copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003 (1) Those copolymers containing a inch) thickness and shall contact foods minimum of 55 percent ethylene and a only of the types identified in table 1 of maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories units by weight may be used in contact III, IV-A, VII-A, and IX under condi- with foods as described in paragraph (b) tions of use F and G described in table of this section. 2 of § 176.170(c) of this chapter. Film (2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch) minimum of 55 percent ethylene and a thickness representing the finished ar- maximum of 15 percent vinyl alcohol ticles shall meet the following extrac- units by weight may be used in contact tive limitation when tested by ASTM with foods as described in paragraph (c) method F34–76 (Reapproved 1980), of this section. ‘‘Standard Test Method for Liquid Ex- (3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’ 40 percent ethylene and 60 to 83 percent which is incorporated by reference. The vinyl alcohol units by weight may be availability of this incorporation by used in contact with foods as described reference is given in paragraph (b) of in paragraph (d) of this section. this section. The film when extracted (b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30 shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to inch) thickness and shall contact foods exceed 0.0078 milligram per square cen- only of the types identified in table 1 of timeter (0.05 milligram per square § 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor- I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid- conditions of use D through G de- ing by a factor of five. scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007 meter (0.005) inch thickness rep- inch) thickness and may contact all resenting the finished article shall foods, except those containing more meet the following extractive limita- than 8 percent alcohol, under condi- tion when tested by ASTM method tions of use B through H described in

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table 2 of § 176.170(c) of this chapter. (a) For the purpose of this section, Film samples of 0.018 centimeter (0.007 fluorocarbon resins consist of basic res- inch) thickness representing the fin- ins produced as follows: ished articles shall meet the following (1) Chlorotrifluoroethylene resins extractive limitation when tested by produced by the homopolymerization ASTM method F34–76 (Reapproved of chlorotrifluoroethylene. 1980), ‘‘Standard Test Methods for Liq- (2) Chlorotrifluoroethylene-1,1- uid Extraction of Flexible Barrier Ma- difluoroethylene copolymer resins pro- terials,’’ which is incorporated by ref- duced by copolymerization of erence. The availability of this incor- chlorotrifluoroethylene and 1,1- poration by reference is given in para- difluoroethylene. graph (b) of this section. The film when (3) Chlorotrifluoroethylene-1,1- extracted with distilled water at 100 °C difluoroethylene-tetrafluoroethylene (212 °F) for 30 minutes yields ethylene- co-polymer resins produced by co- vinyl acetate-vinyl alcohol polymerization of not to exceed 0.093 milligram per chlorotrifluoroethylene, 1,1- square centimeter (0.6 milligram per difluoroethylene, and tetrafluoro- square inch) of food contact surface as ethylene. determined by a method entitled ‘‘An- (4) Ethylene-chlorotrifluoroethylene alytical Method of Determining the copolymer resins produced by copolym- Amount of EVOH in the Extractives erization of nominally 50 mole percent Residue of EVOH Film,’’ dated March of ethylene and 50 mole percent of 23, 1987, as developed by the Kuraray chlorotrifluoroethylene. The copoly- Co., Ltd., which is incorporated by ref- mer shall have a melting point of 239 to erence in accordance with 5 U.S.C. 243 °C and a melt index of less than or 552(a) and 1 CFR part 51. Copies may be equal to 20 as determined by ASTM obtained from the Office of Food Addi- Method D 3275–89 ‘‘Standard Specifica- tive Safety (HFS–200)), Center for Food tion for E-CTFE-Fluoroplastic Mold- Safety and Applied Nutrition, Food and ing, Extrusion, and Coating Mate- Drug Administration, 5001 Campus Dr., rials,’’ which is incorporated by ref- College Park, MD 20740, 240–402–1200, or erence in accordance with 5 U.S.C. may be examined at the Food and Drug 552(a) and 1 CFR part 51. Copies may be Administration’s Main Library, 10903 obtained from the American Society New Hampshire Ave., Bldg. 2, Third for Testing and Materials, 1916 Race Floor, Silver Spring, MD 20993, 301–796– St., Philadelphia, PA 19013, or may be 2039, or at the National Archives and examined at the National Archives and Records Administration (NARA). For Records Administration (NARA). For information on the availability of this information on the availability of this material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (e) The provisions of this section are (b) Fluorocarbon resins that are iden- not applicable to ethylene-vinyl ace- tified in paragraph (a) of this section tate-vinyl alcohol copolymers used in and that comply with extractive limi- the food-packaging adhesives com- tations prescribed in paragraph (c) of plying with § 175.105 of this chapter. this section may be used as articles or [47 FR 41531, Sept. 21, 1982, as amended at 49 components of articles intended for use FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, in contact with food as follows: 2000; 78 FR 14665, Mar. 7, 2013; 81 FR 5593, Feb. (1) Fluorocarbon resins that are iden- 3, 2016] tified in paragraphs (a)(1), (a)(2), and (a)(3) of this section and that comply § 177.1380 Fluorocarbon resins. only with the extractive limitations Fluorocarbon resins may be safely prescribed in paragraphs (c)(1) and used as articles or components of arti- (c)(2) of this section may be used when cles intended for use in contact with such use is limited to articles or com- food, in accordance with the following ponents of articles that are intended prescribed conditions: for repeated use in contact with food or

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that are intended for one-time use in rated from the exterior layer(s) by a contact with foods only of the types functional barrier, such as aluminum identified in § 176.170(c) of this chapter, foil. Upon review of the physical prop- table 1, under Types I, II, VI, VII-B, erties of a particular construction, the and VIII. Food and Drug Administration may (2) Fluorocarbon resins that are iden- consider other layers to serve as func- tified in paragraph (a)(4) of this section tional barriers. This regulation is not and that comply with the extractive intended to limit these constructions limitations prescribed in paragraphs as to shape, degree of flexibility, thick- (c)(1) and (c)(2) of this section may be ness, or number of layers. These layers used only when such use is limited to may be laminated, extruded, co- articles or components of articles that extruded, or fused. are intended for repeated use in con- (b) When containers subject to this tact with food. regulation undergo heat sterilization (3) In accordance with current good to produce shelf-stable foods, certain manufacturing practice, those food- control measures (in addition to the contact articles intended for repeated food additive requirements in para- use shall be thoroughly cleansed prior graphs (c) and (d) of this section) are to their first use in contact with food. necessary to ensure proper food steri- (c) Extractives limitations are appli- lization and package integrity. Refer cable to the basic resins in the form of to parts 108, 110, 113, and 114 of this pellets that have been ground or cut chapter for details. into small particles that will pass (c) Subject to the provisions of this through a U.S. Standard Sieve No. 6 paragraph, food-contact articles pro- and that will be held on a U.S. Stand- duced from high-temperature lami- ard Sieve No. 10. nates may be safely used to package all (1) A 100-gram sample of the resin food types except those containing pellets, when extracted with 100 milli- more than 8 percent ethyl alcohol. liters of distilled water at reflux tem- (1) Polymeric films/layers. Films or lay- perature for 8 hours, shall yield total ers not separated from food by a func- extractives not to exceed 0.003 percent tional barrier must meet the following by weight of the resins. requirements: (2) A 100-gram sample of the resin (i) Films/layers may consist of the pellets, when extracted with 100 milli- following: liters of 50 percent (by volume) ethyl (a) Polyolefin resins complying with alcohol in distilled water at reflux item 2.2 or 3.2 of the table in temperature for 8 hours, shall yield § 177.1520(c). total extractives not to exceed 0.003 (b) Polymeric resin blends formu- percent by weight of the resins. lated from a base polymer complying (3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying tractives not to exceed 0.01 percent by with § 177.1350. weight of the resins. (c) Polymeric resin blends formulated [42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in § 177.1520(c) blended with no more than § 177.1390 Laminate structures for use 38 percent by weight of a homopolymer at temperatures of 250 ≥F and of isobutylene complying with above. § 177.1420(a)(1). (a) The high-temperature laminates (d) Polyethylene phthalate resins identified in this section may be safely complying with § 177.1630(e)(4) (i) and used for food contact at temperatures (ii). not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply erwise specified. These articles are lay- with item 10.3 of the table in ered constructions that are optionally § 177.1500(b) of this chapter when ex- bonded with adhesives. The interior tracted with water and heptane under (food-contact) layer(s) may be sepa- the conditions of time and temperature

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specified for condition of use A, as set trimethylcyclohexyl isocyanate (CAS forth in Table 2 of § 176.170(c) of this Reg. No. 4098–71–9) and optional chapter. trimethoxysilane coupling agents con- (f) Nylon 6⁄12 resins (CAS Reg. No. taining amino, epoxy, ether, and/or 25191–04–2) complying with item 13.3 of mercapto groups not to exceed 3 per- the table in § 177.1500(b), for use as cent by weight of the cured adhesive. nonfood-contact layers of laminated (b) Urethane cross-linking agent films and in rigid multilaminate con- comprising not more than 25 percent structions with polypropylene outer by weight of the cured adhesive and layers. Laminate structures with au- formulated from 3-isocyanatomethyl- thorized food-contact materials yield 3,5,5-trimethylcyclohexyl isocyanate no more than 0.15 milligrams of epsilon- (CAS Reg. No. 4098–71–9) adduct of caprolactam and 0.04 milligrams of trimethylol propane (Cas Reg. No. 77– omega-laurolactam per square inch 99–6) and/or 1,3-bis(isocyanatomethyl) when extracted with 95 percent ethanol benzene (CAS Reg. No. 25854–16–4) at 121 °C (250 °F) for 2 hours. adduct of trimethylol propane. (g) Polymeric resins that comply (v) Polyester-epoxy-urethane adhe- with an applicable regulation in this sives formulated from the following: chapter which permits food type and (a) Polyester resin formed by the re- time/temperature conditions to which action of polybasic acids and the container will be exposed, includ- polyhydric alcohols listed in ing sterilization processing. § 175.300(b)(3)(vii) of this chapter. Aze- (ii) Adjuvants used in these layers laic acid may also be used as a must comply with an applicable regu- polybasic acid. lation that permits food type and time/ (b) Epoxy resin listed in temperature conditions to which the § 175.300(b)(3)(viii)(a) of this chapter and container will be exposed, including comprising no more than 30 percent by sterilization processing. weight of the cured adhesive. (2) Adhesives. The use of adhesives in these containers is optional. Adhesives (c) Urethane cross-linking agent com- may be formulated from the following prising no more than 14 percent weight substances, subject to the prescribed of the cured adhesive and formulated limitations: from 3-isocyanatomethyl-3,5.5- (i) Any substance suitable for use in trimethylcyclohexyl isocyanate formulating adhesives that complies cyanurate (CAS Reg. No. 53880–05–0). with an applicable regulation of this (vi) Polyurethane-polyester resin- chapter which permits food type and epoxy adhesives formulated from the time/temperature conditions to which following mixture: the container will be exposed, includ- (a)(1) Polyester-polyurethanediol res- ing sterilization processing. ins prepared by the reaction of a mix- (ii) Substances complying with ture of polybasic acids and polyhydric § 175.105 of this chapter may be used in alcohols listed in § 175.300(b)(3)(vii) of these constructions, provided they are this chapter and 3-isocyanatomethyl- separated from the interior (food-con- 3,5,5-trimethylcyclohexyl isocyanate tact) layer(s) by a functional barrier as (CAS Reg. No. 4098–71–9). discussed under paragraph (a) of this (2) Polyester resin formed by the re- section. action of polybasic acids and (iii) Maleic anhydride adduct of poly- polyhydric alcohols listed in propylene complying with § 175.300 of § 175.300(b)(3)(vii) of this chapter. Addi- this chapter. tionally, azelaic acid and 1,6- (iv) Polyester-urethane adhesive for hexanediol may also be used as use at temperatures not exceeding 121 reactants in lieu of a polyhydric alco- °C (250 °F) and formulated from the fol- hol. lowing: (3) Epoxy resin listed in (a) Polyester-urethanediol resin pre- § 175.300(b)(3)(viii)(a) of this chapter and pared by the reaction of a mixture of comprising not more than 5 percent by polybasic acids and polyhydric alcohols weight of the cured adhesive. listed in § 175.300(b)(3)(vii) of this chap- (4) Optional trimethoxy silane curing ter, 3-isocyanatomethyl-3,5,5- agents, containing amino, epoxy, ether,

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or mercapto groups not in excess of 3 (i) Nonvolatile extractives. (a) For use percent of the cured adhesive. at temperatures not to exceed 121 °C (b) Urethane cross-linking agent, (250 °F): The container interior (food- comprising not more than 20 percent contact side) shall be extracted with by weight of the cured adhesive, and deionized distilled water at 121 °C (250 formulated from trimethylol propane °F) for 2 hours. (CAS Reg. No. 77–99–6) adducts of 3– (1) The chloroform-soluble fraction of isocyanatomethyl–3,5,5– the total nonvolatile extractives for trimethylcyclohexyl isocyanate (CAS containers using adhesives listed in Reg. No. 4098–71–9) or 1,3- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), bis(isocyanatomethyl)benzene (CAS (c)(2)(iv), and (c)(2)(vii) of this section Reg. No. 25854–16–4). shall not exceed 0.0016 milligram per (vii) Polyester-polyurethane resin- square centimeter (0.01 milligram per acid dianhydride adhesives for use at square inch) as determined by a meth- temperatures not to exceed 121 °C (250 od entitled ‘‘Determination of Non- °F), in contact only with food Types I, II, VIA, VIB, VIIB, and VIII as de- Volatile Chloroform Soluble Residues scribed in Table I of § 176.170 of this in Retort Pouch Water Extracts,’’ chapter, and formulated from the fol- which is incorporated by reference. lowing mixture: Copies are available from the Center (a)(1) Polyesterpolyurethanediol res- for Food Safety and Applied Nutrition ins prepared by the reaction of a mix- (HFS–200), Food and Drug Administra- ture of polybasic acids and polyhydric tion, 5001 Campus Dr., College Park, alcohols listed in § 175.300(b)(3)(vii) of MD 20740, and may be examined at the this chapter and 3-isocyanatomethyl- Food and Drug Administration’s Main 3,5,5-trimethylcyclohexyl isocyanate Library, 10903 New Hampshire Ave., (CAS Reg. No. 4098–71–9). Additionally, Bldg. 2, Third Floor, Silver Spring, MD dimethylol propionic acid and 1,6- 20993, 301–796–2039, or at the National hexanediol may be used alone or in Archives and Records Administration combination as reactants in lieu of a (NARA). For information on the avail- polybasic acid and a polyhydric alco- ability of this material at NARA, call hol. 202–741–6030, or go to: http:// (2) Acid dianhydride formulated from www.archives.gov/federallregister/ 3a,4,5,7a-tetrahydro-7-methyl-5- codeloflfederallregulations/ (tetrahydro-2,5-dioxo-3-furanyl)-1,3- ibrllocations.html. isobenzofurandione (CAS Reg. No. (2) The chloroform-soluble fraction of 73003–90–4), comprising not more than the total nonvolatile extractives for one percent of the cured adhesive. containers using adhesives listed in (b) Urethane cross-linking agent, paragraph (c)(2)(v) of this section shall comprising not more than twelve per- not exceed 0.016 milligram per square cent by weight of the cured adhesive, centimeter (0.10 milligram per square and formulated from trimethylol pro- inch) as determined by a method titled pane (CAS Reg. No. 77–99–6) adducts of ‘‘Determination of Non-volatile Chlo- 3-isocyanatomethyl-3,5,5- roform Soluble Residues in Retort trimethylcyclohexyl isocyanate (CAS Pouch Water Extracts,’’ which is incor- Reg. No. 4098–71–9) and/or 1,3- bis(isocyanatomethyl)benzene (CAS porated by reference in paragraph Reg. No. 363–48–31). (c)(3)(i)(a)(1) of this section. (3) Test specifications. These specifica- (b) For use at temperatures not to ex- tions apply only to materials on the ceed 135 °C (275 °F): The container inte- food-contact side of a functional bar- rior (food-contact side) shall be ex- rier, if present. All tests must be per- tracted with deionized distilled water formed on containers made under pro- at 135 °C (275 °F) for 1 hour. duction conditions. Laminated struc- (1) The chloroform-soluble fraction of tures submitted to extraction proce- the total nonvolatile extractives for dures must maintain complete struc- containers using no adhesive, or adhe- tural integrity (particularly with re- sives listed in paragraphs (c)(2) (i), (ii), gard to delamination) throughout the and (iii) of this section shall not exceed test. 0.0020 milligram per square centimeter

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(0.013 milligram per square inch) as de- crons) may be used as the food-contact termined by a method titled ‘‘Deter- surface of the container. mination of Non-volatile Chloroform (3) Container test specifications. On Soluble Residues in Retort Pouch exposure to distilled water at 250 °F Water Extracts,’’ which is incorporated (121 °C) for 2 hours, extractives from by reference. The availability of this the food-contact side of the nylon 12 incorporation by reference is given in multilayered construction shall not ex- paragraph (c)(3)(i)(a)(1) of this section. ceed 0.05 milligram per square inch (2) The chloroform-soluble fraction of (0.0078 milligram per square centi- the total nonvolatile extractives for meter) as total nonvolatile extractives. containers using adhesives listed in paragraph (c)(2)(v) of this section shall [45 FR 2843, Jan. 15, 1980, as amended at 47 not exceed 0.016 milligram per square FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; centimeter (0.10 milligram per square 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, inch) as determined by a method titled 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR ‘‘Determination of Non-volatile Chlo- 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; roform Soluble Residues in Retort 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, Pouch Water Extracts,’’ which is incor- 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668, porated by reference. The availability Mar. 26, 2004; 81 FR 5593, Feb. 3, 2016] of this incorporation by reference is given in paragraph (c)(3)(i)(a)(1) of this § 177.1395 Laminate structures for use section. at temperatures between 120 ≥F and (3) The chloroform-soluble fraction of 250 ≥F. the total nonvolatile extractives for (a) The laminates identified in this containers using adhesives listed in section may be safely used at the speci- paragraph (c)(2)(vi) of this section shall fied temperatures. These articles are not exceed 0.008 milligram per square layered structures that are optionally centimeter (0.05 milligram per square bonded with adhesives. In these arti- inch) as determined by a method enti- cles, the food-contact layer does not tled, ‘‘Determination of Non-volatile function as a barrier to migration of Chloroform Soluble Residues in Retort components from non-food-contact lay- Pouch Water Extracts,’’ which is incor- ers. The layers may be laminated, ex- porated by reference in paragraph truded, coextruded, or fused. (c)(3)(i)(a)(1) of this section. (b) Laminate structures may be man- (ii) Volatiles. Volatile substances em- ufactured from: ployed in the manufacture of high-tem- perature laminates must be removed to (1) Polymers and adjuvants com- the greatest extent possible in keeping plying with § 177.1390 of this chapter. with good manufacturing practice pre- (2) Any polymeric resin listed in scribed in § 174.5(a) of this chapter. these regulations so long as the use of (d) Nylon 12/aluminum foil high-tem- the resin in the structure complies perature laminates: Subject to the pro- with the conditions of use (food type visions of this paragraph, containers and time/temperature) specified in the constructed of nylon 12 laminated to regulation for that resin. aluminum foil may be safely used at (3) Optional adjuvant substances used temperatures no greater than 250 °F in accordance with § 174.5 of this chap- (121 °C) in contact with all food types ter. except those containing more than 8 (4) The following substances in non- percent alcohol. food-contact layers only: (1) The container is constructed of aluminum foil to which nylon 12 film is fused. Prior to fusing the nylon 12, the aluminum foil may be optionally precoated with a coating complying with § 175.300 of this chapter. (2) Nylon 12 resin complying with § 177.1500 and having an average thick- ness not to exceed 0.0016 inch (41 mi-

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Substances Limitations Substances Limitations

Ethylene/1,3–phenylene oxy- For use only with poly- Nylon 6/69 resins complying For use with nonalcoholic ethylene isophthalate/ ethylene terephthalate as with § 177.1500(b), item 14, foods under conditions of terephthalate copolymer the food-contact layer, of this chapter (CAS Reg. use B, C, D, E, F, G, and (CAS Reg. No. 87365–98–8) complying with No. 51995–62–1). H described in table 2 of complying with § 177.1345. § 177.1630 under condi- § 176.170 of this chapter. tions of use C through G Laminate structures with described in table 2 of authorized food-contact § 176.170(c) of this chap- materials may contain ter. Laminate structures, nylon 6/69 resins pro- when extracted with 8 vided that the nitrogen percent ethanol at 150 °F content of aqueous ex- for 2 hours shall not yield tracts of a representative m-pheny lenedioxy-O,O′- laminate (obtained at 100 diethyl isophthalate or cy- °C (212 °F) for 8 hours) clic bis(ethylene does not exceed 15 isophthalate) in excess of micrograms per square 7.8 micrograms/square centimeter (100 decimeter (0.5 micrograms per square microgram/square inch) of inch). food-contact surface. Nylon 6/12 resins complying For use with nonalcoholic with § 177.1500(b), item foods at temperatures not [52 FR 33575, Sept. 4, 1987, as amended at 53 13.2, of this chapter (CAS to exceed 100 °C (212 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, Reg. No. 25191–04–2). °F). Laminate structures 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, with authorized food-con- Oct. 17, 1997] tact materials yield no more than 0.15 milligram § 177.1400 Hydroxyethyl cellulose film, of epsilon-caprolactam water-insoluble. and 0.04 milligram of omega-laurolactam per Water-insoluble hydroxyethyl cel- square inch when ex- lulose film may be safely used for tracted with water at 100 °C (212 °F) for 5 hours. packaging food in accordance with the Nylon 6/66 resins complying For use only with: following prescribed conditions: with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (a) Water-insoluble hydroxyethyl cel- of this chapter (CAS Reg. temperatures not to ex- lulose film consists of a base sheet 24993–04–2). ceed 82.2 °C (180 °F). Laminate structures with manufactured by the ethoxylation of authorized food-contact cellulose under controlled conditions, materials yield no more to which may be added certain optional than 0.15 milligram of ep- substances of a grade of purity suitable silon-caprolactam per square inch when ex- for use in food packaging as constitu- tracted with water at 82.2 ents of the base sheet or as coatings °C (180 °F) for 5 hours. applied to impart desired technological 2. Nonalcoholic foods at properties. temperatures not to ex- ceed 100 °C (212 °F). (b) Subject to any limitations pre- Laminate films with au- scribed in parts 170 through 189 of this thorized food-contact ma- chapter, the optional substances used terials yield no more than in the base sheet and coating may in- 0.15 milligram of epsilon- caprolactam per square clude: inch when extracted with (1) Substances generally recognized water at 100 °C (212 °F) as safe in food. for 5 hours. (2) Substances permitted to be used in water-insoluble hydroxyethyl cel- lulose film by prior sanction or ap- proval and under conditions specified in such sanctions or approval, and sub- stances listed in part 181, subpart B of this chapter. (3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of water-insoluble hydroxyethyl cel- lulose film. (4) Substances identified in and used in compliance with § 177.1200(c).

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(c) Any substance employed in the (b) The polymers identified in para- production of the water-insoluble hy- graph (a) of this section may contain droxyethyl cellulose film described in optional adjuvant substances required this section that is the subject of a reg- in the production of the polymers. The ulation in parts 174, 175, 176, 177, 178 optional adjuvant substances required and § 179.45 of this chapter conforms in the production of the polymers may with any specification in such regula- include substances generally recog- tion. nized as safe in food, substances used in § 177.1420 Isobutylene polymers. accordance with a prior sanction or ap- proval, and aluminum chloride. Isobutylene polymers may be safely (c) The provisions of this section are used as components of articles in- tended for use in producing, manufac- not applicable to polyisobutylene used turing, packing, processing, preparing, in food-packaging adhesives complying treating, packaging, transporting, or with § 175.105 of this chapter. holding food, in accordance with the following prescribed conditions: § 177.1430 Isobutylene-butene copoly- (a) For the purpose of this section, mers. isobutylene polymers are those pro- Isobutylene-butene copolymers iden- duced as follows: tified in paragraph (a) of this section (1) Polyisobutylene produced by the may be safely used as components of homopolymerization of isobutylene articles intended for use in contact such that the finished polymers have a with food, subject to the provisions of molecular weight of 750,000 (Flory) or this section. higher. (a) For the purpose of this section, (2) Isobutylene-isoprene copolymers isobutylene-butene copolymers consist produced by the copolymerization of of basic copolymers produced by the isobutylene with not more than 3 copolymerization of isobutylene with molar percent of isoprene such that the finished polymers have a molecular mixtures of n-butenes such that the weight of 300,000 (Flory) or higher. finished basic copolymers contain not (3) Chlorinated isobutylene-isoprene less than 45 weight percent of polymer copolymers produced when units derived from isobutylene and isobutylene-isoprene copolymers (mo- meet the specifications prescribed in lecular weight 300,000 (Flory) or higher) paragraph (b) of this section when test- are modified by chlorination with not ed by the methods described in para- more than 1.3 weight-percent of chlo- graph (c) of this section. rine. (b) Specifications:

Maximum Isobutylene-butene copolymers Molecular Viscosity (range) bromine weight (range) value

1. Used as release agents in petroleum wax complying with 300 to 5,000 ... 40 to 20,000 seconds 40 § 178.3710 of this chapter. Saybolt at 200 °F. 2. Used as plasticizers in polyethylene or polypropylene complying 300 to 5,000 ... 40 to 20,000 seconds 40 with § 177.1520, and in polystyrene complying with § 177.1640. Saybolt at 200 °F. 3. Used as components of nonfood articles complying with 300 to 5,000 ... 40 to 20,000 seconds 40 §§ 175.300, 176.170, 176.210, 177.2260(d)(2), 177.2800, and Saybolt at 200 °F. 178.3570 (provided that addition to food does not exceed 10 parts per million), or § 176.180 of this chapter. 4. Used as production aids in the manufacture of expanded 150 to 5,000 ... Less than 20,000 seconds 90. (foamed) polystyrene articles complying with § 177.1640 of this Saybolt at 200 °F. chapter. 5. Used in release coatings on backings or linings for pressure-sen- 150 to 5,000 ... Less than 20,000 seconds 90 sitive adhesive labels complying with § 175.125 of this chapter. Saybolt at 200 °F.

(c) The analytical methods for deter- (1) Molecular weight. Molecular mining whether isobutylene-butene co- weight shall be determined by Amer- polymers conform to the specifications ican Society for Testing and Materials in paragraph (b) are as follows: (ASTM) method D2503–82, ‘‘Standard Test Method for Molecular Weight

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(Relative Molecular Mass) of Hydro- tain optional adjuvant substances re- carbons by Thermoelectric Measure- quired in the production of the resins. ment of Vapor Pressure,’’ which is in- (b) The optional adjuvant substances corporated by reference. Copies may be required in the production of the resins obtained from the American Society may include substances generally rec- for Testing Materials, 100 Barr Harbor ognized as safe in food, substances used Dr., West Conshohocken, Philadelphia, in accordance with a prior sanction or PA 19428-2959, or may be examined at approval, and the following: the National Archives and Records Ad- ministration (NARA). For information List of substances Limitations on the availability of this material at Butyl alcohol ...... Not to exceed 300 p.p.m. as re- NARA, call 202–741–6030, or go to: http:// sidual solvent in finished resin. www.archives.gov/federallregister/ Ethyl alcohol. Toluene ...... Not to exceed 1,000 p.p.m. as re- codeloflfederallregulations/ sidual solvent in finished resin. ibrllocations.html. (2) Viscosity. Viscosity shall be deter- (c) 4,4′-Isopropylidenediphenol-ep- mined by ASTM method D445–74, ‘‘Test ichlorohydrin resins shall meet the fol- for Kinematic Viscosity of Transparent lowing nonvolatile extractives limita- and Opaque Liquids,’’ which is incor- tions: porated by reference. The availability (1) Maximum extractable nonvolatile of this incorporation by reference is fraction of 2 parts per million when ex- given in paragraph (c)(1) of this sec- tracted with distilled water at 70 °C for tion. 2 hours, using a volume-to-surface (3) Maximum bromine value. Maximum ratio of 2 milliliters per square inch. bromine value shall be determined by (2) Maximum extractable nonvolatile ASTM method D1492–78, ‘‘Standard fraction of 3 parts per million when ex- Test Method for Bromine Index of Aro- tracted with n-heptane at 70 °C for 2 matic Hydrocarbons by Coulometric hours, using a volume-to-surface ratio Titration,’’ which is incorporated by of 2 milliliters per square inch. reference. The availability of this in- (3) Maximum extractable nonvolatile corporation by reference is given in fraction of 6 parts per million when ex- paragraph (c)(1) of this section. tracted with 10 percent (by volume) (d) The provisions of this section are ethyl alcohol in distilled water at 70 °C not applicable to isobutylene-butene for 2 hours, using a volume-to-surface copolymers used as provided under ratio of 2 milliliters per square inch. § 175.105 of this chapter. (d) The provisions of this section are ′ [52 FR 11641, Apr. 10, 1987, as amended at 63 not applicable to 4,4 -isopropylidene- FR 36175, July 2, 1998] diphenol-epichlorohydrin resins listed in other sections of subchapter B of § 177.1440 4,4′-Isopropylidenediphenol- this chapter. epichlorohydrin resins minimum molecular weight 10,000. § 177.1460 Melamine-formaldehyde res- 4,4′-Isopropylidenediphenol-epichlo- ins in molded articles. rohydrin resins having a minimum mo- Melamine-formaldehyde resins may lecular weight of 10,000 may be safely be safely used as the food-contact sur- used as articles or components of arti- face of molded articles intended for use cles intended for use in producing, in producing, manufacturing, packing, manufacturing, packing, processing, processing, preparing, treating, pack- preparing, treating, packaging, trans- aging, transporting, or holding food in porting, or holding food in accordance accordance with the following pre- with the following prescribed condi- scribed conditions: tions: (a) For the purpose of this section, (a) 4,4′-Isopropylidenediphenol-ep- melamine-formaldehyde resins are ichlorohydrin resins consist of basic those produced when 1 mole of mel- resins produced by the condensation of amine is made to react with not more equimolar amounts of 4,4′- than 3 moles of formaldehyde in water isopropylidenediphenol and solution. epichlorohydrin terminated with phe- (b) The resins may be mixed with re- nol, to which may have been added cer- fined woodpulp and the mixture may

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contain other optional adjuvant sub- method D1243–79, ‘‘Standard Test Meth- stances which may include the fol- od for Dilute Solution Viscosity of lowing: Vinyl Chloride Polymers,’’ which is in- corporated by reference. Copies may be List of substances Limitations obtained from the American Society Colorants used in accord- for Testing Materials, 100 Barr Harbor ance with § 178.3297 Dr., West Conshohocken, Philadelphia, of this chapter. Dioctyl phthalate ...... For use as lubricant. PA 19428-2959, or may be examined at Hexamethylenetetramine For use only as polymerization the National Archives and Records Ad- reaction control agent. ministration (NARA). For information Phthalic acid anhydride .. Do. Zinc stearate ...... For use as lubricant. on the availability of this material at NARA, call 202–741–6030, or go to: http:// (c) The molded melamine-formalde- www.archives.gov/federallregister/ hyde articles in the finished form in codeloflfederallregulations/ which they are to contact food, when ibrllocations.html. extracted with the solvent or solvents (iii) Residual acrylonitrile monomer characterizing the type of food and content is not more than 11 parts per under the conditions of time and tem- million as determined by gas chroma- perature as determined from tables 1 tography. and 2 of § 175.300(d) of this chapter, (iv) Acetonitrile-soluble fraction shall yield net chloroform-soluble ex- after refluxing the base polymer in ace- tractives not to exceed 0.5 milligram tonitrile for 1 hour is not greater than per square inch of food-contact surface. 95 percent by weight of the basic co- [42 FR 14572, Mar. 15, 1977, as amended at 56 polymers. FR 42933, Aug. 30, 1991] (2) Extractives limitations. The fol- lowing extractive limitations are de- § 177.1480 Nitrile rubber modified ac- termined by an infrared rylonitrile-methyl acrylate copoly- spectrophotometric method titled, mers. ‘‘Infrared Spectrophotometric Deter- Nitrile rubber modified acrylonitrile- mination of Polymer Extracted from methyl acrylate copolymers identified Borex ® 210 Resin Pellets,’’ which is in- in this section may be safely used as corporated by reference. Copies are components of articles intended for available from the Center for Food food-contact use under conditions of Safety and Applied Nutrition (HFS– use D, E, F, or G described in table 2 of 200), Food and Drug Administration, § 176.170(c) of this chapter, subject to 5001 Campus Dr., College Park, MD the provisions of this section. 20740, or available for inspection at the (a) For the purpose of this section, National Archives and Records Admin- nitrile rubber modified acrylonitrile- istration (NARA). For information on methyl acrylate copolymers consist of basic copolymers produced by the graft the availability of this material at copolymerization of 73–77 parts by NARA, call 202–741–6030, or go to: http:// weight of acrylonitrile and 23–27 parts www.archives.gov/federallregister/ by weight of methyl acrylate in the codeloflfederallregulations/ presence of 8–10 parts by weight of bu- ibrllocations.html.Copies are applicable tadiene-acrylonitrile copolymers con- to the basic copolymers in the form of taining approximately 70 percent by particles of a size that will pass weight of polymer units derived from through a U.S. standard sieve No. 6 and butadiene. that will be held on a U.S. standard (b) The nitrile rubber modified acry- sieve No. 10: lonitrile-methyl acrylate basic copoly- (i) Extracted copolymer not to ex- mers meet the following specifications ceed 2.0 parts per million in aqueous and extractives limitations: extract obtained when a 100-gram sam- (1) Specifications. (i) Nitrogen content ple of the basic copolymers is extracted is in the range 16.5–19 percent as deter- with 250 milliliters of demineralized mined by Kjeldahl analysis. (deionized) water at reflux temperature (ii) Intrinsic viscosity in acetonitrile for 2 hours. at 25 °C is not less than 0.29 deciliter (ii) Extracted copolymer not to ex- per gram as determined by ASTM ceed 0.5 part per million in n-heptane

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extract obtained when a 100-gram sam- adipic acid, and 21.6±1.2 weight percent ple of the basic copolymers is extracted terephthalic acid. with 250 milliliters of reagent grade n- (8) Nylon 612 resins are manufactured heptane at reflux temperature for 2 by the condensation of hours. hexamethylenediamine and (c) Acrylonitrile copolymers identi- dodecanedioic acid. fied in this section shall comply with (9) Nylon 12 resins are manufactured the provisions of § 180.22 of this chap- by the condensation of omega- ter. laurolactam. (d) Acrylonitrile copolymers identi- (10)(i) Impact modified Nylon MXD–6 fied in this section are not authorized resins (CAS Reg. No. 59655–05–9) manu- to be used to fabricate beverage con- factured by the condensation of adipic tainers. acid, 1,3-benzenedimethanamine, and alpha-(3-aminopropyl)-omega-(3-amino- [42 FR 14572, Mar. 15, 1977, as amended at 42 propoxy)poly- oxyethylene under such FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, conditions that the alpha-(3-amino- 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR propyl)-omega-(3-aminopropoxy) 14481, Apr. 2, 1996] polyoxyethylene monomer content does not exceed 7 percent by weight of § 177.1500 Nylon resins. the finished resin. (ii) Nylon MXD–6 resins (CAS Reg. The nylon resins listed in paragraph No. 25718–70–1) manufactured by the (a) of this section may be safely used to condensation of adipic acid and 1,3- produce articles intended for use in benzenedimethanamine. processing, handling, and packaging (11) Nylon 12T resins are manufac- food, subject to the provisions of this tured by the condensation of omega- section: laurolactam (CAS Reg. No. 0947–04–6), (a) The nylon resins are manufac- isophthalic acid (CAS Reg. No. 0121–91– tured as described in this paragraph so 5), and bis(4-amino-3-methylcycl- as to meet the specifications prescribed ohexyl)methane (CAS Reg. No. 6864–37– in paragraph (b) of this section when 5) such that the composition in terms tested by the methods described in of ingredients is 34.4±1.5 weight percent paragraph (d) of this section. omega-laurolactam, 26.8±0.4 weight per- (1) Nylon 66 resins are manufactured cent isophthalic acid, and 38.8±0.5 by the condensation of hexamethylene- weight percent bis(4-amino-3- diamine and adipic acid. methylcyclohexyl)-methane. (2) Nylon 610 resins are manufactured (12) Nylon 6I/6T resins (CAS Reg. No. by the condensation of hexamethylene- 25750–23–6) are manufactured by the diamine and sebacic acid. condensation of (3) Nylon 66/610 resins are manufac- hexamethylenediamine, terephthalic tured by the condensation of equal- acid, and isophthalic acid such that 65 weight mixtures of nylon 66 salts and to 80 percent of the polymer units are nylon 610 salts. derived from hexamethylene (4) Nylon 6/66 resins manufactured by isophthalamide. the condensation and polymerization of (13)(i) Nylon 6/12 resins (CAS Reg. No. Nylon 66 salts and epsilon-caprolactam. 25191–04–2) are manufactured by the co- (5) Nylon 11 resins are manufactured polymerization of a 1 to 1 ratio by by the condensation of 11- weight of epsilon-caprolactam and aminoundecanoic acid. omega-laurolactam. (6) Nylon 6 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No. by the polymerization of epsilon- 25191–04–2) are manufactured by the co- caprolactam. polymerization of a ratio of at least 80 (7) Nylon 66T resins are manufac- weight percent of epsilon-caprolactam tured by the condensation of and no more than 20 weight percent of hexamethyl-enediamine, adipic acid, omega-laurolactam. and terephthalic acid such that com- (14) Nylon 6/69 resins (CAS Reg. No. position in terms of ingredients is 51995–62–1) are manufactured by the 43.1±0.2 weight percent hexamethyl- condensation of 49.5 + 0.5 weight per- enediamine, 35.3±1.2 weight percent cent epsilon-caprolactam, 19.4 + 0.2

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weight percent hexamethylenediamine by the condensation of 50 mol percent and 31.2 + 0.3 weight percent azelaic 1,4-benzenedicarboxylic acid, dimethyl acid. ester and 50 mol percent of an (15) Nylon 46 resins (CAS Reg. No. equimolar mixture of 2,2,4-trimethyl- 50327–77–0) are manufactured by the 1,6-hexanediamine and 2,4,4-trimethyl- condensation of 1,4-butanediamine and 1,6-hexanediamine. adipic acid. (b) Specifications: (16) Nylon resins PA 6–3–T (CAS Reg- istry No. 26246–77–5) are manufactured

Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate

1. Nylon 66 resins ...... 1.14±.015 475–495 Dissolves in ...... 1.5 1.5 0.2 0.2 1 h. 2. Nylon 610 resins ...... 1.09±.015 405–425 Insoluble ...... 1.0 2.0 1.0 1.0 after 1 h. 3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in ...... 1.5 2.0 1.0 1.0 1 h. 4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ...... do...... 2.0 2.0 1.5 1.5 silon-caprolactam mon- omer content not to ex- ceed 0.7 percent by weight. 4.2 Nylon 6/66 resins with 1.14±.015 380–425 ...... do...... 0.8 1.0 0.5 0.5 combined caprolactam content greater than 60 percent and residual ep- silon-caprolactam mon- omer content not to ex- ceed 0.4 percent by weight. For use only as specified in § 177.1395 of this chapter (CAS Reg. No. 24993–04–2). 5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble ...... 30 .35 .25 .3 in articles intended for 1- after 1 h. time use or repeated use in contact with food. 5.2 Nylon 11 resins for use 1.04±.015 355–375 ...... do...... 35 1.60 .35 .40 only: a. In articles intended for repeated use in contact with food. b. In side-seam cements for articles intended for 1-time use in contact with food and which are in compliance with § 175.300 of this chap- ter. 6.1 Nylon 6 resins ...... 1.15±.015 392–446 Dissolves in ...... 1.0 2.0 1.0 1.0 1 h. 6.2 Nylon 6 resins for use 1.15±.015 392–446 ...... do...... 1.5 2.0 1.0 1.0 only in food-contact films having an average thick- ness not to exceed 0.001 in. 7. Nylon 66T resins for use 1.16±.015 482–518 Insoluble ...... 1.0 1.0 .25 .25 only in food-contact films after 1 h. having an average thick- ness not to exceed 0.001 in.

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Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate

8. Nylon 612 resins for use 1.06±.015 406–420 ...... do...... 50 1.50 .50 .50 only in articles intended for repeated use in con- tact with food at tempera- tures not to exceed 212 °F. 9. Nylon 12 resins for use 1.01±.015 335–355 ...... do...... 1.0 2.0 1.50 1.50 only:. a. In food-contact films hav- ing an average thickness not to exceed 0.0016 inch intended for use in contact with nonalcoholic food under the conditions of use A (sterilization not to exceed 30 minutes at a temperature not to ex- ceed 250 °F), and B through H of table 2 of § 176.170(c) of this chap- ter, except as provided in § 177.1390(d) b. In coatings intended for repeated use in contact with all food types de- scribed in table 1 of § 176.170(c) of this chap- ter, except those con- taining more than 8 per- cent alcohol, under con- ditions of use B through H described in table 2 of § 176.170(c) of this chap- ter. 10.1 Nylon MXD–6 and im- 1.21±0.02 437–491 Dissolves in ...... 2.0 2.5 1.0 1.0 pact modified Nylon 1h. MXD–6 film having an average thickness not to exceed 40 microns (0.0016 inch) for use in processing, handling, and packaging of food of types V and IX listed in table 1 of § 176.170(c) of this chapter under condi- tions of use C, D, E, F, G, and H in table 2 of § 176.170(C) of this chapter.

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Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate

10.2 Impact modified Nylon 1.21±0.02 437–491 do...... 2.0 2.5 1.0 1.0 MXD–6 resins for use as polymer use as polymer modifiers in Nylon 6 resin films complying with paragraph (a)(6) of this section, at levels not to exceed 13 percent by weight of films whose av- erage thickness will not exceed 15 microns (0.6 mils). The finished film is used for packaging, transporting, or holding food, excluding bev- erages containing more than 8 percent alcohol (by volume) at tempera- tures not to exceed 49 °C (120 °F) (conditions of use E, F, and G in table 2 of § 176.170(c) of this chapter). 10.3 Nylon MXD–6 resins 1.22±0.02 455–470 Dissolves in 1.0 1.5 0.2 0.2 for use only as nonfood- 1 h. contact layers of: (1) Mul- tilayer films and (2) rigid plastic containers com- posed of polypropylene food-contact and exterior layers, as defined in § 177.1520(c), item 1.1(a) and 1.1(b), of this chap- ter. The finished food- contact laminate, in the form in which it contacts food, when extracted with the food simulating sol- vent or solvents charac- terizing the conditions of the intended use as de- termined from Table 2 of § 176.170(c) of this chap- ter, shall yield not more than 0.5 micrograms of m-xylylenediamine-adipic acid cyclic monomer per square inch of food-con- tact surface, when the food simulating solvent is analyzed by any appro- priate, properly validated method. 11. Nylon 12T resins for 1.06±0.015 N/A Insoluble ...... 0.1 ...... 0.5 0.5 use in contact with all after 1 types of food except hour. those containing more than 8 percent alcohol. 12. Nylon 6I/6T resins for 1.207±0.1 N/A Insoluble ...... 0.2 1.0 0.1 0.1 use in contact with all after 1 types of food except al- hour. coholic beverages con- taining more than 8 per- cent alcohol.

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Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate

13.1 Nylon 6/12 resins for 1.06±0.015 260–285 Dissolves in Greater than 140 ..... 2.0 ...... 1.5 1.5 use only in food-contact 1 hour. films having an average thickness not to exceed 51 microns (0.002 inch). The finished film is in- tended to contact all foods except those con- taining more than 8 per- cent ethanol under condi- tions of use B, C, D, E, F, G, and H listed in table 2 of § 176.170(c) of this chapter. 13.2 Nylon 6/12 resins with 1.10±0.15 380–400 Dissolves in Greater than 160 ..... 0.8 1.0 0.5 0.5 residual epsilon- 1 h. caprolactam not to ex- ceed 0.5 percent by weight and residual omega-laurolactam not to exceed 0.1 percent by weight. For use only as specified in § 177.1395 of this chapter. 13.3 Nylon 6/12 resins with 1.13 ±0.15 400–420 Dissolves in ...... 1.0 1.5 0.5 0.5 residual epsilon- 1 h. caprolactam not to ex- ceed 0.8 percent by weight and residual omega-laurolactam not to exceed 0.1 percent by weight. For use only as specified in § 177.1390 of this chapter. 14. Nylon 6/69 resins for 1.09±0.02 270–277 ...... >140 using the meth- 3.0 use only as specified in od described in 21 CFR 177.1395 of this § 177.1500(c)(5)(ii) chapter. of this chapter. 15. Nylon 46 resins for use 1.18±0.015 551–592 Dissolves in ...... 0.3 0.2 0.2 0.3 only in food-contact 1 h. membrane filters in- tended for repeated use. The finished membrane filter is intended to con- tact beverages containing no more than 13 percent alcohol, under conditions of use E, F, and G listed in table 2 of § 176.170(c) of this chapter. 16. Nylon resins PA 6–3–T 1.12±0.03 NA Insoluble >110 ...... 0.007 0.64 0.003 0 for repeated-use (exclud- after 1 h. ing bottles) in contact with food of type VIA and VIB described in table 1 of § 176.170(c) of this chapter under conditions of use D through H de- scribed in table 2 of § 176.170(c) of this chap- ter with a hot-fill tempera- ture limitation of 40 °C.

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(c) Nylon modifier—(1) Identity. Co- of Nylon modifiers listed in paragraph polyester-graft-acrylate copolymer is (c)(1) of this section may include: the substance 1,4-benzenedicarboxylic (A) Substances generally recognized acid, polymer with 1,4-butanediol, (E)- as safe for use in food and food pack- 2-butenedioic acid, 1,2-ethanediol, aging; ethyl 2-propenoate, hexanedioic acid (B) Substances subject to prior sanc- and 2-propenoic acid, graft (CAS Reg. tion or approval for use in Nylon resins No. 175419–23–5), and is derived from and used in accordance with such sanc- grafting of 25 weight percent of acrylic tions or approval; and polymer with 75 weight percent of co- (C) Optional substances required in polyester. The copolyester is polym- the production of the additive identi- erized terephthalic acid (55 mol%), fied in this paragraph and other op- adipic acid (40 mol%), and fumaric acid tional substances that may be required (5 mol%) with ethylene glycol (40 to accomplish the intended physical or mol%) and 1,4-butanediol (60 mol%). technical effect. The acrylic polymer is made from (d) Analytical methods—(1) Specific acrylic acid (70 mol%) and ethyl acry- gravity. Specific gravity shall be deter- late (30 mol%). mined by weighing a 1-gram to 5-gram (2) Specifications. The finished copoly- sample first in air and then in freshly ester-graft-acrylate copolymer shall boiled distilled water at 23 °C±2 °C. meet the following specifications: (2) Melting point. The melting point (i) Weight average molecular weight shall be determined as follows: Use a 15,000–35,000, hot-stage apparatus. The use of crossed nicol prisms with a microscope hot (ii) pH 7.2 to 8.2, and stage and reading of the thermometer (iii) Glass transition temperature when the birefringence disappears in- ¥ ¥ ° 15 to 25 C. creases the accuracy. If the crossed (3) Conditions of use. (i) Copolyester- nicol apparatus is not available, use graft acrylate copolymer described in the lowest temperature at which the paragraph (c)(1) of this section is in- sample becomes transparent or the tended to improve the adhesive quali- sharp edges or corners of the sample ties of film. It is limited for use as a become rounded as the melting point. modifier of Nylon 6 and Nylon 6 modi- In case of doubt as to the onset of fied with Nylon MXD–6 at a level not melting, the sample is prodded with a to exceed 0.17 weight percent of the ad- sharp instrument. If it sticks to the ditive in the finished film. heating block, it is considered to have (ii) The finished film is used for pack- melted. If the melting point is low, dry aging, transporting, or holding all the sample in an oven at 85 °C for 24 types of foods under conditions of use B hours in a nitrogen atmosphere then through H, described in table 2 of repeat the test. § 176.170(c) of this chapter, except that (3) Solubility in boiling 4.2N HCl. The in the case of Nylon 6 films modified test shall be run on a sample approxi- with Nylon MXD–6 (complying with mately the size of a 1⁄8-inch cube in at § 177.1500, item 10.2), the use complies least 25 milliliters of 4.2 normal hydro- with the conditions of use specified in chloric acid. table 2. (4) Maximum extractable fraction in se- (iii) Extractives. Food contact films lected solvents. The procedure for deter- described in paragraphs (c)(1) of this mining the maximum extractable frac- section, when extracted with solvent or tion of the nylon resins in selected sol- solvents prescribed for the type of food vents is as follows: and under conditions of time and tem- (i) Film should be cut with ordinary perature specified for the intended use, scissors into pieces of a convenient size shall yield total extractives not to ex- such as 1⁄4-inch squares, for the extrac- ceed 0.5 milligram per inch squared of tion tests described in this section. The food-contact surface when tested by granules of nylon molding powders are the methods described in § 176.170(d) of in the proper form for the extraction this chapter. tests. Samples of fabricated articles (iv) Optional adjuvant substances. The such as pipe, fittings, and other similar substances employed in the production articles must be cut to approximately

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the size of the molding powder. This Copies are available from the Center can be done conveniently by using a for Food Safety and Applied Nutrition small-scale commercial plastics (HFS–200), Food and Drug Administra- granulator and cutting the sample tion, 5001 Campus Dr., College Park, through a screen having 1⁄4-inch mesh. MD 20740, or available for inspection at Fine particles should be separated from the National Archives and Records Ad- the cut resin by screening through a 20- ministration (NARA). For information mesh screen. The material retained on on the availability of this material at the screen is suitable for the extraction NARA, call 202–741–6030, or go to: http:// tests. www.archives.gov/federallregister/ (ii) The organic solvents must be of codeloflfederallregulations/ American Chemical Society analytical ibrllocations.html. reagent grade; distilled water is used. (ii) The viscosity number (VN) for Approximately 30 grams of the pre- Nylon 6/69 and Nylon PA–6–3–T resins pared sample is weighed to the nearest in a 99 percent cresol solution (5 milli- milligram. The weighed resin is trans- grams resin per milliliter) shall be de- ferred to a 500-milliliter round-bottom termined at 25 °C (77 °F) by method ISO flask equipped with a reflux condenser. 307–1984(E), ‘‘Plastics-Polyamides-De- Approximately 300-milliliters of sol- termination of Viscosity Number,’’ vent is added to the flask and the con- which is incorporated by reference. The tents refluxed gently for 8 hours with a availability of this incorporation by heating mantle. The solvent is then fil- reference is given in paragraph (d)(5)(i) tered off immediately while still hot, of this section. using a Buchner funnel approximately 5 inches in diameter, a suction flask, [42 FR 14572, Mar. 15, 1977] and a hardened filter paper (Whatman EDITORIAL NOTE: For FEDERAL REGISTER ci- No. 50 or equivalent). The paper is wet tations affecting § 177.1500, see the List of with the solvent and a slight suction CFR Sections Affected, which appears in the applied just before starting the filtra- Finding Aids section of the printed volume and at www.fdsys.gov. tion. The resin is washed twice with approximately 100-milliliter portions of § 177.1520 Olefin polymers. solvent and the combined filtrate and washings are reduced to approximately The olefin polymers listed in para- 25 milliliters by evaporation at reduced graph (a) of this section may be safely pressure (50 millimeters to 100 millime- used as articles or components of arti- ters of mercury, absolute), heating as cles intended for use in contact with necessary. The contents of the flask food, subject to the provisions of this are transferred to an evaporation dish section. (which has been held in a vacuum des- (a) For the purpose of this section, iccator over anhydrous calcium sulfate olefin polymers are basic polymers until constant weight has been at- manufactured as described in this para- tained) and carefully evaporated to graph, so as to meet the specifications dryness. The weight of the solid residue prescribed in paragraph (c) of this sec- is determined by difference after hold- tion, when tested by the methods de- ing in a vacuum desiccator over anhy- scribed in paragraph (d) of this section. drous calcium sulfate until constant (1)(i) Polypropylene consists of basic weight has been attained. The percent polymers manufactured by the cata- of solids extracted is calculated by di- lytic polymerization of propylene. viding the weight of the solid residue (ii) Propylene homopolymer consists by the weight of the sample and multi- of basic polymers manufactured by the plying by 100. catalytic polymerization of propylene (5) Viscosity number (VN). (i) The vis- with a metallocene catalyst. cosity number (VN) for Nylon 6/12 resin (2)(i) Polyethylene consists of basic in a 96 percent sulfuric acid solution (5 polymers manufactured by the cata- milligrams resin per milliliter) shall be lytic polymerization of ethylene. determined at 25 °C (77 °F) by method (ii) Fumaric acid-grafted poly- ISO 307–1984(E), ‘‘Plastics-Polyamides- ethylene (CAS Reg. No. 26877–81–6) con- Determination of Viscosity Number,’’ sists of basic polymers manufactured which is incorporated by reference. by the catalytic polymerization of

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ethylene followed by reaction with fu- units derived from butene-1 with the maric acid in the absence of free rad- remainder being propylene. ical initiators. Such polymers shall (d) Olefin basic terpolymers manufac- contain grafted fumaric acid at levels tured by the catalytic copolymeriza- not to exceed 2 percent by weight of tion of ethylene, hexene-1, and either the finished polymer. propylene or butene-1, shall contain (3) Olefin basic copolymers consist of not less than 85 weight percent poly- basic copolymers manufactured by the mer units derived from ethylene. catalytic copolymerization of: (e) Olefin basic copolymers manufac- (i) Two or more of the 1-alkenes hav- tured by the catalytic polymerization ing 2 to 8 carbon atoms. Such olefin of ethylene and octene-1, or ethylene, basic copolymers contain not less than octene-1, and either hexene-1, butene-1, 96 weight-percent of polymer units de- propylene, or 4-methylpentene-1 shall rived from ethylene and/or propylene, contain not less than 80 weight percent except that: of polymer units derived from ethyl- (a)(1) Olefin basic copolymers manu- ene. factured by the catalytic copolym- (ii) 4-Methylpentene-1 and 1-alkenes erization of ethylene and hexene-1 or having from 6 to 18 carbon atoms. Such ethylene and octene-1 shall contain not olefin basic copolymers shall contain less than 90 weight-percent of polymer not less than 95 molar percent of poly- units derived from ethylene; mer units derived from 4- (2) Olefin basic copolymers manufac- methylpentene-1, except that copoly- tured by the catalytic copolymeriza- mers manufactured with 1-alkenes hav- tion of ethylene and hexene-1 shall con- ing from 12 to 18 carbon atoms shall tain not less than 80 but not more than contain not less than 97 molar percent 90 weight percent of polymer units de- of polymer units derived from 4- rived from ethylene. methylpentene-1; or (3) Olefin basic copolymers manufac- (iii) Ethylene and propylene that tured by the catalytic copolymeriza- may contain as modifiers not more tion of ethylene and pentene-1 shall than 5 weight-percent of total polymer contain not less than 90 weight-percent of polymer units derived from ethyl- units derived by copolymerization with ene. one or more of the following mono- mers: (4) Olefin basic copolymers manufac- tured by the catalytic polymerization 5-Ethylidine-2-norbornene. of ethylene and octene-1 shall contain 5-Methylene-2-norbornene. not less than 50 weight-percent of poly- mer units derived from ethylene. (iv) Ethylene and propylene that may contain as a modifier not more than 4.5 (b) Olefin basic copolymers manufac- tured by the catalytic copolymeriza- weight percent of total polymer units tion of ethylene and 4-methylpentene-1 derived by copolymerization with 1,4- shall contain not less than 89 weight- hexadiene. percent of polymer units derived from (v) Ethylene and butene-1 copolymers ethylene; (CAS Reg. No. 25087–34–7) that shall (c)(1) Olefin basic copolymers manu- contain not less than 80 weight percent factured by the catalytic copolym- of polymer units derived from ethyl- erization of two or more of the mono- ene. mers ethylene, propylene, butene-1, 2- (vi) Olefin basic copolymers (CAS methylpropene-1, and 2,4,4- Reg. No. 61615–63–2) manufactured by trimethylpentene-1 shall contain not the catalytic copolymerization of less than 85 weight-percent of polymer ethylene and propylene with 1,4- units derived from ethylene and/or pro- hexadiene, followed by reaction with pylene; fumaric acid in the absence of free rad- (2) Olefin basic copolymers manufac- ical initiators. Such polymers shall tured by the catalytic copolymeriza- contain not more than 4.5 percent of tion of propylene and butene-1 shall polymer units deriving from 1,4- contain greater than 15 but not greater hexadiene by weight of total polymer than 35 weight percent of polymer prior to reaction with fumaric acid and

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not more than 2.2 percent of grafted fu- (6) Ethylene-maleic anhydride co- maric acid by weight of the finished polymers (CAS Reg. No. 9006–26–2) con- polymer. taining no more than 2 percent by (vii) Ethylene and 2-norbornene (CAS weight of copolymer units derived from Reg. No. 26007–43–2) copolymers that maleic anhydride. shall contain not less than 30 and not (b) The basic olefin polymers identi- more than 70 mole percent of polymer fied in paragraph (a) of this section units derived from 2-norbornene. may contain optional adjuvant sub- (4) Poly(methylpentene) consists of stances required in the production of basic polymers manufactured by the catalytic polymerization of 4- such basic olefin polymers. The op- methylpentene-1. tional adjuvant substances required in (5) Polyethylene graft copolymers the production of the basic olefin poly- consist of polyethylene complying with mers or finished food-contact articles item 2.2 of paragraph (c) of this section may include substances permitted for which subsequently has 3a,4,7,7a- such use by applicable regulations in tetrahydromethyl-4,7- parts 170 through 189 of this chapter, methanoisobenzofuran-1,3-dione graft- substances generally recognized as safe ed onto it at a level not to exceed 1.7 in food and food packaging, substances percent by weight of the finished co- used in accordance with a prior sanc- polymer. tion or approval, and the following:

Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para- erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV-B, VI-A through 220 °C (428 °F), and the subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified in table 1 of § 176.170(c) of of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de- ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV-A, V, VII-A, and IX identified in table 1 of ‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap- as determined by ASTM Method D 611–82, ‘‘Standard Test ter. Methods for Aniline Point and Mixed Aniline Point of Petro- leum Products and Hydrocarbon Solvents,’’ both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5001 Campus Dr., Col- lege Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For informa- tion on the availability of this material at NARA, call 202– 741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Colorants used in accordance with § 178.3297 of this chapter. 2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene 63–7). homopolymer complying with § 177.1520(c), item 1.1 and olefin copolymers complying with § 177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the max- imum concentration of tert-butyl alcohol in the polymer does not exceed 100 parts per million, as determined by a method titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5001 Campus Dr., Col- lege Park, MD 20740, or available for inspection at the Na- tional Archives and Records Administration (NARA). For in- formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.

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Substance Limitations

Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section, polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene. 14–7), and polypropylene (CAS Reg. No. 9003–07–0), re- sulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as de- termined by a method entitled, ‘‘Determination of the Total Acrylic in PP–MMA/BA Polymers,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Addi- tive Safety, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For information on the avail- ability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html. Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con- °C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin- approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I, by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of 3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap- parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi- rials,’’ both of which are incorporated by reference in accord- fied in table 1 of § 176.170(c) of this chapter and under con- ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are ditions of use D through G described in table 2 of available from the American Society for Testing and Mate- § 176.170(c) of this chapter. rials, 100 Barr Harbor Dr., West Conshohocken, Philadel- phia, PA 19428-2959, or from the Center For Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- tion, 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administra- tion (NARA). For information on the availability of this mate- rial at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin 79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev- rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de- Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi- Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H. incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar- chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin 68937–54–2). polymers that comply with § 177.1520(c) at levels not to ex- ceed 0.3 percent by weight of the polymer. The finished polymer is used in contact with foods under conditions of use B through H described in table 2 of § 176.170 of this chapter.

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Substance Limitations

Triisopropanolamine (CAS Reg. No. 122–20–3) ...... For use as a Zeigler-Natta-type catalyst deactivator and anti- oxidant in the production of olefin polymers complying with § 177.1520(c), items 2.1, 2.2, and 2.3, and having a min- imum density of 0.94 grams per cubic centimeter, and co- polymers complying with § 177.1520(c), items 3.1 and 3.2, for use in contact with all foods under the following condi- tions of use: (a) films with a maximum thickness of 0.102 millimeter (0.004 inch) may be used under conditions A through H defined in table 2 of § 176.170(c) of this chapter; and (b) articles with thickness greater than 0.102 millimeter (0.004 inch) may be used under conditions C through G de- fined in table 2 of § 176.170(c) of this chapter. Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers. more than 6 percent. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap- by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H. available from the Center for Food Safety and Applied Nutri- tion (HFS–200), Food and Drug Administration, 5001 Cam- pus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev- less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de- 100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi- 3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H. Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incor- porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the avail- ability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html..

(c) Specifications:

Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)— hexane at speci- lene at specified fied temperatures temperatures

1.1a. Polypropylene described in paragraph 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C (a)(1)(i) of this section temperature 1.1b. Propylene homopolymer described in 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C paragraph (a)(1)(ii) of this section temperature 1.2. Polypropylene, noncrystalline; for use 0.80–0.88 only to plasticize polyethylene described under items 2.1 and 2.2 of this table, pro- vided that such plasticized polymers meet the maximum extractable fraction and max- imum soluble fraction specifications pre- scribed for such basic polyethylene

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Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)— hexane at speci- lene at specified fied temperatures temperatures

1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C. only: To plasticize polypropylene described by item 1.1 of this table, provided that such plasticized polymers meet the maximum ex- tractable fraction and maximum soluble fraction specifications prescribed for such basic polypropylene, and further provided that such plasticized polypropylene contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV-B, VI-B, VII-B, and VIII; and for use at levels not to exceed 50 pct by weight of any mixture employed as a food- contact coating provided such coatings con- tact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV-B, VI-B, VII-B, and VIII 2.1. Polyethylene for use in articles that con- 0.85–1.00 ...... 5.5 pct at 50 °C 11.3 pct at 25 °C tact food except for articles used for pack- ing or holding food during cooking 2.2. Polyethylene for use in articles used for 0.85–1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3. Polyethylene for use only as component 0.85–1.00 ...... 53 pct at 50 °C 75 pct at 25 °C of food-contact coatings at levels up to and including 50 percent by weight of any mix- ture employed as a food-contact coating 2.4. Olefin polymers described in paragraph (a)(2)(ii) of this section, having a melt flow index not to exceed 17 grams/per 10 min- utes as determined by the method de- scribed in paragraph (d)(7) of this section, for use in blends with other polymers at lev- els not to exceed 20 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV-A, V, VI-C, VII-A, and IX identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.1a. Olefin copolymers described in para- 0.85–1.00 ...... 5.5 pct at 50 °C 30 pct at 25 °C graph (a)(3)(i) of this section for use in arti- cles that contact food except for articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(a)(3) of this section and listed in item 3.1c of this table and olefin copolymers described in paragraph (a)(3)(i)(e) of this section and listed in item 3.1b of this table 3.1b. Olefin copolymers described in para- 0.9–1.00 ...... Do Do. graph (a)(3)(i)(e) of this section for use in contact with food only under conditions of use D, E, F, G, and H described in § 176.170(c) of this chapter, table 2 3.1c. Olefin copolymers described in para- Not less than 0.92 graph (a)(3)(i)(a)(3) of this section for use in contact with food only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2; except that such copolymers when used in contact with food of the types identified in § 176.170(c), table 1, under types III, IVA, V, VIIA, and IX, shall be used only under conditions of use D, E, F, and G described in § 176.170(c) of this chapter, table 2

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Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)— hexane at speci- lene at specified fied temperatures temperatures

3.2a. Olefin copolymers described in para- 0.85–1.00 ...... 2.6 pct at 50 °C Do. graph (a)(3)(i) of this section for use in arti- cles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(c)(2) of this section and listed in item 3.2b of this table; except that olefin copolymers containing 89 to 95 percent ethylene with the remainder being 4-methyl-pentene-1 contacting food Types III, IVA, V, VIIA, and IX identified in § 176.170(c) of this chapter, table 1, shall not exceed 0.051 millimeter (mm) (0.002 inch (in)) in thickness when used under conditions of use A and shall not exceed 0.102 mm (0.004 in) in thickness when used under conditions of use B, C, D, E, and H described in § 176.170(c) of this chapter, table 2. Additionally, olefin copoly- mers described in (a)(3)(i)(a)(2) of this sec- tion may be used only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2, in con- tact with all food types identified in § 176.170(c) of this chapter, table 1 3.2b. Olefin copolymers described in para- Do. graph (a)(3)(i)(c)(2) of this section have a melt flow index no greater than 10 grams per 10 minutes as determined by the meth- od described in paragraph (d)(7) of this sec- tion, and the thickness of the finished poly- mer contacting food shall not exceed 0.025 mm (0.001 in). Additionally, optional adju- vants permitted for use in olefin copolymers complying with item 3.2a of this table may be used in the production of this copolymer 3.. Olefin copolymers described in para- 0.85–0.92 graph (a)(3)(i)(a)(4) of this section have a melt flow index no greater than 50 grams per 10 minutes as determined by the meth- od described in paragraph (d)(7) of this sec- tion. Articles manufactured using these polymers may be used with all types of food under conditions of use C through H as de- scribed in table 2 of § 176.170(c) of this chapter 3.3a. Olefin copolymers described in para- graph (a)(3)(ii) of this section and manufac- tured with 1-alkenes having from 6 to 10 carbon atoms 3.3b. Olefin copolymers described in para- graph (a)(3)(ii) of this section, provided that such olefin polymers have a melt tempera- ture of 220 °C to 250 °C (428 °F to 482 °F) as determined by the method described in paragraph (d)(8) of this section and min- imum intrinsic viscosity of 1.0 as determined in paragraph (d)(9) of this section.

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Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)— hexane at speci- lene at specified fied temperatures temperatures

3.4. Olefin copolymers, primarily non-crys- 0.85–0.90 talline, described in par. (a)(3) (iii) of this section provided that such olefin polymers have a minimum viscosity average molec- ular weight of 120,000 as determined by the method described in par. (d)(5) of this sec- tion and a minimum Mooney viscosity of 35 as determined by the method described in par. (d)(6) of this section, and further pro- vided that such olefin copolymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, III, IV-B, VI, VII, VIII, and IX 3.5. Olefin copolymers, primarily non-crys- 0.85–0.90 talline, described in paragraph (a)(3)(iv) of this section, provided that such olefin poly- mers have a minimum viscosity average molecular weight of 95,600 as determined by the method described in paragraph (d)(5) of this section, and further provided that such olefin polymers are used only in blends with olefin polymers described under items 1.1, 2.1, and 2.2 of this table at a maximum level of 25 pct by weight, and provided that such olefin copolymers con- tact food only of the types identified in § 176.170 (c) of this chapter, table 1, under Types I, II, IV-B, VI, VII-B, and VIII at tem- peratures not exceeding 190 °F 3.6. Olefin copolymers described in para- Not less than 0.88 graph (a)(3)(v) of this section for use in blends with olefin polymer resins have a melt flow index no greater than 5 grams/10 minutes as determined by the method de- scribed in paragraph (d)(7) of this section and the thickness of the finished blends shall not exceed 0.1 millimeter (0.004 inch). The ethylene/butene-1 copolymer may be used subject to the following conditions: (1) For use at a level not to exceed 20 weight percent in polypropylene as described under item 1.1 of this table. (2) For use at a level not to exceed 40 weight percent in polyethylene as described under items 2.1 and 2.2 of this table. (3) For use at a level not to exceed 40 weight percent in olefin copolymers as described under items 3.1 and 3.2 of this table

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Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)— hexane at speci- lene at specified fied temperatures temperatures

3.7. Ethylene/propylene copolymers, meeting Not less than 0.86 the identity described in paragraph (a)(3)(i) of this section, containing not less than 80 mole-percent of polymer units derived from ethylene and having a minimum viscosity average molecular weight of 95,000 as de- termined by the method described in para- graph (d)(5) of this section, and a minimum Mooney viscosity of 13 as determined by the method described in paragraph (d)(6) of this section. Ethylene/propylene copolymers described in this item 3.7 are to be used only in blends with other olefin polymers complying with this section, at levels not to exceed 30 percent by weight of the total polymer blend, and in contact with food only of types identified in § 176.170(c) of this chapter, Table 1, under Types I, II, III, IV-B, VI, VII, VIII, and IX. Additionally, optional adjuvants permitted for use in olefin copoly- mers complying with item 3.4 of this table may be used in the production of this copolymer 3.8. Olefin polymers described in paragraph (a)(3)(vi) of this section, having a melt flow index not to exceed 9.2 grams per 10 min- utes as determined by the method de- scribed in paragraph (d)(7) of this section, for use in blends with other polymers at lev- els not to exceed 8 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV-A, V, VI-C, VII-A, and IX, identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under condi- tions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.9. Olefin copolymers described in paragraph Not less than 1.0 (a)(3)(vii) of this section may only be used in contact with dry foods, Type VIII, as iden- tified in § 176.170(c) of this chapter, Table 1 4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux 7.5 pct at 25 °C temperature 5. Polyethylene copolymer described in para- Not less than 0.94 ...... 0.45 pct at 15 °C 1.8 pct at 25 °C graph (a)(5) of this section and having a melt index not to exceed 2, for use, either alone or in blends with other olefin poly- mers, subject to the limitation that when contacting foods of types III, IV-A, V, VI-C, VII-A, VIII, and IX identified in § 176.170(c) of this chapter, table 1, the thickness of the film (in mils) containing the polyethylene graft copolymer times the concentration of the polyethylene graft copolymer shall not exceed a value of 2 6. Ethylene-maleic anhydride copolymers de- 0.92 or greater ...... 1.36 pct at 50 °C 2.28 pct at 25 °C scribed in paragraph (a)(6) of this section for use as the adhesive component in multi- laminate structures, or as the sealant layer in flexible packaging, in contact with food at temperatures not exceeding 49 °C (120 °F)

(d) The analytical methods for deter- this section are as follows, and are ap- mining whether olefin polymers con- plicable to the basic polymer in film form to the specifications prescribed in form not exceeding 4 mils in thickness.

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The film to be tested shall be cut into polypropylene, and poly(methylpentene). approximately 1-inch squares by any A sample is refluxed in the solvent for convenient method that avoids con- 2 hours and filtered at the boiling tamination by dust, dirt, or grease point. The filtrate is evaporated and (NOTE: Do not touch samples with bare the total residue weighed as a measure fingers—use forceps to hold or transfer of the solvent extractable fraction. samples). (a) Apparatus. (1) Erlenmeyer flasks, (1) Density. Density shall be deter- 250-milliliter, with ground joint. mined by ASTM method D1505–68 (Re- (2) Condensers, Allihn, 400-millimeter approved 1979), ‘‘Standard Test Method jacket, with ground joint. for Density of Plastics by the Density- (3) Funnels, ribbed 75-millimeter di- Gradient Technique,’’ which is incor- ameter, stem cut to 40 millimeters. porated by reference. Copies may be (4) Funnels, Buchner type, with obtained from the American Society coarse-porosity fritted disc, 60-milli- for Testing Materials, 100 Barr Harbor meter diameter. Dr., West Conshohocken, Philadelphia, ( ) Bell jar for vacuum filtration into PA 19428-2959, or may be examined at 5 the National Archives and Records Ad- beaker. ministration (NARA). For information (b) Reagent. n-Hexane, commercial ° on the availability of this material at grade, specific gravity 0.663–0.667 (20 C/ ° ° ° NARA, call 202–741–6030, or go to: http:// 20 C), boiling range 66 C-69 C, or www.archives.gov/federallregister/ equivalent. codeloflfederallregulations/ (c) Procedure. Weigh 1 gram of sample ibrllocations.html. accurately and place in a 250-milliliter (2) Melting point or softening point—(i) Erlenmeyer flask containing two or Melting point. The melting point shall three boiling stones. Add 100 milliliters be determined by ASTM method D2117– of solvent, attach the flask to the con- 82, ‘‘Standard Test Method for Melting denser (use no grease), and reflux the Point of Semicrystalline Polymers by mixture for 2 hours. Remove the flask the Hot Stage Microscopy Method,’’ from the heat, disconnect the con- which is incorporated by reference. The denser, and filter rapidly, while still availability of this incorporation by hot, through a small wad of glass wool reference is given in paragraph (d)(1) of packed in a short-stem funnel into a this section. tared 150-millimeter beaker. Rinse the (ii) Softening point. The softening flask and filter with two 10-milliliter point shall be determined by ASTM portions of the hot solvent, and add the method E28–67 (Reapproved 1982), rinsings to the filtrate. Evaporate the ‘‘Standard Test Method for Softening filtrate on a stream bath with the aid Point by Ring-and-Ball Apparatus,’’ of a stream of nitrogen. Dry the res- which is incorporated by reference. The idue in a vacuum oven at 110 °C for 2 availability of this incorporation by hours, cool in a desiccator, and weigh reference is given in paragraph (d)(1) of to the nearest 0.0001 gram. Determine this section. the blank on 120 milliliters of solvent (3) Maximum extractable fraction in n- evaporated in a tared 150-milliliter hexane—(i) Olefin copolymers described beaker. Correct the sample residue for in paragraph (a)(3)(ii) of this section, this blank if significant. Calculation:

Grams of residue = Percent extractable with n-hexane. Grams of sample ×100

(ii) Olefin copolymers described in para- residue weighed as a measure of the graph (a)(3)(i) of this section and poly- solvent extractable fraction. Alter- ethylene. A preweighed sample is ex- natively, the sample is reweighed after tracted at 50 °C for 2 hours and filtered. the extraction period to give a measure The filtrate is evaporated and the total of the solvent extractable fraction. The

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maximum n-hexane-extractable frac- vent temperature has reached 50 °C, tion may be determined by the meth- disconnect the heater, remove the resin ods set forth in paragraphs (d)(3)(ii)(a) kettle from the heating jacket, and de- through (d)(3)(ii)(i) of this section. cant the solvent, while still warm, (a) Extraction apparatus. Two-liter, through a coarse filter paper placed on straight-walled, Pyrex (or equivalent) top of a fritted-glass funnel, collecting resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity. ient for this purpose. The cover is Determine the weight of the filtrate re- fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery stirrer driven by an air motor or explo- should be at least 90 percent of the sion-proof electric motor, and a reflux original solvent. Losses due to evapo- condenser. The kettle is fitted with an ration during heating and filtering electric heating mantle of appropriate have been found not to exceed 10 per- size and shape, which is controlled by a cent. Transfer about half of the solvent variable-voltage transformer. filtrate to a 1-liter beaker placed on an (b) Evaporating apparatus. Rapid opening in the steam bath and imme- evaporation of large volumes of solvent diately cover with the special ‘‘gas’’ requires special precautions to prevent cover, the inlet tube of which has been contamination by dust. This is facili- attached with flexible tetrafluoro- tated by a special ‘‘gas’’ cover con- ethylene tubing to a source of high-pu- sisting of an inverted flat Pyrex crys- rity nitrogen in series with a stainless tallizing dish of an appropriate size (190 steel heating coil immersed directly in millimeters × 100 millimeters) to fit a the body of the steam bath. Maintain a 1-liter beaker. Through the center of positive flow of warm nitrogen gas the dish are sealed an inlet tube for throughout the evaporation of the sol- preheated, oxygen-free nitrogen, and an outlet tube located 1 inch off center. vent, adding the remainder of the fil- Nitrogen is fed from the supply source trate from the Erlenmeyer flask as the evaporation proceeds. When the volume through a coil of 1⁄4-inch stainless steel tubing immersed in the same steam of the solvent has been reduced to bath used to supply heat for solvent about 50 milliliters, transfer the con- evaporation. All connections are made centrated liquid to a previously tared with flexible tetrafluoroethylene tub- weighing dish of suitable size. Wash the ing. beaker twice with 20–30 milliliter por- (c) Reagents—(1) n-Hexane. Spectro- tions of warm solvent, adding the grade n-hexane. washings to the weighing dish while (2) Nitrogen. High-purity dry nitrogen continuing to evaporate the remainder containing less than 10 parts per mil- of the solvent under the gas cover with lion of oxygen. its flow of warm nitrogen directed to- (d) Procedure. Transfer 2.5 grams (ac- ward the center of the dish. In the curately weighed to nearest 0.001 gram) event that an insoluble residue that of the polymer to the resin kettle. Add cannot be removed with warm solvent 1 liter of solvent and clamp top in posi- remains in the beaker, it may be nec- tion. Start water flowing through jack- essary to heat with a small amount of et of the reflux condenser and apply air a higher boiling solvent such as ben- pressure to the stirring motor to zene or toluene, transferring these produce vigorous agitation. Turn on washings to the weighing dish before heating jacket with transformer set at final evaporation to dryness. Transfer a predetermined voltage to bring the the weighing dish with its residue to a temperature of the contents to 50 °C vacuum desiccator, and allow it to re- within 20–25 minutes. As the thermom- main overnight (at least 12 hours), eter reading approaches 45 °C–47 °C, re- after which the net weight of the dry duce the voltage to the predetermined residue is determined to the nearest setting that will just maintain the 0.0001 gram. Correct the result for any temperature at 50 °C. Do not overshoot solvent blank equivalent to the non- the prescribed temperature. Should volatile matter determined to be con- this occur discard the test and start tained in the amount of solvents used afresh. Exactly 2 hours after the sol- in the test.

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(e) Extraction apparatus for alternate should be prepared by the same process method. Two-liter extraction vessel, as will be used with the production such as a resin kettle or round bottom resin. Using gloves and metal tweezers flask, fitted with an Allihn condenser to avoid sample contamination, cut (size C), a 45/50 male joint with a Teflon about 2.7 grams of the prepared film (4 sleeve, and a Teflon coated stir bar. mils or less in thickness) into about 1- Water bath maintained at 49.5 °C ±0.5 inch squares using clean sharp scissors. °C containing a submersible magnetic Proceed with Option 1 or 2. stirrer motor with power supply. Other Option 1. Using tweezers and noting suitable means of maintaining tem- the number of film pieces, transfer 2.5 perature control, such as electric heat- grams (accurately weighed to 0.1 milli- ing mantles, may be used provided that gram) of polymer to the extraction ves- the temperature range can be strictly sel. Extract the film sample for 2 maintained. hours. Allow the vessel to cool and fil- (f) Sample basket (Optional). A per- ter the contents through a fritted por- forated stainless steel cylindrical bas- ket that is approximately 1.5 inches in celain funnel. Wash the film pieces diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry- forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a 33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to The basket should pass freely through verify that none were lost during the the 45/50 female joint of the extraction transfer. Place the beaker in the vacu- flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80 °C ±5 °C. After bolt is attached to the lid for posi- 2 hours, remove and place in a desic- tioning the basket in the extraction cator to cool to room temperature vessel. The positioning rod, approxi- (about 1 hour). After cooling, reweigh mately 18 inches long and made from the film pieces to the nearest 0.1 milli- 1⁄16 inch outside diameter 316 stainless gram. Calculate the percent hexane- steel welding rod or equivalent and extractables content from the weight hooked at both ends, is used to position loss of the original sample. Multiply the basket in the extraction apparatus. the result by 0.935 and compare with (g) Vacuum oven. Capable of main- extraction limits in paragraph (c) of taining 80 °C ±5 °C and a minimum of this section. Repeat the above proce- 635 millimeters of mercury pressure. dure for successive samples. (h) Reagents. n-Hexane, reagent or Option 2. Transfer 2.5±0.05 grams of spectrograde, aromatic free (less than 1 the prepared 1-inch film sections into a milligram per liter), minimum 85 per- tared sample basket and accurately cent n-hexane. This reagent may be re- weigh to the nearest 0.1 milligram. used until it contains a maximum of 1.5 Carefully raise the condenser until the grams polyolefin extractables or has hook on the positioning rod is above been used for 12 determinations. the neck of the 2-liter extraction ves- (i) Procedure. Assemble the extraction sel. The basket should be totally below vessel, condenser, and magnetic stir the level of n-hexane solvent. Extract bar. Add n-hexane (1 liter) to the ex- the sample resin film for 2 hours and traction vessel and clamp the assembly into a water bath set at 49.5 °C ±0.5 °C. then raise the basket above the solvent Start the water flowing through the level to drain momentarily. Remove jacket of the reflux condenser. Adjust the basket and rinse the contents by the air flow through the stirring motor immersing several times in fresh n- to give a smooth and uniform stir rate. hexane. Allow the basket to dry be- Allow the n-hexane to preheat for 1 tween rinsings. Remove the excess sol- hour to bring the temperature to 49.5 vent by briefly blowing the basket with °C±0.5 °C. Temperature is a critical fac- a stream of nitrogen or dry air. Place tor in this analysis and it must not the basket in the vacuum oven for 2 vary more than 1 °C. If the temperature hours at 80 °C ±5 °C. After 2 hours, re- exceeds these limits, the test must be move and place in a desiccator to cool discontinued and restarted. Blown, to room temperature (about 1 hour). compression molded, or extrusion cast After cooling, reweigh the basket to films can be tested. Ideally, the film the nearest 0.1 milligram. Calculate

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the percent hexane extractables con- thylamine in 1 liter of industrial grade tent from the weight loss of the origi- xylene having specific gravity 0.856– nal sample. Multiply the result by 0.935 0.867 (20 °C/20 °C) and boiling range 123 and compare with extraction limits in °C–160 °C. paragraph (c) of this section. Repeat (c) Procedure. Weigh 1 to 2 grams of the above procedure for successive sample to the nearest 0.001 gram and samples. The same solvent charge place in a 125-milliliter Pyrex reagent should remain clear and can be used for bottle containing a 1-inch long tetra- at least 12 determinations. Applica- fluoroethylene-resin-coated stirring tions of solvent reuse should be con- bar. Add 100 milliliters of solvent, set firmed for each resin type before use. the stopper in lightly, and place the (4) Maximum soluble fraction in xy- bottle in the heating mantle or alu- lene—(i) Olefin copolymers described in minum block maintained at a tempera- paragraph (a)(3)(ii) of this section, poly- ture of 120 °C, and stir with a magnetic propylene, and poly(methylpen-tene). A stirrer until the sample is completely sample is dissolved completely in xy- dissolved. Remove the bottle from the lene by heating and stirring in a bottle heat and allow it to cool 1 hour in the with little free space. The solution is air, without stirring. Then place the allowed to cool without stirring, bottle in a water bath maintained at 25 whereupon the insoluble portion pre- °C ±0.5 °C, and allow to stand 1 hour cipitates and is filtered off; the total without stirring. Next, remove the bot- solids content of the filtrate is then de- tle from the water bath, shake, and termined as a measure of the soluble pour part of the contents into the fraction. coarse-porosity fritted-glass funnel. (a) Apparatus. (1) Pyrex (or equiva- Apply suction, and draw 30–40 milli- lent) reagent bottle, 125-milliliter, liters of filtrate through, adding more glass-stoppered. slurry to the funnel, and catching the (2) Heating mantle of size for 150-mil- filtrate in a large test tube. (If the liliter beaker (or suitable aluminum slurry is hard to filter, add 10 grams of block to fit the 125-milliter bottle de- diatomaceous earth filter aid to the scribed in paragraph (d)(4)(i)(a)(1) of bottle and shake vigorously just prior this section. to the filtration.) Pipet a suitable ali- (3) Magnetic stirrer for use under the quot (preferably 20 milliliters) of the heating mantle (combination magnetic filtrate into a tared aluminum dispos- stirrer and hotplate may be used if alu- able dish. Place the dish on a steam minum block is used in place of heat- bath covered with a fresh sheet of alu- ing mantle). minum foil and invert a short-stemmed (4) Variable-voltage transformer, 7.5 4-inch funnel over the dish. Pass nitro- amperes. gen (heated if desired) down through (5) Tetrafluoroethylene-resin-coated the funnel at a rate sufficient to just stirring bar, 1-inch long. ripple the surface of the solvent. When (6) Constant temperature water bath the liquid has evaporated, place the maintained at 25 °C±0.5 °C. dish in a vacuum oven at 140 °C and (7) Aluminum dishes, 18 millimeters × less than 50 millimeters mercury pres- 60 millimeters, disposable. sure for 2 hours. Cool in a desiccator (8) Funnel, Buchner type, with and weigh. (Note: If the residue value coarse-porosity fritted disc, 30–60 milli- seems high, redry in the vacuum oven meter diameter. for one-half hour to ensure complete (b) Reagent. Xylene with antioxidant. removal of all xylene solvent.) Calcula- Dissolve 0.020 gram of phenyl-b- naph- tion:

Grams of residue 100 milliters ××=100 Percent soluble in xylene Grams of sample volume of aliquot in milliliters

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(ii) Olefin copolymers described in para- reflux condenser and apply full voltage graph (a)(3)(i) of this section and poly- (115 volts) to the heating mantle. When ethylene. A sample is extracted in xy- the xylene starts to boil, reduce the lene at reflux temperature for 2 hours voltage to a level just sufficient to and filtered. The filtrate is evaporated maintain reflux. After refluxing for at and the total residue weighed as a least 2 hours, disconnect the power measure of soluble fraction. source to the mantle, remove the ket- (a) Apparatus—(1) Extraction appa- tle, and allow to cool in air until the ratus. Two-liter, straight-walled Pyrex temperature of the contents drops to 50 (or equivalent) resin kettles, fitted °C, after which the kettle may be rap- with ground-glass covers, are most con- idly cooled to 25 °C–30 °C by immersing venient for this purpose. The cover is in a cold water bath. Transfer the ket- equipped with a thermometer and an tle to a constant temperature bath set efficient reflux condenser. The kettle is to maintain 25 °C ±0.1 °C, and allow to fitted with an electric heating mantle equilibrate for a least 1 hour (may be of appropriate size and shape which is left overnight if convenient). Break up controlled by a variable-voltage trans- any precipitated polymers that may former. have formed, and decant the xylene so- (2) Constant temperature water bath. It lution successively through a fast filter must be large enough to permit immer- paper and then through a fritted-glass sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer maintain 25 °C ±0.1 °C. flask, collecting only the first 450 mil- (3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any consisting of a flat Pyrex crystallizing attempt to collect more of the xylene dish (190 millimeters × 100 millimeters) solution usually results in clogging the inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the through center and an outlet tube 1 weight of the filtrate obtained to the inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate, cover is inserted in an electric heating quantitatively, from the Erlenmeyer mantle equipped with a variable-volt- flask to the 1-liter beaker, insert the age transformer. The outlet tube is at- beaker in its heating mantle, add a tached to an efficient condenser glass-coated magnetic stirring bar, and mounted on a receiving flask for sol- mount the gas cover in place, con- vent recovery and having an outlet for necting the inlet tube to the nitrogen connection to an aspirator pump. The source and the outlet to the condenser heating mantle (with the beaker) is of the receiving flask. Start a flow of mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into An infrared heat lamp is mounted the gas cover and connect an aspirator vertically 3–4 inches above the gas to the receiver using a free-flow rate cover to prevent condensation of the equivalent to 6–7 liters of air per solvent inside the cover. Make all con- minute. With the infrared lamp on, ad- nections with flexible tetrafluoro- just the voltage to the heating mantle ethylene tubing. to give a distillation rate of 12–13 milli- (b) Reagents—(1) Xylene. American liters per minute when the magnetic Chemical Society reagent grade that stirrer is revolving just fast enough to has been redistilled through a promote good boiling. When the vol- fractionating column to reduce the ume of solvent in the beaker has been nonvolatile residue. reduced to 30–50 milliliters, transfer (2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit- containing less than 104 parts per mil- able weighing dish that has been pre- lion oxygen. viously tared (dry). Rinse the beaker (c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the 1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain- and clamp top in position after insert- der of the xylene on an electric ing a piece of glass rod to prevent hotplate set at low heat under the gas bumping during reflux. Start water cover with a stream of nitrogen di- flowing through the jacket of the rected toward the center of the dish.

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Avoid any charring of the residue. termined at 100 °C. The apparatus con- Transfer the weighing dish to a vacu- taining the sample is warmed for 1 um desiccator at room temperature minute, run for 8 minutes, and vis- and allow to remain under reduced cosity measurements are then made. pressure for at least 12 hours (over- (7) Melt flow index. The melt flow night), after which determine the net index of olefin polymers described weight of the residue to the nearest below shall be determined by ASTM 0.0001 gram. Correct the result for non- method D–1238–82, ‘‘Standard Test volatile solvent blank obtained by Method for Flow Rates of Thermo- evaporating the equivalent amount of plastics by Extrusion Plastometer,’’ xylene under identical conditions. Cal- which is incorporated by reference in culate the weight of residue originally accordance with 5 U.S.C. 552(a). The present in the total weight of solvent availability of this incorporation by (840 grams), using the appropriate fac- reference is given in paragraph (d)(1) of tor based on the weight of filtrate this section. The olefin polymers and evaporated. test conditions and procedures are as (5) Viscosity average molecular weight follows: olefin copolymers described in paragraphs List of polymers Conditions/procedures (a)(3) (iii) and (iv) of this section. The viscosity average molecular weight Olefin copolymers described in para- Condition L, proce- shall be determined from the kine- graph (a)(3)(i)(c)(2) of this section. dure A. Olefin copolymers described in para- Condition E, proce- matic viscosity (using ASTM method graph (a)(3)(v) of this section. dure A. D445–74, ‘‘Test for Kinematic Viscosity Olefin polymers described in para- Condition E, proce- of Transparent and Opaque Liquids’’ graph (a)(2)(ii) of this section. dure A. Olefin polymers described in para- Condition E, proce- (Revised 1974), which is incorporated by graph (a)(3)(vi) of this section. dure A. reference; copies are available from American Society for Testing and Ma- (8) Melting peak temperature. The melt terials (ASTM), 100 Barr Harbor Dr., temperature of the olefin polymers de- West Conshohocken, Philadelphia, PA scribed in paragraph (a)(3)(ii) of this 19428-2959, or available for inspection at section shall be determined by ASTM the National Archives and Records Ad- method D 3418–82, ‘‘Standard Test ministration (NARA). For information Method for Transition Temperatures of on the availability of this material at Polymers by Thermal Analysis,’’ which NARA, call 202–741–6030, or go to: http:// is incorporated by reference in accord- www.archives.gov/federallregister/ ance with 5 U.S.C. 552(a). The avail- codeloflfederallregulations/ ability of this incorporation by ref- ibrllocations.html.) of solutions of the erence is given in paragraph (d)(1) of copolymers in solvents and at tempera- this section. tures as follows: (9) Intrinsic viscosity. The intrinsic (i) Olefin polymers described in para- viscosity of the olefin polymers de- graph (a)(3)(iii) of this section in scribed in paragraph (a)(3)(ii) of this decahydronaphthalene at 135 °C. section shall be determined by ASTM (ii) Olefin polymers described in method D 1601–78, ‘‘Standard Test paragraph (a)(3)(iv) of this section in Method for Dilute Solution Viscosity tetrachloroethylene at 30 °C. of Ethylene Polymers,’’ which is incor- (6) Mooney viscosity—olefin copolymers porated by reference in accordance described in paragraph (a)(3)(iii) of this with 5 U.S.C. 552(a). The availability of section. Mooney viscosity is determined this incorporation by reference is given by ASTM method D1646–81, ‘‘Standard in paragraph (d)(1) of this section. Test Method for Rubber—Viscosity and (e) Olefin copolymers described in Vulcanization Characteristics (Mooney paragraph (a)(3) (i) of this section and Viscometer),’’ which is incorporated by polyethylene, alone or in combination, reference (the availability of this in- may be subjected to irradiation bom- corporation by reference is given in bardment from a source not to exceed paragraph (d)(1) of this section), using 2.3 million volts intensity to cause mo- the large rotor at a temperature of 100 lecular crosslinking of the polymers to °C, except that a temperature of 127 °C impart desired properties, such as in- shall be used for those copolymers creased strength and increased ability whose Mooney viscosity cannot be de- to shrink when exposed to heat.

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(f) The olefin polymers identified in (3) Substances authorized under ap- and complying with this section, when plicable regulations in this part and in used as components of the food-contact parts 175 and 178 of this chapter and surface of any article that is the sub- subject to any limitations prescribed ject of a regulation in parts 174, 175, therein. 176, 177, 178, and § 179.45 of this chapter, (4) The following substances, subject shall comply with any specifications to any limitations prescribed: and limitations prescribed by such reg- ulation for the article in the finished List of substances Limitations form in which it is to contact food. Lithium polysilicate containing For use only as a compo- (g) The provisions of this section are not more than 20 weight per- nent of repeated-use not applicable to olefin polymers iden- cent silica, not more than 2.1 coatings not exceeding tified in § 175.105(c) (5) of this chapter percent lithium oxide and 0.030 millimeter (0.0012 and used in food-packaging adhesives having a maximum mole inch) in thickness where ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally complying with § 175.105 of this chapter. cured at minimum sinter- [42 FR 14572, Mar. 15, 1977] ing temperatures of 371 °C (700 °F). Lithium ex- EDITORIAL NOTE: For FEDERAL REGISTER ci- tractives shall not exceed tations affecting § 177.1520, see the List of 1.55 milligrams per CFR Sections Affected, which appears in the square decimeter (0.1 milligram per square inch) Finding Aids section of the printed volume of coating surface when and at www.fdsys.gov. tested in accordance with paragraph (e)(2) of this § 177.1550 Perfluorocarbon resins. section. Naphthalene sulfonic acid For use only: Perfluorocarbon resins identified in formaldehyde condensate, 1. As a component of re- this section may be safely used as arti- sodium salt. peated-use coatings, cles or components of articles intended based on the to contact food, subject to the provi- perfluorocarbon resin identified in paragraph sions of this section: (a)(1) of this section, not (a) Identity. For the purpose of this to exceed 0.030 milli- section, perfluorocarbon resins are meter (0.0012 inch) in those produced by: (1) The thickness, and at a level not to exceed 0.4 weight homopolymerization and/or copolym- percent of the coating. erization of hexafluoropropylene and 2. As a component of re- tetrafluoroethylene, and (2) the co- peated-use coatings, based on the polymerization of perfluorocarbon resin perfluoropropylvinylether and tetra- identified in paragraph fluoroethylene (CAS Reg. No. 26655–00– (a)(2) of this section, not 5). The resins shall meet the extrac- to exceed 0.10 millimeter (0.004 inch) in thickness, tives limitations in paragraph (d) of and at a level not to ex- this section. ceed 0.4 weight percent (b) Optional components. The of the coating. perfluorocarbon resins identified in paragraph (a) of this section as well as (c) Optional processing. Poly- tetra- articles or coating made from these fluoroethylene resins may be irradi- resins may include the following op- ated by either a cobalt-60 sealed tional components except that the source, at a maximum dose of gamma resin identified in paragraph (a)(2) of radiation not to exceed 7.5 megarads, this section may not be used with the or an electron beam at energy levels optional component, lithium not to exceed 2.5 million electron volts polysilicate, mentioned in paragraph with a maximum dosage of 7.5 (b)(4) of this section. megarads, to produce lubricant pow- (1) Substances generally recognized ders having a particle diameter of not as safe (GRAS) in food or food pack- more than 20 microns for use only as aging subject to any limitations cited components of articles intended for re- on their use. peated use in contact with food. (2) Substances used in accordance (d) Specifications—(1) Infrared identi- with a prior sanction or approval, sub- fication. Perfluorocarbon resins can be ject to any limitations cited in the identified by their characteristic infra- prior sanction or approval. red spectra.

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(2) Melt-viscosity. (i) The perfluoro- this material at NARA, call 202–741– carbon resins identified in paragraph 6030, or go to: http://www.archives.gov/ (a)(1) of this section shall have a melt federallregister/ viscosity of not less than 104 poises at codeloflfederallregulations/ 380 °C (716 °F) as determined by ASTM ibrllocations.html. The requirements of method D1238–82, ‘‘Standard Test Meth- this paragraph do not apply to poly- od for Flow Rates of Thermoplastics by tetrafluoroethylene resin lubricant Extrusion Plastometer,’’ which is in- powders described in paragraph (c) of corporated by reference. Copies may be this section. obtained from the American Society (e) Limitations. 1 (1) Perfluorocarbon- for Testing Materials, 100 Barr Harbor molded articles having a surface area Dr., West Conshohocken, Philadelphia, of 6.45 square decimeters (100 square PA 19428-2959, or may be examined at inches) or more and at least 1.27 milli- the National Archives and Records Ad- meters (0.05 inch) thick shall be ex- ministration (NARA). For information tracted at reflux temperatures for 2 on the availability of this material at hours separately with distilled water, NARA, call 202–741–6030, or go to: http:// 50 percent ethanol, n-heptane, and www.archives.gov/federallregister/ ethyl acetate. codeloflfederallregulations/ (2) Perfluorocarbon resins identified ibrllocations.html. The melt viscosity in paragraphs (a)(1) and (2) of this sec- of the perfluorocarbon resins identified tion and intended for use as coatings or in paragraph (a)(1) of this section shall components of coatings shall meet not vary more than 50 percent within extractability limits prescribed in one-half hour at 380 °C (716 °F). paragraph (e)(3) of this section when (ii) Perfluorocarbon resins identified the resins in the form of coatings de- in paragraph (a)(2) of this section shall scribed in paragraphs (e)(2) (i) and (ii) have a melt viscosity of not less than of this section are extracted at reflux 104 poises at 372 °C (702 °F) as deter- temperatures for 2 hours separately mined by a more detailed method ti- with distilled water, 8 percent ethanol, tled ‘‘Determination of Melt Viscosity, and n-heptane: Molecular Weight Distribution Index (i) Perfluorocarbon resin coatings and Viscosity Stability,’’ which is in- based on resins identified in paragraph corporated by reference. Copies are (a)(1) of this section shall be applied to available from the Center for Food both sides of a 0.025-millimeter (0.001 Safety and Applied Nutrition (HFS– inch) thick aluminum foil to a thick- 200), Food and Drug Administration, ness of 0.025 millimeter (0.001 inch) 5001 Campus Dr., College Park, MD after thermal curing at 399 °C (750 °F) 20740, or available for inspection at the for 10 minutes. If a primer is used, the National Archives and Records Admin- total thickness of the primer plus top- istration (NARA). For information on coat shall equal 0.025 millimeter (0.001 the availability of this material at inch) after heat curing. NARA, call 202–741–6030, or go to: http:// (ii) Perfluorocarbon resin coatings www.archives.gov/federallregister/ based on resins identified in paragraph codeloflfederallregulations/ (a)(2) of this section shall be applied to ibrllocations.html. both sides of a 0.025-millimeter (0.001 (3) Thermal instability index. The ther- mal instability index of the tetra- 1 A more detailed procedure of extraction fluoroethylene homopolymer shall not conditions is entitled, ‘‘Preparation of Ex- exceed 50 as determined by ASTM tracts,’’ which is incorporated by reference. method D1457–56T, ‘‘Test for Thermal Copies are available from the Center for Instablility index of Tetrafluoro- Food Safety and Applied Nutrition (HFS– ethylene Homopolymer’’ (Revised 1956), 200), Food and Drug Administration, 5001 which is incorporated by reference. Campus Dr., College Park, MD 20740, or Copies are available from University available for inspection at the National Ar- Microfilms International, 300 N. Zeeb chives and Records Administration (NARA). For information on the availability of this Rd., Ann Arbor, MI 48106, or available material at NARA, call 202–741–6030, or go to: for inspection at the National Archives http://www.archives.gov/federallregister/ and Records Administration (NARA). codeloflfederallregulations/ For information on the availability of ibrllocations.html.

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inch) thick aluminum foil to a thick- (250 °F) for 2 hours, shall yield total ness of 0.10 millimeter (0.004 inch) after nonvolatile extractives not to exceed thermal curing at 427 °C (800 °F) for 10 2.33 micrograms per square centimeter minutes. If a primer is used, the total (15 micrograms per square inch) of the thickness of the primer plus topcoat exposed resin surface. shall equal 0.10 millimeter (0.004 inch) (d) Limitations. Polyarylate resin ar- after heat curing. ticles may be used in contact with all (3) The extracted surfaces shall meet foods except beverages containing the following extractability limits: more than 8 volume percent ethanol (i) Total extractives not to exceed 3.1 under conditions of use A through H, milligrams per square decimeter (0.2 described in table 2 of § 176.170(c) of this milligram per square inch). chapter. (ii) Fluoride extractives calculated as [52 FR 35540, Sept. 22, 1987] fluorine not to exceed 0.46 milligram per square decimeter (0.03 milligram § 177.1556 Polyaryletherketone resins. per square inch). The poly(oxy-1,4-phenylenecarbonyl- (f) Conditions of use. Perfluorocarbon 1,4-phenyleneoxy-1,4- resins identified in paragraph (a)(2) of phenylenecarbonyl-1,4- this section are limited to use as coat- phenylenecarbonyl-1,4-phenylene) res- ings or components of coatings for arti- ins (CAS Reg. No. 55088–54–5 and CAS cles intended for repeated food-contact Reg. No. 60015–05–6 and commonly re- use. ferred to as polyaryletherketone res- [43 FR 44834, Sept. 29, 1978, as amended at 47 ins) identified in paragraph (a) of this FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, section may be safely used as articles 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, or components of articles intended for Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR repeated use in contact with food, sub- 14481, Apr. 2, 1996] ject to the provisions of this section. (a) Identity. Polyaryletherketone res- § 177.1555 Polyarylate resins. ins consist of basic resins produced by Polyarylate resins (CAS Reg. No. reacting 4,4′-diphenoxy benzophenone 51706–10–6) may be safely used as arti- and terephthaloyl dichloride in such a cles or components of articles intended way that the finished resins have a for use in contact with food in accord- minimum weight average molecular ance with the following prescribed con- weight of 20,000 grams per mole, as de- ditions: termined by light scattering measure- (a) Identity. Polyarylate resins (1, 3- ments in sulfuric acid at room tem- benzenedicarboxylic acid, diphenyl perature. ester, polymer with diphenyl 1,4- (b) Optional adjuvant substances. The benzenedicarboxylate and 4-4′-(1- basic polyaryletherketone resins iden- methylethylidine) bis(phenol)) are tified in paragraph (a) of this section formed by melt polycondensation of may contain optional adjuvant sub- bisphenol-A with diphenylisophthalate stances required in the production of and diphenylterephthalate. such basic resins. These adjuvants may (b) Specifications. (1) The finished co- include substances used in accordance polymers shall contain from 70 to 80 with § 174.5 of this chapter and the fol- weight percent of polymer units de- lowing: rived from diphenylisophthalate and 20 (1) Benzoyl chloride, poly(tetrafluoro to 30 weight percent of polymer units ethylene). derived from diphenylterephthalate. (2) [Reserved] (2) Polyarylate resins shall have a (c) Extractive limitations. The finished minimum weight average molecular food-contact article yields net total ex- weight of 20,000. tractives in each extracting solvent (3) Polyarylate resins may be identi- not to exceed 0.052 milligram per fied by their characteristic infrared square inch (corresponding to 0.008 mil- spectra. ligram per square centimeter) of food- (c) Extractive limitations. The finished contact surface, when extracted at polyarylate resins in sheet form at reflux temperature for 2 hours with the least 0.5 millimeter (0.020 inch) thick, following solvents: Distilled water, 50 when extracted with water at 121 °C percent (by volume) ethyl alcohol in

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distilled water, 3 percent acetic acid paragraph and further identified as re- (by weight) in distilled water, and n- quired: heptane. (d) In testing the finished food-con- Substances Limitations tact article made of Sulfolane ..... Not to exceed 0.15 percent as residual sol- polyaryletherketone resin, use a sepa- vent in the finished basic resin. rate test sample for each required ex- tracting solvent. (c) Extractive limitations. The finished [61 FR 42381, Aug. 15, 1996] polyarylsulfone resin when extracted for 2 hours with the following solvents § 177.1560 Polyarylsulfone resins. at the specified temperatures yields total extractives in each extracting Polyarylsulfone resins (CAS Reg. No. 79293–56–4) may be safely used as arti- solvent not to exceed 0.008 milligram cles or components of articles intended per square centimeter of food-contact surface: distilled water at 121 °C (250 for use in contact with food, at tem- ° peratures up to and including normal F), 50 percent (by volume) ethyl alco- ° ° baking temperatures, in accordance hol in distilled water at 71.1 C (160 F), with the following prescribed condi- 3 percent acetic acid in distilled water ° ° tions: at 100 C (212 F), and n-heptane at 65.6 ° ° (a) Identity. Polyarylsulfone resins C (150 F). are copolymers containing not more NOTE: In testing the finished polyaryl- than 25 percent of oxy-p-phenylene- sulfone resin use a separate test sample for oxy-p-phenylenesulfonyl-p-phenylene each required extracting solvent. polymer units and not less than 75 per- [50 FR 31046, July 24, 1985] cent of oxy-p-phenylenesulfonyl-p- phenylene-oxy-p-phenylenesulfonyl-p- § 177.1570 Poly-1-butene resins and phenylene polymer units. The copoly- butene/ethylene copolymers. mers have a minimum reduced vis- The poly-1-butene resins and butene/ cosity of 0.40 deciliter per gram in 1- methyl-2-pyrrolidinone in accordance ethylene copolymers identified in this with ASTM method D2857–70 (Re- section may be safely used as articles approved 1977), ‘‘Standard Test Method or components of articles intended for for Dilute Solution Viscosity of Poly- use in contact with food subject to the mers,’’ which is incorporated by ref- provisions of this section. erence. Copies may be obtained from (a) Identity. Poly-1-butene resins are the American Society for Testing and produced by the catalytic polymeriza- Materials, 100 Barr Harbor Dr., West tion of 1-butene liquid monomer. Conshohocken, Philadelphia, PA 19428- Butene/ethylene copolymers are pro- 2959, or may be examined at the Na- duced by the catalytic polymerization tional Archives and Records Adminis- of 1-butene liquid monomer in the pres- tration (NARA). For information on ence of small amounts of ethylene the availability of this material at monomer so as to yield no higher than NARA, call 202–741–6030, or go to: http:// a 6-weight percent concentration of www.archives.gov/federallregister/ polymer units derived from ethylene in codeloflfederallregulations/ the copolymer. ibrllocations.html. (b) Specifications and limitations. Poly- (b) Optional adjuvant substances. The 1-butene resins and butene/ethylene co- basic polyarylsulfone resins identified polymers shall conform to the speci- in paragraph (a) of this section may fications prescribed in paragraph (b)(1) contain optional adjuvant substances of this section, and shall meet the required in the production of such extractability limits prescribed in basic copolymers. These optional adju- paragraph (b)(2) of this section. vant substances may include sub- (1) Specifications—(i) Infrared identi- stances permitted for such use by regu- fication. Poly-1-butene resins and lations in parts 170 through 179 of this butene/ethylene copolymers can be chapter, substances generally recog- identified by their characteristic infra- nized as safe in food, substances used in red spectra. accordance with a prior sanction of ap- (ii) Viscosity. Poly-1-butene resins and proval, and substances named in this the butene/ethylene copolymers have

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an intrinsic viscosity 1.0 to 3.2 as deter- contact with food under conditions of mined by ASTM method D1601–78, use B, C, D, E, F, G, or H described in ‘‘Standard Test Method for Dilute So- table 2 of § 176.170(c) of this chapter, lution Viscosity of Ethylene Poly- subject to the provisions of this section mers,’’ which is incorporated by ref- and provided that the maximum erence. Copies may be obtained from extractables from test films 0.1 to 0.2 the American Society for Testing Ma- millimeter (0.004 to 0.008 inch) in thick- terials, 100 Barr Harbor Dr., West ness do not exceed 0.80 percent by Conshohocken, Philadelphia, PA 19428- weight of the polymer when extracted 2959, or may be examined at the Na- in a soxhlet extractor for 6 hours with tional Archives and Records Adminis- refluxing 95 percent ethanol. tration (NARA). For information on (iii) Poly-1-butene resins may be used the availability of this material at as articles or components of articles NARA, call 202–741–6030, or go to: http:// intended for packaging or holding food www.archives.gov/federallregister/ during cooking, provided that the codeloflfederallregulations/ thickness of such polymers in the form ibrllocations.html. in which they contact food shall not (iii) Density. Poly-1-butene resins exceed 0.1 millimeter (0.004 inch) and have a density of 0.904 to 0.920 gms/cm3, yield maximum extractables of not and butene/ethylene copolymers have a more than 2.5 percent by weight of the density of 0.890 to 0.916 gms/cm3 as de- polymer when films are extracted for 2 termined by ASTM method D1505–68 hours at 50 °C (122 °F) in n-heptane. (Reapproved 1979), ‘‘Standard Test [42 FR 14572, Mar. 15, 1977, as amended at 49 Method for Density of Plastics by the FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, Density-Gradient Technique,’’ which is 1985] incorporated by reference. The avail- ability of this incorporation by ref- § 177.1580 Polycarbonate resins. erence is given in paragraph (b)(1)(ii) of Polycarbonate resins may be safely this section. used as articles or components of arti- (iv) Melt index. Poly-1-butene resins cles intended for use in producing, have a melt index of 0.1 to 24 and the manufacturing, packing, processing, butene/ethylene copolymers have a preparing, treating, packaging, trans- melt index of 0.1 to 20 as determined by porting, or holding food, in accordance ASTM method D1238–82, condition E, with the following prescribed condi- ‘‘Standard Test Method for Flow Rates tions: of Thermoplastics by Extrusion Plas- (a) Polycarbonate resins are poly- tometer,’’ which is incorporated by ref- esters produced by: erence. The availability of this incor- (1) The condensation of 4,4′-iso- poration by reference is given in para- propylidenediphenol and carbonyl chlo- graph (b)(1)(ii) of this section. ride to which may have been added cer- (2) Limitations. Poly-1-butene resins tain optional adjuvant substances re- and butene/ethylene copolymers for use quired in the production of the resins; in articles that contact food, and for or by articles used for packing or holding (2) The reaction of molten 4,4′-iso- food during cooking shall yield no propylidenediphenol with molten di- more than the following extractables: phenyl carbonate in the presence of the (i) Poly-1-butene resins may be used disodium salt of 4,4′-isopro- as articles or components of articles pylidenediphenol. intended for use in contact with food, (3) The condensation of 4,4′-isopro- provided that the maximum pylidenediphenol, carbonyl chloride, extractables do not exceed 2.5 percent and 0.5 percent weight maximum of by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to molded samples are tested for 2 hours which may have been added certain op- at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in (ii) Butene/ethylene copolymers con- the production of branched taining no more than 6 percent by polycarbonate resins. weight of polymer units derived from (b) The optional adjuvant substances ethylene may be used as articles or required in the production of resins components of articles intended for produced by the methods described in

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paragraph (a)(1) and (3) of this section in infant feeding bottles (baby bottles) may include substances generally rec- and spill-proof cups, including their ognized as safe in food, substances used closures and lids, designed to help train in accordance with a prior sanction or babies and toddlers to drink from cups approval, and the following: (sippy cups).

List of substances Limitations [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, p-tert-Butylphenol ...... 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Chloroform ...... Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR p-Cumylphenol (CAS Reg. For use only as a chain ter- No. 599–64–4). minator at a level not to ex- 41902, July 17, 2012] ceed 5 percent by weight of the resin. § 177.1585 Polyestercarbonate resins. Ethylene dichloride. Heptane. Polyestercarbonate resins may be Methylene chloride. safely used as articles or components Monochlorobenzene ...... Not to exceed 500 p.p.m. as of articles intended for use in pro- residual solvent in finished resin. ducing, manufacturing, packing, proc- Pentaerythritol tetrastearate For use only as a mold re- essing, preparing, treating, packaging, (CAS Reg. No. 115–83–3). lease agent, at a level not or holding food, in accordance with the to exceed 0.5 percent by following prescribed conditions: weight of the finished resin. Phenol (CAS Reg. No. 108– (a) Polyestercarbonate resins (CAS 95–2). Reg. No. 71519–80–7) are produced by the Pyridine. condensation of 4,4′- Toluene: (CAS Reg. No. Not to exceed 800 parts per 108–88–3). million as residual solvent isopropylidenediphenol, carbonyl chlo- in finished resin. ride, terephthaloyl chloride, and Triethylamine. isophthaloyl chloride such that the fin- ished resins are composed of 45 to 85 (c) Polycarbonate resins shall con- molepercent ester, of which up to 55 form to the specification prescribed in mole-percent is the terephthaloyl iso- paragraph (c)(1) of this section and mer. The resins are manufactured shall meet the extractives limitations using a phthaloyl chloride/carbonyl prescribed in paragraph (c)(2) of this chloride mole ratio of 0.81 to 5.7/1 and section. isophthaloyl chloride/terephthaloyl (1) Specification. Polycarbonate resins chloride mole ratio of 0.81/1 or greater. can be identified by their char- The resins are also properly identified acteristic infrared spectrum. by CAS Reg. No. 114096–64–9 when pro- (2) Extractives limitations. The duced with the use of greater than 2 polycarbonate resins to be tested shall but not greater than 5 weight percent be ground or cut into small particles p-cumylphenol (CAS Reg. No. 599–64–4), that will pass through a U.S. standard as an optional adjuvant substance in sieve No. 6 and that will be held on a accordance with paragraph (b)(2) of U.S. standard sieve No. 10. this section. (i) Polycarbonate resins, when ex- (b) Optional adjuvants. The optional tracted with distilled water at reflux adjuvant substances required in the temperature for 6 hours, shall yield production of resins identified in para- total extractives not to exceed 0.15 per- graph (a) of this section may include: cent by weight of the resins. (1) Substances used in accordance (ii) Polycarbonate resins, when ex- with § 174.5 of this chapter. tracted with 50 percent (by volume) (2) Substances identified in ethyl alcohol in distilled water at § 177.1580(b). reflux temperature for 6 hours, shall (3) Substances regulated in yield total extractives not to exceed § 178.2010(b) of this chapter for use in 0.15 percent by weight of the resins. polycarbonate resins complying with (iii) Polycarbonate resins, when ex- § 177.1580: tracted with n-heptane at reflux tem- perature for 6 hours, shall yield total Provided, That the substances are used extractives not to exceed 0.15 percent in accordance with any limitation on by weight of the resins. concentration, conditions of use, and (d) Polycarbonate resins may be used food types specified in § 178.2010(b) of in accordance with this section except this chapter.

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(c) Polyestercarbonate resins shall reflux temperature for 6 hours, shall conform to the specifications pre- yield total nonvolatile extractives not scribed in paragraph (c)(1) of this sec- to exceed 0.005 percent by weight of the tion and shall meet the extractive lim- resins. itations prescribed in paragraph (c)(2) (iii) Polyestercarbonate resins, when of this section. extracted with n-heptane at reflux (1) Specifications. Polyestercarbonate temperature for 6 hours, shall yield resins identified in paragraph (a) of total nonvolatile extractives not to ex- this section can be identified by their ceed 0.002 percent by weight of the res- characteristic infrared spectrum. The ins. resins shall comply with either or both (3) Residual methylene chloride levels in of the following specifications: polyestercarbonate resins. Polyester- (i) The solution intrinsic viscosity of carbonate resin articles in the finished the polyestercarbonate resins shall be form shall not contain residual meth- a minimum of 0.44 deciliter per gram, ylene chloride in excess of 5 parts per as determined by a method entitled million as determined by a method ti- ‘‘Intrinsic Viscosity (IV) of Lexan ® tled ‘‘Analytical Method for Deter- Polyestercarbonate Resin by a Single mination of Residual Methylene Chlo- Point Method Using Dichloromethane ride in Polyestercarbonate Resin,’’ de- as the Solvent,’’ developed by the Gen- veloped by the General Electric Co., eral Electric Co., September 20, 1985, which is incorporated by reference in July 23, 1991, which is incorporated by accordance with 5 U.S.C. 552(a) and 1 reference in accordance with 5 U.S.C. CFR part 51. Copies are available from 552(a) and 1 CFR part 51. Copies are the Office of Food Additive Safety, available from the Center for Food Center for Food Safety and Applied Nu- Safety and Applied Nutrition (HFS– trition (HFS–215), Food and Drug Ad- 200), Food and Drug Administration, ministration, 5001 Campus Dr., College 5001 Campus Dr., College Park, MD Park, MD 20740, or may be examined at 20740, or may be examined at the Na- the Food and Drug Administration’s tional Archives and Records Adminis- Main Library, 10903 New Hampshire tration (NARA). For information on Ave., Bldg. 2, Third Floor, Silver the availability of this material at Spring, MD 20993, 301–796–2039, or at the NARA, call 202–741–6030, or go to: http:// National Archives and Records Admin- www.archives.gov/federallregister/ istration (NARA). For information on codeloflfederallregulations/ the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// [57 FR 3940, Feb. 3, 1992, as amended at 64 FR www.archives.gov/federallregister/ 27178, May 19, 1999; 81 FR 5594, Feb. 3, 2015] codeloflfederallregulations/ ibrllocations.html. § 177.1590 Polyester elastomers. (ii) A minimum weight-average mo- lecular weight of 27,000, as determined The polyester elastomers identified by gel permeation chromatography in paragraph (a) of this section may be using polystyrene standards. safely used as the food-contact surface (2) Extractives limitations. The of articles intended for use in contact polyestercarbonate resins to be tested with bulk quantities of dry food of the shall be ground or cut into small par- type identified in § 176.170(c) of this ticles that will pass through a U.S. chapter, table 1, under Type VIII, in ac- standard sieve No. 6 and that will be cordance with the following prescribed held on U.S. standard sieve No. 10. conditions: (i) Polyestercarbonate resins, when (a) For the purpose of this section, extracted with distilled water at reflux polyester elastomers are those pro- temperature for 6 hours, shall yield duced by the ester exchange reaction total nonvolatile extractives not to ex- when one or more of the following ceed 0.005 percent by weight of the res- phthalates—dimethyl terephthalate, ins. dimethyl orthophthalate, and dimethyl (ii) Polyestercarbonate resins, when isophthalate—is made to react with extracted with 50 percent (by volume) alpha-hydroomega-hydroxypoly ethyl alcohol in distilled water at (oxytetramethylene) and/or 1,4-

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butanediol such that the finished elas- this section may contain optional adju- tomer has a number average molecular vant substances required in the produc- weight between 20,000 and 30,000. tion of basic resins or finished food- (b) Optional adjuvant substances em- contact articles. The optional adjuvant ployed in the production of the poly- substances required in the production ester elastomers or added thereto to of the basic polymer may include sub- impart desired technical or physical stances permitted for such use by ap- properties may include the following plicable regulations as set forth in part substances: 174 of this chapter. (c) Specifications and extractives limita- List of substances Limitations tions—(1) Specifications. Polyetherimide 4,4′ - Bis (alpha, alpha-di- For use only as an anti- resin identified in paragraph (a) of this methyl-benzyl) oxidant. section shall have an intrinsic vis- diphenylamine. cosity in chloroform at 25 °C (77 °F) of Tetrabutyl titanate ...... For use only as a catalyst. not less than 0.35 deciliter per gram as determined by a method titled ‘‘In- (c) An appropriate sample of the fin- trinsic Viscosity of ULTEM ished polyester elastomer in the form Polyetherimide Using Chloroform as in which it contacts food when sub- the Solvent,’’ which is incorporated by jected to ASTM method D968–81, reference. Copies are available from ‘‘Standard Test Methods for Abrasion the Center for Food Safety and Applied Resistance of Organic Coatings by the Nutrition (HFS–200), Food and Drug Falling Abrasive Tester,’’ which is in- Administration, 5001 Campus Dr., Col- corporated by reference (Copies may be lege Park, MD 20740, or available for in- obtained from the American Society spection at the National Archives and for Testing Materials, 100 Barr Harbor Records Administration (NARA). For Dr., West Conshohocken, Philadelphia, information on the availability of this PA 19428-2959, or may be examined at material at NARA, call 202–741–6030, or the National Archives and Records Ad- go to: http://www.archives.gov/ ministration (NARA). For information federallregister/ on the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federallregister/ (2) Extractive limitations. Extractive codeloflfederallregulations/ limitations are applicable to the basic ibrllocations.html.), using No. 50 emery polyetherimide resin in the form of abrasive in lieu of Ottawa sand, shall molded discs of thickness 0.16 centi- exhibit an abrasion coefficient of not meter (0.063 inch). The resin discs when less than 100 liters per mil of thickness. extracted with distilled water at 121 °C [42 FR 14572, Mar. 15, 1977, as amended at 49 (250 °F) for 2 hours yield total nonvola- FR 10109, Mar. 19, 1984] tile extractives of not more than 12.3 micrograms per square centimeter. § 177.1595 Polyetherimide resin. [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. The polyetherimide resin identified 3, 1985] in this section may be safely used as an article or component of an article in- § 177.1600 Polyethylene resins, car tended for use in contact with food, boxyl modified. subject to the provisions of this sec- Carboxyl-modified polyethylene res- tion. ins may be safely used as the food-con- (a) Identity. For the purpose of this tact surface of articles intended for use section, the polyetherimide resin is 1,3- in contact with food in accordance isobenzofurandione, 5,5′[(1-methyl- with the following prescribed condi- ethylidene)bis(4,1-phenyleneoxy)] bis- tions: polymer with 1,3-benzenediamine (CAS (a) For the purpose of this section, Reg. No. 61128–46–9), and is derived from carboxyl-modified polyethylene resins the condensation reaction of m- consist of basic polymers produced phenylenediamine and bisphenol A- when ethylene-methyl acrylate basic dianhydride. copolymers, containing no more than (b) Optional adjuvants. The basic 25 weight percent of polymer units de- polymer identified in paragraph (a) of rived from methyl acrylate, are made

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to react in an aqueous medium with (Copies may be obtained from the one or more of the following sub- American Society for Testing Mate- stances: rials, 100 Barr Harbor Dr., West Ammonium hydroxide. Conshohocken, Philadelphia, PA 19428- Calcium carbonate. 2959, or may be examined at the Na- Potassium hydroxide. tional Archives and Records Adminis- Sodium hydroxide. tration (NARA). For information on (b) The finished food-contact article, the availability of this material at when extracted with the solvent or sol- NARA, call 202–741–6030, or go to: http:// vents characterizing the type of food www.archives.gov/federallregister/ and under the conditions of time and codeloflfederallregulations/ temperature characterizing the condi- ibrllocations.html.), and has a 7.0 per- tions of its intended use as determined cent maximum extractable fraction in ° from tables 1 and 2 of § 176.170(c) of this n-hexane at 50 C, as determined by the chapter, yields total extractives in method described in § 177.1520(d)(3)(ii). each extracting solvent not to exceed (b) Chlorinated polyethylene may be 0.5 milligram per square inch of food- used in contact with all types of food, contact surface as determined by the except that when used in contact with methods described in § 176.170(d) of this fatty food of Types III, IV-A, V, VII-A, chapter; and if the finished food-con- and IX described in table 1 of § 176.170(c) tact article is itself the subject of a of this chapter, chlorinated poly- regulation in parts 174, 175, 176, 177, 178, ethylene is limited to use only as a and § 179.45 of this chapter, it shall also modifier admixed at levels not exceed- comply with any specifications and ing 15 weight percent in plastic articles limitations prescribed for it by that prepared from polyvinyl chloride and/ regulation. In testing the finished food- or from vinyl chloride copolymers com- contact articles, a separate test sample plying with § 177.1980. is to be used for each required extract- [42 FR 14572, Mar. 15, 1977, as amended at 49 ing solvent. FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, (c) The provisions of paragraph (b) of 1994] this section are not applicable to carboxyl-modified polyethylene resins § 177.1615 Polyethylene, fluorinated. used in food-packaging adhesives com- plying with § 175.105 of this chapter. Fluorinated polyethylene, identified in paragraph (a) of this section, may be § 177.1610 Polyethylene, chlorinated. safely used as food-contact articles in accordance with the following pre- Chlorinated polyethylene identified in this section may be safely used as scribed conditions: articles or components of articles that (a) Fluorinated polyethylene food- contact food, except for articles used contact articles are produced by modi- for packing or holding food during fying the surface of polyethylene arti- cooking, subject to the provisions of cles through action of fluorine gas in this section. combination with gaseous nitrogen as (a) For the purpose of this section, an inert diluent. Such modification af- chlorinated polyethylene consists of fects only the surface of the polymer, basic polymers produced by the direct leaving the interior unchanged. chlorination of polyethylene con- Fluorinated polyethylene articles are forming to the density, maximum n- manufactured from basic resins con- hexane extractable fraction, and max- taining not less than 85 weight-percent imum xylene soluble fraction specifica- of polymer units derived from ethylene tions prescribed under item 2.1 of the and identified in § 177.1520 (a)(2) and table in § 177.1520(c). Such chlorinated (3)(i). polyethylene contains a maximum of 60 (b) Fluorinated polyethylene articles percent by weight of total chlorine, as conform to the specifications and use determined by ASTM 1method D1303–55 limitations of § 177.1520(c), items 2.1 and (Reapproved 1979), ‘‘Standard Test 3.1. Method for Total Chlorine in Vinyl (c) The finished food-contact article, Chloride Polymers and Copolymers,’’ when extracted with the solvent or sol- which is incorporated by reference vents characterizing the type of food

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and under conditions of time and tem- used as provided in §§ 175.105 and 176.210 perature characterizing the conditions of this chapter, and § 177.2800. The pro- of its intended use as determined from visions of paragraph (b) of this section tables 1 and 2 of § 176.170(c) of this chap- are not applicable to oxidized poly- ter, yields fluoride ion not to exceed 5 ethylene used as provided in §§ 175.125 parts per million calculated on the and 176.170(a)(5) of this chapter and basis of the volume of food held by the § 177.1200. food-contact article. § 177.1630 Polyethylene phthalate [48 FR 39057, Aug. 29, 1983] polymers. § 177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers Oxidized polyethylene identified in identified in this section may be safely paragraph (a) of this section may be used as, or components of plastics safely used as a component of food-con- (films, articles, or fabric) intended for tact articles, in accordance with the use in contact with food in accordance following prescribed conditions: with the following prescribed condi- (a) Oxidized polyethylene is the basic tions: resin produced by the mild air oxida- (a) Polyethylene phthalate films con- tion of polyethylene conforming to the sist of a base sheet of ethylene density, maximum n-hexane extract- terephthalate polymer, ethylene able fraction, and maximum xylene terephthalate-isophthalate copolymer, soluble fraction specifications pre- or ethylene-1,4-cyclohexylene scribed under item 2.3 of the table in dimethylene terephthalate copoly- § 177.1520(c). Such oxidized polyethylene esters described in § 177.1315(b)(3), to has a minimum number average molec- which have been added optional sub- ular weight of 1,200, as determined by stances, either as constituents of the high temperature vapor pressure os- base sheet or as constituents of coat- mometry, contains a maximum of 5 ings applied to the base sheet. percent by weight of total oxygen, and (b) Polyethylene phthalate articles has an acid value of 9 to 19. consist of a base polymer of ethylene (b) The finished food-contact article, terephthalate polymer, or ethylene-1,4- when extracted with the solvent or sol- cyclohexylene dimethylene vents characterizing the type of food terephthalate copolyesters described in and under the conditions of time and § 177.1315(b)(3), to which have been temperature characterizing the condi- added optional substances, either as tions of its intended use as determined constituents of the base polymer or as from tables 1 and 2 of § 176.170(c) of this constituents of coatings applied to the chapter, yields net acidified chloro- base polymer. form-soluble extractives not to exceed (c)(1) Polyethylene phthalate 0.5 milligram per square inch of food- spunbonded nonwoven fabric consist of contact surface when tested by the continuous filaments of ethylene methods described in § 177.1330(c), ex- terephthalate polymer and ethylene cept that net acidified chloroform-solu- terephthalate-isophthalate copolymer ble extractives from paper and paper- to which may have been added optional board complying with § 176.170 of this adjuvant substances required in their chapter may be corrected for wax, pet- preparation and finishing. rolatum, and mineral oil as provided in (2) The ethylene terephthalate- § 176.170(d) (5)(iii)(b) of this chapter. If isophthalate copolymer component of the finished food-contact article is the fabric shall not exceed 25 percent itself the subject of a regulation in by weight. The filaments may be blend- parts 174, 175, 176, 177, 178 and § 179.45 of ed with other fibers regulated for the this chapter, it shall also comply with specific use and the spunbonded fabric any specifications and limitations pre- may be further bonded by application scribed for it by such regulations. of heat and/or pressure. (NOTE: In testing the finished food-con- (3) The fabric shall be used only in tact article, use a separate test sample accordance with paragraph (i) of this for each extracting solvent.) section. (c) The provisions of this section are (d) The quantity of any optional sub- not applicable to oxidized polyethylene stance employed in the production of

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polyethylene phthalate plastics does Ethylene-1,4-cyclohexylene dimethylene not exceed the amount reasonably re- terephthalate copolyesters described in quired to accomplish the intended § 177.1315(b)(3). physical or technical effect or any lim- Ethylene terephthalate polymer: Prepared by the condensation of dimethyl itations further provided. Any sub- terephthalate and ethylene glycol. stance employed in the production of Ethylene terephthalate polymer: Prepared polyethylene phthalate plastics that is by the condensation of terephthalic acid the subject of a regulation in parts 174, and ethylene glycol. 175, 176, 177, 178 and 179 of this chapter (iii) Coatings: conforms with any specification in Acrylic copolymers (CAS Reg. No. 30394–86– such regulation. 6): Prepared by reaction of ethyl acrylate (e) Substances employed in the pro- (CAS Reg. No. 140–88–5), methyl methacry- duction of polyethylene phthalate plas- late (CAS Reg. No. 80–62–6), and tics include: methacrylamide (CAS Reg. No. 79–39–0) (1) Substances generally recognized blended with melamine-formaldehyde resin as safe in food. (CAS Reg. No. 68002–20–0). For use in coat- (2) Substances subject to prior sanc- ings for polyethylene phthalate films com- tion or approval for use in poly- plying with paragraph (a) of this section.— ethylene phthalate plastics and used in Ethylene azelate-terephthalate copolymer: The copolymer, dissolved in 1,1,2-trichloro- accordance with such sanction or ap- ethane and/or methylene chloride, may be proval. used as a heat-activated sealant on poly- (3) Substances which by regulation in ethylene terephthalate film intended for parts 174, 175, 176, 177, 178 and § 179.45 of sealing polyethylene terephthalate pouch- this chapter may be safely used as es that are used as containers of either components of resinous or polymeric nonalcoholic beverages or alcoholic bev- food-contact surfaces subject to the erages containing not more than 15 percent provisions of such regulation. ethyl alcohol. The copolymer has a (4) Substances identified in this para- terephthalate/azelate molecular ratio of 1.25/1.00 and a relative viscosity of not less graph (e)(4) subject to the limitations than 1.5 as determined by a method title prescribed: ‘‘General Procedure of Determining the Relative Viscosity of Resin Polymers,’’ LIST OF SUBSTANCES AND LIMITATIONS which is incorporated by reference. Copies (i) Base sheet: are available from the Center for Food Safety and Applied Nutrition (HFS–200), Ethylene terephthalate copolymers: Pre- Food and Drug Administration, 5001 Cam- pared by the condensation of dimethyl pus Dr., College Park, MD 20740, or avail- terephthalate or terephthalic acid with able for inspection, at the National Ar- ethylene glycol, modified with one or more chives and Records Administration of the following: Azelaic acid, dimethyl (NARA). For information on the avail- azelate, dimethyl sebacate, sebacic acid. Ethylene terephthalate copolymers: Pre- ability of this material at NARA, call 202– pared by the condensation of dimethyl 741–6030, or go to: http://www.archives.gov/ terephthalate or terephthalic acid with federallregister/ ethylene glycol, modified with one or more codeloflfederallregulations/ of the following: Azelaic acid, dimethyl ibrllocations.html. Total residual copoly- azelate, dimethyl sebacate, sebacic acid, mer solvent (1,1,2-trichloroethane and/or pyromellitic dianhydride. The level of methylene chloride) shall not exceed 0.13 pyromellitic dianhydride shall not exceed milligram per square inch of film, and food 0.5 percent by weight of the finished co- contact of the film shall be limited to not polymer which may be used under condi- more than 1 square inch per 250 grams of tions of use E through H as described in beverage. table 2 of § 176.170(c) of this chapter. 2-Ethylhexyl acrylate copolymerized with Ethylene terephthalate-isophthalate copoly- one or more of the following: mers: Prepared by the condensation of Acrylonitrile. dimethyl terephthalate or terephthalic Methacrylonitrile. acid and dimethyl isophthalate or iso- Methyl acrylate. phthalic acid with ethylene glycol. The Methyl methacrylate. finished copolymers contain either: Itaconic acid. (a) 77 to 83 weight percent or Vinylidene chloride copolymerized with one (b) At least 97 weight percent of polymer or more of the following: units derived from ethylene Methacrylic acid and its methyl, ethyl, terephthalate. propyl, butyl, or octyl esters. Acrylic acid and its methyl, ethyl, propyl, (ii) Base sheet and base polymer: butyl, or octyl esters.

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Acrylonitrile. formation on the availability of this ma- Methacrylonitrile. terial at NARA, call 202–741–6030, or go Vinyl chloride. to: http://www.archives.gov/ Itaconic acid. federallregister/ Styrene-maleic anhydride resin, partial 2- codeloflfederallregulations/ butoxyethyl ester, ammonium salt (CAS ibrllocations.html. Reg. No. 68890–80–2). For use only as a coat- The modifier is used at a level not to ex- ing for polyethylene phthalate films com- ceed 5 percent by weight of polyethylene plying with paragraph (a) of this section, terephthalate film. The average thick- at levels not to exceed 0.025 gram per ness of the finished film shall not exceed square meter (0.016 milligram per square 0.016 millimeter (0.0006 inch). inch) of the film, in contact with food of Hexanedioic acid polymer with 1,3- types VIII and IX in table 1 of § 176.170(c) of benzenedimethanamine (CAS Reg. No. this chapter, under use conditions E, F, 25718–70–1) meeting the specifications in and G in table 2 of § 176.170(c) of this chap- § 177.1500(b), item 10, when tested by the ter. methods given in § 177.1500(c). The modi- fier is used in polyethylene terephthalate (iv) Emulsifiers: at a level not to exceed 30 percent by Sodium dodecylbenzenesulfonate: As an ad- weight of the polyethylene juvant in the application of coatings to the terephthalate. base sheet or base polymer. Chloroform-soluble extractives shall not Sodium lauryl sulfate: As an adjuvant in the exceed 0.08 milligram/centimeter2 (0.5 application of coatings to the base sheet or milligram/inch2) of food-contact surface base polymer. of the modified polyethylene 2-Sulfoethyl methacrylate, sodium salt (CAS terephthalate article when exposed to Reg. No. 1804–87–1). For use only in copoly- the following solvents at temperatures mer coatings on polyethylene phthalate and times indicated: film under conditions of use E, F, and G de- (a) Distilled water at 49 °C (120 °F) for 24 scribed in table 2 of § 175.300(d) of this chap- hours; ter, and limited to use at a level not to ex- (b) n-Heptane at 49 °C (120 °F) for 24 hours; ceed 2.0 percent by weight of the dry co- (c) 8 percent ethyl alcohol at 49 °C (120 °F) polymer coating. for 24 hours. For use in contact with all types of foods (v) Modifier: except (a) those containing more than 8 1,4-Benzenedicarboxylic acid, dimethyl ester, percent alcohol, or (b) those at tempera- polymer with 1,4-butanediol and a-hydro- tures over 49 °C (120 °F). omega-hydroxypoly(oxy-1,4-butanediyl) CAS Reg. No. 9078–71–1) meeting the fol- (f) Polyethylene phthalate plastics lowing specifications: conforming with the specifications pre- Melting point: 200° to 215 °C as determined scribed in paragraph (f)(1) of this sec- by ASTM method D2117–82, ‘‘Standard tion are used as provided in paragraph Test Method for Melting Point of (f)(2) of this section: Semicrystalline Polymers by the Hot (1) Specifications. (i) The food contact Stage Microscopy Method,’’ which is in- corporated by reference. Copies may be surface, when exposed to distilled obtained from the American Society for water at 250 °F for 2 hours, yields chlo- Testing Materials, 100 Barr Harbor Dr., roform-soluble extractives not to ex- West Conshohocken, Philadelphia, PA ceed 0.5 mg/in2 of food contact surface 19428-2959, or may be examined at the Na- exposed to the solvent; and tional Archives and Records Administra- (ii) The food contact surface, when tion (NARA). For information on the exposed to n-heptane at 150 °F for 2 availability of this material at NARA, hours, yields chloroform-soluble ex- call 202–741–6030, or go to: http:// tractives not to exceed 0.5 mg/in2 of www.archives.gov/federallregister/ codeloflfederallregulations/ food contact surface exposed to the sol- ibrllocations.html. vent. Density: 1.15 to 1.20 as determined by ASTM (2) Conditions of use. The plastics are method D1505–68 (Reapproved 1979), used for packaging, transporting, or ‘‘Standard Test Method for Density of holding food, excluding alcoholic bev- Plastics by the Density-Gradient Tech- erages, at temperatures not to exceed nique,’’ which is incorporated by ref- 250 °F. erence. Copies may be obtained from the (g) Polyethylene phthalate plastics American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, conforming with the specifications pre- Philadelphia, PA 19428-2959, or may be scribed in paragraph (g)(1) of this sec- examined at the National Archives and tion are used as provided in paragraph Records Administration (NARA). For in- (g)(2) of this section.

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(1) Specifications. (i) The food contact including filtration, at temperatures surface meets the specifications in not exceeding 212 °F. paragraph (f)(1) of this section; and (iii) Filtration of bulk alcoholic bev- (ii) The food contact surface when ex- erages, not exceeding 50 percent alco- posed to 50 percent ethyl alcohol at 120 hol by volume, at temperatures not ex- °F for 24 hours, yields chloroform-solu- ceeding 120 °F. ble extractives not to exceed 0.5 mg/in2 (j) Polyethylene phthalate plastics, of food contact surface exposed to the composed of ethylene terephthalate- solvent. isophthalate containing a minimum of (2) Conditions of use. The plastics are 98 weight percent of polymer units de- used for packaging, transporting, or rived from ethylene terephthalate, or holding alcoholic beverages that do not ethylene-1,4-cyclohexylene exceed 50 percent alcohol by volume. dimethylene terephthalate copoly- (h) Uncoated polyethylene phthalate esters described in § 177.1315(b)(3), con- plastics consisting of a base sheet or forming with the specifications pre- base polymer prepared as prescribed scribed in paragraph (j)(1) of this sec- from substances identified in para- tion, are used as provided in paragraph graphs (e)(4)(i) and (ii) of this section (j)(2) of this section. and conforming with the specifications (1) Specifications. (i) The food contact prescribed in paragraph (h)(1) of this surface meets the specifications in section are used as provided in para- paragraph (f)(1) of this section and graph (h)(2) of this section: (ii)(a) Containers with greater than 500 (1) Specifications. (i) The food contact mL capacity. The food-contact surface surface, when exposed to distilled when exposed to 95 percent ethanol at water at 250 °F for 2 hours yields chlo- 120 °F for 24 hours should not yield roform-soluble extractives not to ex- chloroform-soluble extractives in ex- ceed 0.02 milligram/inch 2 of food con- cess of 0.005 mg/in 2. tact surface exposed to the solvent; and (b) Containers with less than or equal to (ii) The food contact surface, when 500 mL capacity. The food contact sur- ° exposed to n-heptane at 150 F for 2 face when exposed to 95 percent eth- hours, yields chloroform-soluble ex- anol at 120 °F for 24 hours should not tractives not to exceed 0.02 milligram/ yield chloroform-soluble extractives in 2 inch of food contact surface exposed excess of 0.05 mg/in 2. to the solvent. (2) Conditions of use. The plastics are (2) Conditions of use. The plastics are used for packaging, transporting, or used to contain foods during oven bak- holding alcoholic foods that do not ex- ing or oven cooking at temperatures ceed 95 percent alcohol by volume. above 250 °F. (i) Polyethylene phthalate fabric, [42 FR 14572, Mar. 15, 1977, as amended at 42 identified in paragraph (c) of this sec- FR 18611, Apr. 8, 1977; 44 FR 40886, July 13, tion and conforming with the specifica- 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, tions prescribed in paragraph (i)(1) of Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984; this section, is used only as provided in 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, paragraph (i)(2) of this section. 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, (1) Specifications. Chloroform-soluble Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR extractives shall not exceed 0.2 milli- 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995; gram/inch 2 of food-contact surface 61 FR 46718, Sept. 5, 1996] when exposed to the following solvents at temperatures and times indicated: § 177.1632 (i) Distilled water at 212 °F for 2 Poly(phenyleneterephthalamide) hours. resins. (ii) n-Heptane at 150 °F for 2 hours. Poly(phenyleneterephthalamide) res- (iii) 50 percent ethyl alcohol at 120 °F ins identified in paragraph (a) of this for 24 hours. section may be safely used as articles (2) Conditions of use. The plastics are or components of articles intended for intended for: repeated contact with food. (i) Dry food contact. (a) Identity. For the purpose of this (ii) Bulk food (excluding alcoholic section, the poly(phenylene- beverages) repeated use applications, terephthalamide) resins (CAS Reg. No.

