Title 21—Food and Drugs

Home , Anticaking agent, Asparagus, Birch tar, CAS Registry Number, Curdlan, Dicarbonate

(This book contains parts 170 to 199)

Part

CHAPTER I—Food and Drug Administration, Department of Health and Human Services (Continued) ...... 170

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(Parts 170 to 199)

EDITORIAL NOTE: Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994, and 69 FR 18803, Apr. 9, 2004.

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

Part Page 170 Food additives...... 5 171 Food additive petitions ...... 24 172 Food additives permitted for direct addition to food for human consumption ...... 30 173 Secondary direct food additives permitted in food for human consumption ...... 122 174 Indirect food additives: General ...... 155 175 Indirect food additives: Adhesives and components of coatings ...... 156 176 Indirect food additives: Paper and paperboard components ...... 198 177 Indirect food additives: Polymers ...... 237 178 Indirect food additives: Adjuvants, production aids, and sanitizers ...... 359 179 Irradiation in the production, processing and handling of food ...... 453 180 Food additives permitted in food or in contact with food on an interim basis pending additional study ...... 459 181 Prior-sanctioned food ingredients ...... 464 182 Substances generally recognized as safe ...... 469 184 Direct food substances affirmed as generally recognized as safe ...... 482 186 Indirect food substances affirmed as generally recognized as safe ...... 587 189 Substances prohibited from use in human food ...... 592 190 Dietary supplements...... 599

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Part Page 191–199 [Reserved]

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PART 170—FOOD ADDITIVES 170.106 Notification for a food contact substance 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 food additive 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 experimental 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 substances 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 Glycine (aminoacetic acid) in food for or otherwise affecting the characteris- human consumption. tics of food. A material used in the pro- 170.60 Nitrites and/or nitrates in curing pre- duction of containers and packages is mixes. subject to the definition if it may reasonably 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 notification 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 flavor, 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 diet, 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 gelatin 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) Gelatins, 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) Dairy product 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 flavors. 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, pork, 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, peanuts, co- from. conut, and nut and peanut spreads.

