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 AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, 371. Sec. 170.3 Definitions. SOURCE: 42 FR 14483, Mar. 15, 1977, unless 170.6 Opinion letters on sta- otherwise noted. tus. EDITORIAL NOTE: Nomenclature changes to 170.10 Food additives in standardized foods. part 170 appear at 66 FR 56035, Nov. 6, 2001 170.15 Adoption of regulation on initiative and 69 FR 13717, Mar. 24, 2004. of Commissioner. 170.17 Exemption for investigational use and procedure for obtaining authoriza- Subpart A—General Provisions tion to market edible products from ex- perimental animals. § 170.3 Definitions. 170.18 Tolerances for related food additives. For the purposes of this subchapter, 170.19 Pesticide chemicals in processed the following definitions apply: foods. (a) Secretary means the Secretary of Health and Human Services. Subpart B—Food Additive Safety (b) Department means the Department 170.20 General principles for evaluating the of Health and Human Services. safety of food additives. (c) Commissioner means the Commis- 170.22 Safety factors to be considered. sioner of Food and Drugs. 170.30 Eligibility for classification as gen- (d) As used in this part, the term act erally recognized as safe (GRAS). means the Federal Food, Drug, and 170.35 Affirmation of generally recognized as safe (GRAS) status. Cosmetic Act approved June 25, 1936, 52 170.38 Determination of food additive sta- Stat. 1040 et seq., as amended (21 U.S.C. tus. 301–392). 170.39 Threshold of regulation for sub- (e)(1) Food additives includes all sub- stances used in food-contact articles. stances not exempted by section 201(s) of the act, the intended use of which Subpart C—Specific Administrative Rulings results or may reasonably be expected and Decisions to result, directly or indirectly, either 170.45 Fluorine-containing compounds. in their becoming a component of food 170.50 (aminoacetic acid) in food for or otherwise affecting the characteris- human consumption. tics of food. A material used in the pro- 170.60 and/or in curing pre- duction of containers and packages is mixes. subject to the definition if it may rea- sonably be expected to become a com- Subpart D—Premarket Notifications ponent, or to affect the characteristics, 170.100 Submission of a premarket notifica- directly or indirectly, of food packed in tion for a food contact substance (FCN) the container. ‘‘Affecting the charac- to the Food and Drug Administration teristics of food’’ does not include such (FDA). physical effects, as protecting contents 170.101 Information in a premarket notifica- tion for a food contact substance (FCN). of packages, preserving shape, and pre- 170.102 Confidentiality of information in a venting moisture loss. If there is no premarket notification for a food contact migration of a packaging component substance (FCN). from the package to the food, it does 170.103 Withdrawal without prejudice of a not become a component of the food premarket notification for a food contact and thus is not a food additive. A sub- substance (FCN). stance that does not become a compo- 170.104 Action on a premarket notification nent of food, but that is used, for exam- for a food contact substance (FCN). 170.105 The Food and Drug Administration’s ple, in preparing an ingredient of the (FDA’s) determination that a premarket food to give a different , texture, notification for a food contact substance or other characteristic in the food, (FCN) is no longer effective. may be a food additive.

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(2) Uses of food additives not requiring (j) The term nonperishable processed a listing regulation. Use of a substance food means any processed food not sub- in a food contact article (e.g., food- ject to rapid decay or deterioration packaging or food-processing equip- that would render it unfit for consump- ment) whereby the substance migrates, tion. Examples are flour, sugar, cere- or may reasonably be expected to mi- als, packaged cookies, and crackers. grate, into food at such levels that the Not included are hermetically sealed use has been exempted from regulation foods or manufactured dairy products as a food additive under § 170.39, and and other processed foods requiring re- food contact substances used in accord- frigeration. ance with a notification submitted (k) General recognition of safety shall under section 409(h) of the act that is be determined in accordance with effective. § 170.30. (3) A food contact substance is any sub- (l) Prior sanction means an explicit stance that is intended for use as a approval granted with respect to use of component of materials used in manu- a substance in food prior to September facturing, packing, packaging, trans- 6, 1958, by the Food and Drug Adminis- porting, or holding food if such use is tration or the United States Depart- not intended to have any technical ef- ment of Agriculture pursuant to the fect in such food. Federal Food, Drug, and Cosmetic Act, (f) Common use in food means a sub- the Poultry Products Inspection Act, stantial history of consumption of a or the Meat Inspection Act. substance for food use by a significant (m) Food includes human food, sub- number of consumers. stances migrating to food from food- (g) The word substance in the defini- contact articles, pet food, and animal tion of the term ‘‘food additive’’ in- feed. cludes a food or food component con- (n) The following general food cat- sisting of one or more ingredients. egories are established to group spe- (h) Scientific procedures include those cific related foods together for the pur- human, animal, analytical, and other pose of establishing tolerances or limi- scientific studies, whether published or tations for the use of direct human unpublished, appropriate to establish food ingredients. Individual food prod- the safety of a substance. ucts will be included within these cat- (i) Safe or safety means that there is egories according to the detailed clas- a reasonable certainty in the minds of sifications lists contained in Exhibit competent scientists that the sub- 33B of the report of the National Acad- stance is not harmful under the in- emy of Sciences/National Research tended conditions of use. It is impos- Council report, ‘‘A Comprehensive Sur- sible in the present state of scientific vey of Industry on the Use of Food knowledge to establish with complete Chemicals Generally Recognized as certainty the absolute harmlessness of Safe’’ (September 1972), which is incor- the use of any substance. Safety may porated by reference. Copies are avail- be determined by scientific procedures able from the National Technical Infor- or by general recognition of safety. In mation Service (NTIS), 5285 Port Royal determining safety, the following fac- Rd., Springfield, VA 22161, or at the Na- tors shall be considered: tional Archives and Records Adminis- (1) The probable consumption of the tration (NARA). For information on substance and of any substance formed the availability of this material at in or on food because of its use. NARA, call 202–741–6030, or go to: http:// (2) The cumulative effect of the sub- www.archives.gov/federallregister/ stance in the , taking into account codeloflfederallregulations/ any chemically or pharmacologically ibrllocations.html. related substance or substances in such (1) Baked goods and baking mixes, in- diet. cluding all ready-to-eat and ready-to- (3) Safety factors which, in the opin- bake products, flours, and mixes re- ion of experts qualified by scientific quiring preparation before serving. training and experience to evaluate the (2) Beverages, alcoholic, including safety of food and food ingredients, are malt beverages, wines, distilled liq- generally recognized as appropriate. uors, and cocktail mix.

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(3) Beverages and beverage bases, (18) Fresh poultry, including only nonalcoholic, including only special or fresh or home-frozen poultry and game spiced teas, soft drinks, coffee sub- birds and home-prepared fresh poultry- stitutes, and fruit and vegetable fla- containing dishes, salads, appetizers, or vored drinks. sandwich spreads made therefrom. (4) Breakfast cereals, including (19) Fresh vegetables, tomatoes, and ready-to-eat and instant and regular potatoes, including only fresh and hot cereals. home-prepared vegetables. (5) Cheeses, including curd and whey (20) Frozen dairy desserts and mixes, cheeses, cream, natural, grating, proc- including ice cream, ice milks, sher- essed, spread, dip, and miscellaneous bets, and other frozen dairy desserts cheeses. and specialties. (6) Chewing gum, including all forms. (21) Fruit and water ices, including (7) Coffee and tea, including regular, all frozen fruit and water ices. decaffeinated, and instant types. (22) , puddings, and fillings, (8) Condiments and relishes, includ- including flavored gelatin desserts, ing plain seasoning sauces and spreads, puddings, custards, parfaits, pie fill- olives, pickles, and relishes, but not ings, and gelatin base salads. spices or herbs. (23) Grain products and pastas, in- (9) Confections and frostings, includ- cluding macaroni and noodle products, ing candy and flavored frostings, rice dishes, and frozen multicourse marshmallows, baking chocolate, and meals, without meat or vegetables. brown, lump, rock, maple, powdered, (24) Gravies and sauces, including all and raw sugars. meat sauces and gravies, and tomato, (10) analogs, including milk, buttery, and specialty sauces. nondairy milk, frozen or liquid cream- (25) Hard candy and cough drops, in- ers, coffee whiteners, toppings, and cluding all hard type candies. other nondairy products. (26) Herbs, seeds, spices, seasonings, (11) Egg products, including liquid, frozen, or dried eggs, and egg dishes blends, extracts, and flavorings, includ- made therefrom, i.e., egg roll, egg foo ing all natural and artificial spices, young, egg salad, and frozen multi- blends, and . course egg meals, but not fresh eggs. (27) Jams and jellies, home-prepared, (12) Fats and oils, including mar- including only home-prepared jams, garine, dressings for salads, butter, jellies, fruit butters, preserves, and salad oils, shortenings and cooking sweet spreads. oils. (28) Jams and jellies, commercial, in- (13) Fish products, including all pre- cluding only commercially processed pared main dishes, salads, appetizers, jams, jellies, fruit butters, preserves, frozen multicourse meals, and spreads and sweet spreads. containing fish, shellfish, and other (29) Meat products, including all aquatic animals, but not fresh fish. meats and meat containing dishes, sal- (14) Fresh eggs, including cooked ads, appetizers, frozen multicourse eggs and egg dishes made only from meat meals, and sandwich ingredients fresh shell eggs. prepared by commercial processing or (15) Fresh fish, including only fresh using commercially processed meats and frozen fish, shellfish, and other with home preparation. aquatic animals. (30) Milk, whole and skim, including (16) Fresh fruits and fruit juices, in- only whole, lowfat, and skim fluid cluding only raw fruits, citrus, melons, milks. and berries, and home-prepared ‘‘ades’’ (31) Milk products, including flavored and punches made therefrom. milks and milk drinks, dry milks, top- (17) Fresh meats, including only fresh pings, snack dips, spreads, weight con- or home-frozen beef or veal, , lamb trol milk beverages, and other milk or- or mutton and home-prepared fresh igin products. meat-containing dishes, salads, appe- (32) Nuts and nut products, including tizers, or sandwich spreads made there- whole or shelled tree nuts, , co- from. conut, and nut and spreads.

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(33) Plant 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 . 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 centrates, dilutions, ‘‘ades’’, and drink growth of microorganisms and subse- substitutes made therefrom. quent spoilage, including fungistats, (36) Processed vegetables and vege- mold and rope inhibitors, and the ef- table juices, including all commer- fects listed by the National Academy of cially processed vegetables, vegetable Sciences/National Research Council dishes, frozen multicourse vegetable under ‘‘.’’ meals, and vegetable juices and blends. (3) Antioxidants: Substances used to (37) Snack foods, including chips, preserve food by retarding deteriora- pretzels, and other novelty snacks. tion, rancidity, or discoloration due to (38) Soft candy, including candy bars, oxidation. chocolates, fudge, mints, and other (4) Colors and coloring adjuncts: Sub- chewy or nougat candies. stances used to impart, preserve, or en- (39) Soups, home-prepared, including hance the color or shading of a food, in- meat, fish, poultry, vegetable, and cluding color stabilizers, color fixa- combination home-prepared soups. tives, color-retention agents, etc. (40) Soups and soup mixes, including (5) Curing and pickling agents: Sub- commercially prepared meat, fish, stances imparting a unique flavor and/ poultry, vegetable, and combination or color to a food, usually producing an soups and soup mixes. increase in shelf life stability. (41) Sugar, white, granulated, includ- (6) Dough strengtheners: Substances ing only white granulated sugar. used to modify starch and gluten, (42) Sugar substitutes, including thereby producing a more stable dough, granulated, liquid, and tablet sugar including the applicable effects listed substitutes. by the National Academy of Sciences/ (43) Sweet sauces, toppings, and syr- National Research Council under ups, including chocolate, berry, fruit, ‘‘.’’ corn syrup, and maple sweet sauces and (7) Drying agents: Substances with toppings. moisture-absorbing ability, used to (o) The following terms describe the maintain an environment of low mois- physical or technical functional effects ture. for which direct human food ingredi- (8) Emulsifiers and emulsifier salts: ents may be added to foods. They are Substances which modify surface ten- adopted from the National Academy of sion in the component phase of an Sciences/National Research Council na- emulsion to establish a uniform disper- tional survey of food industries, re- sion or emulsion. ported to the Food and Drug Adminis- (9) : Enzymes used to im- tration under the contract title ‘‘A prove food processing and the quality Comprehensive Survey of Industry on of the finished food. the Use of Food Chemicals Generally (10) Firming agents: Substances added Recognized as Safe’’ (September 1972), to precipitate residual pectin, thus which is incorporated by reference. strengthening the supporting tissue

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and preventing its collapse during (23) pH control agents: Substances processing. added to change or maintain active (11) Flavor enhancers: Substances acidity or basicity, including buffers, added to supplement, enhance, or mod- acids, alkalies, and neutralizing ify the original taste and/or aroma of a agents. food, without imparting a char- (24) Processing aids: Substances used acteristic taste or aroma of its own. as manufacturing aids to enhance the (12) Flavoring agents and adjuvants: appeal or utility of a food or food com- Substances added to impart or help im- ponent, including clarifying agents, part a taste or aroma in food. clouding agents, catalysts, flocculents, (13) Flour treating agents: Substances filter aids, and crystallization inhibi- added to milled flour, at the mill, to tors, etc. improve its color and/or baking quali- (25) Propellants, aerating agents, and ties, including bleaching and maturing gases: Gases used to supply force to agents. expel a product or used to reduce the (14) Formulation aids: Substances used amount of oxygen in contact with the to promote or produce a desired phys- food in packaging. ical state or texture in food, including (26) Sequestrants: Substances which carriers, binders, fillers, plasticizers, combine with polyvalent metal ions to film-formers, and tableting aids, etc. form a soluble metal complex, to im- (15) Fumigants: Volatile substances prove the quality and stability of prod- used for controlling insects or pests. ucts. (16) Humectants: Hygroscopic sub- (27) Solvents and vehicles: Substances stances incorporated in food to pro- used to extract or dissolve another sub- mote retention of moisture, including stance. moisture-retention agents and anti- (28) Stabilizers and thickeners: Sub- dusting agents. stances used to produce viscous solu- (17) Leavening agents: Substances tions or dispersions, to impart body, used to produce or stimulate produc- improve consistency, or stabilize emul- tion of in baked goods sions, including suspending and body- to impart a light texture, including ing agents, setting agents, jellying yeast, yeast foods, and calcium salts agents, and bulking agents, etc. listed by the National Academy of (29) Surface-active agents: Substances Sciences/National Research Council used to modify surface properties of under ‘‘dough conditioners.’’ liquid food components for a variety of (18) Lubricants and release agents: Sub- effects, other than emulsifiers, but in- stances added to food contact surfaces cluding solubilizing agents, to prevent ingredients and finished dispersants, detergents, wetting products from sticking to them. agents, rehydration enhancers, whip- (19) Non-nutritive sweeteners: Sub- ping agents, foaming agents, and de- stances having less than 2 percent of foaming agents, etc. the caloric value of sucrose per equiva- lent unit of sweetening capacity. (30) Surface-finishing agents: Sub- stances used to increase palatability, (20) supplements: Substances which are necessary for the body’s nu- preserve gloss, and inhibit discolora- tritional and metabolic processes. tion of foods, including glazes, polishes, , and protective coatings. (21) Nutritive sweeteners: Substances having greater than 2 percent of the ca- (31) Synergists: Substances used to act loric value of sucrose per equivalent or react with another food ingredient unit of sweetening capacity. to produce a total effect different or (22) Oxidizing and reducing agents: greater than the sum of the effects pro- Substances which chemically oxidize duced by the individual ingredients. or reduce another food ingredient, (32) Texturizers: Substances which af- thereby producing a more stable prod- fect the appearance or feel of the food. uct, including the applicable effect list- [42 FR 14483, Mar. 15, 1977, as amended at 47 ed by the National Academy of FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, Sciences/National Research Council 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, under ‘‘dough conditioners.’’ July 17, 1995; 67 FR 35729, May 21, 2002]

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§ 170.6 Opinion letters on food addi- Drug Administration are hereby re- tive status. voked. (e) The prior opinions of the kind de- (a) Over the years the Food and Drug scribed in paragraph (c) of this section Administration has given informal will be replaced by qualified and cur- written opinions to inquiries as to the rent opinions if the recipient of each safety of articles intended for use as such letter forwards a copy of each to components of, or in contact with, the Department of Health and Human food. Prior to the enactment of the Services, Food and Drug Administra- Food Additives Amendment of 1958 tion, Center for Food Safety and Ap- (Pub. L. 85–929; Sept. 6, 1958), these plied , 5100 Paint Branch opinions were given pursuant to sec- Pkwy., College Park, MD 20740, along tion 402(a)(1) of the Federal Food, with a copy of his letter of inquiry, on Drug, and Cosmetic Act, which reads in or before July 23, 1970. part: ‘‘A food shall be deemed to be (f) This section does not apply to food adulterated if it bears or contains any additive status opinion letters per- poisonous or deleterious substance taining to articles that were considered which may render it injurious to by the Food and Drug Administration health’’. to be food additives nor to articles in- (b) Since enactment of the Food Ad- cluded in regulations in parts 170 ditives Amendment, the Food and Drug through 189 of this chapter if the arti- Administration has advised such in- cles are used in accordance with the re- quirers that an article: quirements of such regulations. (1) Is a food additive within the meaning of section 201(s) of the act; or [42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12, 1989] (2) Is generally recognized as safe (GRAS); or § 170.10 Food additives in standard- (3) Has prior sanction or approval ized foods. under that amendment; or (a) The inclusion of food ingredients (4) Is not a food additive under the in parts 170 through 189 of this chapter conditions of intended use. does not imply that these ingredients (c) In the interest of the public may be used in standardized foods un- health, such articles which have been less they are recognized as optional in- considered in the past by the Food and gredients in applicable food standards. Drug Administration to be safe under Where a petition is received for the the provisions of section 402(a)(1), or to issuance or amendment of a regulation be generally recognized as safe for establishing a definition and standard their intended use, or to have prior of identity for a food under section 401 sanction or approval, or not to be food of the Act, which proposes the inclu- additives under the conditions of in- sion of a food additive in such defini- tended use, must be reexamined in the tion and standard of identity, the pro- light of current scientific information visions of the regulations in this part and current principles for evaluating shall apply with respect to the infor- the safety of food additives if their use mation that must be submitted with is to be continued. respect to the food additive. Since sec- (d) Because of the time span in- tion 409(b)(5) of the Act requires that volved, copies of many of the letters in the Secretary publish notice of a peti- which the Food and Drug Administra- tion for the establishment of a food-ad- tion has expressed an informal opinion ditive regulation within 30 days after concerning the status of such articles filing, notice of a petition relating to a may no longer be in the file of the Food definition and standard of identity and Drug Administration. In the ab- shall also be published within that sence of information concerning the time limitation if it includes a request, names and uses made of all the articles so designated, for the establishment of referred to in such letters, their safety a regulation pertaining to a food addi- of use cannot be reexamined. For this tive. reason all food additive status opinions (b) If a petition for a definition and of the kind described in paragraph (c) standard of identity contains a pro- of this section given by the Food and posal for a food-additive regulation,

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and the petitioner fails to designate it (b) If intended for use in animals as such, the Commissioner, upon deter- other than laboratory research animals mining that the petition includes a and if the edible products of the ani- proposal for a food-additive regulation, mals are to be marketed as food, per- shall so notify the petitioner and shall mission for the marketing of the edible thereafter proceed in accordance with products as food has been requested by the regulations in this part. the sponsor, and authorization has (c) A regulation will not be issued al- been granted by the Food and Drug Ad- lowing the use of a food additive in a ministration in accordance with § 511.1 food for which a definition and stand- of this chapter or by the Department of ard of identity is established, unless its Agriculture in accordance with 9 CFR issuance is in conformity with section 309.17, and it bears a label which states 401 of the Act or with the terms of a prominently, in addition to the other temporary permit issued under § 130.17 information required by the Act, the of this chapter. When the contemplated warning: use of such additive complies with the Caution. Contains a new food additive for terms of a temporary permit, the food use only in investigational animals. Not for additive regulation will be conditioned use in humans. on such compliance and will expire Edible products of investigational animals with the expiration of the temporary are not to be used for food unless authoriza- permit. tion has been granted by the U.S. Food and Drug Administration or by the U.S. Depart- § 170.15 Adoption of regulation on ini- ment of Agriculture. tiative of Commissioner. (c) If intended for nonclinical labora- (a) The Commissioner upon his own tory studies in food-producing animals, initiative may propose the issuance of the study is conducted in compliance a regulation prescribing, with respect with the regulations set forth in part 58 to any particular use of a food additive, of this chapter. the conditions under which such addi- [42 FR 14483, Mar. 15, 1977, as amended at 43 tive may be safely used. Notice of such FR 60021, Dec. 22, 1978] proposal shall be published in the FED- ERAL REGISTER and shall state the rea- § 170.18 Tolerances for related food ad- sons for the proposal. ditives. (b) Action upon a proposal made by (a) Food additives that cause similar the Commissioner shall proceed as pro- or related pharmacological effects will vided in part 10 of this chapter. be regarded as a class, and in the ab- [42 FR 14486, Mar. 15, 1977, as amended at 42 sence of evidence to the contrary, as FR 15673, Mar. 22, 1977] having additive toxic effects and will be considered as related food additives. § 170.17 Exemption for investigational (b) Tolerances established for such use and procedure for obtaining au- related food additives may limit the thorization to market edible prod- amount of a common component that ucts from experimental animals. may be present, or may limit the A food additive or food containing a amount of biological activity (such as food additive intended for investiga- inhibition) that may be tional use by qualified experts shall be present or may limit the total amount exempt from the requirements of sec- of related food additives that may be tion 409 of the Act under the following present. conditions: (c) Where food additives from two or (a) If intended for investigational use more chemicals in the same class are in vitro or in laboratory research ani- present in or on a food, the tolerance mals, it bears a label which states for the total of such additives shall be prominently, in addition to the other the same as that for the additive hav- information required by the act, the ing the lowest numerical tolerance in warning: this class, unless there are available Caution. Contains a new food additive for methods that permit quantitative de- investigational use only in laboratory re- termination of the amount of each food search animals or for tests in vitro. Not for additive present or unless it is shown use in humans. that a higher tolerance is reasonably

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required for the combined additives to by the regulations in this part. Food accomplish the physical or technical that is itself ready to eat, and which effect for which such combined addi- contains a higher residue than allowed tives are intended and that the higher for the raw agricultural commodity, tolerance will be safe. may not be legalized by blending or (d) Where residues from two or more mixing with other foods to reduce the additives in the same class are present residue in the mixed food below the tol- in or on a food and there are available erance prescribed for the raw agricul- methods that permit quantitative de- tural commodity. termination of each residue, the quan- tity of combined residues that are Subpart B—Food Additive Safety within the tolerance may be deter- mined as follows: § 170.20 General principles for evalu- (1) Determine the quantity of each ating the safety of food additives. residue present. (2) Divide the quantity of each res- (a) In reaching a decision on any pe- idue by the tolerance that would apply tition filed under section 409 of the if it occurred alone, and multiply by Act, the Commissioner will give full 100 to determine the percentage of the consideration to the specific biological permitted amount of residue present. properties of the compound and the (3) Add the percentages so obtained adequacy of the methods employed to for all residues present. demonstrate safety for the proposed (4) The sum of the percentage shall use, and the Commissioner will be not exceed 100 percent. guided by the principles and procedures for establishing the safety of food addi- § 170.19 Pesticide chemicals in proc- tives stated in current publications of essed foods. the National Academy of Sciences-Na- When pesticide chemical residues tional Research Council. A petition occur in processed foods due to the use will not be denied, however, by reason of raw agricultural commodities that of the petitioner’s having followed pro- bore or contained a pesticide chemical cedures other than those outlined in in conformity with an exemption the publications of the National Acad- granted or a tolerance prescribed under emy of Sciences-National Research section 408 of the Act, the processed Council if, from available evidence, the food will not be regarded as adulter- Commissioner finds that the proce- ated so long as good manufacturing dures used give results as reliable as, practice has been followed in removing or more reliable than, those reasonably any residue from the raw agricultural to be expected from the use of the out- commodity in the processing (such as lined procedures. In reaching a deci- by peeling or washing) and so long as sion, the Commissioner will give due the concentration of the residue in the weight to the anticipated levels and processed food when ready to eat is not patterns of consumption of the additive greater than the tolerance prescribed specified or reasonably inferrable. For for the raw agricultural commodity. the purposes of this section, the prin- But when the concentration of residue ciples for evaluating safety of additives in the processed food when ready to eat set forth in the abovementioned publi- is higher than the tolerance prescribed cations will apply to any substance for the raw agricultural commodity, that may properly be classified as a the processed food is adulterated unless food additive as defined in section the higher concentration is permitted 201(s) of the Act. by a tolerance obtained under section (b) Upon written request describing 409 of the Act. For example, if fruit the proposed use of an additive and the bearing a residue of 7 parts per million proposed experiments to determine its of DDT permitted on the raw agricul- safety, the Commissioner will advise a tural commodity is dried and a residue person who wishes to establish the in excess of 7 parts per million of DDT safety of a food additive whether he be- results on the , the dehy- lieves the experiments planned will drated fruit is adulterated unless the yield data adequate for an evaluation higher tolerance for DDT is authorized of the safety of the additive.

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§ 170.22 Safety factors to be consid- generally available data and informa- ered. tion. An ingredient not in common use In accordance with section in food prior to January 1, 1958, may 409(c)(5)(C) of the Act, the following achieve general recognition of safety safety factors will be applied in deter- only through scientific procedures. mining whether the proposed use of a (2) A substance used in food prior to food additive will be safe: Except where January 1, 1958, may be generally rec- evidence is submitted which justifies ognized as safe through experience use of a different safety factor, a safety based on its common use in food when factor in applying animal experimen- that use occurred exclusively or pri- tation data to man of 100 to 1, will be marily outside of the United States if used; that is, a food additive for use by the information about the experience man will not be granted a tolerance establishes that the use of the sub- that will exceed 1⁄100th of the maximum stance is safe within the meaning of amount demonstrated to be without the act (see § 170.3(i)). Common use in harm to experimental animals. food prior to January 1, 1958, that oc- curred outside of the United States § 170.30 Eligibility for classification as shall be documented by published or generally recognized as safe other information and shall be corrobo- (GRAS). rated by information from a second, (a) General recognition of safety may independent source that confirms the be based only on the views of experts history and circumstances of use of the qualified by scientific training and ex- substance. The information used to perience to evaluate the safety of sub- document and to corroborate the his- stances directly or indirectly added to tory and circumstances of use of the food. The basis of such views may be ei- substance must be generally available; ther (1) scientific procedures or (2) in that is, it must be widely available in the case of a substance used in food the country in which the history of use prior to January 1, 1958, through expe- has occurred and readily available to rience based on common use in food. interested qualified experts in this General recognition of safety requires country. Persons claiming GRAS sta- common knowledge about the sub- tus for a substance based on its com- stance throughout the scientific com- mon use in food outside of the United munity knowledgeable about the safety States should obtain FDA concurrence of substances directly or indirectly that the use of the substance is GRAS. added to food. (d) The food ingredients listed as (b) General recognition of safety GRAS in part 182 of this chapter or af- based upon scientific procedures shall firmed as GRAS in part 184 or § 186.1 of require the same quantity and quality this chapter do not include all sub- of scientific evidence as is required to stances that are generally recognized obtain approval of a food additive regu- as safe for their intended use in food. lation for the ingredient. General rec- Because of the large number of sub- ognition of safety through scientific stances the intended use of which re- procedures shall ordinarily be based sults or may reasonably be expected to upon published studies which may be result, directly or indirectly, in their corroborated by unpublished studies becoming a component or otherwise af- and other data and information. fecting the characteristics of food, it is (c)(1) General recognition of safety impracticable to list all such sub- through experience based on common stances that are GRAS. A food ingre- use in food prior to January 1, 1958, dient of natural biological origin that may be determined without the quan- has been widely consumed for its nutri- tity or quality of scientific procedures ent properties in the United States required for approval of a food additive prior to January 1, 1958, without known regulation. General recognition of safe- detrimental effects, which is subject ty through experience based on com- only to conventional processing as mon use in food prior to January 1, practiced prior to January 1, 1958, and 1958, shall be based solely on food use for which no known safety hazard ex- of the substance prior to January 1, ists, will ordinarily be regarded as 1958, and shall ordinarily be based upon GRAS without specific inclusion in

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part 182, part 184 or § 186.1 of this chap- (6) Substances of natural biological ter. origin intended for consumption for (e) Food ingredients were listed as other than their nutrient properties. GRAS in part 182 of this chapter during (g) A food ingredient that is not 1958–1962 without a detailed scientific GRAS or subject to a prior sanction re- review of all available data and infor- quires a food additive regulation pro- mation relating to their safety. Begin- mulgated under section 409 of the act ning in 1969, the Food and Drug Admin- before it may be directly or indirectly istration has undertaken a systematic added to food. review of the status of all ingredients (h) A food ingredient that is listed as used in food on the determination that GRAS in part 182 of this chapter or af- they are GRAS or subject to a prior firmed as GRAS in part 184 or § 186.1 of sanction. All determinations of GRAS this chapter shall be regarded as GRAS status or food additive status or prior only if, in addition to all the require- sanction status pursuant to this review ments in the applicable regulation, it shall be handled pursuant to §§ 170.35, also meets all of the following require- 170.38, and 180.1 of this chapter. Affir- ments: mation of GRAS status shall be an- (1) It complies with any applicable nounced in part 184 or § 186.1 of this food grade specifications of the Food chapter. Chemicals Codex, 2d Ed. (1972), or, if (f) The status of the following food specifically indicated in the GRAS af- ingredients will be reviewed and af- firmation regulation, the Food Chemi- firmed as GRAS or determined to be a cals Codex, 3d Ed. (1981), which are in- food additive or subject to a prior sanc- corporated by reference, except that tion pursuant to § 170.35, § 170.38, or any substance used as a component of § 180.1 of this chapter: articles that contact food and affirmed (1) Any substance of natural biologi- as GRAS in § 186.1 of this chapter shall cal origin that has been widely con- comply with the specifications therein, sumed for its nutrient properties in the or in the absence of such specifications, United States prior to January 1, 1958, without known detrimental effect, for shall be of a purity suitable for its in- which no health hazard is known, and tended use. Copies may be obtained which has been modified by processes from the National Academy Press, 2101 first introduced into commercial use Constitution Ave. NW., Washington, after January 1, 1958, which may rea- DC 20418, or at the National Archives sonably be expected significantly to and Records Administration (NARA). alter the composition of the substance. For information on the availability of (2) Any substance of natural biologi- this material at NARA, call 202–741– cal origin that has been widely con- 6030, or go to: http://www.archives.gov/ sumed for its nutrient properties in the federallregister/ United States prior to January 1, 1958, codeloflfederallregulations/ without known detrimental effect, for ibrllocations.html. which no health hazard is known, that (2) It performs an appropriate func- has had significant alteration of com- tion in the food or food-contact article position by breeding or selection after in which it is used. January 1, 1958, where the change may (3) It is used at a level no higher than be reasonably expected to alter the nu- necessary to achieve its intended pur- tritive value or the concentration of pose in that food or, if used as a compo- toxic constituents. nent of a food-contact article, at a (3) Distillates, isolates, extracts, and level no higher than necessary to concentration of extracts of GRAS sub- achieve its intended purpose in that ar- stances. ticle. (4) Reaction products of GRAS sub- (i) If a substance is affirmed as GRAS stances. in part 184 or § 186.1 of this chapter with (5) Substances not of a natural bio- no limitation other than good manu- logical origin, including those for facturing practice, it shall be regarded which evidence is offered that they are as GRAS if its conditions of use are not identical to a GRAS counterpart of significantly different from those re- natural biological origin. ported in the regulation as the basis on

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which the GRAS status of the sub- uses, and any limitations proposed for stance was affirmed. If the conditions purposes other than safety. of use are significantly different, such (2) The FEDERAL REGISTER notice will use of the substance may not be GRAS. allow a period of 60 days during which In such a case a manufacturer may not any interested person may review the rely on the regulation as authorizing data and information and/or file com- the use but must independently estab- ments with the Division of Dockets lish that the use is GRAS or must use Management. Copies of all comments the substance in accordance with a received shall be made available for ex- food additive regulation. amination in the Division of Dockets (j) If an ingredient is affirmed as Management’s office. GRAS in part 184 or § 186.1 of this chap- (3) The Commissioner will evaluate ter with specific limitation(s), it may all comments received. If he concludes be used in food only within such limi- that there is convincing evidence that tation(s) (including the category of the substance is GRAS as described in food(s), the functional use(s) of the in- § 170.30, he will publish a notice in the gredient, and the level(s) of use). Any FEDERAL REGISTER listing the sub- use of such an ingredient not in full stance as GRAS in part 182, part 184, or compliance with each such established part 186 of this chapter, as appropriate. limitation shall require a food additive (4) If, after evaluation of the com- regulation. ments, the Commissioner concludes (k) Pursuant to § 170.35, a food ingre- that there is a lack of convincing evi- dient may be affirmed as GRAS in part dence that the substance is GRAS and 184 or § 186.1 of this chapter for a spe- that it should be considered a food ad- cific use(s) without a general evalua- ditive subject to section 409 of the Act, tion of use of the ingredient. In addi- he shall publish a notice thereof in the tion to the use(s) specified in the regu- FEDERAL REGISTER in accordance with lation, other uses of such an ingredient § 170.38. may also be GRAS. Any affirmation of (c)(1) Persons seeking the affirmation GRAS status for a specific use(s), with- of GRAS status of substances as pro- out a general evaluation of use of the vided in § 170.30(e), except those subject ingredient, is subject to reconsider- to the NAS/NRC GRAS list survey (36 ation upon such evaluation. FR 20546; October 23, 1971), shall submit (l) New information may at any time a petition for GRAS affirmation pursu- require reconsideration of the GRAS ant to part 10 of this chapter. Such pe- status of a food ingredient. Any change tition shall contain information to es- in part 182, part 184, or § 186.1 of this tablish that the GRAS criteria as set chapter shall be accomplished pursuant forth in § 170.30 (b) or (c) have been met, to § 170.38. in the following form: [42 FR 14483, Mar. 15, 1977, as amended at 49 (i) Description of the substance, in- FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, cluding: 1988] (a) Common or usual name. § 170.35 Affirmation of generally recog- (b) Chemical name. nized as safe (GRAS) status. (c) Chemical Abstract Service (CAS) registry number. (a) The Commissioner, either on his initiative or on the petition of an in- (d) Empirical formula. terested person, may affirm the GRAS (e) Structural formula. status of substances that directly or (f) Specifications for food grade ma- indirectly become components of food. terial, including arsenic and heavy (b)(1) If the Commissioner proposes metals. (Recommendation for any on his own initiative that a substance change in the Food Chemicals Codex is entitled to affirmation as GRAS, he monograph should be included where will place all of the data and informa- applicable.) tion on which he relies on public file in (g) Quantitative compositions. the office of the Division of Dockets (h) Manufacturing process (excluding Management and will publish in the any trade secrets). FEDERAL REGISTER a notice giving the (ii) Use of the substance, including: name of the substance, its proposed (a) Date when use began.

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(b) Information and reports or other ing the name of the substance, its pro- data on past uses in food. posed use, and any limitations pro- (c) Foods in which used, and levels of posed for reasons other than safety. A use in such foods, and for what pur- copy of the notice will be mailed to the poses. petitioner at the time the original is (iii) Methods for detecting the sub- sent to the FEDERAL REGISTER. stance in food, including: (3)(i) If intended uses of the sub- (a) References to qualitative and stance include uses in meat, meat food quantitative methods for determining product, or poultry product subject to the substance(s) in food, including the regulation by the U.S. Department of type of analytical procedures used. Agriculture (USDA) under the Poultry (b) Sensitivity and reproducibility of Products Inspection Act (PPIA) (21 such method(s). U.S.C. 451 et seq.) or Federal Meat In- (iv) Information to establish the safe- spection Act (FMIA) (21 U.S.C. 601 et ty and functionality of the substance seq.), FDA shall, upon filing of the peti- in food. Published scientific literature, tion, forward a copy of the petition or evidence that the substance is identical relevant portions thereof to the Food to a GRAS counterpart of natural bio- Safety and Inspection Service, USDA, logical origin, and other data may be for simultaneous review under the submitted to support safety. Any ad- PPIA and FMIA. verse information or consumer com- (ii) FDA will ask USDA to advise plaints shall be included. Complete bib- whether the proposed meat and poultry liographic references shall be provided uses comply with the FMIA and PPIA where a copy of the article is not pro- or, if not, whether use of the substance vided. would be permitted in products under (v) A statement signed by the person USDA jurisdiction under specified con- responsible for the petition that to the ditions or restrictions. best of his knowledge it is a represent- (4) The notice of filing in the FED- ative and balanced submission that in- ERAL REGISTER will allow a period of 60 cludes unfavorable information, as well days during which any interested per- as favorable information, known to son may review the petition and/or file him pertinent to the evaluation of the comments with the Division of Dockets safety and functionality of the sub- Management. Copies of all comments stance. received shall be made available for ex- (vi) If nonclinical laboratory studies amination in the Division of Dockets are involved, additional information Management’s office. and data submitted in support of filed (5) The Commissioner will evaluate petitions shall include, with respect to the petition and all available informa- each nonclinical study, either a state- tion including all comments received. ment that the study was conducted in If the petition and such information compliance with the requirements set provide convincing evidence that the forth in part 58 of this chapter, or, if substance is GRAS as described in the study was not conducted in compli- § 170.30 he will publish an order in the ance with such regulations, a brief FEDERAL REGISTER listing the sub- statement of the reason for the non- stance as GRAS in part 182, part 184, or compliance. part 186 of this chapter, as appropriate. (vii) [Reserved] (6) If, after evaluation of the petition (viii) A claim for categorical exclu- and all available information, the Com- sion under § 25.30 or § 25.32 of this chap- missioner concludes that there is a ter or an environmental assessment lack of convincing evidence that the under § 25.40 of this chapter. substance is GRAS and that it should (2) Within 30 days after the date of be considered a food additive subject to filing the petition, the Commissioner section 409 of the Act, he shall publish will place the petition on public file in a notice thereof in the FEDERAL REG- the office of the Division of Dockets ISTER in accordance with § 170.38. Management and will publish a notice (7) The notice of filing in the FED- of filing in the FEDERAL REGISTER giv- ERAL REGISTER will request submission ing the name of the petitioner and a of proof of any applicable prior sanc- brief description of the petition includ- tion for use of the ingredient under

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conditions different from those pro- (3) The Commissioner will evaluate posed to be determined to be GRAS. all comments received. If he concludes The failure of any person to come for- that there is a lack of convincing evi- ward with proof of such an applicable dence that the substance is GRAS or is prior sanction in response to the notice otherwise exempt from the definition of filing will constitute a waiver of the of a food additive in section 201(s) of right to assert or rely on such sanction the Act, he will publish a notice there- at any later time. The notice of filing of in the FEDERAL REGISTER. If he con- will also constitute a proposal to estab- cludes that there is convincing evi- lish a regulation under part 181 of this dence that the substance is GRAS, he chapter, incorporating the same provi- will publish an order in the FEDERAL sions, in the event that such a regula- REGISTER listing the substance as tion is determined to be appropriate as GRAS in part 182, part 184, or part 186 a result of submission of proof of such of this chapter, as appropriate. an applicable prior sanction in re- (c) A FEDERAL REGISTER notice deter- sponse to the notice of filing. mining that a substance is a food addi- (Information collection requirements were tive shall provide for the use of the ad- approved by the Office of Management and ditive in food or food contact surfaces Budget under control number 0910–0132) as follows: (1) It may promulgate a food additive [42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, regulation governing use of the addi- 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, tive. July 29, 1997; 65 FR 51762, Aug. 25, 2000] (2) It may promulgate an interim food additive regulation governing use § 170.38 Determination of food addi- of the additive. tive status. (3) It may require discontinuation of (a) The Commissioner may, in ac- the use of the additive. cordance with § 170.35(b)(4) or (c)(5), (4) It may adopt any combination of publish a notice in the FEDERAL REG- the above three approaches for dif- ISTER determining that a substance is ferent uses or levels of use of the addi- not GRAS and is a food additive sub- tive. ject to section 409 of the 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

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of such an applicable prior sanction in the Food and Drug Administration’s response to the proposal. files or from other appropriate sources; [42 FR 14488, Mar. 15, 1977, as amended at 42 (3) The substance has no technical ef- FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, fect in or on the food to which it mi- 1989] grates; and (4) The substance use has no signifi- § 170.39 Threshold of regulation for cant adverse impact on the environ- substances used in food-contact ar- ticles. ment. (b) Notwithstanding paragraph (a) of (a) A substance used in a food-con- this section, the Food and Drug Admin- tact article (e.g., food-packaging or istration reserves the right to decline food-processing equipment) that mi- to grant an exemption in those cases in grates, or that may be expected to mi- which available information estab- grate, into food will be exempted from regulation as a food additive because it lishes that the proposed use may pose a becomes a component of food at levels public health risk. The reasons for the that are below the threshold of regula- agency’s decision to decline to grant an tion if: exemption will be explained in the (1) The substance has not been shown Food and Drug Administration’s re- to be a carcinogen in humans or ani- sponse to the requestor. mals, and there is no reason, based on (c) A request for the Food and Drug the chemical structure of the sub- Administration to exempt a use of a stance, to suspect that the substance is substance from regulation as a food ad- a carcinogen. The substance must also ditive shall include three copies of the not contain a carcinogenic impurity or, following information (If part of the if it does, must not contain a carcino- submitted material is in a foreign lan- genic impurity with a TD50 value based guage, it must be accompanied by an on chronic feeding studies reported in English translation verified to be com- the scientific literature or otherwise plete and accurate in accordance with available to the Food and Drug Admin- § 10.20(c)(2) of this chapter): istration of less than 6.25 milligrams (1) The chemical composition of the per kilogram bodyweight per day (The substance for which the request is TD50, for the purposes of this section, is made, including, whenever possible, the feeding dose that causes cancer in the name of the chemical in accord- 50 percent of the test animals when ance with current Chemical Abstract corrected for tumors found in control Service (CAS) nomenclature guidelines animals. If more than one TD50 value and a CAS registry number, if avail- has been reported in the scientific lit- able; erature for a substance, the Food and (2) Detailed information on the con- Drug Administration will use the low- ditions of use of the substance (e.g., est appropriate TD50 value in its re- temperature, type of food with which view.); the substance will come into contact, (2) The substance presents no other the duration of the contact, and wheth- health or safety concerns because: er the food-contact article will be for (i) The use in question has been shown to result in or may be expected repeated or single use applications); to result in dietary concentrations at (3) A clear statement as to whether or below 0.5 parts per billion, cor- the request for exemption from regula- responding to dietary exposure levels tion as a food additive is based on the at or below 1.5 micrograms/person/day fact that the use of the substance in (based on a diet of 1,500 grams of solid the food-contact article results in a di- food and 1,500 grams of liquid food per etary concentration at or below 0.5 person per day); or parts per billion, or on the fact that it (ii) The substance is currently regu- involves the use of a regulated direct lated for direct addition into food, and food additive for which the dietary ex- the dietary exposure to the substance posure is at or below 1 percent of the resulting from the proposed use is at or acceptable dietary intake (ADI); below 1 percent of the acceptable daily (4) Data that will enable the Food intake as determined by safety data in and Drug Administration to estimate

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the daily dietary concentration result- posed use of the substance. The request ing from the proposed use of the sub- should contain either a claim for cat- stance. These data should be in the egorical exclusion as specified in § 25.32 form of: of this chapter or an environmental as- (i) Validated migration data obtained sessment as specified in § 25.40 of this under worst-case (time/temperature) chapter. intended use conditions utilizing ap- (d) Data to be reviewed under this propriate food simulating solvents; section shall be submitted to the Food (ii) Information on the amount of the and Drug Administration’s Office of substance used in the manufacture of Premarket Approval (HFS–200), 5100 the food-contact article; or Paint Branch Pkwy., College Park, MD (iii) Information on the residual level 20740. of the substance in the food-contact ar- (e) The Food and Drug Administra- ticle. For repeat-use articles, an esti- tion will inform the requestor by letter mate of the amount of food that con- whether the specific food-contact ap- tacts a specific unit of surface area plication is exempt from regulation as over the lifetime of the article should a food additive or not. Although a sub- also be provided. (In cases where data stance that migrates to food at a level are provided only in the form of manu- that results in a dietary concentration facturing use levels or residual levels at or below the threshold of regulation of the substance present in the food- contact article, the Food and Drug Ad- will not be the subject of a regulation ministration will calculate a worst- published in the FEDERAL REGISTER case dietary concentration level as- and will not appear in the Code of Fed- suming 100 percent migration.) A de- eral Regulations, the Food and Drug tailed description of the analytical Administration will maintain a list of method used to quantify the substance substances exempted from regulation should also be submitted along with as food additives under this section on data used to validate the detection display at the Division of Dockets limit. Management. This list will include the (iv) In cases where there is no detect- name of the company that made the re- able migration into food or food quest, the chemical name of the sub- simulants, or when no residual level of stance, the specific use for which it has a substance is detected in the food-con- received an exemption from regulation tact article by a suitable analytical as a food additive, and any appropriate method, the Food and Drug Adminis- limitations on its use. The list will not tration will, for the purposes of esti- include any trade names. This list will mating the dietary concentration, con- enable interested persons to see the sider the validated detection limit of types of uses of food-contact materials the method used to analyze for the sub- being exempted under the regulation. stance. Interested persons may also obtain a (5) The results of an analysis of exist- copy of the list of exempted substances ing toxicological information on the by contacting the Food and Drug Ad- substance and its impurities. This in- ministration’s Office of Premarket Ap- formation on the substance is needed proval (HFS–200), 5100 Paint Branch to show whether an animal carcinogen Pkwy., College Park, MD 20740. For ac- bioassay has been carried out, or tions requiring an environmental as- whether there is some other basis for sessment, the agency’s finding of no suspecting that the substance is a car- significant impact and the evidence cinogen or potent toxin. This type of supporting that finding, contained in information on the impurities is need- the petitioner’s environmental assess- ed to show whether any of them are ment, also will be available for public carcinogenic, and, if carcinogenic, inspection at the Division of Dockets whether their TD50 values are greater Management in accordance with than 6.25 milligrams per kilogram § 25.51(b)(2) of this chapter. Requests for bodyweight per day in accordance with copies of releasable information con- paragraph (a)(1) of this section. tained in submissions requesting ex- (6) Information on the environmental emptions from the food additive regu- impact that would result from the pro- lations will be handled in accordance

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with the Food and Drug Administra- and Drug Administration plans to no- tion’s Freedom of Information Act pro- tify other manufacturers by means of a cedures, as described in part 20 of this notice published in the FEDERAL REG- chapter. In particular, data and infor- ISTER of its decision to revoke an ex- mation that fall within the definitions emption issued for a specific use of a of a trade secret or confidential com- substance in a food contact article. mercial or financial information are (h) Guidance documents to assist re- not available for public disclosure in questors in the preparation of submis- accordance with § 20.61(c) of this chap- sions seeking exemptions from the food ter. additive regulations are available from (f) If the request for an exemption the Food and Drug Administration’s from regulation as a food additive is Office of Premarket Approval (HFS– not granted, the requestor may submit 200), 5100 Paint Branch Pkwy., College a petition to the Food and Drug Ad- Park, MD 20740. Interested persons are ministration for reconsideration of the encouraged to obtain specific guidance decision in accordance with the provi- from the Food and Drug Administra- sions of § 10.33 of this chapter. tion on the appropriate protocols to be (g) If the Food and Drug Administra- used for obtaining migration data, on tion receives significant new informa- the validation of the analytical meth- tion that raises questions about the di- ods used to quantify migration levels, etary concentration or the safety of a on the procedures used to relate migra- substance that the agency has exempt- tion data to dietary exposures, and on ed from regulation, the Food and Drug any other issue not specifically covered Administration may reevaluate the in the Food and Drug Administration’s substance. If the Food and Drug Ad- guidance documents. ministration tentatively concludes that the information that is available [60 FR 36595, July 17, 1995, as amended at 62 about the substance no longer supports FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, an exemption for the use of the food- 2000] contact material from the food addi- tive regulations, the agency will notify Subpart C—Specific Administra- any persons that requested an exemp- tive Rulings and Decisions tion for the substance of its tentative decision. The requestors will be given § 170.45 Fluorine-containing com- an opportunity to show why the use of pounds. the substance should not be regulated The Commissioner of Food and Drugs under the food additive provisions of has concluded that it is in the interest the act. If the requestors fail to ade- of the public health to limit the addi- quately respond to the new evidence, tion of fluorine compounds to foods (a) the agency will notify them that fur- to that resulting from the fluoridation ther use of the substance in question of public water supplies, (b) to that re- for the particular use will require a sulting from the fluoridation of bottled food additive regulation. This notifica- water within the limitation established tion will be placed on public display at in § 165.110(d) of this chapter, and (c) to the Division of Dockets Management that authorized by regulations (40 CFR as part of the file of uses of substances part 180) under section 408 of the Act. exempted from regulation as food addi- tives. The Food and Drug Administra- [42 FR 14483, Mar. 15, 1977, as amended at 72 tion recognizes that manufacturers FR 10357 Mar. 8, 2007] other than those that actually made a 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:

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(1) Reports in scientific literature in- taining such food additives, is required dicate that adverse effects were found to establish safety. in cases where high levels of glycine (b) Nitrites and/or nitrates, when were administered in diets of experi- packaged separately from flavoring mental animals. and seasoning in curing premixes, may (2) Current usage information indi- continue to be used under prior sanc- cates that the daily dietary intake of tions in the commercial curing of meat glycine by humans may be substan- and meat products and poultry prod- tially increasing due to changing use ucts and in accordance with the provi- patterns in food technology. sions of §§ 172.170 and 172.175 of this Therefore, the Food and Drug Adminis- chapter that apply to meat curing tration no longer regards glycine and preparations for the home curing of its salts as generally recognized as safe meat and meat products, including for use in human food and all out- poultry and wild game. To assure safe standing letters expressing sanction for use of such ingredients the labeling of such use are rescinded. the premixes shall bear instructions to (b) The Commissioner of Food and the user that such separately packaged Drugs concludes that by May 8, 1971, ingredients are not to be combined manufacturers: until just prior to use. Encapsulating (1) Shall reformulate food products or coating some or all of the ingredi- for human use to eliminate added gly- ents does not constitute separate pack- cine and its salts; or aging. (2) Shall bring such products into compliance with an authorizing food Subpart D—Premarket additive regulation. A food additive pe- Notifications tition supported by toxicity data is re- quired to show that any proposed level SOURCE: 67 FR 35729, May 21, 2002, unless of glycine or its salts added to foods for otherwise noted. human consumption will be safe. (c) The status of glycine as generally § 170.100 Submission of a premarket recognized as safe for use in animal notification for a food contact sub- feed, as prescribed in § 582.5049 of this stance (FCN) to the Food and Drug chapter, remains unchanged because Administration (FDA). the additive is considered an essential (a) An FCN is effective for the food nutrient in certain animal feeds and is contact substance manufactured or safe for such use under conditions of prepared by the manufacturer or sup- good feeding practice. plier identified in the FCN submission. If another manufacturer or supplier § 170.60 Nitrites and/or nitrates in cur- wishes to market the same food con- ing premixes. 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 , 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 spice 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 (b) FDA may choose not to accept an are not formed in curing premixes con- FCN for either of the following:

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(1) A use of a food contact substance (b) All data and other information that is the subject of a regulation in that form the basis of the determina- parts 173 through 189 of this chapter; or tion that the food contact substance is (2) A use of a food contact substance safe under the intended conditions of that is the subject of an exemption use. Data must include primary bio- under the threshold of regulation proc- logical data and chemical data. ess described in § 170.39. (c) A good laboratory practice state- (c) A petition must be submitted ment for each nonclinical laboratory under § 171.1 of this chapter to author- study, as defined under § 58.3(d) of this ize the safe use of a food contact sub- chapter, that is submitted as part of stance in either of the following cir- the FCN, in the form of either: cumstances, unless FDA agrees to ac- (1) A signed statement that the study cept an FCN for the proposed use. was conducted in compliance with the (1) The use of the food contact sub- good laboratory practice regulations stance increases the cumulative die- under part 58 of this chapter; or tary concentration to a certain level. (2) A brief signed statement listing For a substance that is a biocide (e.g., the reason(s) that the study was not it is intended to exert microbial tox- conducted in compliance with part 58 icity), this level is equal to or greater of this chapter. than 200 parts per billion in the daily (3) Data from any study conducted diet (0.6 milligram (mg)/person/day). after 1978 but not conducted in compli- For a substance that is not a biocide, ance with part 58 of this chapter must this level is equal to or greater than 1 be validated by an independent third part per million in the daily diet (3 mg/ party prior to submission to the Food person/day); or and Drug Administration (FDA), and (2) There exists a bioassay on the the report and signed certification of food contact substance, FDA has not the validating party must be submitted reviewed the bioassay, and the bio- as part of the notification. assay is not clearly negative for car- (d) Information to address FDA’s re- cinogenic effects. sponsibility under the National Envi- (d) A manufacturer or supplier for ronmental Policy Act, in the form of which a notification is effective must either: keep a current address on file with (1) A claim of categorical exclusion FDA. under § 25.30 or § 25.32 of this chapter; or (1) The current address may be either (2) An environmental assessment the manufacturer’s (or supplier’s) ad- complying with § 25.40 of this chapter. dress or the address of the manufactur- (e) A completed and signed FDA er’s (or supplier’s) agent. Form No. 3480. (2) FDA will deliver correspondence to the manufacturer’s or supplier’s cur- § 170.102 Confidentiality of informa- rent address. tion in a premarket notification for a food contact substance (FCN). § 170.101 Information in a premarket (a) During the 120-day period of the notification for a food contact sub- Food and Drug Administration (FDA) stance (FCN). review of an FCN, FDA will not dis- An FCN must contain the following: close publicly any information in that (a) A comprehensive discussion of the FCN. basis for the manufacturer’s or sup- (b) FDA will not disclose publicly the plier’s determination that the use of information in an FCN that is with- the food contact substance is safe. This drawn prior to the completion of FDA’s discussion must: review. (1) Discuss all information and data (c) Once FDA completes its review of submitted in the notification; and an FCN, the agency will make its con- (2) Address any information and data clusion about the FCN publicly avail- that may appear to be inconsistent able. For example, if FDA objects to a with the determination that the pro- notification 90 days after the date of posed use of the food contact substance receipt, the agency would make avail- is safe. able its objection at that time.

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(d) By submitting an FCN to FDA, ing to the FCN or FDA has issued an the manufacturer or supplier waives objection letter. any claim to confidentiality of the in- formation required to adequately de- § 170.104 Action on a premarket notifi- scribe the food contact substance and cation for a food contact substance (FCN). the intended conditions of use that are the subject of that FCN. (a) If the Food and Drug Administra- (e) The following data and informa- tion (FDA) does not object to an FCN tion in an FCN are available for public within the 120-day period for FDA re- disclosure, unless extraordinary cir- view, the FCN becomes effective. cumstances are shown, on the 121st day (b) If an FCN is complete when re- after receipt of the notification by ceived, the 120-day review period begins FDA, except that no data or informa- on the date FDA receives the FCN. tion are available for public disclosure (1) If any element required under if the FCN is withdrawn under § 170.103. § 170.101 is missing from an FCN, then (1) All safety and functionality data FDA will not accept that FCN and FDA and information submitted with or in- will send an FCN nonacceptance letter corporated by reference into the notifi- to the manufacturer or supplier. If the cation. Safety and functionality data manufacturer or supplier submits the include all studies and tests of a food missing information before FDA sends contact substance on animals and hu- an FCN nonacceptance letter, the 120- mans and all studies and tests on a day review period begins on the date of food contact substance for establishing receipt of the missing information. (2) If FDA accepts an FCN, then FDA identity, stability, purity, potency, will acknowledge in writing its receipt performance, and usefulness. of that FCN. (2) A protocol for a test or study, un- (c) Objection to an FCN: less it is exempt from disclosure under (1) If FDA objects to an FCN, then § 20.61 of this chapter. FDA will send an FCN objection letter. (3) A list of all ingredients contained The date of the letter will be the date in a food contact substance, excluding of FDA’s objection for purposes of sec- information that is exempt from dis- tion 409(h)(2)(A) of the act. closure under § 20.61 of this chapter. (2) If FDA objects to an FCN within Where applicable, an ingredient list the 120-day period for FDA review, the will be identified as incomplete. FCN will not become effective. (4) An assay method or other analyt- (3) FDA may object to an FCN if any ical method, unless it serves no regu- part of FDA’s 120-day review occurs latory or compliance purpose and is ex- during a period when this program is empt from disclosure under § 20.61 of not funded as required in section this chapter. 409(h)(5) of the act. (5) All correspondence and written (d) If FDA and a manufacturer or summaries of oral discussions relating supplier agree that the notifier may to the notification, except information submit a food additive petition pro- that is exempt for disclosure under posing the approval of the food contact § 20.61 of this chapter. substance for the use in the manufac- (6) All other information not subject turer’s or supplier’s FCN, FDA will to an exemption from disclosure under consider that FCN to be withdrawn by subpart D of part 20 of this chapter. the manufacturer or supplier on the date the petition is received by FDA. § 170.103 Withdrawal without preju- dice of a premarket notification for § 170.105 The Food and Drug Adminis- a food contact substance (FCN). tration’s (FDA’s) determination that A manufacturer or supplier may a premarket notification for a food withdraw an FCN without prejudice to contact substance (FCN) is no a future submission to the Food and longer effective. Drug Administration (FDA) if FDA has (a) If data or other information avail- not completed review of the FCN. For able to FDA, including data not sub- the purpose of this section, FDA’s re- mitted by the manufacturer or sup- view is completed when FDA has al- plier, demonstrate that the intended lowed 120 days to pass without object- use of the food contact substance is no

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longer safe, FDA may determine that PART 171—FOOD ADDITIVE the authorizing FCN is no longer effec- PETITIONS tive. (b) If FDA determines that an FCN is Subpart A—General Provisions no longer effective, FDA will inform the manufacturer or supplier in writing Sec. of the basis for that determination. 171.1 Petitions. 171.6 Amendment of petition. FDA will give the manufacturer or sup- 171.7 Withdrawal of petition without preju- plier an opportunity to show why the dice. FCN should continue to be effective 171.8 Threshold of regulation for substances and will specify the time that the man- used in food-contact articles. ufacturer or supplier will have to re- spond. Subpart B—Administrative Actions on Applications (c) If the manufacturer or supplier fails to respond adequately to the safe- 171.100 Regulation based on petition. ty concerns regarding the notified use, 171.102 Effective date of regulation. FDA will publish a notice of its deter- 171.110 Procedure for objections and hear- mination that the FCN is no longer ef- ings. 171.130 Procedure for amending and repeal- fective. FDA will publish this notice in ing tolerances or exemptions from toler- the FEDERAL REGISTER, stating that a ances. detailed summary of the basis for AUTHORITY: 21 U.S.C. 321, 342, 348, 371. FDA’s determination that the FCN is no longer effective has been placed on SOURCE: 42 FR 14489, Mar. 15, 1977, unless otherwise noted. public display and that copies are available upon request. The date that the notice publishes in the FEDERAL Subpart A—General Provisions REGISTER is the date on which the noti- § 171.1 Petitions. fication is no longer effective. (d) FDA’s determination that an FCN (a) Petitions to be filed with the is no longer effective is final agency Commissioner under the provisions of section 409(b) of the Federal Food, action subject to judicial review. Drug, and Cosmetic Act (the act) shall § 170.106 Notification for a food con- be submitted in triplicate (quadru- tact substance formulation plicate, if intended uses include use in (NFCSF). meat, meat food product, or poultry product). If any part of the material (a) In order for the Food and Drug submitted is in a foreign language, it Administration (FDA) to accept an shall be accompanied by an accurate NFCSF, any food additive that is a and complete English translation. The component of the formulation must be petition shall state petitioner’s post of- authorized for its intended use in that fice address to which published notices NFCSF. or orders issued or objections filed pur- (b) FDA may publish a notice in the suant to section 409 of the Act may be FEDERAL REGISTER stating that the sent. agency has insufficient resources to re- (b) Pertinent information may be in- view NFCSFs. From the date that this corporated in, and will be considered as notice publishes in the FEDERAL REG- part of, a petition on the basis of spe- ISTER, FDA will no longer accept cific reference to such information sub- NFCSFs. mitted to and retained in the files of (c) An NFCSF must contain the fol- the Food and Drug Administration. lowing: However, any reference to unpublished (1) A completed and signed FDA information furnished by a person other than the applicant will not be Form No. 3479; and considered unless use of such informa- (2) Any additional documentation re- tion is authorized in a written state- quired to establish that each compo- ment signed by the person who sub- nent of the formulation already may be mitted it. Any reference to published marketed legally for its intended use. information offered in support of a food

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additive petition should be accom- be followed by a complete quantitative panied by reprints or photostatic cop- statement of composition. Reasonable alter- ies of such references. natives for any listed substance may be spec- ified. (c) Petitions shall include the fol- If the petitioner does not himself perform lowing data and be submitted in the all the manufacturing, processing, and pack- following form: ing operations for a food additive, the peti- tion shall identify each person who will per- (Date) form a part of such operations and designate Name of petitioner lllllllllllll the part. Post-office address lllllllllllll The petition shall include stability data, Date lllllllllllllllllllll and, if the data indicate that it is needed to Name of food additive and proposed use ll insure the identity, strength, quality, or pu- llllllllllllllllllllllll rity of the additive, the expiration date that Office of Food Additive Safety (HFS–200), will be employed. Center for Food Safety and Applied Nutri- B. The amount of the food additive pro- tion, Food and Drug Administration, 5100 posed for use and the purposes for which it is Paint Branch Pkwy., College Park, MD 20740. proposed, together with all directions, rec- ommendations, and suggestions regarding DEAR SIRS: the proposed use, as well as specimens of the The undersigned, lllll submits this labeling proposed for the food additive and petition pursuant to section 409(b)(1) of the any labeling that will be required by applica- Federal Food, Drug, and Cosmetic Act with ble provisions of the Federal Food, Drug, and respect to lllll Cosmetic Act on the finished food by reason (Name of the food additive and proposed use) of the use of the food additive. If the additive results or may reasonably be expected to re- Attached hereto, in triplicate (quadru- sult from the use of packaging material, the plicate, if intended uses include use in meat, petitioner shall show how this may occur meat food product, or poultry product), and and what residues may reasonably be antici- constituting a part of this petition are the pated. following: (Typewritten or other draft-labeling copy A. The name and all pertinent information will be accepted for consideration of the pe- concerning the food additive, including tition, provided a statement is made that chemical identity and composition of the final printed labeling identical in content to food additive, its physical, chemical, and bi- the draft copy will be submitted as soon as ological properties, and specifications pre- available and prior to the marketing of the scribing the minimum content of the desired food additive.) component(s) and identifying and limiting (If the food additive is one for which a tol- the reaction byproducts and other impuri- erance limitation is required to assure its ties. Where such information is not avail- safety, the level of use proposed should be no able, a statement as to the reasons why it is higher than the amount reasonably required not should be submitted. to accomplish the intended physical or other When the chemical identity and composi- technical effect, even though the safety data tion of the food additive is not known, the may support a higher tolerance.) petition shall contain information in suffi- C. Data establishing that the food additive cient detail to permit evaluation regarding will have the intended physical or other 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

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or not the food additive will be safe for its tioner. Nothing herein shall prevent intended use. The reports ordinarily should reference to published data. include detailed data derived from appro- (g) A petition shall be retained but priate animal and other biological experi- shall not be filed if any of the data pre- ments in which the methods used and the re- sults obtained are clearly set forth. The peti- scribed by section 409(b) of the Act are tion shall not omit without explanation any lacking or are not set forth so as to be reports of investigations that would bias an readily understood. evaluation of the safety of the food additive.) (h)(1) The following data and infor- F. Proposed tolerances for the food addi- mation in a food additive petition are tive, if tolerances are required in order to in- available for public disclosure, unless sure its safety. A petitioner may include a extraordinary circumstances are proposed regulation. shown, after the notice of filing of the G. If submitting petition to modify an ex- isting regulation issued pursuant to section petition is published in the FEDERAL 409(c)(1)(A) of the Act, full information on REGISTER or, if the petition is not each proposed change that is to be made in promptly filed because of deficiencies the original regulation must be submitted. in it, after the petitioner is informed The petition may omit statements made in that it will not be filed because of the the original petition concerning which no deficiencies involved: change is proposed. A supplemental petition (i) All safety and functionality data must be submitted for any change beyond and information submitted with or in- the variations provided for in the original petition and the regulation issued on the corporated by reference in the petition. basis of the original petition. (ii) A protocol for a test or study, un- H. The petitioner is required to submit ei- less it is shown to fall within the ex- ther a claim for categorical exclusion under emption established for trade secrets § 25.30 or 25.32 of this chapter or an environ- and confidential commercial informa- mental assessment under § 25.40 of this chap- tion in § 20.61 of this chapter. ter. (iii) Adverse reaction reports, prod- Yours very truly, uct experience reports, consumer com- Petitioner llllllllllllllllll plaints, and other similar data and in- By llllllllllllllllllllll formation, after deletion of: (Indicate authority) (a) Names and any information that (d) The petitioner will be notified of would identify the person using the the date on which his petition is filed; product. and an incomplete petition, or one that (b) Names and any information that has not been submitted in triplicate, would identify any third party involved will usually be retained but not filed as with the report, such as a physician or a petition under section 409 of the Act. hospital or other institution. The petitioner will be notified in what (iv) A list of all ingredients contained respects his petition is incomplete. in a food additive, whether or not it is (e) The petition must be signed by in descending order of predominance. A the petitioner or by his attorney or particular ingredient or group of ingre- 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

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and they no longer represent a trade tioner does not wish to supplement or secret or confidential commercial or fi- explain the petition and requests in nancial information as defined in § 20.61 writing that it be filed as submitted, of this chapter: the petition shall be filed and the peti- (i) Manufacturing methods or proc- tioner so notified. esses, including quality control proce- (iii) Notwithstanding paragraph dures. (i)(1)(ii) of this section, the petition (ii) Production, sales, distribution, shall not be filed if the Food and Drug and similar data and information, ex- Administration determines that the cept that any compilation of such data use identified in the petition should be and information aggregated and pre- the subject of an FCN under section pared in a way that does not reveal 409(h) of the act rather than a petition. data or information which is not avail- (2) The Commissioner will publish in able for public disclosure under this the FEDERAL REGISTER within 30 days provision is available for public disclo- from the date of filing of such petition, sure. a notice of the filing, the name of the (iii) Quantitative or semiquantita- petitioner, and a brief description of tive formulas. the proposal in general terms. In the (3) All correspondence and written case of a food additive which becomes a summaries of oral discussions relating component of food by migration from to a food additive petition are avail- packaging material, the notice shall able for public disclosure in accordance include the name of the migratory sub- with the provisions of part 20 of this stance, and where it is different from chapter when the food additive regula- that of one of the original components, tion is published in the FEDERAL REG- the name of the parent component, the ISTER. maximum quantity of the migratory (4) For purposes of this regulation, substance that is proposed for use in safety and functionality data include food, and the physical or other tech- all studies and tests of a food additive nical effect which the migratory sub- on animals and humans and all studies stance or its parent component is in- and tests on a food additive for iden- tended to have in the packaging mate- tity, stability, purity, potency, per- rial. A copy of the notice will be formance, and usefulness. mailed to the petitioner when the (i)(1)(i) Within 15 days after receipt, original is forwarded to the FEDERAL the Food and Drug Administration will REGISTER for publication. notify the petitioner of the acceptance (j) The Commissioner may request a or nonacceptance of a petition, and if full description of the methods used in, not accepted, the reasons therefor. If and the facilities and controls used for, accepted, the petitioner will be sent a the production of the food additive, or letter stating this and the date of the a sample of the food additive, articles letter shall become the date of filing used as components thereof, or of the 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

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Act shall be moved forward 1 day for USDA jurisdiction under specified con- each day after the mailing date of the ditions or restrictions. request taken by the petitioner to sub- [42 FR 14489, Mar. 15, 1977, as amended at 42 mit the sample. If the information or FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, sample is requested a reasonable time 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, in advance of the 180 days, but is not 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, submitted within such 180 days after Aug. 25, 2000; 67 FR 35731, May 21, 2002; 72 FR filing of the petition, the petition will 10357, Mar. 8, 2007] be considered withdrawn without prej- udice. § 171.6 Amendment of petition. (k) If nonclinical laboratory studies After a petition has been filed, the are involved, petitions filed with the petitioner may submit additional in- Commissioner under section 409(b) of formation or data in support thereof. the act shall include, with respect to In such cases, if the Commissioner de- each nonclinical study contained in the termines that the additional informa- petition, either a statement that the tion or data amount to a substantive study has been, or will be, conducted in amendment, the petition as amended compliance with the good laboratory will be given a new filing date, and the practice regulations as set forth in part time limitation will begin to run anew. 58 of this chapter, or, if any such study If nonclinical laboratory studies are in- was not conducted in compliance with volved, additional information and such regulations, a brief statement of data submitted in support of filed peti- the reason for the noncompliance. tions shall include, with respect to (l) [Reserved] each nonclinical study, either a state- (m) If clinical investigations involv- ment that the study was conducted in ing human subjects are involved, peti- compliance with the requirements set tions filed with the Commissioner forth in part 58 of this chapter, or, if under section 409(b) of the Act shall in- the study was not conducted in compli- clude statements regarding each such ance with such regulations, a brief clinical investigation relied upon in statement of the reason for the non- the petition that it either was con- compliance. ducted in compliance with the require- [50 FR 7492, Feb. 22, 1985, as amended at 50 ments for institutional review set forth 16668, Apr. 26, 1985] in part 56 of this chapter, or was not subject to such requirements in accord- § 171.7 Withdrawal of petition without ance with § 56.104 or § 56.105, and that it prejudice. was conducted in compliance with the (a) In some cases the Commissioner requirements for informed consent set will notify the petitioner that the peti- forth in part 50 of this chapter. tion, while technically complete, is in- (n)(1) If intended uses of the food ad- adequate to justify the establishment ditive include uses in meat, meat food of a regulation or the regulation re- 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.