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26125–61–1) are produced by the polym- refluxed in a 50 percent ethanol/water erization of terephthalolyl chloride mixture for 24 hours, yields total with p-phenylenediamine. The extractables not exceeding 0.65 percent poly(phenyleneterephthalamide) resin by weight of the sample. fibers and yarns may contain optional (d) Conditions of use. (1) adjuvant substances required in their Poly(phenyleneterephthalamide) resins preparation and finishing. in the form of continuous filament (b) Optional adjuvant substances. The yarns and fibers may be used as compo- poly(phenyleneterephthalamide) resins nents of articles intended for repeated identified in paragraph (a) of this sec- use in contact with food at tempera- tion may contain the following op- tures not to exceed 260 °C (500 °F). All tional adjuvant substances, subject to items are scoured prior to use by agita- any limitation on their use: tion in a water bath containing 0.5 (1) Optional adjuvant substances au- gram/liter of tetrasodium thorized for this use in accordance with pyrophosphate and 0.5 percent deter- § 174.5 of this chapter. gent. The items are agitated at 80 °C (2) Optional finish components, total (180 °F) for 20 minutes, and then sub- weight not to exceed 1 percent by jected to a cold water rinse. weight of the base polymer, as follows: (2) Poly(phenyleneterephthalamide) resins in the form of pulp may be used List of substances Limitations as gaskets and packing for food proc- Diundecylphthalate (CAS essing equipment at temperatures not Reg. No. 3648–20–2). to exceed 260 °C (500 °F). Mono- and dipotassium salts of lauryl phosphate (CAS [57 FR 3125, Jan. 28, 1992, as amended at 69 Reg. No. 39322–78–6). FR 24512, May 4, 2004] o-Phenylphenol (CAS Reg. For use as a for fin- No. 90–43–7). ish coating materials. Not § 177.1635 Poly(p-methylstyrene) and to exceed 0.01 percent by weight of the base poly- rubber-modified poly(p-methyl- mer. styrene). Poly(oxyethylene/ Poly(p-methylstyrene) and rubber- oxypropylen- e)monobutylether (CAS modified poly(p-methylstyrene) identi- Reg. No. 9038–95–3). fied in this section may be safely used Poly(oxyethylene) as components of articles intended for mono(nonylphenyl)ether (CAS Reg. No. 9016–45– use in contact with food, subject to the 9). provisions of this section: Polyvinyl methylether (CAS (a) Identity. For the purposes of this Reg. No. 9003–09–2). section, poly(p-methylstyrene) and Poly(oxyethylene) sorbitol monolaurate tetraoleate rubber-modified poly(p-methylstyrene) (CAS Reg. No. 71243–28– are basic polymers, manufactured as 2). described in this paragraph, meeting Poly(oxyethylene) sorbitol hexaoleate (CAS Reg. No. the specifications prescribed in para- 57171–56–9). graph (c) of this section. 4,4′-Butylidenebis (6-tert- For use only as an oxidation (1) Poly(p-methylstyrene) (CAS Reg. butyl-m-cresol) (CAS Reg. inhibitor for finish coating No. 24936–41–2) polymer produced by the No. 85–60–9). materials. Not to exceed 0.01 percent by weight of polymerization of p-methylstyrene. the base polymer. (2) Rubber-modified poly(p- methylstyrene) (CAS Reg. No. 33520–88– (c) Specifications. (1) 6) polymer produced by combining sty- Poly(phenyleneterephthalamide) resins rene-butadiene copolymer and/or in the form of continuous filament polybutadiene with poly(p- yarns or fibers that have been scoured methylstyrene), either during or after in accordance with paragraph (d)(1) of polymerization of the poly(p- this section, when refluxed in a 50 per- methylstyrene), such that the finished cent ethanol/water mixture for 24 polymers contain not less than 75 hours, yields total extractables not ex- weight percent of total polymer units ceeding 0.5 percent by weight of the derived from p-methylstyrene) mon- sample. omer. (2) Poly(phenyleneterephthalamide) (b) Optional adjuvants. The basic resins in the form of pulp, when polymers identified in paragraph (a) of

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this section may contain optional adju- (a)(1) and (a)(2), respectively, of this vant substances required in the produc- section shall be used in contact with tion of such basic polymers. Such op- food only under conditions of use B tional adjuvant substances may in- through H set forth in table 2 of clude substances permitted for such § 176.170(c) of this chapter. use by applicable regulations in this [48 FR 31384, July 8, 1983, as amended at 54 chapter, substances generally recog- FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, nized as safe in food, substances gen- 1990] erally recognized as safe in indirect ad- ditives, and substances used in accord- § 177.1637 Poly(oxy-1,2- ance with prior sanction or approval. ethanediyloxycarbonyl-2,6- (c) Specifications. (1) Poly(p- naphthalenediylcarbonyl) resins. methylstyrene) basic polymers identi- Poly(oxy-1,2-ethanediyloxycarbonyl- fied in paragraph (a)(1) of this section 2,6-naphthalenediylcarbonyl) resins shall contain not more than 1 weight identified in paragraph (a) of this sec- percent of total residual p- tion may be safely used as articles or methystyrene monomer, as determined components of articles intended for use by a gas chromatographic method ti- in contact with food in accordance tled, ‘‘Gas Chromatographic Deter- with the following conditions: mination of PMS and PET in PPMS (a) Identity. For the purpose of this Basic Polymers,’’ which is incorporated section, poly(oxy-1,2- by reference. Copies are available from ethanediyloxycarbonyl-2,6- the Center for Food Safety and Applied naphthalenediylcarbonyl) resins (CAS Nutrition (HFS–200), Food and Drug Reg. No. 24968–11–4) are polymers Administration, 5001 Campus Dr., Col- formed by catalytic transesterification lege Park, MD 20740, or available for in- of 2,6-dimethylnaphthalene spection at the National Archives and dicarboxylate with ethylene glycol fol- Records Administration (NARA). For lowed by catalytic polycondensation. information on the availability of this (b) Specifications—(1) Density. The material at NARA, call 202–741–6030, or density of poly(oxy-1,2- go to: http://www.archives.gov/ ethanediyloxycarbonyl-2,6- federallregister/ naphthalenediylcarbonyl) resins shall codeloflfederallregulations/ be between 1.33 and 1.40 grams per ibrllocations.html. cubic centimeter. (2) Rubber-modified poly(p- (2) Inherent viscosity. The finished methylstyrene) basic polymers identi- food-contact article shall have a min- fied in paragraph (a)(2) of this section imum inherent viscosity of 0.55 deci- shall contain not more than 0.5 weight liter per gram in a solution of 0.1 gram percent of total residual p- of polymer in 100 milliliters of a 25/40/ methylstyrene monomer, as deter- 35 (weight/weight/weight) solution of p- mined by the method identified in chlorophenol/tetrachloroethane/phenol. paragraph (c)(1) of this section The viscosity is determined by East- (d) Other specifications and limitations. man Chemical Co.’s method ECD-A-AC- The poly(p-methylstyrene) and rubber- G-V-1-5, ‘‘Determination of Dilute So- modified poly(p-methylstyrene) identi- lution Viscosity of Polyesters,’’ dated fied in and complying with this sec- May 31, 1988, which is incorporated by tion, when used as components of the reference in accordance with 5 U.S.C. food-contact surface of any article that 552(a) and 1 CFR part 51. Copies are is the subject of a regulation in parts available from the Office of Food Addi- 175, 176, 177, 178 and § 179.45 of this chap- tive Safety (HFS–200), Center for Food ter, shall comply with any specifica- Safety and Applied Nutrition, Food and tions and limitations prescribed by Drug Administration, 5001 Campus Dr., such regulation for the article in the College Park, MD 20740, 240–402–1200, or finished form in which it is to contact may be examined at the Food and Drug food. Administration’s Main Library, 10903 (e) Conditions of use. Poly(p- New Hampshire Ave., Bldg. 2, Third methylstyrene) basic polymers and Floor, Silver Spring, MD 20993, 301–796– rubber-modified poly(p-methylstyrene) 2039, or at the National Archives and basic polymers identified in paragraphs Records Administration (NARA). For

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information on the availability of this the finished basic polymers contain not material at NARA, call 202–741–6030, or less than 75 weight percent of total go to: http://www.archives.gov/ polymer units derived from styrene federallregister/ monomer. codeloflfederallregulations/ (b) Optional adjuvants. The basic ibrllocations.html. polymers identified in paragraph (a) of (c) Extraction limitations. A 0.5 milli- this section may contain optional adju- meter (0.02 inch) thick sheet of resin vant substances required in the produc- when extracted with water at 121 °C tion of such basic polymers. Such op- (250 °F) for 2 hours shall yield total tional adjuvant substances may in- nonvolatile extractives not exceeding clude substances permitted for such 2.0 micrograms per square inch of ex- use by regulations in parts 170 through posed resin surface. 189 of this chapter, substances gen- (d) Conditions of use. The finished erally recognized as safe in food, and food contact article shall be: substances used in accordance with a (1) Used in contact only with food of prior sanction or approval. Types I, II, IVB, VIA, VIB, VIIB, and (c) Specifications. (1) Polystyrene VIII identified in table 1 of § 176.170(c) basic polymers identified in paragraph of this chapter, under conditions of use (a)(1) of this section shall contain not A through H described in table 2 of more than 1 weight percent of total re- § 176.170(c) of this chapter; and with food of Types III, IVA, V, VIC, VIIA, sidual styrene monomer, as determined and IX identified in table 1 of by the method described in paragraph § 176.170(c) of this chapter, under condi- (d) of this section, except that when tions of use C through H described in used in contact with fatty foods of table 2 of § 176.170(c) of this chapter; Types III, IV-A, V, VII-A, and IX de- and scribed in table 1 of § 176.170(c) of this (2) Identified in a manner that will chapter, such polystyrene basic poly- differentiate the article from articles mers shall contain not more than 0.5 made of other polymeric resins to fa- weight percent of total residual sty- cilitate collection and sorting. rene monomer. (2) Rubber-modified polystyrene [61 FR 14965, Apr. 4, 1996, as amended at 78 basic polymers identified in paragraph FR 14666, Mar. 7, 2013; 81 FR 5594, Feb. 3, 2016] (a)(2) of this section shall contain not § 177.1640 Polystyrene and rubber- more than 0.5 weight percent of total modified polystyrene. residual styrene monomer, as deter- Polystyrene and rubber-modified pol- mined by the method described in para- ystyrene identified in this section may graph (d) of this section. be safely used as components of arti- (d) Analytical method for determination cles intended for use in contact with of total residual styrene monomer con- food, subject to the provisions of this tent—(1) Scope. This method is suitable section. for the determination of residual sty- (a) Identity. For the purposes of this rene monomer in all types of styrene section, polystyrene and rubber-modi- polymers. fied polystyrene are basic polymers (2) Principle. The sample is dissolved manufactured as described in this para- in methylene chloride. An aliquot of graph so as to meet the specifications the solution is injected into a gas chro- prescribed in paragraph (c) of this sec- matograph. The amount of styrene tion when tested by the method de- monomer present is determined from scribed in paragraph (d) of this section. the area of the resulting peak. (1) Polystyrene consists of basic poly- (3) Apparatus—(i) Gas chromatograph. mers produced by the polymerization Beckman GC-2A gas chromatograph of styrene. with hydrogen flame detector or appa- (2) Rubber-modified polystyrene con- ratus of equivalent sensitivity. sists of basic polymers produced by (ii) Chromatograph column. One-quar- combining styrene-butadiene copoly- ter inch outside diameter stainless mers and/or polybutadiene with poly- steel tubing (0.028 inch wall thickness), styrene, either during or after polym- 4 feet in length, packed with 20 percent erization of the polystyrene, such that polyethylene glycol (20,000 molecular

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weight) on alkaline treated 60–80 mesh polystyrene identified in and com- firebrick. plying with this section, when used as (iii) Recorder. Millivolt range of 0–1, components of the food-contact surface chart speed of 30 inches per hour. of any article that is the subject of a (4) Reagents. Compressed air, purified; regulation in parts 174, 175, 176, 177, 178 gas; hydrogen gas; methylene and § 179.45 of this chapter, shall com- chloride, redistilled; and styrene mon- ply with any specifications and limita- omer, redistilled. tions prescribed by such regulation for (5) Operating conditions for the gas the article in the finished form in chromatograph. (i) The column is oper- which it is to contact food. ated at a temperature of 100 °C with a (f) Nonapplicability. The provisions of helium flow rate of 82 milliliters per this section are not applicable to poly- minute. styrene and rubber-modified poly- (ii) The hydrogen burner is operated styrene used in food-packaging adhe- with 15 pounds per square inch of air sives complying with § 175.105 of this pressure and 7 pounds per square inch chapter. of hydrogen pressure. (iii) The attenuation of the hydrogen § 177.1650 Polysulfide polymer- flame detector is set at 2 × 102. polyepoxy resins. (6) Standardization. (i) Prepare a Polysulfide polymer-polyepoxy res- standard solution by weighing accu- ins may be safely used as the food-con- rately 15 to 20 milligrams of styrene tact surface of articles intended for monomer into a 2-ounce bottle con- packaging, transporting, holding, or taining 25.0 milliliters of methylene otherwise contacting dry food, in ac- chloride. Cap the bottle tightly and cordance with the following prescribed shake to thoroughly mix the solution. conditions: (ii) By means of a microliter syringe, (a) Polysulfide polymer-polyepoxy inject 1 microliter of the standard solu- resins are the reaction products of liq- tion into the gas chromatograph. Meas- uid polysulfide polymers and ure the area of the styrene monomer polyfunctional epoxide resins, cured peak which emerges after approxi- with the aid of mately 12 minutes. tri(dimethylaminomethyl) phenol, to (7) Procedure. (i) Transfer 1 gram of which have been added certain optional sample (accurately weighed to the substances to impart desired techno- nearest 0.001 gram to a 2-ounce bottle logical properties to the resins. Subject and add several glass beads. Pipette to any limitations prescribed in this 25.0 milliliters of methylene chloride section, the optional substances may into the bottle. Cap the bottle tightly include: and place on a mechanical shaker. (1) Substances generally recognized Shake until the polymer is completely as safe in food and food packaging. dissolved. If any insoluble residue re- (2) Substances the use of which is mains, allow the bottle to stand (or permitted under applicable regulations centrifuge at a low speed) until a clear in this part, prior sanctions, or approv- supernatant layer appears. als. (ii) By means of a microliter syringe, (3) Substances named in this subpara- inject 3 microliters of the clear super- graph and further identified as re- natant liquid into the gas chro- quired: matograph. (iii) Measure the area of the resulting List of substances Limitations styrene monomer peak. Compare the Bis(2-chloroethyl) formal. sample peak area with the area pro- Bis(dichloropropyl) formal ...... Cross-linking agent. duced by the standard styrene mon- Butyl alcohol ...... Solvent. omer solution. Calculation: Carbon black (channel process). Chlorinated paraffins ...... Cross-linking agent. Percent residual styrene monomer = Milli- Epoxidized linseed oil. grams monomer in standard × peak area of Epoxidized soybean oil. × Epoxy resins (as listed in sample / Peak area of monomer standard § 175.300(b)(3)(viii)(a) of this chap- sample weight in grams × 30 ter).. Ethylene glycol monobutyl ether ...... Solvent. (e) Other specifications and limitations. Magnesium chloride. The polystyrene and rubber-modified Methyl isobutyl ketone ...... Solvent.

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List of substances Limitations in such a way that the finished resins have a minimum number average mo- Naphthalene sulfonic acid-formalde- hyde condensate, sodium salt. lecular weight of 15,000, as determined Sodium dibutyl naphthalene Wetting agent. by osmotic pressure in sulfonate. monochlorobenzene; or Sodium hydrosulfide. (2) 1,1′-Sulfonylbis[4-chlorobenzene] Sodium polysulfide. ′ b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent. polymer with 4,4 -(1- ether. methylethylidene)bis[phenol] (min- Titanium dioxide. imum 92 percent) and 4,4′- Toluene ...... Solvent. sulfonylbis[phenol] (maximum 8 per- Trichloroethane ...... Cross-linking agent. 1,2,3-Trichloropropane ...... Do. cent) (CAS Reg. No. 88285–91–0) pro- Urea-formaldehyde resins. duced when a mixture of 4,4′- Xylene ...... Solvent. isopropylidenediphenol (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (b) The resins are used as the food- (maximum 8 percent) is made to react contact surface for dry food. with 4,4′-dichlorodiphenyl sulfone in (c) An appropriate sample of the fin- such a way that the finished resin has ished resin in the form in which it con- a minimum number average molecular tacts food, when subjected to ASTM weight of 26,000, as determined by os- method D968–81, ‘‘Standard Test Meth- motic pressure in dimethylformamide. ods for Abrasion Resistance of Organic (b) The basic polysulfone resins iden- Coatings by the Falling Abrasive tified in paragraph (a) of this section Tester,’’ which is incorporated by ref- may contain optional adjuvant sub- erence (Copies may be obtained from stances required in the production of the American Society for Testing Ma- such basic resins. The optional adju- terials, 100 Barr Harbor Dr., West vant substances required in the produc- Conshohocken, Philadelphia, PA 19428- tion of the basic polysulfone resins 2959, or may be examined at the Na- may include substances described in tional Archives and Records Adminis- § 174.5(d) of this chapter and the fol- tration (NARA). For information on lowing: the availability of this material at NARA, call 202–741–6030, or go to: http:// List of substances Limitations www.archives.gov/federallregister/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as codeloflfederallregulations/ residual solvent in finished basic ibrllocations.html.), using No. 50 Emery resin in paragraph (a)(1) of this section. abrasive in lieu of Ottawa sand, shall Monochlorobenzene .. Not to exceed 500 parts per million exhibit and abrasion coefficient of not as residual solvent in finished less than 20 liters per mil of film thick- basic resin in paragraph (a)(1) of this section. ness. N-methyl-2- Not to exceed 0.01 percent (100 [42 FR 14572, Mar. 15, 1977, as amended at 49 pyrrolidone. parts per million) as residual sol- vent in finished basic resin in para- FR 10110, Mar. 19, 1984] graph (a)(2) of this section.

§ 177.1655 Polysulfone resins. (c) Polysulfone resins, when ex- Polysulfone resins identified in para- tracted at reflux temperatures for 6 graph (a) of this section may be safely hours with the solvents—distilled used as articles or components of arti- water, 50 percent (by volume) ethyl al- cles intended for use in contact with cohol in distilled water, 3 percent ace- food, in accordance with the following tic acid in distilled water, and n- prescribed conditions: heptane, yield total extractives in each (a) For the purpose of this section, extracting solvent not to exceed 0.0078 polysulfone resins are: milligram per square centimeter (0.05 (1) Poly(oxy-p-phenylenesulfonyl-p- milligram per square inch) of resin sur- phenyleneoxy-p- face. Note: In testing the finished phenyleneisopropylidene-p-phenylene) polysulfone resins, use a separate resin resins (CAS Reg. No. 25154–01–2) con- test sample for each required extract- sisting of basic resins produced when ing solvent. the disodium salt of 4,4′- (d) Polysulfone resins intended for re- isopropylidenediphenol is made to peated use in contact with food may be react with 4,4′-dichlorodiphenyl sulfone used under conditions of use A through

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H in table 2 of § 176.170(c) of this chap- (2) Poly(tetramethylene ter. The resins intended for single-serv- terephthalate) in the finished form in ice food-contact use may be used only which it is to contact food shall yield under condition of use H described in total extractives as follows: table 2 of § 176.170(c) of this chapter. (i) Not to exceed 0.08 milligram per square inch of food contact surface [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, when extracted for 2 hours at 250 °F 1986; 61 FR 29475, June 11, 1996] with distilled water. (ii) Not to exceed 0.02 milligram per § 177.1660 Poly (tetramethylene terephthalate). square inch of food contact surface when extracted for 2 hours at 150 °F Poly(tetramethylene terephthalate) with n-heptane. (poly (oxytetramethyleneoxyter- (iii) Not to exceed 0.04 milligram per ephthaloyl)) [Chemical Abstracts Serv- square inch of food contact surface ice Registry No. 24968–12–5] identified when extracted for 2 hours at 212 °F in this section may be safely used as with 3 percent aqueous acetic acid. articles or components of articles in- (iv) Not to exceed 0.02 milligram per tended to contact food, in accordance square inch of food contact surface with the following prescribed condi- when extracted for 2 hours at 65.6 °C tions: (150 °F) with 50 percent ethanol. (a) Identity. For the purpose of this [42 FR 14572, Mar. 15, 1977, as amended at 50 section, poly (tetramethylene FR 20748, May 20, 1985; 52 FR 20069, May 29, terephthalate) is the reaction product 1987] of dimethyl terephthalate with 1,4- butanediol to which may have been § 177.1670 Polyvinyl alcohol film. added certain optional substances to Polyvinyl alcohol film may be safely impart desired technological properties used in contact with food of the types to the polymer. identified in § 176.170(c) of this chapter, (b) Optional adjuvant substances. table 1, under Types V, VIII, and IX, in Poly(tetramethylene terephthalate) accordance with the following pre- identified in paragraph (a) of this sec- scribed conditions: tion may contain optional adjuvant (a) The polyvinyl alcohol film is pro- substances. The quantity of any op- duced from polyvinyl alcohol having a tional adjuvant substance employed in minimum viscosity of 4 centipoises the production of the polymer does not when a 4-percent aqueous solution is exceed the amount reasonably required tested at 20 °C. to accomplish the intended technical (b) The finished food-contact film for or physical effect. Such adjuvants may use in contact with Food Types V or include substances generally recog- IX, when extracted with the solvent nized as safe in food, substances used in characterizing the type of food and accordance with prior sanction, and under the conditions of time and tem- substances permitted under applicable perature characterizing its intended regulations in this part. use as determined from tables 1 and 2 (c) Specifications. (1) Inherent vis- of § 176.170(c) of this chapter, yields cosity of a 0.50 percent solution of the total extractives not to exceed 0.078 polymer in phenol/tetrachloroethane milligram per square centimeter (0.5 (60/40 weight ratio) solvent is not less milligram per square inch) of food-con- than 0.6 as determined using a Wagner tact surface when tested by ASTM viscometer (or equivalent) and cal- method F34–76 (Reapproved 1980), culated from the following equation: ‘‘Standard Test Method for Liquid Ex- traction of Flexible Barrier Materials,’’ (natural log arithm of N ) which is incorporated by reference. Inherent = r viscos ity Copies may be obtained from the Amer- (c) ican Society for Testing Materials, 100 where: Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be Nr = Ratio of flow time of the polymer solu- tion to that of the solvent and c = poly- examined at the National Archives and mer concentration of the test solution in Records Administration (NARA). For grams per 100 milliliters. information on the availability of this

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material at NARA, call 202–741–6030, or 1,4–Cyclohexane dimethanol (CAS Reg. No. go to: http://www.archives.gov/ 105–08–8). federallregister/ 2,2-Dimethyl-1,3-propanediol. codeloflfederallregulations/ Ethylene glycol. 1,6–Hexanediol (CAS Reg. No. 629–11–8).a– ibrllocations.html. Hydro–w–hydroxypoly(oxy–1,4–butanediyl) (c) The finished food-contact film (CAS Reg. No. 25190–06–1). shall not be used as a component of a-Hydro-omega-hydroxypoly (oxytetra- food containers intended for use in con- methylene). tact with water. a,a′-(Isopropylidenedi-p-phenylene)bis[omega- hydroxypoly (oxypropylene)(3–4 moles)], [42 FR 14572, Mar. 15, 1977, as amended at 49 average molecular weight 675. FR 10110, Mar. 19, 1984] Maleic anhydride. Methyl oxirane polymer with oxirane (CAS § 177.1680 Polyurethane resins. Reg. No. 9003–11–6). The polyurethane resins identified in Methyl oxirane polymer with oxirane, ether paragraph (a) of this section may be with 1,2,3–propanetriol (CAS Reg. No. 9082– 00–2). safely used as the food-contact surface a,a′a″,a″′-Neopentanetetrayltetrakis [omega- of articles intended for use in contact hydroxypoly (oxypropylene) (1–2 moles)], with bulk quantities of dry food of the average molecular weight 400. type identified in § 176.170(c) of this Pentaerythritol-linseed oil alcoholysis prod- chapter, table 1, under Type VIII, in ac- uct. cordance with the following prescribed Phthalic anhydride. conditions: Polybutylene glycol. (a) For the purpose of this section, Polyethyleneadipate modified with ethanol- amine with the molar ratio of the amine to polyurethane resins are those produced the adipic acid less than 0.1 to 1. when one or more of the isocyanates Poly(oxycarbonylpentamethylene). listed in paragraph (a)(1) of this section Polyoxypropylene ethers of 4.4′-isopropyl- is made to react with one or more of idenediphenol (containing an average of 2– the substances listed in paragraph 4 moles of propylene oxide). (a)(2) of this section: Polypropylene glycol. (1) Isocyanates: a,a′,a″-1,2,3-Propanetriyltris [omega- hydroxypoly (oxypropylene) (15–18 moles)], Bis(isocyanatomethyl) benzene (CAS Reg. average molecular weight 3,000. No. 25854–16–4). Propylene glycol. Bis(isocyanatomethyl) cyclohexane (CAS a,a′,a″-[Propylidynetris (methylene)] tris Reg. No. 38661–72–2). [omega-hydroxypoly (oxypropylene) (min- 4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- imum 1.5 moles)], minimum molecular tolylene diisocyanate). weight 400. Diphenylmethane diisocyanate. a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]- Hexamethylene diisocyanate. omega-hydroxypoly(oxyethylene) (5 moles), 3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- average molecular weight 425. hexyl isocyanate. Trimethylol propane. 4,4-Methylenebis(cyclohexyl isocyanate). Toluene diisocyanate. (b) Optional adjuvant substances em- ployed in the production of the poly- (2) List of substances: urethane resins or added thereto to im- Adipic acid. part desired technical or physical prop- 1,4-Butanediol. erties may include the following sub- 1,3-Butylene glycol. stances:

List of substances Limitations

1-[(2-Aminoethyl)amino]2-propanol ...... As a curing agent. 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... As a preservative. Colorants used in accordance with § 178.3297 of this chapter.. Dibutyltin diacetate ...... As a catalyst. Dibutyltin dichloride ...... Do. Dibutyltin dilaurate ...... Do. N,N-Dimethyldodecylamine ...... Do. N-Dodecylmorpholine ...... Do. a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer. ]]bis[omega-hydroxypoly-(oxyethylene) (136–170 moles)], av- erage molecular weight 15,000. 4,4′-Methylenedianiline ...... As a curing agent. 1,1′,1″-Nitrilotri-2-propanol ...... Do.

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List of substances Limitations

2,2′-(p-Phenylenedioxy) diethanol ...... Do. Polyvinyl isobutyl ether. Polyvinyl methyl ether. Soyaalkyd resin ...... Conforming in composition with § 175.300 of this chapter and containing litharge not to exceed that residual from its use as the reaction catalyst and creosol not to exceed that re- quired as an antioxidant. Tetrakis [methylene–(2,5–di-tert-butyl-4-hydroxyhydrocinna- Stabilizer. mate)]methane (CAS Reg. No. 6683–19–8). N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ...... As a curing agent. Triethanolamine ...... Do. Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent. 57609–64–0).

(c) An appropriate sample of the fin- § 177.1810 Styrene block polymers. ished resin in the form in which it con- The styrene block polymers identi- tacts food, when subjected to ASTM fied in paragraph (a) of this section method D968–81, ‘‘Standard Test Meth- may be safely used as articles or as ods for Abrasion Resistance of Organic components of articles intended for use Coatings by the Falling Abrasive in contact with food, subject to provi- Tester,’’ which is incorporated by ref- sions of this section. erence (Copies may be obtained from (a) For the purpose of this section, the American Society for Testing Ma- styrene block polymers are basic poly- terials, 100 Barr Harbor Dr., West mers manufactured as described in this Conshohocken, Philadelphia, PA 19428- paragraph, so that the finished poly- 2959, or may be examined at the Na- mers meet the specifications prescribed tional Archives and Records Adminis- in paragraph (b) of this section, when tration (NARA). For information on tested by the methods described in the availability of this material at paragraph (c) of this section. NARA, call 202–741–6030, or go to: http:// (1) Styrene block polymers with 1,3- www.archives.gov/federallregister/ butadiene are those produced by the codeloflfederallregulations/ catalytic solution polymerization of ibrllocations.html.), using No. 50 Emery styrene and 1,3-butadiene. abrasive in lieu of Ottawa sand, shall (2) Styrene block polymers with 2- exhibit an abrasion coefficient of not methyl-1,3-butadiene are those pro- duced by the catalytic solution polym- less than 20 liters per mil of film thick- erization of styrene and 2-methyl-1,3- ness. butadiene. [42 FR 14572, Mar. 15, 1977, as amended at 46 (3) Styrene block polymers with 1,3- FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, butadiene, hydrogenated are those pro- 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, duced by the catalytic solution polym- Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] erization of styrene and 1,3-butadiene, and subsequently hydrogenated. (b) Specifications:

Maximum extract- Maximum extract- able fraction in dis- able fraction in 50 Molecular Glass transi- tilled water at spec- percent ethanol at Styrene block polymers weight Solubility tion points ified temperatures, specified tempera- (minimum) times, and tures, times, and thicknesses thicknesses

1. (i) Styrene block polymers with 1,3- 29,000 Completely ¥98 °C 0.0039 mg/cm2 0.002 mg/cm2 (0.01 butadiene; for use as articles or as soluble in (¥144 °F) (0.025 mg/in2) of mg/in2) of sur- components of articles that contact toluene. to ¥71 °C surface at reflux face at 66 °C food of Types I, II, IV-B, VI, VII-B, (¥96 °F) temperature for (150 °F) for 2 hr and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm § 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick conditions of use D, E, F, and G de- 122 °C thick sample. sample. scribed in table 2 in § 176.170(c) of (252 °F). this chapter.

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Maximum extract- Maximum extract- able fraction in dis- able fraction in 50 Molecular Glass transi- tilled water at spec- percent ethanol at Styrene block polymers weight Solubility tion points ified temperatures, specified tempera- (minimum) times, and tures, times, and thicknesses thicknesses

(ii) Styrene block polymers with 1,3-bu- 29,000 ...... do ...... do ...... do ...... Do. tadiene; for use as components of pressure-sensitive adhesives that contact food of Types I, II, IV-B, VI, VII-B, and VIII identified in table 1 in § 176.170(c) of this chapter under conditions of use C, D, E, F and G described in table 2 in § 176.170(c) of this chapter, provided the pressure- sensitive adhesives be applied only to closure tapes for sealing con- tainers having a capacity of not less than 160 cc (5.5 fluid ounces) and that the area of the adhesive ex- posed to food shall not exceed 4.03 cm2 (0.625 in2). The pressure-sen- sitive adhesive may contain terpene resins as identified in § 175.125(b)(2) of this chapter. 2. Styrene block polymers with 2-meth- 29,000 ...... do ...... ¥65 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 yl-1,3-butadiene; for use as articles (¥85 °F) mg/in2) of sur- mg/in2) of sur- or as components of articles that to ¥47 °C face at reflux face at 66 °C contact food of Types I, II, IV-B, VI, (¥53 °F) temperature for 2 (150 °F) for 2 hr VII-B, and VIII identified in table 1 in and 86 °C hr on a 0.071 cm on a 0.071 cm § 176.170(c) of this chapter. (187 °F) to (0.028 in) thick (0.028 in) thick 122 °C sample. (Option- sample. (Option- (252 °F). ally, maximum ally, maximum net residue solu- net residue solu- ble in chloroform ble in chloroform shall not exceed shall not exceed 0.00020 mg/cm2 0.00040 mg/cm2 (0.0013 mg/in2) (0.0025 mg/in2) of surface.). of surface.) 3. (i) Styrene block polymers with 1,3- 16,000 ...... do ...... ¥50 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 butadiene, hydrogenated (CAS Reg. (¥58 °F) mg/in2) of sur- mg/in2) of sur- No. 66070–58–4): for use as articles to ¥30 °C face at reflux face at 66 °C or as components of articles that (¥22 °F) temperature for 2 (150 °F) for 2 hr contact food of Types I, II, IV-B, VI, and 92 °C hr on a 0.071 cm on a 0.071 cm VII-B, and VIII identified in table 1 in (198 °F) to (0.028 in) thick (0.028 in) thick § 176.170(c) of this chapter. 98 °C (208 sample. sample. °F). (ii) Styrene block polymers with 1,3-bu- 16,000 ...... do ...... do ...... do ...... Do. tadiene, hydrogenated (CAS Reg. No. 66070–58–4): for use at levels not to exceed 42.4 percent by weight as a component of closures with sealing gaskets that would contact food of Types III, IV-A, V, VII-A, VIII, and IX identified in table 1 in § 176.170(c) of this chapter, and in condition of use D as described under table 2 in § 176.170(c) of this chapter.

(c) The analytical methods for deter- (2) Glass transition points. The glass mining whether styrene block poly- transition points shall be determined mers conform to the specifications pre- by either of the following methods: scribed in this section are as follows (i) ASTM method D2236–70 (‘‘Stand- and are applicable to the finished poly- ard Method of Test for Dynamic Me- mer. chanical Properties of Plastics by (1) Molecular weight. Molecular Means of Torsional Pendulum,’’ which weight shall be determined by intrinsic is incorporated by reference; copies are viscosity (or other suitable method). available from American Society for Testing and Materials (ASTM), 100

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Barr Harbor Dr., West Conshohocken, (3) Maximum extractable fractions in Philadelphia, PA 19428-2959, or avail- distilled water and 50 percent ethanol and able for inspection at the National Ar- the maximum net residue solubles in chlo- chives and Records Administration roform. The maximum extractable frac- (NARA). For information on the avail- tions in distilled water and 50 percent ability of this material at NARA, call ethanol, and the maximum net residue 202–741–6030, or go to: http:// solubles in chloroform, shall be deter- www.archives.gov/federallregister/ mined in accordance with § 176.170(d)(3) codeloflfederallregulations/ of this chapter using a sandwich form ibrllocations.html.) modified by using a of the finished copolymer of the speci- forced resonant vibration instead of a fied thickness and for the time and fixed vibration and by using fre- temperature specified in paragraph (b) quencies of 25 to 40 cycles per second of this section. instead of 0.1 to 10 cycles per second. (d) The provisions of this section are (ii) Direct reading viscoelastometric not applicable to butadiene-styrene co- method titled ‘‘Direct Reading Viscoelastrometric Method for Deter- polymers listed in other sections of mining Glass Transition Points of Sty- this subpart. rene Block Polymers’’ (which is incor- (e) The provisions of this section are porated by reference; copies are avail- not applicable to styrene block poly- able from the Center for Food Safety mers with 1,3-butadiene listed in and Applied Nutrition (HFS–200), Food § 175.105 of this chapter. and Drug Administration, 5001 Campus [42 FR 14572, Mar. 15, 1977, as amended at 42 Dr., College Park, MD 20740, or avail- FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, able for inspection at the National Ar- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, chives and Records Administration June 12, 1989; 58 FR 65546, Dec. 15, 1993] (NARA). For information on the avail- ability of this material at NARA, call § 177.1820 Styrene-maleic anhydride 202–741–6030, or go to: http:// copolymers. www.archives.gov/federallregister/ Styrene-maleic anhydride copoly- codeloflfederallregulations/ mers identified in paragraph (a) of this ibrllocations.html.), by which the glass section may be safely used as articles transition points are determined in the or components of articles intended for tensile mode of deformation at a fre- use in contact with food, subject to quency of 35 hertz using a Rheovibron provisions of this section. Model DDV-II (or equivalent) Direct Reading Viscoelastometer. Take maxi- (a) For the purpose of this section, ma in the out-of-phase component of styrene-maleic anhydride copolymers the complex modulus as the glass tran- are those produced by the polymeriza- sition points. For block polymers of tion of styrene and maleic anhydride so low styrene content or for simple block that the finished polymers meet the polymers, the polymer may be treated specifications prescribed in paragraph with 0.3 part per hundred dicumyl per- (b) of this section, when tested by the oxide and cured for 30 minutes at 153 °C methods described in paragraph (c) of to accentuate the upper transition this section. point. (b) Specifications:

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Maximum extract- Maximum extract- Molecular Residual able fraction in dis- able fraction in n- weight Residual sty- maleic anhy- tilled water at spec- heptane at speci- Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures, number omer omer times, and particle times, and particle average) size size

1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr maleic anhydride units by weight; for temperature for 1 utilizing particles use as articles or as components of hr utilizing par- of a size that will articles that contact food of Types I, ticles of a size pass through a II, III, IV-A, IV-B, V, VI-B (except car- that will pass U.S. standard bonated beverages), VII-A, VII-B, through a U.S. sieve No. 10 and VIII, and IX identified in table 1 in standard sieve will be held on a § 176.170(c) of this chapter under No. 10 and will U.S. standard conditions of use B, C, D, E, F, G, be held on a sieve No. 20. and H described in table 2 in U.S. standard § 176.170(c) of this chapter. sieve No. 20. 2. Styrene-maleic anhydride copolymer ...... 0.3 ...... 0.1 ...... 0.015 weight per- 1.0 weight percent modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F) No. 27288–99–9) containing not temperature for 1 for 2 hours uti- more than 15 percent maleic anhy- hour utilizing par- lizing particles of dride units by weight and not more ticles of a size a size that will than 20 percent styrene-butadiene that will pass pass through a and/or butadiene rubber units by through a U.S. U.S. standard weight; for use (except carbonated standard sieve sieve No. 10 and beverage bottles) as articles or as No. 10 and will will be held on a components of articles that contact be held on a U.S. standard food of Types I, II, III, IV-A, IV-B, V, U.S. standard sieve No. 20. VI, VII-A, VII-B, VIII, and IX identified sieve No. 20. in table I in § 176.170(c) of this chap- ter under conditions of use B, C, D, E, F, G, and H described in table 2 in § 176.170(c) of this chapter.

(c) The analytical methods for deter- codeloflfederallregulations/ mining conformance with specifica- ibrllocations.html. tions for styrene-maleic anhydride co- (d) The provisions of this section are polymers prescribed in this section are not applicable to styrene-maleic anhy- as follows: dride copolymers listed in other sec- (1) Molecular weight. Molecular tions of this subpart. weight shall be determined by mem- brane osmometry. [42 FR 14572, Mar. 15, 1977, as amended at 47 (2) Residual styrene monomer content. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, Residual styrene monomer content 1982; 54 FR 24898, June 12, 1989] shall be determined by the method de- § 177.1830 Styrene-methyl methacry- scribed in § 177.1640(d). late copolymers. (3) Residual maleic anhydride monomer content. Residual maleic anhydride Styrene-methyl methacrylate co- monomer content shall be determined polymers identified in this section may by a gas chromatographic method ti- be safely used as components of plastic tled ‘‘Determination of Residual Ma- articles intended for use in contact leic Anhydride in Polymers by Gas with food, subject to the provisions of Chromatography,’’ which is incor- this section. porated by reference. Copies are avail- (a) For the purpose of this section, able from the Center for Food Safety styrene-methyl methacrylate copoly- and Applied Nutrition (HFS–200), Food mers consist of basic copolymers pro- and Drug Administration, 5001 Campus duced by the copolymerization of sty- Dr., College Park, MD 20740, or avail- rene and methyl methacrylate such able for inspection at the National Ar- that the finished basic copolymers con- chives and Records Administration tain more than 50 weight percent of (NARA). For information on the avail- polymer units derived from styrene. ability of this material at NARA, call (b) The finished plastic food-contact 202–741–6030, or go to: http:// article, when extracted with the sol- www.archives.gov/federallregister/ vent or solvents characterizing the

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type of food and under the conditions Substances Limitations of time and temperature characterizing (3) Adjuvant substance, As a solvent in the prepara- the conditions of intended use as deter- dimethylformamide. tion of fibryl. mined from tables 1 and 2 of § 176.170(c) of this chapter, yields extractives not (d) Textryls meeting the conditions to exceed the following when tested by of test prescribed in paragraph (d)(1) of the methods prescribed in § 177.1010(c); this section are used as prescribed in (1) Total nonvolatile extractives not paragraph (d)(2) of this section. to exceed 0.3 milligram per square inch (1) Conditions of test. Textryls, when of surface tested. extracted with distilled water at reflux (2) Potassium permanganate oxidiz- temperature for 1 hour, yield total ex- able distilled water and 8 and 50 per- tractives not to exceed 1 percent. cent alcohol extractives not to exceed an absorbance of 0.15. (2) Uses. Textryls are used for pack- (3) Ultraviolet-absorbing distilled aging or holding food at ordinary tem- water and 8 and 50 percent alcohol ex- peratures and in the brewing of hot tractives not to exceed an absorbance beverages. of 0.30. (4) Ultraviolet-absorbing n-heptane § 177.1900 Urea-formaldehyde resins in molded articles. extractives not to exceed an absorb- ance of 0.40. Urea-formaldehyde resins may be safely used as the food-contact surface § 177.1850 Textryls. of molded articles intended for use in Textryls identified in this section contact with food, in accordance with may be safely used as articles or com- the following prescribed conditions: ponents of articles, intended for use in (a) For the purpose of this section, producing, manufacturing, packing, urea-formaldehyde resins are those processing, preparing, treating, pack- produced when 1 mole of urea is made aging, transporting or holding food, to react with not more than 2 moles of subject to the provisions of this sec- formaldehyde in water solution. tion. (b) The resins may be mixed with re- (a) Textryls are nonwoven sheets pre- fined wood pulp and the mixture may pared from natural or synthetic fibers, contain other optional adjuvant sub- bonded with fibryl (Fibryl consists of a stances which may include the fol- polymeric resin in fibrous form com- lowing: mingled with fiber to facilitate sheet formation and subsequently heat cured List of substances Limitations to fuse the fibryl and effect bonding). Hexamethylenetetramine ...... For use only as polymeriza- (b) Textryls are prepared from the fi- tion-control agent. bers, fibryls, and adjuvants identified Tetrachlorophthalic acid an- Do. in paragraph (c) of this section, and hydride. subject to limitations prescribed in Zinc stearate ...... For use as lubricant. that paragraph, provided that any sub- stance that is the subject of a regula- (c) The finished food-contact article, tion in parts 174, 175, 176, 177, 178 and when extracted with the solvent or sol- § 179.45 of this chapter conforms with vents characterizing the type of food any specifications in such regulation and under the conditions of time and for that substance as a component of temperature characterizing the condi- polymeric resins used as food contact tions of its intended use as determined surfaces. from tables 1 and 2 of § 175.300(d) of this (c) The fibers, fibryls, and adjuvants chapter, yields total extractives in permitted are as follows: each extracting solvent not to exceed 0.5 milligram per square inch of food- Substances Limitations contact surface as determined by the (1) Fibers prepared from pol- Conforming with § 177.1630. methods described in § 175.300(e) of this yethylene terephthalate chapter. resins. (2) Fibryls prepared from As the basic polymer. NOTE: In testing the finished food-contact vinyl chloride-vinyl acetate article, use a separate test sample for each copolymer. required extracting solvent.

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§ 177.1950 Vinyl chloride-ethylene co- codeloflfederallregulations/ polymers. ibrllocations.html. The vinyl chloride-ethylene copoly- (2) Extractives limitations. The fol- mers identified in paragraph (a) of this lowing extractives limitations are de- section may be safely used as compo- termined by the methods described in nents of articles intended for contact paragraph (d) of this section: with food, under conditions of use D, E, (i) Total extractives do not exceed F, or G described in table 2 of § 176.170 0.10 weight-percent when extracted (c) of this chapter, subject to the provi- with n-heptane at 150 °F for 2 hours. sions of this section. (ii) Total extractives do not exceed (a) For the purpose of this section, 0.03 weight-percent when extracted vinyl chloride-ethylene copolymers with water at 150 °F for 2 hours. consist of basic copolymers produced (iii) Total extractives obtained by ex- by the copolymerization of vinyl chlo- tracting with water at 150 °F for 2 ride and ethylene such that the fin- hours contain no more than 0.5 milli- ished basic copolymers meet the speci- gram of vinyl chloride-ethylene copol- fications and extractives limitations ymer per 100 grams of sample tested as prescribed in paragraph (c) of this sec- determined from the organic chlorine tion, when tested by the methods de- content. The organic chlorine content scribed in paragraph (d) of this section. is determined as described in paragraph (b) The basic vinyl chloride-ethylene (d)(3) of this section. copolymers identified in paragraph (a) (d) Analytical methods: The analyt- of this section may contain optional ical methods for determining whether adjuvant substances required in the vinyl chloride-ethylene basic copoly- production of such basic copolymers. mers conform to the extractives limi- The optional adjuvant substances re- tations prescribed in paragraph (c) of quired in the production of the basic this section are as follows and are ap- vinyl chloride-ethylene copolymers plicable to the basic copolymers in may include substances permitted for powder form having a particle size such such use by regulations in parts 170 that 100 percent will pass through a through 189 of this chapter, substances U.S. Standard Sieve No. 40 and 80 per- generally recognized as safe in food, cent will pass through a U.S. Standard and substances used in accordance with Sieve No. 80: a prior sanction or approval. (1) Reagents—(i) Water. All water used (c) The vinyl chloride-ethylene basic in these procedures shall be copolymers meet the following speci- demineralized (deionized), freshly dis- fications and extractives limitations: tilled water. (1) Specifications. (i) Total chlorine (ii) n-Heptane. Reagent grade, freshly content is in the range of 53 to 56 per- distilled n-heptane shall be used. cent as determined by any suitable an- (2) Determination of total amount of ex- alytical procedure of generally accept- tractives. All determinations shall be ed applicability. done in duplicate using duplicate (ii) Intrinsic viscosity in blanks. Approximately 400 grams of cyclohexanone at 30 °C is not less than sample (accurately weighed) shall be 0.50 deciliter per gram as determined placed in a 2-liter Erlenmeyer flask. by ASTM method D1243–79, ‘‘Standard Add 1,200 milliliters of solvent and Test Method for Dilute Solution Vis- cover the flask with aluminum foil. cosity of Vinyl Chloride Polymers,’’ The covered flask and contents are sus- which is incorporated by reference. pended in a thermostated bath and are Copies may be obtained from the Amer- kept, with continual shaking at 150 °F ican Society for Testing Materials, 100 for 2 hours. The solution is then fil- Barr Harbor Dr., West Conshohocken, tered through a No. 42 Whatman filter Philadelphia, PA 19428-2959, or may be paper, and the filtrate is collected in a examined at the National Archives and graduated cylinder. The total amount Records Administration (NARA). For of filtrate (without washing) is meas- information on the availability of this ured and called A milliliters. The fil- material at NARA, call 202–741–6030, or trate is transferred to a Pyrex (or go to: http://www.archives.gov/ equivalent) beaker and evaporated on a federallregister/ steam bath under a stream of nitrogen

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to a small volume (approximately 50–60 aqueous extract or to a vacuum oven at milliliters). The concentrated filtrate 150 °F in the case of the heptane ex- is then quantitatively transferred to a tract. In the case of the aqueous ex- tared 100-milliliter Pyrex beaker using tract, the evaporation to constant small, fresh portions of solvent and a weight is completed in 15 minutes at rubber policeman to effect the transfer. 230 °F; and in the case of heptane ex- The concentrated filtrate is evaporated tract, it is overnight under vacuum at almost to dryness on a hotplate under 150 °F. The residue is weighed and cor- nitrogen, and is then transferred to a rected for the solvent blank. Calcula- drying oven at 230 °F in the case of the tion:

Gramsof corrected residue 1, 200 milliliters Total extractives expressed as ××=100 Grams of sample Volume of filtrate percent by weight of sample. A in milliliters

(3) Vinyl chloride-ethylene copolymer extract and washings are collected in a content of aqueous extract—(i) Principle. 1,500-milliliter beaker. The solution is The vinyl chloride-ethylene copolymer evaporated carefully on a steam plate content of the aqueous extract can be to a volume of approximately 50 milli- determined by determining the organic liters and then transferred quan- chlorine content and calculating the titatively, a little at a time, to a clean amount of copolymer equivalent to the 22-milliliter Parr cup, also on the organic chlorine content. steam plate. The solution is evaporated (ii) Total organic chlorine content. A to dryness. Next 0.25 gram of sucrose weighed sample of approximately 400 and 0.5 gram of benzoic acid are added grams is extracted with 1,200 milliliters to the cup. One scoop (approximately of water at 150 °F for 2 hours, filtered, 15 grams) of sodium peroxide is then and the volume of filtrate is measured added to the cup. The bomb is assem- (A milliliters) as described in para- bled and ignition is conducted in the graph (d)(2) of this section. usual fashion. (a) A slurry of Amberlite IRA–400, or (d) After the bomb has cooled, it is equivalent, is made with distilled rinsed thoroughly with distilled water water in a 150-milliliter beaker. The and disassembled. The top of the bomb slurry is added to a chromatographic is rinsed into a 250-milliliter beaker column until it is filled to about half with distilled water. The beaker is its length. This should give a volume of resin of 15–25 milliliters. The liquid placed on the steam plate. The bomb must not be allowed to drain below the cup is placed in the beaker and care- top of the packed column. fully tipped over to allow the water to (b) The column is regenerated to the leach out the combustion mixture. basic (OH) form by slowly passing After the bubbling has stopped, the cup through it (10–15 milliliters per minute) is removed from the beaker and rinsed 10 grams of sodium hydroxide dissolved thoroughly. The solution is cooled to in 200 milliliters of water. The column room temperature and cautiously neu- is washed with distilled water until the tralized with concentrated nitric acid effluent is neutral to phenolphthalein. by slowly pouring the acid down a stir- One drop of methyl red indicator is ring rod until the bubbling ceases. The added to the A milliliters of filtered solution is cooled and an equal volume aqueous extract and, if on the basic of acetone is added. side (yellow), nitric acid is added drop (e) The solution is titrated with 0.005 by drop until the solution turns pink. N silver nitrate using standard poten- (c) The extract is deionized by pass- tiometric titration techniques with a ing it through the exchange column at silver electrode as indicator and a po- a rate of 10–15 milliliters per minute. tassium nitrate modified calomel elec- The column is washed with 200 milli- trode as a reference electrode. An ex- liters of distilled water. The deionized panded scale recording titrimeter.

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Metrohm Potentiograph 2336 or equiva- (iii) Calculations. lent, should be used; a complete blank must be run in duplicate.

Milligrams of aqueous extracted TF××64.3 = ×100 copolymer per 100-gram sample Weight of sample in grams

where: agent, respectively, in their produc- T = Milliliters of silver nitrate (sample tion. minus blank) × normality of silver ni- (b) Specifications and limitations. The trate. vinyl chloride-hexene-1 basic copoly- F = 1,200 / A (as defined above) mers meet the following specifications (e) The vinyl chloride-ethylene co- and extractives limitations: polymers identified in and complying (1) Specifications. (i) Total chlorine with this section, when used as compo- content is 53 to 56 percent as deter- nents of the food-contact surface of mined by any suitable analytical pro- any article that is the subject of a reg- cedure of generally accepted applica- ulation in parts 174, 175, 176, 177, 178 bility. and § 179.45 of this chapter, shall com- (ii) Inherent viscosity in ° ply with any specifications and limita- cyclohexanone at 30 C is not less than tions prescribed by such regulation for 0.59 deciliters per gram as determined the article in the finished form in by ASTM method D1243–79, ‘‘Standard which it is to contact food. Test Method for Dilute Solution Vis- cosity of Vinyl Chloride Polymers,’’ (f) The provisions of this section are which is incorporated by reference. not applicable to vinyl chloride-ethyl- Copies may be obtained from the Amer- ene copolymers used as provided in ican Society for Testing Materials, 100 §§ 175.105 and 176.180 of this chapter. Barr Harbor Dr., West Conshohocken, [42 FR 14572, Mar. 15, 1977, as amended at 49 Philadelphia, PA 19428-2959, or may be FR 10110, Mar. 19, 1984] examined at the National Archives and Records Administration (NARA). For § 177.1960 Vinyl chloride-hexene-1 co- information on the availability of this polymers. material at NARA, call 202–741–6030, or The vinyl chloride-hexene-1 copoly- go to: http://www.archives.gov/ mers identified in paragraph (a) of this federallregister/ section or as components of articles in- codeloflfederallregulations/ tended for use in contact with food, ibrllocations.html. under conditions of use D, E, F, or G (2) Extractives limitations. The fol- described in table 2 of § 176.170(c) of this lowing extractives limitations are de- chapter, subject to the provisions of termined by the methods prescribed in this section. § 177.1970(d). (a) Identity. For the purposes of this (i) Total extractives do not exceed section vinyl chloride-hexene-1 copoly- 0.01 weight percent when extracted mers consist of basic copolymers pro- with water at 150 °F for 2 hours. duced by the copolymerization of vinyl (ii) Total extractives do not exceed chloride and hexene-1 such that the fin- 0.30 weight percent when extracted ished copolymers contain not more with n-heptane at 150 °F for 2 hours. than 3 mole-percent of polymer units (c) Other specifications and limitations. derived from hexene-1 and meet the The vinyl chloride-hexene-1 copoly- specifications and extractives limita- mers identified in and complying with tions prescribed in paragraph (b) of this this section, when used as components section. The copolymers may option- of the food-contact surface of any arti- ally contain hydroxypropyl methyl- cle that is subject to a regulation in cellulose and trichloroethylene used as parts 174, 175, 176, 177, 178 and § 179.45 of a suspending agent and chain transfer this chapter, shall comply with any

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specifications and limitations pre- Conshohocken, Philadelphia, PA 19428- scribed by such regulation for the arti- 2959, or may be examined at the Na- cle in the finished form in which it is tional Archives and Records Adminis- to contact food. tration (NARA). For information on [42 FR 14572, Mar. 15, 1977, as amended at 49 the availability of this material at FR 10110, Mar. 19, 1984] NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 177.1970 Vinyl chloride-lauryl vinyl codeloflfederallregulations/ ether copolymers. ibrllocations.html. The vinyl chloride-lauryl vinyl ether (2) Extractives limitations. The fol- copolymers identified in paragraph (a) lowing extractives limitations are de- of this section may be used as an arti- termined by the method described in cle or as a component of an article in- paragraph (d) of this section: tended for use in contact with food sub- (i) Total extractives do not exceed ject to the provisions of this section. 0.03 weight-percent when extracted (a) Identity. For the purposes of this with water at 150 °F for 2 hours. section vinyl chloride-lauryl vinyl (ii) Total extractives do not exceed ether copolymers consist of basic co- 0.60 weight-percent when extracted polymers produced by the copolym- with n-heptane at 150 °F for 2 hours. erization of vinyl chloride and lauryl (d) Analytical methods. The analytical vinyl ether such that the finished co- methods for determining total extrac- polymers contain not more than 3 tives are applicable to the basic co- weight-percent of polymer units de- polymers in powder form having a par- rived from lauryl vinyl ether and meet ticle size such that 100 percent will the specifications and extractives limi- pass through a U.S. Standard Sieve No. tations prescribed in paragraph (c) of 40 and such that not more than 10 per- this section. cent will pass through a U.S. Standard (b) Optional adjuvant substances. The Sieve No. 200. basic vinyl chloride-lauryl vinyl ether (1) Reagents—(i) Water. All water used copolymers identified in paragraph (a) in these procedures shall be of this section may contain optional demineralized (deionized), freshly dis- adjuvant substances required in the tilled water. production of such basic copolymers. (ii) n-Heptane. Reagent grade, freshly These optional adjuvant substances distilled n-heptane shall be used. may include substances permitted for (2) Determination of total amount of ex- such use by regulations in parts 170 tractives. Place an accurately weighed through 189 of this chapter, substances sample of suitable size in a clean generally recognized as safe in food, borosilicate flask, and for each gram of and substances used in accordance with sample add 3 milliliters of solvent pre- a prior sanction or approval. viously heated to 150 °F. Maintain the (c) Specifications and limitations. The temperature of the contents of the vinyl chloride-lauryl vinyl ether basic flask at 150 °F for 2 hours using a hot copolymers meet the following speci- plate while also maintaining gentle fications and extractives limitations: mechanical agitation. Filter the con- (1) Specifications. (i) Total chlorine tents of the flask rapidly through No. content is 53 to 56 percent as deter- 42 Whatman filter paper with the aid of mined by any suitable analytical pro- suction. Transfer the filtrate to flat cedure of generally accepted applica- glass dishes that are warmed on a hot bility. plate and evaporate the solvent with (ii) Inherent viscosity in the aid of a stream of filtered air. When cylcoHhexanone at 30 °C is not less the volume of the filtrate has been re- than 0.60 deciliter per gram as deter- duced to 10 to 15 milliliters, transfer mined by ASTM method D1243–79, the filtrate to tared 50-milliliter ‘‘Standard Test Method for Dilute So- borosilicate glass beakers and com- lution Viscosity of Vinyl Chloride plete evaporation to a constant weight Polymers,’’ which is incorporated by in a 140 °F vacuum oven. Carry out a reference. Copies may be obtained from corresponding blank determination the American Society for Testing Ma- with each solvent. Determine the terials, 100 Barr Harbor Dr., West weight of the residue corrected for the

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solvent blank and calculate the result (ii) Intrinsic viscosity in cyclo- as percent of the initial weight of the hexanone at 30 °C is not less than 0.50 resin sample taken for analysis. deciliter per gram as determined by (e) Other specifications and limitations. ASTM method D1243–79, ‘‘Standard The vinyl chloride-lauryl vinyl ether Test Method for Dilute Solution Vis- copolymers identified in and complying cosity of Vinyl Chloride Polymers,’’ with this section, when used as compo- which is incorporated by reference. nents of the food-contact surface of Copies may be obtained from the Amer- any article that is subject to a regula- ican Society for Testing Materials, 100 tion in parts 174, 175, 176, 177, 178 and Barr Harbor Dr., West Conshohocken, § 179.45 of this chapter, shall comply Philadelphia, PA 19428-2959, or may be with any specifications and limitations examined at the National Archives and prescribed by such regulation for the Records Administration (NARA). For article in the finished form in which it information on the availability of this is to contact food. material at NARA, call 202–741–6030, or [42 FR 14572, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/ FR 10110, Mar. 19, 1984] federallregister/ codeloflfederallregulations/ § 177.1980 Vinyl chloride-propylene co- ibrllocations.html. polymers. (2) Extractives limitations. The fol- The vinyl chloride-propylene copoly- lowing extractives limitations are de- mers identified in paragraph (a) of this termined by the methods described in section may be safely used as compo- paragraph (d) of this section: nents of articles intended for contact (i) Total extractives do not exceed with food, subject to the provisions of 0.10 weight-percent when extracted this section. with n-heptane at 150 °F for 2 hours. (a) For the purpose of this section, (ii) Total extractives do not exceed vinyl chloride-propylene copolymers 0.03 weight-percent when extracted consist of basic copolymers produced with water at 150 °F for 2 hours. by the copolymezation of vinyl chlo- (iii) Total extractives obtained by ex- ride and propylene such that the fin- tracting with water at 150 °F for 2 ished basic copolymers meet the speci- hours contain no more than 0.17 milli- fications and extractives limitations gram of vinyl chloride-propylene co- prescribed in paragraph (c) of this sec- polymer per 100 grams of sample tested tion, when tested by the methods de- as determined from the organic chlo- scribed in paragraph (d) of this section. rine content. For the purpose of this (b) The basic vinyl chloride-pro- section, the organic chlorine content is pylene copolymers identified in para- the difference between the total chlo- graph (a) of this section may contain rine and ionic chlorine contents deter- optional adjuvant substances required mined as described in paragraph (d) of in the production of such basic copoly- this section. mers. The optional adjuvant sub- (d) Analytical methods: The analyt- stances required in the production of ical methods for determining whether the basic vinyl chloride-propylene co- vinyl chloride-propylene basic copoly- polymers may include substances per- mers conform to the extractives limi- mitted for such use by regulations in tations prescribed in paragraph (c) of parts 170 through 189 of this chapter, this section are as follows and are ap- substances generally recognized as safe plicable to the basic copolymers in in food, and substances used in accord- powder form having a particle size such ance with a prior sanction or approval. that 100 percent will pass through a (c) The vinyl chloride-propylene U.S. Standard Sieve No. 40 and 80 per- basic copolymers meet the following cent will pass through a U.S. Standard specifications and extractives limita- Sieve No. 80: tions: (1) Reagents—(i) Water. All water used (1) Specifications. (i) Total chlorine in these procedures shall be content is in the range of 53 to 56 per- demineralized (deionized), freshly dis- cent as determined by any suitable an- tilled water. alytical procedure of generally accept- (ii) n-Heptane. Reagent grade, freshly ed applicability. distilled n-heptane shall be used.

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(2) Determination of total amount of ex- to a small volume (approximately 50–60 tractives. All determinations shall be milliliters). The concentrated filtrate done in duplicate using duplicate is then quantitatively transferred to a blanks. Approximately 400 grams of tared 100-milliliter Pyrex beaker using sample (accurately weighed) shall be small, fresh portions of solvent and a placed in a 2-liter Erlenmeyer flask. rubber policeman to effect the transfer. Add 1,200 milliliters of solvent and The concentrated filtrate is evaporated cover the flask with aluminum foil. almost to dryness on a hotplate under The covered flask and contents are sus- nitrogen, and is then transferred to a pended in a thermostated bath and are drying oven at 230 °F in the case of the kept, with continual shaking, at 150 °F aqueous extract or to a vacuum oven at for 2 hours. The solution is then fil- 150 °F in the case of the heptane ex- tered through a No. 42 Whatman filter tract. In the case of the aqueous ex- paper, and the filtrate is collected in a tract the evaporation to constant graduated cylinder. The total amount weight is completed in 15 minutes at of filtrate (without washing) is meas- 230 °F; and in the case of heptane ex- ured and called A milliliters. The fil- tract, it is overnight under vacuum at trate is transferred to a Pyrex (or 150 °F. The residue is weighed and cor- equivalent) beaker and evaporated on a rected for the solvent blank. Calcula- steam bath under a stream of nitrogen tion:

Gramsof corrected residue 1, 200 milliliters Total extractives expressed as ××=100 Grams of sample Volume of filtrate percent by weight of sample. A in milliliters

(3) Vinyl chloride-propylene copolymer sembled, water is added to the recess at content of aqueous extract—(i) Principle. the top of the bomb and ignition is con- The vinyl chloride-propylene copoly- ducted in the usual fashion using a mer content of the aqueous extract can Meeker burner. The heating is contin- be determined by determining the or- ued for 1 minute after the water at the ganic chlorine content and calculating top has evaporated. The bomb is the amount of copolymer equivalent to quenched in water, rinsed with distilled the organic chlorine content. The or- water, and placed in a 400-milliliter ganic chlorine content is the difference beaker. The bomb cover is rinsed with between the total chlorine content and water, catching the washings in the the ionic chlorine content. same 400-milliliter beaker. The bomb is (ii) Total chlorine content. A weighed covered with distilled water and a sample is extracted with water at 150 watch glass and heated until the melt °F for 2 hours, filtered, and the volume has dissolved. The bomb is removed, of filtrate is measured (A milliliters) as rinsed, catching the rinsings in the described in paragraph (d)(2) of this beaker, and the solution is acidified section. Two drops of 50 percent by with concentrated nitric acid using weight sodium hydroxide solution are methyl purple as an indicator. The added to prevent loss of chloride from beaker is covered with a watch glass, ammonium chloride, if present, and the and the contents are boiled gently for solution is evaporated to approxi- 10–15 minutes. After cooling to room mately 15 milliliters. The concentrated temperature the solution is made filtrate is quantitatively transferred to slightly alkaline with 50 percent by a 22-milliliter Parr bomb fusion cup weight sodium hydroxide solution, and gently evaporated to dryness. To then acidified with dilute (1:5) nitric the contents of the cup are added 3.5 acid. Then 1.5 milliliters of 2 N nitric grams of granular sodium peroxide, 0.1 acid per 100 milliliters of solution is gram of powdered starch, and 0.02 gram added and the solution is titrated with potassium nitrate; and the contents 0.005 N silver nitrate to the equivalence are mixed thoroughly. The bomb is as- potential end point using an expanded

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scale pH meter (Beckman Model 76, or equivalent). A complete blank must be run in duplicate. Calculation:

Grams of sample 1,200 milliliters Milliequivalents of total chlorine in ××=100 (B− C) Volume of filtrate aqueous extract of 100 grams of sample A in milliliters

where: solution is evaporated to approxi- A = volume of filtrate obtained in extraction. mately 150 milliliters. The solution is B = milliliters of silver nitrate solution used quantitatively transferred to a 250-mil- × in sample titration normality of silver liliter beaker, methyl purple indicator nitrate solution. C = milliliters of silver nitrate solution used is added, and the solution is neutral- in blank titration × normality of silver ized with 0.1 N nitric acid. For each 100 nitrate solution. milliliters of solution is added 1.5 mil- (iii) Ionic chlorine content. A weighed liliters of 2 N nitric acid. The solution sample is extracted with water at 150 is titrated with 0.005 N silver nitrate to °F for 2 hours, filtered, and the volume the equivalence potential end point, of filtrate is measured (A milliliters) as using the expanded scale pH meter de- in paragraph (d)(2) of this section. Two scribed in paragraph (d)(3)(ii) of this drops of 50 percent by weight sodium section. A complete blank must be run hydroxide solution are added and the in duplicate. Calculation:

DE− 1, 200 milliliters Milliequivalents of ionic chlorine in ××=100 Grams of sample Volume of filtrate aqueousextract of100 gramsof sample. A in milliliters

where: (b) Vinyl chloride-propylene copolymer A = volume of filtrate obtained in extraction. content. Milligrams of vinyl chloride- D = milliliters of silver nitrate solution used propylene copolymer in aqueous ex- in sample titration × normality of silver tract of 100 grams of sample equal nitrate solution. milliequivalents of organic chlorine in E = milliliters of silver nitrate solution used aqueous extract of 100 grams of sample in blank titration × normality of silver nitrate solution. (as calculated in paragraph (d)(3)(iv) (a) of this section) multiplied by 84.5. (iv) Organic chlorine content and vinyl NOTE: The conversion factor, 84.5, is de- chloride-propylene copolymer content of rived from the equivalent weight of chlorine aqueous extract. The organic chlorine divided by the chlorine content of the content and the vinyl chloride pro- heptane extractable fraction.) pylene copolymer content of the aque- (e) The vinyl chloride-propylene co- ous extract is calculated as follows: polymers identified in and complying (a) Organic chlorine content. Milli- with this section, when used as compo- equivalents of organic chlorine in nents of the food-contact surface of aqueous extract of 100 grams of sample any article that is the subject of a reg- equal milliequivalents of total chlorine ulation in parts 174, 175, 176, 177, 178 in aqueous extract of 100 grams of sam- and § 179.45 of this chapter, shall com- ple (as calculated in paragraph (d)(3)(ii) ply with any specifications and limita- of this section) minus milliequivalents tions prescribed by such regulation for of ionic chlorine in aqueous extract of the article in the finished form in 100 grams of sample (as calculated in which it is to contact food. paragraph (d)(3)(iii) of this section).

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(f) The provisions of this section are (2) The weight average molecular not applicable to vinyl chloride-pro- weight of the copolymer is not less pylene copolymers used in food-pack- than 50,000 when determined by gel per- aging adhesives complying with meation chromatography using tetra- § 175.105 of this chapter. hydrofuran as the solvent. The gel per- meation chromatograph is calibrated [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984] with polystyrene standards. The basic gel permeation chromatographic meth- § 177.1990 Vinylidene chloride/methyl od is described in ANSI/ASTM D3536–76, acrylate copolymers. ‘‘Standard Test Method for Molecular The vinylidene chloride/methyl acry- Weight Averages and Molecular Weight late copolymers (CAS Reg. No. 25038– Distribution of Polystyrene by Liquid 72–6) identified in paragraph (a) of this Exclusion Chromatography (Gel Per- section may be safely used as an article meation Chromatography-GPC),’’ or as a component of an article in- which is incorporated by reference. tended for use in contact with food sub- Copies are available from University ject to the provisions of this section. Microfilms International, 300 North Zeeb Rd., Ann Arbor, MI 48106, or avail- (a) Identity. For the purposes of this section vinylidene chloride/methyl ac- able for inspection at the National Ar- rylate copolymers consist of basic co- chives and Records Administration polymers produced by the copolym- (NARA). For information on the avail- erization of vinylidene chloride and ability of this material at NARA, call methyl acrylate such that the copoly- 202–741–6030, or go to: http:// mers contain not more than 15 weight- www.archives.gov/federallregister/ percent of polymer units derived from codeloflfederallregulations/ methyl acrylate. ibrllocations.html. (b) Optional adjuvant substances. The (3) Residual vinylidene chloride and basic vinylidene chloride/methyl acry- residual methyl acrylate in the copoly- late copolymers identified in paragraph mer in the form in which it will con- (a) of this section may contain optional tact food (unsupported film, barrier adjuvant substances required in the layer, or as a copolymer for blending) production of such basic copolymers. will not exceed 10 parts per million and These optional adjuvant substances 5 parts per million, respectively, as de- may include substances permitted for termined by either a gas such use by regulations in parts 170 chromatographic method titled ‘‘De- through 179 of this chapter, substances termination of Residual Vinylidene generally recognized as safe in food, Chloride and Methyl Acrylate in Vinyl- and substances used in accordance with idene Chloride/Methyl Acrylate Co- a prior sanction or approval. polymer Resins and Films,’’ or, alter- (c) Specifications. (1) The methyl acry- natively, ‘‘Residual Methyl Acrylate late content is determined by an infra- and Vinylidene Chloride Monomers in red spectrophotometric method titled Saran MA/VDC Resins and Pellets by ‘‘Determination of Copolymer Ratio in Headspace Gas Chromatography,’’ Vinylidene Chloride/Methyl Acrylate dated March 3, 1986, which are incor- Copolymers,’’ which is incorporated by porated by reference in accordance reference. Copies are available from with 5 U.S.C. 552(a). Copies are avail- the Center for Food Safety and Applied able from the Center for Food Safety Nutrition (HFS–200), Food and Drug and Applied Nutrition (HFS–200), Food Administration, 5001 Campus Dr., Col- and Drug Administration, 5001 Campus lege Park, MD 20740, or available for in- Dr., College Park, MD 20740, or avail- spection at the National Archives and able for inspection at the National Ar- Records Administration (NARA). For chives and Records Administration information on the availability of this (NARA). For information on the avail- material at NARA, call 202–741–6030, or ability of this material at NARA, call go to: http://www.archives.gov/ 202–741–6030, or go to: http:// federallregister/ www.archives.gov/federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html.

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(d) Extractives limitations. The basic the copolymerization of vinylidene copolymer resin in the form of granules chloride/methyl acrylate/methyl meth- that will pass through a U.S. Standard acrylate such that the basic polymers Sieve No. 45 (350 microns) shall meet or the finished food-contact articles the following extractives limitations: meet the specifications prescribed in (1) 10-gram samples of the resin, paragraph (d) of this section. when extracted separately with 100 (b) Optional adjuvant substances. The milliliters of distilled water at 121 °C basic vinylidene chloride/methyl acry- (250 °F) for 2 hours, and 100 milliliters late/methyl methacrylate polymers of n-heptane at 66 °C (150 °F) for 2 identified in paragraph (a) of this sec- hours, shall yield total nonvolatile ex- tion may contain optional adjuvant tractives not to exceed 0.5 percent by substances required in the production weight of the resin. of such basic polymers. These optional (2) The basic copolymer in the form adjuvant substances may include sub- of film when extracted separately with stances permitted for such use by regu- distilled water at 121 °C (250 °F) for 2 lations in parts 170 through 179 of this hours shall yield total nonvolatile ex- chapter, substances generally recog- tractives not to exceed 0.047 milligram nized as safe in food, and substances per square centimeter (0.3 milligram used in accordance with a prior sanc- per square inch). tion of approval. (e) Conditions of use. The copolymers (c) Conditions of use. The polymers may be safely used as articles or com- may be safely used as articles or as ponents of articles intended for use in components of articles intended for use producing, manufacturing, processing, in producing, manufacturing, proc- preparing, treating, packaging, trans- essing, preparing, treating, packaging, porting, or holding food, including transporting, or holding food, including processing of packaged food at tem- processing of packaged food at tem- peratures not to exceed 135 °C (275 °F). peratures up to 121 °C (250 °F). (f) Other specifications and limitations. (d) Specifications and limitations. The The vinylidene chloride-methyl acry- vinylidene chloride/methyl acrylate/ late copolymers identified in and com- methyl methacrylate basic polymers plying with this section, when used as and/or finished food-contact articles components of the food contact surface meet the following specifications and of any article that is subject to a regu- limitations: lation in parts 174 through 178 and (1)(i) The basic vinylidene chloride/ § 179.45 of this chapter, shall comply methyl acrylate/methyl methacrylate with any specifications and limitations polymers contain not more than 2 prescribed by such regulation for the weight percent of polymer units de- article in the finished form in which it rived from methyl acrylate monomer is to contact food. and not more than 6 weight percent of [48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. polymer units derived from methyl 31, 1983, as amended at 53 FR 47185, Nov. 22, methacrylate monomer. 1988; 54 FR 24898, June 12, 1989] (ii) The basic polymers are limited to a thickness of not more than 0.005 cen- § 177.2000 Vinylidene chloride/methyl timeter (0.002 inches). acrylate/methyl methacrylate poly- (2) The weight average molecular mers. weight of the basic polymer is not less The vinylidene chloride/methyl acry- than 100,000 when determined by gel late/methyl methacrylate polymers permeation chromatography using tet- (CAS Reg. No. 34364–83–5) identified in rahydrofuran as the solvent. The gel paragraph (a) of this section may be permeation chromatography is cali- safely used as articles or as a compo- brated with polystyrene standards. The nent of articles intended for use in con- basic gel permeation chromatographic tact with food subject to the provisions method is described in ANSI/ASTM of this section. D3536–76, which is incorporated by ref- (a) Identity. For the purpose of this erence. Copies are available from the section, vinylidene chloride/methyl ac- American Society for Testing Mate- rylate/methyl methacrylate polymers rials, 100 Barr Harbor Dr., West consist of basic polymers produced by Conshohocken, Philadelphia, PA 19428-

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2959, or available for inspection at the Methods for the specifications in this National Archives and Records Admin- paragraph (b), titled ‘‘Chlorine and istration (NARA). For information on Bromine—Coulometric Titration Meth- the availability of this material at od by Aminco Chloridometer,’’ NARA, call 202–741–6030, or go to: http:// ‘‘Hypolon ® Synthetic Rubber—Deter- www.archives.gov/federallregister/ mination of Sulfur by Parr Bomb,’’ and codeloflfederallregulations/ ASTM method D2857–70 (Reapproved ibrllocations.html. 1977), ‘‘Standard Test Method for Di- (3) The basic polymer or food-contact lute Solution Viscosity of Polymers,’’ article described in paragraph (a) of are incorporated by reference. Copies this section, when extracted with the of the ASTM method may be obtained solvent or solvents characterizing the from the American Society for Testing type of food and under the conditions Materials, 100 Barr Harbor Dr., West of time and temperature characterizing Conshohocken, Philadelphia, PA 19428- the conditions of its intended use as de- 2959. Copies of the other two methods termined from tables 1 and 2 of are available from the Center for Food § 176.170(c) of this chapter, yields net Safety and Applied Nutrition (HFS– chloroform-soluble extractives in each 200), Food and Drug Administration, extracting solvent not to exceed .08 5001 Campus Dr., College Park, MD milligram per square centimeter (0.5 20740. Copies of all three methods may milligram per square inch) of food-con- be examined at the National Archives tact surface when tested by the meth- and Records Administration (NARA). ods described in § 176.170(d). If the fin- For information on the availability of ished food-contact article is itself the this material at NARA, call 202–741– subject of a regulation in parts 174 6030, or go to: http://www.archives.gov/ through 178 and § 179.45 of this chapter, federallregister/ it shall also comply with any specifica- codeloflfederallregulations/ tions and limitations prescribed for it ibrllocations.html. by the regulation. (c) The additive is used as the article, or a component of articles, intended for [49 FR 29578, July 23, 1984] use as liners and covers for reservoirs intended for the storage of water for Subpart C—Substances for Use drinking purposes. Only as Components of Arti- (d) Substances permitted by § 177.2600 cles Intended for Repeated may be employed in the preparation of Use ethylene polymers, chlorosulfonated, subject to any limitations prescribed § 177.2210 Ethylene polymer, chloro- therein. sulfonated. (e) The finished ethylene copolymers, Ethylene polymer, chlorosulfonated chlorosulfonated shall conform to as identified in this section may be § 177.2600(e) and (g). safely used as an article or component [42 FR 14572, Mar. 15, 1977, as amended at 49 of articles intended for use in contact FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, with food, subject to the provisions of 1989] this section. (a) Ethylene polymer, chloro- § 177.2250 Filters, microporous poly- sulfonated is produced by chloro- meric. sulfonation of a carbon tetrachloride Microporous polymeric filters identi- solution of polyethylene with chlorine fied in paragraph (a) of this section and sulfuryl chloride. may be safely used, subject to the pro- (b) Ethylene polymer, chloro- visions of this section, to remove par- sulfonated shall meet the following ticles of insoluble matter in producing, specifications: manufacturing, processing, and pre- (1) Chlorine not to exceed 25 percent paring bulk quantities of liquid food. by weight. (a) Microporous polymeric filters (2) Sulfur not to exceed 1.15 percent consist of a suitably permeable, contin- by weight. uous, polymeric matrix of polyvinyl (3) Molecular weight is in the range chloride, vinyl chloride-propylene, or of 95,000 to 125,000. vinyl chloride-vinyl acetate, in which

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finely divided silicon dioxide is embed- (c) Any substance employed in the ded. Cyclohexanone may be used as a production of resin-bonded filters that solvent in the production of the filters. is the subject of a regulation in parts (b) Any substance employed in the 174, 175, 176, 177, 178 and § 179.45 of this production of microporous polymeric chapter conforms with any specifica- filters that is the subject of a regula- tion in such regulation. tion in parts 170 through 189 of this (d) Substances employed in the pro- chapter must conform with any speci- duction of resin-bonded filters include fication in such regulation. the following, subject to any limita- (c) Cyclohexanone when used as a sol- tions provided: vent in the production of the filters shall not exceed 0.35 percent by weight LIST OF SUBSTANCES AND LIMITATIONS of the microporous polymeric filters. (1) Fibers: (d) The microporous polymeric filters may be colored with colorants used in Cellulose pulp. accordance with § 178.3297 of this chap- Cotton. ter. Nylon. (From nylon resins complying with (e) The temperature of food being the provisions of applicable regulations in subchapter B of this chapter. processed through the microporous pol- Polyethylene terephthalate complying in ymeric filters shall not exceed 180 °F. composition with the provisions of (f) The microporous polymeric filters § 177.1630; for use in inline filtration only as shall be maintained in a sanitary man- provided for in paragraphs (e) and (f) of ner in accordance with good manufac- this section. turing practice so as to prevent poten- Rayon (viscose). tial microbial adulteration of the food. (2) Substances employed in fiber fin- (g) To assure safe use of the micro- ishing: porous polymeric filters, the label or labeling shall include adequate direc- BHT. Butyl (or isobutyl) palmitate or stearate. tions for a pre-use treatment, con- 2,5-Di-tert-butyl hydroquinone for use only in sisting of washing with a minimum of lubricant formulations for rayon fiber fin- 2 gallons of potable water at a tem- ishing and at a usage level not to exceed perature of 180 °F for each square foot 0.1 percent by weight of the lubricant for- of filter, prior to the filter’s first use in mulations. contact with food. Dimethylpolysiloxane. 4-Ethyl-4-hexadecyl morpholinium ethyl sul- [42 FR 14572, Mar. 15, 1977, as amended at 56 fate for use only as a lubricant in the man- FR 42933, Aug. 30, 1991] ufacture of polyethylene terephthalate fi- bers specified in paragraph (d)(1) of this § 177.2260 Filters, resin-bonded. section at a level not to exceed 0.03 percent Resin-bonded filters may be safely by weight of the finished fibers. used in producing, manufacturing, Fatty acid (C10-C18) diethanolamide conden- sates. processing, and preparing food, subject Fatty acids derived from animal or vegetable to the provisions of this section. fats and oils, and salts of such acids, sin- (a) Resin-bonded filters are prepared gle or mixed, as follows: from natural or synthetic fibers to Aluminum. which have been added substances re- Ammonium. quired in their preparation and fin- Calcium. ishing, and which are bonded with res- Magnesium. Potassium. ins prepared by condensation or polym- Sodium. erization of resin-forming materials, Triethanolamine. together with adjuvant substances re- Fatty acid (C10-C18) mono- and diesters of quired in their preparation, applica- polyoxyethylene glycol (molecular weight tion, and curing. 400–3,000). (b) The quantity of any substance Methyl esters of fatty acids (C10-C18). employed in the production of the Mineral oil. resin-bonded filter does not exceed the Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740 (b) amount reasonably required to accom- of this chapter. plish the intended physical or technical Polyoxyethylene (4 mols) ethylenediamine effect or any limitation further pro- monolauramide for use only in lubricant vided. formulations for rayon fiber finishing and

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at a usage level not to exceed 10 percent by (f) Resin-bonded filters conforming weight of the lubricant formulations. with the specifications of paragraph (f) Ricebran oil. (1) of this section are used as provided Titanium dioxide. in paragraph (e)(2) of this section: (3) Resins: (1) Total extractives. The finished fil- Acrylic polymers produced by polymerizing ter, when exposed to distilled water at ethyl acrylate alone or with one or more of 145 °F for 2 hours, yields total extrac- the monomers: Acrylic acid, acrylonitrile, tives not to exceed 4 percent by weight N-methylolacrylamide, and styrene. The of the filter. finished copolymers shall contain at least (2) Conditions of use. It is used to fil- 70 weight percent of polymer units derived ter milk or potable water at operating from ethyl acrylate, no more than 2 weight temperatures not to exceed 145 °F. percent of total polymer units derived (g) Resin-bonded filters conforming from acrylic acid, no more than 10 weight percent of total polymer units derived with the specifications of paragraph (g) from acrylonitrile, no more than 2 weight (1) of this section are used as provided percent of total polymer units derived in paragraph (g)(2) of this section: from N-methylolacrylamide, and no more (1) Total extractives. The finished fil- than 25 weight percent of total polymer ter, when exposed to n-hexane at reflux units derived from styrene. For use only as temperature for 2 hours, yields total provided in paragraph (m) of this section. extractives not to exceed 0.5 percent by Melamine-formaldehyde. weight of the filter. Melamine-formaldehyde chemically modified with one or more of the amine catalysts (2) Conditions of use. It is used to fil- identified in § 175.300(b)(3)(xiii) of this chap- ter edible oils. ter. (h) Resin-bonded filters conforming Melamine-formaldehyde chemically modified with the specifications of paragraph (h) with methyl alcohol. (1) of this section are used as provided Melamine-formaldehyde chemically modified in paragraph (h)(2) of this section: with urea; for use only as provided for in (1) Total extractives. The finished fil- paragraphs (e), (f), (g), (h), and (i) of this section. ter, when exposed to distilled water at Phenol-formaldehyde resins. 212 °F for 2 hours, yields total extrac- Polyvinyl alcohol. tives not to exceed 4 percent by weight Polyvinyl alcohol with the copolymer of of the filter. acrylic acid-allyl sucrose. (2) Conditions of use. It is used to fil- Polyvinyl alcohol with melamine formalde- ter milk, coffee, tea, and potable water hyde. at temperatures not to exceed 212 °F. Polyvinyl acetate with melamine formalde- (i) Resin-bonded filters conforming hyde. p--Toluenesulfonamide-formaldehyde chemi- with the specifications of paragraph (i) cally modified with one or more of the (1) of this section are used as provided amine catalysts identified in § 175.300 in paragraph (i)(2) of this section: (b)(3)(xiii) of this chapter. (1) Total extractives. The finished fil- (4) Adjuvant substances: ter, when exposed to distilled water for 2 hours at a temperature equivalent to, Dimethyl polysiloxane with methylcellulose or higher than, the filtration tempera- and sorbic acid (as an antifoaming agent). ture of the aqueous food, yields total Phosphoric acid. extractives not to exceed 4 percent, by (5) Colorants: Colorants used in ac- weight, of the filter. cordance with § 178.3297 of this chapter. (2) Conditions of use. It is used in com- (e) Resin-bonded filters conforming mercial filtration of bulk quantities of with the specifications of paragraph (e) nonalcoholic, aqueous foods having a (1) of this section are used as provided pH above 5.0. in paragraph (e)(2) of this section: (j) Resin-bonded filters conforming (1) Total extractives. The finished fil- with the specifications of paragraph (j) ter, when exposed to distilled water at (1) of this section are used as provided 100 °F for 2 hours, yields total extrac- in paragraph (j)(2) of this section: tives not to exceed 2.8 percent by (1) Total extractives. The finished fil- weight of the filter. ter, when exposed to 5 percent (by (2) Conditions of use. It is used to fil- weight) acetic acid for 2 hours at a ter milk or potable water at operating temperature equivalent to, or higher temperatures not to exceed 100 °F. than, the filtration temperature of the

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aqueous food, yields total extractives not to exceed 1.2 percent by weight of not to exceed 4 percent, by weight, of the filter. the filter. (n) Acrylonitrile copolymers identi- (2) Conditions of use. It is used in com- fied in this section shall comply with mercial filtration of bulk quantities of the provisions of § 180.22 of this chap- nonalcoholic, aqueous foods having a ter. pH of 5.0 or below. (k) Resin-bonded filters conforming [42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991] with the specifications of paragraph (k) (1) of this section are used as provided § 177.2280 4,4′-Isopropylidenediphenol- in paragraph (k)(2) of this section: epichlorohydrin thermosetting (1) Total extractives. The finished fil- epoxy resins. ter, when exposed to 8 percent (by vol- 4,4′-Isopropylidenediphenol-epichlo- ume) ethyl alcohol in distilled water rohydrin thermosetting epoxy resins for 2 hours at a temperature equivalent may be safely used as articles or com- to, or higher than, the filtration tem- ponents of articles intended for re- perature of the alcoholic beverage, peated use in producing, manufac- yields total extractives not to exceed 4 turing, packing, processing, preparing, percent, by weight, of the filter. treating, packaging, transporting, or (2) Conditions of use. It is used in com- holding food, in accordance with the mercial filtration of bulk quantities of following prescribed conditions: alcoholic beverages containing not (a) The basic thermosetting epoxy more than 8 percent alcohol. ′ (l) Resin-bonded filters conforming resin is made by reacting 4,4 - with the specifications of paragraph (l) isopropylidenediphenol with epichloro- (1) of this section are used as provided hydrin. in paragraph (l)(2) of this section: (b) The resin may contain one or (1) Total extractives. The finished fil- more of the following optional sub- ter, when exposed to 50 percent (by vol- stances provided the quantity used ume) ethyl alcohol in distilled water does not exceed that reasonably re- for 2 hours at a temperature equivalent quired to accomplish the intended ef- to, or higher than, the filtration tem- fect: perature of the alcoholic beverage, Allyl glycidyl ether ...... As curing system additive. yields total extractives not to exceed 4 Di- and tri-glycidyl ester mix- As modifier at levels not to percent, by weight, of the filter. ture resulting from the re- exceed equal parts by (2) Conditions of use. It is used in com- action of epichlorohydrin weight of the 4,4′- mercial filtration of bulk quantities of with mixed dimers and isopropylidenediphenol- trimers of unsaturated C18 epichlorohydrin basic resin alcoholic beverages containing more monobasic fatty acids de- and limited to use in con- than 8 percent alcohol. rived from animal and veg- tact with alcoholic bev- (m) Resin-bonded filters fabricated etable fats and oils. erages containing not more than 8 percent of alcohol. from acrylic polymers as provided in 1,2-Epoxy-3-phenoxypropane As curing system additive. paragraph (d)(3) of this section to- Glyoxal ...... Do. gether with other substances as pro- 4,4′-Isopropylidenediphenol ... Do. vided in paragraph (d), (1), (2), and (4) 4,4′-Methylenedianiline ...... Do. of this section may be used as follows: m-Phenylenediamine ...... Do. (1) The finished filter may be used to Tetrahydrophthalic anhydride Do. filter milk or potable water at oper- (c) In accordance with good manufac- ating temperatures not to exceed 100 turing practice, finished articles con- °F, provided that the finished filter taining the resins shall be thoroughly when exposed to distilled water at 100 cleansed prior to their first use in con- °F for 2 hours yields total extractives tact with food. not to exceed 1 percent by weight of (d) The provisions of this section are the filter. ′ (2) The finished filter may be used to not applicable to 4,4 -isopropylidenedi- filter milk or potable water at oper- phenol-epichlorohydrin resins listed in ating temperatures not to exceed 145 other sections of parts 174, 175, 176, 177, °F, provided that the finished filter 178 and 179 of this chapter. when exposed to distilled water at 145 [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, °F for 2 hours yields total extractives 1984]

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§ 177.2355 Mineral reinforced nylon § 177.2400 Perfluorocarbon cured resins. elastomers. Mineral reinforced nylon resins iden- Perfluorocarbon cured elastomers tified in paragraph (a) of this section identified in paragraph (a) of this sec- may be safely used as articles or com- tion may be safely used as articles or ponents of articles intended for re- components of articles intended for re- peated use in contact with nonacidic peated use in contact with nonacid food (pH above 5.0) and at use tempera- food (pH above 5.0), subject to the pro- tures not exceeding 212 °F. in accord- visions of this section. ance with the following prescribed con- (a) Identity. (1) For the purpose of ditions: this section, perfluorocarbon cured (a) For the purpose of this section elastomers are produced by the mineral reinforced nylon resins terpolymerizing tetrafluorethylene consist of nylon 66, as identified in and (CAS Reg. No. 116–14–3), complying with the specifications of perfluoromethyl vinyl ether (CAS Reg. § 177.1500, reinforced with up to 40 No. 1187–93–5), and perfluoro-2- phenoxypropyl vinyl ether (CAS Reg. weight percent of calcium silicate and No. 24520–19–2) and subsequent curing of up to 0.5 weight percent 3- the terpolymer (CAS Reg. No. 26658–70– (triethoxysilyl) propylamine (Chemical 8) using the crosslinking agent, phenol, Abstracts Service Registry No. 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl) 000919302) based on the weight of the ethylidene] bis-,dipotassium salt (CAS calcium silicate. Reg. No. 25088–69–1) and accelerator, (b) The mineral reinforced nylon res- 1,4,7,10,13,16-hexaoxacyclooctadecane ins may contain up to 0.2 percent by (CAS Reg. No. 17455–13–9). weight of titanium dioxide as an op- (2) The perfluorocarbon base polymer tional adjuvant substance. shall contain no less than 40 weight- (c) The mineral reinforced nylon res- percent of polymer units derived from ins with or without the optional sub- tetrafluoroethylene, no less than 40 stance described in paragraph (b) of weight-percent of polymer units de- this section, and in the form of 1⁄8-inch rived from perfluoromethyl vinyl ether molded test bars, when extracted with and no more than 5 weight-percent the solvents, i.e., distilled water and 50 polymer units derived from perfluoro-2- percent (by volume) ethyl alcohol in phenoxy-propyl vinyl ether. distilled water, at reflux temperature (3) The composition limitations of for 24 hours using a volume-to-surface the cured elastomer, calculated as ratio of 2 milliliters of solvent per parts per 100 parts of terpolymer, are square inch of surface tested, shall as follows: meet the following extractives limita- Phenol, 4,4′-[2,2,2-trifluoro-1- tions: (trifluoromethyl)-ethylidene] bis- (1) Total extractives not to exceed 5.0 ,dipotassium salt—not to exceed 5 parts. milligrams per square inch of food-con- 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not tact surface tested for each solvent. to exceed 5 parts. (2) The ash after ignition of the ex- (b) Optional adjuvant substances. The tractives described in paragraph (c)(1) perfluorocarbon cured elastomer iden- of this section, not to exceed 0.5 milli- tified in paragraph (a) of this section gram per square inch of food-contact may contain the following optional ad- surface tested. juvant substances, subject to any limi- (d) In accordance with good manufac- tations cited on their use: turing practice, finished articles con- (1) Substances generally recognized taining the mineral reinforced nylon as safe (GRAS) in food or food pack- resins shall be thoroughly cleansed aging. prior to their first use in contact with (2) Substances used in accordance food. with a prior sanction. (3) Substances authorized under ap- [42 FR 54533, Oct. 7, 1977, as amended at 42 FR plicable regulations in this part and in 61594, Dec. 6, 1977] parts 175 and 178 of this chapter and

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subject to any limitations prescribed (2) Fluoride extractives calculated as therein. fluorine not to exceed 0.47 milligram (4) Substances identified in this para- per square decimeter (0.03 milligram graph (b)(4) subject to such limitations per square inch). as are provided: (e) Conditions of use. In accordance with current good manufacturing prac- Substances Limitations tice, finished food contact articles con- Carbon black (channel proc- Not to exceed 15 parts per taining the perfluorocarbon cured ess of furnace combustion 100 parts of the elastomers shall be thoroughly cleaned process) (CAS Reg. No. terpolymer. prior to their first use in contact with 1333–86–4). food. Magnesium oxide (CAS Reg. Not to exceed 5 parts per No. 1309–48–4). 100 parts of the [49 FR 43050, Oct. 26, 1984] terpolymer. § 177.2410 Phenolic resins in molded (c) Specifications—(1) Infrared identi- articles. fication. Perfluorocarbon cured Phenolic resins identified in this sec- elastomers may be identified by the tion may be safely used as the food- characteristic infrared spectra of the contact surface of molded articles in- pyrolysate breakdown product that is tended for repeated use in contact with obtained by heating and decomposing nonacid food (pH above 5.0), in accord- the elastomer using the method enti- ance with the following prescribed con- tled ‘‘Qualitative Identification of ditions: Kalrez ® by Infrared Examination of (a) For the purpose of this section, Pyrolysate.’’ This method is incor- the phenolic resins are those produced porated by reference. Copies of the when one or more of the phenols listed method are available from the Center in paragraph (a)(1) of this section are for Food Safety and Applied Nutrition made to react with one or more of the (HFS–200), Food and Drug Administra- aldehydes listed in paragraph (a)(2) of tion, 5001 Campus Dr., College Park, this section, with or without aniline MD 20740, or available for inspection at and/or anhydro-formaldehyde aniline the National Archives and Records Ad- (hexahydro-1, 3,5-triphenyl-s-triazine): ministration (NARA). For information (1) Phenols: on the availability of this material at NARA, call 202–741–6030, or go to: http:// p-tert-Amylphenol. www.archives.gov/federallregister/ p-tert-Butylphenol. codeloflfederallregulations/ o-, m-, and p-Cresol. ibrllocations.html. p-Octylphenol. Phenol. (2) Thermogravimetry. Perfluorocarbon o- and p-Phenylethylphenol mixture pro- cured elastomers have a major decom- duced when phenol is made to react with position peak occurring at 490° ±15 °C styrene in the presence of sulfuric acid cat- (914 °F). Less than 1.5 percent of the alyst. elastomers will volatilize below 400 °C (2) Aldehydes: (752 °F) when run under nitrogen at a 10 °C or 18 °F per minute heating rate Acetaldehyde. using a Du Pont Thermal Analyzer Formaldehyde. Model 1099 with Model 951 TGA unit or Paraldehyde. the equivalent. (b) Optional adjuvant substances em- (d) Extractive limitations. Articles fab- ployed in the production of the phe- ricated from perfluorocarbon cured nolic resins or added thereto to impart elastomers having a thickness of at desired technical or physical properties least 1.0 millimeter (0.039 inch) when include the following: extracted at reflux temperatures for 2 hours separately with distilled water, Asbestos fiber. 50 percent ethanol, and n-heptane, Barium hydroxide ...... For use as catalyst. Calcium stearate ...... For use as lubricant. shall meet the following extractability Carbon black (channel proc- limits: ess). (1) Total extractives not to exceed 3.1 Diatomaceous earth. Glass fiber. milligrams per square decimeter (0.2 Hexamethylenetetramine ...... For use as curing agent. milligrams per square inch). Mica.

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Oxalic acid ...... For use as catalyst. Substance Limitations Zinc stearate ...... For use as lubricant. Diphenyl sulfone ...... Not to exceed 0.2 percent by (c) The finished food-contact article, weight as a residual sol- vent in the finished basic when extracted with distilled water at resin. reflux temperature for 2 hours, using a volume-to-surface ratio of 2 milliliters (c) Extractive limitations. The finished of distilled water per square inch of food contact article, when extracted at surface tested, shall meet the following reflux temperatures for 2 hours with extractives limitations: the following four solvents, yields in (1) Total extractives not to exceed each extracting solvent net chloroform 0.15 milligram per square inch of food- soluble extractives not to exceed 0.05 contact surface. milligrams per square inch of food con- tact surface: Distilled water, 50 percent (2) Extracted phenol not to exceed (by volume) ethanol in distilled water, 0.005 milligram per square inch of food- 3 percent acetic acid in distilled water, contact surface. and n-heptane. In testing the final food (3) No extracted aniline when tested contact article, a separate test sample by a spectrophotometric method sen- shall be used for each extracting sol- sitive to 0.006 milligram of aniline per- vent. square inch of food-contact surface. (d) In accordance with good manufac- [63 FR 20315, Apr. 24, 1998] turing practice, finished molded arti- § 177.2420 Polyester resins, cross- cles containing the phenolic resins linked. shall be thoroughly cleansed prior to Cross-linked polyester resins may be their first use in contact with food. safely used as articles or components of articles intended for repeated use in § 177.2415 Poly(aryletherketone) res- contact with food, in accordance with ins. the following prescribed conditions: Poly(aryletherketone) resins identi- (a) The cross-linked polyester resins fied in paragraph (a) of this section are produced by the condensation of may be safely used as articles or com- one or more of the acids listed in para- ponents of articles intended for re- graph (a)(1) of this section with one or peated use in contact with food subject more of the alcohols or epoxides listed to the provisions of this section. in paragraph (a)(2) of this section, fol- (a) Identity. For the purposes of this lowed by copolymerization with one or section, poly(aryletherketone) resins more of the cross-linking agents listed are poly(p-oxyphenylene p- in paragraph (a)(3) of this section: oxyphenylene p-carboxyphenylene) res- (1) Acids: ins (CAS Reg. No. 29658–26–2) produced Adipic. by the polymerization of hydroquinone Fatty acids, and dimers thereof, from nat- and 4,4′-difluorobenzophenone, and ural sources. Fumaric. have a minimum weight-average mo- Isophthalic. lecular weight of 12,000, as determined Maleic. by gel permeation chromatography in Methacrylic. comparison with polystyrene stand- Orthophthalic. ards, and a minimum mid-point glass Sebacic. ° Terephthalic. transition temperature of 142 C, as de- Trimellitic. termined by differential scanning calorimetry. (2) Polyols and polyepoxides: (b) Optional adjuvant substances. The Butylene glycol. basic resins identified in paragraph (a) Diethylene glycol. may contain optional adjuvant sub- 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. stances used in their production. These Ethylene glycol. adjuvants may include substances de- Glycerol. scribed in § 174.5(d) of this chapter and 4,4′-Isopropylidenediphenol-epichlorohydrin. the following: Mannitol. a-Methyl glucoside.

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Pentaerythritol. Triglycidyl isocyanurate (CAS Reg. No. 2451– Polyoxypropylene ethers of 4,4′-isopropylide- 62–9), for use only in coatings contacting nediphenol (containing an average of 2–7.5 bulk quantities of dry food of the type moles of propylene oxide). identified in § 176.170(c) of this chapter, Propylene glycol. table 1, under type VIII. Sorbitol. Vinyl toluene. Trimethylol ethane. Trimethylol propane. (b) Optional adjuvant substances em- 2,2,4-Trimethyl-1,3-pentanediol. ployed to facilitate the production of (3) Cross-linking agents: the resins or added thereto to impart desired technical or physical properties Butyl acrylate. include the following, provided that Butyl methacrylate. the quantity used does not exceed that Ethyl acrylate. Ethylhexyl acrylate. reasonably required to accomplish the Methyl acrylate. intended physical or technical effect Methyl methacrylate. and does not exceed any limitations Styrene. prescribed in this section:

Limitations (limits of addition expressed as percent by weight List of substances of finished resin)

1. Inhibitors: Total not to exceed 0.08 percent. Benzoquinone ...... 0.01 percent. tert-Butyl catechol. TBHQ. Di-tert-butyl hydroquinone. Hydroquinone. 2. Accelerators: Total not to exceed 1.5 percent. Benzyl trimethyl ammonium chloride ...... 0.05 percent. Calcium naphthenate. Cobalt naphthenate. Copper naphthenate. N, N-Diethylaniline ...... 0.4 percent. N, N-Dimethylaniline ...... Do. Ethylene guanidine hydrochloride ...... 0.05 percent. 3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ke- tone peroxide may be used as the sole catalyst at levels not to exceed 2 percent. Azo-bis-isobutyronitrile. Benzoyl peroxide. tert-Butyl perbenzoate. Chlorbenzoyl peroxide. Cumene hydroperoxide. Dibutyltin oxide (CAS Reg. No. 818–08–6) ...... For use in the polycondensation reaction at levels not to ex- ceed 0.2 percent of the polyester resin. Dicumyl peroxide. Hydroxybutyltin oxide (CAS Reg. No. 2273–43–0) ...... For use in the polycondensation reaction at levels not to ex- ceed 0.2 percent of the polyester resin. Lauroyl peroxide. p-Menthane hydroperoxide. Methyl ethyl ketone peroxide. Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850– For use in the polycondensation reaction at levels not to ex- 94–4). ceed 0.2 percent of the polyester resin. 4. Solvents for inhibitors, accelerators, and catalysts: Butyl benzyl phthalate (containing not more than 1.0 per- cent by weight of dibenzyl phthalate). Dibutyl phthalate. Diethylene glycol ...... As a solvent for benzyl trimethyl ammonium chloride or ethyl- ene guanidine hydrochloride only. Dimethyl phthalate. Methyl alcohol. Styrene. Triphenyl phosphate. 5. Reinforcements: Asbestos. Glass fiber. Polyester fiber produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this sec- tion with one or more of the alcohols listed in paragraph (a)(2) of this section. 6. Miscellaneous materials: Castor oil, hydrogenated. a-Methylstyrene.

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Limitations (limits of addition expressed as percent by weight List of substances of finished resin)

Polyethylene glycol 6000. Silicon dioxide. Wax, petroleum ...... Complying with § 178.3710 of this chapter.

(c) The cross-linked polyester resins, ins shall be thoroughly cleansed prior with or without the optional sub- to their first use in contact with food. stances described in paragraph (b) of this section, and in the finished form in § 177.2440 Polyethersulfone resins. which they are to contact food, when Polyethersulfone resins identified in extracted with the solvent or solvents paragraph (a) of this section may be characterizing the type of food and safely used as articles or components under the conditions of time and tem- of articles intended for repeated use in perature characterizing the conditions contact with food in accordance with of their intended use, as determined the following prescribed conditions: from tables 1 and 2 of § 176.170(c) of this (a) For the purpose of this section, chapter, shall meet the following ex- polyethersulfone resins are: tractives limitations: (1) Poly(oxy-p-phenylenesulfonyl-p- (1) Net chloroform-soluble extrac- phenylene) resins (CAS Reg. No. 25667– tives not to exceed 0.1 milligram per 42–9), which have a minimum number square inch of food-contact surface average molecular weight of 16,000. tested when the prescribed food-simu- ′ lating solvent is water or 8 or 50 per- (2) 1,1 -sulfonylbis[4-chlorobenzene] ′ cent alcohol. polymer with 4,4 -(1-methylethyl- idene)bis[phenol] (maximum 8 percent) (2) Total nonvolatile extractives not and 4,4′-sulfonylbis[phenol] (minimum to exceed 0.1 milligram per square inch 92 percent) (CAS Reg. No. 88285–91–0), of food-contact surface tested when the which have a minimum number aver- prescribed food-simulating solvent is age molecular weight of 26,000. heptane. (3) In paragraphs (a)(1) and (a)(2) of (d) In accordance with good manufac- this section, the minimum number av- turing practice, finished articles con- erage molecular weight is determined taining the cross-linked polyester res- by reduced viscosity in dimethyl form- ins shall be thoroughly cleansed prior amide in accordance with ASTM meth- to their first use in contact with food. od D2857–70 (Reapproved 1977), ‘‘Stand- [42 FR 14572, Mar. 15, 1977, as amended at 48 ard Test Method for Dilute Solution FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, Viscosity of Polymers,’’ which is incor- 1989] porated by reference. Copies may be obtained from the American Society § 177.2430 Polyether resins, chlori- for Testing Materials, 100 Barr Harbor nated. Dr., West Conshohocken, Philadelphia, Chlorinated polyether resins may be PA 19428-2959, or may be examined at safely used as articles or components the Office of Food Additive Safety of articles intended for repeated use in (HFS–200), Center for Food Safety and producing, manufacturing, packing, Applied Nutrition, Food and Drug Ad- processing, preparing, treating, pack- ministration, 5001 Campus Dr., College aging, transporting, or holding food, in Park, MD 20740, 240–402–1200 or at the accordance with the following pre- National Archives and Records Admin- scribed conditions: istration (NARA). For information on (a) The chlorinated polyether resins the availability of this material at are produced by the catalytic polym- NARA, call 202–741–6030, or go to: http:// erization of 3,3-bis(chloromethyl)- www.archives.gov/federallregister/ oxetane, and shall contain not more codeloflfederallregulations/ than 2 percent residual monomer. ibrllocations.html. (b) In accordance with good manufac- (b) The basic resins identified in turing practice, finished articles con- paragraphs (a)(1) and (a)(2) of this sec- taining the chlorinated polyether res- tion may contain optional adjuvant

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substances described in § 174.5(d) of this (b) Specifications. (1) Polyamide-imide chapter and the following: resins identified in paragraph (a)(1) of this section shall have a nitrogen con- List of substances Limitations tent of not less than 7.8 weight percent Diphenylsulfone ...... Not to exceed 0.2 percent as re- and not more than 8.2 weight percent. sidual solvent in the finished Polyamide-imide resins identified in basic resin described in para- paragraph (a)(2) of this section shall graph (a)(1) of this section. Dimethyl sulfoxide ...... Not to exceed 0.01 percent as have a nitrogen content of not less residual solvent in the finished than 7.5 weight percent and not more basic resin described in para- than 7.8 weight percent. Nitrogen con- graph (a)(1) of this section. tent is determined by the Dumas Nitro- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as residual solvent in the finished gen Determination as set forth in the basic resin described in para- ‘‘Official Methods of Analysis of the graph (a)(2) of this section. Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections (c) The finished food-contact article, 7.016–7.020, which is incorporated by when extracted at reflux temperatures reference in accordance with 5 U.S.C. for 2 hours with the following four sol- 552(a). Copies may be obtained from the vents, yields net chloroform-soluble ex- AOAC INTERNATIONAL, 481 North tractives in each extracting solvent Frederick Ave., suite 500, Gaithersburg, not to exceed 0.02 milligram per square MD 20877, or may be examined at the inch of food-contact surface: distilled National Archives and Records Admin- water, 50 percent (by volume) ethyl al- istration (NARA). For information on cohol in distilled water, 3 percent ace- the availability of this material at tic acid in distilled water, and n- NARA, call 202–741–6030, or go to: http:// heptane. (Note: In testing the finished www.archives.gov/federallregister/ food-contact article, use a separate codeloflfederallregulations/ test sample for each required extract- ibrllocations.html. ing solvent.) (2) Polyamide-imide resins identified (d) In accordance with good manufac- in paragraph (a)(1) of this section shall turing practice, finished food-contact have a solution viscosity of not less articles containing the than 1.200. Polyamide-imide resins polyethersulfone resins shall be thor- identified in paragraph (a)(2) of this oughly cleansed before their first use section shall have a solution viscosity in contact with food. of not less than 1.190. Solution vis- [44 FR 34493, June 15, 1979, as amended at 47 cosity shall be determined by a method FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, titled ‘‘Solution Viscosity’’ which is in- 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, corporated by reference in accordance Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013] with 5 U.S.C. 552(a). Copies are avail- able from the Center for Food Safety § 177.2450 Polyamide-imide resins. and Applied Nutrition (HFS–200), Food Polyamide-imide resins identified in and Drug Administration, 5001 Campus paragraph (a) of this section may be Dr., College Park, MD 20740, or avail- safely used as components of articles able for inspection at the National Ar- intended for repeated use in contact chives and Records Administration with food, in accordance with the fol- (NARA). For information on the avail- lowing prescribed conditions: ability of this material at NARA, call (a) Identity. (1) For the purpose of 202–741–6030, or go to: http:// this section the polyamide-imide resins www.archives.gov/federallregister/ are derived from the condensation re- codeloflfederallregulations/ action of substantially equimolar parts ibrllocations.html. of trimellitic anhydride and p,p′- (3) The polyamide-imide resins iden- diphenylmethane diisocyanate. tified in paragraph (a)(1) of this section (2) The polyamide-imide resins (CAS are heat cured at 600 °F for 15 minutes Reg. No. 31957–38–7) derived from the when prepared for extraction tests and condensation reaction of equimolar the residual monomers: p,p- parts of benzoyl chloride-3,4- diphenylmethane diisocyanate should dicarboxylic anhydride and 4,4′- not be present at greater than 100 parts diphenylmethanediamine. per million and trimellitic anhydride

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should not be present at greater than cleansed prior to their first use in con- 500 parts per million. Residual mono- tact with food. mers are determined by gas chroma- [42 FR 14572, Mar. 15, 1977, as amended at 47 tography (the gas chromatography FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, method titled ‘‘Amide-Imide Polymer 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, Analysis—Analysis of Monomer Con- Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR tent,’’ is incorporated by reference in 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] accordance with 5 U.S.C. 552(a). Copies § 177.2460 Poly(2,6-dimethyl-1,4-phen- are available from the Center for Food ylene) oxide resins. Safety and Applied Nutrition (HFS– The poly(2,6-dimethyl-1,4-phenylene) 200), Food and Drug Administration, oxide resins identified in paragraph (a) 5001 Campus Dr., College Park, MD of this section may be used as an arti- 20740, or available for inspection at the cle or as a component of an article in- National Archives and Records Admin- tended for use in contact with food sub- istration (NARA). For information on ject to the provisions of this section. the availability of this material at (a) Identity. For the purposes of this NARA, call 202–741–6030, or go to: http:// section, poly(2,6-dimethyl-1,4-phen- www.archives.gov/federallregister/ ylene) oxide resins consist of basic res- codeloflfederallregulations/ ins produced by the oxidative coupling ibrllocations.html.). of 2,6-xylenol such that the finished (c) Extractive limitations are appli- basic resins meet the specifications cable to the polyamide-imide resins and extractives limitations prescribed identified in paragraphs (a) (1) and (2) in paragraph (c) of this section. of this section in the form of films of 1 (b) Optional adjuvant substances. The mil uniform thickness after coating basic poly(2,6-dimethyl-1,4-phenylene) and heat curing at 600 °F for 15 minutes oxide resins identified in paragraph (a) on stainless steel plates, each having of this section may contain optional such resin-coated surface area of 100 adjuvant substances required in the square inches. The cured-resin film production of such basic resins. The op- coatings shall be extracted in accord- tional adjuvant substances required in the production of the basic poly(2,6-di- ance with the method described in methyl-1,4-phenylene) oxide resins may § 176.170(d)(3) of this chapter, using a include substances permitted for such plurality of spaced, coated stainless use by regulations in parts 170 through steel plates, exposed to the respective 189 of this chapter, substances gen- food simulating solvents. The resin erally recognized as safe in food, sub- shall meet the following extractive stances used in accordance with a prior limitations under the corresponding sanction or approval, and the fol- extraction conditions: lowing: (1) Distilled water at 250 °F for 2 Limitations (expressed as hours: Not to exceed 0.01 milligram per List of substances percent by weight of finished square inch. basic resin) ° (2) Three percent acetic acid at 212 F Diethylamine ...... Not to exceed 0.16 percent for 2 hours: Not to exceed 0.05 milli- as residual catalyst. gram per square inch. Methyl alcohol ...... Not to exceed 0.02 percent as residual solvent. (3) Fifty percent ethyl alcohol at 160 Toluene ...... Not to exceed 0.2 percent as °F for 2 hours: Not to exceed 0.03 milli- residual solvent. gram per square inch. (4) n-Heptane at 150 °F for 2 hours: (c) Specifications and extractives limita- Not to exceed 0.05 milligram per square tions. The poly(2,6-dimethyl-1,4-phen- inch. ylene) oxide basic resins meet the fol- lowing: (d) In accordance with good manufac- (1) Specifications. Intrinsic viscosity turing practice, those food contact ar- is not less than 0.30 deciliter per gram ticles, having as components the poly- as determined by ASTM method D1243– amide-imide resins identified in para- 79, ‘‘Standard Test Method for Dilute graph (a) of this section and intended Solution Viscosity of Vinyl Chloride for repeated use shall be thoroughly Polymers,’’ which is incorporated by

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reference, modified as follows. Copies section, when used as components of of the incorporation by reference may the food-contact surface of any article be obtained from the American Society that is the subject of a regulation in for Testing Materials, 100 Barr Harbor parts 174, 175, 176, 177, 178 and § 179.45 of Dr., West Conshohocken, Philadelphia, this chapter, shall comply with any PA 19428-2959, or may be examined at specifications and limitations pre- the National Archives and Records Ad- scribed by such regulation for the arti- ministration (NARA). For information cle in the finished form in which it is on the availability of this material at to contact food. NARA, call 202–741–6030, or go to: http:// (e) Uses. The poly(2,6-dimethyl-1,4- www.archives.gov/federallregister/ codeloflfederallregulations/ phenylene) oxide resins identified in ibrllocations.html. and complying with the limitations in (i) Solvent: Chloroform, reagent grade this section may be used as articles or containing 0.01 percent tert- components of articles intended for re- butylcatechol. peated food-contact use or as articles (ii) Resin sample: Powdered resin ob- or components of articles intended for tained from production prior to mold- single-service food-contact use only ing or extrusion. under the conditions described in (iii) Viscometer: Cannno-Ubbelohde se- § 176.170(c) of this chapter, table 2, con- ries 25 dilution viscometer (or equiva- ditions of use H. lent). (iv) Calculation: The calculation [42 FR 14572, Mar. 15, 1977, as amended at 49 method used is that described in appen- FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, 1998] dix X.1.3 (ASTM method D1243–79, cited and incorporated by reference in para- § 177.2465 Polymethylmethacrylate/ graph (c)(1) of this section) with the re- poly(trimethoxysilylpropyl)meth- duced viscosity determined for three acrylate copolymers. concentration levels (0.4, 0.2, and 0.1 gram per deciliter) and extrapolated to Polymethylmethacrylate/ zero concentration for intrinisic vis- poly(trimethoxysilylpropyl) methacry- cosity. The following formula is used late copolymers (CAS Reg. No. 26936– for determining reduced viscosity: 30–1) may be safely used as components of surface primers used in conjunction Reduced viscosity in terms tt− with silicone polymers intended for re- = o peated use and complying with § 175.300 of deciliters per gram × tco of this chapter and § 177.2600, in accord- where: ance with the following prescribed con- t = Solution efflux time. ditions. to = Solvent efflux time. (a) Identity. For the purpose of this c = Concentration of solution in terms of section, polymethylmethacrylate/ grams per deciliter. poly(trimethoxysilylpropyl)methacry- (2) Extractives limitations. Total resin late copolymers are produced by the extracted not to exceed 0.02 weight-per- polymerization of methylmethacrylate cent when extracted with n-heptane at and 160 °F for 2 hours as determined using trimethoxysilylpropylmethacrylate. 200 milliliters of reagent grade n- (b) Conditions of use. (1) The heptane which has been freshly dis- polymethylmethacrylate/ tilled before use and 25 grams of poly poly(trimethoxysilylpropyl)methacry- (2,-6-dimethyl-1,4-phenylene) oxide late copolymers are used at levels not resin. The resin as tested is in pellet to exceed 6.0 percent by weight of the form having a particle size such that primer formulation. 100 percent of the pellets will pass (2) The copolymers may be used in through a U.S. Standard Sieve No. 6 food contact applications with all food and 100 percent of the pellets will be types under conditions of use B held on a U.S. Standard Sieve No. 10. through H as described in table 2 of (d) Other limitations. The poly(2,6-di- § 176.170(c) of this chapter. methyl-1,4-phenylene) oxide resins identified in and complying with this [59 FR 5948, Feb. 9, 1994]

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§ 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec- mer. ular weight of the copolymer is 15,000 Polyoxymethylene copolymer identi- as determined by a method titled fied in this section may be safely used ‘‘Number Average Molecular Weight,’’ as an article or component of articles which is incorporated by reference. intended for food-contact use in ac- Copies are available from the Center cordance with the following prescribed for Food Safety and Applied Nutrition conditions: (HFS–200), Food and Drug Administra- (a) Identity. For the purpose of this tion, 5001 Campus Dr., College Park, section, polyoxymethylene copolymers MD 20740, or available for inspection at are identified as the following: The re- the National Archives and Records Ad- action product of trioxane (cyclic ministration (NARA). For information trimer of formaldehyde) and ethylene on the availability of this material at oxide (CAS Reg. No. 24969–25–3) or the NARA, call 202–741–6030, or go to: http:// reaction product of trioxane (cyclic www.archives.gov/federallregister/ trimer of formaldehyde) and a max- codeloflfederallregulations/ imum of 5 percent by weight of ibrllocations.html. butanediol formal (CAS Reg. No. 25214 (d) Extractive limitations. (1) Polyoxy- 85–1). Both copolymers may have cer- methylene copolymer in the finished tain optional substances added to im- part desired technological properties to form in which it is to contact food, the copolymer. when extracted with the solvent or sol- (b) Optional adjuvant substances. The vents characterizing the type of food polyoxymethylene copolymer identi- and under conditions of time and tem- fied in paragraph (a) of this section perature as determined from tables 1 may contain optional adjuvant sub- and 2 of § 175.300(d) of this chapter, stances required in its production. The shall yield net chloroform-soluble ex- quantity of any optional adjuvant sub- tractives not to exceed 0.5 milligram stance employed in the production of per square inch of food-contact surface. the copolymer does not exceed the (2) Polyoxymethylene copolymer amount reasonably required to accom- with or without the optional sub- plish the intended technical or physical stances described in paragraph (b) of effect. Such adjuvants may include this section, when ground or cut into substances generally recognized as safe particles that pass through a U.S.A. in food, substances used in accordance Standard Sieve No. 6 and that are re- with prior sanction, substances per- tained on a U.S.A. Standard Sieve No. mitted under applicable regulations in 10, shall yield total extractives as fol- parts 170 through 189 of this chapter, lows: and the following: (i) Not to exceed 0.20 percent by (1) Stabilizers (total amount of stabi- weight of the copolymer when ex- lizers not to exceed 2.0 percent and amount of any one stabilizer not to ex- tracted for 6 hours with distilled water ceed 1.0 percent of polymer by weight) at reflux temperature. (ii) Not to exceed 0.15 percent by Calcium ricinoleate. weight of the copolymer when ex- Cyanoguanidine. Hexamethylene bis(3,5-di-tert-butyl-4- tracted for 6 hours with n-heptane at hydroxyhydrocinnamate) (CAS Reg. No. reflux temperature. 35074–77–2). (e) Conditions of use. (1) The Melamine-formaldehyde resin. polyoxymethylene copolymer is for use 2,2′-Methylenebis(4-methyl-6-tert-butyl- as articles or components of articles phenol). intended for repeated use. Nylon 6/66, weight ratio 2/3. Tetrakis [methylene (3,5-di-tert-butyl-4- (2) Use temperature shall not exceed hydroxyhydrocinnamate)] methane. 250 °F. (2) Lubricant: N,N′Distearoylethyl- (3) In accordance with good manufac- enediamine. turing practice, finished articles con- (c) Specifications. (1) Polyoxymeth- taining polyoxymethylene copolymer ylene copolymer can be identified by its characteristic infrared spectrum.

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shall be thoroughly cleansed before Substances Limitations their first use in contact with food. Nylon 66/610/6 terpolymer, At a maximum level of 1.5 [42 FR 14572, Mar. 15, 1977, as amended at 48 respective proportions of percent by weight of FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, nylon polymers by weight homopolymer. are: 3/2/4. 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Nylon 612/6 copolymer (CAS Do. May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR Reg. No. 51733-10-9), 24898, June 12, 1989] weight ratio 6/1. Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5 § 177.2480 Polyoxymethylene butyl-4-hydroxy-hydro- percent by weight of homopolymer. cinnamate)] methane. homopolymer. Polyoxymethylene homopolymer (2) Lubricant. N,N′-Distearoylethyl- identified in this section may be safely enediamine. used as articles or components of arti- (3) Molding assistant. Polyethylene cles intended for food-contact use in glycol 6,000. accordance with the following pre- (c) Specifications. (1) scribed conditions: Polyoxymethylene homopolymer can (a) Identity. For the purpose of this be identified by its characteristic in- section, polyoxymethylene homopoly- frared spectrum. mer is polymerized formaldehyde (2) Minimum number average molec- [Chemical Abstracts Service Registry ular weight of the homopolymer is No. 9002–81–7]. Certain optional adju- 25,000. vant substances, described in para- (3) Density of the homopolymer is be- graph (b) of this section, may be added tween 1.39 and 1.44 as determined by to impart desired technological prop- ASTM method D1505–68 (Reapproved erties to the homopolymer. 1979), ‘‘Standard Test Method for Den- (b) Optional adjuvant substances. The sity of Plastics by the Density-Gra- polyoxymethylene homopolymer iden- dient Technique,’’ which is incor- tified in paragraph (a) of this section porated by reference. Copies may be may contain optional adjuvant sub- obtained from the American Society stances in its production. The quantity for Testing Materials, 100 Barr Harbor of any optional adjuvant substance em- Dr., West Conshohocken, Philadelphia, ployed in the production of the PA 19428-2959, or may be examined at homopolymer does not exceed the the National Archives and Records Ad- amount reasonably required to accom- ministration (NARA). For information plish the intended effect. Such adju- on the availability of this material at vants may include substances gen- NARA, call 202–741–6030, or go to: http:// erally recognized as safe in food, sub- www.archives.gov/federallregister/ stances used in accordance with prior codeloflfederallregulations/ sanction, substances permitted under ibrllocations.html. ° applicable regulations in this part, and (4) Melting point is between 172 C ° the following: and 184 C as determined by ASTM method D2133–66, ‘‘Specifications for (1) Stabilizers. The homopolymer may Acetal Resin Injection Molding and Ex- contain one or more of the following trusion Materials’’ (Revised 1966), stabilizers. The total amount of stabi- which is incorporated by reference. lizers shall not exceed 1.9 percent of Copies are available from American So- homopolymer by weight, and the quan- ciety for Testing and Materials tity of individual stabilizer used shall (ASTM), 100 Barr Harbor Dr., West not exceed the limitations set forth Conshohocken, Philadelphia, PA 19428- below: 2959, or available for inspection at the Substances Limitations National Archives and Records Admin- istration (NARA). For information on Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- the availability of this material at butyl-4-hydroxy-hydro- cent by weight of cinnamate) (CAS Reg. No. homopolymer. The finished NARA, call 202–741–6030, or go to: http:// 35074–77–2). articles shall not be used www.archives.gov/federallregister/ for foods containing more codeloflfederallregulations/ than 8 percent alcohol. ibrllocations.html. 2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5 tert-butylphenol). percent by weight of (d) Extractive limitations. (1) homopolymer. Polyoxymethylene homopolymer, in

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the finished form which is to contact cleansed prior to first use in contact food, when extracted with the solvent with food. or solvents characterizing the type of [42 FR 14572, Mar. 15, 1977, as amended at 43 food and under conditions of time and FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, temperature characterizing the condi- 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, tions of intended use under paragraphs Mar. 19, 1984; 54 FR 24898, June 12, 1989] (c)(3) and (d) of § 175.300 of this chapter and as limited by paragraph (e) of this § 177.2490 Polyphenylene sulfide res- ins. section, shall yield net chloroform- soluble extractives not to exceed 0.5 Polyphenylene sulfide resins milligram per square inch of food-con- (poly(1,4-phenylene sulfide) resins) may tact surface. be safely used as coatings or compo- nents of coatings of articles intended (2) Polyoxymethylene homopolymer, for repeated use in contact with food, with or without the optional adjuvant in accordance with the following pre- substances described in paragraph (b) scribed conditions. of this section, when ground or cut into (a) Polyphenylene sulfide resins con- particles that pass through a U.S.A. sist of basic resins produced by the re- Standard Sieve No. 6 and that are re- action of equimolar parts of p- tained on a U.S.A. Standard Sieve No. dichlorobenzene and sodium sulfide, 10, shall yield extractives as follows: such that the finished resins meet the (i) Formaldehyde not to exceed 0.0050 following specifications as determined percent by weight of homopolymer as by methods titled ‘‘Oxygen Flask Com- determined by a method titled ‘‘Form- bustion-Gravimetric Method for Deter- aldehyde Release and Formaldehyde mination of Sulfur in Organic Com- Analysis,’’ which is incorporated by pounds,’’ ‘‘Determination of the Inher- reference. Copies are available from ent Viscosity of Polyphenylene Sul- Center for Food Safety and Applied Nu- fide,’’ and ‘‘Analysis for trition (HFS–200) Food and Drug Ad- Dichlorobenzene in Ryton ministration, 5001 Campus Dr., College Polyphenylene Sulfide,’’ which are in- Park, MD 20740, or available for inspec- corporated by reference. Copies are tion at the National Archives and available from the Center for Food Records Administration (NARA). For Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, information on the availability of this 5001 Campus Dr., College Park, MD material at NARA, call 202–741–6030, or 20740, or available for inspection at the go to: http://www.archives.gov/ National Archives and Records Admin- federallregister/ istration (NARA). For information on codeloflfederallregulations/ the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (ii) Total extractives not to exceed www.archives.gov/federallregister/ 0.20 percent by weight of homopolymer codeloflfederallregulations/ when extracted for 6 hours with dis- ibrllocations.html. tilled water at reflux temperature and (1) Sulfur content: 28.2–29.1 percent 0.15 percent by weight of homopolymer by weight of finished resin. when extracted for 6 hours with n- (2) Minimum inherent viscosity: 0.13 heptane at reflux temperature. deciliters per gram. (e) Conditions of use. (1) Polyoxy- (3) Maximum residual p- methylene homopolymer is for use as dichlorobenzene: 0.8 ppm. articles or components of articles in- (b) Subject to any limitations pre- tended for repeated use. scribed in parts 170 through 189 of this (2) Use temperature shall not exceed chapter, the following optional sub- 250 °F. stances may be added to the polyphenylene sulfide basic resins in an (3) In accordance with good manufac- amount not to exceed that reasonably turing practice, finished articles con- required to accomplish the intended taining polyoxymethylene physical or technical effect. homopolymer shall be thoroughly (1) Substances generally recognized as safe in food.

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(2) Substances used in accordance acetic acid such that the finished res- with prior sanction or approval. ins meet the specifications set forth in (3) Substances the use of which is paragraph (c) of this section. The permitted in coatings under regula- polyphenylene sulfide used to manufac- tions in parts 170 through 189 of this ture polyphenylene sulfone is prepared chapter. by the reaction of sodium sulfide and p- (c) The finished coatings are ther- dichlorobenzene, and has a minimum mally cured at temperatures of 700 °F weight average molecular weight of and above. 5,000 Daltons. (d) Polyphenylene sulfide resin coat- (b) Optional adjuvant substances. The ings may be used in contact with food basic polyphenylene sulfone resins at temperatures not to exceed the boil- identified in paragraph (a) of this sec- ing point of water; provided that the tion may contain optional adjuvant finished cured coating, when extracted substances required in the production at reflux temperatures for 8 hours sepa- of such basic resins. These optional ad- rately with distilled water, 50 percent juvant substances may include sub- ethanol in water, and 3 percent acetic stances permitted for such use by regu- acid, yields total extractives in each lations in parts 170 through 189 of this extracting solvent not to exceed 0.02 chapter, substances generally recog- milligram per square inch of surface nized as safe in food, or substances and when extracted at reflux tempera- used in accordance with a prior sanc- ture for 8 hours with heptane yields tion or approval. total extractives not to exceed 0.1 mil- (c) Specifications. The glass transition ligram per square inch of surface. temperature of the polymer is 360±5 °C (e) Polyphenylene sulfide resin coat- as determined by the use of differential ings containing perfluorocarbon resins scanning calorimetry. complying with § 177.1550 may be used in contact with food at temperatures [65 FR 15058, Mar. 21, 2000] up to and including normal baking and frying temperatures; provided that the § 177.2510 Polyvinylidene fluoride res- finished cured coating, when extracted ins. at reflux temperatures for 2 hours sepa- Polyvinylidene fluoride resins may rately with distilled water, 50 percent be safely used as articles or compo- ethanol in water, 3 percent acetic acid nents of articles intended for repeated and heptane, yields total extractives in use in contact with food, in accordance each extracting solvent not to exceed with the following prescribed condi- 0.2 milligram per square inch of surface tions: and when extracted at reflux tempera- (a) For the purpose of this section, ture for 1 hour with diphenyl ether the polyvinylidene fluoride resins con- yields total extractives not to exceed sist of basic resins produced by the po- 4.5 milligrams per square inch of sur- lymerization of vinylidene fluoride. face. (b) The finished food-contact article, [42 FR 14572, Mar. 15, 1977, as amended at 47 when extracted at reflux temperatures FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, for 2 hours with the solvents distilled 1989] water, 50 percent (by volume) ethyl al- cohol in distilled water, and n-heptane, § 177.2500 Polyphenylene sulfone res- yields total extractives in each ex- ins. tracting solvent not to exceed 0.01 mil- The polyphenylene sulfone resins ligram per square inch of food-contact (CAS Reg. No. 31833–61–1) identified in surface tested; and if the finished food- paragraph (a) of this section may be contact article is itself the subject of a safely used as articles or components regulation in parts 174, 175, 176, 177, 178 of articles intended for repeated use in and § 179.45 of this chapter, it shall also contact with food, subject to the provi- comply with any specifications and sions of this section. limitations prescribed for it by that (a) Identity. For the purpose of this regulation. (NOTE: In testing the fin- section, polyphenylene sulfone resins ished food-contact article, use a sepa- consist of basic resin produced by re- rate test sample for each required ex- acting polyphenylene sulfide with per- tracting solvent.)

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(c) In accordance with good manufac- dichloride (CAS Reg. No. 39443–76–0). turing practice, finished food-contact The membrane is the food contact sur- articles containing the polyvinylidene face and may be applied as a film on a fluoride resins shall be thoroughly suitable support. Its maximum weight cleansed prior to their first use in con- is 512 milligrams per square decimeter tact with food. (33 milligrams per square inch). (4) A cross-linked high molecular § 177.2550 Reverse osmosis mem- branes. weight polyamide reaction product of poly(N-vinyl-N-methylamine) (CAS Substances identified in paragraph Reg. No. 31245–56–4), N,N′-bis(3- (a) of this section may be safely used as aminopropyl)ethylenediamine (CAS reverse osmosis membranes intended Reg. No. 10563–26–5), 1,3- for use in processing bulk quantities of benzenedicarbonyl dichloride (CAS liquid food to separate permeate from Reg. No. 99–63–8) and 1,3,5- food concentrate or in purifying water benzenetricarbonyl trichloride (CAS for food manufacturing under the fol- lowing prescribed conditions: Reg. No. 4422–95–1). The membrane is (a) Identity. For the purpose of this the food-contact surface. Its maximum section, reverse osmosis membranes weight is 20 milligrams per square deci- may consist of either of the following meter (1.3 milligrams per square inch) formulations: as a thin film composite on a suitable (1) A cross-linked high molecular support. weight polyamide reaction product of (5) A polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with 83044–99–9) or piperazine (CAS Reg. No. piperazine (CAS Reg. No. 110–85–0) and 110–85–0). The membrane is on the food- 1,2-diaminoethane (CAS Reg. No. 107– contact surface, and its maximum 15–3). The membrane is the food-con- weight is 62 milligrams per square deci- tact layer and may be applied as a film meter (4 milligrams per square inch) as on a suitable support. Its maximum a thin film composite on a suitable weight is 15 milligrams per square deci- support. meter (1 milligram per square inch). (2) A cross-linked polyetheramine (b) Optional adjuvant substances. The (CAS Reg. No. 101747–84–6), identified as basic polymer identified in paragraph the copolymer of epichlorohydrin, 1,2- (a) of this section may contain optional ethanediamine and 1,2-dichloroethane, adjuvant substances required in the whose surface is the reaction product production of such basic polymer. of this copolymer with 2,4- These optional adjuvant substances toluenediisocyanate (CAS Reg. No. of may include substances permitted for the final polymer is 99811–80–0) for use such use by regulations in parts 170 as the food-contact surface of reverse through 186 of this chapter, substances osmosis membranes used in processing generally recognized as safe in food, liquid food. The composite membrane and substances used in accordance with is on the food-contact surface and its maximum weight is 4.7 milligrams per a prior sanction or approval. square decimeter (0.3 milligrams per (c) Supports. Suitable supports for re- square inch) as a thin film composite verse osmosis membranes are mate- on a suitable support. The maximum rials permitted for such use by regula- weight of the 2,4-toluenediisocyanate tions in parts 170 through 186 of this component of the thin film composite chapter, substances generally recog- is 0.47 milligrams per square decimeter nized as safe in food, and substances (0.03 milligrams per square inch). used in accordance with a prior sanc- (3) For the purpose of this section, tion or approval. the reverse osmosis membrane consists (d) Conditions of use. (1) Reverse os- of a polyaramide identified as 2,4- mosis membranes described in para- diaminobenzenesulfonic acid, calcium graphs (a)(1), (a)(2), (a)(3), and (a)(5) of salt (2:1) polymer with 1,3- this section may be used in contact benzenediamine, 1,3-benzenedicarbonyl with all types of liquid food at tem- dichloride, and 1,4-benzenedicarbonyl peratures up to 80 °C (176 °F).

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(2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with tion may be used in contact with all any specification in such regulation. types of liquid food, except food con- (i) Elastomers. taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer. temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers (3) Reverse osmosis membranes shall complying with § 177.1210. be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol accordance with current good manufac- dimethacrylate copolymers containing not turing practice so as to prevent micro- more than 5 weight percent of polymer bial adulteration of food. units derived from ethylene glycol dimethacrylate. (4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co- osmosis membranes and their supports polymer. shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly- their first use in accordance with cur- mer. rent good manufacturing practice. Chloroprene polymers. Chlorotrifluoroethylene-vinylidene fluoride [49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer. FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5 Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units de- rived from 5-methylene-2-norbornene and/ § 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene. repeated use. Ethylene-propylene-dicyclopentadiene co- Rubber articles intended for repeated polymer. use may be safely used in producing, Ethylene-propylene-1,4-hexadiene copoly- mers containing no more than 8 weight manufacturing, packing, processing, percent of total polymer units derived preparing, treating, packaging, trans- from 1,4-hexadiene. porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co- provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro- (a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly- from natural and/or synthetic polymers mers are modified by hydrogenation of the and adjuvant substances as described olefinic unsaturation to leave either: (1) Not more than 10 percent trans olefinic in paragraph (c) of this section. unsaturation and no a, b-olefinic (b) The quantity of any substance unsaturation as determined by a method employed in the production of rubber entitled ‘‘Determination of Residual a, b- articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1, quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South fect in the rubber article and shall not Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 percent to 20 percent olefinic be intended to accomplish any effect in unsaturation and Mooney viscosities great- food. er than 45 (ML 1 + 4 @ 100 °C), as deter- (c) Substances employed in the prep- mined by ASTM Standard Method D1646– aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber— following, subject to any limitations Viscosity and Vulcanization Characteris- prescribed: tics (Mooney Viscometer),’’ which are both (1) Substances generally recognized incorporated by reference in accordance as safe for use in food or food pack- with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- ies of these methods may be obtained from aging. the Office of Food Additive Safety (HFS– (2) Substances used in accordance 200), Center for Food Safety and Applied with the provisions of a prior sanction Nutrition, Food and Drug Administration, or approval. 5001 Campus Dr., College Park, MD 20740, (3) Substances that by regulation in 240–402–1200, or may be examined at the parts 170 through 189 of this chapter Food and Drug Administration’s Main Li- may be safely used in rubber articles, brary, 10903 New Hampshire Ave., Bldg. 2, subject to the provisions of such regu- Third Floor, Silver Spring, MD 20993, 301– 796–2039, or at the National Archives and lation. Records Administration (NARA). For in- (4) Substances identified in this para- formation on the availability of this mate- graph (c)(4), provided that any sub- rial at NARA, call 202–741–6030, or go to: stance that is the subject of a regula- http://www.archives.gov/federallregister/

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codeloflfederallregulations/ Silicone (Fsi) elastomers containing meth- ibrllocations.html. A copy of ASTM Stand- yl and fluorine groups. ard Method D1646–92 may also be obtained Silicone (PVsi) elastomers containing from the American Society for Testing and phenyl, methyl, and vinyl groups. Materials, 100 Barr Harbor Dr., West Styrene-butadiene copolymer. Conshohocken, PA 19428–2959. Vinylidene fluoride-hexafluoropropylene co- Isobutylene-isoprene copolymer. polymers (minimum number average mo- Polyamide/polyether block copolymers (CAS lecular weight 70,000 as determined by os- Reg. No. 77402–38–1 prepared by reacting a motic pressure in methyl ethyl ketone). copolymer of omega-laurolactam and adipic Vinylidene fluoride-hexafluoropropylene- acid with poly(tetramethylene ether gly- tetrafluoroethylene copolymers (minimum col). The polyamide and polyether compo- number average molecular weight 100,000 nents are reacted in ratios such that the as determined by osmotic pressure in polyamide component constitutes a min- methyl ethyl ketone). imum of 30 weight-percent of total polymer units. The copolymers may be used in con- (ii) Vulcanization materials—(a) Vul- tact with foods of Types I, II, III, IV, V, VI, canizing agents. VII, VIII, and IX identified in table 1 of ′ § 176.170(c) of this chapter at temperatures 4,4 -Bis(aminocyclohexyl)methane carbamate not to exceed 150 °F except that those co- for use only as cross-linking agent in the polymers prepared with less than 50 vulcanization of vinylidene weight-percent of polyamide are limited to fluoridehexafluoropropylene copolymer use in contact with such foods at tempera- and vinylidene fluoride- tures not to exceed 100 °F. hexafluoropropylene-tetrafluoroethylene Polybutadiene. copolymer elastomers identified under Polyester elastomers derived from the reac- paragraph (c)(4)(i) of this section and lim- tion of dimethyl terephthalate, 1,4- ited to use at levels not to exceed 2.4 per- butanediol, and a-hydro-omega- cent by weight of such copolymers. hydroxypoly (oxytetramethylene). Addi- Diisopropyl xanthogen polysulfide (a 1:2:1 tionally, trimethyl trimellitate may be mixture of O,O-di(1-methylethyl)trithio- used as a reactant. The polyester bis-thioformate, O,O-di(1- elastomers may be used only in contact methylethyl)tetrathio-bis-thioformate, with foods containing not more than 8 per- and O,O-di(1-methylethyl)pentathio-bis- cent alcohol and limited to use in contact thioformate) for use as a cross linking with food at temperatures not exceeding agent in the vulcanization of natural rub- 150 °F. ber, styrene-butadiene copolymer, acrylo- Polyisoprene. nitrile-butadiene copolymer, and ethylene- Polyurethane resins (CAS Reg. Nos. 37383–28– propylene terpolymers identified under 1 or 9018–04–6) derived from the reaction of paragraph (c)(4)(i) of this section and lim- diphenylmethane diisocyanate with 1,4- ited to use at levels not to exceed 2.4 per- butanediol and polytetramethylene ether cent by weight of such copolymers. glycol. Hexamethylenediamine carbamate for use Polyurethane resins derived from reactions only as cross-linking agent in the vul- of diphenylmethane diisocyanate with canization of vinylidene fluoride- adipic acid and 1,4-butanediol. hexafluoropropylene copolymer and vinyli- Rubber, natural. dene fluoride-hexafluoropropylene-tetra- Silicone basic polymer as described in ASTM fluoroethylene copolymer elastomers iden- method D1418–81, ‘‘Standard Practice for tified under paragraph (c)(4)(i) of this sec- Rubber and Rubber Latices—Nomen- tion and limited to use at levels not to ex- clature,’’ which is incorporated by ref- ceed 1.5 percent by weight of such copoly- erence. Copies may be obtained from the mers. American Society for Testing Materials, Sulfur, ground. 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be ex- (b) Accelerators (total not to exceed 1.5 amined at the National Archives and percent by weight of rubber product). Records Administration (NARA). For in- 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- formation on the availability of this mate- fide. rial at NARA, call 202–741–6030, or go to: Benzoyl peroxide. http://www.archives.gov/federallregister/ 1,3-Bis(2-benzothiazolylmercaptomethyl) codeloflfederallregulations/ urea. ibrllocations.html. N-tert-Butyl-2-benzothiazole sulfenamide. Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number groups. 670–705). Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine yl and phenyl groups. reaction product. Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate. yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide.