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(33) Plant protein products, including Copies are available from the National the National Academy of Sciences/Na- Technical Information Service (NTIS), tional Research Council ‘‘reconstituted 5285 Port Royal Rd., Springfield, VA vegetable protein’’ category, and meat, 22161, or at the National Archives and poultry, and fish substitutes, analogs, Records Administration (NARA). For and extender products made from plant information on the availability of this proteins. material at NARA, call 202–741–6030, or (34) Poultry products, including all go to: http://www.archives.gov/ poultry and poultry-containing dishes, federallregister/ salads, appetizers, frozen multicourse codeloflfederallregulations/ poultry meals, and sandwich ingredi- ibrllocations.html. ents prepared by commercial proc- (1) Anticaking agents and free-flow essing or using commercially processed agents: Substances added to finely pow- poultry with home preparation. dered or crystalline food products to (35) Processed fruits and fruit juices, prevent caking, lumping, or agglomer- including all commercially processed ation. fruits, citrus, berries, and mixtures; (2) Antimicrobial agents: Substances salads, juices and juice punches, con- used to preserve food by preventing 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 ‘‘preservatives.’’ 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, ‘‘dough conditioner.’’ 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: 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 carbon dioxide 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 equivalent unit of sweetening capacity. (30) Surface-finishing agents: Sub- stances used to increase palatability, (20) Nutrient 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, waxes, 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 Nutrition, 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 proof 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- cholinesterase 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 quantity of combined residues that are Subpart B—Food Additive Safety within the tolerance may be determined 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 dried fruit, 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 occurred 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 common 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 affirmation 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 infor 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 included 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 articles. 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 additive 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 additives. 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 required 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 amines, including erence any information in FDA’s files but not limited to essential oils, diso- provided that the manufacturer or sup- dium inosinate, disodium guanylate, plier is authorized to reference the in- hydrolysates of animal or plant origin formation. The FCN must include in- (such as hydrolyzed vegetable protein), formation establishing that the manu- oleoresins of spices, soy products, and facturer or supplier is authorized to 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 nitrosamines (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 subchapter, 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 information 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 information (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 prejudice 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 respond. 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 specified. (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 petition 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 results 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 existing 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 prejudice. § 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 exempted 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 Fumaric acid and salts of fumaric acid. Subpart A—General Provisions 172.365 Kelp. 172.370 Iron-choline citrate complex. Sec. 172.372 N-Acetyl-L-methionine. 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 nitrate. 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 nitrite. 172.535 Disodium inosinate. 172.177 Sodium nitrite used in processing 172.540 DL-Alanine. 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 soybean 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 wax. 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-coconut 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 propylene glycol. 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 reference. 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. Melting point 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 ethylenediaminetetraacetate) 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 Preservative. 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 yolk. 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 million) 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 amine 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 burette) 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 preparations. (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 kidney 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 million) 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 million) § 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 solution: 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 additive 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 chloride 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 aqueous solution 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 content 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 refractive index of 1.5012 at 100 °C. Color of WG or paler. Pentaerythritol ester of maleic anhydride-modi- Acid number of 134–145; drop-softening point of 127 °C–173 °C; saponifica- fied wood rosin. tion number of less than 280; and a color of M or paler. Do ...... Acid number of 176–186; drop-softening point of 110 °C–118 °C; saponification 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 availability 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 percent 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-hexa- 360–400 ...... 02 decane, insert the head assembly, allow nitrogen 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 adjust 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 incorporated 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, coconuts, 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 (acorn), 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 edible vegetable oil using 1-butanol. Fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing sulfation, the reaction mixture FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, is washed with water and neutralized 1984; 54 FR 24896, June 12, 1989] with aqueous sodium or potassium hy- § 172.255 Polyacrylamide. droxide. Prior to sulfation, the butyl oleate reaction mixture meets the fol- Polyacrylamide containing not more lowing specifications: than 0.2 percent of acrylamide mon- (1) Not less than 90 percent butyl ole- omer may be safely used as a film ate. former in the imprinting of soft-shell (2) Not more than 1.5 percent unsa- gelatin capsules when the amount used ponifiable matter. is not in excess of the minimum re- (b) The additive is used or intended quired to produce the intended effect. for use at a level not to exceed 2 per- § 172.260 Oxidized polyethylene. cent by weight in an aqueous emulsion in dehydrating grapes to produce rai- Oxidized polyethylene may be safely sins, whereby the residue of the addi- used as a component of food, subject to tive on the raisins does not exceed 100 the following restrictions: parts per million. (a) Oxidized polyethylene is the basic resin produced by the mild air oxida- [57 FR 12711, Apr. 13, 1992] tion of polyethylene. The polyethylene used in the oxidation process conforms § 172.275 Synthetic paraffin and suc- to the 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 nutrients added to ° ° 112 C–118 C, as determined by ASTM foods in accordance with the following method E28–67 (Reapproved 1982), conditions: ‘‘Standard Test Method for Softening (a) The food additive consists of one Point By Ring-and-Ball Apparatus,’’ or more of the following individual which is incorporated by reference. amino acids in the free, hydrated or 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-Arginine L-Asparagine Records Administration (NARA). For L-Aspartic acid information on the availability of this L-Cysteine material at NARA, call 202–741–6030, or L-Cystine go to: http://www.archives.gov/ L-Glutamic acid