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(c) Any petitioner who has a food ad- the petitioner of such order and the ditive petition pending before the agen- reasons for such action; or by order cy and who subsequently submits a deny the petition, and shall notify the premarket notification for a food con- petitioner of such order and of the rea- tact substance (FCN) for a use or uses sons for such action. described in such petition shall be (b) The regulation shall describe the deemed to have withdrawn the petition conditions under which the substance for such use or uses without prejudice may be safely used in any meat prod- to a future filing on the date the FCN uct, meat food product, or poultry is received by the Food and Drug Ad- product subject to the Federal Meat In- ministration. spection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspec- [42 FR 14489, Mar. 15, 1977, as amended at 67 tion Act (PPIA) (21 U.S.C. 451 et seq.). FR 35731, May 21, 2002] (c) If the Commissioner determines § 171.8 Threshold of regulation for that additional time is needed to study substances used in food-contact ar- and investigate the petition, he shall ticles. by written notice to the petitioner ex- Substances used in food-contact arti- tend the 90-day period for not more cles (e.g., food-packaging or food-proc- than 180 days after the filing of the pe- essing equipment) that migrate or that tition. may be expected to migrate into food [42 FR 14489, Mar. 15, 1977, as amended at 65 at negligible levels may be reviewed FR 51763, Aug. 25, 2000] under § 170.39 of this chapter. The Food and Drug Administration will exempt § 171.102 Effective date of regulation. substances whose uses it determines A regulation published in accordance meet the criteria in § 170.39 of this with § 171.100(a) shall become effective chapter from regulation as food addi- upon publication in the FEDERAL REG- tives and, therefore, a food additive pe- ISTER. tition will not be required for the ex- empted use. § 171.110 Procedure for objections and hearings. [60 FR 36596, July 17, 1995] Objections and hearings relating to food additive regulations under section Subpart B—Administrative Actions 409 (c), (d), or (h) of the Act shall be on Applications governed by part 12 of this chapter. § 171.100 Regulation based on petition. [42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977] (a) The Commissioner will forward for publication in the FEDERAL REG- § 171.130 Procedure for amending and ISTER, within 90 days after filing of the repealing tolerances or exemptions petition (or within 180 days if the time from tolerances. is extended as provided for in section (a) The Commissioner, on his own 409(c)(2) of the Act), a regulation pre- initiative or on the petition of any in- scribing the conditions under which terested person, pursuant to part 10 of the food additive may be safely used this chapter, may propose the issuance (including, but not limited to, speci- of a regulation amending or repealing a fications as to the particular food or regulation pertaining to a food additive classes of food in or on which such ad- or granting or repealing an exception ditive may be used, the maximum for such additive. quantity that may be used or per- (b) Any such petition shall include an mitted to remain in or on such food, assertion of facts, supported by data, the manner in which such additive may showing that new information exists be added to or used in or on such food, with respect to the food additive or and any directions or other labeling or that new uses have been developed or packaging requirements for such addi- old uses abandoned, that new data are tive deemed necessary by him to assure available as to toxicity of the chem- the safety of such use), and prior to the ical, or that experience with the exist- forwarding of the order to the FEDERAL ing regulation or exemption may jus- REGISTER for publication shall notify tify its amendment or repeal. New data

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shall be furnished in the form specified Subpart D—Special Dietary and Nutritional in §§ 171.1 and 171.100 for submitting pe- Additives titions. 172.310 Aluminum nicotinate. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.315 Nicotinamide-ascorbic acid complex. FR 15674, Mar. 22, 1977] 172.320 Amino acids. 172.325 Bakers yeast protein. 172.330 Calcium pantothenate, calcium chlo- PART 172—FOOD ADDITIVES PER- ride double salt. MITTED FOR DIRECT ADDITION TO 172.335 D-Pantothenamide. FOOD FOR HUMAN CONSUMP- 172.340 Fish protein isolate. 172.345 Folic acid (folacin). TION 172.350 and salts of fumaric acid. Subpart A—General Provisions 172.365 Kelp. 172.370 Iron-choline citrate complex. Sec. 172.372 N-Acetyl-L-. 172.5 General provisions for direct food ad- 172.375 Potassium iodide. ditives. 172.379 Vitamin D2. 172.380 Vitamin D3. Subpart B—Food Preservatives 172.385 Whole fish protein concentrate. 172.395 Xylitol. 172.105 Anoxomer. 172.399 Zinc methionine sulfate. 172.110 BHA. 172.115 BHT. Subpart E—Anticaking Agents 172.120 Calcium disodium EDTA. 172.410 Calcium silicate. 172.130 Dehydroacetic acid. 172.430 Iron ammonium citrate. 172.133 Dimethyl dicarbonate. 172.480 Silicon dioxide. 172.135 Disodium EDTA. 172.490 Yellow prussiate of soda. 172.140 Ethoxyquin. 172.145 Heptylparaben. Subpart F—Flavoring Agents and Related 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- Substances phenol. 172.510 Natural flavoring substances and 172.155 Natamycin (pimaricin). natural substances used in conjunction 172.160 Potassium . with flavors. 172.165 Quaternary ammonium chloride 172.515 Synthetic flavoring substances and combination. adjuvants. 172.167 Silver nitrate and hydrogen peroxide 172.520 Cocoa with dioctyl sodium sulfo- solution. succinate for manufacturing. 172.170 Sodium nitrate. 172.530 Disodium guanylate. 172.175 Sodium . 172.535 Disodium inosinate. 172.177 used in processing 172.540 DL-. smoked chub. 172.560 Modified hop extract. 172.180 Stannous chloride. 172.575 Quinine. 172.185 TBHQ. 172.580 Safrole-free extract of sassafras. 172.585 Sugar beet extract flavor base. 172.190 THBP. 172.590 Yeast-malt sprout extract.

Subpart C—Coatings, Films and Related Subpart G—Gums, Chewing Gum Bases Substances and Related Substances 172.210 Coatings on fresh citrus fruit. 172.610 Arabinogalactan. 172.215 Coumarone-indene resin. 172.615 Chewing gum base. 172.225 Methyl and ethyl esters of fatty 172.620 Carrageenan. acids produced from edible fats and oils. 172.623 Carrageenan with polysorbate 80. 172.230 Microcapsules for flavoring sub- 172.626 Salts of carrageenan. stances. 172.655 Furcelleran. 172.235 Morpholine. 172.660 Salts of furcelleran. 172.250 Petroleum naphtha. 172.665 Gellan gum. 172.255 Polyacrylamide. 172.695 Xanthan gum. 172.260 Oxidized polyethylene. Subpart H—Other Specific Usage Additives 172.270 Sulfated butyl oleate. 172.275 Synthetic paraffin and succinic de- 172.710 Adjuvants for pesticide use dilu- rivatives. tions. 172.280 Terpene resin. 172.712 1,3–Butylene glycol.

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172.715 Calcium lignosulfonate. 172.863 Salts of fatty acids. 172.720 Calcium lactobionate. 172.864 Synthetic fatty alcohols. 172.723 Epoxidized oil. 172.866 Synthetic glycerin produced by the 172.725 Gibberellic acid and its potassium hydrogenolysis of carbohydrates. salt. 172.867 Olestra. 172.730 Potassium bromate. 172.868 Ethyl cellulose. 172.735 Glycerol ester of rosin. 172.869 Sucrose oligoesters. 172.736 Glycerides and polyglycides of hy- 172.870 Hydroxypropyl cellulose. drogenated vegetable oils. 172.872 Methyl ethyl cellulose. 172.755 Stearyl monoglyceridyl citrate. 172.874 Hydroxypropyl methylcellulose. 172.765 Succistearin (stearoyl propylene gly- 172.876 Castor oil. col hydrogen succinate). 172.878 White mineral oil. 172.770 Ethylene oxide polymer. 172.880 Petrolatum. 172.775 Methacrylic acid-divinylbenzene co- 172.882 Synthetic isoparaffinic petroleum polymer. hydrocarbons. 172.780 Acacia (gum arabic). 172.884 Odorless light petroleum hydro- 172.785 Listeria-specific bacteriophage prepa- carbons. ration. 172.886 Petroleum . Subpart I—Multipurpose Additives 172.888 Synthetic petroleum wax. 172.890 Rice bran wax. 172.800 Acesulfame potassium. 172.892 Food starch-modified. 172.802 Acetone peroxides. 172.894 Modified cottonseed products in- 172.804 Aspartame. tended for human consumption. 172.806 Azodicarbonamide. 172.896 Dried yeasts. 172.808 Copolymer condensates of ethylene 172.898 Bakers yeast glycan. oxide and propylene oxide. AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, 172.809 Curdlan. 172.810 Dioctyl sodium sulfosuccinate. 379e. 172.811 Glyceryl tristearate. SOURCE: 42 FR 14491, Mar. 15, 1977, unless 172.812 Glycine. otherwise noted. 172.814 Hydroxylated lecithin. 172.816 Methyl glucoside- oil ester. EDITORIAL NOTE: Nomenclature changes to 172.818 Oxystearin. part 172 appear at 61 FR 14482, Apr. 2, 1996, 66 172.820 Polyethylene gylcol (mean molec- FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, ular weight 200–9,500). 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880, 172.822 Sodium lauryl sulfate. July 15, 2005, 70 FR 67651, Nov. 8, 2005, and 70 172.824 Sodium mono- and dimethyl naph- FR 72074, Dec. 1, 2005. thalene sulfonates. 172.826 Sodium stearyl fumarate. Subpart A—General Provisions 172.828 Acetylated monoglycerides. 172.829 Neotame. § 172.5 General provisions for direct 172.830 Succinylated monoglycerides. food additives. 172.831 Sucralose. 172.832 Monoglyceride citrate. (a) Regulations prescribing condi- 172.833 Sucrose acetate isobutyrate (SAIB). tions under which food additive sub- 172.834 Ethoxylated mono- and diglycerides. stances may be safely used predicate 172.836 Polysorbate 60. usage under conditions of good manu- 172.838 Polysorbate 65. 172.840 Polysorbate 80. facturing practice. For the purposes of 172.841 Polydextrose. this part, good manufacturing practice 172.842 Sorbitan monostearate. shall be defined to include the fol- 172.844 Calcium stearoyl-2-lactylate. lowing restrictions. 172.846 Sodium stearoyl lactylate. (1) The quantity of the substance 172.848 Lactylic esters of fatty acids. added to food does not exceed the 172.850 Lactylated fatty acid esters of glyc- amount reasonably required to accom- erol and . 172.852 Glyceryl-lacto esters of fatty acids. plish its intended physical, nutritive, 172.854 Polyglycerol esters of fatty acids. or other technical effect in food. 172.856 Propylene glycol mono- and diesters (2) Any substance intended for use in of fats and fatty acids. or on food is of appropriate food grade 172.858 Propylene glycol alginate. and is prepared and handled as a food 172.859 Sucrose fatty acid esters. ingredient. 172.860 Fatty acids. 172.861 Cocoa butter substitute from coco- (b) The existence of a regulation pre- nut oil, palm kernel oil, or both oils. scribing safe conditions of use for a 172.862 Oleic acid derived from tall oil fatty food additive shall not be construed to acids. relieve the use of the substance from

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compliance with any other provision of www.archives.gov/federallregister/ the Act. codeloflfederallregulations/ (c) The existence of any regulation ibrllocations.html. prescribing safe conditions of use for a (3) Phenol content: Not less than 3.2 nutrient substance does not constitute milliequivalent/gram and not more a finding that the substance is useful than 3.8 milliequivalent/gram as deter- or required as a supplement to the diet mined by a method entitled ‘‘Total of humans. Phenols,’’ 1982, which is incorporated by reference. Copies are available from Subpart B—Food Preservatives the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug § 172.105 Anoxomer. Administration, 5100 Paint Branch Anoxomer as identified in this sec- Pkwy., College Park, MD 20740, or at tion may be safely used in accordance the National Archives and Records Ad- with the following conditions: ministration (NARA). For information (a) Anoxomer is 1,4-benzenediol, 2- on the availability of this material at (1,1-dimethylethyl)-polymer with NARA, call 202–741–6030, or go to: http:// diethenylbenzene, 4-(1,1-dimethyl- www.archives.gov/federallregister/ ethyl)phenol, 4- methoxyphenol, 4,4′-(1- codeloflfederallregulations/ methylethylidene)bis(phenol) and 4- ibrllocations.html. methylphenol (CAS Reg. No. 60837–57–2) (4) Heavy metals as lead (as Pb), not prepared by condensation polymeriza- more than 10 parts per million. Arsenic tion of divinylbenzene (m- and p-) with (as As), not more than 3 parts per mil- tert-butylhydroquinone, tert-butyl- lion. Mercury (as Hg), not more than 1 phenol, hydroxyanisole, p-cresol and part per million. 4,4′-isopropylidenediphenol. (c) Anoxomer may be safely used as (b) The polymeric antioxidant meets an antioxidant in food at a level of not the following specifications: more than 5,000 parts per million based (1) Polymer, not less than 98.0 per- on fat and oil content of the food. cent as determined by an ultraviolet [48 FR 18798, Apr. 26, 1983, as amended at 54 method entitled ‘‘Ultraviolet Assay, FR 24896, June 12, 1989] ‘‘1982, which is incorporated by ref- erence. Copies are available from the § 172.110 BHA. Center for Food Safety and Applied Nu- The food additive BHA (butylated hy- trition (HFS–200), Food and Drug Ad- droxyanisole) alone or in combination ministration, 5100 Paint Branch Pkwy., with other antioxidants permitted in College Park, MD 20740, or at the Na- food for human consumption in this tional Archives and Records Adminis- subpart B may be safely used in or on tration (NARA). For information on specified foods, as follows: the availability of this material at (a) The BHA meets the following NARA, call 202–741–6030, or go to: http:// specification: www.archives.gov/federallregister/ codeloflfederallregulations/ Assay (total BHA), 98.5 percent minimum. ibrllocations.html. 48 °C minimum. (2) Molecular weight: Total mono- (b) The BHA is used alone or in com- mers, dimers and trimers below 500 not bination with BHT, as an antioxidant more than 1 percent as determined by a in foods, as follows: method entitled ‘‘Low Molecular Weight Anoxomer Analysis,’’ 1982, Limitations (total BHA which is incorporated by reference. Food and BHT) Copies are available from the Center parts per million for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- Dehydrated potato shreds ...... 50 tion, 5100 Paint Branch Pkwy., College Active dry yeast ...... 1 1,000 Beverages and desserts prepared from dry Park, MD 20740, or at the National Ar- mixes ...... 1 2 chives and Records Administration Dry breakfast cereals ...... 50 (NARA). For information on the avail- Dry diced glazed fruit ...... 1 32 Dry mixes for beverages and desserts ...... 1 90 ability of this material at NARA, call Emulsion stabilizers for shortenings ...... 200 202–741–6030, or go to: http:// Potato flakes ...... 50

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Limitations § 172.120 Calcium disodium EDTA. (total BHA Food and BHT) The food additive calcium disodium parts per million EDTA (calcium disodium ethylene- diaminetetraacetate) may be safely Potato granules ...... 10 used in designated foods for the pur- Sweet potato flakes ...... 50 poses and in accordance with the condi- 1 BHA only. tions prescribed, as follows: (c) To assure safe use of the additive: (a) The additive contains a minimum (1) The label of any market package of 99 percent by weight of either the di- of the additive shall bear, in addition hydrate C10H12O8N2CaNa2·2H2O or the to the other information required by trihydrate C10H12O8N2CaNa2·3H2O, or the Act, the name of the additive. any mixture of the two. (2) When the additive is marketed in (b) It is used or intended for use as a suitable carrier, in addition to meet- follows: ing the requirement of paragraph (c)(1) (1) Alone, in the following foods at of this section, the label shall declare not to exceed the levels prescribed, cal- the percentage of the additive in the culated as the anhydrous compound: mixture. Limita- (3) The label or labeling of dry mixes tion for beverages and desserts shall bear Food (parts Use per mil- adequate directions for use to provide lion) that beverages and desserts prepared from the dry mixes contain no more Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. than 2 parts per million BHA. Canned carbonated soft 33 Promote flavor reten- drinks. tion. § 172.115 BHT. Canned white potatoes 110 Promote color retention. Clams (cooked canned) 340 Promote color retention. The food additive BHT (butylated hy- Crabmeat (cooked 275 Retard struvite forma- droxytoluene), alone or in combination canned). tion; promote color with other antioxidants permitted in retention. this subpart B may be safely used in or Cucumbers pickled ...... 220 Promote color, flavor, and texture retention. on specified foods, as follows: Distilled alcoholic bev- 25 Promote stability of (a) The BHT meets the following erages. color, flavor, and/or specification: Assay (total BHT) 99 per- product clarity. Dressings, nonstandard- 75 . cent minimum. ized. (b) The BHT is used alone or in com- Dried lima beans 310 Promote color retention. bination with BHA, as an antioxidant (cooked canned). in foods, as follows: Egg product that is 1 200 Preservative. hard-cooked and con- Limitations sists, in a cylindrical (total BHA shape, of egg white Food and BHT) with an inner core of parts per egg . million Fermented malt bev- 25 Antigushing agent. erages. Dehydrated potato shreds ...... 50 French dressing ...... 75 Preservative. Dry breakfast cereals ...... 50 Legumes (all cooked 365 Promote color retention. Emulsion stabilizers for shortenings ...... 200 canned, other than Potato flakes ...... 50 dried lima beans, pink Potato granules ...... 10 beans, and red Sweetpotato flakes ...... 50 beans). Mayonnaise ...... 75 Do. (c) To assure safe use of the additive: Mushrooms (cooked 200 Promote color retention. (1) The label of any market package canned). Oleomargarine ...... 75 Preservative. of the additive shall bear, in addition Pecan pie filling ...... 100 Promote color retention. to the other information required by Pink beans (cooked 165 Promote color retention. the Act, the name of the additive. canned). (2) When the additive is marketed in Potato salad ...... 100 Preservative. Processed dry pinto 800 Promote color retention. a suitable carrier, in addition to meet- beans. ing the requirement of paragraph (c)(1) Red beans (cooked 165 Promote color retention. of this section, the label shall declare canned). Salad dressing ...... 75 Preservative. the percentage of the additive in the Sandwich spread ...... 100 Do. mixture. Sauces ...... 75 Do.

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Limita- Sodium salt of dehydroacetic acid: Assay, tion minimum 98 percent (dry basis). Food (parts Use per mil- (b) It is used or intended for use as a lion) preservative for cut or peeled squash, Shrimp (cooked 250 Retard struvite forma- and is so used that no more than 65 canned). tion; promote color retention. parts per million expressed as dehydro- Spice extractives in 60 Promote color and fla- acetic acid remains in or on the pre- soluble carriers. vor retention. pared squash. Spreads, artificially col- 100 Promote color retention. ored and lemon-fla- (c) The label or labeling of any pack- vored or orange-fla- age of the additive intended for use in vored. food shall bear adequate directions for 1 By weight of egg yolk portion. use to insure compliance with this sec- (2) With disodium EDTA (disodium tion. ethylenediaminetetraacetate) in the § 172.133 Dimethyl dicarbonate. following foods at not to exceed, in combination, the levels prescribed, cal- Dimethyl dicarbonate (CAS Reg. No. culated as anhydrous C10H12O8N2CaNa2: 4525–33–1) may be safely used in food in accordance with the following pre- Limita- tion scribed conditions: Food (parts Use (a) The additive meets the following per mil- lion) specifications: (1) The additive has a purity of not Dressings, nonstandardized .... 75 Preservative. French dressing ...... 75 Do. less than 99.8 percent as determined by Mayonnaise ...... 75 Do. the following titration method: Salad dressing ...... 75 Do. Sandwich spread ...... 100 Do. PRINCIPLES OF METHOD Sauces ...... 75 Do. Dimethyl dicarbonate (DMDC) is mixed (c) To assure safe use of the additive: with excess diisobutylamine with which it (1) The label and labeling of the addi- reacts quantitatively. The excess is tive container shall bear, in addition to backtitrated with acid. the other information required by the APPARATUS Act, the name of the additive. (2) The label or labeling of the addi- 250-milliliter (mL) Beaker tive container shall bear adequate use 100-mL Graduate cylinder directions to provide a final food prod- 25-mL Pipette uct that complies with the limitations 10-mL Burette (automatic, eg., Metrohm bu- rette) provided in paragraph (b) of this sec- Stirrer tion. Device for potentiometric titration (d) In the standardized foods listed in Reference electrode paragraph (b) of this section, the addi- Glass electrode tives are used only in compliance with the applicable standards of identity for REAGENTS such foods. Acetone, analytical-grade [42 FR 14491, Mar. 15, 1977, as amended at 48 Solution of 1 N diisobutylamine in chloro- FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, benzene, distilled 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, 1 N Acetic Acid Aug. 8, 2000] PROCEDURE § 172.130 Dehydroacetic acid. Accurately weigh in about 2 grams of the The food additive dehydroacetic acid sample (W) and dissolve in 100 mL acetone. and/or its sodium salt may be safely Add accurately 25 mL of the 1 N diisobutyl- used in accordance with the following amine solution by pipette and allow to stand prescribed conditions: for 5 minutes. Subsequently, titrate the re- (a) The food additive meets the fol- action mixture potentiometrically with 1 N lowing specifications: hydrochloric acid (consumption=a mL) while stirring. For determining the blank con- Dehydroacetic acid: Melting point, 109 °C–111 sumption, carry out the analysis without a °C; assay, minimum 98 percent (dry basis). sample (consumption=b mL).

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CALCULATION cent, in an amount not to exceed 250 parts per million. ()ba− ×13. 4 (c) To ensure the safe use of the food = % DMDC additive, the label of the package con- W taining the additive shall bear, in addi- NOTE: For adding the diisobutylamine so- tion to other information required by lution, always use the same pipette and wait the Federal Food, Drug, and Cosmetic for a further three drops to fall when the Act: flow has stopped. (1) The name of the additive ‘‘di- (2) The additive contains not more methyl dicarbonate.’’ than 2,000 ppm (0.2 percent) dimethyl (2) The intended use of the additive. carbonate as determined by a method (3) Adequate directions for use to en- entitled ‘‘Gas Chromatography Method sure compliance with this section. for Dimethyl Carbonate Impurity in [53 FR 41329, Oct. 21, 1988, as amended at 58 Dimethyl Dicarbonate,’’ which is incor- FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; porated by reference in accordance 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, with 5 U.S.C. 552(a). Copies are avail- 1996; 66 FR 13653, Mar. 7, 2001] able from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 § 172.135 Disodium EDTA. Paint Branch Pkwy., College Park, MD The food additive disodium EDTA 20740, or at the National Archives and (disodium ethylenediaminetetraace- Records Administration (NARA). For tate) may be safely used in designated information on the availability of this foods for the purposes and in accord- material at NARA, call 202–741–6030, or ance with the following prescribed con- go to: http://www.archives.gov/ ditions: federallregister/ (a) The additive contains a minimum codeloflfederallregulations/ of 99 percent disodium ethylenedia- ibrllocations.html. minetetraacetate dihydrate (b) The additive is used or intended (C10H14O8N2Na2·2H2O). for use as a microbial control agent in (b) It is used or intended for use as the following beverages under normal follows: circumstances of bottling, canning, or (1) Alone, in the following foods at other forms of final packaging, where not to exceed the levels prescribed, cal- 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, filtration, or other technologies Food (parts Use per mil- prior to the use of dimethyl dicar- lion) bonate: Aqueous multivitamin prep- 150 With iron salts as a (1) In wine, dealcoholized wine, and arations. stabilizer for vita- low alcohol wine in an amount not to min B 12 in liquid exceed 200 parts per million. multivitamin prep- arations. (2) In ready-to-drink teas in an Canned black-eyed peas .... 145 Promote color re- amount not to exceed 250 parts per mil- tention. lion. Canned beans ...... 165 Preservative. Canned strawberry pie filling 500 Promote color re- (3) In carbonated or noncarbonated, tention. nonjuice-containing (less than or equal Cooked sausage ...... 36 As a cure accel- to 1 percent juice), flavored or erator with so- unflavored beverages containing added dium ascorbate or ascorbic acid. electrolytes (5–20 milliequivalents/liter Dressings, nonstandardized 75 Preservative. sodium ion (Na+) and 3–7 milli- French dressing ...... 75 Do. equivalents/liter potassium ion (K+)) in Frozen white potatoes in- 100 Promote color re- cluding cut potatoes. tention. an amount not to exceed 250 parts per Gefilte fish balls or patties in 1 50 Inhibit discoloration. million. packing medium. (4) In carbonated, dilute beverages Legumes (all cooked 165 Promote color re- canned, other than black- tention. containing juice, fruit flavor, or both, eyed peas). with juice content not to exceed 50 per- Mayonnaise ...... 75 Preservative.

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Limita- § 172.140 Ethoxyquin. tion Food (parts Use (a) Ethoxyquin (1,2-dihydro-6-ethoxy- per mil- lion) 2,2,4-trimethylquinoline) may be safely used as an antioxidant for preservation Ready-to-eat cereal prod- 2 315 Promote color re- ucts containing dried ba- tention. of color in the production of chili pow- nanas. der, paprika, and ground chili at levels Salad dressing ...... 75 Preservative. not in excess of 100 parts per million. Sandwich spread ...... 100 Do. (b) In order to provide for the safe Sauces ...... 75 Do. use of the additive in feed prepared in 1 Based on total weight of finished product including packing medium. accordance with §§ 573.380 and 573.400 of 2 In dried banana component of cereal product. this chapter, tolerances are established (2) With calcium disodium EDTA for residues of ethoxyquin in or on edi- (calcium disodium ethylenediamine- ble products of animals as follows: tetraacetate; calcium disodium 5 parts per million in or on the uncooked fat (ethylenedinitrilo) tetraacetate), in the of meat from animals except poultry. following foods at not to exceed, in 3 parts per million in or on the uncooked combination, the levels prescribed, cal- liver and fat of poultry. culated as anhydrous C10H12O8N2CaNa2: 0.5 part per million in or on the uncooked muscle meat of animals. Limita- 0.5 part per million in poultry eggs. tion Food (parts Use Zero in milk. per mil- lion) § 172.145 Heptylparaben. Dressings, nonstandardized 75 Preservative. (a) The food additive heptylparaben French dressing ...... 75 Do. Mayonnaise ...... 75 Do. is the chemical n-heptyl p-hydroxy- Salad dressing ...... 75 Do. benzoate. Sandwich spread ...... 100 Do. (b) It may be safely used to inhibit Sauces ...... 75 Do. microbiological spoilage in accordance with the following prescribed condi- (3) Alone, as a sequestrant in the tions: nonnutritive sweeteners that are listed (1) In fermented malt beverages in in § 180.37 of this chapter and that, in amounts not to exceed 12 parts per mil- addition, are designed for aqueous solu- tion: Provided, That the amount of the lion. additive, calculated as anhydrous cal- (2) In noncarbonated soft drinks and cium disodium EDTA, does not exceed fruit-based beverages in amounts not 0.1 percent by weight of the dry non- to exceed 20 parts per million, when nutritive sweetener. standards of identity established under (c) To assure the safe use of the addi- section 401 of the Act (21 U.S.C. 341) do tive: not preclude such use. (1) The label and labeling of the addi- tive container shall bear, in addition to § 172.150 4-Hydroxymethyl-2,6-di-tert- the other information required by the butylphenol. act, the name of the additive. The food additive 4-hydroxymethyl- (2) The label or labeling of the addi- 2,6-di-tert-butylphenol may be safely tive container shall bear adequate use used in food in accordance with the fol- directions to provide a final food prod- lowing prescribed conditions: uct that complies with the limitations (a) The additive has a solidification provided in paragraph (b) of this sec- point of 140 °C–141 °C. tion. (b) The additive is used as an anti- (d) In the standardized foods listed in oxidant alone or in combination with paragraphs (b) (1) and (2) of this section other permitted antioxidants. the additives are used only in compli- (c) The total amount of all anti- ance with the applicable standards of oxidants added to such food shall not identity for such foods. exceed 0.02 percent of the oil or fat con- [42 FR 14491, Mar. 15, 1977, as amended at 65 tent of the food, including the essential FR 48379, Aug. 8, 2000] (volatile) oil content of the food.

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§ 172.155 Natamycin (pimaricin). § 172.165 Quaternary ammonium chlo- ride combination. (a) Natamycin (CAS Reg. No. 7681–93– 8), also known as pimaricin, is a pol- The food additive, quaternary ammo- yene macrolide antimycotic substance nium chloride combination, may be possessing an empirical formula of safely used in food in accordance with the following conditions: C33H47NO13 and a molecular weight of 665.7. (a) The additive contains the fol- (b) The additive shall conform to the lowing compounds: n-dodecyl dimethyl following specifications: benzyl ammonium chloride (CAS Reg. No. 139–07–1); n-dodecyl dimethyl ethyl- Purity: 97 percent ±2 percent on an anhy- benzyl ammonium chloride (CAS Reg. drous basis. No. 27479–28–3); n-hexadecyl dimethyl Arsenic: Not more than 1 part per million. benzyl ammonium chloride (CAS Reg. Heavy metals (as Pb): Not more than 20 parts No. 122–18–9); n-octadecyl dimethyl per million. benzyl ammonium chloride (CAS Reg. (c) The additive may be applied on No. 122–19–0); n-tetradecyl dimethyl cheese, as an antimycotic, in amounts benzyl ammonium chloride (CAS Reg. not to exceed 20 milligrams per kilo- No. 139–08–2); n-tetradecyl dimethyl gram (20 parts per million) in the fin- ethylbenzyl ammonium chloride (CAS ished product as determined by Inter- Reg. No. 27479–29–4). national Dairy Federation (IDF) Stand- (b) The additive meets the following ard 140A:1992, ‘‘Cheese and Cheese specifications: pH (5 percent active so- Rind-Determination of Natamycin Con- lution) 7.0–8.0; total amines, maximum tent-Method by Molecular Absorption 1 percent as combined free amines and Spectrometry and by High-Perform- amine hydrochlorides. ance Liquid Chromatography,’’ which (c) The additive is used as an anti- is incorporated by reference. The Di- microbial agent, as defined in rector of the Office of the Federal Reg- § 170.3(o)(2) of this chapter, in raw sugar ister approves this incorporation by cane juice. It is added prior to clari- reference in accordance with 5 U.S.C. fication when further processing of the 552(a) and 1 CFR part 51. Copies are sugar cane juice must be delayed. available from the Division of Product (d) The additive is applied to the Policy (HFS–206), Center for Food Safe- sugar juice in the following quantities, ty and Applied Nutrition, Food and based on the weight of the raw cane: Drug Administration, 5100 Paint Parts per Branch Pkwy., College Park, MD 20740, Component million or may be examined at the Center for n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 Food Safety and Applied Nutrition’s n-Dodecyl dimethyl ethylbenzyl ammonium Library, 5100 Paint Branch Pkwy., Col- chloride ...... 3.4–13.5 lege Park, MD 20740, or at the National n-Hexadecyl dimethyl benzyl ammonium chlo- Archives and Records Administration ride ...... 1.5–6.0 n-Octadecyl dimethyl benzyl ammonium chlo- (NARA). For information on the avail- ride ...... 0.25–1.0 ability of this material at NARA, call n-Tetradecyl dimethyl benzyl ammonium chlo- 202–741–6030, or go to: http:// ride ...... 3.0–12.0 n-Tetradecyl dimethyl ethylbenzyl ammonium www.archives.gov/federallregister/ chloride ...... 1.6–6.5 codeloflfederallregulations/ ibrllocations.html. [50 FR 3890, Jan. 29, 1985] [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, § 172.167 Silver nitrate and hydrogen 1998; 66 FR 13847, Mar. 8, 2001] peroxide solution. An containing a § 172.160 Potassium nitrate. mixture of silver nitrate and hydrogen The food additive potassium nitrate peroxide may be safely used in accord- may be safely used as a curing agent in ance with the following prescribed con- the processing of cod roe, in an amount ditions: not to exceed 200 parts per million of (a) The additive is used as an anti- the finished roe. microbial agent in bottled water.

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(b) Hydrogen peroxide meets the at the National Archives and Records specifications of the ‘‘Food Chemicals Administration (NARA). For informa- Codex,’’ 6th ed. (2008), pp. 463 and 464, tion on the availability of this mate- which is incorporated by reference. The rial at NARA, call 202–741–6030 or go to: Director of the Federal Register ap- http://www.archives.gov/federallregister/ proves this incorporation by reference codelofl federallregulations/ in accordance with 5 U.S.C. 552(a) and 1 ibrllocations.html. CFR part 51. You may obtain copies (e) Substances generally recognized from the United States Pharmacopeial as safe in or on food may be used to Convention, 12601 Twinbrook Pkwy., stabilize the additive to ensure that Rockville, MD 20852 (Internet address the additive will perform its intended http://www.usp.org). Copies may be ex- technical effect. amined at the Center for Food Safety (f) The additive may not be added to and Applied Nutrition’s Library, Food bottled water that has been filtered or and Drug Administration, 5100 Paint is intended to be filtered through a sil- Branch Pkwy., College Park, MD 20740, ver-containing water filter. 301–436–2163, or at the National Ar- (g) Bottled water must meet the chives and Records Administration quality standards for bottled water in (NARA). For information on the avail- § 165.110(b)(2) through (b)(5) of this ability of this material at NARA, call chapter, including the limits specified 202–741–6030 or go to: http:// for total silver and nitrate, unless the www.archives.gov/federallregister/ water bears a label statement of sub- codeloflfederallregulations/ standard quality, as provided for under ibrllocations.html. § 165.110(c) of this chapter. (c) The amount of silver added will not exceed 17 micrograms per kilogram [74 FR 11478, Mar. 18, 2009] in the treated bottled water, and the amount of hydrogen peroxide will not § 172.170 Sodium nitrate. exceed 23 milligrams per kilogram in The food additive sodium nitrate the treated bottled water. Analyses for may be safely used in or on specified silver and hydrogen peroxide shall be foods in accordance with the following conducted on samples of treated bot- prescribed conditions: tled water at the site of bottling, using (a) It is used or intended for use as samples of the water intended for follows: treatment for the blank determination. (d)(1) The amount of silver in the (1) As a preservative and color fixa- treated bottled water is determined tive, with or without sodium nitrite, in using the method for silver designated smoked, cured sablefish, smoked, cured in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). salmon, and smoked, cured shad, so (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 Center parts per million in the finished meat for Food Safety and Applied Nutri- product. tion’s Library, Food and Drug Admin- (b) To assure safe use of the additive, istration, 5100 Paint Branch Pkwy., in addition to the other information re- College Park, MD 20740, 301–436–2163, or quired by the Act:

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(1) The label of the additive or of a (ii) A statement of the concentration mixture containing the additive shall of the additive in any mixture. bear: (2) If in a retail package intended for (i) The name of the additive. household use, the label and labeling of (ii) A statement of the concentration the additive, or of a mixture con- of the additive in any mixture. taining the additive, shall bear ade- (2) If in a retail package intended for quate directions for use to provide a household use, the label and labeling of final food product which complies with the additive, or of a mixture con- the limitations prescribed in paragraph taining the additive, shall bear ade- (a) of this section. quate directions for use to provide a (3) If in a retail package intended for final food product that complies with household use, the label of the addi- the limitations prescribed in paragraph tive, or of a mixture containing the ad- (a) of this section. ditive, shall bear the statement ‘‘Keep (3) If in a retail package intended for out of the reach of children’’. household use, the label of the additive or of a mixture containing the addi- § 172.177 Sodium nitrite used in proc- tive, shall bear the statement ‘‘Keep essing smoked chub. out of the reach of children’’. The food additive sodium nitrite may be safely used in combination with salt § 172.175 Sodium nitrite. (NaCl) to aid in inhibiting the out- The food additive sodium nitrite may growth and toxin formation from Clos- be safely used in or on specified foods tridium botulinum type E in the com- in accordance with the following pre- mercial processing of smoked chub in scribed conditions: accordance with the following pre- (a) It is used or intended for use as scribed conditions: follows: (a) All fish in smoking establish- (1) As a color fixative in smoked ments shall be clean and wholesome cured tunafish products so that the and shall be expeditiously processed, level of sodium nitrite does not exceed packed, and stored under adequate san- 10 parts per million (0.001 percent) in itary conditions in accordance with the finished product. good manufacturing practice. (2) As a preservative and color fixa- (b) The brining procedure is con- tive, with or without sodium nitrate, trolled in such a manner that the in smoked, cured sablefish, smoked, water phase portion of the edible por- cured salmon, and smoked, cured shad tion of the finished smoked product has so that the level of sodium nitrite does a salt (NaCl) content of not less than not exceed 200 parts per million and the 3.5 percent, as measured in the loin level of sodium nitrate does not exceed muscle, and the sodium nitrite content 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

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storage and distribution. All shipping exceed 0.02 percent of the oil or fat con- containers, retail packages, and ship- tent of the food, including the essential ping records shall indicate with appro- (volatile) oil content of the food. priate notice the perishable nature of the product and specify that the prod- § 172.190 THBP. uct shall be held under refrigeration (38 The food additive THBP (2,4,5-tri- °F or below) until consumed. hydroxybutyrophenone) may be safely (e) To assure safe use of the additive: used in food in accordance with the fol- (1) The label and labeling of the addi- lowing prescribed conditions: tive container shall bear, in addition to (a) The food additive has a melting the other information required by the point of 149 °C–153 °C. Act, the name of the additive. (b) It is used as an antioxidant alone (2) The label or labeling of the addi- or in combination with other permitted tive container shall bear adequate di- antioxidants. rections to assure use in compliance (c) The total antioxidant content of a with the provisions of this section. food containing the additive will not § 172.180 Stannous chloride. exceed 0.02 percent of the oil or fat con- tent of the food, including the essential The food additive stannous chloride (volatile) oil content of the food. may be safely used for color retention in asparagus packed in glass, with lids lined with an inert material, in an Subpart C—Coatings, Films and amount not to exceed 20 parts per mil- Related Substances lion calculated as tin (Sn). § 172.210 Coatings on fresh citrus fruit. § 172.185 TBHQ. Coatings may be applied to fresh cit- The food additive TBHQ, which is the rus fruit for protection of the fruit in chemical 2-(1,1-dimethylethyl)-1,4-benz- accordance with the following condi- enediol (Chemical Abstracts Service tions: Registry Number 1948–33–0), also known (a) The coating is applied in the min- as tertiary butylhydroquinone, may be imum amount required to accomplish safely used in food in accordance with the intended effect. the following prescribed conditions: (b) The coating may be formulated (a) The food additive has a melting from the following components, each point of 126.5 °C–128.5 °C. used in the minimum quantity required (b) It is used as an antioxidant alone to accomplish the intended effect: or in combination with BHA and/or (1) Substances generally recognized BHT. as safe for the purpose or previously (c) The total antioxidant content of a sanctioned for the purpose. food containing the additive will not (2) One or more of the following:

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 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.

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Component Limitations

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.

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. Potassium persulfate ...... 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 sulfuric acid 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. Barr Harbor Dr., West Conshohocken, The food additive coumarone-indene Philadelphia, PA 19428-2959, or may be resin may be safely used on grapefruit, examined at the National Archives and lemons, limes, oranges, tangelos, and Records Administration (NARA). For tangerines in accordance with the fol- information on the availability of this lowing prescribed conditions: material at NARA, call 202–741–6030, or (a) The food additive is manufactured go to: http://www.archives.gov/ by the polymerization of a crude, federallregister/ heavy coal-tar solvent naphtha meet- codeloflfederallregulations/ ing the following specifications: ibrllocations.html. (1) It is a mixture of indene, indan (2) Refractive index (n25/D) 1.63–1.64. (hydrindene), substituted benzenes, and (c) It is used or intended for use as a related compounds. protective coating for grapefruit, lem- (2) It contains no more than 0.25 per- ons, limes, oranges, tangelos, and tan- cent tar bases. gerines whereby the maximum amount (3) 95 percent distills in the range 167 of the resin remaining on the fruit does °C–184 °C. not exceed 200 parts per million on a (b) The food additive meets the fol- fresh-weight basis. lowing specifications: (d) To assure safe use of the additive: (1) Softening point, ring and ball: 126 (1) The label of the market package °C minimum as determined by ASTM or any intermediate premix of the ad- method E28–67 (Reapproved 1982), ditive shall bear, in addition to the ‘‘Standard Test Method for Softening other information required by the act: Point by Ring-and-Ball Apparatus,’’ (i) The name of the additive, cou- which is incorporated by reference. marone-indene resin. Copies may be obtained from the Amer- (ii) A statement of the concentration ican Society for Testing Materials, 100 of the additive therein.

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(2) The label or accompanying label- Arabinogalactan—Complying with § 172.610; ing shall bear adequate directions that, as adjuvant. if followed, will result in a finished Silicon dioxide—Complying with § 172.480; as food not in conflict with the require- adjuvant. ments of this section. (3) In lieu of the components listed in paragraph (a)(2) of this section, the fol- [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984] lowing components:

§ 172.225 Methyl and ethyl esters of COMPONENT AND LIMITATIONS fatty acids produced from edible Glutaraldehyde—As cross-linking agent for fats and oils. insolubilizing a coacervate of gum arabic Methyl esters and ethyl esters of and gelatin. fatty acids produced from edible fats n-Octyl alcohol—As a defoamer. and oils may be safely used in food, (4) In lieu of the components listed in subject to the following prescribed con- paragraphs (a)(2) and (3) of this section, ditions: the following component: (a) The additive consists of a mixture of either methyl or ethyl esters of COMPONENT AND LIMITATIONS fatty acids produced from edible fats and oils and meets the following speci- Petroleum wax—Complying with § 172.886. fications: Not to exceed 50 percent by combined weight of the microcapsule and spice-fla- (1) Not less than 90 percent methyl or voring substance. ethyl esters of fatty acids. (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 microcapsules formulated from compo- [57 FR 12711, Apr. 13, 1992] nents listed in paragraph (a)(2) of this section may be used only for encap- § 172.230 Microcapsules for flavoring sulating lemon oil, distilled lime oil, substances. 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.

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(a) It is used as the salt(s) of one or APPARATUS more of the fatty acids meeting the re- Separatory funnels. 250-milliliter, and 2,000- quirements of § 172.860, as a component milliliter capacity, equipped with tetra- of protective coatings applied to fresh fluoroethylene polymer stopcocks. fruits and vegetables. Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck. (b) It is used at a level not in excess Evaporation flask. 250-milliliter capacity of that reasonably required to produce all-glass flask equipped with 24/40 standard its intended effect. taper stopper having inlet and outlet tubes to permit passage of nitrogen across the sur- § 172.250 Petroleum naphtha. face of the container liquid to be evaporated. Condenser. 24/40 joints, fitted with drying Petroleum naphtha may be safely tube, length optional. used in food in accordance with the fol- Spectrophotometric cells. Fused quartz cells, lowing conditions: optical path length in the range of 5,000 cen- ± (a) The additive is a mixture of liquid timeters 0.005 centimeter; also for checking spectrophotometer performance only, optical hydrocarbons, essentially paraffinic path length in the range 1,000 centimeter and naphthenic in nature obtained ±0.005 centimeter. With distilled water in the from petroleum, cells, determine any absorbance difference. (b) The additive is refined to meet Spectrophotometer. Spectral range 250–400 μ μ the following specifications when sub- m with spectral slit width of 2 m or less; under instrument operating conditions for jected to the procedures described in these absorbance measurements, the spectro- this paragraph. photometer shall also meet the following (1) Boiling-point range: 175 °F–300 °F. performance requirements: (2) Nonvolatile residue: 0.002 gram Absorbance repeatability, ±0.01 at 0.4 absorb- per 100 milliliters maximum. ance. (3) Ultraviolet absorbance limits, as Absorbance accuracy, 1 ±0.05 at 0.4 absorb- follows: ance. Wavelength repeatability, ±0.2 millimicron. ± Maximum Wavelength accuracy, 1.0 millimicron. absorb- Ultraviolet lamp. Long wavelength (3400– ance per Wavelength (milli-microns) centimeter 3800A°). optical pathlength REAGENTS

280–289 ...... 0.15 Isooctane (2,2,4-trimethylpentane). Use 180 290–299 ...... 13 milliliters in a 250-milliliter Erlenmeyer 300–359 ...... 08 flask, add 1 milliliter of purified n-- 360–400 ...... 02 decane, insert the head assembly, allow ni- trogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and ANALYTICAL SPECIFICATION FOR PETROLEUM vacuum line in such a way as to prevent any NAPHTHA back flow of condensate into the flask. The

GENERAL INSTRUCTIONS 1 As determined by procedure using potas- All glassware should be scrupulously sium chromate for reference standard and cleaned to remove all organic matter such as described in National Bureau of Standards oil, grease, detergent residues, etc. Examine Circular 484, Spectrophotometry, U.S. De- all glassware, including stoppers and stop- partment of Commerce, (1949). The accuracy cocks, under ultraviolet light to detect any is to be determined by comparison with the residual fluorescent contamination. As a pre- standard values at 290, 345, and 400 milli- cautionary measure, it is recommended prac- microns. The procedure is incorporated by tice to rinse all glassware with purified iso- reference. Copies of the material incor- octane immediately before use. No grease is porated by reference are available from the to be used on stopcocks or joints. Great care Center for Food Safety and Applied Nutri- to avoid contamination of petroleum naph- tion (HFS–200), Food and Drug Administra- tha samples in handling and to assure ab- tion, 5100 Paint Branch Pkwy., College Park, sence of any extraneous material arising MD 20740, or available for inspection at the National Archives and Records Administra- from inadequate packaging is essential. Be- tion (NARA). For information on the avail- cause some of the polynuclear hydrocarbons ability of this material at NARA, call 202– sought in this test are very susceptible to 741–6030, or go to: http://www.archives.gov/ photo-oxidation, the entire procedure is to federallregister/codeloflfederallregulations/ be carried out under subdued light. ibrllocations.html.

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contents of the flask are evaporated on a tube into the flask, mix until the sodium steam bath until 1 milliliter of residue re- borohydride is dissolved, and allow to stand mains. Dissolve the 1 milliliter of hexa- for 30 minutes at room temperature, with decane residue in isooctane and make up to intermittent swirling. At the end of this 25 milliliters. Determine the absorbance in a time, disconnect the flask and evaporate the 5-centimeter path length cell compared to methyl alcohol on the steam bath under ni- isooctane as reference. The absorbance trogen until sodium borohydride begins to should not exceed 0.01 per centimeter path drop out of solution. Remove the flask and length between 280–400 mμ. If necessary, iso- let it cool. octane may be purified by passage through a Add 6 milliliters of isooctane to the flask column of activated silica gel (Grade 12, Da- and swirl to wash the crystalline slurry. vidson Chemical Co., Baltimore, Md., or Carefully transfer the isooctane extract to a equivalent) or by distillation. 250-milliliter separatory funnel. Dissolve the Methyl alcohol, A.C.S. reagent grade. Use 10 crystals in the flask with about 25 milliliters milliliters and proceed as with isooctane. of distilled water and pour this also into the The absorbance per centimeter of path separatory funnel. Adjust the water volume length should be 0.00 between 280–400 mμ. in the separatory funnel to about 100 milli- Methyl alcohol may be purified by simple liters and shake for 1 minute. After separa- distillation or by refluxing in the presence of tion of the layers, draw off the aqueous layer potassium hydroxide (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 hydrocarbon 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/

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codeloflfederallregulations/ scribed in item 2.3 of the table in ibrllocations.html. § 177.1520(c) of this chapter. The Determination of nonvolatile residue. For hy- oxidized polyethylene has a minimum drocarbons boiling below 121 °C, determine the nonvolatile residue by ASTM method number average molecular weight of D1353–78, ‘‘Standard Test Method for Non- 1,200, as determined by high tempera- volatile Matter in Volatile Solvents for Use ture vapor pressure osmometry; con- in Paint, Varnish, Lacquer, and Related tains a maximum of 5 percent by Products;’’ for those boiling above 121 °C, use weight of total oxygen; and has an acid ASTM method D381–80, ‘‘Standard Test value of 9 to 19. Method for Existent Gum in Fuels by Jet (b) The additive is used or intended Evaporation,’’ which methods are incor- porated by reference. Copies may be obtained for use as a protective coating or com- from the American Society for Testing Ma- ponent of protective coatings for fresh terials, 100 Barr Harbor Dr., West avocados, bananas, beets, , Conshohocken, Philadelphia, PA 19428-2959, eggplant, garlic, grapefruit, lemons, or may be examined at the National Ar- limes, mango, muskmelons, onions, or- chives and Records Administration (NARA). anges, papaya, peas (in pods), pine- For information on the availability of this apple, plantain, pumpkin, rutabaga, material at NARA, call 202–741–6030, or go to: squash (), sweetpotatoes, tan- http://www.archives.gov/federallregister/ codeloflfederallregulations/ gerines, turnips, watermelon, Brazil ibrllocations.html. nuts, chestnuts, filberts, hazelnuts, pe- 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 that reasonably required to accomplish Sulfate butyl oleate may be safely the intended effect or to exceed any used in food, subject to the following prescribed limitations. prescribed conditions: (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 vegetable oil using 1-butanol. Fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing , 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 density, 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

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be safely used as a component of food, federallregister/ subject to the following restrictions: codeloflfederallregulations/ (a) The additive is prepared with 50 ibrllocations.html. percent Fischer-Tropsch process syn- (b) It is used or intended for use as thetic paraffin, meeting the definition follows: and specifications of § 172.615, and 50 (1) As a moisture barrier on soft gela- percent of such synthetic paraffin to tin capsules in an amount not to ex- which is bonded succinic anhydride and ceed 0.07 percent of the weight of the succinic acid derivatives of isopropyl capsule. alcohol, polyethylene glycol, and poly- (2) As a moisture barrier on powders propylene glycol. It consists of a mix- of ascorbic acid or its salts in an ture of the Fischer-Tropsch process amount not to exceed 7 percent of the paraffin (alkane), alkyl succinic anhy- weight of the powder. dride, alkyl succinic anhydride iso- [42 FR 14491, Mar. 15, 1977, as amended at 49 propyl half ester, dialkyl succinic an- FR 10104, Mar. 19, 1984] hydride polyethylene glycol half ester, 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 § 172.280 Terpene resin. acid and nicotinamide, melting in the 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 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 an- Copies may be obtained from the Amer- hydrous form or as the hydrochloride, ican Society for Testing Materials, 100 sodium or potassium salts: Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be L-Alanine examined at the National Archives and L- L- Records Administration (NARA). For L- information on the availability of this L- material at NARA, call 202–741–6030, or L-Cystine go to: http://www.archives.gov/ L-Glutamic acid

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L- Records Administration (NARA). For Aminoacetic acid (glycine) information on the availability of this L- material at NARA, call 202–741–6030, or L- L- go to: http://www.archives.gov/ L-Lysine federallregister/ DL-Methionine (not for infant foods) codeloflfederallregulations/ L-Methionine ibrllocations.html.) for the following: L- L- L-Asparagine L- L-Aspartic acid L- L-Glutamine L- L-Histidine L- (c) The additive(s) is used or intended L- for use to significantly improve the bi- (b) The food additive meets the fol- ological quality of the total protein in lowing specifications: a food containing naturally occurring (1) As found in ‘‘Food Chemicals primarily-intact protein that is consid- Codex,’’ National Academy of Sciences/ ered a significant dietary protein National Research Council (NAS/NRC), source, provided that: 3d Ed. (1981), which is incorporated by (1) A reasonable daily adult intake of reference (Copies may be obtained from the finished food furnishes at least 6.5 the National Academy Press, 2101 Con- grams of naturally occurring primarily stitution Ave. NW., Washington, DC intact protein (based upon 10 percent of 20418, or may be examined at the Na- the daily allowance for the ‘‘reference’’ tional Archives and Records Adminis- adult male recommended by the Na- tration (NARA). For information on tional Academy of Sciences in ‘‘Rec- the availability of this material at ommended Dietary Allowances,’’ NAS NARA, call 202–741–6030, or go to: http:// Publication No. 1694, 7th Ed. (1968), www.archives.gov/federallregister/ which is incorporated by reference. codeloflfederallregulations/ Copies are available from the Center ibrllocations.html.) for the following: for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- L-Alanine tion, 5100 Paint Branch Pkwy., College L-Arginine Park, MD 20740, or available for inspec- L-Arginine Monohydrochloride L-Cysteine Monohydrochloride tion at the National Archives and L-Cystine Records Administration (NARA). For Aminoacetic acid (glycine) information on the availability of this L-Leucine material at NARA, call 202–741–6030, or DL-Methionine go to: http://www.archives.gov/ L-Methionine federallregister/ L-Tryptophan codeloflfederallregulations/ L-Phenylalanine ibrllocations.html. L-Proline L-Serine (2) The additive(s) results in a pro- L-Threonine tein efficiency ratio (PER) of protein Hydrochloride in the finished ready-to-eat food equiv- L-Isoleucine alent to casein as determined by the L- Monohydrochloride method specified in paragraph (d) of Monopotassium L-glutamate this section. L-Tyrosine (3) Each (or combination L-Valine of the minimum number necessary to (2) As found in ‘‘Specifications and achieve a statistically significant in- Criteria for Biochemical Compounds,’’ crease) added results in a statistically NAS/NRC Publication, 3rd Ed. (1972), significant increase in the PER as de- which is incorporated by reference termined by the method described in (Copies are available from the Center paragraph (d) of this section. The min- for Food Safety and Applied Nutrition imum amount of the amino acid(s) to (HFS–200), Food and Drug Administra- achieve the desired effect must be used tion, 5100 Paint Branch Pkwy., College and the increase in PER over the pri- Park, MD 20740, or available for inspec- marily-intact naturally occurring pro- tion at the National Archives and tein in the food must be substantiated

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as a statistically significant difference make such records available upon re- with at least a probability (P) value of quest at all reasonable hours by any of- less than 0.05. ficer or employee of the Food and Drug (4) The amount of the additive added Administration, or any other officer or for nutritive purposes plus the amount employee acting on behalf of the Sec- naturally present in free and combined retary of Health and Human Services (as protein) form does not exceed the and shall permit such officer or em- following levels of amino acids ex- ployee to conduct such inventories of pressed as percent by weight of the raw and finished materials on hand as total protein of the finished food: he deems necessary and otherwise to check the correctness of such records. Percent by weight of (e) To assure safe use of the additive, total pro- the label and labeling of the additive tein (ex- pressed as and any premix thereof shall bear, in free amino addition to the other information re- acid) quired by the Act, the following: L-Alanine ...... 6.1 (1) The name of the amino acid(s) L-Arginine ...... 6.6 contained therein including the spe- L-Aspartic acid (including L-asparagine) ...... 7.0 cific optical and chemical form. L-Cystine (including L-cysteine) ...... 2.3 L-Glutamic acid (including L-glutamine) ...... 12.4 (2) The amounts of each amino acid Aminoacetic acid (glycine) ...... 3.5 contained in any mixture. L-Histidine ...... 2.4 (3) Adequate directions for use to L-Isoleucine ...... 6.6 L-Leucine ...... 8.8 provide a finished food meeting the L-Lysine ...... 6.4 limitations prescribed by paragraph (c) L- and DL-Methionine ...... 3.1 of this section. L-Phenylalanine ...... 5.8 L-Proline ...... 4.2 (f) The food additive amino acids L-Serine ...... 8.4 added as nutrients to special dietary L-Threonine ...... 5.0 foods that are intended for use solely L-Tryptophan ...... 1.6 under medical supervision to meet nu- L-Tyrosine ...... 4.3 L-Valine ...... 7.4 tritional requirements in specific med- ical conditions and comply with the re- (d) Compliance with the limitations quirements of part 105 of this chapter concerning PER under paragraph (c) of are exempt from the limitations in this section shall be determined by the paragraphs (c) and (d) of this section method described in sections 43.212– and may be used in such foods at levels 43.216, ‘‘Official Methods of Analysis of not to exceed good manufacturing the Association of Official Analytical practices. Chemists,’’ 13th Ed. (1980), which is in- [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. corporated by reference. Copies may be 28, 1977, as amended at 47 FR 11836, Mar. 19, obtained from the AOAC INTER- 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, NATIONAL, 481 North Frederick Ave., June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR suite 500, Gaithersburg, MD 20877, or 14480, Apr. 2, 1996] may be examined at the National Ar- chives and Records Administration § 172.325 Bakers yeast protein. (NARA). For information on the avail- Bakers yeast protein may be safely ability of this material at NARA, call used in food in accordance with the fol- 202–741–6030, or go to: http:// lowing conditions: www.archives.gov/federallregister/ (a) Bakers yeast protein is the insol- codeloflfederallregulations/ uble proteinaceous material remaining ibrllocations.html. Each manufacturer after the mechanical rupture of yeast or person employing the additive(s) cells of Saccharomyces cerevisiae and re- under the provisions of this section moval of whole cell walls by cen- shall keep and maintain throughout trifugation and separation of soluble the period of his use of the additive(s) cellular materials. and for a minimum of 3 years there- (b) The additive meets the following after, records of the tests required by specifications on a dry weight basis: this paragraph and other records re- (1) Zinc salts less than 500 parts per quired to assure effectiveness and com- million (ppm) as zinc. pliance with this regulation and shall (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 selenium. 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 to remove fat and moisture. The food additive calcium chloride 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 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 Ether 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- the Orphan Drug Act (21 U.S.C. anol by weight. 360ee(b)(3)), at levels not to exceed the [46 FR 38072, July 24, 1981, as amended at 47 amount necessary to meet the distinc- FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, tive nutritional requirements of the 1989] disease or condition for which the food is formulated. § 172.345 Folic acid (folacin). (g) Folic acid may be added to food Folic acid (CAS Reg. No. 59–30–3), for special dietary use at levels not to also known as folacin or folate, may be exceed the amount necessary to meet safely used in food as a nutrient in ac- the special dietary needs for which the cordance with the following prescribed food is formulated. conditions: (h) Folic acid may be added to foods (a) Folic acid is the chemical N-[4- represented as meal-replacement prod- [[(2-amino-1,4-dihydro-4-oxo-6-pteri- ucts, in amounts not to exceed: dinyl)methyl]amino]benzoyl]-L-glu- μ tamic acid. (1) Four hundred g per serving if the (b) Folic acid meets the specifica- food is a meal-replacement that is rep- tions of the ‘‘Food Chemicals Codex,’’ resented for use once per day; or 4th ed. (1996), pp. 157–158, which is in- (2) Two hundred μg per serving if the corporated by reference in accordance food is a meal-replacement that is rep- with 5 U.S.C. 552(a) and 1 CFR part 51. resented for use more than once per Copies are available from the National day. Academy Press, Box 285, 2101 Constitu- [61 FR 8807, Mar. 5, 1996, as amended at 61 FR tion Ave. NW., Washington, DC 20055 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999] (Internet address http://www.nap.edu), or may be examined at the Center for § 172.350 Fumaric acid and salts of fu- Food Safety and Applied Nutrition’s maric acid. Library, Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College Fumaric acid and its calcium, fer- Park, MD 20740, or at the National Ar- rous, magnesium, potassium, and so- chives and Records Administration dium salts may be safely used in food (NARA). For information on the avail- in accordance with the following pre- ability of this material at NARA, call scribed conditions: 202–741–6030, or go to: http:// (a) The additives meet the following www.archives.gov/federallregister/ specifications: codeloflfederallregulations/ (1) Fumaric acid contains a minimum ibrllocations.html. of 99.5 percent by weight of fumaric (c) Folic acid may be added to foods acid, calculated on the anhydrous subject to a standard of identity estab- basis. lished under section 401 of the Federal (2) The calcium, magnesium, potas- Food, Drug, and Cosmetic Act (the act) sium, and sodium salts contain a min- when the standard of identity specifi- imum of 99 percent by weight of the re- cally provides for the addition of folic spective salt, calculated on the anhy- acid. drous basis. Ferrous fumarate contains (d) Folic acid may be added, at levels a minimum of 31.3 percent total iron not to exceed 400 micrograms (μg) per serving, to breakfast cereals, as defined and not more than 2 percent ferric under § 170.3(n)(4) of this chapter, and iron. to corn grits at a level such that each (b) With the exception of ferrous fu- pound of corn grits contains not more marate, fumaric acid and the named than 1.0 milligram of folic acid. salts are used singly or in combination (e) Folic acid may be added to infant in food at a level not in excess of the formula in accordance with section amount reasonably required to accom- 412(i)(1) of the act or with regulations plish the intended effect. issued under section 412(i)(2) of the act (c) Ferrous fumarate is used as a which are codified in § 107.100 of this source of iron in foods for special die- chapter. tary use, when the use is consistent (f) Folic acid may be added to a med- with good nutrition practice. ical food, as defined in section 5(b)(3) of