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Dibenzoyl-p-quinone dioxime. (c) Retarders (total not to exceed 10 per- Dibenzylamine. cent of weight of rubber product). Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine. bis-thioformate, O,O-di(1- Phthalic anhydride. methylethyl)tetrathio-bis-thioformate, Salicylic acid. and O,O-di(1-methylethyl)pentathio-bis- thioformate). (d) Activators (total not to exceed 5 per- Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except 895–85–2) for use only as a crosslinking magnesium oxide may be used at higher agent in silicone polymers and elastomers levels). identified under paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by Diethylamine. weight of such polymers and elastomers Fatty acid amines, mixed. where the total of all accelerators does not Fatty acids. exceed 1.5 percent by weight of rubber Magnesium carbonate. product. Magnesium oxide, light and heavy. Di-tert-butyl peroxide. Oleic acid, dibutylamine salt Dibutyl xanthogen disulfide. (dibutylammonium oleate). 2,4-Dichlorobenzoyl peroxide. Stannous chloride. Dicumyl peroxide. Tall oil fatty acids. N,N-Dimethylcyclohexylamine salt of Tetrachloro-p-benzoquinone. dibutyldithiocarbamic acid. Triethanolamine. 2,6-Dimethylmorpholine thiobenzothiazol. Zinc salts of fatty acids. Dipentamethylenethiuram hexasulfide (CAS (iii) Antioxidants and antiozonants Reg. No. 971–15–3). Diphenylguanidine. (total not to exceed 5 percent by weight of Diphenylguanidine phthalate. rubber product). 1,3-Diphenyl-2-thiourea. Aldol-a-naphthylamine. 2,2′-Dithiobis[benzothiazole]. Alkylated (C and/or C ) phenols. 4,4′-Dithiodimorpholine. 4 8 BHT (butylated hydroxytoluene). N,N′-Di-o-tolylguanidine. 4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]- Di-o-tolylguanidine salt of 2,6-di-tert-butylphenol (CAS Reg. No. 991– pyrocatecholborate. 84–4) for use only as a stabilizer at levels Ethylenediamine carbamate. not to exceed 0.5 percent by weight of the Heptaldehyde-aniline resin (iodine number finished rubber product. 430–445). Hexamethylenetetramine. Butylated reaction product of p-cresol and 2-Mercaptobenzothiazole. dicyclopentadiene as identified in 2-Mercaptothiazoline. § 178.2010(b) of this chapter. N-Oxydiethylene-benzothiazole-2- Butylated, styrenated cresols identified in sulfenamide. § 178.2010(b) of this chapter. ′ Piperidinium pentamethylenedithiocarba- 4,4 -Butylidinebis(6-tert-butyl-m-cresol). ′ mate. N-Cyclohexyl-N -phenylphenylenediamine. Potassium pentamethylenedithiocarbamate. p,p′-Diaminodiphenylmethane. p-Quinone dioxime. 2,5-Di-tert-amylhydroquinone. Sodium dibutyldithiocarbamate. Diaryl-p-phenylenediamine, where the aryl Sodium dimethyldithiocarbamate. group may be phenyl, tolyl, or xylyl. Stannous oleate for use only as an accel- 2,6-Di-tert-butyl-p-phenylphenol. erator for silicone elastomers. 1,2-Dihydro-2,2,4-trimethyl-6- Tetrabutylthiuram monosulfide. dodecylquinoline. Tetraethylthiuram disulfide. 1,2-Dihydro-2,2,4-trimethyl-6- (1,1,4,4-Tetramethyltetramethylene)bis [tert- ethoxyquinoline. butyl peroxide]. 1,2-Dihydro-2,2,4-trimethyl-6- Tetramethylthiuram monosulfide. phenylquinoline. Thiram (tetramethylthiuram disulfide). 4,4′-Dimethoxydiphenylamine. Triallyl cyanurate. 4,6-Dinonyl-o-cresol. Triethylenetetramine. N,N′-Dioctyl-p-phenylenediamine. 1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone resin. (triethyltrimethylenetriamine). Diphenylamine-acetone-formaldehyde resin. Triphenylguanidine. N,N′-Diphenylethylenediamine. Zinc butyl xanathate. N,N′-Disalicylalpropylenediamine. Zinc dibenzyl dithiocarbamate. N,N′-Di-o-tolylethylenediamine. Zinc dibutyldithiocarbamate. Hydroquinone monobenzyl ether. Zinc diethyldithiocarbamate. Isopropoxydiphenylamine. Zinc 2-mercaptobenzothiazole. N-Isopropyl-N′-phenyl-p-phenylenediamine. Ziram (zinc dimethyldithiocarbamate). 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol).

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2,2′-Methylenebis(4-methyl-6-tert-butyl- Diisooctyl sebacate. phenol). Dioctyl adipate. 2,2′-Methylenebis(4-methyl-6-nonylphenol). Dioctyl phthalate. 2,2′-Methylenebis(4-methyl-6-tert- Dioctyl sebacate. octylphenol). Dipentene resin. Monooctyl- and dioctyldiphenylamine. Diphenyl ketone. N,N′-Di-b-naphthyl-p-phenylenediamine. Fatty acids. Phenyl-a-naphthylamine. Fatty acids, hydrogenated. Phenyl-b-naphthylamine. Isooctyl ester of tall oil fatty acids. Phenyl-b-naphthylamine-acetone aromatic Lanolin. amine resin (average molecular weight 600; a-Methylstyrene-vinyltoluene copolymer nitrogen content 5.3 percent). resins (molar ratio 1 a-methylstyrene to 3 o- and p-Phenylphenol. vinyltoluene). Polybutylated (mixture) 4,4′- Mineral oil; (1) In rubber articles complying isopropylidenediphenol. with this section, not to exceed 30 percent Sodium pentachlorophenate. by weight; (2) Alone or in combination Styrenated cresols produced when 2 moles of with waxes, petroleum, total not to exceed styrene are made to react with 1 mole of a 45 percent by weight of rubber articles that mixture of phenol and o-, m-, and p-cresols contain at least 20 percent by weight of so that the final product has a Brookfield ethylene-propylene copolymer elastomer viscosity at 25 °C of 1400 to 1700 centipoises. complying with paragraph (c)(4)(i) of this Styrenated phenol. section, in contact with foods of Types I, 4,4′-Thiobis (6-tert-butyl-m-cresol). II, III, IV, VI, VII, VIII, and IX idenified in Toluene-2,4-diamine. table 1 of § 176.170(c) of this chapter. N-o-Tolyl-N′-phenyl-p-phenylenediamine. Montan wax. p(p-Tolylsufanilamide) diphenylamine. n-Octyl n-decyl adipate. Tri(mixed mono- and dinonylphenyl) n-Octyl n-decyl phthalate. phosphite. Petrolatum. Tri(nonylphenyl) phosphite-formaldehyde Petroleum hydrocarbon resin resins produced when 1 mole of (cyclopentadiene type), hydrogenated. tri(nonylphenyl) phosphite is made to Petroleum hydrocarbon resin (produced by react with 1.4 moles of formaldehyde or the homo- and copolymerization of dienes produced when 1 mole of nonylphenol is and olefins of the aliphatic, alicyclic, and made to react with 0.36 mole of formalde- monobenzenoid arylalkene types from dis- hyde and the reaction product is then fur- tillates of cracked petroleum stocks). ther reacted with 0.33 mole of phosphorus Petroleum hydrocarbon resin (produced by trichloride. The finished resins have a min- the catalytic polymerization and subse- imum viscosity of 20,000 centipoises at 25 quent hydrogenation of styrene, °C, as determined by LV-series Brookfield vinyltoluene, and indene types from dis- viscometer (or equivalent) using a No. 4 tillates of cracked petroleum stocks). spindle at 12 r.p.m., and have an organic Petroleum oil, sulfonated. phosphorus content of 4.05 to 4.15 percent Phenol-formaldehyde resin. by weight. Pine tar. Polybutene. (iv) Plasticizers (total not to exceed 30 Polystyrene. percent by weight of rubber product un- Propylene glycol. less otherwise specified). n-Propyl ester of tall oil fatty acids. Rapeseed oil vulcanized with rubber maker’s n-Amyl n-decyl phthalate. sulfur. Butylacetyl ricinoleate. Rosins and rosin derivatives identified in n-Butyl ester of tall oil fatty acids. § 175.105(c)(5) of this chapter. Butyl laurate. Soybean oil vulcanized with rubber maker’s Butyl oleate. sulfur. Butyl stearate. Styrene-acrylonitrile copolymer. Calcium stearate. Terpene resins. Castor oil. Triethylene glycol dicaprate. Coumarone-indene resins. Triethylene glycol dicaprylate. 2,2′-Dibenzamidodiphenyl disulfide. Waxes, petroleum. Dibenzyl adipate. Xylene (or toluene) alkylated with Dibutoxyethoxyethyl adipate. dicyclopentadiene. Dibutyl phthalate. Zinc 2-benzamidothiophenate. Dibutyl sebacate. (v) Fillers. Didecyl adipate. Didecyl phthalate. Aluminum hydroxide. Diisodecyl adipate. Aluminum silicate. Diisodecyl phthalate. Asbestos fiber, chrysotile or crocidolite. Diisooctyl adipate. Barium sulfate.

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Carbon black (channel process or furnace levels not to exceed 0.3 percent by weight combustion process; total carbon black not of the sealants and caulking materials. to exceed 50 percent by weight of rubber Dodecyl mercaptan isomers, single or mixed. product; furnace combustion black content 2-Ethoxyethanol. not to exceed 10 percent by weight of rub- Iodoform. ber products intended for use in contact p-Menthane hydroperoxide. with milk or edible oils). a-(p-Nonylphenyl)-omega-hydroxypoly (oxy- Cork. ethylene) mixture of dihydrogen phosphate Cotton (floc, fibers, fabric). and monohydrogen phosphate esters, bar- Mica. ium salt; the nonyl group is a propylene Nylon (floc, fibers, fabric). trimer isomer and the poly (oxyethylene) Silica. content averages 9 moles; for use only as Titanium dioxide. residual polymerization emulsifier at lev- Zinc carbonate. els not to exceed 0.7 percent by weight of Zinc sulfide. ethylene-propylene-1,4-hexadiene copoly- (vi) Colorants. Colorants used in ac- mers identified under paragraph (c)(4)(i) of cordance with § 178.3297 of this chapter. this section. ′ (vii) Lubricants (total not to exceed 2 4,4 -Oxybis (benzenesulfonhydrazide) as chemical blowing agent. percent by weight of rubber product). Phenothiazine. Polyethylene. Potassium persulfate. Sodium stearate. Sodium formaldehyde sulfoxylate. Sodium polysulfide. (viii) Emulsifiers. Sodium nitrite. Fatty acid salts, sodium or potassium. Sodium salt of ethylenediamine tetraacetic Naphthalene sulfonic acid-formaldehyde con- acid and glycine. densate, sodium salt. Sodium sulfide. Rosins and rosin-derivatives identified in Styrene monomer. § 175.105(c)(5) of this chapter. Tall oil. Sodium decylbenzenesulfonate Thioxylenois as peptizing agents. Sodium dodecylbenzenesulfonate Tridecyl mercaptan. Sodium lauryl sulfate. Zinc 4-tert-butylthiophenate as peptizing Tall oil mixed soap (calcium, potassium, and agent. sodium). (d) Rubber articles intended for use (ix) Miscellaneous (total not to exceed 5 with dry food are so formulated and percent by weight of rubber product). cured under conditions of good manu- Animal glue as described in § 178.3120 of this facturing practice as to be suitable for chapter. repeated use. Azodicarbonamide as chemical blowing (e) Rubber articles intended for re- agent. peated use in contact with aqueous 2-Anthraquinone sulfonic acid sodium salt food shall meet the following specifica- for use only as polymerization inhibitor in tions: The food-contact surface of the chloroprene polymers and not to exceed rubber article in the finished form in 0.03 percent by weight of the chloroprene which it is to contact food, when ex- polymers. 1,2-Benzisothiazolin-3-one (CAS Reg. No. tracted with distilled water at reflux 2634–33–5) for use as a biocide in uncured temperature, shall yield total extrac- liquid rubber latex not to exceed 0.02 per- tives not to exceed 20 milligrams per cent by weight of the latex solids, where square inch during the first 7 hours of the total of all items listed in paragraph extraction, nor to exceed 1 milligram (c)(4)(ix) of this section does not exceed 5 per square inch during the succeeding 2 percent of the rubber product. hours of extraction. n-Butyllithium for use only as polymeriza- tion catalyst for polybutadiene. (f) Rubber articles intended for re- 4-tert-Butyl-o-thiocresol as peptizing agent. peated use in contact with fatty foods tert-Butyl peracetate. shall meet the following specifications: p-tert-Butylpyrocatechol. The food-contact surface of the rubber Dialkyl (C8–C18) dimethylammonium chlo- article in the finished form in which it ride for use only as a flocculating agent in is to contact food, when extracted with the manufacture of silica. n-hexane at reflux temperature, shall Di- and triethanolamine. Diethyl xanthogen disulfide. yield total extractives not to exceed 4-(Diiodomethylsulfonyl) toluene, Chemical 175 milligrams per square inch during Abstracts Service Registry No. 20018–09–01, the first 7 hours of extraction, nor to for use as an antifungal preservative at exceed 4 milligrams per square inch

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during the succeeding 2 hours of ex- taining the resins shall be thoroughly traction. cleansed prior to their first use in con- (g) In accordance with good manufac- tact with food. turing practice finished rubber articles intended for repeated use in contact § 177.2800 Textiles and textile fibers. with food shall be thoroughly cleansed Textiles and textile fibers may safely prior to their first use in contact with be used as articles or components of ar- food. ticles intended for use in producing, (h) The provisions of this section are manufacturing, packing, processing, not applicable to rubber nursing-bottle preparing, treating, packaging, trans- nipples. porting, or holding food, subject to the (i) Acrylonitrile copolymers identi- provisions of this section. fied in this section shall comply with (a) The textiles and textile fibers are the provisions of § 180.22 of this chap- prepared from one or more of the fibers ter. identified in paragraph (d) of this sec- [42 FR 14572, Mar. 15, 1977] tion and from certain other adjuvant substances required in the production EDITORIAL NOTE: For FEDERAL REGISTER ci- of the textiles or textile fibers or added tations affecting § 177.2600, see the List of CFR Sections Affected, which appears in the to impart desired properties. Finding Aids section of the printed volume (b) The quantity of any adjuvant sub- and at www.fdsys.gov. stance employed in the production of textiles or textile fibers does not ex- § 177.2710 Styrene-divinylbenzene res- ceed the amount reasonably required ins, cross-linked. to accomplish the intended physical or Styrene-divinylbenzene cross-linked technical effect or any limitation fur- copolymer resins may be safely used as ther provided. articles or components of articles in- (c) Any substance employed in the tended for repeated use in producing, production of textiles or textile fibers manufacturing, packing, processing, that is the subject of a regulation in preparing, treating, packaging, trans- parts 174, 175, 176, 177, 178 and § 179.45 of porting, or holding food, in accordance this chapter conforms with any speci- with the following prescribed condi- fication in such regulation. tions: (d) Substances employed in the pro- (a) The resins are produced by the co- duction of or added to textiles and tex- polymerization of styrene with tile fibers may include: divinylbenzene. (1) Substances generally recognized (b) The resins meet the extractives as safe in food. limitations prescribed in this para- (2) Substances subject to prior sanc- graph: tion or approval for use in textiles and (1) The resins to be tested are ground textile fibers and used in accordance or cut into small particles that will with such sanction or approval. pass through a U.S. standard sieve No. (3) Substances generally recognized 3 and that will be held on a U.S. stand- as safe for use in cotton and cotton fab- ard sieve No. 20. rics used in dry-food packaging. (2) A 100-gram sample of the resins, (4) Substances that by regulation in when extracted with 100 milliliters of this part may safely be used in the pro- ethyl acetate at reflux temperature for duction of or as a component of tex- 1 hour, yields total extractives not to tiles or textile fibers and subject to exceed 1 percent by weight of the res- provisions of such regulation. ins. (5) Substances identified in this para- (c) In accordance with good manufac- graph (d)(5), subject to such limitations turing practice, finished articles con- as are provided:

List of substances Limitations

(i) Fibers: Cotton. Polyethylene terephthalate complying in composition with For use only in the manufacture of items for repeated use. the provisions of § 177.1630(e)(4)(ii). Rayon.

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List of substances Limitations

(ii) Adjuvant substances: Aluminum stearate. Borax ...... For use as preservative only. Butyl-acetyl ricinoleate. Colorants used in accordance with § 178.3297 of this chapter.. Di-tert-butyl hydroquinone. Dimethylpolysiloxane. Ethylenediaminetetraacetic acid, sodium salt. 4-Ethyl-4-hexadecyl morpholinium ethyl sulfate ...... For use only as a lubricant in the manufacture of polyethylene terephthalate fibers specified in paragraph (d)(5)(i) of this section at a level not to exceed 0.03 percent by weight of the finished fibers. Eugenol. Fats, oils, fatty acids, and fatty alcohols derived from castor, coconut, cottonseed, fish, mustardseed, palm, peanut, rapeseed, ricebran, soybean, sperm, and tall oils and tallow. Fats, oils, fatty acids, and fatty alcohols described in the pre- ceding item reacted with one or more of the following sub- stances: n-Butyl and isobutyl alcohol. Diethylene glycol. Diethanolamine. Glycerol. Hexylene glycol (2-methyl-2,4-pentanediol). Hydrogen. Isopropyl alcohol. Methyl alcohol. Oxygen. Polyethylene glycol (molecular weight 400–3,000). Potassium hydroxide. Propylene glycol. Sodium hydroxide. Sulfuric acid. Formaldehyde ...... For use as preservative only. Glyceryl mono-12-hydroxystearate. 2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2- imidazolinium ethyl sulfate. Hexylene glycol (2-methyl,-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Methyl ester of sulfated ricebran oil. Mineral oil ...... For use only at a level not to exceed 0.15 percent by weight of finished fibers. Mono- and diisopropylated m- and p-cresols (isothymol deriva- tive). N-Oleyl, N′-acetyl, N′-b-hydroxy-ethylenediamine. Petrolatum. Petroleum sulfonate. Pine oil. Polybutene, hydrogenated; complying with the identity pre- scribed under 21 CFR 178.3740(b) of this chapter. Polyethylene, oxidized (air blown). Polyvinyl acetate. Polyvinyl alcohol. Potassium soap of a saponified sulfated castor oil. Sodium bis(2,6-dimethylheptyl-4) sulfosuccinate. Sodium dioctyl sulfosuccinate. Sodium dodecyl benzenesulfonate. Sodium fluoride ...... For use as preservative only. Sodium hydrosulfite. Sodium hypochlorite. Sodium lauryl sulfate. Sodium 2-mercaptobenzothiazole ...... Do. Sodium pentachlorophenate ...... Do. Styrene-butadiene copolymer. Sulfated butyl, isobutyl and propyl oleate. Tallow. Tallow, sulfonated. Titanium dioxide. Triethanolamine. Ultramarine blue. Waxes, petroleum. Zinc hydrosulfite.

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(e) Textile and textile fibers are used practice so as to prevent potential mi- as articles or components of articles crobial adulteration of the food. that contact dry food only. (e) Ultrafiltration membranes identi- (f) The provisions of this section are fied in paragraph (a)(4) may be used to not applicable to jute fibers used as filter aqueous or acidic foods con- prescribed by § 178.3620(d)(2) of this taining up to 13 percent of alcohol at chapter. temperatures not to exceed 21 °C (70 °F). [42 FR 14572, Mar. 15, 1977, as amended at 46 (f) To assure safe use of the ultra-fil- FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, tration membranes, the label or label- 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 30, 1991] ing shall include adequate directions for a pre-use treatment, consisting of § 177.2910 Ultra-filtration membranes. conditioning and washing with a min- imum of 8 gallons of potable water Ultra-filtration membranes identi- prior to their first use in contact with fied in paragraphs (a)(1), (a)(2), (a)(3), food. and (a)(4) of this section may be safely (g) Acrylonitrile copolymers identi- used in the processing of food, under fied in this section shall comply with the following prescribed conditions; the provisions of § 180.22 of this chap- (a)(1) Ultra-filtration membranes ter. that consist of paper impregnated with cured phenol-formaldehyde resin, [42 FR 14572, Mar. 15, 1977, as amended at 53 which is used as a support and is coat- FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, ed with a vinyl chloride-acrylonitrile 1993; 60 FR 54426, Oct. 24, 1995] copolymer. (2) Ultra-filtration membranes that PART 178—INDIRECT FOOD ADDI- consist of a sintered carbon support TIVES: ADJUVANTS, PRODUCTION that is coated with zirconium oxide AIDS, AND SANITIZERS (CAS Reg. No. 1314–23–4) containing up to 12 percent yttrium oxide (CAS Reg. Subpart A [Reserved] No. 1314–36–9). (3) Ultra-filtration membranes that Subpart B—Substances Utilized To Control consist of an aluminum oxide support the Growth of Microorganisms that is coated with zirconium oxide Sec. (CAS Reg. No. 1314–23–4) containing up 178.1005 Hydrogen peroxide solution. to 5 percent yttrium oxide (CAS Reg. 178.1010 Sanitizing solutions. No. 1314–36–9). Subpart C—Antioxidants and Stabilizers (4) Ultrafiltration membranes that consist of a microporous 178.2010 Antioxidants and/or stabilizers for poly(vinylidene fluoride) membrane polymers. with a hydrophilic surface modifier 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl- consisting of hydroxypropyl acrylate/ phenol. tetraethylene glycol diacrylate copoly- 178.2650 Organotin stabilizers in vinyl chlo- ride plastics. mer. (b) Any substance employed in the Subpart D—Certain Adjuvants and production of ultra-filtration mem- Production Aids branes that is the subject of a regula- tion in parts 174, 175, 176, 177, 178 and 178.3010 Adjuvant substances used in the § 179.45 of this chapter conforms with manufacture of foamed plastics. 178.3120 Animal glue. the specifications of such regulation. 178.3125 Anticorrosive agents. (c) Ultra-filtration membranes are 178.3130 Antistatic and/or antifogging used in the physical separation of dis- agents in food-packaging materials. solved or colloidally suspended varying 178.3280 Castor oil, hydrogenated. molecular size components of liquids 178.3290 Chromic chloride complexes. during the commercial processing of 178.3295 Clarifying agents for polymers. bulk quantities of food. 178.3297 Colorants for polymers. 178.3300 Corrosion inhibitors used for steel (d) Ultra-filtration membranes shall or tinplate. be maintained in a sanitary manner in 178.3400 Emulsifiers and/or surface-active accordance with good manufacturing agents.

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178.3450 Esters of stearic and palmitic acids. Subpart B—Substances Utilized To 178.3480 Fatty alcohols, synthetic. Control the Growth of Micro- 178.3500 Glycerin, synthetic. 178.3505 Glyceryl tri-(12-acetoxystearate). organisms 178.3520 Industrial starch-modified. § 178.1005 Hydrogen peroxide solution. 178.3530 Isoparaffinic petroleum hydro- carbons, synthetic. Hydrogen peroxide solution identi- 178.3570 Lubricants with incidental food fied in this section may be safely used contact. to sterilize polymeric food-contact sur- 178.3600 Methyl glucoside-coconut oil ester. faces identified in paragraph (e)(1) of 178.3610 a-Methylstyrene-vinyltoluene res- this section. ins, hydrogenated. (a) Identity. For the purpose of this 178.3620 Mineral oil. section, hydrogen peroxide solution is 178.3650 Odorless light petroleum hydro- an aqueous solution containing not carbons. more than 35 percent hydrogen per- 178.3690 Pentaerythritol adipate-stearate. oxide (CAS Reg. No. 7722–84–1) by 178.3700 Petrolatum. weight, meeting the specifications pre- 178.3710 Petroleum wax. scribed in paragraph (c) of this section. 178.3720 Petroleum wax, synthetic. 178.3725 Pigment dispersants. (b) Optional adjuvant substances. Hy- 178.3730 Piperonyl butoxide and pyrethrins drogen peroxide solution identified in as components of bags. paragraph (a) of this section may con- 178.3740 Plasticizers in polymeric sub- tain substances generally recognized as stances. safe in or on food, substances generally 178.3750 Polyethylene glycol (mean molec- recognized for their intended use in ular weight 200–9,500). food packaging, substances used in ac- 178.3760 Polyethylene glycol (400) cordance with a prior sanction or ap- monolaurate. proval, and substances permitted by 178.3770 Polyhydric alcohol esters of applicable regulations in parts 174 oxidatively refined (Gersthofen process) through 179 of this chapter. montan wax acids. (c) Specifications. Hydrogen peroxide 178.3780 Polyhydric alcohol esters of long solution shall meet the specifications chain monobasic acids. of the Food Chemicals Codex, 7th ed. 178.3790 Polymer modifiers in semirigid and (2010), pp. 496–497, which is incorporated rigid vinyl chloride plastics. by reference. Hydrogen peroxide solu- 178.3800 Preservatives for wood. tion shall also meet the specifications 178.3850 Reinforced wax. for ‘‘Acidity,’’ ‘‘Chloride,’’ and ‘‘Other 178.3860 Release agents. requirements’’ for Hydrogen Peroxide 178.3870 Rosins and rosin derivatives. Concentrate in the United States Phar- 178.3900 Sodium pentachlorophenate. macopeia 36th Revision (2013), pp. 3848– 178.3910 Surface lubricants used in the man- ufacture of metallic articles. 3849, which is incorporated by ref- 178.3930 Terpene resins. erence. The Director of the Office of 178.3940 Tetraethylene glycol di-(2-ethyl- the Federal Register approves this in- hexoate). corporation by reference in accordance 178.3950 Tetrahydrofuran. with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. States Pharmacopeial Convention, SOURCE: 42 FR 14609, Mar. 15, 1977, unless 12601 Twinbrook Pkwy., Rockville, MD otherwise noted. 20852 (Internet address http:// www.usp.org). Copies may be examined EDITORIAL NOTE: Nomenclature changes to part 178 appear at 61 FR 14482, Apr. 2, 1996, 66 at the Food and Drug Administration’s FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, Main Library, 10903 New Hampshire 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 72074, Ave., Bldg. 2, Third Floor, Silver Dec. 1, 2005, 81 FR 49896, July 29, 2016. Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin- istration (NARA). For information on Subpart A [Reserved] the availability of this material at NARA, call 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr- locations.html.

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(d) Limitations. No use of hydrogen 108, 110, 113, and 114 of this chapter as peroxide solution in the sterilization of applicable. food packaging material shall be con- sidered to be in compliance if more [46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; than 0.5 part per million of hydrogen 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. peroxide can be determined in distilled 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, water packaged under production con- Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR ditions (assay to be performed imme- 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 diately after packaging). FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, (e) Conditions of use. (1) Hydrogen per- 1992; 78 FR 71467, Nov. 29, 2013] oxide solution identified in and com- plying with the specifications in this § 178.1010 Sanitizing solutions. section may be used by itself or in Sanitizing solutions may be safely combination with other processes to used on food-processing equipment and treat food-contact surfaces to attain utensils, and on other food-contact ar- commercial sterility at least equiva- ticles as specified in this section, with- lent to that attainable by thermal in the following prescribed conditions: processing for metal containers as pro- (a) Such sanitizing solutions are vided for in part 113 of this chapter. used, followed by adequate draining, Food-contact surfaces include the fol- before contact with food. lowing: (b) The solutions consist of one of the Substances Limitations following, to which may be added com- ponents generally recognized as safe Ethylene-acrylic acid Complying with § 177.1310 of this and components which are permitted copolymers. chapter. Ethylene-carbon mon- Complying with § 177.1312 of this by prior sanction or approval. oxide copolymers. chapter. (1) An aqueous solution containing Ethylene-methyl acry- Complying with § 177.1340 of this potassium, sodium, or calcium hypo- late copolymer resins. chapter. Ethylene-vinyl acetate Complying with § 177.1350 of this chlorite, with or without the bromides copolymers. chapter. of potassium, sodium, or calcium. Ionomeric resins ...... Complying with § 177.1330 of this (2) An aqueous solution containing chapter. Isobutylene polymers... Complying with § 177.1420 (a)(1) dichloroisocyanuric acid, and (a)(2) of this chapter. trichloroisocyanuric acid, or the so- Olefin polymers ...... Complying with § 177.1520 of this dium or potassium salts of these acids, chapter. with or without the bromides of potas- Polycarbonate resins ... Complying with § 177.1580 of this chapter. sium, sodium, or calcium. Polyethylene- Complying with § 177.1630 of this (3) An aqueous solution containing terephthalate poly- chapter (excluding polymers de- potassium iodide, sodium p- mers. scribed in § 177.1630(c)) of this chapter. toluenesulfonchloroamide, and sodium Poly-l-butene resins Complying with § 177.1570 of this lauryl sulfate. and butene/ethylene chapter. (4) An aqueous solution containing copolymers. Polystryrene and rub- Complying with § 177.1640 of this iodine, butoxy monoether of mixed ber-modified poly- chapter. (ethylene-propylene) polyalkylene gly- styrene polymers. col having a cloudpoint of 90°–100 °C in Vinylidene chloride/ Complying with § 177.1990 of this 0.5 percent aqueous solution and an av- methyl acrylate co- chapter. polymers. erage molecular weight of 3,300, and ethylene glycol monobutyl ether. Addi- (2) The packaging materials identi- tionally, the aqueous solution may fied in paragraph (e)(1) of this section contain diethylene glycol monoethyl may be used for packaging all commer- ether as an optional ingredient. cially sterile foods except that the (5) An aqueous solution containing olefin polymers may be used in articles elemental iodine, hydriodic acid, a-(p- for packaging foods only of the types nonylphenyl)-omega-hydroxypoly-(oxy- identified in § 176.170(c) of this chapter, ethylene) (complying with the identity table 1, under Categories I, II, III, IV-B, prescribed in § 178.3400(c) and having a V, and VI. maximum average molecular weight of (3) Processed foods packaged in the 748) and/or polyoxyethylene- materials identified in paragraph (e)(1) polyoxypropylene block polymers (hav- of this section shall conform with parts ing a minimum average molecular

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weight of 1,900). Additionally, the aque- n-alkyl (C12-C18) dimethyl ethylbenzyl ous solution may contain isopropyl al- ammonium chloride (having an average cohol as an optional ingredient. molecular weight of 384). In addition to (6) An aqueous solution containing use on food-processing equipment and elemental iodine, sodium iodide, so- utensils, this solution may be used on dium dioctylsulfosuccinate, and food-contact surfaces in public eating polyoxyethylene-polyoxypropylene places. block polymers (having a minimum av- (12) An aqueous solution containing erage molecular weight of 1,900). the sodium salt of sulfonated oleic (7) An aqueous solution containing acid, polyoxyethylene- dodecylbenzenesulfonic acid and either polyoxypropylene block polymers (hav- isopropyl alcohol or polyoxyethylene- ing an average molecular weight of polyoxypropylene block polymers (hav- 2,000 and 27 to 31 moles of ing a minimum average molecular polyoxypropylene). In addition to use weight of 2,800). In addition to use on on food-processing equipment and food-processing equipment and uten- utensils, this solution may be used on sils, this solution may be used on glass glass bottles and other glass containers bottles and other glass containers in- intended for holding milk. All equip- tended for holding milk. ment, utensils, glass bottles, and other (8) An aqueous solution containing glass containers treated with this sani- elemental iodine, butoxy monoether of tizing solution shall have a drainage mixed (ethylene-propylene) period of 15 minutes prior to use in polyalkylene glycol having a minimum contact with food. average molecular weight of 2,400 and (13) An aqueous solution containing a-lauroyl-omega-hydroxypoly (oxy- elemental iodine and alkyl (C12-C15) ethylene) with an average 8–9 moles of monoether of mixed (ethylene-pro- ethylene oxide and an average molec- pylene) polyalkylene glycol, having a ular weight of 400. In addition to use on cloud-point of 70°–77 °C in 1 percent food-processing equipment and uten- aqueous solution and an average mo- sils, this solution may be used on bev- lecular weight of 807. erage containers, including milk con- (14) An aqueous solution containing tainers or equipment. Rinse water iodine, butoxy monoether of mixed treated with this solution can be recir- (ethylene-propylene) polyalkylene gly- culated as a preliminary rinse. It is not col, having a cloud-point of 90°–100 °C to be used as final rinse. in 0.5 percent aqueous solution and an (9) An aqueous solution containing n- average molecular weight of 3,300, and alkyl (C12-C18) benzyldimethylam- polyoxyethylene-polyoxypropylene monium chloride compounds having block polymers (having a minimum av- average molecular weights of 351 to 380. erage molecular weight of 2,000). The alkyl groups consist principally of (15) An aqueous solution containing groups with 12 to 16 carbon atoms and lithium hypochlorite. contain not more than 1 percent each (16) An aqueous solution containing of groups with 8 and 10 carbon atoms. equal amounts of n-alkyl (C12-C18) ben- Additionally, the aqueous solution may zyl dimethyl ammonium chloride and contain either ethyl alcohol or iso- n-alkyl (C12-C14) dimethyl ethylbenzyl propyl alcohol as an optional ingre- ammonium chloride (having average dient. molecular weights of 377 to 384), with (10) An aqueous solution containing the optional adjuvant substances trichloromelamine and either sodium tetrasodium ethylenediaminetetra- lauryl sulfate or dodecyl- acetate and/or alpha-(p-nonylphenol)- benzenesulfonic acid. In addition to use omega-hydroxy poly (oxyethylene) hav- on food-processing equipment and ing an average poly- (oxyethylene) con- utensils and other food-contact arti- tent of 11 moles. Alpha-hydro-omega- cles, this solution may be used on bev- hydroxypoly-(oxyethylene) erage containers except milk con- poly(oxypropoylene) (15 to 18 mole tainers or equipment. minimum) poly (oxyethylene) block co- (11) An aqueous solution containing polymer, having a minimum molecular equal amounts of n-alkyl (C12-C18) ben- weight of 1,900 (CAS Registry No. 9003– zyl dimethyl ammonium chloride and 11–6) may be used in lieu of alpha- (p-

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nonylphenol)-omega-hydroxy- The ratio of compound (1) to compound poly(oxyethylene) having an average (2) is 60 to 40. poly(oxyethylene) content of 11 moles. (23) An aqueous solution containing In addition to use on food-processing n-alkyl (C12-C16) benzyl- equipment and utensils, this solution dimethylammonium chloride and may be used on food-contact surfaces didecyldimethylammonium chloride. in public eating places. (24) An aqueous solution containing (17) An aqueous solution containing elemental iodine (CAS Reg. No. 7553–56– di-n-alkyl(C8-C10)dimethyl ammonium 2), alpha-[p-(1,1,3,3-tetramethylbutyl)- chlorides having average molecular phenyl]-omega-hydroxypoly-(oxy- weights of 332–361 and either ethyl al- ethylene) produced with one mole of cohol or isopropyl alcohol. In addition the phenol and 4 to 14 moles ethylene to use on food-processing equipment oxide, and alpha-alkyl(C12-C15)-omega- and utensils, this solution may be used hydroxy[poly(oxyethylene) on food-contact surfaces in public eat- poly(oxypropylene)] (having an average ing places. molecular weight of 965). (18) An aqueous solution containing (25) An aqueous solution containing n-alkyl(C12-C18) benzyldimethylammo- elemental iodine (CAS Reg. No. 7553–56– nium chloride, sodium metaborate, 2), potassium iodide (CAS Reg. No. alpha-terpineol and alpha[p-(1,1,3,3- 7681–11–0), and isopropanol (CAS Reg. tetramethylbutyl)phenyl] -omega-hy- No. 67–63–0). In addition to use on food droxy-poly (oxyethylene) produced processing equipment and utensils, this with one mole of the phenol and 4 to 14 solution may be used on beverage con- moles ethylene oxide. tainers, including milk containers and (19) An aqueous solution containing equipment and on food-contact sur- sodium dichloroisocyanurate and faces in public eating places. tetrasodium ethylenediaminetetra- (26) [Reserved] acetate. In addition to use on food- (27) An aqueous solution containing processing equipment and utensils, this decanoic acid (CAS Reg. No. 334–48–5), solution may be used on food-contact octanoic acid (CAS Reg. No. 124–07–2), surfaces in public eating places. and sodium 1-octanesulfonate (CAS (20) An aqueous solution containing Reg. No. 5324–84–5). Additionally, the ortho-phenylphenol, ortho-benzyl-para- aqueous solution may contain iso- chlorophenol, para- propyl alcohol (CAS Reg. No. 67–63–0) tertiaryamylphenol, sodium -alpha- as an optional ingredient. alkyl(C12-C15)-omega-hydroxypoly (oxy- (28) An aqueous solution containing ethylene) sulfate with the sulfonated 9-octadecenoic acid (CAS poly(oxyethylene) content averaging Reg. No. 68988–76–1) and sodium one mole, potassium salts of coconut xylenesulfonate (CAS Reg. No. 1300–72– oil fatty acids, and isopropyl alcohol or 7). hexylene glycol. (29) An aqueous solution containing (21) An aqueous solution containing dodecyldiphenyloxidedisulfonic acid sodium dodecylbenzenesulfonate. In ad- (CAS Reg. No. 30260–73–2), sulfonated dition to use on food-processing equip- tall oil fatty acid (CAS Reg. No. 68309– ment and utensils, this solution may 27–3), and neo-decanoic acid (CAS Reg. be used on glass bottles and other glass No. 26896–20–8). In addition to use on containers intended for holding milk. food-processing equipment and uten- (22) An aqueous solution containing sils, this solution may be used on glass (1) di-n-alkyl(C8-C10) bottles and other glass containers in- dimethylammonium chloride com- tended for holding milk. pounds having average molecular (30) An aqueous solution containing weights of 332–361, (2) n-alkyl (C12-C18) hydrogen peroxide (CAS Reg. No. 7722– benzyldimethylammonium chloride 84–1), peracetic acid (CAS Reg. No. 79– compounds having average molecular 21–0), acetic acid (CAS Reg. No. 64–19– weights of 351–380 and consisting prin- 7), and 1-hydroxyethylidene-1,1- cipally of alkyl groups with 12 to 16 diphosphonic acid (CAS Reg. No. 2809– carbon atoms with or without not over 21–4). 1 percent each of groups with 8 and 10 (31) An aqueous solution containing carbon atoms, and (3) ethyl alcohol. elemental iodine, alpha-alkyl(C10-C14)- 369

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omega-hydroxypoly(oxyethylene)poly- of oxychloro species (predominantly (oxypropylene) of average molecular chlorite and chlorate) followed by dilu- weight between 768 and 837, and alpha- tion with potable water to provide the alkyl(C12-C18)-omega- concentration of available chlorine di- hydroxypoly(oxyethylene) oxide described in paragraph (c)(29) of poly(oxypropylene) of average molec- this section. ular weight between 950 and 1,120. In (35) An aqueous solution containing addition to use on food-processing decanoic acid (CAS Reg. No. 334–48–5), equipment and utensils, this solution octanoic acid (CAS Reg. No. 124–07–2), may be used on food-contact surfaces lactic acid (CAS Reg. No. 050–21–5), in public eating places. phosphoric acid (CAS Reg. No. 7664–38– (32) An aqueous solution containing 2) and a mixture of the sodium salt of (i) di-n-alkyl(C8-C10)dimethyl- ammo- naphthalenesulfonic acid (CAS Reg. nium chloride compounds having aver- No. 1321–69–3); the methyl, dimethyl, age molecular weights of 332 to 361, (ii) and trimethyl dervatives of the sodium n-alkyl(C12-C18)benzyldimethyl- ammo- salt of naphthalenesulfonic acid; and a nium chloride compounds having aver- mixture of the sodium salt of age molecular weights of 351 to 380 and naphthalenesulfonic acid, and the consisting principally of alkyl groups methyl, dimethyl, and trimethyl de- with 12 to 16 carbon atoms with no rivatives of the sodium salt of more than 1 percent of groups with 8 naphthalenesulfonic acid alkylated at 3 and 10, (iii) ethyl alcohol, and (iv) percent by weight with C6-C9 linear alpha-(p-nonylphenyl)-omega- olefins, as components of a sanitizing hydroxypoly(oxyethylene) produced by solution to be used on food-processing the condensation of 1 mole of p- equipment and utensils. The methyl nonylphenol with 9 to 12 moles of and dimethyl substituted derivatives ethylene oxide. The ratio of compound (described within this paragraph (i) to compound (ii) is 3 to 2. (b)(35)) constitute no less than 70 per- (33) An aqueous solution containing cent by weight of the mixture of (i) di-n-alkyl-(C8-C10)- naphthalenesulfonates. dimethylammonium chloride com- (36) The sanitizing solution contains pounds having average molecular decanoic acid (CAS Reg. No. 334–48–5); weights of 332 to 361; (ii) n-alkyl(C12- octanoic acid (CAS Reg. No. 124–07–2); C18) -benzyldimethylammonium chlo- lactic acid (CAS Reg. No. 050–21–5); ride compounds having molecular phosphoric acid (CAS Reg. No. 7664–38– weights of 351 to 380 and consisting 2); a mixture of 1-octanesulfonic acid principally of alkyl groups with 12 to 16 (CAS Reg. No. 3944–72–7), and 1- carbon atoms with no more than 1 per- octanesulfonic-2-sulfinic acid (CAS cent of the groups with 8 to 10; and (iii) Reg. No. 113652–56–5) or 1,2- tetrasodium ethylenediamine octanedisulfonic acid (CAS Reg. No. tetraacetate. Additionally, the aqueous 113669–58–2); the condensate of four solution contains either alpha-(p- moles of nonylphenyl)-omega-hydroxypoly-(oxy- poly(oxyethylene)poly(oxypropylene) ethylene) or alpha-alkyl(C11-C15)-omega- block copolymers with one mole of hydroxypoly-(oxyethylene), each pro- ethylenediamine (CAS Reg. No. 11111– duced with 9 to 13 moles of ethylene 34–5); and the optional ingredient oxide. The ratio of compound (i) to FD&C Yellow No. 5 (CAS Reg. No. compound (ii) is 3 to 2. 001934210). In addition to use on food- (34) An aqueous solution of an equi- processing equipment and utensils, this librium mixture of oxychloro species solution may be used on dairy-proc- (predominantly chlorite, chlorate, and essing equipment. chlorine dioxide) generated either (i) (37) The sanitizing solution contains by directly metering a concentrated sodium hypochlorite (CAS Reg. No. chlorine dioxide solution, prepared just 7681–52–9), trisodium phosphate (CAS prior to use, into potable water to pro- Reg. No. 7601–54–9), sodium lauryl sul- vide the concentration of available fate (CAS Reg. No. 151–21–3), and potas- chlorine dioxide stated in paragraph sium permanganate (CAS Reg. No. (c)(29) of this section, or (ii) by acidifi- 7722–64–7). Magnesium oxide (CAS Reg. cation of an aqueous alkaline solution No. 1309–48–4) and potassium bromide

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(CAS Reg. No. 7758–02–3) may be added dextrin, or both starch and dextrin as optional ingredients to this sani- (CAS Reg. No. 9004–53–9); and the op- tizing solution. In addition to use on tional ingredient methylene blue (CAS food-processing equipment and uten- Reg. No. 61–73–4). In addition to use on sils, this solution may be used on food- food-processing equipment and uten- contact surfaces in public eating sils, this solution may be used on food- places. contact surfaces in public eating (38) An aqueous solution containing places. hydrogen peroxide (CAS Reg. No. 7722– (42) An aqueous solution containing 84–1); peroxyacetic acid (CAS Reg. No. decanoic acid (CAS Reg. No. 334–48–5), 79–21–0); acetic acid (CAS Reg. No. 64– nonanoic acid (CAS Reg. No. 112–05–0), 19–7); sulfuric acid (CAS Reg. No. 7664– phosphoric acid (CAS Reg. No. 7664–38– 93–9); and 2,6-pyridinedicarboxylic acid 2), propionic acid (CAS Reg No. 79–09– (CAS Reg. No. 499–83–2). In addition to 04), and sodium 1-octanesulfonate (CAS use on food-processing equipment and Reg. No. 5324–84–5). Sulfuric acid (CAS utensils, this solution may be used on Reg. No. 7664–93–9) may be added as an dairy-processing equipment. optional ingredient. In addition to use (39) An aqueous solution containing on food-processing equipment and phosphoric acid (CAS Reg. No. 7664–38– utensils, this solution may be used on 2); octenyl succinic acid (CAS Reg. No. dairy-processing equipment. 28805–58–5); N,N-dimethyloctanamine (43) An aqueous solution of iodine (CAS Reg. No. 7378–99–6); and a mixture and hypochlorous acid generated by of n-carboxylic acids (C6-C12, consisting the dilution of an aqueous acidic (21.5 of not less than 56 percent octanoic percent nitric acid) solution of iodine acid and not less than 40 percent deca- monochloride. In addition to use on noic acid). This solution may be used food-processing equipment and uten- on food-processing equipment and sils, this solution may be used on utensils, including dairy-processing dairy-processing equipment. equipment. (44) An aqueous solution of citric (40) An aqueous solution prepared by combining elemental iodine (CAS Reg. acid, disodium ethylenediaminetetra- No. 7553–56–2); hydriodic acid (CAS Reg. acetate, sodium lauryl sulfate, and No. 10034–85–2); sodium N-cyclohexyl-N- . In addition to palmitoyl taurate (CAS Reg. No. 132– use on food-processing equipment and 43–4); chloroacetic acid, sodium salt re- utensils, this solution may be used on action products with 4,5-dihydro-2- dairy-processing equipment. undecyl-1H-imidazole-1-ethanol and so- (45) An aqueous solution of hydrogen dium hydroxide (CAS Reg. No. 68608–66– peroxide, acetic acid, peroxyacetic 2); dodecylbenzene sulfonic acid (CAS acid, octanoic acid, peroxyoctanoic Reg. No. 27176–87–0); phosphoric acid acid, sodium 1-octanesulfonate, and 1- (CAS Reg. No. 7664–38–2); isopropyl al- hydroxyethylidene-1,1-diphosphonic cohol (CAS Reg. No. 67–63–0); and cal- acid. In addition to use on food-proc- cium chloride (CAS Reg. No. 10043–52– essing equipment and utensils, this so- 4). In addition to use on food-proc- lution may be used on food-contact essing equipment and utensils, this so- surfaces in public eating places, sub- lution may be used on dairy-processing ject to the limitations in paragraph equipment. (c)(39) of this section. (41) An aqueous solution containing (46) An aqueous solution of chlorine n-alkyl(C12- dioxide and related oxychloro species C16)benzyldimethylammonium chlo- generated by acidification of an aque- ride, having average molecular weights ous solution of sodium chlorite with a ranging from 351 to 380 wherein the solution of sodium gluconate, citric alkyl groups contain principally 12 to acid, phosphoric acid, and sodium 16 carbons and not more than 1 percent mono- and each of the groups with 8 and 10 carbon didodecylphenoxybenzenedisulfonate. atoms; ammonium chloride (CAS Reg. In addition to use on food-processing No. 12125–02–9); calcium stearate (CAS equipment and utensils, this solution Reg. No. 1592–23–0); sodium bicarbonate may be used on dairy-processing equip- (CAS Reg. No. 144–55–8); starch or ment.

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(c) The solutions identified in para- parts per million of active quaternary graph (b) of this section will not exceed compound. the following concentrations: (9) The solution identified in para- (1) Solutions identified in paragraph graph (b)(12) of this section shall pro- (b)(1) of this section will provide not vide not more than 200 parts per mil- more than 200 parts per million of lion of sulfonated oleic acid, sodium available halogen determined as avail- salt. able chlorine. (10) Solutions identified in paragraph (2) Solutions identified in paragraph (b)(15) of this section will provide not (b)(2) of this section will provide not more than 200 parts per million of more than 100 parts per million of available chlorine and not more than 30 available halogen determined as avail- ppm lithium. able chlorine. (11) Solutions identified in paragraph (3) Solution identified in paragraph (b)(16) of this section shall provide not (b)(3) of this section will provide not more than 200 parts per million of ac- more than 25 parts per million of ti- tive quaternary compound. tratable iodine. The solutions will con- (12) Solutions identified in paragraph tain the components potassium iodide, (b)(17) of this section shall provide, sodium p-toluenesulfonchloramide and when ready to use, a level of 150 parts sodium lauryl sulfate at a level not in per million of the active quaternary excess of the minimum required to compound. produce their intended functional ef- (13) Solutions identified in paragraph fect. (b)(18) of this section shall provide not (4) Solutions identified in paragraph more than 200 parts per million of ac- (b)(4), (5), (6), (8), (13), and (14) of this tive quaternary compound and not section will contain iodine to provide more than 66 parts per million of not more than 25 parts per million of alpha[p-(1,1,3,3-tetramethylbutyl) titratable iodine. The adjuvants used phenyl]-omega-hydroxypoly (oxy- with the iodine will not be in excess of ethylene). the minimum amounts required to ac- (14) Solutions identified in paragraph complish the intended technical effect. (b)(19) of this section shall provide, (5) Solutions identified in paragraph when ready to use, a level of 100 parts (b)(7) of this section will provide not per million of available chlorine. more than 400 parts per million (15) Solutions identified in paragraph dodecylbenzenesulfonic acid and not (b)(20) of this section are for single use more than 80 parts per million of applications only and shall provide, polyoxyethylene-polyoxypropylene when ready to use, a level of 800 parts block polymers (having a minimum av- per million of total active phenols con- erage molecular weight of 2,800) or not sisting of 400 parts per million ortho- more than 40 parts per million of iso- phenylphenol, 320 parts per million propyl alcohol. ortho-benzyl-para-chlorophenol and 80 (6) Solutions identified in paragraph parts per million para- (b)(9) of this section shall provide when tertiaryamylphenol. ready to use no more than 200 parts per (16) Solution identified in paragraph million of the active quaternary com- (b)(21) of this section shall provide not pound. more than 430 parts per million and not (7) Solutions identified in paragraph less than 25 parts per million of sodium (b)(10) of this section shall provide not dodecylbenzenesulfonate. more than sufficient (17) Solutions identified in paragraph trichloromelamine to produce 200 parts (b)(22) of this section shall provide, per million of available chlorine and ei- when ready to use, at least 150 parts ther sodium lauryl sulfate at a level per million and not more than 400 parts not in excess of the minimum required per million of active quaternary com- to produce its intended functional ef- pound. fect or not more than 400 parts per mil- (18) Solutions identified in paragraph lion of dodecylbenzenesulfonic acid. (b)(23) of this section shall provide at (8) Solutions identified in paragraph least 150 parts per million and not (b)(11) of this section shall provide, more than 200 parts per million of the when ready to use, not more than 200 active quaternary compound.

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(19) Solutions identified in para- (27) Solutions identified in paragraph graphs (b)(24), (b)(25), and (b)(43) of this (b)(32) of this section shall provide, section shall provide at least 12.5 parts when ready to use, at least 150 parts per million and not more than 25 parts per million and no more than 400 parts per million of titratable iodine. The ad- per million of active quarternary com- juvants used with the iodine shall not pounds in solutions containing no more be in excess of the minimum amounts than 600 parts per million water hard- required to accomplish the intended ness. The adjuvants used with the technical effect. quarternary compounds will not exceed (20)–(21) [Reserved] the amounts required to accomplish (22) Solutions identified in paragraph the intended technical effect. (b)(27) of this section shall provide, (28) Solutions identified in paragraph when ready to use, at least 109 parts (b)(33) of this section shall provide, per million and not more than 218 parts when ready to use, at least 150 parts per million of total active fatty acids per million and not more than 400 parts and at least 156 parts per million and per million of active quaternary com- not more than 312 parts per million of pounds. The adjuvants used with the the sodium 1-octanesulfonate. quaternary compounds shall not exceed (23) Solutions identified in paragraph the amounts required to accomplish (b)(28) of this section shall provide, the intended technical effect. when ready to use, at least 156 parts Tetrasodium ethylenediamine per million and not more than 312 parts tetraacetate shall be added at a min- per million of sulfonated 9- imum level of 60 parts per million. Use octadecenoic acid, at least 31 parts per of these sanitizing solutions shall be million and not more then 62 parts per limited to conditions of water hardness million of sodium xylenesulfonate. not in excess of 300 parts per million. (24) Solutions identified in paragraph (29) Solutions identified in paragraph (b)(29) of this section will provide at (b)(34) of this section should provide, least 237 parts per million and not when ready to use, at least 100 parts more than 474 parts per million per million and not more than 200 parts dodecyldiphenyloxidedisulfonic acid, at per million available chlorine dioxide least 33 parts per million and not more as determined by the method titled than 66 parts per million sulfonated ‘‘Iodometric Method for the Deter- tall oil fatty acid, and at least 87 parts mination of Available Chlorine Dioxide per million and not more than 174 parts (50–250 ppm available ClO2),’’ which is per million neo-decanoic acid. incorporated by reference. Copies are (25) Solutions identified in paragraph available from the Center for Food (b)(30) of this section shall provide, Safety and Applied Nutrition (HFS– when ready to use, not less than 550 200), Food and Drug Administration, parts per million and not more than 5001 Campus Dr., College Park, MD 1,100 parts per million hydrogen per- 20740, or available for inspection at the oxide, not less than 100 parts per mil- National Archives and Records Admin- lion and not more than 200 parts per istration (NARA). For information on million peracetic acid, not less than 150 the availability of this material at parts per million and not more than 300 NARA, call 202–741–6030, or go to: http:// parts per million acetic acid, and not www.archives.gov/federallregister/ less than 15 parts per million and not codeloflfederallregulations/ more than 30 parts per million 1- ibrllocations.html. hydroxyethylidene-1,1-diphosphonic (30) Solutions identified in paragraph acid. (b)(35) of this section shall provide, (26) The solution identified in para- when ready for use, at least 117 parts graph (b)(31) of this section shall pro- per million and not more than 234 parts vide, when ready to use, at least 12.5 per million of total fatty acids and at parts per million and not more than 25 least 166 parts per million and not parts per million of titratable iodine. more than 332 parts per million of a The adjuvants used with the iodine will mixture of naphthalenesulfonates. The not be in excess of the minimum adjuvants phosphoric acid and lactic amounts required to accomplish the in- acid, used with decanoic acid, octanoic tended technical effect. acid, and sodium naphthalenesulfonate

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and its alkylated derivatives, will not per million of sodium lauryl sulfate; be in excess of the minimum amounts and at least 0.1 part per million and required to accomplish the intended not more than 0.3 part per million of technical effects. potassium permanganate. (31) Solutions identified in paragraph (iii) Magnesium oxide when used in (b)(36) of this section shall provide, paragraph (c)(32) (i) or (ii) of this sec- when ready for use, at least 29 parts per tion shall not be used in excess of the million and not more than 58 parts per minimum amount required to accom- million decanoic acid; at least 88 parts plish its intended technical effect. per million and not more than 176 parts (33) Solutions identified in paragraph per million of octanoic acid; at least 69 (b)(38) of this section shall provide parts per million and not more than 138 when ready for use not less than 300 parts per million of lactic acid; at least parts per million and not more than 465 256 parts per million and not more than parts per million of hydrogen peroxide; 512 parts per million of phosphoric not less than 200 parts per million and acid; at least 86 parts per million and not more than 315 parts per million of not more than 172 parts per million of peroxyacetic acid; not less than 200 1-octanesulfonic acid; at least 51 parts parts per million and not more than 340 per million and not more than 102 parts parts per million of acetic acid; not per million of 1-octanesulfonic-2- less than 10 parts per million and not sulfinic acid or 1,2-octanedisulfonic more than 20 parts per million of sul- acid; and at least 10 parts per million furic acid; and not less than 0.75 parts and not more than 20 parts per million per million and not more than 1.2 parts of the condensate of four moles of per million of 2,6-pyridinedicarboxylic poly(oxyethylene)poly(oxypropylene) acid. block copolymers with one mole of (34) Solutions identified in paragraph ethylenediamine. The colorant adju- (b)(39) of this section shall provide vant FD&C Yellow No. 5 shall not be when ready for use not less than 460 used in excess of the minimum amount parts per million and not more than 625 required to accomplish the intended parts per million of phosphoric acid, technical effect. and all components shall be present in (32)(i) The solution identified in para- the following proportions: 1 part phos- graph (b)(37) of this section without po- phoric acid to 0.25 octenyl succinic acid tassium bromide shall provide, when to 0.18 part N,N-dimethyloctanamine to ready to use, at least 100 parts per mil- 0.062 part of a mixture of n-carboxylic lion and not more than 200 parts per acids (C6-C12, consisting of not less million of available halogen deter- than 56 percent octanoic acid and not mined as available chlorine; at least less than 40 percent decanoic acid). 2,958 parts per million and not more (35) Solutions identified in paragraph than 5,916 parts per million of tri- (b)(40) of this section shall provide sodium phosphate; at least 1 part per when ready for use not less than 12.5 million and not more than 3 parts per parts per million and not more than million of sodium lauryl sulfate; and at 25.0 parts per million of titratable io- least 0.3 part per million and not more dine; and not less than 2.7 parts per than 0.7 part per million on potassium million and not more than 5.5 parts per permanganate. million of dodecylbenzene sulfonic (ii) The solution identified in para- acid. All components shall be present graph (b)(37) of this section with potas- in the following proportions: 1.0 part sium bromide shall provide, when dodecylbenzene sulfonic acid to 43 ready to use, at least 25 parts per mil- parts sodium N-cyclohexyl-N-palmitoyl lion and not more than 200 parts per taurate to 7.7 parts chloroacetic acid, million of available halogen deter- sodium salt, reaction products with 4,5- mined as available chlorine; at least 15 dihydro-2-undecyl-1H-imidazole-1-eth- parts per million and not more than 46 anol and sodium hydroxide to 114 parts parts per million of potassium bro- phosphoric acid to 57 parts isopropyl mide; at least 690 parts per million and alcohol to 3.0 parts calcium chloride. not more than 2,072 parts per million of (36) Solutions identified in paragraph trisodium phosphate; at least 0.3 part (b)(41) of this section shall provide, per million and not more than 1 part when ready for use, not less than 150

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parts per million and not more than 200 contact surfaces in public eating places parts per million of n-alkyl(C12- and dairy and beverage containers, C16)benzyldimethylammonium chlo- shall provide when ready for use at ride; and not more than 0.4 part per least 72 parts per million and not more million of the colorant methylene blue. than 216 parts per million of hydrogen Components shall be present in the peroxide; at least 46 parts per million product used to prepare the solution in and not more than 138 parts per million the following proportions: 1 part n- of peroxyacetic acid; at least 40 parts alkyl(C12- per million and not more than 122 parts C16)benzyldimethylammonium chloride per million of octanoic acid (including to 0.24 part ammonium chloride to 0.08 peroxyoctanoic acid); at least 281 parts part calcium stearate to 0.60 part so- per million and not more than 686 parts dium bicarbonate to 0.08 part starch or per million of acetic acid; at least 7 dextrin, or a combination of starch and parts per million and not more than 34 dextrin. parts per million of 1- (37)(i) The solution identified in para- hydroxyethylidene-1,1-diphosphonic graph (b)(42) of this section not con- acid; and at least 36 parts per million taining sulfuric acid shall provide when and not more than 109 parts per million ready for use not less than 45 parts per of sodium 1-octanesulfonate. million and not more than 90 parts per (ii) The solution identified in para- million of decanoic acid; and all com- graph (b)(45) of this section, when used ponents shall be present in the fol- on food-contact equipment and utensils lowing proportions (weight/weight (w/ in warewashing machines, including w)): 1 part decanoic acid to 1 part nona- warewashing machines in public eating noic acid to 9.5 parts phosphoric acid to places, at temperatures no less than 120 3.3 parts propionic acid to 3.3 parts so- °F (49 °C) shall provide when ready for dium 1-octanesulfonate. use at least 30 parts per million and (ii) The solution identified in para- not more than 91 parts per million of graph (b)(42) of this section containing hydrogen peroxide; at least 19 parts per sulfuric acid shall provide when ready million and not more than 58 parts per for use not less than 45 parts per mil- million of peroxyacetic acid; at least 17 lion and not more than 90 parts per parts per million and not more than 52 million of decanoic acid; and all com- parts per million of octanoic acid (in- ponents shall be present in the fol- cluding peroxyoctanoic acid); at least lowing proportions (w/w): 1 part deca- 119 parts per million and not more than noic acid to 1 part nonanoic acid to 2.8 290 parts per million of acetic acid; at parts phosphoric acid to 3.3 parts propi- least 3 parts per million and not more onic acid to 3.3 parts sodium 1- than 14 parts per million of 1- octanesulfonate to 3.2 parts sulfuric hydroxyethylidene-1,1-diphosphonic acid. acid; and at least 15 parts per million (38) The solution identified in para- and not more than 46 parts per million graph (b)(44) of this section shall pro- of sodium 1-octanesulfonate. vide, when ready for use, at least 16,450 (iii) The solution identified in para- parts per million and not more than graph (b)(45) of this section, when used 32,900 parts per million of citric acid; at on dairy or beverage containers, shall least 700 parts per million and not provide when ready for use at least 36 more than 1,400 parts per million of di- parts per million and not more than 108 sodium ethylenediaminetetraacetate; parts per million of hydrogen peroxide; at least 175 parts per million and not at least 23 parts per million and not more than 350 parts per million of so- more than 69 parts per million of per- dium lauryl sulfate; and at least 175 oxyacetic acid; at least 20 parts per parts per million and not more than 350 million and not more than 61 parts per parts per million of monosodium phos- million of octanoic acid (including phate. peroxyoctanoic acid); at least 140 parts (39)(i) The solution identified in para- per million and not more than 343 parts graph (b)(45) of this section, when used per million of acetic acid; at least 3 on food processing equipment and uten- parts per million and not more than 17 sils, including dairy and beverage-proc- parts per million of 1- essing equipment but excluding food- hydroxyethylidene-1,1-diphosphonic

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acid; and at least 18 parts per million didodecylphenoxybenzenedisulfonate. and not more than 55 parts per million Other components listed under para- of sodium 1-octanesulfonate. graph (b)(46) of this section shall be (40) The solution identified in para- used in the minimum amount nec- graph (b)(46) of this section shall pro- essary to produce the intended effect. vide, when ready for use, at least 100 (d) Sanitizing agents for use in ac- parts per million and not more than 200 cordance with this section will bear la- parts per million of chlorine dioxide as beling meeting the requirements of the determined by the method developed Federal Insecticide, Fungicide, and by Bio-cide International, Inc., enti- Rodenticide Act. tled, ‘‘Iodometric Method for the De- termination of Available Chlorine Di- [42 FR 14609, Mar. 16, 1977] oxide (50–250 ppm Available ClO2),’’ EDITORIAL NOTE: For FEDERAL REGISTER ci- dated June 11, 1987, which is incor- tations affecting § 178.1010, see the List of porated by reference in accordance CFR Sections Affected, which appears in the with 5 U.S.C. 552(a) and 1 CFR part 51. Finding Aids section of the printed volume Copies of this method are available and at www.fdsys.gov. from the Office of Food Additive Safety (HFS–200), Center for Food Safety and Subpart C—Antioxidants and Applied Nutrition, Food and Drug Ad- Stabilizers ministration, 5001 Campus Dr., College Park, MD 20740, 240–402–1200, and may § 178.2010 Antioxidants and/or stabi- be examined at the Food and Drug Ad- lizers for polymers. ministration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, The substances listed in paragraph Silver Spring, MD 20993, 301–796–2039, or (b) of this section may be safely used as at the National Archives and Records antioxidants and/or stabilizers in poly- Administration (NARA). For informa- mers used in the manufacture of arti- tion on the availability of this mate- cles or components of articles intended rial at NARA, call 202–741–6030, or go for use in producing, manufacturing, to: http://www.archives.gov/ packing, processing, preparing, treat- federallregister/ ing, packaging, transporting, or hold- codeloflfederallregulations/ ing food, subject to the provisions of ibrllocations.html; at least 380 parts per this section: million and not more than 760 parts per (a) The quantity used shall not ex- million of sodium gluconate; and at ceed the amount reasonably required least 960 parts per million and not to accomplish the intended technical more than 1,920 parts per million of so- effect. dium mono- and (b) List of substances:

Substances Limitations

N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only: trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with §§ 175.105 and numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter. content is in the range 5.4–5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta- diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings com- plying with § 175.300, § 176.170, or § 175.320 of this chapter. The aver- age thickness of such coatings and closure-sealing gaskets shall not ex- ceed 0.004 inch. Alkylthiophenolics: ...... For use only: 1. Acid-catalyzed condensation reaction products 1. At levels not to exceed 2 percent by weight of adhesives complying with of 4-nonylphenol, formaldehyde, and 1- § 175.105 of this chapter, of pressure-sensitive adhesives complying with dodecanethiol (CAS Reg. No. 164907–73–7).. § 175.125 of this chapter, and of rubber articles complying with § 177.2600 of this chapter. 2. Acid-catalyzed condensation reaction products 2. Do. of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 203742–97–6)..

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Substances Limitations

p-tert-Amylphenolformaldehyde resins produced For use only at levels not to exceed 2.1 percent by weight of polyamide when one mole of p-tert-amylphenol is made to resins that are: react under acid conditions with one mole of 1. Derived from dimerized vegetable oil acids (containing not more than 20 formaldehyde. percent of monomer acids) and ethylenediamine. 2. Used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 1,4-Benzenedicarboxylic acid, bis[2-(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin poly- dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hy- mers complying with § 177.1520 of this chapter. droxy-5-methylphenyl]methyl]-4-methyl- phenyl]ester (CAS Reg. No. 57569–40–1). 2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only: phenylethyl)phenol (CAS Reg. No. 70321–86–7). 1. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter. 2. At levels not to exceed 3.0 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 2-(2H-Benzotriazol-2-yl)-4-(1, 1, 3, 3- For use only at levels not to exceed 0.5 percent by weight of polycarbonate tetramethylbutyl) phenol (CAS Reg. No. 3147– resins complying with § 177.1580 of this chapter: Provided, That the fin- 75–9). ished resins contact food only under conditions of use E, F, and G de- scribed in table 2 of § 176.170(c) of this chapter. 2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5- For use only: (octyloxy)phenol (CAS Reg. No. 2725–22–6).. 1. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter in contact with food types I, II, IV-B, VI, VII-B, and VIII described in § 176.170(c) of this chapter, table 1, under conditions of use D through G as described in § 176.170(c), table 2, of this chapter. 2. At levels not to exceed 0.1 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in contact with food under conditions of use A through H as described in § 176.170(c), table 2, of this chapter. 3. At levels not to exceed 0.04 percent by weight of polyethylene and olefin copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94 gram per cubic centimeter, in contact with food under conditions of use A through H as described in § 176.170, table 2, of this chapter provided that the finished articles used in contact with fatty food types III, IV-A, V, VII-A, and IX as described in table 1 of § 176.170(c) of this chapter hold a minimum of 2 gallons (7.6 liters) of food. 4. At levels not to exceed 0.4 percent by weight of ethylene copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b, having a density of less than 0.94 gram per cubic centimeter, in contact with food under conditions of use B through H, as described in § 176.170(c), table 2, of this chapter provided that the finished articles used in contact with fatty food types III, IV-A, V, VII-A, and IX hold a min- imum of 5 gallons (18.9 liters) of food. 5. At levels not to exceed 0.04 percent by weight of polyethylene having a density of less than 0.94 gram per cubic centimeter, and olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food under conditions of use D through G as described in § 176.170(c) of this chapter, table 2, provided that the finished articles used in contact with fatty food types III, IV-A, V, VII-A, and IX hold a minimum of 5 gallons (18.9 liters) of food. b, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS For use only: Reg. No. 37625–75–5); CAS synonym: 1-[(beta- 1. At levels not to exceed 0.3 percent by weight of all polymers for use in (octadecylthio)ethyl]-3(or 4)- contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under conditions (octadecylthio)cyclohexane. of use B through H as described in tables 1 and 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyolefins complying with § 177.1520 of this chapter, for use in contact with food of types III, IV-A, V, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176.170(c) of this chapter. Bis(2,2,6,6-tetramethyl-4-piperidinyl) sebacate For use only: (CAS Reg. No. 52829–07–9). 1. In adhesives complying with § 175.105 of this chapter. 2. At levels not to exceed 0.1 percent by weight of pressure-sensitive adhe- sives complying with § 175.125 of this chapter.

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Substances Limitations

Bis(2,4-di-tert-butyl-6-methylphenyl) ethyl For use only: phosphite (CAS Reg. No. 145650–60–8). 1. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter. The finished polymers may only be used with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of propylene polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.4, or 3.5, or 3.1a (where the density of this polymer is at least 0.85 gram per cubic centimeter and less than 0.91 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV- A, V, VI-C, VII-A, and IX, and under conditions of use B through H de- scribed in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.1 percent by weight of high-density ethylene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use C (maximum temperature 70 °C) through G described in table 2 of § 176.170(c) of this chapter. Pro- vided, that the finished food contact articles have a volume of at least 18.9 liters (5 gallons). 4. At levels not to exceed 0.01 percent by weight of low-density ethylene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished poly- mers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Provided, that the average thickness of such polymers in the form in which they contact food shall not exceed 0.001 inch. 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)- For use only: hydrazine (CAS Reg. No. 32687–78–8). 1. As provided in § 175.105 of this chapter. 2. At levels not exceeding 0.1 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with parts 175, 176, 177, and 181 of this chapter. 3. At levels not exceeding 0.1 percent by weight of polyoxymethylene co- polymers complying with § 177.2470 of this chapter and of polyoxymethylene homopolymers complying with § 177.2480 of this chap- ter. 2,6-Bis(1-methylheptadecyl)-p-cresol ...... For use only at levels not exceeding 0.3 percent by weight of olefin poly- mers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. The average thickness of such polymers in the form in which they contact fatty food or food containing more than 8 percent of alcohol shall not exceed 0.004 inch. 3,9-Bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]- For use only: 2,4,8,10-tetraoxa-3,9- 1. At levels not to exceed 0.15 percent by weight of all polymers, except as diphosphaspiro[5.5]undecane (CAS Reg. No. specified below. 154862–43–8), which may contain not more 2. At levels not to exceed 0.2 percent by weight of polycarbonate resins than 2 percent by weight of triisopropanolamine complying with § 177.1580 of this chapter. (CAS Reg. No. 122–20–3). 3. At levels not to exceed 0.3 percent by weight of polyetherimide resins complying with § 177.1595 of this chapter.

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Substances Limitations

5,7-Bis(1,1-dimethylethyl)-3-hydroxy-2(3H)- For use only: benzofuranone, reaction products with o-xylene 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- (CAS Reg. No. 181314–48–7). plying with § 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.02 percent by weight of: (a) Propylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymer may only be used in contact with food of types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; or (b) Ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV- A, V, VI-C, VII-A, and IX, and under conditions of use B through H de- scribed in Table 2 of § 176.170(c) of this chapter; provided that the fin- ished food-contact articles have a volume of at least 18.9 liters (5 gal- lons). 3. At levels not to exceed 0.02 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished poly- mers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; provided that the average thick- ness of such polymers in the form in which they contact food shall not exceed 50 micrometers (0.002 inch). 3,9-Bis[2-{3-(3-tert-butyl-4-hydroxy-5- For use only: methylphenyl)propionyloxy}-1,1-dimethylethyl]- 1. At levels not to exceed 0.2 percent by weight of polypropylene complying 2,4,8,10-tetraoxaspiro[5.5]undecane (CAS Reg. with § 177.1520(c), item 1.1 of this chapter. The finished polymer is to be No. 90498–90–1). used in contact with food only under conditions of use D through H de- scribed in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520(c) of this chapter, item 2.1, provided that the polymer has a minimum density of 0.94 grams per cubic centimeter and is used in contact with food only under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene. The finished polymer is to be used in contact with food of types I, II, IV-B, VI-A, VI-B, VI-C, VII-B, and VIII under conditions of use A through H described in ta- bles 1 and 2 of § 176.170(c) of this chapter.

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Substances Limitations

4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only: tert-butylphenol (CAS Reg. No. 991–84–4). 1. At levels not to exceed 0.5 percent by weight: in styrene block copoly- mers complying with § 177.1810 of this chapter; in rosins and rosin de- rivatives complying with § 175.300(b)(3)(v) of this chapter; in can end ce- ment formulations complying with § 175.300(b)(3)(xxxi) of this chapter; in side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter; in petroleum alicyclic hydrocarbon resins and terpene resins complying with § 175.320(b)(3) of this chapter; in rosin and rosin deriva- tives complying with § 176.170(a)(5) of this chapter; in petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with § 176.170(b)(2) of this chapter; in terpene resins complying with § 175.300(b)(2)(xi) of this chapter, when such terpene resins are used in accordance with § 176.170(b)(1) of this chapter; in resins and polymers complying with § 176.180(b) of this chapter; in closures with sealing gas- kets complying with § 177.1210 of this chapter; in petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b) of this chapter; and in reinforced wax complying with § 178.3850 of this chapter. 2. At levels not to exceed 0.2 percent by weight of the finished cellophane complying with § 177.1200 of this chapter. 3. At levels not to exceed 0.1 percent by weight in polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter: Provided, That the finished polystyrene and rubber-modified polystyrene polymer contact food only under conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 4. In adhesives complying with § 175.105 of this chapter; in pressure-sen- sitive adhesives complying with § 175.125 of this chapter; and as pro- vided in § 177.2600 of this chapter. 4,4′-Bis(a,a-dimethylbenzyl)diphenylamine (CAS For use at levels not to exceed 0.3 percent by weight of polypropylene Reg. No. 10081–67–1). complying with § 177.1520(c) of this chapter. The polypropylene articles are limited to use in contact with non-fatty foods only. Boric acid (CAS Reg. No. 10043–35–3) ...... For use only at levels not to exceed 0.16 percent by weight of ethylene- vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3) and (d) of this chapter. 1,3–Butanediol. Butylated reaction product of p-cresol and For use only: dicyclopentadiene produced by reacting p-cresol 1. As components of nonfood articles complying with §§ 175.105 and and dicyclopentadiene in an approximate mole 177.2600(c)(4)(iii) of this chapter. ratio of 1.5 to 1, respectively, followed by 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/ alkylation with isobutylene so that the butyl con- styrene copolymers. The finished copolymers may be used in contact tent of the final product is not less than 18 per- with food of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under conditions cent. of use B through H, as described in tables 1 and 2 of § 176.170(c) of this chapter, and with food of Types III, IV-A, V, VI-C, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176.170(c) of this chapter.

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Substances Limitations

Butylated, styrenated cresols produced when For use only: equal moles of isobutylene, styrene, and a 1. As provided in §§ 175.105 and 177.2600 of this chapter. metacresol-paracresol mixture having a no more 2. At levels not to exceed 0.5 percent by weight of polystyrene, rubber- than 3 °C distillation range including 202 °C are modified polystyrene, or olefin polymers complying with § 177.1520 (c) of made to react so that the final product meets this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4, or com- the following specifications: Not less than 95 plying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 percent by weight of total alkylated phenols con- of this chapter, used in articles that contact food only unded the condi- sisting of 13–25 percent by weight of butylated tions described in § 176.170(c) of this chapter, table 2, under conditions m- and p-cresols, 26–38 percent by weight of of use C through G. styrenated m- and p-cresols, 37–49 percent by weight of butylated styrenated m- and p-cresols, and not more than 10 percent by weight total of alkylated xylenols, alkylated o-cresol, alkylated phenol, and alkylated ethylphenol; acidity not more than 0.003 percent; and refractive index at 25 °C of 1.5550–1.5650, as determined by ASTM method D1218–82, ‘‘Standard Test Meth- od for Refractive Index and Refractive Disper- sion of Hydrocarbon Liquids,’’ which is incor- porated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be exam- ined at the National Archives and Records Ad- ministration (NARA). For information on the availability of this material at NARA, call 202– 741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html.. 2-tert-Butyl-a(3-tert-butyl-4-hydroxyphenyl)-p-cu- For use only: menyl bis(p-nonylphenyl) phosphite; the nonyl 1. As components of nonfood articles complying with §§ 175.105 and group is a propylene trimer isomer and the 177.2600 of this chapter. phosphorus content is in the range 3.8–4.0 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta- weight percent. diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings com- plying with § 175.300, § 175.320, or § 176.170 of this chapter. The aver- age thickness of such coatings and closure-sealing gaskets shall not ex- ceed 0.004 inch. 2-(3′-tert-Butyl-2′-hydroxy-5′-methyl-phenyl)-5- For use only at levels not to exceed 0.5 percent by weight of olefin poly- chlorobenzotriazole with a melting point of 137– mers complying with § 177.1520(c) of this chapter, provided that the fin- 141 °C. ished polymer contacts foods only of the types identified in Categories I, II, IV-B, VI-A and B, VII-B, and VIII in table 1, § 176.170 of this chapter. 4,4′-Butylidenebis(6-tert-butyl-m-cresol) ...... For use only. 1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polypropylene complying with § 177.1520 of this chapter and for use at levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520 of this chapter, provided that the finished polypropylene and polyethylene con- tact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, and VIII. Butyric acid, 3,3-bis(3-tert-butyl-4- For use only: hydroxyphenyl)ethylene ester (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of olefin copolymers com- 32509–66–3). plying with § 177.1520(c) of this chapter, items 3.1 and 3.2 except that when used in contact with foods described as types III, IV-A, V, VII-A, and IX in table 1 of § 176.170(c) of this chapter, the olefin copolymers may only be used under conditions of use E, F, and G set forth in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight-percent of polymer units derived from propylene). 3. At levels not to exceed 0.2 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2. Calcium benzoate..

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Substances Limitations

Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy- For use only: benzyl)phosphonate] (CAS Reg. No. 65140–91– 1. At levels not to exceed 0.25 percent by weight of polypropylene that 2). complies with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. 2. At levels not to exceed 0.2 percent by weight of polyethylene and olefin copolymers that comply with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 3.6. Finished polymers having a density less than 0.94 gram per cubic centimeter shall be used in contact with food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter. 4. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhe- sives complying with § 175.125 of this chapter. 5. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva- tives complying with § 175.300(b)(3)(v) of this chapter. 6. At levels not to exceed 0.5 percent by weight of can end cement formu- lations complying with § 175.300(b)(3)(xxxi) of this chapter. 7. At levels not to exceed 0.5 percent by weight of side seam cement for- mulations complying with § 175.300(b)(3)(xxxii) of this chapter. 8. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy- drocarbon resins complying with § 175.320(b)(3) of this chapter. 9. At levels not to exceed 0.5 percent by weight of rosin and rosin deriva- tives complying with § 176.170(a)(5) of this chapter; and petroleum alicy- clic hydrocarbon resins, or the hydrogenated product thereof, complying with § 176.170(b)(2) of this chapter. 10. At levels not to exceed 0.5 percent by weight of resins and polymers used as components of paper and paperboard in contact with dry food in compliance with § 176.180 of this chapter. 11. At levels not to exceed 0.5 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 12. At levels not to exceed 0.5 percent by weight of the finished rubber arti- cle complying with § 177.2600 of this chapter. 13. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b). 14. At levels not to exceed 0.5 percent by weight of reinforced wax com- plying with § 178.3850. 15. At levels not to exceed 0.3 percent by weight of polyethylene phthalate polymers, complying with § 177.1630 of this chapter. Provided, that the finished polymers contact food only under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter. Calcium myristate.. Calcium ricinoleate...... For use only at levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter. Calcium stearate.. Carbethoxymethyl diethyl phosphonate (CAS Reg. At levels not to exceed 0.07 percent by weight of polyethylene phthalate No. 867–13–0). polymers complying with § 177.1630 of this chapter. Cerium stereate (CAS Reg. No. 10119–53–6) ...... For use only at levels not to exceed 0.5 percent by weight in rigid and semirigid vinyl chloride homo- and copolymer articles modified in accord- ance with § 178.3790(b)(1) of this chapter that contact food under condi- tions of use B through H described in table 2 of § 176.170(c) of this chap- ter. Cupric acetate and lithium iodide ...... For use at levels not exceeding 0.025 percent cupric acetate and 0.065 percent lithium iodide by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at tempera- tures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0012 inch. Cuprous iodide ...... For use at levels not exceeding 0.01 percent cuprous iodide by weight of nylon 66T resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.001 inch. Cuprous iodide and cuprous bromide ...... For use at levels not exceeding 0.0025 percent cuprous iodide and 0.0175 percent cuprous bromide by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at tempera- tures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0015 inch. Cyanoguanidine ...... For use only at levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter.

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Substances Limitations

Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only at levels not to exceed 0.1 percent by weight of ethylene-vinyl (CAS Reg. No. 3806–34–6); the phosphorus acetate copolymers complying with § 177.1350 of this chapter that con- content is in the range of 7.8 to 8.2 weight per- tact food under conditions of use E, F, and G described in table 2 of cent. § 176.170(c) of this chapter. Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only: (CAS Reg. No. 3806–34–6) (which may contain 1. At levels not to exceed 0.25 percent by weight of olefin polymers com- not more than 1 percent by weight of plying with § 177.1520(c) of this chapter, items 1.1, 2.1, and 3.1. triisopropanolamine (CAS Reg. No. 122–20–3)); 2. At levels not to exceed 0.25 percent by weight of olefin polymers com- the phosphorus content is in the range of 7.8 to plying with § 177.1520(c) of this chapter, item 2.2, that contact food 8.2 weight percent. Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.15 percent by weight of olefin polymers com- plying with § 177.1520, items 1.1 and 3.2, that contact food Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.20 percent by weight of polystyrene and/or rub- ber modified polystyrene complying with § 177.1640 of this chapter that contact food under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 4,4′-Cyclohexylidenebis(2-cyclohexylphenol) ...... For use only at levels not to exceed 0.1 percent by weight of olefin poly- mers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII. Dicetyl thiodipropionate having a melting point of The concentration of this additive and any other permitted antioxidants in 59°–62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram E324–79, ‘‘Standard Test Method for Relative per square inch of food-contact surface. Initial and Final Melting Points and the Melting Range of Organic Chemicals,’’ and a saponifica- tion value in the range 176–183 as determined by ASTM method D1962–67 (Reapproved 1979), ‘‘Standard Test Method for Saponification Value of Drying Oils, Fatty Acids, and Polym- erized Fatty Acids,’’ which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadel- phia, PA 19428-2959, or may be examined at the National Archives and Records Administra- tion (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.. Didodecyl-1,4-dihydro-2,6-dimethyl-3,5- For use only at levels not to exceed 0.3 percenmt by weight in rigid poly- pyridinedicarboxylate (CAS Reg. No. 36265–41– mer articles modified in accordance with § 178.3790 that contact food, 5). under conditions of use E, F, and G described in table 2 of § 176.170 of this chapter. 2,6-Di(a-methyl benzyl)-4-methyl phenol [Chemical For use only at levels not to exceed 0.2 percent by weight of olefin poly- Abstracts Service Registry No. 1817–68–1]. mers complying with item 3.4 in § 177.1520(c) of this chapter, provided that such olefin polymers are limited to use at a level not to exceed 25 percent by weight in other olefin polymers complying with § 177.1520 of this chapter; and the total amount in such finished olefin polymers not to exceed 0.05 percent by weight, including the level that may be contrib- uted by its presence at 6 percent in the item ‘‘butylated, styrenated cresols * * * ’’ listed in this paragraph; and further provided that the fin- ished olefin polymers are intended for contact with foods, except those containing more than 8 percent alcohol. 2,4-Dimethyl-6-(1-methylpentadecyl)phenol (CAS For use only: Reg. No. 134701–20–5). 1. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter, under conditions of use C through H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.033 percent by weight of rigid polyvinyl chlo- ride, under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Dimethyl succinate polymer with 4-hydroxy- For use only: 2,2,6,6-tetramethyl-1-piperidineethanol (CAS 1. At levels not to exceed 0.3 percent by weight of olefin polymers com- Reg. No. 65447–77–0). plying with § 177.1520 of this chapter and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter and under condi- tions of use B through H described in table 2 of § 176.170(c) of this chap- ter. Dimethyltin/monomethyltin For use only at levels not to exceed 2 percent by weight: isooctylmercaptoacetates consisting of 5 to 90 1. In rigid polyvinyl chloride used in the manufacture of pipes intended for percent by weight of monomethyltin tris contact with water in food-processing , and (isooctylmercaptoacetate) (CAS Reg. No. 2. In rigid polyvinyl chloride and in rigid vinyl chloride copolymers complying 54849–38–6) or monomethyltin tris(2- with § 177.1950 of this chapter or § 177.1980 of this chapter for use in ethylhexylmercaptoacetate) (CAS Reg. No. contact with food of Types I, II, III, IV (except liquid milk), V, VI, VII, VIII, 57583–34–3) and 10 to 95 percent by weight of and IX described in table 1 of § 176.170(c) of this chapter under condi- dimethyltin bis (isooctylmercaptoacetate) (CAS tions of use C through G described in table 2 of § 176.170(c) of this Reg. No. 26636–01–1) or dimethyltin bis(2– chapter at temperatures not to exceed 88 °C (190 °F). ethylhexylmercaptoacetate) (CAS Reg. No. 57583–35–4), and no more than 0.4 percent by weight of trimethyltin compounds, and having the following specifications: Tin content (as Sn) in the range of 15 to 21 percent and mercaptosulfur content in the range of 11 to 13.5 percent. Other alkyltin compounds are not to exceed 20 ppm. Dimyristyl thiodipropionate having a melting point Finished food-contact articles containing this additive shall meet the extrac- of 48°–52 °C as determined by ASTM method tives limitations prescribed in § 176.170(c) of this chapter. E324–79, ‘‘Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,’’ and a saponifica- tion equivalent in the range 280–290 as deter- mined by ASTM method D1962–67 (Re- approved 1979), ‘‘Standard Test Method for Sa- ponification Value of Drying Oils, Fatty Acids, and Polymerized Fatty Acids,’’ which are incor- porated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia PA 19103, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.. Di(n-octyl)tin bis(2-ethylhexyl maleate) [CAS Reg. For use only at levels not to exceed 0.5 percent by weight of acrylonitrile No. 10039–33–5] having 12.5 to 15.0 percent by copolymers complying with §§ 177.1020 and 177.1030 of this chapter and weight of tin (Sn) and having a saponification used in contact with all food types under conditions of use C through G number of 260 to 280. The additive is made described in table 2 of § 176.170(c) of this chapter. from di(n-octyl)tin oxide meeting the specifica- tions of § 178.2650(a)(1). N,N′-Diphenylthiourea ...... For use only: 1. At levels not to exceed 0.5 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 2. At levels not to exceed 0.5 percent by weight of vinyl chloride-vinyl ace- tate copolymers containing not more than 20 molar percent of vinyl ace- tate. 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- For use only hexyloxy)phenol (CAS Reg. No. 147315–50–2). 1. At levels not to exceed 0.5 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polyester elastomers complying with § 177.1590 of this chapter. 3. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter, in contact with food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter.

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Substances Limitations

2,6-Di-tert-butyl-4-ethylphenol ...... For use only in contact with nonalcoholic foods: 1. At levels not exceeding 0.04 mg/in 2 of food contact surface and not ex- ceeding 0.1 percent by weight in ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, and 3.3; § 177.1340; and § 177.1350 of this chapter. The average thick- ness of such polymers and copolymers in the form in which they contact food shall not exceed 0.0025 in. 2. At levels not exceeding 0.04 mg/in 2 of food contact surface in ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, and 3.3; § 177.1340; and § 177.1350 of this chapter. The average thickness of such polymers and copolymers in the form in which they contact food shall be greater than 0.0025 in but shall not exceed 0.025 in. 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid For use only: triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine- 1. At levels not to exceed 0.5 percent by weight of polypropylene complying 2,4,6-(1H,3H,5H)-trione (CAS Reg. No. 34137- with § 177.1520 of this chapter in articles that contact food not in excess 09-2). of high temperature heat-sterilized condition of use A described in § 176.170(c) of this chapter, table 2. 2. At levels not to exceed 0.5 percent by weight of polyethylene complying with § 177.1520 of this chapter in articles that contact food not in excess of high temperature heat-sterilized condition of use A described in 176.170(c) of this chapter, table 2. 3. In adhesives complying with § 175.105 of this chapter. 4. At levels not to exceed 0.25 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, 3.5, and 4.0. 5. At levels not to exceed 2 percent by weight of polyester elastomers, complying with § 177.1590 of this chapter, in contact with dry food only, and finished rubber articles for repeated use, complying with § 177.2600 of this chapter, in contact with all foods, at temperatures not to exceed 150 °F. Di-tert-butyl-m-cresyl phosphonite condensation For use only: product with biphenyl (CAS Reg. No. 178358– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 58–2) produced by the condensation of 4,6-di- plying with § 177.1520(c) of this chapter, items 1.1, 2.1, 2.2, 3.1(a), tert-butyl-m-cresol with the Friedel-Crafts addi- 3.1(b), 3.2(a), or 3.2(b). tion product (phosphorus trichloride and biphenyl) so that the food additive has a min- imum phosphorus content of 5.0 percent. Di-tert-butylphenyl phosphonite condensation For use only: product with biphenyl (CAS Reg. No. 119345– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 01–6) produced by the condensation of 2,4-di- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.3a, tert-butylphenol with the Friedel-Crafts addition 3.3b, 3.4, 3.5, and 3.1a (where the density is not less than 0.85 gram per product (phosphorus trichloride and biphenyl) so cubic centimeter and not more than 0.91 gram per cubic centimeter); and that the food additive has a minimum phos- 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6 (where the density is not less than phorus content of 5.4 percent, an acid value not 0.94 gram per cubic centimeter) and 5. exceeding 10 mg KOH/gm, and a melting range 2. At levels not to exceed 0.1 percent by weight of polycarbonate resins of 85 °C to 110 °C (185 °F to 230 °F). complying with § 177.1580 of this chapter. 3. At levels not to exceed 0.2 percent by weight of polystyrene and 0.3 per- cent by weight of rubber-modified polystyrene complying with § 177.1640 of this chapter. 4. At levels not to exceed 0.15 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, and 3.6 (where the polyethylene component has a density less than 0.94 gram per cubic centimeter). 5. At levels not to exceed 0.1 percent by weight of repeated use rubber ar- ticles complying with § 177.2600 of this chapter.

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Substances Limitations

2,4-Di-tert-butylphenyl-3,5-di-tert-butyl-4-hydroxy- For use only: benzoate (CAS Reg. No. 4221–80–1). 1. At levels not to exceed 0.6 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 1.1: (1) when used in sin- gle-use articles that contact food of types I, II, IV-B, VI-A, VI-B, VII-B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when used in repeated-use articles that contact food of types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter. The additive is used under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.25 percent by weight of olefin polymers having a density of not less than 0.94 gram per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2: (1) when used in single-use articles that contact food of types I, II, IV-B, VI-A, VI- B, VII-B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when used in repeated-use articles that contact food of types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chap- ter. The additive is used under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2- For use only: hydroxyphenyl)ethyl]phenyl acrylate (CAS Reg. 1. At levels not to exceed 0.2 percent by weight of polypropylene complying No. 123968–25–2). with § 177.1520 of this chapter in contact with food under conditions of use D through G as described in Table 2 of § 176.170(c) of this chapter, except that polypropylene containing the additive at levels not to exceed 0.075 percent by weight may contact food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 1.0 percent by weight of of styrene block poly- mers complying with § 177.1810 of this chapter. The additive is used under conditions of use D through G as described in Table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 1.0 percent by weight of polystyrene and rubber modified polystyrene complying with § 177.1640 of this chapter in contact with food under conditions of use D through G as described in Table 2 of § 176.170(c) of this chapter. N,N″–1,2–Ethanediylbis[N–[3–[[4,6- For use only: bis[butyl(1,2,2,6,6-pentamethyl-4- 1. At levels not to exceed 0.06 percent by weight of olefin polymers com- piperidinyl)amino]-1,3,5-triazin-2- plying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, or 1.3. yl]amino]propyl]-N′,N″-dibutyl-N′,N″-bis(1,2,2,6,6- The finished polymers may only be used in contact with food of the pentamethyl-4-piperidinyl)-1,3,5-triazine-2,4,6-tri- Types III, IV-A, V, VI-C, VII-A, and IX as described in table 1 of amine] (CAS Reg. No. 106990–43–6). § 176.170(c) of this chapter, and under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.08 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII as described in table 1 of § 176.170(c) of this chapter, and under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. Ethylenebis(oxyethylene)-bis-(3-tert-butyl-4-hy- 1. At levels not to exceed 0.3 percent by weight of polystyrene and/or rub- droxy-5-methylhydrocinnamate) (CAS Reg. No. ber modified polystyrene polymers complying with § 177.1640 of this 36443–68–2). chapter. 2. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter. 3. At levels not to exceed 0.75 percent by weight of polyoxymethylene co- polymers used in accordance with § 177.2470 of this chapter. The fin- ished articles shall not be used for foods containing more than 15 per- cent alcohol. 4. At levels not to exceed 0.25 percent by weight of polyoxymethylene homopolymers used in accordance with § 177.2480 of this chapter. The finished articles shall not be used for foods containing more than 15 per- cent alcohol. 5. At levels not to exceed 0.2 percent by weight of rigid vinyl chloride plas- tics prepared from vinyl chloride homopolymers and/or vinly chloride co- polymers used in accordance with a prior sanction or applicable regula- tions in parts 175, 176, and 177 of this chapter. The vinyl chloride co- polymers shall contain not less than 50 weight percent of total polymer units derived from vinyl chloride. 6. At levels not to exceed 0.1 percent by weight of vinylidene chloride homopolymers and/or vinylidene chloride copolymers used in accordance with a prior sanction or applicable regulations in parts 175, 176, and 177 of this chapter. The vinylidene chloride copolymers shall contain not less than 50 weight percent of total polymer units derived from vinylidene chloride. 7. In adhesives used in accordance with § 175.105 of this chapter.

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Substances Limitations

2,2′-Ethylidenebis(4,6-di-tert-butylphenol) (CAS For use only: Reg. No. 35958–30–6). 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1, or 3.2 (where the polymers complying with items 3.1 and 3.2 contain primarily polymer units derived from propylene). 2. At levels not to exceed 0.05 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3. The fin- ished polymers are to be used only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.075 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3 (where the density of each of these polymers is not less than 0.94 g/cc) and item 3.1 or 3.2 (where each of these polymers contains primarily polymer units derived from ethylene). 4. At levels not to exceed 0.05 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 3.3, 3.4, 3.5, or 4. 5. At levels not to exceed 0.1 percent by weight of ethylene vinyl acetate copolymers complying with § 177.1350 of this chapter and under condi- tions of use C through G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.1 percent by weight of rigid or semirigid poly- vinyl chloride and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 7. At levels not to exceed 0.2 percent by weight of acrylonitrile-butadiene- styrene copolymers containing less than 30 percent by weight of acrylo- nitrile and under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 8. At levels not to exceed 0.1 percent by weight of polystyrene complying with § 177.1640 of this chapter and under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 9. At levels not to exceed 0.2 percent by weight of rubber-modified poly- styrene complying with § 177.1640 of this chapter. 10. In adhesives complying with § 175.105 of this chapter.

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Substances Limitations

2,2′-Ethylidenebis(4,6-di-tert- For use only: butylphenyl)fluorophosphonite (CAS Reg. No. 1. As provided in § 175.105 of this chapter. 118337–09–0). 2. In all polymers used in contact with food of types I, II, IV-B, VI-A, VI-B, VII-B, and VIII, under conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 per- cent by weight of polymers. 3. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1, in contact with food of types III, IV-A, V, VII-A, and IX, under: (a) Conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 percent by weight of the polymer; or (b) Condition of use A, limited to levels not to exceed 0.1 percent by weight of the polymer; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 4. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a or 3.2a, and containing not less than 85 percent by weight of poly- mer units derived from propylene, in contact with food of types III, IV-A, V, VII-A, and IX, and under: (a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels no greater than 0.2 percent by weight of the copolymers; or (b) Conditions of use A, B, and H, limited to levels no greater than 0.1 per- cent by weight of the olefin copolymers; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 5. In olefin polymers complying with § 177.1520(c) of this chapter, items 1.2 or 1.3 in contact with food of types III, IV-A, V, VII-A, and IX, under con- ditions of use A through H, described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1 percent by weight of the poly- mers; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch). 6. In polyethylene complying with § 177.1520(c) of this chapter, items 2.1 or 2.2, having a density of not less than 0.94, in contact with food of types III, IV-A, V, VII-A, and IX, and under: (a) Conditions of use B through H, described in Tables 1 and 2 of § 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by weight of the polymers; or (b) Condition of use A, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.1 percent by weight of the poly- mer; provided that the food-contact surface has an average thickness not exceeding 125 micrometers (0.005 inch). 7. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b, containing not less than 85 percent by weight of polymer units derived from ethylene and having a density of not less than 0.94, in contact with food of types III, IV-A, V, VII-A, and IX, and under: (a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by weight of the copolymers; or (b) Conditions of use A, B, and H, limited to levels not to exceed 0.1 per- cent by weight of the copolymers; provided that the food-contact surface has an average thickness not exceeding 125 micrometers (0.005 inch). 8. In olefin polymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b containing not less than 85 percent by weight of polymer units derived from ethylene, in contact with food of types III, IV- A, V, VII-A, and IX, under conditions of use A through H, as described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1 percent by weight of the copolymer; provided that the food-contact sur- face has an average thickness not exceeding 75 micrometers (0.003 inch). 9. In polyethylene phthalate polymers complying with § 177.1630 of this chapter in contact with food of types III, IV-A, V, VI-C, VII-A, and IX, and under: (a) Conditions of use B through H, described in tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.3 percent by weight of the polymers; or (b) Condition of use A with food of types III, IV-A, V, VII-A, and IX, and lim- ited to levels not to exceed 0.1 percent by weight of the polymers; pro- vided that the film thickness does not exceed 875 micrometers (0.035 inch). Hexadecyl 3,5-di-tert-butyl-4-hydroxybenzoate For use only at levels not to exceed 0.5 percent by weight of olefin poly- (CAS Reg. No. 67845–93–6). mers complying with § 177.1520 of this chapter.

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Substances Limitations

Hexamethylenebis (3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate) (CAS Reg. No. 35074- 1. As provided in § 177.2470(b)(1) and § 177.2480(b)(1) of this chapter. 77-2). 2. In adhesives complying with § 175.105 of this chapter. 3. At levels not to exceed 1 percent by weight in pressure-sensitive adhe- sives complying with § 175.125 of this chapter. 4. At levels not to exceed 1 percent by weight in can end cement formula- tions complying with § 175.300(b)(3)(xxxi) of this chapter. 5. At levels not to exceed 1 percent by weight in side seam cement formu- lations complying with § 175.300(b)(3)(xxxii) of this chapter. 6. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro- carbon resins, polyamide resins, and terpene resins complying with § 175.320 of this chapter. 7. At levels not to exceed 1 percent by weight in rosin and rosin derivatives when used in accordance with § 176.170(a)(5) of this chapter. 8. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro- carbon resins or their hydrogenated products complying with § 176.170(b)(2) of this chapter. 9. At levels not to exceed 1 percent by weight in terpene resins complying with § 175.300(b)(3)(xi) of this chapter, when such terpene resins are used in accordance with § 176.170(b)(1) of this chapter. 10. At levels not to exceed 1 percent by weight in resins and polymers au- thorized for use in accordance with § 176.180 of this chapter. 11. At levels not to exceed 1 percent by weight in closures with sealing gaskets complying with § 177.1210 of this chapter. 12. At levels not to exceed 1 percent by weight in rubber articles intended for repeated use complying with § 177.2600 of this chapter. 13. At levels not to exceed 1 percent by weight in petroleum hydrocarbon resin and rosins and rosin derivatives used in accordance with § 178.3800 of this chapter. 14. At levels not to exceed 1 percent by weight in reinforced wax complying with § 178.3850 of this chapter. N,N′-Hexamethylenebis (3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamamide) (CAS Reg. No. 1. At levels not to exceed 1 percent by weight of nylon resins complying 23128–74–7). with § 177.1500(b) of this chapter, items 1 through 8, that contact food only of the types identified in categories in § 176.170(c) of this chapter, table 1 except VI-A and VI-C. 2. At levels not to exceed 0.75 percent by weight of nylon 12 resins com- plying with § 177.1500(b) of this chapter, item 9, that contact food only of the types identified in categories in § 176.170(c) of this chapter, table 1, except VI-A and VI-C. 3. At levels not to exceed 0.6 percent by weight of polyester resins com- plying with § 175.300(b)(3)(vii) of this chapter. 4. At levels not to exceed 0.6 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 5. At levels not to exceed 0.6 percent by weight of repeated use rubber ar- ticles complying with § 177.2600 of this chapter. 6. At levels not to exceed 0.5 percent by weight of polyoxymethylene co- polymer complying with § 177.2470 of this chapter. 7. At levels not to exceed 0.5 percent by weight of polyoxymethylene homopolymer complying with § 177.2480 of this chapter. 1,6–Hexanediamine, N,N′-bis(2,2,6,6-tetramethyl- For use only as a stabilizer at levels not to exceed 0.3 percent by weight of 4-piperidinyl)-, polymers with morpholine-2,4,6- olefin polymers complying with § 177.1520(c) of this chapter. The finished trichloro-1,3,5-triazine reaction products, polymers are to contact food only under conditions of use C, D, E, F, and methylated (CAS Reg. No. 193098–40–7). G, as described in Table 2 of § 176.170(c) of this chapter. Provided that the finished food-contact articles have a volume of at least 18.9 liters (5 gallons).

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Substances Limitations

1,6-Hexanediamine, N,N’-bis(2,2,6,6-tetramethyl-4- For use only: piperidinyl)-, polymer with 2,4,6-trichloro-1,3,5- 1. At levels not to exceed 0.5 percent by weight of propylene polymers and triazine, reaction products with N-butyl-1- copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, butanamine and N-butyl-2,2,6,6-tetramethyl-4- 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only piperidinamine (CAS Reg. No. 192268–64–7). of the types identified in § 176.170(c) of this chapter, table 1, under cat- egories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of propylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under cat- egories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.5 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chap- ter, table 1, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.05 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chap- ter, table 1, under categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 5. At levels not to exceed 0.5 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.01 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter), or 5. The finished polymers may contact food only of the types identified in § 176.170(c) of this chapter, table 1, under categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. 2-Hydroxy-4-isooctoxy-benzophenone. Chemical For use only at levels not to exceed 0.5 percent by weight of olefin copoly- Abstracts (CA) name: Methanone, [2-hydroxy-4- mers complying with § 177.1520(c) of this chapter: Items 1.1, 1.2, 1.3, (isooctyloxy) phenyl]phenyl; CA Registry No. 2.1, 2.2, 2.3, 3.1, 3.2, 3.3 or 4: Provided, That the finished polymer con- 33059–05–1. tacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, VII-B and VIII under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

2(2′-Hydroxy-5′-methylphenyl)benzotriazole meet- For use only: ing the following specification: melting point 1. As component of nonfood articles complying with § 177.1010 of this 126°–132 °C (258.8°–269.6 °F) (CAS Reg. No. chapter. 2440–22–4). 2. At levels not to exceed 0.25 percent by weight of rigid polyvinyl chloride and/or rigid vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. In polystyrene that complies with § 177.1640 of this chapter and that is limited to use in contact with dry food of Type VIII described in table 1 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.25 percent by weight of polystyrene and/or rub- ber-modified polystyrene polymers complying with § 177.1640 of this chapter intended to contact nonalcoholic food: Provided, That the finished basic rubber-modified polystyrene polymers in contact with fatty foods shall contain not less than 90 weight percent of total polymer units de- rived from styrene monomer. 5. At levels not to exceed 0.5 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. Provided, That the finished polycarbonate resins contact food only of Types I, II, III, IV, V, VI-A, VI-B, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter and under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 6. At levels not to exceed 0.5 percent by weight of ethylene-1,4- cyclohexylene dimethylene terephthalate copolymers complying with § 177.1315 of this chapter and of ethylene phthalate polymers complying with § 177.1630 of this chapter and that contact food only under condi- tions of use D through G described in table 2, § 176.170(c) of this chap- ter. 2-Hydroxy-4-n-octoxy-benzophenone ...... For use only at levels not to exceed 0.5 percent by weight of olefin poly- mers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymer con- tacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, IV-B, VII-B, and VIII , and under the conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

4,4′-Isopropylidenediphenol alkyl(C12-C15) For use only at levels not exceeding 1.0 percent by weight in rigid polyvinyl phosphites; the phosphorus content is in the chloride and/or rigid vinyl chloride copolymers complying with range of 5.2–5.6 weight percent. §§ 177.1950, 177.1970 or 177.1980 of this chapter, and used in contact with food, except milk, only under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use D through G. Magnesium salicylate ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly- mers complying with § 177.1980 of this chapter: Provided, That total salicylates (calculated as the acid) do not exceed 0.3 percent by weight of such polymers. 2-Methyl-4,6-bis-[(octylthio)methyl] phenol (CAS For use only: Reg. No. 110553–27–0). 1. In adhesives complying with § 175.105 of this chapter. 2. At levels not to exceed 0.5 percent by weight of can-end cements and side-seam cements complying with § 175.300(b)(xxxi) and (xxxii) of this chapter. 3. At levels not to exceed 1 percent by weight of pressure sensitive adhe- sives complying with § 175.125 of this chapter petrolium alicyclic hydro- carbon resins complying with § 176.170 of this chapter, resins and poly- mers complying with § 176.180 of this chapter, and closures with sealing gaskets complying with § 177.1210 of this chapter. 4. At levels not to exceed 1.7 percent by weight of the finished rubber prod- ucts complying with § 177.2600 of this chapter. 5. At levels not to exceed 0.1 percent by weight of petroleum alicyclic hy- drocarbon resins complying with § 175.320 of this chapter; rubber-modi- fied polystyrene complying with § 177.1640 of this chapter; and petroleum hydrocarbon resins and rosins and rosins and rosin derivatives complying with § 178.3800 of this chapter. 6. At levels not to exceed 0.2 percent by weight of styrene block polymenrs complying with § 177.1810 of this chapter that contact food of Types I, II, IV-B, VI, VII-B, and VIII described in table 1, § 176.170(c) of this chapter, only under conditions of use C through H described in table 2, § 176.170(c) of this chapter.

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Substances Limitations

2,2′-Methylenebis(4,6-di-tert-butylphenyl)2- For use only at levels not to exceed 0.25 percent by weight of poly- ethylhexyl phosphite (CAS Reg. No. 126050– propylene complying with § 177.1520 of this chapter. The finished poly- 54–2). mers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B, VII-B, and VIII under conditions of use B through H described in table 2, § 176.170(c) of this chapter, and with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-A, VI-C, VII-A, and IX under conditions of use C through G described in table 2, § 176.170(c) of this chapter. 2,2′-Methylenebis (6-tert-butyl-4-ethylphenol) ...... For use only: 1. In acrylonitrile-butadiene-styrene copolymers at levels not to exceed 0.6 percent by weight of the copolymer. 2. In semirigid and rigid acrylic and modified acrylic plastics complying with § 177.1010 of this chapter at levels not to exceed 0.1 percent by weight of the plastic. 4,4′-Methylenebis (2,6-di-tert-butyl-phenol) ...... For use only: 1. As provided in § 175.105 of this chapter. 2. At levels not to exceed 0.25 percent by weight of petroleum hydrocarbon resins used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 3. At levels not to exceed 0.25 percent by weight of terpene resins used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 4. At levels not to exceed 0.5 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the polyethylene end product contacts foods only of the types identified in Categories I, II, IV- B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chapter. 5. At levels not to exceed 0.5 percent by weight of polybutadiene used in rubber articles complying with § 177.2600 of this chapter: Provided, That the rubber end product contacts foods only of the types identified in Cat- egories I, II, IV-B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chap- ter. 2,2′-Methylenebis(4-methyl-6-tert-butylphenol) ...... For use only: 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying with sec. 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 used in articles that contact food of the types iden- tified in sec. 176.170(c) of this chapter, table 1, under Categories I, II, IV- B, VI, VII-B, and VIII. 2. At levels not to exceed 1 percent by weight of polyoxymethylene copoly- mer as provided in sec. 177.2470(b)(1) of this chapter. 3. At levels not to exceed 0.5 percent by weight of polyoxymethylene homopolymer as provided in § 177.2480(b)(1) of this chapter. 2,2′-Methylenebis(4-methyl-6-tert-butylphenol) For use only: monoacrylate (CAS Reg. No. 61167–58–6). 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of styrene block ploymers complying with § 177.1810 of this chapter. 3. At levels not to exceed 1 percent by weight of adhesives complying with § 175.105 of this chapter and pressure sensitive adhesives complying with § 175.125 of this chapter. 4. At levels not to exceed 0.5 percent by weight of acrylonitrile-butadiene- styrene copolymers that comply with § 177.1020 of this chapter when used in articles that contact food only under conditions of use E, F, and G as described in table 2, § 176.170 (c) of this chapter. 2,2′-Methylenebis[6-(1-methylcyclo-hexyl)-p-cresol] For use only: 1. As provided in § 177.1210 of this chapter. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the finished polyethylene contacts foods only of the type identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, and VIII. 3. In polyethylene complying with § 177.1520 of this chapter: Provided, That the finished polyethylene contacts foods only of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV, V, VI-A, VII, and IX, and only at temperatures not to exceed room temperature: And further provided, That percentage concentration of the antioxidant in the polyethylene, when multiplied by the thickness in inches of the finished polyethylene, shall not be greater than 0.0005. 2,2′-Methylenebis(4-methyl-6-nonylphenol) and For use only in acrylonitrile-butadiene-styrene copolymers used in contact 2,6-bis(2-hydroxy-3-nonyl-5-methyl-benzyl)-p- with nonalcoholic foods. cresol mixtures (varying proportions).

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Substances Limitations

Methyltin-2-mercaptoethyloleate sulfide, which is For use only in rigid poly(vinyl chloride) and rigid vinyl chloride copolymers defined as one or more of the following: complying with §§ 177.1950 and 177.1980 of this chapter, respectively, used in the manufacture of pipes and pipe fittings intended for contact with water in food processing plants, at levels not to exceed: 1. 1.0 percent by weight in pipes, and 2. 2.0 percent by weight in pipe fittings. 1. 9-Octadecenoic acid (Z)-, 2-mercaptoethyl ester, reaction products with dichlorodime thylstannane, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 68442–12–6); 2. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, 2-mercaptoethyl decanoate, 2-mercaptoethyl octanoate, so- dium sulfide, and trichloromethylstannane (CAS Reg. No. 151436–98–5); or 3. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 201687–57–2);and which has the following specifications: Tin content (as Sn) 5 to 21 percent by weight; mercaptosulfur content 5 to 13 percent by weight; acid value no greater than 4. Methyltin-2-Mercaptoethyloleate sulfide may also be used with one or more of the fol- lowing optional substances: 1.1a 2-Mercaptoethyl oleate (CAS Reg. No. 59118–78–4), 1.1b 2-Mercaptoethyl tallate (CAS Reg. No. 68440–24–4), 1.1c 2-Mercaptoethyl octanoate (CAS Reg. No. 57813–59–9), 1.1d 2-Mercaptoethyl decanoate (CAS Reg. No. 68928–33–6), alone or in combination; not to exceed 40 percent by weight of the stabilizer formulation; 2.1 2-Mercaptoethanol (CAS Reg. No. 60–24– 2): Not to exceed 2 percent by weight of the stabilizer formulation. 3.1 Mineral oil (CAS Reg. No. 8012–95–1): Not to exceed 40 percent by weight of the stabilizer formulation. 4.1 Butylated hydroxytoluene (CAS Reg. No. 128–37–0): Not to exceed 5 percent by weight of the stabilizer formulation. The total of the optional substances (1.1a through 4.1) shall not exceed 60 percent by weight of the stabilizer formulation. Nylon 66/610/6 terpolymer (see § 177.1500 of this For use only at levels not to exceed 1.5 percent by weight of chapter for identification) polyoxymethylene homopolymer as provided in § 177.2480 (b)(1) of this chapter. Nylon 612/6 copolymer. (CAS Reg. No. 51733– For use only at levels not to exceed 1.5 percent by weight of 10–9), weight ratio 6/1. polyoxymethylene homopolymer as provided in § 177.2480(b)(1).

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Substances Limitations

Octadecyl 3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate (CAS Reg. No. 2082– 1. At levels not exceeding 0.25 percent by weight of olefin polymers com- 79–3). plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. 2. As provided in §§ 175.105 and 177.1010(a)(5) of this chapter. 3. At levels not exceeding 0.25 percent by weight of polystyrene and/or rub- ber-modified polystyrene polymers complying with § 177.1640 of this chapter, except that the finished basic rubber-modified polystyrene poly- mers in contact with fatty foods shall contain not less than 85 weight per- cent of total polymer units derived from styrene monomer. 4. At levels not to exceed 0.5 percent by weight of acrylonitrile-butadiene- styrene copolymers used in accordance with prior sanction or regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter. 5. At levels not exceeding 0.25 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, items 3.4 and 3.5 as follows: (a) item 3.4, Provided, That the finished copolymer contacts foods only of types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, III, IV-B, VI, VII, VIII, and IX; (b) item 3.5, Provided, That the finished copolymer contacts non-fatty foods only of types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII. 6. At levels not exceeding 0.05 percent by weight of modified semi-rigid and rigid vinyl chloride plastics modified with methacrylate-butadiene-sty- rene copolymers in accordance with § 178.3790. 7. At levels not exceeding 0.2 percent by weight of rigid polyvinyl chloride. 8. At levels not to exceed 0.3 percent by weight of polycarbonate resins that comply with § 177.1580 and that contact food only under conditions of use E, F, and G described in table 2, § 176.170(c) of this chapter. 9. At levels not exceeding 0.1 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 10. At levels not to exceed 0.2 percent by weight of nitrile rubber-modified acrylonitrile-methyl acrylate copolymers that comply with § 177.1480 of this chapter when used in articles that contact food only under conditions of use D, E, F, and G described in table 2, § 176.170(c) of this chapter. 11. At levels not exceeding 0.3 percent by weight of styrene block polymers complying with § 177.1810 of this chapter when used in articles that con- tact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII, and under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. 12. At levels not exceeding 0.2 percent by weight of vinylidene chloride homopolymers and/or vinylidene chloride copolymers complying with ap- plicable regulations in parts 175, 176, 177, 179, and 181 of this chapter. The vinylidene chloride copolymers shall contain not less than 50 weight percent of total polymer units derived from vinylidene chloride. 13. At levels not exceeding 0.025 percent by weight of chlorinated isobutylene-isoprene copolymers complying with § 177.1420(a)(3) of this chapter. 14. At levels not exceeding 0.5 percent by weight of the finished rubber ar- ticle complying with § 177.2600 of this chapter.

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Substances Limitations

7-Oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21- For use only: one,2,2,4,4-tetramethyl-,hydrochloride, reaction 1. At levels not to exceed 0.5 percent by weight of olefin polymers com- products with epichlorohydrin, hydrolyzed, po- plying with § 177.1520 of this chapter, items 1.1, 3.1, and 3.2, where the lymerized (CAS Reg. No. 202483–55–4). copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene; in contact with all types of food described in Table 1 of § 176.170 of this chapter, pro- vided that the finished food-contact article will have a capacity of at least 18.9 liters (5 gallons) when in contact with food of types III, IV-A, V, VII- A, and IX, described in Table 1 of § 176.170 of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers com- plying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, and 3.2, having a density of not less than 0.94 gram/milliliter, where the copolymers com- plying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from ethylene; in contact with food only under con- ditions of use C, D, E, F, and G, described in Table 2 of § 176.170 of this chapter, provided that the finished food-contact article will have a capac- ity of at least 18.9 liters (5 gallons) when in contact with food of types III, IV-A, V, VII-A, and IX, described in Table 1 of § 176.170 of this chapter. 3. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.0, having a density of less than 0.94 gram/milliliter, in con- tact with food only under conditions of use D, E, F, and G, described in Table 2 of § 176.170 of this chapter, provided that the finished food-con- tact article will have a capacity of at least 18.9 liters (5 gallons) except that, films and molded articles containing not more than 0.2 percent by weight of the stabilizer may contact aqueous food of types I, II, IV-B, VI, and VIII, described in Table 1 of § 176.170 of this chapter with no restric- tions on the amount of food contacted. Oxidized bis(hydrogenated tallow alkyl)amines ...... For use only: 1. At levels not to exceed 0.1 percent by weight of polypropylene polymers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1a (density not less than 0.85 gram per cubic centimeter and less than 0.91 gram per cubic centimeter), 3.2b, 3.4, and 3.5. The finished polymers may be used in contact with food types I, II, IV-B, VII-B and VIII de- scribed in table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter and with food types III, IV-A, V, VI, VII-A, and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use D through H de- scribed in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.075 percent by weight of high-density poly- ethylene polymers complying with § 177.1520(c) of this chapter, item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (density not less than 0.94 gram per cubic centimeter), and 5. The finished polymers may be used in contact with food types I, II, IV-B, VII-B and VIII described in table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter, and with food types III, IV-A, V, VI, VII-A and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use D through H described in table 2 of § 176.170(c) of this chapter. 2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4- For use only: hydroxyphenyl)propionate] (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber- 70331–94–1). modified polystyrene complying with § 177.1640 of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. 3. At levels not to exceed 0.5 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 4.0 that contact food Types I, II, IV-B, VI, VII-B and VIII de- scribed in table 1 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, and 4.0 that contact food Types III, IV-A, V, VII-A, and IX described in table 1 of § 176.170(c) of this chapter; except that olefin copolymers com- plying with items 3.1 and 3.2 where the majority of polymer units are de- rived from propylene may contain the additive at levels not to exceed 0.5 percent by weight. 5. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying with item 3.4 of § 177.1520(c) of this chapter, that contact food Types III, VII-A, and IX described in table 1 of § 176.170(c) of this chap- ter; except that olefin copolymers complying with item 3.4 where the ma- jority of the polymer units are derived from propylene may contain the ad- ditive at levels not to exceed 0.5 percent by weight.

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Substances Limitations

Pentaerythritol and its stearate ester ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly- mers complying with § 177.1980 of this chapter: Provided, That the total amount of pentaerythritol and/or pentaerythritol stearate (calculated as free pentaerythritol) does not exceed 0.4 percent by weight of such poly- mers. N-Phenylbenzenamine reaction products with For use at levels not to exceed 0.5 percent by weight of pressure-sensitive 2,4,4-trimethylpentenes (CAS Reg. No. 68411– adhesives complying with § 175.125 of this chapter. 46–1). Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate (CAS Reg. No. 64502–13–2). polymers complying with § 177.1630 of this chapter, such that the poly- mers contact foods only of Type VI-B described in table 1 of § 176.170(c) of this chapter. Phosphorous acid, cyclic butylethyl propanediol, For use only: 2,4,6-tri-tert-butylphenyl ester (CAS Reg. No. 1. At levels not to exceed 0.2 percent by weight of olefin polymers com- 161717–32–4), which may contain not more plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, and items than 1 percent by weight of triisopropanolamine 2.1, 2.2, or 2.3 (where the density of these polymers is not less than 0.94 (CAS Reg. No. 122–20–3). gram per cubic centimeter), and items 3.1 or 3.2, provided that the fin- ished polymer contacts foods of types I, II, and VI-B as described in table 1 of § 176.170(c) of this chapter only under conditions of use B, C, D, E, F, G, and H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, that con- tact food of types III, IV, V, VI-A, VI-C, VII, VIII, and IX as described in table 1 of § 176.170(c) of this chapter, only under conditions of use C, D, E, F, and G as described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.1 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b, having a density less than 0.94 grams per cubic centimeter, in contact with food only of types III, IV, V, VI-A, VI-C, VII, VIII, and IX and under conditions of use B, C, D, E, F, G, and H as described in tables 1 and 2 of § 176.170(c) of this chapter; provided that the food-contact surface does not exceed 0.003 inch (0.076 mm) in thickness. 4. At levels not to exceed 0.1 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a), 3.1(b), 3.1(c), 3.2 (a), or 3.2(b), having a density not less than 0.94 grams per cubic centimeter, in contact with foods only of types III, IV, V, VI-A, VI-C, VII, VIII, and IX identified in Table 1 of § 176.170(c) of this chapter, and under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter; provided that the food-contact surface does not exceed 0.003 inch (0.076 mm) in thickness. Phosphorous acid, cyclic neopentanetetrayl For use only at levels not to exceed 0.10 percent by weight of olefin poly- bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. mers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 26741–53–7) which may contain not more than 2.2, 2.3, 3.1, or 3.2, and limited to use in contact with food only under 1 percent by weight of triisopropanolamine (CAS conditions of use B, C, D, E, F, G, and H described in table 2 of Reg. No. 122–20–3). § 176.170(c) of this chapter. Olefin polymers that contain more than 50 weight-percent of polymer units derived from ethylene shall have a den- sity equal to or greater than 0.94 gram per cubic centimeter. Phosphorous acid, cyclic neopentanetetrayl bis For use only: (2,6-di-tert-butyl-4-methylphenyl)ester (CAS 1. At levels not to exceed 0.25 percent by weight of polypropylene Reg. No. 80693–00–1). homopolymer and copolymers complying with § 177.1520 of this chapter, for use with all food types described in table 1 of § 176.170(c) of this chapter only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.05 percent by weight of polymers complying with § 177.1520(c) of this chapter, item 3.1 or 3.2, and with a maximum thickness of 100 micrometers (0.004 inch) for use with all food types under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Phosphorous acid, cyclic neopentanetetrayl For use only: bis(2,4-di-tert-butylphenyl)ester (CAS Reg. No. 1. At levels not to exceed 0.86 percent by weight in polyvinyl chloride and/ 26741–53–7). or vinyl chloride copolymers that comply with §§ 177.1950, 177.1960, 177.1970, or 177.1980 of this chapter for use with all food types de- scribed in table 1 of § 176.170(c) of this chapter, except those containing more than 15 percent alcohol, under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.25 percent by weight of polycarbonate resins that comply with § 177.1580 of this chapter for use with all food types de- scribed in table 1 of § 176.170(c) of this chapter, except those containing more than 15 percent alcohol, under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.05 percent by weight in olefin polymers com- plying with § 177.1520(c) of this chapter, item 3.1, that contain more than 50 weight percent of polymer units derived from ethylene and whose density is less than 0.94 gram per cubic centimeter. The average thick- ness of such polymers intended for use in contact with food types V and VII-A described in table 1 of § 176.170(c) of this chapter shall not exceed 80 micrometers (0.003 inch). Poly(1,4-cyclohexylenedimethylene-3,3′- For use only: thiodipropionate) partially terminated with stearyl 1. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1, alcohol and produced when approximately equal and used in contact with nonfatty, nonalcoholic food. moles of 1,4-cyclohexanedimethanol and 3,3′- 2. At levels not to exceed 0.5 percent by weight of polypropylene complying thiodipropionic acid are made to react in the with § 177.1520(c) of this chapter, item 1.1, and used in contact with presence of stearyl alcohol so that the final fatty, nonalcoholic food. The average thickness of such polymers in the product has an average molecular weight in the form in which they contact fatty nonalcoholic food shall not exceed 0.005 range of 1,800–2,200, as determined by vapor inch. pressure osmometry, and has a maximum acid value of 2.5. Poly[(1,3-dibutyldistannthianediylidene)-1,3-dithio] For use only at levels not to exceed 0.2 by percent weight in polyvinyl chlo- having the formula [C8H18Sn2S3]n (where n aver- ride resin where such resin constitutes not less than 98.7 percent of a ages 1.5–2) and produced so as to meet the fol- finished semirigid or rigid polyvinyl chloride food-contact surface, pro- lowing specifications: Softening point, 130–145 vided that the finished food-contact article is employed only to package °C; volatile components at 150 °C, less than 1.0 meat, cheese, and food Types I, VIII, and IX as described in table 1 of percent; sulphur (sulfide) content in the range § 176.170(c) of this chapter. The finished food-contact article containing 20.5–22.0 percent; tin content in the range this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48 52.0–53.2 percent. hours, using a volume-to-surface ratio of 2 milliliters per square inch of surface tested, shall yield tin (Sn) not to exceed 0.0005 milligram per square inch of food-contact surface. Poly[(6-morpholino-s-triazine-2,4-diyl)[(2,2,6,6- For use only: tetramethyl-4-piperidyl)imino]hexamethylene 1. At levels not to exceed 0.3 percent by weight of polypropylene complying [(2,2,6,6-tetramethyl-4-piperidyl)imino]] (CAS with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3, and of ethyl- Reg. No. 82451–48–7). ene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.3, and 3.1, whose specific gravity is not less than 0.94. The finished polymers are to contact food only under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.3, and 3.1, whose specific gravity is less than 0.94, and of olefin polymers complying with items 3.3., 3.4, 3.5, and 4.0. The finished polymers are to contact food in articles having a volume of at least 18.9 liters (5 gallons) only under con- ditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. Poly[[6-[(1,1,3,3-tetramethybutyl) amino]-s-triazine- For use only: 2,4-diyl][2,2,6,6-tetramethyl-4- 1. At levels not to exceed 0.3 percent by weight of polypropylene complying piperidyl)imino]hexamethylene[(2,2,6,6- with § 177.1520 of this chapter. tetramethyl-4-piperidyl)imino]] (CAS Reg. No. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying 70624–18–9). with § 177.1520 of this chapter, that has a density equal to or greater than 0.94 gram per cubic centimeter. 3. At levels not to exceed 0.3 percent by weight of polyethylene that has a density less than 0.94 gram per cubic centimeter complying with § 177.1520 of this chapter, items 2.1, 2.2, and 2.3, and of olefin polymers and copolymers complying with items 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4. The finished polymers are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter, and when contacting fatty foods of Types III, IV-A, V, VII-A, and IX described in table 1 of § 176.170(c) of this chapter, the finished articles are to have a volume of at least 18.9 liters (5 gallons).

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Substances Limitations

Potassium bromide and either cupric acetate or For use at levels not exceeding 0.18 percent potassium bromide and 0.005 cupric carbonate. percent copper as cupric acetate or cupric carbonate by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0015 inch. 1,3-propanediamine, N,N-1,2-ethanediylbis-, poly- For use only: mer with 2,4,6-trichloro-1,3,5-triazine, reaction 1. At levels not to exceed 0.3 percent by weight of polypropylene complying products with N-butyl-2,2,6,6-tetramethyl-4- with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. piperidinamine (CAS Reg. No. 136504–96–6). 2. At levels not to exceed 0.2 percent by weight of olefin polymers having a density greater than or equal to 0.94 grams per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, and 3.2. 3. At levels not to exceed 0.3 percent by weight of olefin polymers having a density less than 0.94 grams per cubic centimeter and complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.0. The finished polymers are to contact food only under condi- tions of use B through H described in Table 2 of § 176.170(c) of this chapter, and when used in contact with fatty foods of Types III, IV-A, V, VII-A, and IX as described in Table 1 of § 176.170(c) of this chapter, the finished articles are to have a volume of at least 18.9 liters (5 gallons). N,N′-1,3-Propanediylbis (3,5-di-tert-butyl-4- For use only at levels not to exceed 0.6 percent by weight of rubber articles hydroxyhydrocinnamamide) (CAS Reg. No. for repeated use complying with § 177.2600 of this chapter. 69851–61–2). Siloxanes and silicones, methyl hydrogen, reaction For use as an ultraviolet (UV) stabilizer only at levels not to exceed 0.33 products with 2,2,6,6-tetramethyl-4-(2- percent by weight of polypropylene complying with § 177.1520(c) of this propenyloxy)piperidine (CAS Reg. No. 182635– chapter, items 1.1a, 1.1b, 1.2, and 1.3, under conditions of use D, E, F, 99–0). and G, as described in Table 2 of § 176.170 of this chapter. Stearoylbenzoylmethane (CAS Reg. No. 58446– For use only at levels not to exceed 0.5 percent by weight of vinyl chloride 52–9) consisting of a mixture of b–diketones homopolymers modified in accordance with § 178.3790(b)(1). The fin- produced by the condensation of acetophenone ished polymers may be used in contact with food containing up to 50 per- and technical methyl stearate.. cent alcohol under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Styrenated diphenylamine (CAS Reg. No. 68442– For use only in adhesives complying with § 175.105 of this chapter and in 68–2). rubber articles intended for repeated use complying with § 177.2600 of this chapter. Tetradecanoic acid, lithium salt (CAS Reg. No. For use only at levels not to exceed 0.15 percent by weight of poly- 20336–96–3). propylene and polypropylene copolymers complying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b. The fin- ished polymers may only be used in contact with food of Types I, II, IV-B, VI-B, VII-B, and VIII as described in table 1 of § 176.170(c) of this chap- ter under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter, and with food of Types III, IV-A, V, VI-A, VI- C, VII-A, and IX described in table 1 of § 176.170(c) of this chapter under conditions of use C through G as described in table 2 of § 176.170(c) of this chapter. 2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin co- dimethylethyl)dibenzo[d,f][1,3,2]- polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, dioxaphosphepin-6-yl]oxy]-N,N-bis[2-[[2,4,8,10- 1.3, 2.1, 2.2, or 2.3: Provided, That the density of the olefin polymers tetrakis(1,1- complying with items 2.1, 2.2, or 2.3 is not less than 0.94 gram per cubic dimethylethy- centimeter: And further provided, That the finished polymers contact food l)dibenzo[d,f][1,3,2]dioxaphosphepin-6- only of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII described in table 1, of yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410– § 176.170(c) of this chapter, under conditions of use B through H de- 33–9). scribed in table 2 of § 176.170(c) of this chapter and food only of Types III, IV-A, V, VI-C, VII-A, and IX described in table 1 of § 176.170(c) of this chapter, under conditions of use C through G described in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

Tetrakis [methylene(3,5- di-tert-butyl-4- For use only: hydroxyhydro- cinnamate)] methane (CAS Reg. 1. At levels not to exceed 0.5 percent by weight of all polymers used as in- No. 6683–19–8). direct additives in food packaging, except as specified below. 2. At levels not to exceed 0.1 percent by weight of petroleum wax or syn- thetic petroleum wax complying with § 176.170(a)(5) of this chapter. 3. At levels not to exceed 1.0 percent by weight of: (a) Pressure sensitive adhesives complying with § 175.125 of this chap- ter. (b) Can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter. (c) Petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3) of this chapter, § 176.170(b)(2) of this chapter, or their hydrogenated products complying with § 176.170(b)(2) of this chapter. (d) Rosin and rosin derivatives used in accordance with parts 175 through 178 of this chapter. (e) Terpene resins complying with § 175.300(b)(2)(xi) of this chapter when such terpene resins are used in accordance with § 176.170(b) of this chapter. (f) Resins and polymers complying with § 176.180 of this chapter. (g) Closures with sealing gaskets complying with § 177.1210 of this chap- ter. (h) Polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter. (i) Petroleum hydrocarbon resin complying with § 178.3800. (j) Reinforced wax complying with § 178.3850. 4,4-Thiobis(6-tert-butyl-m-cresol) ...... For use only: 1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.25 percent by weight of polyethylene complying with § 177.1520 of this chapter: Provided, That the specific gravity of the polyethylene is not less than 0.926: And further provided, That the fin- ished polyethylene contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, and VIII. Thiodiethylene bis(3,5-di-tert-butyl-4- For use only: hydroxyhydrocinnamate) (CAS Reg. No. 41484- 1. In adhesives complying with § 175.105 of this chapter. 35-9). 2. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhe- sives complying with § 175.125 of this chapter, petroleum alicyclic hydro- carbon resins complying with § 176.170 of this chapter, resins and poly- mers complying with § 176.180 of this chapter, closures with sealing gas- kets complying with § 177.1210 of this chapter, and finished rubber prod- ucts complying with § 177.2600 of this chapter. Thiodipropionic acid. 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4- For use only: hydroxybenzyl) benzene (CAS Reg. No. 1709– 1. At levels not to exceed 0.5 percent by weight of polymers except nylon 70–2). resins identified in § 177.1500 of this chapter. 2. At levels not to exceed 1 percent by weight of nylon resins identified in § 177.1500 of this chapter. Tri(mixed mono-and dinonylphenyl) phosphite (which may contain not more than 1 percent by weight of triisopropanolamine).. 1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0 parts propionate (CAS Reg. No. 64253–30–1). per 100 parts rubber. 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-tri- For use only: azine-2,4,6(1H,3H,5H)trione (CAS Reg. No. 1. At levels not to exceed 0.25 percent by weight of polypropylene com- 27676–62–6). plying with § 177.1520 of this chapter. 2. In polyethylene complying with § 177.1520 of this chapter: (a) At levels not to exceed 0.1 weight percent. (b) At levels not to exceed 0.5 weight percent in contact with nonfatty food. 3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5- ethylidine-2-norbornene terpolymers complying with § 177.1520 of this chapter. The maximum thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 4. At levels not exceeding 0.1 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, or 3.5. 5. At levels not exceeding 0.25 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, items 3.1 and 3.2, and also con- taining not less than 85 weight percent of polymer units derived from pro- pylene. 6. At levels not to exceed 0.2 percent by weight of olefin polymers com- plying with § 177.1520(c)(4) of this chapter. The finished polymers may be used in contact with food under conditions of use A through H de- scribed in table 2 of § 176.170(c) of this chapter.

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Substances Limitations

1,3,5-Tris(3,5-di-tert-butyl-4-hydro- For use only in contact with nonfatty foods: xyhydrocinnamoyl) hexahydro-s-triazine. 1. At levels not to exceed 0.25 percent by weight of polypropylene com- plying with § 177.1520 of this chapter. 2. At levels not to exceed 0.1 percent by weight of polyethylene complying with § 177.1520 of this chapter. 3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5- ethylidine-2-norbornene terpolymers complying with § 177.1520 of this chapter. The maximum thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethyl- For use only: benzyl)-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione. 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- [CAS Reg. No. 40601–76–1]. plying with § 177.1520 of this chapter, under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber- modified polystyrene that comply with § 177.1640 of this chapter, pro- vided that the finished polystyrene and rubber-modified polystyrene con- tact food only under the conditions described in § 176.170(c) of this chap- ter, table 2, under conditions of use E through G.

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Substances Limitations

Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. For use only: No. 31570–04–4). 1. At levels not to exceed 0.5 percent by weight of elastomers used in rub- ber articles complying with § 177.2600 of this chapter. 2. At levels not to exceed 1 percent by weight of nylon resins complying with § 177.1500 of this chapter: Provided, That the finished polymer con- tacts food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.3 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 4. At levels not to exceeds 0.2 percent by weight of polystyrene and rub- ber-modified polystyrene polymers complying with § 177.1640 of this chapter: Provided, that the finished polymer contacts food only under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 5. At levels not to exceed 0.25 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 1.1, 1.2, or 1.3. 6. At levels not to exceed 0.2 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b). The finished polymers complying with items 2.1, 2.2, or 2.3 having a density less than 0.94 gram per cubic cen- timeter and a thickness greater than 0.051 millimeter (0.002 inch), either shall have a level of tris(2,4-di-tert-butylphenyl)phosphite that shall not exceed 0.062 milligram per square inch of food-contact surface or shall contact all food types identified in Table 1 of § 176.170(c) of this chapter only under conditions of use E, F, and G described in Table 2 of § 176.170(c) of this chapter. 7. At levels not to exceed 0.2 percent by weight of ethylene-vinyl-acetate copolymers complying with § 177.1350 of this chapter, and that are lim- ited to use in contact with food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. The average thick- ness of such polymers in the form in which they contact fatty food shall not exceed 0.1 millimeter (0.004 inch). 8. At levels not to exceed 0.2 percent by weight of olefin polymers com- plying with § 177.1520(c) of this chapter, item 4. The finished polymers having a thickness greater than 0.051 millimeter (0.002 inch), shall con- tact food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 9. At levels not to exceed 0.5 percent by weight of acrylic and modified acrylic plastics, semirigid and rigid, complying with § 177.1010 of this chapter. 10. At levels not to exceed 0.1 percent by weight of isobutylene polymers complying with § 177.1420 of this chapter. 11. In adhesives complying with § 175.105 of this chapter. 12. At levels not to exceed 0.5 percent by weight of pressure sensitive ad- hesives complying with § 175.125 of this chapter. 13. At levels not to exceed 0.5 percent by weight of can end cement formu- lations complying with § 175.300(b)(3) (xxxi) of this chapter. 14. At levels not to exceed 0.5 percent by weight of side seam cement for- mulations complying with § 175.300(b)(3) (xxxii) of this chapter. 15. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy- drocarbon resins complying with § 175.320(b)(3) of this chapter. 16. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy- drocarbon resins or their hydrogenated products complying with § 176.170(b) (2) of this chapter. 17. At levels not to exceed 0.5 percent by weight of resins and polymers complying with § 176.180(b) of this chapter. 18. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva- tives complying with § 176.210(d)(3) of this chapter. 19. At levels not to exceed 0.5 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 20. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon resin, and rosins and rosin derivatives complying with § 178.3800(b). 21. At levels not to exceed 0.5 percent by weight of reinforced wax com- plying with § 178.3850. 22. At levels not to exceed 0.5 percent by weight of olefin copolymers com- plying with § 177.1520(c) of this chapter, item 3.3. The finished polymers may be used in contact with food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 23. At levels not to exceed 0.15 percent by weight of poly-1-butene resins and butene/ethylene copolymers complying with § 177.1570 of this chap- ter: Provided, that the finished polymer contacts food only under condi- tions of use B through H described in table 2 of § 176.170(c) of this chap- ter.