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L-Glutamine Records Administration (NARA). For Aminoacetic acid (glycine) information on the availability of this L-Histidine material at NARA, call 202–741–6030, or L-Isoleucine L-Leucine go to: http://www.archives.gov/ L-Lysine federallregister/ DL-Methionine (not for infant foods) codeloflfederallregulations/ L-Methionine ibrllocations.html.) for the following: L-Phenylalanine L-Proline L-Asparagine L-Serine L-Aspartic acid L-Threonine L-Glutamine L-Tryptophan L-Histidine L-Tyrosine (c) The additive(s) is used or intended L-Valine 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 Glutamic Acid Hydrochloride in the finished ready-to-eat food equiv- L-Isoleucine alent to casein as determined by the L-Lysine Monohydrochloride method specified in paragraph (d) of Monopotassium L-glutamate this section. L-Tyrosine (3) Each amino acid (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 (expressed 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 medical 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 ethanol 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 Kjeldahl Method for Nitrate- formation required by the Act, the fol- Free Samples (20)—Official Final Ac- lowing: tion. (1) The name of the additive ‘‘cal- (2) Moisture content shall not be cium chloride double salt of d-calcium more than 10 percent by weight of the pantothenate’’ or ‘‘calcium chloride final product, as determined by the double salt of dl-calcium panto- method described in section 24.003, Air thenate’’, whichever is appropriate. Drying (1)—Official First Action. (2) A statement of the appropriate (3) Fat content shall not be more concentration of the additive, ex- than 0.5 percent by weight of the final pressed as pantothenic acid. 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 dietary supplement, 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 citric acid may be safely used as a curring vegetable protein in the food source of iron in foods for special die- must be substantiated as a statis- tary use. tically significant difference with at least a probability (P) value of less § 172.372 N-Acetyl-L-methionine. than 0.05. The food additive N-acetyl-L-methio- (4) The amount of the additive added nine may be safely added to food (ex- for nutritive purpose shall not exceed cept infant foods and foods containing the level that will provide a total of 3.1 added nitrites/nitrates) as a source of percent L- and DL-methionine (ex- L-methionine for use as a nutrient in pressed as the free amino acid) by accordance with the following condi- weight of the total protein of the fin- tions: ished food, including the amount natu- (a) N-Acetyl-L-methionine (Chemical rally present in free and combined (as Abstracts Service Registry No. 65–82–7) protein) form. is the derivative of the amino acid me- (5) The additive shall not be added to thionine formed by addition of an ace- infant foods or to foods containing tyl group to the alpha-amino group of added nitrites/nitrates. methionine. It may be in the free, hy- (d) Compliance with the limitations drated or anhydrous form, or as the so- concerning PER under paragraph (c) of dium or potassium salts. the section shall be determined by the (b) The additive meets the following method described in sections 43.212– specifications: 43.216, ‘‘Official Methods of Analysis of (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 requirements in specific medical condi- (b) Vitamin D2 meets the specifications 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 inter, 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 specifications of the Food Chemicals Codex, 5th 240 mL (prepared beverage) in soy-pro- ed. (2004), pp. 498–499, which is incor- tein based meal replacement 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 exceed 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 sodium 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 distillates) 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 alkaloids in finished beverage Cinchona, yellow, bark ...... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do. hybrids of these with other spp. of Cinchona.. Copaiba ...... South American spp. of Copaifera L. 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) ...... Quillaja saponaria Mol. Red saunders (red sandalwood) ...... Pterocarpus san alinus L ...... In alcoholic beverages only Rhatany root ...... Krameria triandra Ruiz et Pav. or K. argentea Mart. Rhubarb, garden root ...... Rheum rhaponticum L ...... Do. Rhubarb root ...... Rheum officinale Baill., R. palmatum L., or other spp. (excepting R. rhaponticum L.) or hybrids of Rheum grown in China. Roselle ...... Hibiscus sabdariffa L ...... Do. Rosin (colophony) ...... Pinus palustris Mill., and other Pinus spp ...... Do. St. Johnswort leaves, flowers, and caulis ...... Hypericum perforatum L ...... Hypericin-free alcohol distillate form only; in alcoholic 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; finished 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 reference. 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 disulfide; 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. Ethyl nitrite. 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. cinnamaldehyde; cyclamen aldehyde. o-Methoxycinnamaldehyde. Methyl isovalerate. 2-Methoxy-4-methylphenol; 4-methyl- Methyl laurate. guaiacol; 2-methoxy-p-cresol. Methyl mercaptan; methanethiol. 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; dimethyl 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. Pyruvic acid. 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 extract 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 chloride, 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 hydrogen 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 absorptivity 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 availability 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, determined 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 combination. 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 conditions: 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 fermentation 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 copolymer 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 information 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 distillation 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 incorporated 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 refin 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 examined 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 derived 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 (stearoyl 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 directions 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 potency 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-purpose 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 necessary 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- sugar substitute 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 inspection 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 poultry 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 specifications 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 addition 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 exceed 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 glycine. § 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 peracid, 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 diatomaceous 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 employing 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 milliliter of standard solution. ETHYLENE GLYCOL AND DIETHYLENE GLYCOL CONTENT OF POLYETHYLENE GLYCOLS PROCEDURE The analytical method for determining Weigh approximately 4 grams of polyethylene 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 sorbitol 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 percent 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 acetylation 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- succinylation 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 percent–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 followed 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 nonstandardized 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 foaming agent 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 soft drink 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 sections 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 percent. 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 combination 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 products 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 physical 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 glycerin, 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 carboxylic acid 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 prescribed 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 equivalent). 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. absorbance 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 capacity. 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 absorbance. 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 milliequivalent). 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 equivalents 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 which contains, on an anhydrous basis, not more than 4.6