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§ 172.365 Kelp. tate; 50 ppm ethyl alcohol; 10 ppm Kelp may be safely added to a food as methyl alcohol; and 10 ppm acetone, a source of the essential mineral io- when used as processing solvents. dine, provided the maximum intake of (c) The additive is used or intended the food as may be consumed during a for use as a source of L-methionine to period of one day, or as directed for use improve significantly the biological in the case of a , quality of the total protein in a food will not result in daily ingestion of the containing naturally occurring pri- additive so as to provide a total marily intact vegetable protein that is amount of iodine in excess of 225 considered a significant dietary protein micrograms for foods labeled without source, provided that: reference to age or physiological state; (1) A reasonable daily adult intake of and when age or the conditions of preg- the finished food furnishes at least 6.5 nancy or lactation are specified, in ex- grams of naturally occurring primarily cess of 45 micrograms for infants, 105 intact vegetable protein. micrograms for children under 4 years (2) The additive results in a protein of age, 225 micrograms for adults and efficiency ratio (PER) of protein in the children 4 or more years of age, and 300 finished ready-to-eat food equivalent micrograms for pregnant or lactating to casein as determined by the method women. The food additive kelp is the specified in paragraph (d) of this sec- dehydrated, ground product prepared tion. from Macrocystis pyrifera, Laminaria (3) The use of the additive results in digitata, Laminaria saccharina, and Lam- a statistically significant increase in inaria cloustoni. the PER as determined by the method described in paragraph (d) of this sec- § 172.370 Iron-choline citrate complex. 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 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 (1) Purity assay, on a dry basis: Min- the Association of Official Analytical imum 99 percent. Chemists,’’ 13th Ed. (1980), which is in- (2) Residue on ignition: Maximum 0.1 corporated by reference. Copies may be percent. obtained from the AOAC INTER- (3) Specific optical rotation NATIONAL, 481 North Frederick Ave., 20 [alpha] D: Between ¥19° and ¥23°. suite 500, Gaithersburg, MD 20877, or (4) The additive may contain residues may be examined at the National Ar- of not more than 500 ppm ethyl ace- chives and Records Administration

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(NARA). For information on the avail- (a) Potassium iodide may be safely ability of this material at NARA, call added to a food as a source of the es- 202–741–6030, or go to: http:// sential mineral iodine, provided the www.archives.gov/federallregister/ maximum intake of the food as may be codeloflfederallregulations/ consumed during a period of one day, ibrllocations.html. Each manufacturer or as directed for use in the case of a or person employing the additive under dietary supplement, will not result in the provisions of this section shall daily ingestion of the additive so as to keep and maintain throughout the pe- provide a total amount of iodine in ex- riod of use of the additive and for a cess of 225 micrograms for foods labeled minimum of 3 years thereafter, records without reference to age or physio- of the tests required by this paragraph logical state; and when age or the con- and other records required to assure ef- ditions of pregnancy or lactation are fectiveness and compliance with this specified, in excess of 45 micrograms regulation. Those records shall be for infants, 105 micrograms for children made available upon request at all rea- under 4 years of age, 225 micrograms sonable hours by any officer or em- for adults and children 4 or more years ployee acting on behalf of the Sec- of age, and 300 micrograms for preg- retary of Health and Human Services. nant or lactating women. Those officers or employees shall be (b) To assure safe use of the additive, permitted to conduct inventories of in addition to the other information re- raw and finished materials on hand as quired by the Act, the label of the addi- are deemed necessary to verify the tive shall bear: records. (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 Vitamin D2. quired by the Act, the following: (1) The name of the additive con- Vitamin D2 may be used safely in tained therein. foods as a nutrient supplement defined (2) The amounts of additive and each under § 170.3(o)(20) of this chapter in ac- amino acid contained in any mixture. cordance with the following prescribed conditions: (3) Adequate directions for use to , also known as provide a finished food meeting the (a) Vitamin D2 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 D is pro- (f) When the food additive is added as 2 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- quirements in specific medical condi- (b) Vitamin D2 meets the specifica- tions and these foods comply with the tions of the Food Chemicals Codex, 6th requirements of part 105 of this chap- ed. (2008), pp. 1013 and 1014, which is in- ter, the food additive is exempt from corporated by reference. The Director the limitations in paragraphs (c)(1) of the Federal Register approves this through (4) and (d) of this section and incorporation by reference in accord- may be used in those foods at levels ance with 5 U.S.C 552(a) and 1 CFR part not to exceed good manufacturing 51. You may obtain a copy from the practices. United States Pharmacopeial Conven- tion, 12601 Twinbrook Pkwy., Rock- [43 FR 27784, June 27, 1978, as amended at 46 ville, MD 20852 (Internet address: http:// FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, www.usp.org). You may inspect a copy 1984; 54 FR 24897, June 12, 1989] at the Center for Food Safety and Ap- plied Nutrition’s Library, Food and § 172.375 Potassium iodide. Drug Administration, 5100 Paint The food additive potassium iodide Branch Pkwy., College Park, MD 20740, may be safely used in accordance with 301–436–1071, or at the National Ar- the following prescribed conditions: chives and Records Administration

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(NARA). For information on the avail- codeloflfederallregulations/ ability of this material at NARA, call ibrllocations.html. 202–741–6030, or go to: http:// (c) The additive may be used as fol- www.archives.gov/federallregister/ lows:

Category of Food Maximum Levels in Food (as Served)

Soy beverages 50 International Units (IU)/100 grams (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] fined under § 170.3(n)(35) of this chapter) that are fortified with greater than or § 172.380 Vitamin D3. equal to 33 percent of the reference Vitamin D3 may be used safely in daily intake (RDI) of calcium per 240 foods as a nutrient supplement defined mL, excluding fruit juices that are spe- under § 170.3(o)(20) of this chapter in ac- cially formulated or processed for in- cordance with the following prescribed fants. conditions: (2) At levels not to exceed 100 IU per (a) Vitamin D3, also known as chole- 240 mL in fruit juice drinks (as defined calciferol, is the chemical 9,10- under § 170.3(n)(35) of this chapter) that seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. are fortified with greater than or equal Vitamin D3 occurs in and is isolated to 10 percent of the RDI of calcium per from fish liver oils. It also is manufac- 240 mL, excluding fruit juice drinks tured by ultraviolet irradiation of 7-de- that are specially formulated or proc- hydrocholesterol produced from choles- essed for infants. terol and is purified by crystallization. (3) At levels not to exceed 140 IU per (b) Vitamin D3 meets the specifica- tions of the Food Chemicals Codex, 5th 240 mL (prepared beverage) in soy-pro- ed. (2004), pp. 498–499, which is incor- tein based beverages porated by reference. The Director of (powder or liquid) that are represented the Office of the Federal Register ap- for special dietary use in reducing or proves this incorporation by reference maintaining body weight in accordance in accordance with 5 U.S.C. 552(a) and 1 with § 105.66 of this chapter. CFR part 51. You may obtain copies (4) At levels not to exceed 100 IU per from the National Academy Press, 500 40 grams in meal replacement bars or Fifth St. NW., Washington, DC 20001 other-type bars that are represented (Internet address http://www.nap.edu). for special dietary use in reducing or Copies may be examined at the Center maintaining body weight in accordance for Food Safety and Applied Nutri- with § 105.66 of this chapter. tion’s Library, Food and Drug Admin- (5) At levels not to exceed 81 IU per 30 istration, 5100 Paint Branch Pkwy., grams in cheese and cheese products as College Park, MD 20740, or at the Na- defined under § 170.3(n)(5) of this chap- tional Archives and Records Adminis- ter, excluding cottage cheese, ricotta tration (NARA). For information on cheese, and hard grating cheeses such the availability of this material at as Parmesan and Romano as defined in NARA, call 202–741–6030, or go to: http:// §§ 133.165 and 133.183 of this chapter, and www.archives.gov/federallregister/ those defined by standard of identity in codeloflfederallregulations/ ibrllocations.html. § 133.148 of this chapter. (c) The additive may be used as fol- [68 FR 9003, Feb. 27, 2003, as amended at 70 lows: FR 36025, June 22, 2005; 70 FR 37257, June 29, (1) At levels not to exceed 100 Inter- 2005; 70 FR 69438, Nov. 16, 2005] national Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as de-

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§ 172.385 Whole fish protein con- scribed in section 24.003 of the AOAC. centrate. See paragraph (c)(1) of this section for The food additive whole fish protein availability of the material incor- concentrate may be safely used as a porated by reference. food supplement in accordance with (3) Fat content shall not exceed 0.5 the following prescribed conditions: percent by weight of the final product, (a) The additive is derived from as determined by the method described whole, wholesome hake and hakelike in section 24.005 of the AOAC. See para- fish, herring of the genera Clupea, men- graph (c)(1) of the this section for haden, and anchovy of the species En- availability of the material incor- graulis mordax, handled expeditiously porated by reference. and under sanitary conditions in ac- (4) The additive may contain residues cordance with good manufacturing of isopropyl alcohol and ethylene di- practices recognized as proper for fish chloride not in excess of 250 parts per that are used in other forms for human million and 5 parts per million, respec- food. tively, when used as solvents in the ex- (b) The additive consists essentially traction process. of a dried fish protein processed from (5) Microwave radiation meeting the the whole fish without removal of requirements of § 179.30 of this chapter heads, fins, tails, viscera, or intestinal may be used to reduce residues of the contents. It is prepared by solvent ex- solvents used in the extraction process. traction of fat and moisture with iso- (6) The additive shall contain not in propyl alcohol or with ethylene dichlo- excess of 100 parts per million fluorides ride followed by isopropyl alcohol, ex- (expressed as F). cept that the additive derived from (7) The additive shall be free of Esch- herring, menhaden and anchovy is pre- erichia coli and pathogenic organisms, pared by solvent extraction with iso- including Salmonella, and shall have a propyl alcohol alone. Solvent residues total bacterial plate count of not more are reduced by conventional heat dry- than 10,000 per gram. ing and/or microwave radiation and (8) The additive shall have no more there is a partial removal of bone. than a faint characteristic fish odor (c) The food additive meets the fol- and taste. lowing specifications: (1) Protein content (N × 6.25) shall (d) When the additive is used or in- not be less than 75 percent by weight of tended for use in the household as a the final product, as determined by the protein supplement in food for regular method described in section 2.057 in consumption by children up to 8 years ‘‘Official Methods of Analysis of the of age, the amount of the additive from Association of Official Analytical this source shall not exceed 20 grams 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 fluoride 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.

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(3) Labels of manufactured foods con- (a) The additive is the chemical taining the additive shall bear, in the green ferric ammonium citrate. ingredient statement, the name of the (b) The additive is used, or intended additive, ‘‘whole fish protein con- for use as an anticaking agent in salt centrate’’ in the proper order of de- for human consumption so that the creasing predominance in the finished level of iron ammonium citrate does food. not exceed 25 parts per million (0.0025 percent) in the finished salt. [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, (c) To assure safe use of the additive 1989] the label or labeling of the additive shall bear, in addition to the other in- § 172.395 Xylitol. formation required by the Act: Xylitol may be safely used in foods (1) The name of the additive. (2) Adequate directions to provide a for special dietary uses, provided the final product that complies with the amount used is not greater than that limitations prescribed in paragraph (b) required to produce its intended effect. of this section. § 172.399 Zinc methionine sulfate. § 172.480 Silicon dioxide. Zinc methionine sulfate, CAS Reg. The food additive silicon dioxide may No. 56329–42–1, may be safely used in be safely used in food in accordance accordance with the following pre- with the following conditions: scribed conditions: (a) The food additive is manufactured (a) The additive is the product of the by vapor phase hydrolysis or by other reaction between equimolar amounts of means whereby the particle size is such zinc sulfate and DL-methionine in puri- as to accomplish the intended effect. fied water. (b) It is used as an anticaking agent, (b) The additive meets the following subject to the following conditions: specifications: (1) It is used in only those foods in Zinc content—19 to 22 percent. which the additive has been dem- C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- onstrated to have an anticaking effect. cent. (2) It is used in an amount not in ex- Cadmium—not more than 0.05 part per mil- cess of that reasonably required to lion. produce its intended effect. (c) The additive is used in tablet form (3) [Reserved] as a source of dietary zinc. (4) It is used in an amount not to ex- ceed 2 percent by weight of the food. [46 FR 58297, Dec. 1, 1981] (c) It is used or intended for use as a stabilizer in the production of beer, and Subpart E—Anticaking Agents is removed from the beer by filtration prior to final processing. § 172.410 Calcium silicate. (d) It is used or intended for use as an Calcium silicate, including synthetic adsorbent for dl-a-tocopheryl acetate calcium silicate, may be safely used in and pantothenyl alcohol in tableted food in accordance with the following foods for special dietary use, in an prescribed conditions: amount not greater than that required (a) It is used as an anticaking agent to accomplish the intended physical or in food in an amount not in excess of technical effect. that reasonably required to produce its intended effect. § 172.490 Yellow prussiate of soda. (b) It will not exceed 2 percent by (a) The food additive yellow prussiate weight of the food, except that it may of soda (sodium ferrocyanide decahy- be present up to 5 percent by weight of drate; Na4Fe(CN)6·10H2O contains a baking powder. minimum of 99 percent by weight of so- dium ferrocyanide decahydrate. § 172.430 Iron ammonium citrate. (b) The additive is used or intended Iron ammonium citrate may be safe- for use as an anticaking agent in salt ly used in food in accordance with the and as an adjuvant in the production of following prescribed conditions: dendritic crystals of salt in an amount

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needed to produce its intended effect (a) They are used in the minimum but not in excess of 13 parts per million quantity required to produce their in- calculated as anhydrous sodium ferro- tended physical or technical effect and cyanide. in accordance with all the principles of [42 FR 14491, Mar. 15, 1977, as amended at 58 good manufacturing practice. FR 17098, Apr. 1, 1993] (b) In the appropriate forms (plant parts, fluid and solid extracts, con- Subpart F—Flavoring Agents and centrates, absolutes, oils, gums, bal- Related Substances sams, resins, oleoresins, waxes, and dis- tillates) they consist of one or more of § 172.510 Natural flavoring substances the following, used alone or in com- and natural substances used in con- bination with flavoring substances and junction with flavors. adjuvants generally recognized as safe Natural flavoring substances and in food, previously sanctioned for such natural adjuvants may be safely used use, or regulated in any section of this in food in accordance with the fol- part. lowing conditions.

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 root 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 Benzoin 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. Camphor 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 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. Cork, oak ...... Quercus suber L., or Q. occidentalis F. Gay ...... In alcoholic beverages only Costmary ...... Chrysanthemum balsamita L ...... Do.

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Common name Scientific name Limitations

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) roots ...... 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. Galbanum ...... Ferula galbaniflua Boiss. et Buhse and other Ferula spp. Gambir (catechu, pale) ...... Uncaria 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. Guarana ...... 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 fern ...... 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. Myrrh ...... 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.

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Common name Scientific name Limitations

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) ...... 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 ...... Hypericum perforatum L ...... Hypericin-free alcohol dis- tillate form only; in alco- holic beverages only 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. Turpentine ...... 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.

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[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- Amyl heptanoate. stances and adjuvants. Amyl hexanoate. Amyl octanoate. Synthetic flavoring substances and Anisole; methoxybenzene. adjuvants may be safely used in food in Anisyl acetate. accordance with the following condi- Anisyl alcohol; p-methoxybenzyl alcohol. tions. Anisyl butyrate (a) They are used in the minimum Anisyl formate. Anisyl phenylacetate. quantity required to produce their in- Anisyl propionate. tended effect, and otherwise in accord- Beechwood creosote. ance with all the principles of good Benzaldehyde dimethyl acetal. manufacturing practice. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- (b) They consist of one or more of the oxan-5-ol. following, used alone or in combination Benzaldehyde propylene glycol acetal; 4- with flavoring substances and adju- methyl-2-phenyl-m-dioxolane. vants generally recognized as safe in Benzenethiol; thiophenol. Benzoin; 2-hydroxy-2-phenylacetophenone. food, prior-sanctioned for such use, or Benzophenone; diphenylketone. regulated by an appropriate section in Benzyl acetate. this part. Benzyl acetoacetate. Benzyl alcohol. Acetal; acetaldehyde diethyl acetal. Benzyl benzoate. Acetaldehyde phenethyl propyl acetal. Benzyl butyl ether. ′ Acetanisole; 4 -methoxyacetophenone. Benzyl butyrate. Acetophenone; methyl phenyl ketone. Benzyl cinnamate. Allyl anthranilate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Allyl butyrate. tiglate. Allyl cinnamate. Benzyl ; dibenzyl disulfide. Allyl cyclohexaneacetate. Benzyl ethyl ether. Allyl cyclohexanebutyrate. Benzyl formate. Allyl cyclohexanehexanoate. 3-Benzyl-4-heptanone; benzyl dipropyl ke- Allyl cyclohexaneproprionate. tone. Allyl cyclohexanevalerate. Benzyl isobutyrate. Allyl disulfide. Benzyl isovalerate. Allyl 2-ethylbutyrate. Benzyl mercaptan; a-toluenethiol. Allyl hexanoate; allyl caproate. Benzyl methoxyethyl acetal; acetaldehyde Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- benzyl b-methoxyethyl acetal. ene-1-yl)-1,6-heptadiene-3-one. Benzyl phenylacetate. Allyl isothiocyanate; mustard oil. Benzyl propionate. Allyl isovalerate. Benzyl salicylate. Allyl mercaptan; 2-propene-1-thiol. Birch tar oil. Allyl nonanoate. Borneol; d-camphanol. Allyl octanoate. Bornyl acetate. Allyl phenoxyacetate. Bornyl formate. Allyl phenylacetate. Bornyl isovalerate. Allyl propionate. Bornyl valerate. Allyl sorbate; allyl 2,4-hexadienoate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca- Allyl sulfide. hydro-la-isopropyl-3aa-methyl-6-meth- Allyl tiglate; allyl trans-2-methyl-2- ylene-cyclobuta [1,2:3,4] dicyclopentene. butenoate. 2-Butanol. Allyl 10-undecenoate. 2-Butanone; methyl ethyl ketone. Ammonium isovalerate. Butter acids. Ammonium sulfide. Butter esters. Amyl alcohol; pentyl alcohol. Butyl acetate. Amyl butyrate. Butyl acetoacetate. a-Amylcinnamaldehyde. Butyl alcohol; 1-butanol. a-Amylcinnamaldehyde dimethyl acetal. Butyl anthranilate. a-Amylcinnamyl acetate. Butyl butyrate. a-Amylcinnamyl alcohol. Butyl butyryllactate; lactic acid, butyl a-Amylcinnamyl formate. ester, butyrate. a-Amylcinnamyl isovalerate. a-Butylcinnamaldehyde. Amyl formate. Butyl cinnamate.

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Butyl 2-decenoate. Citronellyl valerate. Butyl ethyl malonate. p-Cresol. Butyl formate. Cuminaldehyde; cuminal; p-isopropyl benz- Butyl heptanoate. aldehyde. Butyl hexanoate. Cyclohexaneacetic acid. Butyl p-hydroxybenzoate. Cyclohexaneethyl acetate. Butyl isobutyrate. Cyclohexyl acetate. Butyl isovalerate. Cyclohexyl anthranilate. Butyl lactate. Cyclohexyl butyrate. Butyl laurate. Cyclohexyl cinnamate. Butyl levulinate. Cyclohexyl formate. Butyl phenylacetate. Cyclohexyl isovalerate. Butyl propionate. Cyclohexyl propionate. Butyl stearate. p-Cymene. Butyl sulfide. g-Decalactone; 4-hydroxy-decanoic acid, g- Butyl 10-undecenoate. lactone. Butyl valerate. g-Decalactone; 5-hydroxy-decanoic acid, d- Butyraldehyde. lactone. Cadinene. Decanal dimethyl acetal. Camphene; 2,2-dimethyl-3-methylene- 1-Decanol; decylic alcohol. norbornane. 2-Decenal. d-Camphor. 3-Decen-2-one; heptylidene acetone. Carvacrol; 2-p-cymenol. Decyl actate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Decyl butyrate. Carveol; p-mentha-6,8-dien-2-ol. Decyl propionate. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Dibenzyl ether. terpinenol. 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy- cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- droxy-butyric acid, g-lactone. one. Dibutyl sebacate. Carvyl acetate. Diethyl malate. Carvyl propionate. Diethyl malonate; ethyl malonate. b-Caryophyllene. Diethyl sebacate. Caryophyllene alcohol. Diethyl succinate. Caryophyllene alcohol acetate. Diethyl tartrate. b-Caryophyllene oxide; 4-12,12-trimethyl-9- 2,5-Diethyltetrahydrofuran. methylene-5-oxatricylo [8.2.0.0 4,6] dode- Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl- cane. 3-isopropenylcyclohexanol. Cedarwood oil alcohols. Dihydrocarvone. Cedarwood oil terpenes. Dihydrocarvyl acetate. 1,4-Cineole. m-Dimethoxybenzene. 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.

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Ethyl 2-acetyl-3-phenylpropionate; ethyl- Formic acid benzyl acetoacetate. (2-Furyl)-2-propanone; furyl acetone. Ethyl aconitate, mixed esters. 1-Furyl-2-propanone; furyl acetone. Ethyl acrylate. Fusel oil, refined (mixed amyl alcohols). Ethyl r-anisate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Ethyl anthranilate. octadien-1-yl acetoacetate. Ethyl benzoate. Geranyl acetone; 6,10-dimethyl-5,9- Ethyl benzoylacetate. undecadien-2-one. a-Ethylbenzyl butyrate; a-phenylpropyl bu- Geranyl benzoate. tyrate. Geranyl butyrate. Ethyl brassylate; tridecanedioic acid cyclic Geranyl formate. ethylene glycol diester; cyclo 1,13-ethyl- Geranyl hexanoate enedioxytridecan-1,13-dione. Geranyl isobutyrate. 2-Ethylbutyl acetate. Geranyl isovalerate. 2-Ethylbutyraldehyde. Geranyl phenylacetate. 2-Ethylbutyric acid. Geranyl propionate. Ethyl cinnamate. Glucose pentaacetate. Ethyl crotonate; trans-2-butenoic acid ethyl- Guaiacol; μ-methoxyphenol. ester. Guaiacyl acetate; μ-methoxyphenyl acetate. Ethyl cyclohexanepropionate. Guaiacyl phenylacetate. Ethyl decanoate. Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10- 2-Ethylfuran. octahydroazulene. Ethyl 2-furanpropionate. Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy- 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. isopropyl)-d9,10-octahydroazulene acetate. Ethyl heptanoate. g-Heptalactone; 4-hydroxyheptanoic acid, g- 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. lactone. Ethyl hexanoate. Heptanal; enanthaldehyde. Ethyl isobutyrate. Heptanal dimethyl acetal. Ethyl isovalerate. Heptanal 1,2-glyceryl acetal. Ethyl lactate. 2,3-Heptanedione; acetyl valeryl. Ethyl laurate. 3-Heptanol. Ethyl levulinate. 2-Heptanone; methyl amyl ketone. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- 3-Heptanone; ethyl butyl ketone. one. 4-Heptanone; dipropyl ketone. Ethyl 2-methylbutyrate. cis-4-Heptenal; cis-4-hepten-1-al. Ethyl myristate. Heptyl acetate. . Heptyl alcohol; enanthic alcohol. Ethyl nonanoate. Heptyl butyrate. Ethyl 2-nonynoate; ethyl octyne carbonate. Heptyl cinnamate. Ethyl octanoate. Heptyl formate. 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. Eucalyptol; 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 eugenol. 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.

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Hexyl isovalerate. a-Isobutylphenethyl alcohol; isobutyl benzyl Hexyl 2-methylbutyrate. carbinol; 4-methyl-1-phenyl-2-pentanol. Hexyl octanoate. Isobutyl phenylacetate. Hexyl phenylacetate; n-hexyl phenylacetate. Isobutyl propionate. Hexyl propionate. Isobutyl salicylate. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- 2-Isobutylthiazole. octanal. Isobutyraldehyde. Hydroxycitronellal diethyl acetal. Isobutyric acid. Hydroxycitronellal dimethyl acetal. Isoeugenol; 2-methoxy-4-propenylphenol. Hydroxycitronellol; 3,7-dimethyl-1,7- Isoeugenyl acetate. octanediol. Isoeugenyl benzyl ether; benzyl isoeugenol. N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- pelargonyl vanillylamide. anisole; ethyl isoeugenol. 5-Hydroxy-4-octanone; butyroin. Isoeugenyl formate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Isoeugenyl methyl ether; 4-propenyl- benzyl acetone. veratrole; methyl isoeugenol. Indole. Isoeugenyl phenylacetate. a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Isojasmone; mixture of 2-hexylidenecyclo- yl)-3-buten-2-one. pentanone and 2-hexyl-2-cyclopenten-1-one. b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- a-Isomethylionone; 4-(2,6,6-trimethyl-2- yl)-3-buten-2-one. cyclohexen-1-yl)-3-methyl-3-buten-2-one; methyl -ionone. a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- g 1-yl)-3-buten-2-one; 6-methylionone. Isopropyl acetate. Isoamyl acetate. r-Isopropylacetophenone. Isoamyl acetoacetate. Isopropyl alcohol; isopropanol. Isopropyl benzoate. Isoamyl alcohol; isopentyl alcohol; 3-methyl- -Isopropylbenzyl alcohol; cuminic alcohol; 1-butanol. r -cymen-7-ol. Isoamyl benzoate. r Isopropyl butyrate. Isoamyl butyrate. Isopropyl cinnamate. Isoamyl cinnamate. Isopropyl formate. Isoamyl formate. Isopropyl hexanoate. Isoamyl 2-furanbutyrate; a-isoamyl furfuryl- Isopropyl isobutyrate. propionate. Isopropyl isovalerate. Isoamyl 2-furanpropionate; a-isoamyl fur- r-Isopropylphenylacetaldehyde; r-cymen-7- furylacetate. carboxaldehyde. Isoamyl hexanoate. Isopropyl phenylacetate. Isoamyl isobutyrate. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso- Isoamyl isovalerate. propylhydrocinnamaldehyde; cuminyl ac- Isoamyl laurate. etaldehyde. 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. Linalool 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.

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Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. Methyl-5-hepten-2-ol. Menthadienol; p-mentha-1,8(10)-dien-9-ol. 6-Methyl-5-hepten-2-one. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Methyl hexanoate. Menthadienyl acetate; p-mentha-1,8(10)-dien- Methyl 2-hexanoate. 9-yl acetate. Methyl p-hydroxybenzoate; methylparaben. p-Menth-3-en-1-ol. Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclo- 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl hexen-1-yl)-4-penten-3-one. acetate. Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo- Menthol; 2-isopropyl-5-methylcyclohexanol. hexen-1-yl)-4-penten-3-one. Menthone; p-menthan-3-one. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo- Menthyl acetate; p-menth-3-yl acetate. hexen-1-yl-)-4-penten-3-one. Menthyl isovalerate; p-menth-3-yl iso- Methyl isobutyrate. valerate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- o-Methoxybenzaldehyde. hyde; a-methyl-p-isopropylhydro- p-Methoxybenzaldehyde; p-anisaldehyde. cinnamal- dehyde; cyclamen aldehyde. o-Methoxycinnamaldehyde. Methyl isovalerate. 2-Methoxy-4-methylphenol; 4-methyl- Methyl laurate. guaiacol; 2-methoxy-p-cresol. Methyl mercaptan; . 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- Methyl o-methoxybenzoate. tone. Methyl N-methylanthranilate; dimethyl an- 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- thranilate. one; methoxystyryl isopropyl ketone. Methyl 2-methylbutyrate. 1-(p-Methoxyphenyl)-1-penten-3-one; a- Methyl-3-methylthiopropionate. methylanisylidene acetone; ethone. Methyl 4-methylvalerate. 1-(p-Methoxyphenyl)-2-propanone; Methyl myristate. anisylmethyl ketone; anisic ketone. Methyl b-naphthyl ketone; 2′-acetonaph- 2-Methoxy-4-vinylphenol; p-vinylguaiacol. thone. Methyl acetate. Methyl nonanoate. 4′-Methylacetophenone; p-methylaceto- Methyl 2-nonenoate. phenone; methyl p-tolyl ketone. Methyl 2-nonynoate; methyloctyne car- 2-Methylallyl butyrate; 2-methyl-2-propenl- bonate. yl butyrate. 2-Methyloctanal; methyl hexyl acetaldehyde. Methyl anisate. Methyl octanoate. o-Methylanisole; o-cresyl methyl ether. Methyl 2-octynoate; methyl heptine car- p-Methylanisole; p-cresyl methyl ether; p- bonate. methoxytoluene. 4-Methyl-2,3-pentanedione; acetyl iso- Methyl benzoate. butyryl. Methylbenzyl acetate, mixed o-,m-,p-. 4-Methyl-2-pentanone; methyl isobutyl ke- a-Methylbenzyl acetate; styralyl acetate. tone. a-Methylbenzyl alcohol; styralyl alcohol. b-Methylphenethyl alcohol; hydratropyl al- a-Methylbenzyl butyrate; styralyl butyrate. cohol. a-Methylbenzyl isobutyrate; styralyl iso- Methyl phenylacetate. butyrate. 3-Methyl-4-phenyl-3-butene-2-one. a-Methylbenzyl formate; styralyl formate. 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- a-Methylbenzyl propionate; styralyl propio- phenylethyl carbinyl acetate. nate. 2-Methyl-4-phenyl-2-butyl isobutyrate; 2-Methyl-3-buten-2-ol. dimethylphenyl ethylcarbinyl isobutyrate. 2-Methylbutyl isovalerate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl Methyl p-tert-butylphenylacetate. phenylacetaldehyde. 2-Methylbutyraldehyde; methyl ethyl acetal- Methyl 4-phenylbutyrate. dehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- 3-Methylbutyraldehyde; isovaleraldehyde. butyl ketone. Methyl butyrate. Methyl 3-phenylpropionate; methyl hydro- 2-Methylbutyric acid. cinnamate. a-Methylcinnamaldehyde. Methyl propionate. p-Methylcinnamaldehyde. 3-Methyl-5-propyl-2-cyclohexen-1-one. Methyl cinnamate. Methyl sulfide. 2-Methyl-1,3-cyclohexadiene. 3-Methylthiopropionaldehyde; methional. Methylcyclopentenolone; 3-methylcyclopen- 2-Methyl-3-tolylpropionaldehyde, mixed o-, tane-1,2-dione. m-, p-. Methyl disulfide; . 2-Methylundecanal; methyl nonyl acetal- Methyl ester of rosin, partially hydrogenated dehyde. (as defined in § 172.615); methyl Methyl 9-undecenoate. dihydroabietate. Methyl 2-undecynoate; methyl decyne car- Methyl heptanoate. bonate. 2-Methylheptanoic acid. Methyl valerate. 6-Methyl-3,5-heptadien-2-one. 2-Methylvaleric acid.

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Myrcene; 7-methyl-3-methylene-1,6-octa- Phenethyl anthranilate. diene. Phenethyl benzoate. Myristaldehyde; tetradecanal. Phenethyl butyrate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Phenethyl cinnamate. hexanol. Phenethyl formate. Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Phenethyl isobutyrate. Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Phenethyl isovalerate. 3-ol. Phenethyl 2-methylbutyrate. Neryl acetate. Phenethyl phenylacetate. Neryl butyrate. Phenethyl propionate. Neryl formate. Phenethyl salicylate. Neryl isobutyrate. Phenethyl senecioate; phenethyl 3,3-di- Neryl isovalerate. methylacrylate. Neryl propionate. Phenethyl tiglate. 2,6-Nonadien-1-ol. Phenoxyacetic acid. g-Nonalactone; 4-hydroxynonanoic acid, g- 2-Phenoxyethyl isobutyrate. lactone; aldehyde C–18. Phenylacetaldehyde; a-toluic aldehyde. Nonanal; pelargonic aldehyde. Phenylacetaldehyde 2,3-butylene glycol ace- 1,3-Nonanediol acetate, mixed esters. tal. Nonanoic acid; pelargonic acid. Phenylacetaldehyde dimethyl acetal. 2-Nonanone; methylheptyl ketone. Phenylacetaldehyde glyceryl acetal. 3-Nonanon-1-yl acetate; 1-hydroxy-3- Phenylacetic acid; a-toluic acid. nonanone acetate. 4-Phenyl-2-butanol; phenylethyl methyl car- Nonyl acetate. binol. Nonyl alcohol; 1-nonanol. 4-Phenyl-3-buten-2-ol; methyl styryl car- Nonyl octanoate. binol. Nonyl isovalerate. 4-Phenyl-3-buten-2-one. Nootkatone; 5,6-dimethyl-8-isopropenyl- 4-Phenyl-2-butyl acetate; phenylethyl meth- bicyclo[4,4,0]-dec-1-en-3-one. yl carbinyl acetate. Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- 1-Phenyl-3-methyl-3-pentanol; phenylethyl octatriene. methyl ethyl carbinol. g-Octalactone; 4-hydroxyoctanoic acid, g-lac- 1-Phenyl-1-propanol; phenylethyl carbinol. tone. 3-Phenyl-1-propanol; hydrocinnamyl alcohol. Octanal; caprylaldehyde. 2-Phenylpropionaldehyde; hydratropalde- Octanal dimethyl acetal. hyde. 1-Octanol; octyl alcohol. 3-Phenylpropionaldehyde; hydrocinnamal- 2-Octanol. dehyde. 3-Octanol. 2-Phenylpropionalde-hyde dimethyl acetal; 2-Octanone; methyl hexyl ketone. hydratropic aldehyde dimethyl acetal. 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. Pine tar oil. w-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, w-lactone; pentadecanolide; an- Piperidine. gelica lactone. Piperine. 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. 64

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Polysorbate 80; polyoxyethylene (20) sorbitan Tetramethyl ethylcyclohexenone; mixture of monooleate. 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- Potassium acetate. one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- Propenylguaethol; 6-ethoxy-m-anol. hexen-1-one. Propionaldehyde. 2-Thienyl mercaptan; 2-thienylthiol. Propyl acetate. Thymol. Propyl alcohol; 1-propanol. Tolualdehyde glyceryl acetal, mixed o, m, p. p-Propyl anisole; dihydroanethole. Tolualdehydes, mixed o, m, p. Propyl benzoate. p-Tolylacetaldehyde. Propyl butyrate. o-Tolyl acetate; o-cresyl acetate. Propyl cinnamate. p-Tolyl acetate; p-cresyl acetate. Propyl disulfide. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- Propyl formate. tone. Propyl 2-furanacrylate. p-Tolyl isobutyrate. Propyl heptanoate. p-Tolyl laurate. Propyl hexanoate. p-Tolyl phenylacetate. Propyl p-hydroxybenzoate; propylparaben. 2-(p-Tolyl)-propionaldehyde; p-methylhydra- 3-Propylidenephthalide. tropic aldehyde. Propyl isobutyrate. Tributyl acetylcitrate. Propyl isovalerate. 2-Tridecenal. Propyl mercaptan. 2,3-Undecadione; acetyl nonyryl. a-Propylphenethyl alcohol. g-Undecalactone; 4-hydroxyundecanoic acid Propyl phenylacetate. g-lactone; peach aldehyde; aldehyde C–14. Propyl propionate. Undecenal. Pulegone; p-menth-4(8)-en-3-one. 2-Undecanone; methyl nonyl ketone. Pyridine. 9-Undecenal; undecenoic aldehyde. Pyroligneous acid extract. 10-Undecenal. Pyruvaldehyde. Undecen-1-ol; undecylenic alcohol. . 10-Undecen-1-yl acetate. Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- Undecyl alcohol. citronellol. Valeraldehyde; pentanal. Rhodinyl acetate. Valeric acid; pentanoic acid. Rhodinyl butyrate. Vanillin acetate; acetyl vanillin. Rhodinyl formate. Veratraldehyde. Rhodinyl isobutyrate. Verbenol; 2-pinen-4-ol. Rhodinyl isovalerate. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2- Rhodinyl phenylacetate. butanone. Rhodinyl propionate. (c) D-Decalactone and D- Rum ether; ethyl oxyhydrate. dodecalactone when used separately or Salicylaldehyde. in combination in oleomargarine are Santalol, a and b. Santalyl acetate. used at levels not to exceed 10 parts per Santalyl phenylacetate. million and 20 parts per million, re- 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. b-Terpineol. sential (volatile) oil content of the fla- 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. § 172.520 Cocoa with dioctyl sodium Tetrahydrofurfuryl butyrate. sulfosuccinate for manufacturing. Tetrahydrofurfuryl propionate. 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

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chapter and § 172.810, is used or in- (i) A solution of the food additive sol- tended for use as a flavoring substance ids is made up in approximately 0.012 n in dry beverage mixes whereby the alkaline methyl alcohol (6 milliliters amount of dioctyl sodium sulfo- of 1 n sodium hydroxide diluted to 500 succinate does not exceed 75 parts per milliliters with methyl alcohol) to million of the finished beverage. The show an absorbance at 253 millimicrons labeling of the dry beverage mix shall of 0.6 to 0.9 per centimeter. (This ab- bear adequate directions to assure use sorbance is obtained by approximately in compliance with this section. 0.03 milligram solids permilliliter.) The ultraviolet absorption spectrum of this § 172.530 Disodium guanylate. solution exhibits the following charac- Disodium guanylate may be safely teristics: An absorption peak at 253 used as a flavor enhancer in foods, at a millimicrons; no absorption peak at 325 level not in excess of that reasonably to 330 millimicrons; the absorbance at required to produce the intended effect. 268 millimicrons does not exceed the absorbance at 272 millimicrons. § 172.535 Disodium inosinate. (ii) The boron content of the food ad- The food additive disodium inosinate ditive does not exceed 310 parts per may be safely used in food in accord- million (0.0310 percent), calculated as ance with the following prescribed con- boron. ditions: (2) The additive is manufactured (a) The food additive is the disodium from hops by a sequence of extractions salt of inosinic acid, manufactured and and fractionations, using benzene, light purified so as to contain no more than petroleum spirits, and methyl alcohol 150 parts per million of soluble barium as solvents, followed by isomerization in the compound disodium inosinate by potassium carbonate treatment. with seven and one-half molecules of Residues of solvents in the modified water of crystallization. hop extract shall not exceed 1.0 part (b) The food additive is used as a fla- per million of benzene, 1.0 part per mil- voring adjuvant in food. lion of light petroleum spirits, and 250 parts per million of methyl alcohol. § 172.540 DL-Alanine. The light petroleum spirits and ben- DL-Alanine (a racemic mixture of D- zene solvents shall comply with the and L-alanine; CAS Reg. No. 302–72–7) specifications in § 172.250 except that the boiling point range for light petro- may be safely used as a flavor enhancer ° ° 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 sodium hydroxide treatment. Residues § 172.560 Modified hop extract. 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

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of n-butyl alcohol, and 1 part per mil- residue limitations as prescribed in lion of ethyl acetate. The light petro- paragraph (b)(5) of this section, and a leum spirits and benzene solvents shall boron content level not in excess of 300 comply with the specifications in parts per million (0.0300 percent), cal- § 172.250 except that the boiling point culated as boron. range for light petroleum spirits is 150 (8) The additive is manufactured °F to 300 °F. from hops as a nonisomerizable non- (5) The additive is manufactured volatile hop resin by an initial extrac- from hops by an initial extraction and tion and fractionation using one or fractionation using one or more of the more of the solvents listed in para- following solvents: Ethylene dichlo- graph (b)(5) of this section followed by ride, hexane, isopropyl alcohol, methyl a sequence of aqueous extractions and alcohol, methylene chloride, trichloro- removal of nonaqueous solvents to less ethylene, and water; followed by than 0.5 percent. The additive is added isomerization by calcium chloride or to the wort before or during cooking in magnesium chloride treatment in the manufacture of beer. ethylene dichloride, methylene chlo- ride, or trichloroethylene and a further § 172.575 Quinine. sequence of extractions and fraction- Quinine, as the hydrochloride salt or ations using one or more of the sol- sulfate salt, may be safely used in food vents set forth in this paragraph. Resi- in accordance with the following condi- dues of the solvents in the modified tions: hop extract shall not exceed 125 parts per million of hexane; 150 parts per mil- Uses Limitations lion of ethylene dichloride, methylene In carbonated bev- Not to exceed 83 parts per million, as chloride, or trichloroethylene; or 250 erages as a flavor. quinine. Label shall bear a promi- parts per million of isopropyl alcohol nent declaration of the presence of quinine either by the use of the or methyl alcohol. word ‘‘quinine’’ in the name of the (6) The additive is manufactured article or through a separate dec- from hops by an initial extraction and laration. fractionation using one or more of the solvents listed in paragraph (b)(5) of § 172.580 Safrole-free extract of sas- this section followed by: Hydro- safras. genation using palladium as a catalyst The food additive safrole-free extract in methyl alcohol, ethyl alcohol, or of sassafras may be safely used in ac- isopropyl alcohol acidified with hydro- cordance with the following prescribed chloric or sulfuric acid; oxidation with conditions: peracetic acid; isomerization by cal- (a) The additive is the aqueous ex- cium chloride or magnesium chloride tract obtained from the root bark of treatment in ethylene dichloride, the plant Sassafras albidum (Nuttall) methylene chloride, or trichloro- Nees (Fam. Lauraceae). ethylene (alternatively, the hydro- (b) It is obtained by extracting the genation and isomerization steps may bark with dilute alcohol, first concen- be performed in reverse order); and a trating the alcoholic solution by vacu- further sequence of extractions and um distillation, then diluting the con- fractionations using one or more of the centrate with water and discarding the solvents listed in paragraph (b)(5) of oily fraction. this section. The additive shall meet (c) The purified aqueous extract is the residue limitations as prescribed in safrole-free. paragraph (b)(5) of this section. (d) It is used as a flavoring in food. (7) The additive is manufactured from hops as set forth in paragraph § 172.585 Sugar beet extract flavor (b)(6) of this section followed by reduc- base. tion with sodium borohydride in aque- Sugar beet extract flavor base may ous alkaline methyl alcohol, and a se- be safely used in food in accordance quence of extractions and fraction- with the provisions of this section. ations using one or more of the sol- (a) Sugar beet extract flavor base is vents listed in paragraph (b)(5) of this the concentrated residue of soluble section. The additive shall meet the sugar beet extractives from which

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sugar and glutamic acid have been re- (a) The additive is produced by par- covered, and which has been subjected tial hydrolysis of yeast extract (de- to ion exchange to minimize the con- rived from Saccharomyces cereviseae, centration of naturally occurring trace Saccharomyces fragilis, or Candida utilis) minerals. using the sprout portion of malt barley (b) It is used as a flavor in food. as the source of enzymes. The additive contains a maximum of 6 percent 5′ nu- § 172.590 Yeast-malt sprout extract. cleotides by weight. Yeast-malt sprout extract, as de- (b) The additive may be used as a fla- scribed in this section, may be safely vor enhancer in food at a level not in used in food in accordance with the fol- excess of that reasonably required to lowing prescribed conditions: produce the intended effect.

Subpart G—Gums, Chewing Gum Bases and Related Substances

§ 172.610 Arabinogalactan. Arabinogalactan may be safely used in food in accordance with the following conditions: (a) Arabinogalactan is a polysaccharide extracted by water from Western larch wood, having galactose units and arabinose units in the approximate ratio of six to one. (b) It is used in the following foods in the minimum quantity required to produce its intended effect as an emulsifier, stabilizer, binder, or bodying agent: Essential oils, nonnutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes.

§ 172.615 Chewing gum base. The food additive chewing gum base may be safely used in the manufacture of chewing gum in accordance with the following prescribed conditions: (a) The food additive consists of one or more of the following substances that meet the specifications and limitations prescribed in this paragraph, used in amounts not to exceed those required to produce the intended physical 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.

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

Family Genus and species

Natural rubber (smoked sheet and latex sol- Hevea brasiliensis. ids).

Synthetic Specifications

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

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

Family Genus and species

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.

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

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(d) The carrageenan and salts of car- (2) Range of sulfate content: 8 per- rageenan so produced are not used in cent to 19 percent, on a dry-weight foods for which standards of identity basis. exist unless the standards provide for (c) The food additive is used or in- the use of carrageenan, or salts of car- tended for use in the amount necessary rageenan, combined with polysorbate for an emulsifier, stabilizer, or thick- 80. ener in foods, except for those stand- (e) The carrageenan and salts of car- ardized foods that do not provide for rageenan produced in accordance with such use. this section, and foods containing the (d) To assure safe use of the additive, same, in addition to the other require- the label and labeling of the additive ments of the Act, are labeled to show shall bear the name of the additive, the presence of polysorbate 80, and the furcelleran. label or labeling of the carrageenan § 172.660 Salts of furcelleran. and salts of carrageenan so produced bear adequate directions for use. The food additive salts of furcelleran may be safely used in food in accord- § 172.626 Salts of carrageenan. ance with the following prescribed con- ditions: The food additive salts of carra- (a) The food additive consists of fur- geenan may be safely used in food in celleran, meeting the provisions of accordance with the following pre- § 172.655, modified by increasing the scribed conditions: concentration of one of the naturally (a) The food additive consists of car- occurring salts (ammonium, calcium, rageenan, meeting the provisions of potassium, or sodium) of furcelleran to § 172.620, modified by increasing the the level that it is the dominant salt in concentration of one of the naturally the additive. occurring salts (ammonium, calcium, (b) The food additive is used or in- potassium, or sodium) of carrageenan tended for use in the amount necessary to the level that it is the dominant salt for an emulsifier, stabilizer, or thick- in the additive. ener in foods, except for those stand- (b) The food additive is used or in- ardized foods that do not provide for tended for use in the amount necessary such use. 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 § 172.665 Gellan gum. by reason of the modification, e.g., ‘‘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 weight polysaccharide gum produced The food additive furcelleran may be from Pseudomonas elodea by a pure cul- safely used in food in accordance with ture process and purified the following prescribed conditions: by recovery with isopropyl alcohol. It (a) The food additive is the refined is composed of tetrasaccharide repeat hydrocolloid prepared by aqueous ex- units, each containing one molecule of traction of furcellaria fastigiata of the rhamnose and glucuronic acid, and two class Rodophyceae (red seaweed). molecules of glucose. The glucuronic (b) The food additive conforms to the acid is neutralized to a mixed potas- following: sium, sodium, calcium, and magnesium (1) It is a sulfated polysaccharide the salt. The polysaccharide may contain dominant hexose units of which are ga- acyl (glyceryl and acetyl) groups as the lactose and anhydrogalactose. O-glycosidically linked esters.

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(b) The strain of P. elodea is non- used in foods where standards of iden- pathogenic and nontoxic in man and tity established under section 401 of animals. the Federal Food, Drug, and Cosmetic (c) The additive is produced by a Act do not preclude such use. process that renders it free of viable (f) To assure safe use of the additive: cells of P. elodea. (1) The label of its container shall (d) The additive meets the following bear, in addition to other information specifications: required by the Federal Food, Drug, (1) Positive for gellan gum when sub- and Cosmetic Act, the name of the ad- jected to the following identification ditive and the designation ‘‘food tests: grade’’. (i) A 1-percent solution is made by (2) The label or labeling of the food hydrating 1 gram of gellan gum in 99 additive container shall bear adequate milliliters of distilled water. The mix- directions for use. ture is stirred for about 2 hours, using [55 FR 39614, Sept. 28, 1990, as amended at 57 a motorized stirrer and a propeller- FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, type stirring blade. A small amount of 1999] the above solution is drawn into a wide bore pipet and transferred into a solu- § 172.695 Xanthan gum. tion of 10-percent calcium chloride. A The food additive xanthan gum may tough worm-like gel will form in- be safely used in food in accordance stantly. with the following prescribed condi- (ii) To the 1-percent distilled water tions: solution prepared for identification (a) The additive is a polysaccharide test (i), 0.50 gram of sodium chloride is gum derived from Xanthomonas added. The solution is heated to 80 °C campestris by a pure-culture fermenta- with stirring, held at 80 °C for 1 tion process and purified by recovery minute, and allowed to cool to room with isopropyl alcohol. It contains D- temperature without stirring. A firm glucose, D-mannose, and D-glucuronic gel will form. acid as the dominant hexose units and (2) Residual isopropyl alcohol (IPA) is manufactured as the sodium, potas- not to exceed 0.075 percent as deter- sium, or calcium salt. mined by the procedure described in (b) The strain of Xanthomonas the Xanthan Gum monograph, the campestris is nonpathogenic and ‘‘Food Chemicals Codex,’’ 4th ed. (1996), nontoxic in man or other animals. pp. 437–438, which is incorporated by (c) The additive is produced by a reference in accordance with 5 U.S.C. process that renders it free of viable 552(a) and 1 CFR part 51. Copies are cells of Xanthomonas campestris. available from the National Academy (d) The additive meets the following Press, Box 285, 2101 Constitution Ave. specifications: NW., Washington, DC 20055 (Internet (1) Residual isopropyl alcohol not to address http://www.nap.edu), or may be exceed 750 parts per million. examined at the Center for Food Safety (2) An aqueous solution containing 1 and Applied Nutrition’s Library, Food percent of the additive and 1 percent of and Drug Administration, 5100 Paint potassium chloride stirred for 2 hours Branch Pkwy., College Park, MD 20740, has a minimum viscosity of 600 centi- or at the National Archives and poises at 75 °F, as determined by Records Administration (NARA). For Brookfield Viscometer, Model LVF (or information on the availability of this equivalent), using a No. 3 spindle at 60 material at NARA, call 202–741–6030, or r.p.m., and the ratio of viscosities at 75 go to: http://www.archives.gov/ °F and 150 °F is in the range of 1.02 to federallregister/ 1.45. codeloflfederallregulations/ (3) Positive for xanthan gum when ibrllocations.html. subjected to the following procedure: (e) The additive is used or intended for use in accordance with current good LOCUST BEAN GUM GEL TEST manufacturing practice as a stabilizer Blend on a weighing paper or in a weighing and thickener as defined in § 170.3(o)(28) pan 1.0 gram of powdered locust bean gum of this chapter. The additive may be with 1.0 gram of the powdered polysaccharide

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to be tested. Add the blend slowly (approxi- Compare the results with a curve of the op- mately 1⁄2 minute) at the point of maximum tical density versus concentration of an au- agitation to a stirred solution of 200 milli- thentic sample of pyruvic acid that has been liters of distilled water previously heated to run through the procedure starting with the 80 °C in a 400-milliliter beaker. Continue me- preparation of the hydrazone. chanical stirring until the mixture is in solu- Record the percent by weight of pyruvic tion, but stir for a minimum time of 30 min- acid in the test polysaccharide. Note ‘‘posi- utes. Do not allow the water temperature to tive’’ for xanthan gum if the sample contains drop below 60 °C. more than 1.5 percent of pyruvic acid and Set the beaker and its contents aside to ‘‘negative’’ for xanthan gum if the sample cool in the absence of agitation. Allow a contains less than 1.5 percent of pyruvic acid minimum time of 2 hours for cooling. Exam- by weight. ine the cooled beaker contents for a firm (e) The additive is used or intended rubbery gel formation after the temperature for use in accordance with good manu- ° drops below 40 C. facturing practice as a stabilizer, emul- In the event that a gel is obtained, make sifier, thickener, suspending agent, up a 1 percent solution of the polysaccharide to be tested in 200 milliliters of distilled bodying agent, or foam enhancer in water previously heated to 80 °C (omit the lo- foods for which standards of identity cust bean gum). Allow the solution to cool established under section 401 of the Act without agitation as before. Formation of a do not preclude such use. gel on cooling indicates that the sample is a (f) To assure safe use of the additive: gelling polysaccharide and not xanthan gum. (1) The label of its container shall Record the sample as ‘‘positive’’ for xan- bear, in addition to other information than gum if a firm, rubbery gel forms in the required by the Act, the name of the presence of locust bean gum but not in its additive and the designation ‘‘food absence. Record the sample as ‘‘negative’’ for grade’’. xanthan gum if no gel forms or if a soft or brittle gel forms both with locust bean gum (2) The label or labeling of the food and in a 1 percent solution of the sample additive container shall bear adequate (containing no locust bean gum). directions for use. (4) Positive for xanthan gum when subjected to the following procedure: Subpart H—Other Specific Usage Additives PYRUVIC ACID TEST § 172.710 Adjuvants for pesticide use Pipet 10 milliliters of an 0.6 percent solu- dilutions. tion of the polysaccharide in distilled water The following surfactants and related (60 milligrams of water-soluble gum) into a adjuvants may be safely added to pes- 50-milliliter flask equipped with a standard ticide use dilutions by a grower or ap- taper glass joint. Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux plicant prior to application to the the mixture for 3 hours. Take precautions to growing crop: avoid loss of vapor during the refluxing. Cool n-Alkyl (C8-C18) amine acetate, where the the solution to room temperature. Add dis- alkyl groups (C8-C18) are derived from coco- tilled water to make up any weight loss from nut oil, as a surfactant in emulsifier blends the flask contents. at levels not in excess of 5 percent by weight Pipet 1 milliliter of a 2,4-dinitrophenyl- of the emulsifier blends that are added to hydrazine reagent (0.5 percent in 2N hydro- herbicides for application to corn and sor- chloric acid) into a 30-milliliter separatory ghum. funnel followed by a 2-milliliter aliquot (4 Di-n-alkyl (C8-C18) dimethyl ammonium milligrams of water-soluble gum) of the chloride, where the alkyl groups (C8-C18) are polysaccharide hydrolyzate. Mix and allow derived from coconut oil, as surfactants in the reaction mixture to stand at room tem- emulsifier blends at levels not in excess of 5 perature for 5 minutes. Extract the mixture percent by weight of emulsifier blends that with 5 milliliters of ethyl acetate. Discard are added to herbicides for application to the aqueous layer. corn or sorghum. Extract the hydrazone from the ethyl ace- Diethanolamide condensate based on a tate with three 5 milliliter portions of 10 per- mixture of saturated and unsaturated soy- cent sodium carbonate solution. Dilute the bean oil fatty acids (C16-C18) as a surfactant combined sodium carbonate extracts to 100 in emulsifier blends that are added to the milliliters with additional 10 percent sodium herbicide atrazine for application to corn. carbonate in a 10-milliliter volumetric flask. Diethanolamide condensate based on Measure the optical density of the sodium stripped coconut fatty acids (C10 C18) as a carbonate solution at 375 millimicrons. surfactant in emulsifier blends that are

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added to the herbicide atrazine for applica- tional Archives and Records Adminis- tion to corn. tration (NARA). For information on a-(p-Dodecylphenyl)-omega-hydroxypoly the availability of this material at (oxyethylene) produced by the condensation NARA, call 202–741–6030, or go to: http:// of 1 mole of dodecylphenol (dodecyl group is a proplyene tetramer isomer) with an aver- www.archives.gov/federallregister/ age of 4–14 or 30–70 moles of ethylene oxide; codeloflfederallregulations/ if a blend of products is used, the average ibrllocations.html. number of moles of ethylene oxide reacted to (c) It is used in the manufacture of produce any product that is a component of sausage casings as a formulation aid as the blend shall be in the range of 4–14 or 30– defined in § 170.3(o)(14) of this chapter 70. and as a processing aid as defined in Ethylene dichloride. § 170.3(o)(24) of this chapter. Polyglyceryl phthalate ester of coconut oil fatty acids. [62 FR 26228, May 13, 1997] a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- omega-hydroxypoly(oxyethylene) produced § 172.715 Calcium lignosulfonate. by the condensation of 1 mole of p-(1,1,3,3- Calcium lignosulfonate may be safely tetramethylbutyl) phenol with an average of used in or on food, subject to the provi- 4–14 or 30–70 moles of ethylene oxide; if a blend of products is used, the average num- sions of this section. ber of moles of ethylene oxide reacted to (a) Calcium lignosulfonate consists of produce any product that is a component of sulfonated lignin, primarily as calcium the blend shall be in the range of 4–14 or 30– and sodium salts. 70. (b) It is used in an amount not to ex- a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- ceed that reasonably required to ac- omega-hydroxypoly(oxyethylene) produced complish the intended physical or tech- by the condensation of 1 mole of p-(1,1,3,3- nical effect when added as a dispersing tetramethylbutyl) phenol with 1 mole of agent and stabilizer in pesticides for ethylene oxide. preharvest or postharvest application Sodium acrylate and acrylamide copoly- mer with a minimum average molecular to bananas. weight of 10,000,000 in which 30 percent of the polymer is comprised of acrylate units and 70 § 172.720 Calcium lactobionate. percent acrylamide units, for use as a drift The food additive calcium control agent in herbicide formulations ap- lactobionate may be safely used in food plied to crops at a level not to exceed 0.5 in accordance with the following pre- ounces of the additive per acre. scribed conditions: (a) The food additive is the calcium § 172.712 1,3-Butylene glycol. salt of lactobionic acid (4-(b,D- The food additive 1,3-butylene glycol galactosido)-D-gluconic acid) produced (CAS Reg. No. 107–88–0) may be safely by the oxidation of lactose. used in food in accordance with the fol- (b) It is used or intended for use as a lowing prescribed conditions: firming agent in dry pudding mixes at (a) It is prepared by the aldol con- a level not greater than that required densation of acetaldehyde followed by to accomplish the intended effect. catalytic hydrogenation. (b) The food additive shall conform § 172.723 Epoxidized soybean oil. to the identity and specifications listed Epoxidized soybean oil may be safely in the monograph entitled ‘‘1,3-Butyl- used in accordance with the following ene Glycol’’ in the Food Chemicals prescribed conditions: Codex, 4th ed. (1996), p. 52, which is in- (a) The additive is prepared by react- corporated by reference in accordance ing soybean oil in toluene with hydro- with 5 U.S.C. 552(a) and 1 CFR part 51. gen peroxide and formic acid. Copies are available from the Office of (b) It meets the following specifica- Premarket Approval, Center for Food tions: Safety and Applied Nutrition, 5100 (1) Epoxidized soybean oil contains Paint Branch Pkwy., College Park, MD oxirane oxygen, between 7.0 and 8.0 per- 20740, or may be examined at the Cen- cent, as determined by the American ter for Food Safety and Applied Nutri- Oil Chemists’ Society (A.O.C.S.) meth- tion’s Library, Food and Drug Admin- od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- istration, 5100 Paint Branch Pkwy., approved 1989, which is incorporated by College Park, MD 20740, or at the Na- reference in accordance with 5 U.S.C

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552(a) and 1 CFR part 51. Copies are § 172.725 Gibberellic acid and its po- available from the American Oil Chem- tassium salt. ists’ Society, P. O. Box 3489, Cham- The food additives gibberellic acid paign, IL 61826–3489, or may be exam- and its potassium salt may be used in ined at the Division of Petition Control the malting of barley in accordance (HFS–215), Center for Food Safety and with the following prescribed condi- Applied Nutrition, Food and Drug Ad- tions: ministration, 1110 Vermont Ave. NW., (a) The additives meet the following suite 1200, Washington, DC, or at the specifications: National Archives and Records Admin- (1) The gibberellic acid is produced istration (NARA). For information on by deep-culture fermentation of a suit- the availability of this material at able nutrient medium by a strain of NARA, call 202–741–6030, or go to: http:// Fusarium moniliforme or a selection of www.archives.gov/federallregister/ this culture. codeloflfederallregulations/ (2) The gibberellic acid produced is of ibrllocations.html. 80 percent purity or better. (2) The maximum iodine value is 3.0, (3) The empirical formula of as determined by A.O.C.S. method Cd gibberellic acid is represented by 1–25, ‘‘Iodine Value of Fats and Oils C19H22O6. Wijs Method,’’ revised 1993, which is in- (4) Potassium gibberellate is the po- corporated by reference in accordance tassium salt of the specified gibberellic with 5 U.S.C. 552(a) and 1 CFR part 51. acid. The availability of this incorporation (5) The potassium gibberellate is of 80 by reference is given in paragraph percent purity or better. (b)(1) of this section. (6) The gibberellic acid or potassium gibberellate may be diluted with sub- (3) The heavy metals (as Pb) content stances generally recognized as safe in cannot be more than 10 parts per mil- foods or with salts of fatty acids con- lion, as determined by the ‘‘Heavy Met- forming to § 172.863. als Test,’’ of the ‘‘Food Chemicals (b) They are used or intended for use Codex,’’ 4th ed. (1996), pp. 760–761, Meth- in the malting of barley under condi- od II (with a 2-gram sample and 20 tions whereby the amount of either or microgram of lead ion in the control), both additives present in the malt is which is incorporated by reference in not in excess of 2 parts per million ex- accordance with 5 U.S.C. 552(a) and 1 pressed as gibberellic acid, and the CFR part 51. Copies are available from treated malt is to be used in the pro- the National Academy Press, Box 285, duction of fermented malt beverages or 2101 Constitution Ave. NW., Wash- distilled spirits only, whereby the fin- ington, DC 20055 (Internet address ished distilled spirits contain none and http://www.nap.edu), or may be exam- the finished malt beverage contains ined at the Center for Food Safety and not more than 0.5 part per million of Applied Nutrition’s Library, Food and gibberellic acid. Drug Administration, 5100 Paint (c) To insure the safe use of the food Branch Pkwy., College Park, MD 20740, additives the label of the package shall or at the National Archives and bear, in addition to the other informa- Records Administration (NARA). For tion required by the Act: information on the availability of this (1) The name of the additive, material at NARA, call 202–741–6030, or ‘‘gibberellic acid’’ or ‘‘potassium go to: http://www.archives.gov/ gibberellate’’, whichever is appro- federallregister/ priate. codeloflfederallregulations/ (2) An accurate statement of the con- ibrllocations.html. centration of the additive contained in the package. (c) The additive is used as a halogen (3) Adequate use directions to provide stabilizer in brominated soybean oil at not more than 2 parts per million of a level not to exceed 1 percent. gibberellic acid in the finished malt. [60 FR 32903, June 26, 1995, as amended at 64 (4) Adequate labeling directions to FR 1759, Jan. 12, 1999] provide that the final malt is properly

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labeled as described in paragraph (d) of beverages only’’, or ‘‘Distiller’s Malt— this section. To be used in the production of dis- (d) To insure the safe use of the addi- tilled spirits only’’, whichever is the tive the label of the treated malt shall case. bear, in addition to the other informa- tion required by the Act, the state- § 172.735 Glycerol ester of rosin. ments: Glycerol ester of wood rosin, gum (1) ‘‘Contains not more than 2 parts rosin, or tall oil rosin may be safely per million lll’’, the blank being used in food in accordance with the fol- filled in with the words ‘‘gibberellic lowing prescribed conditions: acid’’ or ‘‘potassium gibberellate’’, (a) It has an acid number of 3 to 9, a whichever is appropriate; and ° (2) ‘‘Brewer’s malt—To be used in the drop-softening point of 88 to 96 C; and production of fermented malt bev- a color of N or paler as determined in erages only’’ or ‘‘Distiller’s malt—To accordance with Official Naval Stores be used in the production of distilled Standards of the United States. It is spirits only’’, whichever is appropriate. purified by countercurrent steam dis- tillation or steam stripping. § 172.730 Potassium bromate. (b) It is used to adjust the density of The food additive potassium bromate citrus oils used in the preparation of may be safely used in the malting of beverages whereby the amount of the barley under the following prescribed additive does not exceed 100 parts per conditions: million of the finished beverage. (a)(1) It is used or intended for use in [42 FR 14491, Mar. 15, 1977, as amended at 70 the malting of barley under conditions FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22, whereby the amount of the additive 2007] present in the malt from the treatment does not exceed 75 parts per million of § 172.736 Glycerides and polyglycides bromate (calculated as Br), and the of hydrogenated vegetable oils. treated malt is used only in the pro- The food additive glycerides and duction of fermented malt beverages or polyglycides of hydrogenated vegetable distilled spirits. oils may be safely used in food in ac- (2) The total residue of inorganic bro- cordance with the following prescribed mides in fermented malt beverages, re- conditions: sulting from the use of the treated (a) The additive is manufactured by malt plus additional residues of inor- heating a mixture of hydrogenated oils ganic bromides that may be present 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 bromide (calculated as Br). No toler- generally recognized as safe for this ance is established for bromide in dis- use to yield the finished product. tilled spirits because there is evidence (b) The additive consists of a mixture that inorganic bromides do not pass of mono-, di- and tri-glycerides and over in the distillation process. polyethylene glycol mono- and di- (b) To assure safe use of the additive, esters of fatty acids (polyglycides) of the label or labeling of the food addi- hydrogenated vegetable oils and meets tive shall bear, in addition to the other the following specifications: information required by the Act, the (1) Total ester content, greater than following: 90 percent as determined by a method (1) The name of the additive. entitled ‘‘Determination of Esterified (2) Adequate directions for use. Glycerides and Polyoxyethylene (c) To assure safe use of the additive, Glycols,’’ approved November 16, 2001, the label or labeling of the treated printed by Gattefosse S.A.S., and in- malt shall bear, in addition to other in- corporated by reference. The Director formation required by the Act, the of the Office of the Federal Register statement, ‘‘Brewer’s Malt—To be used approves this incorporation by ref- in the production of fermented malt erence in accordance with 5 U.S.C.