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Substances Limitations

Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane For use only: (CAS Reg. No. 1843–03–4). 1. At levels not to exceed 0.25 percent by weight of polymers used as pro- vided in § 176.180 of this chapter. 2. At levels not to exceed 0.25 percent by weight of the following polymers when used in articles that contact food of Types I, II, IV-B, VI-B, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter: Olefin poly- mers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride poly- mers; and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. At levels not to exceed 0.1 percent by weight of the following polymers when used in articles that contact food of Types III, IV-A, V, VI-A, VI-C, VII-A, and IX described in table 1 of § 176.170(c) of this chapter: Olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride polymers; and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 4. As provided in § 175.105 of this chapter. 5. At levels not to exceed 0.2 percent by weight of polystyrene and/or modi- fied polystyrene polymers identified in § 177.1640 of this chapter. 6. At levels not to exceed 0.25 percent by weight of acrylonitrile-butadiene- styrene copolymers used in contact with nonalcoholic foods. 7. At levels not to exceed 1 percent by weight of closure-sealing gasket compositions complying with § 177.1210(b) of this chapter. Zinc dibutyldithiocarbamate (CAS Reg. No. 136– For use only: 23–2). 1. At levels not to exceed 0.2 percent by weight of isobutyleneisoprene co- polymers complying with § 177.1420 of this chapter: Provided, That the finished copolymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VII, VIII, and IX. 2. At levels not to exceed 0.02 percent by weight of polypropylene poly- mers complying with § 177.1520(c), item 1.1 of this chapter. Zinc palmitate. Zinc salicylate ...... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly- mers complying with § 177.1980 of this chapter: Provided, That total salicylates (calculated as the acid) do not exceed 0.3 percent by weight of such polymers. Zinc stearate. 1 Copies are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103.

[42 FR 14609, Mar. 15, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 178.2010, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 178.2550 4-Hydroxymethyl-2,6-di-tert- § 178.2650 Organotin stabilizers in butylphenol. vinyl chloride plastics. 4-Hydroxymethyl-2,6-di-tert-butyl- The organotin chemicals identified in phenol may be safely used as an anti- paragraph (a) of this section may be oxidant in articles intended for use in safety used alone or in combination, at contact with food, in accordance with levels not to exceed a total of 3 parts the following prescribed conditions: per hundred of resin, as stabilizers in (a) The additive has a solidification vinyl chloride homopolymers and co- point of 140°–141 °C. polymers complying with the provi- (b) The concentration of the additive sions of § 177.1950 or § 177.1980 of this and any other permitted antioxidants chapter and that are identified for use in the finished food-contact article in contact with food of types I, II, III, does not exceed a total of 0.5 milligram IV (except liquid milk), V, VI (except per square inch of food-contact surface. malt beverages and carbonated non- alcoholic beverages), VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, except for the organotin chemical identified in paragraph (a)(3)

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of this section, which may be used in (3) C10-16-Alkyl mercaptoacetates re- contact with food of types I through IX action products with at temperatures not exceeding 75 °C dichlorodioctylstannane and (167 °F), and further that the organotin trichlorooctylstannane (CAS Reg. No. chemicals identified in paragraphs (a) 83447–69–2) is an organotin chemical (5) and (6) of this section may be used mixture having 10.8 to 11.8 percent by in contact with food of types I through weight of tin (Sn) and having 8.0 to 8.6 IX at temperatures not exceeding 66 °C percent by weight of mercapto sulfur. (150 °F), conditions of use D through G It is made from a mixture of di(n- described in table 2 of § 176.170(c) of this octyl)tin dichloride and (n-octyl)tin chapter, and further that dodecyltin trichloride which has an organotin chemicals identified in paragraph (a)(7) composition that is not less than 95 of this section which may be used in percent by weight di(n-octyl)tin dichlo- contact with food of types I, II, III, IV ride/(n-octyl)tin trichloride, and not (except liquid milk), V, VI (except malt more than 1.5 percent by weight of beverages and carbonated nonalcoholic tri(n-octyl)tin chloride. The alkyl rad- beverages), VII, VIII, and IX described ical in the mercaptoacetate is derived in table 1 of § 176.170(c) of this chapter from a mixture of saturated n-alcohols at temperatures not exceeding 71 °C which has a composition that is not (160 °F), in accordance with the fol- less than 50 percent by weight lowing prescribed conditions: tetradecyl alcohol, and that is not more than 50 percent by weight total of (a) For the purpose of this section, decyl alcohol and/or dodecyl alcohol, the organotin chemicals are those list- and/or hexadecyl alcohol. ed in paragraphs (a) (1), (2), (3), (4), (5), (4) (n-Octyl)tin S,S′S″ tris(isooctyl- (6), and (7) of this section. ′ mercaptoacetate) is an octyltin chem- (1) Di(n-octyl)tin S,S - ical having the formula n- bis(isooctylmercaptoacetate) is an C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No. octyltin chemical having 15.1 to 16.4 26401–86–5) having 13.4 to 14.8 percent by percent by weight of tin (Sn) and hav- weight of tin (Sn) and having 10.9 to ing 8.1 to 8.9 percent by weight of mer- 11.9 percent by weight of mercapto sul- capto sulfur. It is made from di(n- fur. It is made from (n-octyl)tin tri- octyl)tin dichloride or di(n-octyl)tin chloride. The isooctyl radical in the oxide. The isooctyl radical in the mercaptoacetate is derived from oxo mercaptoacetate is derived from oxo process isooctyl alcohol. The (n- process isooctyl alcohol. Di(n-octyl)tin octyl)tin trichloride has an organotin dichloride has an organotin composi- composition that is not less than 95 tion that is not less than 95 percent by percent by weight of (n-octyl)tin tri- weight of di(n-octyl)tin dichloride and chloride and not more than 5 percent not more than 5 percent by weight of by weight of tri(n-octyl)tin chloride. tri(n-octyl)tin chloride. Di(n-octyl)tin (5) Bis(beta-carbobutoxyethyl)tin oxide has an organotin composition bis(isooctylmercaptoacetate) (CAS that is not less than 95 percent by Reg. No. 63397–60–4) is an estertin weight of di(n-octyl)tin oxide and not chemical having 14.0 to 15.0 percent by more than 5 percent by weight of weight of tin (Sn) and having 7.5 to 8.5 bis[tri(n-octyl)tin] oxide, and/or mono percent by weight of mercapto sulfur. n-octyltin oxide. It is made from bis(beta- (2) Di(n-octyl) tin maleate polymer is carbobutoxyethyl)tin dichloride. The an octyltin chemical having the for- isooctyl radical in the mercaptoacetate mula [(C8H17)2SnC4H2O4]n (where n is be- is derived from oxo process primary tween 2 and 4 inclusive), having 25.2 to octyl alcohols. The bis(beta- 26.6 percent by weight of tin (Sn) and carbobutoxyethyl)tin dichloride has an having a saponification number of 225 organotin composition that is not less to 255. It is made from di(n-octyl)tin di- than 95 percent by weight of bis(beta- chloride or di(n-octyl)tin oxide meet- carbobutoxyethyl)tin dichloride and ing the specifications prescribed for not more than 5 percent by weight of di(n-octyl) tin dichloride or di(n-octyl) bis(beta-carbobutoxyethyltin tri- tin oxide in paragraph (a)(1) of this sec- chloride. The triestertin chloride con- tion. tent of bis(beta-carbobutoxyethyltin)

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dichloride shall not exceed 0.02 percent. cover at least three equilibrium peri- p odic determinations, as follows: (6) Beta-carbobutoxyethyltin (i) The exposure time for the first de- tris(isooctylmercaptoacetate) (CAS termination shall be at least 72 hours Reg. No. 63438–80–2) is an estertin for aqueous solvents, and at least 6 chemical having 13.0 to 14.0 percent by hours for heptane. weight of tin (Sn) and having 10.5 to (ii) Subsequent determinations shall 11.5 percent by weight of mercapto sul- be at a minimum of 24-hour intervals fur. It is made from beta- for aqueous solvents, and 2-hour inter- carbobutoxyethyltin trichloride. The vals for heptane. These tests shall yield isooctyl radical in the mercaptoacetate total octylin stabilizers not to exceed is derived from oxo process primary 0.5 parts per million as determined by octyl alcohol. The beta- analytical method entitled ‘‘Atomic carbobutoxyethyltin trichloride has an Absorption Spectrometric Determina- organotin composition that is not less tion of Sub-part-per-Million Quantities than 95 percent by weight of beta- of Tin in Extracts and Biological Mate- carbobutoxyethyltin trichloride and rials with Graphite Furnace,’’ Analyt- not more than 5 percent total of ical Chemistry, Vol. 49, p. 1090–1093 triestertin chloride and diestertin chlo- (1977), which is incorporated by ref- ride. erence. Copies are available from the (7) The dodecyltin stabilizer is a mix- Center for Food Safety and Applied Nu- ture of 50 to 60 percent by weight of n- trition (HFS–200), Food and Drug Ad- dodecyltin S,S′,S″- ministration, 5001 Campus Dr., College tris(isooctylmercaptoacetate) (CAS Park, MD 20740, or available for inspec- Reg. No. 67649–65–4) and 40 to 50 percent tion at the National Archives and by weight of di(n-dodecyl)tin S,S′- di(isooctylmercaptoacetate) (CAS Reg. Records Administration (NARA). For No. 84030–61–5) having 13 to 14 percent information on the availability of this by weight of tin (Sn) and having 8 to 9 material at NARA, call 202–741–6030, or percent by weight of mercapto sulfur. go to: http://www.archives.gov/ It is made from a mixture of dodecyltin federallregister/ trichloride and di(dodecyl)tin dichlo- codeloflfederallregulations/ ride which has not more than 0.2 per- ibrllocations.html. cent by weight of dodecyltin tri- (iii) Subsequent determinations for chloride, not more than 2 percent by the dodecyltin mixture described in weight of dodecylbutyltin dichloride paragraph (a)(7) of this section shall be and not more than 3 percent by weight at a minimum of 24-hour intervals for of tri(dodecyl)tin chloride. The aqueous solvents and 2-hour intervals isooctyl radical in the mercaptoacetate for heptane. These tests shall yield is derived from oxo process primary di(n-octyl)tin S,S′- octyl alcohols. bis(isooctylmercaptoacetate), or di(n- (b) The vinyl chloride plastic con- octyl)tin maleate polymer, or (C10-C16)- tainers, film or panels in the finished alkylmercaptoacetate reaction prod- form in which they are to contact food, ucts with dichlorodioctylstannane and shall meet the following limitations: trichlorooctylstannane, or n-octyltin (1) The finished plastics intended for S,S′,S″-tris(isooctylmercaptoacetate), contact with foods of the types listed tris(isooctylmercaptoacetate) and di(n- in this section shall be extracted with dodecyl)tin the solvent or solvents characterizing bis(isooctylmercaptoacetate) or any those types of foods as determined combination thereof, not to exceed 0.5 from table 2 of § 176.170(c) of this chap- parts per million as determined by an ter at the temperature reflecting the analytical method entitled ‘‘Atomic conditions of intended use as deter- Absorption Spectrophotometric Deter- mined therein. Additionally, extrac- mination of Sub-part-per-Million Quan- tion tests for acidic foods shall be in- tities of Tin in Extracts and Biological cluded and simulated by 3-percent ace- Materials with Graphite Furnace,’’ An- tic acid at temperatures specified for alytical Chemistry, Vol. 49, pp. 1090–1093 water in table 2 of § 176.170(c) of this (1977), which is incorporated by ref- chapter. The extraction tests shall erence in accordance with 5 U.S.C.

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552(a). The availability of this incorpo- List of substances Limitations ration by reference is given in para- 1,1,2,2-Tetra- For use only as a blowing agent ad- graph (b)(1)(ii) of this section. chloroethylene. juvant in polystyrene at a level not (2) In lieu of the tests prescribed in to exceed 0.3 percent by weight of paragraph (b) (1) of this section, the finished foamed polystyrene in- tended for use in contact with food finished plastics intended for contact only of the types identified in with foods only of Types II, V, VI-A § 176.170(c) of this chapter, table (except malt beverages), and VI-C may 1, under Categories I, II, VI, and VIII. be end-tested with food-simulating sol- Toluene ...... For use only as a blowing agent ad- vents, under conditions of time and juvant in polystyrene at a level not temperature, as specified below, where- to exceed 0.35 percent by weight of finished foamed polystyrene. by such tests shall yield the octyltin residues cited in paragraph (b)(1) of [47 FR 22090, May 21, 1982, as amended at 58 this section not in excess of 0.5 ppm: FR 64895, Dec. 10, 1993] Tem- perature § 178.3120 Animal glue. Food-simulating solvent Time (degrees (hours) Fahr- Animal glue may be safely used as a enheit) component of articles intended for use in producing, manufacturing, packing, Type II ...... Acetic acid, 3 pct ...... 48 135 Type V ...... Heptane ...... 2 100 processing, preparing, treating, pack- Type VI-A .... Ethyl alcohol, 8 pct ...... 24 120 aging, transporting, or holding food, Type VI-C .... Ethyl alcohol, 50 per- 24 120 subject to the provisions of this sec- cent. tion. (a) Animal glue consists of the pro- [42 FR 14609, Mar. 15, 1977, as amended at 47 teinaceous extractives obtained from FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, hides, bones, and other collagen-rich 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, substances of animal origin (excluding Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR diseased or rotted animals), to which 62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR may be added other optional adjuvant 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; substances required in its production 54 FR 24898, June 12, 1989] or added to impart desired properties. (b) The quantity of any substance Subpart D—Certain Adjuvants and employed in the production of animal Production Aids glue does not exceed the amount rea- sonably required to accomplish the in- § 178.3010 Adjuvant substances used in tended physical or technical effect nor the manufacture of foamed plastics. any limitation further provided. The following substances may be (c) Any substance employed in the production of animal glue and which is safely used as adjuvants in the manu- the subject of a regulation in parts 174, facture of foamed plastics intended for 175, 176, 177, 178 and § 179.45 of this chap- use in contact with food, subject to any ter conforms with any specification in prescribed limitations: such regulation. List of substances Limitations (d) Optional adjuvant substances em- ployed in the production of animal glue Azodicarbonamide ..... For use as a blowing agent in pol- include: yethylene complying with item 2.1 (1) Substances generally recognized in § 177.1520(c) of this chapter at a level not to exceed 5 percent by as safe in food. weight of finished foamed poly- (2) Substances subject to prior sanc- ethylene. tion or approval for use in animal glue 1,1-Difluoroethane For use as a blowing agent in poly- and used in accordance with such sanc- (CAS Reg. No. 75– styrene. 37–6). tion or approval. Isopentane ...... For use as a blowing agent in poly- (3) Substances identified in this para- styrene. graph (d)(3) and subject to such limita- n-Pentane ...... Do. tions as are provided:

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List of substances Limitations

Alum (double sulfate of aluminum and ammonium, potassium, or sodium). 4-Chloro-3-methylphenol(p-chlorome-tacresol) ...... For use as preservative only. Chromium potassium sulfate (chrome alum) ...... For use only in glue used as a colloidal flocculant added to the pulp suspension prior to the sheet- forming operation in the manufacture of paper and paper board. 3,5-Dimethyl-1,3,5,H-tetrahydrothiadia-zine-2-thione ...... For use as preservative only. Disodium cyanodithioimidocarbonate ...... Do. Defoaming agents ...... As provided in § 176.210 of this chapter. Ethanolamine. Ethylenediamine. Formaldehyde ...... For use as a preservative only. Potassium N-methyldithiocarbamate ...... Do. Potassium pentachlorophenate ...... Do. Rosins and rosin derivatives ...... As provided in § 178.3870. Sodium chlorate. Sodium dodecylbenzenesulfonate. Sodium 2-mercaptobenzothiazole ...... For use as preservative only. Sodium pentachlorophenate ...... Do. Sodium o-phenylphenate ...... Do. Zinc dimethyldithiocarbamate ...... Do. Zinc 2-mercaptobenzothiazole ...... Do.

(e) The conditions of use are as fol- food-contact materials subject to the lows: provisions of this section: (1) The use of animal glue in any sub- stance or article that is the subject of Substances Limitations a regulation in this subpart conforms Zinc hydroxy For use only as a component of resinous with any specifications or limitations phosphite and polymeric food-contact coatings in- prescribed by such regulation for the (CAS Reg. tended for repeated use in contact with No. 55799– dry foods. finished form of the substance or arti- 16–1). cle. (2) It is used as an adhesive or compo- [50 FR 21835, May 29, 1985] nent of an adhesive in accordance with the provisions of § 175.105 of this chap- § 178.3130 Antistatic and/or anti- ter. fogging agents in food-packaging (3) It is used as a colloidal flocculant materials. added to the pulp suspension prior to The substances listed in paragraph the sheet-forming operation in the (b) of this section may be safely used as manufacture of paper and paperboard. antistatic and/or antifogging agents in (4) It is used as a protective colloid in food-packaging materials, subject to resinous and polymeric emulsion coat- the provisions of this section: ings. (a) The quantity used shall not ex- ceed the amount reasonably required § 178.3125 Anticorrosive agents. to accomplish the intended technical The substances listed in this section effect. may be used as anticorrosive agents in (b) List of substances:

List of substances Limitations

N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or For use only: derived from the combined fatty acids of coconut oil. 1. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of polyolefin film used for pack- aging meat, fresh fruits, and fresh vegetables. The average thickness of such polyolefin film shall not exceed 0.003 inch. 2. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of ethylene-vinyl acetate copoly- mer film complying with § 177.1350 of this chapter and used for packaging meat, fresh fruits, fresh vegetables, and dry food of Type VIII described in table 1 of § 176.170(c) of this chapter. The average thickness of such ethylene-vinyl ace- tate copolymer film shall not exceed 0.003 inch when used for packaging meat, fresh fruits, and fresh vegetables.

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List of substances Limitations

Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene) For use only as an antistatic and/or antifogging agent at levels not to exceed 0.2 pct by weight in polyolefin film not exceed- ing 0.001 inch thickness. Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10-C18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by cent C14-C16). weight of polyolefin films that comply with § 177.1520 of this chapter: Provided, that the finished olefin polymers contact foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX de- scribed in table 1 of § 176.170(c) of this chapter, and under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 2. As antistatic agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene com- plying with § 177.1640(c) of this chapter under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.

Aluminum Borate ((9Al2O3)·2(B2O3), CAS Reg. No. 11121–16– For use only: 7) produced by reaction between aluminum oxide and/or alu- 1. At levels not to exceed 1 percent by weight of poly- minum hydroxide with boric acid and/or metaboric acid at propylene films complying with § 177.1520(c) of this chapter, temperatures in excess of 1000 °C. item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin- ished polymers may be used in contact with all food types identified in Table 1 of § 176.170(c) of this chapter, under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch. 2. At levels not to exceed 2 percent by weight of poly- propylene films complying with § 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin- ished polymers may be used in contact with all food types identified in Table 1 of § 176.170(c) of this chapter under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch.

N,N-Bis(2-hydroxyethyl)alkyl(C12-C18)amine ...... For use only as an antistatic agent at levels not to exceed 0.1 pct by weight of polyolefin food-contact films.

N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. For use only: 70955–14–5). 1. As an antistatic agent at levels not to exceed 0.2 percent by weight in molded or extruded high-density polyethylene (hav- ing a density ≥0.95 g/cm3 and polypropylene containers that contact food only of the types identified in § 176.170(c) of this chapter, Table 1, under types I, VI-B, VII-B, and VIII, under the conditions of use E through G described in Table 2 of § 176.170(c) of this chapter, provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.1 percent by weight in molded or extruded polypropylene homopolymers and copolymers that contact food only of the types identified in § 176.170(c) of this chapter, Table 1, under Types II, III, IV, V, VII-A, and IX, under the conditions of use C through G described in Table 2 of § 176.170(c) of this chapter.

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List of substances Limitations

N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only: (C14–C18) are derived from tallow.. 1. As an antistatic agent at levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of food-contact surface in vinylidene chloride co- polymer coatings complying with § 175.320, § 177.1200, or § 177.1630 of this chapter, provided that such coatings con- tact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV, VII, VIII, and IX under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter. The finished copolymers shall contain at least 70 weight pct of polymer units derived from vinylidene chloride; and shall contain not more than 5 weight pct of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid. N,N-Bis(2-hydroxyethyl)dodecanamide produced when For use only: diethanolamine is made to react with methyl laurate such 1. As an antistatic agent at levels not to exceed 0.5 percent by that the finished product: Has a minimum melting point of 36 weight of molded or extruded polyethylene containers in- °C; has a minimum amide assay of 90 percent; contains no tended for contact with , chocolate syrup, liquid sweet- more than 2 percent by weight of free diethanolamine; and eners, condiments, flavor extracts and liquid flavor con- contains no more than 0.5 percent by weight of N,N, bis(2- centrates, grated cheese, light and heavy cream, yogurt, and hydroxyethyl)piperazine, as determined by paper chroma- foods of Type VIII as described in table 1 of § 176.170(c) of tography method. this chapter. 2. As an antistatic agent at levels not to exceed 0.2 percent by weight in polypropylene films complying with § 177.1520 of this chapter, and used in contact with food of Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of § 176.170(c) of this chap- ter. The average thickness of such polypropylene film shall not exceed 0.001 inches (30 micrometers). N,N-Bis(2-hydroxyethyl) dodecanamide produced when For use only as an antistatic agent at levels not to exceed 0.5 diethanolamine is made to react with methyl laurate such percent by weight of molded or extruded polyethylene con- that the finished product: Has a minimum melting point of 36 tainers intended for contact with honey, chocolate syrup, liq- °C; has a minimum amide assay of 90 percent; contains no uid sweeteners, condiments, flavor extracts and liquid flavor more than 2 percent by weight of free diethanolamine; and concentrates, grated cheese, light and heavy cream, yogurt, contains no more than 0.5 percent by weight of N,N′-bis(2- and foods of Type VIII as described in table 1 of hydroxyethyl) piperazine, as determined by paper chroma- § 176.170(c) of this chapter. tography method. N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts For use only as an antistatic agent at levels not to exceed 0.45 Service Registry No. 10213–78–2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of Service Registry No. 66810–88–6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use salt), Chemical Abstracts Service Registry No. 24170–14–7, B through H described in table 2 of § 176.170(c). The aver- as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed ethylene oxide with octadecylamine and further reacting this 0.002 inch. product with sodium monochloroacetate and sodium hydrox- ide, such that the final product has: A nitrogen content of 3.3–3.8 percent; a melting point of 42°–50 °C; and a pH of 10.0–11.5 in a 1 percent by weight aqueous solution. a-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by For use only as an antistatic agent at levels not to exceed 0.2 the condensation of 1 mole of n-dodecanol with an average pct by weight in low-density polyethylene film having an av- of 9.5 moles of ethylene oxide to form a condensate having erage thickness not exceeding 0.005 inch. a hydroxyl content of 2.7 to 2.9 pct and having a cloud point of 80 °C to 92 °C in 1 pct by weight aqueous solution. Glycerol ester mixtures of ricinoleic acid, containing not more As an antifogging agent at levels not exceeding 1.5 pct by than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct weight of permitted plasticized vinyl chloride homo-and/or triricinoleate, and 3.3 pct free glycerine. copolymers. N-Methacryloyloxyethyl-N,N-dimethylammonium-a-N-methyl For use only as an antistatic agent at levels not to exceed 0.2 carboxylate chloride sodium salt, octadecyl methacrylate, percent by weight of polyolefin films that contact foods under ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2- the conditions of use B through H described in table 2 of pyrrolidone copolymer (CAS Reg. No. 66822–60–4). § 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch).

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List of substances Limitations

Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl For use only as an antistatic agent at levels such that the ester (CAS Reg. No. 52497–24–2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent ene distearate (CAS Reg. No. 94945–28–5), and octadecyl additive does not exceed 16, in polypropylene films com- bis(hydroxyethyl)amine (CAS Reg. No. 10213–78–2), as the plying with § 177.1520(c)1.1 of this chapter, and used for major components of a mixture prepared by reacting ethyl- packaging food (except for food containing more than 8 per- ene oxide with octadecylamine and further reacting this prod- cent alcohol) under conditions of use B through H described uct with octadecanoic acid, such that the final product has: a in table 2 of § 176.170(c) of this chapter. maximum acid value of 5 mg KOH/g and total amine value of 86±6 mg KOH/g as determined by a method entitled ‘‘Total Amine Value,’’ which is incorporated by reference. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Ad- ministration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html..

[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999; 76 FR 59249, Sept. 26, 2011]

§ 178.3280 Castor oil, hydrogenated. (a) The quantity used shall not ex- Hydrogenated castor oil may be safe- ceed the amount reasonably required ly used in the manufacture of articles to accomplish the intended technical or components of articles intended for effect. use in contact with food subject to the (b) The additive is used as follows: provisions of this section.

Use Limitations

1. As a lubricant for vinyl chloride polymers used in the manu- For use only at levels not to exceed 4 pct by weight of vinyl facture of articles or components of articles authorized for chloride polymers. food-contact use. 2. As a component of cellophane ...... Complying with § 177.1200 of this chapter. 3. As a component of resinous and polymeric coatings ...... Complying with § 175.300 of this chapter. 4. As a component of paper and paperboard in contact with Complying with § 176.170 of this chapter. aqueous and fatty food. 5. As a component of closures with sealing gaskets for food Complying with § 177.1210 of this chapter. containers. 6. As a component of cross-linked polyester resins ...... Complying with § 177.2420 of this chapter. 7. As a component of olefin polymers complying with For use only at levels not to exceed 2 percent by weight of the § 177.1520 of this chapter. polymer.

[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]

§ 178.3290 Chromic chloride com- complish the intended technical effect plexes. nor exceed 7 micrograms of chromium Myristo chromic chloride complex per square inch of closure area. and stearato chromic chloride complex (b) The packaging container which may be safely used as release agents in has its closure area treated with the the closure area of packaging con- release agent shall have a capacity of tainers intended for use in producing, not less than 120 grams of food per manufacturing, packing, processing, square inch of such treated closure preparing, treating, packaging, trans- area. porting, or holding food, subject to the provisions of this section: (a) The quantity used shall not ex- ceed that reasonably required to ac-

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§ 178.3295 Clarifying agents for poly- nents of articles intended for use in mers. contact with food, subject to the provi- Clarifying agents may be safely used sions of this section: in polymers that are articles or compo-

Substances Limitations

Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hy- For use only as a clarifying agent at levels not to exceed 0.25 droxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]- percent by weight of polypropylene and polypropylene co- (CAS Reg. No. 151841–65–5). polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2. The finished polymers contact food only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of § 176.170(c) of this chap- ter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and IX as identified in Table 1 of § 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of § 176.170(c) of this chapter. Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072–96–1) ... For use only as a clarifying agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or 3.2b, where the copolymers complying with items 3.1a, 3.2a, or 3.2b contain not less than 85 weight percent of polymer units derived from propylene. Di(p-tolylidene) sorbitol (CAS Reg. No. 54686–97–4) ...... For use only as a clarifying agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with § 177.1520(c) of this chapter, item 1.1, and in olefin copoly- mers complying with § 177.1520(c) of this chapter, item 3.1 (containing at least 85 weight percent of polymer units de- rived from propylene), in contact with all food types under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. Dibenzylidene sorbitol (CAS Reg. No. 32647–67–9) formed by For use only as a clarifying agent for olefin polymers com- the condensation of two moles of benzaldehyde with one plying with § 177.1520(c) 1.1, 3.1, and 3.2 of this chapter mole of sorbitol, such that the final product has a minimum under conditions of use C, D, E, F, and G, described in table content of 95 percent dibenzylidene sorbitol. 2 of § 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer. Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861–56–2) For use only as a clarifying agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene. The finished polymers shall be used in con- tact with food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. Polyvinylcyclohexane (CAS Reg. No. 25498–06–0) ...... For use only as a clarfiying agent for polypropylene complying with § 177.1520(c) of this chapter, item 1.1., and in pro- pylene containing copolymers complying with § 177.1520(c) of this chapter, items 3.1 and 3.2, at a level not exceeding 0.1 percent by weight of the polyolefin. Sodium di(p-tert-butylphenyl)phosphate (CAS Reg. No. 10491– For use only as a clarifying agent at a level not exceeding 0.35 31–3). parts per hundred of the resin in olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units de- rived from propylene).

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Substances Limitations

Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only: (CAS Reg. No. 85209–91–2). 1. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene). The finished polymers contact foods only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in table 1 of § 176.170(c) of this chapter and limited to conditions of use B through H, de- scribed in table 2 of § 176.170(c), or foods of all types, lim- ited to conditions of use C through H described in table 2 of § 176.170(c). 2. As a clarifying agent at levels not exceeding 0.10 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1(a) or 1.1(b) and of olefin polymers com- plying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not less than 85 weight percent of the polymer units derived from polypropylene.) The finished polymers shall be used in contact with foods only under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter. 3. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 2.2, where the finished polymer contacts food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identi- fied in Table 1 of § 176.170(c) of this chapter, and limited to conditions of use B through H described in Table 2 of § 176.170(c) of this chapter, or foods of types III, IV-A, V, VI- C, and VII-A as identified in Table 1 of § 176.170(c) of this chapter and limited to conditions of use C through G de- scribed in Table 2 of § 176.170(c) of this chapter.

[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]

§ 178.3297 Colorants for polymers. (b) The colorant must be used in ac- cordance with current good manufac- The substances listed in paragraph turing practice, including use levels (e) of this section may be safely used as which are not in excess of those reason- colorants in the manufacture of arti- ably required to accomplish the in- cles or components of articles intended tended coloring effect. for use in producing, manufacturing, (c) Colorants in this section must packing, processing, preparing, treat- conform to the description and speci- ing, packaging, transporting, or hold- fications indicated. If a polymer de- ing food, subject to the provisions and scribed in this section is itself the sub- definitions set forth in this section: ject of a regulation promulgated under (a) The term colorant means a dye, section 409 of the Federal Food, Drug, pigment, or other substance that is and Cosmetic Act, it shall also comply used to impart color to or to alter the with any specifications and limitations color of a food-contact material, but prescribed by that regulation. Extrac- that does not migrate to food in tion testing guidelines to conduct stud- amounts that will contribute to that ies for additional uses of colorants food any color apparent to the naked under this section are available from eye. For the purpose of this section, the term ‘‘colorant’’ includes sub- the Food and Drug Administration free stances such as optical brighteners and of charge from the Food and Drug Ad- fluorescent whiteners, which may not ministration, Center for Food Safety themselves be colored, but whose use is and Applied Nutrition, 5001 Campus intended to affect the color of a food- Dr., College Park, MD 20740, 240–402– contact material. 1200

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(d) Color additives and their lakes chapter, may also be used as colorants listed for direct use in foods, under the for food-contact polymers. provisions of the color additive regula- (e) List of substances: tions in parts 73, 74, 81, and 82 of this

Substances Limitations

Aluminum. Aluminum hydrate. Aluminum and potassium silicate (mica). Aluminum mono-, di-, and tristearate. Aluminum silicate (China clay). 4-[[5-[[[4-(Aminocarbonyl) phenyl] amino]carbonyl]- 2- For use at levels not to exceed 1 percent by weight of poly- methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hy- mers. The finished articles are to contact foods only under droxy-2-naphthalene-carboxamide (C.I. Pigment Red 187, conditions of use B through H described in table 2 of CAS Reg. No. 59487–23–9). § 176.170(c) of this chapter. N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H- For use at levels not to exceed 1 percent by weight of poly- benzimidazol-5-yl)amino]carbonyl]-2- mers. The finished articles are to contact food only under oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS conditions of use B through H described in table 2 of Reg. No. 74441–05–7). § 176.170(c) of this chapter. Anthra(2,1,9-def:(6,5,10-d′e′f)diisoquinoline-1,3,8,10(2H,9H)- For use at levels not to exceed 1% by weight of polymers. The tetrone (C.I. Pigment Violet 29; CAS Reg. No. 81–33–4). finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. Barium sulfate. Bentonite. Bentonite, modified with 3-dimethyldioctadecylammonium ion. 1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione For use at levels not to exceed 0.0004 percent by weight of (CAS Reg. No. 116–75–6). polyethylene phthalate polymers complying with § 177.1630 of this chapter. 3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4- For use only at levels not to exceed 1 percent by weight of dione (C.I. Pigment Red 254, CAS Reg. No. 84632–65–5). polymers. The finished articles are to contact food only under conditions of use B through H, described in table 2 of § 176.170(c) of this chapter. 4,4′-Bis(4-anilino-6-diethanolamine-a-triazin-2-ylamino)-2,2′-stil- For use only in the textile fibers specified in § 177.2800 of this bene disulfonic acid, disodium salt. chapter. 4,4′-Bis(4-anilino-6-methylethanolamine-a-triazin-2-ylamino)- Do. 2,2′-stilbene disulfonic acid, disodium salt. Burnt umber. Calcium carbonate. Calcium silicate. Calcium sulfate. Carbon black (channel process, prepared by the impingement process from stripped natural gas). 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 1.0 percent by weight of the yl]azo]-5-methylbenzenesulfonic acid, calcium salt (1:1); (C.I. finished polymers. The finished articles are to contact food Pigment Yellow 191, CAS Reg. No. 129423–54–7). only under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter. 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 0.5 percent by weight of poly- yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): mers. The finished articles are to contact food under condi- (C.I. Pigment Yellow 191:1, CAS Reg. No. 154946–66–4). tions of use A through H described in Table 2 of § 176.170(c) of this chapter. Chrome antimony titanium buff rutile (C.I. Pigment Brown 24, For use at levels not to exceed 1 percent by weight of poly- CAS Reg. No. 68186–90–3). mers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter.

Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. For use only: 77288). 1. In polymers used in contact with food at a level not to ex- ceed 5 percent by weight of the polymer, except as specified below. 2. In olefin polymers complying with § 177.1520 of this chapter. 3. In repeat-use rubber articles complying with § 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber articles.

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Substances Limitations

Cobalt aluminate ...... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4- 4′isopropylidenediphenol-epichlorohydrin epoxy resins com- plying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter. 6. At levels not to exceed 5 percent by weight of all polymers except those listed under limitations 1 through 5 of this item. The finished articles are to contact food under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. Copper chromite black spinel (C.I. Pigment Black 28, CAS For use at levels not to exceed 5 percent by weight of poly- Reg. No. 68186–91–4). mers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. D&C Red No. 7 and its lakes. Diatomaceous earth. 4,4′-Diamino-[1,1′-bianthracene]-9,9′,10,10′-tetrone (CAS Reg. For use at levels not to exceed 1 percent by weight of poly- No. 4051–63–2). mers. The finished articles are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. For use at levels not to exceed 1.0 percent by weight of poly- Pigment Red 202, CAS Reg. No. 3089–17–6). mers. 4,5-Dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H- For use only: pyrazol-4- yl)azo)benzenesulfonic acid, calcium salt(1:1), 1. At levels not to exceed 1 percent by weight of polypropylene (C.I. Pigment Yellow 183, CAS Reg. No. 65212–77–3). polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, 1.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.4, or 3.5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 1 percent by weight of high density polyethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.6 (density not less than 0.94 grams per cubic centimeter), or 5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of § 176.170(c) of this chapter. 5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]- For use at levels not to exceed 1 percent by weight of poly- 2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102– mers. The finished articles are to contact food only under 84–2). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,9-Dimethylanthra(2,1,9-def:6,5,10-d′e′f′)diisoquinoline- For use at levels not to exceed 1 percent by weight of poly- 1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. mers. The finished articles are to contact food only under No. 5521–31–3). conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. 3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1- For use at levels not to exceed 1 percent by weight of poly- ethanediyl)azo]]bis[4-chloro-N-(5-chloro-2-methylphenyl)- mers. The finished articles are to contact food only under benzamide] (CAS Reg. No. 5280–80–8). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy- For use at levels not to exceed 1 percent by weight of poly- 3,1-naphthalenediyl) azo]] bis(4-methylbenzoic acid), bis(2- mers. The finished articles are to contact food only under chloroethyl) ester (CAS Reg. No. 68259–05–2). conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2,2′-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3- For use at levels not to exceed 1.0 percent by weight of poly- dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. mers. The finished articles are to contact food only under Pigment Yellow 180, CAS Reg. No. 77804–81–0). conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 2,2′-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS For use as an optical brightener for all polymers at a level not Reg. No. 1533–45–5). to exceed 0.025 percent by weight of polymer. The finished polymer shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII at temperatures not to ex- ceed 275 °F.

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Substances Limitations

High-purity furnace black (CAS Reg. No. 1333–86–4) con- For use at levels not to exceed 2.5 percent by weight of the taining total polynuclear aromatic hydrocarbons not to ex- polymer. ceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled ‘‘Determination of PAH Content of Carbon Black,’’ dated July 8, 1994, as developed by the Cabot Corp., which is incor- porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Cam- pus Dr., College Park, MD 20740, 240–402–1200, or may be examined at the Food and Drug Administration’s Main Li- brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Sil- ver Spring, MD 20993, 301–796–2039, or at the National Ar- chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html. Iron oxides. Kaolin-modified, produced by treating kaolin with a reaction For use only in olefin polymers complying with § 177.1520 of product of isopropyl titanate and oleic acid in which 1 mole this chapter at levels not to exceed 40 percent by weight of of isopropyl titanate is reacted with 1 to 2 moles of oleic olefin polymer. acid. The reaction product will not exceed 8 percent of the modified kaolin. The oleic acid used shall meet the require- ments specified in § 172.860 of this chapter. Magnesium oxide. Magnesium silicate (talc). Manganese Violet (manganese ammonium pyrophosphate; For use at levels not to exceed 2 percent by weight of poly- CAS Reg. No. 10101–66–3).. mers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo- benzoxazolyl)stilbene (CAS Registry No. 5242–49–9) and ride and not to exceed 0.03 percent by weight in all other lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used benzoxazolyl)stilbene (CAS Registry No. 2397–00–4) and only under conditions of use D, E, F, and G described in 4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533–45– table 2 of § 176.170(c) of this chapter. 5). 7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in: No. 3333–62–8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter and a nitrogen content of 10.7 to 11.2 percent. only at levels such that the product of concentration of the optical brightener (expressed in parts per million by weight of the olefin polymer) multiplied by the thickness of the olefin polymer (expressed in thousandths of an inch and limited to no more than 0.400 inch) shall not exceed 500; provided that the level of the brightener shall not exceed 20 parts per million by weight of the olefin polymer, and further that the olefin polymers shall comply with specifications for items 1.1, 2.1, 3.1, 3.3, and 4 of § 177.1520(c) of this chapter. The polymer may be used under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use E, F, and G. 2. Polyethylene terephthalate specified in § 177.2800(d)(5)(i) of this chapter at a level not to exceed 0.035 percent by weight of the finished fibers. Nickel antimony titanium yellow rutile (C.I. Pigment Yellow 53, For use at levels not to exceed 1 percent by weight of poly- CAS Reg. No. 8007–18–9). mers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. 1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly- anthracenedione (CAS Reg. No. 4118–16–5). ethylene phthalate polymers that comply with § 177.1630 of this chapter. The finished articles are to contact food only under conditions of use E, F, and G described in table 2, § 176.170(c) of this chapter, except, when such articles are used with food types III, IV-A, and V, described in table 1, § 176.170(c) of this chapter, the finished articles are to con- tact food only under conditions of use D, E, F, and G. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–8). Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260). C.I. Pigment red 38 (C.I. No. 21120) ...... For use only in rubber articles for repeated use complying with § 177.2600 of this chapter; total use is not to exceed 10 per- cent by weight of rubber article.

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Substances Limitations

Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900). Sienna (raw and burnt). Silica. 2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction For use only at levels not to exceed 1 percent by weight of products with p-phenyllenediamine and sodium methoxide polymers. The finished articles are to contact food only (CAS reg. No. 106276–80–6). under conditins of use B through H, described in table 2, of § 176.170(c) of this chapter. 4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3- For use only at levels not to exceed 1 percent by weight of dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione polymers. The finished articles are to contact food only (C. I. Pigment Yellow 138, CAS Reg. No.30125–47–4). under conditions of use C through H, as described in table 2 of § 176.170(c) of this chapter; provided further that the fin- ished articles shall not be filled at temperatures exceeding 158 °F (70 °C). 2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. For use as an optical brightener: No. 7128–64–5). 1. In all polymers at levels not to exceed 0.015 percent by weight of the polymer. The finished articles are to contact food only under conditions of use A through H described in table 2 of § 176.170(c) of this chapter. 2. In all polymers at levels not to exceed 0.05 percent by weight of the polymer. The finished articles shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter, under Categories I, II, IV-B, VI-A, VI-B, VI-C, VII-B, and VIII under conditions of use A through H de- scribed in table 2 of § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter and in pressure-sensitive adhesives complying with § 175.125 of this chapter. Titanium dioxide. Titanium dioxide-barium sulfate. Titanium dioxide-magnesium silicate. Ultramarines ...... As identified in § 73.2725 of this chapter. Zinc carbonate ...... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamineformaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4′- isopropylidene diphenol-epichlorohydrin epoxy resins com- plying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter. Zinc chromate ...... For use only in rubber articles for repeated use complying with § 177.2600 of this chapter; total use is not to exceed 10 per- cent by weight of rubber article. Zinc oxide ...... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4′- isopropylidene-diphenol-epichlorohydrin epoxy resins com- plying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter. Zinc sulfide ...... For use at levels not to exceed 10 percent by weight.

[48 FR 46775, Oct. 14, 1983]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 178.3297, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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§ 178.3300 Corrosion inhibitors used List of substances Limitations for steel or tinplate. Propylene glycol. Corrosion inhibitors may be safely used for steel or tinplate intended for § 178.3400 Emulsifiers and/or surface- use in, or to be fabricated as, food con- active agents. tainers or food-processing or handling The substances listed in paragraph equipment, subject to the provisions of (c) of this section may be safely used as this section. emulsifiers and/or surface-active (a) The corrosion inhibitors are pre- agents in the manufacture of articles pared from substances identified in this or components of articles intended for section and used subject to the limita- use in producing, manufacturing, pack- tions prescribed. ing, processing, preparing, treating, (b) The following corrosion inhibitors packaging, transporting, or holding or adjuvants are used in amounts not food, subject to the provisions of this to exceed those reasonably required to section. accomplish the intended physical or (a) The quantity used shall not ex- technical effect: ceed the amount reasonably required (1) Corrosion inhibitors (active ingre- to accomplish the intended technical dients) used in packaging materials for effect; and the quantity that may be- the packaging of steel or tinplate or ar- come a component of food as a result of ticles fabricated therefrom: such use shall not be intended to, nor in fact, accomplish any physical or List of substances Limitations technical effect in the food itself. Dicyclohexylamine and its salts of (b) The use as an emulsifier and/or fatty acids derived from animal surface-active agent in any substance or vegetable oil. or article that is the subject of a regu- Dicyclohexylamine nitrite. lation in parts 174, 175, 176, 177, 178 and Morpholine and its salts of fatty acids derived from animal or § 179.45 of this chapter conforms with vegetable oils. any specifications and limitations pre- scribed by such regulation for the fin- (2) Adjuvants employed in the appli- ished form of the substance or article. cation and use of corrosion inhibitors: (c) List of substances:

List of substances Limitations

a-Alkyl-, a-alkenyl-, and a-alkylaryl-omega- For use only at levels not to exceed 0.5 pct by weight of coat- hydroxypoly(oxyethylene) mixture consisting of 30 weight pct ings complying with § 175.320 of this chapter and limited to of a-(2,4,6-triisobutylphenyl)-omega- use as an emulsifier for polyhydric alcohol diesters used as hydroxypoly(oxyethylene) having an average provided in § 178.3770(b). The weight of the finished coating poly(oxyethylene) content of 7 moles and 70 weight pct of a shall not exceed 2 milligrams per square inch of food-contact 1:1 weight ratio mixture of a-(Z)-9-octadecenyl-omega- surface. hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles and a-alkyl(C16-C18)- omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles. n-Alkylbenzenesulfonic acid (alkyl group consisting of not less For use only as emulsifiers and/or surface active agents as than 95 percent C10 to C16) and its ammonium, calcium, components of nonfood articles complying with §§ 175.300, magnesium, potassium, and sodium salts. 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010, 177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of this chapter and § 178.3120.

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List of substances Limitations

Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10-C18 with not less than 50 per- 1. As provided in § 176.170 of this chapter. cent C14-C16). 2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 3. As emulsifiers in vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished polymer contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter, and limited to conditions of use E, F, and G de- scribed in table 2 of § 176.170 of this chapter. 4. As emulsifiers and/or surface-active agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modi- fied polystyrene complying with § 177.1640(c) of this chapter under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. a-Alkyl-omega-hydroxypoly(oxyethylene) produced by con- densation of 1 mole of C11-C15 straight-chain randomly substitued secondary alcohols with an average of 7–20 moles of ethylene oxide.

alpha Olefin sulfonate [alkyl group is in the range of C10-C18 For use only: with not less than 50 percent C14-C16], ammonium, calcium, 1. In acrylonitrile-butadiene copolymers identified in magnesium, potassium, and sodium salts. § 177.2600(c)(4)(i) of this chapter. 2. At levels not to exceed 1 percent by weight of acrylic coat- ings complying with § 175.300(b)(3)(xx) of this chapter and having a maximum thickness of 0.051 millimeter (0.002 inch). The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter. 3. At levels not to exceed 2 percent by weight of vinyl chloride copolymer coatings having a maximum thickness of 0.051 millimeter (0.002 inch) and complying with § 175.300(b)(3)(xv) of this chapter. The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of § 176.170(c) of this chapter. 4. As provided in § 175.105 of this chapter. Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium For use only as an emulsifier at levels not to exceed 0.3 per- salt (CAS Reg. No. 32612–48–9). cent by weight of styrene-butadiene copolymer coatings for paper and paperboard complying with § 176.170 of this chapter. Ammonium salt of epoxidized oleic acid, produced from For use only: epoxidized oleic acid (predominantly dihydroxystearic and 1. As a polymerization emulsifier at levels not to exceed 1.5 acetoxyhydroxystearic acids) meeting the following specifica- pct by weight of vinyl chloride polymers used as components tions: Acid number 160–180, saponification number 210– of nonfood articles complying with §§ 175.105, 175.300, 235, iodine number 2–15, and epoxy groups 0–0.4 percent. 176.170, 176.180, and 177.1210 of this chapter. Such vinyl chloride polymers are limited to polyvinyl chloride and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. 2. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride-vinyl acetate copolymers used as components of nonfood articles complying with §§ 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent as provided in §§ 175.105, salt (also known as butanedioic acid, sulfo-1,4-diisodecyl 175.125, 176.170, and 176.180 of this chapter. ester, ammonium salt [CAS Reg. No. 144093–88–9]).. a-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) pro- duced by the condensation of 1 mole of di-sec-butylphenol with an average of 4–14 or 30–50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a com- ponent of the blend shall be in the range 4–14 or 30–50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49– For use only as an emulsifier at levels not to exceed 5 percent 8). by weight of polymers intended for use in coatings. a-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydro- gen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 103–111 and that are produced by the esterification of the condensation product of 1 mole of n-dodecyl alcohol with 4–4.5 moles of ethylene oxide.

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List of substances Limitations

a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) pro- duced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an aver- age of 4–14 or 30–50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50. Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only: salt (CAS Reg. No. 9084–06–4). 1. At levels not to exceed 10 micrograms/in2 (0.16 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings ap- plied to films of propylene polymers complying with § 177.1520 of this chapter. 2. At levels not to exceed 14 micrograms/in2 (0.21 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings ap- plied to films of polyethylene phthalate polymers complying with § 177.1630 of this chapter. a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49–59 and that are produced by the esterification of a-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in § 178.3400(c) and having an average poly(oxyethylene) content of 5.5–6.5 moles. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 62–72 and that are produced by the esterification of ′-(p-nonylphenyl)omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in § 178.3400(c) and having an average poly(oxyethylene) content of 9–10 moles. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 98–110 and that are produced by the esterification of a-(p-nonylphenyl)-omega- hydroxypoly (oxyethylene) complying with the identity pre- scribed in § 178.3400(c) and having an average poly(oxyethylene) content of 45–55 moles. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of nonylphenol (nonyl group is a propylene trimer isomer) with an average of 4–14 or 30– 50 moles of ethylene oxide: if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium or sodium salt: the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content average 4 moles. Polyethyleneglycol alkyl(C10-C12)ether sulfosuccinate, disodium For use only at levels not to exceed 5 percent by weight of salt (CAS Reg. No. 68954–91–6). total monomers used in the emulsion polymerization of poly- vinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4–12 For use in coatings at levels not to exceed 1 mg per square moles) propanol] of minimum molecular weight 3500. foot of food-contact surface. Poly(oxypropylene) (45–48 moles) block polymer with For use only as a surface-active agent at levels not to exceed poly(oxyethylene). The finished block polymers meet the fol- 0.5 percent by weight of polyolefin film or polyolefin coatings. lowing specifications: Average molecular weight 11,000– Such polyolefin film and polyolefin coatings shall have an av- 18,000; hydroxyl number 6.2–10.2; ·cloud point above 100 erage thickness not to exceed 0.005 inch and shall be lim- °C. for 10 pct solution. ited to use in contact with foods that have a pH above 5.0 and that contain no more than 8 pct of alcohol. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate) meeting the following specifications: Saponification number 40–50, acid number 0–2, hydroxyl number 60–108, oxy- ethylene content 70–74 pct. Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41–52, oxyethylene content 66–70.5 pct. Polysorbate 60 conforming to the identity prescribed in § 172.836 of this chapter. Polysorbate 65 conforming to the identity prescribed in § 172.838 of this chapter. Polysorbate 80 conforming to the identity prescribed in § 172.840 of this chapter.

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List of substances Limitations

Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meet- ing the following specifications: Saponification number 80– 95, oxyethylene content 46–50 percent. Sodium 1,4-dicylcohexyl sulfosuccinate. Sodium 1,4-dihexyl sulfosuccinate. Sodium 1,4 diisobutyl sulfosuccinate. Sodium dioctyl sulfosuccinate. Sodium 1,4-dipentyl sulfosuccinate. Sodium 1,4-ditridecyl sulfosuccinate. Sodium lauryl sulfate. Sodium monoalkylphenoxybenzenedisulfonate and sodium dialkylphenoxybenzenedisulfonate mixtures containing not less than 70 pct of the monoalkylated product where the alkyl group is C8C16. Sorbitan monolaurate meeting the following specifications. Sa- ponification number 153–170; and hydroxyl number 330–360. Sorbitan monooleate meeting the following specifications: Sa- ponification number 145–160, hydroxyl number 193–210. Sorbitan monopalmitate meeting the following specifications: Saponification No. 140–150; and hydroxyl No. 275–305. Sorbitan monostearate conforming to the identity prescribed in § 172.842 of this chapter. Sorbitan trioleate meeting the following specifications: Saponi- fication No. 170–190; and hydroxyl No. 55–70. Sorbitan tristearate meeting the following specifications: Sa- ponification No. 176–188; and hydroxyl No. 66–80. Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl For use only at levels not to exceed 5 percent by weight of ether, disodium salt (CAS Reg. No. 39354–45–5). total monomers used in the emulsion polymerization of poly- vinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl For use only at levels not to exceed 5 percent by weight of the ether, disodium salt (alcohol moiety produced by condensa- total coating monomers used in the emulsion polymerization tion of 1 mole nonylphenol and an average of 9–10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended ethylene oxide) (CAS Reg. No. 9040–38–4). for use as coatings for paper and paperboard. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl] omega- hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4–14 or 30–40 moles of ethylene oxide; if a blend of prod- ucts is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4–14 or 30–50. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied to tea-bag material. a-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of di- hydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 75–85 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5–6.5 moles of ethylene oxide. a-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of di- hydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 58–70 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 9–10 moles of ethylene oxide.

(d) The provisions of this section are Finding Aids section of the printed volume not applicable to emulsifiers and/or and at www.fdsys.gov. surface-active agents listed in § 175.105(c)(5) of this chapter and used in § 178.3450 Esters of stearic and pal- mitic acids. food-packaging adhesives complying with § 175.105 of this chapter. The ester stearyl palmitate or palmityl stearate or mixtures thereof [42 FR 14609, Mar. 15, 1977] may be safely used as adjuvants in EDITORIAL NOTE: For FEDERAL REGISTER ci- food-packaging materials when used in tations affecting § 178.3400, see the List of accordance with the following pre- CFR Sections Affected, which appears in the scribed conditions:

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(a) They are used or intended for use www.archives.gov/federallregister/ as plasticizers or lubricants in poly- codeloflfederallregulations/ styrene intended for use in contact ibrllocations.html. with food. (1) Synthetic fatty alcohols. (i) Hexyl, (b) They are added to the formulated octyl, decyl, lauryl, myristyl, cetyl, polymer prior to extrusion. and stearyl alcohols meeting the speci- (c) The quantity used shall not ex- fications and definition prescribed in ceed that required to accomplish the § 172.864 of this chapter, except that intended technical effect. they may contain not more than 0.8 weight percent total diols. § 178.3480 Fatty alcohols, synthetic. (ii) Lauryl, myristyl, cetyl, and ste- Synthetic fatty alcohols may be safe- aryl alcohols manufactured by the ly used as components of articles in- process described in § 172.864(a)(2) of tended for use in contact with food, this chapter such that lauryl and and in synthesizing food additives and myristyl alcohols meet the specifica- other substances permitted for use as tions in § 172.864(a)(1)(i) of this chapter, components of articles intended for use and cetyl and stearyl alcohols meet the in contact with food in accordance specifications in § 172.864(a)(1)(ii) of this with the following prescribed condi- chapter. tions: (2) Conditions of use. (i) Synthetic (a) The food additive consists of fatty fatty alcohols as substitutes for the alcohols meeting the specifications and corresponding naturally derived fatty definition prescribed in § 172.864 of this alcohols permitted for use in compli- chapter, except as provided in para- ance with § 178.3910. graph (c) of this section. (ii) Synthetic lauryl alcohol as a sub- (b) It is used or intended for use as stitute for the naturally derived lauryl follows: alcohol permitted as an intermediate (1) As substitutes for the cor- in the synthesis of sodium lauryl sul- responding naturally derived fatty al- fate used in compliance with § 178.3400. cohols permitted for use as components of articles intended for use in contact [42 FR 14609, Mar. 15, 1977, as amended at 47 with food by existing regulations in FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, parts 174, 175, 176, 177, 178 and § 179.45 of 1989] this chapter: Provided, That the use is § 178.3500 Glycerin, synthetic. in compliance with any prescribed lim- itations. Synthetic glycerin may be safely (2) As substitutes for the cor- used as a component of articles in- responding naturally derived fatty al- tended for use in packaging materials cohols used as intermediates in the for food, subject to the provisions of synthesis of food additives and other this section: substances permitted for use as compo- (a) It is produced by the hydro- nents of food-contact articles. genolysis of carbohydrates, and shall (c) Synthetic fatty alcohols identi- contain not in excess of 0.2 percent by fied in paragraph (c)(1) of this section weight of a mixture of butanetriols. may contain not more than 0.8 weight (b) It is used in a quantity not to ex- percent of total diols as determined by ceed that amount reasonably required a method titled ‘‘Diols in Monohydroxy to produce its intended physical or Alcohol by Miniature Thin Layer Chro- technical effect, and in accordance matography (MTLC),’’ which is incor- with any limitations prescribed by ap- porated by reference. Copies are avail- plicable regulations in parts 174, 175, able from the Center for Food Safety 176, 177, 178 and 179 of this chapter. It and Applied Nutrition (HFS–200), Food shall not be intended to, nor in fact ac- and Drug Administration, 5001 Campus complish, any direct physical or tech- Dr., College Park, MD 20740, or avail- nical effect in the food itself. able for inspection at the National Ar- chives and Records Administration § 178.3505 Glyceryl tri-(12-acetoxy- (NARA). For information on the avail- stearate). ability of this material at NARA, call Glyceryl tri-(12-acetoxystearate) 202–741–6030, or go to: http:// (CAS Reg. No. 139–43–5) may be safely

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used as a component of articles in- § 178.3520 Industrial starch-modified. tended for use in producing, manufac- Industrial starch-modified may be turing, packing, processing, preparing, safely used as a component of articles treating, packaging, transporting, or intended for use in producing, manu- holding food, subject to the provisions facturing, packing, processing, pre- of this section. paring, treating, packaging, trans- (a) The additive is applied to the sur- porting, or holding food, subject to the face of calcium carbonate at a level not provisions of this section. to exceed 1 weight-percent of the total (a) Industrial starch-modified is iden- mixture. tified as follows: (b) The calcium carbonate/glyceryl (1) A food starch-modified or starch tri-(12-acetoxystearate) mixture is used or any combination thereof that has as an adjuvant in polymers in contact been modified by treatment with one of with nonfatty foods at a level not to the reactants hereinafter specified, in exceed 20 weight-percent of the poly- an amount reasonably required to mer. achieve the desired functional effect but in no event in excess of any limita- [50 FR 1503, Jan. 11, 1985] tion prescribed, with or without subse- quent treatment as authorized in § 172.892 of this chapter.

List of reactants Limitations

Ammonium persulfate, not to exceed 0.3 pct. or in alkaline starch not to exceed 0.6 pct.. (4-Chlorobutene-2) trimethylammonium chloride, not to exceed Industrial starch modified by this treatment shall be used only 5 pct. as internal sizing for paper and paperboard intended for food packaging. b-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct. Dimethylaminoethyl methacrylate, not to exceed 3 pct. Dimethylol ethylene urea, not to exceed 0.375 pct ...... Industrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging. 2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5 pct. Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide in finished product. Phosphoric acid, not to exceed 6 pct and urea, not to exceed Industrial starch modified by this treatment shall be used only 20 pct. as internal sizing for paper and paperboard intended for food packaging and as surface sizing and coating for paper and paperboard that contact food only of Types IV-A, V, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter.

(2) A starch irradiated under one of (ii) An electron beam source at a the following conditions to produce maximum energy of 7 million electron free radicals for subsequent graft po- volts of ionizing radiation, maximum lymerization with the reactants listed absorbed dose not to exceed 5.0 in this paragraph (a)(2): megarads. (i) Radiation from a sealed cobalt 60 source, maximum absorbed dose not to exceed 5.0 megarads.

List of reactants Limitations

Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium For use only as a retention aid and dry strength agent em- methyl sulfate, such that the finished industrial starch-modi- ployed before the sheet-forming operation in the manufac- fied shall contain: ture of paper and paperboard intended to contact food, and used at a level not to exceed 0.25 pct by weight of the fin- ished dry paper and paperboard fibers. 1. Not more than 60 weight percent vinyl copolymer (of which not more than 32 weight percent is [2- (methacryloyloxy)ethyl] trimethylammonium methyl sul- fate).

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List of reactants Limitations

2. Not more than 0.20 pct residual acrylamide. 3. A minimum nitrogen content of 9.0 pct.

(b) The following adjuvants may be Nonvolatile residue 0.002 gram per 100 milli- used as surface-active agents in the liters maximum. processing of industrial starch-modi- Synthetic isoparaffinic petroleum hydro- fied: carbons containing antioxidants shall meet the specified ultraviolet absorbance limits Polyethylene glycol (400) dilaurate. after correction for any absorbance due to Polyethylene glycol (400) monolaurate. the antioxidants. The ultraviolet absorb- Polyoxyethylene (4) lauryl ether. ance shall be determined by the procedure (c) To insure safe use of the indus- described for application to mineral oil trial starch-modified, the label of the under ‘‘Specifications’’ on page 66 of the food additive container shall bear the ‘‘Journal of the Association of Official Ag- name of the additive ‘‘industrial ricultural Chemists,’’ Vol. 45 (February starch-modified,’’ and in the instance 1962), which is incorporated by reference, of an industrial starch-modified which disregarding the last sentence of that pro- is limited with respect to conditions of cedure. For hydrocarbons boiling below 121 ° use, the label of the food additive con- C, the nonvolatile residue shall be deter- mined by ASTM method D1353–78, ‘‘Stand- tainer shall contain a statement of ard Test Method for Nonvolatile Matter in such limited use. Volatile Solvents for Use in Paint, Var- [42 FR 14609, Mar. 15, 1977, as amended at 42 nish, Lacquer, and Related Products;’’ for FR 49453, Sept. 27, 1977] those boiling above 121 °C, ASTM proce- dure D381–80, ‘‘Standard Test Method for § 178.3530 Isoparaffinic petroleum hy- Existent Gum in Fuels by Jet Evapo- drocarbons, synthetic. ration,’’ which are incorporated by ref- Isoparaffinic petroleum hydro- erence. Copies may be obtained from the carbons, synthetic, may be safely used American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, in the production of nonfood articles Philadelphia, PA 19428-2959, or may be ex- intended for use in producing, manu- amined at the National Archives and facturing, packing, processing, pre- Records Administration (NARA). For in- paring, treating, packaging, trans- formation on the availability of this mate- porting, or holding food, subject to the rial at NARA, call 202–741–6030, or go to: provisions of this section. http://www.archives.gov/federallregister/ (a) The isoparaffinic petroleum hy- codeloflfederallregulations/ drocarbons, produced by synthesis from ibrllocations.html. petroleum gases consist of a mixture of (b) Isoparaffinic petroleum hydro- liquid hydrocarbons meeting the fol- lowing specifications: carbons may contain antioxidants au- thorized for use in food in an amount Boiling point 63°–260 °C, as determined by not to exceed that reasonably required ASTM method D86–82, ‘‘Standard Method to accomplish the intended technical for Distillation of Petroleum Products,’’ which is incorporated by reference. Copies effect. may be obtained from the American Soci- (c) Isoparaffinic petroleum hydro- ety for Testing Materials, 100 Barr Harbor carbons are used in the production of Dr., West Conshohocken, Philadelphia, PA nonfood articles. The quantity used 19428-2959, or may be examined at the Na- shall not exceed the amount reason- tional Archives and Records Administra- ably required to accomplish the in- tion (NARA). For information on the avail- ability of this material at NARA, call 202– tended technical effect, and the resid- 741–6030, or go to: http://www.archives.gov/ ual remaining in the finished article federallregister/ shall be the minimum amount reason- codeloflfederallregulations/ ably attainable. ibrllocations.html. Ultraviolet absorbance: [42 FR 14609, Mar. 15, 1977, as amended at 47 260–319 millimicrons—1.5 maximum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 320–329 millimicrons—0.08 maximum. 1984] 330–350 millimicrons—0.05 maximum.

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§ 178.3570 Lubricants with incidental (a) The lubricants are prepared from food contact. one or more of the following sub- stances: Lubricants with incidental food con- (1) Substances generally recognized tact may be safely used on machinery as safe for use in food. used for producing, manufacturing, (2) Substances used in accordance packing, processing, preparing, treat- with the provisions of a prior sanction ing, packaging, transporting, or hold- or approval. ing food, subject to the provisions of (3) Substances identified in this para- this section: graph (a)(3).

Substances Limitations

Aluminum stearoyl benzoyl hydroxide ...... For use only as a thickening agent in mineral oil lubricants at a level not to exceed 10 pct by weight of the mineral oil. N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1- For use as a copper deactivator at a level not to exceed 0.1 methanamine (CAS Reg. No. 94270–86–7). percent by weight of the lubricant. BHA. BHT. a-Butyl-omega-hydroxypoly(oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million. produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol; minimum molecular weight 1,500; Chemical Abstracts Serv- ice Registry No. 9038–95–3. a-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do. weight 1,500; Chemical Abstracts Service Registry No. 9003–13–8. Castor oil ...... Do. Castor oil, dehydrated ...... Do. Castor oil, partially dehydrated ...... Do. Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a 68953–58–2), which may contain up to 7 percent by weight level not to exceed 15 percent by weight of the mineral oil. 1,6-hexanediol (CAS Reg. No. 629–11–8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14-C18) and where the aluminum silicate is derived from bentonite. Dimethylpolysiloxane (viscosity greater than 300 centistokes) ... Addition to food not to exceed 1 part per million. Di (n-octyl) phosphite (CAS Reg. No. 1809–14–9) ...... For use only as an extreme pressure-antiwear adjuvant at a level not to exceed 0.5 percent by weight of the lubricant. Disodium decanedioate (CAS Reg. No. 17265–14–4) ...... For use only: 1. As a corrosion inhibitor or rust preventative in mineral oil- bentonite lubricants at a level not to exceed 2 percent by weight of the grease. 2. As a corrosion inhibitor or rust preventative only in greases at a level not to exceed 2 percent by weight of the grease. Disodium EDTA (CAS Reg. No. 139–33–3) ...... For use only as a chelating agent and sequestrant at a level not to exceed 0.06 percent by weight of lubricant at final use dilution. Ethoxylated resin phosphate ester mixture consisting of the fol- For use only as a surfactant to improve lubricity in lubricating lowing compounds: fluids complying with this section at a level not to exceed 5 percent by weight of the lubricating fluid. 1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-tert- butylphenol with 2 to 4 moles of formaldehyde and sub- sequent ethoxylation with 4 to 12 moles of ethylene oxide;. 2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mix- ture of dihydrogen phosphate and monohydrogen phos- phate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-nonylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide; and. 3. n-Tridecyl alcohol mixture of dihydrogen phosphate and monohydrogen phosphate esters (40 to 80 percent of the mixture; CAS Reg. No. 56831–62–0). Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids. 2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS For use at levels not to exceed 0.5 percent by weight of the lu- Reg. No. 95–38–5). bricant. Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 35074–77–2). by weight of the lubricant.

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Substances Limitations

a-Hydro-omega-hydroxypoly (oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million. produced by random condensation of mixtures of ethylene oxide and propylene oxide containing 25 to 75 percent by weight of ethylene oxide; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003–11–6. 12-Hydroxystearic acid. Isopropyl oleate ...... For use only as an adjuvant (to improve lubricity) in mineral oil lubricants. Magnesium ricinoleate ...... For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil. Mineral oil ...... Addition to food not to exceed 10 parts per million. N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110– For use as a corrosion inhibitor at levels not to exceed 0.5 per- 25–8). cent by weight of the lubricant. N-phenylbenzenamine, reaction products with 2,4,4- For use only as an antioxidant at levels not to exceed 0.5 per- trimethylpentene (CAS Reg. No. 68411–46–1). cent by weight of the lubricant. Petrolatum ...... Complying with § 178.3700. Addition to food not to exceed 10 parts per million. Phenyl-a-and/or phenyl-b-naphthylamine ...... For use only, singly or in combination, as antioxidant in mineral oil lubricants at a level not to exceed a total of 1 percent by weight of the mineral oil. Phosphoric acid, mono- and dihexyl esters, compounds with For use only as an adjuvant at levels not to exceed 0.5 per- tetramethylnonylamines and C11-14 alkylamines. cent by weight of the lubricant. Phosphoric acid, mono- and diisooctyl esters, reacted with tert- For use only as a corrosion inhibitor or rust preventative alkyl and (C12-C14) primary amines (CAS Reg. No. 68187– inlubricants at a level not to exceed 0.5 percent by weight of 67–7). the lubricant. Phosphorothioic acid, O, O, O-triphenyl ester, tert-butyl deriva- For use only as an extreme pressure-antiwear adjuvant at a tives (CAS Reg. No. 192268–65–8). level not to exceed 0.5 percent by weight of the lubricant. Polyurea, having a nitrogen content of 9–14 percent based on For use only as an adjuvant in mineral oil lubricants at a level the dry polyurea weight, produced by reacting tolylene not to exceed 10 percent by weight of the mineral oil. diisocyanate with tall oil fatty acid (C16 and C18) amine and ethylene diamine in a 2:2:1 molar ratio. Polybutene (minimum average molecular weight 80,000) ...... Addition to food not to exceed 10 parts per million. Polybutene, hydrogenated; complying with the identity pre- Do. scribed under § 178.3740. Polyethylene ...... Do. Polyisobutylene (average molecular weight 35,000–140,000 For use only as a thickening agent in mineral oil lubricants. (Flory)). Sodium nitrite ...... For use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil. Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro- For use only as an antioxidant in lubricants at a level not to ex- cinnamate)]methane (CAS Reg. No. 6683–19–8). ceed 0.5 percent by weight of the lubricant. Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 41484-35-9). by weight of the lubricant. Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS For use only as an extreme pressure-antiwear adjuvant at lev- Reg. No. 126019–82–7). els not to exceed 0.5 percent by weight of the lubricant. Triphenyl phosphorothionate (CAS Reg. No. 597–82–0) ...... For use as an adjuvant in lubricants herein listed at a level not to exceed 0.5 percent by weight of the lubricant. Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570– For use only as a stabilizer at levels not to exceed 0.5 percent 04–4). by weight of the lubricant. Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) For use as an antioxidant at levels not to exceed 0.5 percent (CAS Reg. No. 41484–35–9). by weight of the lubricant. Zinc sulfide ...... For use at levels not to exceed 10 percent by weight of the lu- bricant.

(b) The lubricants are used on food- (c) Any substance employed in the processing equipment as a protective production of the lubricants described antirust film, as a release agent on gas- in this section that is the subject of a kets or seals of tank closures, and as a regulation in parts 174, 175, 176, 177, 178 lubricant for machine parts and equip- and § 179.45 of this chapter conforms ment in locations in which there is ex- with any specification in such regula- posure of the lubricated part to food. tion. The amount used is the minimum re- [42 FR 14609, Mar. 15, 1977] quired to accomplish the desired tech- nical effect on the equipment, and the EDITORIAL NOTE: For FEDERAL REGISTER ci- addition to food of any constituent tations affecting § 178.3570, see the List of CFR Sections Affected, which appears in the identified in this section does not ex- Finding Aids section of the printed volume ceed the limitations prescribed. and at www.fdsys.gov.

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§ 178.3600 Methyl glucoside-coconut oil this chapter may be used as a compo- ester. nent of nonfood articles provided such Methyl glucoside-coconut oil ester use complies with any applicable limi- identified in § 172.816(a) of this chapter tations in parts 170 through 189 of this may be safely used as a processing aid chapter. The use of white mineral oil in (filter aid) in the manufacture of or on food itself, including the use of starch, including industrial starch- white mineral oil as a protective coat- modified complying with § 178.3520, in- ing or release agent for food, is subject tended for use as a component of arti- to the provisions of § 172.878 of this cles that contact food. chapter. (b) Technical white mineral oil iden- § 178.3610 α-Methylstyrene- tified in paragraph (b)(1) of this section vinyltoluene resins, hydrogenated. may be used as provided in paragraph Hydrogenated a-methylstyrene- (b)(2) of this section. vinyltoluene copolymer resins having a (1) Technical white mineral oil con- molar ratio of 1 a-methylstyrene to 3 sists of specially refined distillates of vinyltoluene may be safely used as virgin petroleum or of specially refined components of polyolefin film intended distillates that are produced syn- for use in contact with food, subject to thetically from petroleum gases. Tech- the following provisions: nical white mineral oil meets the fol- (a) Hydrogenated a-methylstyrene- lowing specifications: vinyltoluene copolymer resins have a (i) Saybolt color 20 minimum as de- drop-softening point of 125° to 165 °C termined by ASTM method D156–82, and a maximum absorptivity of 0.17 ‘‘Standard Test Method for Saybolt liter per gram centimeter at 266 nano- Color of Petroleum Products (Saybolt meters, as determined by methods ti- Chromometer Method),’’ which is in- tled ‘‘Determination of Softening Point corporated by reference. Copies may be (Drop Method)’’ and ‘‘Determination of obtained from the American Society Unsaturation of Resin 1977,’’ which are for Testing Materials, 100 Barr Harbor incorporated by reference. Copies are Dr., West Conshohocken, Philadelphia, available from the Center for Food PA 19428-2959, or may be examined at Safety and Applied Nutrition (HFS– the National Archives and Records Ad- 200), Food and Drug Administration, ministration (NARA). For information 5001 Campus Dr., College Park, MD on the availability of this material at 20740, or available for inspection at the NARA, call 202–741–6030, or go to: http:// National Archives and Records Admin- www.archives.gov/federallregister/ istration (NARA). For information on codeloflfederallregulations/ the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (ii) Ultraviolet absorbance limits as www.archives.gov/federallregister/ follows: codeloflfederallregulations/ ibrllocations.html. Maximum absorb- (b) The polyolefin film is produced μ ance per from olefin polymers complying with Wavelength (m ) centimeter optical § 177.1520 of this chapter, and the aver- pathlength age thickness of the film in the form in which it contacts food does not exceed 280 to 289 ...... 4.0 290 to 299 ...... 3.3 0.002 inch. 300 to 329 ...... 2.3 [42 FR 14609, Mar. 15, 1977, as amended at 47 330 to 350 ...... 0.8 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989] Technical white mineral oil containing antioxidants shall meet the specified § 178.3620 Mineral oil. ultraviolet absorbance limits after cor- Mineral oil may be safely used as a rection for any absorbance due to the component of nonfood articles intended antioxidants. The ultraviolet absorb- for use in contact with food, subject to ance shall be determined by the proce- the provisions of this section: dure described for application to min- (a) White mineral oil meeting the eral oil under ‘‘Specification’’ on page specifications prescribed in § 172.878 of 66 of the ‘‘Journal of the Association of

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Official Agricultural Chemists,’’ Vol- reference is given in paragraph (b)(1)(i) ume 45 (February 1962) (which is incor- of this section. porated by reference; copies are avail- (iii) Ultraviolet absorbance limits as able from the Center for Food Safety follows as determined by the analytical and Applied Nutrition (HFS–200), Food method described in paragraph (c)(3) of and Drug Administration, 5001 Campus this section: Dr., College Park, MD 20740, or avail- able for inspection at the National Ar- Maximum absorb- chives and Records Administration Wavelength (mμ) ance per (NARA). For information on the avail- centimeter optical ability of this material at NARA, call pathlength 202–741–6030, or go to: http:// www.archives.gov/federallregister/ 280 to 289 ...... 0.7 290 to 299 ...... 0.6 codeloflfederallregulations/ 300 to 359 ...... 0.4 ibrllocations.html.), disregarding the 360 to 400 ...... 09 last two sentences of that procedure and substituting therefor the fol- (2) The mineral oil may be used wher- lowing: Determine the absorbance of ever mineral oil is permitted for use as the mineral oil extract in a 10-milli- a component of nonfood articles com- meter cell in the range from 260–350 plying with §§ 175.105 and 176.210 of this mμ, inclusive, compared to the solvent chapter and § 178.3910 (for use only in control. If the absorbance so measured rolling of metallic foil and sheet exceeds 2.0 at any point in range 280–350 stock), §§ 176.200, 177.2260, 177.2600, and mμ, inclusive, dilute the extract and 177.2800 of this chapter. the solvent control, respectively, to (3) The analytical method for deter- twice their volume with dimethyl sulf- mining ultraviolet absorbance limit is oxide and remeasure the absorbance. as follows: Multiply the remeasured absorbance values by 2 to determine the absorb- GENERAL INSTRUCTIONS ance of the mineral oil extract per cen- Because of the sensitivity of the test, the timeter optical pathlength. possibility of errors arising from contamina- (2) Technical white mineral oil may tion is great. It is of the greatest importance be used wherever mineral oil is per- that all glassware be scrupulously cleaned to mitted for use as a component of remove all organic matter such as oil, nonfood articles complying with grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, §§ 175.105, 176.200, 176.210, 177.2260, under ultraviolet light to detect any residual 177.2600, and 177.2800 of this chapter and fluorescent contamination. As a pre- §§ 178.3570 and 178.3910. cautionary measure it is recommended prac- (3) Technical white mineral oil may tice to rinse all glassware with purified iso- contain any antioxidant permitted in octane immediately before use. No grease is food by regulations issued in accord- to be used on stopcocks or joints. Great care ance with section 409 of the Act, in an to avoid contamination of oil samples in amount not greater than that required handling and to assure absence of any extra- neous material arising from inadequate to produce its intended effect. packaging is essential. Because some of the (c) Mineral oil identified in para- polynuclear hydrocarbons sought in this test graph (c)(1) of this section may be used are very susceptible to photo-oxidation, the as provided in paragraph (c)(2) of this entire procedure is to be carried out under section. subdued light. (1) The mineral oil consists of virgin petroleum distillates refined to meet APPARATUS the following specifications: Separatory funnels. 250-milliliter, 500-milli- (i) Initial boiling point of 450 °F min- liter, 1,000-milliliter, and preferably 2,000- imum. milliliter capacity, equipped with tetra- (ii) Color 5.5 maximum as determined fluoroethylene polymer stopcocks. by ASTM method D1500–82, ‘‘Standard Reservoir. 500-milliliter capacity, equipped with a 24/40 standard taper male fitting at Test Method for ASTM Color of Petro- the bottom and a suitable ball-joint at the leum Products (ASTM Color Scale),’’ top for connecting to the nitrogen supply. which is incorporated by reference. The The male fitting should be equipped with availability of this incorporation by glass hooks.

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Chromatographic tube. 180 millimeters in REAGENTS AND MATERIALS length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, frit- Organic solvents. All solvents used through- ted-glass disc, a tetrafluoroethylene polymer out the procedure shall meet the specifica- stopcock, and a female 24/40 standard tapered tions and tests described in this specifica- fitting at the opposite end. (Overall length of tion. The isooctane, benzene, acetone, and the column with the female joint is 235 milli- methyl alcohol designated in the list fol- meters.) The female fitting should be lowing this paragraph shall pass the fol- equipped with glass hooks. lowing test: Disc. Tetrafluoroethylene polymer 2-inch To the specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milli- diameter disk approximately 3⁄16-inch thick with a hole bored in the center to closely fit liter of purified n-hexadecane and evaporate the stem of the chromatographic tube. on the steam bath under a stream of nitro- Suction flask. 250-milliliter or 500-milliliter gen (a loose aluminum foil jacket around the filter flask. flask will speed evaporation). Discontinue Condenser. 24/40 joints, fitted with a drying evaporation when not over 1 milliliter of res- tube, length optional. idue remains. (To the residue from benzene Evaporation flask (optional). 250-milliliter or add a 10-milliliter portion of purified iso- 500-milliliter capacity all-glass flask octane, reevaporate, and repeat once to in- equipped with standard taper stopper having sure complete removal of benzene.) inlet and outlet tubes to permit passage of Alternatively, the evaporation time can be nitrogen across the surface of contained liq- reduced by using the optional evaporation uid to be evaporated. flask. In this case the solvent and n-hexa- Spectrophotometric cells. Fused quartz cells, decane are placed in the flask on the steam optical path length in the range of 5,000 cen- bath, the tube assembly is inserted, and a timeter ±0.005 centimeter; also for checking stream of nitrogen is fed through the inlet spectrophotometer performance only, optical tube while the outlet tube is connected to a path length in the range 1,000 centimeter solvent trap and vacuum line in such a way ±0.005 centimeter. With distilled water in the as to prevent any flow-back of condensate cells, determine any absorbance differences. into the flask. Spectrophotometer. Spectral range 250 milli- Dissolve the 1 milliliter of hexadecane res- microns—400 millimicrons with spectral slit idue in isooctane and make to 25 milliliters width of 2 millimicrons or less; under instru- volume. Determine the absorbance in the 5- ment operating conditions for these absorb- centimeter path length cells compared to ance measurements, the spectrophotometer isooctane as reference. The absorbance of the shall also meet the following performance solution of the solvent residue (except for requirements: methyl alcohol) shall not exceed 0.01 per cen- Absorbance repeatability, ±0.01 at 0.4 ab- timeter path length between 280 and 400 mμ. sorbance. For methyl alcohol this absorbance value Absorbance accuracy 1 ±0.05 at 0.4 absorb- shall be 0.00. ance. Isooctane (2,2,4-trimethylpentane). Use 180 Wavelength accuracy, ±1.0 millimicron. milliliters for the test described in the pre- Nitrogen cylinder. Water-pumped or equiva- ceding paragraph. Purify, if necessary, by lent purity nitrogen in cylinder equipped passage through a column of activated silica with regulator and valve to control flow at 5 gel (Grade 12, Davison Chemical Company, p.s.i.g. Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter. 1 As determined by procedure using potas- sium chromate for reference standard and Benzene, A.C.S. reagent grade. Use 150 milli- described in National Bureau of Standards liters for the test. Purify, if necessary, by Circular 484, Spectrophotometry, U.S. De- distillation or otherwise. partment of Commerce (1949). The accuracy Acetone, A.C.S. reagent grade. Use 200 milli- is to be determined by comparison with the liters for the test. Purify, if necessary, by standard values at 290, 345, and 400 milli- distillation. microns. Circular 484 is incorporated by ref- Eluting mixtures: erence. Copies are available from the Center 1. 10 percent benzene in isooctane. Pipet 50 for Food Safety and Applied Nutrition (HFS– milliliters of benzene into a 250-milliliter 200), Food and Drug Administration, 5001 glass-stoppered volumetric flask and adjust Campus Dr., College Park, MD 20740, or to volume with isooctane, with mixing. available for inspection at the National Ar- 2. 20 percent benzene in isooctane. Pipet 50 chives and Records Administration (NARA). milliliters of benzene into a 250-milliliter For information on the availability of this glass-stoppered volumetric flask and adjust material at NARA, call 202–741–6030, or go to: to volume with isooctane, with mixing. http://www.archives.gov/federallregister/ 3. Acetone-benzene-water mixture. Add 20 codeloflfederallregulations/ milliliters of water to 380 milliliters of ace- ibrllocations.html. tone and 200 milliliters of benzene, and mix.

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n-Hexadecane, 99-percent olefin-free. Dilute meter to 2 centimeters thick. Reheat the 1.0 milliliter of n-hexadecane to 25 milliliters mixture at 160 °C ±1 °C for 2 hours, and store with isooctane and determine the absorbance in a tightly closed flask. in a 5-centimeter cell compared to isooctane Sodium sulfate, anhydrous, A.C.S. reagent as reference point between 280 mμ–400 mμ. grade, preferably in granular form. For each The absorbance per centimeter path length bottle of sodium sulfate reagent used, estab- shall not exceed 0.00 in this range. Purify, if lish as follows the necessary sodium sulfate necessary, by percolation through activated prewash to provide such filters required in silica gel or by distillation. the method: Place approximately 35 grams of Methyl alcohol, A.C.S. reagent grade. Use anhydrous sodium sulfate in a 30-milliliter 10.0 milliliters of methyl alcohol. Purify, if course, fritted-glass funnel or in a 65-milli- necessary, by distillation. meter filter funnel with glass wool plug; Dimethyl sulfoxide. Spectrophotometric wash with successive 15-milliliter portions of grade (Crown Zellerbach Corporation, the indicated solvent until a 15-milliliter Camas, Washington, or equivalent). Absorb- portion of the wash shows 0.00 absorbance ance (1-centimeter cell, distilled water ref- per centimeter path length between 280 mμ erence, sample completely saturated with ni- and 400 mμ when tested as prescribed under trogen). ‘‘Organic solvents.’’ Usually three portions of wash solvent are sufficient. Absorb- Before proceeding with analysis of a sam- Wavelength ance (max- ple, determine the absorbance in a 5-centi- imum) meter path cell between 250 millimicrons and 261.5 ...... 1.00 400 millimicrons for the reagent blank by 270 ...... 20 carrying out the procedure, without an oil 275 ...... 09 sample, recording the spectra after the ex- 280 ...... 06 traction stage and after the complete proce- 300 ...... 015 dure as prescribed. The absorbance per centi- meter pathlength following the extraction There shall be no irregularities in the ab- stage should not exceed 0.02 in the wave- sorbance curve within these wavelengths. length range from 280 mμ to 400 mμ; the ab- Phosphoric acid. 85 percent A.C.S. reagent sorbance per centimeter pathlength fol- grade. lowing the complete procedure should not Sodium borohydride. 98 percent. exceed 0.02 in the wavelength range from 280 Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 400 mμ. If in either spectrum the char- ery Company, Westvaco Division, distributed by acteristic benzene peaks in the 250 mμ–260 chemical supply firms, or equivalent). Place 100 mμ region are present, remove the benzene grams of the magnesium oxide in a large by the procedure under ‘‘Organic solvents’’ beaker, add 700 milliliters of distilled water and record absorbance again. to make a thin slurry, and heat on a steam Place 300 milliliters of dimethyl sulfoxide bath for 30 minutes with intermittent stir- in a 1-liter separatory funnel and add 75 mil- ring. Stir well initially to insure that all the liliters of phosphoric acid. Mix the contents adsorbent is completely wetted. Using a of the funnel and allow to stand for 10 min- Buchner funnel and a filter paper (Schleicher utes. (The reaction between the sulfoxide & Schuell No. 597, or equivalent) of suitable and the acid is exothermic. Release pressure diameter, filter with suction. Continue suc- after mixing, then keep funnel stoppered.) tion until water no longer drips from the Add 150 milliliters of isooctane and shake to funnel. Transfer the adsorbent to a glass pre-equilibrate the solvents. Draw off the in- trough lined with aluminum foil (free from dividual layers and store in glass-stoppered rolling oil). Break up the magnesia with a flasks. clean spatula and spread out the adsorbent Weigh a 20-gram sample of the oil and on the aluminum foil in a layer about 1 cen- transfer to a 500-milliliter separatory funnel timeter to 2 centimeters thick. Dry for 24 containing 100 milliliters of pre-equilibrated hours at 160 °C ±1 °C. Pulverize the magnesia sulfoxide-phosphoric acid mixture. Complete with mortar and pestle. Sieve the pulverized the transfer of the sample with small por- adsorbent between 60–180 mesh. Use the mag- tions of preequilibrated isooctane to give a nesia retained on the 180-mesh sieve. total volume of the oil and solvent of 75 mil- Celite 545. Johns Mansville Company, diato- liliters. Shake the funnel vigorously for 2 maceous earth, or equivalent. minutes. Set up three 250-milliliter sepa- Magnesium oxide-Celite 545 mixture (2 + 1) by ratory funnels with each containing 30 milli- weight. Place the magnesium oxide (60–180 liters of pre-equilibrated isooctane. After mesh) and the Celite 545 in 2 to 1 propor- separation of liquid phases, carefully draw tions, respectively, by weight in a glass- off lower layer into the first 250-milliliter stoppered flask large enough for adequate separatory funnel and wash in tandem with mixing. Shake vigorously for 10 minutes. the 30-milliliter portions of isooctane con- Transfer the mixture to a glass trough lined tained in the 250-milliliter separatory fun- with aluminum foil (free from rolling oil) nels. Shaking time for each wash is 1 and spread it out on a layer about 1 centi- minute. Repeat the extraction operation

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with two additional portions of the sulf- denser equipped with a 24/40 joint and with a oxide-acid mixture and wash each extractive drying tube into the flask, mix until the in tandem through the same three portions borohydride is dissolved, and allow to stand of isooctane. for 30 minutes at room temperature, with Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe- liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the erably 2-liter) containing 480 milliliters of methyl alcohol on the steam bath under ni- distilled water; mix, and allow to cool for a trogen until the sodium borohydride begins few minutes after the last extractive has to come out of the solution. Then add 10 mil- been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol- the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10 nel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory milliliters of isooctane and concentrate to a funnel (preferably 2-liter) and repeat the ex- volume of approximately 5 milliliters. Swirl traction with 80 milliliters of isooctane. the flask repeatedly to assure adequate Draw off and discard the aqueous layer. washing of the sodium borohydride residues. Wash each of the 80-milliliter extractives Fit the tetrafluoroethylene polymer disc three times with 100-milliliter portions of on the upper part of the stem of the distilled water. Shaking time for each wash chromatographic tube, then place the tube is 1 minute. Discard the aqueous layers. Fil- with the disc on the suction flask and apply ter the first extractive through anhydrous the vacuum (approximately 135 millimeters sodium sulfate prewashed with isooctane (see Hg pressure). Weigh out 14 grams of the 2:1 Sodium sulfate under ‘‘Reagents and Mate- magnesium oxide-Celite 545 mixture and rials’’ for preparation of filter) into a 250- pour the adsorbent mixture into the milliliter Erlenmeyer flask (or optionally chromatographic tube in approximately 3- into the evaporation flask). Wash the first centimeter layers. After the addition of each separatory funnel with the second 80-milli- layer, level off the top of the adsorbent with liter isooctane extractive and pass through a flat glass rod or metal plunger by pressing the sodium sulfate. Then wash the second down firmly until the adsorbent is well and first separatory funnels successively packed. Loosen the topmost few millimeters with a 20-milliliter portion of isooctane and of each adsorbent layer with the end of a pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n-hexa- metal rod before the addition of the next decane and evaporate the isooctane on the layer. Continue packing in this manner until steam bath under nitrogen. Discontinue all the 14 grams of the adsorbent is added to evaporation when not over 1 milliliter of res- the tube. Level off the top of the adsorbent idue remains. To the residue, add a 10-milli- by pressing down firmly with a flat glass rod liter portion of isooctane, reevaporate to 1 or metal plunger to make the depth of the milliliter of hexadecane, and repeat this op- adsorbent bed approximately 12.5 centi- eration once. meters in depth. Turn off the vacuum and re- Quantitatively transfer the residue with move the suction flask. Fit the 500–milliliter isooctane to a 200-milliliter volumetric reservoir onto the top of the flask, make to volume, and mix. Determine chromatographic column and prewet the col- the absorbance of the solution in the 1-centi- umn by passing 100 milliliters of isooctane meter pathlength cells compared to iso- through the column. Adjust the nitrogen octane as reference between 280 mμ–400 mμ pressure so that the rate of descent of the (take care to lose none of the solution in fill- isooctane coming off the column is between ing the sample cell). Correct the absorbance 2–3 milliliters per minute. Discontinue pres- values for any absorbance derived from re- sure just before the last of the isooctane agents as determined by carrying out the reaches the level of the adsorbent. (Caution: procedure without an oil sample. If the cor- Do not allow the liquid level to recede below rected absorbance does not exceed the limits the adsorbent level at any time.) Remove the prescribed in this paragraph, the oil meets reservoir and decant the 5–milliliter iso- the ultraviolet absorbance specifications. If the corrected absorbance per centimeter octane concentrate solution onto the column pathlength exceeds the limits prescribed in and with slight pressure again allow the liq- this paragraph, proceed as follows: Quan- uid level to recede to barely above the ad- titatively transfer the isooctane solution to sorbent level. Rapidly complete the transfer a 125-milliliter flask equipped with 24/40 similarly with two 5–milliliter portions of joint, and evaporate the isooctane on the isooctane, swirling the flask repeatedly each steam bath under a stream of nitrogen to a time to assure adequate washing of the res- volume of 1 milliliter of hexadecane. Add 10 idue. Just before the final 5–milliliter wash milliliters of methyl alcohol and approxi- reaches the top of the adsorbent, add 100 mil- mately 0.3 gram of sodium borohydride. liliters of isooctane to the reservoir and con- (Minimize exposure of the borohydride to the tinue the percolation at the 2–3 milliliters atmosphere. A measuring dipper may be per minute rate. Just before the last of the used.) Immediately fit a water-cooled con- isooctane reaches the adsorbent level, add

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100 milliliters of 10 percent benzene in iso- 2 percent, as determined by ASTM octane to the reservoir and continue the per- method D86–82, ‘‘Standard Method for colation at the aforementioned rate. Just be- Distillation of Petroleum Products,’’ fore the solvent mixture reaches adsorbent level, add 25 milliliters of 20 percent benzene which is incorporated by reference. The in isooctane to the reservoir and continue availability of this incorporation by the percolation at 2–3 milliliters per minute reference is given in paragraph (b)(1)(i) until all this solvent mixture has been re- of this section. moved from the column. Discard all the (ii) Ultraviolet absorbance limits as elution solvents collected up to this point. Add 300 milliliters of the acetone-benzene- follows as determined by the method water mixture to the reservoir and percolate described in paragraph (d)(3) of this through the column to eluate the section. polynuclear compounds. Collect the eluate in a clean 1-liter separatory funnel. Allow the Maximum column to drain until most of the solvent absorb- μ ance per mixture is removed. Wash the eluate three Wavelength (m ) centimeter times with 300-milliliter portions of distilled optical water, shaking well for each wash. (The addi- pathlength tion of small amounts of sodium chloride fa- cilitates separation.) Discard the aqueous 280 to 299 ...... 2.3 layer after each wash. After the final separa- 300 to 319 ...... 1.2 tion, filter the residual benzene through an- 320 to 359 ...... 8 hydrous sodium sulfate pre-washed with ben- 360 to 400 ...... 3 zene (see Sodium sulfate under ‘‘Reagents and Materials’’ for preparation of filter) into (iii) Pyrene content not to exceed a a 250-milliliter Erlenmeyer flask (or option- maximum of 25 parts per million as de- ally into the evaporation flask). Wash the termined by the method described in separatory funnel with two additional 20- paragraph (d)(3) of this section. milliliter portions of benzene which are also (2) The mineral oil may be used only filtered through the sodium sulfate. Add 1 milliliter of n-hexadecane and completely re- in the processing of jute fiber employed move the benzene by evaporation under ni- in the production of textile bags in- trogen, using the special procedure to elimi- tended for use in contact with the fol- nate benzene as previously described under lowing types of food: Dry grains and ‘‘Organic solvents.’’ Quantitatively transfer dry seeds (for example, beans, peas, the residue with isooctane to a 200-milliliter volumetric flask and adjust to volume. De- rice, and lentils); whole root crop vege- termine the absorbance of the solution in the tables of the types identified in 40 CFR 1-centimeter pathlength cells compared to 180.34(f); unshelled and shelled nuts (in- isooctane as reference between 250 mμ–400 cluding peanuts); and dry animal feed. mμ. Correct for any absorbance derived from The finished processed jute fiber shall the reagents as determined by carrying out contain no more than 6 percent by the procedure without an oil sample. If ei- ther spectrum shows the characteristic ben- weight of residual mineral oil. zene peaks in the 250 mμ–260 mμ region, evap- (3) The analytical method for deter- orate the solution to remove benzene by the mining ultraviolet absorbance limits procedure under ‘‘Organic solvents.’’ Dis- and pyrene content is as follows: solve the residue, transfer quantitatively, and adjust to volume in isooctane in a 200- I. Apparatus. A. Assorted beakers, sepa- milliliter volumetric flask. Record the ab- ratory funnels fitted with tetrafluoro- sorbance again. If the corrected absorbance ethylene polymer stopcocks, and graduated does not exceed the limits proposed in this cylinders. paragraph, the oil meets the proposed ultra- B. Volumetric flasks, 200-milliliter. violet absorbance specifications. C. A chromatographic column made from (d) Mineral oil identified in para- nominal 1.3 centimeters outside diameter × graph (d)(1) of this section may be used 75 centimeters glass tubing tapered at one end and joined to a 2-millimeter-bore tetra- as provided in paragraph (d)(2) of this fluoroethylene polymer stopcock. The oppo- section. site end is flanged and joined to a female 24/ (1) The mineral oil consists of virgin 40 standard taper fitting. This provides for petroleum distillates refined to meet accommodating the 500-milliliter reservoir the following specifications: described in item I.E below. (i) Distillation endpoint at 760 milli- D. A chromatographic column made from meters pressure not to exceed 371 °C, nominal 1.7 centimeters outside diameter × with a maximum residue not to exceed 115 centimeters glass tubing tapered at one

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end and joined to a 2-millimeter-bore tetra- n-hexadecane residue in isooctane and make fluoroethylene polymer stopcock. The oppo- to 10-milliliter volume. Determine the ab- site end is flanged and joined to a 2.5 centi- sorbance in 1.0-centimeter pathlength cells meters outside diameter × 9.0 centimeters compared to water as reference. The absorb- glass tube having a female 24/40 standard ance of the solution of solvent residue shall taper fitting. This provides for accommo- not exceed 0.05 between 280 and 400 mμ. dating the 500-milliliter reservoir described 1. Isooctane (2,2,4-trimethylpentane). Use 240 in item I. E below. milliliters for the above test. Purify, if nec- E. A 500-milliliter reservoir having a 24/40 essary, by passage through a column of acti- standard taper male fitting at bottom and a vated silica gel. suitable ball joint at the top for connecting 2. Benzene. Use 200 milliliters for the above to the nitrogen supply. The female fitting of test. Purify, if necessary, by distillation or the chromatographic columns described in otherwise. items I. C and D above and the male fitting 3. Cyclohexane. Use 70 milliliters for the of the reservoir described in this item E above test. Purify, if necessary, by distilla- should both be equipped with glass hooks. tion, silica gel percolation, or otherwise. (NOTE: Rubber stoppers are not to be used. 4. Nitromethane. Use 125 milliliters for the Stopcock grease is not to be used on ground- above test. Purify, if necessary, by distilla- glass joints in this method.) tion or otherwise. 5. n-Hexadecane. Determine the absorbance F. A spectrophotometer equipped to auto- on this solvent directly. Purify, if necessary, matically record absorbance of liquid sam- by silica gel percolation or otherwise. ples in 1-centimeter pathlength cells in the B. Other materials—1. Pyrene standard ref- spectral region of 280–400 mμ with a spectral μ erence. Pyrene, reagent grade, melting point slit width of 2 m or less. At an absorbance ° level of about 0.4, absorbance measurements range 150–152 C. (Organic Chemical 3627, shall be repeatable within ±0.01 and accurate Eastman Kodak Co., Rochester, N.Y., or within ±0.05. Wavelength measurements shall equivalent). The standard reference absorb- be repeatable with ±0.2 mμ and accurate ance is the absorbance at 334 millimicrons of within ±1.0 mμ. Instrument operating condi- a standard reference solution of pyrene con- tions are selected to realize this performance taining a concentration of 1.0 milligram per under dynamic (automatic) recording oper- liter in purified isooctane measured against ations. Accuracy of absorbance measure- isooctane of the same spectral purity in 1.0- ments are determined at 290, 345, and 400 mμ, centimeter cells. (This absorbance will be ap- using potassium chromate as the reference proximately 0.28.) standard. (National Bureau of Standards Cir- 2. Chrysene solution. Prepare a solution at a cular 484, Spectrophotometry, U.S. Depart- concentration of 5.0 milligrams per liter by ment of Commerce, 1949.) dissolving 5.0 milligrams of chrysene in puri- G. Two fused quartz cells having fied isooctane in a 1-liter volumetric flask. pathlengths of 1.00±0.005 centimeter or bet- Adjust to volume with isooctane. ter. 3. Nitrogen gas. Water pumped or equivalent II. Purity of reagents and materials. Reagent- purity, cylinder with regulator, and valve grade chemicals shall be used in all tests. It control flow at 5 p.s.i. is further specified that each chemical shall 4. Silica gel. 100–200 mesh (Davison Chem- be tested for purity in accordance with the ical, Baltimore, Md., Grade 923, or equiva- instruction given under ‘‘Reagents and Mate- lent), purified and activated by the following rials’’ in III below. In addition, a blank run procedure: Place about 1 kilogram of silica by the procedure shall be made on each puri- gel in a large column and wash with con- fied lot of reagents and materials. Unless taminant-free benzene until a 200-milliliter otherwise indicated, references to water sample of the benzene coming off the column shall be understood to mean distilled water. will pass the ultraviolet absorption test for III. Reagents and materials— A. Organic sol- benzene. This test is performed as stipulated vents. All solvents used throughout the pro- under ‘‘Organic solvents’’ in A under III cedure shall meet the specifications and above. When the silica gel has been suffi- tests described in this section III. The iso- ciently cleaned, activate the gel before use octane, benzene, cyclohexane, nitromethane, by placing the 1-kilogram batch in a shallow and n-hexadecane designated shall pass the container in a layer no greater than 1 inch in following test: To the specified quantity of depth and heating in an oven (Caution! Ex- solvent in a 150-milliliter beaker, add 1 milli- plosion Hazard) at 130 °C. for 16 hours, and liter of purified n-hexadecane and evaporate store in a vacuum desiccator. Reheating on the steam bath under a stream of nitro- about once a week is necessary if the silica gen. Discontinue evaporation when not over gel is repeatedly removed from the desic- 1 milliliter of residue remains (to the residue cator. from benzene and nitromethane add a 10-mil- 5. Aluminum oxide (Aluminum Co. of America, liliter portion of purified isooctane, re-evap- Grade F-20, or equivalent grade). 80–200 mesh, orate, and repeat once to insure complete re- purified and activated by the following pro- moval of solvent). Dissolve the 1 milliliter of cedure: Place about 1 kilogram of aluminum

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oxide in a large column and wash with con- tion until a 100-milliliter eluate has been ob- taminant-free benzene until a 200-milliliter tained. sample of the benzene coming off the column h. Measure the amount of chrysene in this will pass the ultraviolet absorption test for 100-milliliter fraction by ultraviolet anal- benzene. This test is performed as stipulated ysis. If the aluminum oxide is satisfactory, under ‘‘Organic solvents’’ in A under III more than 80 percent of the original amount above. (Caution! Remove Benzene From Ad- of chrysene should be found in this fraction. sorbent Under Vacuum To Minimize Explo- (NOTE: If the amount of chrysene recovered sion Hazard in Subsequent Heating!) When is less than 80 percent, the original batch of the aluminum oxide has been sufficiently aluminum oxide should be sieved between cleaned and freed of solvent, activate it be- 100–160 mesh. Activation and testing of this fore use by placing the 1-kilogram batch in a sieved batch should indicate a satisfactory shallow container in a layer no greater than aluminum oxide for use.) 1 inch in depth. Heat in an oven at 130 °C for IV. Sampling. Precautions must be taken to 16 hours. Upon removal from heat, store at insure that an uncontaminated sample of the atmospheric pressure over 80 percent (by mineral oil is obtained since ultraviolet ab- weight) sulfuric acid in a desiccator for at sorption is very sensitive to small amounts least 36 hours before use. This gives alu- of extraneous material contaminating the minum oxide with between 6 to 9.5 percent sample through careless handling. volatiles. This is determined by heating a V. Procedure. A. Blank. Before proceeding weighed sample of the prepared aluminum with the analysis of a sample, determine the oxide at 2,000 °F for 2 hours and then quickly absorbance of the solvent residues by car- reweighing. To insure the proper adsorptive rying out the procedure without a sample. properties of the aluminum oxide, perform B. Sample. 1. Weigh out 20.0 grams ±0.1 the following test: gram of the mineral oil into a beaker and a. Weigh 50 grams ±1 gram of the activated transfer to a 250-milliliter separatory funnel aluminum oxide and pack into the fitted with a tetrafluoroethylene polymer chromatographic column (1.3 centimeters × stopcock, using enough cyclohexane (25 mil- 75 centimeters) described under ‘‘Apparatus’’ liliters) to give a final total volume of 50 in C under I above. Use glass wool at the col- milliliters (mineral oil plus cyclohexane). umn exit to prevent the aluminum oxide 2. Add 25 milliliters of nitromethane satu- from passing through the column. rated with cyclohexane and shake by hand b. Place a 250-milliliter graduated cylinder vigorously for 3 minutes. Recover the lower under the column to measure the amount of nitromethane layer in a 150-milliliter beaker eluate coming from the column. containing 1 milliliter of n-hexadecane and c. Prewet the aluminum oxide by passing evaporate on the steam bath under nitrogen. 40 milliliters of isooctane through the col- Repeat the extraction four more times, re- umn. Adjust the nitrogen pressure so that covering each extract in the 150-milliliter the rate of descent of the isooctane coming beaker. Exercise care not to fill the beaker off the column is between 1.5 to 2.5 milli- to such a capacity that solvent losses may liters per minute. occur. Evaporate the combined d. Just prior to the last of the isooctane nitromethane extracts to 1 milliliter of n- reaching the top of the aluminum oxide bed, hexadecane residue containing the add 10 milliliters of the isooctane solution nitromethane-soluble mineral oil extrac- containing 5.0 milligrams of chrysene per tives. (NOTE: Complete removal of the liter. nitromethane is essential. This can be as- e. Continue percolation until the isooctane sured by two successive additions of 5 milli- is just above the aluminum oxide. Then add liters of isooctane and reevaporation.) 200 milliliters of a mixture of benzene and 3. Remove the beaker from the steam bath isooctane (331⁄3 percent benzene and 662⁄3 per- and allow to cool. cent isooctane by volume) to the reservoir 4. Weigh 50 grams ±1 gram of activated alu- and continue percolation. minum oxide and pack into the f. Continue percolation, collecting the chromatographic column (1.3 centimeters × eluates (40 milliliters of the prewet solution, 75 centimeters) described under ‘‘Apparatus’’ 10 milliliters of the sample solution, and 200 in C under I above. (NOTE: A small plug of milliliters of the gradient solution) in the glass wool is placed at the column exit to 250-milliliter graduated cylinder until the prevent the aluminum oxide from passing level of the gradient solution is just above through the column. After adding aluminum the aluminum oxide. Add 200 milliliters of oxide, tap the column lightly to remove air the eluting solution of benzene and isooctane voids. All percolations using aluminum oxide (90 percent benzene and 10 percent isooctane are performed under nitrogen pressure. The by volume) to the column and continue col- 500-milliliter reservoir described under ‘‘Ap- lecting until a total of 250 milliliters of solu- paratus’’ in E under I above is to be used to tion has been obtained. This may be dis- hold the elution solvents.) carded. Now begin to collect the final eluate. 5. Prewet the column by adding 40 milli- g. Place a 100-milliliter graduated cylinder liters of isooctane to the column. Adjust ni- under the column and continue the percola- trogen pressure so that rate of descent of the

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isooctane coming off the column is 2.0 to 3.0 glass-stoppered Erlenmeyer flask. Add to the milliliters per minute. Be careful to main- silica gel 46.2 grams (41 milliliters) of tain the level of solvent in the reservoir to nitromethane. Stopper and shake the flask prevent air from entering the aluminum vigorously until no lumps of silica gel are oxide bed. New or additional solvent is added observed and then shake occasionally during just before the last portion of the previous a period of 1 hour. The resultant solvent enters the bed. To minimize possible nitromethane-treated silica gel is 29 weight- photo-oxidation effects, the following proce- percent nitro-methane and 71 weight-percent dures (steps 6 through 18) shall be carried out silica gel. in subdued light. 15. Place a small plug of glass wool in the 6. Before the last of the isooctane reaches tapered end of the 1.7 centimeters outside di- the top of the aluminum oxide bed, release ameter × 115 centimeters column, described the nitrogen pressure and turn off the stop- under ‘‘Apparatus’’ in D of I above, adjacent cock on the column. Transfer the n-hexa- to the stopcock to prevent silica gel from decane residue from the 150-milliliter beaker passing through the stopcock. Pack the from procedure step 3 above onto the col- nitromethane-treated silica gel into the col- umn, using several washes of isooctane (total umn, tapping lightly. The resultant silica gel volume of washes should be no greater than bed should be about 95 centimeters in depth. 10–15 milliliters). Place into a flask 170 milliliters of isooctane 7. Open the stopcock and continue percola- saturated with nitromethane. tion until the isooctane is about 1 centi- 16. Place a 100-milliliter graduated cyl- meter above the top of the aluminum oxide inder under the column and transfer the res- bed. Add 200 milliliters of isooctane to the idue from the beaker in procedure step 13 reservoir, and continue the percolation at above with several washes of the 170 milli- the specified rate. liters of isooctane, saturated with 8. Just before the isooctane surface reaches nitromethane, onto the top of the column. the top of the aluminum oxide bed, add 200 (Total volume of washes should be no greater milliliters of a mixture of benzene and iso- than 10 to 15 milliliters.) Permit isooctane octane (331⁄3 percent benzene and 662⁄3 percent solution to enter the silica gel bed until the isooctane by volume) to the reservoir, and liquid level is at the top bed level. Place the continue the percolation. remaining amount of the 170 milliliters of 9. Just before the surface of this mixture isooctane, saturated with nitromethane, in reaches the top of the aluminum oxide bed, the reservoir above the bed for percolation release the nitrogen pressure, turn off the through the silica gel. Apply nitrogen pres- stopcock, and discard all the elution solvents sure to the top of the column, adjusting the collected up to this point. pressure so that the isooctane is collected at 10. Add to the reservoir 300 milliliters of a the rate of 2.5 to 3.5 milliliters per minute, mixture of benzene and isooctane (90 percent and percolate isooctane through the bed benzene and 10 percent isooctane by volume), until a quantity of 75.0 milliliters of eluate is place a 25-milliliter graduated cylinder collected. Discard the 75 milliliters of eluate. under the column, continue the percolation Turn off the stopcock and add 250 milliliters until 20 milliliters of eluate has been col- of benzene to the reservoir above the bed. lected, and then discard the eluate. Use a 400-milliliter beaker to collect the re- 11. At this point, place a clean 250-milli- maining eluate. liter Erlenmeyer flask under the column. 17. Open the stopcock, renew the pressure, Continue the percolation and collect all the and percolate the remaining isooctane and remaining eluate. benzene through the column eluting the re- (NOTE: Allow the column to drain com- maining aromatics. Transfer the eluate in pletely. An increase in the nitrogen pressure small portions from the 400 milliliter beaker may be necessary as the last of the solvent to a 150-milliliter beaker containing 1 milli- comes off the column.) liter of n-hexadecane and evaporate on the 12. Place 1 milliliter of n-hexadecane into a steam bath under nitrogen. Rinse the 400- 150-milliliter beaker. Place this onto a steam milliliter beaker well with small portions of bath under a nitrogen stream and transfer in isooctane to obtain a complete transfer. small portions the eluate from step 11 above. (NOTE: Complete removal of the Wash out the Erlenmeyer flask with small nitromethane and benzene is essential. This amounts of benzene and transfer to the evap- can be assured by successive additions of 5 oration beaker. Evaporate until only 1 milli- milliliters of isooctane and reevaporation.) liter of hexadecane residue remains. (NOTE: 18. Transfer the residue with several wash- Complete removal of the benzene is essen- es of isooctane into a 200-milliliter volu- tial. This can be assured by two successive metric flask. Add isooctane to mark. additions of 5 milliliters of isooctane and re- 19. Record the spectrum of the sample solu- evaporation.) tion in a 1-centimeter cell compared to iso- 13. Remove the beaker from the steam bath octane from 270 to 400 mμ. After making nec- and cool. essary corrections in the spectrum for cell 14. Place a sample of 113.5 grams activated differences and for the blank absorbance, 100- 200-mesh silica gel in a 500-milliliter record the maximum absorbance in each of

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the wavelength intervals (mμ), 280–299, 300– fied wavelength intervals shall not exceed 319, 320–359, 360–400. the limits prescribed in paragraph (d)(1)(ii) a. If the spectrum then shows no discern- of this section. ible peak corresponding to the absorbance d. If the spectrum as a whole of the sample maximum of the pyrene reference standard solution is in any respect clearly incompat- solution at 334 mμ, the maximum ible with the presence of pyrene as the absorbances in the respective wavelength in- source of the peak at 334 mμ, then the max- tervals recorded shall not exceed those pre- imum absorbances in the respective wave- scribed in paragraph (d)(1)(ii) of this section. length intervals without correction for any b. If such a peak is evident in the spectrum assumed pyrene content shall not exceed the of the sample solution, and the spectrum as limits prescribed in paragraph (d)(1)(ii) of a whole is not incompatible with that of a this section. pyrene contaminant yielding such a peak of the observed absorbance, calculate the con- [42 FR 14609, Mar. 15, 1977, as amended at 47 centration of pyrene that would yield this FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, peak (334 m) by the base-line technique de- 1984; 54 FR 24898, June 12, 1989] scribed in ASTM method E169–63 (Re- approved 1981), ‘‘Standard Recommended § 178.3650 Odorless light petroleum hy- Practices for General Techniques of Ultra- drocarbons. violet Quantitative Analysis,’’ which is in- Odorless light petroleum hydro- corporated by reference. The availability of this incorporation by reference is given in carbons may be safely used, as a com- paragraph (b)(1)(i) of this section. Correct ponent of nonfood articles intended for each of the maximum absorbances in the re- use in contact with food, in accordance spective specified wavelength intervals by with the following prescribed condi- subtracting the absorbance due to pyrene, tions: determined as follows: (a) The additive is a mixture of liquid Cp × Sa hydrocarbons derived from petroleum Absorbance due to pyrene = or synthesized from petroleum gases. Sp The additive is chiefly paraffinic, isoparaffinic, or naphthenic in nature. where: (b) The additive meets the following Cp = Calculated concentration of pyrene in specifications: sample solution; Sp = Concentration of pyrene reference (1) Odor is faint and not kerosenic. standard solution in same units of con- (2) Initial boiling point is 300 °F min- centration; imum. Sa = Absorbance of pyrene reference stand- (3) Final boiling point is 650 °F max- ard solution at wavelength of maximum imum. absorbance of sample solution in the re- spective specified wavelength intervals. (4) Ultraviolet absorbance limits de- termined by method specified in Also calculate the pyrene content of the oil sample in parts per million as follows: § 178.3620(b)(1)(ii), as follows: × Maximum Pyrene content = (/200 1000 )C = absorb- 10C μ ance per (p.p.m.) Wavelength (M ) centimeter 20/ 1000 optical where: pathlength C = Calculated concentration of pyrene in 280 to 289 ...... 4.0 milligrams per liter of sample solution. 290 to 299 ...... 3.3 c. The pyrene content so determined shall 300 to 329 ...... 2.3 not exceed 25 p.p.m. The maximum 330 to 360 ...... 8 absorbances corrected for pyrene content as described in this step 19 for each of the speci- (c) The additive is used as follows:

Use Limitations

As a plasticizer and absorber oil in the manufacture of In an amount not to exceed that required to produce intended polyolefin articles authorized for food contact use. effect, consistent with good manufacturing practice. As a lubricant of fibers of textiles authorized for food contact At a use level not to exceed 0.15 percent by weight of finished use. fibers. As a component of adhesives ...... Complying with § 175.105 of this chapter. As a defoamer in the manufacture of paper and paperboard .... Complying with § 176.210 of this chapter. As a defoamer in coatings ...... Complying with § 176.200 of this chapter.

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§ 178.3690 Pentaerythritol adipate-ste- NARA, call 202–741–6030, or go to: http:// arate. www.archives.gov/federallregister/ Pentaerythritol adipate-stearate codeloflfederallregulations/ identified in paragraph (a) of this sec- ibrllocations.html. tion may be safely used as a lubricant (3) Saponification number of 270–280 in the fabrication of rigid and semi- as determined by ASTM method D1387– rigid polyvinyl chloride and/or vinyl 78, ‘‘Standard Test Method for Acid chloride-propylene copolymers com- Number (Empirical) of Synthetic and plying with § 177.1980 of this chapter Natural Waxes’’ (Revised 1978), which is used as articles or components of arti- incorporated by reference. Copies are cles that contact food, excluding food available from American Society for with alcohol content greater than 8 Testing and Materials (ASTM), 100 percent under conditions of use of E, F, Barr Harbor Dr., West Conshohocken, and G described in table 2 in § 175.300(d) Philadelphia, PA 19428-2959, or avail- of this chapter, subject to the provi- able for inspection at the National Ar- sions of this section. chives and Records Administration (a) Identity. For the purpose of this (NARA). For information on the avail- section, pentaerythritol adipate-stea- ability of this material at NARA, call rate is an ester of pentaerythritol with 202–741–6030, or go to: http:// adipic acid and stearic acid and its as- www.archives.gov/federallregister/ sociated fatty acids (chiefly palmitic), codeloflfederallregulations/ with adipic acid comprising 14 percent ibrllocations.html. and stearic acid and its associated (4) Iodine number not to exceed 2 as acids (chiefly palmitic) comprising 71 determined by Iodine Absorption Num- percent of the organic moieties. ber, Hanus Method, of the ‘‘Official (b) Specifications. Pentaerythritol adi- Methods of Analysis of the Association pate-stearate has the following speci- of Official Analytical Chemists,’’ sec- fications: tions 28.018–28.019, 13th Ed. (1980), which (1) Melting point (dropping) of 55–58 is incorporated by reference. Copies °C as determined by ASTM method may be obtained from the AOAC D566–76 (Reapproved 1982), ‘‘Standard INTERNATIONAL, 481 North Frederick Test Method for Dropping Point of Lu- Ave., suite 500, Gaithersburg, MD 20877, bricating Grease,’’ which is incor- or may be examined at the National porated by reference. Copies may be Archives and Records Administration obtained from the American Society (NARA). For information on the avail- for Testing Materials, 100 Barr Harbor ability of this material at NARA, call Dr., West Conshohocken, Philadelphia, 202–741–6030, or go to: http:// PA 19428-2959, or may be examined at www.archives.gov/federallregister/ the National Archives and Records Ad- codeloflfederallregulations/ ministration (NARA). For information ibrllocations.html. on the availability of this material at (c) The total amount of ester (cal- NARA, call 202–741–6030, or go to: http:// culated as free pentaerythritol) shall www.archives.gov/federallregister/ not exceed 0.4 percent by weight of the codeloflfederallregulations/ polyvinyl chloride and/or the vinyl ibrllocations.html. chloride-propylene copolymers com- (2) Acid value not to exceed 15 as de- plying with § 177.1980. termined by ASTM method D1386–78, [45 FR 1018, Jan. 4, 1980, as amended at 47 FR ‘‘Standard Test Method for Saponifica- 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; tion Number (Empirical) of Synthetic 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. and Natural Waxes’’ (Revised 1978), 29, 1992; 70 FR 40880, July 15, 2005; 70 FR 67651, which is incorporated by reference. Nov. 8, 2005] Copies are available from American So- ciety for Testing and Materials § 178.3700 Petrolatum. (ASTM), 100 Barr Harbor Dr., West Petrolatum may be safety used as a Conshohocken, Philadelphia, PA 19428- component of nonfood articles in con- 2959, or available for inspection at the tact with food, in accordance with the National Archives and Records Admin- following conditions: istration (NARA). For information on (a) Petrolatum complies with the the availability of this material at specifications set forth in the United

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States Pharmacopeia XX (1980) for Ultraviolet absorbance per centi- white petrolatum or in the National meter pathlength: Formulary XV (1980) for yellow petro- latum. Millimicrons Maximum (b) Petrolatum meets the following 280 to 289 ...... 0.15 ultraviolet absorbance limits when 290 to 299 ...... 12 subjected to the analytical procedure 300 to 359 ...... 08 described in § 172.886(b) of this chapter: 360 to 400 ...... 02 Ultraviolet absorbance per centi- meter pathlength: (c) Petroleum wax may contain any antioxidant permitted in food by regu- Millimicrons Maximum lations issued in accordance with sec- 280 to 289 ...... 0.25 tion 409 of the act, in an amount not 290 to 299 ...... 20 greater than that required to produce 300 to 359 ...... 14 its intended effect. 360 to 400 ...... 04 (d) Petroleum wax may contain a (c) It is used or intended for use as a total of not more than 1 weight percent protective coating of the surfaces of of residues of the following polymers metal or wood tanks used in fermenta- when such residues result from use of tion process, in an amount not in ex- the polymers as processing aids (filter cess of that required to produce its in- aids) in the production of the petro- tended effect. leum wax: Homopolymers and/or co- (d) Petrolatum as defined by this sec- polymers derived from one or more of tion may be used for the functions de- the mixed n-alkyl (C12, C14, C16, and C18) scribed and within the limitations pre- methacrylate esters where the C12 and scribed by specific regulations in parts C14 alkyl groups are derived from coco- 175, 176, 177, and 178 of this chapter nut oil and the C16 and C18 groups are which prescribe uses of petrolatum. derived from tallow. For the purpose of cross-reference, (e) Petroleum wax may contain 2-hy- such specific regulations include: droxy-4-n-octoxybenzophenone as a sta- §§ 175.105, 175.125, 175.300, 176.170, 176.200, bilizer at a level not to exceed 0.01 176.210, 177.2600, 177.2800, and 178.3570 of weight percent of the petroleum wax. this chapter. (f) Petroleum wax may contain (e) Petrolatum may contain any anti- poly(alkylacrylate) (CAS Reg. No. oxidant permitted in food by regula- 27029–57–8), as described in § 172.886(c)(2) tions issued pursuant to section 409 of of this chapter, as a processing aid in the act, in an amount not greater than the manufacture of petroleum wax. that required to produce its intended effect. [42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986] [42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, § 178.3720 Petroleum wax, synthetic. 1990] Synthetic petroleum wax may be § 178.3710 Petroleum wax. safely used in applications and under Petroleum wax may be safely used as the same conditions where naturally a component of nonfood articles in con- derived petroleum wax is permitted in tact with food, in accordance with the subchapter B of this chapter as a com- following conditions: ponent of articles intended to contact (a) Petroleum wax is a mixture of food, provided that the synthetic petro- solid hydrocarbons, paraffinic in na- leum wax meets the definition and ture, derived from petroleum, and re- specifications prescribed in § 172.888 of fined to meet the specifications pre- this chapter. scribed in this section. (b) The petroleum wax meets the fol- § 178.3725 Pigment dispersants. lowing ultraviolet absorbance limits Subject to the provisions of this reg- when subjected to the analytical proce- ulation, the substances listed in this dure described in § 172.886(b) of this section may be safely used as pigment chapter. dispersants in food-contact materials.

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Substances Limitations

Dimethylolpropionic acid (CAS Reg. No. 4767–03–7) ...... For use only at levels not to exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all foods under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. Phosphorylated tall oil fatty acids (CAS Reg. No. 68604–99–9), For use only at levels not to exceed 1.0 percent by weight of prepared by the reaction of dimethyl hydrogen phosphite the pigment. The pigmented polymeric films may contact all with tall oil fatty acids. food under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. For use only at levels not to exceed 0.45 percent by weight of with 1,1′,1″-nitrilotris [2-propanol] (1:1) (CAS Reg. No. the pigment. The pigmented articles may contact all food 221281–21–6). under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11- For use only at levels not to exceed 0.5 percent by weight of methoxy-11-oxoundecyl (CAS Reg. No. 155419–59–3). the pigment. The pigmented polymers may contact all foods under conditions of use C, D, E, F, and G described in Table 2 of § 176.170(c) of this chapter. Trimethylolethane (CAS Reg. No. 77–85–0) ...... For use only at levels not to exceed 0.45 percent by weight of inorganic pigment. The pigmented articles may contact all food under conditions of use A through H described in Table 2 of § 176.170(c) of this chapter.

[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]

§ 178.3730 Piperonyl butoxide and graph (b) of this section may be safely pyrethrins as components of bags. used as plasticizers in polymeric sub- Piperonyl butoxide in combination stances used in the manufacture of ar- with pyrethrins may be safely used for ticles or components of articles in- insect control on bags that are in- tended for use in producing, manufac- tended for use in contact with dried turing, packing, processing, preparing, feed in compliance with §§ 561.310 and treating, packaging, transporting, or 561.340 of this chapter, or that are in- holding food. tended for use in contact with dried (a) The quantity used shall not ex- food in compliance with §§ 193.60 and ceed the amount reasonably required 193.390 of this chapter. to accomplish the intended technical effect. § 178.3740 Plasticizers in polymeric substances. (b) List of substances: Subject to the provisions of this reg- ulation, the substances listed in para-

Substances Limitations

Butylbenzyl phthalate ...... For use only: 1. As provided in §§ 175.105 and 176.180 of this chapter. 2. In polymeric substances used in food-contact articles complying with § 175.300, § 175.320, or § 176.170 of this chapter: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate. 3. In polymeric substances used in other permitted food-contact articles: Provided, That the butyl benzyl phthalate contains not more than 1 per- cent by weight of dibenzyl phthalate; and Provided further, That the fin- ished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and tem- perature characterizing the conditions of its intended use as determined from tables 1 and 2 of § 175.300(d) of this chapter, shall yield net chloro- form-soluble extractives not to exceed 0.5 mg. per square inch, as deter- mined by the methods prescribed in § 175.300(e) of this chapter. 1,3-Butylene glycoladipic acid polyester (1,700– For use at levels not exceeding 33 percent by weight of polyvinyl chloride 2,200 molecular weight) terminated with a 16 homopolymers used in contact with food (except foods that contain more percent by weight mixture of myristic, palmitic, than 8 percent of alcohol) at temperatures not to exceed room tempera- and stearic acids. ture. The average thickness of such homopolymers in the form in which they contact food shall not exceed 0.004 inch.

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Substances Limitations

Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl For use only under the conditions listed below, and excluding use as a groups are derived from linear alpha olefins by component of resinous and polymeric coatings described in § 175.300 of the oxo process. this chapter. 1. At levels not to exceed 24 percent by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The aver- age thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not to exceed 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they con- tact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The aver- age thickness of such polymer in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty foods hav- ing a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.

Di-n-alkyl adipate made from C6 C8-C10 (predomi- For use only: nately C8 and C10) or C8-C10 synthetic fatty alco- 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride hols complying with § 172.864 of this chapter. homo- and/or copolymers used in contact with nonfatty foods. The aver- age thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they con- tact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The aver- age thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in which they contact food shall not exceed 0.002 inch. Dicyclohexyl phthalate ...... For use only: 1. As provided in §§ 175.105, 176.170, 176.180, and 177.1200 of this chap- ter. 2. Alone or in combination with other phthalates, in plastic film or sheet pre- pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co- polymers complying with § 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid. Di(2-ethylhexyl) adipate ......

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Substances Limitations

Diisononyl adipate ...... For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty, non- alcoholic foods having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty, non- alcoholic foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. Diisononyl phthalate ...... For use only at levels not exceeding 43 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. Di(2-ethylhexyl) azelate ...... For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic food. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty, non- alcoholic food having a fat and oil content not exceeding a total of 30 percent by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. Di-n-hexylazelate ...... For use only: 1. In polymeric substances used in contact with nonfatty food. 2. In polymeric substances used in contact with fatty food and limited to use at levels not exceeding 15 pct by weight of such polymeric sub- stance except as provided under limitation 3. 3. At levels greater than 15 but not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F or G described in table 2 of § 176.170(c) of this chapter, with fatty food having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. Dihexyl phthalate ...... For use only: 1. As provided in § 175.105 of this chapter. 2. In articles that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B, and VIII. Diphenyl phthalate ...... For use only: 1. As provided in § 175.105 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet pre- pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co- polymers complying with § 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid. Epoxidized butyl esters of linseed oil fatty acids .... Iodine number, maximum 5; oxirane oxygen, minimum 7.8 pct. Epoxidized linseed oil ...... Iodine number, maximum 5; oxirane oxygen, minimum 9-pct. Mineral oil, white.

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Substances Limitations

Polybutene, hydrogenated (minimum viscosity at For use only: 99 °F, 39 Saybolt Universal seconds, as deter- 1. In polymeric substances used in contact with non-fatty food. mined by ASTM methods D445–82 (‘‘Standard 2. In polyethylene complying with § 177.1520 of this chapter and used in Test Method for Kinematic Viscosity of Trans- contact with fatty food, provided that the hydrogenated polybutene is parent and Opaque Liquids (and the Calculation added in an amount not to exceed 0.5 pct by weight of the polyethylene, of Dynamic Viscosity)’’) and D2161–82 (‘‘Stand- and further provided that such plasticized polyethylene shall not be used ard Method for Conversion of Kinematic Vis- as a component of articles intended for packing or holding food during cosity to Saybolt Universal Viscosity or to cooking. Saybolt Furol Viscosity’’), and bromine number 3. In polystyrene complying with § 177.1640 of this chapter and used in of 3 or less, as determined by ASTM method contact with fatty food, provided that the hydrogenated polybutene is D1492–78 (‘‘Standard Test Method for Bromine added in an amount not to exceed 5 pct by weight of the polystyrene, Index of Aromatic Hydrocarbons by Coulometric and further provided that such plasticized polystyrene shall not be used Titration’’), which are incorporated by reference. as a component of articles intended for packing or holding food during Copies may be obtained from the American So- cooking. ciety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428- 2959, or may be examined at the National Ar- chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.. Polyisobutylene (mol weight 300–5,000) ...... For use in polyethylene complying with § 177.1520 of this chapter, provided that the polyisobutylene is added in an amount not exceeding 0.5 pct by weight of the polyethylene, and further provided that such plasticized pol- yethylene shall not be used as a component of articles intended for pack- ing or holding food during cooking. Polyisobutylene complying with § 177.1420 of this chapter. Polypropylene glycol (CAS registry No. 25322–69– For use only in polystyrene plastics, identified in § 177.1640(a)(1), in an 4) (minimum mean molecular weight 1,200). amount not to exceed 6 pct by weight of the finished food-contact article. Propylene glycol azelate (average mol. weight For use only at levels not exceeding 41 pct by weight of permitted polyvinyl 3,000). chloride coatings. Such coatings shall be used only as bulk food contact surfaces of articles intended for repeated use, complying with § 177.2600 of this chapter. Triethylene glycol ...... Diethylene glycol content not to exceed 0.1 pct. 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate ...... For use only in cellulosic plastics in an amount not to exceed 15 pct by weight of the finished food-contact article, provided that the finished plas- tic article contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII.

(c) The use of the plasticizers in any (b) It contains no more than 0.2 per- polymeric substance or article subject cent total by weight of ethylene and to any regulation in parts 174, 175, 176, diethylene glycols if its mean molec- 177, 178 and 179 of this chapter must ular weight is 350 or higher and no comply with any specifications and more than 0.5 percent total by weight limitations prescribed by such regula- of ethylene and diethylene glycols if its tion for the finished form of the sub- mean molecular weight is below 350, stance or article. when tested by the analytical methods [42 FR 14609, Mar. 15, 1977, as amended at 42 prescribed in § 172.820(b) of this chapter. FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, (c) The provisions of paragraph (b) of 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, this section are not applicable to poly- Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] ethylene glycols used in food-pack- aging adhesives complying with § 178.3750 Polyethylene glycol (mean § 175.105 of this chapter. molecular weight 200–9,500). Polyethylene glycol identified in this § 178.3760 Polyethylene glycol (400) section may be safely used as a compo- monolaurate. nent of articles intended for use in con- Polyethylene glycol (400) tact with food, in accordance with the monolaurate containing not more than following prescribed conditions: 0.1 percent by weight of ethylene and/ (a) The additive is an addition poly- or diethylene glycol may be used at a mer of ethylene oxide and water with a level not to exceed 0.3 percent by mean molecular weight of 200 to 9,500. weight of twine as a finish on twine to

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be used for tying meat provided the on the availability of this material at twine fibers are produced from nylon NARA, call 202–741–6030, or go to: http:// resins complying with § 177.1500 of this www.archives.gov/federallregister/ chapter. codeloflfederallregulations/ ibrllocations.html.) using as solvent xy- § 178.3770 Polyhydric alcohol esters of lene-ethyl alcohol in a 2:1 ratio instead oxidatively refined (Gersthofen of toluene-ethyl alcohol in a 2:1 ratio. process) montan wax acids. (3) Saponification value 100–160, as Polyhydric alcohol esters of determined by ASTM method D1387–78 oxidatively refined (Gersthofen proc- (‘‘Standard Test Method for Saponi- ess) montan wax acids identified in this fication Number (Empirical) of Syn- section may be safely used as compo- thetic and Natural Waxes’’ (Revised nents of articles intended for use in 1978), which is incorporated by ref- contact with food in accordance with erence; copies are available from Amer- the following prescribed conditions: ican Society for Testing and Materials (a) The polyhydric alcohol esters (ASTM), 100 Barr Harbor Dr., West identified in this paragraph may be Conshohocken, Philadelphia, PA 19428- used as lubricants in the fabrication of 2959, or available for inspection at the vinyl chloride plastic food-contact ar- National Archives and Records Admin- ticles prepared from polyvinyl chloride istration (NARA). For information on and/or from vinyl chloride copolymers the availability of this material at complying with § 177.1980 of this chap- NARA, call 202–741–6030, or go to: http:// ter. Such esters meet the following www.archives.gov/federallregister/ specifications and are produced by par- codeloflfederallregulations/ tial esterification of oxidatively re- ibrllocations.html.) using xylene-ethyl fined (Gersthofen process) montan wax alcohol in a 2:1 ratio instead of ethyl acids by either ethylene glycol or 1,3- alcohol in preparation of potassium hy- butanediol with or without neutraliza- droxide solution. tion of unreacted carboxylic groups (4) Ultraviolet absorbance limits as with calcium hydroxide: follows, as determined by the analyt- (1) Dropping point 76°–105 °C, as de- ical method described in this subpara- termined by ASTM method D566–76 graph: (Reapproved 1982), ‘‘Standard Test Ultraviolet absorbance per centi- Method for Dropping Point of Lubri- meter pathlength. cating Grease,’’ which is incorporated Millimicrons Maximum by reference. Copies may be obtained from the American Society for Testing 280 to 289 ...... 0.07 290 to 299 ...... 06 Materials, 100 Barr Harbor Dr., West 300 to 359 ...... 04 Conshohocken, Philadelphia, PA 19428- 360 to 400 ...... 01 2959, or may be examined at the Na- tional Archives and Records Adminis- ANALYTICAL METHOD tration (NARA). For information on the availability of this material at GENERAL INSTRUCTIONS NARA, call 202–741–6030, or go to: http:// Because of the sensitivity of the test, the www.archives.gov/federallregister/ possibility of errors arising from contamina- codeloflfederallregulations/ tion is great. It is of the greatest importance ibrllocations.html. that all glassware be scrupulously cleaned to remove all organic matter such as oil, (2) Acid value 10–20, as determined by grease, detergent residues, etc. Examine all ASTM method D1386–78 (‘‘Standard glassware, including stoppers and stopcocks, Test Method for Acid Number (Empir- under ultraviolet light to detect any residual ical) of Synthetic and Natural Waxes’’ fluorescent contamination. As a pre- (Revised 1978), which is incorporated by cautionary measure it is recommended prac- reference; copies are available from tice to rinse all glassware with purified iso- American Society for Testing and Ma- octane immediately before use. No grease is terials (ASTM), 100 Barr Harbor Dr., to be used on stopcocks or joints. Great care to avoid contamination of wax samples in West Conshohocken, Philadelphia, PA handling and to assure absence of any extra- 19428-2959, or available for inspection at neous material arising from inadequate the National Archives and Records Ad- packaging is essential. Because some of the ministration (NARA). For information polynuclear hydrocarbons sought in this test

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are very susceptible to photo-oxidation, the Absorbance accuracy, 1 ±0.05 at 0.4 absorb- entire procedure is to be carried out under ance. subdued light. Wavelength repeatability, ±0.2 milli- micron. APPARATUS Wavelength accuracy, ±1.0 millimicron. Separatory funnels. 250-milliliter, 500-milli- Recording time, 50 seconds. liter, 1,000-milliliter, and preferably 2,000- Time constant, 0.6 second. milliliter capacity, equipped with tetra- Sensitivity, 30. fluoroethylene polymer stopcocks. Ordinate scale, 90–100 percent transmission Reservoir. 1,000-milliliter capacity, through scale. equipped with a 24/40 standard taper male fit- Abscissa scale, 8X. ting at the bottom and a suitable balljoint at Nitrogen cylinder. Water-pumped or equiva- the top. lent purity nitrogen in cylinder equipped Chromatographic tube. 1,200 millimeters in with regulator and valve to control flow at 5 length, inside diameter to be 16.5 millimeters p.s.i.g. ±0.5 millimeter, equipped with a coarse, frit- ted-glass disc, a tetrafluoroethylene polymer REAGENTS AND MATERIALS stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of Organic solvents. All solvents used through- the column with the female joint is 1,255 mil- out the procedure shall meet the specifica- limeters.) The female fitting should be tions and tests described in this specifica- equipped with glass hooks. tion. The isooctane and benzene designated Disc. Tetrafluoroethylene polymer 2-inch in the list following this paragraph shall diameter disc approximately 3⁄16-inch thick pass the following test: with a hole bored in the center to closely fit To be specified quantity of solvent in a 250- the stem of the chromatographic tube. milliliter Erlenmeyer flask, add 1 milliliter Heating jackets. Conical, for 500-milliliter of purified n-hexadecane and evaporate on and 1,000-milliliter separatory funnels. (Used the steam bath under a stream of nitrogen (a with variable transformer heat control.) loose aluminum foil jacket around the flask Suction flask. 250-milliliter or 500-milliliter will speed evaporation). Discontinue evapo- filter flask. ration when not over 1 milliliter of residue Condenser. 24⁄40 joints, fitted with a drying remains. (To the residue from benzene add a tube, length optional. 10-milliliter portion of purified isooctane, re- Evaporation flasks (optional). A 250-milli- evaporate, and repeat once to insure com- liter or 500-milliliter capacity and a 1-liter plete removal of benzene.) capacity all-glass flask equipped with stand- Alternatively, the evaporation time can be ard taper stopper having inlet and outlet reduced by using the optional evaporation tubes to permit passage of nitrogen across flask. In this case the solvent and n-hexa- the surface of contained liquid to be evapo- decane are placed in the flask on the steam rated. bath, the tube assembly is inserted, and a Vacuum distillation assembly. All glass (for stream of nitrogen is fed through the inlet purification of dimethyl sulfoxide) 2-liter tube while the outlet tube is connected to a distillation flask with heating mantle; solvent trap and vacuum line in such a way Vigreaux vacuum-jacketed condenser (or as to prevent any flow-back of condensate equivalent) about 45 centimeters in length into the flask. and distilling head with separable cold finger condenser. Use of tetrafluoroethylene poly- 1 As determined by procedure using potas- mer sleeves on the glass joints will prevent sium chromate for reference standard and freezing. Do not use grease on stopcocks or described in National Bureau of Standards joints. Circular 484, Spectrometry, U.S. Department ° Oil bath. Capable of heating to 90 C. of Commerce (1949). The accuracy is to be de- Spectrophotometric cells. Fused quartz cells, termined by comparison with the standard optical pathlength in the range 1.000 centi- values at 290, 345, and 400 millimicrons. Cir- ± meter 0.005 centimeter. With distilled water cular 484 is incorporated by reference. Copies in the cells, determine any absorbance dif- are available from the Center for Food Safe- ferences. ty and Applied Nutrition (HFS–200), Food Spectrophotometer. Spectral range 250 milli- and Drug Administration, 5001 Campus Dr., microns-400 millimicrons with spectral slit College Park, MD 20740, or available for in- width of 0.2 millimicron or less; under in- spection at the National Archives and strument operating conditions for these ab- Records Administration (NARA). For infor- sorbance measurements. The spectrophotom- mation on the availability of this material eter shall also meet the following perform- at NARA, call 202–741–6030, or go to: http:// ance requirements: www.archives.gov/federallregister/ Absorbance repeatability, ±0.01 at 0.4 ab- codeloflfederallregulations/ sorbance. ibrllocations.html.