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hydroxypropyl groups per (3) The ash content on a dry basis has anhydroglucose unit. The additive has a maximum of 0.6 percent. a minimum viscosity of 145 centipoises (c) The food additive is used as an for 10 percent by weight aqueous solu- aerating, emulsifying, and foaming tion at 25 °C. agent, in an amount not in excess of (2) A cellulose ether containing pro- that reasonably required to produce its pylene glycol groups attached by an intended effect. ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16 percent § 172.874 Hydroxypropyl weight in weight (w/w) on an anhydrous methylcellulose. basis, i.e., 0.1 to 0.4 hydroxypropyl The food additive hydroxypropyl groups per anhydroglucose unit. The methylcellulose (CAS Reg. No. 9004–65– common name for this form of the ad- 3) may be safely used in food, except in ditive is low substituted hydroxypropyl standardized foods which do not pro- cellulose. vide for such use if: (b) The additive is used or intended (a) The additive complies with the for use as follows: definition and specifications prescribed (1) The additive identified in para- in the National Formulary, 12th edi- graph (a)(1) of this section is used or tion. intended for use as an emulsifier, film (b) It is used or intended for use as an former, protective colloid, stabilizer, emulsifier, film former, protective col- suspending agent, or thickener, in ac- loid, stabilizer, suspending agent, or cordance with good manufacturing thickener, in accordance with good practice. manufacturing practice. (2) The additive identified in para- (c) To insure safe use of the additive, graph (a)(2) of this section is used or the container of the additive, in addi- intended for use as a binder and dis- tion to being labeled as required by the integrator in tablets or wafers con- general provisions of the act, shall be taining dietary supplements of vita- accompanied by labeling which con- mins and/or minerals. The additive is tains adequate directions for use to used in accordance with good manufac- provide a final product that complies turing practice. with the limitations prescribed in para- [46 FR 50065, Oct. 9, 1981] graph (b) of this section. [42 FR 14491, Mar. 15, 1977, as amended at 47 § 172.872 Methyl ethyl cellulose. FR 38273, Aug. 31, 1982] The food additive methyl ethyl cellulose may be safely used in food in ac- § 172.876 Castor oil. cordance with the following prescribed The food additive castor oil may be conditions. safely used in accordance with the fol- (a) The additive is a cellulose ether lowing conditions: having the general formula (a) The additive meets the specifica- [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is tions of the United States Pharma- the number of methyl groups and y is copeia XX (1980). the number of ethyl groups. The aver- (b) The additive is used or intended age value of x is 0.3 and the average for use as follows: value of y is 0.7. (b) The additive meets the following Use and Limitations specifications: Hard candy production—As a release agent (1) The methoxy content shall be not and antisticking agent, not to exceed 500 less than 3.5 percent and not more than parts per million in hard candy. Vitamin and mineral tablets—As a compo- 6.5 percent, calculated as OCH3, and the ethoxy content shall be not less than nent of protective coatings. 14.5 percent and not more than 19 per- [42 FR 14491, Mar. 15, 1977, as amended at 49 cent, calculated as OC2H5, both meas- FR 10105, Mar. 19, 1984] ured on the dry sample. (2) The viscosity of an aqueous solu- § 172.878 White mineral oil. tion, 2.5 grams of the material in 100 White mineral oil may be safely used milliliters of water, at 20 °C, is 20 to 60 in food in accordance with the fol- centipoises. lowing conditions:

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(a) White mineral oil is a mixture of the Center for Food Safety and Applied liquid hydrocarbons, essentially par- Nutrition (HFS–200), Food and Drug affinic and naphthenic in nature ob- Administration, 5100 Paint Branch tained from petroleum. It is refined to Pkwy., College Park, MD 20740, or meet the following specifications: available for inspection at the National (1) It meets the test requirements of Archives and Records Administration the United States Pharmacopeia XX (NARA). For information on the avail- (1980) for readily carbonizable sub- ability of this material at NARA, call stances (page 532). 202–741–6030, or go to: http:// (2) It meets the test requirements of www.archives.gov/federallregister/ U.S.P. XVII for sulfur compounds (page codeloflfederallregulations/ 400). (3) It meets the specifications pre- ibrllocations.html. scribed in the ‘‘Journal of the Associa- (b) White mineral oil may contain tion of Official Analytical Chemists,’’ any antioxidant permitted in food by Volume 45, page 66 (1962), which is in- regulations issued in accordance with corporated by reference, after correc- section 409 of the Act, in an amount tion of the ultraviolet absorbance for not greater than that required to any absorbance due to added anti- produce its intended effect. oxidants. Copies of the material incor- (c) White mineral oil is used or in- porated by reference are available from 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 chapter. 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 manufacturing 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 manufacturing 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 practice. 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 manufacturing 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 prevent or retard access of air, evaporation, and contamination § 172.886 Petroleum wax. with wild organisms during fermentation. 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 nature, 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 maximum. (4) Ultraviolet absorbance limits determined 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 million 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 milliliter 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 portions, 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 liquid 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 milliliters 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 manufacturing 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, paraffinic 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 commercially processed Limitations foods. Chlorine, as sodium hypochlorite, Acrolein, 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 propylene 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 enzyme 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 cottonseed 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 copolymer. 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 defined 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 Cetylpyridinium chloride. 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 copolymerization 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 prepared 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, hydrogen, hydroxyl, magnesium, potas- (14) Epichlorohydrin cross-linked sium, sodium, and sulfate except that: with ammonia. 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 dextran 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 filtration.

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 dispersions 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 recombinant 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 organism 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; family, 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 tetrafluoroethylene 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 requirements: 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 specifications 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- transferase 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 phosphorylation 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 absorbance 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 hydrocarbons 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 bakery 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 ethylene 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 maximum 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 information 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 accordance 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 material 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 combination 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 subsequently 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 anhydride. 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 laurate 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 section. 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 potable 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 industry 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 percent 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 hydrocarbons. 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/ following substances: Carbon dioxide, federallregister/ nitrous oxide, propane, and codeloflfederallregulations/ibrllocations.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 erucic 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 absorption 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- codeloflfederal regulations/ 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 preparations 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 accordance 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 enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance 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 applied 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. 123–03–05) may be safely used in shall not exceed 0.8 percent by weight. food in accordance with the following When application of the additive is not conditions: 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] described in USP 30/NF 25, May 1, 2007, pp. 1700–1701, which is incorporated by § 173.385 Sodium methyl sulfate. reference. The Director of the Office of Sodium methyl sulfate may be the Federal Register approves this in- present in pectin in accordance with corporation by reference in accordance the following conditions. with 5 U.S.C. 552(a) and 1 CFR part 51. (a) It is present as the result of You may obtain copies from the United methylation of pectin by sulfuric acid States Pharmacopeial Convention, and methyl alcohol and subsequent Inc., 12601 Twinbrook Pkwy., Rock- treatment with sodium bicarbonate. ville, MD 20852, or you may examine a (b) It does not exceed 0.1 percent by copy at the Center for Food Safety and weight of the pectin. Applied Nutrition’s Library, Food and Drug Administration, 5100 Paint § 173.395 Trifluoromethane sulfonic Branch Pkwy., College Park, MD 20740, acid. or at the National Archives and Trifluoromethane sulfonic acid has Records Administration (NARA). For the empirical formula CF3SO3H (CAS information on the availability of this Reg. No. 1493–13–6). The catalyst material at NARA, call 202–741–6030, or (Trifluoromethane sulfonic acid) may go to: http://www.archives.gov/federal- safely be used in the production of register/cfr/ibr-locations.html. cocoa butter substitute from palm oil (b) The additive is used in food as an (1-palmitoyl-2-oleoyl-3-stearin) (see antimicrobial agent as defined in § 184.1259 of this chapter) in accordance § 170.3(o)(2) of this chapter to treat the with the following conditions: surface of raw poultry carcasses. The (a) The catalyst meets the following solution in which the additive is used specifications: to treat raw poultry carcasses shall also contain propylene glycol (CAS Appearance, Clear liquid. Color, Colorless to amber. Reg. No. 57–55–6) complying with Neutralization equivalent, 147–151. § 184.1666 of this chapter, at a con- Water, 1 percent maximum. centration of 1.5 times that of Fluoride ion, 0.03 percent maximum. cetylpyridinium chloride. Heavy metals (as Pb), 30 parts per million (c) The additive is used as follows: maximum. (1) As a fine mist spray of an ambient Arsenic (as As), 3 parts per million max- temperature aqueous solution applied imum. to raw poultry carcasses prior to im- (b) It is used at levels not to exceed mersion in a chiller, at a level not to 0.2 percent of the reaction mixture to exceed 0.3 gram cetylpyridinium chlo- catalyze the directed esterification. ride per pound of raw poultry carcass, (c) The esterification reaction is provided that the additive is used in quenched with steam and water and systems that collect and recycle solu- the catalyst is removed with the aque- tion that is not carried out of the sys- ous phase. Final traces of catalyst are tem with the treated poultry carcasses; removed by washing batches of the or product three times with an aqueous (2) As a liquid aqueous solution ap- solution of 0.5 percent sodium bicar- plied to raw poultry carcasses either bonate.