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552(a) and 1 CFR part 51. You may ob- www.archives.gov/federallregister/ tain a copy from the Office of Food Ad- codeloflfederallregulations/ ditive Safety, 5100 Paint Branch Pkwy., ibrllocations.html. College Park, MD 20740 or you may ex- (4) 1,4-Dioxane, not greater than 10 amine a copy at the Center for Food milligrams per kilogram (mg/kg), and Safety and Applied Nutrition’s Li- ethylene oxide, not greater than 1 mg/ brary, Food and Drug Administration, kg, as determined by a gas 5100 Paint Branch Pkwy., College Park, chromatographic method entitled MD 20740, or at the National Archives ‘‘Determination of Ethylene Oxide and and Records Administration (NARA). 1,4-Dioxane by Headspace Gas Chroma- For information on the availability of tography,’’ approved November 5, 1998, this material at NARA, call 202–741– printed by Gattefosse S.A.S., and in- 6030, or go to http://www.archives.gov/ corporated by reference in accordance federallregister/ with 5 U.S.C. 552(a) and 1 CFR part 51; codeloflfederallregulations/ see paragraph (b)(1) of this section for ibrllocations.html. availability of the incorporation by (2) Acid value, not greater than 2, reference. and hydroxyl value, not greater than 56 (c) The additive is used or intended as determined by the methods entitled for use as an excipient in dietary sup- ‘‘Acid Value,’’ p. 934 and ‘‘Hydroxyl plement tablets, capsules, and liquid Value,’’ p. 936, respectively, in the formulations that are intended for in- Food Chemicals Codex, 5th ed., effec- gestion in daily quantities measured in tive January 1, 2004, and incorporated drops or similar small units of meas- by reference in accordance with 5 ure. U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Acad- [71 FR 12620, Mar. 13, 2006] emies Press, 500 Fifth St. NW., Wash- § 172.755 Stearyl monoglyceridyl cit- ington, DC 20055 (Internet address rate. http://www.nap.edu), or may be exam- ined at the Center for Food Safety and The food additive stearyl Applied Nutrition’s Library, 5100 Paint monoglyceridyl citrate may be safely Branch Pkwy., College Park, MD 20740, used in food in accordance with the fol- or at the National Archives and lowing provisions: Records Administration (NARA). For (a) The additive is prepared by con- information on the availability of this trolled chemical reaction of the fol- material at NARA, call 202–741–6030, or lowing: go to http://www.archives.gov/ Reactant Limitations federallregister/ codeloflfederallregulations/ Citric acid ...... ibrllocations.html. Monoglycerides of fatty Prepared by the glycerolysis of ed- acids. ible fats and oils or derived from (3) Lead, not greater than 0.1 mg/kg fatty acids conforming with as determined by the American Oil § 172.860. Chemists’ Society (A.O.C.S.) method Stearyl alcohol...... Derived from fatty acids con- Ca 18c–91, ‘‘Determination of Lead by forming with § 172.860, or de- rived synthetically in conformity Direct Graphite Furnace Atomic Ab- with § 172.864. sorption Spectrophotometry,’’ updated 1995, and incorporated by reference in (b) The additive stearyl accordance with 5 U.S.C. 552(a) and 1 monoglyceridyl citrate, produced as CFR part 51. Copies are available from described under paragraph (a) of this American Oil Chemists’ Society, P. O. section, meets the following specifica- Box 3489, Champaign, IL 61826–3489, or tions: may be examined in the library at the Center for Food Safety and Applied Nu- Acid number 40 to 52. trition, 5100 Paint Branch Pkwy., Col- Total citric acid 15 to 18 percent. Saponification number 215–255. lege Park, MD 20740, or at the National Archives and Records Administration (c) The additive is used or intended (NARA). For information on the avail- for use as an emulsion stabilizer in or ability of this material at NARA, call with shortenings containing emulsi- 202–741–6030, or go to http:// fiers.

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§ 172.765 Succistearin (stearoyl pro- (c) The additive is used as a carrier of pylene glycol hydrogen succinate). vitamin B12 in foods for special dietary use. The food additive succistearin (ste- aroyl propylene glycol hydrogen succi- § 172.780 Acacia (gum arabic). nate) may be safely used in food in ac- The food additive may be safely used cordance with the following prescribed in food in accordance with the fol- conditions: lowing prescribed conditions: (a) The additive is the reaction prod- (a) Acacia (gum arabic) is the dried uct of succinic anhydride, fully hydro- gummy exudate from stems and genated vegetable oil (predominantly branches of trees of various species of C16 or C18 fatty acid chain length), and the genus Acacia, family Leguminosae. propylene glycol. (b) The ingredient meets the speci- (b) The additive meets the following fications of the ‘‘Food Chemicals specifications: Codex,’’ 5th Ed. (2004), pp. 210 and 211, Acid number 50–150. which is incorporated by reference. The Hydroxyl number 15–50. Director of the Office of the Federal Succinated ester content 45–75 percent. Register approves this incorporation by reference in accordance with 5 (c) The additive is used or intended U.S.C. 552(a) and 1 CFR part 51. You for use as an emulsifier in or with may obtain copies from the National shortenings and edible oils intended for Academies Press, 500 Fifth St. NW., use in cakes, cake mixes, fillings, Washington, DC 20001 (Internet ad- icings, pastries, and toppings, in ac- dress: http://www.nap.edu). Copies may cordance with good manufacturing be examined at the Center for Food practice. Safety and Applied Nutrition’s Li- brary, Food and Drug Administration, § 172.770 Ethylene oxide polymer. 5100 Paint Branch Pkwy., College Park, The polymer of ethylene oxide may MD 20740, or at the National Archives be safely used as a foam stabilizer in and Records Administration (NARA). fermented malt beverages in accord- For information on the availability of ance with the following conditions. this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ (a) It is the polymer of ethylene federallregister/ oxide having a minimum viscosity of codeloflfederalregulations/ 1,500 centipoises in a 1 percent aqueous ibrllocations.html. ° solution at 25 C. (c) The ingredient is used as a thick- (b) It is used at a level not to exceed ener, emulsifier, or stabilizer in alco- 300 parts per million by weight of the holic beverages at a use level not to ex- fermented malt beverage. ceed 20 percent in the final beverage. (c) The label of the additive bears di- rections for use to insure compliance [70 FR 8034, Feb. 17, 2005] with paragraph (b) of this section. § 172.785 Listeria-specific bacteriophage preparation. § 172.775 Methacrylic acid- divinylbenzene copolymer. The additive may be safely used as an antimicrobial agent specific for Listeria Methacrylic acid-divinylbenzene co- monocytogenes (L. monocytogenes) in ac- polymer may be safely used in food in cordance with the following conditions: accordance with the following pre- (a) Identity. (1) The additive consists scribed conditions: of a mixture of equal proportions of six (a) The additive is produced by the different individually purified lytic- polymerization of methacrylic acid and type (lacking lysogenic activity) divinylbenzene. The divinylbenzene bacteriophages (phages) specific functions as a cross-linking agent and against L. monocytogenes. constitutes a minimum of 4 percent of (2) Each phage is deposited at, and the polymer. assigned an identifying code by, a sci- (b) Aqueous extractives from the ad- entifically-recognized culture collec- ditive do not exceed 2 percent (dry tion center, and is made available to basis) after 24 hours at 25 °C. FDA upon request.

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(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–102TM,’’ (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 fol- reference. Copies are available at loca- lowing L. monocytogenes isolates avail- tions cited in paragraph (b)(1) of this able from American Type Culture Col- section. lection (ATCC): ATCC 35152 (serogroup (5) The additive is negative for L. 1/2a), ATCC 19118 (serogroup 4b), and monocytogenes. The modified version of ATCC 15313 (serogroup 1/2b). The ana- the U.S. Department of Agriculture’s lytical method for determining the po- tency of the additive entitled ‘‘Deter- method for determining L. TM mination of Potency of LMP–102TM,’’ monocytogenes entitled ‘‘LMP–102 dated October 9, 2003, and printed by Listeria monocytogenes Sterility Test- Intralytix, Inc., is incorporated by ref- ing,’’ dated May 24, 2004, and printed by erence. The Director of the Office of Intralytix, Inc., is incorporated by ref- the Federal Register approves this in- erence. Copies are available at loca- corporation by reference in accordance tions cited in paragraph (b)(1) of this with 5 U.S.C. 552(a) and 1 CFR part 51. section. You may obtain a copy from the Office (6) The additive is negative for gram- of Food Additive Safety (HFS–200), positive and gram-negative bacteria Center for Food Safety and Applied Nu- capable of growing in commonly used trition, Food and Drug Administration, microbiological media (e.g., Luria- 5100 Paint Branch Pkwy., College Park, Bertani (LB) medium), including Esch- MD 20740, or you may examine a copy erichia coli, Salmonella species and at the Center for Food Safety and Ap- coagulase-positive Staphylococci, as de- plied Nutrition’s Library, 5100 Paint termined by the ‘‘Method to Determine Branch Pkwy., College Park, MD 20740, Microbial Contamination,’’ dated July or at the National Archives and 11, 2003, and printed by Intralytix, Inc., Records Administration (NARA). For is incorporated by reference. Copies are information on the availability of this available at locations cited in para- material at NARA, call 202–741–6030, or graph (b)(1) of this section. go to: http://www.archives.gov/ federallregister/ (7) Total organic carbon (TOC) is less codeloflfederallregulations/ than or equal to 36 mg/kg. The analyt- ibrllocations.html. ical method for determining TOC enti- (2) The mean phage titer of each tled ‘‘Determination of Total Organic monophage in the additive is 1 × 109 Carbon by Automated Analyzer,’’ dated plaque forming units (PFU)/ml. The an- March 30, 2001, and printed by alytical method for determining phage Intralytix, Inc., is incorporated by ref- titer entitled ‘‘Method to Determine erence. Copies are available at loca- Lytic Activity/Phage Titer,’’ dated No- tions cited in paragraph (b)(1) of this vember 6, 2001, and printed by section. Intralytix, Inc., is incorporated by ref- (c) Conditions of use. The additive is erence. Copies are available at loca- used in accordance with current good tions cited in paragraph (b)(1) of this manufacturing practice to control L. section. monocytogenes by direct application to (3) The phages present in the prepara- meat and poultry products that comply tion must not contain a functional por- with the ready-to-eat definition in 9 tion of any of the toxin-encoding se- CFR 430.1. Current good manufacturing quences described in 40 CFR 725.421(d). practice is consistent with direct spray No sequences derived from genes en- application of the additive at a rate of coding bacterial 16S ribosomal RNA approximately 1 mL of the additive per are present in the complete genomic 500 cm2 product surface area. sequence of the phages. (4) L. monocytogenes toxin, [71 FR 47731, Aug. 18, 2006] listeriolysin O (LLO), is not greater

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Subpart I—Multipurpose Additives uses, it shall be labeled in compliance with part 105 of this chapter. § 172.800 Acesulfame potassium. [53 FR 28382, July 28, 1988, as amended at 57 Acesulfame potassium (CAS Reg. No. FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, 55589–62–3), also known as acesulfame Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003] K, may be safely used as a general-pur- pose sweetener and flavor enhancer in § 172.802 Acetone peroxides. foods generally, except in meat and The food additive acetone peroxides poultry, in accordance with current may be safely used in flour, and in good manufacturing practice and in an bread and rolls where standards of amount not to exceed that reasonably identity do not preclude its use, in ac- required to accomplish the intended cordance with the following prescribed technical effect in foods for which conditions: standards of identity established under (a) The additive is a mixture of section 401 of the Federal Food, Drug, monomeric and linear dimeric acetone and Cosmetic Act do not preclude such peroxide, with minor proportions of use, under the following conditions: higher polymers, manufactured by re- (a) Acesulfame potassium is the po- action of hydrogen peroxide and ace- tassium salt of 6-methyl-1,2,3- tone. oxathiazine-4(3H)-one-2,2-dioxide. (b) The additive may be mixed with (b) The additive meets the following an edible carrier to give a concentra- specifications: tion of: (1) 3 grams to 10 grams of hy- (1) Purity is not less than 99 percent drogen peroxide equivalent per 100 on a dry basis. The purity shall be de- grams of the additive, plus carrier, for termined by a method titled use in flour maturing and bleaching; or ‘‘Acesulfame Potassium Assay,’’ which (2) approximately 0.75 gram of hydro- is incorporated by reference. Copies are gen peroxide equivalent per 100 grams available from the Center for Food of the additive, plus carrier, for use in Safety and Applied Nutrition (HFS– dough conditioning. 200), Food and Drug Administration, (c) It is used or intended for use: (1) 5100 Paint Branch Pkwy., College Park, In maturing and bleaching of flour in a MD 20740, or available for inspection at quantity not more than sufficient for the National Archives and Records Ad- such effect; and (2) as a dough-condi- ministration (NARA). For information tioning agent in bread and roll produc- on the availability of this material at tion at not to exceed the quantity of NARA, call 202–741–6030, or go to: http:// hydrogen peroxide equivalent nec- essary for the artificial maturing ef- www.archives.gov/federallregister/ fect. codeloflfederallregulations/ (d) To insure safe use of the additive, ibrllocations.html. the label of the food additive container (2) Fluoride content is not more than and any intermediate premix thereof 30 parts per million, as determined by shall bear, in addition to the other in- method III of the Fluoride Limit Test formation required by the act: of the Food Chemicals Codex, 3d Ed. (1) The name of the additive, ‘‘ace- (1981), p. 511, which is incorporated by tone peroxides’’. reference. Copies are available from (2) The concentration of the additive the National Academy Press, 2101 Con- expressed in hydrogen peroxide equiva- stitution Ave. NW., Washington, DC lents per 100 grams. 20418, or available for inspection at the (3) Adequate use directions to provide National Archives and Records Admin- a final product that complies with the istration (NARA). For information on limitations prescribed in paragraph (c) the availability of this material at of this section. NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 172.804 Aspartame. codeloflfederallregulations/ The food additive aspartame may be ibrllocations.html. safely used in food in accordance with (c) If the food containing the additive good manufacturing practice as a is represented to be for special dietary sweetening agent and a flavor enhancer

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in foods for which standards of identity and Drug Administration, 5100 Paint established under section 401 of the act Branch Pkwy., College Park, MD 20740, do not preclude such use under the fol- and at the National Archives and lowing conditions: Records Administration (NARA). For (a) Aspartame is the chemical 1- information on the availability of this methyl N-L-a-aspartyl-L-phenylalanine material at NARA, call 202–741–6030, or (C14H18N2O5). go to: http://www.archives.gov/ (b) The additive meets the specifica- federallregister/ tions of the ‘‘Food Chemicals Codex,’’ codeloflfederallregulations/ 3d Ed. (1981) pp. 28–29 and First Supple- ibrllocations.html. ment p. 5, which is incorporated by ref- (d) To assure safe use of the additive, erence in accordance with 5 U.S.C. in addition to the other information re- 552(a). Copies are available from the National Academy Press, 2101 Constitu- quired by the Act: tion Ave. NW., Washington, DC 20418, (1) The principal display panel of any or may be examined at the Center for intermediate mix of the additive for Food Safety and Applied Nutrition’s manufacturing purposes shall bear a Library, Food And Drug Administra- statement of the concentration of the tion, 5100 Paint Branch Pkwy., College additive contained therein; Park, MD 20740, or at the National Ar- (2) The label of any food containing chives and Records Administration the additive shall bear, either on the (NARA). For information on the avail- principal display panel or on the infor- ability of this material at NARA, call mation panel, the following statement: 202–741–6030, or go to: http:// www.archives.gov/federallregister/ PHENYLKETONURICS: CONTAINS codeloflfederallregulations/ PHENYLALANINE ibrllocations.html. (c)(1) When aspartame is used as a The statement shall appear in the la- tablet for sweetening beling prominently and conspicuously hot beverages, including coffee and tea, as compared to other words, state- L-leucine may be used as a lubricant in ments, designs or devices and in bold the manufacture of such tablets at a type and on clear contrasting back- level not to exceed 3.5 percent of the ground in order to render it likely to weight of the tablet. be read and understood by the ordinary (2) When aspartame is used in baked individual under customary conditions goods and baking mixes, the amount of of purchase and use. the additive is not to exceed 0.5 percent (3) When the additive is used in a by weight of ready-to-bake products or sugar substitute for table use, its label of finished formulations prior to bak- shall bear instructions not to use in ing. Generally recognized as safe cooking or baking. (GRAS) ingredients or food additives (4) Packages of the dry, free-flowing approved for use in baked goods shall additive shall prominently display the be used in combination with aspartame sweetening equivalence in teaspoons of to ensure its functionality as a sweet- sugar. ener in the final baked product. The (e) If the food containing the additive level of aspartame used in these prod- purports to be or is represented for spe- ucts is determined by an analytical method entitled ‘‘Analytical Method cial dietary uses, it shall be labeled in for the Determination of Aspartame compliance with part 105 of this chap- and Diketopiperazine in Baked Goods ter. and Baking Mixes,’’ October 8, 1992, [39 FR 27319, July 26, 1974] which was developed by the Nutrasweet Co. Copies are available from the Office EDITORIAL NOTE: For FEDERAL REGISTER ci- of Premarket Approval (HFS–200), Cen- tations affecting § 172.804, see the List of CFR Sections Affected, which appears in the ter for Food Safety and Applied Nutri- Finding Aids section of the printed volume tion, 5100 Paint Branch Pkwy., College and at www.fdsys.gov. Park, MD 20740, or are available for in- spection at the Center for Food Safety and Applied Nutrition’s Library, Food

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§ 172.806 Azodicarbonamide. minimum cloud point of 9 °C–12 °C in 10 percent aqueous solution. The food additive azodicarbonamide (4) a-Hydro-omega-hydroxy-poly(ox- may be safely used in food in accord- yethylene) poly (oxypropylene)-(51–57 ance with the following prescribed con- moles) poly(oxyethylene) block copoly- ditions: mer, having an average molecular (a) It is used or intended for use: weight of 14,000 and a cloud point above (1) As an aging and bleaching ingre- 100 °C in 1 percent aqueous solution. dient in cereal flour in an amount not (b) The additive is used or intended to exceed 2.05 grams per 100 pounds of for use as follows: flour (0.0045 percent; 45 parts per mil- (1) The additive identified in para- lion). graph (a)(1) of this section is used in (2) As a dough conditioner in bread practice as a solubilizing and stabi- baking in a total amount not to exceed lizing agent in flavor concentrates 0.0045 percent (45 parts per million) by (containing authorized flavoring oils) weight of the flour used, including any for use in foods for which standards of quantity of azodicarbonamide added to identity established under section 401 flour in accordance with paragraph of the Act do not preclude such use, (a)(1) of this section. provided that the weight of the addi- (b) To assure safe use of the additive: tive does not exceed the weight of the (1) The label and labeling of the addi- flavoring oils in the flavor concentrate. tive and any intermediate premix pre- (2) The additive identified in para- pared therefrom shall bear, in addition graph (a)(2) of this section is used as a to the other information required by processing aid and wetting agent in the Act, the following: combination with dioctyl sodium sulfo- (i) The name of the additive. succinate for fumaric acid as pre- (ii) A statement of the concentration scribed in § 172.810. or the strength of the additive in any (3) The additive identified in para- intermediate premixes. graph (a)(3) of this section is used: (2) The label or labeling of the food (i) As a surfactant and defoaming additive shall also bear adequate direc- agent, at levels not to exceed 0.05 per- tions for use. cent by weight, in scald baths for poul- try defeathering, followed by potable § 172.808 Copolymer condensates of water rinse. The temperatures of the ethylene oxide and propylene oxide. 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) block 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

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from the nonpathogenic and section 401 of the act do not preclude nontoxicogenic bacterium Alcaligenes such use. faecalis var. myxogenes. [61 FR 65941, Dec. 16, 1996] (b) Curdlan meets the following spec- ifications when it is tested according § 172.810 Dioctyl sodium sulfosuc- to the methods described or referenced cinate. in the document entitled ‘‘Analytical The food additive dioctyl sodium Methods for Specification Tests for sulfosuccinate, which meets the speci- Curdlan,’’ by Takeda Chemical Indus- fications of the Food Chemicals Codex, tries, Ltd., 12–10 Nihonbashi, 2–Chome, 3d Ed. (1981), pp. 102–104, which is incor- Chuo-ku, Tokyo, 103, Japan, 1996, which porated by reference (Copies may be is incorporated by reference in accord- obtained from the National Academy ance with 5 U.S.C. 552(a) and 1 CFR Press, 2101 Constitution Ave. NW., part 51. Copies are available from the Washington, DC 20418, or may be exam- Division of Petition Control (HFS–215), ined at the National Archives and Center for Food Safety and Applied Nu- Records Administration (NARA). For trition, Food and Drug Administration, information on the availability of this 5100 Paint Branch Pkwy., College Park, material at NARA, call 202–741–6030, or MD 20740, or may be examined at the go to: http://www.archives.gov/ Center for Food Safety and Applied Nu- federallregister/ trition’s Library, Food and Drug Ad- codeloflfederallregulations/ ministration, 5100 Paint Branch Pkwy., ibrllocations.html.), may be safely used College Park, MD 20740, or at the Na- in food in accordance with the fol- tional Archives and Records Adminis- lowing prescribed conditions: tration (NARA). For information on (a) As a wetting agent in the fol- the availability of this material at lowing fumaric acid-acidulated foods: NARA, call 202–741–6030, or go to: http:// Dry gelatin dessert, dry beverage base, www.archives.gov/federallregister/ and fruit juice drinks, when standards codeloflfederallregulations/ of identity do not preclude such use. ibrllocations.html. The labeling of the dry gelatin dessert (1) Positive for curdlan. and dry beverage base shall bear ade- (2) Assay for curdlan (calculated as quate directions for use, and the addi- anhydrous glucose), not less than 80 tive shall be used in such an amount percent. that the finished gelatin dessert will (3) pH of 1 percent aqueous suspen- contain not in excess of 15 parts per sion, 6.0–7.5. million of the additive and the finished (4) Lead, not more than 0.5 mg/kg. beverage or fruit juice drink will con- (5) Heavy metals (as Pb), not more tain not in excess of 10 parts per mil- than 0.002 percent. lion of the additive. (b) As a processing aid in sugar fac- (6) Total nitrogen, not more than 0.2 tories in the production of unrefined percent. cane sugar, in an amount not in excess (7) Loss on drying, not more than 10 of 0.5 part per million of the additive percent. per percentage point of sucrose in the (8) Residue on ignition, not more juice, syrup, or massecuite being proc- than 6 percent. essed, and so used that the final molas- (9) Gel strength of 2 percent aqueous ses will contain no more than 25 parts suspension, not less than 600×103 dyne per million of the additive. per square centimeter. (c) As a solubilizing agent on gums (10) Aerobic plate count, not more and hydrophilic colloids to be used in than 103 per gram. food as stabilizing and thickening (11) Coliform bacteria, not more than agents, when standards of identity do 3 per gram. not preclude such use. The additive is (c) Curdlan is used or intended for used in an amount not to exceed 0.5 use in accordance with good manufac- percent by weight of the gums or hy- turing practice as a formulation aid, drophilic colloids. processing aid, stabilizer and thick- (d) As an emulsifying agent for cocoa ener, and texturizer in foods for which fat in noncarbonated beverages con- standards of identity established under taining cocoa, whereby the amount of

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the additive does not exceed 25 parts Uses Limitations per million of the finished beverage. 1. As a crystallization accel- Not to exceed 1 percent of (e) As a dispersing agent in ‘‘cocoa erator in cocoa products, in the combined weight of with dioctyl sodium sulfosuccinate for imitation chocolate, and in the formulation. manufacturing’’ that conforms to the compound coatings. provisions of § 163.117 of this chapter 2. As a formulation aid as de- Not to exceed 0.5 percent. fined in § 170.3(o)(14) of this and the use limitations prescribed in chapter, lubricant and release § 172.520, in an amount not to exceed 0.4 agent as defined in percent by weight thereof. § 170.3(o)(18) of this chapter, and surface-finishing agent as (f) As a processing aid and wetting defined in § 170.3(o)(30) of agent in combination with a-hydro- this chapter in food. omega -hydroxy - poly(oxyethylene) - 3. As a formulation aid as de- Not to exceed 3.0 percent poly-(oxypropylene) (53–59 moles) fined in § 170.3(o)(14) of this of the combined weight chapter in confections. of the formulation. poly(oxyethylene) (14–16 moles) block 4. As a formulation aid as de- Not to exceed 1.0 percent copolymer, having a molecular weight fined in § 170.3(o)(14) of this of the combined weight range of 3,500–4,125 and a cloud point of chapter in fats and oils as de- of the formulation. ° ° fined in § 170.3 (n)(12) of this 9 C–12 C in 10 percent aqueous solu- chapter. tion, for fumaric acid used in fumaric 5. As a winterization and frac- Not to exceed 0.5 percent acid-acidulated dry beverage base and tionation aid in fat and oil by weight of the proc- in fumaric acid-acidulated fruit juice processing. essed fat or oil. drinks, when standards of identity do not preclude such use. The labeling of (d) To assure safe use of the additive: the dry beverage base shall bear ade- (1) In addition to the other informa- quate directions for use, and the addi- tion required by the act, the label or tives shall be used in such an amount labeling of the additive shall bear the that the finished beverage or fruit juice name of the additive. drink will contain not in excess of a (2) The label of the additive shall total of 10 parts per million of the bear adequate directions to provide a dioctyl sodium sulfosuccinate-block final product that complies with the copolymer combination. limitations prescribed in paragraph (c) [42 FR 14491, Mar. 15, 1977, as amended at 49 of this section. FR 10105, Mar. 19, 1984] [53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994] § 172.811 Glyceryl tristearate. The food additive glyceryl tristearate § 172.812 Glycine. may be safely used in food in accord- The food additive glycine may be ance with the following prescribed con- safely used for technological purposes ditions: in food in accordance with the fol- (a) The food additive (CAS Reg. No. lowing prescribed conditions: 555–43–1) is prepared by reacting stearic (a) The additive complies with the acid with glycerol in the presence of a specifications of the ‘‘Food Chemicals suitable catalyst. Codex,’’ 3d Ed. (1981), p. 140, which is in- (b) The food additive meets the fol- corporated by reference. Copies may be lowing specifications: obtained from the National Academy Acid number: Not to exceed 1.0. Press, 2101 Constitution Ave. NW., Iodine number: Not to exceed 1.0. Washington, DC 20418, or may be exam- Saponification number: 186–192. ined at the National Archives and Hydroxyl number: Not to exceed 5.0. Records Administration (NARA). For Free glycerol content: Not to exceed 0.5 per- information on the availability of this cent. material at NARA, call 202–741–6030, or Unsaponifiable matter: Not to exceed 0.5 per- go to: http://www.archives.gov/ cent. federal register/ Melting point (Class II): 69 °C–73 °C. l codeloflfederallregulations/ (c) The additive is used or intended ibrllocations.html. for use as follows when standards of (b) The additive is used or intended identity established under section 401 for use as follows: of the Act do not preclude such use:

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Uses Limitations § 172.816 Methyl glucoside-coconut oil ester. As a masking agent for the Not to exceed 0.2 percent in bitter aftertaste of sac- the finished beverage. Methyl glucoside-coconut oil ester charin used in manufac- may be safely used in food in accord- tured beverages and bev- ance with the following conditions: erage bases. As a stabilizer in mono- and Not to exceed 0.02 percent of (a) It is the methyl glucoside-coconut diglycerides prepared by the mono- and oil ester having the following specifica- the glycerolysis of edible diglycerides. tions: fats or oils. Acid number: 10–20 (c) To assure safe use of the additive, Hydroxyl number: 200–300 in addition to the other information re- pH (5% aqueous): 4.8–5.0 Saponification number: 178–190 quired by the Act: (1) The labeling of the additive shall (b) It is used or intended for use as bear adequate directions for use of the follows: additive in compliance with the provi- (1) As an aid in crystallization of su- sions of this section. crose and dextrose at a level not to ex- ceed the minimum quantity required to (2) The labeling of beverage bases produce its intended effect. containing the additive shall bear ade- (2) As a surfactant in molasses at a quate directions for use to provide that level not to exceed 320 parts per million beverages prepared therefrom shall in the molasses. contain no more than 0.2 percent gly- cine. § 172.818 Oxystearin. [42 FR 14491, Mar. 15, 1977, as amended at 49 The food additive oxystearin may be FR 10105, Mar. 19, 1984] safely used in foods, when such use is not precluded by standards of identity § 172.814 Hydroxylated lecithin. in accordance with the following condi- The food additive hydroxylated tions: (a) The additive is a mixture of the lecithin may be safely used as an emul- glycerides of partially oxidized stearic sifier in foods in accordance with the and other fatty acids obtained by heat- following conditions: ing hydrogenated cottonseed or soy- (a) The additive is obtained by the bean oil under controlled conditions, in treatment of lecithin in one of the fol- the presence of air and a suitable cata- lowing ways, under controlled condi- lyst which is not a food additive as so tions whereby the separated fatty acid defined. The resultant product meets fraction of the resultant product has the following specifications: an acetyl value of 30 to 38: Acid number: Maximum 15. (1) With hydrogen peroxide, benzoyl Iodine number: Maximum 15. peroxide, lactic acid, and sodium hy- Saponification number: 225–240. droxide. Hydroxyl number: 30–45. (2) With hydrogen peroxide, acetic Unsaponifiable material: Maximum 0.8 per- acid, and sodium hydroxide. cent. Refractive index (butyro): 60±1 at 48 °C. (b) It is used or intended for use, in accordance with good manufacturing (b) It is used or intended for use as a practice, as an emulsifier in foods, ex- crystallization inhibitor in vegetable cept for those standardized foods that oils and as a release agent in vegetable do not provide for such use. oils and vegetable shortenings, where- (c) To assure safe use of the additive, by the additive does not exceed 0.125 the label of the food additive container percent of the combined weight of the oil or shortening. shall bear, in addition to the other in- (c) To insure safe use of the additive, formation required by the Act: the label and labeling of the additive (1) The name of the additive, container shall bear, in addition to the ‘‘hydroxylated lecithin’’. other information required by the Act: (2) Adequate directions for its use. (1) The name of the additive. (2) Adequate directions to provide an 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 ethyl- ethylene and diethylene glycol content ene glycol peak. of polyethylene glycols having mean B=milligrams of ethylene glycol per milli- molecular weights below 450. liter of standard solution. C=Peak height in millimeters of the diethylene glycol peak. ANALYTICAL METHOD D=Milligrams of diethylene glycol per mil- liliter 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 flame 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 sample Inlet temperature: 260 °C. weight in grams) Carrier gas (nitrogen) flow rate: 70 milli- Percent diethylene glycol=(F×D)/(C×sample liters per minute. 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: (1) As a dough conditioner in yeast- (b) Neotame meets the following leavened bakery products in an amount specifications when it is tested accord- not to exceed 0.5 percent by weight of ing to the methods described or ref- the flour used. erenced in the document entitled (2) As a conditioning agent in dehy- ‘‘Specifications and Analytical Meth- drated potatoes in an amount not to ods for Neotame’’ dated April 3, 2001, exceed 1 percent by weight thereof. by the NutraSweet Co., 699 North (3) As a stabilizing agent in Wheeling Rd., Mount Prospect, IL nonyeast-leavened bakery products in 60056. The Director of the Office of the an amount not to exceed 1 percent by Federal Register has approved the in- weight of the flour used. corporation by reference of this mate- (4) As a conditioning agent in proc- rial in accordance with 5 U.S.C. 552(a) essed cereals for cooking in an amount and 1 CFR part 51. Copies are available not to exceed 1 percent by weight of from the Office of Food Additive Safety the dry cereal, except for foods for (HFS–200), Center for Food Safety and which standards of identity preclude Applied Nutrition, 5100 Paint Branch such use. Pkwy., College Park, MD 20740. Copies (5) As a conditioning agent in starch- may be examined at the Center for thickened or flour-thickened foods in Food Safety and Applied Nutrition’s an amount not to exceed 0.2 percent by Library, 5100 Paint Branch Pkwy., rm. weight of the food. 1C–100, College Park, MD 20740, or at the National Archives and Records Ad- § 172.828 Acetylated monoglycerides. ministration (NARA). For information The food additive acetylated on 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: codeloflfederallregulations/ (a) The additive is manufactured by: ibrllocations.html. (1) The interesterification of edible (1) Assay for neotame, not less than fats with triacetin and in the presence 97.0 percent and not more than 102.0 of catalytic agents that are not food percent on a dry basis. additives or are authorized by regula- (2) Free dipeptide acid (N-[N-(3,3- tion, followed by a molecular distilla- dimethylbutyl)-L-a-aspartyl]-L- tion or by steam stripping; or phenylalanine), not more than 1.5 per- (2) The direct of edible cent. monoglycerides with acetic anhydride (3) Other related substances, not without the use of catalyst or molec- more than 2.0 percent. ular distillation, and with the removal (4) Lead, not more than 2.0 milli- by vacuum distillation, if necessary, of 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- (b) The additive meets the specifica- cept in meat and poultry, in accord- tions of the ‘‘Food Chemicals Codex,’’ ance with current good manufacturing 4th ed. (1996), pp. 398–400, which is in- practice, in an amount not to exceed corporated by reference in accordance that reasonably required to accomplish with 5 U.S.C. 552(a) and 1 CFR part 51. the intended technical effect, in foods Copies are available from the Division for which standards of identity estab- of Product Policy (HFS–206), Center for lished under section 401 of the Federal Food Safety and Applied Nutrition, Food, Drug, and Cosmetic Act do not Food and Drug Administration, 5100 preclude such use. Paint Branch Pkwy., College Park, MD (d) When neotame is used as a sugar 20740, or may be examined at the Cen- substitute tablet, L-leucine may be ter for Food Safety and Applied Nutri- used as a lubricant in the manufacture tion’s Library, 5100 Paint Branch of tablets at a level not to exceed 3.5 Pkwy., College Park, MD 20740, or at percent of the weight of the tablet. the National Archives and Records Ad- (e) If the food containing the additive ministration (NARA). For information purports to be or is represented to be on the availability of this material at for special dietary use, it shall be la- NARA, call 202–741–6030, or go to: http:// beled in compliance with part 105 of www.archives.gov/federallregister/ this chapter. codeloflfederallregulations/ [67 FR 45310, July 9, 2002] ibrllocations.html. (c) The additive may be used as a § 172.830 Succinylated monoglycerides. sweetener in foods generally, in accord- The food additive succinylated ance with current good manufacturing monoglycerides may be safely used in practice in an amount not to exceed food in accordance with the following that reasonably required to accomplish prescribed conditions: the intended effect. (a) The additive is a mixture of semi- (d) If the food containing the additive and neutral succinic acid esters of purports to be or is represented to be mono- and diglycerides produced by the for special dietary use, it shall be la- of a product obtained by beled in compliance with part 105 of the glycerolysis of edible fats and oils, this chapter. or by the direct esterification of glyc- [63 FR 16433, Apr. 3, 1998, as amended at 64 erol with edible fat-forming fatty FR 43909, Aug. 12, 1999] acids. (b) The additive meets the following § 172.832 Monoglyceride citrate. specifications: A food additive that is a mixture of Succinic acid content: 14.8%–25.6% glyceryl monooleate and its citric acid Melting point: 50 °C–60 °C. monoester manufactured by the reac- Acid number: 70–120 tion of glyceryl monooleate with citric (c) The additive is used or intended acid under controlled conditions may for use in the following foods: be safely used as a synergist and solu- (1) As an emulsifier in liquid and bilizer for antioxidants in oils and fats, plastic shortenings at a level not to ex- when used in accordance with the con- ceed 3 percent by weight of the short- ditions prescribed in this section. ening. (a) The food additive meets the fol- (2) As a dough conditioner in bread lowing specifications: baking, when such use is permitted by an appropriate food standard, at a level Acid number, 70–100. not to exceed 0.5 percent by weight of Total citric acid (free and combined), 14 per- cent–17 percent. the flour used. (b) It is used, or intended for use, in § 172.831 Sucralose. antioxidant formulations for addition (a) Sucralose is the chemical 1,6- to oils and fats whereby the additive dichloro-1,6-dideoxy-b-D- does not exceed 200 parts per million of fructofuranosyl-4-chloro-4-deoxy-a-D- the combined weight of the oil or fat galactopyranoside (CAS Reg. No. 56038– and the additive. 13–2). (c) To assure safe use of the additive:

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(1) The container label shall bear, in codeloflfederallregulations/ addition to the other information re- ibrllocations.html. quired by the Act, the name of the ad- (3) Acid value: Not to exceed 0.20 de- ditive. termined using 50 grams of sample by (2) The label or accompanying label- the ‘‘Guide to Specifications for Gen- ing shall bear adequate directions for eral Notices, General Analytical Tech- the use of the additive which, if fol- niques, Identification Tests, Test Solu- lowed, will result in a food that com- tions, and Other Reference Materials,’’ plies with the requirements of this sec- in the ‘‘Compendium of Food Additive tion. Specifications, Addendum 4, FAO Food 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- Sucrose acetate isobutyrate may be tion for availability of the incorpora- safely used in foods in accordance with tion by reference. 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 the Center for Food Safety and Applied Where SV = Saponification value Nutrition’s Library, 5100 Paint Branch (2) Saponification value: 524–540 de- Pkwy., College Park, MD 20740, or at termined using 1 gram of sample by the the National Archives and Records Ad- ‘‘Guide to Specifications for General ministration (NARA). For information Notices, General Analytical Tech- on the availability of this material at niques, Identification Tests, Test Solu- NARA, call 202–741–6030, or go to: http:// tions, and Other Reference Materials,’’ www.archives.gov/federallregister/ in the ‘‘Compendium of Food Additive codeloflfederallregulations/ Specifications, Addendum 4, Food and ibrllocations.html. Agriculture Organization of the United (5) Triacetin: Not to exceed 0.10 per- Nations (FAO), Food and Nutrition cent determined by gas chroma- Paper 5, Revision 2’’ (1991), pp. 203 and tography as described in the ‘‘Guide to 204, which is incorporated by reference, Specifications for General Notices, in accordance with 5 U.S.C. 552(a) and 1 General Analytical Techniques, Identi- CFR part 51. Copies are available from fication Tests, Test Solutions, and the Office of Premarket Approval, Cen- Other Reference Materials,’’ in the ter for Food Safety and Applied Nutri- ‘‘Compendium of Food Additive Speci- tion (HFS–200), Food and Drug Admin- fications, Addendum 4, FAO Food and istration, 5100 Paint Branch Pkwy., Nutrition Paper 5, Revision 2,’’ (1991), College Park, MD 20740, or may be ex- pp. 13–26, which is incorporated by ref- amined at the Center for Food Safety erence; see paragraph (b)(2) of this sec- and Applied Nutrition’s Library, 5100 tion for availability of the incorpora- Paint Branch Pkwy., College Park, MD tion by reference. 20740, or at the National Archives and (c) The food additive is used as a sta- Records Administration (NARA). For bilizer (as defined in § 170.3(o)(28) of this information on the availability of this chapter) of emulsions of flavoring oils material at NARA, call 202–741–6030, or in nonalcoholic beverages. go to: http://www.archives.gov/ (d) The total SAIB content of a bev- federallregister/ erage containing the additive does not

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exceed 300 milligrams/kilogram of the (d) When the name ‘‘polyglycerate finished beverage. 60’’ is used in labeling it shall be fol- lowed by either ‘‘polyoxyethylene (20) [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999] mono-and diglycerides of fatty acids’’ or ‘‘ethoxylated mono- and § 172.834 Ethoxylated mono- and diglycerides’’ in parentheses. diglycerides. [42 FR 14491, Mar. 15, 1977, as amended at 42 The food additive ethoxylated mono- FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, and diglycerides (polyoxyethylene (20) 1985] mono- and diglycerides of fatty acids) § 172.836 Polysorbate 60. (polyglycerate 60) may be safely used in food in accordance with the fol- The food additive polysorbate 60 lowing prescribed conditions: (polyoxyethylene (20) sorbitan mono- (a) The food additive is manufactured stearate) which is a mixture of by: polyoxyethylene ethers of mixed par- (1) Glycerolysis of edible fats pri- tial stearic and palmitic acid esters of marily composed of stearic, palmitic, sorbitol anhydrides and related com- and myristic acids; or pounds, may be safely used in food in (2) Direct esterification of glycerol accordance with the following pre- with a mixture of primarily stearic, scribed conditions: palmitic, and myristic acids; (a) The food additive is manufactured by reacting stearic acid (usually con- to yield a product with less than 0.3 taining associated fatty acids, chiefly acid number and less than 0.2 percent palmitic) with sorbitol to yield a prod- water, which is then reacted with uct with a maximum acid number of 10 ethylene oxide. and a maximum water content of 0.2 (b) The additive meets the following percent, which is then reacted with specifications: ethylene oxide. (b) The food additive meets the fol- Saponification number, 65–75. lowing specifications: Acid number, 0–2. Hydroxyl number, 65–80. Saponification number 45–55. Oxyethylene content, 60.5–65.0 percent. Acid number 0–2. Hydroxyl number 81–96. (c) The additive is used or intended Oxyethylene content 65 percent–69.5 percent. for use in the following foods when standards of identity established under (c) It is used or intended for use as section 401 of the Act do not preclude follows: such use: (1) As an emulsifier in whipped edible oil topping with or without one or a Use Limitations combination of the following: (i) Sorbitan monostearate; 1. As an emulsifier in pan-re- Not to exceed levels required (ii) Polysorbate 65; lease agents for and as a to produce the intended ef- dough conditioner in yeast- fects, total not to exceed (iii) Polysorbate 80; leavened bakery products. 0.5 percent by weight of the flour used. whereby the maximum amount of the 2. As an emulsifier in cakes Not to exceed 0.5 percent by additive or additives used does not ex- and cake mixes. weight of the dry ingredi- ceed 0.4 percent of the weight of the ents. finished whipped edible oil topping; ex- 3. As an emulsifier in Not to exceed 0.45 percent whipped vegetable oil top- by weight of the finished cept that a combination of the additive pings and topping mixes. whipped vegetable oil top- with sorbitan monostearate may be pings. used in excess of 0.4 percent, provided 4. As an emulsifier in icings Not to exceed 0.5 percent by that the amount of the additive does and icing mixes. weight of the finished icings. not exceed 0.77 percent and the amount 5. As an emulsifier in frozen Not to exceed 0.2 percent by of sorbitan monostearate does not ex- desserts. weight of the finished fro- ceed 0.27 percent of the weight of the zen desserts. finished whipped edible oil topping. 6. As an emulsifier in edible Not to exceed 0.4 percent by vegetable fat-water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake sions intended for use as table fat-water emulsions. mixes, with or without one or a com- substitutes for milk or bination of the following: cream in beverage coffee. (i) Polysorbate 65.

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(ii) Sorbitan monostearate. (7) As an emulsifier in nonstandard- ized dressings whereby the maximum When used alone, the maximum amount of the additive does not exceed amount of polysorbate 60 shall not ex- 0.3 percent of the weight of the finished ceed 0.46 percent of the cake or cake dressings. mix, on a dry-weight basis. When used (8) As an emulsifier, alone or in com- with polysorbate 65 and/or sorbitan bination with polysorbate 80, in monostearate, it shall not exceed 0.46 shortenings and edible oils intended for percent, nor shall the polysorbate 65 use in foods as follows, when standards exceed 0.32 percent or the sorbitan of identity established under section monostearate exceed 0.61 percent, and 401 of the act do not preclude such use: no combination of these emulsifiers (i) It is used alone in an amount not shall exceed 0.66 percent of the cake or to exceed 1 percent of the weight of the cake mix, all calculated on a dry- finished shortening or oil. weight basis. (ii) It is used with polysorbate 80 in (3) As an emulsifier, alone or in com- any combination providing no more bination with sorbitan monostearate, than 1 percent of polysorbate 60 and no in nonstandardized confectionery coat- more than 1 percent of polysorbate 80, ings and standardized cacao products provided that the total combination specified in §§ 163.123, 163.130, 163.135, does not exceed 1 percent of the fin- 163.140, 163.145, and 163.150 of this chap- ished shortening or oil. ter, as follows: (iii) The 1–percent limitation speci- (i) It is used alone in an amount not fied in paragraph (c)(8) (i) and (ii) of to exceed 0.5 percent of the weight of this section may be exceeded in premix the finished nonstandardized confec- concentrates of shortening or edible oil tionery coating or standardized cacao if the labeling complies with the re- product. quirements of paragraph (d) of this sec- (ii) It is used with sorbitan mono- tion. stearate in any combination of up to (9) As an emulsifier in solid-state, ed- 0.5 percent of polysorbate 60 and up to ible vegetable fat-water emulsions in- 1 percent of sorbitan monostearate: tended for use as substitutes for milk Provided, That the total combination or cream in beverage coffee, with or does not exceed 1 percent of the weight without one or a combination of the of the finished nonstandardized confec- following: tionery coating or standardized cacao (i) Polysorbate 65. product. (ii) Sorbitan monostearate. (4) [Reserved] The maximum amount of the additive (5) As an emulsifier in cake icings or additives shall not exceed 0.4 per- and cake fillings, with or without one cent by weight of the finished edible or a combination of the following: vegetable fat-water emulsion. (i) Polysorbate 65. (10) As a in non- (ii) Sorbitan monostearate. alcoholic mixes, to be added to alco- When used alone, the maximum holic beverages in the preparation of amount of polysorbate 60 shall not ex- mixed alcoholic drinks, at a level not ceed 0.46 percent of the weight of the to exceed 4.5 percent by weight of the cake icings and cake fillings. When nonalcoholic mix. used with polysorbate 65 and/or sorbi- (11) As a dough conditioner in yeast- tan monostearate, it shall not exceed leavened bakery products in an amount 0.46 percent, nor shall the polysorbate not to exceed 0.5 percent by weight of 65 exceed 0.32 percent or the sorbitan the flour used. monostearate exceed 0.7 percent, and (12) As an emulsifier, alone or in no combination of these emulsifiers combination with sorbitan monostea- shall exceed 1 percent of the weight of rate, in the minimum quantity re- the cake icing or cake filling. quired to accomplish the intended ef- (6) To impart greater opacity to fect, in formulations of white mineral sugar-type confection coatings where- oil conforming with § 172.878 and/or pe- by the maximum amount of the addi- troleum wax conforming with § 172.886 tive does not exceed 0.2 percent of the for use as protective coatings on raw weight of the finished sugar coating. fruits and vegetables.

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(13) As a dispersing agent in artifi- tristearate), which is a mixture of cially sweetened gelatin desserts and in polyoxyethylene ethers of mixed ste- artificially sweetened gelatin dessert aric acid esters of sorbitol anhydrides mixes, whereby the amount of the addi- and related compounds, may be safely tive does not exceed 0.5 percent on a used in food in accordance with the fol- dry-weight basis. lowing prescribed conditions: (14) As an emulsifier in chocolate fla- (a) The food additive is manufactured vored syrups, whereby the maximum by reacting stearic acid (usually con- amount of the additive does not exceed taining associated fatty acids, chiefly 0.05 percent in the finished product. palmitic) with sorbitol to yield a prod- (15) As a surfactant and wetting uct with a maximum acid number of 15 agent for natural and artificial colors and a maximum water content of 0.2 in food as follows: percent, which is then reacted with (i) In powdered mixes in an ethylene oxide. amount not to exceed 4.5 percent by (b) The food additive meets the fol- weight of the mix. lowing specifications: (ii) In sugar-based gelatin dessert Saponification number 88–98. mixes in an amount not to exceed 0.5 Acid number 0–2. percent by weight of the mix. Hydroxyl number 44–60. (iii) In artificially sweetened gelatin Oxyethylene content 46 percent–50 percent. dessert mixes in an amount not to ex- (c) The additive is used, or intended ceed 3.6 percent by weight of the mix. for use, as follows: (iv) In sugar-based pudding mixes in (1) As an emulsifier in ice cream, fro- an amount not to exceed 0.5 percent by zen custard, ice milk, fruit sherbet and weight of the mix. nonstandardized frozen desserts when (v) In artificially sweetened pudding used alone or in combination with mixes in an amount not to exceed 0.5 polysorbate 80, whereby the maximum percent by weight of the mix. amount of the additives, alone or in (16) As an emulsifier in ice cream, combination, does not exceed 0.1 per- frozen custard, fruit sherbet, and non- cent of the finished frozen dessert. standardized frozen desserts when used (2) As an emulsifier in cakes and cake alone or in combination with poly- mixes, with or without one or a com- sorbate 65 and/or polysorbate 80, where- bination of the following: by the maximum amount of the addi- (i) Sorbitan monostearate. tives, alone or in combination, does not (ii) Polysorbate 60. exceed 0.1 percent of the finished frozen 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. tions prescribed in paragraph (c) of this (3) 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 (i) Sorbitan monostearate; FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, (ii) Polysorbate 60; 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 28, 1999] (iii) Polysorbate 80; whereby the maximum amount of the § 172.838 Polysorbate 65. additive or additives used does not ex- The food additive polysorbate 65 ceed 0.4 percent of the weight of the (polyoxyethylene (20) sorbitan finished whipped edible oil topping.

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(4) As an emulsifier in solid-state, ed- sorbitol to yield a product with a max- ible vegetable fat-water emulsions in- imum acid number of 7.5 and a max- tended for use as substitutes for milk imum water content of 0.5 percent, or cream in beverage coffee, with or which is then reacted with ethylene without one or a combination of the oxide. following: (b) The food additive meets the fol- (i) Sorbitan monostearate. lowing specifications: (ii) Polysorbate 60. Saponification number 45–55. The maximum amount of the additive Acid number 0–2. or additives shall not exceed 0.4 per- Hydroxyl number 65–80. cent by weight of the finished edible Oxyethylene content 65 percent–69.5 percent. vegetable fat-water emulsion. (c) The additive is used or intended (5) As an emulsifier in cake icings for use as follows: and cake fillings, with or without one (1) An emulsifier in ice cream, frozen or a combination of the following: custard, ice milk, fruit sherbet, and (i) Sorbitan monostearate. nonstandardized frozen desserts, when (ii) Polysorbate 60. used alone or in combination with polysorbate 65 whereby the maximum When used alone, the maximum amount of the additives, alone or in amount of polysorbate 65 shall not ex- combination, does not exceed 0.1 per- ceed 0.32 percent of the weight of the cent of the finished frozen dessert. cake icing or cake filling. When used (2) In yeast-defoamer formulations with sorbitan monostearate and/or whereby the maximum amount of the polysorbate 60, it shall not exceed 0.32 additive does not exceed 4 percent of percent, nor shall the sorbitan mono- the finished yeast defoamer and the stearate exceed 0.7 percent or the poly- maximum amount of the additive in sorbate 60 exceed 0.46 percent, and no the yeast from such use does not ex- combination of these emulsifiers shall ceed 4 parts per million. exceed 1 percent of the weight of the (3) As a solubilizing and dispersing cake icing or cake filling. agent in pickles and pickle products, (d) To assure safe use of the additive, whereby the maximum amount of the in addition to the other information re- additive does not exceed 500 parts per quired by the Act: million. (1) The label of the additive and any (4) As a solubilizing and dispersing intermediate premixes shall bear: agent in: (i) The name of the additive. (i) Vitamin-mineral preparations (ii) A statement of the concentration containing calcium caseinate in the ab- or strength of the additive in any in- sence of fat-soluble vitamins, whereby termediate premixes. 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 shall not exceed 300 milligrams from § 172.840 Polysorbate 80. the recommended daily dose of the The food additive polysorbate 80 preparations. (polyoxyethylene (20) sorbitan (iii) In vitamin-mineral preparations monooleate), which is a mixture of containing both calcium caseinate and polyoxyethylene ethers of mixed par- fat-soluble vitamins, whereby the max- tial oleic acid esters of sorbitol anhy- imum intake of polysorbate 80 shall drides and related compounds, may be not exceed 475 milligrams from the rec- safely used in food in accordance with ommended daily dose of the prepara- the following prescribed conditions: tions. (a) The food additive is manufactured (5) As a surfactant in the production by reacting oleic acid (usually con- of coarse crystal sodium chloride taining associated fatty acids) with whereby the maximum amount of the

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additive in the finished sodium chlo- prior to application of such dilutions to ride does not exceed 10 parts per mil- the growing crop. Residues resulting lion. from such use are exempt from the re- (6) In special dietary foods, as an quirement of a tolerance. When so used emulsifier for edible fats and oils, with or intended for use, the additive shall directions for use which provide for the be exempt from the requirements of ingestion of not more than 360 milli- paragraph (d)(1) of this section. grams of polysorbate 80 per day. (13) As a defoaming agent in the prep- (7) As a solubilizing and dispersing aration of the creaming mixture for agent for dill oil in canned spiced green cottage cheese and lowfat cottage beans, not to exceed 30 parts per mil- cheese, as identified in §§ 133.128 and lion. 133.131 of this chapter, respectively, (8) As an emulsifier, alone or in com- whereby the amount of the additive bination with polysorbate 60, in does not exceed .008 percent by weight shortenings and edible oils intended for of the finished products. use in foods as follows, when standards (14) As a surfactant and wetting of identity established under section agent for natural and artificial colors 401 of the act do not preclude such use: for use in barbecue sauce where the (i) It is used alone in an amount not level of the additive does not exceed to exceed 1 percent of the weight of the 0.005 percent by weight of the barbecue finished shortening or oil. sauce. (ii) It is used with polysorbate 60 in (d) To assure safe use of the additive, any combination providing no more in addition to the other information re- than 1 percent of polysorbate 80 and no quired by the Act: more than 1 percent of polysorbate 60, (1) The label of the additive and any provided that the total combination intermediate premixes shall bear: does not exceed 1 percent of the fin- (i) The name of the additive. ished shortening or oil. (ii) A statement of the concentration (iii) The 1–percent limitation speci- or strength of the additive in any in- fied in paragraph (c)(8) (i) and (ii) of termediate premixes. this section may be exceeded in premix (2) The label or labeling shall bear concentrates of shortening or edible oil adequate directions to provide a final if the labeling complies with the re- product that complies with the limita- quirements of paragraph (d) of this sec- tions prescribed in paragraph (c) of this tion. section. (9) As an emulsifier in whipped edible [42 FR 14491, Mar. 15, 1977, as amended at 43 oil topping with or without one or a FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, combination of the following: 1980; 46 FR 8466, Jan. 27, 1981] (i) Sorbitan monostearate; (ii) Polysorbate 60; § 172.841 Polydextrose. (iii) Polysorbate 65; Polydextrose as identified in this sec- whereby the maximum amount of the tion may be safely used in food in ac- additive or additives used does not ex- cordance with the following prescribed ceed 0.4 percent of the weight of the conditions: finished whipped edible oil topping. (a)(1) Polydextrose (CAS Reg. No. (10) It is used as a wetting agent in 68424–04–4) is a partially metabolizable scald water for poultry defeathering, water-soluble polymer prepared by the followed by potable water rinse. The condensation of a melt which consists concentration of the additive in the either of approximately 89 percent D- scald water does not exceed 0.0175 per- glucose, 10 percent sorbitol, and 1 per- cent. cent citric acid or of approximately 90 (11) As a dispersing agent in gelatin percent D-glucose, 10 percent sorbitol, desserts and in gelatin dessert mixes, and 0.1 percent phosphoric acid, on a whereby the amount of the additive weight basis. does not exceed 0.082 percent on a dry- (2) Polydextrose may be partially weight basis. neutralized with potassium hydroxide, (12) As an adjuvant added to herbi- or partially reduced by transition cide use and plant-growth regulator metal catalytic hydrogenation in aque- use dilutions by a grower or applicator ous solution.

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(b) The additive meets the specifica- food in accordance with the following tions of the ‘‘Food Chemicals Codex,’’ prescribed conditions: 5th ed. (January 1, 2004), pp. 336–339, (a) The food additive is manufactured and the First Supplement to the 5th by reacting stearic acid (usually con- Edition of the Food Chemicals Codex taining associated fatty acids, chiefly (March 1, 2006), p. 37, which are incor- palmitic) with sorbitol to yield essen- porated by reference. The Director of tially a mixture of esters. the Office of the Federal Register ap- (b) The food additive meets the fol- proves this incorporation by reference lowing specifications: in accordance with 5 U.S.C. 552(a) and 1 Saponification number, 147–157 CFR part 51. You may obtain a copy Acid number, 5–10 from The National Academies Press, Hydroxyl number, 235–260 500 Fifth St. NW., Washington, DC 20001 (c) It is used or intended for use, (Internet address http://www.nap.edu). alone or in combination with poly- You may inspect a copy at the Center sorbate 60 as follows: for Food Safety and Applied Nutri- (1) As an emulsifier in whipped edible tion’s Library, Food and Drug Admin- oil topping with or without one or a istration, 5100 Paint Branch Pkwy., combination of the following: College Park, MD 20740, or at the Na- (i) Polysorbate 60; tional Archives and Records Adminis- (ii) Polysorbate 65; tration (NARA). For information on (iii) Polysorbate 80; the availability of this material at whereby the maximum amount of the NARA, call 202–741–6030, or go to: http:// additive or additives used does not ex- www.archives.gov/federal-register/cfr/ibr- ceed 0.4 percent of the weight of the locations.html. finished whipped edible oil topping; ex- (c) When standards of identity estab- cept that a combination of the additive lished under section 401 of the act do with polysorbate 60 may be used in ex- not preclude such use, polydextrose cess of 0.4 percent: Provided, That the may be used in accordance with cur- amount of the additive does not exceed rent good manufacturing practices as a 0.27 percent and the amount of poly- bulking agent, formulation aid, humec- sorbate 60 does not exceed 0.77 percent tant, and texturizer in all foods, except of the weight of the finished whipped meat and poultry, baby food, and in- edible oil topping. fant formula. (2) As an emulsifier in cakes and cake (d) If the food containing the additive mixes, with or without one or a com- purports to be or is represented for spe- bination of the following: cial dietary uses, it shall be labeled in (i) Polysorbate 65. compliance with part 105 of this chap- (ii) Polysorbate 60. ter. When used alone, the maximum (e) The label and labeling of food a amount of sorbitan monostearate shall single serving of which would be ex- not exceed 0.61 percent of the cake or pected to exceed 15 grams of the addi- cake mix, on a dry-weight basis. When tive shall bear the statement: ‘‘Sen- used with polysorbate 65 and/or poly- sitive individuals may experience a sorbate 60, it shall not exceed 0.61 per- laxative effect from excessive con- cent, nor shall the polysorbate 65 ex- sumption of this product’’. ceed 0.32 percent or the polysorbate 60 [46 FR 30081, June 5, 1981, as amended at 59 exceed 0.46 percent, and no combina- FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, tion of the emulsifiers shall exceed 0.66 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, percent of the weight of the cake or June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR cake mix, calculated on a dry-weight 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; basis. 72 FR 46564, Aug. 21, 2007] (3) As an emulsifier, alone or in com- bination with polysorbate 60 in non- § 172.842 Sorbitan monostearate. standardized confectionery coatings The food additive sorbitan monostea- and standardized cacao products speci- rate, which is a mixture of partial ste- fied in §§ 163.123, 163.130, 163.135, 163.140, aric and palmitic acid esters of sorbitol 163.145, and 163.150 of this chapter, as anhydrides, may be safely used in or on follows:

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(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 food in accordance with the following When used alone, the maximum prescribed conditions: amount of sorbitan monostearate shall (a) The additive, which is a mixture not exceed 0.7 percent of the weight of of calcium salts of stearoyl lactylic the cake icing or cake filling. When acids and minor proportions of other used with polysorbate 65 and/or poly- calcium salts of related acids, is manu- sorbate 60, it shall not exceed 0.7 per- factured by the reaction of stearic acid cent, nor shall the polysorbate 65 ex- and lactic acid and conversion to the ceed 0.32 percent or the polysorbate 60 calcium salts. exceed 0.46 percent, and no combina- (b) The additive meets the following tion of these emulsifiers shall exceed 1 specifications: percent of the weight of the cake icing 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 (c) It is used or intended for use as without one or a combination of the follows: following: (1) As a dough conditioner in yeast- (i) Polysorbate 60. leavened bakery products and prepared (ii) Polysorbate 65. mixes for yeast-leavened bakery prod- ucts in an amount not to exceed 0.5 The maximum amount of the additive part for each 100 parts by weight of or additives shall not exceed 0.4 per- flour used. cent by weight of the finished edible (2) As a whipping agent in: vegetable fat-water emulsion. (i) Liquid and frozen egg white at a (6) It is used alone as a rehydration level not to exceed 0.05 percent. aid in the production of active dry (ii) Dried egg white at a level not to yeast in an amount not to exceed 1 per- exceed 0.5 percent. cent by weight of the dry yeast. (iii) Whipped vegetable oil topping at (7) As an emulsifier, alone or in com- a level not to exceed 0.3 percent of the bination with polysorbate 60, in the weight of the finished whipped vege- minimum quantity required to accom- table oil topping. plish the intended effect, in formula- (3) As a conditioning agent in dehy- tions of white mineral oil conforming drated potatoes in an amount not to with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof. conforming with § 172.886 for use as pro- (d) To assure safe use of the additive: tective coatings on raw fruits and vege- (1) The label and labeling of the food tables. additive and any intermediate premix (d) To assure safe use of the additive, prepared therefrom shall bear, in addi- in addition to the other information re- tion to the other information required quired by the Act: by the act, the following:

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(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. (6) As an emulsifier, stabilizer, or § 172.846 Sodium stearoyl lactylate. 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- [45 FR 51767, Aug. 5, 1980, as amended at 49 ined at the National Archives and FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, Records Administration (NARA). For 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. information on the availability of this 27, 1986; 65 FR 60859, Oct. 13, 2000] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 172.848 Lactylic esters of fatty acids. federallregister/ Lactylic esters of fatty acids may be codeloflfederallregulations/ safely used in food in accordance with ibrllocations.html. the following prescribed conditions: (c) It is used or intended for use as (a) They are prepared from lactic follows when standards of identity es- acid and fatty acids meeting the re- tablished under section 401 of the Act quirements of § 172.860(b) and/or oleic do not preclude such use: acid derived from tall oil fatty acids (1) As a dough strengthener, emulsi- meeting the requirements of § 172.862. fier, or processing aid in baked prod- (b) They are used as emulsifiers, plas- ucts, pancakes, and waffles, in an ticizers, or surface-active agents in the amount not to exceed 0.5 part for each following foods, when standards of 100 parts by weight of flour used. identity do not preclude their use: (2) As a surface-active agent, emulsi- Foods Limitations fier, or stabilizer in icings, fillings, puddings, and toppings, at a level not Bakery mixes ...... to exceed 0.2 percent by weight of the Baked products ...... Cake icings, fillings, and toppings finished food. Dehydrated fruits and vegetables (3) As an emulsifier or stabilizer in Dehydrated fruit and vegetable liquid and solid edible fat-water emul- juices. Edible vegetable fat-water emul- As substitutes for milk or sions intended for use as substitutes sions. cream in beverage cof- for milk or cream in beverage coffee, at fee. a level not to exceed 0.3 percent by Frozen desserts ...... Liquid shortening ...... For household use. weight of the finished edible fat-water Pancake mixes ...... emulsion. Precooked instant rice ......