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Dissolve the 1 milliliter of hexadecane res- nitrogen. Discontinue evaporation when not idue in isooctane and make up to 25 milli- over 1 milliliter of residue remains. To the liters volume. Determine the absorbance in residue, add a 10-milliliter portion of iso- the 1-centimeter pathlength cells compared octane and reevaporate to 1 milliliter of to isooctane as reference. The absorbance of hexadecane. Again, add 10 milliliters of iso- the solution of the solvent residue (except octane to the residue and evaporate to 1 mil- for methyl alcohol) shall not exceed 0.01 per liliter of hexadecane to insure complete re- centimeter pathlength between 280 mμ and moval of all volatile materials. Dissolve the 400 mμ. 1 milliliter of hexadecane in isooctane and Isooctane (2,2,4-trimethylpentane). Use 180 make to 25-milliliter volume. Determine the milliliters for the test described in the pre- absorbance in 1-centimeter pathlength cells ceding paragraph. Purify, if necessary, by compared to isooctane as reference. The ab- passage through a column of activated silica sorbance of the solution should not exceed gel (Grade 12, Davison Chemical Co., Balti- 0.02 per centimeter pathlength in the 280 mμ- more, Md., or equivalent) about 90 centi- 400 mμ range. (NOTE: Difficulty in meeting meters in length and 5 centimeters to 8 cen- this absorbance specification may be due to timeters in diameter. organic impurities in the distilled water. Benzene, A.C.S. reagent grade. Use 150 milli- Repetition of the test omitting the dimethyl liters for the test. Purify, if necessary, by sulfoxide will disclose their presence. If nec- distillation or otherwise. essary to meet the specification, purify the n-Hexadecane, 99 percent olefin-free. Dilute water by redistillation, passage through an 1.0 milliliter of n-hexadecane to 25 milliliters ion-exchange resin, or otherwise.) with isooctane and determine the absorbance Purify, if necessary, by the following pro- in a 1-centimeter cell compared to isooctane cedure: To 1,500 milliliters of dimethyl sulf- as reference point between 280 mμ-400 mμ. oxide in a 2-liter glass-stoppered flask, add The absorbance per centimeter pathlength 6.0 milliliters of phosphoric acid and 50 shall not exceed 0.00 in this range. If nec- grams of Norit A (decolorizing carbon, alka- essary, purify by filtering through a column line) or equivalent. Stopper the flask, and containing 100 grams of aluminum oxide (use with the use of a magnetic stirrer (tetra- same grade as described below) in the lower fluoroethylene polymer coated bar) stir the half and 100 grams of activated silica gel in solvent for 15 minutes. Filter the dimethyl the upper half keeping the column at 150 °C., sulfoxide through four thicknesses of fluted for a period of 15 hours or overnight. The paper (18.5 centimeters, Schleicher & first 100 milliliters of eluate are used. Purifi- Schuell, No. 597, or equivalent). If the initial cation can also be accomplished by distilla- filtrate contains carbon fines, refilter tion. through the same filter until a clear filtrate Dimethyl sulfoxide. Pure grade, clear, is obtained. Protect the sulfoxide from air water-white, m.p. 18° minimum. Dilute 120 and moisture during this operation by cov- milliliters of dimethyl sulfoxide with 240 ering the solvent in the funnel and collection milliliters of distilled water in a 500-milli- flask with a layer of isooctane. Transfer the liter separatory funnel, mix and allow to filtrate to a 2-liter separatory funnel and cool for 5–10 minutes. Add 40 milliliters of draw off the dimethyl sulfoxide into the 2- isooctane to the solution and extract by liter distillation flask of the vacuum dis- shaking the funnel vigorously for 2 minutes. tillation assembly and distill at approxi- Draw off the lower aqueous layer into a sec- mately 3-millimeter Hg pressure or less. Dis- ond 500-milliliter separatory funnel and re- card the first 200-milliliter fraction of the peat the extraction with 40 milliliters of iso- distillate and replace the distillate collec- octane. Draw off and discard the aqueous tion flask with a clean one. Continue the dis- layer. Wash each of the 40-milliliter extrac- tillation until approximately 1 liter of the tives three times with 50-milliliter portions sulfoxide has been collected. of distilled water. Shaking time for each At completion of the distillation, the rea- wash is 1 minute. Discard the aqueous lay- gent should be stored in glass-stoppered bot- ers. Filter the first extractive through anhy- tles since it is very hygroscopic and will drous sodium sulfate prewashed with iso- react with some metal containers in the octane (see Sodium sulfate under ‘‘Reagents presence of air. and materials’’ for preparation of filter), into Phosphoric acid. 85 percent A.C.S. reagent a 250-milliliter Erlenmeyer flask, or option- grade. ally into the evaporating flask. Wash the Aluminum oxide (80–200 mesh Woelm neutral first separatory funnel with the second 40- activity grade 1 [Brockmann], Alupharm Chemi- milliliter isooctane extractive, and pass cals, New Orleans, La., or equivalent). Pipette through the sodium sulfate into the flask. 1 milliliter of distilled water into a dry 250- Then wash the second and first separatory milliliter Erlenmeyer flask equipped with a funnels successively with a 10-milliliter por- ground-glass stopper. Stopper the flask and tion of isooctane, and pass the solvent rotate it in such a manner as to completely through the sodium sulfate into the flask. wet out the inside surfaces. When this has Add 1 milliliter of n-hexadecane and evapo- been done add 180 grams of the aluminum rate the isooctane on the steam bath under oxide and shake until no lumps or wet spots

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remain. Allow to stand at room temperature the wax redissolves. (Remove stopper from for a period of 2 hours. At the end of this the funnel at intervals to release pressure.) time the water should be evenly distributed When the wax is in solution, remove the fun- throughout the aluminum oxide powder, and nel from the jacket and shake it vigorously it should have the same free flowing prop- for 2 minutes. Set up three 250-milliliter erties as the original material (flow velocity separatory funnels with each containing 30 with water 0.2 milliliter per minute). At this milliliters of preequilibrated isooctane. point the aluminum oxide has an activity of After separation of the liquid phases, allow 1 as expressed in Brockmann degrees, and to cool until the main portion of the wax-iso- the amount of added water is 0.5 percent by octane solution begins to show a precipitate. volume. This product is used in toto and as Gently swirl the funnel when precipitation is, without further screening. first occurs on the inside surface of the fun- Sodium sulfate, anhydrous, A.C.S. reagent nel to accelerate this process. Carefully draw grade, preferably in granular form. For each off the lower layer, filter it slowly through a bottle of sodium sulfate reagent used, estab- thin layer of glass wool fitted loosely in a fil- lish as follows the necessary sodium sulfate ter funnel into the first 250-milliliter sepa- prewash to provide such filters required in ratory funnel, and wash in tandem with the the method: Place approximately 35 grams of 30-milliliter portions of isooctane contained anhydrous sodium sulfate in a 30-milliliter in the 250-milliliter separatory funnels. coarse, fritted-glass funnel or in a 65-milli- Shaking time for each wash is 1 minute. Re- meter filter funnel with glass wool plug; peat the extraction operation with two addi- wash with successive 15-milliliter portions of tional portions of the sulfoxide-acid mixture, the indicated solvent until a 15-milliliter replacing the funnel in the jacket after each portion of the wash shows 0.00 absorbance extraction to keep the wax in solution and per centimeter pathlength between 280 mμ washing each extractive in tandem through and 400 mμ when tested as prescribed under the same three portions of isooctane. ‘‘Organic solvents.’’ Usually three portions Collect the successive extractives (300 mil- of wash solvent are sufficient. liliters total) in a separatory funnel (pref- erably 2-liter), containing 480 milliliters of PROCEDURE distilled water, mix, and allow to cool for a few minutes after the last extractive has Before proceeding with analysis of a sam- been added. Add 80 milliliters of isooctane to ple, determine the absorbance in a 1-centi- the solution and extract by shaking the fun- meter path cell between 250 mμ and 400 mμ nel vigorously for 2 minutes. Draw off the for the reagent blank by carrying out the lower aqueous layer into a second separatory procedure, without a wax sample, at room funnel (preferably 2-liter) and repeat the ex- temperature, recording the spectrum after traction with 80 milliliters of isooctane. the complete procedure as prescribed. The Draw off and discard the aqueous layer. absorbance per centimeter pathlength fol- Wash each of the 80-milliliter extractives lowing the complete procedure should not three times with 100-milliliter portions of exceed 0.04 in the wavelength range from 280 distilled water. Shaking time for each wash mμ to 299 mμ, inclusive, nor 0.02 in the wave- is 1 minute. Discard the aqueous layers. Fil- length range from 300 mμ to 400 mμ. If in ei- ter the first extractive through anhydrous ther spectrum the characteristic benzene sodium sulfate prewashed with isooctane (see peaks in the 250 mμ-260 mμ region are Sodium sulfate under ‘‘Reagents and Mate- present, remove the benzene by the proce- rials’’ for preparation of filter) into a 250- dure under ‘‘Organic solvents’’ and record milliliter Erlenmeyer flask (or optionally absorbance again. Place 300 milliliters of di- into the evaporation flask). Wash the first methyl sulfoxide in a 1-liter separatory fun- separatory funnel with the second 80-milli- nel and add 75 milliliters of phosphoric acid. liter isooctane extractive and pass through Mix the contents of the funnel and allow to the sodium sulfate. Then wash the second stand for 10 minutes. (The reaction between and first separatory funnels successively the sulfoxide and the acid is exothermic. Re- with a 20-milliliter portion of isooctane and lease pressure after mixing, then keep funnel pass the solvent through the sodium sulfate stoppered.) Add 150 milliliters of isooctane into the flask. Add 1 milliliter of n-hexa- and shake to preequilibrate the solvents. decane and evaporate the isooctane using an Draw off the individual layers and store in aspirator vacuum under nitrogen and in an glass-stoppered flasks. oil bath temperature of approximately 90 °C. In a 1-liter separatory funnel place a rep- Discontinue evaporation when not over 1 resentative 25-gram sample of wax, add 50 milliliter of residue remains. To the residue, milliliters of isooctane, heat gently, stir add a 10-milliliter portion of isooctane, re- until the wax is in solution; add 100 milli- evaporate to 1 milliliter of hexadecane, and liters of preequilibrated sulfoxide-phosphoric repeat this operation once. acid mixture and shake, making sure it re- Reserve the residue for column chroma- mains in solution. If the wax comes out of tography on the aluminum oxide. Fit the solution during these operations, let the tetrafluoroethylene polymer disc on the stoppered funnel remain in the jacket until upper part of the stem of the

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chromatographic tube, then place the tube (b) The polyhydric alcohol esters with the disc on the suction flask and apply identified in this paragraph may be the vacuum (approximately 135 millimeters used as release agents in resinous and Hg pressure). Weigh out 180 grams of the alu- polymeric coatings for polyolefin films minum oxide and pour the adsorbent mixture complying with § 175.320 of this chapter. into the chromatographic tube in approxi- mately 30-centimeter layers. After the addi- Such esters meet the following speci- tion of each layer, level off the top of the ad- fications and are produced by partial sorbent with a flat glass rod or metal plung- esterification of oxidatively refined er by pressing down firmly until the adsorb- (Gersthofen process) montan wax acids ent is well packed. Loosen the topmost few with equimolar proportions of ethylene millimeters of each adsorbent layer with the glycol and 1,3-butanediol: end of a metal rod before the addition of the (1) Dropping point 77°–82 °C, as deter- next layer. Continue packing in this manner mined by ASTM method D566–76 (Re- until all the 180 grams of the adsorbent is approved 1982), ‘‘Standard Test Method added to the tube. Level off the top of the ad- for Dropping Point of Lubricating sorbent by pressing down firmly with a flat glass rod or metal plunger to make the depth Grease,’’ which is incorporated by ref- of the adsorbent bed approximately 80 centi- erence. The availability of this incor- meters in depth. Turn off the vacuum and re- poration by reference is given in para- move the suction flask. Dissolve the hexa- graph (a)(1) of this section. decane residue in 10 milliliters of warm ben- (2) Acid value 25–35, as determined by zene and decant the solution onto the col- ASTM method D1386–78 (‘‘Standard umn and allow the liquid level to recede to Test Method for Acid Number (Empir- barely above the adsorbent level. Rapidly ical) of Synthetic and Natural Waxes’’ complete the transfer similarly with two 10- (Revised 1978), which is incorporated by milliliter portions of benzene swirling the reference; copies are available from flask repeatedly each time to assure ade- quate washing of the residue. Fix the 1,000- American Society for Testing and Ma- milliliter reservoir onto the top of the terials (ASTM), 100 Barr Harbor Dr., chromatographic column. Just before the West Conshohocken, Philadelphia, PA final 10-milliliter wash reaches the top of the 19428-2959, or available for inspection at adsorbent, add 670 milliliters of benzene to the National Archives and Records Ad- the reservoir and continue the percolation at ministration (NARA). For information the 2–3 milliliter per minute rate until a on the availability of this material at total of 670 milliliters of benzene has been NARA, call 202–741–6030, or go to: http:// utilized. Collect the eluate in a clean 1-liter www.archives.gov/federallregister/ Erlenmeyer flask (or optionally into a 1-liter codeloflfederallregulations/ evaporation flask). Allow the column to ibr locations.html.) using as solvent xy- drain until most of the solvent mixture is re- l moved. Add 1 milliliter of n-hexadecane and lene-ethyl alcohol in a 2:1 ratio instead completely remove the benzene by evapo- of toluene-ethyl alcohol in a 1:2 ratio. ration under nitrogen, using the special pro- (3) Saponification value 135–150, as cedure to eliminate benzene as previously determined by ASTM method D1387–78 described under ‘‘Organic Solvents.’’ Quan- (‘‘Standard Test Method for Saponi- titatively transfer the residue with isooctane fication Number (Empirical) of Syn- to a 25-milliliter volumetric flask and adjust thetic and Natural Waxes’’ (Revised to volume. Determine the absorbance of the 1978), which is incorporated by ref- solution in the 1-centimeter pathlength cells erence; copies are available from Amer- compared to isooctane as reference between 250 mμ-400 mμ. Correct for any absorbance ican Society for Testing and Materials derived from the reagents as determined by (ASTM), 100 Barr Harbor Dr., West carrying out the procedure without a wax Conshohocken, Philadelphia, PA 19428- sample. If either spectrum shows the char- 2959, or available for inspection at the acteristic benzene peaks in the 250 mμ-260 mμ National Archives and Records Admin- region, evaporate the solution to remove istration (NARA). For information on benzene by the procedure under ‘‘Organic the availability of this material at Solvents.’’ Dissolve the residue, transfer NARA, call 202–741–6030, or go to: http:// quantitatively, and adjust to volume in iso- www.archives.gov/federallregister/ octane in a 25-milliliter volumetric flask. Record the absorbance again. If the cor- codeloflfederallregulations/ rected absorbance does not exceed the limits ibrllocations.html.) using xylene-ethyl prescribed in paragraph (a) of this section, alcohol in a 2:1 ratio instead of ethyl the wax meets the ultraviolet absorbance alcohol in preparation of potassium hy- specifications. droxide solution.

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(4) Ultraviolet absorbance limits reference in accordance with 5 U.S.C. specified in paragraph (a)(4) of this sec- 552(a); the availability of this incorpo- tion, as determined by the analytical ration by reference is given in para- method described therein. graph (a)(2) of this section), using as a (c) The polyhydric alcohol esters of solvent xylene-ethyl alcohol in a 2:1 oxidatively refined (Gersthofen proc- ratio instead of toluene-ethyl alcohol ess) montan wax acids, identified in in a 2:1 ratio. paragraph (a) or (b) of this section, (3) Saponification value 130–160, as may also be used as a component of an determined by ASTM Method D–1387–78 aqueous dispersion of vinylidene chlo- ‘‘Standard Test Method for Saponifica- ride copolymers, subject to the condi- tion Number (Empirical) of Synthetic tions described in paragraphs (c) (1) and Natural Waxes’’ (Revised 1978), and (2) of this section. (which is incorporated by reference in (1) The aqueous dispersion of the ad- accordance with 5 U.S.C. 552(a); the ditive contains not more that 18 per- availability of this incorporation by cent polyhydric alcohol esters of reference is given in paragraph (a)(3) of oxidatively refined (Gersthofen proc- this section), using xylene-ethyl alco- ess) montan wax acids, not more than 2 hol in a 2:1 ratio instead of ethyl alco- percent poly(oxyethylene) (minimum hol in the preparation of potassium hy- 20 moles of ethylene oxide) oleyl ether droxide solution. (CAS Reg. No. 9004–98–2), and not more (4) Ultraviolet absorbance limits than 1 percent poly(oxyethylene) (min- specified in paragraph (a)(4) of this sec- imum 3 moles ethylene oxide) cetyl al- tion, as determined by the analytical cohols (CAS Reg. No. 9004–95–9). method described therein. (2) The aqueous dispersion described [42 FR 14609, Mar. 15, 1977, as amended at 47 in paragraph (c)(1) of this section is FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, used as an additive to aqueous disper- 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, sions of vinylidene chloride copoly- June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR mers, regulated in §§ 175.300, 175.320, 17512, Apr. 5, 1993; 69 FR 24512, May 4, 2004] 175.360, 176.170, 176,180, and 177.1630 of this chapter, at levels not to exceed 1.5 § 178.3780 Polyhydric alcohol esters of percent (solids basis) in the finished long chain monobasic acids. coating. Polyhydric alcohol esters of long (d) The polyhydric alcohol esters chain monobasic acids identified in identified in this paragraph may be this section may be safely used as lu- used as lubricants in the fabrication of bricants in the fabrication of polyvinyl vinyl chloride plastic food contact arti- chloride and/or polyvinyl chloride co- cles prepared from vinyl chloride poly- polymer articles complying with mers. Such esters meet the following § 177.1980 of this chapter that contact specifications and are produced by par- food of Types I, II, IV-B, VI-B, VII-B, tial esterification of oxidatively re- and VIII identified in table 1 in fined (Gersthofen process) montan wax § 176.170(c) of this chapter under condi- acids with glycerol followed by neu- tions of use E, F, and G described in tralization: table 2 in § 176.170(c) of this chapter, (1) Dropping point 79 to 85 °C, as de- subject to the provisions of this sec- termined by the American Society for tion. Testing and Materials (ASTM), Method (a) Identity. For the purpose of this D–566–76 (Reapproved 1982), ‘‘Standard section, polyhydric alcohol esters of Test Method for Dropping Point of Lu- long chain monobasic acids consist of bricating Grease,’’ which is incor- polyhydric alcohol esters having num- porated by reference in accordance ber average molecular weights in the with 5 U.S.C. 552(a). The availability of range of 1,050 to 1,700. The esters are this incorporation by reference is given produced by the reaction of either in paragraph (a)(1) of this section. ethylene glycol or glycerol with long (2) Acid value 20–30, as determined by chain monobasic acids containing from ASTM Method D–1386–78 ‘‘Standard 9 to 49 carbon atoms obtained by the Test Method for Acid Number (Empir- ozonization of long chain alpha-olefins, ical) of Synthetic and Natural Waxes’’ the unreacted carboxylic acids in the (Revised 1978) (which is incorporated by formation of the glycerol esters being

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neutralized with calcium hydroxide to reference. Copies are available from produce a composition having up to 2 American Association of Oil Chemists, percent by weight calcium. The alpha- 36 East Wacker Drive, Chicago, IL olefins, obtained from the polymeriza- 60601, or available for inspection at the tion of ethylene, have 20 to 50 carbon National Archives and Records Admin- atoms and contain a minimum of 75 istration (NARA). For information on percent by weight straight chain alpha- the availability of this material at olefins and not more than 25 percent NARA, call 202–741–6030, or go to: http:// vinylidene compounds. www.archives.gov/federallregister/ (b) Specifications. The polyhydric al- codeloflfederallregulations/ cohol esters have the following speci- ibrllocations.html. fications: (4) Ultraviolet absorbance as speci- (1) Melting point of 60–80 °C for the fied in § 178.3770(a)(4) of this chapter ethylene glycol ester and 90–105 °C for when tested by the analytical method the glycerol ester as determined by the described therein. Fisher Johns method as described in [42 FR 14609, Mar. 15, 1977, as amended at 47 ‘‘Semimicro Qualitative Organic Anal- FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, ysis—The Systematic Identification of 1989; 61 FR 14481, Apr. 2, 1996] Organic Compounds,’’ by Cheronis and Entrikin, 2d Ed., Interscience Pub- § 178.3790 Polymer modifiers in lishers, NY, which is incorporated by semirigid and rigid vinyl chloride reference. Copies are available from plastics. the Center for Food Safety and Applied The polymers identified in paragraph Nutrition (HFS–200), Food and Drug (a) of this section may be safely Administration, 5001 Campus Dr., Col- admixed, alone or in mixture with lege Park, MD 20740, or available for in- other permitted polymers, as modifiers spection at the National Archives and in semirigid and rigid vinyl chloride Records Administration (NARA). For plastic food-contact articles prepared information on the availability of this from vinyl chloride homopolymers and/ material at NARA, call 202–741–6030, or or from vinyl chloride copolymers com- go to: http://www.archives.gov/ plying with § 177.1950, § 177.1970, and/or federallregister/ § 177.1980 of this chapter, in accordance codeloflfederallregulations/ with the following prescribed condi- ibrllocations.html. tions: (2) Acid value 15–25 for each ester as (a) For the purpose of this section, determined by the A.O.C.S. method the polymer modifiers are identified as Trla-64T ‘‘Titer Test,’’ which is incor- follows: porated by reference. Copies are avail- (1) Acrylic polymers identified in this able from American Association of Oil subparagraph provided that such poly- Chemists, 36 East Wacker Drive, Chi- mers contain at least 50 weight-percent cago, IL 60601, or available for inspec- of polymer units derived from one or tion at the National Archives and more of the monomers listed in para- Records Administration (NARA). For graph (a)(1)(i) of this section. information on the availability of this (i) Homopolymers and copolymers of material at NARA, call 202–741–6030, or the following monomers: go to: http://www.archives.gov/ n-Butyl acrylate. federallregister/ n-Butyl methacrylate. codeloflfederallregulations/ Ethyl acrylate. ibrllocations.html. The method is modi- Methyl methacrylate. fied to use as the acid solvent a 1:1 vol- (ii) Copolymers produced by co- ume mixture of anhydrous isopropyl al- polymerizing one or more of the mono- cohol and toluene. The solution is mers listed in paragraph (a)(1)(i) of this titrated with 0.1N methanolic sodium section with one or more of the fol- hydroxide. lowing monomers: (3) Saponification value 120–160 for Acrylonitrile. the ethylene glycol ester and 90–130 for Butadiene. the glycerol ester as determined the a-Methylstyrene. A.O.C.S. method Trla-64T ‘‘Saponifica- Styrene. tion Value,’’ which is incorporated by Vinylidene chloride.

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(iii) Polymers identified in para- than 30 weight-percent of polymer graphs (a)(1) (i) and (ii) of this section units derived from copolymers of meth- containing no more than 5 weight-per- yl methacrylate, a-methylstyrene and cent of total polymer units derived by acrylonitrile and may optionally con- copolymerization with one or more of tain up to 15 weight-percent of polymer the following monomers: units derived from butadiene-styrene Acrylic acid. copolymers. 1,3-Butylene glycol dimethacrylate. (c) No chemical reactions, other than Divinylbenzene. addition reactions, occur among the Methacrylic acid. vinyl chloride polymers and the modi- (iv) Mixtures of polymers identified fying polymers present in the polymer in paragraph (a)(1) (i), (ii), and (iii) of mixture used in the manufacture of the this section; provided that no chemical finished plastic food-contact article. reactions, other than addition reac- (d) The finished plastic food-contact tions, occur when they are mixed. article, when extracted with the sol- (2) Polymers identified in paragraph vent or solvents characterizing the (a)(1) of this section combined during type of food and under the conditions their polymerization with butadiene- of time and temperature characterizing styrene copolymers; provided that no the conditions of its intended use as de- chemical reactions, other than addi- termined from tables 1 and 2 of tion reactions, occur when they are § 176.170(c) of this chapter, yields ex- combined. Such combined polymers tractives not to exceed the limits pre- may contain 50 weight-percent or more scribed in § 177.1010 (b) (1), (2), (3), and of total polymer units derived from the (4) of this chapter when tested by the butadiene-styrene copolymers. methods prescribed in § 177.1010 (c) of (b) The polymer content of the fin- this chapter. ished plastic food-contact article con- (e) Acrylonitrile copolymers identi- sists of: fied in this section shall comply with (1) Not less than 80 weight-percent of the provisions of § 180.22 of this chap- polymer units derived from the vinyl ter. chloride polymers identified in the in- troduction to this section and not more § 178.3800 Preservatives for wood. than 5 weight-percent of polymer units Preservatives may be safely used on derived from polymers identified in wooden articles that are used or in- paragraph (a)(1) of this section and tended for use in packaging, trans- may optionally contain up to 15 porting, or holding raw agricultural weight-percent of polymer units de- products subject to the provisions of rived from butadiene-styrene copoly- this section: mers; or (a) The preservatives are prepared (2) Not less than 50 weight-percent of from substances identified in para- polymer units derived from the vinyl graph (b) of this section and applied in chloride polymers identified in the in- amounts not to exceed those necessary troduction to this section, not more to accomplish the technical effect of than 50 weight-percent of polymer protecting the wood from decay, mil- units derived from homopolymers and/ dew, and water absorption. or copolymers of ethyl acrylate and (b) The substances permitted are as methyl methacrylate, and not more follows:

List of substances Limitations

Copper-8-quinolinolate. Mineral spirits. Paraffin wax ...... Used singly or in combination so as to constitute not less than 50% of the solids. Petroleum hydrocarbon resin, produced by the homo- and co- Do. polymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene type from distillates of cracked petroleum stocks. Pentachlorophenol and its sodium salt ...... Not to exceed 50 p.p.m. in the treated wood, calculated as pentachlorophenol.

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List of substances Limitations

Rosins and rosin derivatives ...... As provided in § 178.3870. Zinc salt of sulfonated petroleum.

§ 178.3850 Reinforced wax. List of substances Limitations Reinforced wax may be safely used as Copolymer of isobutylene modi- an article or component of articles in- fied with isoprene. Petroleum wax, Type I and Type tended for use in producing, manufac- II. turing, packing, processing, trans- Polyethylene. porting, or holding food subject to the Rosins and rosin derivatives as provisions of this section. provided in § 178.3870. Synthetic wax polymer as de- Not to exceed 5 percent (a) Reinforced wax consists of petro- scribed in § 176.170(a)(5) of by weight of the petro- leum wax to which have been added this chapter. leum wax. certain optional substances required in its production, or added to impart de- (e) Reinforced wax conforming with sired physical or technical properties. the specifications in this paragraph is (b) The quantity of any optional ad- used as provided in paragraph (e)(2) of juvant substance employed in the pro- this section. duction of or added to reinforced wax (1) The chloroform-soluble portion of does not exceed the amount reasonably the water extract obtained by exposing required to accomplish the intended reinforced wax to demineralized water physical or technical effect or any lim- at 70 °F for 48 hours shall not exceed 0.5 itation provided in this section. milligram per square inch of food-con- (c) Any substance employed in the tact surface. production of reinforced wax, including (2) It is used as a packaging material any optional substance, that is the sub- or component of packaging materials ject of a regulation in parts 174, 175, for cheese and cheese products. 176, 177, 178 and § 179.45 of this chapter, [42 FR 14609, Mar. 15, 1977, as amended at 47 conforms with any specification in FR 1288, Jan. 12, 1982] such regulation. (d) The substances and optional adju- § 178.3860 Release agents. vant substances employed in the pro- Substances listed in paragraph (b) of duction of or added to reinforced wax this section may be safely used as re- include: lease agents in petroleum wax com- (1) Substances generally recognized plying with § 178.3710 and in polymeric as safe in food. resins that contact food, subject to the (2) Substances subject to prior sanc- provisions of this section. tion for use in reinforced wax and used (a) The quantity used shall not ex- in accordance with such sanction or ap- ceed the amount reasonably required proval. to accomplish the intended technical (3) Substances identified in this sub- effect or any limitations prescribed in paragraph and subject to any limita- this section. tions provided therein: (b) Release agents:

List of substances Limitations

Erucamide (erucylamide). Formaldehyde, polymer with 1-naphthalenol (CAS For use only as an antiscaling or release agent, applied on the internal Reg. No. 25359–91–5). parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million. N,N′-Dioleoylethylenediamine ...... For use only in polyvinyl chloride films in amounts such that the concentra- tion of the substance in these films in the form in which the films contact food shall not exceed 0.055 milligram of the substance per square inch of film. Oleyl palmitamide. Polybutene, hydrogenated; complying with the For use only subject to the limitations prescribed for hydrogenated identity prescribed under § 178.3740(b). polybutene under § 178.3740(b).

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List of substances Limitations

Poly(vinyl acetate/vinyl N-octadecylcarbamate) For use only in application to the backing of pressuresensitive adhesive (CAS Reg. No. 70892–21–6) produced by the tapes at levels not to exceed 0.2 milligram per square centimeter (1.29 reaction between stoichiometrically equivalent milligrams per square inch) of backing. amounts of octadecyl isocyanate and vinyl alco- hol/vinyl acetate copolymer; minimum average molecular weight is 500,000. Rice bran wax ...... For use only in plastics intended for contact with dry foods identified as Type VIII in table 1 of § 176.170(c) of this chapter, at levels not in excess of 1.0 percent by weight of the polymer. Saturated fatty acid amides manufactured from fatty acids derived from animal, marine, or vege- table fats and oils. Stearyl erucamide.

[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]

§ 178.3870 Rosins and rosin deriva- cent, a minimum drop-softening point tives. of 79 °C, and a color of X or paler. The rosins and rosin derivatives iden- (iii) Partially dimerized rosin, tified in paragraph (a) of this section dimerized by sulfuric acid catalyst to a may safely be used in the manufacture drop-softening point of 95°–105 °C and a of articles or components of articles in- color of WG or paler. tended for use in producing, manufac- (iv) Fully dimerized rosin, dimerized turing, packing, processing, preparing, by sulfuric acid catalyst, and from treating, packaging, transporting, or which sufficient nondimerized rosin holding food, subject to the provisions has been removed by distillation to of this section. achieve a minimum drop-softening (a) The rosins and rosin derivatives point of 143 °C, and a color of H or are identified as follows: paler. (1) Rosins: (v) Disproportionated rosin, catalyt- (i) Gum rosin, refined to color grade ically disproportionated to a minimum of K or paler. dehydroabietic acid content of 35 per- (ii) Wood rosin, refined to color grade cent, a maximum abietic acid content of K or paler. of 1 percent, a maximum content of (iii) Tall oil rosin, refined to color substituted phenanthrenes (as retene) grade of K or paler. of 0.25 percent, and a color of WG or (iv) Dark tall oil rosin, a fraction re- paler. sulting from the refining of tall oil (3) Rosin esters manufactured from rosin produced by multicolumnar dis- rosins and modified rosins identified in tillation of crude tall oil to effect re- paragraphs (a)(1) and (2) of this section: moval of fatty acids and pitch compo- (i) Glycerol ester of wood rosin puri- nents and having a saponification num- fied by steam stripping to have an acid ber of from 110–135 and 32 percent–44 number of 3 to 9, a drop-softening point percent rosin acids. ° ° (v) Dark wood rosin, all or part of the of 88 –96 C, and a color of N or paler. residue after the volatile terpene oils (ii) Glycerol ester of partially hydro- are distilled from the oleoresin ex- genated wood rosin, having an acid tracted from pine wood. number of 3 to 10, a drop-softening (2) Modified rosins manufactured point of 79°–88 °C, and a color of N or from rosins identified in paragraph paler. (a)(1) of this section: (iii) Glycerol ester of partially (i) Partially hydrogenated rosin, cat- dimerized rosin, having an acid number alytically hydrogenated to a maximum of 3 to 8, a drop-softening point of 109°– refractive index of 1.5012 at 100 °C, and 119 °C, and a color of M or paler. a color of WG or paler. (iv) Glycerol ester of fully dimerized (ii) Fully hydrogenated rosin, cata- rosin, having an acid number of 5 to 16, lytically hydrogenated to a maximum a drop-softening point of 165°–175 °C, dehydroabietic acid content of 2 per- and a color of H or paler.

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(v) Glycerol ester of maleic anhy- (xiv) Mixed methyl and pentaeryth- dride-modified wood rosin, having an ritol ester of maleic anhydride-modi- acid number of 30 to 40, a drop-soft- fied wood rosin, having an acid number ening point of 138°–146 °C, a color of M of 73 to 83, a drop-softening point of or paler, and a saponification number 113°–123 °C, a color of M or paler, and a less than 280. saponification number less than 280. (vi) Methyl ester of rosin, partially (xv) Triethylene glycol ester of par- hydrogenated, purified by steam strip- tially hydrogenated wood rosin, having ping to have an acid number of 4 to 8, an acid number of 2 to 10, a color of K a refractive index of 1.5170 to 1.5205 at or paler, and a viscosity of 350 to 425 20 °C, and a viscosity of 23 to 66 poises seconds Saybolt at 100 °C. at 25 °C. (xvi) Glycerol ester of maleic anhy- (vii) Pentaerythritol ester of wood dride-modified wood rosin, having an rosin, having an acid number of 6 to 16, acid number of 17 to 23, a drop-soft- a drop-softening point of 109°–116 °C, ening point of 136°–140 °C, a color of M and a color of M or paler. or paler, and a saponification number (viii) Pentaerythritol ester of par- less than 280. For use only in cello- tially hydrogenated wood rosin, having phane complying with § 177.1200 of this an acid number of 7 to 18, a drop-soft- chapter. ening point of 102°–110 °C, and a color of (xvii) Citric acid-modified glycerol K or paler. ester of rosin, having an acid number (ix) Pentaerythritol ester of maleic less than 20, a drop-softening point of anhydride-modified wood rosin, having 105°–115 °C, and a color of K or paler. an acid number of 8 to 16, a drop-soft- For use only as a blending agent in ening point of 154°–162 °C, a color of M coatings for cellophane complying with or paler, and having a saponification § 177.1200 of this chapter. number less than 280. (xviii) Glycerol ester of tall oil rosin, (x) Pentaerythritol ester of maleic purified by steam stripping to have an anhydride-modified wood rosin, having acid number of 5–12, a softening point an acid number of 9 to 16, a drop-soft- of 80°–88 °C, and a color of N or paler. ening point of 130°–140 °C, a color of N (xix) Glycerol ester of maleic anhy- or paler, and having a saponification dride-modified tall oil rosin, having an number less than 280. acid number of 30 to 40, a drop-soft- (xi) Pentaerythritol ester of maleic ening point of 141°–146 °C, a color of N anhydride-modified wood rosin, having or paler, and a saponification number an acid number of 134 to 145, a drop- less than 280. softening point of 127°–137 °C, a color of (xx) Glycerol ester of M or paler, and having a saponification disproportionated tall oil rosin, having number less than 280. an acid number of 5 to 10, a drop-soft- (xii) Pentaerythritol ester of maleic ening point of 84°–93 °C, a color of WG anhydride-modified wood rosin, having or paler, and a saponification number an acid number of 30 to 40, a drop-soft- less than 180. ening point of 131°–137 °C, a color of N (4) Rosin salts and sizes—Ammo- or paler, and having a saponification nium, calcium, potassium, sodium, or number less than 280. zinc salts of rosin manufactured by the (xiii) Pentaerythritol ester of maleic partial or complete saponification of anhydride-modified wood rosin, further any one of the rosins or modified rosins modified by reaction with 4,4′-iso- identified in paragraph (a)(1) and (2) of propyl-idenediphenol-formaldehyde this section, or blends thereof, and condensate, having an acid number of with or without modification by reac- 10 to 22, a drop-softening point of 162°– tion with one or more of the following: 172 °C, a color of K or paler, a saponi- (i) Formaldehyde. fication number less than 280, and a (ii) Fumaric acid. maximum ultraviolet absorbance of (iii) Maleic anhydride. 0.14 at 296 mμ (using a 1-centimeter cell (iv) Saligenin. and 200 milligrams of the rosin ester (b) The quantity used shall not ex- per liter of solvent consisting of ethyl ceed the amount reasonably required alcohol made alkaline by addition of to accomplish the intended technical 0.1 percent of potassium hydroxide). effect.

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(c) The use in any substance or arti- (4) Viscosity: Viscosity in poises cle that is the subject of a regulation shall be as determined by ASTM meth- in parts 174, 175, 176, 177, 178 and § 179.45 od D1824–66 (Reapproved 1980), ‘‘Stand- of this chapter shall conform with any ard Test Method for Apparent Vis- specifications and limitations pre- cosity of Plastisols and Organosols at scribed by such regulation for the fin- Low Shear Rates by Brookfield Vis- ished form of the substance or article. cometer,’’ and in Saybolt seconds by (d) The provisions of this section are ASTM method D88–81, ‘‘Standard Test not applicable to rosins and rosin de- Method for Saybolt Viscosity,’’ which rivatives identified in § 175.300(b)(3)(v) are incorporated by reference. The of this chapter and used in resinous availability of this incorporation by and polymeric coatings complying with reference is given in paragraph (f)(1) of § 175.300 of this chapter. this section. (e) The provisions of this section are (5) Softening point: Softening point not applicable to rosins and rosin de- shall be as determined by ASTM meth- rivatives identified in § 175.105(c)(5) of od E28–67, ‘‘Standard Test Method for this chapter and used in defoaming Softening Point by Ring and Ball Ap- agents complying with § 176.210 of this paratus’’ (Reapproved 1977), which is chapter, food-packaging adhesives incorporated by reference. Copies are complying with § 175.105 of this chapter, available from American Society for and rubber articles complying with Testing and Materials (ASTM), 100 § 177.2600 of this chapter. Barr Harbor Dr., West Conshohocken, (f) The analytical methods for deter- Philadelphia, PA 19428-2959, or avail- mining whether rosins and rosin de- rivatives conform to the specifications able for inspection at the National Ar- prescribed in paragraph (a) of this sec- chives and Records Administration tion are as follows: (NARA). For information on the avail- (1) Color: Color shall be as deter- ability of this material at NARA, call mined by ASTM method D509–70 (Re- 202–741–6030, or go to: http:// approved 1981), ‘‘Standard Methods of www.archives.gov/federallregister/ Sampling and Grading Rosin,’’ which is codeloflfederallregulations/ incorporated by reference. Copies may ibrllocations.html. be obtained from the American Society (6) Analytical methods for deter- for Testing Materials, 100 Barr Harbor mining drop-softening point, saponi- Dr., West Conshohocken, Philadelphia, fication number, and any other speci- PA 19428-2959, or may be examined at fications not listed under paragraphs the National Archives and Records Ad- (f)(1) through (5) of this section, titled: ministration (NARA). For information (i) ‘‘Determination of Abeitic Acid and on the availability of this material at Dehydroabietic Acid in Rosins’’; (ii) NARA, call 202–741–6030, or go to: http:// ‘‘Determination of Softening Point of www.archives.gov/federallregister/ Solid Resins’’; (iii) ‘‘Determination of codeloflfederallregulations/ Saponification Number of Rosin ibrllocations.html. Esters,’’ and (iv) ‘‘Determination of (2) Refractive index: Refractive index Phenolic Modification of Rosin Deriva- shall be as determined by ASTM meth- tives,’’ which are incorporated by ref- od D1747–62 (Reapproved 1978), ‘‘Stand- erence. Copies are available from the ard Test Method for Refractive Index of Center for Food Safety and Applied Nu- Viscous Materials,’’ which is incor- trition (HFS–200), Food and Drug Ad- porated by reference. The availability ministration, 5001 Campus Dr., College of this incorporation by reference is Park, MD 20740, or available for inspec- given in paragraph (f)(1) of this section. tion at the National Archives and (3) Acid number: Acid number shall Records Administration (NARA). For be as determined by ASTM method information on the availability of this D465–82, ‘‘Standard Test Methods for material at NARA, call 202–741–6030, or Acid Number of Rosin,’’ which is incor- go to: http://www.archives.gov/ porated by reference. The availability federallregister/ of this incorporation by reference is given in paragraph (f)(1) of this section.

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codeloflfederallregulations/ § 178.3910 Surface lubricants used in ibrllocations.html. the manufacture of metallic arti- cles. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, The substances listed in this section 1984; 54 FR 24899, June 12, 1989] may be safely used in surface lubri- cants employed in the manufacture of § 178.3900 Sodium metallic articles that contact food, pentachlorophenate. subject to the provisions of this sec- Sodium pentachlorophenate may be tion. (a) The following substances may be safely used as a preservative for ammo- used in surface lubricants used in the nium alginate employed as a proc- rolling of metallic foil or sheet stock essing aid in the manufacture of poly- provided that total residual lubricant vinyl chloride emulsion polymers in- remaining on the metallic article in tended for use as articles or compo- the form in which it contacts food does nents of articles that contact food at not exceed 0.015 milligram per square temperatures not to exceed room tem- inch of metallic food-contact surface: perature. The quantity of sodium (1) Substances identified in para- pentachlorophenate used shall not ex- graphs (b)(1) and (2) of this section. ceed 0.5 percent by weight of ammo- (2) Substances identified in this para- nium alginate solids. graph.

List of substances Limitations

a-Butyl-W-–hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038–95–3) produced by random condensa- tion of a 1:1 mixture by weight of ethylene oxide and pro- pylene oxide with butanol and having a minimum molecular weight of 1,000. a–Butyl–W–hydroxypoly(oxypropylene) (CAS Reg. No. 9003- 13–8) having a minimum molecular weight of 1000. a–Lauroyl–W–hydroxpoly(oxyethylene) (CAS Reg. No. 9004– 81–3) having a minimum molecular weight of 200. Acetate esters derived from synthetic straight chain alcohols (complying with § 172.864 of this chapter) that have even numbers of carbon atoms in the range C8-C18. alpha-Alkyl–omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of C12-C15 straight chain primary al- cohols with an average of 3 moles of ethylene oxide (CAS Reg. No. 68002–97–1). Benzotriazole (CAS Reg. No. 95–14–7). Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789– Not to be used in combination with sodium nitrite. 79–5). Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No. 116438–56–3). N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102–79–4). Tert-Butyl alcohol. Di(2-ethylhexyl)phthalate. Diethyl phthalate. Diethylene glycol monobutylether (CAS Reg. No. 112–34–5). Dimers, trimers, and/or their partial methyl esters; such dimers For use only at a level not to exceed 10 percent by weight of and trimers are of unsaturated C18 fatty acids derived from finished lubricant formulation. animal and vegetable fats and oils and/or tall oil, and such partial methyl esters meet the following specifications: Sa- ponification value 180–200, acid value 70–130, and max- imum iodine value 120. Di-n-octyl sebacate. Ethylenediaminetetraacetic acid, sodium salts. Isopropyl alcohol. Isopropyl laurate (CAS Reg. No. 10233–13–3) ...... For use at a level not to exceed 10 percent by weight of the finished lubricant formulation. Isopropyl oleate. Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043–30–5). Methyl esters of coconut oil fatty acids. Methyl esters of fatty acids (C16-C18) derived from animal and vegetable fats and oils. Polybutene, hydrogenated: complying with the identity pre- scribed under § 178.3740(b). Polyethylene glycol (400) monostearate. Polyisobutylene (minimum molecular weight 300).

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List of substances Limitations

Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791–26–2). Polyvinyl alcohol. Sodium nitrite ...... For use only as a rust inhibitor in lubricant formulations pro- vided the total residual sodium nitrite on the metallic article in the form in which it contacts food does not exceed 0.007 milligram per square inch of metallic food-contact surface. Sodium petroleum sulfonate, MW 440–450 (CAS Reg. No. 68608–26–4) derived from naphthenic oil having a Saybolt viscosity range of 500–600 Saybolt Universal Seconds (SUS at 37–8 °C (100 °F) as determined by ASTM method D88– 81, ‘‘Standard Test Method for Saybolt Viscosity,’’ which is incorporated by reference. Copies are available from the American Society for Testing Materials, 1961 Race St., Philadelphia, PA 19103, or available for inspection at the Na- tional Archives and Records Administration (NARA). For in- formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Synthetic alcohol mixture of straight-and branched-chain alco- hols that have even numbers of carbon atoms in the range C4C18 and that are prepared from ethylene, aluminum, and hydrogen such that the finished synthetic alcohol mixture contains not less than 75 pct of straight-chain primary alco- hols and contains not less than 85 pct total C10 and C12 al- cohols. Synthetic primary alcohol mixture of straight- and branched- For use at a level not to exceed 8 pct by weight of the finished chain alcohols that contain at least 99 pct primary alcohols lubricant formulation. consisting of the following: not less than 70 pct normal alco- hols; not less than 96.5 pct C12-C15 alcohols; and not more than 2.5 pct alpha, omega C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene frac- tion, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight, 207±4; hydroxyl number, 266–276. Synthetic primary alcohol mixture of straight- and branched- For use only at a level not to exceed 8 pct by weight of the fin- chain alcohols that contain at least 99 pct primary alcohols ished lubricant formulation. consisting of the following: not less than 70 percent normal alcohols; not less than 93 pct C12-C13 alcohols; not more than 5 pct C14-C15 alcohols; and not more than 2.5 pct alpha, omega, C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon mon- oxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight 194±5; hydroxyl number, 283–296. Tallow, sulfonated. Triethanolamine.

(3) Mineral oil conforming to the affinic, isoparaffinic, napthenic, or aro- identity prescribed in § 178.3620(c). matic in nature, and meet the fol- (4) Light petroleum hydrocarbons lowing specifications: identified in paragraph (a)(4) (i) of this (a) Initial boiling point is 24 °C min- section: Provided, That the total resid- imum and final boiling point is 288 °C ual lubricant on the metallic article in maximum, as determined by ASTM the form in which it contacts food method D86–82, ‘‘Standard Method for meets the ultraviolet absorbance lim- Distillation of Petroleum Products,’’ its prescribed in paragraph (a) (4) (ii) of which is incorporated by reference. this section as determined by the ana- Copies may be obtained from the Amer- lytical method described in paragraph ican Society for Testing Materials, 100 (a) (4) (iii) of this section. Barr Harbor Dr., West Conshohocken, (i) Light petroleum hydrocarbons are Philadelphia, PA 19428-2959, or may be derived by distillation from virgin pe- examined at the National Archives and troleum stocks or are synthesized from Records Administration (NARA). For petroleum gases. They are chiefly par- information on the availability of this

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material at NARA, call 202–741–6030, or under ultraviolet light to detect any residual go to: http://www.archives.gov/ fluorescent contamination. As a pre- federallregister/ cautionary measure it is recommended prac- codeloflfederallregulations/ tice to rinse all glassware with purified iso- octane immediately before use. No grease is ibrllocations.html. to be used on stopcocks or joints. Great care (b) Nonvolatile residue is 0.005 gram to avoid contamination of oil samples in per 100 milliliters, maximum, as deter- handling and to assure absence of any extra- mined by ASTM method D381–80, neous material arising from inadequate ‘‘Standard Test Method for Existent packaging is essential. Because some of the Gum in Fuels by Jet Evaporation,’’ polynuclear hydrocarbons sought in this test when the final boiling point is 121 °C or are very susceptible to photo-oxidation, the above and by ASTM method D1353–78, entire procedure is to be carried out under subdued light. ‘‘Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in APPARATUS Paint, Varnish, Lacquer, and Related Separatory funnels. 250-milliliter, 500-milli- Products,’’ when the final boiling point liter, 1,000-milliliter, and preferably 2,000- is below 121 °C. These ASTM methods milliliter capacity, equipped with tetra- are incorporated by reference. The fluoroethylene polymer stopcocks. availability of these incorporations by Evaporation flask (optional). 250-milliliter or reference is given in paragraph 500-milliliter capacity all-glass flask (a)(4)(i)(a) of this section. equipped with standard-taper stopper having (c) Saybolt color 20 minimum as de- inlet and outlet tubes to permit passage of termined by ASTM method D156–82, nitrogen across the surface of contained liq- uid to be evaporated. ‘‘Standard Test Method for Saybolt Spectrophotometric cells. Fused quartz cells, Color of Petroleum Products (Saybolt optical path length in the range of 5,000 cen- Chromometer Method),’’ which is in- timeters ±0.005 centimeter; also for checking corporated by reference. The avail- spectrophotometer performance only, optical ability of this incorporation by ref- path length in the range 1.000 centimeter erence is given in paragraph (a)(4)(i)(a) ±0.005 centimeter. With distilled water in the of this section. cells, determine any absorbance differences. (d) Aromatic component content Spectrophotometer. Special range 250 millicrons-400 millimicrons with spectral slit shall not exceed 32 percent. width of 2 millimicrons or less; under instru- (e) Conforms with ultraviolet absorb- ment operating conditions for these absorb- ance limits prescribed in § 178.3620(c) as ance measurements, the spectrophotometer determined by the analytical method shall also meet the following performance described therein. requirements: (ii) Ultraviolet absorbance limits on Absorbance repeatability, ±0.01 at 0.4 ab- residual lubricants are as follows: sorbance. Absorbance accuracy, 1 ±0.05 at 0.4 absorb- Maximum ance. absorb- Wavelength repeatability, ±0.2 milli- ance per 5 Wavelength (mμ) centi- micron. meters op- Wavelength accuracy, ±1.0 millimicron. tical pathlength 1 As determined by procedure using potas- 280–289 ...... 0.7 sium chromate for reference standard and 290–299 ...... 6 described in National Bureau of Standards 300–359 ...... 4 Circular 484, Spectrometry, U.S. Department 360–400 ...... 09 of Commerce (1949), which is incorporated by (iii) The analytical method for deter- reference. Copies are available from the Cen- ter for Food Safety and Applied Nutrition mining ultraviolet absorbance limits (HFS–200), Food and Drug Administration, on residual lubricants is as follows: 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Ar- GENERAL INSTRUCTIONS chives and Records Administration (NARA). Because of the sensitivity of the test, the For information on the availability of this possibility of errors arising from contamina- material at NARA, call 202–741–6030, or go to: tion is great. It is of the greatest importance http://www.archives.gov/federallregister/ that all glassware be scrupulously cleaned to codeloflfederallregulations/ remove all organic matter such as oil, ibrllocations.html. The accuracy is to be de- grease, detergent, residues, etc. Examine all termined by comparison with the standard glassware including stoppers and stopcocks, values at 210, 345, and 400 millimicrons.

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Soxhlet apparatus. 60-millimeter diameter Absorb- body tubes fitted with condenser and 500-mil- Wavelength ance (max- liliter round-bottom boiling flask. A supply imum) of paper thimbles to fit is required. 280 ...... 06 Nitrogen cylinder. Water-pumped or equiva- 300 ...... 015 lent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 There shall be no irregularities in the ab- p.s.i.g. sorbance curve within these wavelengths. Phosphoric acid. 85 percent A.C.S. reagent REAGENTS AND MATERIALS grade. Organic solvents. All solvents used through- Sodium sulfate, anhydrous, A.C.S. reagent out the procedure shall meet the specifica- grade, preferably in granular form. For each tions and tests described in this specifica- bottle of sodium sulfate reagent used, estab- tion. The isooctane (2,2,4-trimethylpentane) lish as follows the necessary sodium sulfate shall pass the following test: prewash to provide such filters required in Place 180 milliliters of solvent in a 250-mil- the method: Place approximately 35 grams of liliter Erlenmeyer flask, add 1 milliliter of anhydrous sodium sulfate in a 30-milliliter purified n-hexadecane and evaporate on the coarse, fritted-glass funnel or in a 65-milli- steam bath under a stream of nitrogen (a liter filter funnel with glass wool plug; wash loose aluminum foil jacket around the flask with successive 15-milliliter portions of the will speed evaporation). Discontinue evapo- indicated solvent until a 15-milliliter portion ration when not over 1 milliliter of residue of the wash shows 0.00 absorbance per centi- remains. meter path length between 280 mμ and 400 mμ Alternatively, the evaporation time can be when tested as prescribed under ‘‘Organic reduced by using the optional evaporation solvents.’’ Usually three portions of wash flask. In this case the solvent and n-hexa- solvent are sufficient. decane are placed in the flask on the steam Before proceeding with analysis of a sam- bath, the tube assembly is inserted, and a ple, determine the absorbance in a 5-centi- stream of nitrogen is fed through the inlet meter path cell between 250 millimicrons and tube while the outlet tube is connected to a 400 millimicrons for the reagent blank by solvent trap and vacuum line in such a way carrying out the procedure, without a metal as to prevent any flow-back of condensate sample. The absorbance per centimeter path into the flask. length should not exceed 0.02 in the wave- Dissolve the 1 milliliter of hexadecane res- length range from 280 mμ to 400 mμ. idue in isooctane and make to 25 milliliters Place 300 milliliters of dimethyl sulfoxide volume. Determine the absorbance in the 5- in a 1-liter separatory funnel and add 75 mil- centimeter path length cells compared to liliters of phosphoric acid. Mix the contents isooctane as reference. The absorbance of the of the funnel and allow to stand for 10 min- solution of the solvent residue shall not ex- utes. (The reaction between the sulfoxide ceed 0.01 per centimeter path length between and the acid is exothermic. Release pressure 280 and 400 mμ. Purify, if necessary, by pas- after mixing, then keep funnel stoppered.) sage through a column of activated silica gel Add 150 milliliters of isooctane and shake to (Grade 12, Davison Chemical Co., Baltimore, pre-equilibrate the solvents. Draw off the in- Maryland, or equivalent) about 90 centi- dividual layers and store in glass-stoppered meters in length and 5 centimeters to 8 cen- flasks. timeters in diameter. n-Hexadecane, 99-percent olefin-free. Dilute PROCEDURE 1.0 milliliter of n-hexadecane to 25 milliliters Sample. Select metal foil or sheet stock for with isooctane and determine the absorbance the test which has not been previously con- in a 5-centimeter cell compared to isooctane taminated by careless handling or exposure as reference point between 280 mμ-400 mμ. to atmospheric dust and fumes. A commer- The absorbance per centimeter path length cial coil in the form supplied for spindle shall not exceed 0.00 in this range. Purify, if mounting in a packaging line or wrapping necessary, by percolation through activated machine is most suitable. Strip off the out- silica gel or by distillation. Dimethyl sulfoxide. Spectrophotometric side turn of metal and discard. Carefully grade (Crown Zellerbach Corp., Camas, avoid contamination or damage from han- Washington, or equivalent). Absorbance (1- dling the metal (wear gloves). Remove a 16– centimeter cell, distilled water reference, 18-foot length from the coil and place it on a sample completely saturated with nitrogen). flat surface protected by a length of new kraft paper. Cut four 15-foot strips from the Absorb- sample, each 3 inches wide (avoid tearing the Wavelength ance (max- edges of the strips). Using a piece of suitable imum) glass rod, roll the strips of metal into loose 261.5 ...... 1.00 coils and insert each into a Soxhlet thimble. 270 ...... 20 Each turn of coil should be visibly separated 275 ...... 09 from the adjacent turn.

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Extraction. Fill each of the four Soxhlet tractive through anhydrous sodium sulfate tubes with purified isooctane (see under pre-washed with isooctane (see sodium sul- heading ‘‘Reagents and Materials,’’ above) fate under ‘‘Reagents and Materials’’ for until siphon action occurs and then refill the preparation of filter) into a 250-milliliter Er- tube body. Supply heat to the boiling flask lenmeyer flask (or optionally into the evapo- and allow extraction to continue for at least ration flask). Wash the first separatory fun- 8 hours or until repeated weighings of the nel with the second 80-milliliter isooctane dried and cooled coil show no further weight extractive and pass through the sodium sul- loss. fate. Then wash the second and first sepa- Combine the isooctane extracts from the ratory funnels successively with a 20-milli- four Soxhlet units in a suitable beaker, rins- liter portion of isooctane and pass the sol- ing each tube and flask into the beaker with vent through the sodium sulfate into the fresh purified solvent. Evaporate the solvent flask. Add 1 milliliter of n-hexadecane and under an atmosphere of inert gas (nitrogen) evaporate the isooctane on the steam bath to residual volume of 50–60 milliliters and under nitrogen. Discontinue evaporation transfer this solution to a 500-milliliter sepa- when not over 1 milliliter of residue remains. ratory funnel containing 100 milliliters of To the residue, add a 10-milliliter portion of pre-equilibrated sulfoxide-phosphoric acid mixture. Complete the transfer of the sample isooctane, reevaporate to 1 milliliter of with small portions of pre-equilibrated iso- hexadecane, and repeat this operation once. octane to give a total volume of the residue Quantitatively transfer the residue with and solvent of 75 milliliters. Shake the fun- isooctane to a 25-milliliter volumetric flask, nel vigorously for 2 minutes. Set up three make to volume, and mix. Determine the ab- 250-milliliter separatory funnels with each sorbance of the solution in 5-centimeter containing 30 milliliters of pre-equilibrated pathlength cells compared to isooctane as isooctane. After separation of liquid phases, reference between 280mμ–400mμ (take care to carefully draw off lower layer into the first lose none of the solution in filling the sam- 250-milliliter separatory funnel and wash in ple cell). Correct the absorbance values for tandem with the 30-milliliter portion of iso- any absorbance derived from reagents as de- octane contained in the 250-milliliter sepa- termined by carrying out the procedure ratory funnels. Shaking time for each wash without a metal sample. If the corrected ab- is 1 minute. Repeat the extraction operation sorbance does not exceed the limits pre- with two additional portions of the sulf- scribed in this paragraph, the residue meets oxide-acid mixture and wash each extractive the ultraviolet absorbance specifications. in tandem through the same three portions of isooctane. (b) The following substances may be Collect the successive extractives (300 mil- used in surface lubricants used to fa- liliters total) in a separatory funnel (pref- cilitate the drawing, stamping, or erably 2-liter) containing 480 milliliters of forming of metallic articles from rolled distilled water; mix, and allow to cool for a foil or sheet stock by further proc- few minutes after the last extractive has been added. Add 80 milliliters of isooctane to essing provided that the total residual the solution and extract by shaking the fun- lubricant remaining on the metallic ar- nel vigorously for 2 minutes. Draw off the ticle in the form in which it contacts lower aqueous layer into a second separatory food does not exceed 0.2 milligram per funnel (preferably 2-liter) and repeat the ex- square inch of food-contact surface: traction with 80 milliliter of isooctane. Draw (1) Antioxidants used in compliance off and discard the aqueous layer. Wash each with regulations in parts 170 through of the 80 milliliter extractives three times with 100-milliliter portions distilled water. 189 of this chapter. Shaking time for each wash is 1 minute. Dis- (2) Substances identified in this sub- card the aqueous layers. Filter the first ex- paragraph.

List of substances Limitations

Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl stearate. Castor oil. Dibutyl sebacate. Di(2-ethylhexyl) azelate. Di(2-ethylhexyl) sebacate. Diisodecyl phthalate. Dimethylpolysiloxane ...... Conforming to the identity prescribed in § 181.28 of this chap- ter. Dipropylene glycol. Epoxidized soybean oil ...... Conforming to the identity prescribed in § 181.27 of this chap- ter.

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List of substances Limitations

Fatty acids derived from animal and vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum Magnesium Potassium Sodium Zinc Fatty alcohols, straight-chain with even number carbon atoms (C10 or greater). Isobutyl stearate. Lanolin. Linoleic acid amide. Mineral oil ...... Conforming to the identity prescribed in § 178.3620 (a) or (b). Mono-, di-, and tristearyl citrate. Oleic acid amide. Palmitic acid amide. Petrolatum ...... Conforming to the identity prescribed in § 178.3700. Phosphoric acid, mono- and dihexyl esters, compounds with For use only at levels not to exceed 0.5 percent by weight of tetramethylnonylamines and C11–14-alkylamines (CAS Reg. the finished surface lubricant formulation. No. 80939–62–4). Polyethylene glycol (molecular weight 300 or greater) ...... Mono- and diethylene glycol content not to exceed a total of 0.2 pct. Stannous stearate. Stearic acid amide. Stearyl stearate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] For use at a level not to exceed 0.5 percent by weight of the methane (CAS Registry No. 6683–19–8). finished surface lubricant formulation. Triethylene glycol ...... Diethylene glycol content not to exceed 0.1 pct. Wax, petroleum ...... Complying with § 178.3710.

(c) The substances identified in para- with any applicable specifications pre- graph (a)(2) of this section may be used scribed by such regulation. in surface lubricants used to facilitate [42 FR 14609, Mar. 15, 1977, as amended at 48 the drawing, stamping, and forming of FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; metallic articles from rolled foil and 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. sheet stock provided that total resid- 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, ual lubricant remaining on the metal- Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR lic article in the form in which it con- 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; tacts food does not exceed 0.015 milli- 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999; 69 FR 24512, May 4, 2004] gram per square inch of food-contact surface. § 178.3930 Terpene resins. (d) Subject to any prescribed limita- tions, the quantity of surface lubricant The terpene resins identified in para- graph (a) of this section may be safely used in the manufacture of metallic ar- used as components of polypropylene ticles shall not exceed the least film intended for use in contact with amount reasonably required to accom- food, and the terpene resins identified plish the intended technical effect and in paragraph (b) of this section may be shall not be intended to nor, in fact, safely used as components of polyolefin accomplish any technical effect in the film intended for use in contact with food itself. food; (e) The use of the surface lubricants (a) Terpene resins consisting of the in the manufacture of any article that hydrogenated polymers of terpene hy- is the subject of a regulation in parts drocarbons obtainable from sulfate tur- 174, 175, 176, 177, 178 and § 179.45 of this pentine and meeting the following chapter must comply with any speci- specifications: Drop-softening point of fications prescribed by such regulation 118°–138 °C; iodine value less than 20. for the finished form of the article. (b) Terpene resins consisting of poly- (f) Any substance that is listed in mers of beta-pinene and meeting the this section and the subject of a regula- following specifications: Acid value tion in parts 174, 175, 176, 177, 178 and less than 1; saponification number less § 179.45 of this chapter shall comply than 1; color less than 4 on the Gardner

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scale as measured in 50 percent mineral Subpart C—Packaging Materials for spirits solution. Irradiated Foods § 178.3940 Tetraethylene glycol di-(2- 179.45 Packaging materials for use during ethylhexoate). the irradiation of prepackaged foods. Tetraethylene glycol di-(2- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 373, ethylhexoate) containing not more 374. than 22 parts per million ethylene and/ SOURCE: 42 FR 14635, Mar. 15, 1977, unless or diethylene glycols may be used at a otherwise noted. level not to exceed 0.7 percent by EDITORIAL NOTE: Nomenclature changes to weight of twine as a finish on twine to part 179 appear at 70 FR 72074, Dec. 1, 2005. be used for tying meat provided the twine fibers are produced from nylon resins complying with § 177.1500 of this Subpart A [Reserved] chapter. Subpart B—Radiation and § 178.3950 Tetrahydrofuran. Radiation Sources Tetrahydrofuran may be safely used in the fabrication of articles intended § 179.21 Sources of radiation used for for packaging, transporting, or storing inspection of food, for inspection of packaged food, and for controlling foods, subject to the provisions of this food processing. section. (a) It is used as a solvent in the cast- Sources of radiation for the purposes ing of film from a solution of poly- of inspection of foods, for inspection of meric resins of vinyl chloride, vinyl ac- packaged food, and for controlling food etate, or vinylidene chloride that have processing may be safely used under been polymerized singly or copolym- the following conditions: erized with one another in any com- (a) The radiation source is one of the bination, or it may be used as a solvent following: in the casting of film prepared from (1) X-ray tubes producing X-radiation vinyl chloride copolymers complying from operation of the tube source at a with § 177.1980 of this chapter. voltage of 500 kilovolt peak or lower. (b) The residual amount of tetra- (2) Sealed units producing radiations hydrofuran in the film does not exceed at energy levels of not more than 2.2 1.5 percent by weight of film. million electron volts from one of the following : -241, ce- PART 179—IRRADIATION IN THE sium-137, cobalt-60, iodine-125, - 85, -226, and strontium-90. PRODUCTION, PROCESSING AND (3) Sealed units producing HANDLING OF FOOD radiation from the Califor- nium-252 (CAS Reg. No. 13981–17–4) to Subpart A [Reserved] measure moisture in food. Subpart B—Radiation and Radiation (4) Machine sources producing X-radi- Sources ation at energies no greater than 10 million electron volts (MeV). Sec. (5) Monoenergetic neutron sources 179.21 Sources of radiation used for inspec- producing at energies not less tion of food, for inspection of packaged than 1 MeV but no greater than 14 food, and for controlling food processing. 179.25 General provisions for food irradia- MeV. tion. (b) To assure safe use of these radi- 179.26 Ionizing radiation for the treatment ation sources: of food. (1) The label of the sources shall 179.30 Radiofrequency radiation for the bear, in addition to the other informa- heating of food, including microwave fre- tion required by the Act: quencies. (i) Appropriate and accurate informa- 179.39 Ultraviolet radiation for the proc- essing and treatment of food. tion identifying the source of radi- 179.41 Pulsed light for the treatment of ation. food. (ii) The maximum energy of radi- 179.43 Carbon dioxide for etching food. ation emitted by X-ray tube sources.

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(iii) The maximum energy of X-radi- a food contact substance for such use ation emitted by machine source. submitted under § 170.100 of this chap- (iv) The minimum and maximum en- ter. ergy of radiation emitted by neutron (d) Radiation treatment of food shall source. conform to a scheduled process. A (2) The label or accompanying label- scheduled process for food irradiation ing shall bear: is a written procedure that ensures (i) Adequate directions for installa- that the radiation dose range selected tion and use. by the food irradiation processor is (ii) A statement that no food shall be adequate under commercial processing exposed to radiation sources listed in conditions (including atmosphere and paragraph (a) (1) and (2) of this section temperature) for the radiation to so as to receive an absorbed dose in ex- achieve its intended effect on a specific cess of 10 grays. product and in a specific facility. A (iii) A statement that no food shall food irradiation processor shall operate be exposed to a radiation source listed with a scheduled process established by in paragraph (a)(3) of this section so as qualified persons having expert knowl- to receive an absorbed dose in excess of edge in radiation processing require- 2 milligrays. ments of food and specific for that food (iv) A statement that no food shall be and for that irradiation processor’s exposed to a radiation source listed in treatment facility. paragraph (a)(4) of this section so as to (e) A food irradiation processor shall receive a dose in excess of 0.5 gray maintain records as specified in this (Gy). section for a period of time that ex- (v) A statement that no food shall be ceeds the shelf life of the irradiated exposed to a radiation source listed in food product by 1 year, up to a max- paragraph (a)(5) of this section so as to imum of 3 years, whichever period is receive a dose in excess of 0.01 gray shorter, and shall make these records (Gy). available for inspection and copy by [42 FR 14635, Mar. 15, 1977, as amended at 48 authorized employees of the Food and FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, Drug Administration. Such records 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, shall include the food treated, lot iden- Apr. 10, 2001; 69 FR 76404, Dec. 21, 2004] tification, scheduled process, evidence of compliance with the scheduled proc- § 179.25 General provisions for food ir- ess, ionizing energy source, source cali- radiation. bration, dosimetry, dose distribution in For the purposes of § 179.26, current the product, and the date of irradia- good manufacturing practice is defined tion. to include the following restrictions: (a) Any firm that treats foods with [51 FR 13399, Apr. 18, 1986, as amended at 67 ionizing radiation shall comply with FR 9585, Mar. 4, 2002; 67 FR 35731, May 21, 2002; 80 FR 56168, Sept. 17, 2015] the requirements of parts 110 and 117 of this chapter and other applicable regu- § 179.26 Ionizing radiation for the lations. treatment of food. (b) Food treated with ionizing radi- ation shall receive the minimum radi- Ionizing radiation for treatment of ation dose reasonably required to ac- foods may be safely used under the fol- complish its intended technical effect lowing conditions: and not more than the maximum dose (a) Energy sources. Ionizing radiation specified by the applicable regulation is limited to: for that use. (1) Gamma rays from sealed units of (c) Packaging materials subjected to the cobalt-60 or cesium- irradiation incidental to the radiation 137. treatment and processing of pre- (2) Electrons generated from machine packaged food shall be in compliance sources at energies not to exceed 10 with § 179.45, shall be the subject of an million electron volts. exemption for such use under § 170.39 of (3) X rays generated from machine this chapter, or shall be the subject of sources at energies not to exceed 5 mil- an effective premarket notification for lion electron volts (MeV), except as

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permitted by paragraph (a)(4) of this Use Limitations section. 7. For the sterilization of frozen, pack- Minimum dose 44 (4) X rays generated from machine aged meats used solely in the Na- kGy (4.4 Mrad). sources using tantalum or gold as the tional Aeronautics and Space Admin- Packaging mate- target material and using energies not istration space flight programs. rials used need not comply with to exceed 7.5 (MeV). § 179.25(c) pro- (b) Limitations. vided that their use is otherwise Use Limitations permitted by ap- plicable regula- 1. For control of Trichinella spiralis in Minimum dose 0.3 tions in parts 174 pork carcasses or fresh, non-heat- kiloGray (kGy) through 186 of processed cuts of pork carcasses. (30 kilorad this chapter. (krad)); maximum 8. For control of foodborne pathogens Not to exceed 4.5 dose not to ex- in, and extension of the shelf-life of, kGy maximum ceed 1 kGy (100 refrigerated or frozen, uncooked for refrigerated krad). products that are meat within the products; not to meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy 2. For growth and maturation inhibition Not to exceed 1 byproducts within the meaning of 9 maximum for fro- of fresh foods. kGy (100 krad). CFR 301.2(tt), or meat food products zen products. 3. For disinfestation of arthropod pests Do. within the meaning of 9 CFR in food. 301.2(uu), with or without nonfluid 4. For microbial disinfection of dry or Not to exceed 10 seasoning, that are otherwise com- dehydrated enzyme preparations (in- kGy (1 megarad posed solely of intact or ground cluding immobilized enzymes). (Mrad)). meat, meat byproducts, or both meat 5. For microbial disinfection of the fol- Not to exceed 30 and meat byproducts. lowing dry or dehydrated aromatic kGy (3 Mrad). 9. For control of Salmonella in fresh Not to exceed 3.0 vegetable substances when used as shell eggs.. kGy. ingredients in small amounts solely 10. For control of microbial pathogens Not to exceed 8.0 for flavoring or aroma: culinary herbs, on seeds for sprouting.. kGy. seeds, spices, vegetable seasonings 11. For the control of Vibrio bacteria Not to exceed 5.5 that are used to impart flavor but that and other foodborne microorganisms kGy. are not either represented as, or ap- in or on fresh or frozen molluscan pear to be, a vegetable that is eaten shellfish.. for its own sake, and blends of these 12. For control of food-borne pathogens Not to exceed 4.0 aromatic vegetable substances. Tur- and extension of shelf-life in fresh kGy. meric and paprika may also be irradi- iceberg lettuce and fresh spinach.. ated when they are to be used as 13. For control of foodborne pathogens, Not to exceed 4.5 color additives. The blends may con- and extension of shelf-life, in kGy. tain sodium chloride and minor unrefrigerated (as well as refrig- amounts of dry food ingredients ordi- erated) uncooked meat, meat byprod- narily used in such blends. ucts, and certain meat food products. 6. For control of food-borne pathogens Not to exceed 4.5 14. For control of food-borne pathogens Not to exceed 6.0 in fresh (refrigerated or kGy for non-fro- in, and extension of the shelf-life of, kGy. unrefrigerated) or frozen, uncooked zen products; not chilled or frozen raw, cooked, or par- poultry products that are: (1) Whole to exceed 7.0 tially cooked crustaceans or dried carcasses or disjointed portions (or kGy for frozen crustaceans (water activity less than other parts) of such carcasses that products. 0.85), with or without spices, min- are ‘‘ready-to-cook poultry’’ within the erals, inorganic salts, citrates, citric meaning of 9 CFR 381.l(b) (with or acid, and/or calcium disodium EDTA. without nonfluid seasoning; includes, e.g., ground poultry), or (2) mechani- (c) Labeling. (1) The label and label- cally separated poultry product (a finely comminuted ingredient pro- ing of retail packages of foods irradi- duced by the mechanical deboning of ated in conformance with paragraph (b) poultry carcasses or parts of car- of this section shall bear the following casses). logo along with either the statement

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‘‘Treated with radiation’’ or the when shipped to a food manufacturer statement ‘‘Treated by irradiation’’ in or processor for further processing, la- addition to information required by beling, or packing. other regulations. The logo shall be placed prominently and conspicuously [51 FR 13399, Apr. 18, 1986, as amended at 53 in conjunction with the required state- FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, ment. The radiation disclosure state- 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR ment is not required to be more promi- 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 nent than the declaration of ingredi- FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, ents required under § 101.4 of this chap- 2000; 65 FR 64607, Oct. 30, 2000; 69 FR 76846, ter. As used in this provision, the term Dec. 23, 2004; 70 FR 48072, Aug. 16, 2005; 73 FR ‘‘radiation disclosure statement’’ 49603, Aug. 22, 2008; 77 FR 71316, 71321, Nov. 30, means the written statement that dis- 2012; 79 FR 20779, Apr. 14, 2014] closes that a food has been inten- tionally subject to irradiation. § 179.30 Radiofrequency radiation for (2) For irradiated foods not in pack- the heating of food, including age form, the required logo and phrase microwave frequencies. ‘‘Treated with radiation’’ or ‘‘Treated Radiofrequency radiation, including by irradiation’’ shall be displayed to microwave frequencies, may be safely the purchaser with either (i) the label- used for heating food under the fol- ing of the bulk container plainly in view or (ii) a counter sign, card, or lowing conditions: other appropriate device bearing the (a) The radiation source consists of information that the product has been electronic equipment producing radio treated with radiation. As an alter- waves with specific frequencies for this native, each item of food may be indi- purpose authorized by the Federal vidually labeled. In either case, the in- Communications Commission. formation must be prominently and (b) The radiation is used or intended conspicuously displayed to purchasers. for use in the production of heat in The labeling requirement applies only food wherever heat is necessary and ef- to a food that has been irradiated, not fective in the treatment or processing to a food that merely contains an irra- of food. diated ingredient but that has not itself been irradiated. § 179.39 Ultraviolet radiation for the (3) For a food, any portion of which is processing and treatment of food. irradiated in conformance with para- Ultraviolet radiation for the proc- graph (b) of this section, the label and essing and treatment of food may be labeling and invoices or bills of lading shall bear either the statement safely used under the following condi- ‘‘Treated with radiation—do not irra- tions: diate again’’ or the statement ‘‘Treated (a) The radiation sources consist of by irradiation—do not irradiate again’’ low pressure mercury lamps emitting

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90 percent of the emission at a wave- (b) The ultraviolet radiation is used length of 253.7 nanometers (2,537 or intended for use as follows: Angstroms).

Irradiated food Limitations Use

Food and food products ...... Without ozone production: high fat-content food irradiated Surface microorganism con- in vacuum or in an inert atmosphere; intensity of radi- trol. ation, 1 W (of 2,537 A. radiation) per 5 to 10 ft.2. Potable water ...... Without ozone production; coefficient of absorption, 0.19 Sterilization of water used in per cm or less; flow rate, 100 gal/h per watt of 2,537 A. food production. radiation; water depth, 1 cm or less; lamp-operating temperature, 36 to 46 °C.. Juice products ...... Turbulent flow through tubes with a minimum Reynolds Reduction of human patho- number of 2,200.. gens and other microorga- nisms.

[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]

§ 179.41 Pulsed light for the treatment ing, and the etched area is imme- of food. diately rewaxed after treatment; and Pulsed light may be safely used for (c) The maximum total energy to treatment of foods under the following which the etched citrus fruit is exposed conditions: from the use of the carbon dioxide laser (a) The radiation sources consist of shall not exceed 1.5 × 10¥3 J, and the flashlamps designed to emit maximum total etched surface area of broadband radiation consisting of the citrus fruit shall not exceed 0.122 wavelengths covering the range of 200 cm2. to 1,100 nanometers (nm), and operated [77 FR 34215, June 11, 2012] so that the pulse duration is no longer than 2 milliseconds (msec); (b) The treatment is used for surface Subpart C—Packaging Materials microorganism control; for Irradiated Foods (c) Foods treated with pulsed light shall receive the minimum treatment § 179.45 Packaging materials for use reasonably required to accomplish the during the irradiation of pre- intended technical effect; and packaged foods. (d) The total cumulative treatment The packaging materials identified shall not exceed 12.0 Joules/square cen- in this section may be safely subjected timeter (J/cm2.) to irradiation incidental to the radi- ation treatment and processing of pre- [61 FR 42383, Aug. 15, 1996] packaged foods, subject to the provi- § 179.43 Carbon dioxide laser for etch- sions of this section and to the require- ing food. ment that no induced radioactivity is Carbon dioxide laser light may be detectable in the packaging material safely used for etching information on itself: the surface of food under the following (a) The radiation of the food itself conditions: shall comply with regulations in this (a) The radiation source consists of a part. carbon dioxide laser designed to emit (b) The following packaging mate- pulsed infrared radiation with a wave- rials may be subjected to a dose of ra- length of 10.6 micrometers such that diation, not to exceed 10 kilograys, un- the maximum energy output of the less otherwise indicated, incidental to laser does not exceed 9.8 × 10¥3 joules the use of gamma, electron beam, or X- per square centimeter (J/cm2); radiation in the radiation treatment of (b) The carbon dioxide laser shall be prepackaged foods: used only for etching information on (1) Nitrocellulose-coated or vinyli- the skin of fresh, intact citrus fruit, dene chloride copolymer-coated cello- providing the fruit has been adequately phane complying with § 177.1200 of this washed and waxed prior to laser etch- chapter.

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(2) Glassine paper complying with percent when extracted with n-hexane § 176.170 of this chapter. at reflux temperature for 2 hours. The (3) Wax-coated paperboard complying finished film may contain adjuvant with § 176.170 of this chapter. substances used in compliance with (4) Polyolefin film prepared from one §§ 178.3740 and 181.22 through 181.30 of or more of the basic olefin polymers this chapter. complying with § 177.1520 of this chap- (9) Vinylidene chloride-vinyl chloride ter. The finished film may contain: copolymer film prepared from vinyli- (i) Adjuvant substances used in com- dene chloride-vinyl chloride basic co- pliance with §§ 178.3740 and 181.22 polymers containing not less than 70 through 181.30 of this chapter, sodium weight percent of vinylidene chloride citrate, sodium lauryl sulfate, poly- and having a viscosity of 0.50–1.50 cen- vinyl chloride, and materials as listed tipoises as determined by ASTM meth- in paragraph (d)(2)(i) of this section. od D729–81, ‘‘Standard Specification for (ii) Coatings comprising a vinylidene Vinylidene Chloride Molding Com- chloride copolymer containing a min- pounds,’’ which is incorporated by ref- imum of 85 percent vinylidene chloride erence. Copies may be obtained from with one or more of the following co- the American Society for Testing Ma- monomers: Acrylic acid, acrylonitrile, terials, 100 Barr Harbor Dr., West itaconic acid, methyl acrylate, and Conshohocken, Philadelphia, PA 19428- methyl methacrylate. 2959, or may be examined at the Na- (5) Kraft paper prepared from un- tional Archives and Records Adminis- bleached sulfate pulp to which rosin, tration (NARA). For information on complying with § 178.3870 of this chap- the availability of this material at ter, and alum may be added. The kraft NARA, call 202–741–6030, or go to: http:// paper is used only as a container for www.archives.gov/federallregister/ flour and is irradiated with a dose not codeloflfederallregulations/ exceeding 500 grays. ibrllocations.html. The finished film (6) Polyethylene terephthalate film may contain adjuvant substances used prepared from the basic polymer as de- in compliance with §§ 178.3740 and 181.22 scribed in § 177.1630(e)(4)(i) and (ii) of through 181.30 of this chapter. this chapter. The finished film may (10) Nylon 11 conforming to § 177.1500 contain: of this chapter. (i) Adjuvant substances used in com- (c) Ethylene-vinyl acetate copoly- pliance with §§ 178.3740 and 181.22 mers complying with § 177.1350 of this through 181.30 of this chapter, sodium chapter. The ethylene-vinyl acetate citrate, sodium lauryl sulfate, poly- packaging materials may be subjected vinyl chloride, and materials as listed to a dose of radiation, not to exceed 30 in paragraph (d)(2)(i) of this section. kilogray (3 megarads), incidental to (ii) Coatings comprising a vinylidene the use of gamma, electron beam, or X- chloride copolymer containing a min- radiation in the radiation treatment of imum of 85 percent vinylidene chloride packaged foods. with one or more of the following co- (d) The following packaging mate- monomers: Acrylic acid, acrylonitrile, rials may be subjected to a dose of ra- itaconic acid, methyl acrylate, and diation, not to exceed 60 kilograys inci- methyl methacrylate. dental to the use of gamma, electron (iii) Coatings consisting of poly- beam, or X-radiation in the radiation ethylene conforming to § 177.1520 of this processing of prepackaged foods: chapter. (1) Vegetable parchments, consisting (7) Polystyrene film prepared from of a cellulose material made from styrene basic polymer. The finished waterleaf paper (unsized) treated with film may contain adjuvant substances concentrated sulfuric acid, neutralized, used in compliance with §§ 178.3740 and and thoroughly washed with distilled 181.22 through 181.30 of this chapter. water. (8) Rubber hydrochloride film pre- (2) Films prepared from basic poly- pared from rubber hydrochloride basic mers and with or without adjuvants, as polymer having a chlorine content of follows: 30–32 weight percent and having a max- (i) Polyethylene film prepared from imum extractable fraction of 2 weight the basic polymer as described in

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§ 177.1520(a) of this chapter. The fin- ished film may contain one or more of the following added substances:

Substances Limitations

Amides of erucic, linoleic, oleic, palmitic, and stearic acid ...... Not to exceed 1 pct by weight of the polymer. BHA as described in § 172.110 of this chapter ...... Do. BHT as described in § 172.115 of this chapter ...... Do. Calcium and sodium propionates ...... Do. Petroleum wax as described in § 178.3710 of this chapter ...... Do. Polypropylene, noncrystalline, as described in § 177.1520(c) of Not to exceed 2 pct by weight of the polymer. this chapter. Stearates of aluminum, calcium, magnesium, potassium, and Not to exceed 1 pct by weight of the polymer. sodium as described in § 172.863(a) of this chapter. Triethylene glycol as described in § 178.3740(b) of this chapter Do. Mineral oil as described in § 178.3620 (a) or (b) of this chapter Do.

(ii) Polyethylene terephthalate film PART 180—FOOD ADDITIVES PER- prepared from the basic polymer as de- MITTED IN FOOD OR IN CON- scribed in § 177.1630(e)(4)(ii) of this TACT WITH FOOD ON AN IN- chapter. The finished film may contain one or more of the added substances TERIM BASIS PENDING ADDI- listed in paragraph (d)(2)(i) of this sec- TIONAL STUDY tion. (iii) Nylon 6 films prepared from the Subpart A—General Provisions nylon 6 basic polymer as described in Sec. § 177.1500(a)(6) of this chapter and meet- 180.1 General. ing the specifications of item 6.1 of the table in § 177.1500(b) of this chapter. Subpart B—Specific Requirements for The finished film may contain one or Certain Food Additives more of the added substances listed in paragraph (d)(2)(i) of this section. 180.22 Acrylonitrile copolymers. (iv) Vinyl chloride-vinyl acetate co- 180.25 Mannitol. polymer film prepared from the basic 180.30 Brominated vegetable oil. 180.37 Saccharin, ammonium saccharin, cal- copolymer containing 88.5 to 90.0 cium saccharin, and sodium saccharin. weight percent of vinyl chloride with 10.0 to 11.5 weight percent of vinyl ace- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; tate and having a maximum volatility 42 U.S.C. 241. of not over 3.0 percent (1 hour at 105 °C) EDITORIAL NOTE: Nomenclature changes to and viscosity not less than 0.30 deter- part 180 appear at 61 FR 14482, Apr. 2, 1996, 66 mined by ASTM method D1243–79, FR 56035, Nov. 6, 2001, 81 FR 49896, July 29, ‘‘Standard Test Method for Dilute So- 2016. lution Viscosity of Vinyl Chloride Polymers,’’ Method A, which is incor- Subpart A—General Provisions porated by reference. The availability of this incorporation by reference is § 180.1 General. given in paragraph (b)(9) of this sec- (a) Substances having a history of tion. The finished film may contain use in food for human consumption or one or more of the added substances in food contact surfaces may at any listed in paragraph (d)(2)(i) of this sec- time have their safety or functionality tion. brought into question by new informa- (e) Acrylonitrile copolymers identi- tion that in itself is not conclusive. An fied in this section shall comply with interim food additive regulation for the provisions of § 180.22 of this chap- the use of any such substance may be ter. promulgated in this subpart when new information raises a substantial ques- [42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, tion about the safety or functionality 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, of the substance but there is a reason- Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR able certainty that the substance is 10575, Feb. 16, 2001] not harmful and that no harm to the

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public health will result from the con- Commissioner shall include, with re- tinued use of the substance for a lim- spect to each study, either a statement ited period of time while the question that the study has been or will be con- raised is being resolved by further ducted in compliance with the good study. laboratory practice regulations as set (b) No interim food additive regula- forth in part 58 of this chapter, or, if tion may be promulgated if the new in- any such study was not conducted in formation is conclusive with respect to compliance with such regulations, a the question raised or if there is a rea- brief statement of the reason for the sonable likelihood that the substance noncompliance. is harmful or that continued use of the (5) [Reserved] substance will result in harm to the (6) If clinical investigations involving public health. human subjects are involved, such in- (c) The Commissioner, on his own ini- vestigations filed with the Commis- tiative or on the petition of any inter- sioner shall include, with respect to ested person, pursuant to part 10 of this each investigation, a statement that chapter, may propose an interim food the investigation either was conducted additive regulation. A final order pro- in compliance with the requirements mulgating an interim food additive for institutional review set forth in regulation shall provide that continued part 56 of this chapter, or was not sub- use of the substance in food is subject ject to such requirements in accord- to each of the following conditions: ance with §§ 56.104 or 56.105, and that it (1) Use of the substance in food or has been or will be conducted in com- food contact surfaces must comply pliance with the requirements for in- with whatever limitations the Commis- formed consent set forth in part 50 of sioner deems to be appropriate under this chapter. the circumstances. (d) Promptly upon completion of the (2) Within 60 days following the effec- studies undertaken on the substance, tive date of the regulation, an inter- the Commissioner will review all avail- ested person shall satisfy the Commis- able data, will terminate the interim sioner in writing that studies adequate food additive regulation, and will ei- and appropriate to resolve the ques- ther issue a food additive regulation or tions raised about the substance have will require elimination of the sub- been undertaken, or the Food and Drug stance from the food supply. Administration may undertake the (e) The Commissioner may consult studies. The Commissioner may extend with advisory committees, professional this 60-day period if necessary to re- organizations, or other experts in the view and act on proposed protocols. If field, in evaluating: no such commitment is made, or ade- (1) Whether an interim food additive quate and appropriate studies are not regulation is justified, undertaken, an order shall imme- (2) The type of studies necessary and diately be published in the FEDERAL appropriate to resolve questions raised REGISTER revoking the interim food ad- about a substance, ditive regulation effective upon publi- (3) Whether interim results indicate cation. the reasonable likelihood that a health (3) A progress report shall be filed on hazard exists, or the studies every January 1 and July 1 (4) Whether the data available at the until completion. If the progress report conclusion of those studies justify a is inadequate or if the Commissioner food additive regulation. concludes that the studies are not (f) Where appropriate, an emergency being pursued promptly and diligently action level may be issued for a sub- or if interim results indicate a reason- stance subject to paragraph (a) of this able likelihood that a health hazard ex- section that is not an approved food ad- ists, an order will promptly be pub- ditive, pending the issuance of a final lished in the FEDERAL REGISTER revok- interim food additive regulation. Such ing the interim food additive regula- an action level shall be issued pursuant tion effective upon publication. to sections 306 and 402(a) of the act to (4) If nonclinical laboratory studies identify, based upon available data, a are involved, studies filed with the safe level of use for the substance.

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Such an action level shall be issued in food contact surface—0.3 part per mil- a notice published in the FEDERAL REG- lion calculated on the basis of the vol- ISTER and shall be followed as soon as ume of the container when extracted to practicable by a proposed interim food equilibrium at 120 °F with food-simu- additive regulation. Where the avail- lating solvents appropriate to the in- able data do not permit establishing an tended conditions of use. action level for the safe use of a sub- (3) In the case of repeated-use arti- stance, use of the substance may be cles—0.003 milligram/square inch when prohibited. The identification of a pro- extracted at a time equivalent to ini- hibited substance may be made in part tial batch usage utilizing food-simu- 189 of this chapter when appropriate. lating solvents and temperatures ap- propriate to the intended conditions of [42 FR 14636, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, use. 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, The food-simulating solvents shall in- Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR clude, where applicable, distilled 39634, Sept. 27, 1989] water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either n- Subpart B—Specific Requirements heptane or an appropriate oil or fat. for Certain Food Additives (b) Where necessary, current regula- tions permitting the use of acrylo- § 180.22 Acrylonitrile copolymers. nitrile copolymers shall be revised to Acrylonitrile copolymers may be specify limitations on acrylonitrile/ safely used on an interim basis as arti- mercaptan complexes utilized in the cles or components of articles intended production of acrylonitrile copolymers. for use in contact with food, in accord- Such copolymers, if they contain re- ance with the following prescribed con- versible acrylonitrile/mercaptan com- ditions: plexes and are used in other than re- (a) Limitations for acrylonitrile peated-use conditions, shall be tested monomer extraction for finished food- to determine the identity of the com- contact articles, determined by a plex and the level of the complex method of analysis titled ‘‘Gas-Solid present in the food-contact article. Chromatographic Procedure for Deter- Such testing shall include determina- mining Acrylonitrile Monomer in Ac- tion of the rate of decomposition of the rylonitrile-Containing Polymers and complex at temperatures of 100 °F, 160 Food Simulating Solvents,’’ which is °F, and 212 °F using 3 percent acetic incorporated by reference. Copies are acid as the hydrolic agent. Acrylo- available from the Center for Food nitrile monomer levels, acrylonitrile/ Safety and Applied Nutrition (HFS– mercaptan complex levels, acrylo- 200), Food and Drug Administration, nitrile levels, descriptions of 5001 Campus Dr., College Park, MD the analytical methods used to deter- 20740, or available for inspection at the mine the complex and the acrylonitrile National Archives and Records Admin- migration, and validation studies of istration (NARA). For information on these analytical methods shall be sub- the availability of this material at mitted by June 9, 1977, to the Center NARA, call 202–741–6030, or go to: http:// for Food Safety and Applied Nutrition www.archives.gov/federallregister/ (HFS–200), Food and Drug Administra- codeloflfederallregulations/ tion, 5001 Campus Dr., College Park, ibrllocations.html. MD 20740, unless an extension is grant- (1) In the case of single-use articles ed by the Food and Drug Administra- having a volume to surface ratio of 10 tion for good cause shown. Analytical milliliters or more per square inch of methods for the determination of acry- food contact surface—0.003 milligram/ lonitrile complexes with n-dodecyl- square inch when extracted to equi- mercaptan, n-octyl mercaptan, and 2- librium at 120 °F with food-simulating mercaptoethanol, titled ‘‘Determina- solvents appropriate to the intended tion of b-Dodecyl- conditions of use. mercaptopropionitrile in NR–16R Aque- (2) In the case of single-use articles ous Extracts’’ and ‘‘Measurement of b- having a volume to surface ratio of less (2-Hdroxyethylmercapto) Propionitrile than 10 milliliters per square inch of in Heptane Food-Simulating Solvent,’’

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are incorporated by reference. Copies tween acrylonitrile monomer and cya- are available from the Center for Food nide ion, and (6) a literature search on Safety and Applied Nutrition (HFS– the effects of chronic ingestion of hy- 200), Food and Drug Administration, drogen cyanide. Data on levels of acryl- 5001 Campus Dr., College Park, MD amide extractable from acrylonitrile 20740, or available for inspection at the copolymers shall also be submitted. National Archives and Records Admin- Protocols of testing should be sub- istration (NARA). For information on mitted for review to the Center for the availability of this material at Food Safety and Applied Nutrition NARA, call 202–741–6030, or go to: http:// (HFS–200), Food and Drug Administra- www.archives.gov/federallregister/ tion, 5001 Campus Dr., College Park, codeloflfederallregulations/ MD 20740. ibrllocations.html. (f) Acrylonitrile copolymers may be (c) The following data shall be pro- used in contact with food only if au- vided for finished food-contact articles thorized in parts 174 through 179 or intended for repeated use: § 181.32 of this chapter, except that (1) Qualitative and quantitative mi- other uses of acrylonitrile copolymers gration values at a time equivalent to in use prior to June 14, 1976, may con- initial batch usage, utilizing solvents tinue under the following conditions: and temperatures appropriate to the (1) On or before August 13, 1976, each intended conditions of use. use of acrylonitrile copolymers in a (2) Qualitative and quantitative mi- manner not authorized by § 181.32 of gration values at the time of equi- this chapter or parts 174 through 179 of librium extractions, utilizing solvents this chapter shall be the subject of a and temperatures appropriate to the notice to the Center for Food Safety intended conditions of use. and Applied Nutrition (HFS–200), Food (3) Data on the volume and/or weight and Drug Administration, 5001 Campus of food handled during the initial batch Dr., College Park, MD 20740. Such no- time period(s), during the equilibrium tice shall be accompanied by a state- test period, and over the estimated life ment of the basis, including any arti- of the food-contact surface. cles and correspondence, on which the (d) Where acrylonitrile copolymers user in good faith believed the use to represent only a minor component of a be prior-sanctioned. The Commissioner polymer system, calculations based on of Food and Drugs shall, by notice in 100 percent migration of the acrylo- the FEDERAL REGISTER, identify any nitrile component may be submitted in use of acrylonitrile copolymers not in lieu of the requirements of paragraphs accordance with this paragraph. Those (a), (b), and (c) of this section in sup- uses are thereafter unapproved food ad- port of the continued safe use of acry- ditives and consequently unlawful. lonitrile copolymers. (2) Any use of acrylonitrile copoly- (e) On or before September 13, 1976, mers subject to paragraph (f)(1) of this any interested person shall satisfy the section shall be the subject of a peti- Commissioner of Food and Drugs that tion submitted on or before December toxicological feeding studies adequate 13, 1976, in accordance with § 171.1 of and appropriate to establish safe condi- this chapter, unless an extension of tions for the use of acrylonitrile co- time is granted by the Food and Drug polymers have been, or soon will be, Administration for good cause shown. undertaken. Toxicity studies of acrylo- Any application for extension shall be nitrile monomer shall include: (1) Life- by petition submitted in accordance time feeding studies with a mamma- with the requirements of part 10 of this lian species, preferably with animals chapter. If a petition is denied, in exposed in utero to the chemical, (2) whole or in part, those uses subject to studies of multigeneration reproduc- the denial are thereafter unapproved tion with oral administration of the food additives and consequently unlaw- test material, (3) assessment of ful. teratogenic and mutagenic potentials, (3) Any use of acrylonitrile copoly- (4) subchronic oral administration in a mers subject to paragraph (f)(1) of this nonrodent mammal, (5) tests to deter- section shall meet the acrylonitrile mine any synergistic toxic effects be- monomer extraction limitation set

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forth in paragraph (a) of this section in § 170.3(o)(24) of this chapter, sta- and shall be subject to the require- bilizer and thickener as defined in ments of paragraph (b) of this section. § 170.3(o)(28) of this chapter, surface-fin- (g) In addition to the requirements of ishing agent as defined in § 170.3(o)(30) this section, the use of acrylonitrile co- of this chapter, and texturizer as de- polymers shall comply with all applica- fined in § 170.3(o)(32) of this chapter. ble requirements in other regulations (d) The ingredient is used in food at in this part. levels not to exceed 98 percent in pressed mints and 5 percent in all other [42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, hard candy and cough drops as defined 1989; 61 FR 14246, Apr. 1, 1996] in § 170.3(n)(25) of this chapter, 31 per- cent in chewing gum as defined in § 180.25 Mannitol. § 170.3(n)(6) of this chapter, 40 percent (a) Mannitol is the chemical in soft candy as defined in § 170.3(n)(38) of this chapter, 8 percent in confections 1,2,3,4,5,6,-hexanehexol (C6H14O6) a hexahydric alcohol, differing from sor- and frostings as defined in § 170.3(n)(9) bitol principally by having a different of this chapter, 15 percent in non- optical rotation. Mannitol is produced standardized jams and jellies, commer- by one of the following processes: cial, as defined in § 170.3(n)(28) of this (1) The electrolytic reduction or chapter, and at levels less than 2.5 per- transition metal catalytic hydro- cent in all other foods. genation of sugar solutions containing (e) The label and labeling of food glucose or fructose. whose reasonably foreseeable consump- (2) The fermentation of sugars or tion may result in a daily ingestion of sugar alcohols such as glucose, sucrose, 20 grams of mannitol shall bear the fructose, or sorbitol using the yeast statement ‘‘Excess consumption may Zygosaccharomyces rouxii. have a laxative effect’’. (3) A pure culture fermentation of (f) In accordance with § 180.1, ade- sugars such as fructose, glucose, or quate and appropriate feeding studies maltose using the nonpathogenic, have been undertaken for this sub- nontoxicogenic bacterium stance. Continued uses of this ingre- intermedius (fermentum). dient are contingent upon timely and (b) The ingredient meets the speci- adequate progress reports of such tests, fications of the ‘‘Food Chemicals and no indication of increased risk to Codex,’’ 3d Ed. (1981), pp. 188–190, which public health during the test period. is incorporated by reference. Copies (g) Prior sanctions for this ingredient may be obtained from the National different from the uses established in Academy Press, 2101 Constitution Ave. this regulation do not exist or have NW., Washington, DC 20418, or may be been waived. examined at the National Archives and [42 FR 14636, Mar. 15, 1977, as amended at 49 Records Administration (NARA). For FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996; information on the availability of this 69 FR 65542, Nov. 15, 2004] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 180.30 Brominated vegetable oil. federallregister/ The food additive brominated vege- codeloflfederallregulations/ table oil may be safely used in accord- ibrllocations.html. ance with the following prescribed con- (c) The ingredient is used as an ditions: anticaking agent and free-flow agent as (a) The additive complies with speci- defined in § 170.3(o)(1) of this chapter, fications prescribed in the ‘‘Food formulation aid as defined in § 170.3(o) Chemicals Codex,’’ 3d Ed. (1981), pp. 40– (14) of this chapter, firming agent as 41, which is incorporated by reference, defined in § 170.3(o)(10) of this chapter, except that free fatty acids (as oleic) flavoring agent and adjuvant as defined shall not exceed 2.5 percent and iodine in § 170.3(o)(12) of this chapter, lubri- value shall not exceed 16. Copies of the cant and release agent as defined in material incorporated by reference § 170.3(o)(18) of this chapter, nutritive may be obtained from the National sweetener as defined in § 170.3(o)(21) of Academy Press, 2101 Constitution Ave. this chapter, processing aid as defined NW., Washington, DC 20418, or may be

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examined at the National Archives and Main Library, 10903 New Hampshire Records Administration (NARA). For Ave., Bldg. 2, Third Floor, Silver information on the availability of this Spring, MD 20993, 301–796–2039, or at the material at NARA, call 202–741–6030, or National Archives and Records Admin- go to: http://www.archives.gov/ istration (NARA). For information on federallregister/ the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030 or go to: http:// ibrllocations.html. www.archives.gov/federal-register/cfr/ibr- (b) The additive is used on an interim locations.html. basis as a stabilizer for flavoring oils (c) Authority for such use shall ex- used in fruit-flavored beverages, for pire when the Commissioner receives which any applicable standards of iden- the final reports on the ongoing studies tity do not preclude such use, in an in Canada and publishes an order on amount not to exceed 15 parts per mil- the safety of saccharin and its salts lion in the finished beverage, pending based on those reports and other avail- the outcome of additional toxicological able data. studies on which periodic reports at 6- month intervals are to be furnished (d) The additives are used or intended and final results submitted to the Food for use as a sweetening agent only in and Drug Administration promptly special dietary foods, as follows: after completion of the studies. (1) In beverages, fruit juice drinks, and bases or mixes when prepared for [42 FR 14636, Mar. 15, 1977, as amended at 49 consumption in accordance with direc- FR 5610, Feb. 14, 1984] tions, in amounts not to exceed 12 mil- § 180.37 Saccharin, ammonium sac- ligrams of the additive, calculated as charin, calcium saccharin, and so- saccharin, per fluid ounce. dium saccharin. (2) As a sugar substitute for cooking The food additives saccharin, ammo- or table use, in amounts not to exceed nium saccharin, calcium saccharin, and 20 milligrams of the additive, cal- sodium saccharin may be safely used as culated as saccharin, for each ex- sweetening agents in food in accord- pressed teaspoonful of sugar sweet- ance with the following conditions, if ening equivalency. the substitution for nutritive sweet- (3) In processed foods, in amounts not eners is for a valid special dietary pur- to exceed 30 milligrams of the additive, pose and is in accord with current spe- calculated as saccharin, per serving of cial dietary food regulations and poli- designated size. cies or if the use or intended use is for (e) The additives are used or intended an authorized technological purpose for use only for the following techno- other than calorie reduction: logical purposes: (a) Saccharin is the chemical, 1,2- (1) To reduce bulk and enhance fla- benzisothiazolin-3-one - 1,1 - dioxide vors in chewable vitamin tablets, (C7H5NO3S). The named salts of sac- chewable mineral tablets, or combina- charin are produced by the additional tions thereof. neutralization of saccharin with the (2) To retain flavor and physical proper base to yield the desired salt. properties of chewing gum. (b) The food additives meet the speci- (3) To enhance flavor of flavor chips fications of the Food Chemicals Codex, 7th ed. (2010), pp. 52–54, 153–154, 898–899, used in nonstandardized bakery prod- 961–962, which is incorporated by ref- ucts. erence. The Director of the Office of (f) To assure safe use of the additives, the Federal Register approves this in- in addition to the other information re- corporation by reference in accordance quired by the Act: with 5 U.S.C. 552(a) and 1 CFR part 51. (1) The label of the additive and any You may obtain copies from the United intermediate mixes of the additive for States Pharmacopeial Convention, manufacturing purposes shall bear: 12601 Twinbrook Pkwy., Rockville, MD (i) The name of the additive. 20852 (Internet address http:// (ii) A statement of the concentration www.usp.org). Copies may be examined of the additive, expressed as saccharin, at the Food and Drug Administration’s in any intermediate mix.

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(iii) Adequate directions for use to EDITORIAL NOTE: Nomenclature changes to provide a final food product that com- part 181 appear at 61 FR 14482, Apr. 2, 1996, plies with the limitations prescribed in and 66 FR 56035, Nov. 6, 2001. paragraphs (d) and (e) of this section. (2) The label of any finished food Subpart A—General Provisions product containing the additive shall bear: § 181.1 General. (i) The name of the additive. (a) An ingredient whose use in food (ii) The amount of the additive, cal- or food packaging is subject to a prior culated as saccharin, as follows: sanction or approval within the mean- (a) For beverages, in milligrams per ing of section 201(s)(4) of the Act is ex- empt from classification as a food addi- fluid ounce; tive. The Commissioner will publish in (b) For cooking or table use products, this part all known prior sanctions. in milligrams per dispensing unit; Any interested person may submit to (c) For processed foods, in terms of the Commissioner a request for publi- the weight or size of a serving which cation of a prior sanction, supported by shall be that quantity of the food con- evidence to show that it falls within taining 30 milligrams or less of the ad- section 201(s)(4) of the Act. ditive. (b) Based upon scientific data or in- (iii) When the additive is used for cal- formation that shows that use of a orie reduction, such other labeling as is prior-sanctioned food ingredient may required by part 105 of this chapter. be injurious to health, and thus in vio- [42 FR 14636, Mar. 15, 1977, as amended at 49 lation of section 402 of the Act, the FR 5610, Feb. 14, 1984; 72 FR 10357, Mar. 8, Commissioner will establish or amend 2007; 78 FR 71467, Nov. 29, 2013] an applicable prior sanction regulation to impose whatever limitations or con- PART 181—PRIOR-SANCTIONED ditions are necessary for the safe use of the ingredient, or to prohibit use of the FOOD INGREDIENTS ingredient. (c) Where appropriate, an emergency Subpart A—General Provisions action level may be issued for a prior- Sec. sanctioned substance, pending the 181.1 General. issuance of a final regulation in ac- 181.5 Prior sanctions. cordance with paragraph (b) of this sec- tion. Such an action level shall be Subpart B—Specific Prior-Sanctioned Food issued pursuant to section 402(a) of the Ingredients Act to identify, based upon available data, conditions of use of the substance 181.22 Certain substances employed in the that may be injurious to health. Such manufacture of food-packaging mate- an action level shall be issued in a no- rials. 181.23 Antimycotics. tice published in the FEDERAL REG- 181.24 Antioxidants. ISTER and shall be followed as soon as 181.25 Driers. practicable by a proposed regulation in 181.26 Drying oils as components of finished accordance with paragraph (b) of this resins. section. Where the available data dem- 181.27 Plasticizers. onstrate that the substance may be in- 181.28 Release agents. jurious at any level, use of the sub- 181.29 Stabilizers. stance may be prohibited. The identi- 181.30 Substances used in the manufacture fication of a prohibited substance may of paper and paperboard products used in be made in part 189 of this chapter food packaging. when appropriate. 181.32 Acrylonitrile copolymers and resins. 181.33 Sodium nitrate and potassium ni- [42 FR 14638, Mar. 15, 1977, as amended at 42 trate. FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, 181.34 Sodium nitrite and potassium nitrite. 1989]

AUTHORITY: 21 U.S.C. 321, 342, 348, 371. § 181.5 Prior sanctions.

SOURCE: 42 FR 14638, Mar. 15, 1977, unless (a) A prior sanction shall exist only otherwise noted. for a specific use(s) of a substance in

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food, i.e., the level(s), condition(s), porating the same provisions, in the product(s), etc., for which there was ex- event that such a regulation is deter- plicit approval by the Food and Drug mined to be appropriate as a result of Administration or the United States submission of proof of such an applica- Department of Agriculture prior to ble prior sanction in response to the September 6, 1958. proposal. (b) The existence of a prior sanction exempts the sanctioned use(s) from the Subpart B—Specific Prior- food additive provisions of the Act but Sanctioned Food Ingredients not from the other adulteration or the misbranding provisions of the Act. § 181.22 Certain substances employed (c) All known prior sanctions shall be in the manufacture of food-pack- the subject of a regulation published in aging materials. this part. Any such regulation is sub- Prior to the enactment of the food ject to amendment to impose whatever additives amendment to the Federal limitation(s) or condition(s) may be Food, Drug, and Cosmetic Act, sanc- necessary for the safe use of the ingre- tions were granted for the usage of the dient, or revocation to prohibit use of substances listed in §§ 181.23, 181.24, the ingredient, in order to prevent the 181.25, 181.26, 181.27, 181.28, 181.29, and adulteration of food in violation of sec- 181.30 in the manufacture of packaging tion 402 of the Act. materials. So used, these substances (d) In proposing, after a general eval- are not considered ‘‘food additives’’ uation of use of an ingredient, regula- within the meaning of section 201(s) of tions affirming the GRAS status of the Act, provided that they are of good substances added directly to human commercial grade, are suitable for as- food in part 184 of this chapter or sub- sociation with food, and are used in ac- stances in food-contact surfaces in part cordance with good manufacturing 186 of this chapter, or establishing a practice. For the purpose of this sub- food additive regulation for substances part, good manufacturing practice for added directly to human food in parts food-packaging materials includes the 172 and 173 of this chapter or food addi- restriction that the quantity of any of tives in food-contact surfaces in parts these substances which becomes a com- 174, 175, 176, 177, 178 and § 179.45 of this ponent of food as a result of use in chapter, the Commissioner shall, if he food-packaging materials shall not be is aware of any prior sanction for use intended to accomplish any physical or of the ingredient under conditions dif- technical effect in the food itself, shall ferent from those proposed in the regu- be reduced to the least amount reason- lation, concurrently propose a separate ably possible, and shall not exceed any regulation covering such use of the in- limit specified in this subpart. gredient under this part. If the Com- missioner is unaware of any such appli- [42 FR 56728, Oct. 28, 1977] cable prior sanction, the proposed regu- lation will so state and will require any § 181.23 Antimycotics. person who intends to assert or rely on Substances classified as such sanction to submit proof of its ex- antimycotics, when migrating from istence. Any food additive or GRAS food-packaging material shall include: regulation promulgated after a general evaluation of use of an ingredient con- Calcium propionate. stitutes a determination that excluded Methylparaben (methyl p-hydroxybenzoate). uses would result in adulteration of the Propylparaben (propyl p-hydroxybenzoate). food in violation of section 402 of the Sodium benzoate. Sodium propionate. Act, and the failure of any person to Sorbic acid. come forward with proof of such an ap- plicable prior sanction in response to a [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. proposal will constitute a waiver of the 28, 1977] right to assert or rely on such sanction at any later time. The notice will also § 181.24 Antioxidants. constitute a proposal to establish a Substances classified as antioxidants, regulation under this part, incor- when migrating from food-packaging

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material (limit of addition to food, Diisooctyl phthalate (for foods of high water 0.005 percent) shall include: content only). Diphenyl-2-ethylhexyl phosphate. Butylated hydroxyanisole. Epoxidized soybean oil (iodine number max- Butylated hydroxytoluene. imum 6; and oxirane oxygen, minimum, 6.0 Dilauryl thiodipropionate. percent). Distearyl thiodipropionate. Ethylphthalyl ethyl glycolate. Gum guaiac. Glycerol monooleate. Nordihydroguairetic acid. Monoisopropyl citrate. Propyl gallate. Mono, di-, and tristearyl citrate. Thiodipropionic acid. Triacetin (glycerol triacetate). 2,4,5-Trihydroxy butyrophenone. Triethyl citrate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 3-(2-Xenolyl)-1,2-epoxypropane. 28, 1977] [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 50 FR 49536, Dec. 3, § 181.25 Driers. 1985] Substances classified as driers, when migrating from food-packaging mate- § 181.28 Release agents. rial shall include: Substances classified as release Cobalt caprylate. agents, when migrating from food- Cobalt linoleate. packaging material shall include: Cobalt naphthenate. Cobalt tallate. Dimethylpolysiloxane (substantially free Iron caprylate. from hydrolyzable chloride and alkoxy Iron linoleate. groups, no more than 18 percent loss in ° Iron naphthenate. weight after heating 4 hours at 200 C.; vis- Iron tallate. cosity 300 centisokes, 600 centisokes at 25 ° ° Manganese caprylate. C, specific gravity 0.96 to 0.97 at 25 C, re- ° Manganese linoleate. fractive index 1.400 to 1.404 at 25 C). Manganese naphthenate. Linoleamide (linoleic acid amide). Manganese tallate. Oleamide (oleic acid amide). Palmitamide (palmitic acid amide). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Stearamide (stearic acid amide). 28, 1977] [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. § 181.26 Drying oils as components of 28, 1977] finished resins. § 181.29 Stabilizers. Substances classified as drying oils, when migrating from food-packaging Substances classified as stabilizers, material (as components of finished when migrating from food-packaging resins) shall include: material shall include: Chinawood oil (tung oil). Aluminum mono-, di-, and tristearate. Dehydrated castor oil. Ammonium citrate. Linseed oil. Ammonium potassium hydrogen phosphate. Tall oil. Calcium glycerophosphate. Calcium phosphate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Calcium hydrogen phosphate. 28, 1977] Calcium oleate. Calcium acetate. § 181.27 Plasticizers. Calcium carbonate. Substances classified as plasticizers, Calcium ricinoleate. when migrating from food-packaging Calcium stearate. material shall include: Disodium hydrogen phosphate. Magnesium glycerophosphate. Acetyl tributyl citrate. Magnesium stearate. Acetyl triethyl citrate. Magnesium phosphate. p-tert-Butylphenyl salicylate. Magnesium hydrogen phosphate. Butyl stearate. Mono-, di-, and trisodium citrate. Butylphthalyl butyl glycolate. Mono-, di-, and tripotassium citrate. Dibutyl sebacate. Potassium oleate. Di-(2-ethylhexyl) phthalate (for foods of high Potassium stearate. water content only). Sodium pyrophosphate. Diethyl phthalate. Sodium stearate. Diisobutyl adipate. Sodium tetrapyrophosphate.

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Stannous stearate (not to exceed 50 parts per Vinylidine chlorides (polymerized). million tin as a migrant in finished food). Zinc orthophosphate (not to exceed 50 parts § 181.32 Acrylonitrile copolymers and per million zinc as a migrant in finished resins. food). Zinc resinate (not to exceed 50 parts per mil- (a) Acrylonitrile copolymers and res- lion zinc as a migrant in finished food). ins listed in this section, containing less than 30 percent acrylonitrile and [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. complying with the requirements of 28, 1977] paragraph (b) of this section, may be § 181.30 Substances used in the manu- safely used as follows: facture of paper and paperboard (1) Films. (i) Acrylonitrile/butadiene/ products used in food packaging. styrene copolymers—no restrictions. Substances used in the manufacture (ii) Acrylonitrile/butadiene copoly- of paper and paperboard products used mers—no restrictions. in food packaging shall include: (iii) Acrylonitrile/butadiene copoly- mer blended with vinyl chloride-vinyl Aliphatic polyoxyethylene ethers.* acetate (optional at level up to 5 per- 1-Alkyl (C6-C18)3-amino-3-aminopropane monoacetate.* cent by weight of the vinyl chloride Borax or boric acid for use in adhesives, resin) resin—for use only in contact sizes, and coatings.* with oleomargarine. Butadiene-styrene copolymer. (iv) Acrylonitrile/styrene copoly- Chromium complex of perfluoro-octane mer—no restrictions. sulfonyl glycine for use on paper and pa- (2) Coatings. (i) Acrylonitrile/buta- perboard which is waxed.* diene copolymer blended with poly- Disodium cyanodithioimidocarbamate with ethylene diamine and potassium N-methyl vinyl chloride resins—for use only on dithiocarbamate and/or sodium 2- paper and paperboard in contact with mercaptobenzothiazole (slimicides).* meats and lard. Ethyl acrylate and methyl methacrylate co- (ii) Polyvinyl chloride resin blended polymers of itaconic acid or methacrylic with either acrylonitrile/butadiene co- acid for use only on paper and paperboard polymer or acrylonitrile/butadiene sty- which is waxed.* rene copolymer mixed with neoprene, Hexamethylene tetramine as a setting agent for protein, including casein.* for use as components of conveyor 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl belts to be used with fresh fruits, vege- (C6-C17) imidazolinium chloride.* tables, and fish. Itaconic acid (polymerized). (iii) Acrylonitrile/butadiene/styrene Melamine formaldehyde polymer. copolymer—no restrictions. Methyl acrylate (polymerized). (iv) Acrylonitrile/styrene copoly- Methyl ethers of mono-, di-, and tripropylene mer—no restrictions. glycol.* Myristo chromic chloride complex. (3) Rigid and semirigid containers. (i) Nitrocellulose. Acrylonitrile/butadiene/styrene copoly- Polyethylene glycol 400. mer—for use only as piping for han- Polyvinyl acetate. dling food products and for repeated- Potassium pentachlorophenate as a slime use articles intended to contact food. control agent.* (ii) Acrylonitrile/styrene resin—no Potassium trichlorophenate as a slime con- restrictions. trol agent.* Resins from high and low viscosity polyvinyl (iii) Acrylonitrile/butadiene copoly- alcohol for fatty foods only. mer blended with polyvinyl chloride Rubber hydrochloride. resin—for use only as extruded pipe. Sodium pentachlorophenate as a slime con- (b) Limitations for acrylonitrile trol agent.* monomer extraction for finished food- Sodium-trichlorophenate as a slime control contact articles, determined by using agent.* the method of analysis titled ‘‘Gas- Stearato-chromic chloride complex. Titanium dioxide.* Solid Chromatographic Procedure for Urea formaldehyde polymer. Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers and *Under the conditions of normal use, these Food-Simulating Solvents,’’ which is substances would not reasonably be expected incorporated by reference. Copies are to migrate to food, based on available sci- available from the Center for Food entific information and data. Safety and Applied Nutrition (HFS–

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200), Food and Drug Administration, nitrite, in the production of cured red 5001 Campus Dr., College Park, MD meat products and cured poultry prod- 20740, or available for inspection at the ucts. National Archives and Records Admin- [48 FR 1705, Jan. 14, 1983] istration (NARA). For information on the availability of this material at § 181.34 Sodium nitrite and potassium NARA, call 202–741–6030, or go to: http:// nitrite. www.archives.gov/federallregister/ Sodium nitrite and potassium nitrite codeloflfederallregulations/ are subject to prior sanctions issued by ibrllocations.html. the U.S. Department of Agriculture for (1) In the case of single-use articles use as color fixatives and preservative having a volume to surface ratio of 10 milliliters or more per square inch of agents, with or without sodium or po- food-contact surface—0.003 milligram/ tassium nitrate, in the curing of red square inch when extracted to equi- meat and poultry products. librium at 120 °F with food-simulating [48 FR 1705, Jan. 14, 1983] solvents appropriate to the intended conditions of use. PART 182—SUBSTANCES (2) In the case of single-use articles GENERALLY RECOGNIZED AS SAFE having a volume to surface ratio of less than 10 milliliters per square inch of Subpart A—General Provisions food-contact surface—0.3 part per mil- lion calculated on the basis of the vol- Sec. ume of the container when extracted to 182.1 Substances that are generally recog- equilibrium at 120 °F with food-simu- nized as safe. lating solvents appropriate to the in- 182.10 Spices and other natural seasonings tended conditions of use. and flavorings. 182.20 Essential oils, oleoresins (solvent- (3) In the case of repeated-use arti- free), and natural extractives (including cles—0.003 milligram/square inch when distillates). extracted at a time equivalent to ini- 182.40 Natural extractives (solvent-free) tial batch usage utilizing food-simu- used in conjunction with spices, lating solvents and temperatures ap- seasonings, and flavorings. propriate to the intended conditions of 182.50 Certain other spices, seasonings, es- use. sential oils, oleoresins, and natural ex- tracts. The food-simulating solvents shall in- 182.60 Synthetic flavoring substances and clude, where applicable, distilled adjuvants. water, 8 percent or 50 percent ethanol, 182.70 Substances migrating from cotton 3 percent acetic acid, and either n- and cotton fabrics used in dry food pack- heptane or an appropriate oil or fat. aging. (c) Acrylonitrile monomer may 182.90 Substances migrating to food from paper and paperboard products. present a hazard to health when in- 182.99 Adjuvants for pesticide chemicals. gested. Accordingly, any food-contact article containing acrylonitrile copoly- Subpart B—Multiple Purpose GRAS Food mers or resins that yield acrylonitrile Substances monomer in excess of that amount pro- vided for in paragraph (b) of this sec- 182.1045 Glutamic acid. tion shall be deemed to be adulterated 182.1047 Glutamic acid hydrochloride. in violation of section 402 of the Act. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. [42 FR 14638, Mar. 15, 1977, as amended at 47 182.1087 Sodium acid pyrophosphate. FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 182.1125 Aluminum sulfate. 1989] 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. § 181.33 Sodium nitrate and potassium 182.1131 Aluminum sodium sulfate. nitrate. 182.1180 Caffeine. Sodium nitrate and potassium ni- 182.1217 Calcium phosphate. 182.1235 Caramel. trate are subject to prior sanctions 182.1320 Glycerin. issued by the U.S. Department of Agri- 182.1480 Methylcellulose. culture for use as sources of nitrite, 182.1500 Monoammonium glutamate. with or without sodium or potassium 182.1516 Monopotassium glutamate.

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182.1711 Silica aerogel. 182.8159 Biotin. 182.1745 Sodium carboxymethylcellulose. 182.8217 Calcium phosphate. 182.1748 Sodium caseinate. 182.8223 Calcium pyrophosphate. 182.1778 Sodium phosphate. 182.8250 Choline bitartrate. 182.1781 Sodium aluminum phosphate. 182.8252 Choline chloride. 182.1810 Sodium tripolyphosphate. 182.8778 Sodium phosphate. 182.8890 Tocopherols. Subpart C—Anticaking Agents 182.8892 a-Tocopherol acetate. 182.2122 Aluminum calcium silicate. 182.8985 Zinc chloride. 182.2227 Calcium silicate. 182.8988 . 182.2437 Magnesium silicate. 182.8991 Zinc oxide. 182.2727 Sodium aluminosilicate. 182.8994 Zinc stearate. 182.2729 Sodium calcium aluminosilicate, 182.8997 Zinc sulfate. hydrated. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 182.2906 Tricalcium silicate. SOURCE: 42 FR 14640, Mar. 15, 1977, unless Subpart D—Chemical Preservatives otherwise noted. 182.3013 Ascorbic acid. 182.3041 Erythorbic acid. Subpart A—General Provisions 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. § 182.1 Substances that are generally 182.3149 Ascorbyl palmitate. recognized as safe. 182.3169 Butylated hydroxyanisole. (a) It is impracticable to list all sub- 182.3173 Butylated hydroxytoluene. stances that are generally recognized 182.3189 Calcium ascorbate. 182.3225 Calcium sorbate. as safe for their intended use. However, 182.3280 Dilauryl thiodipropionate. by way of illustration, the Commis- 182.3616 Potassium bisulfite. sioner regards such common food in- 182.3637 Potassium metabisulfite. gredients as salt, pepper, vinegar, bak- 182.3640 Potassium sorbate. ing powder, and monosodium glu- 182.3731 Sodium ascorbate. tamate as safe for their intended use. 182.3739 Sodium bisulfite. This part includes additional sub- 182.3766 Sodium metabisulfite. 182.3795 Sodium sorbate. stances that, when used for the pur- 182.3798 Sodium sulfite. poses indicated, in accordance with 182.3862 . good manufacturing practice, are re- 182.3890 Tocopherols. garded by the Commissioner as generaly recognized as safe for such Subpart E—Emulsifying Agents [Reserved] uses. (b) For the purposes of this section, Subpart F—Dietary Supplements good manufacturing practice shall be [Reserved] defined to include the following re- Subpart G—Sequestrants strictions: (1) The quantity of a substance added 182.6085 Sodium acid phosphate. to food does not exceed the amount 182.6197 Calcium diacetate. reasonably required to accomplish its 182.6203 Calcium hexametaphosphate. 182.6215 Monobasic calcium phosphate. intended physical, nutritional, or other 182.6285 Dipotassium phosphate. technical effect in food; and 182.6290 Disodium phosphate. (2) The quantity of a substance that 182.6757 Sodium gluconate. becomes a component of food as a re- 182.6760 Sodium hexametaphosphate. sult of its use in the manufacturing, 182.6769 Sodium metaphosphate. processing, or packaging of food, and 182.6778 Sodium phosphate. which is not intended to accomplish 182.6787 Sodium pyrophosphate. any physical or other technical effect 182.6789 Tetra sodium pyrophosphate. 182.6810 Sodium tripolyphosphate. in the food itself, shall be reduced to the extent reasonably possible. Subpart H—Stabilizers (3) The substance is of appropriate food grade and is prepared and handled 182.7255 Chondrus extract. as a food ingredient. Upon request the Commissioner will offer an opinion, Subpart I—Nutrients based on specifications and intended 182.8013 Ascorbic acid. use, as to whether or not a particular

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grade or lot of the substance is of suit- ‘‘affirmed as GRAS’’ under part 184 or able purity for use in food and would 186 of this chapter; ‘‘food additive regu- generally be regarded as safe for the lation’’ under parts 170 through 180 of purpose intended, by experts qualified this chapter; ‘‘interim food additive to evaluate its safety. regulation’’ under part 180 of this chap- (c) The inclusion of substances in the ter; or ‘‘prohibited from use in food’’ list of nutrients does not constitute a under part 189 of this chapter. finding on the part of the Department that the substance is useful as a sup- [42 FR 14640, Mar. 15, 1977, as amended at 53 plement to the diet for humans. FR 44875, Nov. 7, 1988] (d) Substances that are generally rec- ognized as safe for their intended use § 182.10 Spices and other natural within the meaning of section 409 of seasonings and flavorings. the act are listed in this part. When Spices and other natural seasonings the status of a substance has been re- and flavorings that are generally rec- evaluated, it will be deleted from this ognized as safe for their intended use, part, and will be issued as a new regu- within the meaning of section 409 of lation under the appropriate part, e.g., the Act, are as follows:

Common name Botanical name of plant source

Alfalfa herb and seed ...... Medicago sativa L. ...... Pimenta officinalis Lindl. Ambrette seed ...... Hibiscus abelmoschus L. Angelica ...... Angelica archangelica L. or other spp. of Angelica. Angelica root ...... Do. Angelica seed ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Anise, star ...... Illicium verum Hook. f. Balm (lemon balm) ...... Melissa officinalis L. Basil, bush ...... Ocimum minimum L. Basil, sweet ...... Ocimum basilicum L. Bay ...... Laurus nobilis L. Calendula ...... Calendula officinalis L. Camomile (chamomile), English or Roman ...... Anthemis nobilis L. Camomile (chamomile), German or Hungarian ...... Matricaria chamomilla L. Capers ...... Capparis spinosa L. Capsicum ...... Capsicum frutescens L. or Capsicum annuum L. Caraway ...... Carum carvi L. Caraway, black (black cumin) ...... Nigella sativa L. Cardamom (cardamon) ...... Elettaria cardamomum Maton. Cassia, Chinese ...... Cinnamomum cassia Blume. Cassia, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia, Saigon ...... Cinnamomum loureirii Nees. Cayenne pepper ...... Capsicum frutescens L. or Capsicum annuum L. Celery seed ...... Apium graveolens L. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chives ...... Allium schoenoprasum L. , Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon, Chinese ...... Cinnamomum cassia Blume. Cinnamon, Saigon ...... Cinnamomum loureirii Nees. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Cumin, black (black caraway) ...... Nigella sativa L. Elder flowers ...... Sambucus canadensis L. Fennel, common ...... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ...... Foeniculum vulgare Mill. var. duice (DC.) Alex. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Ginger ...... Zingiber officinale Rosc. Grains of paradise ...... Amomum melegueta Rosc. Horehound (hoarhound) ...... Marrubium vulgare L. Horseradish ...... Armoracia lapathifolia Gilib. Hyssop ...... Hyssopus officinalis L. Lavender ...... Lavandula officinalis Chaix. Linden flowers ...... Tilia spp. Mace ...... Myristica fragrans Houtt.

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Common name Botanical name of plant source

Marigold, pot ...... Calendula officinalis L. Marjoram, pot ...... Majorana onites (L.) Benth. Marjoram, sweet ...... Majorana hortensis Moench. Mustard, black or brown ...... Brassica nigra (L.) Koch. Mustard, brown ...... Brassica juncea (L.) Coss. Mustard, white or yellow ...... Brassica hirta Moench. ...... Myristica fragrans Houtt. Oregano (oreganum, Mexican oregano, Mexican Lippia spp. sage, origan). Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, cayenne ...... Capsicum frutescens L. or Capsicum annuum L. Pepper, red ...... Do. Pepper, white ...... Piper nigrum L. Peppermint ...... Mentha piperita L. Poppy seed ...... Papayer somniferum L. Pot marigold ...... Calendula officinalis L. Pot marjoram ...... Majorana onites (L.) Benth. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Savory, summer ...... Satureia hortensis L. (Satureja). Savory, winter ...... Satureia montana L. (Satureja). Sesame ...... Sesamum indicum L. Spearmint ...... Mentha spicata L. Star anise ...... Illicium verum Hook. f. Tarragon ...... Artemisia dracunculus L. Thyme ...... Thymus vulgaris L. Thyme, wild or creeping ...... Thymus serpyllum L. Turmeric ...... Curcuma longa L. ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary ...... Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

§ 182.20 Essential oils, oleoresins (sol- ing distillates) that are generally rec- vent-free), and natural extractives ognized as safe for their intended use, (including distillates). within the meaning of section 409 of Essential oils, oleoresins (solvent- the Act, are as follows: free), and natural extractives (includ-

Common name Botanical name of plant source

Alfalfa ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Almond, bitter (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Ambrette (seed) ...... Hibiscus moschatus Moench. Angelica root ...... Angelica archangelica L. Angelica seed ...... Do. Angelica stem ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Asafetida ...... Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm) ...... Melissa officinalis L. Balsam of Peru ...... Myroxylon pereirae Klotzsch. Basil ...... Ocimum basilicum L. Bay leaves ...... Laurus nobilis L. Bay (myrcia oil) ...... Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange) ...... Citrus aurantium L. subsp. bergamia Wright et Arn. Bitter almond (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Bois de rose ...... Aniba rosaeodora Ducke. Cacao ...... Theobroma cacao L. Camomile (chamomile) flowers, Hungarian ...... Matricaria chamomilla L. Camomile (chamomile) flowers, Roman or English Anthemis nobilis L. Cananga ...... Cananga odorata Hook. f. and Thoms.

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Common name Botanical name of plant source

Capsicum ...... Capsicum frutescens L. and Capsicum annuum L. Caraway ...... Carum carvi L. Cardamom seed (cardamon) ...... Elettaria cardamomum Maton. Carob bean ...... Ceratonia siliqua L. Carrot ...... Daucus carota L. Cascarilla bark ...... Croton eluteria Benn. Cassia bark, Chinese ...... Cinnamomum cassia Blume. Cassia bark, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia bark, Saigon ...... Cinnamomum loureirii Nees. Celery seed ...... Apium graveolens L. Cherry, wild, bark ...... Prunus serotina Ehrh. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chicory ...... Cichorium intybus L. Cinnamon bark, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon bark, Chinese ...... Cinnamomum cassia Blume. Cinnamon bark, Saigon ...... Cinnamomum loureirii Nees. Cinnamon leaf, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese ...... Cinnamomum cassia Blume. Cinnamon leaf, Saigon ...... Cinnamomum loureirii Nees. Citronella ...... Cymbopogon nardus Rendle. Citrus peels ...... Citrus spp. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Coca (decocainized) ...... Erythroxylum coca Lam. and other spp. of Erythroxylum. Coffee ...... Coffea spp. Cola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Curacao orange peel (orange, bitter peel) ...... Citrus aurantium L. Cusparia bark ...... Galipea officinalis Hancock. Dandelion ...... Taraxacum officinale Weber and T. laevigatum DC. Dandelion root ...... Do. Dog grass (quackgrass, triticum) ...... Agropyron repens (L.) Beauv. Elder flowers ...... Sambucus canadensis L. and S. nigra I. Estragole (esdragol, esdragon, tarragon) ...... Artemisia dracunculus L. Estragon (tarragon) ...... Do. Fennel, sweet ...... Foeniculum vulgare Mill. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Geranium, East Indian ...... Cymbopogon martini Stapf. Geranium, rose ...... Pelargonium graveolens L’Her. Ginger ...... Zingiber officinale Rosc. Grapefruit ...... Citrus paradisi Macf. Guava ...... Psidium spp. Hickory bark ...... Carya spp. Horehound (hoarhound) ...... Marrubium vulgare L. Hops ...... Humulus lupulus L. Horsemint ...... Monarda punctata L. Hyssop ...... Hyssopus officinalis L. Immortelle ...... Helichrysum augustifolium DC. Jasmine ...... Jasminum officinale L. and other spp. of Jasminum. Juniper (berries) ...... Juniperus communis L. Kola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries ...... Laurus nobilis L. Laurel leaves ...... Laurus spp. Lavender ...... Lavandula officinalis Chaix. Lavender, spike ...... Lavandula latifolia Vill. Lavandin ...... Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lemon ...... Citrus limon (L.) Burm. f. Lemon balm (see balm). Lemon grass ...... Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf. Lemon peel ...... Citrus limon (L.) Burm. f. Lime ...... Citrus aurantifolia Swingle. Linden flowers ...... Tilia spp. Locust bean ...... Ceratonia siliqua L, Lupulin ...... Humulus lupulus L. Mace ...... Myristica fragrans Houtt. Mandarin ...... Citrus reticulata Blanco. Marjoram, sweet ...... Majorana hortensis Moench. Mate´ ...... Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ...... Mentha spp. Menthyl acetate ...... Do.

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Common name Botanical name of plant source

Molasses (extract) ...... Saccarum officinarum L. Mustard ...... Brassica spp. Naringin ...... Citrus paradisi Macf. Neroli, bigarade ...... Citrus aurantium L. Nutmeg ...... Myristica fragrans Houtt. Onion ...... Allium cepa L. Orange, bitter, flowers ...... Citrus aurantium L. Orange, bitter, peel ...... Do. Orange leaf ...... Citrus sinensis (L.) Osbeck. Orange, sweet ...... Do. Orange, sweet, flowers ...... Do. Orange, sweet, peel ...... Do. Origanum ...... Origanum spp. Palmarosa ...... Cymbopogon martini Stapf. Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, white ...... Do. Peppermint ...... Mentha piperita L. Peruvian balsam ...... Myroxylon pereirae Klotzsch. Petitgrain ...... Citrus aurantium L. Petitgrain lemon ...... Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine ...... Citrus reticulata Blanco. Pimenta ...... Pimenta officinalis Lindl. Pimenta leaf ...... Pimenta officinalis Lindl. Pipsissewa leaves ...... Chimaphila umbellata Nutt. Pomegranate ...... Punica granatum L. Prickly ash bark ...... Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava- herculis L. Rose absolute ...... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of roses) ...... Do. Rose buds ...... Do. Rose flowers ...... Do. Rose fruit (hips) ...... Do. Rose geranium ...... Pelargonium graveolens L’Her. Rose leaves ...... Rosa spp. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Sage, Spanish ...... Salvia lavandulaefolia Vahl. St. John’s bread ...... Ceratonia siliqua L. Savory, summer ...... Satureia hortensis L. Savory, winter ...... Satureia montana L. Schinus molle ...... Schinus molle L. Sloe berries (blackthorn berries) ...... Prunus spinosa L. Spearmint ...... Mentha spicata L. Spike lavender ...... Lavandula latifolia Vill. Tamarind ...... Tamarindus indica L. Tangerine ...... Citrus reticulata Blanco. Tarragon ...... Artemisia dracunculus L. Tea ...... Thea sinensis L. Thyme ...... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white ...... Do. Thyme, wild or creeping ...... Thymus serpyllum L. Triticum (see dog grass). Tuberose ...... Polianthes tuberosa L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers ...... Viola odorata L. Violet leaves ...... Do. Violet leaves absolute ...... Do. Wild cherry bark ...... Prunus serotina Ehrh. Ylang-ylang ...... Cananga odorata Hook. f. and Thoms. Zedoary bark ...... Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043, 21044, May 22, 1985]

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§ 182.40 Natural extractives (solvent- seasonings, and flavorings that are free) used in conjunction with generally recognized as safe for their spices, seasonings, and flavorings. intended use, within the meaning of Natural extractives (solvent-free) section 409 of the Act, are as follows: used in conjunction with spices,

Common name Botanical name of plant source

Apricot kernel (persic oil) ...... Prunus armeniaca L. Peach kernel (persic oil) ...... Prunus persica Sieb. et Zucc. Peanut stearine ...... Arachis hypogaea L. Persic oil (see apricot kernel and peach kernel). Quince seed ...... Cydonia oblonga Miller.

[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]

§ 182.50 Certain other spices, tracts that are generally recognized as seasonings, essential oils, safe for their intended use, within the oleoresins, and natural extracts. meaning of section 409 of the Act, are Certain other spices, seasonings, es- as follows: sential oils, oleoresins, and natural ex-

Common name Derivation

Ambergris ...... Physeter macrocephalus L. Castoreum ...... Castor fiber L. and C. canadensis Kuhl. Civet (zibeth, zibet, zibetum) ...... Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber. Cognac oil, white and green ...... Ethyl oenanthate, so-called. Musk (Tonquin musk) ...... Musk deer, Moschus moschiferus L.

§ 182.60 Synthetic flavoring substances Methyl anthranilate (methyl-2- and adjuvants. aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, Synthetic flavoring substances and heliotropin). adjuvants that are generally recog- Vanillin. nized as safe for their intended use, within the meaning of section 409 of [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, the Act, are as follows: 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Acetaldehyde (ethanal). Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anisole). § 182.70 Substances migrating from Benzaldehyde (benzoic aldehyde). cotton and cotton fabrics used in N-Butyric acid (butanoic acid). dry food packaging. d- or l-Carvone (carvol). Substances migrating to food from (cinnamic aldehyde). Citral (2,6-dimethyloctadien-2,6-al-8, gera- cotton and cotton fabrics used in dry nial, neral). food packaging that are generally rec- Decanal (N-decylaldehyde, capraldehyde, ognized as safe for their intended use, capric aldehyde, caprinaldehyde, aldehyde within the meaning of section 409 of C-10). the Act, are as follows: Ethyl acetate. Ethyl butyrate. Beef tallow. 3-Methyl-3-phenyl glycidic acid ethyl ester Carboxymethylcellulose. (ethyl-methyl-phenyl-glycidate, so-called Coconut oil, refined. strawberry aldehyde, C-16 aldehyde). Cornstarch. Ethyl vanillin. Gelatin. (3,7-dimethyl-2,6 and 3,6-octadien-1- Lard. ol). Lard oil. Geranyl acetate (geraniol acetate). Oleic acid. Limonene (d-, l-, and dl-). Peanut oil. Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Potato starch. ol). Sodium acetate. Linalyl acetate (bergamol). Sodium chloride.

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Sodium silicate. Finding Aids section of the printed volume Sodium tripolyphosphate. and at www.fdsys.gov. Soybean oil (hydrogenated). Talc. § 182.99 Adjuvants for pesticide chemi- Tallow (hydrogenated). cals. Tallow flakes. Tapioca starch. Adjuvants, identified and used in ac- Tetrasodium pyrophosphate. cordance with 40 CFR 180.910 and 40 Wheat starch. CFR 180.920, which are added to pes- Zinc chloride. ticide use dilutions by a grower or ap- [42 FR 14640, Mar. 15, 1977, as amended at 43 plicator prior to application to the raw FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, agricultural commodity, are exempt 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, from the requirement of tolerances 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; under section 409 of the Federal Food, 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Drug, and Cosmetic Act (21 U.S.C. 348). 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, [76 FR 59249, Sept. 26, 2011] July 30, 1986; 60 FR 62208, Dec. 5, 1995] Subpart B—Multiple Purpose GRAS § 182.90 Substances migrating to food from paper and paperboard prod- Food Substances ucts. § 182.1045 Glutamic acid. Substances migrating to food from paper and paperboard products used in (a) Product. Glutamic acid. food packaging that are generally rec- (b) [Reserved] ognized as safe for their intended use, (c) Limitations, restrictions, or expla- within the meaning of section 409 of nation. This substance is generally rec- the Act, are as follows: ognized as safe when used as a salt sub- stitute in accordance with good manu- Alum (double sulfate of aluminum and am- facturing practice. monium potassium, or sodium). Aluminum hydroxide. § 182.1047 Glutamic acid hydro- Aluminum oleate. chloride. Aluminum palmitate. Casein. (a) Product. Glutamic acid hydro- Cellulose acetate. chloride. Cornstarch. (b) [Reserved] Diatomaceous earth filler. (c) Limitations, restrictions, or expla- Ethyl cellulose. nation. This substance is generally rec- Ethyl vanillin. Glycerin. ognized as safe when used as a salt sub- Oleic acid. stitute in accordance with good manu- Potassium sorbate. facturing practice. Silicon dioxides. Sodium aluminate. § 182.1057 Hydrochloric acid. Sodium chloride. (a) Product. Hydrochloric acid. Sodium hexametaphosphate. Sodium hydrosulfite. (b) [Reserved] Sodium phosphoaluminate. (c) Limitations, restrictions, or expla- Sodium silicate. nation. This substance is generally rec- Sodium sorbate. ognized as safe when used as a buffer Sodium tripolyphosphate. and neutralizing agent in accordance Sorbitol. with good manufacturing practice. Soy protein, isolated. Starch, acid modified. § 182.1073 Phosphoric acid. Starch, pregelatinized. Starch, unmodified. (a) Product. Phosphoric acid. Talc. (b) Conditions of use. This substance Vanillin. is generally recognized as safe when Zinc hydrosulfite. used in accordance with good manufac- Zinc sulfate. turing practice. [42 FR 14640, Mar. 15, 1977] § 182.1087 Sodium acid pyrophosphate. EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 182.90, see the List of CFR (a) Product. Sodium acid Sections Affected, which appears in the pyrophosphate.