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(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 inspection at the National Archives and [43 FR 54237, Nov. 11, 1978, as amended at 49 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 nonfatty 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 tains not more than a total of 2 percent CFR part 51. Copies are available from by weight of free amine and amine hy- the Center for Food Safety and Applied

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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 following, 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 technical 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 (2) Any substance used as a compo- food at negligible levels may be re- nent of articles that contact food shall viewed under § 170.39 of this chapter.

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The Food and Drug Administration food in accordance with the following will exempt substances whose uses it prescribed conditions: determines meet the criteria in § 170.39 (1) The adhesive is prepared from one of this chapter from regulation as food or more of the optional substances additives and, therefore, a food addi- named in paragraph (c) of this section, tive petition will not be required for subject to any prescribed limitations. the exempted use. (2) The adhesive is either separated from the food by a functional barrier or [60 FR 36596, July 17, 1995] used subject to the following additional limitations: PART 175—INDIRECT FOOD ADDI- (i) In dry foods. The quantity of adhe- TIVES: ADHESIVES AND COMPO- sive that contacts packaged dry food NENTS OF COATINGS shall not exceed the limits of good manufacturing practice. Subpart A [Reserved] (ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts Subpart B—Substances for Use Only as packaged fatty and aqueous foods shall Components of Adhesives not exceed the trace amount at seams Sec. and at the edge exposure between pack- 175.105 Adhesives. aging laminates that may occur within 175.125 Pressure-sensitive adhesives. the limits of good manufacturing practice. Subpart C—Substances for Use as (b) Under normal conditions of use Components of Coatings the packaging seams or laminates will 175.210 Acrylate ester copolymer coating. remain firmly bonded without visible 175.230 Hot-melt strippable food coatings. separation. 175.250 Paraffin (synthetic). (b) To assure safe usage of adhesives, 175.260 Partial phosphoric acid esters of pol- the label of the finished adhesive con- yester resins. tainer shall bear the statement ‘‘food- 175.270 Poly(vinyl fluoride) resins. 175.300 Resinous and polymeric coatings. packaging adhesive’’. 175.320 Resinous and polymeric coatings for (c) Subject to any limitation pre- polyolefin films. scribed in this section and in any other 175.350 Vinyl acetate/crotonic acid copoly- regulation promulgated under section mer. 409 of the Act which prescribes safe 175.360 Vinylidene chloride copolymer coat- conditions of use for substances that ings for nylon film. may be employed as constituents of ad- 175.365 Vinylidene chloride copolymer coatings for polycarbonate film. hesives, the optional substances used 175.380 Xylene-formaldehyde resins con- in the formulation of adhesives may in- densed with 4,4′-isopropylidenediphenol- clude the following: epichlorohydrin epoxy resins. (1) Substances generally recognized 175.390 Zinc-silicon dioxide matrix coatings. as safe for use in food or food pack- AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. aging. (2) Substances permitted for use in SOURCE: 42 FR 14534, Mar. 15, 1977, unless otherwise noted. adhesives by prior sanction or approval and employed under the specific condi- EDITORIAL NOTE: Nomenclature changes to tions of use prescribed by such sanc- part 175 appear at 61 FR 14482, Apr. 2, 1996, 66 tion or approval. FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. (3) Flavoring substances permitted for use in food by regulations in this part, provided that such flavoring sub- Subpart A [Reserved] stances are volatilized from the adhesives during the packaging fabrication Subpart B—Substances for Use process. Only as Components of Adhesives (4) Color additives approved for use in food. § 175.105 Adhesives. (5) Substances permitted for use in (a) Adhesives may be safely used as adhesives by other regulations in this components of articles intended for use subchapter and substances named in in packaging, transporting, or holding this subparagraph: Provided, however,