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Foods Limitations (a) They are prepared from corn oil, cottonseed oil, lard, palm oil from Pudding mixes ...... fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the (c) They are used in an amount not fatty acids derived from these sub- greater than required to produce the stances (hydrogenated and nonhydro- intended physical or technical effect, genated) meeting the requirements of and they may be used with shortening § 172.860(b) and/or oleic acid derived and edible fats and oils when such are from tall oil fatty acids meeting the required in the foods identified in para- requirements of § 172.862. graph (b) of this section. (b) They are used as emulsifiers in § 172.850 Lactylated fatty acid esters food, in amounts not greater than that of glycerol and propylene glycol. required to produce the intended phys- ical or technical effect. The food additive lactylated fatty (c) Polyglycerol esters of a mixture acid esters of glycerol and propylene of stearic, oleic, and coconut fatty glycol may be safely used in food in ac- acids are used as a cloud inhibitor in cordance with the following prescribed vegetable and salad oils when use is conditions: not precluded by standards of identity. (a) The additive is a mixture of esters The fatty acids used in the production produced by the lactylation of a prod- of the polyglycerol esters meet the re- uct obtained by reacting edible fats or quirements of § 172.860(b), and the oils with propylene glycol. polyglycerol esters are used at a level (b) The additive meets the following not in excess of the amount required to specifications: Water insoluble com- perform its cloud-inhibiting effect. bined lactic acid, 14–18 percent; and Oleic acid derived from tall oil fatty acid number, 12 maximum. acids conforming with § 172.862 may be (c) It is used in amounts not in excess used as a substitute for or together of that reasonably required to produce with the oleic acid permitted by this the intended physical effect as an paragraph. emulsifier, plasticizer, or surface-ac- (d) Polyglycerol esters of butter oil tive agent in food. fatty acids are used as emulsifiers in combination with other approved emul- § 172.852 Glyceryl-lacto esters of fatty sifiers in dry, whipped topping base. acids. The fatty acids used in the production Glyceryl-lacto esters of fatty acids of the polyglycerol esters meet the re- (the lactic acid esters of mono- and quirements of § 172.860(b), and the diglycerides) may be safely used in polyglycerol esters are used at a level food in accordance with the following not in excess of the amount required to prescribed conditions: perform their emulsifying effect. (a) They are manufactured from glyc- erin, lactic acid, and fatty acids con- § 172.856 Propylene glycol mono- and forming with § 172.860 and/or oleic acid diesters of fats and fatty acids. derived from tall oil fatty acids con- Propylene glycol mono- and diesters forming with § 172.862 and/or edible fats of fats and fatty acids may be safely and oils. used in food, subject to the following (b) They are used in amounts not in prescribed conditions: excess of those reasonably required to (a) They are produced from edible accomplish their intended physical or fats and/or fatty acids in compliance technical effect as emulsifiers and plas- with § 172.860 and/or oleic acid derived ticizers in food. from tall oil fatty acids in compliance with § 172.862. § 172.854 Polyglycerol esters of fatty (b) They are used in food in amounts acids. not in excess of that reasonably re- Polyglycerol esters of fatty acids, up quired to produce their intended effect. to and including the decaglycerol esters, may be safely used in food in ac- § 172.858 Propylene glycol alginate. cordance with the following prescribed The food additive propylene glycol conditions: alginate (CAS Reg. No. 9005–37–2) may

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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- exceed 0.9 percent by weight of the fin- propanol) may be used in the prepara- ished product. tion of sucrose fatty acid esters. (4) As an emulsifier, stabilizer, or (b) Sucrose fatty acid esters meet the thickener in fats and oils at a level not following specifications: to exceed 1.1 percent by weight of the (1) The total content of mono-, di-, finished product. and tri-esters is not less than 80 per- (5) As an emulsifier, stabilizer, or cent as determined by a method title thickener in gelatins and puddings at a ‘‘Sucrose Fatty Acid Esters, Method of level not to exceed 0.6 percent by Assay,’’ which is incorporated by ref- weight of the finished product. erence. Copies are available from the (6) As a stabilizer or thickener in gra- Center for Food Safety and Applied Nu- vies and in sweet sauces at a level not trition (HFS–200), Food and Drug Ad- to exceed 0.5 percent by weight of the ministration, 5100 Paint Branch Pkwy., finished product. College Park, MD 20740, or available for (7) As a stabilizer in jams and jellies inspection at the National Archives at a level not to exceed 0.4 percent by and Records Administration (NARA). weight of the finished product. For information on the availability of (8) As an emulsifier, stabilizer, or this material at NARA, call 202–741– thickener in condiments and relishes 6030, or go to: http://www.archives.gov/

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federallregister/ tled ‘‘Determination of Dimethyl Sulf- codeloflfederallregulations/ oxide,’’ which is incorporated by ref- ibrllocations.html. erence. Copies are available from the (2) The free sucrose content is not Center for Food Safety and Applied Nu- more than 5 percent as determined by trition (HFS–200), Food and Drug Ad- Test S.2 in the method titled ‘‘Sucrose ministration, 5100 Paint Branch Pkwy., Fatty Acid Esters, Method of Assay,’’ College Park, MD 20740, or available for which is incorporated by reference. The inspection at the National Archives availability of this incorporation by and Records Administration (NARA). reference is given in paragraph (b)(1) of For information on the availability of this section. this material at NARA, call 202–741– (3) The acid value is not more than 6. 6030, or go to: http://www.archives.gov/ (4) The residue on ignition (sulfated federallregister/ ash) is not more than 2 percent. codeloflfederallregulations/ (5) The total ethyl acetate content is ibrllocations.html. not more than 350 parts per million as (11) The total isobuytl alcohol (2- determined by a method titled ‘‘Deter- methyl-1-propanol) content is not more mination of Ethyl Acetate,’’ which is than 10 parts per million as determined incorporated by reference. Copies are by a method entitled ‘‘Determination available from the Center for Food of Isobutyl Alcohol,’’ which is incor- Safety and Applied Nutrition (HFS– porated by reference. Copies are avail- 200), Food and Drug Administration, able from the Center for Food Safety 5100 Paint Branch Pkwy., College Park, and Applied Nutrition (HFS–200), Food MD 20740, or available for inspection at and Drug Administration, 5100 Paint the National Archives and Records Ad- Branch Pkwy., College Park, MD 20740, ministration (NARA). For information or available for inspection at the Na- on the availability of this material at tional Archives and Records Adminis- NARA, call 202–741–6030, or go to: http:// tration (NARA). For information on www.archives.gov/federallregister/ the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federallregister/ (6) Arsenic is not more than 3 parts codeloflfederallregulations/ per million. ibrllocations.html. (7) Total heavy metal content (as Pb) (c) Sucrose fatty acid esters may be is not more than 50 parts per million. used as follows when standards of iden- (8) Lead is not more than 10 parts per tity established under section 401 of million. the Federal Food, Drug, and Cosmetic (9) The total content of methyl ethyl Act do not preclude such use: ketone or of methanol shall not be (1) As emulsifiers as defined in more than 10 parts per million as deter- § 170.3(o)(8) of this chapter, or as stabi- mined by a method titled ‘‘Methyl lizers as defined in § 170.3(o)(28) of this Ethyl Ketone Test; Methyl Alcohol chapter, in baked goods and baking Test,’’ which is incorporated by ref- mixes as defined in § 170.3(n)(1) of this erence. Copies are available from the chapter, in chewing gum as defined in Center for Food Safety and Applied Nu- § 170.3(n)(6) of this chapter, in coffee trition (HFS–200), Food and Drug Ad- and tea beverages with added dairy in- ministration, 5100 Paint Branch Pkwy., gredients and/or dairy product ana- College Park, MD 20740, or available for logues, in confections and frostings as inspection at the National Archives defined in § 170.3(n)(9) of this chapter, and Records Administration (NARA). in dairy product analogues as defined For information on the availability of in § 170.3(n)(10) of this chapter, in frozen this material at NARA, call 202–741– dairy desserts and mixes as defined in 6030, or go to: http://www.archives.gov/ § 170.3(n)(20) of this chapter, and in federallregister/ whipped milk products. codeloflfederallregulations/ (2) As texturizers as defined in ibrllocations.html. § 170.3(o)(32) of this chapter in biscuit (10) The total dimethyl sulfoxide con- mixes, in chewing gum as defined in tent is not more than 2 parts per mil- § 170.3(n)(6) of this chapter, in confec- lion as determined by a method enti- tions and frostings as defined in

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§ 170.3(n)(9) of this chapter, and in the 13th Ed. (1980) of the ‘‘Official surimi-based fabricated seafood prod- Methods of Analysis of the Association ucts. of Official Analytical Chemists,’’ which (3) As components of protective coat- is incorporated by reference. Copies are ings applied to fresh apples, avocados, available from the AOAC INTER- bananas, banana plantains, limes, mel- NATIONAL, 481 North Frederick Ave., ons (honeydew and cantaloupe), pa- suite 500, Gaithersburg, MD 20877, or paya, peaches, pears, pineapples, and available for inspection at the National plums to retard ripening and spoiling. Archives and Records Administration (d) Sucrose fatty acid esters are used (NARA). For information on the avail- in accordance with current good manu- ability of this material at NARA, call facturing practice and in an amount 202–741–6030, or go to: http:// not to exceed that reasonably required www.archives.gov/federallregister/ to accomplish the intended effect. codeloflfederallregulations/ [47 FR 55475, Dec. 10, 1982, as amended at 48 ibrllocations.html. FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, (2) Chick-edema factor shall be deter- 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR mined by the bioassay method de- 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] scribed in ‘‘Official Methods of Anal- ysis of the Association of Official Ana- § 172.860 Fatty acids. lytical Chemists,’’ 13th Ed. (1980), sec- The food additive fatty acids may be tions 28.127–28.130, which is incor- safely used in food and in the manufac- porated by reference. Copies may be ture of food components in accordance obtained from the AOAC INTER- with the following prescribed condi- NATIONAL, 481 North Frederick Ave., tions: suite 500, Gaithersburg, MD 20877, or (a) The food additive consists of one may be examined at the National Ar- or any mixture of the following chives and Records Administration straight-chain monobasic carboxylic (NARA). For information on the avail- acids and their associated fatty acids ability of this material at NARA, call manufactured from fats and oils de- 202–741–6030, or go to: http:// rived from edible sources: Capric acid, www.archives.gov/federallregister/ caprylic acid, lauric acid, myristic codeloflfederallregulations/ acid, oleic acid, palmitic acid, and ste- ibrllocations.html. aric acid. (3) The gas chromatographic-electron (b) The food additive meets the fol- capture method for testing fatty acids lowing specifications: for chick-edema shall be the method (1) Unsaponifiable matter does not described in the ‘‘Journal of the Asso- exceed 2 percent. ciation of Official Analytical Chem- (2) It is free of chick-edema factor: ists,’’ Volume 50 (No. 1), pages 216–218 (i) As evidenced during the bioassay method for determining the chick- (1967), or the modified method using a edema factor as prescribed in para- sulfuric acid clean-up procedure, as de- graph (c)(2) of this section; or scribed in the ‘‘Journal of the Associa- (ii) As evidenced by the absence of tion of the Offical Analytical Chem- chromatographic peaks with a reten- ists,’’ Volume 51 (No. 2), pages 489–490 tion time relative to aldrin (RA) be- (1968), which are incorporated by ref- tween 10 and 25, using the gas erence. See paragraph (c)(2) of this sec- chromatographic-electron capture tion for availability of these ref- method prescribed in paragraph (c)(3) erences. of this section. If chromatographic (d) It is used or intended for use as peaks are found with RA values be- follows: tween 10 and 25, the food additive shall (1) In foods as a lubricant, binder, meet the requirements of the bioassay and as a defoaming agent in accordance method prescribed in paragraph (c)(2) with good manufacturing practice. of this section for determining chick- (2) As a component in the manufac- edema factor. ture of other food-grade additives. (c) For the purposes of this section: (e) To assure safe use of the additive, (1) Unsaponifiable matter shall be de- the label and labeling of the additive termined by the method described in and any premix thereof shall bear, in

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addition to the other information re- used in food and as a component in the quired by the act, the following: manufacture of food-grade additives in (1) The common or usual name of the accordance with the following pre- acid or acids contained therein. scribed conditions: (2) The words ‘‘food grade,’’ in jux- (a) The additive consists of purified taposition with and equally as promi- oleic acid separated from refined tall nent as the name of the acid. oil fatty acids. [42 FR 14491, Mar. 15, 1977, as amended at 47 (b) The additive meets the following FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, specifications: 1984; 54 FR 24897, June 12, 1989] (1) Specifications for oleic acid pre- scribed in the ‘‘Food Chemicals § 172.861 Cocoa butter substitute from Codex.’’ 3d Ed. (1981), pp. 207–208, which coconut oil, palm kernel oil, or both is incorporated by reference, except oils. that titer (solidification point) shall The food additive, cocoa butter sub- not exceed 13.5 °C and unsaponifiable stitute from coconut oil, palm kernel matter shall not exceed 0.5 percent. oil, or both oils, may be safely used in Copies of the material incorporated by food in accordance with the following reference may be obtained from the conditions: National Academy Press, 2101 Constitu- (a) Cocoa butter substitute from co- tion Ave. NW., Washington, DC 20418, conut oil, palm kernel oil (CAS Reg. or may be examined at the National No. 85665–33–4), or both oils is a mixture Archives and Records Administration of triglycerides. It is manufactured by (NARA). For information on the avail- esterification of glycerol with food- ability of this material at NARA, call grade fatty acids (complying with 202–741–6030, or go to: http:// § 172.860) derived from edible coconut www.archives.gov/federallregister/ oil, edible palm kernel oil, or both oils. codeloflfederallregulations/ (b) The ingredient meets the fol- ibrllocations.html. lowing specifications: (2) The resin acid content does not Acid number: Not to exceed 0.5. exceed 0.01 as determined by ASTM Saponification number: 220 to 260. method D1240–82, ‘‘Standard Test Meth- Iodine number: Not to exceed 3. od for Rosin Acids in Fatty Acids,’’ Melting range: 30 to 44 °C. which is incorporated by reference. (c) The ingredient is used or intended Copies may be obtained from the Amer- for use as follows: ican Society for Testing Materials, 100 (1) As coating material for sugar, Barr Harbor Dr., West Conshohocken, table salt, vitamins, citric acid, suc- Philadelphia, PA 19428-2959, or may be cinic acid, and spices; and examined at the National Archives and (2) In compound coatings, cocoa Records Administration (NARA). For creams, cocoa-based sweets, toffees, information on the availability of this caramel masses, and chewing sweets as material at NARA, call 202–741–6030, or defined in § 170.3 (n)(9) and (n)(38) of go to: http://www.archives.gov/ this chapter, except that the ingredient federallregister/ may not be used in a standardized food codeloflfederallregulations/ unless permitted by the standard of ibrllocations.html. identity. (3) The requirements for absence of (d) The ingredient is used in accord- chick-edema factor as prescribed in ance with current good manufacturing § 172.860. practice and in an amount not to ex- (c) It is used or intended for use as ceed that reasonably required to ac- follows: complish the intended effect. (1) In foods as a lubricant, binder, [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, and defoaming agent in accordance 1992] with good manufacturing practice. (2) As a component in the manufac- § 172.862 Oleic acid derived from tall ture of other food-grade additives. oil fatty acids. (d) To assure safe use of the additive, The food additive oleic acid derived the label and labeling of the additive from tall oil fatty acids may be safely and any premix thereof shall bear, in

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addition to the other information re- (i) Hexyl, octyl, decyl, lauryl, and quired by the Act, the following: myristyl alcohols contain not less than (1) The common or usual name of the 99 percent of total alcohols and not less acid. than 96 percent of straight chain alco- (2) The words ‘‘food grade’’ in jux- hols. Any nonalcoholic impurities are taposition with and equally as promi- primarily paraffins. nent as the name of the acid. (ii) Cetyl and stearyl alcohols con- [42 FR 14491, Mar. 15, 1977, as amended at 49 tain not less than 98 percent of total FR 10105, Mar. 19, 1984] 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 copper, acids conforming with § 172.862. chromium, 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. C H ), and utilizing an external coolant (c) To assure safe use of the additive, 2 4 such that these alcohols meet the spec- the label and labeling of the additive and any premix thereof shall bear, in ifications prescribed in paragraph (a)(1) addition to the other information re- (i) and (iii) of this section. quired by the Act, the following: (3) n-Octyl; manufactured by the (1) The common or usual name of the hydrodimerization of 1,3-butadiene, fol- fatty acid salt or salts contained there- lowed by catalytic hydrogenation of in. the resulting dienol, and distillation to (2) The words ‘‘food grade,’’ in jux- produce n-octyl alcohol with a min- taposition with and equally as promi- imum purity of 99 percent. The analyt- nent as the name of the salt. ical method for n-octyl alcohol entitled ‘‘Test Method [Normal-octanol]’’ dated § 172.864 Synthetic fatty alcohols. October 2003, and printed by Kuraray Synthetic fatty alcohols may be safe- Co., Ltd., is incorporated by reference. ly used in food and in the synthesis of The Director of the Office of the Fed- food components in accordance with eral Register approves this incorpora- the following prescribed conditions: tion by reference in accordance with 5 (a) The food additive consists of any U.S.C. 552(a) and 1 CFR part 51. You one of the following fatty alcohols: may obtain a copy from the Office of (1) Hexyl, octyl, decyl, lauryl, Food Additive Safety, 5100 Paint myristyl, cetyl, and stearyl; manufac- Branch Pkwy., College Park, MD 20740, tured by fractional distillation of alco- or you may examine a copy at the Cen- hols obtained by a sequence of oxida- ter for Food Safety and Applied Nutri- tion and hydrolysis of organo-alu- tion’s Library, Food and Drug Admin- minums generated by the controlled re- istration, 5100 Paint Branch Pkwy., action of low molecular weight College Park, MD 20740, or at the Na- trialkylaluminum with purified ethyl- tional Archives and Records Adminis- ene (minimum 99 percent by volume tration (NARA). For information on C2H4), and utilizing the hydrocarbon the availability of this material at solvent as defined in paragraph (b) of NARA, call 202–741–6030, or go to http:// this section, such that: www.archives.gov/federallregister/

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codeloflfederallregulations/ vent samples in handling and to assure ab- ibrllocations.html. sence of any extraneous material arising (b) The hydrocarbon solvent used in from inadequate packaging is essential. Be- the process described in paragraph cause some of the polynuclear hydrocarbons 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 uid hydrocarbons essentially paraffinic be carried out under subdued light. in nature, derived from petroleum and refined to meet the specifications de- APPARATUS scribed in paragraph (b)(1) of this sec- Chromatographic tube. 450 millimeters in tion when subjected to the procedures length (packing section), inside diameter 19 described in paragraph (b) (2) and (3) of millimeters ±1 millimeter, equipped with a this section. wad of clean Pyrex brand filtering wool (Cor- (1) The hydrocarbon solvent meets ning Glass Works Catalog No. 3950 or equiva- 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 (ii) Ultraviolet absorbance limits as end. Overall length of the tube is 670 milli- follows: meters. Stainless steel rod. 2 feet in length, 2 to 4 Maximum millimeters in diameter. absorb- ance per Vacuum oven. Similar to Labline No. 3610 Wavelength (millicrons) centimeter but modified as follows: A copper tube one- optical fourth inch in diameter and 13 inches in path length length is bent to a right angle at the 4-inch 280–289 ...... 0.15 point and plugged at the opposite end; eight 290–299 ...... 12 copper tubes one-eighth inch in diameter and 300–359 ...... 05 5 inches in length are silver soldered in 360–400 ...... 02 drilled holes (one-eighth inch in diameter) to the one-fourth-inch tube, one on each side at (2) Use ASTM method D86–82, the 5-, 7.5-, 10- and 12.5-inch points; the one- ‘‘Standard Method for Distillation of eighth-inch copper tubes are bent to conform Petroleum Products,’’ which is incor- with the inner periphery of the oven. porated by reference, to determine Beakers. 250-milliliter and 500-milliliter ca- pacity. boiling point range. Copies of the ma- Graduated cylinders. 25-milliliter, 50-milli- terial incorporated by reference may liter, and 150-milliliter capacity. be obtained from the American Society Tuberculin syringe. 1-milliliter capacity, for Testing Materials, 100 Barr Harbor with 3-inch, 22-gauge needle. Dr., West Conshohocken, Philadelphia, Volumetric flask. 5-milliliter capacity. PA 19428-2959, or may be examined at Spectrophotometric cells. Fused quartz the National Archives and Records Ad- ground glass stoppered cells, optical path length in the range of 1.000 centimeter ±0.005 ministration (NARA). For information centimeter. With distilled water in the cells, on the availability of this material at determine any absorbance difference. NARA, call 202–741–6030, or go to: http:// Spectrophotometer. Spectral range 250 milli- www.archives.gov/federallregister/ microns—400 millimicrons with spectral slit codeloflfederallregulations/ width of 2 millimicrons or less: under instru- ibrllocations.html. ment operating conditions for these absorb- (3) The analytical method for deter- ance measurements, the spectrophotometer mining ultraviolet absorbance limits is shall also meet the following performance requirements: as follows: Absorbance repeatability, ±0.01 at 0.4 ab- sorbance. GENERAL INSTRUCTIONS Absorbance accuracy, 1 ±0.05 at 0.4 absorb- All glassware should be scrupulously ance. cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine 1 As determined by using potassium chro- all glassware, including stoppers and stop- mate for reference standard and described in cocks, under ultraviolet light to detect any National Bureau of Standards Circular 484, residual fluorescent contamination. As a pre- Spectrophotometry, U.S. Department of cautionary measure, it is recommended prac- Commerce, (1949). The accuracy is to be de- tice to rinse all glassware with purified iso- termined by comparison with the standard octane immediately before use. No grease is values at 290, 345, and 400 millimicrons. Cir- to be used on stopcocks or joints. Great care cular 484 is incorporated by reference. Copies to avoid contamination of hydrocarbon sol- Continued

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Wavelength repeatability, ±0.2 milli- equivalent). Use 20 milliliters for test. If nec- micron. essary, 1,2-dichloroethane may be purified by Wavelength accuracy, ±1.0 millimicron. distillation. Nitrogen cylinder. Water-pumped or equiva- Eluting mixtures: lent purity nitrogen in cylinder equipped 1. 10 percent 1,2-dichloroethane in hexane. with regulator and valve to control flow at 5 Pipet 100 milliliters of 1,2-dichloroethane p.s.i.g. into a 1-liter glass-stoppered volumetric flask and adjust to volume with hexane, with REAGENTS AND MATERIALS mixing. Organic solvents. All solvents used through- 2. 40 percent benzene in hexane. Pipet 400 out the procedure shall meet the specifica- milliliters of benzene into a 1-liter glass- tions and tests described in this specifica- stoppered volumetric flask and adjust to vol- tion. The isooctane, benzene, hexane, and 1,2- ume with hexane, with mixing. dichloroethane designated in the list fol- n-Hexadecane, 99 percent olefin-free. Dilute lowing this paragraph shall pass the fol- 1.0 milliliter of n-hexadecane to 5 milliliters lowing test: with isooctane and determine the absorbance To the specified quantity of solvent in a in a 1-centimeter cell compared to isooctane 250-milliliter beaker, add 1 milliliter of puri- as reference between 280 mμ-400mμ. The ab- fied n-hexadecane and evaporate in the vacu- sorbance per centimeter path length shall um oven under a stream of nitrogen. Dis- not exceed 0.00 in this range. If necessary, n- continue evaporation when not over 1 milli- hexadecane may be purified by percolation liter of residue remains. (To the residue from through activated silica gel or by distilla- benzene add a 5-milliliter portion of purified tion. isooctane, reevaporate, and repeat once to Silica gel, 28–200 mesh (Grade 12, Davison insure complete removal of benzene.) Chemical Co., Baltimore, Md., or equivalent). Dissolve the 1 milliliter of hexadecane res- Activate as follows: Weigh about 900 grams idue in isooctane and make to 5 milliliters into a 1-gallon bottle, add 100 milliliters of volume. Determine the absorbance in the 1- de-ionized water, seal the bottle and shake centimeter path length cells compared to and roll at intervals for 1 hour. Allow to isooctane as reference. The absorbance of the equilibrate overnight in the sealed bottle. solution of the solvent residue shall not ex- Activate the gel at 150 °C for 16 hours, in a ceed 0.02 per centimeter path length between 2-inch × 7-inch × 12-inch porcelain pan loose- 280 and 300 mμ and shall not exceed 0.01 per ly covered with aluminum foil, cool in a centimeter path length between 300 and 400 dessicator, transfer to a bottle and seal. mμ. Isooctane (2,2,4-trimethylpentane). Use 10 PROCEDURE milliliters for the test described in the pre- Determination of ultraviolet absorbance. Be- ceding paragraph. If necessary, isooctane fore proceeding with the analysis of a sample may be purified by passage through a column determine the absorbance in a 1-centimeter of activated silica gel (Grade 12, Davison path cell for the reagent blank by carrying Chemical Co., Baltimore, Md., or equiva- out the procedure without a sample. Record lent). the absorbance in the wavelength range of Benzene, spectro grade (Burdick and Jackson 280 to 400 millimicrons. Typical reagent Laboratories, Inc., Muskegon, Mich., or equiva- blank absorbance in this range should not lent). Use 80 milliliters for the test. If nec- exceed 0.04 in the 280 to 299 millimicron essary, benzene may be purified by distilla- range, 0.02 in the 300 to 359 millimicron tion or otherwise. range, and 0.01 in the 360 to 400 millimicron Hexane, spectro grade (Burdick and Jackson range. If the characteristic benzene peaks in Laboratories, Inc., Muskegon, Mich., or equiva- the 250 to 260 millimicron region are present, lent). Use 650 milliliters for the test. If nec- remove the benzene by the procedure de- essary, hexane may be purified by distilla- scribed above under ‘‘Reagents and Mate- tion or otherwise. rials,’’ ‘‘Organic Solvents,’’ and record ab- 1,2-Dichloroethane, spectro grade (Matheson, sorbance again. Coleman, and Bell, East Rutherford, N.J., or Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. are available from the Center for Food Safe- Raise and drop the column on a semisoft, ty and Applied Nutrition (HFS–200), Food clean surface for about 1 minute to settle the and Drug Administration, 5100 Paint Branch gel. Pour 100 milliliters of hexane into the Pkwy., College Park, MD 20740, or available column with the stopcock open and allow to for inspection at the National Archives and drain to about one-half inch above the gel. Records Administration (NARA). For infor- Turn off the stopcock and allow the column mation on the availability of this material to cool for 30 minutes. After cooling, vibrate at NARA, call 202–741–6030, or go to: http:// the column to eliminate air and stir the top www.archives.gov/federallregister/ 1 to 2 inches with a small diameter stainless codeloflfederallregulations/ steel rod. Take care not to get the gel above ibrllocations.html. the liquid and onto the sides of the column.

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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] 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) with a 250-milliliter beaker. Add two sepa- Synthetic glycerin produced by the 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 200 milliliters. When the final 10 percent 1,2- (a) It shall contain not in excess of dichloroethane fraction is about one-half 0.2 percent by weight of a mixture of inch above the top of the gel bed, replace the butanetriols. receiving beaker (discard the 1,2- (b) It is used or intended for use in an dichloroethane eluate) with a 250-milliliter amount not to exceed that reasonably beaker containing 1 milliliter of hexadecane. required to produce its intended effect. Adjust the elution rate to 2 to 3 milliliters per minute, add two 25-milliliter portions of 40 percent benzene and allow each to sepa- § 172.867 Olestra. rately elute as before to within about one- Olestra, as identified in this section, half inch of the gel bed. Finally, add 150 mil- may be safely used in accordance with liliters of 40 percent benzene for a total of 200 milliliters. Evaporate the benzene in the the following conditions: oven with vacuum and sufficient nitrogen (a) Olestra is a mixture of octa-, flow to just ripple the top of the benzene so- hepta-, and hexa-esters of sucrose with lution. When the benzene is removed (as de- fatty acids derived from edible fats and termined by a constant volume of hexa- oils or fatty acid sources that are gen- decane) add 5 milliliters of isooctane and erally recognized as safe or approved evaporate. Repeat once to insure complete for use as food ingredients. The chain removal of benzene. Remove the beaker and cover with aluminum foil (previously rinsed lengths of the fatty acids are no less with hexane) until cool. than 12 carbon atoms. Quantitatively transfer the hexadecane (b) Olestra meets the specifications residue to a 5-milliliter volumetric flask and of the Food Chemicals Codex, 4th edi- dilute to volume with isooctane. Determine tion, 1st supplement (1997), pp. 33–35, the absorbance of the solution in 1-centi- which is incorporated by reference. The meter path length cells between 280 and 400 Director of the Office of the Federal millimicrons using isooctane as a reference. Correct the absorbance values for any ab- Register approves this incorporation sorbance derived from reagents as deter- by reference in accordance with 5 mined by carrying out the procedure without U.S.C. 552(a) and 1 CFR part 51. You a sample. If the corrected absorbance does may obtain copies from the National not exceed the limits prescribed in para- Academy Press, 2101 Constitution Ave. graph (b)(1)(ii) of this section, the sample NW., Washington, DC 20418 (Internet meets the ultraviolet absorbance specifica- address http://www.nap.edu). Copies tions for hydrocarbon solvent. may be examined at the Center for (c) Synthetic fatty alcohols may be Food Safety and Applied Nutrition’s used as follows: Library, Food and Drug Administra- (1) As substitutes for the cor- tion, 5100 Paint Branch Pkwy., College responding naturally derived fatty al- Park, MD 20740, or at the National Ar- cohols permitted in food by existing chives and Records Administration regulations in this part or part 173 of (NARA). For information on the avail- this chapter provided that the use is in ability of this material at NARA, call compliance with any prescribed limita- 202–741–6030, or go to: http:// tions. www.archives.gov/federallregister/ (2) As substitutes for the cor- codeloflfederallregulations/ responding naturally derived fatty al- ibrllocations.html.

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(c) Olestra may be used in place of taining on an anhydrous basis not more fats and oils in prepackaged ready-to- than 2.6 ethoxy groups per eat savory (i.e., salty or piquant but anhydroglucose unit. not sweet) snacks and prepackaged, (b) It is used or intended for use as unpopped popcorn kernels that are follows: ready-to-heat. In such foods, the addi- (1) As a binder and filler in dry vita- tive may be used in place of fats and min preparations. oils for frying or baking, in dough con- (2) As a component of protective ditioners, in sprays, in filling ingredi- coatings for vitamin and mineral tab- ents, or in flavors. lets. (d) To compensate for any inter- (3) As a fixative in flavoring com- ference with absorption of fat soluble pounds. vitamins, the following vitamins shall be added to foods containing olestra: § 172.869 Sucrose oligoesters. 1.9 milligrams alpha-tocopherol equiva- lents per gram olestra; 51 retinol Sucrose oligoesters, as identified in equivalents per gram olestra (as this section, may be safely used in ac- retinyl acetate or retinyl palmitate); 12 cordance with the following conditions: IU vitamin D per gram olestra; and 8 μg (a) Sucrose oligoesters consist of vitamin K1 per gram olestra. mixtures of sucrose fatty acid esters (e)(1) Vitamins A, D, E, and K present with an average degree of in foods as a result of the requirement esterification ranging from four to in paragraph (d) of this section shall be seven. It is produced by declared in the listing of ingredients. interesterification of sucrose with Such vitamins shall not be considered methyl esters of fatty acids derived in determining nutrient content for the from edible fats and oils (including hy- nutritional label or for any nutrient drogenated fats and oils). The only sol- claims, express or implied. vents which may be used in the prepa- (i) An asterisk shall follow vitamins ration of sucrose oligoesters are di- A, D, E, and K in the listing of ingredi- methyl sulfoxide, isobutyl alcohol, and ents; those solvents generally recognized as (ii) The asterisk shall appear as a su- safe in food. perscript following each vitamin; (b) Sucrose oligoesters meet the spec- (iii) Immediately following the ingre- ifications in the methods listed in the dient list an asterisk and statement, table in this paragraph. The methods ‘‘Dietarily insignificant’’ shall appear cited for determining compliance with prominently and conspicuously as spec- each specification are incorporated by ified in § 101.2(c) of this chapter; reference, in accordance with 5 U.S.C. (2) Olestra shall not be considered as 552(a) and 1 CFR part 51. Copies of the a source of fat or calories for purposes methods may be examined at the Cen- of §§ 101.9 and 101.13 of this chapter. ter for Food Safety and Applied Nutri- [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, tion’s Library, room 1C–100, 5100 Paint 1996, as amended at 68 FR 46402, Aug. 5, 2003; Branch Pkwy., College Park, MD 20740, 69 FR 29432, May 24, 2004] or at the National Archives and Records Administration (NARA). For § 172.868 Ethyl cellulose. information on the availability of this The food additive ethyl cellulose may material at NARA, call 202–741–6030, or be safely used in food in accordance go to: http://www.archives.gov/ with the following prescribed condi- federallregister/ tions: codeloflfederallregulations/ (a) The food additive is a cellulose ibrllocations.html. Copies of the meth- ether containing ethoxy (OC2H5) groups ods are available from the sources list- attached by an ether linkage and con- ed in the table in this paragraph:

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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, 5100 Paint Branch Pkwy., 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, National Academy Press, Method I (Commercial Fatty 2101 Constitution Ave. NW, Acids), in the Food Chemi- Washington, DC 20418 cals Codex, 4th ed. (1996), (Internet: http:// p. 820. www.nap.edu).

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition, Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 751–752, (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 First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45.

(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. Spectrophotometric Graph- ite Furnace Method,’’ Meth- od I, in the Food Chemicals Codex, 4th ed. (1996), pp. 763–765.

(c) The additive is used as an emulsi- § 172.870 Hydroxypropyl cellulose. fier (as defined in § 170.3(o)(8) of this The food additive hydroxypropyl cel- chapter) or stabilizer (as defined in lulose may be safely used in food, ex- § 170.3(o)(28) of this chapter) in choco- cept standardized foods that do not late and in butter-substitute spreads, provide for such use, in accordance at a level not to exceed 2.0 percent; ex- with the following prescribed condi- cept that the additive may not be used tions: in a standardized food unless permitted (a) The additive consists of one of the by the standard of identity. following: (1) A cellulose ether containing pro- [68 FR 50072, Aug. 20, 2003] pylene glycol groups attached by an ether linkage that contains, on an an- hydrous basis, not more than 4.6

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hydroxypropyl groups per (2) The viscosity of an aqueous solu- anhydroglucose unit. The additive has tion, 2.5 grams of the material in 100 a minimum viscosity of 10 centipoises milliliters of water, at 20 °C, is 20 to 60 for a 10 percent by weight aqueous so- centipoises. lution at 25 degrees C. (3) The ash content on a dry basis has (2) A cellulose ether containing pro- a maximum of 0.6 percent. pylene glycol groups attached by an (c) The food additive is used as an ether linkage having a hydroxypropoxy aerating, emulsifying, and foaming (OC3H6OH) content of 5 to 16 percent agent, in an amount not in excess of weight in weight (w/w) on an anhydrous that reasonably required to produce its basis, i.e., 0.1 to 0.4 hydroxypropyl intended effect. groups per anhydroglucose unit. The common name for this form of the ad- § 172.874 Hydroxypropyl ditive is low substituted hydroxypropyl methylcellulose. cellulose. The food additive hydroxypropyl (b) The additive is used or intended methylcellulose (CAS Reg. No. 9004–65– for use as follows: 3) may be safely used in food, except in (1) The additive identified in para- standardized foods which do not pro- graph (a)(1) of this section is used or vide for such use if: intended for use as an emulsifier, film (a) The additive complies with the former, protective colloid, stabilizer, definition and specifications prescribed suspending agent, or thickener in food, in the National Formulary, 12th edi- in accordance with good manufacturing 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: [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is (a) The additive meets the specifica- the number of methyl groups and y is tions of the United States Pharma- the number of ethyl groups. The aver- copeia XX (1980). age value of x is 0.3 and the average (b) The additive is used or intended value of y is 0.7. for use as follows: (b) The additive meets the following specifications: Use and Limitations (1) The methoxy content shall be not Hard candy production—As a release agent less than 3.5 percent and not more than and antisticking agent, not to exceed 500 6.5 percent, calculated as OCH3, and the parts per million in hard candy. ethoxy content shall be not less than Vitamin and mineral tablets—As a compo- 14.5 percent and not more than 19 per- nent of protective coatings. cent, calculated as OC2H5, both meas- [42 FR 14491, Mar. 15, 1977, as amended at 49 ured on the dry sample. FR 10105, Mar. 19, 1984]

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§ 172.878 White mineral oil. any absorbance due to added anti- oxidants. Copies of the material incor- White mineral oil may be safely used porated by reference are available from in food in accordance with the fol- the Center for Food Safety and Applied lowing conditions: Nutrition (HFS–200), Food and Drug (a) White mineral oil is a mixture of Administration, 5100 Paint Branch liquid hydrocarbons, essentially par- Pkwy., College Park, MD 20740, or affinic and naphthenic in nature ob- available for inspection at the National tained from petroleum. It is refined to Archives and Records Administration meet the following specifications: (NARA). For information on the avail- (1) It meets the test requirements of ability of this material at NARA, call the United States Pharmacopeia XX 202–741–6030, or go to: http:// (1980) for readily carbonizable sub- www.archives.gov/federallregister/ stances (page 532). codeloflfederallregulations/ (2) It meets the test requirements of ibrllocations.html. U.S.P. XVII for sulfur compounds (page (b) White mineral oil may contain 400). any antioxidant permitted in food by (3) It meets the specifications pre- regulations issued in accordance with scribed in the ‘‘Journal of the Associa- section 409 of the Act, in an amount tion of Official Analytical Chemists,’’ not greater than that required to Volume 45, page 66 (1962), which is in- produce its intended effect. corporated by reference, after correc- (c) White mineral oil is used or in- tion of the ultraviolet absorbance for 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. 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]

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§ 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 320–329 millimicrons—0.08 maximum. antioxidant permitted in food by regu- 330–350 millimicrons—0.05 maximum. lations issued in accordance with sec- Nonvolatile residual: 0.002 gram per 100 tion 409 of the Act, in an amount not milliliters maximum. greater than that required to produce Synthetic isoparaffinic petroleum hydro- its intended effect. carbons containing antioxidants shall meet the specified ultraviolet absorbance limits [42 FR 14491, Mar. 15, 1977, as amended at 49 after correction for any absorbance due to FR 10105, Mar. 19, 1984] the antioxidants. The ultraviolet absorbance shall be determined by the procedure de- § 172.882 Synthetic isoparaffinic petro- scribed for application of mineral oil, dis- leum hydrocarbons. regarding the last sentence of the procedure, under ‘‘Specifications’’ on page 66 of the Synthetic isoparaffinic petroleum ‘‘Journal of the Association of Official Ana- hydrocarbons may be safely used in lytical Chemists,’’ Volume 45 (February food, in accordance with the following 1962), which is incorporated by reference. conditions: Copies are available from the Center for (a) They are produced by synthesis Food Safety and Applied Nutrition (HFS– from petroleum gases and consist of a 200), Food and Drug Administration, 5100 mixture of liquid hydrocarbons meet- Paint Branch Pkwy., College Park, MD 20740, ing the following specifications: or available for inspection at the National Archives and Records Administration Boiling point 93–260 °C as determined by (NARA). For information on the availability ASTM method D86–82, ‘‘Standard Method for of this material at NARA, call 202–741–6030, Distillation of Petroleum Products,’’ which or go to: http://www.archives.gov/ is incorporated by reference. Copies may be federallregister/codeloflfederallregulations/ obtained from the American Society for ibrllocations.html. For hydrocarbons boiling Testing Materials, 100 Barr Harbor Dr., West below 250 °F, the nonvolatile residue shall be Conshohocken, Philadelphia, PA 19428-2959, determined by ASTM method D1353–78, or may be examined at the National Ar- ‘‘Standard Test Method for Nonvolatile Mat- chives and Records Administration (NARA). ter in Volatile Solvents for Use in Paint, For information on the availability of this Varnish, Lacquer, and Related Products;’’ material at NARA, call 202–741–6030, or go to: for those boiling above 121 °C, ASTM method http://www.archives.gov/federallregister/ D381–80, ‘‘Standard Test Method for Existent codeloflfederallregulations/ Gum in Fuels by Jet Evaporation’’ shall be ibrllocations.html. used. These methods are incorporated by ref- Ultraviolet absorbance: erence. Copies may be obtained from the 260–319 millimicrons—1.5 maximum. American Society for Testing Materials, 100

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Barr Harbor Dr., West Conshohocken, Phila- § 178.3620(b)(1)(ii) of this chapter, as fol- delphia, PA 19428-2959, or may be examined lows: at the National Archives and Records Ad- ministration (NARA). For information on Maximum the availability of this material at NARA, absorb- call 202–741–6030, or go to: http:// μ ance per Wavelength m centimeter www.archives.gov/federallregister/ optical codeloflfederallregulations/ pathlength ibrllocations.html. 280–289 ...... 4.0 (b) Isoparaffinic petroleum hydro- 290–299 ...... 3.3 carbons may contain antioxidants au- 300–329 ...... 2.3 thorized for use in food in an amount 330–360 ...... 8 not to exceed that reasonably required to accomplish the intended technical (c) The additive is used as follows: effect nor to exceed any prescribed lim- Use Limitations itations. (c) Synthetic isoparaffinic petroleum As a coating on shell eggs ...... In an amount not to ex- hydrocarbons are used or intended for ceed good manufac- use as follows: turing practice. As a defoamer in processing beet Complying with sugar and yeast. § 173.340 of this chap- Uses Limitations ter. 1. In the froth-flotation cleaning of In an amount not to ex- As a float on fermentation fluids in In an amount not to ex- vegetables. ceed good manufac- the manufacture of vinegar and ceed good manufac- turing practice. wine to prevent or retard ac- turing practice. 2. As a component of insecticide Do. cess of air, evaporation, and formulations for use on proc- wild yeast contamination during essed foods. fermentation. 3. As a component of coatings on Do. In the froth-flotation cleaning of Do. fruits and vegetables. vegetables. 4. As a coating on shell eggs ...... Do. As a component of insecticide for- Do. 5. As a float on fermentation Do. mulations used in compliance fluids in the manufacture of vin- with regulations issued in parts egar and wine and on brine 170 through 189 of this chapter. used in curing pickles, to pre- vent or retard access of air, evaporation, and contamination § 172.886 Petroleum wax. with wild organisms during fer- mentation. Petroleum wax may be safely used in or on food, in accordance with the fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, (a) Petroleum wax is a mixture of 1984; 54 FR 24897, June 12, 1989] solid hydrocarbons, paraffinic in na- ture, derived from petroleum, and re- § 172.884 Odorless light petroleum hy- fined to meet the specifications pre- drocarbons. scribed by this section. Odorless light petroleum hydro- (b) Petroleum wax meets the fol- carbons may be safely used in food, in lowing ultraviolet absorbance limits accordance with the following pre- when subjected to the analytical proce- scribed conditions: dure described in this paragraph. (a) The additive is a mixture of liquid hydrocarbons derived from petroleum Maximum or synthesized from petroleum gases. ultraviolet absorb- The additive is chiefly paraffinic, ance per isoparaffinic, or naphthenic in nature. centimeter path length (b) The additive meets the following specifications: 280–289 millimicrons ...... 0.15 (1) Odor is faint and not kerosenic. 290–299 millimicrons ...... 0.12 (2) Initial boiling point is 300 °F min- 300–359 millimicrons ...... 0.08 imum. 360–400 millimicrons ...... 0.02 (3) Final boiling point is 650 °F max- imum. (4) Ultraviolet absorbance limits de- termined by method specified in

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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- Because of the sensitivity of the test, the mer sleeves on the glass joints will prevent possibility of errors arising from contamina- freezing. Do not use grease on stopcocks or tion is great. It is of the greatest importance joints. that all glassware be scrupulously cleaned to Spectrophotometric cells. Fused quartz cells, remove all organic matter such as oil, optical path length in the range of 5.000 cen- ± grease, detergent residues, etc. Examine all timeters 0.005 centimeter; also for checking glassware, including stoppers and stopcocks, spectrophotometer performance only, optical under ultraviolet light to detect any residual path length in the range 1.000 centimeter ± fluorescent contamination. As a pre- 0.005 centimeter. With distilled water in the cautionary measure it is recommended prac- cells, determine any absorbance differences. tice to rinse all glassware with purified iso- Spectrophotometer. Spectral range 250 milli- octane immediately before use. No grease is microns–400 millimicrons with spectral slit to be used on stopcocks or joints. Great care width of 2 millimicrons or less, under instru- to avoid contamination of wax samples in ment operating conditions for these absorb- handling and to assure absence of any extra- ance measurements, the spectrophotometer neous material arising from inadequate shall also meet the following performance packaging is essential. Because some of the requirements: ± polynuclear hydrocarbons sought in this test Absorbance repeatability, 0.01 at 0.4 ab- are very susceptible to photo-oxidation, the sorbance. 1 ± entire procedure is to be carried out under Absorbance accuracy, 0.05 at 0.4 absorb- subdued light. ance. Wavelength repeatability, ±0.2 milli- APPARATUS micron. Wavelength accuracy, ±1.0 millimicron. Separatory funnels. 250–milliliter, 500–milli- Nitrogen cylinder. Water-pumped or equiva- liter, 1,000–milliliter, and preferably 2,000– lent purity nitrogen in cylinder equipped milliliter capacity, equipped with tetra- with regulator and valve to control flow at 5 fluoroethylene polymer stopcocks. p.s.i.g. Reservoir. 500–milliliter capacity, equipped with a 24/40 standard taper male fitting at REAGENTS AND MATERIALS the bottom and a suitable ball-joint at the Organic solvents. All solvents used through- top for connecting to the nitrogen supply. out the procedure shall meet the specifica- The male fitting should be equipped with tions and tests described in this specifica- glass hooks. tion. The isooctane, benzene, acetone, and Chromatographic tube. 180 millimeters in methyl alcohol designated in the list fol- length, inside diameter to be 15.7 millimeters lowing this paragraph shall pass the fol- ±0.1 millimeter, equipped with a coarse, frit- lowing test: ted-glass disc, a tetrafluoroethylene polymer To the specified quantity of solvent in a stopcock, and a female 24/40 standard tapered 250–milliliter Erlenmeyer flask, add 1 milli- fitting at the opposite end. (Overall length of liter of purified n-hexadecane and evaporate the column with the female joint is 235 milli- on the steam bath under a stream of nitro- meters.) The female fitting should be gen (a) loose aluminum foil jacket around equipped with glass hooks. Disc. Tetrafluoroethylene polymer 2–inch 1 diameter disc approximately 3⁄16–inch thick As determined by using potassium chro- with a hole bored in the center to closely fit mate for reference standard and described in the stem of the chromatographic tube. National Bureau of Standards Circular 484, Heating jacket. Conical, for 500–milliliter Spectrophotometry, U.S. Department of separatory funnel. (Used with variable trans- Commerce, (1949). The accuracy is to be de- former heat control.) termined by comparison with the standard Suction flask. 250–milliliter or 500–milliliter values at 290, 345, and 400 millimicrons. Cir- filter flask. cular 484 is incorporated by reference. Copies Condenser. 24/40 joints, fitted with a drying are available from the Center for Food Safe- tube, length optional. ty and Applied Nutrition (HFS–200), Food Evaporation flask (optional). 250–milliliter and Drug Administration, 5100 Paint Branch or 500–milliliter capacity all-glass flask Pkwy., College Park, MD 20740, or available equipped with standard taper stopper having for inspection at the National Archives and inlet and outlet tubes to permit passage of Records Administration (NARA). For infor- nitrogen across the surface of contained liq- mation on the availability of this material uid to be evaporated. at NARA, call 202–741–6030, or go to: http:// Vacuum distillation assembly. All glass (for www.archives.gov/federallregister/ purification of dimethyl sulfoxide); 2–liter codeloflfederallregulations/ distillation flask with heating mantle; ibrllocations.html.

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the flask will speed evaporation). Dis- milliliters of distilled water in a 500–milli- continue evaporation when not over 1 milli- liter separatory funnel, mix and allow to liter of residue remains. (To the residue from cool for 5–10 minutes. Add 40 milliliters of benzene add a 10–milliliter portion of puri- isooctane to the solution and extract by fied isooctane, reevaporate, and repeat once shaking the funnel vigorously for 2 minutes. to insure complete removal of benzene.) Draw off the lower aqueous layer into a sec- Alternatively, the evaporation time can be ond 500–milliliter separatory funnel and re- reduced by using the optional evaporation peat the extraction with 40 milliliters of iso- flask. In this case the solvent and n-hexa- octane. Draw off and discard the aqueous decane are placed in the flask on the steam layer. Wash each of the 40–milliliter extrac- bath, the tube assembly is inserted, and a tives three times with 50–milliliter portions stream of nitrogen is fed through the inlet of distilled water. Shaking time for each tube while the outlet tube is connected to a wash is 1 minute. Discard the aqueous lay- solvent trap and vacuum line in such a way ers. Filter the first extractive through anhy- as to prevent any flow-back of condensate drous sodium sulfate prewashed with iso- into the flask. octane (see Sodium sulfate under ‘‘Reagents Dissolve the 1 milliliter of hexadecane res- and Materials’’ for preparation of filter), into idue in isooctane and make to 25 milliliters a 250–milliliter Erlenmeyer flask, or option- volume. Determine the absorbance in the 5– ally into the evaporating flask. Wash the centimeter path length cells compared to first separatory funnel with the second 40– isooctane as reference. The absorbance of the milliliter isooctane extractive, and pass solution of the solvent residue (except for through the sodium sulfate into the flask. methyl alcohol) shall not exceed 0.01 per cen- Then wash the second and first separatory timeter path length between 280 and 400 mμ. funnels successively with a 10–milliliter por- For methyl alcohol this absorbance value tion of isooctane, and pass the solvent shall be 0.00. through the sodium sulfate into the flask. Isooctane (2,2,4–trimethylpentane). Use 180 Add 1 milliliter of n-hexadecane and evapo- milliliters for the test described in the pre- rate the isooctane on the steam bath under ceding paragraph. Purify, if necessary, by nitrogen. Discontinue evaporation when not passage through a column of activated silica over 1 milliliter of residue remains. To the gel (Grade 12, Davison Chemical Company, residue, add a 10–milliliter portion of iso- Baltimore, Maryland, or equivalent) about 90 octane and reevaporate to 1 milliliter of centimeters in length and 5 centimeters to 8 hexadecane. Again, add 10 milliliters of iso- centimeters in diameter. octane to the residue and evaporate to 1 mil- Benzene, A.C.S. reagent grade. Use 150 milli- liliter of hexadecane to insure complete re- liters for the test. Purify, if necessary, by moval of all volatile materials. Dissolve the distillation or otherwise. 1 milliliter of hexadecane in isooctane and Acetone, A.C.S. reagent grade. Use 200 milli- make to 25–milliliter volume. Determine the liters for the test. Purify, if necessary, by reference. The absorbance of the solution distillation. should not exceed 0.02 per centimeter path Eluting mixtures: length in the 280 mμ–400 mμ range. (NOTE. 1. 10 percent benzene in isooctane. Pipet 50 Difficulty in meeting this absorbance speci- milliliters of benzene into a 500–milliliter fication may be due to organic impurities in glass-stoppered volumetric flask and adjust the distilled water. Repetition of the test to volume with isooctane, with mixing. omitting the dimethyl sulfoxide will disclose 2. 20 percent benzene in isooctane. Pipet 50 their presence. If necessary to meet the spec- milliliters of benzene into a 250–milliliter ification, purify the water by redistillation, glass-stoppered volumetric flask, and adjust passage through an ion-exchange resin, or to volume with isooctane, with mixing. otherwise.) 3. Acetone-benzene-water mixture. Add 20 Purify, if necessary, by the following pro- milliliters of water to 380 milliliters of ace- cedure: To 1,500 milliliters of dimethyl sulf- tone and 200 milliliters of benzene, and mix. oxide in a 2–liter glass-stoppered flask, add n-Hexadecane, 99 percent olefin-free. Dilute 6.0 milliliters of phosphoric acid and 50 1.0 milliliter of n-hexadecane to 25 milliliters grams of Norit A (decolorizing carbon, alka- with isooctane and determine the absorbance line) or equivalent. Stopper the flask, and in a 5–centimeter cell compared to isooctane with the use of a magnetic stirrer (tetra- as reference point between 280 mμ–400 mμ. fluoroethylene polymer coated bar) stir the The absorbance per centimeter path length solvent for 15 minutes. Filter the dimethyl shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted necessary, by percolation through activated paper (18.5 centimeters, Schleicher & silica gel or by distillation. Schuell, No. 597, or equivalent). If the initial Methyl alcohol, A.C.S. reagent grade. Use filtrate contains carbon fines, refilter 10.0 milliliters of methyl alcohol. Purify, if through the same filter until a clear filtrate necessary, by distillation. is obtained. Protect the sulfoxide from air Dimethyl sulfoxide. Pure grade, clear, and moisture during this operation by cov- water-white, m.p. 18° minimum. Dilute 120 ering the solvent in the funnel and collection milliliters of dimethyl sulfoxide with 240 flask with a layer of isooctane. Transfer the

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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 absorbent is completely wetted. Using a Place 300 milliliters of dimethyl sulfoxide Buchner funnel and a filter paper (Schleicher in a 1–liter separatory funnel and add 75 mil- & Schuell No. 597, or equivalent) of suitable liliters of phosphoric acid. Mix the contents diameter, filter with suction. Continue suc- of the funnel and allow to stand for 10 min- tion until water no longer drips from the utes. (The reaction between the sulfoxide funnel. Transfer the absorbent to a glass and the acid is exothermic. Release pressure trough lined with aluminum foil (free from after mixing, then keep funnel stoppered.) rolling oil). Break up the magnesia with a Add 150 milliliters of isooctane and shake to clean spatula and spread out the absorbent preequilibrate the solvents. Draw off the in- on the aluminum foil in a layer about 1 cen- dividual layers and store in glass-stoppered timeter to 2 centimeters thick. Dry for 24 flasks. hours at 160 °C ±1 °C. Pulverize the magnesia Place a representative 1–kilogram sample with mortar and pestle. Sieve the pulverized of wax, or if this amount is not available, the absorbent between 60–180 mesh. Use the mag- entire sample, in a beaker of a capacity nesia retained on the 180–mesh sieve. about three times the volume of the sample Celite 545. Johns-Manville Company, diato- and heat with occasional stirring on a steam maceous earth, or equivalent. bath until the wax is completely melted and Magnesium oxide-Celite 545 mixture (2+ 1) by homogeneous. Weigh four 25–gram ±0.2 gram weight. Place the magnesium oxide (60–180 portions of the melted wax in separate 100– mesh) and the Celite 545 in 2 to 1 propor- milliliter beakers. Reserve three of the por- tions, respectively, by weight in a glass- tions for later replicate analyses as nec- stoppered flask large enough for adequate essary. Pour one weighed portion imme- mixing. Shake vigorously for 10 minutes. diately after remelting (on the steam bath) Transfer the mixture to a glass trough lined into a 500–milliliter separatory funnel con- with aluminum foil (free from rolling oil) taining 100 milliliters of the preequilibrated and spread it out on a layer about 1 centi- sulfoxide-phosphoric acid mixture that has meter to 2 centimeters thick. Reheat the been heated in the heating jacket at a tem- mixture at 160 °C ±1 °C for 2 hours, and store perature just high enough to keep the wax in a tightly closed flask. melted. (NOTE: In preheating the sulfoxide- Sodium sulfate, anhydrous, A.C.S. reagent acid mixture, remove the stopper of the sepa- grade, preferably in granular form. For each ratory funnel at intervals to release the bottle of sodium sulfate reagent used, estab- pressure.) lish as follows the necessary sodium sulfate Promptly complete the transfer of the prewash to provide such filters required in sample to the funnel in the jacket with por- the method: Place approximately 35 grams of tions of the preequilibrated isooctane, warm- anhydrous sodium sulfate in a 30–milliliter ing the beaker, if necessary, and using a coarse, fritted-glass funnel or in a 65–milli- total volume of just 50 milliliters of the sol- meter filter funnel with glass wool plug; vent. If the wax comes out of solution during wash with successive 15–milliliter portions of these operations, let the stoppered funnel re- the indicated solvent until a 15–milliliter main in the jacket until the wax redissolves. portion of the wash shows 0.00 absorbance (Remove stopper from the funnel at intervals

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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 lower aqueous layer into a second separatory volume of approximately 5 milliliters. Swirl funnel (preferably 2–liter) and repeat the ex- the flask repeatedly to assure adequate traction with 80 milliliters of isooctane. washing of the sodium borohydride residues. Draw off and discard the aqueous layer. Fit the tetrafluoroethylene polymer disc Wash each of the 80–milliliter extractives on the upper part of the stem of the three times with 100–milliliter portions of chromatographic tube, then place the tube distilled water. Shaking time for each wash with the disc on the suction flask and apply is 1 minute. Discard the aqueous layers. Fil- the vacuum (approximately 135 millimeters ter the first extractive through anhydrous Hg pressure). Weight out 14 grams of the 2:1 sodium sulfate prewashed with isooctane (see magnesium oxide-Celite 545 mixture and Sodium Sulfate under ‘‘Reagents and Mate- pour the adsorbent mixture into the rials’’ for preparation of filter) into a 250– chromatographic tube in approximately 3– milliliter Erlenmeyer flask (or optionally centimeter layers. After the addition of each into the evaporation flask). Wash the first layer, level off the top of the adsorbent with separatory funnel with the second 80–milli- a flat glass rod or metal plunger by pressing liter isooctane extractive and pass through down firmly until the adsorbent is well the sodium sulfate. Then wash the second packed. Loosen the topmost few millimeters and first separatory funnels successively of each adsorbent layer with the end of a with a 20–milliliter portion of isooctane and metal rod before the addition of the next pass the solvent through the sodium sulfate layer. Continue packing in this manner until into the flask. Add 1 milliliter of n-hexa- all the 14 grams of the adsorbent is added to decane and evaporate the isooctane on the the tube. Level off the top of the adsorbent steam bath under nitrogen. Discontinue by pressing down firmly with a flat glass rod evaporation when not over 1 milliliter of res- or metal plunger to make the depth of the idue remains. To the residue, add a 10–milli- adsorbent bed approximately 12.5 centi- liter portion of isooctane, reevaporate to 1 meters in depth. Turn off the vacuum and re- milliliter of hexadecane, and repeat this op- move the suction flask. Fit the 500–milliliter eration once. reservoir onto the top of the Quantitatively transfer the residue with chromatographic column and prewet the col- isooctane to a 25–milliliter volumetric flask, umn by passing 100 milliliters of isooctane make to volume, and mix. Determine the ab- through the column. Adjust the nitrogen sorbance of the solution in the 5–centimeter pressure so that the rate of descent of the path length cells compared to isooctane as isooctane coming off of the column is be- reference between 280 mμ–400 mμ (take care tween 2–3 milliliters per minute. Discontinue

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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 quired to produce their intended effect: time to assure adequate washing of the res- (1) Antioxidants permitted in food by idue. Just before the final 5–milliliter wash regulations issued in accordance with reaches the top of the adsorbent, add 100 mil- 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 179529–36–3), made from long chain (C18- at the aforementioned rate. Just before the C ) methacrylate esters, having: solvent mixture reaches adsorbent level, add 22 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 until most of the solvent mixture is re- for Determining Weight-Average and moved. Wash the eluate three times with Number-Average Molecular Weight and 300–milliliter portions of distilled water, for Determining Alkylacrylate Mon- shaking well for each wash. (The addition of small amounts of sodium chloride facilitates omer Content of Poly(alkylacrylate) separation.) Discard the aqueous layer after used as Processing Aid in Manufacture each wash. After the final separation, filter of Petroleum Wax,’’ which is incor- the residual benzene through anhydrous so- porated by reference in accordance dium sulfate prewashed with benzene (see So- with 5 U.S.C. 552(a) and 1 CFR part 51. dium sulfate under ‘‘Reagents and Materials’’ Copies are available from the Office of for preparation of filter) into a 250–milliliter Premarket Approval (HFS–200), Center Erlenmeyer flask (or optionally into the evaporation flask). Wash the separatory fun- for Food Safety and Applied Nutrition, nel with two additional 20–milliliter portions Food and Drug Administration, 5100 of benzene which are also filtered through Paint Branch Pkwy., College Park, MD the sodium sulfate. Add 1 milliliter of n- 20740, or may be examined at the Cen- hexadecane and completely remove the ben- ter for Food Safety and Applied Nutri- zene by evaporation under nitrogen, using tion’s Library, Food and Drug Admin- the special procedure to eliminate benzene istration, 5100 Paint Branch Pkwy., as previously described under ‘‘Organic Sol- College Park, MD 20740 or at the Na- vents.’’ Quantitatively transfer the residue with isooctane to a 25–milliliter volumetric tional Archives and Records Adminis- flask and adjust to volume. Determine the tration (NARA). For information on absorbance of the solution in the 5–centi- the availability of this material at meter path length cells compared to iso- NARA, call 202–741–6030, or go to: http:// octane as reference between 250 mμ–400 mμ. www.archives.gov/federallregister/ Correct for any absorbance derived from the codeloflfederallregulations/ reagents as determined by carrying out the ibrllocations.html. Petroleum wax shall procedure without a wax sample. If either contain not more than 1,050 parts per spectrum shows the characteristic benzene peaks in the 250 mμ–260 mμ region, evaporate million of poly(alkylacrylate) or the solution to remove benzene by the proce- poly(alkylmethacrylate) residues as dure under ‘‘Organic Solvents.’’ Dissolve the determined by a method entitled residue, transfer quantitatively, and adjust ‘‘Method for Determining Residual

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Level of Poly(alkylacrylate) in Petro- Use Limitations leum Wax,’’ which is incorporated by On cheese and raw fruits and In an amount not to exceed reference. Copies are available from vegetables as a protective good manufacturing prac- the addresses cited in this paragraph. coating. tice. (d) Petroleum wax is used or intended As a defoamer in food ...... In accordance with § 173.340 for use as follows: of this chapter.

Use Limitations [42 FR 14491, Mar. 15, 1977, as amended at 59 In chewing gum base, as a mas- In an amount not to ex- FR 10986, Mar. 9, 1994] ticatory substance. ceed good manufac- turing practice. § 172.890 Rice bran wax. On cheese and raw fruits and Do. vegetables as a protective coat- Rice bran wax may be safely used in ing. food in accordance with the following As a defoamer in food ...... In accordance with conditions: § 173.340 of this chap- (a) It is the refined wax obtained ter. As a component of microcapsules In accordance with from rice bran and meets the following for spice-flavoring substances. § 172.230 of this chap- specifications: ter. Melting point 75 °C to 80 °C. Free fatty acids, maximum 10 percent. [42 FR 14491, Mar. 15, 1977, as amended at 45 Iodine number, maximum 20. FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, Saponification number 75 to 120. 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR (b) It is used or intended for use as 44122, Aug. 13, 1999] follows:

§ 172.888 Synthetic petroleum wax. Food Limitation in food Use

Synthetic petroleum wax may be Candy ...... 50 p.p.m ...... Coating. safely used in or on foods in accordance Fresh fruits and fresh ...... do ...... Do. with the following conditions: vegetables. Chewing gum ...... 21⁄2 pct ...... Plasticizing (a) Synthetic petroleum wax is a material. mixture of solid hydrocarbons, par- affinic in nature, prepared by either catalytic polymerization of ethylene or § 172.892 Food starch-modified. copolymerization of ethylene with lin- Food starch-modified as described in ear (C3 to C12) alpha-olefins, and refined this section may be safely used in food. to meet the specifications prescribed in The quantity of any substance em- this section. ployed to effect such modification shall (b) Synthetic petroleum wax meets not exceed the amount reasonably re- the ultraviolet absorbance limits of quired to accomplish the intended § 172.886(b) when subjected to the ana- physical or technical effect, nor exceed lytical procedure described therein. any limitation prescribed. To insure (c) Synthetic petroleum wax has a safe use of the food starch-modified, number average molecular weight of the label of the food additive container not less than 500 nor greater than 1,200 shall bear the name of the additive as determined by vapor pressure os- ‘‘food starch-modified’’ in addition to mometry. other information required by the Act. (d) Synthetic petroleum wax may Food starch may be modified by treat- contain any antioxidant permitted in ment prescribed as follows: food by regulations issued in accord- (a) Food starch may be acid-modified ance with section 409 of the act, in an by treatment with hydrochloric acid or amount not greater than that required sulfuric acid or both. to produce its intended effect. (b) Food starch may be bleached by (e) Synthetic petroleum wax is used treatment with one or more of the fol- or intended for use as follows: lowing:

Use Limitations Limitations

In chewing gum base, as a In accordance with § 172.615 Active oxygen obtained from hy- masticatory substance. in an amount not to exceed drogen peroxide and/or per- good manufacturing prac- acetic acid, not to exceed 0.45 tice. percent of active oxygen.

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Limitations Limitations

Ammonium persulfate, not to ex- Vinyl acetate ...... Acetyl groups in food ceed 0.075 percent and sulfur starch-modified not to dioxide, not to exceed 0.05 per- exceed 2.5 percent. cent. Chlorine, as calcium hypochlorite, The finished food starch- (e) Food starch may be etherified by not to exceed 0.036 percent of modified is limited to dry starch. use only as a compo- treatment with one of the following: nent of batter for com- mercially processed Limitations foods. Chlorine, as sodium hypochlorite, , not to exceed 0.6 per- not to exceed 0.0082 pound of cent. chlorine per pound of dry starch. Epichlorohydrin, not to exceed Potassium permanganate, not to Residual manganese 0.3 percent. exceed 0.2 percent. (calculated as Mn), not Epichlorohydrin, not to exceed Residual propylene to exceed 50 parts per 0.1 percent, and propylene chlorohydrin not more million in food starch- oxide, not to exceed 10 per- than 5 parts per million modified. cent, added in combination or in food starch-modified. Sodium chlorite, not to exceed 0.5 in any sequence. percent. Epichlorohydrin, not to exceed Do. 0.1 percent, followed by pro- pylene oxide, not to exceed 25 (c) Food starch may be oxidized by percent. treatment with chlorine, as sodium hy- Propylene oxide, not to exceed Do. pochlorite, not to exceed 0.055 pound of 25 percent. chlorine per pound of dry starch. (d) Food starch may be esterified by (f) Food starch may be esterified and treatment with one of the following: etherified by treatment with one of the following: Limitations Limitations Acetic anhydride ...... Acetyl groups in food starch-modified not to Acrolein, not to exceed 0.6 per- Acetyl groups in food exceed 2.5 percent. cent and vinyl acetate, not to starch-modified not to Adipic anhydride, not to exceed Do. exceed 7.5 percent. exceed 2.5 percent. 0.12 percent, and acetic anhy- Epichlorohydrin, not to exceed 0.3 Acetyl groups in food dride. percent, and acetic anhydride. starch-modified not to Monosodium orthophosphate ...... Residual phosphate in exceed 2.5 percent. food starch-modified Epichlorohydrin, not to exceed 0.3 not to exceed 0.4 per- percent, and succinic anhy- cent calculated as dride, not to exceed 4 percent. phosphorus. Phosphorus oxychloride, not to Residual propylene 1–Octenyl succinic anhydride, not exceed 0.1 percent, and pro- chlorohydrin not more to exceed 3 percent. pylene oxide, not to exceed 10 than 5 parts per million 1–Octenyl succinic anhydride, not percent. in food starch-modi- to exceed 2 percent, and alu- fied. minum sulfate, not to exceed 2 percent. (g) Food starch may be modified by 1-Octenyl succinic anhydride, not Limited to use as a sta- treatment with one of the following: to exceed 3 percent, followed bilizer or emulsifier in by treatment with a beta-amy- beverages and bev- Limitations lase that is either an erage bases as de- approved food additive of is fined in § 170.3(n)(3) of Chlorine, as sodium hypochlorite, Residual propylene generally recognized as safe. this chapter. not to exceed 0.055 pound of chlorohydrin not more Phosphorus oxychloride, not to chlorine per pound of dry than 5 parts per million exceed 0.1 percent. starch; 0.45 percent of active in food starch-modi- Phosphorus oxychloride, not to Acetyl groups in food oxygen obtained from hydrogen fied. exceed 0.1 percent, followed by starch-modified not to peroxide; and propylene oxide, either acetic anhydride, not to exceed 2.5 percent. not to exceed 25 percent. exceed 8 percent, or vinyl ace- Sodium hydroxide, not to exceed tate, not to exceed 7.5 percent. 1 percent. Sodium trimetaphosphate ...... Residual phosphate in food starch-modified not to exceed 0.04 (h) Food starch may be modified by a percent, calculated as combination of the treatments pre- phosphorus. scribed by paragraphs (a), (b), and/or (i) Sodium tripolyphosphate and so- Residual phosphate in dium trimetaphosphate. food starch-modified of this section and any one of the not to exceed 0.4 per- treatments prescribed by paragraph (c), cent calculated as (d), (e), (f), or (g) of this section, sub- phosphorus. Succinic anhydride, not to exceed ject to any limitations prescribed by 4 percent. the paragraphs named.