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(b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.1320 Glycerin. (a) Product. Glycerin. § 182.1125 Aluminum sulfate. (b) Conditions of use. This substance (a) Product. Aluminum sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.1480 Methylcellulose. § 182.1127 Aluminum ammonium sul- (a) Product. U.S.P. methylcellulose, fate. except that the methoxy content shall not be less than 27.5 percent and not (a) Aluminum ammonium Product. more than 31.5 percent on a dry-weight sulfate. basis. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.1129 Aluminum potassium sul- fate. § 182.1500 Monoammonium glutamate. (a) Product. Aluminum potassium sul- (a) Product. Monoammonium glu- fate. tamate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice.

§ 182.1131 Aluminum sodium sulfate. § 182.1516 Monopotassium glutamate. (a) Product. Aluminum sodium sul- (a) Product. Monopotassium glu- fate. tamate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice.

§ 182.1180 Caffeine. § 182.1711 Silica aerogel. (a) Product. Caffeine. (a) Product. Silica aerogel as a finely (b) Tolerance. 0.02 percent. powdered microcellular silica foam (c) Limitations, restrictions, or expla- having a minimum silica content of nation. This substance is generally rec- 89.5 percent. ognized as safe when used in cola-type (b) [Reserved] beverages in accordance with good (c) Limitations, restrictions, or expla- manufacturing practice. nation. This substance is generally rec- ognized as safe when used as a compo- § 182.1217 Calcium phosphate. nent of an anti-foaming agent in ac- (a) Product. Calcium phosphate cordance with good manufacturing (mono-, di-, and tribasic). practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1745 Sodium carboxymethylcellu- used in accordance with good manufac- lose. turing practice. (a) Product. Sodium carboxy- methylcellulose is the sodium salt of § 182.1235 Caramel. carboxymethylcellulose not less than (a) Product. Caramel. 99.5 percent on a dry-weight basis, with (b) Conditions of use. This substance maximum substitution of 0.95 is generally recognized as safe when carboxymethyl groups per

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anhydroglucose unit, and with a min- exceeding 2 percent in table salt and 5 imum viscosity of 25 centipoises for 2 percent in baking powder in accordance percent by weight aqueous solution at with good manufacturing practice. 25 °C. (b) Conditions of use. This substance § 182.2437 Magnesium silicate. is generally recognized as safe when (a) Product. Magnesium silicate. used in accordance with good manufac- (b) Tolerance. 2 percent. turing practice. (c) Limitations, restrictions, or expla- nation. This substance is generally rec- § 182.1748 Sodium caseinate. ognized as safe when used in table salt (a) Product. Sodium caseinate. in accordance with good manufacturing (b) Conditions of use. This substance practice. is generally recognized as safe when used in accordance with good manufac- § 182.2727 Sodium aluminosilicate. turing practice. (a) Product. Sodium aluminosilicate § 182.1778 Sodium phosphate. (sodium silicoaluminate). (b) Tolerance. This substance is gen- (a) Product. Sodium phosphate erally recognized as safe for use at a (mono-, di-, and tribasic). level not exceeding 2 percent in accord- (b) Conditions of use. This substance ance with good manufacturing prac- is generally recognized as safe when tice. used in accordance with good manufac- turing practice. § 182.2729 Sodium calcium aluminosilicate, hydrated. § 182.1781 Sodium aluminum phos- phate. (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium (a) Product. Sodium aluminum phos- silicoaluminate). phate. (b) Tolerance. This substance is gen- (b) Conditions of use. This substance erally recognized as safe for use at a is generally recognized as safe when level not exceeding 2 percent in accord- used in accordance with good manufac- ance with good manufacturing prac- turing practice. tice. § 182.1810 Sodium tripolyphosphate. § 182.2906 Tricalcium silicate. (a) Product. Sodium tripolyphosphate. (a) Product. Tricalcium silicate. (b) Conditions of use. This substance (b) Tolerance. 2 percent. is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing practice. ognized as safe when used in table salt in accordance with good manufacturing Subpart C—Anticaking Agents practice. § 182.2122 Aluminum calcium silicate. Subpart D—Chemical (a) Product. Aluminum calcium sili- Preservatives cate. (b) Tolerance. 2 percent. § 182.3013 Ascorbic acid. (c) Limitations, restrictions, or expla- (a) Product. Ascorbic acid. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used in table salt is generally recognized as safe when in accordance with good manufacturing used in accordance with good manufac- practice. turing practice.

§ 182.2227 Calcium silicate. § 182.3041 Erythorbic acid. (a) Product. Calcium silicate. (a) Product. Erythorbic acid. (b) Tolerance. 2 percent and 5 percent. (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used at levels not turing practice.

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§ 182.3089 Sorbic acid. (b) Conditions of use. This substance (a) Product. Sorbic acid. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- § 182.3280 Dilauryl thiodipropionate. turing practice. (a) Product. Dilauryl § 182.3109 Thiodipropionic acid. thiodipropionate. (a) Product. Thiodipropionic acid. (b) Tolerance. This substance is gen- (b) Tolerance. This substance is gen- erally recognized as safe for use in food erally recognized as safe for use in food when the total content of antioxidants when the total content of antioxidants is not over 0.02 percent of fat or oil is not over 0.02 percent of fat or oil content, including essential (volatile) content, including essential (volatile) oil content of the food, provided the oil content of the food, provided the substance is used in accordance with substance is used in accordance with good manufacturing practice. good manufacturing practice. § 182.3616 Potassium bisulfite. § 182.3149 Ascorbyl palmitate. (a) Product. Potassium bisulfite. (a) Product. Ascorbyl palmitate. (b) [Reserved] (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in accord- turing practice. ance with good manufacturing prac- tice, except that it is not used in § 182.3169 Butylated hydroxyanisole. meats; in food recognized as a source of (a) Product. Butylated hydroxy- vitamin B1; on fruits and vegetables in- anisole. tended to be served raw to consumers (b) Tolerance. This substance is gen- or sold raw to consumers, or to be pre- erally recognized as safe for use in food sented to consumers as fresh. when the total content of antioxidants is not over 0.02 percent of fat or oil [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, content, including essential (volatile) 1990; 59 FR 65939, Dec. 22, 1994] oil content of food, provided the sub- stance is used in accordance with good § 182.3637 Potassium metabisulfite. manufacturing practice. (a) Product. Potassium metabisulfite. § 182.3173 Butylated hydroxytoluene. (b) [Reserved] (a) Product. Butylated hydroxy- (c) Limitations, restrictions, or expla- toluene. nation. This substance is generally rec- (b) Tolerance. This substance is gen- ognized as safe when used in accord- erally recognized as safe for use in food ance with good manufacturing prac- when the total content of antioxidants tice, except that it is not used in is not over 0.02 percent of fat or oil meats; in food recognized as a source of content, including essential (volatile) vitamin B1; on fruits and vegetables in- oil content of food, provided the sub- tended to be served raw to consumers stance is used in accordance with good or sold raw to consumers, or to be pre- manufacturing practice. sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 § 182.3189 Calcium ascorbate. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, (a) Product. Calcium ascorbate. 1990; 59 FR 65939, Dec. 22, 1994] (b) Conditions of use. This substance is generally recognized as safe when § 182.3640 Potassium sorbate. used in accordance with good manufac- (a) Product. Potassium sorbate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.3225 Calcium sorbate. used in accordance with good manufac- (a) Product. Calcium sorbate. turing practice.

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§ 182.3731 Sodium ascorbate. tended to be served raw to consumers (a) Product. Sodium ascorbate. or sold raw to consumers, or to be pre- (b) Conditions of use. This substance sented to consumers as fresh. is generally recognized as safe when [42 FR 14640, Mar. 15, 1977, as amended at 51 used in accordance with good manufac- FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, turing practice. 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3739 Sodium bisulfite. § 182.3862 Sulfur dioxide. (a) Product. Sodium bisulfite. (a) Product. Sulfur dioxide. (b) [Reserved] (b) [Reserved] (c) Limitations, restrictions, or expla- (c) Limitations, restrictions, or expla- nation. This substance is generally rec- nation. This substance is generally rec- ognized as safe when used in accord- ognized as safe when used in accord- ance with good manufacturing prac- ance with good manufacturing prac- tice, except that it is not used in tice, except that it is not used in meats; in food recognized as a source of meats; in food recognized as a source of vitamin B1; on fruits or vegetables in- vitamin B1; on fruits or vegetables in- tended to be served raw to consumers tended to be served raw to consumers or sold raw to consumers, or to be pre- or sold raw to consumers, or to be pre- sented to the consumer as fresh. sented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3766 Sodium metabisulfite. § 182.3890 Tocopherols. (a) Product. Sodium metabisulfite. (a) Product. Tocopherols. (b) [Reserved] (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in accord- turing practice. ance with good manufacturing prac- tice, except that it is not used in Subpart E—Emulsifying Agents meats; in food recognized as a source of [Reserved] vitamin B1; on fruits or vegetables in- tended to be served raw to consumers or sold raw to consumers, or to be pre- Subpart F—Dietary Supplements sented to consumers as fresh. [Reserved]

[42 FR 14640, Mar. 15, 1977, as amended at 51 1 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, Subpart G—Sequestrants 1990; 59 FR 65939, Dec. 22, 1994] § 182.6085 Sodium acid phosphate. § 182.3795 Sodium sorbate. (a) Product. Sodium acid phosphate. (a) Product. Sodium sorbate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.6197 Calcium diacetate. § 182.3798 Sodium sulfite. (a) Product. Calcium diacetate. (a) Product. Sodium sulfite. (b) Conditions of use. This substance (b) [Reserved] is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing practice. ognized as safe when used in accord- ance with good manufacturing prac- 1 For the purpose of this subpart, no at- tice, except that it is not used in tempt has been made to designate those meats; in food recognized as a source of sequestrants that may also function as vitamin B1; on fruits or vegetables in- chemical preservatives. 486

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§ 182.6203 Calcium (b) Conditions of use. This substance hexametaphosphate. is generally recognized as safe when (a) Product. Calcium used in accordance with good manufac- hexametaphosphate. turing practice. (b) Conditions of use. This substance § 182.6787 Sodium pyrophosphate. is generally recognized as safe when used in accordance with good manufac- (a) Product. Sodium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6215 Monobasic calcium phos- used in accordance with good manufac- phate. turing practice. (a) Product. Monobasic calcium phos- phate. § 182.6789 Tetra sodium pyrophos- (b) Conditions of use. This substance phate. is generally recognized as safe when (a) Product. Tetra sodium used in accordance with good manufac- pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6285 Dipotassium phosphate. used in accordance with good manufac- (a) Product. Dipotassium phosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6810 Sodium tripolyphosphate. used in accordance with good manufac- (a) Product. Sodium turing practice. tripolyphosphate. (b) Conditions of use. This substance § 182.6290 Disodium phosphate. is generally recognized as safe when (a) Product. Disodium phosphate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- Subpart H—Stabilizers turing practice. § 182.7255 Chondrus extract. § 182.6757 Sodium gluconate. (a) Product. Chondrus extract (a) Product. Sodium gluconate. (carrageenin). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.6760 Sodium hexametaphosphate. Subpart I—Nutrients (a) Product. Sodium hexametaphosphate. SOURCE: 45 FR 58838, Sept. 5, 1980, unless (b) Conditions of use. This substance otherwise noted. is generally recognized as safe when used in accordance with good manufac- § 182.8013 Ascorbic acid. turing practice. (a) Product. Ascorbic acid. (b) Conditions of use. This substance § 182.6769 Sodium metaphosphate. is generally recognized as safe when (a) Product. Sodium metaphosphate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.8159 Biotin. turing practice. (a) Product. Biotin. (b) Conditions of use. This substance § 182.6778 Sodium phosphate. is generally recognized as safe when (a) Product. Sodium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice.

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§ 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate. (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8994 Zinc stearate. § 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic acid free from chickedema (b) Conditions of use. This substance factor. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic). STANCES AFFIRMED AS GEN- (b) Conditions of use. This substance ERALLY RECOGNIZED AS SAFE is generally recognized as safe when used in accordance with good manufac- Subpart A—General Provisions turing practice. Sec. 184.1 Substances added directly to human § 182.8890 Tocopherols. food affirmed as generally recognized as (a) Product. Tocopherols. safe (GRAS). (b) Conditions of use. This substance is generally recognized as safe when Subpart B—Listing of Specific Substances used in accordance with good manufac- Affirmed as GRAS turing practice. 184.1005 Acetic acid. 184.1007 Aconitic acid. § 182.8892 α-Tocopherol acetate. 184.1009 Adipic acid. (a) Product. a-Tocopherol acetate. 184.1011 Alginic acid. 184.1012 a-Amylase enzyme preparation (b) Conditions of use. This substance from Bacillus stearothermophilus. is generally recognized as safe when 184.1021 Benzoic acid. used in accordance with good manufac- 184.1024 Bromelain. turing practice. 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease § 182.8985 Zinc chloride. enzyme product. (a) Product. Zinc chloride. 184.1033 Citric acid. 184.1034 Catalase (bovine liver). (b) Conditions of use. This substance 184.1061 Lactic acid. is generally recognized as safe when 184.1063 Enzyme-modified lecithin. used in accordance with good manufac- 184.1065 Linoleic acid. turing practice. 184.1069 Malic acid.

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184.1077 Potassium acid tartrate. 184.1307 Ferric sulfate. 184.1081 Propionic acid. 184.1307a Ferrous ascorbate. 184.1090 Stearic acid. 184.1307b Ferrous carbonate. 184.1091 Succinic acid. 184.1307c Ferrous citrate. 184.1095 Sulfuric acid. 184.1307d Ferrous fumarate. 184.1097 Tannic acid. 184.1308 Ferrous gluconate. 184.1099 Tartaric acid. 184.1311 Ferrous lactate. 184.1101 Diacetyl tartaric acid esters of 184.1315 Ferrous sulfate. mono- and diglycerides. 184.1316 Ficin. 184.1115 Agar-agar. 184.1317 Garlic and its derivatives. 184.1120 Brown algae. 184.1318 Glucono delta-lactone. 184.1121 Red algae. 184.1321 Corn gluten. 184.1133 Ammonium alginate. 184.1322 Wheat gluten. 184.1135 Ammonium bicarbonate. 184.1323 Glyceryl monooleate. 184.1137 Ammonium carbonate. 184.1324 Glyceryl monostearate. 184.1138 Ammonium chloride. 184.1328 Glyceryl behenate. 184.1139 Ammonium hydroxide. 184.1329 Glyceryl palmitostearate. 184.1140 Ammonium citrate, dibasic. 184.1330 Acacia (gum arabic). 184.1141a Ammonium phosphate, monobasic. 184.1333 Gum ghatti. 184.1141b Ammonium phosphate, dibasic. 184.1339 Guar gum. 184.1143 Ammonium sulfate. 184.1343 Locust (carob) bean gum. 184.1148 Bacterially-derived carbohydrase 184.1349 Karaya gum (sterculia gum). enzyme preparation. 184.1351 Gum tragacanth. 184.1150 Bacterially-derived protease en- 184.1355 Helium. zyme preparation. 184.1366 Hydrogen peroxide. 184.1155 Bentonite. 184.1370 Inositol. 184.1157 Benzoyl peroxide. 184.1372 Insoluble glucose isomerase enzyme 184.1165 n-Butane and iso-butane. preparations. 184.1185 Calcium acetate. 184.1375 Iron, elemental. 184.1187 Calcium alginate. 184.1386 Isopropyl citrate. 184.1191 Calcium carbonate. 184.1387 Lactase enzyme preparation from 184.1193 Calcium chloride. Candida pseudotropicalis. 184.1195 Calcium citrate. 184.1388 Lactase enzyme preparation from 184.1199 . Kluyveromyces lactis. 184.1201 Calcium glycerophosphate. 184.1400 Lecithin. 184.1205 Calcium hydroxide. 184.1408 Licorice and licorice derivatives. 184.1206 Calcium iodate. 184.1409 Ground limestone. 184.1207 . 184.1415 Animal lipase. 184.1210 Calcium oxide. 184.1420 Lipase enzyme preparation derived 184.1212 Calcium pantothenate. from Rhizopus niveus. 184.1221 Calcium propionate. 184.1425 Magnesium carbonate. 184.1229 Calcium stearate. 184.1426 Magnesium chloride. 184.1230 Calcium sulfate. 184.1428 Magnesium hydroxide. 184.1240 Carbon dioxide. 184.1431 Magnesium oxide. 184.1245 Beta-carotene. 184.1434 Magnesium phosphate. 184.1250 Cellulase enzyme preparation de- 184.1440 Magnesium stearate. rived from Trichoderma longibrachi- 184.1443 Magnesium sulfate. atum. 184.1443a Malt. 184.1257 and its derivatives. 184.1444 Maltodextrin. 184.1259 Cocoa butter substitute. 184.1445 Malt syrup (malt extract). 184.1260 . 184.1446 Manganese chloride. 184.1261 Copper sulfate. 184.1449 Manganese citrate. 184.1262 Corn silk and corn silk extract. 184.1452 Manganese gluconate. 184.1265 Cuprous iodide. 184.1461 Manganese sulfate. 184.1271 L-Cysteine. 184.1472 Menhaden oil. 184.1272 L-Cysteine monohydrochloride. 184.1490 Methylparaben. 184.1277 Dextrin. 184.1498 Microparticulated protein product. 184.1278 Diacetyl. 184.1505 Mono- and diglycerides. 184.1282 Dill and its derivatives. 184.1521 Monosodium phosphate derivatives 184.1287 Enzyme-modified fats. of mono- and diglycerides. 184.1293 Ethyl alcohol. 184.1530 Niacin. 184.1295 Ethyl formate. 184.1535 Niacinamide. 184.1296 Ferric ammonium citrate. 184.1537 Nickel. 184.1297 Ferric chloride. 184.1538 Nisin preparation. 184.1298 Ferric citrate. 184.1540 Nitrogen. 184.1301 Ferric phosphate. 184.1545 Nitrous oxide. 184.1304 Ferric pyrophosphate. 184.1553 Peptones.

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184.1555 Rapeseed oil. 184.1945 Vitamin B12. 184.1560 Ox bile extract. 184.1950 Vitamin D. 184.1563 Ozone. 184.1973 Beeswax (yellow and white). 184.1583 Pancreatin. 184.1976 Candelilla wax. 184.1585 Papain. 184.1978 Carnauba wax. 184.1588 Pectins. 184.1979 Whey. 184.1595 Pepsin. 184.1979a Reduced lactose whey. 184.1610 Potassium alginate. 184.1979b Reduced minerals whey. 184.1613 Potassium bicarbonate. 184.1979c Whey protein concentrate. 184.1619 Potassium carbonate. 184.1983 Bakers yeast extract. 184.1622 Potassium chloride. 184.1984 Zein. 184.1625 Potassium citrate. 184.1985 Aminopeptidase enzyme prepara- 184.1631 Potassium hydroxide. tion derived from lactococcus lactis. 184.1634 Potassium iodide. 184.1635 Potassium iodate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 184.1639 Potassium lactate. SOURCE: 42 FR 14653, Mar 15, 1977, unless 184.1643 Potassium sulfate. otherwise noted. 184.1655 Propane. 184.1660 Propyl gallate. EDITORIAL NOTE: Nomenclature changes to 184.1666 Propylene glycol. part 184 appear at 66 FR 56035, Nov. 6, 2001, 66 184.1670 Propylparaben. FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, 184.1676 Pyridoxine hydrochloride. 2003, 69 FR 13717, Mar. 24, 2004, 70 FR 40880, 184.1685 Rennet (animal-derived) and July 15, 2005, 70 FR 67651, Nov. 8, 2005, 81 FR chymosin preparation (fermentation-de- 49897, July 29, 2016. rived). 184.1695 Riboflavin. Subpart A—General Provisions 184.1697 Riboflavin-5′-phosphate (sodium). 184.1698 Rue. § 184.1 Substances added directly to 184.1699 Oil of rue. human food affirmed as generally 184.1702 Sheanut oil. recognized as safe (GRAS). 184.1721 Sodium acetate. 184.1724 Sodium alginate. (a) The direct human food ingredi- 184.1733 Sodium benzoate. ents listed in this part have been re- 184.1736 Sodium bicarbonate. viewed by the Food and Drug Adminis- 184.1742 Sodium carbonate. tration and affirmed to be generally 184.1751 Sodium citrate. recognized as safe (GRAS) for the pur- 184.1754 Sodium diacetate. 184.1763 Sodium hydroxide. poses and under the conditions pre- 184.1764 Sodium hypophosphite. scribed. The regulations in this part 184.1768 Sodium lactate. shall sufficiently describe each ingre- 184.1769a Sodium metasilicate. dient to identify the characteristics of 184.1784 Sodium propionate. the ingredient that has been affirmed 184.1792 Sodium sesquicarbonate. as GRAS and to differentiate it from 184.1801 Sodium tartrate. other possible versions of the ingre- 184.1804 Sodium potassium tartrate. dient that have not been affirmed as 184.1807 Sodium thiosulfate. 184.1835 Sorbitol. GRAS. Ingredients affirmed as GRAS 184.1845 Stannous chloride (anhydrous and in this part are also GRAS as indirect dihydrated). human food ingredients, subject to any 184.1848 Starter distillate. limitations prescribed in parts 174, 175, 184.1851 Stearyl citrate 176, 177, 178 or § 179.45 of this chapter or 184.1854 Sucrose. in part 186 of this chapter. The purity 184.1857 Corn sugar. specifications in this part do not apply 184.1859 Invert sugar. 184.1865 Corn syrup. when the ingredient is used in indirect 184.1866 High fructose corn syrup. applications. However, when used in in- 184.1875 Thiamine hydrochloride. direct applications, the ingredient 184.1878 Thiamine mononitrate. must be of a purity suitable for its in- 184.1890 a-Tocopherols. tended use in accordance with 184.1901 Triacetin. § 170.30(h)(1) of this chapter. 184.1903 Tributyrin. (b) Any ingredient affirmed as GRAS 184.1911 Triethyl citrate. in this part shall be used in accordance 184.1914 Trypsin. 184.1923 Urea. with current good manufacturing prac- 184.1924 Urease enzyme preparation from tice. For the purpose of this part, cur- Lactobacillus fermentum. rent good manufacturing practice in- 184.1930 . cludes the requirements that a direct

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human food ingredient be of appro- such substance in a manner that may priate food grade; that it be prepared lead to deception of the consumer or to and handled as a food ingredient; and any other violation of the Federal that the quantity of the ingredient Food, Drug, and Cosmetic Act (the added to food does not exceed the Act). amount reasonably required to accom- (d) The listing of more than one in- plish the intended physical, nutri- gredient to produce the same techno- tional, or other technical effect in logical effect does not authorize use of food. a combination of two or more ingredi- (1) If the ingredient is affirmed as ents to accomplish the same techno- GRAS with no limitations on its condi- logical effect in any one food at a com- tions of use other than current good bined level greater than the highest manufacturing practice, it shall be re- level permitted for one of the ingredi- garded as GRAS if its conditions of use ents. are consistent with the requirements of (e) If the Commissioner of Food and paragraph (b), (c), and (d) of this sec- Drugs is aware of any prior sanction tion. When the Food and Drug Admin- for use of an ingredient under condi- istration (FDA) determines that it is tions different from those proposed to appropriate, the agency will describe be affirmed as GRAS, he will concur- one or more current good manufac- rently propose a separate regulation turing practice conditions of use in the covering such use of the ingredient regulation that affirms the GRAS sta- under part 181 of this chapter. If the tus of the ingredient. For example, Commissioner is unaware of any such when the safety of an ingredient has applicable prior sanction, the proposed been evaluated on the basis of limited regulation will so state and will re- conditions of use, the agency will de- quire any person who intends to assert scribe in the regulation that affirms or rely on such sanction to submit the GRAS status of the ingredient, one proof of its existence. Any regulation or more of these limited conditions of promulgated pursuant to this section use, which may include the category of constitutes a determination that ex- food(s), the technical effect(s) or func- cluded uses would result in adultera- tional use(s) of the ingredient, and the tion of the food in violation of section level(s) of use. If the ingredient is used 402 of the Act, and the failure of any under conditions that are significantly person to come forward with proof of different from those described in the such an applicable prior sanction in re- regulation, that use of the ingredient sponse to the proposal will constitute a may not be GRAS. In such a case, a waiver of the right to assert or rely on manufacturer may not rely on the reg- such sanction at any later time. The ulation as authorizing that use but notice will also constitute a proposal shall have a basis to conclude that that to establish a regulation under part 181 use is GRAS or shall use the ingredient of this chapter, incorporating the same in accordance with a food additive reg- provisions, in the event that such a ulation. regulation is determined to be appro- (2) If the ingredient is affirmed as priate as a result of submission of proof GRAS with specific limitation(s), it of such an applicable prior sanction in shall be used in food only within such response to the proposal. limitation(s), including the category of (f) The label and labeling of the in- food(s), the functional use(s) of the in- gredient and any intermediate mix of gredient, and the level(s) of use. Any the ingredient for use in finished food use of such an ingredient not in full shall bear, in addition to the other la- compliance with each such established beling required by the Act: limitation shall require a food additive (1) The name of the ingredient, ex- regulation. cept where exempted from such label- (3) If the ingredient is affirmed as ing in part 101 of this chapter. GRAS for a specific use, without a gen- (2) A statement of concentration of eral evaluation of use of the ingredient, the ingredient in any intermediate other uses may also be GRAS. mix; or other information to permit a (c) The listing of a food ingredient in food processor independently to deter- this part does not authorize the use of mine that use of the ingredients will be

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in accordance with any limitations and baked goods as defined in § 170.3(n)(1) of good manufacturing practice gudelines this chapter; 0.8 percent for cheeses as prescribed. defined in § 170.3(n)(5) of this chapter (3) Adequate directions for use to and dairy product analogs as defined in provide a final food product that com- § 170.3(n)(10) of this chapter; 0.5 percent plies with any limitations prescribed for chewing gum as defined in for the ingredient(s). § 170.3(n)(6) of this chapter; 9.0 percent for condiments and relishes as defined [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. in § 170.3(n)(8) of this chapter; 0.5 per- 19, 1983; 62 FR 15110, Mar. 31, 1997; 81 FR 55051, cent for fats and oils as defined in Aug. 17, 2016] § 170.3(n)(12) of this chapter; 3.0 percent for gravies and sauces as defined in Subpart B—Listing of Specific § 170.3(n)(24) of this chapter; 0.6 percent Substances Affirmed as GRAS for meat products as defined in § 170.3(n)(29) of this chapter; and 0.15 § 184.1005 Acetic acid. percent or less for all other food cat- egories. The ingredient may also be (a) Acetic acid (C H O , CAS Reg. No. 2 4 2 used in boiler water additives at levels 64–19–7) is known as ethanoic acid. It not to exceed current good manufac- occurs naturally in plant and animal turing practice. tissues. It is produced by fermentation (e) Prior sanctions for this ingredient of carbohydrates or by organic syn- different from the uses established in thesis. The principal synthetic meth- this section do not exist or have been ods currently employed are oxidation waived. of acetaldehyde derived from ethylene, liquid phase oxidation of butane, and [47 FR 27814, June 25, 1982] reaction of carbon monoxide with methanol derived from natural gas. § 184.1007 Aconitic acid. (b) The ingredient meets the speci- (a) Aconitic acid (1,2,3- fications of the Food Chemicals Codex, propenetricarboxylic acid (C6H6O6), 3d Ed. (1981), p. 8, which is incorporated CAS Reg. No. 000499–12–7) occurs in the by reference. Copies are available from leaves and tubers of Aconitum napellus the National Academy Press, 2101 Con- L. and other Ranunculaceae. stitution Ave. NW., Washington, DC Transaconitic acid can be isolated dur- 20418, or available for inspection at the ing sugarcane processing, by precipita- National Archives and Records Admin- tion as the calcium salt from cane istration (NARA). For information on sugar or molasses. It may be syn- the availability of this material at thesized by sulfuric acid dehydration of NARA, call 202–741–6030, or go to: http:// citric acid, but not by the www.archives.gov/federallregister/ methanesulfonic acid method. codeloflfederallregulations/ (b) The ingredient meets the fol- ibrllocations.html. lowing specifications: (c) The ingredient is used as a curing (1) Assay. Not less than 98.0 percent and pickling agent as defined in of C3H3(COOH)3, using the ‘‘Food § 170.3(o)(5) of this chapter; flavor Chemicals Codex,’’ 4th ed. (1996), pp. enhancer as defined in § 170.3(o)(11) of 102–103, test for citric acid, which is in- this chapter; flavoring agent and adju- corporated by reference in accordance vant as defined in § 170.3(o)(12) of this with 5 U.S.C. 552(a) and 1 CFR part 51, chapter; pH control agent as defined in and a molecular weight of 174.11. Copies § 170.3(o)(23) of this chapter; as a sol- of the material incorporated by ref- vent and vehicle as defined in erence are available from the National § 170.3(o)(27) of this chapter; and as a Academy Press, Box 285, 2101 Constitu- boiler water additive complying with tion Ave. NW., Washington, DC 20055 § 173.310 of this chapter. (Internet address http://www.nap.edu), (d) The ingredient is used in food at or may be examined at Food and Drug levels not to exceed current good man- Administration’s Main Library, 10903 ufacturing practice in accordance with New Hampshire Ave., Bldg. 2, Third § 184.1(b)(1). Current good manufac- Floor, Silver Spring, MD 20993, 301–796– turing practice results in a maximum 2039, or at the National Archives and level as served, of 0.25 percent for Records Administration (NARA). For

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information on the availability of this § 184.1009 Adipic acid. material at NARA, call 202–741–6030, or (a) Adipic acid (C6H10O4, CAS Reg. go to: http://www.archives.gov/ No. 00124–04–9) is also known as 1,4- federallregister/ butanedicarboxylic acid or hexane- codeloflfederallregulations/ dioic acid. It is prepared by nitric acid ibrllocations.html. oxidation of cyclohexanol or (2) Melting point. Not less than 195 °C cyclohexanone or a mixture of the two. and the determination results in de- (b) The ingredient meets the speci- composition of aconitic acid. fications of the Food Chemicals Codex, (3) Heavy metals (as Pb). Not more 3d Ed. (1981), p. 11, which is incor- than 10 parts per million. porated by reference (Copies are avail- (4) Arsenic (as As). Not more than 3 able from the National Academy Press, parts per million. 2101 Constitution Ave., NW., Wash- (5) Oxalate. Passes test. ington, DC 20418, or available for in- (6) Readily carbonizable substances. spection at the National Archives and Passes the test for citric acid of the Records Administration (NARA). For information on the availability of this ‘‘Food Chemicals Codex,’’ 4th ed. (1996), material at NARA, call 202–741–6030, or pp. 102–103, which is incorporated by go to: http://www.archives.gov/ reference in accordance with 5 U.S.C. federallregister/ 552(a) and 1 CFR part 51. The avail- codeloflfederallregulations/ ability of this incorporation by ref- ibrllocations.html.), and the following erence is given in paragraph (b)(1) of additional specifications: this section. (1) The adipic acid is converted to its (7) Residue on ignition. Not more than corresponding amide. The amide is pu- 0.1 percent as determined by the ‘‘Food rified by recrystallization from water Chemicals Codex,’’ 4th ed. (1996), pp. or aqueous ethanol. The melting range 102–103, test for citric acid, which is in- of the amide is 219° to 220 °C. corporated by reference in accordance (2) The adipic acid is converted to its with 5 U.S.C. 552(a) and 1 CFR part 51. corresponding bis-p-p-bromophenacyl The availability of this incorporation ester. The ester is purified by recrys- by reference is given in paragraph tallization from ethanol. The melting (b)(1) of this section. range of the ester is 153° to 154 °C. (c) The ingredient is used as a fla- (c) The ingredient is used as a fla- voring substance and adjuvant as de- voring agent as defined in § 170.3(o)(12) fined in § 170.3(o)(12) of this chapter. of this chapter; leavening agent as de- (d) The ingredient is used in food, in fined in § 170.3(o)(17) of this chapter; accordance with § 184.1(b)(1), at levels and pH control agent as defined in not to exceed good manufacturing § 170.3(o)(23) of this chapter. practice. Current good manufacturing (d) The ingredient is used in foods at practice results in a maximum level, as levels not to exceed current good man- served, of 0.003 percent for baked goods ufacturing practice in accordance with § 184.1(b)(1). Current good manufac- as defined in § 170.3(n)(1) of this chap- turing practice results in maximum ter, 0.002 percent for alcoholic bev- levels, as served, of 0.05 percent for erages as defined in § 170.3(n)(2) of this baked goods as defined in § 170.3(n)(1) of chapter, 0.0015 percent for frozen dairy this chapter; 0.005 percent for non- products as defined in § 170.3(n)(20) of alcoholic beverages as defined in this chapter, 0.0035 percent for soft § 170.3(n)(3) of this chapter; 5.0 percent candy as defined in § 170.3(n)(38) of this for condiments and relishes as defined chapter, and 0.0005 percent or less for in § 170.3(n)(8) of this chapter; 0.45 per- all other food categories. cent for dairy product analogs as de- (e) Prior sanctions for this ingredient fined in § 170.3(n)(10) of this chapter; 0.3 different from the uses established in percent for fats and oil as defined in this section do not exist or have been § 170.3(n)(12) of this chapter; 0.0004 per- waived. cent for frozen dairy desserts as defined [43 FR 47724, Oct. 17, 1978, as amended at 49 in § 170.3(n)(20) of this chapter; 0.55 per- FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, cent for gelatin and puddings as de- 1999; 81 FR 5595, Feb. 3, 2016] fined in § 170.3(n)(22) of this chapter; 0.1

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percent for gravies as defined in § 184.1012 α-Amylase enzyme prepara- § 170.3(n)(24) of this chapter; 0.3 percent tion from Bacillus for meat products as defined in stearothermophilus. § 170.3(n)(29) of this chapter; 1.3 percent (a) a-Amylase enzyme preparation is for snack foods as defined in obtained from the culture filtrate that § 170.3(n)(37) of this chapter; and 0.02 results from a pure culture fermenta- percent or less for all other food cat- tion of a nonpathogenic and egories. nontoxicogenic strain of Bacillus (e) Prior sanctions for adipic acid dif- stearothermophilus. Its characterizing ferent from the uses established in this enzyme activity is a-amylase (1,4 a-D section do not exist or have been glucan glucanohydrolase (E.C. 3.2.1.1)). (b) The ingredient meets the general waived. and additional requirements for en- [47 FR 27810, June 25, 1982] zyme preparations in the ‘‘Food Chemi- cals Codex,’’ 3d ed. (1981), pp. 107–110, § 184.1011 Alginic acid. which is incorporated by reference in (a) Alginic acid is a colloidal, hydro- accordance with 5 U.S.C. 552(a) and 1 philic polysaccharide obtained from CFR part 51. Copies are available from the National Academy Press, 2101 Con- certain brown algae by alkaline extrac- stitution Ave. NW., Washington, DC tion. 20418, or may be examined at the Office (b) The ingredient meets the speci- Food Additive Safety (HFS–200), Center fications of the Food Chemicals Codex, for Food Safety and Applied Nutrition, 3d Ed. (1981), p. 13, which is incor- Food and Drug Administration, 5001 porated by reference. Copies are avail- Campus Dr., College Park, MD 20740, able from the National Academy Press, 240–402–1200, or at the National Ar- 2101 Constitution Ave. NW., Wash- chives and Records Administration ington, DC 20418, or available for in- (NARA). For information on the avail- spection at the National Archives and ability of this material at NARA, call Records Administration (NARA). For 202–741–6030, or go to: http:// information on the availability of this www.archives.gov/federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good manufacturing practices. The affirma- (c) In accordance with § 184.1(b)(2), tion of this ingredient as GRAS as a di- the ingredient is used in food only rect human food ingredient is based within the following specific limita- upon the following current good manu- tions: facturing practice conditions of use: (1) The ingredient is used as an en- Maximum level of Category of food use in food (as Functional use zyme, as defined in § 170.3(o)(9) of this served) chapter, in the hydrolysis of edible Soup and soup Not to exceed cur- Emulsifier, emulsi- starch to produce maltodextrins and mixes, rent good manu- fier salt, nutritive carbohydrate sweeteners. § 170.3(n) (40) facturing prac- § 170.3(o)(8) of (2) The ingredient is used at levels of this chapter. tice. this chapter; for- not to exceed current good manufac- mulation aid, § 170.3(o)(14) of turing practices. this chapter; sta- [60 FR 55789, Nov. 3, 1995, as amended at 78 bilizer, thickener, § 170.3(o)(28) of FR 14666, Mar. 7, 2013] this chapter. § 184.1021 Benzoic acid. (d) Prior sanctions for this ingredient (a) Benzoic acid is the chemical different from the use established in benzenecarboxylic acid (C7H6O2), occur- this section do not exist or have been ring in nature in free and combined waived. forms. Among the foods in which ben- zoic acid occurs naturally are cran- [47 FR 47375, Oct. 26, 1982] berries, prunes, plums, cinnamon, ripe

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, and most berries. Benzoic acid CFR part 51. Copies are available from is manufactured by treating molten the National Academy Press, 2101 Con- phthalic anhydride with steam in the stitution Ave. NW., Washington, DC, or presence of a zinc oxide catalyst, by may be examined at Office of Food Ad- the hydrolysis of benzotrichloride, or ditive Safety (HFS–200), Center for by the oxidation of toluene with nitric Food Safety and Applied Nutrition, acid or sodium bichromate or with air Food and Drug Administration, 5001 in the presence of a transition metal Campus Dr., College Park, MD 20740, salt catalyst. 240–402–1200, and at the National Ar- (b) The ingredient meets the speci- chives and Records Administration fications of the ‘‘Food Chemicals (NARA). For information on the avail- Codex,’’ 3d Ed. (1981), p. 35, which is in- ability of this material at NARA, call corporated by reference. Copies may be 202–741–6030, or go to: http:// obtained from the National Academy www.archives.gov/federallregister/ Press, 2101 Constitution Ave. NW., codeloflfederallregulations/ Washington, DC 20418, or may be exam- ibrllocations.html. ined at the National Archives and (c) In accordance with § 184.1(b)(1), Records Administration (NARA). For the ingredient is used in food with no information on the availability of this limitation other than current good material at NARA, call 202–741–6030, or manufacturing practice. The affirma- go to: http://www.archives.gov/ tion of this ingredient as GRAS as a di- federallregister/ rect food ingredient is based upon the codeloflfederallregulations/ following current good manufacturing ibrllocations.html. practice conditions of use: (c) The ingredient is used as an anti- (1) The ingredient is used as an en- microbial agent as defined in zyme as defined in § 170.3(o)(9) of this § 170.3(o)(2) of this chapter, and as a fla- chapter to hydrolyze proteins or voring agent and adjuvant as defined in polypeptides. § 170.3(o)(12) of this chapter. (d) The ingredient is used in food at (2) The ingredient is used in food at levels not to exceed good manufac- levels not to exceed current good man- turing practice. Current usage results ufacturing practice. in a maximum level of 0.1 percent in [60 FR 32910, June 26, 1995, as amended at 78 food. (The Food and Drug Administra- FR 14666, Mar. 7, 2013] tion has not determined whether sig- nificantly different conditions of use § 184.1025 Caprylic acid. would be GRAS). (a) Caprylic acid [CH3(CH2)6COOH, (e) Prior sanctions for this ingredient CAS Reg. No. 124–07–2] is the chemical different from those uses established in name for octanoic acid. It is considered this section, or different from that set to be a short or medium chain fatty forth in part 181 of this chapter, do not acid. It occurs normally in various exist or have been waived. foods and is commercially prepared by [42 FR 14653, Mar. 15, 1977, as amended at 49 oxidation of n-octanol or by fermenta- FR 5610, Feb. 14, 1984] tion and fractional distillation of the volatile fatty acids present in coconut § 184.1024 Bromelain. oil. (a) Bromelain (CAS Reg. No. 9001–00– (b) The ingredient meets the speci- 7) is an enzyme preparation derived fications of the ‘‘Food Chemicals from the pineapples Ananas comosus Codex,’’ 3d Ed. (1981), p. 207, which is in- and A. bracteatus L. It is a white to corporated by reference. Copies may be light tan amorphous powder. Its char- obtained from the National Academy acterizing enzyme activity is that of a Press, 2101 Constitution Ave. NW., peptide hydrolase (EC 3.4.22.32). Washington, DC 20418, or may be exam- (b) The ingredient meets the general ined at the National Archives and requirements and additional require- Records Administration (NARA). For ments for enzyme preparations in the information on the availability of this Food Chemicals Codex, 3d ed. (1981), p. material at NARA, call 202–741–6030, or 110, which is incorporated by reference go to: http://www.archives.gov/ in accordance with 5 U.S.C. 552(a) and 1 federallregister/

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codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) The ingredient is used as a fla- tion of this ingredient as generally rec- voring agent and adjuvant as defined in ognized as safe as a direct human food § 170.3(o)(12) of this chapter. ingredient is based upon the following (d) The ingredient is used in foods in current good manufacturing practice accordance with § 184.1(b)(1), at levels conditions of use: not to exceed good manufacturing (1) The ingredient is used as an en- practice. Current good manufacturing zyme, as defined in § 170.3(o)(9) of this practices result in maximum levels, as chapter, to hydrolyze proteins or car- served, of: 0.013 percent for baked goods bohydrates. as defined in § 170.3(n)(1) of this chap- (2) The ingredient is used in the fol- ter; 0.04 percent for cheeses as defined lowing foods at levels not to exceed in § 170.3(n)(5) of this chapter; 0.005 per- current good manufacturing practice: cent for fats and oils as defined in alcoholic beverages, as defined in § 170.3(n)(12) of this chapter, for frozen § 170.3(n)(2) of this chapter, candy, nu- dairy desserts as defined in § 170.3(n)(20) tritive sweeteners, and protein of this chapter, for gelatins and pud- hydrolyzates. dings as defined in § 170.3(n)(22) of this chapter, for meat products as defined [48 FR 240, Jan. 4, 1983] in § 170.3(n)(29) of this chapter, and for soft candy as defined in § 170.3(n)(38) of § 184.1033 Citric acid.

this chapter; 0.016 percent for snack (a) Citric acid (C6H8O7, CAS Reg. No. foods as defined in § 170.3(n)(37) of this 77–92–9) is the compound 2-hydroxy- chapter; and 0.001 percent or less for all 1,2,3-propanetricarboxylic acid. It is a other food categories. naturally occurring constituent of (e) Prior sanctions for this ingredient plant and animal tissues. It occurs as different from the uses established in colorless crystals or a white powder this section do not exist or have been and may be anhydrous or contain one waived. mole of water per mole of citric acid. [43 FR 19843, May 9, 1978, as amended at 49 Citric acid may be produced by recov- FR 5611, Feb. 14, 1984] ery from sources such as lemon or pine- apple juice; by mycological fermenta- § 184.1027 Mixed carbohydrase and tion using Candida spp., described in protease enzyme product. §§ 173.160 and 173.165 of this chapter; and (a) Mixed carbohydrase and protease by the solvent extraction process de- enzyme product is an enzyme prepara- scribed in § 173.280 of this chapter for tion that includes carbohydrase and the recovery of citric acid from Asper- protease activity. It is obtained from gillus niger fermentation liquor. the culture filtrate resulting from a (b) The ingredient meets the speci- pure culture fermentation of a non- fications of the Food Chemicals Codex, pathogenic strain of B. licheniformis. 3d ed. (1981), pp. 86–87, and its third sup- (b) The ingredient meets the speci- plement (March 1992), pp. 107–108, which fications of the Food Chemicals Codex, are incorporated by reference in ac- 3d Ed. (1981), p. 107, which is incor- cordance with 5 U.S.C. 552(a) and 1 CFR porated by reference. Copies are avail- part 51. Copies are available from the able from the National Academy Press, National Academy Press, 2101 Constitu- 2101 Constitution Ave. NW., Wash- tion Ave. NW., Washington, DC 20418, ington, DC 20418, or available for in- and the Center for Food Safety and Ap- spection at the National Archives and plied Nutrition (HFS–200), 5001 Campus Records Administration (NARA). For Dr., College Park, MD 20740, or may be information on the availability of this examined at the National Archives and material at NARA, call 202–741–6030, or Records Administration (NARA). For go to: http://www.archives.gov/ information on the availability of this federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html.

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(c) In accordance with § 184.1(b)(1), § 184.1061 Lactic acid. the ingredient is used in food with no (a) Lactic acid (C H O , CAS Reg. limitations other than current good 3 6 3 Nos.: DL mixture, 598–82–3; L-isomer, 79– manufacturing practice. 33–4; D-isomer, 10326–41–7), the chemical (d) Prior sanctions for this ingredient 2-hydroxypropanoic acid, occurs natu- different from the uses established in rally in several foods. It is produced this section do not exist or have been commercially either by fermentation waived. of carbohydrates such as glucose, su- [59 FR 63895, Dec. 12, 1994] crose, or lactose, or by a procedure in- volving formation of lactonitrile from § 184.1034 Catalase (bovine liver). acetaldehyde and and subsequent hydrolysis to lactic (a) Catalase (bovine liver) (CAS Reg. acid. No. 81457–95–6) is an enzyme prepara- (b) The ingredient meets the speci- tion obtained from extracts of bovine fications of the Food Chemicals Codex, liver. It is a partially purified liquid or 3d Ed. (1981), p. 159, which is incor- powder. Its characterizing enzyme ac- porated by reference. Copies are avail- tivity is catalase (EC 1.11.1.6). able from the National Academy Press, (b) The ingredient meets the general 2101 Constitution Avenue, NW., Wash- requirements and additional require- ington, DC 20418, or available for in- ments for enzyme preparations in the spection at the National Archives and Food Chemicals Codex, 3d ed. (1981), p. Records Administration (NARA). For 110, which is incorporated by reference information on the availability of this in accordance with 5 U.S.C. 552(a) and 1 material at NARA, call 202–741–6030, or CFR part 51. Copies are available from go to: http://www.archives.gov/ the National Academy Press, 2101 Con- federallregister/ stitution Ave., NW., Washington, DC codeloflfederallregulations/ 20418, or may be examined at the Office ibrllocations.html. of Food Additive Safety (HFS–200), (c) In accordance with § 184.1(b)(1), Center for Food Safety and Applied Nu- the ingredient is used in food with no trition, Food and Drug Administration, limitation other than current good 5001 Campus Dr., College Park, MD manufacturing practice. The affirma- 20740, 240–402–1200, and at the National tion of this ingredient as generally rec- Archives and Records Administration ognized as safe (GRAS) as a direct (NARA). For information on the avail- human food ingredient is based upon ability of this material at NARA, call the following current good manufac- 202–741–6030, or go to: http:// turing practice conditions of use: www.archives.gov/federallregister/ (1) The ingredient is used as an anti- codeloflfederallregulations/ microbial agent as defined in ibrllocations.html. § 170.3(o)(2) of this chapter; a curing and (c) In accordance with § 184.1(b)(1), pickling agent as defined in § 170.3(o)(5) the ingredient is used in food with no of this chapter; a flavor enhancer as de- limitation other than current good fined in § 170.3(o)(11) of this chapter; a manufacturing practice. The affirma- flavoring agent and adjuvant as defined tion of this ingredient as GRAS as a di- in § 170.3(o)(12) of this chapter; a pH rect food ingredient is based upon the control agent as defined in § 170.3(o)(23) following current good manufacturing of this chapter; and a solvent and vehi- practice conditions of use: cle as defined in § 170.3(o)(27) of this (1) The ingredient is used as an en- chapter. zyme as defined in § 170.3(o)(9) of this (2) The ingredient is used in food, ex- chapter to decompose hydrogen per- cept in infant foods and infant for- oxide. mulas, at levels not to exceed current (2) The ingredient is used in food at good manufacturing practice. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. different from the uses established in this section do not exist or have been [60 FR 32910, June 26, 1995, as amended at 69 waived. FR 24512, May 4, 2004; 78 FR 14666, Mar. 7, 2013] [49 FR 35367, Sept. 7, 1984]

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§ 184.1063 Enzyme-modified lecithin. 20993, 301–796–2039, or at the National (a) Enzyme-modified lecithin is pre- Archives and Records Administration pared by treating lecithin with either (NARA). For information on the avail- ability of this material at NARA, call phospholipase A2 (EC 3.1.1.4) or pan- creatin. 202–741–6030, or go to: http:// (b) The ingredient meets the speci- www.archives.gov/federallregister/ fications in paragraphs (b)(1) through codeloflfederallregulations/ (b)(8) of this section. Unless otherwise ibrllocations.html. noted, compliance with the specifica- (c) In accordance with § 184.1(b)(1), tions listed below is determined ac- the ingredient is used in food with no cording to the methods set forth for limitation other than current good lecithin in the Food Chemicals Codex, manufacturing practice. The affirma- 4th ed. (1996), pp. 220–221, which are in- tion of this ingredient as generally rec- corporated by reference in accordance ognized as safe as a direct human food with 5 U.S.C. 552(a) and 1 CFR part 51. ingredient is based upon the following Copies are available from the National current good manufacturing practice Academy Press, 2101 Constitution Ave. conditions of use: (1) The ingredient is used as an emul- NW., Washington DC 20418, or may be sifier as defined in § 170.3(o)(8) of this examined at the Food and Drug Admin- chapter. istration’s Main Library, 10903 New (2) The ingredient is used at levels Hampshire Ave., Bldg. 2, Third Floor, not to exceed current good manufac- Silver Spring, MD 20993, 301–796–2039, or turing practice. at the National Archives and Records Administration (NARA). For informa- [61 FR 45889, Aug. 30, 1996, as amended at 78 tion on the availability of this mate- FR 14666, Mar. 7, 2013; 81 FR 5595, Feb. 3, 2016] rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 184.1065 Linoleic acid. federallregister/ (a) Linoleic acid ((Z, Z)–9, 12-octadec- codeloflfederallregulations/ adienoic acid (C17H31COOH) (CAS Reg. ibrllocations.html. No. 60–33–3)), a straight chain unsatu- (1) Acetone-insoluble matter rated fatty acid with a molecular (phosphatides), not less than 50.0 per- weight of 280.5, is a colorless oil at cent. room temperature. Linoleic acid may (2) Acid value, not more than 40. be prepared from edible fats and oils by (3) Lead, not more than 1.0 part per various methods including hydrolysis million, as determined by atomic ab- and saponification, the Twitchell sorption spectroscopy. method, low pressure splitting with (4) Heavy metals (as Pb), not more catalyst, continuous high pressure than 20 parts per million. counter current splitting, and medium (5) Hexane-insoluble matter, not pressure autoclave splitting with cata- more than 0.3 percent. lyst. (6) Peroxide value, not more than 20. (b) The ingredient must be of a pu- (7) Water, not more than 4.0 percent. rity suitable for its intended use. The (8) Lysolecithin, 50 to 80 mole percent ingredient must also meet the speci- of total phosphatides as determined by fications in § 172.860(b) of this chapter. ‘‘Determination of Lysolecithin Con- (c) In accordance with § 184.1(b)(1), tent of Enzyme-Modified Lecithin: the ingredient is used in food with no Method I,’’ dated 1985, which is incor- limitation other than current good porated by reference in accordance manufacturing practice. The affirma- with 5 U.S.C. 552(a) and 1 CFR part 51. tion of this ingredient as generally rec- Copies are available from the Office of ognized as safe (GRAS) as a direct Food Additive Safety (HFS–200), Center human food ingredient is based upon for Food Safety and Applied Nutrition, the following current good manufac- Food and Drug Administration, 5001 turing practice conditions of use: Campus Dr., College Park, MD 20740, (1) The ingredient is used as a fla- 240–402–1200, or may be examined at the voring agent and adjuvant as defined in Food and Drug Administration’s Main § 170.3(o)(12) of this chapter and as a nu- Library, 10903 New Hampshire Ave., trient supplement as defined in Bldg. 2, Third Floor, Silver Spring, MD § 170.3(o)(20) of this chapter.

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(2) The ingredient is used in foods at 6.9 percent for hard candy as defined in levels not to exceed current good man- § 170.3(n)(25) of this chapter; 2.6 percent ufacturing practice. The ingredient for jams and jellies as defined in may be used in infant formula in ac- § 170.3(n)(28) of this chapter; 3.5 percent cordance with section 412(g) of the Fed- for processed fruits and fruit juices as eral Food, Drug, and Cosmetic Act (the defined in § 170.3(n)(35) of this chapter; act) or with regulations promulgated 3.0 percent for soft candy as defined in under section 412(a)(2) of the act. § 170.3(n)(38) of this chapter; and 0.7 per- (d) Prior sanctions for this ingredient cent for all other food categories. different from the uses established in (e) Prior sanctions for malic acid dif- this section do not exist or have been ferent from the uses established in this waived. section do not exist or have been waived. [49 FR 48534, Dec. 13, 1984, as amended at 73 FR 8606, Feb. 14, 2008] [44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984] § 184.1069 Malic acid. § 184.1077 Potassium acid tartrate. (a) Malic acid (C4H6O5, CAS Reg. No. of L-form 97–67–6, CAS Reg. No. of DL- (a) Potassium acid tartrate (C4H5KO6, form 617–48–1) is the common name for CAS Reg. No. 868–14–4) is the potassium 1-hydroxy-1, 2-ethanedicarboxylic acid. acid salt of l¥( + )¥tartaric acid and is L ( + ) malic acid, referred to as L- also called potassium bitartrate or malic acid, occurs naturally in various cream of tartar. It occurs as colorless foods. Racemic DL-malic acid does not or slightly opaque crystals or as a occur naturally. It is made commer- white, crystalline powder. It has a cially by hydration of fumaric acid or pleasant, acid taste. It is obtained as a maleic acid. byproduct of wine manufacture. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the ‘‘Food Chemicals fications of the Food Chemicals Codex, Codex,’’ 3d Ed. (1981), pp. 183–184, which 3d Ed. (1981), P. 238, which is incor- is incorporated by reference. Copies porated by reference. Copies are avail- may be obtained from the National able from the National Academy Press, Academy Press, 2101 Constitution Ave. 2101 Constitution Ave. NW., Wash- NW., Washington, DC 20418, or may be ington, DC 20418, or available for in- examined at the National Archives and spection at the National Archives and Records Administration (NARA). For Records Administration (NARA). For information on the availability of this information on the availability of this material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) The ingredients are used as a fla- (c) In accordance with § 184.1(b)(1), vor enhancer as defined in § 170.3(o)(11) the ingredient is used in food with no of this chapter, flavoring agent and ad- limitation other than current good juvant as defined in § 170.3(o)(12) of this manufacturing practice. The affirma- chapter, and pH control agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(23) of this chapter. ognized as safe (GRAS) as a direct (d) The ingredients are used in food, human food ingredient is based upon except baby food, at levels not to ex- the following current good manufac- ceed good manufacturing practice in turing practice conditions of use: accordance with § 184.1(b)(1). Current (1) The ingredient is used as an good manufacturing practice results in anticaking agent as defined in a maximum level, as served, of 3.4 per- § 170.3(o)(1) of this chapter; an anti- cent for nonalcoholic beverages as de- microbial agent as defined in fined in § 170.3(n)(3) of this chapter; 3.0 § 170.3(o)(2) of this chapter; a formula- percent for chewing gum as defined in tion aid as defined in § 170.3(o)(14) of § 170.3(n)(6) of this chapter; 0.8 percent this chapter; a humectant as defined in for gelatins, puddings, and fillings as § 170.3(o)(16) of this chapter; a leavening defined in § 170.3(n)(22) of this chapter; agent as defined in § 170.3(o)(17) of this

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chapter; A pH control agent as defined voring agent as defined in § 170.3(o)(12) in § 170.3(o)(23) of this chapter; a proc- of this chapter. essing aid as defined in § 170.3(o)(24) of (2) The ingredient is used in foods at this chapter; a stabilizer and thickener levels not to exceed current good man- as defined in § 170.3(o)(28) of this chap- ufacturing practice. ter; and a surface-active agent as de- (d) Prior sanctions for this ingredient fined in § 170.3(o)(29) of this chapter. different from the uses established in (2) The ingredient is used in the fol- this section do not exist or have been lowing foods at levels not to exceed waived. current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of [49 FR 13141, Apr. 3, 1984] this chapter; confections and frostings as defined in § 170.3(n)(9) of this chap- § 184.1090 Stearic acid. ter; gelatins and puddings as defined in (a) Stearic acid (C18H36O2, CAS Reg. § 170.3(n)(22) of this chapter; hard candy No. 57–11–4) is a white to yellowish as defined in § 170.3(n)(25) of this chap- white solid. It occurs naturally as a ter; jams and jellies as defined in glyceride in tallow and other animal or § 170.3(n)(28) of this chapter; and soft vegetable fats and oils and is a prin- candy as defined in § 170.3(n)(38) of this cipal constituent of most commercially chapter. hydrogenated fats. It is produced com- (d) Prior sanctions for this ingredient mercially from hydrolyzed tallow de- different from the uses established in rived from edible sources or from this section do not exist or have been hydrolyzed, completely hydrogenated waived. vegetable oil derived from edible [48 FR 52446, Nov. 18, 1983] sources. (b) The ingredient meets the speci- § 184.1081 Propionic acid. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 313, which is incor- (a) Propionic acid (C3H6O2, CAS Reg. No. 79–09–4) is an oily liquid having a porated by reference, and the require- slightly pungent, rancid odor. It is ments of § 172.860(b)(2) of this chapter. manufactured by chemical synthesis or Copies of the Food Chemicals Codex by bacterial fermentation. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave. NW., fications of the Food Chemicals Codex, Washington, DC 20418, or available for 3d Ed. (1981), p. 254, which is incor- inspection at the National Archives porated by reference. Copies are avail- and Records Administration (NARA). able from the National Academy Press, For information on the availability of 2101 Constitution Ave. NW., Wash- this material at NARA, call 202–741– ington, DC 20418, or available for in- 6030, or go to: http://www.archives.gov/ spection at the National Archives and federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a fla- ognized as safe (GRAS) as a direct voring agent and adjuvant as defined in human food ingredient is based upon § 170.3(o)(12) of this chapter. the following current good manufac- (2) The ingredient is used in foods at turing practice conditions of use: levels not to exceed current good man- (1) The ingredient is used as an anti- ufacturing practice. microbial agent as defined in (d) Prior sanctions for this ingredient § 170.3(o)(2) of this chapter and a fla- different from the uses established in

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this section do not exist or have been water, or by reacting (NO) waived. with sulfur dioxide and water. [48 FR 52445, Nov. 18, 1983, as amended at 50 (b) The ingredient meets the speci- FR 49536, Dec. 3, 1985; 69 FR 24512, May 4, fications of the ‘‘Food Chemicals 2004] Codex,’’ 3d Ed. (1981), pp. 317–318, which is incorporated by reference. Copies § 184.1091 Succinic acid. may be obtained from the National

(a) Succinic acid (C4H6O4, CAS Reg. Academy Press, 2101 Constitution Ave. No. 110–15–6), also referred to as amber NW., Washington, DC 20418, or may be acid and ethylenesuccinic acid, is the examined at the National Archives and chemical 1,4-butanedioic acid. It is Records Administration (NARA). For commercially prepared by hydro- information on the availability of this genation of maleic or fumaric acid. It material at NARA, call 202–741–6030, or can also be produced by aqueous alkali go to: http://www.archives.gov/ or acid hydrolysis of succinonitrile. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications of the ‘‘Food Chemicals ibrllocations.html. Codex,’’ 3d Ed. (1981), pp. 314–315, which (c) The ingredient is used as a pH is incorporated by reference. Copies control agent as defined in § 170.3(o)(23) may be obtained from the National of this chapter and processing aid as Academy Press, 2101 Constitution Ave. defined in § 170.3(o)(24) of this chapter. NW., Washington, DC 20418, or may be (d) The ingredient is used in food at examined at the National Archives and levels not to exceed good manufac- Records Administration (NARA). For turing practice in accordance with information on the availability of this § 184.1(b)(1). Current good manufac- material at NARA, call 202–741–6030, or turing practice results in a maximum go to: http://www.archives.gov/ level, as served, of 0.014 percent for al- federallregister/ coholic beverages as defined in codeloflfederallregulations/ § 170.3(n)(2) of this chapter and 0.0003 ibrllocations.html. percent for cheeses as defined in (c) The ingredient is used as a flavor § 170.3(n)(5) of this chapter. enhancer as defined in § 170.3(o)(11) of (e) Prior sanctions for this ingredient this chapter and pH control agent as different from the uses established in defined in § 170.3(o)(23) of this chapter. this section do not exist or have been (d) The ingredient is used in food at waived. levels not to exceed good manufac- turing practice in accordance with [45 FR 6085, Jan. 25, 1980, as amended at 49 § 184.1(b)(1). Current good manufac- FR 5611, Feb. 14, 1984] turing practice results in a maximum level, as served, of 0.084 percent in con- § 184.1097 Tannic acid. diments and relishes as defined in (a) Tannic acid (CAS Reg. No. 1401– § 170.3(n)(8) of this chapter and 0.0061 55–4), or hydrolyzable gallotannin, is a percent in meat products as defined in complex polyphenolic organic struc- § 170.3(n)(29) of this chapter. ture that yields gallic acid and either (e) Prior sanctions for this ingredient glucose or quinic acid as hydrolysis different from the uses established in products. It is a yellowish-white to this section do not exist or have been light brown substance in the form of an waived. amorphous, bulky powder, glistening [44 FR 20657, Apr. 6, 1979, as amended at 49 scales, or spongy masses. It is also FR 5611, Feb. 14, 1984] ordorless, or has a faint characteristic odor, and has an astringent taste. Tan- § 184.1095 Sulfuric acid. nic acid is obtained by solvent extrac-

(a) Sulfuric acid (H2SO4, CAS Reg. tion of nutgalls or excrescences that No. 7664–93–9), also known as oil of vit- form on the young twigs of Quercus riol, is a clear, colorless, oily liquid. It infectoria Oliver and related species of is prepared by reacting sulfur dioxide Quercus. Tannic acid is also obtained (SO2) with oxygen and mixing the re- by solvent extraction of the seed pods sultant sulfur trioxide (SO3) with of Tara (Caesalpinia spinosa) or the 501

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nutgalls of various sumac species, in- Records Administration (NARA). For cluding Rhus semialata, R. coriaria, R. information on the availability of this galabra, and R. typhia. material at NARA, call 202–741–6030, or (b) The ingredient meets the speci- go to: http://www.archives.gov/ fications of the Food Chemicals Codex, federallregister/ 3d Ed. (1981), p. 319, which is incor- codeloflfederallregulations/ porated by reference. Copies are avail- ibrllocations.html. able from the National Academy Press, (c)(1) In accordance with § 184.1(b)(2), 2101 Constitution Ave. NW., Wash- the ingredient is used in food only ington, DC 20418, or available for in- within the following specific limita- spection at the National Archives and tions:

Maximum level of use Category of food in food (as Functional use served) (per- cent)

Baked goods and baking mixes, § 170.3(n)(1) of this 0.01 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. chapter. Alcoholic beverages, § 170.3(n)(2) of this chapter ...... 0 .015 Flavor enhancer, § 170.3(o)(11) of this chapter; fla- voring agent and adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chap- ter. Nonalcoholic beverages and beverage bases, 0 .005 Flavoring agent and adjuvant, § 170.3(o)(12) of this § 170.3(n)(3) of this chapter and for gelatins, pud- chapter; pH control agent, § 170.3(o)(23) of this dings, and fillings, § 170.3(n)(22) of this chapter. chapter. Frozen dairy desserts and mixes, § 170.3(n)(20) of this 0 .04 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter and for soft candy, § 170.3(n)(38) of this chapter. chapter. Hard candy and cough drops, § 170.3(n)(25) of this 0.013 Do. chapter. Meat products, § 170.3(n)(29) of this chapter ...... 0.001 Do.

(2) Tannic acid may be used in ren- Records Administration (NARA). For dered animal fat in accordance with 9 information on the availability of this CFR 318.7. material at NARA, call 202–741–6030, or (d) Prior sanctions for this ingredient go to: http://www.archives.gov/ different from the uses established in federallregister/ this section do not exist or have been codeloflfederallregulations/ waived. ibrllocations.html. [50 FR 21043, May 22, 1985] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1099 Tartaric acid. limitation other than current good manufacturing practice. The affirma- (a) Food grade tartaric acid (C H O , 4 6 6 tion of this ingredient as generally rec- CAS Reg. No. 87–69–4) has the l configu- ognized as safe (GRAS) as a direct ration. The l form of tartaric acid is dextrorotatory in solution and is also human food ingredient is based upon known as l¥( + )¥tartaric acid. Tar- the following current good manufac- taric acid occurs as colorless or trans- turing practice conditions of use: lucent crystals or as a white, crys- (1) The ingredient is used as a firm- talline powder. It is odorless and has ing agent as defined in § 170.3(o)(10) of an acid taste. It is obtained as a by- this chapter; a flavor enhancer as de- product of wine manufacture. fined in § 170.3(o)(11) of this chapter; a (b) The ingredient meets the speci- flavoring agent as defined in fications of the Food Chemicals Codex, § 170.3(o)(12) of this chapter; a humec- 3d Ed. (1981), P. 320, which is incor- tant as defined in § 170.3(o)(16) of this porated by reference. Copies are avail- chapter; and a pH control agent as de- able from the National Academy Press, fined in § 170.3(o)(23) of this chapter. 2101 Constitution Ave. NW., Wash- (2) The ingredient is used in foods at ington, DC 20418, or available for in- levels not to exceed current good man- spection at the National Archives and ufacturing practice.

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(d) Prior sanctions for this ingredient (2) The ingredient is used in the fol- different from the uses established in lowing foods at levels not to exceed this section do not exist or have been current good manufacturing practice: waived. baked goods and baking mixes as de- [48 FR 52447, Nov. 18, 1983, as amended at 50 fined in § 170.3(n)(l) of this chapter; FR 49536, Dec. 3, 1985] nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; confections § 184.1101 Diacetyl tartaric acid esters and frostings as defined in § 170.3(n)(9) of mono- and diglycerides. of this chapter; dairy product analogs (a) Diacetyl tartaric acid esters of as defined in § 170.3(n)(10) of this chap- mono- and diglycerides, also know as ter; and fats and oils as defined in DATEM, are composed of mixed esters § 170.3(n)(12) of this chapter. of glycerin in which one or more of the (d) Prior sanctions for this ingredient hydroxyl groups of glycerin has been different from the uses established in esterified by diacetyl tartaric acid and this section do not exist or have been by fatty acids. The ingredient is pre- waived. pared by the reaction of diacetyl tar- (e) Labeling: The acronym ‘‘DATEM’’ taric anhydride with mono- and may be used on food labeling as the al- diglycerides that are derived from edi- ternate common or usual name for the ble sources. ingredient diacetyl tartaric acid esters (b) The ingredient meets the speci- of mono- and diglycerides. fications of the Food Chemicals Codex, 3d. Ed. (1981), pp. 98–99, which is incor- [54 FR 7403, Feb. 21, 1989, as amended at 54 porated by reference in accordance FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, 1989; 60 FR 15872, Mar. 28, 1995] with 5 U.S.C. 552(a). Copies are avail- able from the National Academy Press, § 184.1115 Agar-agar. 2101 Constitution Avenue NW., Wash- ington, DC 20418, or available for in- (a) Agar-agar (CAS Reg. No. PM 9002– spection at the National Archives and 18–0) is a dried, hydrophyllic, colloidal Records Administration (NARA). For polysaccharide extracted from one of a information on the availability of this number of related species of red algae material at NARA, call 202–741–6030, or (class Rhodophyceae). go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the ‘‘Food Chemicals codeloflfederallregulations/ Codex,’’ 3d Ed. (1981), p. 11, which is in- ibrllocations.html. corporated by reference. Copies may be (c) In accordance with § 184.1(b)(1), obtained from the National Academy the ingredient is used in food with no Press, 2101 Constitution Ave. NW., limitation other than current good Washington, DC 20418, or may be exam- manufacturing practice. The affirma- ined at the National Archives and tion of this ingredient as generally rec- Records Administration (NARA). For ognized as safe (GRAS) as a direct information on the availability of this human food ingredient is based upon material at NARA, call 202–741–6030, or the following current good manufac- go to: http://www.archives.gov/ turing practice conditions of use: federallregister/ (1) The ingredient is used in food as codeloflfederallregulations/ an emulsifier and emulsifier salt as de- ibrllocations.html. fined in § 170.3(o)(8) of this chapter and (c) The ingredient is used in food in a flavoring agent and adjuvant as de- accordance with § 184.1(b)(2) under the fined in § 170.3(o)(12) of this chapter. following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Foods (as served) Percent Functions

Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Confections and frostings, § 170.3(n)(9) of this chapter ...... 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; sta- bilizer, thickener, § 170.3(o)(28) of this chapter; sur- face finisher, § 170.3(o)(30) of this chapter.

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Foods (as served) Percent Functions

Soft candy, § 170.3(n)(38) of this chapter ...... 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 25 Flavoring agent, § 170.3(o)(12) of this chapter; formu- lation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for this ingredient Maximum level of Category of food use in food (as Functional use different from the uses established in served) this section do not exist or have been waived. Spices, Not to exceed cur- Flavor enhancer, seasonings, and rent good manu- § 170.3(o)(11) of [44 FR 19391, Apr. 3, 1979, as amended at 49 flavorings, facturing prac- this chapter; fla- FR 5611, Feb. 14, 1984] § 170.3(n) (26) tice. vor adjuvant, of this chapter. § 170.3(o)(12) of this chapter. § 184.1120 Brown algae. (a) Brown algae are seaweeds of the (d) Prior sanctions for this ingredient species Analipus japonicus, Eisenia different from the use established in bicyclis, Hizikia fusiforme, Kjellmaniella this section do not exist or have been gyrata, Laminaria angustata, Laminaria waived. claustonia, Laminaria digitata, Lam- [47 FR 47376, Oct. 26, 1982] inaria japonica, Laminaria longicruris, Laminaria longissima, Laminaria § 184.1121 Red algae. ochotensis, Laminaria saccharina, (a) Red algae are seaweeds of the spe- Macrocystis pyrifera, Petalonia fascia, cies Gloiopeltis furcata, Porphyra Scytosiphon lomentaria and Undaria crispata, Porphyra deutata, Porphyra pinnatifida. They are harvested prin- perforata, Porphyra suborbiculata, cipally in coastal waters of the north- Porphyra tenera and Rhodymenia ern Atlantic and Pacific oceans. The palmata. Porphyra and Rhodymenia are material is dried and ground or harvested principally along the coasts chopped for use in food. of Japan, Korea, China, Taiwan, and (b) The ingredient meets the speci- the East and West coasts of the United fications for kelp in the Food Chemi- States. Gloiopeltis is harvested prin- cals Codex, 3d Ed. (1981), p. 157, which is cipally in southern Pacific coastal incorporated by reference. Copies are waters. The material is dried and available from the National Academy ground or chopped for use in food. Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci- fications for kelp in the Food Chemi- Washington, DC 20418, or available for cals Codex, 3d Ed. (1981), p. 157, which is inspection at the National Archives incorporated by reference, except that and Records Administration (NARA). the loss on drying is not more than 20 For information on the availability of percent and the maximum allowable this material at NARA, call 202–741– level for iodine is 0.05 percent. Copies 6030, or go to: http://www.archives.gov/ are available from the National Acad- federallregister/ emy Press, 2101 Constitution Ave. NW., codeloflfederallregulations/ Washington, DC 20418, or available for ibrllocations.html. inspection at the National Archives (c) In accordance with § 184.1(b)(2), and Records Administration (NARA). the ingredient is used in food only For information on the availability of within the following specific limita- this material at NARA, call 202–741– tions: 6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) In accordance with § 184.1(b)(2), the ingredient is used in food only

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within the following specific limita- Maximum level of tions: use in Category of food food (as Functional use Maximum level of served) Category of food use in food (as Functional use (percent) served) Gravies and sauces, 0.4 Do. Spices, Not to exceed cur- Flavor enhancer, § 170.3(n)(24) of this seasonings, and rent good manu- § 170.3(o)(11) of chapter. flavorings, facturing prac- this chapter; fla- Jams and jellies, 0.4 Do. § 170.3(n) (26) tice. vor adjuvant, § 170.3(n)(28) of this of this chapter. § 170.3(o)(12) of chapter. this chapter. Sweet sauces, 0.5 Do. § 170.3(n)(43) of this chapter. (d) Prior sanctions for this ingredient All other food cat- 0.1 Humectant, different from the use established in egories. § 170.3(o)(16) of this this section do not exist or have been chapter; stabilizer, thickener, waived. § 170.3(o)(28) of this [47 FR 47376, Oct. 26, 1982] chapter. (d) Prior sanctions for ammonium al- § 184.1133 Ammonium alginate. ginate different from the uses estab- (a) Ammonium alginate (CAS Reg. lished in this section do not exist or No. 9005–34–9) is the ammonium salt of have been waived. alginic acid, a natural polyuronide con- stituent of certain brown algae. Ammo- [47 FR 29950, July 9, 1982] nium alginate is prepared by the neu- § 184.1135 Ammonium bicarbonate. tralization of purified alginic acid with (a) Ammonium bicarbonate appropriate pH control agents. (NH HCO , CAS Reg. No. 1066–33–7) is (b) The ingredient meets the speci- 4 3 prepared by reacting gaseous carbon di- fications of the Food Chemicals Codex, oxide with aqueous ammonia. Crystals 3d Ed. (1981), p. 18, which is incor- of ammonium bicarbonate are precip- porated by reference. Copies are avail- itated from solution and subsequently able from the National Academy Press, washed and dried. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), p. 19, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(2), material at NARA, call 202–741–6030, or the ingredient is used in food only go to: http://www.archives.gov/ within the following specific limita- federallregister/ tions: codeloflfederallregulations/ ibrllocations.html. Maximum level of (c) In accordance with § 184.1(b)(1), use in the ingredient is used in food with no Category of food food (as Functional use served) limitation other than current good (percent) manufacturing practice. The affirma- tion of this ingredient as generally rec- Confections, frostings, 0.4 Stabilizer, thickener, § 170.3(n)(9) of this § 170.3(o)(28) of this ognized as safe (GRAS) as a direct chapter. chapter. human food ingredient is based upon Fats and oils, 0.5 Do. the following current good manufac- § 170.3(n)(12) of this turing practice conditions of use: chapter. (1) The ingredient is used as a dough Gelatins, puddings, 0.5 Do. § 170.3(n)(22) of this strengthener as defined in § 170.3(o)(6) chapter. of this chapter; a leavening agent as

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defined in § 170.3(o)(17) of this chapter; this section do not exist or have been a pH control agent as defined in waived. § 170.3(o)(23) of this chapter; and a [48 FR 52439, Nov. 18, 1983] texturizer as defined in § 170.3(o)(32) of this chapter. § 184.1138 Ammonium chloride. (2) The ingredient is used in food at (a) Ammonium chloride (NH4Cl, CAS levels not to exceed current good man- Reg. No. 12125–02–9) is produced by the ufacturing practice. reaction of sodium chloride and an am- (d) Prior sanctions for this ingredient monium salt in solution. The less solu- different from the uses established in ble sodium salt separates out at ele- this section do not exist or have been vated temperatures, and ammonium waived. chloride is recovered from the filtrate [48 FR 52439, Nov. 18, 1983] on cooling. Alternatively, hydrogen chloride formed by the burning of hy- § 184.1137 Ammonium carbonate. drogen in chlorine is dissolved in water and then reacted with gaseous ammo- (a) Ammonium carbonate ((NH4)2CO3, nia. Ammonium chloride is crystallized CAS Reg. No. 8000–73–5) is a mixture of from the solution. ammonium bicarbonate (NH4HCO3) and (b) The ingredient meets the speci- ammonium carbamate (NH2COONH4). fications of the Food Chemicals Codex, It is prepared by the sublimation of a 3d Ed. (1981), p. 20, which is incor- mixture of ammonium sulfate and cal- porated by reference. Copies are avail- cium carbonate and occurs as a white able from the National Academy Press, powder or a hard, white or translucent 2101 Constitution Ave, NW., Wash- mass. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the National Archives and fications of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 19, which is incor- information on the availability of this porated by reference. Copies are avail- material at NARA, call 202–741–6030, or able from the National Academy Press, go to: http://www.archives.gov/ 2101 Constitution Ave. NW., Wash- federallregister/ ington, DC 20418, or available for in- codeloflfederallregulations/ spection at the National Archives and ibrllocations.html. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food with no material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of this ingredient as generally rec- codeloflfederallregulations/ ognized as safe (GRAS) as a direct ibrllocations.html. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as a dough manufacturing practice. The affirma- strengthener as defined in § 170.3(o)(6) tion of this ingredient as generally rec- of this chapter; a flavor enhancer as de- ognized as safe (GRAS) as a direct fined in § 170.3(o)(11) of this chapter; a human food ingredient is based upon leavening agent as defined in the following current good manufac- § 170.3(o)(17) of this chapter; and a proc- turing practice conditions of use: essing aid as defined in § 107.3(o)(24) of (1) The ingredient is used as a leav- this chapter. ening agent as defined in § 170.3(o)(17) of (2) The ingredient is used in food at this chapter and a pH control agent as levels not to exceed current good man- defined in § 170.3(o)(23) of this chapter. ufacturing practice. (2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [48 FR 52439, Nov. 18, 1983]

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§ 184.1139 Ammonium hydroxide. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no (a) Ammonium hydroxide (NH OH, 4 limitation other than current good CAS Reg. No. 1336–21–6) is produced by manufacturing practice. The affirma- passing ammonia gas into water. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications of the Food Chemicals Codex, human food ingredient is based upon 3d Ed. (1981), p. 20, which is incor- the following current good manufac- porated by reference. Copies are avail- turing practice conditions of use: able from the National Academy Press, (1) The ingredient is used as a flavor 2101 Constitution Ave. NW., Wash- enhancer as defined in § 170.3(o)(11) of ington, DC 20418, or available for in- this chapter and as a pH control agent spection at the National Archives and as defined in § 170.3(o)(23) of this chap- Records Administration (NARA). For ter. information on the availability of this (2) The ingredient is used in non- material at NARA, call 202–741–6030, or alcoholic beverages as defined in go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter and in federallregister/ cheeses as defined in § 170.3(n)(5) of this codeloflfederallregulations/ chapter at levels not to exceed current ibrllocations.html. good manufacturing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section, or different from those set manufacturing practice. The affirma- forth in part 181 of this chapter, do not tion of this ingredient as generally rec- exist or have been waived. ognized as safe (GRAS) as a direct human food ingredient is based upon [59 FR 63896, Dec. 12, 1994, as amended at 73 the following current good manufac- FR 8606, Feb. 14, 2008] turing practice conditions of use: (1) The ingredient is used as a leav- § 184.1141a Ammonium phosphate, monobasic. ening agent as defined in § 170.3(o)(17) of this chapter; a pH control agent as de- (a) Ammonium phosphate, monobasic fined in § 170.3(o)(23) of this chapter; a (NH4H2PO4, CAS Reg. No. 7722–76–1) is surface-finishing agent as defined in manufactured by reacting ammonia § 170.3(o)(30) of this chapter; and as a with phosphoric acid at a pH below 5.8. boiler water additive complying with (b) The ingredient meets the speci- § 173.310 of this chapter. fications of the Food Chemicals Codex, (2) The ingredient is used in food at 3d Ed. (1981), p. 21, which is incor- levels not to exceed current good man- porated by reference. Copies are avail- ufacturing practice. The ingredient able from the National Academy Press, may also be used as a boiler water ad- 2101 Constitution Ave. NW., Wash- ditive at levels not to exceed current ington, DC 20418, or available for in- good manufacturing practice. spection at the National Archives and (d) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this this section do not exist or have been material at NARA, call 202–741–6030, or waived. go to: http://www.archives.gov/ federallregister/ [48 FR 52440, Nov. 18, 1983, as amended at 59 codeloflfederallregulations/ FR 14551, Mar. 29, 1994] ibrllocations.html. (c) In accordance with § 184.1(b)(1), § 184.1140 Ammonium citrate, dibasic. the ingredient is used in food with no (a) Ammonium citrate, dibasic limitation other than current good ((NH4)2HC6H5O7, CAS Reg. No. 3012–65–5) manufacturing practice. The affirma- is the diammonium salt of citric acid. tion of this ingredient as generally rec- It is prepared by partially neutralizing ognized as safe (GRAS) as a direct citric acid with ammonia. human food ingredient is based upon (b) The ingredient must be of a pu- the following current good manufac- rity suitable for its intended use. turing practice conditions of use:

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(1) The ingredient is used as a dough this section do not exist or have been strengthener as defined in § 170.3(o)(6) waived. of this chapter and a pH control agent [48 FR 52440, Nov. 18, 1983] as defined in § 170.3(o)(23) of this chap- ter. § 184.1143 Ammonium sulfate. (2) The ingredient is used in food at (a) Ammonium sulfate ((NH ) SO , levels not to exceed current good man- 4 2 4 CAS Reg. No. 7783–20–2) occurs natu- ufacturing practice. rally and consists of colorless or white, (d) Prior sanctions for this ingredient odorless crystals or granules. It is pre- different from the uses established in pared by the neutralization of sulfuric this section do not exist or have been acid with ammonium hydroxide. waived. (b) The ingredient meets the speci- [48 FR 52440, Nov. 18, 1983] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 22–23, which is § 184.1141b Ammonium phosphate, di- incorporated by reference. Copies may basic. be obtained from the National Acad- (a) Ammonium phosphate, dibasic emy Press, 2101 Constitution Ave. NW., ((NH4)2HPO4, CAS Reg. No. 7783–28–0) is Washington, DC 20418, or may be exam- manufactured by reacting ammonia ined at the National Archives and with phosphoric acid at a pH above 5.8. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 21, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) The ingredient is used as a dough spection at the National Archives and strengthener as defined in § 170.3(o)(6) Records Administration (NARA). For of this chapter, firming agent as de- information on the availability of this fined in § 170.3(o)(10) of this chapter, material at NARA, call 202–741–6030, or and processing aid as defined in go to: http://www.archives.gov/ § 170.3(o)(24) of this chapter. federallregister/ (d) The ingredient is used in food at codeloflfederallregulations/ levels not to exceed good manufac- ibrllocations.html. turing practice in accordance with (c) In accordance with § 184.1(b)(1), § 184.1(b)(1). Current good manufac- the ingredient is used in food with no turing practice results in a maximum limitation other than current good level, as served, of 0.15 percent for manufacturing practice. The affirma- baked goods as defined in § 170.3(n)(1) of tion of this ingredient as generally rec- this chapter and 0.1 percent for gela- ognized as safe (GRAS) as a direct tins and puddings as defined in human food ingredient is based upon § 170.1(n)(22) of this chapter. the following current good manufac- (e) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a dough this section do not exist or have been strengthener as defined in § 170.3(o)(6) waived. of this chapter; a firming agent as de- [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, fined in § 170.3(o)(10) of this chapter; a 1980, as amended at 49 FR 5611, Feb. 14, 1984] leavening agent as defined in § 170.3(o)(17) of this chapter; a pH con- § 184.1148 Bacterially-derived trol agent as defined in § 170.3(o)(23) of carbohydrase enzyme preparation. this chapter; and a processing aid as (a) Bacterially-derived carbohydrase defined in § 170.3(o)(24) of this chapter. enzyme preparation is obtained from (2) The ingredient is used in food at the culture filtrate resulting from a levels not to exceed current good man- pure culture fermentation of a non- ufacturing practice. pathogenic and nontoxigenic strain of (d) Prior sanctions for this ingredient Bacillus subtilis or B. amyloliquefaciens. different from the uses established in The preparation is characterized by the

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presence of the enzymes a-amylase (EC (2) The ingredient is used in food at 3.2.1.1) and b-glucanase (EC 3.2.1.6), levels not to exceed current good man- which catalyze the hydrolysis of O- ufacturing practice. glycosyl bonds in carbohydrates. [64 FR 19894, Apr. 23, 1999, as amended at 81 (b) The ingredient meets the general FR 5595, Feb. 3, 2016] requirements and additional require- ments in the monograph on enzyme § 184.1150 Bacterially-derived protease preparations in the Food Chemicals enzyme preparation. Codex, 4th ed. (1996), pp. 128–135, which (a) Bacterially-derived protease en- is incorporated by reference in accord- zyme preparation is obtained from the ance with 5 U.S.C. 552(a) and 1 CFR culture filtrate resulting from a pure part 51. Copies are available from the culture fermentation of a nonpatho- National Academy Press, 2101 Constitu- genic and nontoxigenic strain of Bacil- tion Ave. NW., Washington, DC 20418, lus subtilis or B. amyloliquefaciens. The or may be examined at the Food and preparation is characterized by the Drug Administration’s Main Library, presence of the enzymes subtilisin (EC 10903 New Hampshire Ave., Bldg. 2, 3.4.21.62) and neutral proteinase (EC Third Floor, Silver Spring, MD 20993, 3.4.24.28), which catalyze the hydrolysis 301–796–2039, or at the National Ar- of peptide bonds in proteins. chives and Records Administration (b) The ingredient meets the general (NARA). For information on the avail- requirements and additional require- ability of this material at NARA, call ments in the monograph on enzyme 202–741–6030, or go to: http:// preparations in the Food Chemicals www.archives.gov/federallregister/ Codex, 4th ed. (1996), pp. 128–135, which codeloflfederallregulations/ is incorporated by reference in accord- ibrllocations.html. In addition, anti- ance with 5 U.S.C. 552(a) and 1 CFR biotic activity is absent in the enzyme part 51. Copies are available from the preparation when determined by an ap- National Academy Press, 2101 Constitu- propriate validated method such as the tion Ave. NW., Washington, DC 20418, method ‘‘Determination of antibiotic or may be examined at the Food and activity’’ in the Compendium of Food Drug Administration’s Main Library, Additive Specifications, vol. 2, Joint 10903 New Hampshire Ave., Bldg. 2, FAO/WHO Expert Committee on Food Third Floor, Silver Spring, MD 20993, Additives (JECFA), Food and Agri- 301–796–2039, or at the National Ar- culture Organization of the United Na- chives and Records Administration tions, Rome, 1992. Copies are available (NARA). For information on the avail- from Bernan Associates, 4611–F Assem- ability of this material at NARA, call bly Dr., Lanham, MD 20706, or from The 202–741–6030, or go to: http:// United Nations Bookshop, General As- www.archives.gov/federallregister/ sembly Bldg., rm. 32, New York, NY codeloflfederallregulations/ 10017, or by inquiries sent to http:// ibrllocations.html. In addition, anti- www.fao.org. Copies may be examined biotic activity is absent in the enzyme at the Center for Food Safety and Ap- preparation when determined by an ap- plied Nutrition’s Library, 5001 Campus propriate validated method such as the Dr., College Park, MD 20740. method ‘‘Determination of antibiotic (c) In accordance with § 184.1(b)(1), activity’’ in the Compendium of Food the ingredient is used in food with no Additive Specifications, vol. 2, Joint limitation other than current good FAO/WHO Expert Committee on Food manufacturing practice. The affirma- Additives (JECFA), Food and Agri- tion of this ingredient as GRAS as a di- culture Organization of the United Na- rect food ingredient is based upon the tions, Rome, 1992. Copies are available following current good manufacturing from Bernan Associates, 4611–F Assem- practice conditions of use: bly Dr., Lanham, MD 20706, or from The (1) The ingredient is used as an en- United Nations Bookshop, General As- zyme as defined in § 170.3(o)(9) of this sembly Bldg., rm. 32, New York, NY chapter to hydrolyze polysaccharides 10017, or by inquiries sent to http:// (e.g., starch). www.fao.org. Copies may be examined

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at the Center for Food Safety and Ap- this section do not exist or have been plied Nutrition’s Library, 5001 Campus waived. Dr., College Park, MD 20740. [47 FR 43367, Oct. 1, 1982, as amended at 73 FR (c) In accordance with § 184.1(b)(1), 8606, Feb. 14, 2008; 76 FR 59249, Sept. 26, 2011] the ingredient is used in food with no limitation other than current good § 184.1157 Benzoyl peroxide. manufacturing practice. The affirma- (a) Benzoyl peroxide ((C6H5CO)2O2, tion of this ingredient as GRAS as a di- CAS Reg. No. 94–36–0) is a colorless, rect food ingredient is based upon the rhombic crystalline solid. It is pre- following current good manufacturing pared by reaction of benzoyl chloride, practice conditions of use: sodium hydroxide, and hydrogen per- (1) The ingredient is used as an en- oxide. zyme as defined in § 170.3(o)(9) of this (b) The ingredient meets the speci- chapter to hydrolyze proteins or fications of the Food Chemicals Codex, polypeptides. 3d Ed. (1981), p. 35, which is incor- (2) The ingredient is used in food at porated by reference. Copies are avail- levels not to exceed current good man- able from the National Academy Press, ufacturing practice. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- [64 FR 19895, Apr. 23, 1999, as amended at 81 spection at the National Archives and FR 5593, Feb. 3, 2016] Records Administration (NARA). For information on the availability of this § 184.1155 Bentonite. material at NARA, call 202–741–6030, or (a) Bentonite (Al2O34SiO2nH2O, CAS go to: http://www.archives.gov/ Reg. No. 1302–78–9) is principally a col- federallregister/ loidal hydrated aluminum silicate. codeloflfederallregulations/ Bentonite contains varying quantities ibrllocations.html. of iron, alkalies, and alkaline earths in (c) In accordance with § 184.1(b)(1), the commercial products. Depending on the ingredient is used in food with no the cations present, natural deposits of limitation other than current good bentonite range in color from white to manufacturing practice. The affirma- gray, yellow, green, or blue. tion of this ingredient as generally rec- Bentonite’s fine particles provide large ognized as safe (GRAS) as a direct total surface area and, hence, pro- human food ingredient is based upon nounced adsorptive capability. the following current good manufac- (b) The ingredient must be of a pu- turing practice conditions of use: rity suitable for its intended use. (1) The ingredient is used as a bleach- (c) In accordance with § 184.1(b)(1), ing agent in food. the ingredient is used in food with no (2) The ingredient is used in the fol- limitation other than current good lowing foods at levels not to exceed current good manufacturing practice: manufacturing practice. The affirma- flour; milk used for production of tion of this ingredient as generally rec- Asiago fresh and Asiago soft cheese ognized as safe (GRAS) as a direct (§ 133.102), Asiago medium cheese human food ingredient is based upon (§ 133.103), Asiago old cheese (§ 133.104), the following current good manufac- Blue cheese (§ 133.106), Caciocavallo turing practice conditions of use: siciliano chesse (§ 133.111), Gorgonzola (1) The ingredient is used as a proc- cheese (§ 133.141), Parmesan and essing aid as defined in § 170.3(o)(24) of reggiano cheese (§ 133.165), Provolone this chapter. cheese (§ 133.181), Romano cheese (2) The ingredient is used in food at (§ 133.183), and Swiss and emmentaler levels not to exceed current good man- cheese (§ 133.195) in part 133 of this ufacturing practice. Current good man- chapter; and annatto-colored whey, ufacturing practice results in no sig- such that the final bleached product nificant residue in foods. conforms to the descriptions and speci- (d) Prior sanctions for this ingredient fications for whey, concentrated whey, different from the uses established in or dried whey in § 184.1979(a) (1), (2), or (3), respectively.

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(d) Prior sanctions for this ingredient spection at the National Archives and different from the uses established in Records Administration (NARA). For this section do not exist or have been information on the availability of this waived. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [51 FR 27173, July 30, 1986] federallregister/ § 184.1165 n-Butane and iso-butane. codeloflfederallregulations/ ibrllocations.html. (a) n-Butane and iso-butane (empir- (c) The ingredient is used as a firm- ical formula C4H10, CAS Reg. Nos. 106– ing agent as defined in § 170.3(o)(10) of 97–8 and 75–28–5, respectively) are color- this chapter; pH control agent as de- less, flammable gases at normal tem- fined in § 170.3(o)(23) of this chapter; peratures and pressures. They are eas- processing aid as defined in § 170.3(o)(24) ily liquefied under pressure at room of this chapter; sequestrant as defined temperature and are stored and shipped in § 170.3(o)(26) of this chapter; sta- in the liquid state. The butanes are ob- bilizer and thickener as defined in tained from natural gas by fraction- § 170.3(o)(28) of this chapter; and ation following absorption in oil, ad- texturizer as defined in § 170.3(o)(32) of sorption to surface-active agents, or re- this chapter. frigeration. (d) The ingredient is used in food at (b) The ingredients must be of a pu- levels not to exceed current good man- rity suitable for their intended use. ufacturing practices in accordance (c) In accordance with § 184.1(b)(1), with § 184.1(b)(1). Current good manu- these ingredients are used in food with facturing practices result in a max- no limitations other than current good imum level, as served, of 0.2 percent for manufacturing practice. The affirma- baked goods as defined in § 170.3(n)(1) of tion of these ingredients as generally this chapter; 0.02 percent for cheese as recognized as safe (GRAS) as direct defined in § 170.3(n)(5) of this chapter; human food ingredients is based upon 0.2 percent for gelatins, puddings, and the following current good manufac- fillings as defined in § 170.3(n)(22) of turing practice conditions of use: this chapter; 0.15 percent for sweet (1) The ingredients are used as pro- sauces, toppings, and syrups as defined pellants, aerating agents, and gases as in § 170.3(n)(43) of this chapter; and defined in § 170.3(o)(25) of this chapter. 0.0001 percent for all other food cat- (2) The ingredients are used in food egories. at levels not to exceed current good (e) Prior sanctions for this ingredient manufacturing practice. different from the uses established in (d) Prior sanctions for these ingredi- this section or in part 181 of this chap- ents different from the uses established ter do not exist or have been waived. in this section do not exist or have [47 FR 27807, June 25, 1982] been waived. [48 FR 57270, Dec. 29, 1983, as amended at 73 § 184.1187 Calcium alginate. FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, (a) Calcium alginate (CAS Reg. No. 2011] 9005–35–0) is the calcium salt of alginic acid, a natural polyuronide constituent § 184.1185 Calcium acetate. of certain brown algae. Calcium algi- (a) Calcium acetate (Ca (C2H3O2)2, nate is prepared by the neutralization CAS Reg. No. 62–54–4), also known as of purified alginic acid with appro- acetate of lime or vinegar salts, is the priate pH control agents, or from so- calcium salt of acetic acid. It may be dium alginate by metathesis with ap- produced by the calcium hydroxide propriate calcium salts. neutralization of acetic acid. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 45, which is incor- 3d Ed. (1981), p. 44, which is incor- porated by reference. Copies are avail- porated by reference. Copies are avail- able from the National Academy Press, able from the National Academy Press, 2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- ington, DC 20418, or available for in- spection at the National Archives and

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Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 46, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(2), spection at the National Archives and the ingredient is used in food only Records Administration (NARA). For within the following specific limita- information on the availability of this tions: material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ Maximum level of federallregister/ use in codeloflfederallregulations/ Category of food food (as Functional use served) ibrllocations.html. (percent) (c) In accordance with § 184.1(b)(1), Baked goods, 0.002 Stabilizer, thickener, the ingredient is used in food with no § 170.3(n)(1) of this § 170.3(o)(28) of this limitation other than current good chapter. chapter. manufacturing practice. Alcoholic beverages, 0.4 Do. § 170.3(n)(2) of this (d) Prior sanctions for this ingredient chapter. different from the uses established in Confections and 0.4 Do. this section, or different from that set frostings, forth in part 181 of this chapter, do not § 170.3(n)(9) of this chapter. exist or have been waived. Egg products, 0.6 Do. § 170.3(n)(11) of this [48 FR 52441, Nov. 18, 1983] chapter. Fats and oils, 0.5 Do. § 184.1193 Calcium chloride. § 170.3(n)(12) of this chapter. (a) Calcium chloride (CaCl2·2H2O, Gelatins, puddings, 0.25 Do. CAS Reg. No. 10035–04–8) or anhydrous § 170.3(n)(22) of this chapter. calcium chloride (CaCl2, CAS Reg. No. Gravies and sauces, 0.4 Do. 10043–52–4) may be commercially ob- § 170.3(n)(24) of this tained as a byproduct in the ammonia- chapter. soda (Solvay) process and as a joint Jams and jellies, 0.5 Do. § 170.3(n)(28) of this product from natural salt brines, or it chapter. may be prepared by substitution reac- Sweet sauces, 0.5 Do. tions with other calcium and chloride § 170.3(n)(43) of this chapter. salts. All other food cat- 0.3 Do. (b) The ingredient meets the speci- egories. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 47, which is incor- (d) Prior sanctions for calcium algi- porated by reference. Copies are avail- nate different from the uses established able from the National Academy Press, in this section do not exist or have 2101 Constitution Ave. NW., Wash- been waived. ington, DC 20418, or available for in- [47 FR 29951, July 9, 1982] spection at the National Archives and Records Administration (NARA). For § 184.1191 Calcium carbonate. information on the availability of this

(a) Calcium carbonate (CaCO3, CAS material at NARA, call 202–741–6030, or Reg. No. 471–34–1) is prepared by three go to: http://www.archives.gov/ common methods of manufacture: federallregister/ (1) As a byproduct in the ‘‘Lime soda codeloflfederallregulations/ process’’; ibrllocations.html. (2) By precipitation of calcium car- (c) The ingredient is used as an bonate from calcium hydroxide in the anticaking agent as defined in ‘‘Carbonation process’’; or § 170.3(o)(1) of this chapter; anti- (3) By precipitation of calcium car- microbial agent as defined in bonate from calcium chloride in the § 170.3(o)(2) of this chapter; curing or ‘‘Calcium chloride process’’. pickling agent as defined in § 170.3(o)(5)

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of this chapter; firming agent as de- acid. It is prepared by neutralizing cit- fined in § 170.3(o)(10) of this chapter; ric acid with calcium hydroxide or cal- flavor enhancer as defined in cium carbonate. It occurs as a fine § 170.3(o)(11) of this chapter; humectant white, odorless powder and usually as defined in § 170.3(o)(16) of this chap- contains four moles of water per mole ter; nutrient supplement as defined in of calcium citrate. § 170.3(o)(20) of this chapter; pH control (b) The ingredient meets the speci- agent as defined in § 170.3(o)(23) of this fications of the Food Chemicals Codex, chapter; processing aid as defined in 3d ed. (1981), pp. 49 and 50, which is in- § 170.3(o)(24) of this chapter; stabilizer corporated by reference in accordance and thickener as defined in § 170.3(o)(28) with 5 U.S.C. 552(a) and 1 CFR part 51. of this chapter; surface-active agent as Copies are available from the National defined in § 170.3(o)(29) of this chapter; Academy Press, 2101 Constitution Ave. synergist as defined in § 170.3(o)(31) of NW., Washington, DC 20418, and the this chapter; and texturizer as defined Center for Food Safety and Applied Nu- in § 170.3(o)(32) of this chapter. trition (HFS–200), 5001 Campus Dr., Col- (d) The ingredient is used in foods at lege Park, MD 20740, or may be exam- levels not to exceed current good man- ined at the National Archives and ufacturing practices in accordance Records Administration (NARA). For with § 184.1(b)(1). Current good manu- information on the availability of this facturing practices result in a max- material at NARA, call 202–741–6030, or imum level, as served, of 0.3 percent for go to: http://www.archives.gov/ baked goods as defined in § 170.3(n)(1) of federallregister/ this chapter and for dairy product codeloflfederallregulations/ analogs as defined in § 170.3(n)(10) of ibrllocations.html. this chapter; 0.22 percent for non- (c) In accordance with § 184.1(b)(1), alcoholic beverages and beverage bases the ingredient is used in food with no as defined in § 170.3(n)(3) of this chap- limitation other than current good ter; 0.2 percent for cheese as defined in manufacturing practice. Calcium cit- § 170.3(n)(5) of this chapter and for proc- rate may also be used in infant formula essed fruit and fruit juices as defined in in accordance with section 412(g) of the § 170.3(n)(35) of this chapter; 0.32 per- Federal Food, Drug, and Cosmetic Act cent for coffee and tea as defined in (the act) or with regulations promul- § 170.3(n)(7) of this chapter; 0.4 percent gated under section 412(a)(2) of the act. for condiments and relishes as defined (d) Prior sanctions for this ingredient in § 170.3(n)(8) of this chapter; 0.2 per- different from the uses established in cent for gravies and sauces as defined this section do not exist or have been in § 170.3(n)(24) of this chapter; 0.1 per- waived. cent for commercial jams and jellies as [59 FR 63896, Dec. 12, 1994] defined in § 170.3(n)(28) of this chapter; 0.25 percent for meat products as de- § 184.1199 Calcium gluconate. fined in § 170.3(n)(29) of this chapter; 2.0 (a) Calcium gluconate percent for plant protein products as ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. defined in § 170.3(n)(33) of this chapter; 299–28–5) is the calcium salt of gluconic 0.4 percent for processed vegetables and acid which may be produced by neu- vegetable juices as defined in tralization of gluconic acid with lime § 170.3(n)(36) of this chapter; and 0.05 or calcium carbonate. percent for all other food categories. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the Food Chemicals Codex, different from the uses established in 3d Ed. (1981), p. 51, which is incor- this section do not exist or have been porated by reference. Copies are avail- waived. able from the National Academy Press, [47 FR 27808, June 25, 1982, as amended at 61 2101 Constitution Ave. NW., Wash- FR 14247, Apr. 1, 1996] ington, DC 20418, or available for in- spection at the National Archives and § 184.1195 Calcium citrate. Records Administration (NARA). For (a) Calcium citrate information on the availability of this (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– material at NARA, call 202–741–6030, or 0994–095) is the calcium salt of citric go to: http://www.archives.gov/

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federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) The ingredient is used as a firm- manufacturing practice. The affirma- ing agent as defined in § 170.3(o)(10) of tion of this ingredient as generally rec- this chapter; formulation aid as defined ognized as safe (GRAS) as a direct in § 170.3(o)(14) of this chapter; human food ingredient is based upon sequestrant as defined in § 170.3(o)(26) of the following current good manufac- this chapter; stabilizer or thickener as turing practice conditions of use: defined in § 170.3(o)(28) of this chapter; (1) The ingredient is used as a nutri- and texturizer as defined in § 170.3(o)(32) ent supplement as defined in of this chapter. § 170.3(o)(20) of this chapter. (d) The ingredient is used in foods at (2) The ingredient is used in gelatins, levels not to exceed current good man- puddings, and fillings as defined in ufacturing practices in accordance § 170.3(n)(22) of this chapter. with § 184.1(b)(1). Current good manu- (d) Prior sanctions for this ingredient facturing practices result in a max- different from the uses established in imum level, as served, of 1.75 percent this section or different from that as for baked goods as defined in set forth in part 181 of this chapter, do § 170.3(n)(1) of this chapter; 0.4 percent not exist or have been waived. for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 4.5 percent [57 FR 10813, Mar. 31, 1992] for gelatins and puddings as defined in § 184.1205 Calcium hydroxide. § 170.3(n)(22) of this chapter; and 0.01 percent for sugar substitutes as defined (a) Calcium hydroxide (Ca(OH)2, CAS in § 170.3(n)(42) of this chapter. Reg. No. 1305–62–0) is also known as (e) Prior sanctions for this ingredient slaked lime or calcium hydrate. It is different from the uses established in produced by the hydration of lime. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 52, which is incor- [47 FR 27808, June 25, 1982] porated by reference. Copies are avail- able from the National Academy Press, § 184.1201 Calcium glycerophosphate. 2101 Constitution Ave. NW., Wash- (a) Calcium glycerophosphate ington, DC 20418, or available for in- (C3H7CaO6P, CAS Reg. No. 27214–00–2) is spection at the National Archives and a fine, white, odorless, almost taste- Records Administration (NARA). For less, slightly hygroscopic powder. It is information on the availability of this prepared by neutralizing glycero- material at NARA, call 202–741–6030, or phosphoric acid with calcium hydrox- go to: http://www.archives.gov/ ide or calcium carbonate. The commer- federallregister/ cial product is a mixture of calcium b- codeloflfederallregulations/ , and D-, and L-a-glycerophosphate. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the ‘‘Food Chemicals the ingredient is used in food with no Codex,’’ 3d Ed. (1981), pp. 51–52, which is limitation other than current good incorporated by reference in accord- manufacturing practice. ance with 5 U.S.C. 552(a) and 1 CFR (d) Prior sanctions for this ingredient part 51. Copies may be obtained from different from the uses established in the National Academy Press, 2101 Con- this section do not exist or have been stitution Ave. NW., Washington, DC waived. 20418, or may be examined at the Na- tional Archives and Records Adminis- [49 FR 26714, June 29, 1984] tration (NARA). For information on the availability of this material at § 184.1206 Calcium iodate. NARA, call 202–741–6030, or go to: http:// (a) Calcium iodate [Ca(IO3)2·H2O, CAS www.archives.gov/federallregister/ Reg. No. 7789–80–2], also referred to as codeloflfederallregulations/ lautarite, does not occur naturally but ibrllocations.html. can be prepared by passing chlorine

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into a hot solution of lime (CaCO3) in ognized as safe (GRAS) as a direct which iodine has been dissolved. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the ‘‘Food Chemicals turing practice conditions of use: Codex,’’ 3d Ed. (1981), p. 53, which is in- (1) The ingredient is used as a firm- corporated by reference. Copies may be ing agent as defined in § 170.3(o)(10) of obtained from the National Academy this chapter; a flavor enhancer as de- Press, 2101 Constitution Ave. NW., fined in § 170.3(o)(11) of this chapter; a Washington, DC 20418, or may be exam- flavoring agent or adjuvant as defined ined at the National Archives and in § 170.3(o)(12) of this chapter; a leav- Records Administration (NARA). For ening agent as defined in § 170.3(o)(17) of information on the availability of this material at NARA, call 202–741–6030, or this chapter; a nutrient supplement as go to: http://www.archives.gov/ defined in § 170.3(o)(20) of this chapter; federallregister/ and a stabilizer and thickener as de- codeloflfederallregulations/ fined in § 170.3(o)(28) of this chapter. ibrllocations.html. (2) The ingredient is used in food, ex- (c) The ingredient is used as a dough cept in infant foods and infant for- strengthener as defined in § 170.3(o)(6) mulas, at levels not to exceed current of this chapter. good manufacturing practice. (d) The ingredient is used in the man- (d) Prior sanctions for this ingredient ufacture of bread in accordance with different from the uses established in § 184.1(b)(2) of this chapter in an this section do not exist or have been amount not to exceed 0.0075 percent waived. based on the weight of the flour. (e) Prior sanctions for this ingredient [49 FR 35367, Sept. 7, 1984] different from the uses established in this section do not exist or have been § 184.1210 Calcium oxide. waived. (a) Calcium oxide (CaO, CAS Reg. No. 1305–78–8) is also known as lime, quick [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb. 14, 1984] lime, burnt lime, or calx. It is produced from calcium carbonate, limestone, or § 184.1207 Calcium lactate. oyster shells by calcination at tem- peratures of 1,700–2,450 °F. (a) Calcium lactate (C6H10CaO6. xH2O, where x is any integer up to 5, CAS (b) The ingredient meets the speci- Reg. No. 814–80–2) is prepared commer- fications of the Food Chemicals Codex, cially by the neutralization of lactic 3d Ed. (1981), p. 55, which is incor- acid with calcium carbonate or cal- porated by reference. Copies are avail- cium hydroxide. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the Food Chemicals Codex, ington, DC 20418, or available for in- 3d Ed. (1981), p. 53, which is incor- spection at the National Archives and porated by reference. Copies are avail- Records Administration (NARA). For able from the National Academy Press, information on the availability of this 2101 Constitution Avenue NW., Wash- material at NARA, call 202–741–6030, or ington, DC 20418, or available for in- go to: http://www.archives.gov/ spection at the National Archives and federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. ibrllocations.html. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- tion of this ingredient as generally rec- [49 FR 26714, June 29, 1984]

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§ 184.1212 Calcium pantothenate. § 184.1221 Calcium propionate.

(a) Calcium pantothenate (a) Calcium propionate (C6H10CaO4, ((C9H16NO5)2Ca, CAS Reg. No. of the D- CAS Reg. No. 4075–81–4) is the calcium isomer, 137–08–6) is a salt of panto- salt of propionic acid. It occurs as thenic acid, one of the vitamins of the white crystals or a crystalline solid, B complex. Only the D-isomer of panto- possessing not more than a faint odor thenic acid has vitamin activity, al- of propionic acid. It is prepared by neu- though both the D-isomer and the DL- tralizing propionic acid with calcium racemic mixture of calcium panto- hydroxide. thenate are used in food. Commercial (b) The ingredient meets the speci- calcium pantothenate is prepared syn- fications of the Food Chemicals Codex, thetically from isobutyraldehyde and 3d Ed. (1981), p. 60, which is incor- formaldehyde via 1,1-dimethyl-2-hy- porated by reference. Copies are avail- droxy-propionaldehyde and able from the National Academy Press, pantolactone. 2101 Constitution Ave. NW., Wash- (b) Calcium pantothenate meets the ington, DC 20418, or available for in- spection at the National Archives and specifications of the Food Chemicals Records Administration (NARA). For Codex, 3d Ed. (1981), p. 56, which is in- information on the availability of this corporated by reference. Copies are material at NARA, call 202–741–6030, or available from the National Academy go to: http://www.archives.gov/ Press, 2101 Constitution Ave. NW., federallregister/ Washington, DC 20418, or available for codeloflfederallregulations/ inspection at the National Archives ibrllocations.html. and Records Administration (NARA). (c) In accordance with § 184.1(b)(1), For information on the availability of the ingredient is used in food with no this material at NARA, call 202–741– limitation other than current good 6030, or go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of this ingredient as generally rec- codeloflfederallregulations/ ognized as safe (GRAS) as a direct ibrllocations.html. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as an anti- manufacturing practice. The affirma- microbial agent as defined in tion of this ingredient as generally rec- § 170.3(o)(2) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredient is used in the fol- human food ingredient is based upon lowing foods at levels not to exceed the following current good manufac- current good manufacturing practice: turing practice conditions of use: baked goods as defined in § 170.3(n)(1) of (1) The ingredient is used as a nutri- this chapter; cheeses as defined in ent supplement as defined in § 170.3(n)(5) of this chapter; confections § 170.3(o)(20) of this chapter. and frostings as defined in § 170.3(n)(9) (2) The ingredient is used in foods at of this chapter; gelatins, puddings, and fillings as defined in § 170.3(n)(22) of levels not to exceed current good man- this chapter; and jams and jellies as de- ufacturing practice. Calcium panto- fined in § 170.3(n)(28) of this chapter. thenate may be used in infant formula (d) Prior sanctions for this ingredient in accordance with section 412(g) of the different from the uses established in Federal Food, Drug, and Cosmetic Act this section do not exist or have been (the act) or with regulations promul- waived. gated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient [49 FR 13141, Apr. 3, 1984] different from the uses established in this section do not exist or have been § 184.1229 Calcium stearate. waived. (a) Calcium stearate (Ca(C17H35COO)2, CAS Reg. No. 1529–23–0) is the calcium [48 FR 51908, Nov. 15, 1983] salt of stearic acid derived from edible

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sources. It is prepared as a white pre- corporated by reference. Copies may be cipitate by mixing calcium chloride obtained from the National Academy and sodium stearate in aqueous solu- Press, 2101 Constitution Ave. NW., tion. Washington, DC 20418, or may be exam- (b) The ingredient meets the speci- ined at the National Archives and fications of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 64, which is incor- information on the availability of this porated by reference, and the require- material at NARA, call 202–741–6030, or ments of § 172.860(b)(2) of this chapter. go to: http://www.archives.gov/ Copies of the Food Chemicals Codex federallregister/ are available from the National Acad- codeloflfederallregulations/ emy Press, 2101 Constitution Ave. NW., ibrllocations.html. Washington, DC 20418, or available for (c) The ingredient is used as an inspection at the National Archives anticaking agent as defined in and Records Administration (NARA). § 170.3(o)(1) of this chapter, color and For information on the availability of this material at NARA, call 202–741– coloring adjunct as defined in 6030, or go to: http://www.archives.gov/ § 170.3(o)(4) of this chapter, dough federallregister/ strengthener as defined in § 170.3(o)(6) codeloflfederallregulations/ of this chapter, drying agent as defined ibrllocations.html. in § 170.3(o)(7) of this chapter, firming (c) In accordance with § 184.1(b)(1), agent as defined in § 170.3(o)(10) of this the ingredient is used in food with no chapter, flour treating agent as defined limitation other than current good in § 170.3(o)(13) of this chapter, formula- manufacturing practice. The affirma- tion aid as defined in § 170.3(o)(14) of tion of this ingredient as generally rec- this chapter, leavening agent as de- ognized as safe (GRAS) as a direct fined in § 170.3(o)(17) of this chapter, nu- human food ingredient is based upon trient supplement as defined in the following current good manufac- § 170.3(o)(20) of this chapter, pH control turing practice conditions of use: agent as defined in § 170.3(o)(23) of this (1) The ingredient is used as a fla- chapter, processing aid as defined in voring agent and adjuvant as defined in § 170.3(o)(24) of this chapter, stabilizer § 170.3(o)(12) of this chapter; a lubricant and thickener as defined in § 170.3(o)(28) and release agent as defined in of this chapter, synergist as defined in § 170.3(o)(18) of this chapter; and a sta- § 170.3(o)(31) of this chapter, and bilizer and thickener as defined in texturizer as defined in § 170.3(o)(32) of § 170.3(o)(28) of this chapter. this chapter. (2) The ingredient is used in foods at (d) The ingredient is used in food at levels not to exceed current good man- levels not to exceed good manufac- ufacturing practice. turing practice in accordance with (d) Prior sanctions for this ingredient § 184.1(b)(1). Current good manufac- different from the uses established in turing practice results in a maximum this section do not exist or have been level, as served, of 1.3 percent for baked waived. goods as defined in § 170.3(n)(1) of this [48 FR 52445, Nov. 18, 1983] chapter, 3.0 percent for confections and frostings as defined in § 170.3(n)(9) of § 184.1230 Calcium sulfate. this chapter, 0.5 percent for frozen dairy desserts and mixes as defined in (a) Calcium sulfate (CaSO4, CAS Reg. § 170.3(n)(20) of this chapter, 0.4 percent No. 7778–18–9 or CaSO4·2H2O, CAS Reg. No. 10101–41–4), also known as plaster of for gelatins and puddings as defined in Paris, anhydrite, and gypsum, occurs § 170.3(n)(22) of this chapter, 0.5 percent naturally and exists as a fine, white to for grain products and pastas as de- slightly yellow-white odorless powder. fined in § 170.3(n)(23) of this chapter, The anhydrous form is prepared by 0.35 percent for processed vegetables as complete dehydration of gypsum, below defined in § 170.3(n)(36) of this chapter, 300 °C, in an electric oven. and 0.07 percent or less for all other (b) The ingredient meets the speci- food categories. fications of the ‘‘Food Chemicals (e) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), p. 66, which is in- different from the uses established in

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this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 73, which is incor- [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, porated by reference. Copies are avail- 1980, as amended at 49 FR 5611, Feb. 14, 1984] able from the National Academy Press, § 184.1240 Carbon dioxide. 2101 Constitution Ave. NW., Washingtion, DC 20418, or available for (a) Carbon dioxide (empirical formula inspection at the National Archives CO2, CAS Reg. No. 124–38–9) occurs as a and Records Administration (NARA). colorless, odorless, noncombustible gas For information on the availability of at normal temperatures and pressures. this material at NARA, call 202–741– The solid form, dry ice, sublimes under 6030, or go to: http://www.archives.gov/ atmospheric pressure at a temperature federallregister/ of ¥78.5 °C. Carbon dioxide is prepared codeloflfederallregulations/ as a byproduct of the manufacture of ibrllocations.html. lime during the ‘‘burning’’ of lime- (c) In accordance with § 184.1(b)(1), stone, from the combustion of carbo- the ingredient is used in food with no naceous material, from fermentation limitation other than current good processes, and from gases found in cer- manufacturing practice. The affirma- tain natural springs and wells. tion of this ingredient as generally rec- (b) The ingredient must be of a pu- ognized as safe (GRAS) as a direct rity suitable for its intended use. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitations other than current good (1) The ingredient is used as a nutri- manufacturing practice. The affirma- ent supplement as defined in tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredient is used in the fol- human food ingredient is based upon lowing foods at levels not to exceed the following current good manufac- current good manufacturing practice: turing practice conditions of use: dairy product analogs as defined in (1) The ingredient is used as a leav- § 170.3(n)(10) of this chapter; fats and ening agent as defined in § 170.3(o)(17) of oils as defined in § 170.3(n)(12) of this this chapter; a processing aid as de- chapter; and processed fruits and fruit fined in § 170.3(o)(24) of this chapter; juices as defined in § 170.3(n)(35) of this and a propellant, aerating agent, and chapter. Beta-carotene may be used in gas as defined in § 170.3(o)(25) of this infant formula as a source of vitamin A chapter. in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (2) The ingredient is used in food at or with regulations promulgated under levels not to exceed current good man- section 412(g) of the act. ufacturing practice. (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [52 FR 25211, July 6, 1987] [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] § 184.1250 Cellulase enzyme prepara- tion derived from Trichoderma § 184.1245 Beta-carotene. longibrachiatum. (a) Beta-carotene (CAS Reg. No. 7235– (a) Cellulase enzyme preparation is 40–7) has the molecular formula C40H56. derived from a nonpathogenic, It is synthesized by saponification of nontoxicogenic strain of Trichoderma vitamin A acetate. The resulting alco- longibrachiatum (formerly T. reesei). The hol is either reacted to form vitamin A enzyme, cellulase, catalyzes the Wittig reagent or oxidized to vitamin A endohydrolysis of 1,4-beta-glycosidic aldehyde. Vitamin A Wittig reagent linkages in cellulose. It is obtained and vitamin A aldehyde are reacted to- from the culture filtrate resulting from gether to form beta-carotene. a pure culture fermentation process.

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(b) The ingredient meets the general Codex,’’ 4th ed. (1996), pp. 104–105, which and additional requirements for en- is incorporated by reference in accord- zyme preparations in the monograph ance with 5 U.S.C. 552(a) and 1 CFR specifications on enzyme preparations part 51. Copies are available from the in the ‘‘Food Chemicals Codex,’’ 4th ed. National Academy Press, Box 285, 2101 (1996), pp. 129 to 134, which is incor- Constitution Ave. NW., Washington, porated by reference in accordance DC 20055 (Internet address http:// with 5 U.S.C. 552(a) and 1 CFR part 51. www.nap.edu), or may be examined at Copies are available from the National the Food and Drug Administration’s Academy Press, 2101 Constitution Ave. Main Library, 10903 New Hampshire NW., Box 285, Washington, DC 20055 Ave., Bldg. 2, Third Floor, Silver (Internet http://www.nap.edu), or may Spring, MD 20993, 301–796–2039, or at the be examined at the Food and Drug Ad- National Archives and Records Admin- ministration’s Main Library, 10903 New istration (NARA). For information on Hampshire Ave., Bldg. 2, Third Floor, the availability of this material at Silver Spring, MD 20993, 301–796–2039, or NARA, call 202–741–6030, or go to: http:// at the National Archives and Records www.archives.gov/federallregister/ Administration (NARA). For informa- codeloflfederallregulations/ tion on the availability of this mate- ibrllocations.html. As determined by rial at NARA, call 202–741–6030, or go analytical methods in the ‘‘Food to: http://www.archives.gov/ Chemicals Codex,’’ clove oleoresin or federallregister/ other natural extractives (other than codeloflfederallregulations/ clove oils) meet the ‘‘Food Chemicals ibrllocations.html. Codex’’ specifications for clove (clove (c) In accordance with § 184.1(b)(1), bud) oil and the following modifica- the ingredient is used in food with no tions: limitation other than current good (1) The assay for phenols, as eugenol, manufacturing practice. The affirma- by the ‘‘Food Chemicals Codex’’ test, tion of this ingredient as generally rec- 4th ed. (pp. 104–105), or the volatile oils ognized as safe (GRAS) as a direct content by the ‘‘Food Chemicals human food ingredient is based upon Codex’’ test, 4th ed. (pp. 104–105) should the following current good manufac- conform to the representation of the turing practice conditions of use: vendor; (1) The ingredient is used in food as an enzyme as defined in § 170.3(o)(9) of (2) Optical rotation of the volatile oil ¥ ° ° this chapter for the breakdown of cel- between 2 and 0 ; lulose. (3) Refractive index of the volatile oil (2) The ingredient is used in food at between 1.527 and 1.538 at 20 °C; levels not to exceed current good man- (4) Specific gravity of the volatile oil ufacturing practice. between 1.036 and 1.060; and (5) Residual solvent free, except those [64 FR 28361, May 26, 1999, as amended at 81 solvents that are GRAS or within tol- FR 5595, Feb. 3, 2016] erance levels as specified in part 173, § 184.1257 Clove and its derivatives. subpart C, of this chapter. (a) Cloves are the dried unopened (c) Clove and its derivatives are used flower buds and calyx tubes, harvested as flavoring agents and adjuvants as before the flowers have opened, of the defined in § 170.3(0)(12) of this chapter. clove tree Eugenia caryophyllata (d) The ingredients are used in food Thunberg, native to tropical Asia. at levels not to exceed good manufac- Their derivatives include essential oils turing practice in accordance with (cloves, CAS Reg. No. 8000–34–8; buds; § 184.1(b)(1). leaves, CAS Reg. No. 8015–97–2; stems, (e) Prior sanctions for these ingredi- CAS Reg. No. 8015–98–3; and eugenol, ents different from the uses established CAS Reg. No. 97–53–0), oleoresins, and in this section do not exist or have natural extractives obtained from been waived. clove buds, leaves, and stems. [44 FR 3964, Jan. 19, 1979, as amended at 47 (b) Clove bud oil, clove leaf oil, clove FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, stem oil, and eugenol meet the speci- 1984; 64 FR 1759, Jan. 12, 1999; 81 FR 5595, Feb. fications of the ‘‘Food Chemicals 3, 2016]

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§ 184.1259 Cocoa butter substitute. Administration (NARA). For informa- (a) The common or usual name for tion on the availability of this mate- the triglyceride 1-palmitoyl-2-oleoyl-3- rial at NARA, call 202–741–6030, or go stearin is ‘‘cocoa butter substitute pri- to: http://www.archives.gov/ marily from palm oil.’’ The common or federallregister/ usual name for the triglyceride 1-3- codeloflfederallregulations/ distearoyl-2-olein is ‘‘cocoa butter sub- ibrllocations.html. stitute primarily from high-oleic saf- (4) Color—clear, bright, and free from flower or sunflower oil.’’ suspended matter. (1) The ingredient 1-palmitoyl-2-ole- (5) Odor and taste—free from foreign oyl-3-stearin is manufactured by: and rancid odor and taste. (i) Directed esterification of fully (6) Residual catalyst (‘‘Official Meth- saturated 1,3-diglycerides (derived from ods of Analysis of the Association of palm oil) with the anhydride of food- Official Analytical Chemists,’’ 13th Ed. grade oleic acid in the presence of the (1980), sections 25.049–25.055, which is catalyst trifluoromethane sulfonic acid incorporated by reference), residual (§ 173.395 of this chapter), or fluorine; limit of detection 0.2 part per (ii) By interesterification of partially million F; multiply fluoride result by saturated 1,2,3-triglycerides (derived 2.63 to convert to residual catalyst. from palm oil) with ethyl stearate in Copies of the material incorporated by the presence of a suitable lipase en- reference may be obtained from the zyme preparation that is either gen- AOAC INTERNATIONAL, 481 North erally recognized as safe (GRAS) or has Frederick Ave., suite 500, Gaithersburg, food additive approval for such use. MD 20877, or may be examined at the (2) The ingredient 1-3-distearoyl-2- National Archives and Records Admin- olein is manufactured by istration (NARA). For information on interesterification of partially unsatu- the availability of this material at rated 1,2,3-triglycerides (derived from NARA, call 202–741–6030, or go to: http:// high-oleic safflower or sunflower oil) www.archives.gov/federallregister/ with ethyl stearate or stearic acid in codeloflfederallregulations/ the presence of a suitable lipase en- ibrllocations.html. The ingredient shall zyme preparation that is either GRAS be washed three times in batches with or has food additive approval for such 0.5 percent sodium bicarbonate to re- use. move catalyst residuals in accordance (b) The ingredient meets the fol- with good manufacturing practice. lowing specifications: (1) Over 90 percent triglycerides, not (7) Residual methanol—5 parts per more than 7 percent diglycerides, not million maximum. more than 1 percent monoglycerides, (8) Residual fatty acid ethyl esters— and not more than 1 percent free fatty not more than 20 parts per million as acids. determined by a ‘‘Modification of (2) Total glycerides—98 percent min- Japan Institute of Oils and Fats: Anal- imum. ysis Method of Residual Ethyl Esters of (3) Heavy metals (as lead), not more Fatty Acids’’ issued by the Fuji Oil than 10 milligrams per kilogram, as de- Co., which is incorporated by reference. termined by the Heavy Metals Test of Copies are available from the Office of the ‘‘Food Chemicals Codex,’’ 4th ed. Food Additive Safety (HFS–200), Center (1996), pp. 760–761, which is incorporated for Food Safety and Applied Nutrition, by reference in accordance with 5 Food and Drug Administration, 5001 U.S.C. 552(a) and 1 CFR part 51. Copies Campus Dr., College Park, MD 20740, are available from the National Acad- 240–402–1200, or available for inspection emy Press, Box 285, 2101 Constitution at the National Archives and Records Ave. NW., Washington, DC 20055 (Inter- Administration (NARA). For informa- net address http://www.nap.edu), or may tion on the availability of this mate- be examined at the Food and Drug Ad- rial at NARA, call 202–741–6030, or go ministration’s Main Library, 10903 New to: http://www.archives.gov/ Hampshire Ave., Bldg. 2, Third Floor, federallregister/ Silver Spring, MD 20993, 301–796–2039, or codeloflfederallregulations/ at the National Archives and Records ibrllocations.html.

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(9) Hexane—not more than 5 parts per porated by reference. Copies are avail- million as determined by the method of able from the National Academy Press, Dupuy et al., ‘‘Rapid Quantitative De- 2101 Constitution Ave. NW., Wash- termination of Residual Hexane in Oils ington, DC. 20418, or available for in- by Direct Gas Chromatography,’’ pub- spection at the National Archives and lished in the ‘‘Journal of the American Records Administration (NARA). For Oil Chemists’ Society,’’ Vol. 52, p. 118– information on the availability of this 120, 1975, which is incorporated by ref- material at NARA, call 202–741–6030, or erence. Copies are available from the go to: http://www.archives.gov/ Division of Food and Color Additives, federallregister/ Center for Food Safety and Applied Nu- codeloflfederallregulations/ trition (HFS–200), Food and Drug Ad- ibrllocations.html. ministration, 5001 Campus Dr., College (c) In accordance with § 184.1(b)(1), Park, MD 20740, or available for inspec- the ingredient is used in food with no tion at the National Archives and limitation other than current good Records Administration (NARA). For manufacturing practice. The affirma- information on the availability of this tion of this ingredient as generally rec- material at NARA, call 202–741–6030, or ognized as safe (GRAS) as a direct go to: http://www.archives.gov/ human food ingredient is based upon federallregister/ the following current good manufac- codeloflfederallregulations/ turing practice conditions of use: ibrllocations.html. (1) The ingredient is used as a nutri- (c) In accordance with § 184.1(b)(1), ent supplement as defined in the ingredient is used in the following § 170.3(o)(20) of this chapter and as a food categories at levels not to exceed synergist as defined in § 170.3(o)(31) of current good manufacturing practice: this chapter. Confections and frostings as defined in (2) The ingredient is used in food at § 170.3(n)(9) of this chapter; coatings of levels not to exceed current good man- soft candy as defined in § 170.3(n)(38) of ufacturing practice. Copper gluconate this chapter; and sweet sauces and top- may be used in infant formula in ac- pings as defined in § 170.3(n)(43) of this cordance with section 412(g) of the Fed- chapter; except that the ingredient eral Food, Drug, and Cosmetic Act (the may not be used in a standardized food Act) or with regulations promulgated unless permitted by the standard of under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient identity. different from the uses established in (d) The ingredient is used in food in this section do not exist or have been accordance with § 184.1(b)(1) at levels waived. not to exceed good manufacturing practice. [49 FR 24119, June 12, 1984] [43 FR 54239, Nov. 11, 1978, as amended at 47 § 184.1261 Copper sulfate. FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, (a) Copper sulfate (cupric sulfate, Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR CuSO4·5 H2O, CAS Reg. No. 7758–99–8) 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999; usually is used in the pentahydrate 78 FR 14666, Mar. 7, 2013; 81 FR 5595, Feb. 3, form. This form occurs as large, deep 2016] blue or ultramarine, triclinic crystals; as blue granules, or as a light blue pow- § 184.1260 Copper gluconate. der. The ingredient is prepared by the (a) Copper gluconate (cupric gluco- reaction of sulfuric acid with cupric nate (CH2OH(CHOH)4COO)2Cu, CAS oxide or with copper metal. Reg. No. 527–09–3) is a substance that (b) The ingredient must be of a pu- occurs as light blue to bluish-green, rity suitable for its intended use. odorless crystals, or as a fine, light (c) In accordance with § 184.1(b)(1), blue powder. It is prepared by the reac- the ingredient is used in food with no tion of gluconic acid solutions with cu- limitation other than current good pric oxide or basic cupric carbonate. manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications of the Food Chemicals Codex, ognized as safe (GRAS) as a direct 3d Ed. (1981), p. 90, which is incor- human food ingredient is based upon

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the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as a nutri- [47 FR 29953, July 9, 1982, as amended at 73 ent supplement as defined in FR 8607, Feb. 14, 2008] § 170.3(o)(20) of this chapter and as a processing aid as defined in § 170.3(o)(24) § 184.1265 Cuprous iodide. of this chapter. (a) Cuprous iodide (copper (I) iodide, (2) The ingredient is used in food at CuI, CAS Reg. No. 7681–65–4) is a pure levels not to exceed current good man- white crystalline powder. It is prepared ufacturing practice. Copper sulfate by the reaction of copper sulfate with may be used in infant formula in ac- potassium iodide under slightly acidic cordance with section 412(g) of the Fed- conditions. eral Food, Drug, and Cosmetic Act (the (b) The ingredient must be of a pu- Act) or with regulations promulgated rity suitable for its intended use. under section 412(a)(2) of the Act. (c) In accordance with § 184.1(b)(2), (d) Prior sanctions for this ingredient the ingredient is used in food only different from the uses established in within the following specific limita- this section do not exist or have been tions: waived. Cat- [49 FR 24119, June 12, 1984, as amended at 73 egory Maximum treatment Functional use FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, of food level in food 2011] Table 0.01 percent ...... Source of dietary iodine. salt. § 184.1262 Corn silk and corn silk ex- tract. (d) Prior sanctions for this ingredient (a) Corn silk is the fresh styles and different from the uses established in stigmas of Zea mays L. collected when this section do not exist or have been the corn is in milk. The filaments are waived. extracted with dilute ethanol to produce corn silk extract. The extract [49 FR 24119, June 12, 1984, as amended at 73 FR 8607, Feb. 14, 2008] may be concentrated at a temperature not exceeding 60 °C. § 184.1271 L-Cysteine. (b) The ingredient must be of a pu- (a) L-Cysteine is the chemical L-2- rity suitable for its intended use. amino-3-mercaptopropanoic acid (c) In accordance with § 184.1(b)(2), (C H O NS). the ingredients are used in food only 3 7 2 (b) The ingredient meets the appro- within the following specific limita- priate part of the specification set tions: forth in the ‘‘Food Chemicals Codex,’’ Maximum 3d Ed. (1981), pp. 92–93, which is incor- level of porated by reference. Copies may be Category of food use in Functional use food (as obtained from the National Academy served) 1 Press, 2101 Constitution Ave. NW., Baked goods and bak- 30 Flavoring agent, Washington, DC 20418, or may be exam- ing mixes, § 170.3(o)(12) of this ined at the National Archives and § 170.3(n)(1) of this chapter. Records Administration (NARA). For chapter. information on the availability of this Nonalcoholic bev- 20 Do. erages, § 170.3(n)(3) material at NARA, call 202–741–6030, or of this chapter. go to: http://www.archives.gov/ Frozen dairy desserts, 10 Do. federallregister/ § 170.3(n)(20) of this code of federal regulations/ chapter. l l l Soft candy, 20 Do. ibrllocations.html. § 170.3(n)(38) of this (c) The ingredient is used to supply chapter. up to 0.009 part of total L-cysteine per All other food cat- 4 Do. egories. 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) 1 Parts per million. of this chapter in yeast-leavened baked (d) Prior sanctions for this ingredient goods and baking mixes as defined in different from the uses established in § 170.3(n)(1) of this chapter.