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(i) Food starch may be modified by mation required by the act, the name treatment with the following enzymes: of the additive as follows: (1) The additive identified in para- Enzyme Limitations 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 flour’’. as safe or approved as (2) The additive identified in para- a food additive for this purpose. The resulting graph (a)(2) of this section as ‘‘defatted nonsweet nutritive sac- cottonseed flour’’. charide polymer has a (3) The additive identified in para- dextrose equivalent of 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). (4) The additive identified in para- Isoamylase (E.C. 3.2.1.68). graph (a)(4) of this section as ‘‘raw Pullulanase (E.C. 3.2.1.41). glandless cottonseed kernels for use in cooked hard candy’’. [42 FR 14491, Mar. 15, 1977, as amended at 43 (d) The Food and Drug Administra- FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, 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 (1) Decorticated, partially defatted, safely used in food provided the total cooked, ground cottonseed kernels; or folic acid content of the yeast does not (2) Decorticated, ground cottonseed exceed 0.04 milligram per gram of yeast kernels, in a process that utilizes n- (approximately 0.008 milligram of hexane as an extracting solvent in such pteroyglutamic acid per gram of a way that no more than 60 parts per yeast). million of n-hexane residues and less than 1 percent fat by weight remain in § 172.898 Bakers yeast glycan. the finished product; or Bakers yeast glycan may be safely (3) Glandless cottonseed kernels used in food in accordance with the fol- roasted to attain a temperature of not lowing conditions: less than 250 °F in the kernel for not (a) Bakers yeast glycan is the less than 5 minutes for use as a snack comminuted, washed, pasteurized, and food, or in baked goods, or in soft dried cell walls of the yeast, Saccharo- candy; or myces cerevisiae. It is composed prin- (4) Raw glandless cottonseed kernels cipally of long chain carbohydrates, may be used in hard candy where the not less than 85 percent on a dry solids kernel temperature during cooking basis. The carbohydrate is composed of will exceed 250 °F for not less than 5 glycan and mannan units in approxi- minutes. mately a 2:1 ratio. (b) The additive is prepared to meet (b) The additive meets the following the following specifications: specifications on a dry weight basis: (1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar- ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead, (2) It contains no added arsenic com- 0.05 ppm mercury, 0.09 ppm selenium, pound and therefore may not exceed a and 10 ppm zinc. maximum natural background level of (c) The viable microbial content of 0.2 part per million total arsenic, cal- the finished ingredient is: culated as As. (1) Less than 10,000 organisms/gram (c) To assure safe use of the additive, by aerobic plate count. the label of the food additive container (2) Less than 10 yeasts and molds/ shall bear, in addition to other infor- gram.

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(3) Negative for Salmonella, E. coli, 173.45 Polymaleic acid and its sodium salt. coagulase positive Staphylococci, Clos- 173.50 Polyvinylpolypyrrolidone. tridium perfringens, Clostridium botu- 173.55 Polyvinylpyrrolidone. linum, or any other recognized micro- 173.60 Dimethylamine-epichlorohydrin co- polymer. bial pathogen or any harmful microbial 173.65 Divinylbenzene copolymer. toxin. 173.70 Chloromethylated aminated styrene- (d) The additive is used or intended divinylbenzene resin. for use in the following foods when 173.73 Sodium polyacrylate. standards of identity established under 173.75 Sorbitan monooleate. section 401 of the Act do not preclude such use: Subpart B—Enzyme Preparations and Microorganisms Use Limitations 173.110 Amyloglucosidase derived from (1) In salad dressings as an emul- Not to exceed a con- Rhizopus niveus. sifier and emulsifier salt as de- centration of 5 percent 173.115 Alpha-acetolactate decarboxylase (a- fined in § 170.3(o)(8) of this of the finished salad ALDC) enzyme preparation derived from chapter, stabilizer and thickener dressing. a recombinant Bacillus subtilis. as defined in § 170.3(o)(28) of this chapter, or texturizer as de- 173.120 Carbohydrase and cellulase derived fined in § 170.3(o)(32) of this from Aspergillus niger. chapter. 173.130 Carbohydrase derived from Rhizopus (2) In frozen dessert analogs as a In an amount not to ex- oryzae. stabilizer and thickener as de- ceed good manufac- 173.135 Catalase derived from Microccocus fined in § 170.3(o)(28) of this turing practice. lysodeikticus. chapter, or texturizer as defined 173.140 Esterase-lipase derived from Mucor in § 170.3(o)(32) of this chapter. (3) In sour cream analogs as a Do. miehei. stabilizer and thickener as de- 173.145 Alpha-Galactosidase derived from fined in § 170.3(o)(28) of this Mortierella vinaceae var. raffinoseutilizer. chapter, or texturizer as defined 173.150 Milk-clotting enzymes, microbial. in § 170.3(o)(32) of this chapter. 173.160 Candida guilliermondii. (4) In cheese spread analogs as Do. 173.165 Candida lipolytica. a stabilizer and thickener as de- ′ fined in § 170.3(o)(28) of this 173.170 Aminoglycoside 3 -phosphotrans- chapter, or texturizer as defined ferase II. in § 170.3(o)(32) of this chapter. (5) In cheese-flavored and sour Do. Subpart C—Solvents, Lubricants, Release cream-flavored snack dips as a Agents and Related Substances stabilizer and thickener as de- fined in § 170.3(o)(28) of this 173.210 Acetone. chapter, or texturizer as defined 173.220 1,3–Butylene glycol. in § 170.3(o)(32) of this chapter. 173.228 Ethyl acetate. 173.230 Ethylene dichloride. (e) The label and labeling of the in- 173.240 Isopropyl alcohol. gredient shall bear adequate directions 173.250 Methyl alcohol residues. to assure that use of the ingredient 173.255 Methylene chloride. complies with this regulation. 173.270 Hexane. 173.275 Hydrogenated sperm oil. [42 FR 14491, Mar. 15, 1977, as amended at 45 173.280 Solvent extraction process for citric FR 58836, Sept. 5, 1980] acid. 173.290 Trichloroethylene. PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN Subpart D—Specific Usage Additives FOOD FOR HUMAN CONSUMP- 173.300 Chlorine dioxide. TION 173.310 Boiler water additives. 173.315 Chemicals used in washing or to as- Subpart A—Polymer Substances and sist in the peeling of fruits and vegeta- Polymer Adjuvants for Food Treatment bles. 173.320 Chemicals for controlling micro- Sec. organisms in cane-sugar and beet-sugar 173.5 Acrylate-acrylamide resins. mills. 173.10 Modified polyacrylamide resin. 173.322 Chemicals used in delinting cotton- 173.20 Ion-exchange membranes. seed. 173.21 Perfluorinated ion exchange mem- 173.325 Acidified sodium chlorite solutions. branes. 173.340 Defoaming agents. 173.25 Ion-exchange resins. 173.342 Chlorofluorocarbon 113 and 173.40 Molecular sieve resins. perfluorohexane.

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173.345 Chloropentafluoroethane. the juice or 10 parts per million by 173.350 Combustion product gas. weight of the liquor or the corn starch 173.355 Dichlorodifluoromethane. hydrolyzate. 173.356 Hydrogen peroxide. 173.357 Materials used as fixing agents in (2) The additive identified in para- the immobilization of enzyme prepara- graph (a)(2) of this section is used to tions. control organic and mineral scale in 173.360 Octafluorocyclobutane. beet sugar juice and liquor or cane 173.368 Ozone. sugar juice and liquor in an amount 173.370 Peroxyacids. not to exceed 2.5 parts per million by 173.375 . weight of the juice or liquor. 173.385 Sodium methyl sulfate. 173.395 Trifluoromethane sulfonic acid. [42 FR 14526, Mar. 15, 1977, as amended at 46 173.400 Dimethyldialkylammonium chlo- FR 30494, June 9, 1981] ride. § 173.10 Modified polyacrylamide AUTHORITY: 21 U.S.C. 321, 342, 348. resin. SOURCE: 42 FR 14526, Mar. 15, 1977, unless Modified polyacrylamide resin may otherwise noted. be safely used in food in accordance EDITORIAL NOTE: Nomenclature changes to with the following prescribed condi- part 173 appear at 61 FR 14482, Apr. 2, 1996, 66 tions: FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. (a) The modified polyacrylamide 27, 2001. resin is produced by the copolymeriza- tion of acrylamide with not more than Subpart A—Polymer Substances 5–mole percent b-methacrylyloxyethy- and Polymer Adjuvants for ltrimethylammonium methyl sulfate. Food Treatment (b) The modified polyacrylamide resin contains not more than 0.05 per- § 173.5 Acrylate-acrylamide resins. cent residual acrylamide. Acrylate-acrylamide resins may be (c) The modified polyacrylamide safely used in food under the following resin is used as a flocculent in the clar- prescribed conditions: ification of beet or cane sugar juice in (a) The additive consists of one of the an amount not exceeding 5 parts per following: million by weight of the juice. (1) Acrylamide-acrylic acid resin (d) To assure safe use of the additive, (hydrolyzed polyacrylamide) is pro- the label and labeling of the additive duced by the polymerization of acryl- shall bear, in addition to the other in- amide with partial hydrolysis, or by formation required by the act, ade- copolymerization of acrylamide and quate directions to assure use in com- acrylic acid, with the greater part of pliance with paragraph (c) of this sec- the polymer being composed of acryl- tion. amide units. (2) Sodium polyacrylate-acrylamide § 173.20 Ion-exchange membranes. resin is produced by the polymerization Ion-exchange membranes may be and subsequent hydrolysis of acrylo- safely used in the processing of food nitrile in a sodium silicate-sodium hy- under the following prescribed condi- droxide aqueous solution, with the tions: greater part of the polymer being com- (a) The ion-exchange membrane is posed of acrylate units. prepared by subjecting a polyethylene (b) The additive contains not more base conforming to § 177.1520 of this than 0.05 percent of residual monomer chapter to polymerization with styrene calculated as acrylamide. until the polystyrene phase of the base (c) The additive is used or intended is not less than 16 percent nor more for use as follows: than 30 percent by weight. The base is (1) The additive identified in para- then modified by reaction with graph (a) (1) of this section is used as a chloromethyl methyl ether, and by flocculent in the clarification of beet subsequent amination with trimethyl- sugar juice and liquor or cane sugar amine, dimethylamine, diethylene- juice and liquor or corn starch triamine, or dimethylethanolamine. hydrolyzate in an amount not to ex- (b) The ion-exchange membrane is ceed 5 parts per million by weight of manufactured so as to comply with the

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following extraction limitations when tary manner in accordance with cur- subjected to the described procedure: rent good manufacturing practice so as Separate square-foot samples of mem- to prevent microbial adulteration of brane weighing approximately 14 grams food. each are cut into small pieces and (4) To assure their safe use, refluxed for 4 hours in 150 cubic centi- perfluorinated ionomer membranes meters of the following solvents: Dis- shall be thoroughly cleaned prior to tilled water, 5 percent acetic acid, and their first use in accordance with cur- 50 percent alcohol. Extraction from rent good manufacturing practice. each sample will not exceed 0.4 percent [59 FR 15623, Apr. 4, 1994] by weight of sample. (c) The ion-exchange membrane will § 173.25 Ion-exchange resins. be used in the production of grapefruit Ion-exchange resins may be safely juice to adjust the ratio of citric acid used in the treatment of food under the to total solids of the grapefruit juice following prescribed conditions: produced. (a) The ion-exchange resins are pre- pared in appropriate physical form, and § 173.21 Perfluorinated ion exchange membranes. consist of one or more of the following: (1) Sulfonated copolymer of styrene Substances identified in paragraph and divinylbenzene. (a) of this section may be safely used as (2) Sulfonated anthracite coal meet- ion exchange membranes intended for ing the requirements of ASTM method use in the treatment of bulk quantities D388–38, Class I, Group 2, ‘‘Standard of liquid food under the following pre- Specifications for Classification of Coal scribed conditions: by Rank,’’ which is incorporated by (a) Identity. The membrane is a co- reference. Copies are available from polymer of ethanesulfonyl fluoride, 2- University Microfilms International, [1-[difluoro-[(trifluoro- 300 N. Zeeb Rd., Ann Arbor, MI 48106, or ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- available for inspection at the National ethoxy]-1,1,2,2,-tetrafluoro-, with tetra- Archives and Records Administration fluoroethylene that has been subse- (NARA). For information on the avail- quently treated to hydrolyze the ability of this material at NARA, call sulfonyl fluoride group to the sulfonic 202–741–6030, or go to: http:// acid. The Chemical Abstracts Service www.archives.gov/federallregister/ name of this polymer is ethanesulfonic codeloflfederallregulations/ acid, 2-[1-[difluoro-[(trifluoro- ibrllocations.html. ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- (3) Sulfite-modified cross-linked phe- ethoxy]-1,1,2,2,-tetrafluoro-, polymer nol-formaldehyde, with modification with tetrafluoroethane (CAS Reg. No. resulting in sulfonic acid groups on 31175–20–9). side chains. (b) Optional adjuvant substances. The (4) Methacrylic acid-divinylbenzene basic polymer identified in paragraph copolymer. (a) of this section may contain optional (5) Cross-linked polystyrene, first adjuvant substances required in the chloromethylated then aminated with production of such basic polymer. trimethylamine, dimethylamine, di- These optional adjuvant substances ethylenetriamine, or dimethylethanol- may include substances used in accord- amine. ance with § 174.5 of this chapter. (6) Diethylenetriamine, triethylene- (c) Conditions of use. (1) tetramine, or tetraethylenepentamine Perfluorinated ion exchange mem- cross-linked with epichlorohydrin. branes described in paragraph (a) of (7) Cross-linked phenol-formaldehyde this section may be used in contact activated with one or both of the fol- with all types of liquid foods at tem- lowing: Triethylene tetramine and peratures not exceeding 70° (158 °F). tetraethylenepentamine. (2) Maximum thickness of the copoly- (8) Reaction resin of formaldehyde, mer membrane is 0.007 inch (0.017 centi- acetone, and tetraethylenepentamine. meter). (9) Completely hydrolyzed copoly- (3) Perfluorinated ion exchange mem- mers of methyl acrylate and branes shall be maintained in a sani- divinylbenzene.

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(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 aminolyzed with dimethylaminopro- one or more of the following: bicarbon- pylamine. ate, calcium, carbonate, chloride, hy- drogen, hydroxyl, magnesium, potas- (14) Epichlorohydrin cross-linked sium, sodium, and sulfate except that: with . The ion-exchange resin identified in (15) Sulfonated tetrapolymer of sty- paragraph (a)(12) of this section is used rene, divinylbenzene, acrylonitrile, and only in accordance with paragraph methyl acrylate derived from a mix- (b)(1) of this section, the ion-exchange ture of monomers containing not more resin identified in paragraph (a)(13) of than a total of 2 percent by weight of this section is used only in accordance acrylonitrile and methyl acrylate. with paragraph (b)(2) of this section, (16) Methyl acrylate-divinylbenzene- the resin identified in paragraph (a)(16) diethylene glycol divinyl ether of this section is used only in accord- terpolymer containing not less than 3.5 ance with paragraph (b)(1) or (b)(2) of percent by weight of divinylbenzene this section, the ion-exchange resin and not more than 0.6 percent by identified in paragraph (a)(17) of this weight of diethylene glycol divinyl section is used only in accordance with ether, aminolyzed with dimethyl- paragraph (b)(3) of this section, the aminopropylamine. ion-exchange resin identified in para- (17) Styrene-divinylbenzene cross- graph (a)(18) of this section is used only linked copolymer, first in accordance with paragraph (b)(4) of chloromethylated then aminated with this section, and the ion-exchange dimethylamine and oxidized with hy- resin identified in paragraph (a)(20) of drogen peroxide whereby the resin con- this section is used only in accordance tains not more than 15 percent by with paragraphs (b)(5) and (d) of this weight of vinyl N,N-dimethylbenzyl- section. amine-N-oxide and not more than 6.5 (1) The ion-exchange resins identified percent by weight of nitrogen. in paragraphs (a) (12) and (16) of this (18) Methyl acrylate-divinylbenzene- section are used to treat water for use diethylene glycol divinyl ether in the manufacture of distilled alco- terpolymer containing not less than 7 holic beverages, subject to the fol- percent by weight of divinylbenzene lowing conditions: and not more than 2.3 percent by (i) The water is subjected to treat- weight of diethylene glycol divinyl ment through a mixed bed consisting of ether, aminolyzed with dimethyl- one of the resins identified in para- aminopropylamine and quaternized graph (a) (12) or (16) of this section and with methyl chloride. one of the strongly acidic cation-ex- (19) Epichlorohydrin cross-linked change resins in the hydrogen form with ammonia and then quaternized identified in paragraphs (a) (1), (2), and with methyl chloride to contain not (11) of this section; or more than 18 percent strong base ca- (ii) The water is first subjected to pacity by weight of total exchange ca- one of the resins identified in para- pacity [Chemical Abstracts Service graph (a) (12) or (16) of this section and name: Oxirane (chloromethyl)-, poly- is subsequently subjected to treatment mer with ammonia, reaction product through a bed of activated carbon or

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one of the strongly acidic cation-ex- through the bed is not less than 0.5 gal- change resins in the hydrogen form lon per cubic foot per minute; or identified in paragraphs (a) (1), (2), and (B) Extracts of the resin will be found (11) of this section. to contain no more than 1 milligram/ (iii) The temperature of the water kilogram dimethylaminopropylamine passing through the resin beds identi- in each of the food simulants, distilled fied in paragraphs (b)(1) (i) and (ii) of water and 10 percent ethanol, when, this section is maintained at 30 °C or following washing and pretreatment of less, and the flow rate of the water the resin in accordance with passing through the beds is not less § 173.25(c)(1), the resin is subjected to than 2 gallons per cubic foot per the following test under conditions minute. simulating the actual temperature and (iv) The ion-exchange resins identi- flow rate of use: ‘‘The Determination of fied in paragraph (a) (12) or (16) of this 3-Dimethylaminopropylamine in Food section are exempted from the require- Simulating Extracts of Ion Exchange ments of paragraph (c)(4) of this sec- Resins,’’ February 4, 1998, which is in- tion, but the strongly acidic cation-ex- corporated by reference in accordance change resins referred to in paragraphs with 5 U.S.C. 552(a) and 1 CFR part 51. (b)(1) (i) and (ii) of this section used in Copies are available from the Division the process meet the requirements of of Petition Control (HFS–215), Center paragraph (c)(4) of this section, except for Food Safety and Applied Nutrition, for the exemption described in para- Food and Drug Administration, 5100 graph (d) of this section. Paint Branch Pkwy., College Park, MD (2) The ion-exchange resins identified 20740, or may be examined at the Cen- in paragraphs (a) (13) and (16) of this ter for Food Safety and Applied Nutri- section are used to treat water and tion’s Library, 5100 Paint Branch aqueous food only of the types identi- Pkwy., College Park, MD 20740, or at fied under Categories I, II, and VI-B in the National Archives and Records Ad- table 1 of § 176.170(c) of this chapter: ministration (NARA). For information Provided, That the temperature of the on the availability of this material at water or food passing through the resin NARA, call 202–741–6030, or go to: http:// beds is maintained at 50 °C or less and www.archives.gov/federallregister/ the flow rate of the water or food pass- codeloflfederallregulations/ ing through the beds is not less than 0.5 ibrllocations.html. gallon per cubic foot per minute. (3) The ion-exchange resin identified (i) The ion-exchange resin identified in paragraph (a)(17) of this section is in paragraph (a)(13) of this section is used only for industrial application to used to treat water and aqueous food treat bulk quantities of aqueous food, only of the types identified under cat- including potable water, or for treat- egories I, II, and VI-B in Table 1 of ment of municipal water supplies, sub- § 176.170(c) of this chapter: Provided, ject to the condition that the tempera- That the temperature of the water or ture of the food or water passing food passing through the resin bed is through the resin bed is maintained at maintained at 50 °C or less and the flow 25 °C or less and the flow rate of the rate of the water or food passing food or water passing through the bed through the bed is not less than 0.5 gal- is not less than 2 gallons per cubic foot lon per cubic foot per minute. per minute. (ii) The ion-exchange resin identified (4) The ion-exchange resin identified in paragraph (a)(16) of this section is in paragraph (a)(18) of this section is used to treat water and aqueous food used to treat aqueous sugar solutions only of the types identified under cat- subject to the condition that the tem- egories I, II, and VI-B in Table 1 of perature of the sugar solution passing § 176.170(c) of this chapter, Provided, through the resin bed is maintained at that either: 82 °C (179.6 °F) or less and the flow rate (A) The temperature of the water or of the sugar solution passing through food passing through the resin bed is the bed is not less than 46.8 liters per maintained at 50 °C or less and the flow cubic meter (0.35 gallon per cubic foot) rate of the water or food passing of resin bed volume per minute.

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(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 this section, the pH range for the resin extractives obtained in the resin test. shall be no less than 2 and no more The solvents used are to be made as than 10, and the temperatures of water follows: and food passing through the resin Distilled water (de-ionized water is distilled). shall not exceed 50 °C. 15 percent ethyl alcohol made by mixing 15 (c) To insure safe use of ion-exchange volumes of absolute ethyl alcohol A.C.S. resins, each ion-exchange resin will be: reagent grade, with 85 volumes of distilled (1) Subjected to pre-use treatment by de-ionized water. the manufacturer and/or the user in ac- 5 percent acetic acid made by mixing 5 parts cordance with the manufacturer’s di- by weight of A.C.S. reagent grade glacial acetic acid with 95 parts by weight of dis- rections prescribed on the label or la- tilled de-ionized water. beling accompanying the resins, to guarantee a food-grade purity of ion- In addition to the organic extractives exchange resins, in accordance with limitation prescribed in this para- good manufacturing practice. graph, the ion-exchange resin identi- (2) Accompanied by label or labeling fied in paragraph (a)(17) of this section, to include directions for use consistent when extracted with each of the named with the intended functional purpose of solvents, distilled water, 50 percent al- the resin. cohol, and 5 percent acetic acid, will be (3) Used in compliance with the label found to result in not more than 7 or labeling required by paragraph (c)(2) parts per million of nitrogen extrac- of this section. tives (calculated as nitrogen) when the (4) Found to result in no more than 1 resin in the free-base form is subjected part per million of organic extractives to the following test immediately be- obtained with each of the named sol- fore each use: Using a separate 1–inch vents, distilled water, 15 percent alco- diameter glass ion-exchange column hol, and 5 percent acetic acid when, for each solvent, prepare each column having been washed and otherwise using 100 milliliters of ready to use ion- treated in accordance with the manu- exchange resin that is to be tested. facturer’s directions for preparing With the bottom outlet closed, fill each them for use with food, the ion-ex- ion-exchange column with one of the change resin is subjected to the fol- three solvents at a temperature of 25 °C lowing test: Using a separate ion-ex- until the solvent level is even with the change column for each solvent, pre- top of the resin bed. Seal each column pare columns using 50 milliliters of the at the top and bottom and store in a ready to use ion-exchange resin that is vertical position at a temperature of 25 to be tested. While maintaining the °C. After 96 hours, open the top of each highest temperature that will be en- column, drain the solvent into a collec- countered in use pass through these tion vessel, and analyze each drained beds at the rate of 350–450 milliliters solvent and a solvent blank for nitro- per hour the three test solvents dis- gen by a standard micro-Kjeldahl tilled water, 15 percent (by volume) method. ethyl alcohol, and 5 percent (by weight) (d)(1) The ion-exchange resins identi- acetic acid. The first liter of effluent fied in paragraphs (a)(1), (a)(2), (a)(11),

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and (a)(15) of this section are exempted sanitary manner in accordance with from the acetic acid extraction re- good manufacturing practice so as to quirement of paragraph (c)(4) of this prevent microbial build-up on the bed section. and adulteration of the product. (2) The ion-exchange resin identified in paragraph (a)(20) of this section § 173.45 Polymaleic acid and its so- shall comply either with: dium salt. (i) The extraction requirement in Polymaleic acid (CAS Reg. No. 26099– paragraph (c)(4) of this section by using 09–2) and its sodium salt (CAS Reg. No. dilute sulfuric acid, pH 3.5 as a sub- 70247–90–4) may be safely used in food stitute for acetic acid; or in accordance with the following pre- (ii) The extraction requirement in paragraph (c)(4) of this section by using scribed conditions: reagent grade hydrochloric acid, di- (a) The additives have a weight-aver- luted to pH 2, as a substitute for acetic age molecular weight in the range of acid. The resin shall be found to result 540 to 850 and a number-average molec- in no more than 25 parts per million of ular weight in the range of 520 to 650, organic extractives obtained with each calculated as the acid. Molecular of the following solvents: Distilled weights shall be determined by a meth- water; 15 percent alcohol; and hydro- od entitled ‘‘Determination of Molec- chloric acid, pH 2. Blanks should be run ular Weight Distribution of for each of the solvents, and correc- Poly(Maleic) Acid,’’ March 17, 1992, pro- tions should be made by subtracting duced by Ciba-Geigy, Inc., Seven Sky- the total extractives obtained with the line Dr., Hawthorne, NY 10532–2188, blank from the total extractives ob- which is incorporated by reference in tained in the resin test. accordance with 5 U.S.C. 552(a) and 1 (e) Acrylonitrile copolymers identi- CFR part 51. Copies are available from fied in this section shall comply with the Division of Product Policy, Center the provisions of § 180.22 of this chap- for Food Safety and Applied Nutrition ter. (HFS–205), Food and Drug Administra- [42 FR 14526, Mar. 15, 1977, as amended at 46 tion, 5100 Paint Branch Pkwy., College FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, Park, MD 20740, or are available for in- 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, spection at the Center for Food Safety Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR and Applied Nutrition’s Library, 5100 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999] Paint Branch Pkwy., College Park, MD § 173.40 Molecular sieve resins. 20740, or at the National Archives and Molecular sieve resins may be safely Records Administration (NARA). For used in the processing of food under the information on the availability of this following prescribed conditions: material at NARA, call 202–741–6030, or (a) The molecular sieve resins consist go to: http://www.archives.gov/ of purified having an average federallregister/ molecular weight of 40,000, cross-linked codeloflfederallregulations/ with epichlorohydrin in a ratio of 1 ibrllocations.html. part of dextran to 10 parts of (b) The additives may be used, indi- epichlorohydrin, to give a stable three vidually or together, in the processing dimensional structure. The resins have of beet sugar juice and liquor or of cane a pore size of 2.0 to 3.0 milliliters per sugar juice and liquor to control min- gram of dry resin (expressed in terms eral scale. of water regain), and a particle size of (c) The additives are to be used so 10 to 300 microns. that the amount of either or both addi- (b) The molecular sieve resins are tives does not exceed 4 parts per mil- thoroughly washed with potable water lion (calculated as the acid) by weight prior to their first use in contact with of the beet or cane sugar juice or liquor food. process stream. (c) Molecular sieve resins are used as the gel filtration media in the final pu- [51 FR 5315, Feb. 13, 1986, as amended at 61 rification of partially delactosed whey. FR 386, Jan. 5, 1996] The gel bed shall be maintained in a

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§ 173.50 Polyvinylpolypyrrolidone. § 173.55 Polyvinylpyrrolidone. The food additive polyvinylpoly- The food additive polyvinylpyrroli- pyrrolidone may be safely used in ac- done may be safely used in accordance cordance with the following prescribed with the following prescribed condi- conditions: tions: (a) The additive is a homopolymer of (a) The additive is a polymer of puri- purified vinylpyrrolidone catalytically fied vinylpyrrolidone catalytically pro- produced under conditions producing duced, having an average molecular polymerization and cross-linking such that an insoluble polymer is produced. weight of 40,000 and a maximum (b) The food additive is so processed unsaturation of 1 percent, calculated as that when the finished polymer is the monomer, except that the refluxed for 3 hours with water, 5 per- polyvinylpyrrolidone used in beer is cent acetic acid, and 50 percent alco- that having an average molecular hol, no more than 50 parts per million weight of 360,000 and a maximum of extractables is obtained with each unsaturation of 1 percent, calculated as solvent. the monomer. (c) It is used or intended for use as a (b) The additive is used or intended clarifying agent in beverages and vin- for use in foods as follows: egar, followed by removal with filtra- tion.

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.

§ 173.60 Dimethylamine- imum viscosity of 175 centipoises at 25 epichlorohydrin copolymer. °C as determined by LVT-series Brook- Dimethylamine-epichlorohydrin co- field viscometer using a No. 2 spindle at 60 RPM (or by another equivalent polymer (CAS Reg. No. 25988–97–0) may method). be safely used in food in accordance (3) The additive contains not more with the following prescribed condi- than 1,000 parts per million of 1,3- tions: dichloro-2-propanol and not more than (a) The food additive is produced by 10 parts per million epichlorohydrin. copolymerization of dimethylamine The epichlorohydrin and 1,3-dichloro-2- and epichlorohydrin in which not more propanol content is determined by an than 5 mole-percent of dimethylamine analytical method entitled ‘‘The Deter- may be replaced by an equimolar mination of Epichlorohydrin and 1,3- amount of ethylenediamine, and in Dichloro-2-Propanol in Dimethyl- which the mole ratio of total amine to amine-Epichlorohydrin Copolymer,’’ epichlorohydrin is approximately 1:1. which is incorporated by reference. (b) The additive meets the following Copies are available from the Center specifications: for Food Safety and Applied Nutrition (1) The nitrogen content of the co- (HFS–200), Food and Drug Administra- polymer is 9.4 to 10.8 weight percent on tion, 5100 Paint Branch Pkwy., College a dry basis. Park, MD 20740, or available for inspec- (2) A 50-percent-by-weight aqueous tion at the National Archives and solution of the copolymer has a min- Records Administration (NARA). For

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information on the availability of this this material at NARA, call 202–741– material at NARA, call 202–741–6030, or 6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. The copolymer is ibrllocations.html. then treated with water according to (4) Heavy metals (as Pb), 2 parts per the manufacturer’s recommendation to million maximum. remove the extraction solvent to guar- (5) Arsenic (as As), 2 parts per million antee a food-grade purity of the resin maximum. at the time of use, in accordance with (c) The food additive is used as a de- current good manufacturing practice. colorizing agent and/or flocculant in (c) The temperature of the aqueous the clarification of refinery sugar liq- food stream contacting the polymer is uors and juices. It is added only at the maintained at 79.4 °C (175 °F) or less. defecation/clarification stage of sugar (d) The copolymer may be used in liquor refining at a concentration not contact with food only of Types I, II, to exceed 150 parts per million of co- and VI-B (excluding carbonated bev- polymer by weight of sugar solids. erages) described in table 1 of para- (d) To assure safe use of the additive, graph (c) of § 176.170 of this chapter. the label and labeling of the additive shall bear, in addition to other infor- [50 FR 61, Jan. 2, 1985] mation required by the Act, adequate directions to assure use in compliance § 173.70 Chloromethylated aminated with paragraph (c) of this section. styrene-divinylbenzene resin. [48 FR 37614, Aug. 19, 1983, as amended at 54 Chloromethylated aminated styrene- FR 24897, June 12, 1989] divinylbenzene copolymer (CAS Reg. No. 60177–39–1) may be safely used in § 173.65 Divinylbenzene copolymer. food in accordance with the following Divinylbenzene copolymer may be prescribed conditions: used for the removal of organic sub- (a) The additive is an aqueous disper- stances from aqueous foods under the sion of styrene-divinylbenzene copoly- following prescribed conditions: mers, first chloromethylated then (a) The copolymer is prepared in ap- aminated with trimethylamine, having propriate physical form and is derived an average particle size of not more by the polymerization of a grade of than 2.0 microns. divinylbenzene which comprises at (b) The additive shall contain no least 79 weight-percent divinylbenzene, more than 3.0 percent nonvolatile, 15 to 20 weight-percent ethylvinyl- soluble extractives when tested as fol- benzene, and no more than 4 weight- lows: One hundred grams of the addi- percent nonpolymerizable impurities. tive is centrifuged at 17,000 r/min for 2 (b) In accordance with the manufac- hours. The resulting clear supernatant turer’s directions, the copolymer de- is removed from the compacted solids scribed in paragraph (a) of this section and concentrated to approximately 10 is subjected to pre-use extraction with grams on a steam bath. The 10-gram a water soluble alcohol until the level sample is again centrifuged at 17,000 r/ of divinylbenzene in the extract is less min for 2 hours to remove any residual than 50 parts per billion as determined insoluble material. The supernatant by a method titled, ‘‘The Determina- from the second centrifugation is then tion of Divinylbenzene in Alcohol Ex- removed from any compacted solids tracts of Amberlite XAD–4,’’ which is and dried to constant residual weight incorporated by reference. Copies of using a steam bath. The percent non- this method are available from the volatile solubles is obtained by divid- Center for Food Safety and Applied Nu- ing the weight of the dried residue by trition (HFS–200), Food and Drug Ad- the weight of the solids in the original ministration, 5100 Paint Branch Pkwy., resin dispersion. College Park, MD 20740, or available for (c) The additive is used as a decol- inspection at the National Archives orizing and clarification agent for and Records Administration (NARA). treatment of refinery sugar liquors and For information on the availability of juices at levels not to exceed 500 parts

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of additive solids per million parts of (c) The additive is used or intended sugar solids. for use as follows: [50 FR 29209, July 18, 1985] (1) As an emulsifier in polymer dis- persions that are used in the clarifica- § 173.73 Sodium polyacrylate. 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 [51 FR 11720, Apr. 7, 1986] solution. As determined by a method entitled ‘‘Determination of Weight Av- erage and Number Average Molecular Subpart B—Enzyme Preparations Weight of Sodium Polyacrylate,’’ and Microorganisms which is incorporated by reference in accordance with 5 U.S.C. 552(a), the ad- § 173.110 Amyloglucosidase derived from Rhizopus niveus. ditive has— (1) A weight average molecular Amyloglucosidase enzyme product, weight of 2,000 to 2,300; and consisting of enzyme derived from (2) A weight average molecular Rhizopus niveus, and diatomaceous sili- weight to number average molecular ca as a carrier, may be safely used in weight ratio of not more than 1.3. Cop- food in accordance with the following ies of the method are available from conditions: the Center for Food Safety and Applied (a) Rhizopus niveus is classified as fol- Nutrition (HFS–200), Food and Drug lows: Class, Phycomycetes; order, Administration, 5100 Paint Branch Mucorales; family, Mucoraceae; genus, Pkwy., College Park, MD 20740, or Rhizopus; species, niveus. available for inspection at the National (b) The strain of Rhizopus niveus is Archives and Records Administration nonpathogenic and nontoxic in man or (NARA). For information on the avail- other animals. ability of this material at NARA, call (c) The enzyme is produced by a proc- 202–741–6030, or go to: http:// ess which completely removes the or- www.archives.gov/federallregister/ ganism Rhizopus niveus from the codeloflfederallregulations/ amyloglucosidase. ibrllocations.html. (d) The additive is used or intended (b) The additive is used to control for use for degrading gelatinized starch mineral scale during the evaporation of into constituent sugars, in the produc- beet sugar juice or cane sugar juice in tion of distilled spirits and vinegar. the production of sugar in an amount (e) The additive is used at a level not not to exceed 3.6 parts per million by to exceed 0.1 percent by weight of the weight of the raw juice. gelatinized starch. [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988] § 173.115 Alpha-acetolactate decarboxylase (α-ALDC) enzyme § 173.75 Sorbitan monooleate. preparation derived from a recom- binant Bacillus subtilis. Sorbitan monooleate may be safely used in accordance with the following The food additive alpha-acetolactate prescribed conditions: decarboxylase (a-ALDC) enzyme prepa- (a) The additive is produced by the ration, may be safely used in accord- esterification of sorbitol with commer- ance with the following conditions: cial oleic acid. (a) The food additive is the enzyme (b) It meets the following specifica- preparation derived from a modified tions: Bacillus subtilis strain that contains the (1) Saponification number, 145–160. gene coding for a-ALDC from Bacillus (2) Hydroxyl number, 193–210. brevis.

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(b)(1) The manufacturer produces the carbohydrase and cellulase enzyme additive from a pure culture fermenta- product. tion of a strain of Bacillus subtilis that (d) The additive is used or intended is nonpathogenic and nontoxigenic in for use as follows: man or other animals. (1) For removal of visceral mass (bel- (2) The manufacturer may stabilize lies) in clam processing. the enzyme preparation with (2) As an aid in the removal of the glutaraldehyde or with other suitable shell from the edible tissue in shrimp approved food additives or generally processing. recognized as safe substances. (e) The additive is used in an amount (3) The enzyme preparation must not in excess of the minimum required meet the general and additional re- to produce its intended effect. quirements for enzyme preparations in the Food Chemicals Codex, 4th ed., 1996, § 173.130 Carbohydrase derived from pp. 133–134, which is incorporated by Rhizopus oryzae. reference. The Director of the Office of the Federal Register approves this in- Carbohydrase from Rhizopus oryzae corporation by reference in accordance may be safely used in the production of with 5 U.S.C. 552(a) and 1 CFR part 51. dextrose from starch in accordance Copies may be obtained from the Na- with the following prescribed condi- tional Academy Press, 2101 Constitu- tions: tion Ave. NW., Washington, DC 20055, (a) Rhizopus oryzae is classified as fol- or may be examined at the Center for lows: Class, Phycomycetes; order, Food Safety and Applied Nutrition, Mucorales; family, Mucoraceae; genus, 5100 Paint Branch Pkwy., College Park, Rhizopus; species, Rhizopus oryzae. MD 20740, or at the National Archives (b) The strain of Rhizopus oryzae is and Records Administration (NARA). nonpathogenic and nontoxic. For information on the availability of (c) The carbohydrase is produced this material at NARA, call 202–741– under controlled conditions to main- 6030, or go to: http://www.archives.gov/ tain nonpathogenicity and nontoxicity, federallregister/ including the absence of aflatoxin. codeloflfederallregulations/ (d) The carbohydrase is produced by a ibrllocations.html. process which completely removes the (c) The additive is used in an amount organism Rhizopus oryzae from the not in excess of the minimum required carbohydrase product. to produce its intended effect as a proc- (e) The carbohydrase is maintained essing aid in the production of alco- under refrigeration from production to holic malt beverages and distilled liq- use and is labeled to include the neces- uors. sity of refrigerated storage. [66 FR 27022, May 16, 2001] § 173.135 Catalase derived from Micro- § 173.120 Carbohydrase and cellulase coccus lysodeikticus. derived from Aspergillus niger. Bacterial catalase derived from Carbohydrase and cellulase enzyme Micrococcus lysodeikticus by a pure cul- preparation derived from Aspergillus ture fermentation process may be safe- niger may be safely used in food in ac- ly used in destroying and removing hy- cordance with the following prescribed drogen peroxide used in the manufac- conditions: ture of cheese, in accordance with the (a) Aspergillus niger is classified as following conditions. follows: Class, Deuteromycetes; order, (a) The organism Micrococcus Moniliales; family, Moniliaceae; genus, lysodeikticus from which the bacterial Aspergillus; species, niger. catalase is to be derived is dem- (b) The strain of Aspergillus niger is onstrated to be nontoxic and nonpatho- nonpathogenic and nontoxic in man or genic. other animals. (b) The organism Micrococcus (c) The additive is produced by a lysodeikticus is removed from the bac- process that completely removes the terial catalase prior to use of the bac- organism Aspergillus niger from the terial catalase.

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(c) The bacterial catalase is used in var. raffinoseutilizer which produces the an amount not in excess of the min- enzyme. imum required to produce its intended (b) The nonpathogenic microorga- effect. nism matches American Type Culture Collection (ATCC) No. 20034, 1 and is § 173.140 Esterase-lipase derived from classified as follows: Mucor miehei. Class: Phycomycetes. Esterase-lipase enzyme, consisting of Order: Mucorales. enzyme derived from Mucor miehei var. Family: Mortierellaceae. Cooney et Emerson by a pure culture fer- Genus: Mortierella. mentation process, with maltodextrin Species: vinaceae. or sweet whey as a carrier, may be Variety: raffinoseutilizer. safely used in food in accordance with (c) The additive is used or intended the following conditions: for use in the production of sugar (su- (a) Mucor miehei var. Cooney et Emer- crose) from sugar beets by addition as son is classified as follows: Class, mycelial pellets to the molasses to in- Phycomycetes; subclass, Zygomycetes; crease the yield of sucrose, followed by order, Mucorales; family, Mucoraceae; removal of the spent mycelial pellets genus, Mucor; species, miehei; variety by filtration. Cooney et Emerson. (d) The enzyme removal is such that (b) The strain of Mucor miehei var. there are no enzyme or mycelial resi- Cooney et Emerson is nonpathogenic and dues remaining in the finished sucrose. nontoxic in man or other animals. [42 FR 14526, Mar. 15, 1977, as amended at 54 (c) The enzyme is produced by a proc- FR 24897, June 12, 1989] ess which completely removes the or- ganism Mucor miehei var. Cooney et § 173.150 Milk-clotting enzymes, micro- Emerson from the esterase-lipase. bial. (d) The enzyme is used as a flavor Milk-clotting enzyme produced by enhancer as defined in § 170.3(o)(12). pure-culture fermentation process may (e) The enzyme is used at levels not be safely used in the production of to exceed current good manufacturing cheese in accordance with the fol- practice in the following food cat- lowing prescribed conditions: egories: cheeses as defined in (a) Milk-clotting enzyme is derived § 170.3(n)(5) of this chapter; fat and oils from one of the following organisms by as defined in § 170.(3)(n)(12) of this chap- a pure-culture fermentation process: ter; and milk products as defined in (1) Endothia parasitica classified as § 170.(3)(n)(31) of this chapter. Use of follows: Class, Ascomycetes; order, this food ingredient is limited to Sphaeriales; family, Diaporthacesae; nonstandarized foods and those foods genus, Endothia; species, parasitica. for which the relevant standards of (2) Bacillus cereus classified as fol- identity permit such use. lows: Class, Schizomycetes; order, (f) The enzyme is used in the min- Eubacteriales; family, Bacillaceae; imum amount required to produce its genus, Bacillus; species, cereus limited technical effect. (Frankland and Frankland). (3) Mucor pusillus Lindt classified as [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, follows: Class, Phycomycetes; subclass, 1983] Zygomycetes; order, Mucorales; fam- ily, Mucoraceae; genus, Mucor; species, § 173.145 Alpha-Galactosidase derived pusillus; variety, Lindt. from Mortierella vinaceae var. (4) Mucor miehei Cooney et Emerson raffinoseutilizer. classified as follows: Class, The food additive alpha-galactosidase Phycomycetes; subclass, Zygomycetes; and parent mycelial microorganism order, Mucorales; family, Mucoraceae; Mortierella vinaceae var. raffinoseutilizer genus, Mucor; species, miehei; variety, may be safely used in food in accord- Cooney et Emerson. ance with the following conditions: (a) The food additive is the enzyme 1 Available from: American Type Culture alpha-galactosidase and the mycelia of Collection, 12301 Parklawn Drive, Rockville, the microorganism Mortierella vinaceae MD 20852.

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(5) Aspergillus oryzae modified by re- standard description for Candida combinant deoxyribonucleic (DNA) guilliermondii variety guilliermondii list- techniques to contain the gene coding ed in ‘‘The Yeasts—A Toxonomic for aspartic proteinase from Study;’’ 2d Ed. (1970), by Jacomina Rhizomucor miehei var. Cooney et Emer- Lodder, which is incorporated by ref- son as defined in paragraph (a)(4) of erence. Copies are available from the this section, and classified as follows: Center for Food Safety and Applied Nu- Class, Blastodeuteromycetes trition (HFS–200), Food and Drug Ad- (Hyphomycetes); order, Phialidales ministration, 5100 Paint Branch Pkwy., (Moniliales); genus, Aspergillus; species College Park, MD 20740, or available for oryzae. inspection at the National Archives (b) The strains of organism identified and Records Administration (NARA). in paragraph (a) of this section are For information on the availability of nonpathogenic and nontoxic in man or this material at NARA, call 202–741– other animals. 6030, or go to: http://www.archives.gov/ (c) The additive is produced by a federallregister/ process that completely removes the codeloflfederallregulations/ generating organism from the milk- ibrllocations.html. clotting enzyme product. (c)(1) The additive is used or intended (d) The additive is used in an amount for use as a pure culture in the fer- not in excess of the minimum required mentation process for the production to produce its intended effect in the of citric acid using an acceptable aque- production of those cheeses for which ous carbohydrate substrate. it is permitted by standards of identity (2) The organism Candida established pursuant to section 401 of quilliermondii is made nonviable and is the Act. completely removed from the citric [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. acid during the recovery and purifi- 28, 1977, as amended at 62 FR 59284, Nov. 3, cation process. 1997] (d) The additive is so used that the citric acid produced conforms to the § 173.160 Candida guilliermondii. specifications of the ‘‘Food Chemicals The food additive Candida Codex,’’ 3d Ed. (1981), under ‘‘Citric guilliermondii may be safely used as the acid,’’ pp. 86–87, which is incorporated organism for fermentation production by reference. Copies may be obtained of citric acid in accordance with the from the National Academy Press, 2101 following conditions: Constitution Ave. NW., Washington, (a) The food additive is the enzyme DC 20418, or may be examined at the system of the viable organism Candida National Archives and Records Admin- guilliermondii and its concomitant me- istration (NARA). For information on tabolites produced during the fer- the availability of this material at mentation process. NARA, call 202–741–6030, or go to: http:// (b)(1) The nonpathogenic and www.archives.gov/federallregister/ nontoxicogenic organism descending codeloflfederallregulations/ from strain, American Type Culture ibrllocations.html. 1 Collection (ATCC) No. 20474, is classi- [42 FR 14526, Mar. 15, 1977, as amended at 47 fied as follows: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, Class: Deuteromycetes. 1984; 54 FR 24897, June 12, 1989] Order: Moniliales. Family: Cryptococcaceae. § 173.165 Candida lipolytica. Genus: Candida. The food additive Candida lipolytica Species: guilliermondii. may be safely used as the organism for Variety: guilliermondii. fermentation production of citric acid (2) The toxonomic characteristics of in accordance with the following condi- the reference culture strain ATCC No. tions: 20474 agree in the essentials with the (a) The food additive is the enzyme system of the organism Candida 1 Available from: American Type Culture lipolytica and its concimitant metabo- Collection, 12301 Parklawn Drive, Rockville, lites produced during the fermentation MD 20852. process.

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(b)(1) The nonpathogenic organism is ANALYTICAL PROCEDURE FOR CITRIC ACID classified as follows: GENERAL INSTRUCTIONS Class: Deuteromycetes. Because of the sensitivity of the test, the Order: Moniliales. possibility of errors arising from contamina- Family: Cryptococcaceae. tion is great. It is of the greatest importance Genus: Candida. that all glassware be scrupulously cleaned to Species: lipolytica. remove all organic matter such as oil, grease, detergent residues, etc. Examine all (2) The taxonomic characteristics of glassware including stoppers and stopcocks, the culture agree in essential with the under ultraviolet light to detect any residual standard description for Candida fluorescent contamination. As a pre- lipolytica variety lipolytica listed in cautionary measure it is recommended prac- ‘‘The Yeasts—A Toxonomic Study,’’ 2d tice to rinse all glassware with purified iso- Ed. (1970), by Jacomina Lodder, which octane immediately before use. No grease is is incorporated by reference. Copies are to be used on stopcocks or joints. Great care to avoid contamination of citric acid sam- available from the Center for Food ples in handling is essential to assure ab- Safety and Applied Nutrition (HFS– sence of any extraneous material arising 200), Food and Drug Administration, from inadequate packaging. Because some of 5100 Paint Branch Pkwy., College Park, the polynuclear hydrocarbons sought in this MD 20740, or available for inspection at test are very susceptible to photo-oxidation, the National Archives and Records Ad- the entire procedure is to be carried out ministration (NARA). For information under subdued light. on the availability of this material at APPARATUS NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ 1. Aluminum foil, oil free. 2. Separatory funnels, 500-milliliter capac- codeloflfederallregulations/ ity, equipped with tetrafluoroethylene poly- ibrllocations.html. mer stopcocks. (c) The additive is used or intended 3. Chromatographic tubes: (a) 80-milli- for use as a pure culture in the fer- meter ID × 900-millimeter length equipped mentation process for the production with tetrafluoroethylene polymer stopcock of citric acid from purified normal and course fritted disk; (b) 18-millimeter ID × alkanes. 300-millimeter length equipped with tetra- fluoroethylene polymer stopcock. (d) The additive is so used that the 4. Rotary vacuum evaporator, Buchi or citric acid produced conforms to the equivalent. specifications of the ‘‘Food Chemicals 5. Spectrophotometer—Spectral range 250– Codex,’’ 3d Ed. (1981), pp. 86–87, which is 400 nanometers with spectral slit width of 2 incorporated by reference. Copies may nanometers or less; under instrument oper- be obtained from the National Acad- ating conditions for these absorbance meas- emy Press, 2101 Constitution Ave. NW., urements, the spectrophotometer shall also Washington, DC 20418, or may be exam- meet the following performance require- ments: ined at the National Archives and Absorbance repeatability, ±0.01 at 0.4 ab- Records Administration (NARA). For sorbance. information on the availability of this Wavelength repeatability, ±0.2 nanometer. material at NARA, call 202–741–6030, or Wavelength accuracy, ±1.0 nanometer. go to: http://www.archives.gov/ The spectrophotometer is equipped with federallregister/ matched 1 centimeter path length quartz codeloflfederallregulations/ microcuvettes with 0.5-milliliter volume ca- ibrllocations.html. The additive meets pacity. the following ultraviolet absorbance 6. Vacuum oven, minimum inside dimen- × × limits when subjected to the analytical sions: 200 mm 200 mm 300 mm deep. procedure described in this paragraph: REAGENTS AND MATERIALS Organic solvents. All solvents used through- Ultraviolet absorbance per centimeter path Maximum length out the procedure shall meet the specifica- tions and tests described in this specifica- 280 to 289 millimicrons ...... 0.25 tion. The methyl alcohol, isooctane, benzene, 290 to 299 millimicrons ...... 0.20 hexane and 1,2-dichloroethane designated in 300 to 359 millimicrons ...... 0.13 the list following this paragraph shall pass 360 to 400 millimicrons ...... 0.03 the following test:

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The specified quantity of solvent is added wash with an additional 6 liters of purified to a 250-milliliter round bottom flask con- water and wash with 3,600 milliliters of puri- taining 0.5 milliliter of purified n-hexa- fied methyl alcohol at a relatively slow rate. decane and evaporated on the rotary evapo- Drain all of the solvents and transfer the rator at 45 °C to constant volume. Six milli- silica gel to an aluminum foil-lined drying liters of purified isooctane are added to this dish. Place foil over the top of the dish. Acti- residue and evaporated under the same con- vate in a vacuum oven at low vacuum (ap- ditions as above for 5 minutes. Determine proximately 750 millimeters Mercury or 27 the absorbance of the residue compared to inches of Mercury below atmospheric pres- purified n-hexadecane as reference. The ab- sure) at 173° to 177 °C for at least 20 hours. sorbance of the solution of the solvent res- Cool under vacuum and store in an amber idue shall not exceed 0.03 per centimeter bottle. path length between 280 and 299 nanometers Sodium sulfate, anhydrous, A.C.S. reagent and 0.01 per centimeter path length between grade. This reagent should be washed with 300 and 400 nanometers. purified isooctane. Check the purity of this Methyl alcohol, A.C.S. reagent grade. Use 100 reagent as described in § 172.886 of this chap- milliliters for the test described in the pre- ter. ceding paragraph. If necessary, methyl alco- Water, purified. All water used must meet hol may be purified by distillation through a the specifications of the following test: Virgreaux column discarding the first and Extract 600 milliliters of water with 50 mil- last ten percent of the distillate or other- liliters of purified isooctane. Add 1 milliliter wise. of purified n-hexadecane to the isooctane ex- Benzene, spectrograde (Burdick and Jackson tract and evaporate the resulting solution to Laboratories, Inc., Muskegon, Mich., or equiva- 1 milliliter. The absorbance of this residue lent). Use 80 milliliters for the test. If nec- shall not exceed 0.02 per centimeter path essary, benzene may be purified by distilla- length between 300–400 nanometers and 0.03 tion or otherwise. per centimeter path length between 280–299 Isooctane (2,2,4-trimethylpentane). Use 100 nanometers. If necessary, water may be puri- milliliters for the test. If necessary, iso- fied by distillation, extraction with purified octane may be purified by passage through a organic solvents, treatment with an absorb- column of activated silica gel, distillation or ent (e.g., activated carbon) followed by fil- otherwise. tration of the absorbent or otherwise. Hexane, spectrograde (Burdick and Jackson Laboratories, Inc., Muskegon, Mich., or equiva- PROCEDURE lent). Use 100 milliliters for the test. If nec- Separate portions of 200 milliliters of puri- essary, hexane may be purified by distilla- fied water are taken through the procedure tion or otherwise. for use as control blanks. Each citric acid 1,2-Dichloroethane, spectrograde (Matheson, sample is processed as follows: Weigh 200 Coleman and Bell, East Rutherford, N.J., or grams of anhydrous citric acid into a 500 mil- equivalent). Use 100 milliliters for the test. If liliter flask and dissolve in 200 milliliters of necessary, 1,2-dichloroethane may be puri- pure water. Heat the solution to 60 °C and fied by distillation or otherwise. transfer to a 500 milliliter separatory funnel. Rinse the flask with 50 milliliters of iso- ELUTING MIXTURES octane and add the isooctane to the sepa- 1. 10 percent 1,2-dichloroethane in hexane. ratory funnel. Gently shake the mixture 90 Prepare by mixing the purified solvents in times (caution: vigorous shaking will cause the volume ratio of 1 part of 1,2- emulsions) with periodic release of the pres- dichloroethane to 9 parts of hexane. sure caused by shaking. 2. 40 percent benzene in hexane. Prepare by Allow the phases to separate for at least 5 mixing the purified solvents in the volume minutes. Draw off the lower aqueous layer ratio of 4 parts of benzene to 6 parts of into a second 500-milliliter separatory funnel hexane. and repeat the extraction with a second ali- n-Hexadecane, 99 percent olefin-free. Deter- quot of 50 milliliters of isooctane. After sep- mine the absorbance compared to isooctane aration of the layers, draw off and discard as reference. The absorbance per centimeter the water layer. Combine both isooctane ex- path length shall not exceed 0.00 in the range tracts in the funnel containing the first ex- of 280–400 nanometers. If necessary, n-hexa- tract. Rinse the funnel which contained the decane may be purified by percolation second extract with 10 milliliters of iso- through activated silica gel, distillation or octane and add this portion to the combined otherwise. isooctane extract. Silica gel, 28–200 mesh (Grade 12, Davison A chromatographic column containing 5.5 Chemical Co., Baltimore, MD, or equivalent). grams of silica gel and 3 grams of anhydrous Activate as follows: Slurry 900 grams of sili- sodium sulfate is prepared for each citric ca gel reagent with 2 liters of purified water acid sample as follows: Fit 18 × 300 column in a 3-liter beaker. Cool the mixture and with a small glass wool plug. Rinse the in- pour into a 80 × 900 chromatographic column side of the column with 10 milliliters of puri- with coarse fritted disc. Drain the water, fied isooctane. Drain the isooctane from the

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column. Pour 5.5 grams of activated silica § 173.170 Aminoglycoside 3′-phospho- gel into the column. Tap the column ap- II. proximately 20 times on a semisoft, clean surface to settle the silica gel. Carefully The food additive aminoglycoside 3′- pour 3 grams of anhydrous sodium sulfate phosphotransferase II may be safely onto the top of the silica gel in the column. used in the development of genetically Carefully drain the isooctane extract of modified cotton, oilseed rape, and to- the citric acid solution into the column in a matoes in accordance with the fol- series of additions while the isooctane is lowing prescribed conditions: draining from the column at an elution rate of approximately 3 milliliters per minute. (a) The food additive is the enzyme Rinse the separatory funnel with 10 milli- aminoglycoside 3′-phosphotransferase liters of isooctane after the last portion of II (CAS Reg. No. 58943–39–8) which cata- the extract has been applied to the column lyzes the of certain and add this rinse to the column. After all of aminoglycoside antibiotics, including the extract has been applied to the column kanamycin, neomycin, and gentamicin. and the solvent layer reaches the top of the ′ sulfate bed, rinse the column with 25 milli- (b) Aminoglycoside 3 -phosphotrans- liters of isooctane followed by 10 milliliters ferase II is encoded by the kanr gene of a 10-percent dichloroethane in hexane so- originally isolated from transposon Tn5 lution. For each rinse solution, drain the col- of the bacterium Escherichia coli. umn until the solvent layer reaches the top (c) The level of the additive does not of the sodium sulfate bed. Discard the rinse exceed the amount reasonably required solvents. Place a 250-milliliter round bottom for selection of plant cells carrying the flask containing 0.5 milliliter of purified n- r hexadecane under the column. Elute the kan gene along with the genetic mate- polynuclear aromatic hydrocarbons from the rial of interest. column with 30 milliliters of 40-percent ben- [59 FR 26711, May 23, 1994] zene in hexane solution. Drain the eluate until the 40-percent benzene in the hexane solvent reaches the top of the sodium sulfate Subpart C—Solvents, Lubricants, bed. Release Agents and Related Evaporate the 40-percent benzene in hexane eluate on the rotary vacuum evapo- Substances rator at 45 °C until only the n-hexadecane residue of 0.5 milliliter remains. Treat the n- § 173.210 Acetone. hexadecane residue twice with the following A tolerance of 30 parts per million is wash step: Add 6 milliliters of purified iso- established for acetone in spice octane and remove the solvents by vacuum oleoresins when present therein as a evaporation at 45 °C to constant volume, i.e., 0.5 milliliter. Cool the n-hexadecane residue residue from the extraction of spice. and transfer the solution to an 0.5-milliliter microcuvette. Determine the absorbance of § 173.220 1,3-Butylene glycol. this solution compared to purified n-hexa- 1,3-Butylene glycol (1,3-butanediol) decane as reference. Correct the absorbance may be safely used in food in accord- values for any absorbance derived from the ance with the following prescribed con- control reagent blank. If the corrected ab- sorbance does not exceed the limits pre- ditions: scribed, the samples meet the ultraviolet ab- (a) The substance meets the fol- sorbance specifications. lowing specifications: The reagent blank is prepared by using 200 (1) 1,3-Butylene glycol content: Not milliliters of purified water in place of the less than 99 percent. citric acid solution and carrying the water (2) Specific gravity at 20/20 °C: 1.004 sample through the procedure. The typical control reagent blank should not exceed 0.03 to 1.006. absorbance per centimeter path length be- (3) Distillation range: 200°–215 °C. tween 280 and 299 nanometers, 0.02 absorb- (b) It is used in the minimum amount ance per centimeter path length between 300 required to perform its intended effect. and 359 nanometers, and 0.01 absorbance per (c) It is used as a solvent for natural centimeter path length between 360 and 400 and synthetic flavoring substances ex- nanometers. cept where standards of identity issued [42 FR 14491, Mar. 15, 1977, as amended at 47 under section 401 of the act preclude FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, such use. 1984; 54 FR 24897, June 12, 1989]

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§ 173.228 Ethyl acetate. § 173.250 Methyl alcohol residues. Ethyl acetate (CAS Reg. No. 141–78–6) Methyl alcohol may be present in the may be safely used in food in accord- following foods under the conditions ance with the following conditions: specified: (a) The additive meets the specifica- (a) In spice oleoresins as a residue tions of the Food Chemicals Codex, 1 from the extraction of spice, at a level (Ethyl Acetate; p. 372, 3d Ed., 1981), not to exceed 50 parts per million. which are incorporated by reference. (b) In hops extract as a residue from (b) The additive is used in accordance the extraction of hops, at a level not to with current good manufacturing prac- exceed 2.2 percent by weight; Provided, tice as a solvent in the decaffeination That: of coffee and tea. (1) The hops extract is added to the wort before or during cooking in the [47 FR 146, Jan. 5, 1982, as amended at 49 FR manufacture of beer. 28548, July 13, 1984] (2) The label of the hops extract specifies the presence of methyl alco- § 173.230 Ethylene dichloride. hol and provides for the use of the hops A tolerance of 30 parts per million is extract only as prescribed by para- established for ethylene dichloride in graph (b)(1) of this section. spice oleoresins when present therein as a residue from the extraction of § 173.255 Methylene chloride. spice; Provided, however, That if resi- Methylene chloride may be present in dues of other chlorinated solvents are food under the following conditions: also present the total of all residues of (a) In spice oleoresins as a residue such solvents shall not exceed 30 parts from the extraction of spice, at a level per million. not to exceed 30 parts per million; Pro- vided, That, if residues of other § 173.240 Isopropyl alcohol. chlorinated solvents are also present, Isopropyl alcohol may be present in the total of all residues of such sol- the following foods under the condi- vents shall not exceed 30 parts per mil- tions specified: lion. (a) In spice oleoresins as a residue (b) In hops extract as a residue from from the extraction of spice, at a level the extraction of hops, at a level not to not to exceed 50 parts per million. exceed 2.2 percent, Provided, That: (b) In lemon oil as a residue in pro- (1) The hops extract is added to the duction of the oil, at a level not to ex- wort before or during cooking in the ceed 6 parts per million. manufacture of beer. (2) The label of the hops extract iden- (c) In hops extract as a residue from tifies the presence of the methylene the extraction of hops at a level not to chloride and provides for the use of the exceed 2.0 percent by weight: Provided, hops extract only as prescribed by That, paragraph (b)(1) of this section. (1) The hops extract is added to the (c) In coffee as a residue from its use wort before or during cooking in the as a solvent in the extraction of caf- manufacture of beer. feine from green coffee beans, at a level (2) The label of the hops extract not to exceed 10 parts per million (0.001 specifies the presence of the isopropyl percent) in decaffeinated roasted coffee alcohol and provides for the use of the and in decaffeinated soluble coffee ex- hops extract only as prescribed by tract (instant coffee). paragraph (c)(1) of this section. § 173.270 Hexane. 1 Copies may be obtained from: National Hexane may be present in the fol- Academy Press, 2101 Constitution Ave. NW., lowing foods under the conditions spec- Washington, DC 20418 or examined at the Na- ified: tional Archives and Records Administration (a) In spice oleoresins as a residue (NARA). For information on the availability of this material at NARA, call 202–741–6030, from the extraction of spice, at a level or go to: http://www.archives.gov/ not to exceed 25 parts per million. federallregister/codeloflfederallregulations/ (b) In hops extract as a residue from ibrllocations.html. the extraction of hops, at a level not to

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exceed 2.2 percent by weight; Provided, (NARA). For information on the avail- That: ability of this material at NARA, call (1) The hops extract is added to the 202–741–6030, or go to: http:// wort before or during cooking in the www.archives.gov/federallregister/ manufacture of beer. codeloflfederallregulations/ (2) The label of the hops extract ibrllocations.html.), and the specifies the presence of the hexane polynuclear aromatic hydrocarbon and provides for the use of the hops ex- specifications of § 173.165. tract only as prescribed by paragraph (d) Residues of n-octyl alcohol and (b)(1) of this section. synthetic isoparaffinic petroleum hy- drocarbons are removed in accordance § 173.275 Hydrogenated sperm oil. with good manufacturing practice. Cur- The food additive hydrogenated rent good manufacturing practice re- sperm oil may be safely used in accord- sults in residues not exceeding 16 parts ance with the following prescribed con- per million (ppm) n-octyl alcohol and ditions: 0.47 ppm synthetic isoparaffinic petro- (a) The sperm oil is derived from ren- leum hydrocarbons in citric acid. dering the fatty tissue of the sperm (e) Tridodecyl amine may be present whale or is prepared by synthesis of as a residue in citric acid at a level not fatty acids and fatty alcohols derived to exceed 100 parts per billion. from the sperm whale. The sperm oil [42 FR 14491, Mar. 15, 1977, as amended at 49 obtained by rendering is refined. The FR 10106, Mar. 19, 1984] oil is hydrogenated. (b) It is used alone or as a component § 173.290 Trichloroethylene. of a release agent or lubricant in bak- ery pans. Tolerances are established for resi- (c) The amount used does not exceed dues of trichloroethylene resulting that reasonably required to accomplish from its use as a solvent in the manu- the intended lubricating effect. facture of foods as follows: Decaffeinated ground coffee 25 parts per million. § 173.280 Solvent extraction process Decaffeinated soluble (in- 10 parts per million. for citric acid. stant) coffee extract. Spice oleoresins ...... 30 parts per million (provided A solvent extraction process for re- that if residues of other covery of citric acid from conventional chlorinated solvents are Aspergillus niger fermentation liquor also present, the total of all residues of such solvents may be safely used to produce food- in spice oleoresins shall grade citric acid in accordance with not exceed 30 parts per the following conditions: million). (a) The solvent used in the process consists of a mixture of n-octyl alcohol meeting the requirements of § 172.864 of Subpart D—Specific Usage this chapter, synthetic isoparaffinic Additives petroleum hydrocarbons meeting the requirements of § 172.882 of this chap- § 173.300 Chlorine dioxide. ter, and tridodecyl amine. Chlorine dioxide (CAS Reg. No. 10049– (b) The component substances are 04–4) may be safely used in food in ac- used solely as a solvent mixture and in cordance with the following prescribed a manner that does not result in for- conditions: mation of products not present in con- (a)(1) The additive is generated by ventionally produced citric acid. one of the following methods: (c) The citric acid so produced meets (i) Treating an aqueous solution of the specifications of the ‘‘Food Chemi- sodium chlorite with either chlorine cals Codex,’’ 3d Ed. (1981), pp. 86–87, gas or a mixture of sodium hypo- which is incorporated by reference chlorite and hydrochloric acid. (Copies may be obtained from the Na- (ii) Treating an aqueous solution of tional Academy Press, 2101 Constitu- sodium chlorate with hydrogen per- tion Ave. NW., Washington, DC 20418, oxide in the presence of sulfuric acid. or may be examined at the National (iii) Treating an aqueous solution of Archives and Records Administration sodium chlorite by electrolysis.

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(2) The generator effluent contains at (2) The additive may be used as an least 90 percent (by weight) of chlorine antimicrobial agent in water used to dioxide with respect to all chlorine spe- wash fruits and vegetables that are not cies as determined by Method 4500–ClO2 raw agricultural commodities in an E in the ‘‘Standard Methods for the Ex- amount not to exceed 3 ppm residual amination of Water and Wastewater,’’ chlorine dioxide as determined by 20th ed., 1998, or an equivalent method. Method 4500–ClO2 E, referenced in para- Method 4500–ClO2 E (‘‘Amperometric graph (a)(2) of this section, or an equiv- Method II’’) is incorporated by ref- alent method. Treatment of the fruits erence in accordance with 5 U.S.C. and vegetables with chlorine dioxide 552(a) and 1 CFR part 51. You may ob- shall be followed by a potable water tain a copy from the Center for Food Safety and Applied Nutrition (HFS– rinse or by blanching, cooking, or can- 200), Food and Drug Administration, ning. 5100 Paint Branch Pkwy., College Park, [60 FR 11900, Mar. 3, 1995. Redesignated at 61 MD 20740, or the American Public FR 14245, Apr. 1, 1996, as amended at 61 FR Health Association, 800 I St. NW., 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; Washington, DC 20001–3750. You may in- 65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14, spect a copy at the Center for Food 2005] Safety and Applied Nutrition’s Li- brary, 5100 Paint Branch Pkwy., Col- § 173.310 Boiler water additives. lege Park, MD, or at the National Ar- Boiler water additives may be safely chives and Records Administration used in the preparation of steam that (NARA). For information on the avail- will contact food, under the following ability of this material at NARA, call conditions: 202–741–6030, or go to: http:// (a) The amount of additive is not in www.archives.gov/federallregister/ excess of that required for its func- codeloflfederallregulations/ tional purpose, and the amount of ibrllocations.html. (b)(1) The additive may be used as an steam in contact with food does not ex- antimicrobial agent in water used in ceed that required to produce the in- poultry processing in an amount not to tended effect in or on the food. exceed 3 parts per million (ppm) resid- (b) The compounds are prepared from ual chlorine dioxide as determined by substances identified in paragraphs (c) Method 4500–ClO2 E, referenced in para- and (d) of this section, and are subject graph (a)(2) of this section, or an equiv- to the limitations, if any, prescribed: alent method. (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’’ (October 23, 1987), which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may be obtained from the Center for Food Safety and Applied Nu- trition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., 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.. Ammonium alginate. Cobalt 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.

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Substances Limitations

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 method prescribed in the ‘‘Food Chemicals Codex,’’ 4th ed. (1996), pp. 744–745, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be examined at the Center for Food Safety and Applied Nutri- tion’s Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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. 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). 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 parts per million in the steam. defined in § 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 306–307, which is incorporated by reference in accord- ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitu- tion Ave. NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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.. Tannin (including quebracho extract). Tetrasodium EDTA. Tetrasodium pyrophosphate.

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(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, § 173.315 Chemicals used in washing in addition to the other information re- or to assist in the peeling of fruits quired by the Act, the label or labeling and vegetables. shall bear: Chemicals may be safely used to (1) The common or chemical name or wash or to assist in the peeling of names of the additive or additives. fruits and vegetables in accordance (2) Adequate directions for use to as- with the following conditions: sure compliance with all the provisions (a) The chemicals consist of one or of this section. more of the following: [42 FR 14526, Mar. 15, 1977, as amended at 45 (1) Substances generally recognized FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, as safe in food or covered by prior sanc- 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. tions for use in washing fruits and 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, vegetables. Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; (2) Substances identified in this sub- 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, paragraph and subject to such limita- 1999; 64 FR 29227, June 1, 1999] tions as are provided:

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. 142

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(3) Sodium mono- and dimethyl naph- (1) The label and labeling of the addi- thalene sulfonates (mol. wt. 245–260) tive container shall bear, in addition to may be used in the steam/scald vacuum the other information required by the peeling of tomatoes at a level not to act, the name of the additive or a exceed 0.2 percent in the condensate or statement of its composition. scald water. (2) The label or labeling of the addi- (4) Substances identified in this para- tive container shall bear adequate use graph (a)(4) for use in flume water for directions to assure use in compliance washing sugar beets prior to the slicing with all provisions of this section. operation and subject to the limita- [42 FR 14526, Mar. 15, 1977, as amended at 42 tions as are provided for the level of FR 29856, June 10, 1977; 42 FR 32229, June 24, the substances in the flume water: 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; Substance Limitations 64 FR 38564, July 19, 1999]

a-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. ethylene) produced by con- § 173.320 Chemicals for controlling microorganisms in cane-sugar and densation of 1 mole of C11- C486315 straight chain ran- beet-sugar mills. domly substituted secondary al- Agents for controlling microorga- cohols with an average of 9 moles of ethylene oxide. nisms in cane-sugar and beet-sugar Linear undecylbenzenesulfonic Do. mills may be safely used in accordance acid. with the following conditions: Dialkanolamide produced by con- Not to exceed 2 ppm. (a) They are used in the control of densing 1 mole of methyl lau- rate with 1.05 moles of microorganisms in cane-sugar and/or diethanolamine. beet-sugar mills as specified in para- Triethanolamine ...... Do. graph (b) of this section. Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. (b) They are applied to the sugar mill Oleic acid conforming with Do. § 172.860 of this chapter. grinding, crusher, and/or diffuser sys- Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. tems in one of the combinations listed Monoethanolamine ...... Do. in paragraph (b) (1), (2), (3), or (5) of Ethylene dichloride ...... Not to exceed 0.2 ppm. this section or as a single agent listed Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. tetraacetate. in paragraph (b) (4) or (6) of this sec- tion. Quantities of the individual addi- (5) Substances identified in this para- tives in parts per million are expressed graph (a)(5) for use on fruits and vege- in terms of the weight of the raw cane tables that are not raw agricultural or raw beets. commodities and subject to the limita- (1) Combination for cane-sugar mills: tions provided: Parts per mil- Substances Limitations lion

Hydrogen peroxide ...... Used in combination with acetic Disodium cyanodithioimidocarbonate ...... 2.5 acid to form peroxyacetic acid. Ethylenediamine ...... 1.0 Not to exceed 59 ppm in wash Potassium N-methyldithiocarbamate ...... 3.5 water. 1-Hydroxyethylidene-1,1- May be used only with peroxy- (2) Combination for cane-sugar mills: diphosphonic acid. acetic acid. Not to exceed 4.8 ppm in wash water. Parts Peroxyacetic acid ...... Prepared by reacting acetic acid per mil- with hydrogen peroxide. Not to lion exceed 80 ppm in wash water. Disodium ethylenebisdithiocarbamate ...... 3.0 (b) The chemicals are used in Sodium dimethyldithiocarbamate ...... 3.0 amounts not in excess of the minimum (3) Combinations for cane-sugar mills required to accomplish their intended and beet-sugar mills: effect. (c) The use of the chemicals listed Parts per mil- under paragraphs (a)(1), (a)(2), and lion (a)(4) is followed by rinsing with pota- ble water to remove, to the extent pos- (i) Disodium ethylenebisdithiocarbamate ...... 3.0 Ethylenediamine ...... 2.0 sible, residues of the chemicals. Sodium dimethyldithiocarbamate ...... 3.0 (d) To assure safe use of the additive: (ii) Disodium cyanodithioimidocarbonate ...... 2.9

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Parts (2) Substances identified in this para- per mil- graph and subject to such limitations lion as are provided: Potassium N-methyldithiocarbamate ...... 4.1 Substances Limitations

(4) Single additive for cane-sugar alpha-Alkyl-omega- May be used at an applica- mills and beet-sugar mills. hydroxypoly-(oxyethylene) tion rate not to exceed 0.3 produced by condensation percent by weight of cot- Parts per million of a linear primary alcohol tonseeds to enhance containing an average delinting of cottonseeds in- 2,2-Dibromo-3-nitrilopropionamide (CAS Not more than chain length of 10 carbons tended for the production Reg. No. 10222–01–2). Limitations: By- 10.0 and not with poly(oxyethylene) hav- of cottonseed oil. Byprod- product molasses, bagasse, and pulp less than 2.0. ing an average of 5 ethyl- ucts including lint, hulls, containing residues of 2,2-dibromo-3- ene oxide units. and meal may be used in nitrilopropionamide are not authorized animal feed. for use in animal feed. An alkanomide produced by May be used at an applica- condensation of coconut oil tion rate not to exceed 0.2 (5) Combination for cane-sugar mills: fatty acids and dietha- percent by weight of cot- nolamine, CAS Reg. No. tonseeds to enhance 068603–42–9. delinting of cottonseeds in- Parts per mil- tended for the production lion of cottonseed oil. Byprod- ucts including lint, hulls, n-Dodecyl dimethyl benzyl ammonium chlo- and meal may be used in ride ...... 0.05±0.005 animal feed. n-Dodecyl dimethyl ethylbenzyl ammonium chloride ...... 0.68±0.068 n-Hexadecyl dimethyl benzyl ammonium [47 FR 8346, Feb. 26, 1982] chloride ...... 0.30±0.030 n-Octadecyl dimethyl benzyl ammonium chloride ...... 0.05±0.005 § 173.325 Acidified sodium chlorite so- n-Tetradecyl dimethyl benzyl ammonium lutions. chloride ...... 0.60±0.060 Acidified sodium chlorite solutions n-Tetradecyl dimethyl ethylbenzyl ammo- may be safely used in accordance with nium chloride ...... 0.32±0.032 the following prescribed conditions: (a) The additive is produced by mix- Limitations. Byproduct molasses, ba- ing an aqueous solution of sodium chlo- gasse, and pulp containing residues of rite (CAS Reg. No. 7758–19–2) with any these quaternary ammonium salts are generally recognized as safe (GRAS) not authorized for use in animal feed. acid. (6) Single additive for beet-sugar (b)(1) The additive is used as an anti- mills: microbial agent in poultry processing Parts per million water in accordance with current in- dustry practice under the following Glutaraldehyde (CAS Reg. No. Not more than 250. conditions: 111–30–8). (i) As a component of a carcass spray or dip solution prior to immersion of (c) To assure safe use of the addi- the intact carcass in a prechiller or tives, their label and labeling shall chiller tank; conform to that registered with the (ii) In a prechiller or chiller solution Environmental Protection Agency. for application to the intact carcass; [42 FR 14526, Mar. 15, 1977, as amended at 47 (iii) As a component of a spray or dip FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, solution for application to poultry car- 1985; 57 FR 8065, Mar. 6, 1992] cass parts; (iv) In a prechiller or chiller solution § 173.322 Chemicals used in delinting for application to poultry carcass cottonseed. parts; or Chemicals may be safely used to as- (v) As a component of a post-chill sist in the delinting of cottonseed in carcass spray or dip solution when ap- 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

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million (ppm), in combination with any commodities in the preparing, packing, GRAS acid at a level sufficient to or holding of the food for commercial achieve a solution pH of 2.3 to 2.9. purposes, consistent with section (3) When used in a prechiller or chill- 201(q)(1)(B)(i) of the act, and not ap- er solution, the additive is used at lev- plied for use under section els that result in sodium chlorite con- 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or centrations between 50 and 150 ppm, in (q)(1)(B)(i)(III) of the act, in accordance combination with any GRAS acid at with current industry standards of levels sufficient to achieve a solution good manufacturing practice. Applied pH of 2.8 to 3.2. as a dip or a spray, the additive is used (c) The additive is used as an anti- at levels that result in chlorite con- microbial agent in accordance with centrations of 500 to 1200 parts per mil- current industry practice in the proc- lion (ppm), in combination with any essing of red meat, red meat parts, and GRAS acid at levels sufficient to organs as a component of a spray or in achieve a pH of 2.3 to 2.9. Treatment of the processing of red meat parts and the raw agricultural commodities with organs as a component of a dip. Applied acidified sodium chlorite solutions as a dip or spray, the additive is used shall be followed by a potable water at levels that result in sodium chlorite rinse, or by blanching, cooking, or can- concentrations between 500 and 1,200 ning. ppm in combination with any GRAS (f) The additive is used as an anti- acid at levels sufficient to achieve a so- microbial agent on processed, lution pH of 2.5 to 2.9. comminuted or formed meat food prod- (d)(1) The additive is used as an anti- ucts (unless precluded by standards of microbial agent in water and ice that identity in 9 CFR part 319) prior to are used to rinse, wash, thaw, trans- port, or store seafood in accordance packaging of the food for commercial with current industry standards of purposes, in accordance with current good manufacturing practice. The addi- industry standards of good manufac- tive is produced by mixing an aqueous turing practice. Applied as a dip or solution of sodium chlorite with any spray, the additive is used at levels GRAS acid to achieve a pH in the range that result in sodium chlorite con- of 2.5 to 2.9 and diluting this solution centrations of 500 to 1200 ppm, in com- with water to achieve an actual use bination with any GRAS acid at levels concentration of 40 to 50 parts per mil- sufficient to achieve a pH of 2.5 to 2.9. lion (ppm) sodium chlorite. Any sea- (g) The additive is used as an anti- food that is intended to be consumed microbial agent in the water applied to raw shall be subjected to a potable processed fruits and processed root, water rinse prior to consumption. tuber, bulb, legume, fruiting (i.e., egg- (2) The additive is used as a single ap- plant, groundcherry, pepino, pepper, plication in processing facilities as an tomatillo, and tomato), and cucurbit antimicrobial agent to reduce patho- vegetables in accordance with current genic bacteria due to cross-contamina- industry standards of good manufac- tion during the harvesting, handling, turing practices, as a component of a heading, evisceration, butchering, stor- spray or dip solution, provided that ing, holding, packing, or packaging of such application be followed by a pota- finfish and crustaceans; or following ble water rinse and a 24-hour holding the filleting of finfish; in accordance period prior to consumption. However, with current industry standards of for processed leafy vegetables (i.e., good manufacturing practice. Applied vegetables other than root, tuber, bulb, as a dip or spray, the additive is used legume, fruiting, and cucurbit vegeta- at levels that result in a sodium chlo- bles) and vegetables in the Brassica rite concentration of 1,200 ppm, in com- [Cole] family, application must be by bination with any GRAS acid at levels dip treatment only, and must be pre- sufficient to achieve a pH of 2.3 to 2.9. ceded by a potable water rinse and fol- Treated seafood shall be cooked prior lowed by a potable water rinse and a to consumption. 24-hour holding period prior to con- (e) The additive is used as an anti- sumption. When used in a spray or dip microbial agent on raw agricultural solution, the additive is used at levels

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that result in sodium chlorite con- go to: http://www.archives.gov/ centrations between 500 and 1,200 ppm, federallregister/ in combination with any GRAS acid at codeloflfederallregulations/ a level sufficient to achieve a solution ibrllocations.html. pH of 2.3 to 2.9. (h) The concentration of sodium chlo- [61 FR 17829, Apr. 23, 1996, as amended at 63 rite is determined by a method entitled FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, ‘‘Determination of Sodium Chlorite: 50 Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR ppm to 1500 ppm Concentration,’’ Sep- 22922, May 7, 2001; 66 FR 31841, June 13, 2001; tember 13, 1995, developed by Alcide 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30, Corp., Redmond, WA, which is incor- 2004] porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. § 173.340 Defoaming agents. Copies are available from the Division Defoaming agents may be safely used of Petition Control (HFS–215), Center for Food Safety and Applied Nutrition, in processing foods, in accordance with Food and Drug Administration, 5100 the following conditions: Paint Branch Pkwy., College Park, MD (a) They consist of one or more of the 20740, or may be examined at the Cen- following: ter for Food Safety and Applied Nutri- (1) Substances generally recognized tion’s Library, 5100 Paint Branch by qualified experts as safe in food or Pkwy., College Park, MD 20740 20204– covered by prior sanctions for the use 0001, or at the National Archives and prescribed by this section. Records Administration (NARA). For (2) Substances listed in this para- information on the availability of this graph (a)(2) of this section, subject to material at NARA, call 202–741–6030, or any limitations imposed:

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.

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Substances Limitations

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- 1,2,2-trifluoroethane) (CAS Reg. No. 76– graph (a)(4), provided they are compo- 13–1, also known as fluorocarbon 113, nents of defoaming agents limited to CFC 113 and FC 113) and 1 percent use in processing beet sugar only, and perfluorohexane (CAS Reg. No. 355–42– subject to the limitations imposed: 0) may be safely used in accordance with the following prescribed condi- Substances Limitations tions: n-Butoxypoly(oxyethylene)- Viscosity range, 4,850–5,350 (a) The additive chlorofluorocarbon poly(oxypropylene)glycol. Saybolt Universal Seconds 113 has a purity of not less than 99.99 (SUS) at 37.8 °C (100 °F). The viscosity range is de- percent. termined by the method (b) The additive mixture is intended ‘‘Viscosity Determination of n-butoxypoly(oxyethylene)- for use to quickly cool or crust-freeze poly(oxypropylene) glycol’’ chickens sealed in intact bags com- dated April 26, 1995, de- posed of substances regulated in parts veloped by Union Carbide Corp., P.O. Box 670, 174, 175, 177, 178, and § 179.45 of this Bound Brook, NJ 08805, chapter and conforming to any limita- which is incorporated by tions or specifications in such regula- reference in accordance with 5 U.S.C. 552(a) and 1 tions. CFR part 51. Copies of the material incorporated by [55 FR 8913, Mar. 9, 1990] reference are available from the Division of Petition § 173.345 Chloropentafluoroethane. Control, Center for Food Safety and Applied Nutri- The food additive tion (HFS–215), Food and chloropentafluoroethane may be safely Drug Administration, 5100 Paint Branch Pkwy., Col- used in food in accordance with the fol- lege Park, MD 20740, and lowing prescribed conditions: may be examined at the (a) The food additive has a purity of Center for Food Safety and Applied Nutrition’s Library, not less than 99.97 percent, and con- 5100 Paint Branch Pkwy., tains not more than 200 parts per mil- College Park, MD 20740, lion saturated fluoro compounds and 10 or at the National Archives and Records Administration parts per million unsaturated fluoro (NARA). For information on compounds as impurities. the availability of this mate- (b) The additive is used or intended rial at NARA, call 202– 741–6030, or go to: http:// for use alone or with one or more of the www.archives.gov/federall following substances: Carbon dioxide, register/codeloflfederal nitrous oxide, propane, and lregulations/ibrlloca- tions.html. octafluorocyclobutane complying with Monoester of alpha-hydro- § 173.360, as an aerating agent for omega-hydroxy- foamed or sprayed food products, with poly(oxyethylene) poly(oxypropylene) any propellant effect being incidental poly(oxyethylene) (15 mole and no more than is minimally nec- minimum) blocked copoly- essary to achieve the aerating func- mer derived from low eru- 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] chloropentafluoroethane. (ii) The percentage of the additive § 173.342 Chlorofluorocarbon 113 and perfluorohexane. present in the case of a mixture. (iii) The designation ‘‘food grade’’. A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-

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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 corporated by reference. The Director solvent is completely immersed. Cool for at of the Federal Register approves this least 15 minutes and then pass 120 liters of incorporation by reference in accord- the test gas through the absorption train at a rate of 30 liters per hour or less. Maintain ance with 5 U.S.C. 552(a) and 1 CFR the coolant bath at 0 °C throughout. Remove part 51. You may obtain copies from the absorption vessel from the bath, dis- the United States Pharmacopeial Con- connect, and warm to room temperature. vention, 12601 Twinbrook Pkwy., Rock- Add isooctane to bring the contents of the ville, MD 20852 (Internet address http:// absorption vessel to 60 milliliters, and mix. www.usp.org). Copies may be examined Determine the absorbance of the solution in the 5-centimeter cell in the range 255 milli- at the Center for Food Safety and Ap- microns to 310 millimicrons, inclusive, com- plied Nutrition’s Library, Food and pared to isooctane. The absorbance of the so- Drug Administration, 5100 Paint lution of combustion product gas shall not Branch Pkwy., College Park, MD 20740, exceed that of the isooctane solvent at any 301–436–2163, or at the National Ar- wavelength in the specified range by more chives and Records Administration than one-third of the standard reference ab- (NARA). For information on the avail- sorbance. ability of this material at NARA, call § 173.355 Dichlorodifluoromethane. 202–741–6030, or go to: http:// www.archives.gov/federallregister/ The food additive dichlorodi- codeloflfederallregulations/ fluoromethane may be safely used in ibr locations.html. food in accordance with the following l prescribed conditions: (b) The additive is used as an anti- (a) The additive has a purity of not microbial agent in the production of less than 99.97 percent. modified whey (including, but not lim- (b) It is used or intended for use, in ited to, whey protein concentrates and accordance with good manufacturing whey protein isolates) by practice, as a direct-contact freezing ultrafiltration methods, at a level not agent for foods. to exceed 0.001 percent by weight of the (c) To assure safe use of the additive: whey, providing that residual hydrogen (1) The label of its container shall peroxide is removed by appropriate bear, in addition to the other informa- chemical or physical means during the tion required by the act, the following: processing of the modified whey. (i) The name of the additive, dichlo- [76 FR 11330, Mar. 2, 2011] 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 additive container shall bear adequate Fixing agents may be safely used in directions for use. the immobilization of enzyme prepara- tions in accordance with the following § 173.356 Hydrogen peroxide. conditions: Hydrogen peroxide (CAS Reg. No. (a) The materials consist of one or 7722–84–1) may be safely used to treat more of the following: food in accordance with the following (1) Substances generally recognized conditions: as safe in food. (a) The additive meets the specifica- (2) Substances identified in this sub- tions of the Food Chemicals Codex, 7th paragraph and subject to such limita- ed. (2010), pp. 496 and 497, which is in- 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 Division of erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be Petition Control, Center for Food Safety obtained from the Division of Petition Control, Center for Food Safety and Applied and Applied Nutrition (HFS–200), 5100 Nutrition (HFS–215), 5100 Paint Branch Pkwy., College Park, MD 20740, or may Paint Branch Pkwy., College Park, MD be examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 20740, and may be examined at the Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Center for Food Safety and Applied Nu- Records Administration (NARA). For information on the availability of this material trition’s Library, 5100 Paint Branch at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ Pkwy., College Park, MD 20740, or at codeloflfederallregulations/ibrllocations.html. 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..

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

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is produced commercially by passing (b)(1) The additive is used as an anti- electrical discharges or ionizing radi- microbial agent on meat carcasses, ation through air or oxygen. parts, trim, and organs in accordance (b) The additive is used as an anti- with current industry practice where microbial agent as defined in the maximum concentration of § 170.3(o)(2) of this chapter. peroxyacids is 220 parts per million (c) The additive meets the specifica- (ppm) as peroxyacetic acid, and the tions for ozone in the Food Chemicals maximum concentration of hydrogen Codex, 4th ed. (1996), p. 277, which is in- peroxide is 75 ppm. corporated by reference. The Director (2) The additive is used as an anti- of the Office of the Federal Register microbial agent on poultry carcasses, approves this incorporation by ref- poultry parts, and organs in accord- erence in accordance with 5 U.S.C. ance with current industry standards 552(a) and 1 CFR part 51. Copies are of good manufacturing practice (unless available from the National Academy precluded by the U.S. Department of Press, 2101 Constitution Ave. NW., Agriculture’s standards of identity in 9 Washington, DC 20055, or may be exam- CFR part 381, subpart P) where the ined at the Office of Premarket Ap- maximum concentration of proval (HFS–200), Center for Food Safe- peroxyacids is 220 parts per million ty and Applied Nutrition, Food and (ppm) as peroxyacetic acid, the max- Drug Administration, 5100 Paint imum concentration of hydrogen per- Branch Pkwy., College Park, MD 20740, oxide is 110 ppm, and the maximum and at the National Archives and concentration of 1-hydroxyethylidene- Records Administration (NARA). For 1,1-diphosphonic acid (HEDP) is 13 ppm. information on the availability of this (c) The concentrations of peroxyacids material at NARA, call 202–741–6030, or and hydrogen peroxide in the additive go to: http://www.archives.gov/ are determined by a method entitled federallregister/ ‘‘Hydrogen Peroxide and Peracid (as codeloflfederallregulations/ Peracetic Acid) Content,’’ July 26, 2000, ibrllocations.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 from the Division of Petition Review, [66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, Center for Food Safety and Applied Nu- 2002] trition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, § 173.370 Peroxyacids. MD 20740, or you may examine a copy Peroxyacids may be safely used in ac- at the Center for Food Safety and Ap- cordance with the following prescribed plied Nutrition’s Library, 5100 Paint conditions: Branch Pkwy., College Park, MD 20740, (a) The additive is a mixture of per- or at the National Archives and oxyacetic acid, octanoic acid, acetic Records Administration (NARA). For acid, hydrogen peroxide, information on the availability of this peroxyoctanoic acid, and 1- material at NARA, call 202–741–6030, or hydroxyethylidene-1,1-diphosphonic go to: http://www.archives.gov/ acid. federallregister/

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codeloflfederallregulations/ prior to or after chilling at an amount ibrllocations.html. not to exceed 5 gallons of solution per carcass, provided that the additive is [65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, used in systems that recapture at least 2002] 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] pp. 1700–1701, which is incorporated by reference. The Director of the Office of § 173.385 Sodium methyl sulfate. the Federal Register approves this in- Sodium methyl sulfate may be corporation by reference in accordance present in pectin in accordance with with 5 U.S.C. 552(a) and 1 CFR part 51. the following conditions. You may obtain copies from the United (a) It is present as the result of States Pharmacopeial Convention, of pectin by sulfuric acid Inc., 12601 Twinbrook Pkwy., Rock- and methyl alcohol and subsequent ville, MD 20852, or you may examine a treatment with sodium bicarbonate. copy at the Center for Food Safety and (b) It does not exceed 0.1 percent by Applied Nutrition’s Library, Food and weight of the pectin. Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, § 173.395 Trifluoromethane sulfonic or at the National Archives and acid. Records Administration (NARA). For information on the availability of this Trifluoromethane sulfonic acid has material at NARA, call 202–741–6030, or the empirical formula CF3SO3H (CAS go to: http://www.archives.gov/federal- Reg. No. 1493–13–6). The catalyst register/cfr/ibr-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- imum. mersion in a chiller, at a level not to 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 (2) As a liquid aqueous solution ap- removed by washing batches of the plied to raw poultry carcasses either product three times with an aqueous

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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, 5100 Paint Branch NARA, call 202–741–6030, or go to: http:// Pkwy., College Park, MD 20740, and www.archives.gov/federallregister/ from the American Oil Chemists’ Soci- codeloflfederallregulations/ ety, P.O. Box 5037, Station A, Cham- ibrllocations.html. paign, IL 61820, or available for inspec- [43 FR 54237, Nov. 11, 1978, as amended at 49 tion at the National Archives and FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, Records Administration (NARA). For 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, information on the availability of this Nov. 8, 2005] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 173.400 Dimethyldialkylammonium federallregister/ chloride. codeloflfederallregulations/ Dimethyldialkylammonium chloride ibrllocations.html. may be safely used in food in accord- (c) The food additive is used as a de- ance with the following prescribed con- colorizing agent in the clarification of ditions: refinery sugar liquors under the fol- (a) The food additive is produced by lowing limitations: one of the following methods: (1) The food additive described in (1) Ammonolysis of natural tallow paragraph (a)(1) of this section is added fatty acids to form amines that are only at the defecation/clarification subsequently reacted with methyl chlo- stage of sugar liquor refining in an ride to form the quaternary ammonium amount not to exceed 700 parts per mil- compounds consisting primarily of lion by weight of sugar solids. dimethyldioctadecylammonium chlo- (2) The food additive described in ride and dimethyldihexadecyl- paragraph (a)(2) of this section is used ammonium chloride. The additive may under the following conditions: contain residues of isopropyl alcohol (i) The additive is adsorbed onto a not in excess of 18 percent by weight support column composed of suitable when used as a processing solvent. polymers that are regulated for con- (2) Ammonolysis of natural tallow tact with aqueous food. Excess non- fatty acids to form amines that are adsorbed additive shall be rinsed away then reacted with 2-ethylhexanal, re- with potable water prior to passage of duced, methylated, and subsequently sugar liquor through the column. reacted with methyl chloride to form (ii) The residue of the additive in the the quaternary ammonium compound decolorized sugar liquor prior to crys- known as dimethyl(2-ethylhexyl) hy- tallization shall not exceed 1 part per drogenated tallow ammonium chloride million of sugar as determined by a and consisting primarily of dimethyl(2- method entitled ‘‘Colorimetric Deter- ethylhexyl)octadecylammonium chlo- mination of Residual Quaternary Am- ride and dimethyl(2-ethyl- monium Compounds (Arquad HTL8) in hexyl)hexadecylammonium chloride. Sugar and Sugar Solutions,’’ June 13, (b) The food additive described in 1990, which is incorporated by reference paragraph (a)(1) of this section con- in accordance with 5 U.S.C. 552(a) and 1

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CFR part 51. Copies are available from (2) Any substance used as a compo- the Center for Food Safety and Applied nent of articles that contact food shall Nutrition (HFS–200), Food and Drug be of a purity suitable for its intended Administration, 5100 Paint Branch use. Pkwy., College Park, MD 20740, or (b) The existence in the subchapter B available for inspection at the National of a regulation prescribing safe condi- Archives and Records Administration tions for the use of a substance as an (NARA). For information on the avail- article or component of articles that ability of this material at NARA, call contact food shall not be construed to 202–741–6030, or go to: http:// relieve such use of the substance or ar- www.archives.gov/federallregister/ ticle from compliance with any other codeloflfederallregulations/ provision of the Federal Food, Drug, ibrllocations.html. and Cosmetic Act. For example, if a (d) To assure safe use of the additive, regulated food-packaging material the label and labeling of the additive were found on appropriate test to im- shall bear, in addition to other infor- part odor or taste to a specific food mation required by the Federal Food, product such as to render it unfit with- Drug, and Cosmetic Act, adequate di- in the meaning of section 402(a)(3) of rections to assure use in compliance the Act, the regulation would not be with paragraph (c) of this section. construed to relieve such use from compliance with section 402(a)(3). [56 FR 42686, Aug. 29, 1991] (c) The existence in this subchapter B of a regulation prescribing safe condi- PART 174—INDIRECT FOOD tions for the use of a substance as an ADDITIVES: GENERAL article or component of articles that contact food shall not be construed as Sec. implying that such substance may be 174.5 General provisions applicable to indi- safely used as a direct additive in food. rect food additives. (d) Substances that under conditions 174.6 Threshold of regulation for substances of good manufacturing practice may be used in food-contact articles. safely used as components of articles AUTHORITY: 21 U.S.C. 321, 342, 348, 371. that contact food include the fol- lowing, subject to any prescribed limi- § 174.5 General provisions applicable tations: to indirect food additives. (1) Substances generally recognized (a) Regulations prescribing condi- as safe in or on food. tions under which food additive sub- (2) Substances generally recognized stances may be safely used predicate as safe for their intended use in food usage under conditions of good manu- packaging. facturing practice. For the purpose of (3) Substances used in accordance this part and parts 175, 176, and 177 of with a prior sanction or approval. this chapter, good manufacturing prac- (4) Substances permitted for use by tice shall be defined to include the fol- regulations in this part and parts 175, lowing restrictions: 176, 177, 178 and § 179.45 of this chapter. (1) The quantity of any food additive (5) Food contact substances used in substance that may be added to food as accordance with an effective pre- a result of use in articles that contact market notification for a food contact food shall not exceed, where no limits substance (FCN) submitted under sec- are specified, that which results from tion 409(h) of the act. use of the substance in an amount not [42 FR 14534, Mar. 15, 1977, as amended at 67 more than reasonably required to ac- FR 35731, May 21, 2002] complish the intended physical or tech- nical effect in the food-contact article; § 174.6 Threshold of regulation for shall not exceed any prescribed limita- substances used in food-contact ar- tions; and shall not be intended to ac- ticles. complish any physical or technical ef- Substances used in food-contact arti- fect in the food itself, except as such cles (e.g., food-packaging or food-proc- may be permitted by regulations in essing equipment) that migrate, or parts 170 through 189 of this chapter. that may be expected to migrate, into

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food at negligible levels may be re- Subpart B—Substances for Use viewed under § 170.39 of this chapter. Only as Components of Adhesives The Food and Drug Administration will exempt substances whose uses it § 175.105 Adhesives. determines meet the criteria in § 170.39 (a) Adhesives may be safely used as of this chapter from regulation as food components of articles intended for use additives and, therefore, a food addi- in packaging, transporting, or holding tive petition will not be required for food in accordance with the following the exempted use. prescribed conditions: [60 FR 36596, July 17, 1995] (1) The adhesive is prepared from one or more of the optional substances PART 175—INDIRECT FOOD ADDI- named in paragraph (c) of this section, TIVES: ADHESIVES AND COMPO- subject to any prescribed limitations. NENTS OF COATINGS (2) The adhesive is either separated from the food by a functional barrier or Subpart A [Reserved] used subject to the following additional limitations: Subpart B—Substances for Use Only as (i) In dry foods. The quantity of adhe- Components of Adhesives sive that contacts packaged dry food shall not exceed the limits of good Sec. manufacturing practice. 175.105 Adhesives. (ii) In fatty and aqueous foods. (a) The 175.125 Pressure-sensitive adhesives. quantity of adhesive that contacts Subpart C—Substances for Use as packaged fatty and aqueous foods shall Components of Coatings not exceed the trace amount at seams and at the edge exposure between pack- 175.210 Acrylate ester copolymer coating. aging laminates that may occur within 175.230 Hot-melt strippable food coatings. the limits of good manufacturing prac- 175.250 Paraffin (synthetic). tice. 175.260 Partial phosphoric acid esters of pol- (b) Under normal conditions of use yester resins. the packaging seams or laminates will 175.270 Poly(vinyl fluoride) resins. remain firmly bonded without visible 175.300 Resinous and polymeric coatings. separation. 175.320 Resinous and polymeric coatings for polyolefin films. (b) To assure safe usage of adhesives, 175.350 Vinyl acetate/crotonic acid copoly- the label of the finished adhesive con- mer. tainer shall bear the statement ‘‘food- 175.360 Vinylidene chloride copolymer coat- packaging adhesive’’. ings for nylon film. (c) Subject to any limitation pre- 175.365 Vinylidene chloride copolymer coat- scribed in this section and in any other ings for polycarbonate film. regulation promulgated under section 175.380 Xylene-formaldehyde resins con- 409 of the Act which prescribes safe ′ densed with 4,4 -isopropylidenediphenol- conditions of use for substances that epichlorohydrin epoxy resins. may be employed as constituents of ad- 175.390 Zinc-silicon dioxide matrix coatings. hesives, the optional substances used AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. in the formulation of adhesives may in- SOURCE: 42 FR 14534, Mar. 15, 1977, unless clude the following: otherwise noted. (1) Substances generally recognized as safe for use in food or food pack- EDITORIAL NOTE: Nomenclature changes to part 175 appear at 61 FR 14482, Apr. 2, 1996, 66 aging. FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. (2) Substances permitted for use in 1, 2005. adhesives by prior sanction or approval and employed under the specific condi- Subpart A [Reserved] tions of use prescribed by such sanc- tion or approval. (3) Flavoring substances permitted for use in food by regulations in this

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part, provided that such flavoring sub- subchapter and substances named in stances are volatilized from the adhe- this subparagraph: Provided, however, sives during the packaging fabrication That any substance named in this process. paragraph and covered by a specific (4) Color additives approved for use in regulation in this subchapter, must food. meet any specifications in such regula- (5) Substances permitted for use in tion. adhesives by other regulations in this

Substances Limitations

Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4). Acetone--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 bifluoride ...... 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. 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. Asbestos. Asphalt, paraffinic and naphthenic. Azelaic acid. Azo-bis-isobutyronitrile. Balata rubber. Barium acetate.

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Substances Limitations

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. 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. Carbon black, channel process. Carbon disulfide-1,1′-methylenedipiperidine reaction product. Carbon tetrachloride. Carboxymethylcellulose.

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Substances Limitations

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. Cumene 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. peroxide. 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.

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Substances Limitations

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. 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 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.

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Substances Limitations

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. 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.

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Substances Limitations

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). Hydrofluoric 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. 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. b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. . 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.

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Substances Limitations

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. Japan wax. 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. Methyl ricinoleate. Methyl salicylate. 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.

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Substances Limitations

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). 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.

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Substances Limitations

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. 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, linseed 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.

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Substances Limitations

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. 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).

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Substances Limitations

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. Polytetrafluoroethylene.. 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. 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.

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Substances Limitations

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. Shellac. 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. 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. Sodium fluoride ...... 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.

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Substances Limitations

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). 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 pitch. 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.

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Substances Limitations

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. Titanium 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. 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.

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Substances Limitations

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. (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2- yl]amino]-2,6-di-tert-butylphenol (CAS Pressure-sensitive adhesives may be Reg. No. 991–84–4) as an antioxidant/ safely used as the food-contact surface stabilizer at a level not to exceed 1.5 of labels and/or tapes applied to food, percent by weight of the finished pres- in accordance with the following pre- sure-sensitive adhesive. scribed conditions: (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert- (a) Pressure-sensitive adhesives pre- butylbenzoxazole) (CAS Reg. No. 7128– pared from one or a mixture of two or 64–5) as an optical brightener at a level more of the substances listed in this not to exceed 0.05 percent by weight of paragraph may be used as the food-con- the finished pressure-sensitive adhe- tact surface of labels and/or tapes ap- sive. plied to poultry, dry food, and proc- (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) essed, frozen, dried, or partially dehy- phenyl]-2-methyl-1-propanone (CAS drated fruits or vegetables. Reg. No. 106797–53–9) as a photoinitiator (1) Substances generally recognized at a level not to exceed 5 percent by as safe in food. weight of the pressure-sensitive adhe- (2) Substances used in accordance sive. with a prior sanction or approval. (9) Butanedioic acid, sulfo-1,4-di-(C9- (3) Color additives listed for use in or C11 alkyl) ester, ammonium salt (also on food in parts 73 and 74 of this chap- known as butanedioic acid sulfo-1, 4- ter. diisodecyl ester, ammonium salt [CAS (4) Substances identified in § 172.615 of Reg. No. 144093–88–9]) as a surface ac- this chapter other than substances tive agent at a level not to exceed 3.0 used in accordance with paragraph percent by weight of the finished pres- (a)(2) of this section. sure-sensitive adhesive. (5) Polyethylene, oxidized; complying (b) Pressure-sensitive adhesives pre- with the identity prescribed in pared from one or a mixture of two or § 177.1620(a) of this chapter. more of the substances listed in this

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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. cured to an insoluble resin. Butadiene-styrene copolymer. (b) Optional substances used in the Butyl rubber. preparation of the polymer and in the Butylated reaction product of p-cresol and preparation and application of the dicyclopentadiene produced by reacting p- emulsion may include substances cresol and dicyclopentadiene in an approxi- named in this paragraph, in an amount mate mole ratio of 1.5 to 1.0, respectively, not to exceed that required to accom- followed by alkylation with isobutylene so that the butyl content of the final product plish the desired technical effect and is not less than 18 percent, for use at levels subject to any limitation prescribed: not to exceed 1.0 percent by weight of the Provided, however, That any substance adhesive formulation. named in this paragraph and covered Chlorinated natural rubber. by a specific regulation in subchapter Isobutylene-styrene copolymer. B of this chapter must meet any speci- Petrolatum. fications in such regulation. Polybutene-1. Polybutene, hydrogenated; complying with List of substances Limitations the identity prescribed under § 178.3740(b) of this chapter. Aluminum stearate. Ammonium lauryl sulfate. Polyisobutylene. Borax ...... Not to exceed the cis-1,4-Polyisoprene. amount required as a Polystyrene. preservative in emul- Propyl gallate. sion defoamer. Rapeseed oil, vulcanized. Disodium hydrogen phosphate ..... Do. Formaldehyde. Rosins and rosin derivatives as provided in Glyceryl monostearate. § 178.3870 of this chapter. Methyl cellulose. Rubber hydrochloride. Mineral oil. Rubber (natural latex solids or crepe, Paraffin wax. smoked or unsmoked). Potassium hydroxide. Terpene resins ( - and -pinene), Potassium persulfate. a b Tallow. homopolymers, copolymers, and conden- Tetrasodium pyrophosphate. sates with phenol, formaldehyde, cou- Titanium dioxide. marone, and/or indene. Tetrasodium ethylenediaminetetraacetate. (c) The coating in the form in which Tri(mixed mono- and dinonylphenyl) it contacts food meets the following phosphite (which may contain not more tests: than 1 percent by weight of (1) An appropriate sample when ex- triisopropanolamine). posed to distilled water at 212 °F for 30 (c) Acrylonitrile copolymers identi- minutes shall yield total chloroform- fied in this section shall comply with soluble extractables not to exceed 0.5 the provisions of § 180.22 of this chap- milligram per square inch. ter. (2) An appropriate sample when ex- ° [42 FR 14534, Mar. 15, 1977, as amended at 42 posed to n-heptane at 120 F for 30 min- FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, utes shall yield total chloroform-solu- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, ble extractables not to exceed 0.5 milli- Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] gram per square inch.

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§ 175.230 Hot-melt strippable food VIIA, and IX identified in table 1 of coatings. § 176.170(c) of this chapter and under Hot-melt strippable food coatings conditions of use E, F, and G described may be safely applied to food, subject in table 2 of § 176.170(c) of this chapter to the provisions of this section. shall be limited to a concentration not (a) The coatings are applied to and exceeding 15 percent by weight of the used as removable coatings for food. finished coating. The congealing point (b) The coatings may be prepared, as shall be determined by ASTM method mixtures, from the following sub- D938–71 (Reapproved 1981), ‘‘Standard stances: Test Method for Congealing Point of (1) Substances generally recognized Petroleum Waxes, Including Petro- as safe in food. latum,’’ which is incorporated by ref- (2) Substances identified in this sub- erence. Copies may be obtained from paragraph. the American Society for Testing Ma- terials, 100 Barr Harbor Dr., West List of substances Limitations Conshohocken, Philadelphia, PA 19428- 2959, or may be examined at the Na- Acetylated monoglycerides ...... Complying with 172.828 of this chapter. tional Archives and Records Adminis- Cellulose acetate butyrate. tration (NARA). For information on Cellulose acetate propionate. the availability of this material at Mineral oil, white ...... For use only as a com- ponent of hot-melt NARA, call 202–741–6030, or go to: http:// strippable food coat- www.archives.gov/federallregister/ ings applied to frozen codeloflfederallregulations/ meats and complying with § 172.878 of this ibrllocations.html. chapter. (2) Oil content. The substance has an oil content not exceeding 2.5 percent as § 175.250 Paraffin (synthetic). determined by ASTM method D721–56T, ‘‘Tentative Method of Test for Oil Con- Synthetic paraffin may be safely tent of Petroleum Waxes’’ (Revised used as an impregnant in, coating on, 1956), which is incorporated by ref- or component of coatings on articles erence. See paragraph (b)(1) of this sec- used in producing, manufacturing, tion for availability of the incorpora- packing, processing, preparing, treat- tion by reference. ing, packaging, transporting, or hold- ing food in accordance with the fol- (3) Absorptivity. The substance has an lowing prescribed conditions: absorptivity at 290 millimicrons in ° (a) The additive is synthesized by the decahydronaphthalene at 88 C not ex- Fischer-Tropsch process from carbon ceeding 0.01 as determined by ASTM monoxide and hydrogen, which are cat- method E131–81a, ‘‘Standard Defini- alytically converted to a mixture of tions of Terms and Symbols Relating paraffin hydrocarbons. Lower molec- to Molecular-Spectroscopy,’’ which is ular-weight fractions are removed by incorporated by reference. See para- distillation. The residue is hydro- graph (b)(1) of this section for avail- genated and may be further treated by ability of the incorporation by ref- percolation through activated char- erence. coal. This mixture can be fractionated (c) The provisions of this section are into its components by a solvent sepa- not applicable to synthetic paraffin ration method, using synthetic used in food-packaging adhesives com- isoparaffinic petroleum hydrocarbons plying with § 175.105. complying with § 178.3530 of this chap- [42 FR 14534, Mar. 15, 1977, as amended at 47 ter. FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, (b) Synthetic paraffin shall conform 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, to the following specifications: Aug. 3, 1995] (1) Congealing point. There is no speci- fication for the congealing point of § 175.260 Partial phosphoric acid synthetic paraffin components, except esters of polyester resins. those components that have a con- Partial phosphoric acid esters of pol- gealing point below 50 °C when used in yester resins identified in this section contact with food Types III, IVA, V, and applied on aluminum may be safely

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used as food-contact coatings, in ac- tional Archives and Records Adminis- cordance with the following prescribed tration (NARA). For information on conditions: the availability of this material at (a) For the purpose of this section, NARA, call 202–741–6030, or go to: http:// partial phosphoric acid esters of poly- www.archives.gov/federallregister/ ester resins are prepared by the reac- codeloflfederallregulations/ tion of trimellitic anhydride with 2,2- ibrllocations.html. dimethyl-1,3-propanediol followed by (1) Solvent. N,N-Dimethylacetamide, reaction of the resin thus produced technical grade. with phosphoric acid anhydride to (2) Solution. Powdered resin and sol- produce a resin having an acid number vent are heated at 120 °C until the resin of 81 to 98 and a phosphorus content of is dissolved. 4.05 to 4.65 percent by weight. (3) Temperature. Flow times of the (b) The coating is chemically bonded solvent and solution are determined at to the metal and cured at temperatures 110 °C. exceeding 450 °F. (4) Viscometer. Cannon-Ubbelohde size (c) The finished food-contact coating, 50 semimicro dilution viscometer (or when extracted with the solvent or sol- equivalent). vents characterizing the type of food (5) Calculation. The calculation meth- and under the conditions of time and od used is that described in appendix X temperature characterizing the condi- 1.3 (ASTM method D1243–79, ‘‘Standard tions of its intended use, as determined Test Method for Dilute Solution Vis- from tables 1 and 2 of § 175.300(d), yields cosity of Vinyl Chloride Polymers,’’ total extractives in each extracting which is incorporated by reference; see solvent not to exceed 0.3 milligrams paragraph (b) of this section for avail- per square inch of food-contact surface, ability of the incorporation by ref- as determined by the methods de- erence) with the reduced viscosity de- scribed in § 175.300(e), and the coating termined for three concentration levels yields 2,2-dimethyl-1,3-propanediol in not greater than 0.5 gram per deciliter each extracting solvent not to exceed and extrapolated to zero concentration 0.3 micrograms per square inch of food- for intrinsic viscosity. The following contact surface. In testing the finished formula is used for determining re- food-contact articles, a separate test duced viscosity: sample is to be used for each required extracting solvent. − Reduced viscosity in terms = tto § 175.270 Poly(vinyl fluoride) resins. of deciliters per gram to× c Poly(vinyl fluoride) resins identified where: in this section may be safely used as t=Solution efflux time. components of food-contact coatings to=Solvent efflux time. for containers having a capacity of not c=Concentration of solution in terms of less than 5 gallons, subject to the pro- grams per deciliter. visions of this section. [42 FR 14534, Mar. 15, 1977, as amended at 47 (a) For the purpose of this section, FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, poly(vinyl fluoride) resins consist of 1984] basic resins produced by the polym- erization of vinyl fluoride. § 175.300 Resinous and polymeric coat- (b) The poly(vinyl fluoride) basic res- ings. ins have an intrinsic viscosity of not Resinous and polymeric coatings less than 0.75 deciliter per gram as de- may be safely used as the food-contact termined by ASTM method D1243–79, surface of articles intended for use in ‘‘Standard Test Method for Dilute So- producing, manufacturing, packing, lution Viscosity of Vinyl Chloride processing, preparing, treating, pack- Polymers,’’ which is incorporated by aging, transporting, or holding food, in reference. Copies may be obtained from accordance with the following pre- the American Society for Testing Ma- scribed conditions: terials, 100 Barr Harbor Dr., West (a) The coating is applied as a contin- Conshohocken, Philadelphia, PA 19428- uous film or enamel over a metal sub- 2959, or may be examined at the Na- strate, or the coating is intended for

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repeated food-contact use and is ap- solvent extraction, or modified by com- plied to any suitable substrate as a bination with maleic anhydride. continuous film or enamel that serves (ii) Reconstituted oils from as a functional barrier between the triglycerides or fatty acids derived food and the substrate. The coating is from the oils listed in paragraph characterized by one or more of the fol- (b)(3)(i) of this section to form esters lowing descriptions: with: (1) Coatings cured by oxidation. Butylene glycol. (2) Coatings cured by polymerization, Ethylene glycol. condensation, and/or cross-linking Pentaerythritol. without oxidation. Polyethylene glycol. (3) Coatings prepared from prepoly- Polypropylene glycol. merized substances. Propylene glycol. (b) The coatings are formulated from Sorbitol. optional substances that may include: Trimethylol ethane. (1) Substances generally recognized Trimethylol propane. as safe in food. (iii) Synthetic drying oils, as the (2) Substances the use of which is basic polymer: permitted by regulations in this part or which are permitted by prior sanc- Butadiene and methylstyrene copolymer. tion or approval and employed under Butadiene and styrene copolymer, blown or the specific conditions, if any, of the unblown. Maleic anhydride adduct of butadiene sty- prior sanction or approval. rene. (3) Any substance employed in the Polybutadiene. production of resinous and polymeric coatings that is the subject of a regula- (iv) Natural fossil resins, as the basic tion in subchapter B of this chapter resin: and conforms with any specification in Copal. such regulation. Substances named in Damar. this paragraph (b)(3) and further identi- Elemi. fied as required: Gilsonite. (i) Drying oils, including the Glycerol ester of damar, copal, elemi, and triglycerides or fatty acids derived sandarac. therefrom: Sandarac. Shellac. Beechnut. Utah coal resin. Candlenut. Castor (including dehydrated). (v) Rosins and rosin derivatives, with Chinawood (tung). or without modification by polymeriza- Coconut. tion, isomerization, incidental Corn. , and/or hydrogenation, Cottonseed. as follows: Fish (refined). (a) Rosins, refined to color grade of K Hempseed. or paler: Linseed. Oiticica. Gum rosin. Perilla. Tall oil rosin. Poppyseed. Wood rosin. Pumpkinseed. (b) Rosin esters formed by reacting Safflower. Sesame. rosin (paragraph (b)(3)(v)(a) of this sec- Soybean. tion) with: Sunflower. 4,4′-sec-Butylidenediphenol-epichlorohydrin Tall oil. (epoxy). Walnut. Diethylene glycol. Ethylene glycol. The oils may be raw, heat-bodied, or Glycerol. blown. They may be refined by filtra- 4,4′-Isopropylidenediphenol-epichlorohydrin tion, degumming, acid or alkali wash- (epoxy). ing, bleaching, distillation, partial de- Methyl alcohol. hydration, partial polymerization, or Pentaerythritol.

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(c) Rosin esters (paragraph (b)(3)(v)(b) 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. of this section) modified by reaction tert-Butyl benzoic acid. with: Fatty acids derived from oils listed in para- graph (b)(3)(i) of this section. Maleic anhydride. Rosins listed in paragraph (b)(3)(v)(a) of this o-, m-, and p-substituted phenol-formalde- section, for use only as reactants in oil- hydes listed in paragraph (b)(3)(vi) of this based or fatty acid-based alkyd resins. section. (c) Polyhydric alcohols: Phenol-formaldehyde. (d) Rosin salts: Butylene glycol. Diethylene glycol. Calcium resinate (limed rosin). 2,2-Dimethyl-1,3-propanediol for use only in Zinc resinate. forming polyester resins for coatings in- tended for use in contact with non-alco- (vi) Phenolic resins as the basic poly- holic foods. mer formed by reaction of phenols with Ethylene glycol. formaldehyde: Glycerol. (a) Phenolic resins formed by reac- . tion of formaldehyde with: a-Methyl glucoside. Pentaerythritol. Alkylated (methyl, ethyl, propyl, isopropyl, Propylene glycol. butyl) phenols. Sorbitol. p-tert-Amylphenol. Triethylene glycol, for use as a component in 4,4′-sec-Butylidenediphenol. polyester resins for coatings not exceeding p-tert-Butylphenol. a coating weight of 4 milligrams per square o-, m-, and p-Cresol. inch and that are intended for contact p-Cyclohexylphenol. under conditions of use D, E, F or G de- 4,4′-Isopropylidenediphenol. scribed in table 2 of paragraph (d) of this p-Nonylphenol. section with alcoholic beverages con- p-Octylphenol. taining less than 8 percent alcohol. 3-Pentadecyl phenol mixture obtained from Trimethylol ethane. cashew nut shell liquid. Trimethylol propane. Phenol. (d) Monohydric alcohols: Phenyl o-cresol. p-Phenylphenol. Cetyl alcohol. Xylenol. Decyl alcohol. Lauryl alcohol. (b) Adjunct for phenolic resins: Alu- Myristyl alcohol. minum butylate. Octyl alcohol. (vii) Polyester resins (including Stearyl alcohol. alkyd-type), as the basic polymers, (e) Catalysts: formed as esters of acids listed in para- graph (b)(3)(vii) (a) and (b) of this sec- Dibutyltin oxide (CAS Reg. No. 818–08–6), not tion by reaction with alcohols in para- to exceed 0.2 percent of the polyester resin. graph (b)(3)(vii) (c) and (d) of this sec- Hydroxybutyltin oxide (CAS Reg. No. 2273– tion. 43–0), not to exceed 0.2 percent of the poly- ester resin. (a) Polybasic acids: Monobutyltin tris(2-ethylhexoate) (CAS Reg. Adipic. No. 23850–94–4), not to exceed 0.2 percent of 1,4-cyclohexanedicarboxylic (CAS Reg. No. the polyester resin. 1076–97–7). (viii) Epoxy resins, catalysts, and ad- Dimerized fatty acids derived from oils listed juncts: in paragraph (b)(3)(i) of this section. Fumaric. (a) Epoxy resins, as the basic poly- Isophthalic. mer: Maleic. (Alkoxy C10-C16)-2,3-epoxypropane, in which 2,6-Naphthalenedicarboxylic. the alkyl groups are even numbered and 2,6-Naphthalenedicarboxylic, dimethyl ester. consist of a maximum of 1 percent C10 car- Orthophthalic. bon atoms and a minimum of 48 percent C12 Sebacic. carbon atoms and a minimum of 18 percent Terephthalic. C14 carbon atoms, for use only in coatings Terpene-maleic acid adduct. that are intended for contact with dry bulk Trimellitic. foods at room temperature. (b) Monobasic acids: 4,4′-sec-Butylidenediphenol-epichlorohydrin. 4,4′-sec-Butylidenediphenol-epichlorohydrin Benzoic acid. reacted with one or more of the drying oils

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or fatty acids listed in paragraph (b)(3)(i) Benzyl alcohol (CAS Reg. No. 100–51–6), for of this section. use only in coatings at a level not to ex- 4,4′-sec-Butylidenediphenol-epichlorohydrin ceed 4 percent by weight of the resin when chemically treated with one or more of such coatings are intended for repeated use the following substances: in contact with foods only of the types Allyl ether of mono-, di-, or trimethylol identified in paragraph (d) of this section, phenol. table 1, under Types I, II, and III, under 4,4′-sec-Butylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described 4,4′-Isopropylidenediphenol-formaldehyde. in table 2 of paragraph (d) of this section; Melamine-formaldehyde. or when such coatings are intended for re- Phenol-formaldehyde. peated use in contact with foods of the Urea-formaldehyde. types identified in paragraph (d) of this Epoxidized polybutadiene. section, table 1, under Types V, VI, VII, Glycidyl ethers formed by reacting and VIII, under conditions of use E or F as phenolnovolak resins with described in table 2 of paragraph (d) of this epichlorohydrin. section. Use shall be limited to coatings 4,4′-Isopropylidenediphenol-epichlorohydrin. for tanks of capacity greater than 530,000 4,4′-Isopropylidenediphenol-epichlorohydrin gallons. reacted with one or more of the drying oils Catalysts and cross-linking agents for epoxy or fatty acids listed in paragraph (b)(3)(i) resins: of this section. 3-Aminomethyl-3,5,5- 4,4′-Isopropylidenediphenol-epichlorohydrin trimethylcyclohexylamine (CAS Reg. No. chemically treated with one or more of 2855–0913–092). the following substances: Cyanoguanidine. Allyl ether of mono-, di-, or trimethylol Dibutyl phthalate, for use only in coatings phenol. for containers having a capacity of 1,000 4,4′-sec-Butylidenediphenol-formaldehyde. gallons or more when such containers are 4,4′-Isopropylidenediphenol-formaldehyde. intended for repeated use in contact with Melamine-formaldehyde. alcoholic beverages containing up to 8 per- 2,2′-[(1-methylethylidene)bis[4,1- cent of alcohol by volume. phenyleneoxy[1-(butoxymethyl)-2,1- 3-Diethylaminopropylamine (CAS Reg. No. ethanediyl]oxymethylene]]bisoxirane, 104–78–9), for use in coatings at a level not CAS Reg. No. 71033–08–4, for use only in to exceed 6 percent by weight of the resin coatings intended for contact with bulk when such coatings are intended for re- dry foods at temperatures below 100 °F. peated use in contact with foods only of Phenol-formaldehyde. the types identified in paragraph (d) of this Urea-formaldehyde. section, table 1, under Types I, II, and III, (b) Catalysts and cross-linking agents under conditions of use C, D, E, or F as de- for epoxy resins: scribed in table 2 of paragraph (d) of this section; or when such coatings are in- 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- tended for repeated use in contact with amine reacted with phenol and formalde- foods of the types identified in paragraph hyde in a ratio of 2.6:1.0:2.0, for use only in (d) of this section, table 1, under Types V, coatings intended for repeated use in con- VI, VII, and VIII, under conditions of use E tact with foods only of the types identified or F as described in table 2 of paragraph (d) in paragraph (d) of this section, table 1, of this section. Use shall be limited to under Category I and Category VIII, at coatings for tanks of capacity greater than temperatures not exceeding 88 °C (190 °F). 530,000 gallons. N-Beta-(aminoethyl)-gamma-aminopropyltri- Diethylenetriamine. methoxysilane (CAS Reg. No. 1760–24–3), for Diphenylamine. use only in coatings at a level not to ex- Ethylenediamine. ceed 1.3 percent by weight of the resin Isophthalyl dihydrazide for use only in coat- when such coatings are intended for re- ings subject to the provisions of paragraph peated use in contact with foods only of (c) (3) or (4) of this section. the types identified in paragraph (d) of this 4,4′-Methylenedianiline, for use only in coat- section, table 1, under Types I, II, and III, ings for containers having a capacity of under conditions of use C, D, E, or F as de- 1,000 gallons or more when such containers scribed in table 2 of paragraph (d) of this are intended for repeated use in contact section; or when such coatings are in- with alcoholic beverages containing up to 8 tended for repeated use in contact with percent of alcohol by volume. foods of the types identified in paragraph N-Oleyl-1,3-propanediamine with not more (d) of this section, table 1, under Types V, than 10 percent by weight of VI, VII, and VIII, under conditions of use E diethylaminoethanol. or F as described in table 2 of paragraph (d) 3-Pentadecenyl phenol mixture (obtained of this section. Use shall be limited to from cashew nutshell liquid) reacted with coatings for tanks of capacity greater than formaldehyde and ethylenediamine in a 530,000 gallons. ratio of 1:2:2 (CAS Reg. No. 68413–28–5).

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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 coholic beverages containing up to 8 per- in contact with foods only of the types cent of alcohol by volume. identified in paragraph (d) of this section, Salicylic acid (CAS Reg. No. 69–72–7), for use table 1, under Types I, II, and III, under only in coatings at a level not to exceed conditions of use C, D, E or F as described 0.35 percent by weight of the resin when in table 2 of paragraph (d) of this section; such coatings are intended for repeated use or when such coatings are intended for re- in contact with foods only of the types peated use in contact with foods of the identified in paragraph (d) of this section, types identified in paragraph (d) of this table 1, under Types I, II, and III, under section, table 1, under Types V, VI, VII, conditions of use C, D, E, or F as described and VIII, under conditions of use E or F as in table 2 of paragraph (d) of this section; described in table 2 of paragraph (d) of this or when such coatings are intended for re- section. Use shall be limited to coatings peated use in contact with foods of the for tanks of capacity greater than 530,000 types identified in paragraph (d) of this gallons. section, table 1, under Types V, VI, VII, Para-Xylylenediamine (1,4 benzenedimethan- and VIII, under conditions of use E or F as amine, CAS Reg. No. 539–48–0), for use only described in table 2 of paragraph (d) of this in coatings at a level not to exceed 0.6 per- section. Use shall be limited to coatings cent by weight of the resin when such coat- for tanks of capacity greater than 530,000 ings are intended for repeated use in con- gallons. tact with foods only of the types identified Stannous 2-ethylhexanoate for use only as a in paragraph (d) of this section, table 1, catalyst at a level not to exceed 1 percent under Types I, II, III, under conditions of by weight of the resin used in coatings that use C, D, E, or F as described in table 2 of are intended for contact with food under paragraph (d) of this section; or when such conditions of use D, E, F, and G described coatings are intended for repeated use in in table 2 of paragraph (d) of this section. contact with foods of the types identified Styrene oxide, for use only in coatings for in paragraph (d) of this section, table 1, containers having a capacity of 1,000 gal- under Types V, VI, VII, and VIII, under lons or more when such containers are in- conditions of use E and F as described in tended for repeated use in contact with al- table 2 of paragraph (d) of this section. Use coholic beverages containing up to 8 per- shall be limited to coatings for tanks of ca- cent of alcohol by volume. pacity greater than 530,000 gallons. Tetraethylenepentamine. (c) Adjuncts for epoxy resins: Tetraethylenepentamine reacted with equimolar quantities of fatty acids. Aluminum butylate. Tri(dimethylaminomethyl) phenol and its Benzoic acid, for use as a component in salts prepared from the fatty acid moieties epoxy resins for coatings not exceeding a of the salts listed in paragraph coating weight of 4 milligrams per square (b)(3)(xxii)(b) of this section, for use only inch and that are intended for contact in coatings subject to the provisions of under conditions of use D, E, F or G de- paragraph (c) (3) or (4) of this section. scribed in table 2 of paragraph (d) of this Triethylenetetramine. section with alcoholic beverages con- Trimellitic anhydride (CAS Reg. No. 552–30– taining less than 8 percent alcohol. 7) for use only as a cross-linking agent at Polyamides from dimerized vegetable oils a level not to exceed 15 percent by weight and the amine catalysts listed in para- of the resin in contact with food under all graph (b)(3)(viii)(b) of this section, as the conditions of use, except that resins in- basic polymer. tended for use with foods containing more Silane coupled silica, prepared from the re- than 8 percent alcohol must contact such action of microcrystalline quartz with N- food only under conditions of use D, E, F, beta-(N-vinylbenzylamino) ethyl-gamma-

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aminopropyltrimethoxy silane, mono- Triethanolamine. hydrogen chloride, for use only in coatings Melamine-formaldehyde chemically modified intended for repeated use in contact with with methyl, ethyl, propyl, isopropyl, foods only of the types identified in para- butyl, or isobutyl alcohol. graph (d) of this section, table 1, under Category I and Category VIII, at tempera- (b) Curing (cross-linking) catalyst for tures not exceeding 88 °C (190 °F). triazine-formaldehyde resins: Succinic anhydride, for use as a component Dodecyl benzenesulfonic acid (C.A. Registry in epoxy resins for coatings not exceeding No. 27176–87–0). a coating weight of 4 milligrams per square inch, and that are intended for contact (xiv) Modifiers (for oils and alkyds, under conditions of use D, E, F or G de- including polyesters), as the basic poly- scribed in table 2 of paragraph (d) of this mer: section with alcoholic beverages con- taining less than 8 percent alcohol. Butyl methacrylate. Cyclopentadiene. (ix) Coumarone-indene resin, as the Methyl, ethyl, butyl, or octyl esters of acryl- basic polymer. ic acid. (x) Petroleum hydrocarbon resin Methyl methacrylate. (cyclopentadiene type), as the basic Styrene. Vinyl toluene. polymer. (xi) Terpene resins, as the basic poly- (xv) Vinyl resinous substance, as the mer, from one or more of the following: basic polymers: Dipentene. Polyvinyl acetate. Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl alcohol. 106168–39–2). For use only with coatings in Polyvinyl butyral. contact with acidic and aqueous foods. Polyvinyl chloride. Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl formal. dipentene copolymer resin (CAS Reg. No. Polyvinylidene chloride. 106168–37–0). For use only with coatings in Polyvinyl pyrrolidone. contact with acidic and aqueous foods. Polyvinyl stearate. a-Pinene. Vinyl chloride-acetate-2,3-epoxypropyl meth- b-Pinene. acrylate copolymers containing not more than 10 weight percent of total polymer (xii) Urea-formaldehyde, resins and units derived from 2,3-epoxypropyl meth- their curing catalyst: acrylate and not more than 0.1 weight per- (a) Urea-formaldehyde resins, as the cent of unreacted 2,3-epoxypropyl meth- basic polymer: acrylate monomer for use in coatings for containers. Urea-formaldehyde. Vinyl chloride-acetate, hydroxyl-modified Urea-formaldehyde chemically modified with copolymer. methyl, ethyl, propyl, isopropyl, butyl, or Vinyl chloride-acetate, hydroxyl-modified isobutyl alcohol. copolymer, reacted with trimellitic anhy- Urea-formaldehyde chemically modified with dride. one or more of the amine catalysts listed Vinyl chloride copolymerized with acryl- in paragraph (b)(3)(viii)(b) of this section. amide and ethylene in such a manner that the finished copolymers have a minimum (b) Curing (cross-linking) catalyst for weight average molecular weight of 30,000 urea-formaldehyde resins: and contain not more than 3.5 weight per- Dodecyl benzenesulfonic acid (C.A. Registry cent of total polymer units derived from No. 27176–87–0). acrylamide; the acrylamide portion may or may not be subsequently partially (xiii) Triazine-formaldehyde resins hydrolyzed. and their curing catalyst: Vinyl chloride copolymerized with one or (a) Triazine-formaldehyde resins, as more of the following substances: the basic polymer: Acrylonitrile. Fumaric acid and/or its methyl, ethyl, Benzoguanamine-formaldehyde. propyl, butyl, amyl, hexyl, heptyl, or octyl Melamine-formaldehyde. esters. Melamine-formaldehyde chemically modified Maleic acid and/or its methyl, ethyl, propyl, with one or more of the following amine butyl, amyl, hexyl, heptyl, or octyl esters. catalysts: 5-Norbornene-2,3-dicarboxylic acid, mono-n- Amine catalysts listed in paragraph butyl ester; for use such that the finished (b)(3)(viii)(b) of this section. vinyl chloride copolymers contain not Dimethylamine-2-methyl-1-propanol. more than 4 weight percent of total poly- Methylpropanolamine. mer units derived from this comonomer.