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(d) This regulation is issued prior to able from the National Academy Press, a general evaluation of use of this in- 2101 Constitution Ave. NW., Wash- gredient in order to affirm as GRAS ington, DC 20418, or available for in- the specific use named. spection at the National Archives and Records Administration (NARA). For [42 FR 14653, Mar. 15, 1977, as amended at 49 information on the availability of this FR 5612, Feb. 14, 1984] material at NARA, call 202–741–6030, or § 184.1272 L-Cysteine go to: http://www.archives.gov/ monohydrochloride. federallregister/ codeloflfederallregulations/ (a) L-Cysteine monohydrochloride is ibrllocations.html. the chemical L-2-amino-3- (c) In accordance with § 184.1(b)(1), mercaptopropanoic acid the ingredient is used in food with no monohydrochloride monohydrate limitation other than current good (C3H7O2NS HCl H2O). manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications of the ‘‘Food Chemicals ognized as safe (GRAS) as a direct Codex,’’ 3d Ed. (1981), pp. 92–93, which is human food ingredient is based upon incorporated by reference. Copies may the following current good manufac- be obtained from the National Acad- turing practice conditions of use: emy Press, 2101 Constitution Ave. NW., (1) The ingredient is used as a formu- Washington, DC 20418, or may be exam- lation aid as defined in § 170.3(o)(14) of ined at the National Archives and this chapter; as a processing aid as de- Records Administration (NARA). For fined in § 170.3(o)(24) of this chapter; as information on the availability of this a stabilizer and thickener as defined in material at NARA, call 202–741–6030, or § 170.3(o)(28) of this chapter; and as a go to: http://www.archives.gov/ surface-finishing agent as defined in federallregister/ § 170.3(o)(30) of this chapter. codeloflfederallregulations/ (2) The ingredient is used in food at ibrllocations.html. levels not to exceed current good man- (c) The ingredient is used to supply ufacturing practice. up to 0.009 part of total L-cysteine per (d) Prior sanctions for this ingredient 100 parts of flour in dough as a dough different from the uses established in strengthener as defined in § 170.3(o)(6) this section do not exist or have been of this chapter in yeast-leavened baked waived. goods and baking mixes as defined in § 170.3(n)(1) of this chapter. [48 FR 51909, Nov. 15, 1983] (d) This regulation is issued prior to § 184.1278 Diacetyl. a general evaluation of use of this in- gredient in order to affirm as GRAS (a) Diacetyl (C4H6O2, CAS Reg. No. the specific use named. 431–03–8) is a clear yellow to yellowish green liquid with a strong pungent [42 FR 14653, Mar. 15, 1977, as amended at 49 odor. It is also known as 2,3- FR 5612, Feb. 14, 1984] butanedione and is chemically syn- thesized from methyl ethyl ketone. It § 184.1277 Dextrin. is miscible in water, glycerin, alcohol, (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. and ether, and in very dilute water so- No. 9004–53–9) is an incompletely lution, it has a typical buttery odor hydrolyzed starch. It is prepared by dry and flavor. heating corn, waxy maize, waxy milo, (b) The ingredient meets the speci- potato, arrowroot, wheat, rice, tapioca, fications of the Food Chemicals Codex, or sago starches, or by dry heating the 3d Ed. (1981), p. 368, which is incor- starches after: (1) Treatment with safe porated by reference. Copies are avail- and suitable alkalis, acids, or pH con- able from the National Academy Press, trol agents and (2) drying the acid or 2101 Constitution Ave. NW., Wash- alkali treated starch. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the National Archives and fication of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 96, which is incor- information on the availability of this porated by reference. Copies are avail- material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ (d) The ingredients are used in food federallregister/ at levels not to exceed good manufac- codeloflfederallregulations/ turing practice. ibrllocations.html. (e) [Reserved] (c) In accordance with § 184.1(b)(1), (f) Prior sanctions for these ingredi- the ingredient is used in food with no ents different from the uses established limitation other than current good in this section do not exist or have manufacturing practice. The affirma- been waived. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct [42 FR 14653, Mar. 15, 1977, as amended at 42 human food ingredient is based upon FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, 1999; 81 FR 5595, Feb. the following current good manufac- 3, 2016] turing practice conditions of use: (1) The ingredient is used as a fla- § 184.1287 Enzyme-modified fats. voring agent and adjuvant as defined in (a) Enzyme-modified refined beef fat, § 170.3(o)(12) of this chapter. enzyme-modified butterfat, and en- (2) The ingredient is used in food at zyme-modified steam-rendered chicken levels not to exceed current good man- fat are prepared from refined beef fat; ufacturing practice. butterfat or milkfat; and steam-ren- (d) Prior sanctions for this ingredient dered chicken fat, respectively, with different from the uses established in enzymes that are generally recognized this section do not exist or have been as safe (GRAS). Enzyme-modified milk waived. powder may be prepared with GRAS [48 FR 51907, Nov. 15, 1983] enzymes from reconstituted milk pow- der, whole milk, condensed or con- § 184.1282 Dill and its derivatives. centrated whole milk, evaporated (a) Dill (American or European) is milk, or milk powder. The lipolysis is the herb and seeds from Anethum maintained at a temperature that is graveolens L., and dill (Indian) is the optimal for the action of the enzyme herb and seeds from Anethum sowa, until appropriate acid development is D.C. Its derivatives include essential attained. The enzymes are then inac- oils, oleoresins, and natural extractives tivated. The resulting product is con- obtained from these sources of dill. centrated or dried. (b) Dill oils meet the description and (b) The ingredients must be of a pu- specifications of the ‘‘Food Chemicals rity suitable for their intended use. Codex,’’ 4th ed. (1996), pp. 122–123, which (c) In accordance with § 184.1(b)(1), is incorporated by reference in accord- the ingredients are used in food with ance with 5 U.S.C. 552(a) and 1 CFR no limitation other than current good part 51. Copies are available from the manufacturing practice. The affirma- National Academy Press, Box 285, 2101 tion of these ingredients as generally Constitution Ave. NW., Washington, recognized as safe (GRAS) as direct DC 20055 (Internet address http:// human food ingredients is based upon www.nap.edu), or may be examined at the following current good manufac- the Food and Drug Administration’s turing practice conditions of use: Main Library, 10903 New Hampshire (1) The ingredients are used as fla- Ave., Bldg. 2, Third Floor, Silver voring agents and adjuvants as defined Spring, MD 20993, 301–796–2039, or at the in § 170.3(o)(12) of this chapter. National Archives and Records Admin- (2) The ingredients are used in food istration (NARA). For information on at levels not to exceed current good the availability of this material at manufacturing practice. NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ (d) Prior sanctions for these ingredi- codeloflfederallregulations/ ents different from the uses established ibrllocations.html. in this section do not exist or have (c) Dill and its derivatives are used as been waived. flavoring agents and adjuvants as de- [52 FR 25976, July 10, 1987, as amended at 73 fined in § 170.3(o)(12) of this chapter. FR 8607, Feb. 14, 2008]

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§ 184.1293 Ethyl alcohol. Records Administration (NARA). For information on the availability of this (a) Ethyl alcohol (ethanol) is the material at NARA, call 202–741–6030, or chemical C H OH. 2 5 go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the ‘‘Food Chemicals codeloflfederallregulations/ Codex,’’ 4th ed. (1996), p. 136, which is ibrllocations.html. incorporated by reference in accord- (c) The ingredient is used as a fla- ance with 5 U.S.C. 552(a) and 1 CFR voring agent and adjuvant as defined in part 51. Copies are available from the § 170.3(o)(12) of this chapter. National Academy Press, Box 285, 2101 (d) The ingredient is used in food at Constitution Ave. NW., Washington, levels not to exceed good manufac- DC 20055 (Internet address http:// turing practice in accordance with www.nap.edu), or may be examined at § 184.1(b)(1). Current good manufac- the Food and Drug Administration’s turing practice results in a maximum Main Library, 10903 New Hampshire level, as served, of 0.05 percent in baked Ave., Bldg. 2, Third Floor, Silver goods as defined in § 170.3(n)(1) of this Spring, MD 20993, 301–796–2039, or at the chapter; 0.04 percent in chewing gum as National Archives and Records Admin- defined in § 170.3(n)(6), hard candy as istration (NARA). For information on defined in § 170.3(n)(25), and soft candy the availability of this material at as defined in § 170.3(n)(38) of this chap- NARA, call 202–741–6030, or go to: http:// ter; 0.02 percent in frozen dairy des- www.archives.gov/federallregister/ serts as defined in § 170.3(n)(20) of this codeloflfederallregulations/ chapter; 0.03 percent in gelatins, pud- ibrllocations.html. dings, and fillings as defined in (c) The ingredient is used as an anti- § 170.3(n)(22) of this chapter; and 0.01 microbial agent as defined in percent in all other food categories. § 170.3(o)(2) of this chapter on pizza (e) Prior sanctions for ethyl formate crusts prior to final baking at levels different from the uses established in not to exceed 2.0 percent by product this section do not exist or have been weight. waived. (d) This regulation is issued prior to [45 FR 22915, Apr. 4, 1980, as amended at 49 general evaluation of use of this ingre- FR 5612, Feb. 14, 1984] dient in order to affirm as GRAS the specific use named. § 184.1296 Ferric ammonium citrate. [42 FR 14653, Mar. 15, 1977, as amended at 49 (a) Ferric ammonium citrate (iron FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, (III) ammonium citrate) is prepared by 1999; 81 FR 5595, Feb. 3, 2016] the reaction of ferric hydroxide with citric acid, followed by treatment with § 184.1295 Ethyl formate. ammonium hydroxide, evaporating, (a) Ethyl formate (C3H6O2, CAS Reg. and drying. The resulting product oc- No. 109–94–4) is also referred to as ethyl curs in two forms depending on the methanoate. It is an ester of formic stoichiometry of the initial reactants. acid and is prepared by esterification (1) Ferric ammonium citrate (iron of formic acid with ethyl alcohol or by (III) ammonium citrate, CAS Reg. No. distillation of ethyl acetate and formic 1332–98–5) is a complex salt of undeter- acid in the presence of concentrated mined structure composed of 16.5 to sulfuric acid. Ethyl formate occurs 18.5 percent iron, approximately 9 per- naturally in some plant oils, fruits, and cent ammonia, and 65 percent citric juices but does not occur naturally in acid and occurs as reddish brown or the animal kingdom. garnet red scales or granules or as a (b) The ingredient meets the speci- brownish-yellowish powder. fications of the ‘‘Food Chemicals (2) Ferric ammonium citrate (iron Codex,’’ 3d Ed. (1981), p. 376, which is in- (III) ammonium citrate, CAS Reg. No. corporated by reference. Copies may be 1333–00–2) is a complex salt of undeter- obtained from the National Academy mined structure composed of 14.5 to 16 Press, 2101 Constitution Ave. NW., percent iron, approximately 7.5 percent Washington, DC 20418, or may be exam- ammonia, and 75 percent citric acid ined at the National Archives and and occurs as thin transparent green

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scales, as granules, as a powder, or as this section do not exist or have been transparent green crystals. waived. (b) The ingredients meet the speci- [53 FR 16864, May 12, 1988, as amended at 73 fications of the Food Chemicals Codex, FR 8607, Feb. 14, 2008] 3d Ed. (1981), pp. 116–117 (Ferric ammo- nium citrate, brown) and p. 117 (Ferric § 184.1298 Ferric citrate. ammonium citrate, green), which is in- corporated by reference. Copies are (a) Ferric citrate (iron (III) citrate, available from the National Academy C6H5FeO7, CAS Reg. No. 2338–05–8) is Press, 2101 Constitution Ave. NW., prepared from reaction of citric acid Washington, DC 20418, or available for with ferric hydroxide. It is a compound inspection at the National Archives of indefinite ratio of citric acid and and Records Administration (NARA). iron. For information on the availability of (b) The ingredient must be of a pu- this material at NARA, call 202–741– rity suitable for its intended use. 6030, or go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food as a nu- codeloflfederallregulations/ trient supplement as defined in ibrllocations.html. § 170.3(o)(20) of this chapter, with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredients are used in food as nu- manufacturing practice. The ingre- trient supplements as defined in dient may also be used in infant for- § 170.3(o)(20) of this chapter, with no mula in accordance with section 412(g) limitation other than current good of the Federal Food, Drug, and Cos- manufacturing practice. The ingredi- metic Act (the act) (21 U.S.C. 350a(g)) ents may also be used in infant formula or with regulations promulgated under in accordance with section 412(g) of the section 412(a)(2) of the act (21 U.S.C. Federal Food, Drug, and Cosmetic Act 350a(a)(2)). (the act) (21 U.S.C. 350a(g)) or with reg- (d) Prior sanctions for this ingredient ulations promulgated under section different from the uses established in 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). this section do not exist or have been (d) Prior sanctions for these ingredi- waived. ents different from the uses established in this section do not exist or have [53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008] been waived. [53 FR 16864, May 12, 1988] § 184.1301 Ferric phosphate. (a) Ferric phosphate (ferric § 184.1297 Ferric chloride. orthophosphate, iron (III) phosphate, (a) Ferric chloride (iron (III) chlo- FePO4·xH2O, CAS Reg. No. 10045–86–0) is ride, FeC13, CAS Reg. No. 7705–08–0) an odorless, yellowish-white to buff- may be prepared from iron and chlorine colored powder and contains from one or from ferric oxide and hydrogen chlo- to four molecules of water of hydra- ride. The pure material occurs as tion. It is prepared by reaction of so- hydroscopic, hexagonal, dark crystals. dium phosphate with ferric chloride or Ferric chloride hexahydrate (iron (III) ferric citrate. chloride hexahydrate, FeC13. 6H20, CAS (b) The ingredient meets the speci- Reg. No. 10025–77–1) is readily formed fications of the Food Chemicals Codex, when ferric chloride is exposed to mois- 3d Ed. (1981), pp. 118–120, which is incor- ture. porated by reference. Copies are avail- (b) The ingredient must be of a pu- able from the National Academy Press, rity suitable for its intended use. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1) the ington, DC 20418, or available for in- ingredient is used in food as a flavoring spection at the National Archives and agent as defined in § 170.3(o)(12) of this Records Administration (NARA). For chapter, with no limitation other than information on the availability of this current good manufacturing practice. material at NARA, call 202–741–6030, or (d) Prior sanctions for this ingredient go to: http://www.archives.gov/ different from the uses established in federallregister/

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codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food as nutri- [53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988] ent supplement as defined in § 170.3(o)(20) of this chapter, with no § 184.1307 Ferric sulfate. limitation other than current good manufacturing practice. The ingre- (a) Ferric sulfate (iron (III) sulfate, dient may also be used in infant for- Fe2(SO4)3 CAS Reg. No. 10028–22–5) is a mula in accordance with section 412(g) yellow substance that may be prepared of the Federal Food, Drug, and Cos- by oxidizing iron (II) sulfate or by metic Act (the act) (21 U.S.C. 350a(g)) treating ferric oxide or ferric hydrox- or with regulations promulgated under ide with sulfuric acid. section 412(a)(2) of the act (21 U.S.C. (b) The ingredient must be of a pu- 350a(a)(2)). rity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food as a fla- this section do not exist or have been voring agent as defined in § 170.3(o)(12) waived. of this chapter, with no limitation [53 FR 16865, May 12, 1988] other than current good manufacturing practice. § 184.1304 Ferric pyrophosphate. (d) Prior sanctions for this ingredient (a) Ferric pyrophosphate (iron (III) different from the uses established in pyrophosphate, Fe4(P207)3·xH2O, CAS this section do not exist or have been Reg. No. 10058–44–3) is a tan or yel- waived. lowish white colorless powder. It is pre- [53 FR 16865, May 12, 1988, as amended at 73 pared by reacting sodium FR 8607, Feb. 14, 2008] pyrophosphate with ferric citrate. (b) The ingredient meets the speci- § 184.1307a Ferrous ascorbate. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 120, which is incor- (a) Ferrous ascorbate (CAS Reg. No. porated by reference. Copies are avail- 24808–52–4) is a reaction product of fer- able from the National Academy Press, rous hydroxide and ascorbic acid. It is 2101 Constitution Ave. NW., Wash- a blue-violet product containing 16 per- ington, DC 20418, or available for in- cent iron. spection at the National Archives and (b) The ingredient must be of a pu- Records Administration (NARA). For rity suitable for its intended use. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food as a nu- go to: http://www.archives.gov/ trient supplement as defined in federallregister/ § 170.3(o)(20) of this chapter, with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The ingre- (c) In accordance with § 184.1(b)(1), dient may also be used in infant for- the ingredient is used in food as a nu- mula in accordance with section 412(g) trient supplement as defined in of the Federal Food, Drug, and Cos- § 170.3(o)(20) of this chapter, with no metic Act (the act) (21 U.S.C. 350a(g)) limitation other than current good or with regulations promulgated under manufacturing practice. The ingre- section 412(a)(2) of the act (21 U.S.C. dient may also be used in infant for- 350a(a)(2)). mula in accordance with section 412(g) (d) Prior sanctions for this ingredient of the Federal Food, Drug, and Cos- metic Act (the act) (21 U.S.C. 350a(g)) different from the uses established in or with regulations promulgated under this section do not exist or have been section 412(a)(2) of the act (21 U.S.C. waived. 350a(a)(2)). [53 FR 16865, May 12, 1988, as amended at 69 (d) Prior sanctions for this ingredient FR 24512, May 4, 2004; 73 FR 8607, Feb. 14, different from the uses established in 2008]

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§ 184.1307b Ferrous carbonate. § 184.1307d Ferrous fumarate. (a) Ferrous carbonate (iron (II) car- (a) Ferrous fumarate (iron (II) fuma- bonate, FeCO3, CAS Reg. No. 563–71–3) rate, (C4H2FeO4), CAS Reg. No. 141–01–5) is an odorless, white solid prepared by is an odorless, reddish-orange to red- treating solutions of iron (II) salts with dish-brown powder. It may contain soft alkali carbonate salts. lumps that produce a yellow streak (b) The ingredient must be of a pu- when crushed. It is prepared by rity suitable for its intended use. admixing hot solutions of ferrous sul- (c) In accordance with § 184.1(b)(1), fate and sodium fumarate. the ingredient is used in food as a nu- (b) The ingredient meets the speci- trient supplement as defined in fications of the Food Chemicals Codex, § 170.3(o)(20) of this chapter, with no 3d Ed. (1981), pp. 120–122, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The ingre- able from the National Academy Press, dient may also be used in infant for- 2101 Constitution Ave NW., Wash- mula in accordance with section 412(g) ington, DC 20418, or available for in- of the Federal Foods, Drug, and Cos- spection at the National Archives and metic Act (the act) (21 U.S.C. 350a(g)) Records Administration (NARA). For or with regulations promulgated under information on the availability of this section 412(a)(2) of the act (21 U.S.C. material at NARA, call 202–741–6030, or 350a(a)(2)). go to: http://www.archives.gov/ (d) Prior sanctions for this ingredient federallregister/ different from the uses established in codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) In accordance with § 184.1(b)(1) the ingredient is used in food as a nutrient [53 FR 16865, May 12, 1988, as amended at 73 supplement as defined in § 170.3(o)(20) of FR 8607, Feb. 14, 2008] this chapter, with no limitation other than current good manufacturing prac- § 184.1307c Ferrous citrate. tice. The ingredient may also be used (a) Ferrous citrate (iron (II) citrate, in infant formula in accordance with (C6H6FeO7), CAS Reg. No. 23383–11–1) is section 412(g) of the Federal Food, a slightly colored powder or white Drug, and Cosmetic Act (the act) (21 crystals. It is prepared from the reac- U.S.C. 350a(g)), or with regulations pro- tion of sodium citrate with ferrous sul- mulgated under section 412(a)(2) of the fate or by direct action of citric acid on act (21 U.S.C. 350a(a)(2)). iron filings. (d) Prior sanctions for this ingredient (b) The ingredient must be of a pu- different from the uses established in rity suitable for its intended use. this section do not exist or have been (c) In accordance with § 184.1(b)(1) the waived. ingredient is used in food as a nutrient [53 FR 16866, May 12, 1988] supplement as defined in § 170.3(o)(20) of this chapter, with no limitation other § 184.1308 Ferrous gluconate. than current good manufacturing prac- (a) Ferrous gluconate (iron (II) gluco- tice. The ingredient may also be used nate dihydrate, C H FeO ·2H O, CAS in infant formula in accordance with 12 22 14 2 Reg. No. 6047-12-7) is a fine yellowish- section 412(g) of the Federal Food, gray or pale greenish-yellow powder or Drug, and Cosmetic Act (the act) (21 granules. It is prepared by reacting hot U.S.C. 350a(g)) or with regulations pro- solutions of barium or calcium gluco- mulgated under section 412(a)(2) of the nate with ferrous sulfate or by heating act (21 U.S.C. 350a(a)(2)). freshly prepared ferrous carbonate with (d) Prior sanctions for this ingredient gluconic acid in aqueous solution. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the Food Chemcials Codex, waived. 3d Ed. (1981), pp. 122–123, which is incor- [53 FR 16866, May 12, 1988, as amended at 73 porated by reference. Copies are avail- FR 8607, Feb. 14, 2008] able from the National Academy Press,

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2101 Constitution Avenue NW., Wash- codeloflfederallregulations/ ington, DC 20418, or available for in- ibrllocations.html. spection at the National Archives and (c) In accordance with § 184.1(b)(1), Records Administration (NARA). For the ingredient is used in food as a nu- information on the availability of this trient supplement as defined in material at NARA, call 202–741–6030, or § 170.3(o)(20) of this chapter and as a go to: http://www.archives.gov/ color fixative for ripe olives, with no federallregister/ other limitation other than current codeloflfederallregulations/ good manufacturing practice. The in- ibrllocations.html. gredient may also be used in infant for- (c) In accordance with § 184.1(b)(1), mula in accordance with section 412(g) the ingredient is used in food as a nu- of the Federal Food, Drug, and Cos- trient supplement as defined in metic Act (the act) (21 U.S.C. 350a(g)) § 170.3(o)(20) of this chapter, with no or with regulations promulgated under limitation other than current good section 412(a)(2) of the act (21 U.S.C. manufacturing practice. The ingre- 350a(a)(2)). dient may also be used in infant for- (d) Prior sanctions for this ingredient mula in accordance with section 412(g) different from the uses established in of the Federal Food, Drug, and Cos- this section do not exist or have been metic Act (the act) (21 U.S.C. 350a(g)) waived. or with regulations promulgated under [53 FR 16866, May 12, 1988, as amended at 61 section 412(a)(2) of the act (21 U.S.C. FR 40319, Aug. 2, 1996; 81 FR 5595, Feb. 3, 2016] 350a(a)(2)). (d) Prior sanctions for this ingredient § 184.1315 Ferrous sulfate. different from the uses established in (a) Ferrous sulfate heptahydrate this section do not exist or have been (iron (II) sulfate heptahydrate, waived. FeSO4·7H2O, CAS Reg. No. 7782–63–0) is [53 FR 16866, May 12, 1988; 53 FR 20939, June prepared by the action of sulfuric acid 7, 1988] on iron. It occurs as pale, bluish-green crystals or granules. Progressive heat- § 184.1311 Ferrous lactate. ing of ferrous sulfate heptahydrate pro- (a) Ferrous lactate (iron (II) lactate, duces ferrous sulfate (dried). Ferrous C6H10FeO6, CAS Reg. No. 5905–52–2) in sulfate (dried) consists primarily of fer- the trihydrate form is a greenish-white rous sulfate monohydrate (CAS Reg. powder or crystalline mass. It is pre- No. 17375–41–6) with varying amounts of pared by reacting calcium lactate or ferrous sulfate tetrahydrate (CAS Reg. sodium lactate with ferrous sulfate, di- No. 20908–72–9) and occurs as a grayish- rect reaction of lactic acid with iron white to buff-colored powder. filings, reaction of ferrous chloride (b) The ingredients meet the speci- with sodium lactate, or reaction of fer- fications of the Food Chemicals Codex, rous sulfate with ammonium lactate. 3d Ed. (1981), p. 123 (Ferrous sulfate (b) The ingredient meets the speci- heptahydrate) and p. 124 (ferrous sul- fications of the Food Chemicals Codex, fate, dried), which is incorporated by 4th ed. (1996), pp. 154 to 155, which is in- reference. Copies are available from corporated by reference in accordance the National Academy Press, 2101 Con- with 5 U.S.C. 552(a) and 1 CFR part 51. stitution Ave., NW., Washington, DC Copies are available from the National 20418, or available for inspection at the Academy Press, 2101 Constitution Ave. National Archives and Records Admin- NW., Washington, DC 20418, or may be istration (NARA). For information on examined at the Food and Drug Admin- the availability of this material at istration’s Main Library, 10903 New NARA, call 202–741–6030, or go to: http:// Hampshire Ave., Bldg. 2, Third Floor, www.archives.gov/federallregister/ Silver Spring, MD 20993, 301–796–2039, or codeloflfederallregulations/ at the National Archives and Records ibrllocations.html. Administration (NARA). For informa- (c) In accordance with § 184.1(b)(1), tion on the availability of this mate- the ingredients are used in food as nu- rial at NARA, call 202–741–6030, or go trient supplements as defined in to: http://www.archives.gov/ § 170.3(o)(20) of this chapter and as a federallregister/ processing aid as defined in § 170.3(o)(24)

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of this chapter, with no limitation (2) The ingredient is used in food at other than current good manufacturing levels not to exceed current good man- practice. The ingredients may also be ufacturing practice. used in infant formula in accordance [60 FR 32910, June 26, 1995, as amended at 78 with section 412(g) of the Federal Food, FR 14666, Mar. 7, 2013] Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations pro- § 184.1317 Garlic and its derivatives. mulgated under section 412(a)(2) of the (a) Garlic is the fresh or dehydrated act (21 U.S.C. 350a(a)(2)). bulb or cloves obtained from Allium (d) Prior sanctions for these ingredi- sativum, a genus of the lily family. Its ents different from the uses established derivatives include essential oils, oleo- in this section do not exist or have resins, and natural extractives ob- been waived. tained from garlic. [53 FR 16866, May 12, 1988] (b) Garlic oil meets the specifications of the ‘‘Food Chemicals Codex,’’ 3d Ed. § 184.1316 Ficin. (1981), p. 132, which is incorporated by (a) Ficin (CAS Reg. No. 9001–33–6) is reference. Copies may be obtained from an enzyme preparation obtained from the National Academy Press, 2101 Con- the latex of species of the genus Ficus, stitution Ave. NW., Washington, DC which include a variety of tropical fig 20418, or may be examined at the Na- trees. It is a white to off-white powder. tional Archives and Records Adminis- Its characterizing enzyme activity is tration (NARA). For information on that of a peptide hydrolase (EC the availability of this material at 3.4.22.3). NARA, call 202–741–6030, or go to: http:// (b) The ingredient meets the general www.archives.gov/federallregister/ requirements and additional require- codeloflfederallregulations/ ments for enzyme preparations in the ibrllocations.html. Food Chemicals Codex, 3d ed. (1981), p. (c) Garlic and its derivatives are used 110, which is incorporated by reference as flavoring agents and adjuvants as in accordance with 5 U.S.C. 552(a) and 1 defined in § 170.3(o)(12) of this chapter. CFR part 51. Copies are available from (d) The ingredients are used in food the National Academy Press, 2101 Con- at levels not to exceed good manufac- stitution Ave., NW., Washington, DC turing practice. 20418, or may be examined at the Office (e) [Reserved] of Food Additive Safety (HFS–200), (f) Prior sanctions for this ingredient Center for Food Safety and Applied Nu- different from the uses established in trition, Food and Drug Administration, this section do not exist or have been 5001 Campus Dr., College Park, MD waived. 20740, 240–402–1200, and at the National [42 FR 14653, Mar. 15, 1977, as amended at 42 Archives and Records Administration FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, (NARA). For information on the avail- 1984] ability of this material at NARA, call 202–741–6030, or go to: http:// § 184.1318 Glucono delta-lactone.

www.archives.gov/federallregister/ (a) Glucono delta-lactone (C6H10O6, codeloflfederallregulations/ CAS Reg. No. 90–80–2), also called D- ibrllocations.html. gluconic acid delta-lactone or D- (c) In accordance with § 184.1(b)(1), glucono-1,5-lactone, is the cyclic 1,5- the ingredient is used in food with no intramolecular ester of D-gluconic limitation other than current good acid. It is prepared by direct crys- manufacturing practice. The affirma- tallization from the aqueous solution tion of this ingredient as GRAS as a di- of gluconic acid. Gluconic acid may be rect food ingredient is based upon the produced by the oxidation of D-glucose following current good manufacturing with bromine water, by the oxidation practice conditions of use: of D-glucose by microorganisms that (1) The ingredient is used as an en- are nonpathogenic and nontoxicogenic zyme as defined in § 170.3(o)(9) of this to man or other animals, or by the oxi- chapter to hydrolyze proteins or dation of D-glucose with enzymes de- polypeptides. rived from these microorganisms.

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(b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 134, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter and a information on the availability of this texturizer as defined in § 170.3(o)(32) of material at NARA, call 202–741–6030, or this chapter. go to: http://www.archives.gov/ (2) The ingredient is used in food at federallregister/ levels not to exceed current good man- codeloflfederallregulations/ ufacturing practice. ibrllocations.html. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [50 FR 8998, Mar. 6, 1985, as amended at 73 FR tion of this ingredient as generally rec- 8607, Feb. 14, 2008] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1322 Wheat gluten. the following current good manufac- (a) Wheat gluten (CAS Reg. No. 8002– turing practice conditions of use: 80–0) is the principal protein compo- (1) The ingredient is used as a curing nent of wheat and consists mainly of and pickling agent as defined in gliadin and glutenin. Wheat gluten is § 170.3(o)(5) of this chapter, leavening obtained by hydrating wheat flour and agent as defined in § 170.3(o)(17) of this mechanically working the sticky mass chapter; pH control agent as defined in to separate the wheat gluten from the § 170.3(o)(23) of this chapter; and starch and other flour components. sequestrant as defined in § 170.3(o)(26) of Vital gluten is dried gluten that has re- this chapter. tained its elastic properties. (2) The ingredient is used at levels (b) The ingredient must be of a pu- not to exceed current good manufac- rity suitable for its intended use. turing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [51 FR 33896, Sept. 24, 1986] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1321 Corn gluten. the following current good manufac- (a) Corn gluten (CAS Reg. No. 66071– turing practice conditions of use: 96–3), also known as corn gluten meal, (1) The ingredient is used as a dough is the principal protein component of strengthener as defined in § 170.3(o)(6) corn endosperm. It consists mainly of of this chapter; a formulation aid as zein and glutelin. Corn gluten is a by- defined in § 170.3(o)(14) of this chapter; product of the wet milling of corn for a nutrient supplement as defined in starch. The gluten fraction is washed § 170.3(o)(20) of this chapter; a proc- to remove residual water soluble pro- essing aid as defined in § 170.3(o)(24) of teins. Corn gluten is also produced as a this chapter; a stabilizer and thickener byproduct during the conversion of the as defined in § 170.3(o)(28) of this chap- starch in whole or various fractions of ter; a surface-finishing agent as defined dry milled corn to corn syrups. in § 170.3(o)(30) of this chapter; and a (b) The ingredient must be of a pu- texturizing agent as defined in rity suitable for its intended use. § 170.3(o)(32) of this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice.

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(d) Prior sanctions for this ingredient glyceryl esters of fatty acids present in different from the uses established in commercial stearic acid. Glyceryl this section do not exist or have been monostearate is prepared by waived. glycerolysis of certain fats or oils that [50 FR 8998, Mar. 6, 1985, as amended at 73 FR are derived from edible sources or by 8607, Feb. 14, 2008] esterification, with glycerin, of stearic acid that is derived from edible § 184.1323 Glyceryl monooleate. sources. (a) Glyceryl monooleate is prepared (b) The ingredient must be of a pu- by esterification of commerical oleic rity suitable for its intended use. acid that is derived either from edible (c) In accordance with § 184.1(b)(1), sources or from tall oil fatty acids the ingredient is used in food with no meeting the requirements of § 172.862 of limitation other than current good this chapter. It contains glyceryl manufacturing practice. monooleate (C21H40O4, CAS Reg. No. (d) Prior sanctions for this ingredient 25496–72–4) and glyceryl esters of fatty different from the uses established in acids present in commercial oleic acid. this section do not not exist or have (b) The ingredient must be of a pu- been waived. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), [54 FR 7403 Feb. 21, 1989, as amended at 73 FR the ingredient is used in food with no 8607, Feb. 14, 2008] limitation other than current good manufacturing practice. The affirma- § 184.1328 Glyceryl behenate. tion of this ingredient as generally rec- (a) Glyceryl behenate is a mixture of ognized as safe (GRAS) as a direct glyceryl esters of behenic acid made human food ingredient is based upon from glycerin and behenic acid (a satu- the following current good manufac- rated C22 fatty acid). The mixture con- turing practice conditions of use: tains predominately glyceryl (1) The ingredient is used as a fla- dibehenate. voring agent and adjuvant as defined in (b) The ingredient meets the fol- § 170.3(o)(12) of this chapter and as a lowing specifications: solvent and vehicle as defined in (1) 10 to 20 percent monoglyceride, 47 § 170.3(o)(27) of this chapter. to 59 percent diglyceride, 26 to 38 per- (2) The ingredient is used in the fol- cent triglyceride, and not more than lowing foods at levels not to exceed 2.5 percent free fatty acids. current good manufacturing practice: (2) Behenic acid. Between 80 and 90 baked goods and baking mixes as de- fined in § 170.3(n)(1) of this chapter; percent of the total fatty acid content. nonalcoholic beverages and beverage (3) Acid value. Not more than 4. bases as defined in § 170.3(n)(3) of this (4) Saponification value. Between 145 chapter; chewing gum as defined in and 165. § 170.3(n)(6) of this chapter; and meat (5) Iodine number. Not more than 3. products as defined in § 170.3(n)(29) of (6) Heavy metals (as Pb). Not more this chapter. than 10 parts per million. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1) of different from the use established in this chapter, the ingredient is used in this section do not exist or have been food with no limitation other than cur- waived. rent good manufacturing practice. The [54 FR 7403 Feb. 21, 1989, as amended at 73 FR affirmation of this ingredient is gen- 8607, Feb. 14, 2008] erally recognized as safe (GRAS) as a direct human food ingredient is based § 184.1324 Glyceryl monostearate. upon the following current good manu- (a) Glyceryl monostearate, also facturing practice conditions of use: known as monostearin, is a mixture of (1) The ingredient is used as a formu- variable proportions of glyceryl mono- lation aid, as defined in § 170.3(o)(14) of stearate (C21H42O4, CAS Reg. No. 31566– this chapter. 31–1), glyceryl monopalmitate (2) The ingredient is used in excipient (C19H38O4, CAS Reg. No. 26657–96–5) and formulations for use in tablets at levels 532

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not to exceed good manufacturing (2) The ingredient is used in excipient practice. formulations for use in tablets at levels [52 FR 42430, Nov. 5, 1987] not to exceed good manufacturing practice. § 184.1329 Glyceryl palmitostearate. [60 FR 63621, Dec. 12, 1995] (a) Glyceryl palmitostearate is a mixture of mono-, di-, and triglyceryl § 184.1330 Acacia (gum arabic). esters of palmitic and stearic acids (a) Acacia (gum arabic) is the dried made from glycerin, palmitic acid, and gummy exudate from stems and stearic acid. branches of trees of various species of (b) The ingredient meets the fol- the genus Acacia, family Leguminosae. lowing specifications: (1) The substance is a mixture of (b) The ingredient meets the speci- mono-, di-, and triglycerides of pal- fications of the ‘‘Food Chemicals mitic acid and stearic acid. Codex,’’ 3d Ed. (1981), p. 7, which is in- (2) Heavy metals (as lead): Not more corporated by reference. Copies may be than 10 parts per million. obtained from the National Academy (c) In accordance with § 184.1(b)(1), Press, 2101 Constitution Ave. NW., the ingredient is used in food with no Washington, DC 20418, or may be exam- limitation other than current good ined at the National Archives and manufacturing practice. The affirma- Records Administration (NARA). For tion of this ingredient as generally rec- information on the availability of this ognized as safe (GRAS) as a direct material at NARA, call 202–741–6030, or human food ingredient is based upon go to: http://www.archives.gov/ the following current good manufac- federallregister/ turing practice conditions of use: codeloflfederallregulations/ (1) The ingredient is used as a formu- ibrllocations.html. lation aid, as defined in § 170.3(o)(14) of (c) The ingredient is used in food this chapter. under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, § 170.3(n)(3) of this chapter 2.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thick- ener, § 170.3(o)(28) of this chapter. Chewing gum, §170.3(n)(6) of this chapter ...... 5.6 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chap- ter; humectant, § 170.3(o)(16) of this chapter; sur- face-finishing agent, § 170.3(o)(30) of this chapter. Confections and frostings, § 170.3(n)(9) of this chapter ...... 12.4 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chap- ter. Dairy product analogs, § 170.3(n)(10) of this chapter ...... 1.3 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.5 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer and thickener, § 170.3(o)(28) of this chapter. Gelatins, puddings, and fillings, § 170.3(n)(22) of this chapter 2.5 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chap- ter.; stabilizer and thickener, § 170.3(o)(28) of this chapter. Hard candy and cough drops, § 170.3(n)(25) of this chapter .. 46.5 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chap- ter. Nuts and nut products, § 170.3(n)(32) of this chapter ...... 8.3 Formulation aid, § 170.3(o)(14) of this chapter; sur- face-finishing agent, § 170.3(o)(30) of this chapter. Quiescently frozen confection products ...... 6.0 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer and thickener, § 170.3(o)(28) of this chapter. Snack foods, §170.3(n)(37) of this chapter ...... 4.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chap- ter.

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

Soft candy, §170.3(n)(38) of this chapter ...... 85.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chap- ter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter, humectant, § 170.3(o)(16) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chap- ter; surface-finishing agent, § 170.3(o)(30) of this chapter. All other food categories ...... 1.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thick- ener, § 170.3(o)(28) of this chapter; surface-fin- ishing agent, § 170.3(o)(30) of this chapter; texturizer, § 170.3(o)(32) of this chapter.

(d) [Reserved] (3) Loss on drying. Not more than 14 (e) Prior sanctions for this ingredient percent dried at 105 °C for 5 hours. different from the uses established in (4) Identification test. Add 0.2 ml of di- this section do not exist or have been luted lead acetate as outlined in ‘‘Offi- waived. cial Methods of Analysis of the Asso- [42 FR 14653, Mar. 15, 1977, as amended at 42 ciation of Official Analytical Chem- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ists,’’ 13th Ed. (1980), section 31.178(b), 1983; 53 FR 5766, Feb. 26, 1988] p. 529, under ‘‘Dilute Basic Lead Ace- tate Standard Solution,’’ which is in- § 184.1333 Gum ghatti. corporated by reference (Copies are (a) Gum ghatti (Indian gum) is an available from the AOAC INTER- exudate from wounds in the bark of NATIONAL, 481 North Frederick Ave., Anogeissus latifolia, a large tree found suite 500, Gaithersburg, MD 20877, or in the dry deciduous forests of India may be examined at the National Ar- and Ceylon. chives and Records Administration (b) The ingredient complies with the (NARA). For information on the avail- following specifications: ability of this material at NARA, call (1) Viscosity of a 1-percent solution. 202–741–6030, or go to: http:// Not less than the minimum or within www.archives.gov/federallregister/ the range claimed by the vendor. codeloflfederallregulations/ (2) Limits of impurities—(i) Arsenic (as AL). Not more than 3 parts per million ibrllocations.html.), to 5 ml of a cold 1- (0.0003 percent); in-100 aqueous solution of the gum. An (ii) Ash (acid-insoluble). Not more immediate, voluminous, opaque pre- than 1.75 percent; cipitate indicates acacia. A small pre- (iii) Ash (total). Not more than 6.0 cipitate or clear solution which pro- percent; duces an opaque flocculent precipitate (iv) Heavy metals (as Pb). Not more upon the addition of 1 ml of 3 N than 40 parts per million (0.004 per- ammonimum hydroxide indicates gum cent); and ghatti. (v) Lead. Not more than 10 parts per (c) The ingredient is used in food million (0.001 percent). under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, nonalcoholic, 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter. § 170.3(n)(3) of this chapter. All other food categories ...... 1 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter.

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(d) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), p. 141, which is in- different from the uses established in corporated by reference. Copies may be this section do not exist or have been obtained from the National Academy waived. Press, 2101 Constitution Ave. NW., [42 FR 14653, Mar. 15, 1977, as amended at 49 Washington, DC 20418, or may be exam- FR 5612, Feb. 14, 1984] ined at the National Archives and Records Administration (NARA). For § 184.1339 Guar gum. information on the availability of this (a) Guar gum is the natural sub- material at NARA, call 202–741–6030, or stance obtained from the maceration of go to: http://www.archives.gov/ the seed of the guar plant, Cyamopsis federallregister/ tetragonoloba (Linne) Taub., or codeloflfederallregulations/ Cyamopsis psoraloides (Lam.) D.C. ibrllocations.html. (b) The ingredient meets the speci- (c) The ingredient is used in food fications of the ‘‘Food Chemicals under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.35 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chap- ter; stabilizer and thickener; § 170.3(o)(28) of this chapter. Breakfast cereals, §170.3(n)(4) of this chapter ...... 1.2 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer and thickener, § 170.3(o)(28) of this chapter. Cheese, § 170.3(n)(5) of this chapter ...... 8 Do. Dairy products analogs, § 170.3(n)(10) of this chapter ...... 1.0 Firming agent, § 170.3(o)(10) of this chapter; formula- tion aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 2.0 Do. Gravies and sauces, § 170.3(n)(24) of this chapter ...... 1.2 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer and thickener, § 170.3(o)(28) of this chapter. Jams and jellies, commercial, § 170.3(n)(28) of this chapter .. 1.0 Do. Milk products, § 170.3(n)(31) of this chapter ...... 6 Do. Processed vegetables and vegetable juices, § 170.3(n)(36) of 2.0 Formulation aid, § 170.3(o)(14) of this chapter; sta- this chapter. bilizer and thickener, § 170.3(o)(28) of this chapter. Soups and soup mixes, § 170.3(n)(40) of this chapter ...... 8 Do. Sweet sauces, toppings and syrups, § 170.3(n)(43) of this 1.0 Do. chapter. All other food categories ...... 5 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chap- ter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chap- ter.

(d) [Reserved] (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), pp. 174–175, which this section do not exist or have been is incorporated by reference. Copies waived. may be obtained from the National Academy Press, 2101 Constitution Ave. [42 FR 14653, Mar. 15, 1977, as amended at 42 NW., Washington, DC 20418, or may be FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, examined at the National Archives and 1984] Records Administration (NARA). For information on the availability of this § 184.1343 Locust (carob) bean gum. material at NARA, call 202–741–6030, or (a) Locust (carob) bean gum is pri- go to: http://www.archives.gov/ marily the macerated endosperm of the federallregister/ seed of the locust (carob) bean tree, codeloflfederallregulations/ Ceratonia siliqua (Linne), a leguminous ibrllocations.html. evergreen tree, with lesser quantities (c) The ingredient is used at levels of seed coat and germ. not to exceed the following maximum levels:

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.15 Stabilizer and thickener, § 170.3(o)(28) of this chapter. chapter. Beverages and beverage bases, nonalcoholic, .25 Do. § 170.3(n)(3) of this chapter. Cheeses, § 170.3(n)(5) of this chapter ...... 8 Do. Gelatins, puddings, and fillings, § 170.3(n)(22) of this .75 Do. chapter. Jams and jellies, commercial, § 170.3(n)(28) of this .75 Do. chapter. All other food categories ...... 5 Do.

(d) [Reserved] Codex,’’ 3d Ed. (1981), p. 157, which is in- (e) Prior sanctions for this ingredient corporated by reference. Copies may be different from the uses established in obtained from the National Academy this regulation do not exist or have Press, 2101 Constitution Ave. NW., been waived. Washington, DC 20418, or may be exam- [42 FR 14653, Mar. 15, 1977, as amended at 42 ined at the National Archives and FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Records Administration (NARA). For 1984] information on the availability of this material at NARA, call 202–741–6030, or § 184.1349 Karaya gum (sterculia gum). go to: http://www.archives.gov/ (a) Karaya gum (sterculia gum) is the federallregister/ dried gummy exudate from the trunk codeloflfederallregulations/ of trees of various species of the genus ibrllocations.html. Sterculia. (c) The ingredient is used in food (b) The ingredient meets the speci- under the following conditions: fications of the ‘‘Food Chemicals

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Frozen dairy desserts and mixes, § 170.3(n)(20) of 0.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and this chapter. thickener, § 170.3(o)(28) of this chapter. Milk products, § 170.3(n)(31) of this chapter ...... 02 Stabilizer and thickener, § 170.3(o)(28) of this chapter. Soft candy, §170.3(n)(38) of this chapter ...... 9 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 002 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter.

(d) [Reserved] (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), p. 337, which is in- this section do not exist or have been corporated by reference. Copies may be waived. obtained from the National Academy Press, 2101 Constitution Ave. NW., [42 FR 14653, Mar. 15, 1977, as amended at 42 Washington, DC 20418, or may be exam- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ined at the National Archives and 1984] Records Administration (NARA). For information on the availability of this § 184.1351 Gum tragacanth. material at NARA, call 202–741–6030, or (a) Gum tragacanth is the exudate go to: http://www.archives.gov/ from one of several species of Astrag- federallregister/ alus gummifier Labillardiere, a shrub codeloflfederallregulations/ that grows wild in mountainous re- ibrllocations.html. gions of the Middle East. (c) The ingredient is used in food under the following conditions:

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Condiments and relishes, § 170.3(n)(8) of this chap- .7 Do. ter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.3 Do. Gravies and sauces, § 170.3(n)(24) of this chapter .. .8 Do. Meat products, § 170.3(n)(29) of this chapter ...... 2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of .2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; this chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 1 Do.

(d) [Reserved] (d) Prior sanctions for this ingredient (e) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [48 FR 57270, Dec. 29, 1983, as amended at 73 [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 8607, Feb. 14, 2008] FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984] § 184.1366 Hydrogen peroxide.

§ 184.1355 Helium. (a) Hydrogen peroxide (H2O2, CAS (a) Helium (empirical formula He, Reg. No. 7722–84–1) is also referred to as CAS Reg. No. 7440–59–7) is a colorless, hydrogen dioxide. It is made by the odorless, flavorless, nonflammable, electrolytic oxidation of sulfuric acid inert gas. It is lighter than air and is or a sulfate to persulfuric acid or a produced by the liquefaction and puri- persulfuric acid salt with subsequent fication of natural gas. hydrolysis and distillation of the hy- (b) The ingredient must be of a pu- drogen peroxide formed; by decomposi- rity suitable for its intended use. tion of barium peroxide with sulfuric (c) In accordance with § 184.1(b)(1), or phosphoric acid; by hydrogen reduc- the ingredient is used in food with no tion of 2-ethylanthraquinone, followed limitations other than current good by oxidation with air, to regenerate manufacturing practice. The affirma- the quinone and produce hydrogen per- tion of this ingredient as generally rec- oxide; or by electrical discharge ognized as safe (GRAS) as a direct through a mixture of hydrogen, oxy- human food ingredient is based upon gen, and water vapor. the following current good manufac- (b) The ingredient meets the speci- turing practice conditions of use: fications of the Food Chemicals Codex, (1) The ingredient is used as a proc- 3d ed. (1981), pp. 146–147, 1 which is in- essing aid as defined in § 170.3(o)(24) of corporated by reference. this chapter. (c) In accordance with § 184.1(b)(2), (2) The ingredient is used in food at the ingredient is used to treat food levels not to exceed current good man- only within the following specific limi- ufacturing practice. tations:

1 Copies may be obtained from the National availability of this material at NARA, call Academy of Sciences, 2101 Constitution Ave. 202–741–6030, or go to: http://www.archives.gov/ NW, Washington, DC 20037, or examined at federallregister/codeloflfederallregulations/ the National Archives and Records Adminis- ibrllocations.html. tration (NARA). For information on the

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Maximum treatment Food level in food (percent) Functional use

Milk, intended for use during the cheesemaking 0.05 ...... Antimicrobial agent as defined in § 170.3 (o)(2) of process as permitted in the appropriate stand- this chapter ards of identity for cheese and related cheese products under part 133 of this chapter. Whey, during the preparation of modified whey by 0.04 ...... do. electrodialysis methods. Dried eggs, dried egg whites, and dried egg yolks Amount sufficient for Oxidizing and reducing agent as defined in § 170.3 as in §§ 160.105, 160.145, and 160.185 of this the purpose. (o)(22) of this chapter chapter. Tripe ...... do ...... Bleaching agent. Beef feet ...... Amount sufficient for Bleaching agent. the purpose. (Hy- drogen peroxide may be in the form of a compound salt, sodium carbonate peroxide). Herring ...... Amount sufficient for do. the purpose. Wine ...... do ...... Oxidizing and reducing agent as defined in § 170.3 (o)(22) of this chapter. Starch ...... 0.15 ...... Antimicrobial agent as defined in § 170.3 (o)(2) of this chapter, to produce thermophile-free starch; Remove sulfur dioxide from starch slurry following steeping and grinding operations of corn refin- ing. Instant tea ...... Amount sufficient for Bleaching agent. the purpose. Corn syrup ...... 0.15 ...... Reduce sulfur dioxide levels in the finished corn syrup. Colored (annatto) cheese whey ...... 0.05 ...... Bleaching agent. Wine vinegar ...... Amount sufficient for Remove sulfur dioxide from wine prior to fermenta- the purpose. tion to produce vinegar. Emulsifiers containing fatty acid esters ...... 1.25 ...... Bleaching agent.

(d) Residual hydrogen peroxide is re- spection at the National Archives and moved by appropriate physical and Records Administration (NARA). For chemical means during the processing information on the availability of this of food where it has been used accord- material at NARA, call 202–741–6030, or ing to paragraph (c) of this section. go to: http://www.archives.gov/ (e) Prior sanctions for this ingredient federallregister/ different from the uses established in codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [46 FR 44439, Sept. 4, 1981, as amended at 51 limitations other than current good FR 27172, July 30, 1986] manufacturing practice. The affirma- tion of this ingredient as generally rec- § 184.1370 Inositol. ognized as safe (GRAS) as a direct (a) Inositol, or myo-inositol (C6H12O6, human food ingredient is based upon CAS Reg. No. 87–89–8), is cis-1,2,3,5- the following current good manufac- trans-4,6-cyclohexanehexol. It occurs turing practice conditions of use: naturally and is prepared from an (1) The ingredient is used as a nutri- aqueous (0.2 percent sulfur dioxide) ex- ent supplement as defined in tract of corn kernels by precipitation § 170.3(o)(20) of this chapter. and hydrolysis of crude phytate. (2) The ingredient is used in special (b) The ingredient meets the speci- dietary foods as defined in part 105 of fications of the Food Chemicals Codex, this chapter at levels not to exceed 3d Ed. (1981), p. 150, which is incor- current good manufacturing practice. porated by reference. Copies are avail- It may also be used in infant formula able from the National Academy Press, in accordance with section 412(g) of the 2101 Constitution Ave. NW., Wash- Act, or with regulations promulgated ington, DC 20418, or available for in- under section 412(a)(2) of the Act.

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(d) Prior sanctions for this ingredient ceed current good manufacturing prac- different from the uses established by tice. this section do not exist or have been [48 FR 5720, Feb. 8, 1983, as amended at 61 FR waived. 43450, Aug. 23, 1996] [47 FR 38278, Aug. 31, 1982] § 184.1375 Iron, elemental. § 184.1372 Insoluble glucose isomerase (a) Iron, elemental (CAS Reg. No. enzyme preparations. 7439–89–6) is metallic iron obtained by any of the following processes: reduced (a) Insoluble glucose isomerase en- iron, electrolytic iron, and carbonyl zyme preparations are used in the pro- iron. duction of high fructose corn syrup de- (1) Reduced iron is prepared by react- scribed in § 184.1866. They are derived ing ground ferric oxide with hydrogen from recognized species of precisely or carbon monoxide at an elevated classified nonpathogenic and temperature. The process results in a nontoxicogenic microorganisms, in- grayish-black powder, all of which cluding Streptomyces rubiginosus, should pass through a 100-mesh sieve. Actinoplanes missouriensis, Streptomyces It is lusterless or has not more than a olivaceus, Streptomyces olivochromogenes, slight luster. When viewed under a mi- and , that have been croscope, it appears as an amorphous grown in a pure culture fermentation powder free from particles having a that produces no antibiotics. They are crystalline structure. It is stable in dry fixed (rendered insoluble) for batch air. production with GRAS ingredients or (2) Electrolytic iron is prepared by may be fixed for further immobiliza- electrodeposition. It is an amorphous, tion with either GRAS ingredients or lusterless, grayish-black powder. It is materials approved under § 173.357 of stable in dry air. this chapter. (3) Carbonyl iron is prepared by the (b) The ingredient meets the general decomposition of iron pentacarbonyl. and additional requirements for en- It occurs as a dark gray powder. When zyme preparations in the Food Chemi- viewed under a microscope, it appears cals Codex, 3d Ed. (1981), p. 107, which is as spheres built up with concentric incorporated by reference. Copies are shells. It is stable in dry air. available from the National Academy (b) Iron, elemental (carbonyl, elec- Press, 2101 Constitution Ave. NW., trolytic, or reduced) meets the speci- Washington, DC 20418, or available for fications of the Food Chemicals Codex, 3d Ed. (1981) (iron, carbonyl, p. 151; inspection at the National Archives iron, electrolytic, pp. 151–152; iron, re- and Records Administration (NARA). duced; pp. 152–153), which is incor- For information on the availability of porated by reference. Copies are avail- this material at NARA, call 202–741– able from the National Academy Press, 6030, or go to: http://www.archives.gov/ 2101 Constitution Ave. NW., Wash- federallregister/ ington, DC 20418, or available for in- codeloflfederallregulations/ spection at the National Archives and ibrllocations.html. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food with no material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of this ingredient as generally rec- codeloflfederallregulations/ ognized as safe (GRAS) as a direct ibrllocations.html. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food as a nu- turing practice conditions of use: trient supplement as defined in (1) The ingredient is used as an en- § 170.3(o)(20) of this chapter, with no zyme, as defined in § 170.3(o)(9) of this limitation other than current good chapter, to convert glucose to fructose. manufacturing practice. The ingre- (2) The ingredient is used in high dient may also be used in accordance fructose corn syrup, at levels not to ex- with section 412(g) of the Federal Food,

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Drug, and Cosmetic Act (the act) (21 tose. It is prepared from yeast that has U.S.C. 350a(g)) or with regulations pro- been grown by a pure culture fermenta- mulgated under section 412(a)(2) of the tion process. act (21 U.S.C. 350a(2)). (b) The ingredient meets the general (d) Prior sanctions for this ingredient requirements and additional require- different from the uses established in ments for enzyme preparations in the this section do not exist or have been Food Chemicals Codex, 3d ed. (1981), pp. waived. 107–110, which are incorporated by ref- erence in accordance with 5 U.S.C. [53 FR 16867, May 12, 1988] 552(a) and 1 CFR part 51. Copies are § 184.1386 Isopropyl citrate. available from the National Academy Press, 2101 Constitution Ave. NW., (a) Isopropyl citrate is a mixture of Washington, DC 20418, or may be exam- the mono-, di-, and triisopropyl esters ined at the Food and Drug Administra- of citric acid. It is prepared by tion’s Main Library, 10903 New Hamp- esterifying citric acid with shire Ave., Bldg. 2, Third Floor, Silver isopropanol. Spring, MD 20993, 301–796–2039, or at the (b) The ingredient must be of a pu- National Archives and Records Admin- rity suitable for its intended use. istration (NARA). For information on (c) In accordance with § 184.1(b)(1), the availability of this material at the ingredient is used in food with no NARA, call 202–741–6030, or go to: http:// limitation other than current good www.archives.gov/federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitations other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as an anti- tion of this ingredient as generally rec- oxidant as defined in § 170.3(o)(3) of this ognized as safe as a direct human food chapter; a sequestrant as defined in ingredient is based upon the following § 170.3(o)(26) of this chapter; and a sol- current good manufacturing practice vent and vehicle as defined in conditions of use: § 170.3(o)(27) of this chapter. (1) The ingredient is used as an en- (2) The ingredient is used in mar- zyme, as defined in § 170.3(o)(9) of this garine in accordance with § 166.110 of chapter, to convert lactose to glucose this chapter; in nonalcoholic beverages and galactose. as defined in § 170.3(n)(3) of this chap- (2) The ingredient is used in food at ter; and in fats and oils as defined in levels not to exceed current good man- § 170.3(n)(12) of this chapter at levels ufacturing practice. Current good man- not to exceed current good manufac- ufacturing practice is limited to use of turing practice. this ingredient to reduce the lactose (d) Prior sanctions for this ingredient content in milk and milk-derived food different from the uses established in products where food standards do not this section, or different from those set preclude such use. forth in part 181 of this chapter, do not [61 FR 7704, Feb. 29, 1996, as amended at 81 exist or have been waived. FR 5595, Feb. 3, 2016] [59 FR 63896, Dec. 12, 1994, as amended at 73 FR 8607, Feb. 14, 2008] § 184.1388 Lactase enzyme preparation from Kluyveromyces lactis. § 184.1387 Lactase enzyme preparation (a) This enzyme preparation is de- from Candida pseudotropicalis. rived from the nonpathogenic, (a) This enzyme preparation is de- nontoxicogenic yeast Kluyveromyces rived from the nonpathogenic, lactis (previously named Saccharomyces nontoxicogenic yeast C. lactis). It contains the enzyme B- pseudotropicalis. It contains the enzyme galactoside galactohydrase (CAS Reg. lactase (b-D-galactoside No. CBS 683), which converts lactose to galactohydrolase, EC 3.2.1.23), which glucose and galactose. It is prepared converts lactose to glucose and galac- from yeast that has been grown in a

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pure culture fermentation and by using porated by reference. Copies are avail- materials that are generally recognized able from the National Academy Press, as safe or are food additives that have 2101 Constitution Ave. NW., Wash- been approved for this use by the Food ington, DC 20418, or available for in- and Drug Administration. spection at the National Archives and (b) The ingredient meets the general Records Administration (NARA). For and additional requirements for en- information on the availability of this zyme preparations in the Food Chemi- material at NARA, call 202–741–6030, or cals Codex, 3d Ed. (1981), p. 107–110, go to: http://www.archives.gov/ which is incorporated by reference. federallregister/ Copies are available from the National codeloflfederallregulations/ Academy Press, 2101 Constitution Ave. ibrllocations.html. NW., Washington, DC 20418, or avail- (c) In accordance with § 184.1(b)(1), able for inspection at the National Ar- the ingredient is used in food with no chives and Records Administration limitation other than current good (NARA). For information on the avail- manufacturing practice. ability of this material at NARA, call (d) Prior sanctions for this ingredient 202–741–6030, or go to: http:// different from the uses established in www.archives.gov/federallregister/ this section do not exist or have been codeloflfederallregulations/ waived. ibr locations.html. l [48 FR 51150, Nov. 7, 1983] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1408 Licorice and licorice deriva- limitation other than current good tives. manufacturing practice. The affirma- (a)(1) Licorice (glycyrrhiza) root is tion of this ingredient as generally rec- the dried and ground rhizome and root ognized as safe as a direct human food portions of Glycyrrhiza glabra or other ingredient is based upon the following species of Glycyrrhiza. Licorice extract current good manufacturing practice is that portion of the licorice root that conditions of use: is, after maceration, extracted by boil- (1) The ingredient is used as an en- ing water. The extract can be further zyme as defined in § 170.3(o)(9) of this purified by filtration and by treatment chapter to convert lactose to glucose with acids and ethyl alcohol. Licorice and galactose. extract is sold as a liquid, paste (2) The ingredient is used in food at (‘‘block’’), or spray-dried powder. levels not to exceed current good man- (2) Ammoniated glycyrrhizin is pre- ufacturing practice. Current good man- pared from the water extract of lico- ufacturing practice is to use this ingre- rice root by acid precipitation followed dient in milk to produce lactase-treat- by neutralization with dilute ammonia. ed milk, which contains less lactose Monoammonium glycyrrhizinate than regular milk, or lactose-reduced (C H O NH 5H O, CAS Reg. No. 1407– milk, which contains at least 70 per- 42 61 16 4 2 03–0) is prepared from ammoniated cent less lactose than regular milk. glycyrrhizin by solvent extraction and [49 FR 47387, Dec. 4, 1984] separation techniques. (b) The ingredients shall meet the § 184.1400 Lecithin. following specifications when analyzed: (a) Commercial lecithin is a natu- (1) Assay. The glycyrrhizin content of rally occurring mixture of the each flavoring ingredient shall be de- phosphatides of choline, ethanolamine, termined by the method in the Official and inositol, with smaller amounts of Methods of Analysis of the Association othe lipids. It is isolated as a gum fol- of Official Analytical Chemists, 13th lowing hydration of solvent-extracted Ed., §§ 19.136–19.140, which is incor- soy, safflower, or corn oils. Lecithin is porated by reference, or by methods bleached, if desired, by hydrogen per- 19.CO1 through 19.CO4 in the Journal of oxide and benzoyl peroxide and dried the Association of Official Analytical by heating. Chemists, 65:471–472 (1982), which are (b) The ingredient meets the speci- also incorporated by reference. Copies fications of the Food Chemicals Codex, of all of these methods are available 3d Ed. (1981), pp. 166–167, which is incor- from the AOAC INTERNATIONAL, 481

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North Frederick Ave., suite 500, Gai- go to: http://www.archives.gov/ thersburg, MD 20877, or available for federallregister/ inspection at the National Archives codeloflfederallregulations/ and Records Administration (NARA). ibrllocations.html. For information on the availability of (3) Acid unsoluble ash. Not more than this material at NARA, call 202–741– 2.5 percent for licorice on an anhydrous 6030, or go to: http://www.archives.gov/ basis as determined by the method in federallregister/ the Food Chemicals Codex, 3d Ed. codeloflfederallregulations/ (1981), p. 466, which is incorporated by ibrllocations.html. reference. (2) Ash. Not more than 9.5 percent for (4) Heavy metals (as Pb). Not more licorice, 2.5 percent for ammoniated than 40 parts per million as determined glycyrrhizin, and 0.5 percent for by method II in the Food Chemicals monoammonium glycyrrhizinate on an anhydrous basis as determined by the Codex, 3d Ed. (1981), p. 512, which is in- method in the Food Chemicals Codex, corporated by reference. 3d Ed. (1981), p. 466, which is incor- (5) Arsenic (As). Not more than 3 parts porated by reference. Copies are avail- per million as determined by the meth- able from the National Academy Press, od in the Food Chemicals Codex. 3d Ed. 2101 Constitution Ave. NW., Wash- (1981), p. 464, which is incorporated by ington, DC 20418, or available for in- reference. spection at the National Archives and (c) In accordance with § 184.1(b)(2), Records Administration (NARA). For these ingredients are used in food only information on the availability of this within the following specific limita- material at NARA, call 202–741–6030, or tions:

Maximum level in food (percent Category of food glycyrrhizin con- Functional use tent of food) (as served)

Baked foods, § 170.3(n)(1) of this chapter ...... 0 .05 Flavor enhancer, § 170.3(o)(11) of this chapter; fla- voring agent, § 170.3(o)(12) of this chapter. Alcoholic beverages, § 170.3(n)(2) of this chapter ..... 0 .1 Flavor enhancer, § 170.3(o)(11) of this chapter; fla- voring agent, § 170.3(o)(12) of this chapter; sur- face-active agent, § 170.3(o)(29) of this chapter. Nonalcoholic beverages, § 170.3(n)(3) of this chapter 0 .15 Do. Chewing gum, § 170.3(n)(6) of this chapter ...... 1 .1 Flavor enhancer, § 170.3(o)(11) of this chapter; fla- voring agent, § 170.3(n)(12) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 16.0 Do. Herbs and seasonings, § 170.3(n)(26) of this chapter 0.15 Do. Plant protein products, § 170.3(n)(33) of this chapter 0 .15 Do. Soft candy, § 170.3(n)(38) of this chapter ...... 3 .1 Do. Vitamin or mineral dietary supplements ...... 0 .5 Do. All other foods except sugar substitutes, 0 .1 Do. § 170.3(n)(42) of this chapter. The ingredient is not permitted to be used as a nonnutritive sweetener in sugar substitutes.

(d) Prior sanctions for this ingredient classifying of naturally occurring lime- different from the uses established in stone. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 173, which is incor- [50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989] porated by reference. Copies are avail- able from the National Academy Press, § 184.1409 Ground limestone. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- (a) Ground limestone consists essen- spection at the National Archives and tially (not less than 94 percent) of cal- Records Administration (NARA). For cium carbonate (CaCO ) and is prepared 3 information on the availability of this by the crushing, grinding, and material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ (2) The ingredient is used in food at federallregister/ levels not to exceed current good man- codeloflfederallregulations/ ufacturing practice. ibrllocations.html. (c) In accordance with § 184.1(b)(1), [60 FR 32911, June 26, 1995, as amended at 78 the ingredient is used in food with no FR 14666, Mar. 7, 2013] limitation other than current good § 184.1420 Lipase enzyme preparation manufacturing practice. derived from Rhizopus niveus. (d) Prior sanctions for this ingredient different from the uses established in (a) Lipase enzyme preparation con- this section do not exist or have been tains lipase enzyme (CAS Reg. No. waived. 9001–62–1), which is obtained from the culture filtrate resulting from a pure [48 FR 52442, Nov. 18, 1983] culture fermentation of a nonpatho- § 184.1415 Animal lipase. genic and nontoxigenic strain of Rhizopus niveus. The enzyme prepara- (a) Animal lipase (CAS Reg. No. 9001– 62–1) is an enzyme preparation obtained tion also contains diatomaceous earth from edible forestomach tissue of as a carrier. The characterizing activ- calves, kids, or lambs, or from animal ity of the enzyme, which catalyzes the pancreatic tissue. The enzyme prepara- interesterification of fats and oils at tion may be produced as a tissue prepa- the 1- and 3-positions of triglycerides, ration or as an aqueous extract. Its is triacylglycerol lipase (EC 3.1.1.3). characterizing enzyme activity is that (b) The ingredient meets the general of a triacylglycerol hydrolase (EC requirements and additional require- 3.1.1.3). ments for enzyme preparations in the (b) The ingredient meets the general monograph on Enzyme Preparations in requirements and additional require- the ‘‘Food Chemicals Codex,’’ 4th ed. ments for enzyme preparations in the (1996), pp. 133 and 134, which is incor- Food Chemicals Codex, 3d ed. (1981), p. porated by reference in accordance 110, which is incorporated by reference with 5 U.S.C. 552(a) and 1 CFR part 51. in accordance with 5 U.S.C. 552(a) and 1 Copies are available from the National CFR part 51. Copies are available from Academy Press, 2101 Constitution Ave. the National Academy Press, 2101 Con- NW., Washington, DC 20418, or may be stitution Ave., NW., Washington, DC examined at the Food and Drug Admin- 20418, or may be examined at the Office istration’s Main Library, 10903 New of Food Additive Safety (HFS–200), Hampshire Ave., Bldg. 2, Third Floor, Center for Food Safety and Applied Nu- Silver Spring, MD 20993, 301–796–2039, or trition, Food and Drug Administration, at the National Archives and Records 5001 Campus Dr., College Park, MD Administration (NARA). For informa- 20740, 240–402–1200, and at the National tion on the availability of this mate- Archives and Records Administration rial at NARA, call 202–741–6030, or go (NARA). For information on the avail- to: http://www.archives.gov/ ability of this material at NARA, call federallregister/ 202–741–6030, or go to: http:// codeloflfederallregulations/ www.archives.gov/federallregister/ ibrllocations.html. codeloflfederallregulations/ ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as GRAS as a di- ognized as safe as a direct human food rect food ingredient is based upon the ingredient is based upon the following following current good manufacturing current good manufacturing practice practice conditions of use: conditions of use: (1) The ingredient is used as an en- (1) The ingredient is used as an en- zyme as defined in § 170.3(o)(9) of this zyme as defined in § 170.3(o)(9) of this chapter to hydrolyze fatty acid chapter for the interesterification of glycerides. fats and oils.

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(2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been [63 FR 24419, May 4, 1998, as amended at 81 waived. FR 5595, Feb. 3, 2016] [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985] § 184.1425 Magnesium carbonate. (a) Magnesium carbonate (molecular § 184.1426 Magnesium chloride. formula approximately (a) Magnesium chloride (MgC12·6H2O, (MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. CAS Reg. No. 7786–30–3) is a colorless, 39409–82–0) is also known as magnesium deliquescent, crystalline material that carbonate hydroxide. It is a white pow- occurs naturally as the mineral der formed either by adding an alkaline bischofite. It is prepared by dissolving carbonate (such as sodium carbonate) magnesium oxide, hydroxide, or car- to a solution of magnesium sulfate or bonate in aqueous hydrochloric acid so- by carbonation of a slurry of magne- lution and crystallizing out magnesium sium hydroxide followed by boiling of chloride hexahydrate. the resulting magnesium carbonate. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 177, which is incor- 3d Ed. (1981), p. 177, which is incor- porated by reference. Copies are avail- porated by reference. Copies are avail- able from the National Academy Press, able from the National Academy Press, 2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- ington, DC 20418, or available for in- spection at the National Archives and spection at the National Archives and Records Administration (NARA). For Records Administration (NARA). For information on the availability of this information on the availability of this material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufac- turing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as an (1) The ingredient is used as a fla- anticaking and free-flow agent as de- voring agent and adjuvant as defined in fined in § 170.3(o)(1) of this chapter; a flour treating agent as defined in § 170.3(o)(12) of this chapter and a nutri- § 170.3(o)(13) of this chapter; a lubricant ent supplement as defined in and release agent as defined in § 170.3(o)(20) of this chapter. § 170.3(o)(18) of this chapter; a nutrient (2) The ingredient is used in foods at supplement as defined in § 170.3(o)(20) of levels not to exceed current good man- this chapter; a pH control agent as de- ufacturing practice. The ingredient fined in § 170.3(o)(23) of this chapter; a also may be used in infant formula in processing aid as defined in § 170.3(o)(24) accordance with section 412(g) of the of this chapter; and a synergist as de- Federal Food, Drug, and Cosmetic Act fined in § 170.3(o)(31) of this chapter. (the act) or with regulations promul- (2) The ingredient is used in foods at gated under section 412(a)(2) of the act. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. different from the uses established in

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this section do not exist or have been It is produced either as a bulky white waived. powder (light) or a relatively dense white powder (heavy) by heating mag- [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985] nesium hydroxide or carbonate. Heat- ing these magnesium salts under mod- § 184.1428 Magnesium hydroxide. erate conditions (400° to 900 °C for a few hours) produces light magnesium (a) Magnesium hydroxide (Mg(OH)2, CAS Reg. No. 1309–42–8) occurs natu- oxide. Heating the salts under more ° rally as the colorless, crystalline min- rigorous conditions (1200 C for 12 eral brucite. It is prepared as a white hours) produces heavy magnesium precipitate by the addition of sodium oxide. Light magnesium oxide is con- hydroxide to a water soluble magne- verted to heavy magnesium oxide by sium salt or by hydration of reactive sustained heating at high tempera- grades of magnesium oxide. tures. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 178, which is incor- 3d Ed. (1981), p. 178, which is incor- porated by reference. Copies are avail- porated by reference. Copies are avail- able from the National Academy Press, able from the National Academy Press, 2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- ington, DC 20418, or available for in- spection at the National Archives and spection at the National Archives and Records Administration (NARA). For Records Administration (NARA). For information on the availability of this information on the availability of this material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufac- turing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as a nutri- (1) The ingredient is used as an ent supplement as defined in anticaking and free-flow agent as de- § 170.3(o)(20) of this chapter; a pH con- fined in § 170.3(o)(1) of this chapter; a trol agent as defined in § 170.3(o)(23) of firming agent as defined in § 170.3(o)(10) this chapter; and a processing aid as of this chapter; a lubricant and release defined in § 170.3(o)(24) of this chapter. agent as defined in § 170.3(o)(18) of this (2) The ingredient is used in foods at chapter; a nutrient supplement as de- levels not to exceed current good man- fined in § 170.3(o)(20) of this chapter; ufacturing practice. and a pH control agent as defined in (d) Prior sanctions for this ingredient § 170.3(o)(23) of this chapter. different from the uses established in (2) The ingredient is used in foods at this section do not exist or have been levels not be exceed current good man- waived. ufacturing practice. The ingredient [50 FR 13559, Apr. 5, 1985, as amended at 64 also may be used in infant formula in FR 405, Jan. 5, 1999] accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act § 184.1431 Magnesium oxide. (the act) or with regulations promul- (a) Magnesium oxide (MgO, CAS Reg. gated under section 412(a)(2) of the act. No. 1309–48–4) occurs naturally as the (d) Prior sanctions for this ingredient colorless, crystalline mineral periclase. different from the uses established in

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this section do not exist or have been accordance with section 412(g) of the waived. Federal Food, Drug, and Cosmetic Act (the act) or with regulations promul- [50 FR 13559, Apr. 5, 1985] gated under section 412(a)(2) of the Act. § 184.1434 Magnesium phosphate. (d) Prior sanctions for this ingredient (a) Magnesium phosphate includes different from the uses established in both magnesium phosphate, dibasic, this section do not exist or have been and magnesium phosphate, tribasic. waived. Magnesium phosphate, dibasic [50 FR 13560, Apr. 5, 1985, as amended at 69 (MgHPO4·3H2O, CAS Reg. No. 7782–0975– FR 24512, May 4, 2004] 094) occurs naturally as the white, crystalline mineral newberyite. It is § 184.1440 Magnesium stearate. prepared commercially as a precipitate (a) Magnesium stearate formed by treating a solution of mag- (Mg(C17H34COO)2, CAS Reg. No. 557–04– nesium sulfate with disodium phos- 0) is the magnesium salt of stearic phate under controlled conditions. acid. It is produced as a white precipi- Magnesium phosphate, tribasic tate by the addition of an aqueous so- (Mg3(PO4)2·xH2O, CAS Reg. No. 7757–87– lution of magnesium chloride to an 1) may contain 4, 5, or 8 molecules of aqueous solution of sodium stearate de- water of hydration. It is produced as a rived from stearic acid that is obtained precipitate from a solution of mag- from edible sources and that conforms nesite with phosphoric acid. to the requirements of § 172.860(b)(2) of (b) Magnesium phosphate, dibasic, this chapter. meets the specifications of the Food (b) The ingredient meets the speci- Chemicals Codex, 3d Ed. (1981), p. 179, fications of the Food Chemicals Codex, which is incorporated by reference. 3d Ed. (1981), p. 182, which is incor- Magnesium phosphate, tribasic, meets the specifications of the Food Chemi- porated by reference. Copies are avail- cals Codex, 3d Ed. (1981), p. 180, which is able from the National Academy Press, incorporated by reference. Copies are 2101 Constitution Ave. NW., Wash- available from the National Academy ington, DC 20418, or available for in- Press, 2101 Constitution Ave. NW., spection at the National Archives and Washington, DC 20418, or available for Records Administration (NARA). For inspection at the National Archives information on the availability of this and Records Administration (NARA). material at NARA, call 202–741–6030, or For information on the availability of go to: http://www.archives.gov/ this material at NARA, call 202–741– federallregister/ 6030, or go to: http://www.archives.gov/ codeloflfederallregulations/ federallregister/ ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used as a lubri- turing practice conditions of use: cant and release agent as defined in (1) The ingredient is used as a nutri- § 170.3(o)(18) of this chapter; a nutrient ent supplement as defined in supplement as defined in § 170.3(o)(20) of § 170.3(o)(20) of this chapter and a pH this chapter; and a processing aid as control agent as defined in § 170.3(o)(23) defined in § 170.3(o)(24) of this chapter. of this chapter. (2) The ingredient is used in foods at (2) The ingredient is used in foods at levels not to exceed current good man- levels not to exceed current good man- ufacturing practice. ufacturing practice. The ingredient (d) Prior sanctions for this ingredient also may be used in infant formula in different from the uses established in

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this section do not exist or have been characterizing enzyme activities are a- waived. amylase (EC 3.2.1.1.) and b-amylase (EC 3.2.1.2). [50 FR 13560, Apr. 5, 1985] (b) The ingredient meets the general § 184.1443 Magnesium sulfate. requirements and additional require- ments for enzyme preparations in the (a) Magnesium sulfate (MgSO4·7H2O, Food Chemicals Codex, 3d ed. (1981), p. CAS Reg. No. 10034–99–8) occurs natu- 110, which is incorporated by reference rally as the mineral epsomite. It is pre- in accordance with 5 U.S.C. 552(a) and 1 pared by neutralization of magnesium CFR part 51. Copies are available from oxide, hydroxide, or carbonate with the National Academy Press, 2101 Con- sulfuric acid and evaporating the solu- stitution Ave., NW., Washington, DC tion to crystallization. 20418, or may be examined at the Office (b) The ingredient meets the speci- of Premarket Approval (HFS–200), Food fications of the Food Chemicals Codex, and Drug Administration, 5001 Campus 3d Ed. (1981), p. 183, which is incor- Dr., College Park, MD 20740, and at the porated by reference. Copies are avail- National Archives and Records Admin- able from the National Academy Press, istration (NARA). For information on 2101 Constitution Ave. NW., Wash- the availability of this material at ington, DC 20418, or available for in- NARA, call 202–741–6030, or go to: http:// spection at the National Archives and www.archives.gov/federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as GRAS as a di- (c) In accordance with § 184.1(b)(1), rect food ingredient is based upon the the ingredient is used in food with no following current good manufacturing limitation other than current good practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as an en- tion of this ingredient as generally rec- zyme as defined in § 170.3(o)(9) of this ognized as safe (GRAS) as a direct chapter to hydrolyze starch or starch- human food ingredient is based upon derived polysaccharides. the following current good manufac- (2) The ingredient is used in food at turing practice conditions of use: levels not to exceed current good man- (1) The ingredient is used as a flavor ufacturing practice. enhancer as defined in § 170.3(o)(11) of [60 FR 32911, June 26, 1995] this chapter; a nutrient supplement as defined in § 170.3(o)(20) of this chapter; § 184.1444 Maltodextrin. and a processing aid as defined in (a) Maltodextrin ((C H O ) , CAS § 170.3(o)(24) of this chapter. 6 10 5 n (2) The ingredient is used in foods at Reg. No. 9050–36–6) is a nonsweet nutri- levels not to exceed current good man- tive saccharide polymer that consists ufacturing practice. of D-glucose units linked primarily by (d) Prior sanctions for this ingredient a-1-4 bonds and that has a dextrose different from the uses established in equivalent (D.E.) of less than 20. It is this section do not exist or have been prepared as a white powder or con- waived. centrated solution by partial hydrol- ysis of corn starch, potato starch, or [50 FR 13560, Apr. 5, 1985] rice starch with safe and suitable acids and enzymes. § 184.1443a Malt. (b)(1) Maltodextrin derived from corn (a) Malt is an enzyme preparation ob- starch must be of a purity suitable for tained from barley which has been soft- its intended use. ened by a series of steeping operations (2) Maltodextrin derived from potato and germinated under controlled condi- starch meets the specifications of the tions. It is a brown, sweet, and viscous Food Chemicals Codex, 3d ed., 3d supp. liquid or a white to tan powder. Its (1992), p. 125, which are incorporated by

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reference in accordance with 5 U.S.C. amounts of amylolytic enzymes and 552(a) and 1 CFR part 51. Copies are plant constituents. Barley is first soft- available from the National Academy ened after cleaning by steeping oper- Press, 2101 Constitution Ave., NW., ations and then allowed to germinate Washington, DC 20418, or at the Divi- under controlled conditions. The ger- sion of Petition Control (HFS–217), minated grain then undergoes proc- Center for Food Safety and Applied Nu- essing, such as drying, grinding, ex- trition, Food and Drug Administration, tracting, filtering, and evaporating, to 5001 Campus Dr., College Park, MD produce malt syrup (malt extract) with 20740, or may be examined at the Na- 75 to 80 percent solids or dried malt tional Archives and Records Adminis- syrup with higher solids content. tration (NARA). For information on (b) The ingredient must be of a pu- the availability of this material at rity suitable for its intended use. NARA, call 202–741–6030, or go to: http:// (c) In accordance with § 184.1(b)(1), www.archives.gov/federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html.. manufacturing practice. The affirma- (3) Maltodextrin derived from rice tion of this ingredient as generally rec- starch meets the specifications of the ognized as safe (GRAS) as a direct Food Chemicals Codex, 4th ed. (1996), human food ingredient is based upon pp. 239 and 240, which is incorporated the following current good manufac- by reference in accordance with 5 turing practice conditions of use: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The ingredient is used as a fla- are available from the National Acad- voring agent and adjuvant as defined in emy Press, 2101 Constitution Ave. NW., § 170.3(o)(12) of this chapter. Washington, DC 20418, or may be exam- (2) The ingredient is used in food at ined at the Food and Drug Administra- levels not to exceed current good man- tion’s Main Library, 10903 New Hamp- ufacturing practice. shire Ave., Bldg. 2, Third Floor, Silver (d) Prior sanctions for this ingredient Spring, MD 20993, 301–796–2039, or at the different from the uses established in National Archives and Records Admin- this section do not exist or have been istration (NARA). For information on waived. the availability of this material at [48 FR 51613, Nov. 10, 1983, as amended at 73 NARA, call 202–741–6030, or go to: http:// FR 8607, Feb. 14, 2008] www.archives.gov/federallregister/ codeloflfederallregulations/ § 184.1446 Manganese chloride. ibrllocations.html. (a) Manganese chloride (MnCl2, CAS (c) In accordance with § 184.1(b)(1), Reg. No. 7773–01–5) is a pink, trans- the ingredient is used in food with no lucent, crystalline product. It is also limitation other than current good known as manganese dichloride. It is manufacturing practice. prepared by dissolving manganous (d) Prior sanctions for this ingredient oxide, pyrolusite (MnO2), or re- different from the uses established in duced manganese ore in hydrochloric this section do not exist or have been acid. The resulting solution is neutral- waived. ized to precipitate heavy metals, fil- [48 FR 51911, Nov. 15, 1983, as amended at 60 tered, concentrated, and crystallized. FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, (b) The ingredient meets the speci- 1998; 81 FR 5596, Feb. 3, 2016] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, which is incor- § 184.1445 Malt syrup (malt extract). porated by reference. Copies are avail- (a) Malt is the product of barley able from the National Academy Press, (Hordeum vulgare L.) germinated under 2101 Constitution Ave. NW., Wash- controlled conditions. Malt syrup and ington, DC 20418, or available for in- malt extract are interchangeable terms spection at the National Archives and for a viscous concentrate of water ex- Records Administration (NARA). For tract of germinated barley grain, with information on the availability of this or without added safe preservative. material at NARA, call 202–741–6030, or Malt syrup is usually a brown, sweet, go to: http://www.archives.gov/ and viscous liquid containing varying federallregister/

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codeloflfederallregulations/ dairy product analogs as defined in ibrllocations.html. § 170.3(n)(10) of this chapter; fish prod- (c) In accordance with § 184.1(b)(1), ucts as defined in § 170.3(n)(13) of this the ingredient is used in food with no chapter; meat products as defined in limitation other than current good § 170.3(n)(29) of this chapter; milk prod- manufacturing practice. The affirma- ucts as defined in § 170.3(n)(31) of this tion of this ingredient as generally rec- chapter; and poultry products as de- ognized as safe (GRAS) as a direct fined in § 170.3(n)(34) of this chapter. human food ingredient is based upon The ingredient may be used in infant the following current good manufac- formulas in accordance with section turing practice conditions of use: 412(g) of the Federal Food, Drug, and (1) The ingredient is used as a nutri- Cosmetic Act (the act) or with regula- ent supplement as defined in tions promulgated under section § 170.3(o)(20) of this chapter. 412(a)(2) of the act. (2) The ingredient may be used in in- (d) Prior sanctions for this ingredient fant formulas in accordance with sec- different from the uses established in tion 412(g) of the Federal Food, Drug, this section do not exist or have been and Cosmetic Act (the act) or with reg- waived. ulations promulgated under section [50 FR 19166, May 7, 1985, as amended at 73 412(a)(2) of the act. FR 8607, Feb. 14, 2008; 76 FR 59250, Sept. 26, (d) Prior sanctions for this ingredient 2011] different from the uses established in this section do not exist or have been § 184.1452 Manganese gluconate. waived. (a) Manganese gluconate [50 FR 19165, May 7, 1985, as amended at 76 (C12H22MnO14·2H2O, CAS Reg. No. 648– FR 59250, Sept. 26, 2011] 0953–0998) is a slightly pink colored powder. It is obtained by reacting man- § 184.1449 Manganese citrate. ganese carbonate with gluconic acid in (a) Manganese citrate (Mn3(C6H5O7)2, aqueous medium and then crystallizing CAS Reg. No. 10024–66–5) is a pale or- the product. ange or pinkish white powder. It is ob- (b) The ingredient meets the speci- tained by precipitating manganese car- fications of the Food Chemicals Codex, bonate from manganese sulfate and so- 3d Ed. (1981), p. 186, which is incor- dium carbonate solutions. The filtered porated by reference. Copies are avail- and washed precipitate is digested first able from the National Academy Press, with sufficient citric acid solution to 2101 Constitution Ave. NW., Wash- form manganous citrate and then with ington, DC 20418, or available for in- sodium citrate to complete the reac- spection at the National Archives and tion. Records Administration (NARA). For (b) The ingredient must be of a pu- information on the availability of this rity suitable for its intended use. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used as a nutri- current good manufacturing practice: ent supplement as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(o)(20) of this chapter. this chapter; nonalcoholic beverages as (2) The ingredient is used in the fol- defined in § 170.3(n)(3) of this chapter; lowing foods at levels not to exceed

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current good manufacturing practice: human food ingredient is based upon baked goods as defined in § 170.3(n)(1) of the following current good manufac- this chapter; nonalcoholic beverages as turing practice conditions of use: defined in § 170.3(n)(3) of this chapter; (1) The ingredient is used as a nutri- dairy product analogs as defined in ent supplement as defined in § 170.3(n)(10) of this chapter; fish prod- § 170.3(o)(20) of this chapter. ucts as defined in § 170.3(n)(13) of this (2) The ingredient is used in the fol- chapter; meat products as defined in lowing foods at levels not to exceed § 170.3(n)(29) of this chapter; milk prod- current good manufacturing practice: ucts as defined in § 170.3(n)(31) of this baked goods as defined in § 170.3(n)(1) of chapter; and poultry products as de- this chapter; nonalcoholic beverages as fined in § 170.3(n)(34) of this chapter. defined in § 170.3(n)(3) of this chapter; The ingredient may be used in infant dairy product analogs as defined in formulas in accordance with section § 170.3(n)(10) of this chapter; fish prod- 412(g) of the Federal Food, Drug, and ucts as defined in § 170.3(n(13) of this Cosmetic Act (the act) or with regula- chapter; meat products as defined in tions promulgated under section § 170.3(n)(29) of this chapter; milk prod- 412(a)(2) of the act. ucts as defined in § 170.3(n)(31) of this (d) Prior sanctions for this ingredient chapter; and poultry products as de- different from the uses established in fined in § 170.3(n)(34) of this chapter. this section do not exist or have been waived. The ingredient may be used in infant formulas in accordance with section [50 FR 19166, May 7, 1985] 412(g) of the Federal Food, Drug, and § 184.1461 Manganese sulfate. Cosmetic Act (the act) or with regula- tions promulgated under section (a) Manganese sulfate (MnSO ·H O, 4 2 412(a)(2) of the act. CAS Reg. No. 7785–0987–097) is a pale pink, granular, odorless powder. It is (d) Prior sanctions for this ingredient obtained by reacting manganese com- different from the uses established in pounds with sulfuric acid. It is also ob- this section do not exist or have been tained as a byproduct in the manufac- waived. ture of hydroquinone. Other manufac- [50 FR 19166, May 7, 1985] turing processes include the action of sulfur dioxide on a slurry of manganese § 184.1472 Menhaden oil. dioxide in sulfuric acid, and the roast- (a) Menhaden oil. (1) Menhaden oil is ing of pyrolusite (MnO ) ore with solid 2 prepared from fish of the genus ferrous sulfate and coal, followed by Brevoortia, commonly known as menha- leaching and crystallization. (b) The ingredient meets the speci- den, by cooking and pressing. The re- fications of the Food Chemicals Codex, sulting crude oil is then refined using 3d Ed. (1981), p. 188, which is incor- the following steps: Storage (winteriza- porated by reference. Copies are avail- tion), degumming (optional), neutral- able from the National Academy Press, ization, bleaching, and deodorization. 2101 Constitution Ave. NW., Wash- Winterization may separate the oil and ington, DC 20418, or available for in- produce a solid fraction. spection at the National Archives and (2) Menhaden oil meets the following Records Administration (NARA). For specifications: information on the availability of this (i) Color and state. Yellow liquid to material at NARA, call 202–741–6030, or white solid. go to: http://www.archives.gov/ (ii) Odor. Odorless to slightly fishy. federallregister/ (iii) Saponification value. Between 180 codeloflfederallregulations/ and 200 as determined by the American ibrllocations.html. Oil Chemists’ Society Official Method (c) In accordance with § 184.1(b)(1), Cd 3–25—‘‘Saponification Value’’ (re- the ingredient is used in food with no approved 1989), which is incorporated limitation other than current good by reference in accordance with 5 manufacturing practice. The affirma- U.S.C. 552(a) and 1 CFR part 51. Copies tion of this ingredient as generally rec- of this publication are available from ognized as safe (GRAS) as a direct the Office of Food Additive Safety,

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Center for Food Safety and Applied Nu- by reference is given in paragraph trition (HFS–200), Food and Drug Ad- (a)(2)(iii) of this section. ministration, 5001 Campus Dr., College (viii) Lead. Not more than 0.1 part Park, MD 20740, or available for inspec- per million as determined by the Amer- tion at the Food and Drug Administra- ican Oil Chemists’ Society Official tion’s Main Library, 10903 New Hamp- Method Ca 18c–91—‘‘Determination of shire Ave., Bldg. 2, Third Floor, Silver Lead by Direct Graphite Furnace Spring, MD 20993, 301–796–2039, or at the Atomic Absorption Spectrometry’’ (re- National Archives and Records Admin- vised 1992), which is incorporated by istration (NARA). For information on reference in accordance with 5 U.S.C. the availability of this material at 552(a) and 1 CFR part 51. The avail- NARA, call 202–741–6030, or go to: http:// ability of this incorporation by ref- www.archives.gov/federallregister/ erence is given in paragraph (a)(2)(iii) codeloflfederallregulations/ of this section. ibrllocations.html. (ix) Mercury. Not more than 0.5 part (iv) Iodine number. Not less than 120 per million as determined by the meth- as determined by the American Oil od entitled ‘‘Biomedical Test Materials Chemists’ Society Recommended Prac- Program: Analytical Methods for the tice Cd 1d–92—‘‘Iodine Value of Fats Quality Assurance of Fish Oil,’’ pub- and Oils, Cyclohexane—Acetic Acid lished in the ‘‘NOAA Technical Memo- Method,’’ which is incorporated by ref- randum NMFS-SEFC-211,’’ F. M. Van erence in accordance with 5 U.S.C. Dolah and S. B. Galloway, editors, Na- 552(a) and 1 CFR part 51. The avail- tional Marine Fisheries Service, U. S. ability of this incorporation by ref- Department of Commerce, pages 71–88, erence is given in paragraph (a)(2)(iii) November, 1988, which is incorporated of this section. by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The (v) Unsaponifiable matter. Not more availability of this incorporation by than 1.5 percent as determined by the reference is given in paragraph American Oil Chemists’ Society Offi- (a)(2)(iii) of this section. cial Method Ca 6b–53—‘‘Unsaponifiable (3) In accordance with § 184.1(b)(2), Matter’’ (reapproved 1989), which is in- the ingredient may be used in food only corporated by reference in accordance within the following specific limita- with 5 U.S.C. 552(a) and 1 CFR part 51. tions to ensure that total intake of The availability of this incorporation eicosapentaenoic acid or by reference is given in paragraph docosahexaenoic acid does not exceed (a)(2)(iii) of this section. 3.0 grams/person/day: (vi) Free fatty acids. Not more than 0.1 percent as determined by the American Maximum level of use in Oil Chemists’ Society Official Method Category of food food (as Ca 5a–40—‘‘Free Fatty Acids’’ (re- served) approved 1989), which is incorporated Baked goods, baking mixes, § 170.3(n)(1) of 5.0 percent by reference in accordance with 5 this chapter. U.S.C. 552(a) and 1 CFR part 51. The Cereals, § 170.3(n)(4) of this chapter ...... 4.0 percent Cheese products, § 170.3(n)(5) of this chap- 5.0 percent availability of this incorporation by ter. reference is given in paragraph Chewing gum, § 170.3(n)(6) of this chapter .. 3.0 percent (a)(2)(iii) of this section. Condiments, § 170.3(n)(8) of this chapter ..... 5.0 percent Confections, frostings, § 170.3(n)(9) of this 5.0 percent (vii) Peroxide value. Not more than 5 chapter. milliequivalents per kilogram of oil as Dairy product analogs, § 170.3(n)(10) of this 5.0 percent determined by the American Oil Chem- chapter. Egg products, § 170.3(n)(11) of this chapter 5.0 percent ists’ Society Official Method Cd 8–53— Fats, oils, § 170.3(n)(12) of this chapter, but 12.0 percent ‘‘Peroxide Value, Acetic Acid—Chloro- not in infant formula. form Method’’ (updated 1992) or Rec- Fish products, § 170.3(n)(13) of this chapter 5.0 percent ommended Practice Cd 8b–90—‘‘Per- Frozen dairy desserts, § 170.3(n)(20) of this 5.0 percent chapter. oxide Value, Acetic Acid—Isooctane Gelatins, puddings, § 170.3(n)(22) of this 1.0 percent Method’’ (updated 1992), which are in- chapter. corporated by reference in accordance Gravies, sauces, § 170.3(n)(24) of this chap- 5.0 percent ter. with 5 U.S.C. 552(a) and 1 CFR part 51. Hard candy, § 170.3(n)(25) of this chapter .... 10.0 percent The availability of this incorporation Jams, jellies, § 170.3(n)(28) of this chapter .. 7.0 percent

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Maximum (ix) Mercury. Not more than 0.5 part level of use in Category of food food (as per million. served) (x) Arsenic (as As). Not more than 0.1

Meat products, § 170.3(n)(29) of this chapter 5.0 percent part per million. Milk products, § 170.3(n)(31) of this chapter 5.0 percent (xi) Lead. Not more than 0.1 part per Nonalcoholic beverages, § 170.3(n)(3) of this 0.5 percent million. chapter. Nut products, § 170.3(n)(32) of this chapter .. 5.0 percent (3) Partially hydrogenated and hy- Pastas, § 170.3(n)(23) of this chapter ...... 2.0 percent drogenated menhaden oils are used as Plant protein products, § 170.3(n)(33) of this 5.0 percent edible fats or oils, as defined in chapter. Poultry products, § 170.3(n)(34) of this chap- 3.0 percent § 170.3(n)(12) of this chapter, in food at ter. levels not to exceed current good man- Processed fruit juices, § 170.3(n)(35) of this 1.0 percent chapter. ufacturing practice. Processed vegetable juices, § 170.3(n)(36) 1.0 percent (4) If the fat or oil is fully hydro- of this chapter. genated, the name to be used on the Snack foods, § 170.3(n)(37) of this chapter .. 5.0 percent Soft candy, § 170.3(n)(38) of this chapter ..... 4.0 percent label of a product containing it shall Soup mixes, § 170.3(n)(40) of this chapter ... 3.0 percent include the term ‘‘hydrogenated,’’ or if Sugar substitutes, § 170.3(n)(42) of this 10.0 percent it is partially hydrogenated, the name chapter. Sweet sauces, toppings, syrups, 5.0 percent shall include the term ‘‘partially hy- § 170.3(n)(43) of this chapter. drogenated,’’ in accordance with White granulated sugar, § 170.3(n)(41) of 4.0 percent this chapter. § 101.4(b)(14) of this chapter. [62 FR 30756, June 5, 1997, as amended at 70 (4) To ensure safe use of the sub- FR 14531, Mar. 23, 2005; 81 FR 5596, Feb. 3, stance, menhaden oil shall not be used 2016] in combination with any other added oil that is a significant source of § 184.1490 Methylparaben. eicosapentaenoic acid or (a) Methylparaben is the chemical docosahexaenoic acid. (b) Hydrogenated and partially hydro- methyl p-hydroxybenzoate. It is pro- genated menhaden oils. (1) Partially hy- duced by the methanol esterification of drogenated and hydrogenated menha- p-hydroxybenzoic acid in the presence den oils are prepared by feeding hydro- of sulfuric acid, with subsequent dis- gen gas under pressure to a converter tillation. containing crude menhaden oil and a (b) The ingredient meets the speci- nickel catalyst. The reaction is begun fications of the ‘‘Food Chemicals at 150 to 160 °C and after 1 hour the Codex,’’ 3d Ed. (1981), p. 199, which is in- temperature is raised to 180 °C until corporated by reference. Copies may be the desired degree of hydrogenation is obtained from the National Academy reached. Hydrogenated menhaden oil is Press, 2101 Constitution Ave. NW., fully hydrogenated. Washington, DC 20418, or may be exam- (2) Partially hydrogenated and hy- ined at the National Archives and drogenated menhaden oils meet the fol- Records Administration (NARA). For lowing specifications: information on the availability of this (i) Color. Opaque white solid. material at NARA, call 202–741–6030, or (ii) Odor. Odorless. go to: http://www.archives.gov/ (iii) Saponification value. Between 180 federallregister/ and 200. codeloflfederallregulations/ (iv) Iodine number. Not more than 119 ibrllocations.html. for partially hydrogenated menhaden (c) The ingredient is used as an anti- oil and not more than 10 for fully hy- drogenated menhaden oil. microbial agent as defined in (v) Unsaponifiable matter. Not more § 170.3(o)(2) of this chapter. than 1.5 percent.— (d) The ingredient is used in food at (vi) Free fatty acids. Not more than 0.1 levels not to exceed good manufac- percent. turing practices. Current good manu- (vii) Peroxide value. Not more than 5 facturing practice results in a max- milliequivalents per kilogram of oil. imum level of 0.1 percent in food. (viii) Nickel. Not more than 0.5 part (e) Prior sanctions for this ingredient per million. different from the uses established in

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this regulation do not exist or have § 184.1505 Mono- and diglycerides. been waived. (a) Mono- and diglycerides consist of [42 FR 14653, Mar. 15, 1977, as amended at 49 a mixture of glyceryl mono- and FR 5612, Feb. 14, 1984] diesters, and minor amounts of triesters, that are prepared from fats § 184.1498 Microparticulated protein or oils or fat-forming acids that are de- product. rived from edible sources. The most (a) Microparticulated protein product prevalent fatty acids include lauric, is prepared from egg whites or milk linoleic, myristic, oleic, palmitic, and protein or a combination of egg whites stearic. Mono- and diglycerides are and milk protein. These protein manufactured by the reaction of glyc- sources may be used alone or in com- erin with fatty acids or the reaction of bination with other safe and suitable glycerin with triglycerides in the pres- ingredients to form the ence of an alkaline catalyst. The prod- microparticulated product. The mix- ucts are further purified to obtain a ture of ingredients is high-shear heat mixture of glycerides, free fatty acids, processed to achieve a smooth and and free glycerin that contains at least creamy texture similar to that of fat. 90 percent-by-weight glycerides. Safe and suitable ingredients used in (b) The ingredient meets the speci- the preparation of the fications of the Food Chemicals Codex, microparticulated protein product 3d Ed. (1981), p. 201, which is incor- must be used in compliance with the porated by reference in accordance limitations of the appropriate regula- with 5 U.S.C. 552(a). Copies are avail- tions in parts 172, 182, and 184 of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (b) The ingredient is used in food in ington, DC 20418, or available for in- accordance with § 184.1(b)(2) at levels spection at the National Archives and not to exceed current good manufac- Records Administration (NARA). For turing practice. The affirmation of the information on the availability of this use of this ingredient as generally rec- material at NARA, call 202–741–6030, or ognized as safe (GRAS) as a direct go to: http://www.archives.gov/ human food ingredient is based upon federallregister/ the following conditions of use: codeloflfederallregulations/ (1) The ingredient is used in food as a ibrllocations.html. (c) In accordance with § 184.1(b)(1), thickener as defined in § 170.3(o)(28) of the ingredient is used in food with no this chapter or as a texturizer as de- limitation other than current good fined in § 170.3(o)(32) of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in frozen tion of this ingredient as generally rec- dessert-type products except that the ognized as safe (GRAS) as a direct ingredient may not be used to replace human food ingredient is based upon the milk fat required in standardized the following current good manufac- frozen desserts. turing practice conditions of use: (3) The name of the ingredient used (1) The ingredient is used in food as a in the ingredient statement on both dough strengthener as defined in bulk and packaged food must include § 170.3(o)(6) of this chapter; an emulsi- the source of the protein (e.g., fier and emulsifier salt as defined in ‘‘microparticulated egg white pro- § 170.3(o)(8) of this chapter; a flavoring tein’’), followed by a parenthetical list- agent and adjuvant as defined in ing of each of the ingredients in the § 170.3(o)(12) of this chapter; a formula- microparticulated protein product, in tion aid as defined in § 170.3(o)(14) of descending order of predominance. this chapter; a lubricant and release Microparticulated protein product agent as defined in § 170.3(o)(18) of this must be used in accordance with this chapter; a solvent and vehicle as de- requirement or its addition to food will fined in § 170.3(o)(27) of this chapter; a be considered by FDA to constitute the stabilizer and thickener as defined in use of an unapproved food additive (see § 170.3(o)(28) of this chapter; a surface- § 184.1(b)(2)). active agent as defined in § 170.3(o)(29) [55 FR 6391, Feb. 23, 1990] of this chapter; a surface-finishing

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agent as defined in § 170.3(o)(30) of this pyridinecarboxylic acid (nicotinic chapter; and a texturizer as defined in acid). It is a non-hygroscopic, stable, § 170.3(o)(32) of this chapter. white, crystalline solid that sublimes (2) The ingredient is used in food at without decomposition at about 230 °C. levels not to exceed current good man- It is soluble in water and alcohol. It is ufacturing practice. insoluble in ether. (d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the ‘‘Food Chemicals this section do not exist or have been Codex,’’ 4th ed. (1996), p. 264, which is waived. incorporated by reference in accord- ance with 5 U.S.C. 552(a) and 1 CFR [54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar. 27, 1992] part 51. Copies are available from the National Academy Press, Box 285, 2101 § 184.1521 Monosodium phosphate de- Constitution Ave. NW., Washington, rivatives of mono- and diglycerides. DC 20055 (Internet address http:// (a) Monosodium phophate derivatives www.nap.edu), or may be examined at of mono- and diglycerides are com- the Food and Drug Administration’s posed of glyceride derivatives formed Main Library, 10903 New Hampshire by reacting mono- and diglycerides Ave., Bldg. 2, Third Floor, Silver that are derived from edible sources Spring, MD 20993, 301–796–2039, or at the with phosphorus pentoxide National Archives and Records Admin- (tetraphosphorus decoxide) followed by istration (NARA). For information on neutralization with sodium carbonate. the availability of this material at (b) The ingredient must be of a pu- NARA, call 202–741–6030, or go to: http:// rity suitable for its intended use. www.archives.gov/federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used in food as the following current good manufac- an emulsifier and emulsifier salt as de- turing practice conditions of use: fined in § 170.3(o)(8) of this chapter, a (1) The ingredient is used as a nutri- lubricant and release agent as defined ent supplement as defined in in § 170.3(o)(18) of this chapter, and as a § 170.3(o)(20) of this chapter. surface-active agent as defined in (2) The ingredient is used in foods at § 170.3(o)(29) of this chapter. levels not to exceed current good man- (2) The ingredient is used in the fol- ufacturing practice. The ingredient lowing foods at levels not to exceed may also be used in infant formula in current good manufacturing practice: accordance with section 412(g) of the dairy product analogs as defined in Federal Food, Drug, and Cosmetic Act § 170.3(n)(10) of this chapter and soft (the Act) or with regulations promul- candy as defined in § 170.3(n)(38) of this gated under section 412(a)(2) of the Act. chapter. (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. [54 FR 7404, Feb. 21, 1989, as amended at 73 2, 1983, as amended at 64 FR 1760, Jan. 12, FR 8607, Feb. 14, 2008] 1999; 81 FR 5596, Feb. 3, 2016]

§ 184.1530 Niacin. § 184.1535 Niacinamide.

(a) Niacin (C6H5NO2, CAS Reg. No. 59– (a) Niacinamide (C6H6N2O, CAS Reg. 67–6) is the chemical 3- No. 98–92–0) is the chemical 3-

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pyridinecarboxylic acid amide (nicotin- limitation other than current good amide). It is a white crystalline powder manufacturing practice. The affirma- that is soluble in water, alcohol, ether, tion of this ingredient as generally rec- and glycerol. It melts between 128° and ognized as safe (GRAS) as a direct 131 °C. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 205, which is incor- (1) The ingredient is used as a cata- porated by reference. Copies are avail- lyst as defined in § 170.3(o)(24) of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (2) The ingredient is used in the hy- ington, DC 20418, or available for in- drogenation of fats and oils as defined spection at the National Archives and in § 170.3(n)(12) of this chapter at levels Records Administration (NARA). For not to exceed current good manufac- information on the availability of this turing practice. Current good manufac- material at NARA, call 202–741–6030, or turing practice includes the removal of go to: http://www.archives.gov/ nickel from fats and oils following hy- federallregister/ drogenation. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. The affirma- [48 FR 51618, Nov. 10, 1983, as amended at 73 tion of this ingredient as generally rec- FR 8607, Feb. 14, 2008] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1538 Nisin preparation. the following current good manufac- (a) Nisin preparation is derived from turing practice conditions of use: pure culture fermentations of certain (1) The ingredient is used as a nutri- strains of Streptococcus lactis ent supplement as defined in Lancefield Group N. Nisin preparation § 170.3(o)(20) of this chapter. contains nisin (CAS Reg. No. 1414–45–5), (2) The ingredient is used in foods at a group of related peptides with anti- levels not to exceed current good man- biotic activity. ufacturing practice. The ingredient (b) The ingredient is a concentrate or may also be used in infant formula in dry material that meets the specifica- accordance with section 412(g) of the tions that follow when it is tested as Federal Food, Drug, and Cosmetic Act described in ‘‘Specifications for Iden- (the act) or with regulations promul- tity and Purity of Some Antibiotics,’’ gated under section 412(a)(2) of the Act. World Health Organization, FAO Nutri- (d) Prior sanctions for this ingredient tion Meeting Report Series, No. 45A, different from the uses established in 1969, which is incorporated by ref- this section do not exist or have been erence. Copies are available from the waived. Division of Dockets Management [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. (HFA–305), Food and Drug Administra- 2, 1983] tion, 5630 Fishers Lane, rm. 1061, Rock- ville, MD 20852, or available for inspec- § 184.1537 Nickel. tion at the National Archives and (a) Elemental nickel (CAS Reg. No. Records Administration (NARA). For 7440–02–0) is obtained from nickel ore information on the availability of this by transforming it to nickel sulfide material at NARA, call 202–741–6030, or (Ni3S2). The sulfide is roasted in air to go to: http://www.archives.gov/ give nickel oxide (NiO). The oxide is federallregister/ then reduced with carbon to give ele- codeloflfederallregulations/ mental nickel. ibrllocations.html. (b) The ingredient must be of a pu- (1) Nisin content, not less than 900 rity suitable for its intended use. international units per milligram. (c) In accordance with § 184.1(b)(1), (2) Arsenic, not more than 1 part per the ingredient is used in food with no million.

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(3) Lead, not more than 2 parts per odorless, flavorless gas that is pro- million. duced commercially by the fraction- (4) Zinc, not more than 25 parts per ation of liquid air. million. (b) The ingredient must be of a pu- (5) Copper, zinc plus copper not more rity suitable for its intended use. than 50 parts per million. (c) In accordance with § 184.1(b)(1), (6) Total plate count, not more than the ingredient is used in food with no 10 per gram. limitations other than current good (7) Escherichia coli, absent in 10 manufacturing practice. The affirma- grams. tion of this ingredient as generally rec- (8) Salmonella, absent in 10 grams. ognized as safe (GRAS) as a direct (9) Coagulase positive staphylococci, human food ingredient is based upon absent in 10 grams. the following current good manufac- (c) The ingredient is used as an anti- turing practice conditions of use: microbial agent as defined in (1) The ingredient is used as a propel- § 170.3(o)(2) of this chapter to inhibit lant, aerating agent, and gas as defined the outgrowth of Clostridium botulinum in § 170.3(o)(25) of this chapter. spores and toxin formation in pasteur- (2) The ingredient is used in food at ized cheese spreads and pasteurized levels not to exceed current good man- process cheese spreads listed in ufacturing practice. § 133.175; pasteurized cheese spread with (d) Prior sanctions for this ingredient fruits, vegetables, or meats as defined different from the uses established in in § 133.176; pasteurized process cheese this section do not exist or have been spread as defined in § 133.179; pasteur- waived. ized process cheese spread with fruits, [48 FR 57270, Dec. 29, 1983, as amended at 73 vegetables, or meats as defined in FR 8607, Feb. 14, 2008] § 133.180 of this chapter. (d) The ingredient is used at levels § 184.1545 Nitrous oxide. not to exceed good manufacturing (a) Nitrous oxide (empirical formula practice in accordance with § 184.1(b)(1) N2O, CAS Reg. No. 10024–97–2) is also of this chapter. The current good man- known as dinitrogen monoxide or ufacturing practice level is the quan- laughing gas. It is a colorless gas, tity of the ingredient that delivers a about 50 percent heavier than air, with maximum of 250 parts per million of a slightly sweet smell. It does not burn nisin in the finished product as deter- but will support combustion. Nitrous mined by the British Standards Insti- oxide is manufactured by the thermal tution Methods, ‘‘Methods for the Esti- decomposition of ammonium nitrate. mation and Differentiation of Nisin in Higher oxides of nitrogen are removed Processed Cheese,’’ BS 4020 (1974), by passing the dry gas through a series which is incorporated by reference. of scrubbing towers. Copies are available from the Division (b) The ingredient must be of a pu- of Dockets Management (HFA–305), rity suitable for its intended use. Food and Drug Administration, rm. 1– (c) In accordance with § 184.1(b)(1), 23, 12420 Parklawn Dr., Rockville, MD the ingredient is used in food with no 20857, or available for inspection at the limitations other than current good National Archives and Records Admin- manufacturing practice. The affirma- istration (NARA). For information on tion of this ingredient as generally rec- the availability of this material at ognized as safe (GRAS) as a direct NARA, call 202–741–6030, or go to: http:// human food ingredient is based upon www.archives.gov/federallregister/ the following current good manufac- codeloflfederallregulations/ turing practice conditions of use: ibrllocations.html. (1) The ingredient is used as a propel- [53 FR 11250, Apr. 6, 1988, as amended at 59 lant, aerating agent, and gas as defined FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, in § 170.3(o)(25) of this chapter. 2003] (2) The ingredient is used in dairy product analogs as defined in § 184.1540 Nitrogen. § 170.3(n)(10) of this chapter at levels (a) Nitrogen (empirical formula N2, not to exceed current good manufac- CAS Reg. No. 7727–37–9) is a colorless, turing practice.

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(d) Prior sanctions for this ingredient which result from the full hydro- different from the uses established in genation of fatty acids occurring in this section do not exist or have been natural rapeseed oil. The rapeseed oil waived. is obtained from the napus and campestris varieties of Brassica of the [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] family Cruciferae. It is prepared by fully hydrogenating refined and § 184.1553 Peptones. bleached rapeseed oil at 310–375 °F, using a catalyst such as nickel, until (a) Peptones are a variable mixture the iodine number is 4 or less. of polypeptides, oligopeptides, and (2) The ingredient meets the fol- amino acids that are produced by par- lowing specifications: Acid value not tial hydrolysis of casein, animal tissue, more than 6, arsenic not more than 3 soy protein isolate, gelatin, defatted parts per million, free glycerin not fatty tissue, egg albumin, or lactal- more than 7 percent, heavy metals (as bumin (whey protein). Peptones are Pb) not more than 10 parts per million, produced from these proteins using iodine number not more than 4, residue proteolytic enzymes that either are on ignition not more than 0.5 percent. considered to be generally recognized (3) The ingredient is used as a sta- as safe (GRAS) or are regulated as food bilizer and thickener as defined in additives. Peptones are also produced § 170.3(o)(28) of this chapter in peanut by denaturing any of the proteins list- butter. The use level of the ingredient ed in this paragraph with safe and suit- is limited by good manufacturing prac- able acids or heat. tice (GMP) to the minimum amount re- (b) The ingredients must be of a pu- quired to produce the intended effect. rity suitable for their intended use. Current good manufacturing practices (c) In accordance with § 184.1(b)(1), result in a maximum level of 2 percent these ingredients are used in food with in peanut butter. no limitation other than current good (b) Superglycerinated fully hydro- manufacturing practice. The affirma- genated rapeseed oil. (1) tion of these ingredients as GRAS as Superglycerinated fully hydrogenated direct human food ingredients is based rapeseed oil is a mixture of mono- and upon the following current good manu- diglycerides with triglycerides as a facturing practice conditions of use: minor component. The fatty acid com- (1) These ingredients are used as nu- position is a mixture of saturated fatty trient supplements as defined in acids present in the same proportions § 170.3(o)(20) of this chapter; as proc- as those resulting from the full hydro- essing aids as defined in § 170.3(o)(24) of genation of fatty acids in natural this chapter; and as surface-active rapeseed oil. It is made by adding ex- agents as defined in § 170.3(o)(29) of this cess glycerol to the fully hydrogenated chapter. rapeseed oil and heating, in the pres- (2) These ingredients are used in food ence of a sodium hydroxide catalyst, to at levels not to exceed current good 330 °F under partial vacuum and steam manufacturing practice. sparging agitation. (d) Prior sanctions for these ingredi- (2) The ingredient meets the speci- ents different from the uses established fications of the ‘‘Food Chemicals in this section do not exist or have Codex,’’ 3d Ed. (1981), p. 201, relating to been waived. mono- and diglycerides, which is incor- [49 FR 25430, June 21, 1984, as amended at 50 porated by reference. Copies may be FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, obtained from the National Academy 2008] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1555 Rapeseed oil. ined at the National Archives and (a) Fully hydrogenated rapeseed oil. (1) Records Administration (NARA). For Fully hydrogenated rapeseed oil is a information on the availability of this mixture of triglycerides in which the material at NARA, call 202–741–6030, or fatty acid composition is a mixture of go to: http://www.archives.gov/ saturated fatty acids. The fatty acids federallregister/ are present in the same porportions codeloflfederallregulations/

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ibrllocations.html. An additional speci- § 184.1560 Ox bile extract. fication requires the iodine number to (a) Ox bile extract (CAS Reg. No. be 4 or less. 8008–63–7), also known as purified (3) The ingredient is used as an emul- oxgall or sodium choleate, is a yel- sifier as defined in § 170.3(o)(8) of this lowish green, soft solid, with a partly chapter in shortenings for cake mixes. sweet, partly bitter, disagreeable taste. The use level of the ingredient is lim- It is the purified portion of the bile of ited by good manufacturing practice an ox obtained by evaporating the alco- (GMP) to the minimum amount re- hol extract of concentrated bile. quired to produce the intended effect. (b) Food-grade ox bile extract shall Current good manufacturing practices meet the specifications of the U.S. result in a maximum level, as served, Pharmacopeia (USP), XIV, 1950, p. 410. 1 of 4 percent of the shortening or 0.5 (c) The ingredient is used as a surfac- percent of the total weight of the cake tant as defined in § 170.3 (o)(29) of this mix. chapter. (c) Low erucic acid rapeseed oil. (1) (d) The ingredient is used in food in Low erucic acid rapeseed oil, also accordance with § 184.1(b)(1) at levels known as canola oil, is the fully re- not to exceed good manufacturing fined, bleached, and deodorized edible practice. Current good manufacturing oil obtained from certain varieties of practice results in a maximum level, as Brassica Napus or B. Campestris of the served, of 0.002 percent for cheese as de- family Cruciferae. The plant varieties fined in § 170.3(n)(5) of this chapter. are those producing oil-bearing seeds (e) Prior sanctions for this ingredient with a low erucic acid content. Chemi- different from the uses established in cally, low erucic acid rapeseed oil is a this section do not exist or have been mixture of triglycerides, composed of waived. both saturated and unsaturated fatty acids, with an erucic acid content of no [43 FR 36064, Aug. 15, 1978. Redesignated and more than 2 percent of the component amended at 50 FR 49537, Dec. 3, 1985] fatty acids. (2) Low erucic acid rapeseed oil as de- § 184.1563 Ozone.

fined in paragraph (c)(1) of this section (a) Ozone (O3, CAS Reg. No. 10028–15– may be partially hydrogenated to re- 6) is an unstable blue gas with a pun- duce the proportion of unsaturated gent, characteristic odor, which occurs fatty acids. When the partially hydro- freely in nature, It is produced com- genated low erucic acid rapeseed oil is mercially by passing electrical dis- used, it shall be referred to as partially charges or ionizing radiation through hydrogenated low erucic acid rapeseed air or oxygen. oil. (b) The ingredient must be of a pu- (3) In addition to limiting the con- rity suitable for its intended use in ac- tent of erucic acid to a level not ex- cordance with § 170.30(h)(1) of this chap- ceeding 2 percent of the component ter. fatty acids, low erucic acid rapeseed oil (c) In accordance with § 184.1(b)(2), and partially hydrogenated low erucic the ingredient is used to treat food acid rapeseed oil must be of a purity only within the following specific limi- suitable for their intended use. tations: (4) Low erucic acid rapeseed oil and partially hydrogenated low erucic acid rapeseed oil are used as edible fats and oils in food, except in infant formula, at levels not to exceed current good manufacturing practice. [42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, 1 Copies may be obtained from: U.S. 1985; 53 FR 52682, Dec. 29, 1988; 73 FR 8608, Pharmacopeial Convention, Inc., 12601 Feb. 14, 2008] Twinbrook Parkway, Rockville, MD 20852.

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(2) The ingredient is used in food at Category of food Maximum treat- Functional use ment level in food levels not to exceed current good man- Bottled water that Not to exceed cur- Antimicrobial ufacturing practice. prior to ozonation rent good man- agent, § 170.3 meets the micro- ufacturing prac- (o)(2) of this [60 FR 32911, June 26, 1995, as amended at 78 biological, phys- tice. Current chapter. FR 14666, Mar. 7, 2013] ical, chemical, good manufac- and radiological turing practice § 184.1585 Papain. quality standards results in a of § 165.110 maximum resid- (a) Papain (CAS Reg. No. 9001–73–4) is (b)(2) through ual level at the a proteolytic enzyme derived from (b)(5) of this time of bottling chapter. of 0.4 milligram Carica papaya L. Crude latex con- of ozone per taining the enzyme is collected from liter of bottled slashed unripe papaya. The food-grade water. product is obtained by repeated filtra- tion of the crude latex or an aqueous [47 FR 50210, Nov. 5, 1982, as amended at 60 solution of latex or by precipitation FR 57130, Nov. 13, 1995] from an aqueous solution of latex. The § 184.1583 Pancreatin. resulting enzyme preparation may be used in a liquid or dry form. (a) Pancreatin (CAS Reg. No. 8049–47– (b) The ingredient meets the speci- 6) is an enzyme preparation obtained fications of the Food Chemicals Codex, from porcine or bovine pancreatic tis- 3d Ed. (1981), pp. 107–110, which is incor- sue. It is a white to tan powder. Its porated by reference. Copies are avail- characterizing enzyme activity that of a peptide hydrolase (EC 3.4.21.36). able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the general requirements and additional require- ington, DC 20418, or available for in- ments in the Food Chemicals Codex, 3d spection at the National Archives and ed. (1981), p. 110, which is incorporated Records Administration (NARA). For by reference in accordance with 5 information on the availability of this U.S.C. 552(a) and 1 CFR part 51. Copies material at NARA, call 202–741–6030, or are available from the National Acad- go to: http://www.archives.gov/ emy Press, 2101 Constitution Ave. NW., federallregister/ Washington, DC 20418, or may be exam- codeloflfederallregulations/ ined at the Office of Food Additive ibrllocations.html. Safety (HFS–200), Center for Food Safe- (c) In accordance with § 184.1(b)(1), ty and Applied Nutrition, Food and the ingredient is used in food with no Drug Administration, 5001 Campus Dr., limitation other than currect good College Park, MD 20740, 240–402–1200, manufacturing practice. The affirma- and at the National Archives and tion of this ingredient as generally rec- Records Administration (NARA). For ognized as safe (GRAS) as a direct information on the availability of this human food ingredient is based upon material at NARA, call 202–741–6030, or the following current good manufac- go to: http://www.archives.gov/ turing conditions of use: federallregister/ (1) The ingredient is used as an en- codeloflfederallregulations/ zyme as defined in § 170.3(o)(9) of this ibrllocations.html. chapter; processing aid as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(24) of this chapter; and the ingredient is used in food with no texturizer as defined in § 170.3(o)(32) of limitation other than current good this chapter. manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as GRAS as a di- levels not to exceed current good man- rect food ingredient is based upon the ufacturing practice. following current good manufacturing (d) Prior sanctions for this ingredient practice conditions of use: different from the uses established in (1) The ingredient is used as an en- this section do not exist or have been zyme as defined in § 170.3(o)(9) of this waived. chapter to hydrolyze proteins or polypeptides. [48 FR 48806, Oct. 21, 1983]

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§ 184.1588 Pectins. (d) Prior sanctions for these ingredi- (a) The pectins (CAS Reg. No. 9000– ents different from the uses established 69–5) are a group of complex, high mo- in this section do not exist or have lecular weight polysaccharides found been waived. in plants and composed chiefly of par- [48 FR 51149, Nov. 7, 1983] tially methylated polygalacturonic acid units. Portions of the carboxly § 184.1595 Pepsin. group occur as methyl esters, and the remaining carboxyl groups exist in the (a) Pepsin (CAS Reg. No. 9001–75–6) is form of the free acid or as its ammo- an enzyme preparation obtained from nium, potassium, or sodium (CAS Reg. the glandular layer of hog stomach. It No. 9000–59–8) salts, and in some types is a white to light tan powder, amber as the acid amide. Thus, the pectins paste, or clear amber to brown liquid. regulated in this section are the high- Its characterizing enzyme activity is ester pectins, low-ester pectins, that of a peptide hydrolase (EC amidated pectins, pectinic acids, and 3.4.23.1). pectinates. Pectin is produced commer- (b) The ingredient meets the general cially by extracting citrus peel, apple requirements and additional require- pomace, or beet pulp with hot dilute ments for enzyme preparations in the acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- Food Chemicals Codex, 3d ed. (1981), p. tract is filtered, and pectin is then pre- 110, which is incorporated by reference cipitated from the clear extract with in accordance with 5 U.S.C. 552(a) and 1 ethanol or isopropanol, or as the cop- CFR part 51. Copies are available from per or aluminum salt. The acid extract the National Academy Press, 2101 Con- is sometimes spray- or roller-dried, or it is concentrated to be sold as liquid stitution Ave. NW., Washington, DC pectin. 20418, or may be examined at the Office (b) The ingredients meet the speci- of Food Additive Safety (HFS–200), fications of the Food Chemical Codex, Center for Food Safety and Applied Nu- 3d Ed. (1981), p. 215, which is incor- trition, Food and Drug Administration, porated by reference. Copies are avail- 5001 Campus Dr., College Park, MD able from the National Academy Press, 20740, 240–402–1200, and at the National 2101 Constitution Ave. NW., Wash- Archives and Records Administration ington, DC 20418, or available for in- (NARA). For information on the avail- spection at the National Archives and ability of this material at NARA, call Records Administration (NARA). For 202–741–6030, or go to: http:// information on the availability of this www.archives.gov/federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredients are used in food with tion of this ingredient as GRAS as a di- no limitation other than current good rect food ingredient is based upon the manufacturing practice. The affirma- tion of these ingredients as generally following current good manufacturing recognized as safe (GRAS) as direct practice conditions of use: human food ingredients is based upon (1) The ingredient is used as an en- the following current good manufac- zyme as defined in § 170.3(o)(9) of this turing practice conditions of use: chapter to hydrolyze proteins or (1) The ingredients are used as emul- polypeptides. sifiers as defined in § 170.3(o)(8) of this (2) The ingredient is used in food at chapter and as stabilizers and thick- levels not to exceed current good man- eners as defined in § 170.3(o)(28) of this ufacturing practice. chapter. (2) The ingredients are used in food [60 FR 32911, June 26, 1995, as amended at 78 at levels not to exceed current good FR 14667, Mar. 7, 2013] manufacturing practice.

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§ 184.1610 Potassium alginate. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, (a) Potassium alginate (CAS Reg. No. 3d Ed. (1981), p. 239, which is incor- 9005–36–1) is the potassium salt of al- porated by reference. Copies are avail- ginic acid, a natural polyuronide con- able from the National Academy Press, stituent of certain brown algae. Potas- 2101 Constitution Ave. NW., Wash- sium alginate is prepared by the neu- ington, DC 20418, or available for in- tralization of purified alginic acid with spection at the National Archives and appropriate pH control agents. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 239, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(2), (1) The ingredient is used as a formu- the ingredient is used in food only lation aid as defined in § 170.3(o)(14) of within the following specific limita- this chapter; nutrient supplemlent as tions: defined in § 170.3(o)(20) of this chapter; Maximum pH control agent as defined in level of § 170.3(o)(23) of this chapter; and proc- use in Category of food food (as Functional use essing aid as defined in § 170.3(o)(24) of served) this chapter. (percent) (2) The ingredient is used in food at Confections and 0.1 Stabilizer, thickener, levels not to exceed current good man- frostings, § 170.3(o)(28) of this ufacturing practice. § 170.3(n)(9) of this chapter chapter. (d) Prior sanctions for this ingredient Gelatins and puddings, 0.7 Do. different from the uses established in § 170.3(n)(22) of this this section do not exist or have been chapter. Processed fruits and 0.25 Do. waived. fruit juices, [48 FR 52442, Nov. 18, 1983] § 170.3(n)(35) of this chapter. All other food cat- 0.01 Do. § 184.1619 Potassium carbonate. egories. (a) Potassium carbonate (K2CO3, CAS (d) Prior sanctions for potassium al- Reg. No. 584–08–7) is produced by the ginate different from the uses estab- following methods of manufacture: lished in this section do not exist or (1) By electrolysis of potassium chlo- have been waived. ride followed by exposing the resultant potassium to carbon dioxide; [47 FR 29951, July 9, 1982] (2) By treating a solution of potas- sium hydroxide with excess carbon di- § 184.1613 Potassium bicarbonate. oxide to produce potassium carbonate; (a) Potassium bicarbonate (KHCO3, (3) By treating a solution of potas- CAS Reg. No. 298–14–6) is made by the sium hydroxide with carbon dioxide to following processes: produce potassium bicarbonate, which (1) By treating a solution of potas- is then heated to yield potassium car- sium hydroxide with carbon dioxide; bonate. (2) By treating a solution of potas- (b) The ingredient meets the speci- sium carbonate with carbon dioxide. fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 240, which is incor- federallregister/ porated by reference. Copies are avail- codeloflfederallregulations/ able from the National Academy Press, ibrllocations.html. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1), ington, D.C. 20418, or available for in- the ingredient is used in food with no spection at the National Archives and limitation other than current good Records Administration (NARA). For manufacturing practice. The affirma- information on the availability of this tion of this ingredient as generally rec- material at NARA, call 202–741–6030, or ognized as safe (GRAS) as a direct go to: http://www.archives.gov/ human food ingredient is based upon federallregister/ the following current good manufac- codeloflfederallregulations/ turing practice conditions of use: ibrllocations.html. (1) The ingredient is used as a flavor (c) In accordance with § 184.1(b)(1), enhancer as defined in § 170.3(o)(11) of the ingredient is used in food with no this chapter; as a flavoring agent as de- limitation other than current good fined in § 170.3(o)(12) of this chapter; as manufacturing practice. the affirma- a nutrient supplement as defined in tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter; as a pH ognized as safe (GRAS) as a direct control agent as defined in § 170.3(o)(23) human food ingredient is based upon of this chapter; and as a stabilizer or the following current good manufac- thickener as defined in § 170.3(o)(28) of turing practice conditions of use: this chapter. (1) The ingredient is used in food as a (2) The ingredient is used in food at flavoring agent and adjuvant as defined levels not to exceed current good man- in § 170.3(o)(12) of this chapter; nutrient ufacturing practice. Potassium chlo- supplement as defined in § 170.3(o)(20) of ride may be used in infant formula in this chapter; pH control agent as de- accordance with section 412(g) of the fined in § 170.3(o)(23) of this chapter; Federal Food, Drug, and Cosmetic Act and processing aid as defined in (the Act) or with regulations promul- § 170.3(o)(24) of this chapter. gated under section 412(a)(2) of the Act. (2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [48 FR 51614, Nov. 10, 1983] this section do not exist or have been waived. § 184.1625 Potassium citrate.

[48 FR 52442, Nov. 18, 1983] (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- § 184.1622 Potassium chloride. tassium salt of citric acid. It is pre- (a) Potassium chloride (KCl, CAS pared by neutralizing citric acid with Reg. No. 7447–40–7) is a white, odorless potassium hydroxide or potassium car- solid prepared from source minerals by bonate. It occurs as transparent crys- fractional crystallization or flotation. tals or a white granular powder, is It is soluble in water and glycerol and odorless and deliquescent, and contains has a saline taste at low concentration one mole of water per mole of potas- levels. sium citrate. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 241, which is incor- 3d ed. (1981), p. 242, which is incor- porated by reference. Copies are avail- porated by reference in accordance able from the National Academy Press, with 5 U.S.C. 552(a) and 1 CFR part 51. 2101 Constitution Ave. NW., Wash- Copies are available from the National ington, DC 20418, or available for in- Academy Press, 2101 Constitution Ave. spection at the National Archives and NW., Washington, DC 20418, and the Records Administration (NARA). For Center for Food Safety and Applied Nu- information on the availability of this trition (HFS–200), 5001 Campus Dr., Col- material at NARA, call 202–741–6030, or lege Park, MD 20740, or may be exam- go to: http://www.archives.gov/ ined at the National Archives and

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Records Administration (NARA). For of this chapter; and a stabilizer and information on the availability of this thickener as defined in § 170.3(o)(28) of material at NARA, call 202–741–6030, or this chapter. go to: http://www.archives.gov/ (2) The ingredient is used in food at federallregister/ levels not to exceed current good man- codeloflfederallregulations/ ufacturing practice. ibrllocations.html. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. (d) Prior sanctions for this ingredient [48 FR 52444, Nov. 18, 1983] different from the uses established in § 184.1634 Potassium iodide. this section, or different from those set forth in part 181 of this chapter, do not (a) Potassium iodide (KI, CAS Reg. exist or have been waived. No. 7681–11–0) is the potassium salt of hydriodic acid. It occurs naturally in [59 FR 63896, Dec. 12, 1994] sea water and in salt deposits, but can § 184.1631 Potassium hydroxide. be prepared by reacting hydriodic acid (HI) with potassium bicarbonate (a) Potassium hydroxide (KOH, CAS (KHCO3). Reg. No. 1310–58–3) is also known as (b) The ingredient meets the speci- caustic potash, potash lye, and potassa. fications of the ‘‘Food Chemicals The empirical formula is KOH. It is a Codex,’’ 3d Ed. (1981), pp. 246–247, which white, highly deliquescent caustic is incorporated by reference. Copies solid, which is marketed in several may be obtained from the National forms, including pellets, flakes, sticks, Academy Press, 2101 Constitution Ave. lumps, and powders. Potassium hydrox- NW., Washington, DC 20418, or may be ide is obtained commercially from the examined at the National Archives and electrolysis of potassium chloride solu- Records Administration (NARA). For tion in the presence of a porous dia- information on the availability of this phragm. material at NARA, call 202–741–6030, or (b) The ingredient meets the speci- go to: http://www.archives.gov/ fications of the Food Chemicals Codex, federallregister/ 3d Ed. (1981), which is incorporated by codeloflfederallregulations/ reference. Copies are available from ibrllocations.html. the National Academy Press, 2101 Con- (c) The ingredient is used as a nutri- stitution Ave. NW., Washington, DC ent supplement as defined in 20418, or available from inspection at the National Archives and Records Ad- § 170.3(o)(20) of this chapter. ministration (NARA). For information (d) The ingredient is used in table on the availability of this material at salt in accordance with § 184.1(b)(2) of NARA, call 202–741–6030, or go to: http:// this chapter as a source of dietary io- www.archives.gov/federallregister/ dine at a maximum level of 0.01 per- codeloflfederallregulations/ cent. ibrllocations.html. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [43 FR 11699, Mar. 21, 1978, as amended at 49 tion of this ingredient as generally rec- FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, ognized as safe (GRAS) as a direct 1996] human food ingredient is based upon the following current good manufac- § 184.1635 Potassium iodate. turing practice conditions of use: (a) Potassium iodate (KIO3, CAS Reg. (1) The ingredient is used as a formu- No. 7758–05–6) does not occur naturally lation aid as defined in § 170.3(o)(14) of but can be prepared by reacting iodine this chapter; a pH control agent as de- with potassium hydroxide. fined in § 170.3(o)(23) of the chapter; a (b) The ingredient meets the speci- processing aid as defined in § 170.3(o)(24) fications of the ‘‘Food Chemicals

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Codex,’’ 3d Ed. (1981), pp. 245–246, which (d) Prior sanctions for this ingredient is incorporated by reference. Copies different from the uses established in may be obtained from the National this section do not exist or have been Academy Press, 2101 Constitution Ave. waived. NW., Washington, DC 20418, or may be [52 FR 10886, Apr. 6, 1987, as amended at 73 examined at the National Archives and FR 8608, Feb. 14, 2008] Records Administration (NARA). For information on the availability of this § 184.1643 Potassium sulfate. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ (a) Potassium sulfate (K2SO4, CAS federallregister/ Reg. No. 7778–80–5) occurs naturally and codeloflfederallregulations/ consists of colorless or white crystals ibrllocations.html. or crystalline powder having a bitter, (c) The ingredient is used as a dough saline taste. It is prepared by the neu- strengthener as defined in § 170.3(o)(6) tralization of sulfuric acid with potas- of this chapter. sium hydroxide or potassium car- (d) The ingredient is used in the man- bonate. ufacture of bread in accordance with (b) The ingredient meets the speci- § 184.1(b)(2) of this chapter in an fications of the ‘‘Food Chemicals amount not to exceed 0.0075 percent Codex,’’ 3d Ed. (1981), p. 252, which is in- based on the weight of the flour. corporated by reference. Copies may be (e) Prior sanctions for this ingredient obtained from the National Academy different from the uses established in Press, 2101 Constitution Ave. NW., this section do not exist or have been Washington, DC 20418, or may be exam- waived. ined at the National Archives and Records Administration (NARA). For [43 FR 11699, Mar. 21, 1978, as amended at 49 information on the availability of this FR 5613, Feb. 14, 1984] material at NARA, call 202–741–6030, or § 184.1639 Potassium lactate. go to: http://www.archives.gov/ federallregister/ (a) Potassium lactate (C3H5O3K, CAS codeloflfederallregulations/ Reg. No. 996–31–6) is the potassium salt ibrllocations.html. of lactic acid. It is a hydroscopic, (c) The ingredient is used as a fla- white, odorless solid and is prepared voring agent and adjuvant as defined in commercially by the neutralization of § 170.3(o)(12) of this chapter. lactic acid with potassium hydroxide. (d) The ingredient is used in food at (b) The ingredient must be of a pu- levels not to exceed good manufac- rity suitable for its intended use. turing practice in accordance with (c) In accordance with § 184.1(b)(1), § 184.1(b)(1). Current good manufac- the ingredient is used in food with no turing practice results in a maximum limitation other than current good level, as served, of 0.015 percent for manufacturing practice. This regula- nonalcoholic beverages as defined in tion does not authorize its use in in- § 170.3(n)(3) of this chapter. fant foods and infant formulas. The af- (e) Prior sanctions for this ingredient firmation of this ingredient as gen- different from the uses established in erally recognized as safe (GRAS) as a this section do not exist or have been direct human food ingredient is based waived. upon the following current good manu- facturing practice conditions of use: [45 FR 6086, Jan. 25, 1980, as amended at 49 (1) The ingredient is used as a flavor FR 5613, Feb. 14, 1984] enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adju- § 184.1655 Propane. vant as defined in § 170.3(o)(12) of this (a) Propane (empirical formula C3H8, chapter; a humectant as defined in CAS Reg. No. 74–98–6) is also known as § 170.3(o)(16) of this chapter; and a pH dimethylmethane or propyl hydrid. It control agent as defined in § 170.3(o)(23) is a colorless, odorless, flammable gas of this chapter. at normal temperatures and pressures. (2) The ingredient is used in food at It is easily liquefied under pressure at levels not to exceed current good man- room temperature and is stored and ufacturing practice. shipped in the liquid state. Propane is

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obtained from natural gas by fraction- tice results in a maximum total con- ation following absorption in oil, ad- tent of antioxidants of 0.02 percent of sorption to surface-active agents, or re- the fat or oil content, including the es- frigeration. sential (volatile) oil content, of the (b) The ingredient must be of a pu- food. rity suitable for its intended use. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section, or different from that limitations other than current good stated in part 181 of this chapter, do manufacturing practice. The affirma- not exist or have been waived. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct [42 FR 14653, Mar. 15, 1977, as amended at 44 human food ingredient is based upon FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, the following current good manufac- 1984] turing practice conditions of use: (1) The ingredient is used as a propel- § 184.1666 Propylene glycol. lant, aerating agent, and gas as defined (a) Propylene glycol (C3H8O2, CAS in § 170.3(o)(25) of this chapter. Reg. No. 57–55–6) is known as 1,2- (2) The ingredient is used in food at propanediol. It does not occur in na- levels not to exceed current good man- ture. Propylene glycol is manufactured ufacturing practice. by treating propylene with chlorinated (d) Prior sanctions for this ingredient water to form the chlorohydrin which different from the uses established in is converted to the glycol by treatment this section do not exist or have been with sodium carbonate solution. It is waived. also prepared by heating glyercol with [48 FR 57271, Dec. 29, 1983, as amended at 73 sodium hydroxide. FR 8608, Feb. 14, 2008] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, § 184.1660 Propyl gallate. 3d Ed. (1981), p. 255, which is incor- (a) Propyl gallate is the n- porated by reference. Copies may be propylester of 3,4,5-trihydroxybenzoic obtained from the National Academy acid (C10H12O5). Natural occurrence of Press, 2101 Constitution Ave. NW., propyl gallate has not been reported. It Washington, DC 20418. It is also avail- is commercially prepared by able for inspection at the National Ar- esterification of gallic acid with propyl chives and Records Administration alcohol followed by distillation to re- (NARA). For information on the avail- move excess alcohol. ability of this material at NARA, call (b) The ingredient meets the speci- 202–741–6030, or go to: http:// fications of the ‘‘Food Chemicals www.archives.gov/federallregister/ Codex,’’ 3d Ed. (1981), pp. 257–258, which codeloflfederallregulations/ is incorporated by reference. Copies ibrllocations.html. may be obtained from the National (c) The ingredient is used as an Academy Press, 2101 Constitution Ave. anticaking agent as defined in NW., Washington, DC 20418, or may be § 170.3(o)(1) of this chapter; antioxidant examined at the National Archives and as defined in § 170.3(o)(3) of this chap- Records Administration (NARA). For ter; dough strengthener as defined in information on the availability of this § 170.3(o)(6) of this chapter; emulsifier material at NARA, call 202–741–6030, or as defined in § 170.3(o)(8) of this chap- go to: http://www.archives.gov/ ter; flavor agent as defined in federallregister/ § 170.3(o)(12) of this chapter; formula- codeloflfederallregulations/ tion aid as defined in § 170.3(o)(14) of ibrllocations.html. this chapter; humectant as defined in (c) The ingredient is used as an anti- § 170.3(o)(16) of this chapter; processing oxidant as defined in § 170.3(o)(3) of this aid as defined in § 170.3(o)(24) of this chapter. chapter; solvent and vehicle as defined (d) The ingredient is used in food at in § 170.3(o)(27) of this chapter; sta- levels not to exceed good manufac- bilizer and thickener as defined in turing practice in accordance with § 170.3(o)(28) of this chapter; surface-ac- § 184.1(b)(1). Good manufacturing prac- tive agent as defined in § 170.3(o)(29) of

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this chapter; and texturizer as defined this regulation do not exist or have in § 170.3(o)(32) of this chapter. been waived. (d) The ingredient is used in foods at [42 FR 14653, Mar. 15, 1977, as amended at 49 levels not to exceed current good man- FR 5613, Feb. 14, 1984] ufacturing practice in accordance with § 184.1(b)(1). Current good manufac- § 184.1676 Pyridoxine hydrochloride. turing practice results in maximum (a) Pyridoxine hydrochloride levels, as served, of 5 percent for alco- (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is holic beverages, as defined in the chemical 3-hydroxy–4,5- § 170.3(n)(2) of this chapter; 24 percent dihydroxymethy–2-methylpyridine hy- for confections and frostings as defined drochloride that is prepared by chem- in § 170.3(n)(9) of this chapter; 2.5 per- ical synthesis. cent for frozen dairy products as de- (b) The ingredient meets the speci- fined in § 170.3(n)(20) of this chapter; 97 fications of the Food Chemicals Codex, percent for seasonings and flavorings 3d Ed. (1981), p. 260, which is incor- as defined in § 170.3(n)(26) of this chap- porated by reference. Copies are avail- ter; 5 percent for nuts and nut products able from the National Academy Press, as defined in § 170.3(n)(32) of this chap- 2101 Constitution Ave. NW., Wash- ter; and 2.0 percent for all other food ington, DC 20418, or available for in- categories. spection at the National Archives and (e) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this this section do not exist or have been material at NARA, call 202–741–6030, or waived. go to: http://www.archives.gov/ federallregister/ [47 FR 27812, June 25, 1982] codeloflfederallregulations/ § 184.1670 Propylparaben. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (a) Propylparaben is the chemical the ingredient is used in food with no propyl p-hydroxybenzoate. It is pro- limitation other than current good duced by the n-propanol esterification manufacturing practice. The affirma- of p-hydroxybenzoic acid in the pres- tion of this ingredient as generally rec- ence of sulfuric acid, with subsequent ognized as safe (GRAS) as a direct distillation. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the ‘‘Food Chemicals turing practice conditions of use: Codex,’’ 3d Ed. (1981), p. 258, which is in- (1) The ingredient is used as a nutri- corporated by reference. Copies may be ent supplement as defined in obtained from the National Academy § 170.3(o)(20) of this chapter. Press, 2101 Constitution Ave. NW., (2) The ingredient is used in the fol- Washington, DC 20418, or may be exam- lowing foods at levels not to exceed ined at the National Archives and current good manufacturing practice: Records Administration (NARA). For baked goods as defined in § 170.3(n)(1) of information on the availability of this this chapter; nonalcoholic beverages material at NARA, call 202–741–6030, or and beverage bases as defined in go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter; breakfast federallregister/ cereals as defined in § 170.3(n)(4) of this codeloflfederallregulations/ chapter; dairy product analogs as de- ibrllocations.html. fined in § 170.3(n)(10) of this chapter; (c) The ingredient is used as an anti- meat products as defined in microbial agent as defined in § 170.3(n)(29) of this chapter; milk prod- § 170.3(o)(2) of this chapter. ucts as defined in § 170.3(n)(31) of this (d) The ingredient is used in food at chapter; plant protein products as de- levels not to exceed good manufac- fined in § 170.3(n)(33) of this chapter; turing practices. Current good manu- and snack foods as defined in facturing practice results in a max- § 170.3(n)(37) of this chapter. Pyridoxine imum level of 0.1 percent in food. hydrochloride may be used in infant (e) Prior sanctions for this ingredient formula in accordance with section different from the uses established in 412(g) of the Federal Food, Drug, and

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Cosmetic Act (the Act) or with regula- (4) Chymosin preparation is a clear tions promulgated under section solution containing the active enzyme 412(a)(2) of the Act. chymosin (E.C. 3.4.23.4). It is derived, (d) Prior sanctions for this ingredient via fermentation, from a nonpatho- different from the uses established in genic and nontoxigenic strain of Asper- this section do not exist or have been gillus niger van Tieghem variety waived. awamori (Nakazawa) Al-Musallam (syn- [48 FR 51615, Nov. 10, 1983] onym A. awamori Nakazawa) con- taining the prochymosin gene. § 184.1685 Rennet (animal-derived) Chymosin is recovered from the fer- and chymosin preparation (fer- mentation broth after acid treatment. mentation-derived). All materials used in the processing (a)(1) Rennet and bovine rennet are and formulating of chymosin prepara- commercial extracts containing the ac- tion must be either generally recog- tive enzyme rennin (CAS Reg. No. 9001– nized as safe (GRAS) or be food addi- 98–3), also known as chymosin (Inter- tives that have been approved by the national Union of Biochemistry En- Food and Drug Administration for this zyme Commission (E.C.) 3.4.23.4). use. Rennet is the aqueous extract prepared from cleaned, frozen, salted, or dried (b) Rennet and chymosin preparation fourth stomachs (abomasa) of calves, meet the general and additional re- kids, or lambs. Bovine rennet is the quirements for enzyme preparations of product from adults of the animals list- the ‘‘Food Chemicals Codex,’’ 3d Ed. ed above. Both products are called (1981), pp. 107–110, which is incorporated rennet and are clear amber to dark by reference in accordance with 5 brown liquid preparations or white to U.S.C. 552(a). Copies are available from tan powders. the National Academy Press, 2101 Con- (2) Chymosin preparation is a clear stitution Avenue NW., Washington, DC solution containing the active enzyme 20418, or are available for inspection at chymosin (E.C. 3.4.23.4). It is derived, the National Archives and Records Ad- via fermentation, from a nonpatho- ministration (NARA). For information genic and nontoxigenic strain of Esch- on the availability of this material at erichia coli K–12 containing the NARA, call 202–741–6030, or go to: http:// prochymosin gene. The prochymosin is www.archives.gov/federallregister/ isolated as an insoluble aggregate that codeloflfederallregulations/ is acid-treated to destroy residual cel- ibrllocations.html. lular material and, after solubilization, (c) In accordance with § 184.1(b)(1), is acid-treated to form chymosin. It the ingredient is used in food with no must be processed with materials that limitation other than current good are generally recognized as safe, or are manufacturing practice. The affirma- food additives that have been approved tion of this ingredient as generally rec- by the Food and Drug Administration ognized as safe as a direct human food for this use. ingredient is based upon the following (3) Chymosin preparation is a clear current good manufacturing practice solution containing the active enzyme conditions of use: chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpatho- (1) The ingredient is used as an en- genic and nontoxigenic strain of zyme as defined in § 170.3(o)(9) of this Kluyveromyces marxianus variety lactis, chapter; a processing aid as defined in containing the prochymosin gene. The § 170.3(o)(24) of this chapter; and a sta- prochymosin is secreted by cells into bilizer and thickener as defined in fermentation broth and converted to § 170.3(o)(28) of this chapter. chymosin by acid treatment. All mate- (2) The ingredient is used in the fol- rials used in the processing and formu- lowing foods at levels not to exceed lating of chymosin must be either gen- current good manufacturing practice: erally recognized as safe (GRAS), or be In cheeses as defined in § 170.3(n)(5) of food additives that have been approved this chapter; frozen dairy desserts and by the Food and Drug Administration mixes as defined in § 170.3(n)(20) of this for this use. chapter; gelatins, puddings, and fillings

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as defined in § 170.3(n)(22) of this chap- this section do not exist or have been ter; and milk products as defined in waived. § 170.3(n)(31) of this chapter. [48 FR 51148, Nov. 7, 1983] (d) Prior sanctions for this ingredient different from the uses established in § 184.1697 Riboflavin–5′-phosphate (so- this section do not exist or have been dium). waived. (a) Riboflavin-5′-phosphate (sodium) [55 FR 10935, Mar. 23, 1990, as amended at 57 (C17H20N4O9PNa·2H2O, CAS Reg. No 130– FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 40–5) occurs as the dihydrate in yellow 1993] to orange-yellow crystals. It is pre- pared by phosphorylation of riboflavin § 184.1695 Riboflavin. with chlorophosphoric acid, (a) Riboflavin (C17H20N4O6, CAS Reg. pyrophosphoric acid, metaphosphoric No. 83–88–5) occurs as yellow to orange- acid, or pyrocatechol cyclic phosphate. yellow needles that are crystallized (b) The ingredient meets the speci- from 2N acetic acid, alcohol, water, or fications of the Food Chemicals Codex, pyridine. It may be prepared by chem- 3d Ed. (1981), p. 263, which is incor- ical synthesis, biosynthetically by the porated by reference. Copies are avail- organism Eremothecium ashbyii, or iso- able from the National Academy Press, lated from natural sources. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington DC 20418, or available for inspec- fications of the Food Chemicals Codex, tion at the National Archives and 3d Ed. (1981), p. 262, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as a nutri- tion of this ingredient as generally rec- ent supplement as defined in ognized as safe (GRAS) as a direct § 170.3(o)(20) of this chapter. human food ingredient is based upon (2) The ingredient is used in milk the following current good manufac- products, as defined in § 170.3(n)(31) of turing practice conditions of use: this chapter, at levels not to exceed (1) The ingredient is used as a nutri- current good manufacturing practice. ent supplement as defined in The ingredient may also be used in in- § 170.3(o)(20) of this chapter. fant formulas in accordance with sec- (2) The ingredient is used in foods at tion 412(g) of the Federal Food, Drug, levels not to exceed current good man- and Cosmetic Act (the Act) or with reg- ufacturing practice. The ingredient ulations promulgated under section may also be used in infant formula in 412(a)(2) of the Act. accordance with section 412(g) of the (d) Prior sanctions for this ingredient Federal Food, Drug, and Cosmetic Act different from the uses established in (the Act) or with regulations promul- this section do not exist or have been gated under section 412(a)(2) of the Act. waived. (d) Prior sanctions for this ingredient different from the uses established in [48 FR 51148, Nov. 7, 1983]

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§ 184.1698 Rue. Ruta—Ruta montana L., Ruta graveolens (a) Rue is the perennial herb of sev- L., Ruta bracteosa L., and Ruta L. eral species of Ruta (Ruta montana L., calepensis (b) Oil of rue meets the specifications Ruta graveolens L., Ruta bracteosa L., of the ‘‘Food Chemicals Codex,’’ 4th ed. and Ruta calepensis L.). The leaves, buds, and stems from the top of the (1996), pp. 342–343, which is incorporated plant are gathered, dried, and then by reference in accordance with 5 crushed in preparation for use, or left U.S.C. 552(a) and 1 CFR part 51. Copies whole. are available from the National Acad- (b) The ingredient is used in all cat- emy Press, Box 285, 2101 Constitution egories of food in accordance with Ave. NW., Washington, DC 20055 (Inter- § 184.1(b)(2) of this chapter at con- net address http://www.nap.edu), or may centrations not to exceed 2 parts per be examined at the Food and Drug Ad- million. ministration’s Main Library, 10903 New (c) Prior sanctions for this ingredient Hampshire Ave., Bldg. 2, Third Floor, different from the uses established in Silver Spring, MD 20993, 301–796–2039, or this section do not exist or have been at the National Archives and Records waived. Administration (NARA). For informa- tion on the availability of this mate- [43 FR 3705, Jan. 27, 1978] rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 184.1699 Oil of rue. federallregister/ (a) Oil of rue is the natural substance codeloflfederallregulations/ obtained by steam distillation of the ibrllocations.html. fresh blossoming plants of rue, the pe- (c) The ingredient is used in food rennial herb of several species of under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Parts per Food (as served) million Function

Baked goods and baking mixes, § 170.3(n)(1), of 10 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. this chapter. Frozen dairy desserts and mixes, § 170.3 (n)(20) of 10 Do. this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 10 Do. All other food categories ...... 4 Do.