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Vinyl acetate. (HFS–200), Food and Drug Administration, Vinylidene chloride. 5100 Paint Branch Pkwy., College Park, Vinyl chloride-vinylidene chloride-2,3- MD 20740, or available for inspection at the epoxypropyl methacrylate copolymers con- National Archives and Records Adminis- taining not more than 10 weight percent of tration (NARA). For information on the total polymer units derived from 2,3- availability of this material at NARA, call epoxypropyl methacrylate and not more 202–741–6030, or go to: http:// than 0.05 weight percent of unreacted 2,3- www.archives.gov/federallregister/ epoxypropyl methacrylate monomer based codeloflfederallregulations/ on polymer solids for use only in coatings ibrllocations.html. for containers intended for contact with foods under conditions B, C, D, E, F, G, or (xx) Acrylics and their copolymers, H described in table 2 of paragraph (d) of as the basic polymer: this section. Acrylamide with ethylacrylate and/or sty- (xvi) Cellulosics, as the basic poly- rene and/or methacrylic acid, subsequently mer: reacted with formaldehyde and butanol. Acrylic acid and the following esters thereof: Carboxymethylcellulose. Ethyl. Cellulose acetate. Methyl. Cellulose acetate-butyrate. Cellulose acetate-propionate. Butyl acrylate-styrene-methacrylic acid-hy- Ethylcellulose. droxyethyl methacrylate copolymers con- Ethyl hydroxyethylcellulose. taining no more than 20 weight percent of Hydroxyethylcellulose. total polymer units derived from meth- Hydroxypropyl methylcellulose. acrylic acid and containing no more than 7 Methylcellulose. weight percent of total polymer units de- Nitrocellulose. rived from hydroxyethyl methacrylate; for use only in coatings that are applied by (xvii) Styrene polymers, as the basic electrodeposition to metal substrates. polymer: Butyl acrylate-styrene-methacrylic acid- hydroxypropyl methacrylate copolymers Polystyrene. containing no more than 20 weight percent a-Methyl styrene polymer. of total polymer units derived from meth- Styrene copolymerized with one or more of acrylic acid and containing no more than 7 the following: weight percent of total polymer units de- Acrylonitrile. rived from hydroxypropyl methacrylate; a-Methylstyrene. for use only in coatings that are applied by (xviii) Polyethylene and its copoly- electrodeposition to metal substrates and mers as the basic polymer: that are intended for contact, under condi- tion of use D, E, F, or G described in table Ethylene-ethyl acrylate copolymer. 2 of paragraph (d) of this section, with food Ethylene-isobutyl acrylate copolymers con- containing no more than 8 percent of alco- taining no more than 35 weight percent of hol. total polymer units derived from isobutyl Ethyl acrylate-styrene-methacrylic acid co- acrylate. polymers for use only as modifiers for Ethylene-vinyl acetate copolymer. epoxy resins listed in paragraph Polyethylene. (b)(3)(viii)(a) of this section. (xix) Polypropylene as the basic poly- Ethyl acrylate-methyl methacrylate-sty- rene-methacrylic acid copolymers for use mer: only as modifiers for epoxy resins listed in Polypropylene. paragraph (b)(3)(viii)(a) of this section. Maleic anhydride adduct of polypropylene 2-Ethylhexyl acrylate-ethyl acrylate copoly- The polypropylene used in the manufac- mers prepared by copolymerization of 2- ture of the adduct complies with ethylhexyl acrylate and ethyl acrylate in a § 177.1520(c), item 1.1; and the adduct has a 7/3 weight ratio and having a number aver- maximum combined maleic anhydride con- age molecular weight range of 5,800 to 6,500 tent of 0.8 percent and a minimum intrin- and a refractive index, nD25° (40 percent in sic viscosity of 0.9, determined at 135 °C on 2,2,4-trimethyl pentane) of 1.4130–1.4190; for a 0.1 percent solution of the modified poly- use as a modifier for nylon resins com- propylene in decahydronaphthalene as de- plying with § 177.1500 of this chapter and for termined by a method titled ‘‘Method for phenolic and epoxy resins listed in para- Determination of Intrinsic Viscosity of graph (b)(3) (vi) and (viii) of this section, Maleic Anhydride Adduct of Poly- respectively, at a level not to exceed 1.5 propylene,’’ which is incorporated by ref- percent of the coating. erence. Copies are available from the Cen- 2-Ethylhexyl acrylate-methyl methacrylate- ter for Food Safety and Applied Nutrition acrylic acid copolymers for use only as

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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: Butyl. (a) Metals: 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 containing no more than 2 weight percent Zirconium. of total polymer units derived from meth- (b) Salts: acrylic acid and containing no more than 9.5 weight percent of total polymer units Caprate. derived from hydroxyethyl methacrylate; Caprylate. for use only in coatings in contact with dry Isodecanoate. food (food type VIII in table 1 of paragraph Linoleate. (d) of this section). 2-(Dimethylamino) eth- Naphthenate. anol (C.A.S. Registry No. 108–01–0) may be Neodecanoate. employed as an optional adjuvant sub- Octoate (2-ethylhexoate). stance limited to no more than 2 weight Oleate. percent based on polymer solids in the Palmitate. coating emulsion. Resinate. Styrene polymers made by the polymeriza- Ricinoleate. tion of any combination of styrene or Soyate. alpha methyl styrene with acrylic acid, Stearate. methacrylic acid, 2-ethyl hexyl acrylate, Tallate. methyl methacrylate, and butyl acrylate. The styrene and alpha methyl styrene, in- (xxiii) Waxes: dividually, may constitute from 0 to 80 Paraffin, Type I. weight percent of the polymer. The other Paraffin, Type II. monomers, individually, may be from 0 to Polyethylene. 40 weight percent of the polymer. The poly- Sperm oil. mer number average molecular weight (M ) n Spermaceti. shall be at least 2,000 (as determined by gel permeation chromatography). The acid (xxiv) Plasticizers: number of the polymer shall be less than 250. The monomer content shall be less Acetyl tributyl citrate. than 0.5 percent. The polymers are for use Acetyl triethyl citrate. only in contact with food of Types IV-A, V, Butyl phthalyl butyl glycolate. VII in table 1 of paragraph (d) of this sec- Butyl stearate. tion, under use conditions E through G in p-tert-Butyl phenyl salicylate. table 2 of paragraph (d), and with food of Dibutyl sebacate. Type VIII without use temperature restric- Diethyl phthalate. tion. Diisobutyl adipate. Diisooctyl phthalate. (xxi) Elastomers, as the basic poly- Epoxidized soybean oil (iodine number max- mer: imum 14; oxirane oxygen content 6% min- imum), as the basic polymer. Butadiene-acrylonitrile copolymer. Ethyl phthalyl ethyl glycolate. Butadiene-acrylonitrile-styrene copolymer. 2-Ethylhexyl diphenyl phosphate. Butadiene-styrene copolymer. Butyl rubber. di-2-Ethylhexyl phthalate. Chlorinated rubber. Glycerol. 2-Chloro-1,3-butadiene (neoprene). Glyceryl monooleate. Natural rubber (natural latex or natural Glyceryl triacetate. latex solids, smoked or unsmoked). Monoisopropyl citrate. Polyisobutylene. Propylene glycol. Rubber hydrochloride. Sorbitol. Styrene-isobutylene copolymer. Mono-, di-, and tristearyl citrate. Triethyl citrate. (xxii) Driers made by reaction of a Triethylene glycol. metal from paragraph (b)(3)(xxii)(a) of 3-(2-Xenolyl)-1,2-epoxypropane.

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(xxv) Release agents, as the basic (CAS Reg. No. 68037–59–2), where the plat- polymer, when applicable: inum content does not exceed 150 parts per million. The following substances may be N,N′-Dioleoylethylenediamine (CAS Reg. No. used as optional polymerization inhibitors: 110–31–6) for use only in ionomeric resins 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. complying with § 177.1330 of this chapter 107–54–0), at a level not to exceed 0.53 and in ethylene vinyl acetate copolymers weight-percent; complying with § 177.1350 of this chapter at 1-Ethynylcyclohexene (CAS Reg. No. 931–49– a level not to exceed 0.0085 milligram per 7), at a level not to exceed 0.64 weight-per- square centimeter (0.055 milligram per cent; square inch) in the finished food-contact Bis(methoxymethyl)ethyl maleate (CAS Reg. article. No. 102054–10–4), at a level not to exceed 1.0 N,N′-Distearoyl ethylenediamine. weight-percent; Linoleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No. Oleic acid amide. 68082–23–5); and Palmitic acid amide. Tetramethyltetravinylcyclotetrasiloxane Petrolatum. (CAS Reg. No. 2554–06–5). Polyethylene wax. Polyoxyethylene glycol monooleate (mol. (b) Curing (cross-linking) catalysts wt. of the polyoxyethylene glycol moiety for silicones (the maximum amount of greater than 300). tin catalyst used shall be that required Polytetrafluoroethylene. to effect optimum cure but shall not Silicones (not less than 300 centistokes vis- exceed 1 part of tin per 100 parts of si- cosity): Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The methyl- loxane resins solids): phenylpolysiloxanes contain not more than Dibutyltin dilaurate. 2.0 percent by weight of cyclosiloxanes Stannous oleate. having up to and including 4 siloxy units. Tetrabutyl titanate. Silicones (not less than 100 centistokes vis- cosity): Dimethylpolysiloxanes and/or (xxix) Surface active agents: methylphenylpolysiloxanes limited to use Ethylene oxide adduct of 2,4,7,9-tetramethyl- only on metal substrates. The 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). methylphenylpolysiloxanes contain not Poly[2-(diethylamino) ethyl methacrylate] more than 2.0 percent by weight of phosphate (minimum intrinsic viscosity in cyclosiloxanes having up to and including 4 water at 25 °C is not less than 9.0 deciliters siloxy units. per gram as determined by ASTM method (xxvi) Colorants used in accordance D1243–79, ‘‘Standard Test Method for Dilute with § 178.3297 of this chapter. Solution Viscosity of Vinyl Chloride Poly- (xxvii) Surface lubricants: mers,’’ which is incorporated by reference (Copies may be obtained from the Amer- Cottonseed oil and other edible oils. ican Society for Testing Materials, 100 Dibutyl sebacate. Barr Harbor Dr., West Conshohocken, Dioctyl sebacate. Philadelphia, PA 19428-2959, or may be ex- Glyceryl monostearate. amined at the National Archives and Lanolin. Records Administration (NARA). For in- Mineral oil, white. formation on the availability of this mate- Palm oil. rial at NARA, call 202–741–6030, or go to: Paraffin, Type I. http://www.archives.gov/federallregister/ Paraffin, Type II. codeloflfederallregulations/ Petrolatum. ibrllocations.html.), for use only as a sus- Stearic acid. pending agent in the manufacture of vinyl (xxviii) Silicones and their curing chloride copolymers and limited to use at catalysts: levels not to exceed 0.1 percent by weight of the copolymers. (a) Silicones as the basic polymer: Sodium dioctyl sulfosuccinate. Siloxane resins originating from methyl hy- Sodium dodecylbenzenesulfonate drogen polysiloxane, dimethyl Sodium lauryl sulfate. polysiloxane, and methylphenyl 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. polysiloxane. Reg. No. 126-86-3), for use only in can coat- Siloxane resins originating from the plat- ings which are subsequently dried and inum-catalyzed reaction product of vinyl- cured at temperatures of at least 193 °C (380 containing dimethylpolysiloxane (CAS °F) for 4 minutes. Reg. No. 68083–18–1 and CAS Reg. No. 68083– (xxx) Antioxidants: 19–2) with methylhydrogen polysiloxane (CAS Reg. No. 63148–57–2) and Butylated hydroxyanisole. dimethylmethylhydrogen polysiloxane Butylated hydroxytoluene.

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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 of the types identified in paragraph (d) of (xxxi) Can end cements (sealing com- 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. N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No. (CAS Reg. No. 26471–45–4) for use only at 23128–74–7. levels not to exceed 23.8 percent by weight Polyamides consisting of the following: of the cement solids in can end cements. Copolymer of omega-laurolactam and Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191– 4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6). Dibenzamido phenyl disulfide. Homopolymer of omega-aminododecanoic Di-b-naphthyl phenylenediamine. acid, CAS Reg. No. 24937–16–4. Dipentamethylene thiuram tetrasulfide. Homopolymer of omega-laurolactam, CAS Isobutylene-isoprene-divinylbenzene copoly- Reg. No. 25038–74–8 (Nylon 12). mers for use only at levels not to exceed 15 Polyamides derived from the following acids percent by weight of the dry cement com- and amines: position. Acids: Naphthalene sulfonic acid-formaldehyde con- Adipic. densate, sodium salt, for use only at levels Azelaic. not to exceed 0.6 percent by weight of the Sebacic. cement solids in can end cements for con- Vegetable oil acids (with or without tainers having a capacity of not less than dimerization). 5 gallons. Amines: Sodium decylbenzene sulfonate. Diethylenetriamine. Sodium nitrite for use only at levels not to Diphenylamine. exceed 0.3 percent by weight of the cement Ethylenediamine. solids in can end cements for containers Hexamethylenediamine. having a capacity of not less than 5 gal- Tetraethylenepentamine. lons. Triethylenetetramine. Sodium pentachlorophenate for use as a pre- Polypropylene glycol CAS Reg. No. 25322–69– servative at 0.1 percent by weight in can- 4. sealing compounds on containers having a Sodium pentachlorophenate for use as a pre- capacity of 5 gallons or more. servative at 0.1 percent by weight in can- Sodium phenylphenate. sealing compounds on containers having a Styrene-maleic anhydride resin, partial capacity of 5 gallons or more. Tetrakis [methylene(3,5-di-tert-butyl-4- methyl and butyl (sec- or iso-) esters, for hydroxyhydrocinnamate)]methane, CAS use only at levels not in excess of 3 percent Reg. No. 6683–19–8. of the cement solids in can end cement for- Toluene sulfonamide formaldehyde resin mulations. (basic polymer). Tetrasodium EDTA (tetrasodium ethylene- Triethylene glycol methacrylate for use only diaminetetraacetate). as polymerization cross-linking agent in Tri (mixed mono- and dinonylphenyl) side seam cements for containers intended phosphite. for use in contact with food only of the Zinc dibutyldithiocarbamate. types identified in paragraph (d) of this (xxxii) Side seam cements: In addi- section, table 1, under Categories I, II, and tion to the substances listed in para- VI. graph (b)(3) (i) to (xxx), inclusive, of Urea. this section, the following may be used. (xxxiii) Miscellaneous materials: p-tert-Butyl perbenzoate as a catalyst for Ammonium citrate. epoxy resin. Ammonium potassium phosphate. epsilon-Caprolactam-(ethylene-ethyl acry- Bentonite, modified by reaction with benzyl late) graft polymer. dimethyl alkyl ammonium chloride, where Dicumyl peroxide for use only as polymeriza- the alkyl groups are derived from hydro- tion catalyst. genated tallow (CAS Reg. No. 71011–24–0).

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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/ Calcium, sodium, and potassium oleates. codeloflfederallregulations/ Calcium, sodium, and potassium ibrllocations.html. For use only in contact ricinoleates. with nonalcoholic and nonfatty foods Calcium, sodium, and potassium stearates. under conditions of use E, F, and G, de- Castor oil, hydrogenated. scribed in table 2 of paragraph (d) this sec- Castor oil, hydrogenated polymer with ethyl- tion. enediamine, 12-hydroxyoctadecanoic acid Decyl alcohol. and sebacic acid (CAS Reg. No. 68604–06–8). 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. The condensation product formed by the 35691–65–7). For use as an antimicrobial reaction of hydrogenated castor oil with agent at levels not to exceed 500 milli- polyamide derived from ethylenediamine, grams per kilogram in emulsion-based sili- sebacic acid and 12-hydroxystearic acid, for cone coatings. use only in coatings at a level not to ex- Disodium hydrogen phosphate. ceed 3.2 percent by weight of the resin Ethyl acetoacetate. when such coatings are intended for re- Hectorite, modified by reaction with a mix- peated use in contact with foods only of ture of benzyl methyl dialkyl ammonium the types identified in paragraph (d) of this chloride and dimethyl dialkyl ammonium section, table 1, under Types I, II, and III, chloride, where the alkyl groups are de- under conditions of use C, D, E, or F as de- rived from hydrogenated tallow (CAS Reg. scribed in table 2 of paragraph (d) of this No. 121888–67–3). For use as a rheological section; or when such coatings are in- agent only in coatings intended to contact tended for repeated use in contact with dry food under repeated-use conditions. foods of the types identified in paragraph Lauryl alcohol. (d) of this section, table 1, under Types V, Lecithin. VI, VII, and VIII, under conditions of use E Magnesium, sodium, and potassium citrate. or F as described in table 2 of paragraph (d) Magnesium glycerophosphate. of this section. Use shall be limited to Magnesium stearate. coatings for tanks of capacity greater than Mono-, di-, and tricalcium phosphate. 530,000 gallons. Monodibutylamine pyrophosphate as Castor oil, sulfated, sodium salt (CAS Reg. sequestrant for iron. No. 68187–76–8), for use only in coatings for Mono-, di-, and trimagnesium phosphate. containers intended for repeated use. Myristyl alcohol. Cetyl alcohol. Octyl alcohol. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Phosphoric acid. Reg. No. 26172–55–4) and 2-methyl-4- Polybutene, hydrogenated; complying with isothiazolin-3-one (CAS Reg. No. 2682–20–4) the identity and limitations prescribed by mixture, at a ratio of 3 parts to 1 part, re- § 178.3740 of this chapter. spectively, manufactured from methyl-3- Poly(ethylene oxide). mercaptopropionate (CAS Reg. No. 2935–90– Siloxanes and silicones, dimethyl, 3- 2) and optionally containing magnesium hydroxypropyl group-terminated, diesters nitrate (CAS Reg. No. 10377–60–3) at a con- with poly(2-oxepanone), diacetates (CAS centration equivalent to the isothiazolone Reg. No. 116810–47–0) at a level not to ex- active ingredients (weight/weight). For use ceed 0.025 weight percent of the finished only as an antimicrobial agent in emul- coating having no greater than a 0.5 mil sion-based silicone coatings at a level not thickness for use as a component of poly- to exceed 50 milligrams per kilogram ester, epoxy, and acrylic coatings com- (based on isothiazolone active ingredient) plying with paragraphs (b)(3)(vii), (viii), in the coating formulations. and (xx) of this section, respectively. Cyclohexanone-formaldehyde resin produced Silver chloride-coated titanium dioxide for when 1 mole of cyclohexanone is made to use only as a preservative in latex emul- react with 1.65 moles of formaldehyde such sions at a level not to exceed 2.2 parts per that the finished resin has an average mo- million (based on silver ion concentration) lecular weight of 600–610 as determined by in the dry coating.

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Sodium pyrophosphate. methacrylonitrile; for use only in coat- Stannous chloride. ings that are intended for contact, Stannous stearate. under conditions of use D, E, F, or G Stannous sulfate. 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- component prepared from terephthalic graph (d) of this section, and limited to use 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 Tridecyl alcohol produced from for use in contact with aqueous foods tetrapropylene by the oxo process, for use and alcoholic foods containing not only as a processing aid in polyvinyl chlo- ride resins. more than 20 percent (by volume) of al- Trimethylolpropane (CAS Reg. No. 77–99–6). cohol under conditions of use D, E, F, For use as a pigment dispersant at levels and G described in table 2 of § 176.170 of not to exceed 0.45 percent by weight of the this chapter. The resin shall contain no pigment. more than 30 weight percent of 2,2-di- Vinyl acetate-dibutyl maleate copolymers methyl-1,3-propanediol. produced when vinyl acetate and dibutyl maleate are copolymerized with or without (c) The coating in the finished form one of the monomers: Acrylic acid or in which it is to contact food, when ex- glycidyl methacrylate. For use only in tracted with the solvent or solvents coatings for metal foil used in contact with characterizing the type of food, and foods that are dry solids with the surface under conditions of time and tempera- containing no free fat or oil. The finished copolymers shall contain at least 50 ture characterizing the conditions of weight-percent of polymer units derived its intended use as determined from ta- from vinyl acetate and shall contain no bles 1 and 2 of paragraph (d) of this sec- more than 5 weight-percent of total poly- tion, shall yield chloroform-soluble ex- mer units derived from acrylic acid or tractives, corrected for zinc extractives glycidyl methacrylate. as zinc oleate, not to exceed the fol- (xxxiv) Polyamide resins derived lowing: from dimerized vegetable oil acids (1) From a coating intended for or (containing not more than 20 percent of employed as a component of a con- monomer acids) and ethylenediamine, tainer not to exceed 1 gallon and in- as the basic resin, for use only in coat- tended for one-time use, not to exceed ings that contact food at temperatures 0.5 milligram per square inch nor to ex- not to exceed room temperature. ceed that amount as milligrams per (xxxv) Polyamide resins having a square inch that would equal 0.005 per- maximum acid value of 5 and a max- cent of the water capacity of the con- imum amine value of 8.5 derived from tainer, in milligrams, divided by the dimerized vegetable oil acids (con- area of the food-contact surface of the taining not more than 10 percent of container in square inches. From a fab- monomer acids), ethylenediamine, and ricated container conforming with the 4,4-bis (4-hydroxyphenyl) pentanoic acid (in an amount not to exceed 10 description in this paragraph (c)(1), the percent by weight of said polyamide extractives shall not exceed 0.5 milli- resins); as the basic resin, for use only gram per square inch of food-contact in coatings that contact food at tem- surface nor exceed 50 parts per million peratures not to exceed room tempera- of the water capacity of the container ture provided that the concentration of as determined by the methods provided the polyamide resins in the finished in paragraph (e) of this section. food-contact coating does not exceed 5 (2) From a coating intended for or milligrams per square inch of food-con- employed as a component of a con- tact surface. tainer having a capacity in excess of 1 (xxxvi) Methacrylonitrile grafted gallon and intended for one-time use, polybutadiene copolymers containing not to exceed 1.8 milligrams per square no more than 41 weight percent of total inch nor to exceed that amount as mil- polymer units derived from ligrams per square inch that would

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equal 0.005 percent of the water capac- TABLE 1—TYPES OF FOOD ity of the container in milligrams, di- I. Nonacid (pH above 5.0), aqueous products; vided by the area of the food-contact may contain salt or sugar or both, and in- surface of the container in square cluding oil-in-water emulsions of low- or inches. high-fat content. (3) From a coating intended for or II. Acidic (pH 5.0 or below), aqueous prod- employed as a component of a con- ucts; may contain salt or sugar or both, tainer for repeated use, not to exceed and including oil-in-water emulsions of 18 milligrams per square inch nor to low- or high-fat content. exceed that amount as milligrams per III. Aqueous, acid or nonacid products con- square inch that would equal 0.005 per- taining free oil or fat; may contain salt, and including water-in-oil emulsions of cent of the water capacity of the con- low- or high-fat content. tainer in milligrams, divided by the IV. Dairy products and modifications: area of the food-contact surface of the A. Water-in-oil emulsion, high- or low-fat. container in square inches. B. Oil-in-water emulsion, high- or low-fat. (4) From coating intended for re- V. Low moisture fats and oils. peated use, and employed other than as VI. Beverages: a component of a container, not to ex- A. Containing alcohol. ceed 18 milligrams per square inch of B. Nonalcoholic. coated surface. VII. Bakery products. (d) Tables: VIII. Dry solids (no end test required).

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OLVENTS 8% alcohol S F, 2 hr. F, 24 hr. ° ° F, 48 hr. ° (time and temperature) SING , U

1,2 ...... 150 ...... 120 ...... 70 OATINGS C Heptane Extractant F, 2 hr. F, 30 min. F, 15 min. F, 30 min. F, 30 min. ° ° ° ° ° F, 30 min. ° (time and temperature) OLYMERIC P F. °

Water ESINOUS OR ...... 120 R EVERAGES B F, 30 min ...... F, 24 hr ...... F, 30 min ...... F, 2 hr ...... F, 2 hr ...... ° ° ° ° ° F, 48 hr ...... F, 24 hr ...... ° ° (time and temperature) ROM F OODS AND F ...... 212 XTRACTIVES E YPES OF T (see Table 1) Types of food MOUNT OF A IMULATING S II, IV–B, VI–B ...... 120 I, II, III, IV–A, IV–B, VI–B,VII ...... 70 I, II, IV–B ...... 212 III, IV–A, VII ...... do ...... III, VII 150 ...... do ...... III, IV–A 120 ...... V do ...... 120 III, IV–A do...... V do ...... VI–A ...... 100 ...... do...... III, IV–A ...... V, VII do ...... VI–A ...... 70 ...... do...... VI–A ...... ETERMINING F) ...... I, IV–B ...... 250 D ° F ...... II, IV–B ...... Fill boiling, cool to 100 F ...... II, IV–B, VI–B ...... 150 ° ° ROCEDURES FOR P EST Condition of use 2—T fat. 1. Aqueous or oil in water emulsion of high low 2. Aqueous, high or low free oil fat ...... III, IV–A, VII ...... do ...... ABLE T Heptane extractant not to be used on wax-lined containers. Heptane extractivity results must be divided by a factor of five in arriving at the for food product. ment in the container). tainer). reheated in container at time of use: 1 2 A. High temperature heat-sterilized (e.g., over 212 B. Boiling water-sterilized ...... II ...... C. Hot filled or pasteurized above 150 D. Hot filled or pasteurized below 150 E. Room temperature filled and stored (no thermal treat- F. Refrigerated storage (no thermal treatment in the con- G. Frozen storage (no thermal treatment in the container) ..H. Frozen storage: Ready-prepared foods intended to be I, II, III, IV–B, VII ...... 70

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(e) Analytical methods—(1) Selection of perature of 190 °F–200 °F before starting extractability conditions. First ascertain to rinse the container. Invert the con- the type of food product (table 1, para- tainer over the top of the fountain and graph (d) of this section) that is being direct a strong stream of hot water packed commercially in the test con- against the bottom and all sides for 1 tainer and the normal conditions of minute, drain, and allow to dry. thermal treatment used in packaging (4) Exposure conditions—(i) Water (250 the type of food involved. Using table 2 °F for 2 hours), simulating high-tempera- (paragraph (d) of this section), select ture heat sterilization. Fill the container the food-simulating solvent or solvents within 1⁄4-inch of the top with a meas- (demineralized distilled water, ured volume of demineralized distilled heptane, and/or 8 percent ethyl alcohol) water. Cover the container with clean and the time-temperature exaggera- aluminum foil and place the container tions of the container-use conditions. on a rack in a pressure cooker. Add a Aqueous products (Types I, II, IV-B, small amount of demineralized dis- and VI-B) require only a water- tilled water to the pressure cooker, but extractability test at the temperature do not allow the water to touch the and time conditions shown for the bottom of the container. Close the most severe ‘‘conditions of use.’’ Aque- cooker securely and start to heat over ous products with free oil or fat, and a suitable burner. When a steady water-oil emulsions (types III, IV-A, stream of steam emerges from the and VII) will require determinations of vent, close the vent and allow the pres- both water extractability and heptane sure to rise to 15 pounds per square extractability. Low-moisture fats and inch (250 °F) and continue to maintain oils (type V with no free water) require this pressure for 2 hours. Slowly re- only the heptane extractability. Alco- lease the pressure, open the pressure holic beverages (type VI-A) require cooker when the pressure reads zero, only the 8 percent alcohol extractant. and composite the water of each rep- Having selected the appropriate ex- licate immediately in a clean Pyrex tractant or extractants simulating var- flask or beaker. Proceed with the de- ious types of foods and beverages and termination of the amount of extrac- the time-temperature exaggerations tives by the method described in para- over normal use, follow the applicable graph (e)(5) of this section. extraction procedure. Adapt the proce- (ii) Water (212 °F for 30 minutes), simu- dure, when necessary, for containers lating boiling water sterilization. Fill the having a capacity of over 1 gallon. container within 1⁄4-inch of the top (2) Selection of coated-container sam- with a measured volume of boiling, ples. For consumer-sized containers up demineralized distilled water. Cover to 1 gallon, quadruplicate samples of the container with clean aluminum foil representative containers (using for and place the container on a rack in a each replicate sample the number of pressure cooker in which a small containers nearest to an area of 180 amount of demineralized distilled square inches) should be selected from water is boiling. Do not close the pres- the lot to be examined. sure vent, but operate at atmospheric (3) Cleaning procedure preliminary to pressure so that there is a continuous determining the amount of extractables escape of a small amount of steam. from coated containers. Quadruplicate Continue to heat for 30 minutes, then samples of representative containers remove the test container and com- should be selected from the lot to be posite the contents of each replicate examined and must be carefully rinsed immediately in a clean Pyrex flask or 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.

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Insert a thermometer in the water and (vii) Water (70 °F for 24 hours), simu- allow the uncovered container to stand lating frozen storage. Bring in a room at 70 °F–85 °F. When the tem- demineralized distilled water to 70 °F perature reads 100 °F, composite the in a clean Pyrex flask. Fill the con- water from each replicate immediately tainer within 1⁄4-inch of the top with a in a clean Pyrex flask or beaker. Pro- measured volume of the 70 °F water ceed with the determination of the and cover with clean aluminum foil. amount of extractives by the method Place the container in a suitable room described in paragraph (e)(5) of this maintained at 70 °F. After 24 hours, im- section. mediately composite the water of each (iv) Water (150° for 2 hours), simulating replicate in a clean Pyrex flask or hot fill or pasteurization below 150 °F. beaker. Proceed with the determina- Preheat demineralized distilled water tion of the amount of extractives by to 150 °F in a clean Pyrex flask. Fill the method described in paragraph (e)(5) of this section. the container within 1⁄4-inch of the top ° with a measured volume of the 150 °F (viii) Water (212 F for 30 minutes), sim- water and cover with clean aluminum ulating frozen foods reheated in the con- 1 foil. Place the test container in an tainer. Fill the container to within ⁄4- oven maintained at 150 °F. After 2 inch of the top with a measured volume hours, remove the test container from of boiling, demineralized distilled the oven and immediately composite water. Cover the container with clean the water of each replicate in a clean aluminum foil and place the container on a rack in a pressure cooker in which Pyrex flask or beaker. Proceed with a small amount of demineralized dis- the determination of the amount of ex- tilled water is boiling. Do not close the tractives by the method described in pressure vent, but operate at atmos- paragraph (e)(5) of this section. ° pheric pressure so that there is a con- (v) Water (120 F for 24 hours), simu- tinuous escape of a small amount of lating room temperature filling and stor- steam. Continue to heat for 30 minutes, age. Preheat demineralized distilled then remove the test container and ° water to 120 F in a clean Pyrex flask. composite the contents of each rep- 1 Fill the container within ⁄4-inch of the licate immediately in a clean Pyrex top with a measured volume of the 120 flask or beaker. Proceed with the de- ° F water and cover with clean alu- termination of the amount of extrac- minum foil. Place the test container in tives by the method described in para- an incubator or oven maintained at 120 graph (e)(5) of this section. ° F. After 24 hours, remove the test con- (ix) Heptane (150 °F for 2 hours) simu- tainer from the incubator and imme- lating high-temperature heat sterilization diately composite the water of each for fatty foods only. Preheat redistilled replicate in a clean Pyrex flask or reagent-grade heptane (boiling point beaker. Proceed with the determina- 208 °F) carefully in a clean Pyrex flask tion of the amount of extractives by on a water bath or nonsparking hot the method described in paragraph plate in a well-ventilated hood to 150 (e)(5) of this section. °F. At the same time preheat a pres- (vi) Water (70 °F for 48 hours), simu- sure cooker or equivalent to 150 °F in lating refrigerated storage. Bring an incubator. This pressure cooker is demineralized distilled water to 70 °F to serve only as a container for the in a clean Pyrex flask. Fill the 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 70 °F water, 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 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

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the heptane of each replicate in a clean tractives by the method described in Pyrex flask or beaker. Proceed with paragraph (e)(5) of this section. the determination of the amount of ex- (xii) Heptane (100 °F for 30 minutes), tractives by the method described in simulating hot fill or pasteurization below paragraph (e)(5) of this section. 150 °F for fatty foods only. Preheat re- (x) Heptane (120 °F for 30 minutes), sim- distilled reagent-grade heptane (boiling ulating boiling water sterilization of fatty point 208 °F) carefully in a clean Pyrex foods only. Preheat redistilled reagent- flask on a water bath or nonsparking grade heptane (boiling point 208 °F) hot plate in a well-ventilated hood to carefully in a clean Pyrex flask on a 100 °F. At the same time, preheat a water bath or nonsparking hot plate in pressure cooker or equivalent to 100 °F a well-ventilated hood to 120 °F. At the in an incubator. This pressure cooker same time, preheat a pressure cooker is to serve only as a container for the or equivalent to 120 °F in an incubator. heptane-containing test package inside This pressure cooker is to serve only as the incubator in order to minimize the a vented container for the heptane-con- danger of explosion. Fill the test con- taining test package inside the incu- tainer within 1⁄4-inch of the top with a bator in order to minimize the danger measured volume of the 100 °F heptane of explosion. Fill the test container and cover with clean aluminum foil. within 1⁄4-inch of the top with a meas- Place the test container in the ured volume of the 120 °F heptane and preheated pressure cooker and then put cover with clean aluminum foil. Place the assembly into a 100 °F incubator. the test container in the preheated After 30 minutes, remove the pressure pressure cooker and then put the as- cooker from the incubator, open the as- sembly into a 120 °F incubator. After 30 sembly and immediately composite the minutes, remove the pressure cooker heptane of each replicate in a clean from the incubator, open the assembly, Pyrex flask or beaker. Proceed with and immediately composite the the determination of the amount of ex- heptane of each replicate in a clean tractives by the method described in Pyrex flask or beaker. Proceed with paragraph (e)(5) of this section. the determination of the amount of ex- (xiii) Heptane (70 °F for 30 minutes), tractives by the method described in simulating room temperature filling and paragraph (e)(5) of this section. storage of fatty foods only. Fill the test (xi) Heptane (120 °F for 15 minutes), container within 1⁄4-inch of the top simulating hot fill or pasteurization above with a measured volume of the 70 °F 150 °F for fatty foods only. Preheat re- heptane and cover with clean alu- distilled reagent-grade heptane (boiling minum foil. Place the test container in point 208 °F) carefully in a clean Pyrex a suitable room maintained at 70 °F. flask on a water bath or nonsparking After 30 minutes, composite the hot plate in a well-ventilated hood to heptane of each replicate in a clean 120 °F. At the same time, preheat a Pyrex flask or beaker. Proceed with pressure cooker or equivalent to 120 °F the determination of the amount of ex- in an incubator. This pressure cooker tractives by the method described in is to serve only as a container for the paragraph (e)(5) of this section. heptane-containing test package inside (xiv) Heptane (120 °F for 30 minutes), the incubator in order to minimize the simulating frozen fatty foods reheated in danger of explosion. Fill the test con- the container. Preheat redistilled rea- tainer within 1⁄4-inch of the top with a gent-grade heptane (boiling point 208 measured volume of the 120 °F heptane °F) carefully in a clean Pyrex flask on and cover with clean aluminum foil. a water bath or hot plate in a well-ven- Place the test container in the tilated hood to 120 °F. At the same 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

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heptane and cover with clean alu- maintained at 70 °F. After 48 hours, im- minum foil. Place the test container in mediately composite the alcohol from the preheated pressure cooker and then each replicate into a clean Pyrex flask. put the assembly into a 120 °F incu- Proceed with the determination of the bator. After 30 minutes, remove the amount of extractives by the method pressure cooker from the incubator, described in paragraph (e)(5) of this open the assembly and immediately section. composite the heptane from each rep- NOTE: The tests specified in paragraph licate into a clean Pyrex flask. Proceed (e)(4) (i) through (xvii) of this section are ap- with the determination of the amount plicable to flexible packages consisting of of extractives by the method described coated metal contacting food, in which case in paragraph (e)(5) of this section. the closure end is double-folded and clamped (xv) Alcohol—8 percent (150 °F for 2 with metal spring clips by which the package hours), simulating alcoholic beverages hot can be suspended. filled or pasteurized below 150 °F. Pre- (5) Determination of amount of extrac- heat 8 percent (by volume) ethyl alco- tives—(i) Total residues. Evaporate the hol in demineralized distilled water to food-simulating solvents from para- 150 °F in a clean Pyrex flask. Fill the graph (e)(4) (i) to (xvii), inclusive, of test container with within 1⁄4-inch of this section to about 100 milliliters in the top with a measured volume of the the Pyrex flask and transfer to a clean, 8 percent alcohol. Cover the container tared platinum dish, washing the flask with clean aluminum foil and place in three times with the solvent used in an oven maintained at 150 °F. After 2 the extraction procedure, and evapo- hours, remove the container from the rate to a few milliliters on a non- oven and immediately composite the sparking low-temperature hotplate. alcohol from each replicate in a clean The last few milliliters should be evap- Pyrex flask. Proceed with the deter- orated in an oven maintained at a tem- mination of the amount of extractives perature of 212 °F. Cool the platinum by the method described in paragraph dish in a desiccator for 30 minutes and (e)(5) of this section. weigh the residue to the nearest 0.1 (xvi) Alcohol—8 percent (120 °F for 24 milligram (e). Calculate the extractives hours), simulating alcoholic beverages in milligrams per square inch and in room-temperature filled and stored. Pre- parts per million for the particular size heat 8 percent (by volume) ethyl alco- of container being tested and for the hol in demineralized distilled water to specific food-simulating solvent used. 120 °F in a clean Pyrex flask. Fill the (a) Water and 8-percent alcohol. test container within 1⁄4-inch of the top with a measured volume of the 8 per- Milligrams extractives = e cent alcohol, cover the container with per square inch clean aluminum foil and place in an s ° oven or incubator maintained at 120 F. Ex= ( e )( a )(1000) After 24 hours, remove the container Extractives residue = from the oven or incubator and imme- ()()cs diately composite the alcohol from each replicate into a clean Pyrex flask. (b) Heptane. Proceed with the determination of the e amount of extractives by the method Milligrams extractives = described in paragraph (e)(5) of this per square inch ()()sF section. ° (xvii) Alcohol—8 percent (70 F for 48 Ex= ( e )( a )(1000) hours), simulating alcoholic beverages in Extractives residue = refrigerated storage. Bring 8 percent (by ()()()csF volume) ethyl alcohol in demineralized distilled water to 70 °F in a clean Pyrex where: Ex=Extractives residue in ppm for any con- flask. Fill the test container within 1⁄4- tainer size. inch of the top with a measured volume e=Milligrams extractives per sample tested. of the 8 percent alcohol. Cover the con- a=Total coated area, including closure in tainer with clean aluminum foil. Place square inches. the test container in a suitable room c=Water capacity of container, in grams.

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s=Surface of coated area tested, in square heating gently over a Meeker-type inches. burner to destroy organic matter and F=Five, the ratio of the amount of extrac- hold at red heat for about 1 minute. tives removed from a coated container by Cool in the air for 3 minutes, and place heptane under exaggerated time-tempera- ture test conditions compared to the the platinum dish in the desiccator for amount extracted by a fat or oil from a 30 minutes and weigh to the nearest 0.1 container tested under exaggerated condi- milligram. Analyze this ash for zinc by tions of thermal sterilization and use. standard Association of Official Agri- e′=Chloroform-soluble extractives residue. cultural Chemists methods or equiva- ee′=Zinc corrected chloroform-soluble ex- lent. Calculate the zinc in the ash as tractive residue. zinc oleate, and subtract from the e′ or ee′ is substituted for e in the above equa- tions when necessary. weight of chloroform-soluble extrac- tives residue (e′) to obtain the zinc-cor- If when calculated by the equations in rected chloroform-soluble extractives paragraph (e)(5)(i) (a) and (b) of this residue (ee′). This ee′ is substituted for section, the concentration of extrac- e in the formulas in paragraph (e)(5)(i) tives residue (Ex) exceeds 50 parts per (a) and (b) of this section. To comply million or the extractives in milli- with the limitations in paragraph (c) of grams per square inch exceed the limi- this section, the chloroform-soluble ex- tations prescribed in paragraph (c) of tractives residue (but after correction this section for the particular con- for the zinc extractives in case of ‘‘C’’ tainer size, proceed to paragraph enamels) must not exceed 50 parts per (e)(5)(ii) of this section (method for de- million and must not exceed in milli- termining the amount of chloroform- grams per square inch the limitations soluble extractives residue). for the particular article as prescribed (ii) Chloroform-soluble extractives res- in paragraph (c) of this section. idue. Add 50 milliliters of chloroform (f) Equipment and reagent require- (freshly distilled reagent grade or a ments—(1) Equipment. grade having an established consist- ently low blank) to the dried and Rinsing equipment, soda fountain pressure- type hot water, consisting in simplest form weighed residue, (e), in the platinum of a 1⁄8-inch–1⁄4-inch inside diameter metal dish, obtained in paragraph (e)(5)(i) of tube attached to a hot water line delivering this section. Warm carefully, and filter 190 °F–200 °F water and bent so as to direct through Whatman No. 41 filter paper in a stream of water upward. a Pyrex funnel, collecting the filtrate Pressure cooker, 21-quart capacity with in a clean, tared platinum dish. Repeat pressure gage, safety release, and removable the chloroform extraction, washing the rack, 12.5 inches inside diameter × 11 inches filter paper with this second portion of inside height, 20 pounds per square inch safe chloroform. Add this filtrate to the operating pressure. original filtrate and evaporate the Oven, mechanical convection, range to in- clude 120 °F–212 °F explosion-proof, inside di- total down to a few milliliters on a mensions (minimum), 19″ × 19″ × 19″, constant low-temperature hotplate. The last few temperature to ±2 °F (water bath may be milliliters should be evaporated in an substituted). oven maintained at 212 °F. Cool the Incubator, inside dimensions (minimum) platinum dish in a desiccator for 30 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion minutes and weigh to the nearest 0.1 proof (water bath may be substituted). milligram to get the chloroform-solu- Constant-temperature room or chamber 70 ble extractives residue (e′). This e′ is °F±2 °F minimum inside dimensions 19″ × 19″ × ″ substituted for e in the equations in 19 . paragraph (e)(5)(i) (a) and (b) of this Hot plate, nonsparking (explosion proof), top 12″ × 20″, 2,500 watts, with temperature section. If the concentration of extrac- control. tives (Ex) still exceeds 50 parts per mil- 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.

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Heptane, reagent grade, freshly redistilled surface of articles intended for use in before use, using only material boiling at 208 producing, manufacturing, packing, ° F. processing, preparing, treating, pack- Alcohol, 8 percent (by volume), prepared from undenatured 95 percent ethyl alcohol aging, transporting, or holding food, in diluted with demineralized or distilled accordance with the following pre- water. scribed conditions: Chloroform, reagent grade, freshly redis- (a) The coating is applied as a contin- tilled before use, or a grade having an estab- uous film over one or both sides of a lished, consistently low blank. Filter paper, Whatman No. 41 or equiva- base film produced from one or more of lent. the basic olefin polymers complying with § 177.1520 of this chapter. The base (g) In accordance with good manufac- turing practice, finished coatings in- polyolefin film may contain optional tended for repeated food-contact use adjuvant substances permitted for use shall be thoroughly cleansed prior to in polyolefin film by applicable regula- their first use in contact with food. tions in parts 170 through 189 of this (h) Acrylonitrile copolymers identi- chapter. fied in this section shall comply with (b) The coatings are formulated from the provisions of § 180.22 of this chap- optional substances which are: ter. (1) Substances generally recognized [42 FR 14534, Mar. 15, 1977] as safe for use in or on food. (2) Substances the use of which is EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 175.300, see the List of CFR permitted under applicable regulations Sections Affected, which appears in the in parts 170 through 189 of this chapter, Finding Aids section of the printed volume by prior sanctions, or approvals. and at www.fdsys.gov. (3) Substances identified in this para- graph (b)(3) and subject to such limita- § 175.320 Resinous and polymeric coat- ings for polyolefin films. tions as are provided: Resinous and polymeric coatings may be safely used as the food-contact

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.

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List of substances Limitations

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. 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 ......

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List of substances Limitations

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).. 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.

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List of substances Limitations

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 ...... 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. Carnauba 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.

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(c) The coating in the finished form List of substances Limitations in which it is to contact food, when ex- Silica. tracted with the solvent or solvents Japan wax. characterizing the type of food, and under conditions of time and tempera- (e) Copolymer of vinyl acetate and ture characterizing the conditions of crotonic acid used as a coating or as a its intended use as determined from ta- component of a coating conforming bles 1 and 2 of § 176.17(c) of this chapter, with the specifications of paragraph shall yield net chloroform-soluble ex- (e)(1) of this section are used as pro- tractives not to exceed 0.5 milligram vided in paragraph (e)(2) of this sec- per square inch of coated surface. tion. (d) Acrylonitrile copolymers identi- (1) Specifications. (i) The chloroform- fied in this section shall comply with soluble portion of the water extractives the provisions of § 180.22 of this chap- of the coated film obtained with dis- ter. tilled water at 120 °F for 24 hours does not exceed 0.5 milligram per square [42 FR 14534, Mar. 15, 1977, as amended at 43 inch of coated surface. FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, (ii) The chloroform-soluble portion of 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, the n-heptane extractives of the coated Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR ° 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 film obtained with n-heptane at 70 F FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, for 30 minutes does not exceed 0.5 milli- 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, gram per square inch of coated surface. June 13, 2000] (2) Conditions of use. The copolymer of vinyl acetate and crotonic acid is § 175.350 Vinyl acetate/crotonic acid used as a coating or as a component of copolymer. a coating for polyolefin films for pack- A copolymer of vinyl acetate and aging bakery products and confec- crotonic acid may be safely used as a tionery. coating or as a component of a coating which is the food-contact surface of § 175.360 Vinylidene chloride copoly- mer coatings for nylon film. polyolefin films intended for packaging 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- tions: (b) The quantity of any optional sub- (a) The coating is applied as a contin- stance does not exceed the amount rea- uous film over one or both sides of a sonably required to accomplish the in- base film produced from nylon resins tended physical or technical effect nor complying with § 177.1500 of this chap- any limitations further provided. ter. (c) Any optional substance that is (b) The coatings are prepared from the subject of a regulation in parts 174, vinylidene chloride copolymers pro- 175, 176, 177, 178, and § 179.45 of this duced by copolymerizing vinylidene chapter conforms with any specifica- chloride with one or more of the mono- tions in such regulation. mers acrylic acid, acrylonitrile, ethyl (d) Optional substances as provided acrylate, methacrylic acid, methyl ac- in paragraph (a) of this section include: rylate, methyl methacrylate (CAS Reg. (1) Substances generally recognized No. 80–62–6; maximum use level 6 as safe in food. weight percent) and 2-sulfoethyl meth- (2) Substances subject to prior sanc- acrylate (CAS Reg. No. 10595–80–9; max- tion or approval for uses with a copoly- imum use level 1 weight percent). The mer of vinyl acetate and crotonic acid finished copolymers contain at least 50 and used in accordance with such sanc- weight percent of polymer units de- tion or approval. rived from vinylidene chloride. The fin- (3) Substances identified in this sub- ished coating produced from vinylidene paragraph and subject to such limita- chloride copolymers produced by co- tions as are provided: polymerizing vinylidene chloride with

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

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food meets the following extractives (c) The optional substances per- limitations when tested by the meth- mitted are as follows: ods provided in § 175.300(e): (1) The coating when extracted with List of substances Limitations distilled water at 180 °F for 24 hours Ethylene glycol ...... As a solvent removed by yields total extractives not to exceed water washing. Iron oxide. 0.05 milligram per square inch of food- Lithium hydroxide ...... Removed by water washing. contact surface. Methyl orange ...... As an acid-base indicator. (2) The coating when extracted with 8 Potassium dichromate ...... Removed by water washing. Silica gel. percent (by volume) ethyl alcohol in Sodium silicate. distilled water at 160 °F for 4 hours Zinc, as particulate metal. yields total extractives not to exceed 0.05 milligram per square inch of food- (d) The coating in the finished form contact surface. in which it is to contact food, when ex- (c) The resins identified in paragraph tracted with the solvent or solvents (a) of this section may be used as a characterizing the type of food, and food-contact coating for articles in- under the conditions of its intended use tended for contact at temperatures not as shown in table 1 and 2 of § 175.300(d) to exceed room temperature with food (using 20 percent alcohol as the solvent of Type VI-C described in table 1 of when the type of food contains approxi- § 176.170(c) of this chapter provided the mately 20 percent alcohol) shall yield coating in the finished form in which it total extractives not to exceed those is to contact food meets the following prescribed in § 175.300(c)(3); lithium ex- 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 Subpart A [Reserved] coatings. 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 Sec. producing, manufacturing, packing, 176.110 Acrylamide-acrylic acid resins. processing, preparing, treating, pack- 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 glycine. to remove soluble substances. 176.170 Components of paper and paperboard (b) The coatings are formulated from 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. 176.230 3,5-Dimethyl-1,3,5,2H- § 175.300. tetrahydrothiadiazine-2-thione. (3) Substances identified in para- 176.250 Poly-1,4,7,10,13-pentaaza-15- graph (c) of this section, subject to the hydroxyhexadecane. limitations prescribed. 176.260 Pulp from reclaimed fiber.

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176.300 Slimicides. their hydrolysis products dialkyl 176.320 Sodium nitrate-urea complex. ketones do not exceed 0.4 percent by 176.350 Tamarind seed kernel powder. weight of the paper or paperboard. AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. (c) The alkyl ketene dimers may be used in the form of an aqueous emul- SOURCE: 42 FR 14554, Mar. 15, 1977, unless otherwise noted. sion which may contain sodium lignosulfonate as a dispersant. EDITORIAL NOTE: Nomenclature changes to part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 § 176.130 Anti-offset substances. FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. Substances named in paragraphs (b) and (c) of this section may be safely Subpart A [Reserved] used to prevent the transfer of inks employed in printing and decorating paper and paperboard used for food Subpart B—Substances for Use packaging in accordance with the pro- Only as Components of Paper visions of this section: and Paperboard (a) The substances are applied to the nonfood contact, printed side of the § 176.110 Acrylamide-acrylic acid res- paper or paperboard in an amount not ins. greater than that required to accom- Acrylamide-acrylic acid resins may plish the technical effect nor greater be safely used as components of arti- than any specific limitations, where cles intended for use in producing, such are provided. 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 necessary to accomplish the technical polysiloxanes. 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- tended for use in producing, manufac- board. 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. as an adjuvant in the manufacture of Ammonium glucoheptonate. Disodium ethylenediamine tetraacetate. paper and paperboard under such condi- Pentasodium salt of diethylenetriamine tions that the alkyl ketene dimers and pentaacetate.

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List of substances Limitations the uncoated or coated food-contact surface of paper and paperboard in- Sodium fructoheptonate. Sodium glucoheptonate. tended for use in producing, manufac- Tetrasodium ethylenediamine tetra- turing, packaging, processing, pre- acetate. paring, treating, packing, transporting, Trisodium N-hydroxyethyl ethylene- diamine triacetate. or holding aqueous and fatty foods, subject to the provisions of this sec- (b) Any one or any combination of tion. Components of paper and paper- the substances named is used or in- board in contact with dry food of the tended for use as chelating agents. type identified under Type VIII of table (c) The substances are added in an 1 in paragraph (c) of this section are amount not greater than that required subject to the provisions of § 176.180. to accomplish the intended technical (a) Substances identified in para- effect nor greater than any specific graph (a) (1) through (5) of this section limitation, where such is provided. may be used as components of the food- § 176.160 Chromium (Cr III) complex contact surface of paper and paper- of N-ethyl-N-heptadecylfluoro-oc- board. Paper and paperboard products tane sulfonyl glycine. shall be exempted from compliance The chromium (Cr III) complex of N- with the extractives limitations pre- ethyl - N -heptadecylfluoro-octane scribed in paragraph (c) of this section: sulfonyl glycine containing up to 20 Provided, That the components of the percent by weight of the chromium (Cr food-contact surface consist entirely of III) complex of heptadecylfluoro-octane one or more of the substances identi- sulfonic acid may be safely used as a fied in this paragraph: And provided fur- component of paper for packaging dry ther, That if the paper or paperboard food when used in accordance with the when extracted under the conditions following prescribed conditions. prescribed in paragraph (c) of this sec- (a) The food additive is used as a tion exceeds the limitations on extrac- component of paper in an amount not tives contained in paragraph (c) of this to exceed 0.5 percent by weight of the section, information shall be available paper. (b)(1) The food-contact surface of the from manufacturing records from paper is overcoated with a polymeric or which it is possible to determine that resinous coating at least 1⁄3-mil in only substances identified in this para- thickness, that meets the provision of graph (a) are present in the food-con- § 176.170; or tact surface of such paper or paper- (2) The treated paper forms one or board. more plies of a paper in a multiwall (1) Substances generally recognized bag and is separated from the food by as safe in food. at least one ply of packaging films or (2) Substances generally recognized grease-resistant papers which serves as as safe for their intended use in paper a functional barrier between the food and paperboard products used in food additive and the food. Such packaging packaging. films or grease-resistant papers con- (3) Substances used in accordance form with appropriate food additive with a prior sanction or approval. regulations. (c) The labeling of the food additive (4) Substances that by regulation in shall contain adequate directions for parts 170 through 189 of this chapter its use to insure compliance with the may be safely used without extractives requirements of paragraphs (a) and (b) limitations as components of the of this section. uncoated or coated food-contact sur- face of paper and paperboard in contact § 176.170 Components of paper and pa- with aqueous or fatty food, subject to perboard in contact with aqueous the provisions of such regulation. and fatty foods. (5) Substances identified in this para- Substances identified in this section graph, as follows: may be safely used as components of

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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). 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/alkali metal 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.

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List of Substances Limitations

Ammonium bis(N-ethyl-2-perfluoroalkylsulfonamido ethyl) For use only as an oil and water repellant at a level not to ex- phosphates, containing not more than 15% ammonium mono ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, feet of treated paper or paperboard of a sheet basis weight where the alkyl group is more than 95% C8 and the salts of 100 pounds or less per 3,000 square feet of paper or pa- have a fluorine content of 50.2% to 52.8% as determined on perboard, and at a level not to exceed 0.5 pound (0.26 a solids basis. pound of fluorine) per 1,000 square feet of treated paper or paperboard having a sheet basis weight greater than 100 lb. per 3,000 square feet as determined by analysis for total flu- orine in the treated paper or paperboard without correction for any fluorine that might be present in the untreated paper or paperboard, when such paper or paperboard is used as follows: 1. In contact, under conditions of use C, D, E, F, G, or H de- scribed in table 2 of paragraph (c) of this section, with non- alcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX de- scribed in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional bak- ing. 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. 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.

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List of Substances Limitations

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. 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).

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List of Substances Limitations

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). 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. Diethanolamine salts of mono- and bis (1H,1H,2H,2H-perfluo- For use only as an oil and water repellant at a level not to ex- roalkyl) phosphates where the alkyl group is even-numbered ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square in the range C8-C18 and the salts have a fluorine content of feet of treated paper or paperboard, as determined by anal- 52.4% to 54.4% as determined on a solids basis. ysis for total fluorine in the treated paper or paperboard with- out correction for any fluorine which might be present in the untreated paper or paperboard, when such paper or paper- board is used in contact with nonalcoholic foods under the conditions of use described in paragraph (c) of this section, table 2, conditions of use (B) through (H).

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List of Substances Limitations

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. 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. Fish oil, 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.

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List of Substances Limitations

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).. 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).

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List of Substances Limitations

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) taurine, 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. Pentanoic acid, 4,4–bis [(gamma-omega-perfluoro-C8–20- For use only as an oil and water repellent and used at a level alkyl)thio] derivatives, compounds with diethanolamine (CAS not to exceed 8 pounds per ton of the finished paper or pa- Reg. No. 71608-61-2). perboard when such paper or paperboard is used in contact with nonalcoholic foods under conditions of use E through H described in table 2 of paragraph (c) of this section. Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265–81–1) For use only as an oil and water repellent at a level not to ex- containing 35 to 40 weight percent fluorine, produced by the ceed 0.5 percent by weight of the finished paper and paper- copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2- board in contact with nonalcoholic foods under conditions of methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2- use C, D, E, F, G, or H described in table 2 of paragraph (c) methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl of this section. ester; and 2-propenoic acid, 2[[(heptadecafluoro- octyl)sulfonyl] methyl amino]ethyl ester. Perfluoroalkyl substituted phosphate ester acids, ammonium For use only as an oil and water repellant at a level not to ex- salts formed by the reaction of 2,2-bis[ (g,w-perfluoroC4-20 ceed 0.44 percent perfluoroalkyl actives by weight of the fin- alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ished paper and paperboard in contact with non-alcoholic ammonium hydroxide. foods under condition of use H as described in table 2 of paragraph (c) of this section; and in contact with food of types III, IV-A, V, VII-A, and IX described in table 1 of para- graph (c) of this section under conditions of use C through G as described in table 2 of paragraph (c) of this section. 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 by vided that the asphalt is used at a level not to exceed 5% by ASTM method D5–73 (Reapproved 1978), ‘‘Standard Test weight of the finished dry paper and paperboard fibers. 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 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.); and maximum weight loss not to exceed 3% when distilled to 371° C, nor to exceed an additional 1.1% when further dis- tilled between 371° C and thermal decomposition. 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.

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List of Substances Limitations

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. 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).

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List of Substances Limitations

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). 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).

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List of Substances Limitations

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. 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.

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List of Substances Limitations

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 and forming operation in such an amount that finished paper and epichlorohydrin so that a 31-percent aqueous solution at paperboard will contain the additive at a level not in excess 25° C has a Stokes viscosity range of 2.5-4.0 as determined of 1 percent by weight of the dry paper and paperboard. by 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 deciliter Polypropylene glycol (minimum molecular weight 1,000). 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.

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List of Substances Limitations

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). 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.

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List of Substances Limitations

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. 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.

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(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.

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.

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List of substances Limitations

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, 5100 Paint Branch Pkwy., 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.. 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. 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.

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List of substances Limitations

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. 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.

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List of substances Limitations

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 oxides ...... 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 (method for determining corrected inch=(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 extractives Analyze this ash for zinc by standard 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 napthalene sulfonic acid-formaldehyde condensate, so- dium 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.. Napthalene 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. . 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 additional 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 bromine 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, and 70 FR 177.1680 Polyurethane resins. 72074, Dec. 1, 2005. 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 Polyvinylidene fluoride 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 this to the temperature-time conditions of 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, 5100 Paint Branch Pkwy., (1) Eighty-four to eighty-nine parts College Park, MD 20740, or available for by weight of a matrix polymer con- inspection at the National Archives taining 73 to 78 parts by weight of acry- and Records Administration (NARA). lonitrile and 22 to 27 parts by weight of For information on the availability of styrene; and this material at NARA, call 202–741– (2) Eleven to sixteen parts by weight 6030, or 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, 5100 Paint Branch propionitrile,’’ which is incorporated by reference. Copies are available Pkwy., College Park, MD 20740, or from the Bureau of Foods (HFS– available for inspection at the National 200), Food and Drug Administra- Archives and Records Administration tion, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, or available (NARA). For information on the avail- for inspection at the National Ar- ability of this material at NARA, call chives and Records Administration 202–741–6030, or go to: http:// (NARA). For information on the availability of this material at NARA, www.archives.gov/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, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, or available methyl methacrylate copolymer iden- for inspection at the National Ar- tified in this section may be safely chives 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, 5100 Paint Branch Pkwy., butadiene and 23 to 28 parts by weight College Park, MD 20740, or available for of styrene and (ii) 5 to 10 parts by inspection at the National Archives weight of a graft polymer having the and Records Administration (NARA). same composition range as the matrix For information on the availability of polymer. this material at NARA, call 202–741– (b) Adjuvants. The copolymer identi- 6030, or 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 5100 Paint Branch Pkwy., College Park, identified in paragraph (c) of this sec- MD 20740, or available for inspection at tion may contain adjuvant substances the National Archives and Records Ad- required in their production, with the ministration (NARA). For information exception that they shall not contain on 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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na- tional 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. 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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na- tional 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. 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), 5100 Paint Branch Pkwy., 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 202–741–6030, or 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, 5100 Resin Pellets,’’ which is incorporated Paint Branch Pkwy., College Park, by reference. Copies are available from MD 20740, or available for inspec- the Center for Food Safety and Applied tion at the National Archives and Records Administration (NARA). For Nutrition (HFS–200), Food and Drug information on the availability of this Administration, 5100 Paint Branch material at NARA, call 202–741– Pkwy., College Park, MD 20740, or 6030, or go to: http:// www.archives.gov/federallregister/ available for inspection at the National codeloflfederallregulations/ Archives and Records Administration ibrllocations.html. (NARA). For information on the avail- ability of this material at NARA, call (c) Specifications. (1) Nitrogen content 202–741–6030, or go to: http:// of the modified copolymer is in the www.archives.gov/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, 5100 Paint polymer is extracted with 250 milli- Branch Pkwy., College Park, MD 20740, liters of freshly distilled water at or available for inspection at the Na- reflux temperature for 2 hours. tional Archives and Records Adminis- (2) The extracted copolymer shall not tration (NARA). For information on exceed 0.5 ppm in n-heptane when a 100- the availability of this material at gram sample of the basic copol-ymer is NARA, call 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, 5100 Paint Branch then sealed and heated to 150 °F in ei- Pkwy., College Park, MD 20740, or ther a circulating air oven or a thermo- available for inspection at the National stat controlled bath for a period of 8 Archives and Records Administration days. (NARA). For information on the avail- (4) The Pyrex glass pressure bottle is ability of this material at NARA, call 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 5100 Paint Branch Pkwy., College Park, and 2 of § 176.170(c) of this chapter, MD 20740, or available for inspection at shall yield extractives not to exceed the National Archives and Records Ad-