(d) Prior sanctions for this ingredient (1) Saponification value of 185 to 195, different from the uses established in (2) Iodine value of 28 to 43, this section do not exist or have been (3) Unsaponifiable matter not to ex- waived. ceed 1.5 percent, [42 FR 14653, Mar. 15, 1977, as amended at 49 (4) Free fatty acids not more than 0.1 FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, percent as oleic acid, 1999; 81 FR 5596, Feb. 3, 2016] (5) Peroxide value not more than 10 milliequivalents/equivalent (meq/eq), § 184.1702 Sheanut oil. (6) Lead not more than 0.1 part per (a) Sheanut oil is produced from million (ppm), sheanuts derived from the Shea tree (7) Copper not more than 0.1 ppm. Butyrospermum parkii and is composed (c) In accordance with § 184.1(b)(3), principally of triglycerides containing the ingredient is used in the following an oleic acid moiety at the 2-position food categories at levels not to exceed and saturated fatty acids, usually ste- current good manufacturing practice, aric or palmitic acids, at the 1- and 3- except that the ingredient may not be positions. used in a standardized food unless per- (b) The ingredient meets the fol- mitted by the standard of identity: lowing specifications when tested using Confections and frostings as defined in any appropriate validated method- § 170.3(n)(9) of this chapter, coatings of ology: soft candy as defined in § 170.3(n)(38) of

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this chapter, and sweet sauces and top- tas as defined in § 170.3(n)(23) of this pings as defined in § 170.3(n)(43) of this chapter and snack foods as defined in chapter. § 170.3(n)(37) of this chapter; 0.15 per- [63 FR 28895, May 27, 1998] cent for hard candy as defined in § 170.3(n)(25) of this chapter; 0.12 per- § 184.1721 Sodium acetate. cent for jams and jellies as defined in § 170.3(n)(28) of this chapter and meat (a) Sodium acetate (C H O Na, CAS 2 3 2 products as defined in § 170.3(n)(29) of Reg. No. 127–09–3 or C H O Na·3H O, 2 3 2 2 this chapter; 0.2 percent for soft candy CAS Reg. No. 6131–90–4) is the sodium salt of acetic acid and occurs naturally as defined in § 170.3(n)(38) of this chap- in plant and animal tissues. Sodium ac- ter; 0.05 percent for soups and soup etate may occur in either the anhy- mixes as defined in § 170.3(n)(40) of this drous or trihydrated form. It is pro- chapter and sweet sauces as defined in duced synthetically by the neutraliza- § 170.3(n)(43) of this chapter. tion of acetic acid with sodium car- (e) Prior sanctions for this ingredient bonate or by treating calcium acetate different from the uses established in with sodium sulfate and sodium bicar- this section do not exist or have been bonate. waived. (b) The ingredient meets the speci- [47 FR 27815, June 25, 1982] fications of the Food Chemicals Codex, 3d Ed. (1981), pp. 272, 273 which is incor- § 184.1724 Sodium alginate. porated by reference. Copies are avail- able from the National Academy Press, (a) Sodium alginate (CAS Reg. No. 2101 Constitution Ave. NW., Wash- 9005–38–3) is the sodium salt of alginic ington, DC 20418, or available for in- acid, a natural polyuronide constituent spection at the National Archives and of certain brown algae. Sodium algi- Records Administration (NARA). For nate is prepared by the neutralization information on the availability of this of purified alginic acid with appro- material at NARA, call 202–741–6030, or priate pH control agents. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), p. 274, which is incor- ibrllocations.html. porated by reference. Copies are avail- (c) The ingredient is used as a fla- able from the National Academy Press, voring agent and adjuvant as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(12) of this chapter; and as a pH ington, DC 20418, or available for in- control agent as defined in § 170.3(o)(23) spection at the National Archives and of this chapter. Records Administration (NARA). For (d) The ingredient is used in food at information on the availability of this levels not to exceed current good man- material at NARA, call 202–741–6030, or ufacturing practice in accordance with go to: http://www.archives.gov/ 184.1(b)(1). Current good manufacturing federallregister/ practice results in a maximum level, as codeloflfederallregulations/ served, of 0.007 percent for breakfast ibrllocations.html. cereals as defined in § 170.3(n)(4) of this (c) In accordance with § 184.1(b)(2), chapter; 0.5 percent for fats and oils as the ingredient is used in food only defined in § 170.3(n)(12) of this chapter; within the following specific limita- 0.6 percent for grain products and pas- tions:

Maximum level of Category of food use in food Functional use (as served) (percent)

Condiments and relishes, § 170.3(n)(8) of this chapter, 1.0 Texturizer, § 170.3(o)(32) of this chapter, formulation aid except pimento ribbon for stuffed olives. § 170.3(o)(14) of this chapter, stabilizer, thickener, § 170.3(o)(28) of this chapter. Pimento ribbon for stuffed olives ...... 6.0 Do. Confections and frostings, § 170.3(n)(9) of this chapter .. 0.3 Stabilizer, thickener, § 170.3(o)(28) of this chapter.

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Maximum level of Category of food use in food Functional use (as served) (percent)

Gelatins and puddings, § 170.3(n)(22) of this chapter ..... 4.0 Firming agent, § 170.3(o)(10) of this chapter; flavor adju- vant, § 170.3(o)(12) of this chapter; stabilizer, thick- ener, § 170.3(o)(28) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 10.0 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of this 2.0 Formulation aid, §170.3(o)(14) of this chapter; chapter. texturizer, § 170.3(o)(32) of this chapter. All other food categories ...... 1.0 Emulsifier, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavor enhancer, § 170.3(o)(11) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface active agent, § 170.3(o)(29) of this chapter.

(d) Prior sanctions for sodium algi- (e) Prior sanctions for this ingredient nate different from the uses established different from the uses established in in this section do not exist or have this section, or different from that set been waived. forth in part 181 of this chapter, do not [47 FR 29951, July 9, 1982, as amended at 48 exist or have been waived. FR 52448, Nov. 18, 1983] [42 FR 14653, Mar. 15, 1977, as amended at 49 § 184.1733 Sodium benzoate. FR 5613, Feb. 14, 1984] (a) Sodium benzoate is the chemical § 184.1736 Sodium bicarbonate. benzoate of soda (C7H5NaO2), produced by the neutralization of benzoic acid (a) Sodium bicarbonate (NaHCO3, with sodium bicarbonate, sodium car- CAS Reg. No. 144–55–8) is prepared by bonate, or sodium hydroxide. The salt treating a sodium carbonate or a so- is not found to occur naturally. dium carbonate and sodium bicarbon- (b) The ingredient meets the speci- ate solution with carbon dioxide. As fications of the ‘‘Food Chemicals carbon dioxide is absorbed, a suspen- Codex,’’ 3d Ed. (1981), p. 278, which is in- sion of sodium bicarbonate forms. The corporated by reference. Copies may be slurry is filtered, forming a cake which obtained from the National Academy is washed and dried. Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci- Washington, DC 20418, or may be exam- fications of the Food Chemicals Codex, ined at the National Archives and 3d Ed. (1981), p. 278, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ ibrllocations.html. Records Administration (NARA). For (c) The ingredient is used as an anti- information on the availability of this microbial agent as defined in material at NARA, call 202–741–6030, or § 170.3(o)(2) of this chapter, and as a fla- go to: http://www.archives.gov/ voring agent and adjuvant as defined in federallregister/ § 170.3(o)(12) of this chapter. codeloflfederallregulations/ (d) The ingredient is used in food at ibrllocations.html. levels not to exceed good manufac- (c) In accordance with § 184.1(b)(1), turing practice. Current usage results the ingredient is used in food with no in a maximum level of 0.1 percent in limitation other than current good food. (The Food and Drug Administra- manufacturing practice. tion has not determined whether (d) Prior sanctions for this ingredient significally different conditions of use different from the uses established in would be GRAS.)

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this section do not exist or have been § 184.1751 Sodium citrate. waived. (a) Sodium citrate (C6H5Na3O7·2H2O, [48 FR 52442, Nov. 18, 1983] CAS Reg. No. 68–0904–092) is the sodium salt of citric acid. It is prepared by § 184.1742 Sodium carbonate. neutralizing citric acid with sodium hydroxide or sodium carbonate. The (a) Sodium carbonate (Na2CO3, CAS Reg. No. 497–19–8) is produced (1) from product occurs as colorless crystals or purified trona ore that has been a white crystalline powder. It may be calcined to soda ash; (2) from trona ore prepared in an anhydrous state or may calcined to impure soda ash and then contain two moles of water per mole of purified; or (3) synthesized from lime- sodium citrate. stone by the Solvay process. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d ed. (1981), pp. 283–284, which is incor- 3d Ed. (1981), p. 280, which is incor- porated by reference in accordance porated by reference. Copies are avail- with 5 U.S.C. 552(a) and 1 CFR part 51. able from the National Academy Press, Copies are available from the National 2101 Constitution Ave. NW., Wash- Academy Press, 2101 Constitution Ave. ington, DC 20418, or available for in- NW., Washington, DC 20418, and the spection at the National Archives and Center for Food Safety and Applied Nu- Records Administration (NARA). For trition (HFS–200), 5001 Campus Dr., Col- information on the availability of this lege Park, MD 20740, or may be exam- material at NARA, call 202–741–6030, or ined at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section, or different from those set (1) The ingredient is used in food as forth in part 181 of this chapter, do not an antioxidant as defined in § 170.3(o)(3) exist or have been waived. of this chapter; curing and pickling agent as defined in § 170.3(o)(5) of this [59 FR 63896, Dec. 12, 1994] chapter; flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chap- § 184.1754 Sodium diacetate. ter; pH control agent as defined in (a) Sodium diacetate (C4H7O4Na·xH2O, § 170.3(o)(23) of this chapter; and proc- CAS Reg. No. 126–96–5) is a molecular essing aid as defined in § 170.3(o)(24) of compound of acetic acid, sodium ace- this chapter. tate, and water of hydration. The tech- (2) The ingredient is used in food at nical grade is prepared synthetically levels not to exceed current good man- by reacting sodium carbonate with ace- ufacturing practice. tic acid. Special grades are produced by (d) Prior sanctions for this ingredient reacting anhydrous sodium acetate and different from the uses established in acetic acid. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 284, which is incor- [48 FR 52442, Nov. 18, 1983, as amended at 50 porated by reference. Copies are avail- FR 49536, Dec. 3, 1985] able from the National Academy Press,

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2101 Constitution Ave. NW., Wash- istration (NARA). For information on ington, DC 20418, or available for in- the availability of this material at spection at the National Archives and NARA, call 202–741–6030, or go to: http:// Records Administration (NARA). For www.archives.gov/federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) The ingredient is used as an anti- tion of this ingredient as generally rec- microbial agent as defined in ognized as safe (GRAS) as a direct § 170.3(o)(2) of this chapter; flavoring human food ingredient is based upon agent and adjuvant as defined in the following current good manufac- § 170.3(o)(12) of this chapter; and pH turing practice conditions of use: control agent as defined in § 170.3(o)(23) (1) The ingredient is used as a pH of this chapter. control agent as defined in § 170.3(o)(23) (d) The ingredient is used in food at of this chapter and as a processing aid levels not to exceed current good man- as defined in § 170.3(o)(24) of this chap- ufacturing practice in accordance with ter. § 184.1(b)(1). Current good manufac- (2) The ingredient is used in foods at turing practice results in a maximum levels not to exceed current good man- level, as served, 0.4 percent for baked ufacturing practice. goods as defined in § 170.3(n)(1) of this (d) Prior sanctions for this ingredient chapter; 0.1 percent for fats and oils as different from the uses established in defined in § 170.3(n)(12) of this chapter, this section do not exist or have been meat products as defined in waived. § 170.3(n)(29) of this chapter and soft candy as defined in § 170.3(n)(38) of this [48 FR 52444, Nov. 18, 1983] chapter; 0.25 percent for gravies and sauces as defined in § 170.3(n)(24) of this § 184.1764 Sodium hypophosphite. chapter; and 0.05 percent for snack (a) Sodium hypophosphite (NaH2PO2, foods as defined in § 170.3(n)(37) of this CAS Reg. No. 7681–53–0) is a white, chapter and soups and soup mixes as odorless, deliquescent granular powder defined in § 170.3(n)(40) of this chapter. with a saline taste. It is also prepared (e) Prior sanctions for this ingredient as colorless, pearly crystalline plates. different from the uses established in It is soluble in water, alcohol, and this section do not exist or have been glycerol. It is prepared by neutraliza- waived. tion of hypophosphorous acid or by di- [47 FR 27815, June 25, 1982] rect aqueous alkaline hydrolysis of white phosphorus. § 184.1763 Sodium hydroxide. (b) The ingredient must be of a pu- (a) Sodium hydroxide (NaOH, CAS rity suitable for its intended use. Reg. No. 1310–73–2) is also known as so- (c) In accordance with § 184.1(b)(1), dium hydrate, soda lye, caustic soda, the ingredient is used in food with no white caustic, and lye. The empirical limitations other than current good formula is NaOH. Sodium hydroxide is manufacturing practice. The affirma- prepared commercially by the elec- tion of this ingredient as generally rec- trolysis of sodium chloride solution ognized as safe (GRAS) as a direct and also by reacting calcium hydroxide human food ingredient is based upon with sodium carbonate. the following current good manufac- (b) The ingredient meets the speci- turing practice conditions of use: fications of the Food Chemicals Codex, (1) The ingredient is used as an emul- 3d Ed. (1981), which is incorporated by sifier or stabilizer, as defined in reference. Copies are available from §§ 170.3(o)(8) and 170.3(o)(28) of this the National Academy Press, 2101 Con- chapter. stitution Ave. NW., Washington, DC (2) The ingredient is used in cod-liver 20418, or available for inspection at the oil emulsions at levels not to exceed National Archives and Records Admin- current good manufacturing practice.

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(d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the use established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- tion of this ingredient as generally rec- [47 FR 38277, Aug. 31, 1982, as amended at 73 FR 8608, Feb. 14, 2008] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1768 Sodium lactate. the following current good manufac- turing practice conditions of use: (a) Sodium lactate (C3H5O3Na, CAS (1) The ingredient is used as a proc- Reg. No. 72–17–3) is the sodium salt of essing aid as defined in § 170.3(o)(24) of lactic acid. It is prepared commercially this chapter. by the neutralization of lactic acid (2) The ingredient is used to treat the with sodium hydroxide. following foods at levels not to exceed (b) The ingredient must be of a pu- current good manufacturing practice: rity suitable for its intended use. for use in washing and lye peeling of (c) In accordance with § 184.1(b)(1), fruits, vegetables, and nuts when used the ingredient is used in food with no in accordance with § 173.315 of this limitation other than current good chapter; for use as a denuding agent in manufacturing practice. This regula- tripe; for use as a hog scald agent in re- tion does not authorize its use in in- moving hair; and for use as a corrosion fant foods and infant formulas. The af- preventative in canned and bottled firmation of this ingredient as gen- water when used in accordance with erally recognized as safe (GRAS) as a § 165.110 of this chapter. direct human food ingredient is based (d) Prior sanctions for this ingredient upon the following current good manu- different from the uses established in facturing practice conditions of use: this section do not exist or have been (1) The ingredient is used as an emul- waived. sifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. § 170.3(o)(11) of this chapter; a flavoring 17, 1985, as amended at 72 FR 10357, Mar. 8, 2007; 73 FR 8608, Feb. 14, 2008] agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humec- § 184.1784 Sodium propionate. tant as defined in § 170.3(o)(16) of this (a) Sodium propionate (C H NaO , chapter; and a pH control agent as de- 3 5 2 CAS Reg. No. 137–40–6) is the sodium fined in § 170.3(o)(23) of this chapter. salt of propionic acid. It occurs as (2) The ingredient is used in food at colorless, transparent crystals or a levels not to exceed current good man- granular crystalline powder. It is odor- ufacturing practice. less, or has a faint acetic-butyric acid (d) Prior sanctions for this ingredient odor, and is deliquescent. It is prepared different from the uses established in by neutralizing propionic acid with so- this section do not exist or have been dium hydroxide. waived. (b) The ingredients meets the speci- [52 FR 10886, Apr. 6, 1987, as amended at 73 fications of the Food Chemicals Codex, FR 8608, Feb. 14, 2008] 3d Ed. (1981), p. 296, which is incor- porated by reference. Copies are avail- § 184.1769a Sodium metasilicate. able from the National Academy Press, (a) Sodium metasilicate (CAS Reg. 2101 Constitution Ave. NW., Wash- No. 6834–92–0) is a strongly alkaline ington DC 20418, or available for inspec- white powder. It does not occur natu- tion at the National Archives and rally but rather is synthesized by melt- Records Administration (NARA). For ing sand with sodium carbonate at 1400 information on the availability of this °C. The commercially available forms material at NARA, call 202–741–6030, or of sodium metasilicate are the anhy- go to: http://www.archives.gov/ drous form (Na2SiO3), the pentahydrate federallregister/ (Na2SiO3·5H2O), and the nonahydrate codeloflfederallregulations/ (Na2SiO3·9H2O). ibrllocations.html. (b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1), rity suitable for its intended use. the ingredient is used in food with no

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limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used as an anti- the following current good manufac- microbial agent as defined in turing practice conditions of use: § 170.3(o)(2) of this chapter and a fla- (1) The ingredient is used as a pH voring agent as defined in § 170.3(o)(12) control agent as defined in § 170.3(o)(23) of this chapter. of this chapter. (2) The ingredient is used in the fol- (2) The ingredient is used in cream at lowing foods at levels not to exceed levels not to exceed current good man- current good manufacturing practice: ufacturing practice. Current good man- baked goods as defined in § 170.3(n)(1) of ufacturing practice utilizes a level of this chapter; nonalcoholic beverages as the ingredient sufficient to control lac- defined in § 170.3(n)(3) of this chapter; tic acid prior to pasteurization and cheeses as defined in § 170.3(n)(5) of this churning of cream into butter. chapter; confections and frostings as (d) Prior sanctions for this ingredient defined in § 170.3(n)(9) of this chapter; different from the uses established in gelatins, puddings, and fillings as de- this section do not exist or have been fined in § 170.3(n)(22) of this chapter; waived. jams and jellies as defined in § 170.3(n)(28) of this chapter; meat prod- [48 FR 52443, Nov. 18, 1983] ucts as defined in § 170.3(n)(29) of this § 184.1801 Sodium tartrate. chapter; and soft candy as defined in § 170.3(n)(38) of this chapter. (a) Sodium tartrate (C4H4Na2O6·2H2O, (d) Prior sanctions for this ingredient CAS Reg. No. 868–18–8) is the disodium ¥ ¥ different from the uses established in salt of l ( + ) tartaric acid. It occurs this section do not exist or have been as transparent, colorless, and odorless waived. crystals. It is obtained as a byproduct of wine manufacture. [49 FR 13142, Apr. 3, 1984] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, § 184.1792 Sodium sesquicarbonate. 3d Ed. (1981), p. 303, which is incor- (a) Sodium sesquicarbonate porated by reference. Copies are avail- (Na2CO3·NaHCO3·2H2O, CAS Reg. No. able from the National Academy Press, 533–96–0) is prepared by: (1) Partial 2101 Constitution Ave. NW., Wash- carbonation of soda ash solution fol- ington, DC 20418, or available for in- lowed by crystallization, centrifuga- spection at the National Archives and tion, and drying; (2) double refining of Records Administration (NARA). For trona ore, a naturally occurring im- information on the availability of this pure sodium sesquicarbonate. material at NARA, call 202–741–6030, or (b) The ingredient meets the speci- go to: http://www.archives.gov/ fications of the Food Chemicals Codex, federallregister/ 3d Ed. (1981), p. 299, which is incor- codeloflfederallregulations/ porated by reference. Copies are avail- ibrllocations.html. able from the National Academy Press, (c) In accordance with § 184.1(b)(1), 2101 Constitution Ave. NW., Wash- the ingredient is used in food with no ington, DC 20418, or available for in- limitation other than current good spection at the National Archives and manufacturing practice. The affirma- Records Administration (NARA). For tion of this ingredient as generally rec- information on the availability of this ognized as safe (GRAS) as a direct material at NARA, call 202–741–6030, or human food ingredient is based upon go to: http://www.archives.gov/ the following current good manufac- federallregister/ turing practice conditions of use: codeloflfederallregulations/ (1) The ingredient is used as an emul- ibrllocations.html. sifier as defined in § 170.3(o)(8) of this

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chapter and as a pH control agent as chapter and jams and jellies as defined defined in § 170.3(o)(23) of this chapter. in § 170.3(n)(28) of this chapter. (2) The ingredient is used in the fol- (d) Prior sanctions for this ingredient lowing foods at levels not to exceed different from the uses established in current good manufacturing practice: this section do not exist or have been cheeses as defined in§ 170.3(n)(5) of this waived. chapter; fats and oils as defined in § 170.3(n)(12) of this chapter; and jams [48 FR 52447, Nov. 18, 1983] and jellies as defined in § 170.3(n)(28) of this chapter. § 184.1807 Sodium thiosulfate. (d) Prior sanctions for this ingredient (a) Sodium thiosulfate (Na2S2O3·5H2O, different from the uses established in CAS Reg. No. 010102–0917–097) is also this section do not exist or have been known as sodium hyposulfite. It is pre- waived. pared synthetically by the reaction of [48 FR 52447, Nov. 18, 1983] sulfides and sulfur dioxide (SO2), the reaction of sulfur and sulfite, or the ox- § 184.1804 Sodium potassium tartrate. idation of metal sulfides and (a) Sodium potassium tartrate hydrosulfides. (b) The ingredient meets the speci- (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– 6) is the sodium potassium salt of l¥( fications of the ‘‘Food Chemicals + )¥tartaric acid and is also called the Codex,’’ 3d Ed. (1981), p. 304, which is in- Rochelle salt. It occurs as colorless corporated by reference. Copies may be crystals or as a white, crystalline pow- obtained from the National Academy der and has a cooling saline taste. It is Press, 2101 Constitution Ave. NW., obtained as a byproduct of wine manu- Washington, DC 20418, or may be exam- facture. ined at the National Archives and (b) The ingredient meets the speci- Records Administration (NARA). For fications of the Food Chemicals Codex, information on the availability of this 3d Ed. (1981), p. 296, which is incor- material at NARA, call 202–741–6030, or porated by reference. Copies are avail- go to: http://www.archives.gov/ able from the National Academy Press, federallregister/ 2101 Constitution Ave. NW., Wash- codeloflfederallregulations/ ington, DC 20418, or available for in- ibrllocations.html. spection at the National Archives and (c) The ingredient is used as a formu- Records Administration (NARA). For lation aid as defined in § 170.3(o)(14) of information on the availability of this this chapter and reducing agent as de- material at NARA, call 202–741–6030, or fined in § 170.3(o)(22) of this chapter. go to: http://www.archives.gov/ (d) The ingredient is used in alco- federallregister/ codeloflfederallregulations/ holic beverages and table salt in ac- ibrllocations.html. cordance with § 184.1(b)(1) at levels not (c) In accordance with § 184.1(b)(1), to exceed good manufacturing practice. the ingredient is used in food with no Current good manufacturing practice limitation other than current good results in a maximum level, as served, manufacturing practice. The affirma- of 0.00005 percent for alcoholic bev- tion of this ingredient as generally rec- erages as defined in § 170.3(n)(2) of this ognized as safe (GRAS) as a direct chapter and 0.1 percent for table salt as human food ingredient is based upon defined in § 170.3(n)(26) of this chapter. the following current good manufac- (e) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as an emul- this section do not exist or have been sifier as defined in § 170.3(o)(8) of this waived. chapter and as a pH control agent as defined in § 170.3(o)(23) of this chapter. [43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984] (2) The ingredient is used in the fol- lowing foods at levels not to exceed current good manufacturing practice: cheeses as defined in § 170.3(n)(5) of this

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§ 184.1835 Sorbitol. in soft candy as defined in § 170.3(n)(38) (a) Sorbitol is the chemical 1,2,3,4,5,6- of this chapter, 30 percent in non- standardized jams and jellies, commer- hexanehexol (C6H14O6), a hexahydric al- cohol, differing from mannitol prin- cial, as defined in § 170.3(n)(28) of this cipally by having a different optical ro- chapter, 30 percent in baked goods and tation. Sorbitol is produced by the baking mixes as defined in § 170.3(n)(1) electrolytic reduction, or the transi- of this chapter, 17 percent in frozen tion metal catalytic hydrogenation of dairy desserts and mixes as defined in sugar solutions containing glucose or § 170.3(n)(20) of this chapter, and 12 per- fructose. cent in all other foods. (b) The ingredient meets the speci- (e) The label and labeling of food fications of the ‘‘Food Chemicals whose reasonably foreseeable consump- Codex,’’ 3d Ed. (1981), p. 308, which is in- tion may result in a daily ingestion of corporated by reference. Copies may be 50 grams of sorbitol shall bear the obtained from the National Academy statement: ‘‘Excess consumption may Press, 2101 Constitution Ave. NW., have a laxative effect.’’ Washington, DC 20418, or may be exam- (f) Prior sanctions for this ingredient ined at the National Archives and different from the uses established in Records Administration (NARA). For this regulation do not exist or have information on the availability of this been waived. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [42 FR 14653, Mar. 15, 1977, as amended at 49 federallregister/ FR 5613, Feb. 14, 1984] codeloflfederallregulations/ ibrllocations.html. § 184.1845 Stannous chloride (anhy- (c) The ingredient is used as an drous and dihydrated). anticaking agent and free-flow agent as (a) Stannous chloride is anhydrous or defined in § 170.3(o)(1) of this chapter, contains two molecules of water of hy- curing and pickling agent as defined in dration. Anhydrous stannous chloride § 170.3(o)(5) of this chapter, drying (SnCl2, CAS Reg. No. 7772–99–8) is the agent as defined in § 170.3(o)(7) of this chloride salt of metallic tin. It is pre- chapter, emulsifier and emulsifier salt pared by reacting molten tin with ei- as defined in § 170.3(o)(8) of this chap- ther chlorine or gaseous tin tetra- ter, firming agent as defined in chloride. Dihydrated stannous chloride § 170.3(o)(10) of this chapter, flavoring (SnCl2·2H2O, CAS Reg. No. 10025–69–1) is agent and adjuvant as defined in the chloride salt of metallic tin that § 170.3(o)(12) of this chapter, formula- contains two molecules of water. It is tion aid as defined in § 170.3(o)(14) of prepared from granulated tin sus- this chapter, humectant as defined in pended in water and hydrochloric acid § 170.3(o)(16) of this chapter, lubricant or chlorine. and release agent as defined in (b) Both forms of the ingredient meet § 170.3(o)(18) of this chapter, nutritive sweetener as defined in § 170.3(o)(21) of the specifications of the Food Chemi- this chapter, sequestrant as defined in cals Codex, 3d Ed. (1981), p. 312, which is § 170.3(o)(26) of this chapter, stabilizer incorporated by reference. Copies are and thickener as defined in § 170.3(o)(28) available from the National Academy of this chapter, surface-finishing agent Press, 2101 Constitution Ave. NW., as defined in § 170.3(o)(30) of this chap- Washington, DC 20418, or available for ter, and texturizer as defined in inspection at the National Archives § 170.3(o)(32) of this chapter. and Records Administration (NARA). (d) The ingredient is used in food at For information on the availability of levels not to exceed good manufac- this material at NARA, call 202–741– turing practices. Current good manu- 6030, or go to: http://www.archives.gov/ facturing practice in the use of sorbitol federallregister/ results in a maximum level of 99 per- codeloflfederallregulations/ cent in hard candy and cough drops as ibrllocations.html. defined in § 170.3(n)(25) of this chapter, (c) The ingredient is used as an anti- 75 percent in chewing gum as defined in oxidant as defined in § 170.3(o)(3) of this § 170.3(n)(6) of this chapter, 98 percent chapter.

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(d) The ingredient is used in food at § 184.1851 Stearyl citrate. levels not to exceed current good man- (a) Stearyl citrate is a mixture of the ufacturing practice in accordance with mono-, di-, and tristearyl esters of cit- § 184.(b)(1). Current good manufacturing ric acid. It is prepared by esterifying practice results in a maximum level, as citric acid with stearyl alcohol. served, of 0.0015 percent or less; cal- (b) The ingredient must be of a pu- culated as tin, for all food categories. rity suitable for its intended use. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from those uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [47 FR 27816, June 25, 1982, as amended at 76 tion of this ingredient as generally rec- FR 59250, Sept. 26, 2011] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1848 Starter distillate. the following current good manufac- (a) Starter distillate (butter starter turing practice conditions of use: distillate) is a steam distillate of the (1) The ingredient is used as an anti- culture of any or all of the following oxidant as defined in § 170.3(o)(3) of this species of bacteria grown on a medium chapter; an emulsifier and emulsifier consisting of skim milk usually for- salt as defined in § 170.3(o)(8) of this tified with about 0.1 percent citric acid: chapter; a sequestrant as defined in Streptococcus lactis, S. cremoris, S. lactis § 170.3(o)(26) of this chapter; and a sur- subsp. diacetylactis, Leuconostoc face-active agent as defined in citrovorum, and L. dextranicum. The in- § 170.3(o)(29) of this chapter. gredient contains more than 98 percent (2) The ingredient is used in mar- water, and the remainder is a mixture garine in accordance with § 166.110 of of butterlike flavor compounds. Diace- this chapter; in nonalcoholic beverages tyl is the major flavor component, con- as defined in § 170.3(n)(3) of this chap- stituting as much as 80 to 90 percent of ter; and in fats and oils as defined in the mixture of organic flavor com- § 170.3(n)(12) of this chapter at levels pounds. Besides diacetyl, starter dis- not to exceed current good manufac- tillate contains minor amounts of acet- turing practice. aldehyde, ethyl formate, ethyl acetate, (d) Prior sanctions for this ingredient acetone, ethyl alcohol, 2-butanone, different from the uses established in acetic acid, and acetoin. this section, or different from those set (b) The ingredient must be of a pu- forth in part 181 of this chapter, do not rity suitable for its intended use. exist or have been waived. (c) In accordance with § 184.1(b)(1), [59 FR 63897, Dec. 12, 1994, as amended at 73 the ingredient is used in food with no FR 8608, Feb. 14, 2008] limitation other than current good manufacturing practice. The affirma- § 184.1854 Sucrose. tion of this ingredient as generally rec- (a) Sucrose (C12H22O11, CAS Reg. No. ognized as safe (GRAS) as a direct 57–50–11–1) sugar, cane sugar, or beet human food ingredient is based upon sugar is the chemical b-D- the following current good manufac- fructofuranosyl-a-D-glucopyranoside. turing practice conditions of use: Sucrose is obtained by crystallization (1) The ingredient is used as a fla- from sugar cane or sugar beet juice voring agent and adjuvant as defined in that has been extracted by pressing or § 170.3(o)(12) of this chapter. diffusion, then clarified and evapo- (2) The ingredient is used in food at rated. levels not to exceed current good man- (b) The ingredient must be of a pu- ufacturing practice. rity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. [48 FR 51907, Nov. 15, 1983, as amended at 73 (d) Prior sanctions for this ingredient FR 8608, Feb. 14, 2008] different from the uses established in

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this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no limitation other than current good [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, manufacturing practice. 1989, as amended at 73 FR 8608, Feb. 14, 2008] (d) Prior sanctions for this ingredient § 184.1857 Corn sugar. different from the uses established in this section do not exist or have been (a) Corn sugar (C6H12O6, CAS Reg. No. waived. 50–99–7), commonly called D-glucose or dextrose, is the chemical a-D- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, glucopyranose. It occurs as the anhy- 1989, as amended at 73 FR 8608, Feb. 14, 2008] drous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of corn starch with safe and suitable acids (a) Corn syrup, commonly called or enzymes, followed by refinement and ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is crystallization from the resulting hy- obtained by partial hydrolysis of corn drolysate. starch with safe and suitable acids or (b) The ingredient meets the speci- enzymes. It may also occur in the de- fications of the Food Chemicals Codex, hydrated form (dried glucose sirup). 3d Ed. (1981), pp. 97–98 under the head- Depending on the degree of hydrolysis, ing ‘‘Dextrose,’’ which is incorporated corn syrup may contain, in addition to by reference in accordance with 5 glucose, maltose and higher U.S.C. 552(a) and 1 CFR part 1. Copies saccharides. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave., NW., fications as defined and determined in Washington, DC 20418, or available for § 168.120(b) or § 168.121(a) of this chapter, inspection at the National Archives as appropriate. and Records Administration (NARA). (c) In accordance with § 184.1(b)(1), For information on the availability of the ingredient is used in food with no this material at NARA, call 202–741– limitation other than current good 6030, or go to: http://www.archives.gov/ manufacturing practice. federallregister/ (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [53 FR 44876, Nov. 7, 1988, as amended at 73 limitation other than current good FR 8608, Feb. 14, 2008] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1866 High fructose corn syrup. different from the uses established in (a) High fructose corn syrup, a sweet, this section do not exist or have been nutritive saccharide mixture con- waived. taining either approximately 42 or 55 percent fructose, is prepared as a clear [53 FR 44876, Nov. 7, 1988] aqueous solution from high dextrose- equivalent corn starch hydrolysate by § 184.1859 Invert sugar. partial enzymatic conversion of glu- (a) Invert sugar (CAS Reg. No. 8013– cose (dextrose) to fructose using an in- 17–0) is an aqueous solution of inverted soluble glucose isomerase enzyme prep- or partly inverted, refined or partly re- aration described in § 184.1372. The fined sucrose, the solids of which con- product containing more than 50 per- tain not more than 0.3 percent by cent fructose (dry weight) is prepared weight of ash. The solution is colorless, through concentration of the fructose odorless, and flavorless, except for portion of the mixture containing less sweetness. It is produced by the hydrol- than 50 percent fructose. ysis or partial hydrolysis of sucrose (b) The ingredient shall conform to with safe and suitable acids or en- the identity and specifications listed in zymes. the monograph entitled ‘‘High-Fruc- (b) The ingredient must be of a pu- tose Corn Syrup’’ in the Food Chemi- rity suitable for its intended use. cals Codex, 4th ed. (1996), pp. 191–192,

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which is incorporated by reference in the following current good manufac- accordance with 5 U.S.C. 552(a) and 1 turing practice conditions of use: CFR part 51. Copies are available from (1) The ingredient is used as a fla- the Office of Food Additive Safety voring agent and adjuvant as defined in (HFS–200), Center for Food Safety and § 170.3(o)(12) of this chapter or as a nu- Applied Nutrition, Food and Drug Ad- trient supplement as defined in ministration, 5001 Campus Dr., College § 170.3(o)(20) of this chapter. Park, MD 20740, 240–402–1200, or may be (2) The ingredient is used in food at examined at the Food and Drug Admin- levels not to exceed current good man- istration’s Main Library, 10903 New ufacturing practice. Thiamine hydro- Hampshire Ave., Bldg. 2, Third Floor, chloride may be used in infant formula Silver Spring, MD 20993, 301–796–2039, or in accordance with section 412(g) of the at the National Archives and Records Federal Food, Drug, and Cosmetic Act Administration (NARA). For informa- (the Act) or with regulations promul- tion on the availability of this mate- gated under section 412(a)(2) of the Act. rial at NARA, call 202–741–6030, or go (d) Prior sanctions for this ingredient to: http://www.archives.gov/ different from the uses established in federallregister/ this section do not exist or have been codeloflfederallregulations/ waived. ibrllocations.html. [48 FR 55124, Dec. 9, 1983] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1878 Thiamine mononitrate. limitation other than current good (a) Thiamine mononitrate manufacturing practice. (C12H17N5O4S, CAS Reg. No. 532–43–4) is [61 FR 43450, Aug. 23, 1996, as amended at 78 the mononitrate salt of thiamine. It FR 14667, Mar. 7, 2013; 81 FR 5596, Feb. 3, 2016] occurs as white crystals or a white crystalline powder and is prepared § 184.1875 Thiamine hydrochloride. from thiamine hydrochloride by dis- (a) Thiamine hydrochloride solving the hydrochloride salt in alka- (C12H17C1N4OS·HCl, CAS Reg. No. 67–03– line solution followed by precipitation 8) is the chloride-hydrochloride salt of of the nitrate half-salt with a stoichio- thiamine. It occurs as hygroscopic metric amount of nitric acid. white crystals or a white crystalline (b) The ingredient meets the speci- powder. The usual method of preparing fications of the Food Chemicals Codex, this substance is by linking the 3d Ed. (1981), p. 325, which is incor- preformed and pyrimidine ring porated by reference. Copies are avail- systems. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the Food Chemicals Codex, ington, DC 20418, or available for in- 3d Ed. (1981), p. 324, which is incor- spection at the National Archives and porated by reference. Copies are avail- Records Administration (NARA). For able from the National Academy Press, information on the availability of this 2101 Constitution Ave. NW., Wash- material at NARA, call 202–741–6030, or ington, DC 20418, or available for in- go to: http://www.archives.gov/ spection at the National Archives and federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter.

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(2) The ingredient is used in food at (2) The ingredients are used in pump- levels not to exceed current good man- cured bacon at levels not to exceed cur- ufacturing practice. Thiamine mono- rent good manufacturing practice. nitrate may be used in infant formula [49 FR 13348, Apr. 4, 1984] in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act § 184.1901 Triacetin. (the Act) or with regulations promul- gated under section 412(a)(2) of the Act. (a) Triacetin (C8 H14O6, CAS Reg. No. (d) Prior sanctions for this ingredient 102–76–1), also known as 1,2,3,- different from the uses established in propanetriol triacetate or glyceryl this section do not exist or have been triacetate, is the triester of glycerin waived. and acetic acid. Triacetin can be pre- pared by heating glycerin with acetic [48 FR 55124, Dec. 9, 1983] anhydride alone or in the presence of finely divided potassium hydrogen sul- α § 184.1890 -Tocopherols. fate. It can also be prepared by the re- (a) The a-tocopherols that are the action of oxygen with a liquid-phase subject of this GRAS affirmation regu- mixture of allyl acetate and acetic acid lation are limited to the following: using a bromide salt as a catalyst. (1) d-a-Tocopherol (CAS Reg. No. 59– (b) The ingredient meets the speci- 02–9) is the chemical [2R,4′R,8′R]-2,5,7,8- fications of the Food Chemicals Codex, tetramethyl-2-(4′,8′,12′-trimethyl- 3d Ed. (1981), pp. 337–338, as revised by tridecyl)-6-chromanol. It occurs com- the First Supplement to the 3d Ed., mercially as a concentrate and is a red, which is incorporated by reference in nearly odorless, viscous oil. It is ob- accordance with 5 U.S.C. 552(a). Copies tained by vacuum steam distillation of are available from the National Acad- edible vegetable oil products. emy Press, 2102 Constitution Ave., NW., (2) dl-a-Tocopherol (CAS Reg. No. Washington, DC 20418, or available for 10191–41–0) is a mixture of inspection at the National Archives stereoisomers of 2,5,7,8-tetramethyl-2- and Records Administration (NARA). (4′,8′,12′-trimethyl-tridecyl)-6- For information on the availability of chromanol. It is chemically syn- this material at NARA, call 202–741– thesized by condensing racemic 6030, or go to: http://www.archives.gov/ isophytol with trimethyl hydro- federallregister/ quinone. It is a pale yellow viscous oil codeloflfederallregulations/ at room temperature. ibrllocations.html. (b) The ingredients meet the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d Ed. (1981), pp. 330–331, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The affirma- able from the National Academy Press, tion of this ingredient as generally rec- 2101 Constitution Ave. NW., Wash- ognized as safe (GRAS) as a direct ington, DC 20418, or available for in- human food ingredient is based upon spection at the National Archives and the following current good manufac- Records Administration (NARA). For turing practice conditions of use: information on the availability of this (1) The ingredient is used in food as a material at NARA, call 202–741–6030, or flavoring agent and adjuvant as defined go to: http://www.archives.gov/ in § 170.3(o)(12) of this chapter; a formu- federallregister/ lation aid as defined in § 170.3(o)(14) of codeloflfederallregulations/ this chapter; and humectant as defined ibrllocations.html. in § 170.3(o)(16) of this chapter; and a (c) In accordance with § 184.1(b)(3), solvent and vehicle as defined in the affirmation of the ingredients as § 170.3(o)(27) of this chapter. generally recognized as safe is limited (2) The ingredient is used in the fol- to the following conditions of use while lowing foods at levels not to exceed the agency concludes the general eval- current good manufacturing practice: uation of all food uses of tocopherols: baked goods and baking mixes as de- (1) The ingredients are used as inhibi- fined in § 170.3(n)(1) of this chapter, al- tors of nitrosamine formation. coholic beverages as defined in

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§ 170.3(n)(2) of this chapter; non- this chapter; alcoholic beverages as de- alcoholic beverages and beverage bases fined in § 170.3(n)(2) of this chapter; as defined in § 170.3(n)(3) of this chap- nonalcoholic beverages as defined in ter; chewing gum as defined in § 170.3(n)(3) of this chapter; fats and oils § 170.3(n)(6) of this chapter; confections as defined in § 170.3(n)(12) of this chap- and frostings as defined in § 170.3(n)(9) ter; frozen dairy desserts and mixes as of this chapter; frozen dairy dessert defined in § 170.3(n)(20) of this chapter; and mixes as defined in § 170.3(n)(20) of gelatins, puddings and fillngs as de- this chapter; gelatins, puddings, and fined in § 170.3(n)(22) of this chapter; fillngs as defined in § 170.3(n)(22) of this and soft candy as defined in chapter; hard candy as defined in § 170.3(n)(38) of this chapter. § 170.3(n)(25) of this chapter; and soft (d) Prior sanctions for this ingredient candy as defined in § 170.3(n)(38) of this different from the uses established in chapter. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, this section do not exist or have been 1989] waived. [54 FR 7404, Feb. 21, 1989] § 184.1911 Triethyl citrate. (a) Triethyl citrate (C12H20O7, CAS § 184.1903 Tributyrin. Reg. No. 77–93–0) is the triethyl ester of

(a) Tributyrin (C15H26O6, CAS Reg. citric acid. It is prepared by esterifying No. 60–01–5), also known as butyrin or citric acid with ethyl alcohol and oc- glyceryl tributyrate, is the triester of curs as an odorless, practically color- glycerin and butyric acid. It is pre- less, oily liquid. pared by esterification of glycerin with (b) The ingredient meets the speci- excess butyric acid. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d ed. (1981), p. 339, which is incor- fication of the Food Chemicals Codex, porated by reference in accordance 3d Ed. (1981), p. 416, which is incor- with 5 U.S.C. 552(a) and 1 CFR part 51. porated by reference in accordance Copies are available from the National with 5 U.S.C. 552(a). Copies are avail- Academy Press, 2101 Constitution Ave. able from the National Academy Press, NW., Washington, DC 20418, and the 2101 Constitution Ave. NW., Wash- Center for Food Safety and Applied Nu- ington, DC 20418, or available for in- trition (HFS–200), 5001 Campus Dr., Col- spection at the National Archives and lege Park, MD 20740, or may be exam- Records Administration (NARA). For ined at the National Archives and information on the availability of this Records Administration (NARA). For material at NARA, call 202–741–6030, or information on the availability of this go to: http://www.archives.gov/ material at NARA, call 202–741–6030, or federallregister/ go to: http://www.archives.gov/ codeloflfederallregulations/ federallregister/ ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generaly rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used in food as a turing practice conditions of use: flavoring agent and adjuvant as defined (1) The ingredient is used as a fla- in § 170.3(o)(12) of this chapter. voring agent as defined in § 170.3(o)(12) (2) The ingredient is used in the fol- of this chapter; a solvent and vehicle as lowing foods at levels not to exceed defined in § 170.3(o)(27) of this chapter; current good manufacturing practice; and a surface-active agent as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(o)(29) of this chapter.

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(2) The ingredient is used in foods at § 184.1923 Urea. levels not to exceed current good man- (a) Urea (CO(NH ) , CAS Reg. No. 57– ufacturing practice. 2 2 13–6) is the diamide of carbonic acid (d) Prior sanctions for this ingredient and is also known as carbamide. It is a different from the uses established in white, odorless solid and is commonly this section, or different from those set produced from CO2 by ammonolysis or forth in part 181 of this chapter, do not from cyanamide by hydrolysis. exist or have been waived. (b) The ingredient must be of a pu- [59 FR 63897, Dec. 12, 1994] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1914 Trypsin. the ingredient is used in food with no (a) Trypsin (CAS Reg. No. 9002–07–7) limitation other than current good manufacturing practice. The affirma- is an enzyme preparation obtained tion of this ingredient as generally rec- from purified extracts of porcine or bo- ognized as safe as a direct human food vine pancreas. It is a white to tan ingredient is based upon the following amorphous powder. Its characterizing current good manufacturing practice enzyme activity is that of a peptide hy- conditions of use: drolase (EC 3.4.21.4). (1) The ingredient is used as a formu- (b) The ingredient meets the general lation aid as defined in § 170.3(o)(14) of requirements and additional require- this chapter and as a fermentation aid. ments for enzyme preparations in the (2) The ingredient is used in yeast- Food Chemicals Codex, 3d ed. (1981), p. raised bakery products; in alcoholic 110, which is incorporated by reference beverages as defined in § 170.3(n)(2) of in accordance with 5 U.S.C. 552(a) and 1 this chapter; and in gelatin products. CFR part 51. Copies are available from (d) Prior sanctions for this ingredient the National Academy Press, 2101 Con- different from the uses established in stitution Ave. NW., Washington, DC this section do not exist or have been 20418, or may be examined at the Office waived. of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nu- [48 FR 51616, Nov. 10, 1983, as amended at 49 trition, Food and Drug Administration, FR 19816, May 10, 1984; 73 FR 8608, Feb. 14, 5001 Campus Dr., College Park, MD 2008] 20740, 240–402–1200, and at the National § 184.1924 Urease enzyme preparation Archives and Records Administration from Lactobacillus fermentum. (NARA). For information on the avail- ability of this material at NARA, call (a) This enzyme preparation is de- 202–741–6030, or go to: http:// rived from the nonpathogenic, www.archives.gov/federallregister/ nontoxicogenic bacterium Lactobacillus codeloflfederallregulations/ fermentum. It contains the enzyme ibrllocations.html. urease (CAS Reg. No. 9002–13–5), which (c) In accordance with § 184.1(b)(1), facilitates the hydrolysis of urea to the ingredient is used in food with no ammonia and carbon dioxide. It is pro- limitation other than current good duced by a pure culture fermentation manufacturing practice. The affirma- process and by using materials that are tion of this ingredient as GRAS as a di- generally recognized as safe (GRAS) or rect food ingredient is based upon the are food additives that have been ap- following current good manufacturing proved for this use by the Food and practice conditions of use: Drug Administration (FDA). (b) The ingredient meets the general (1) The ingredient is used as an en- and additional requirements for en- zyme as defined in § 170.3(o)(9) of this zyme preparations in the ‘‘Food Chemi- chapter to hydrolyze proteins or cals Codex,’’ 3d ed. (1981), pp. 107–110, polypeptides. which is incorporated by reference in (2) The ingredient is used in food at accordance with 5 U.S.C. 552(a) and 1 levels not to exceed current good man- CFR part 51. Copies are available from ufacturing practice. the National Academy Press, 2101 Con- [60 FR 32911, June 26, 1995, as amended at 78 stitution Ave. NW., Washington, DC FR 14667, Mar. 7, 2013] 20418, or available for inspection at the

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National Archives and Records Admin- www.archives.gov/federallregister/ istration (NARA). For information on codeloflfederallregulations/ the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (c) In accordance with § 184.1(b)(1), www.archives.gov/federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The affirma- the following current good manufac- tion of this ingredient as GRAS as a di- turing practice conditions of use: rect human food ingredient is based (1) The ingredient is used in food as a upon the following current good manu- nutrient supplement as defined in facturing practice conditions of use: § 170.3(o)(20) of this chapter. (1) The ingredient is used in wine, as (2) The ingredient is used in foods at defined in 27 CFR 2.5 and 4.10, as an en- levels not to exceed current good man- zyme as defined in § 170.3(o)(9) of this ufacturing practice. Vitamin A may be chapter to convert urea to ammonia used in infant formula in accordance and carbon dioxide. with section 412(g) of the Federal Food, (2) The ingredient is used in food at Drug, and Cosmetic Act (the act) or levels not to exceed current good man- with regulations promulgated under ufacturing practice. Current good man- section 412(a)(2) of the Act. ufacturing practice is limited to use of (d) Prior sanctions for this ingredient this ingredient in wine to inhibit for- different from the uses established in mation of ethyl carbamate. this section do not exist or have been waived. [57 FR 60473, Dec. 21, 1992] [48 FR 51610, Nov. 10, 1983] § 184.1930 Vitamin A. (a)(1) Vitamin A (retinol; CAS Reg. § 184.1945 Vitamin B 12. No. 68–26–8) is the alcohol 9,13-di- (a) Vitamin B12, also known as cyano- methyl-7-(1,1,5-trimethyl-6-cyclohexen- cobalamin (C63H88CoN14O14P, CAS Reg. 5-yl)-7,9,11,13-nonatetraen-15-ol. It may No. 68–0919–099), is produced commer- be nearly odorless or have a mild fishy cially from cultures of Streptomyces odor. Vitamin A is extracted from fish griseus. liver oils or produced by total syn- (b) The ingredient meets the speci- thesis from b-ionone and a propargyl fications of the Food Chemicals Codex, halide. 3d Ed. (1981), p. 343, which is incor- (2) Vitamin A acetate (retinyl ace- porated by reference. Copies are avail- tate; CAS Reg. No. 127–47–9) is the ace- able from the National Academy Press, tate ester of retinol. It is prepared by 2101 Constitution Ave. NW., Wash- esterifying retinol with acetic acid. ington, DC 20418, or available for in- (3) Vitamin A palmitate (retinyl spection at the National Archives and palmitate; CAS Reg. No. 79–81–2) is the Records Administration (NARA). For palmitate ester of retinol. It is pre- information on the availability of this pared by esterifying retinol with pal- material at NARA, call 202–741–6030, or mitic acid. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications for vitamin A in the Food codeloflfederallregulations/ Chemicals Codex, 3d Ed. (1981), p. 342, ibrllocations.html. which is incorporated by reference. (c) In accordance with § 184.1(b)(1), Copies are available from the National the ingredient is used in food with no Academy Press, 2101 Constitution Ave. limitation other than current good NW., Washington, DC 20418, or avail- manufacturing practice. The affirma- able for inspection at the National Ar- tion of this ingredient as generally rec- chives and Records Administration ognized as safe (GRAS) as a direct (NARA). For information on the avail- human food ingredient is based upon ability of this material at NARA, call the following current good manufac- 202–741–6030, or go to: http:// turing practice conditions of use:

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(1) The ingredient is used as a nutri- National Archives and Records Admin- ent supplement as defined in istration (NARA). For information on § 170.3(o)(20) of this chapter. the availability of this material at (2) The ingredient is used in food at NARA, call 202–741–6030, or go to: http:// levels not to exceed current good man- www.archives.gov/federallregister/ ufacturing practice. Vitamin B12 also codeloflfederallregulationsll may be used in infant formula in ac- ibrllocations.html. Vitamin D2 resin cordance with section 412(g) of the Fed- and vitamin D3 resin must be of a pu- eral Food, Drug, and Cosmetic Act (the rity suitable for their intended use. act) or with regulations promulgated (c)(1) In accordance with § 184.1(b)(2), under section 412(a)(2) of the act. the ingredients are used in food as the (d) Prior sanctions for this ingredient sole source of added vitamin D only different from the uses established in within the following specific limita- this section do not exist or have been tions: waived. Category of food Maximum levels in Functional use [50 FR 6341, Feb. 15, 1985] food (as served) Breakfast cereals, 350 (IU/100 Nutrient supple- § 184.1950 Vitamin D. § 170.3(n)(4) of grams). ment, (a) Vitamin D is added to food as the this chapter. § 170.3(o)(20) of this chapter. following food ingredients: Grain products and 90(IU/100 grams) Do. (1) Crystalline vitamin D2 (C28H44O, pastas, CAS Reg. No. 50–14–6), also known as § 170.3(n)(23) of ergocalciferol, is the chemical 9,10- this chapter. Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. seco(5Z,7E,22E)-5,7,10(19),22- of this chapter. ergostatetraen-3-ol. The ingredient is Milk products, 89 (IU/100 grams) Do. produced by ultraviolet irradiation of § 170.3(n)(31) of ergosterol isolated from yeast and re- this chapter. lated fungi and is purified by crys- (2) Vitamin D may be used in infant tallization. formula in accordance with section (2) Crystalline vitamin D (C H O, 3 27 44 412(g) of the Federal Food, Drug, and CAS Reg. No. 67–97–0), also known as Cosmetic Act (the act) or with regula- cholecalciferol, is the chemical 9,10- tions promulgated under section seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- 412(a)(2) of the act. ol. Vitamin D occurs in, and is iso- 3 (3) Vitamin D may be used in mar- lated from, fish liver oils. It is also garine in accordance with § 166.110 of manufactured by ultraviolet irradia- this chapter. tion of 7-dehydrocholesterol produced (d) Prior sanctions for these ingredi- from cholesterol. It is purified by crys- ents different from the uses established tallization. Vitamin D is the vitamin 3 in this section do not exist or have D form that is produced endogenously been waived. in humans through sunlight activation of 7-dehydrocholesterol in the skin. [50 FR 30152, July 24, 1985, as amended at 73 (3) Vitamin D2 resin and vitamin D3 FR 8608, Feb. 14, 2008] resin are the concentrated forms of ir- § 184.1973 Beeswax (yellow and white). radiated ergosterol (D2) and irradiated 7-dehydrocholesterol (D3) that are sepa- (a) Beeswax (CAS Reg. No. 8012–89–3) rated from the reacting materials in is a secretory product of honey bees paragraphs (a) (1) and (2) of this sec- used as a structural material in honey- tion. The resulting products are sold as combs. Beeswax is prepared from hon- food sources of vitamin D without fur- eycombs after removal of the honey by ther purification. draining or centrifuging. The combs (b) Vitamin D2 and vitamin D3 as are melted in hot water or steam or crystals meet the specifications of the with solar heat, and strained. The wax Food Chemicals Codex, 3d Ed. (1981), is refined by melting in hot water to pp. 344 and 345, which is incorporated which sulfuric acid or alkali may be by reference. Copies are available from added to extract impurities. The re- the National Academy Press, 2101 Con- sulting wax is referred to as yellow stitution Ave. NW., Washington, DC beeswax. White beeswax is produced by 20418, or available for inspection at the bleaching the constituent pigments of

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yellow beeswax with peroxides, or pref- porated by reference. Copies are avail- erably it is bleached by sun light. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the ‘‘Food Chemicals ington, DC 20418, or available for in- Codex,’’ 3d Ed. (1981), pp. 34–35, which is spection at the National Archives and incorporated by reference. Copies may Records Administration (NARA). For be obtained from the National Acad- information on the availability of this emy Press, 2101 Constitution Ave. NW., material at NARA, call 202–741–6030, or Washington, DC 20418, or may be exam- go to: http://www.archives.gov/ ined at the National Archives and federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ ibrllocations.html. manufacturing practice. The affirma- (c) The ingredient is used as a fla- tion of this ingredient as generally rec- voring agent and adjuvant as defined in ognized as safe (GRAS) as a direct § 170.3(o)(12) of this chapter, as a lubri- human food ingredient is based upon cant as defined in § 170.3(o)(18) of this the following current good manufac- chapter, and as a surface-finishing turing practice conditions of use: agent as defined in § 170.3(o)(30) of this (1) The ingredient is used as a lubri- chapter. cant as defined in § 170.3(o)(18) of this (d) The ingredient is used in food, in chapter and as a surface-finishing accordance with § 184.1(b)(1) of this agent as defined in § 170.3(o)(30) of this chapter, at levels not to exceed good chapter. manufacturing practice. Current good (2) The ingredient is used in the fol- manufacturing practice results in a lowing foods at levels not to exceed maximum level, as served, of: 0.065 per- current good manufacturing practice: cent for chewing gum as defined in in chewing gum as defined in § 170.3(n)(6) of this chapter; 0.005 per- § 170.3(n)(6) of this chapter and in hard cent for confections and frostings as candy as defined in § 170.3(n)(25) of this defined in § 170.3(n)(9) of this chapter; chapter. 0.04 percent for hard candy as defined (d) Prior sanctions for this ingredient in § 170.3(n)(25) of this chapter; 0.1 per- different from the uses established in cent for soft candy as defined in this section do not exist or have been § 170.3(n)(38) of this chapter; and 0.002 waived. percent or less for all other food cat- egories. [48 FR 51617, Nov. 10, 1983] [43 FR 14644, Apr. 7, 1978, as amended at 49 § 184.1978 Carnauba wax. FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, 1985] (a) Carnauba wax (CAS Reg. No. 008– 015–869) is obtained from the leaves and § 184.1976 Candelilla wax. buds of the Brazilian wax palm (a) Candelilla wax (CAS Reg. No. Copernicia cerifera Martius. The wax is 8006–44–8) is obtained from the can- hard, brittle, sparingly soluble in cold delilla plant. It is a hard, yellowish- organic solvents and insoluble in brown, opaque-to-translucent wax. water. It is marketed in five grades Candelilla wax is prepared by immers- designated No. 1 through No. 5. Grades ing the plants in boiling water con- No. 4 and No. 5 represent the bulk of taining sulfuric acid and skimming off the commercial trade volume. These the wax that rises to the surface. It is commercial grades consist chiefly of composed of about 50 percent hydro- C24 to C32 normal saturated carbons with smaller amounts of esters monofunctional fatty acids and normal and free acids. saturated monofunctional primary al- (b) The ingredient meets the speci- cohols. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 67, which is incor- fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 73, which is incor- lactic acid, or from the curd formation porated by reference. Copies are avail- by direct acidification of milk, is able from the National Academy Press, known as acid whey. Whey obtained 2101 Constitution Ave. NW., Wash- from a procedure in which there is in- ington, DC 20418, or available for in- significant conversion of lactose to lac- spection at the National Archives and tic acid is known as sweet whey. Sweet Records Administration (NARA). For whey has a maximum titratable acid- information on the availability of this ity of not more than 0.16 percent, cal- material at NARA, call 202–741–6030, or culated as lactic acid, and an alka- go to: http://www.archives.gov/ linity of ash of not more than 225 milli- federallregister/ liters of 0.1N hydrochloric acid per 100 codeloflfederallregulations/ grams. The acidity of whey, sweet or ibrllocations.html. acid, may be adjusted by the addition (c) In accordance with § 184.1(b)(1), of safe and suitable pH-adjusting ingre- the ingredient is used in food with no dients. limitation other than current good (2) Concentrated whey. Concentrated manufacturing practice. The affirma- whey is the liquid substance obtained tion of this ingredient as generally rec- by the partial removal of water from ognized as safe (GRAS) as a direct whey, while leaving all other constitu- human food ingredient is based upon ents in the same relative proportions the following current good manufac- as in whey. turing practice conditions of use: (3) Dry or dried whey. Dry or dried (1) The ingredient is used as an whey is the dry substance obtained by anticaking agent as defined § 170.3(o)(1) the removal of water from whey, while of this chapter; as a formulation aid as leaving all other constituents in the defined in § 170.3(o)(14) of this chapter; same relative proportions as in whey. as a lubricant and release agent as de- (b) The ingredients meet the fol- fined in § 170.3(o)(18) of this chapter; lowing specifications: and as a surface-finishing agent as de- (1) The analysis of whey, con- fined in § 170.3(o)(30) of this chapter. centrated whey, and dry (dried) whey, (2) The ingredient is used in the fol- on a dry product basis, based on ana- lowing foods at levels not to exceed lytical methods in the referenced sec- current good manufacturing practice: tions of ‘‘Official Methods of Analysis baked goods and baking mixes as de- of the Association of Official Analyt- fined in § 170.3(n)(1) of this chapter; ical Chemists,’’ 13th ed. (1980), which is chewing gun as defined in § 170.3(n)(6) of incorporated by reference in accord- this chapter; confections and frostings ance with 5 U.S.C. 552(a) and 1 CFR as defined in § 170.3(n)(9) of this chap- part 51, is given in paragraphs (b)(1)(i) ter; fresh fruits and fruit juices as de- through (b)(1)(vii) of this section. Cop- fined in § 170.3(n)(16) of this chapter; ies may be obtained from the AOAC gravies and sauces as defined in INTERNATIONAL, 481 North Frederick § 170.3(n)(24) of this chapter; processed Ave., suite 500, Gaithersburg, MD 20877, fruits and fruit juices as defined in or may be examined at the Food and § 170.3(n)(35) of this chapter; and soft Drug Administration’s Main Library, candy as defined in § 170.3(n)(38) of this 10903 New Hampshire Ave., Bldg. 2, chapter. Third Floor, Silver Spring, MD 20993, (d) Prior sanctions for this ingredient 301–796–2039, or at the National Ar- different from the uses established in chives and Records Administration this section do not exist or have been (NARA). For information on the avail- waived. ability of this material at NARA, call [48 FR 51147, Nov. 7, 1983] 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 184.1979 Whey. codeloflfederallregulations/ (a)(1) Whey. Whey is the liquid sub- ibrllocations.html. stance obtained by separating the co- (i) Protein content, 10 to 15 percent— agulum from milk, cream, or skim as determined by the methods pre- milk in cheesemaking. Whey obtained scribed in section 16.036 (liquid sample), from a procedure, in which a signifi- entitled ‘‘Total Nitrogen—Official cant amount of lactose is converted to Final Action’’ under the heading

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‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may sample), entitled ‘‘Kjeldahl Method’’ be examined at the Food and Drug Ad- under the heading ‘‘Protein—Official ministration’s Main Library, 10903 New Final Action.’’ Hampshire Ave., Bldg. 2, Third Floor, (ii) Fat content, 0.2 to 2.0 percent—as Silver Spring, MD 20993, 301–796–2039, or determined by the methods prescribed at the National Archives and Records in section 16.059 (liquid sample), Administration (NARA). For informa- ‘‘Reese-Gottlieb Method [Reference tion on the availability of this mate- Method] (11)—Official Final Action’’ rial at NARA, call 202–741–6030, or go under the heading ‘‘Fat,’’ or in section to: http://www.archives.gov/ 16.199 (dry sample), entitled ‘‘Fat in federallregister/ Dried Milk (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, 7 to 14 percent—as ibrllocations.html. determined by the methods prescribed (3) The whey must be derived from in section 16.035 (liquid sample), enti- milk that has been pasteurized, or the tled ‘‘Ash (5)—Official Final Action’’ whey and modified whey product must under the heading ‘‘Total Solids,’’ or in be subjected to pasteurization tech- section 16.196 (dry sample), entitled niques or its equivalent before use in ‘‘Ash—Official Final Action’’ under the food. heading ‘‘Dried Milk, Nonfat Dry Milk, (c) Whey, concentrated whey, and dry and Malted Milk.’’ (dried) whey may be used in food in ac- (iv) Lactose content, 61 to 75 per- cordance with good manufacturing cent—as determined by the methods practice as indicated in § 184.1(b)(1). prescribed in section 16.057 (liquid sam- (d) The label on the whey form sold ple), entitled ‘‘Gravimetric Method— to food manufacturers shall read as fol- Official Final Action’’ under the head- lows: ing ‘‘Lactose,’’ or in section 31.061 (dry (1) For whey: ‘‘(Sweet or acid) whey’’ sample), entitled ‘‘Lane-Eynon General or ‘‘whey (ll% titratable acidity). Volumetric Method’’ under the heading (2) For concentrated whey: ‘‘Con- ‘‘Lactose—Chemical Methods—Official centrated (sweet or acid) whey, ll% Final Action.’’ solids’’ or ‘‘Concentrated whey (ll% (v) Moisture content, 1 to 8 percent— titratable acidity), ll% solids’’. as determined by the methods pre- (3) For dry (dried) whey: ‘‘Dry (dried) scribed in section 16.192, entitled (sweet or acid) whey’’ or ‘‘dry (dried) ‘‘Moisture (41)—Official Final Action’’ whey, (ll% titratable acidity)’’. under the heading ‘‘Dried Milk, Nonfat (e) Whey, concentrated whey, or dry Dry Milk, and Malted Milk.’’ (dried) whey in a finished food product (vi) Solids content, variable—as de- shall be listed as ‘‘whey.’’ termined by the methods prescribed in [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, section 16.032, entitled ‘‘Method I—Offi- 1982, as amended at 54 FR 24899, June 12, 1989; cial Final Action’’ under the heading 64 FR 1760, Jan. 12, 1999; 81 FR 5596, Feb. 3, ‘‘Total Solids.’’ 2016] (vii) Titratable Acidity, variable—as determined by the methods prescribed § 184.1979a Reduced lactose whey. in section 16.023, entitled ‘‘Acidity (2)— (a) Reduced lactose whey is the sub- Official Final Action’’ under the head- stance obtained by the removal of lac- ing ‘‘Milk,’’ or by an equivalent poten- tose from whey. The lactose content of tiometric method. the finished dry product shall not ex- (2) Limits of impurities are: Heavy ceed 60 percent. Removal of the lactose metals (as lead). Not more than 10 is accomplished by physical separation parts per million (0.001 percent) as de- techniques such as precipitation, filtra- termined by the method described in tion, or dialysis. As with whey, reduced the ‘‘Food Chemicals Codex,’’ 4th ed. lactose whey can be used as a fluid, (1996), pp. 760–761, which is incorporated concentrate, or a dry product form. by reference in accordance with 5 The acidity of reduced lactose whey U.S.C. 552(a) and 1 CFR part 51. Copies may be adjusted by the addition of safe are available from the National Acad- and suitable pH-adjusting ingredients. emy Press, Box 285, 2101 Constitution (b) The reduced lactose whey meets Ave. NW., Washington, DC 20055 (Inter- the following specifications:

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(1) The analysis of reduced lactose heading ‘‘Lactose—Chemical Meth- whey, on a dry product basis, based on ods—Official Final Action.’’ analytical methods in the referenced (v) Moisture content, 1 to 6 percent— sections of ‘‘Official Methods of Anal- as determined by the method pre- ysis of the Association of Official Ana- scribed in section 16.192, entitled lytical Chemists,’’ 13th ed. (1980), which ‘‘Moisture (41)—Official Final Action’’ is incorporated by reference in accord- under the heading ‘‘Dried Milk, Nonfat ance with 5 U.S.C. 552(a) and 1 CFR Dry Milk, and Malted Milk.’’ part 51, is given in paragraphs (b)(1)(i) (vi) Solids content, variable—as de- through (b)(1)(vii) of this section. Cop- termined by the methods prescribed in ies may be obtained from the AOAC section 16.032, entitled ‘‘Method I—Offi- INTERNATIONAL, 481 North Frederick cial Final Action’’ under the heading Ave., suite 500, Gaithersburg, MD 20877, ‘‘Total Solids.’’ or may be examined at the Food and (vii) Titratable Acidity, variable—as Drug Administration’s Main Library, determined by the methods prescribed 10903 New Hampshire Ave., Bldg. 2, in section 16.023, entitled ‘‘Acidity (2)— Third Floor, Silver Spring, MD 20993, Official Final Action’’ under the head- 301–796–2039, or at the National Ar- ing ‘‘Milk,’’ or by an equivalent poten- chives and Records Administration tiometric method. (NARA). For information on the avail- (2) Limits of impurities are: Heavy ability of this material at NARA, call metals (as lead). Not more than 10 202–741–6030, or go to: http:// parts per million (0.001 percent), as de- www.archives.gov/federallregister/ termined by the method described in codeloflfederallregulations/ the ‘‘Food Chemicals Codex,’’ 4th ed. ibrllocations.html. (1996), pp. 760–761, which is incorporated (i) Protein content, 16 to 24 percent— by reference in accordance with 5 as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies scribed in section 16.036 (liquid sample), are available from the National Acad- entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may sample), entitled ‘‘Kjeldahl Method’’ be examined at the Food and Drug Ad- under the heading ‘‘Protein—Official ministration’s Main Library, 10903 New Final Action.’’ Hampshire Ave., Bldg. 2, Third Floor, (ii) Fat content, 1 to 4 percent—as de- Silver Spring, MD 20993, 301–796–2039, or termined by the methods prescribed in at the National Archives and Records section 16.059 (liquid sample), ‘‘Reese- Administration (NARA). For informa- Gottlieb Method [Reference Method] tion on the availability of this mate- (11)—Official Final Action’’ under the rial at NARA, call 202–741–6030, or go heading ‘‘Fat,’’ or in section 16.199 (dry to: http://www.archives.gov/ sample), entitled ‘‘Fat in Dried Milk federallregister/ (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, 11 to 27 percent—as ibrllocations.html. determined by the methods prescribed (3) The reduced lactose whey shall be in section 16.035 (liquid sample), enti- derived from milk that has been pas- tled ‘‘Ash (5)—Official Final Action’’ teurized, or the reduced lactose whey under the heading ‘‘Total Solids,’’ or in shall be subjected to pasteurization section 16.196 (dry sample), entitled techniques or its equivalent before use ‘‘Ash—Official Final Action’’ under the in food. heading ‘‘Dried Milk, Nonfat Dry Milk, (c) Reduced lactose whey may be and Malted Milk.’’ used in food in accordance with good (iv) Lactose content, not more than manufacturing practice as indicated in 60 percent—as determined by the meth- § 184.1(b)(1). ods prescribed in section 16.057 (liquid (d) The percent of lactose present on sample), entitled ‘‘Gravimetric Meth- a dry product basis, i.e., ‘‘reduced lac- od—Official Final Action’’ under the tose whey (ll% lactose),’’ shall be de- heading ‘‘Lactose,’’ or in section 31.061 clared on the label of the package sold (dry sample), entitled ‘‘Lane-Eynon to food manufacturers. The percent of General Volumetric Method’’ under the lactose may be declared in 5-percent

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increments, expressed as a multiple of entitled ‘‘Total Nitrogen—Official 5, not greater than the actual percent- Final Action’’ under the heading age of lactose in the product, or as an ‘‘Total Solids,’’ or in section 16.193 (dry actual percentage provided that an sample), entitled ‘‘Kjeldahl Method’’ analysis of the product on which the under the heading ‘‘Protein—Official actual percentage is based is supplied Final Action.’’ to the food manufacturer. (ii) Fat content, 1 to 4 percent—as de- (e) The presence of reduced lactose termined by the methods prescribed in whey in a finished food product shall be section 16.059 (liquid sample), ‘‘Reese- listed as ‘‘reduced lactose whey.’’ Gottlieb Method [Reference Method] [46 FR 44440, Sept. 4, 1981, as amended at 54 (11)—Official Final Action’’ under the FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, heading ‘‘Fat,’’ or in section 16.199 (dry 1999; 81 FR 5596, Feb. 3, 2016] sample), entitled ‘‘Fat in Dried Milk (45)—Official Final Action.’’ § 184.1979b Reduced minerals whey. (iii) Ash content, maximum 7 per- (a) Reduced minerals whey is the sub- cent—as determined by the methods stance obtained by the removal of a prescribed in section 16.035 (liquid sam- portion of the minerals from whey. The ple), entitled ‘‘Ash (5)—Official Final dry product shall not contain more Action’’ under the heading ‘‘Total Sol- than 7 percent ash. Reduced minerals ids,’’ or in section 16.196 (dry sample), whey is produced by physical separa- entitled ‘‘Ash—Official Final Action’’ tion techniques such as precipitation, under the heading ‘‘Dried Milk, Nonfat filtration, or dialysis. As with whey, Dry Milk, and Malted Milk.’’ reduced minerals whey can be used as a (iv) Lactose content, maximum 85 fluid, concentrate, or a dry product percent—as determined by the methods form. The acidity of reduced minerals prescribed in section 16.057 (liquid sam- whey may be adjusted by the addi- ple), entitled ‘‘Gravimetric Method— tional of safe and suitable pH-adjusting Official Final Action’’ under the head- ingredients. ing ‘‘Lactose,’’ or in section 31.061 (dry (b) The reduced minerals whey meets sample), entitled ‘‘Lane-Eynon General the following specifications: Volumetric Method’’ under the heading (1) The analysis of reduced minerals whey, on a dry product basis, based on ‘‘Lactose—Chemical Methods—Official analytical methods in the referenced Final Action.’’ sections of ‘‘Official Methods of Anal- (v) Moisture content, 1 to 6 percent— ysis of the Association of Official Ana- as determined by the methods pre- lytical Chemists,’’ 13th ed. (1980), which scribed in section 16.192, entitled is incorporated by reference in accord- ‘‘Moisture (41)—Official Final Action’’ ance with 5 U.S.C. 552(a) and 1 CFR under the heading ‘‘Dried Milk, Nonfat part 51, is given in paragraphs (b)(1)(i) Dry Milk, and Malted Milk.’’ through (b)(1)(vii) of this section. Cop- (vi) Solids content, variable—as de- ies may be obtained from the AOAC termined by the methods prescribed in INTERNATIONAL, 481 North Frederick section 16.032, entitled ‘‘Method I—Offi- Ave., suite 500, Gaithersburg, MD 20877, cial Final Action’’ under the heading or may be examined at the Food and ‘‘Total Solid.’’ Drug Administration’s Main Library, (vii) Titratable Acidity, variable—as 10903 New Hampshire Ave., Bldg. 2, determined by the methods prescribed Third Floor, Silver Spring, MD 20993, in section 16.023, entitled ‘‘Acidity (2)— 301–796–2039, or at the National Ar- Official Final Action’’ under the head- chives and Records Administration ing ‘‘Milk,’’ or by an equivalent poten- (NARA). For information on the avail- tiometric method. ability of this material at NARA, call (2) Limits of impurities are: Heavy 202–741–6030, or go to: http:// metals (as lead). Not more than 10 www.archives.gov/federallregister/ parts per million (0.001 percent), as de- codeloflfederallregulations/ termined by the method described in ibrllocations.html. the ‘‘Food Chemicals Codex,’’ 4th ed. (i) Protein content, 10 to 24 percent— (1996), pp. 760–761, which is incorporated as determined by the methods pre- by reference in accordance with 5 scribed in section 16.036 (liquid sample), U.S.C. 552(a) and 1 CFR part 51. Copies

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are available from the National Acad- may be adjusted by the addition of safe emy Press, Box 285, 2101 Constitution and suitable pH-adjusting ingredients. Ave. NW., Washington, DC 20055 (Inter- (b) The whey protein concentrate net address http://www.nap.edu), or may meets the following specifications: be examined at the Food and Drug Ad- (1) The analysis of whey protein con- ministration’s Main Library, 10903 New centrate, on a dry product basis, based Hampshire Ave., Bldg. 2, Third Floor, on analytical methods in the ref- Silver Spring, MD 20993, 301–796–2039, or erenced sections of ‘‘Official Methods at the National Archives and Records of Analysis of the Association of Offi- Administration (NARA). For informa- cial Analytical Chemists,’’ 13th ed. tion on the availability of this mate- (1980), which is incorporated by ref- rial at NARA, call 202–741–6030, or go erence in accordance with 5 U.S.C. to: http://www.archives.gov/ 552(a) and 1 CFR part 51, is given in federallregister/ paragraphs (b)(1)(i) through (b)(1)(vii) codeloflfederallregulations/ of this section. Copies may be obtained ibrllocations.html. from the AOAC INTERNATIONAL, 481 (3) The reduced minerals whey shall North Frederick Ave., suite 500, Gai- be derived from milk that has been pas- thersburg, MD 20877, or may be exam- teurized, or the reduced minerals whey ined at the Food and Drug Administra- shall be subjected to pasteurization tion’s Main Library, 10903 New Hamp- techniques or its equivalent before use shire Ave., Bldg. 2, Third Floor, Silver in food. Spring, MD 20993, 301–796–2039, or at the (c) The reduced minerals whey may National Archives and Records Admin- be used in food in accordance with good istration (NARA). For information on manufacturing practice as indicated in the availability of this material at § 184.1(b)(1). NARA, call 202–741–6030, or go to: http:// (d) The percent of minerals present www.archives.gov/federallregister/ on a dry product basis, i.e., ‘‘reduced codeloflfederallregulations/ minerals whey (ll% minerals),’’ shall ibrllocations.html. be declared on the label of the package (i) Protein content, minimum 25 per- sold to food manufacturers. The per- cent—as determined by the methods cent of minerals may be declared in 2- prescribed in section 16.036 (liquid sam- percent increments expressed as a mul- ple), entitled ‘‘Total Nitrogen—Offi- tiple of 2, not greater than the actual cials Final Action’’ under the heading percentage of minerals in the product, ‘‘Total Solids,’’ or in section 16.193 (dry or as an actual percentage provided sample), entitled ‘‘Kjeldahl Method’’ that an analysis of the product on under the heading ‘‘Protein—Official which the actual percentage is based is Final Action.’’ supplied to the food manufacturer. (ii) Fat content, 1 to 10 percent—as (e) The presence of reduced minerals determined by the methods prescribed whey in a finished food product shall be in section 16.059 (liquid sample), listed as ‘‘reduced minerals whey’’. ‘‘Reese-Gottlieb Method [Reference [46 FR 44441, Sept. 4, 1981, as amended at 54 Method] (11)—Official Final Action’’ FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, under the heading ‘‘Fat,’’ or in section 1999; 81 FR 5596, Feb. 3, 2016] 16.199 (dry sample), entitled ‘‘Fat in Dried Milk (45)—Official Final Action.’’ § 184.1979c Whey protein concentrate. (iii) Ash content, 2 to 15 percent—as (a) Whey protein concentrate is the determined by the methods prescribed substance obtained by the removal of in section 16.035 (liquid sample), enti- sufficient nonprotein constituents from tled ‘‘Ash (5)—Official Final Action’’ whey so that the finished dry product under the heading ‘‘Total Solids,’’ or in contains not less than 25 percent pro- section 16.196 (dry sample), entitled tein. Whey protein concentrate is pro- ‘‘Ash—Official Final Action’’ under the duced by physical separation tech- heading ‘‘Dried Milk, Nonfat Dry Milk, niques such as precipitation, filtration, and Malted Milk.’’ or dialysis. As with whey, whey protein (iv) Lactose content, maximum 60 concentrate can be used as a fluid, con- percent—as determined by the methods centrate, or dry product form. The prescribed in section 16.057 (liquid sam- acidity of whey protein concentrate ple), entitled ‘‘Gravimetric Method—

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Official Final Action’’ under the head- concentrate (ll% protein),’’ shall be ing ‘‘Lactose,’’ or in section 31.061 (dry declared on the label of the package sample), entitled ‘‘Lane-Eynon General sold to food manufacturers. The per- Volumetric Method’’ under the heading cent of protein may be declared in 5- ‘‘Lactose—Chemical Methods—Official percent increments, expressed as a Final Action.’’ multiple of 5, not greater than the ac- (v) Moisture content, 1 to 6 percent— tual percentage of protein in the prod- as determined by the methods pre- uct, or as an actual percentage pro- scribed in section 16.192, entitled vided that an analysis of the product ‘‘Moisture (41)—Official Final Action’’ on which the actual percentage is under the heading ‘‘Dried Milk, Nonfat based is supplied to the food manufac- Dry Milk, and Malted Milk.’’ turer. (vi) Solids content, variable—as de- (e) The presence of whey protein con- termined by the methods prescribed in centrate in a finished food product section 16.032, entitled ‘‘Method I—Offi- shall be listed as ‘‘whey protein con- cial Final Action’’ under the heading centrate’’. ‘‘Total Solids.’’ (vii) Titratable Acidity, variable—as [46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, determined by the methods prescribed 1999; 81 FR 5596, Feb. 3, 2016] in section 16.023, entitled ‘‘Acidity (2)— Official Final Action’’ under the head- § 184.1983 Bakers yeast extract. ing ‘‘Milk,’’ or by an equivalent poten- (a) Bakers yeast extract is the food tiometric method. ingredient resulting from concentra- (2) Limits of impurities are: Heavy tion of the solubles of mechanically metals (as lead). Not more than 10 ruptured cells of a selected strain of parts per million (0.001 percent), as de- yeast, Saccharomyces cerevisiae. It may termined by the method described in be concentrated or dried. the ‘‘Food Chemicals Codex,’’ 4th ed. (b) The ingredient meets the fol- (1996), pp. 760–761, which is incorporated lowing specifications on a dry weight by reference in accordance with 5 basis: Less than 0.4 part per million U.S.C. 552(a) and 1 CFR part 51. Copies (ppm) arsenic, 0.13 ppm cadmium, 0.2 are available from the National Acad- ppm lead, 0.05 ppm mercury, 0.09 ppm emy Press, Box 285, 2101 Constitution selenium, and 10 ppm zinc. Ave. NW., Washington, DC 20055 (Inter- net address http://www.nap.edu), or may (c) The viable microbial content of be examined at the Food and Drug Ad- the finished ingredient as a con- ministration’s Main Library, 10903 New centrate or dry material is: Hampshire Ave., Bldg. 2, Third Floor, (1) Less than 10,000 organisms/gram Silver Spring, MD 20993, 301–796–2039, or by aerobic plate count. at the National Archives and Records (2) Less than 10 yeasts and molds/ Administration (NARA). For informa- gram. tion on the availability of this mate- (3) Negative for Salmonella, E. coli, rial at NARA, call 202–741–6030, or go coagulase positive Staphylococci, Clos- to: http://www.archives.gov/ tridium perfringens, Clostridium botu- federallregister/ linum, or any other recognized micro- codeloflfederallregulations/ bial pathogen or any harmful microbial ibrllocations.html. toxin. (3) The whey protein concentrate (d) The ingredient is used as a fla- shall be derived from milk that has voring agent and adjuvant as defined in been pasteurized, or the whey protein § 170.3(o)(12) of this chapter at a level concentrate shall be subjected to pas- not to exceed 5 percent in food. teurization techniques or its equiva- (e) This regulation is issued prior to lent before use in food. general evaluation of use of this ingre- (c) The whey protein concentrate dient in order to affirm as GRAS the may be used in food in accordance with specific use named. good manufacturing practice as indi- cated in § 184.1(b)(1). § 184.1984 Zein. (d) The percent of protein present on (a) Zein (CAS Reg. No. 9010–66–6) is a dry product basis, i.e., ‘‘whey protein one of the components of corn gluten.

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It is produced commercially by extrac- tion on the availability of this mate- tion from corn gluten with alkaline rial at NARA, call 202–741–6030, or go aqueous isopropyl alcohol containing to: http://www.archives.gov/ sodium hydroxide. The extract is then federallregister/ cooled, which causes the zein to pre- codeloflfederallregulations/ cipitate. ibrllocations.html. (b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1), rity suitable for its intended use. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitations other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe as a direct human food tion of this ingredient as generally rec- ingredient is based upon the following ognized as safe (GRAS) as a direct current good manufacturing practice human food ingredient is based upon conditions of use: the following current good manufac- (1) The ingredient is used as an en- turing practice conditions of use: zyme, as defined in § 170.3(o)(9) of this (1) The ingredient is used as a sur- chapter, as an optional ingredient for face-finishing agent as defined in flavor development in the manufacture § 170.3(o)(30) of this chapter. of cheddar cheese, in accordance with (2) The ingredient is used in food at § 133.113 of this chapter, and in the levels not to exceed current good man- preparation of protein hydrolysates. ufacturing practice. (2) The ingredient is used at levels (d) Prior sanctions for this ingredient not to exceed current good manufac- different from the uses established in turing practice. this section do not exist or have been waived. [60 FR 54193, Oct. 20, 1995, as amended at 78 FR 14667, Mar. 7, 2013] [50 FR 8999, Mar. 6, 1985, as amended at 73 FR 8608, Feb. 14, 2008] PART 186—INDIRECT FOOD SUB- § 184.1985 Aminopeptidase enzyme STANCES AFFIRMED AS GEN- preparation derived from ERALLY RECOGNIZED AS SAFE lactococcus lactis. (a) Aminopeptidase enzyme prepara- Subpart A—General Provisions tion is derived from the nonpathogenic Sec. and nontoxicogenic bacterium 186.1 Substances added indirectly to human Lactococcus lactis (previously named food affirmed as generally recognized as Streptococcus lactis). The preparation safe (GRAS). contains the enzyme aminopeptidase (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and Subpart B—Listing of Specific Substances other peptidases that hydrolyze milk Affirmed as GRAS proteins. The preparation is produced 186.1093 Sulfamic acid. by pure culture fermentation. 186.1256 Clay (kaolin). (b) The ingredient meets the speci- 186.1275 Dextrans. fications for enzyme preparations in 186.1300 Ferric oxide. the Food Chemicals Codex, 3d ed. (1981), 186.1316 Formic acid. pp. 107–110, which are incorporated by 186.1374 Iron oxides. 186.1551 Hydrogenated fish oil. reference in accordance with 5 U.S.C. 186.1555 Japan wax. 552(a) and 1 CFR part 51. Copies are 186.1557 Tall oil. available from the National Academy 186.1673 Pulp. Press, 2101 Constitution Ave. NW., 186.1750 Sodium chlorite. Washington, DC 20418, or may be exam- 186.1756 Sodium formate. ined at the Office of Food Additive 186.1770 Sodium oleate. Safety (HFS–200), Center for Food Safe- 186.1771 Sodium palmitate. ty and Applied Nutrition, Food and 186.1797 Sodium sulfate. 186.1839 Sorbose. Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1200, or AUTHORITY: 21 U.S.C. 321, 342, 348, 371. at the National Archives and Records SOURCE: 42 FR 14658, Mar. 15, 1977, unless Administration (NARA). For informa- otherwise noted.

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Subpart A—General Provisions has been evaluated on the basis of lim- ited conditions of use, the agency will § 186.1 Substances added indirectly to describe in the regulation that affirms human food affirmed as generally the GRAS status of the indirect ingre- recognized as safe (GRAS). dient, one or more of these limited con- (a) The indirect human food ingredi- ditions of use, which may include the ents listed in this part have been re- category of food-contact surface(s), viewed by the Food and Drug Adminis- technical effect(s) or functional use(s) tration and affirmed to be generally of the indirect ingredient, and the recognized as safe (GRAS) for the pur- level(s) of use. If the ingredient is used poses and under the conditions pre- under conditions that are significantly scribed, providing they comply with different from those described in the the purity specifications listed in this regulation, such use of a substance part or, in the absence of purity speci- may not be GRAS. In such a case, a fications, are of a purity suitable for manufacturer may not rely on the reg- their intended use in accordance with ulation as authorizing that use but § 170.30(h)(1) of this chapter. Certain in- shall have a basis to conclude that the gredients in this part may also be used use is GRAS or shall use the ingredient in food-contact surfaces in accordance in accordance with a food additive reg- with parts 174, 175, 176, 177, 178 or ulation. § 179.45 of this chapter. Ingredients af- (2) If the ingredient is affirmed as firmed as GRAS for direct use in part GRAS with specific limitation(s), it 184 of this chapter are also GRAS as in- shall be used in food-contact surfaces direct human food ingredients in ac- only within such limitation(s), includ- cordance with § 184.1(a) of this chapter. ing the category of food-contact sur- (b) The regulations in this part do face(s), the functional use(s) of the in- not authorize direct addition of any gredient, and the level(s) of use. Any food ingredient to a food. They author- use of such an ingredient not in full ize only the use of these ingredients as compliance with each such established indirect ingredients of food, through limitation shall require a food additive migration from their immediate wrap- regulation. per, container, or other food-contact (3) If the ingredient is affirmed as surface. Any ingredient affirmed as GRAS for a specific use, prior to gen- GRAS in this part shall be used in ac- eral evaluation of use of the ingredient, cordance with current good manufac- other uses may also be GRAS. turing practice. For the purpose of this part, current good manufacturing prac- (c) The listing of a food ingredient in tice includes the requirements that an this part does not authorize the use of indirect human food ingredient be of a such substance for the purpose of add- purity suitable for its intended use, ing the ingredient to the food through and that it be used at a level no higher extraction from the food-contact sur- than reasonably required to achieve its face. intended technical effect in the food- (d) The listing of a food ingredient in contact article. this part does not authorize the use of (1) If the ingredient is affirmed as such substance in a manner that may GRAS with no limitations on its condi- lead to deception to the consumer or to tions of use other than current good any other violation of the Federal manufacturing practice, it shall be re- Food, Drug, and Cosmetic Act (the garded as GRAS if its conditions of use Act). are consistent with the requirements of (e) If the Commissioner of Food and paragraphs (b), (c), and (d) of this sec- Drugs is aware of any prior sanction tion. When the Food and Drug Admin- for use of an ingredient under condi- istration (FDA) determines that it is tions different from those proposed to appropriate, the agency will describe be affirmed as GRAS, he will concur- one or more current good manufac- rently propose a separate regulation turing practice conditions of use in the covering such use of the ingredient regulation that affirms the GRAS sta- under part 181 of this chapter. If the tus of the indirect ingredient. For ex- Commissioner is unaware of any such ample, when the safety of an ingredient applicable prior sanction, the proposed

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regulation will so state and will re- earths. Clay (kaolin) is a white to yel- quire any person who intends to assert lowish or grayish fine powder. There or rely on such sanction to submit are at least three different minerals, proof of its existence. Any regulation kaolinite, dickite, and nacrite, classi- promulgated pursuant to this section fied as kaolin. Kaolinite or china clay constitutes a determination that ex- is whiter, less contaminated with ex- cluded uses would result in adultera- traneous minerals, and less plastic in tion of the food in violation of section water. 402 of the Act, and the failure of any (b) In accordance with § 186.1(b)(1), person to come forward with proof of the ingredient is used as an indirect such an applicable prior sanction in re- human food ingredient with no limita- sponse to the proposal will constitute a tion other than current good manufac- waiver of the right to assert or rely on turing practice. The affirmation of this such sanction at any later time. The ingredient as generally recognized as notice will also constitute a proposal safe (GRAS) as an indirect human food to establish a regulation under part 181 ingredient is based upon the following of this chapter, incorporating the same current good manufacturing practice provisions, in the event that such a conditions of use: regulation is determined to be appro- (1) The ingredient is used in the man- priate as a result of submission of proof ufacture of paper and paperboard that of such an applicable prior sanction in contact food. response to the proposal. (2) The ingredient is used at levels [42 FR 14658, Mar. 15, 1977, as amended at 48 not to exceed current good manufac- FR 48457, 48459, Oct. 19, 1983; 81 FR 55051, Aug. turing practice. 17, 2016] (c) Prior sanctions for this ingredient different from the uses established in Subpart B—Listing of Specific this regulation do not exist or have Substances Affirmed as GRAS been waived. [47 FR 43367, Oct. 1, 1982] § 186.1093 Sulfamic acid. § 186.1275 Dextrans. (a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329–14–6) is a white crystalline (a) Dextrans (CAS Reg. No. 9004–54–0) solid manufactured from urea, sulfur are high molecular weight trioxide, and sulfuric acid. It is soluble polysaccharides produced by bacterial and highly ionized in water. fermentation of sucrose. Commercially (b) In accordance with § 186.1(b)(1), available dextrans are synthesized the ingredient is used as an indirect from sucrose by Leuconostoc food ingredient with no limitations mesenteroides strain NRRL B–512(F). other than current good manufacturing Partial depolymerization and purifi- practice. The affirmation of this ingre- cation of the fermented mixture shall dient as generally recognized as safe produce a product that is free of viable (GRAS) as an indirect human food in- microorganisms. gredient is based upon the current good (b) The ingredient is used or intended manufacturing practice of using this for use as a constituent of food-contact ingredient in the manufacture of paper surfaces. and paperboard that contact food. (c) The ingredient is used at levels (c) Prior sanctions for this ingredient not to exceed good manufacturing different from the uses established in practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [47 FR 29954, July 9, 1982] this section do not exist or have been waived. § 186.1256 Clay (kaolin). [43 FR 29288, July 7, 1978, as amended at 48 (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas FR 48457, Oct. 19, 1983] Reg. No. 1332–58–7) consists of hydrated aluminum silicate. The commercial § 186.1300 Ferric oxide. products of clay (kaolin) contain vary- (a) Ferric oxide (iron (III) oxide, ing quantities of alkalies and alkaline Fe2O3, CAS Reg. No. 1309–37–1) occurs 595

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naturally as the mineral hematite. It (b) In accordance with § 186.1(b)(1), may be prepared synthetically by heat- the ingredient is used as an indirect ing brown iron hydroxide oxide. The human food ingredient with no limita- product is red-brown to black trigonal tion other than current good manufac- crystals. turing practice. The affirmation of this (b) In accordance with § 186.1(b)(1), ingredient as generally recognized as the ingredient is used as an indirect safe (GRAS) as an indirect human food human food ingredient with no limita- ingredient is based upon the following tion other than current good manufac- current good manufacturing practice turing practice. The affirmation of this conditions of use: ingredient as generally recognized as (1) The ingredient is used as a con- safe (GRAS) as an indirect human food stituent of paper and paperboard used ingredient is based upon the following for food packaging. current good manufacturing practice (2) The ingredient is used at levels conditions of use: not to exceed current good manufac- (1) The ingredient is used as a con- turing practice. stituent of paper and paperboard used (c) Prior sanctions for this ingredient for food packaging. different from the uses established in (2) The ingredient is used at levels this section do not exist or have been not to exceed current good manufac- waived. turing practice. (c) Prior sanctions for this ingredient [53 FR 16867, May 12, 1988; 53 FR 20939, June different from the uses established in 7, 1988, as amended at 69 FR 24512, May 4, this section do not exist or have been 2004] waived. § 186.1551 Hydrogenated fish oil. [53 FR 16867, May 12, 1988; 53 FR 20939, June (a) Hydrogenated fish oil (CAS Reg. 7, 1988] No. 91078–95–4) is a class of oils pro- § 186.1316 Formic acid. duced by partial hydrogenation of oils expressed from fish, primarily menha- (a) Formic acid (CH2O2, CAS Reg. No. den, and secondarily herring or tuna. 64–18–6) is also referred to as methanoic Hydrogenation of fish oils uses cata- acid or hydrogen carboxylic acid. It oc- lysts composed of either elemental curs naturally in some insects and is nickel, elemental copper, or a mixture contained in the free acid state in a of these elements. The crude hydro- number of plants. Formic acid is pre- genated fish oil is further processed by pared by the reaction of sodium for- alkali refining, bleaching, and deodori- mate with sulfuric acid and is isolated zation by steam stripping. by distillation. (b) Hydrogenation of fish oils results (b) Formic acid is used as a con- in a final product with a melting point stituent of paper and paperboard used ° for food packaging. greater than 32 C as determined by Section Cc 1–25, Official and Tentative (c) The ingredient is used at levels Methods of the American Oil Chemists’ not to exceed good manufacturing practice in accordance with § 186.1(b)(1). Society method (reapproved 1973) or equivalent. The product has an approx- (d) Prior sanctions for formic acid imate fatty acid composition of 30 to 45 different from the uses established in percent saturated fatty acids, 40 to 55 this section do not exist or have been waived. percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 to 10 per- [45 FR 22915, Apr. 4, 1980] cent trienoic fatty acids, and less than 2 percent tetraenoic or higher § 186.1374 Iron oxides. polyenoic fatty acids. The approximate (a) Iron oxides (oxides of iron, CAS percentages of total fatty acids by car- Reg. No. 1332–37–2) are undefined mix- bon chain length are 15 to 30 percent tures of iron (II) oxide (CAS Reg. No. each of C16, C18, C20, C22, less than 10 1345–25–1, black cubic crystals) and iron percent C14 or lower carbon chain (III) oxide (CAS Reg. No. 1309–37–1, red- length, and less than 1 percent C24 or brown to black trigonal crystals). higher carbon chain length fatty acids.

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(c) The ingredient is used as a con- and consists mainly of tall oil resin stituent of cotton and cotton fabrics acids and tall oil fatty acids. used for dry food packaging. (b) In accordance with § 186.1(b)(1), (d) The ingredient is used at levels the ingredient is used as an indirect not to exceed good manufacturing human food ingredient with no limita- practice in accordance with § 186.1(b)(1). tion other than current good manufac- (e) Prior sanctions for this ingredient turing practice. The affirmation of this different from the use established in ingredient as generally recognized as this section do not exist or have been safe (GRAS) as an indirect human food waived. ingredient is based on the following current good manufacturing practice [44 FR 28323, May 15, 1979, as amended at 49 conditions of use: FR 5614, Feb. 14, 1984; 58 FR 17099, Apr. 1, (1) The ingredient is used as a con- 1993] stituent of cotton and cotton fabrics used for dry food packaging. § 186.1555 Japan wax. (2) The ingredient is used at levels (a) Japan wax (CAS Reg. No. 8001–39– not to exceed current good manufac- 6), also known as Japan tallow or turing practice. sumac wax, is a pale yellow vegetable (c) Prior sanctions for this ingredient tallow, containing glycerides of the different from the uses established in C19-C23 dibasic acids and a high content this section, or from those listed in of tripalmitin. It is prepared from the part 181 of this chapter, do not exist or mesocarp by hot pressing of immature have been waived. fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan, and Indo- [51 FR 16830, May 7, 1986] China), R. vernicifera (Japan), and R. § 186.1673 Pulp. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot (a) Pulp is the soft, spongy pith in- alcohol, benzene, and naphtha, and in- side the stem of a plant such as wood, soluble in water and in cold alcohol. straw, sugarcane, or other natural plant sources. (b) In accordance with paragraph (b) The ingredient is used or intended (b)(1) of this section, the ingredient is for use as a constituent of food pack- used as an indirect human food ingre- aging containers. dient with no limitation other than (c) The ingredient is used in paper current good manufacturing practice. and paperboard made by conventional The affirmation of this ingredient as paper-making processes at levels not to generally recognized as safe (GRAS) as exceed good manufacturing practice. an indirect human food ingredient is (d) Prior sanctions for this ingredient based on the following current good different from the uses established in manufacturing practice conditions of this section do not exist or have been use: waived. (1) The ingredient is used as a con- stituent of cotton and cotton fabrics § 186.1750 Sodium chlorite. used for dry food packaging. (a) Sodium chlorite (NaCLO2, CAS (2) The ingredient is used at levels Reg. No. 7758–19–2) exists as slightly not to exceed current good manufac- hygroscopic white crystals or flakes. It turing practice. is manufactured by passing chlorine di- (c) Prior sanctions for this ingredient oxide into a solution of sodium hydrox- different from the uses established in ide and hydrogen peroxide. this section do not exist or have been (b) the ingredient is used at levels waived. from 125 to 250 parts per million as a [60 FR 62208, Dec. 5, 1995] slimicide in the manufacture of paper and paperboard that contact food. § 186.1557 Tall oil. [45 FR 16470, Mar. 14, 1980] (a) Tall oil (CAS Reg. No. 8002–26–4) is essentially the of the pine tree. It § 186.1756 Sodium formate. is obtained commercially from the (a) Sodium formate (CHNaO2, CAS waste liquors of pinewood pulp mills Reg. No. 141–53–7) is the sodium salt of

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formic acid. It is produced by the reac- § 186.1797 Sodium sulfate. tion of carbon monoxide with sodium (a) Sodium sulfate (Na SO , CAS Reg. hydroxide. 2 4 No. 7757–82–6), also known as Glauber’s (b) The ingredient is used as a con- stituent of paper and paperboard used salt, occurs naturally and exists as for food packaging. colorless crystals or as a fine, white (c) The ingredient is used at levels crystalline powder. It is prepared by not to exceed good manufacturing the neutralization of sulfuric acid with practice in accordance with § 186.1(b)(1). sodium hydroxide. (d) Prior sanctions for sodium for- (b) The ingredient is used as a con- mate different from the uses estab- stituent of paper and paperboard used lished in this section do not exist or for food packaging, and cotton and cot- have been waived. ton fabric used for dry food packaging. (c) The ingredient is used at levels [45 FR 22915, Apr. 4, 1980] not to exceed good manufacturing § 186.1770 Sodium oleate. practice in accordance with § 186.1(b)(1). (d) Prior sanctions for this ingredient (a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143–19–1) is the sodium salt of different from the uses established in oleic acid (cis-9-octadecenoic acid). It this section do not exist or have been exists as a white to yellowish powder waived. with a slight tallow-like odor. Com- [45 FR 6086, Jan. 25, 1980] mercially, sodium oleate is made by mixing and heating flaked sodium hy- § 186.1839 Sorbose. droxide and oleic acid. (a) Sorbose (L-sorbose, sorbinose) (b) In accordance with § 186.1(b)(1), (C H O , CAS Reg. No. 87–79–6) is an the ingredient is used as a constituent 6 12 6 orthorhombic, bisphenoidal crystalline of paper and paperboard for food pack- aging and as a component of lubricants ketohexose. It was originally identifed with incidental food contact in accord- in the juice of mature berries from the ance with § 178.3570 of this chapter, mountain ash (Sorbus aucuparia) where with no limitation other than current it occurs as the result of microbial oxi- good manufacturing practice. dation of sorbitol. It also occurs natu- (c) Prior sanctions for this ingredient rally in other plants. Sorbose can be different from the uses established in synthesized by the catalytic hydro- this section do not exist or have been genation of glucose to D-sorbitol. The waived. resulting sorbitol can be oxidized by Acetobacter xylinum or by Acetobacter [51 FR 39372, Oct. 28, 1986] suboxydans. § 186.1771 Sodium palmitate. (b) The ingredient is used or intended for indirect food use as a constituent of (a) Sodium palmitate (C H O Na, 16 31 2 cotton, cotton fabrics, paper, and pa- CAS Reg. No. 408–35–5) is the sodium salt of palmitic acid (hexadecanoic perboard in contact with dry food. acid). It exists as a white to yellow (c) The ingredient migrates to food at powder. Commercially, sodium levels not to exceed good manufac- palmitate is made by mixing and heat- turing practice. ing flaked sodium hydroxide and pal- (d) Prior sanctions for this ingredient mitic acid. different from the uses established in (b) In accordance with § 186.1(b)(1), this section do not exist or have been the ingredient is used as a constituent waived. of paper and paperboard for food pack- [43 FR 11698, Mar. 21, 1978, as amended at 48 aging with no limitation other than FR 48457, Oct. 19, 1983] current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 39372, Oct. 28, 1986]

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PART 189—SUBSTANCES PROHIB- been shown by adequate scientific data ITED FROM USE IN HUMAN to be safe for use in human food. Use of FOOD any of these substances in violation of this section causes the food involved to Subpart A—General Provisions be adulterated in violation of the act. (b) This section includes only a par- Sec. tial list of substances prohibited from 189.1 Substances prohibited from use in use in human food, for easy reference human food. purposes, and is not a complete list of Subpart B—Prohibited cattle materials substances that may not lawfully be used in human food. No substance may 189.5 Prohibited cattle materials. be used in human food unless it meets all applicable requirements of the act. Subpart C—Substances Generally Prohib- (c) The Commissioner of Food and ited From Direct Addition or Use as Drugs, either on his own initiative or Human Food on behalf of any interested person who 189.110 Calamus and its derivatives. has submitted a petition, may publish 189.113 Cinnamyl anthranilate. a proposal to establish, amend, or re- 189.120 Cobaltous salts and its derivatives. peal a regulation under this section on 189.130 Coumarin. the basis of new scientific evaluation 189.135 Cyclamate and its derivatives. 189.140 Diethylpyrocarbonate (DEPC). or information. Any such petition shall 189.145 Dulcin. include an adequate scientific basis to 189.155 Monochloroacetic acid. support the petition, pursuant to part 189.165 Nordihydroguaiaretic acid (NDGA). 10 of this chapter, and will be published 189.175 P–4000. for comment if it contains reasonable 189.180 Safrole. grounds. 189.190 Thiourea. 189.191 Chlorofluorocarbon propellants. [42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989] Subpart D—Substances Prohibited From In- direct Addition to Human Food Subpart B—Prohibited Cattle Through Food-Contact Surfaces Materials 189.220 Flectol H. 189.240 Lead solders. § 189.5 Prohibited cattle materials. 189.250 Mercaptoimidazoline and 2- mercaptoimidazoline. (a) Definitions. The definitions and in- 189.280 4,4′-Methylenebis (2-chloroanaline). terpretations of terms contained in 189.300 Hydrogenated 4,4′-isopropylidene- section 201 of the Federal Food, Drug, diphenolphosphite ester resins. and Cosmetic Act (the FD&C Act) 189.301 Tin-coated lead foil capsules for apply to such terms when used in this wine bottles. part. The following definitions also AUTHORITY: 21 U.S.C. 321, 342, 348, 371, 381. apply: SOURCE: 42 FR 14659, Mar. 15, 1977, unless (1) Prohibited cattle materials mean otherwise noted. specified risk materials, small intes- tine of all cattle except as provided in EDITORIAL NOTE: Nomenclature changes to part 189 appear at 61 FR 14482, Apr. 2, 1996, 66 paragraph (b)(2) of this section, mate- FR 56035, Nov. 6, 2001, 70 FR 40880, July 15, rial from nonambulatory disabled cat- 2005, and 70 FR 67651, Nov. 8, 2005. tle, material from cattle not inspected and passed, or mechanically separated Subpart A—General Provisions (MS)(Beef). Prohibited cattle materials do not include the following: § 189.1 Substances prohibited from use (i) Tallow that contains no more in human food. than 0.15 percent insoluble impurities, (a) The food ingredients listed in this tallow derivatives, gelatin, hides and section have been prohibited from use hide-derived products, and milk and in human food by the Food and Drug milk products, and Administration because of a deter- (ii) Cattle materials inspected and mination that they present a potential passed from a country designated risk to the public health or have not under paragraph (e) of this section.

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(2) Inspected and passed means that brary, 10903 New Hampshire Ave., Bldg. the product has been inspected and 2, Third Floor, Silver Spring, MD 20993, passed for human consumption by the 301–796–2039, or at the National Ar- appropriate regulatory authority, and chives and Records Administration at the time it was inspected and (NARA). For information on the avail- passed, it was found to be not adulter- ability of this material at NARA, call ated. 202–741–6030, or go to http:// (3) Mechanically separated (MS) (Beef) www.archives.gov/federallregister/ means a meat food product that is fine- codeloflfederallregulations/ ly comminuted, resulting from the me- ibrllocations.html. chanical separation and removal of (7) Tallow derivative means any chem- most of the bone from attached skel- ical obtained through initial hydrol- etal muscle of cattle carcasses and ysis, saponification, or trans- parts of carcasses that meets the speci- esterification of tallow; chemical con- fications contained in 9 CFR 319.5, the version of material obtained by hydrol- U.S. Department of Agriculture regula- tion that prescribes the standard of ysis, saponification, or trans- identity for MS (Species). esterification may be applied to obtain (4) Nonambulatory disabled cattle the desired product. means cattle that cannot rise from a (8) Gelatin means a product that has recumbent position or that cannot been obtained by the partial hydrolysis walk, including, but not limited to, of collagen derived from hides, connec- those with broken appendages, severed tive tissue, and/or bone bones of cattle tendons or ligaments, nerve paralysis, and swine. Gelatin may be either Type fractured vertebral column, or meta- A (derived from an acid-treated pre- bolic conditions. cursor) or Type B (derived from an al- (5) Specified risk material means the kali-treated precursor) that has gone brain, skull, eyes, trigeminal ganglia, through processing steps that include spinal cord, vertebral column (exclud- filtration and sterilization or an equiv- ing the vertebrae of the tail, the trans- alent process in terms of infectivity re- verse processes of the thoracic and duction. lumbar vertebrae, and the wings of the (b) Requirements. (1) No human food sacrum), and dorsal root ganglia of cat- shall be manufactured from, processed tle 30 months of age and older and the with, or otherwise contain, prohibited tonsils and distal ileum of the small in- cattle materials. testine of all cattle. (2) The small intestine is not consid- (6) Tallow means the rendered fat of ered prohibited cattle material if the cattle obtained by pressing or by ap- distal ileum is removed by a procedure plying any other extraction process to that removes at least 80 inches of the tissues derived directly from discrete uncoiled and trimmed small intestine, adipose tissue masses or to other car- as measured from the caeco-colic junc- cass parts and tissues. Tallow must be tion and progressing proximally to- produced from tissues that are not pro- wards the jejunum, or by a procedure hibited cattle materials or must con- tain no more than 0.15 percent insol- that the establishment can dem- uble impurities as determined by the onstrate is equally effective in ensur- method entitled ‘‘Insoluble Impurities’’ ing complete removal of the distal (AOCS Official Method Ca 3a-46), Amer- ileum. ican Oil Chemists’ Society (AOCS), 5th (c) Records. (1) Manufacturers and Edition, 1997, incorporated by reference processors of a human food that is in accordance with 5 U.S.C. 552(a) and 1 manufactured from, processed with, or CFR part 51, or another method equiva- otherwise contains, material from cat- lent in accuracy, precision, and sensi- tle must establish and maintain tivity to AOCS Official Method Ca 3a– records sufficient to demonstrate that 46. You may obtain copies of the meth- the food is not manufactured from, od from AOCS (http://www.aocs.org) 2211 processed with, or does not otherwise W. Bradley Ave. Champaign, IL 61821. contain, prohibited cattle materials. Copies may be examined at the Food (2) Records must be retained for 2 and Drug Administration’s Main Li- years after the date they were created.

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(3) Records must be retained at the of the act, except when used as dietary manufacturing or processing establish- ingredients in dietary supplements. ment or at a reasonably accessible lo- The use or intended use of any prohib- cation. ited cattle material in human food (4) The maintenance of electronic causes the material and the food to be records is acceptable. Electronic adulterated under section 402(a)(2)(C) records are considered to be reasonably of the act if the prohibited cattle mate- accessible if they are accessible from rial is a food additive, unless it is the an onsite location. subject of a food additive regulation or (5) Records required by this section of an investigational exemption for a and existing records relevant to com- food additive under § 170.17 of this chap- pliance with this section must be avail- ter. able to FDA for inspection and copy- (e) Process for designating countries. A ing. country seeking designation must send (6) When filing entry with U.S. Cus- a written request to the Director, Of- toms and Border Protection, the im- fice of the Center Director, Center for porter of record of a human food manu- Food Safety and Applied Nutrition, factured from, processed with, or oth- Food and Drug Administration, at the erwise containing, cattle material address designated in 21 CFR 5.1100. must affirm that the food was manu- The request shall include information factured from, processed with, or oth- about a country’s bovine spongiform erwise contains, cattle material and encephalopathy (BSE) case history, must affirm that the food was manu- risk factors, measures to prevent the factured in accordance with this sec- introduction and transmission of BSE, tion. If a human food is manufactured and any other information relevant to from, processed with, or otherwise con- determining whether specified risk ma- tains, cattle material, then the im- terials, the small intestine of cattle ex- porter of record must, if requested, pro- cept as provided in paragraph (b)(2) of vide within 5 days records sufficient to this section, material from non- demonstrate that the food is not manu- ambulatory disabled cattle, or MS factured from, processed with, or does (Beef) from cattle from the country not otherwise contain, prohibited cat- should be considered prohibited cattle tle material. materials. FDA shall respond in writ- (7) Records established or maintained ing to any such request and may im- to satisfy the requirements of this sub- pose conditions in granting any such part that meet the definition of elec- request. A country designation granted tronic records in § 11.3(b)(6) of this by FDA under this paragraph will be chapter are exempt from the require- subject to future review by FDA, and ments of part 11 of this chapter. may be revoked if FDA determines Records that satisfy the requirements that it is no longer appropriate. of this subpart but that are also re- quired under other applicable statutory [70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006; 73 FR 20793, Apr. 17, provisions or regulations remain sub- 2008; 81 FR 5596, Feb. 3, 2016; 81 FR 14731, Mar. ject to part 11 of this chapter. 18, 2016] (d) Adulteration. (1) Failure of a man- ufacturer or processor to operate in compliance with the requirements of Subpart C—Substances Generally paragraphs (b) or (c) of this section Prohibited From Direct Addi- renders human food adulterated under tion or Use as Human Food section 402(a)(4) of the act. (2) Human food manufactured from, SOURCE: 42 FR 14659, Mar. 15, 1977, unless processed with, or otherwise con- otherwise noted. Redesignated at 69 FR 42273, taining, prohibited cattle materials is July 14, 2004. unfit for human food and deemed adul- terated under section 402(a)(3) of the § 189.110 Calamus and its derivatives. act. (a) Calamus is the dried rhizome of (3) Food additive status. Prohibited Acorus calamus L. It has been used as a cattle materials for use in human food flavoring compound, especially as the are food additives subject to section 409 oil or extract.

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(b) Food containing any added (b) Food containing any added cobal- calamus, oil of calamus, or extract of tous salts is deemed to be adulterated calamus is deemed to be adulterated in in violation of the act based upon an violation of the act based upon an order published in the FEDERAL REG- order published in the FEDERAL REG- ISTER of August 12, 1966 (31 FR 8788). ISTER of May 9, 1968 (33 FR 6967). (c) The analytical method used for § 189.130 Coumarin. detecting oil of calamus (b-asarone) is (a) Coumarin is the chemical 1,2- in the ‘‘Journal of the Association of benzopyrone, C9H6O2. It is found in Official Analytical Chemists,’’ Volume tonka beans and extract of tonka 56, (Number 5), pages 1281 to 1283, Sep- beans, among other natural sources, tember 1973, which is incorporated by and is also synthesized. It has been reference. Copies are available from used as a flavoring compound. the AOAC INTERNATIONAL, 481 North (b) Food containing any added cou- Frederick Ave., suite 500, Gaithersburg, marin as such or as a constituent of MD 20877, also from the Office of Food tonka beans or tonka extract is deemed Additive Safety (HFS–200), Center for to be adulterated under the act, based Food Safety and Applied Nutrition, upon an order published in the FED- Food and Drug Administration, 5001 ERAL REGISTER of March 5, 1954 (19 FR Campus Dr., College Park, MD 20740, 1239). 240–402–1200, or available for inspection (c) The analytical methods used for at the National Archives and Records detecting coumarin in food are in sec- Administration (NARA). For informa- tions 19.016–19.024 of the ‘‘Official Meth- tion on the availability of this mate- ods of Analysis of the Association of rial at NARA, call 202–741–6030, or go Official Analytical Chemists,’’ 13th Ed. to: http://www.archives.gov/ (1980), which is incorporated by ref- federallregister/ erence. Copies may be obtained from codeloflfederallregulations/ the AOAC INTERNATIONAL, 481 North ibrllocations.html. Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the [42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, National Archives and Records Admin- 1989; 78 FR 14667, Mar. 7, 2013] istration (NARA). For information on the availability of this material at § 189.113 Cinnamyl anthranilate. NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ (a) The food additive cinnamyl an- codeloflfederallregulations/ thranilate (C H NO , CAS Reg. No. 87– 16 15 2 ibrllocations.html. 29–6) is the ester of cinnamyl alcohol and anthranilic acid. Cinnamyl an- [42 FR 14659, Mar. 15, 1977, as amended at 49 thranilate is a synthetic chemical that FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, has not been identified in natural prod- 1989] ucts at levels detectable by available methodology. It has been used as a fla- § 189.135 Cyclamate and its deriva- tives. voring agent in food. (b) Food containing any added (a) Calcium, sodium, magnesium and cinnamyl anthranilate is deemed to be potassium salts of cyclohexane sul- adulterated in violation of the act famic acid, (C6H12NO3S)2Ca, based upon an order published in the (C6H12NO3S)Na, (C6H12NO3S)2Mg, and FEDERAL REGISTER of October 23, 1985. (C6H12NO3S)K. Cyclamates are syn- thetic chemicals having a sweet taste [50 FR 42932, Oct. 23, 1985] 30 to 40 times that of sucrose, are not found in natural products at levels de- § 189.120 Cobaltous salts and its de- tectable by the official methodology, rivatives. and have been used as artificial sweet- (a) Cobaltous salts are the chemicals, eners. CoC4H6O4, CoCl2, and CoSO4.They have (b) Food containing any added or de- been used in fermented malt beverages tectable level of cyclamate is deemed as a foam stabilizer and to prevent to be adulterated in violation of the ‘‘gushing.’’ act based upon an order published in

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the FEDERAL REGISTER of October 21, Analytical Chemists,’’ 13th Ed. (1980), 1969 (34 FR 17063). which is incorporated by reference. (c) The analytical methods used for Copies may be obtained from the AOAC detecting cyclamate in food are in sec- INTERNATIONAL, 481 North Frederick tions 20.162–20.172 of the ‘‘Official Meth- Ave., suite 500, Gaithersburg, MD 20877, ods of Analysis of the Association of or may be examined at the National Official Analytical Chemists,’’ 13th Ed. Archives and Records Administration (1980), which is incorporated by ref- (NARA). For information on the avail- erence. Copies may be obtained from ability of this material at NARA, call the AOAC INTERNATIONAL, 481 North 202–741–6030, or go to: http:// Frederick Ave., suite 500, Gaithersburg, www.archives.gov/federallregister/ MD 20877, or may be examined at the codeloflfederallregulations/ National Archives and Records Admin- ibrllocations.html. istration (NARA). For information on the availability of this material at [42 FR 14659, Mar. 15, 1977, as amended at 49 NARA, call 202–741–6030, or go to: http:// FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] www.archives.gov/federallregister/ codeloflfederallregulations/ § 189.155 Monochloroacetic acid. ibrllocations.html. (a) Monochloroacetic acid is the [42 FR 14659, Mar. 15, 1977, as amended at 49 chemical chloroacetic acid, C2H3C1O2. FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, It is a synthetic chemical not found in 1989] natural products, and has been pro- § 189.140 Diethylpyrocarbonate posed as a preservative in alcoholic and (DEPC). nonalcoholic beverages. (a) Diethylpyrocarbonate is the Monochloroacetic acid is permitted in chemical pyrocarbonic acid diethyl food package adhesives with an accept- ed migration level up to 10 parts per ester, C6H10O5. It is a synthetic chem- ical not found in natural products at billion (ppb) under § 175.105 of this chap- levels detectable by available method- ter. The official methods do not detect ology and has been used as a ferment monochloroacetic acid at the 10 ppb inhibitor in alcoholic and nonalcoholic level. beverages. (b) Food containing any added or de- (b) Food containing any added or de- tectable level of monochloroacetic acid tectable level of DEPC is deemed to be is deemed to be adulterated in viola- adulterated in violation of the act tion of the act based upon trade cor- based upon an order published in the respondence dated December 29, 1941 FEDERAL REGISTER of August 2, 1972 (37 (TC–377). FR 15426). (c) The analytical methods used for detecting monochloroacetic acid in § 189.145 Dulcin. food are in sections 20.067–20.072 of the (a) Dulcin is the chemical 4- ‘‘Official Methods of Analysis of the Association of Official Analytical ethoxyphenylurea, C9H12N2O2. It is a synthetic chemical having a sweet Chemists,’’ 13th Ed. (1980), which is in- taste about 250 times that of sucrose, is corporated by reference. Copies may be not found in natural products at levels obtained from the AOAC INTER- detectable by the official methodology, NATIONAL, 481 North Frederick Ave., and has been proposed for use as an ar- suite 500, Gaithersburg, MD 20877, or tificial sweetener. may be examined at the National Ar- (b) Food containing any added or de- chives and Records Administration tectable level of dulcin is deemed to be (NARA). For information on the avail- adulterated in violation of the act, ability of this material at NARA, call based upon an order published in the 202–741–6030, or go to: http:// FEDERAL REGISTER of January 19, 1950 www.archives.gov/federallregister/ (15 FR 321). codeloflfederallregulations/ (c) The analytical methods used for ibrllocations.html. detecting dulcin in food are in sections [42 FR 14659, Mar. 15, 1977, as amended at 49 20.173–20.176 of the ‘‘Official Methods of FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, Analysis of the Association of Official 1989]

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§ 189.165 Nordihydroguaiaretic acid Ave., suite 500, Gaithersburg, MD 20877, (NDGA). or may be examined at the National (a) Nordihydroguaiaretic acid is the Archives and Records Administration chemical 4,4′-(2,3-dimethyltetrame- (NARA). For information on the avail- ability of this material at NARA, call thylene) dipyrocatechol, C18H22O4. It occurs naturally in the resinous 202–741–6030, or go to: http:// exudates of certain plants. The com- www.archives.gov/federallregister/ mercial product, which is synthesized, codeloflfederallregulations/ has been used as an antioxidant in ibrllocations.html. foods. [42 FR 14659, Mar. 15, 1977, as amended at 49 (b) Food containing any added NDGA FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, is deemed to be adulterated in viola- 1989] tion of the act based upon an order published in the FEDERAL REGISTER of § 189.180 Safrole. April 11, 1968 (33 FR 5619). (a) Safrole is the chemical 4-allyl-1,2- (c) The analytical method used for methylenedioxy-benzene, C10H10O2. It is detecting NDGA in food is in section a natural constituent of the sassafras 20.008(b) of the ‘‘Official Methods of plant. Oil of sassafras is about 80 per- Analysis of the AOAC INTER- cent safrole. Isosafrole and NATIONAL,’’ 13th Ed. (1980), which is dihydrosafrole are derivatives of saf- incorporated by reference. Copies may role, and have been used as flavoring be obtained from the AOAC INTER- compounds. NATIONAL, 481 North Frederick Ave., (b) Food containing any added saf- suite 500, Gaithersburg, MD 20877, or role, oil of sassafras, isosafrole, or may be examined at the National Ar- dihydrosafrole, as such, or food con- chives and Records Administration taining any safrole, oil of sassafras, (NARA). For information on the avail- isosafrole, or dihydrosafrole, e.g., sas- ability of this material at NARA, call safras bark, which is intended solely or 202–741–6030, or go to: http:// primarily as a vehicle for imparting www.archives.gov/federallregister/ such substances to another food, e.g., codeloflfederallregulations/ sassafras tea, is deemed to be adulter- ibrllocations.html. ated in violation of the act based upon an order published in the FEDERAL [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, REGISTER of December 3, 1960 (25 FR 1989] 12412). (c) The analytical method used for § 189.175 P–4000. detecting safrole, isosafrole and (a) P–4000 is the chemical 5-nitro-2-n- dihydrosafrole is in the ‘‘Journal of the Association of Official Analytical propoxyaniline, C9H12N2O3. It is a syn- thetic chemical having a sweet taste Chemists,’’ Volume 54 (Number 4), about 4000 times that of sucrose, is not pages 900 to 902, July 1971, which is in- found in natural products at levels de- corporated by reference. Copies are tectable by the official methodology, available from the Office of Food Addi- and has been proposed for use as an ar- tive Safety (HFS–200), Center for Food tificial sweetener. Safety and Applied Nutrition, Food and (b) Food containing any added or de- Drug Administration, 5001 Campus Dr., tectable level of P–4000 is deemed to be College Park, MD 20740, 240–402–1200, or adulterated in violation of the act available for inspection at the National based upon an order published in the Archives and Records Administration FEDERAL REGISTER of January 19, 1950 (NARA). For information on the avail- (15 FR 321). ability of this material at NARA, call (c) The analytical methods used for 202–741–6030, or go to: http:// detecting P–4000 in food are in sections www.archives.gov/federallregister/ 20.177–20.181 of the ‘‘Official Methods of codeloflfederallregulations/ Analysis of the Association of Official ibrllocations.html. Analytical Chemists,’’ 13th Ed. (1980), [42 FR 14659, Mar. 15, 1977, as amended at 42 which is incorporated by reference. FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, Copies may be obtained from the AOAC 1982; 54 FR 24900, June 12, 1989; 78 FR 14667, INTERNATIONAL, 481 North Frederick Mar. 7, 2013; 81 FR 49897, July 29, 2016]

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§ 189.190 Thiourea. (b) Food containing any added or de- tectable level of this substance is (a) Thiourea is the chemical deemed to be adulterated in violation thiocarbamide, CH4N2S. It is a syn- thetic chemical, is not found in natural of the act based upon an order pub- products at levels detectable by the of- lished in the FEDERAL REGISTER of ficial methodology, and has been pro- April 7, 1967 (32 FR 5675). posed as an antimycotic for use in dip- [42 FR 14659, Mar. 15, 1977, as amended at 58 ping citrus. FR 17099, Apr. 1, 1993] (b) Food containing any added or de- tectable level of thiourea is deemed to § 189.240 Lead solders. be adulterated under the act. (a) Lead solders are alloys of metals (c) The analytical methods used for that include lead and are used in the detecting thiourea are in sections construction of metal food cans. 20.115–20.126 of the ‘‘Official Methods of (b) Food packaged in any container Analysis of the Association of Official that makes use of lead in can solder is Analytical Chemists,’’ 13th Ed. (1980), deemed to be adulterated in violation which is incorporated by reference. of the Federal Food, Drug, and Cos- Copies may be obtained from the AOAC metic Act, based upon an order pub- INTERNATIONAL, 481 North Frederick lished in the FEDERAL REGISTER of Ave., suite 500, Gaithersburg, MD 20877, June 27, 1995. or may be examined at the National Archives and Records Administration [60 FR 33109, June 27, 1995] (NARA). For information on the avail- ability of this material at NARA, call § 189.250 Mercaptoimidazoline and 2- 202–741–6030, or go to: http:// mercaptoimidazoline. www.archives.gov/federallregister/ (a) Mercaptoimidazoline and 2- codeloflfederallregulations/ mercaptoimidazoline both have the ibrllocations.html. molecular formula C3H6N2S. They are [42 FR 14659, Mar. 15, 1977, as amended at 49 synthetic chemicals not found in nat- FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, ural products and have been used in the 1989] production of rubber articles that may come into contact with food. § 189.191 Chlorofluorocarbon propel- (b) Food containing any added or de- lants. lectable levels of these substances is The use of in deemed to be adulterated in violation human food as propellants in self-pres- of the act based upon an order pub- surized containers is prohibited as pro- lished in the FEDERAL REGISTER of No- vided by § 2.125 of this chapter. vember 30, 1973 (38 FR 33072). [43 FR 11317, Mar. 17, 1978] § 189.280 4,4′-Methylenebis (2-chloro- analine). Subpart D—Substances Prohibited From Indirect Addition to (a) 4,4′-Methylenebis (2- Human Food Through Food- chloroanaline) has the molecular for- mula, C13H12Cl2N2. It is a synthetic Contact Surfaces chemical not found in natural products and has been used as a polyurethane SOURCE: 42 FR 14659, Mar. 15, 1977, unless curing agent and as a component of otherwise noted. Redesignated at 69 FR 42273, food packaging adhesives and poly- July 14, 2004. urethane resins. § 189.220 Flectol H. (b) Food containing any added or de- tectable level of this substance is (a) Flectol H is the chemical 1,2- deemed to be adulterated in violation dihydro-2,2,4-trimethylquinoline, po- of the act based upon an order pub- lymerized, C H N. It is a synthetic 12 15 lished in the FEDERAL EGISTER chemical not found in natural prod- R of De- ucts, and has been used as a component cember 2, 1969 (34 FR 19073). of food packaging adhesives.

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§ 189.300 Hydrogenated 4,4′-isopropyl- PART 190—DIETARY SUPPLEMENTS idene-diphenolphosphite ester res- ins. Subpart A [Reserved] (a) Hydrogenated 4,4′-isopropylidene- Subpart B—New Dietary Ingredient diphenolphosphite ester resins are the Notification condensation product of 1 mole of triphenyl phosphite and 1.5 moles of Sec. hydrogenated 4,4′-isopropylidene- 190.6 Requirement for premarket notifica- diphenol such that the finished resins tion. have a molecular weight in the range AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of of 2,400 to 3,000. They are synthetic the Federal Food, Drug, and Cosmetic Act chemicals not found in natural prod- (21 U.S.C. 321(ff), 331, 342, 350b, 371). ucts and have been used as anti- SOURCE: 62 FR 49891, Sept. 23, 1997, unless oxidants and as stabilizers in vinyl otherwise noted. chloride polymer resins when such EDITORIAL NOTE: Nomenclature changes to polymer resins are used in the manu- part 190 appear at 66 FR 56035, Nov. 6, 2001. facture of rigid vinyl chloride polymer bottles. Subpart A [Reserved] (b) Food containing any added or de- tectable levels of these substances is Subpart B—New Dietary deemed to be adulterated and in viola- Ingredient Notification tion of the Federal Food, Drug, and Cosmetic Act, based upon an order pub- § 190.6 Requirement for premarket no- tification. lished in the FEDERAL REGISTER of Sep- tember 9, 1987 (52 FR 33929). (a) At least 75 days before intro- ducing or delivering for introduction [54 FR 7188, Feb. 17, 1989] into interstate commerce a dietary supplement that contains a new die- § 189.301 Tin-coated lead foil capsules tary ingredient that has not been for wine bottles. present in the food supply as an article (a) Tin-coated lead foil is composed used for food in a form in which the of a lead foil coated on one or both food has not been chemically altered, sides with a thin layer of tin. Tin-coat- the manufacturer or distributor of that ed lead foil has been used as a capsule supplement, or of the new dietary in- (i.e., as a covering applied over the gredient, shall submit to the Office of cork and neck areas) on wine bottles to Nutritional Products, Labeling and Di- prevent insect infestation, as a barrier etary Supplements (HFS–820), Center to oxygen, and for decorative purposes. for Food Safety and Applied Nutrition, Information received by the Food and Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, Drug Administration establishes that information including any citation to the use of such a capsule on wine bot- published articles that is the basis on tles may reasonably be expected to re- which the manufacturer or distributor sult in lead becoming a component of has concluded that a dietary supple- the wine. ment containing such dietary ingre- (b) The capping of any bottles of wine dient will reasonably be expected to be after February 8, 1996, with a tin-coat- safe. An original and two copies of this ed lead foil capsule renders the wine notification shall be submitted. adulterated and in violation of section (b) The notification required by para- 402(a)(2)(C) of the Federal Food, Drug, graph (a) of this section shall include: and Cosmetic Act because lead from (1) The name and complete address of the capsule, which is an unsafe food ad- the manufacturer or distributor of the ditive within the meaning of section dietary supplement that contains a 409 of the act, may reasonably be ex- new dietary ingredient, or of the new pected to become a component of the dietary ingredient; wine. (2) The name of the new dietary in- gredient that is the subject of the pre- [61 FR 4820, Feb. 8, 1996] market notification, including the

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Latin binomial name (including the au- facturer or distributor of a dietary sup- thor) of any herb or other botanical; plement that contains a new dietary (3) A description of the dietary sup- ingredient shall not introduce, or de- plement or dietary supplements that liver for introduction, into interstate contain the new dietary ingredient in- commerce the dietary supplement that cluding: contains the new dietary ingredient. (i) The level of the new dietary ingre- (d) If the manufacturer or distributor dient in the dietary supplement; and of a dietary supplement that contains a (ii) The conditions of use rec- new dietary ingredient, or of the new ommended or suggested in the labeling dietary ingredient, provides additional of the dietary supplement, or if no con- information in support of the new die- ditions of use are recommended or sug- tary ingredient notification, the agen- gested in the labeling of the dietary cy will review all submissions per- supplement, the ordinary conditions of taining to that notification, including use of the supplement; responses made to inquiries from the (4) The history of use or other evi- agency, to determine whether they are dence of safety establishing that the dietary ingredient, when used under substantive and whether they require the conditions recommended or sug- that the 75-day period be reset. If the gested in the labeling of the dietary agency determines that the new sub- supplement, will reasonably be ex- mission is a substantive amendment, pected to be safe, including any cita- FDA will assign a new filing date. FDA tion to published articles or other evi- will acknowledge receipt of the addi- dence that is the basis on which the tional information and, when applica- distributor or manufacturer of the die- ble, notify the manufacturer of the new tary supplement that contains the new filing date, which is the date of receipt dietary ingredient has concluded that by FDA of the information that con- the new dietary supplement will rea- stitutes the substantive amendment. sonably be expected to be safe. Any ref- (e) FDA will not disclose the exist- erence to published information offered ence of, or the information contained in support of the notification shall be in, the new dietary ingredient notifica- accompanied by reprints or photostatic tion for 90 days after the filing date of copies of such references. If any part of the notification. After the 90th day, all the material submitted is in a foreign information in the notification will be language, it shall be accompanied by placed on public display, except for any an accurate and complete English information that is trade secret or oth- translation; and erwise confidential commercial infor- (5) The signature of the person des- mation. ignated by the manufacturer or dis- (f) Failure of the agency to respond tributor of the dietary supplement that to a notification does not constitute a contains a new dietary ingredient. finding by the agency that the new die- (c) FDA will acknowledge its receipt tary ingredient or the dietary supple- of a notification made under section ment that contains the new dietary in- 413 of the Federal Food, Drug, and Cos- gredient is safe or is not adulterated metic Act (the act) and will notify the under section 402 of the act. submitter of the date of receipt of such a notification. The date that the agen- [62 FR 49891, Sept. 23, 1997, as amended at 66 cy receives the notification submitted FR 17359, Mar. 30, 2001, 81 FR 49897, July 29, under paragraph (a) of this section is 2016] the filing date for the notification. For 75 days after the filing date, the manu- PARTS 191–199 [RESERVED]

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