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That any substance named in this meet any specifications in such regula- paragraph and covered by a specific tion. regulation in this subchapter, must

Substances Limitations

Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4). Acetone-urea-formaldehyde resin. N-Acetyl ethanolamine. Acetyl tributyl citrate. Acetyl triethyl citrate. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt (CAS Reg. No. 35641–59–9). Albumin, blood. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983–55–0). 4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6-C18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols. Alkyl (C7-C12) benzene. Alkyl (C10-C20) dimethylbenzyl ammonium chloride. n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium For use as preservative only. cyclohexylsulfamate. Alkyl ketene dimers as described in § 176.120 of this chapter. Alkyl (C7-C12) naphthalene. alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111–41–1). 3-Aminopropanediol ...... For use only in the preparation of polyurethane resins. 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, stabilizer 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, stabilizer, 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. 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).

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Substances Limitations

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 polyester 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. Castor oil, polyoxyethylated (4–84 moles ethylene oxide). Cellulose acetate butyrate. Cellulose acetate propionate. Ceresin wax (ozocerite). Cetyl alcohol. Chloracetamide. Chloral hydrate.

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Substances Limitations

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 approximately 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 concentration 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. Diacetyl 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. 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.

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Substances Limitations

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. Dipropylene glycol dibenzoate. Dipropylene glycol monomethyl ether. Dipropylene glycol copolymer of adipic acid and phthalic anhydride. Disodium cyanodithioimidocarbonate. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49–8). N,N′-Distearoylethylenediamine. Distearyl thiodipropionate. 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only. droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione. 4,4′-Dithiodimorpholine. n-Dodecylmercaptan. tert-Dodecylmercaptan. Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts. Elemi gum. Epichlorohydrin-4,4′-isopropylidenediphenol resin. Epichlorohydrin-4,4′-sec-butylidenediphenol resin. Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin. Epichlorohydrin-phenolformaldehyde resin. Erucamide (erucylamide). Ethanolamine.

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Substances Limitations

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) containing not more than 30 weight percent of the units derived from carbon 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 percent 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 derived 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 hydrogenated, 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, stabilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Formaldehyde. Formaldehyde o- and p-toluene sulfonamide. Formamide. Fumaratochromium (III) nitrate. Furfural. Furfuryl alcohol. Fumaric acid. gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822–56–5). Glutaraldehyde. Glycerides, di- and monoesters. Glycerol polyoxypropylene triol, minimum average molecular weight 250 For use only in the preparation of polyester and poly- (CAS Reg. No. 25791–96–2). urethane resins in adhesives.

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Substances Limitations

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 terpene 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, stabilizer, 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 resins. 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 chloride. Hydroxyethyldiethylenetriamine. b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. Hydroxyethyl starch. Hydroxyethylurea ...... Hydroxylamine sulfate. 5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5- For use only as an antibacterial preservative. hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly- [methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixture. Hydroxypropyl methylcellulose. 2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate. 2-Imidazolidinone. 3–Iodo–2–propynyl-N-butyl carbamate (CAS Reg. No. 55406–53–6) ...... For use only as an antifungal preservative. Iodoform ...... For use only as polymerization-control agent. Isoascorbic acid. Isobutyl alcohol (isobutanol). Isobutylene-isoprene copolymer. Isodecyl benzoate (CAS Reg. No. 131298–44–7). Isophorone. Isopropanolamine (mono-, di-, tri-). Isopropyl acetate. Isopropyl alcohol (isopropanol). Isopropyl-m- and p-cresol (thymol derived). 4,4′-Isopropylidenediphenol. 4,4′-Isopropylidenediphenol, polybutylated mixture ...... For use as preservative only. Isopropyl peroxydicarbonate. p-Isopropoxy diphenylamine. 4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanol. Itaconic acid. Japan wax. Kerosene.

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Substances Limitations

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, stabilizer, 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. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 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.

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Substances Limitations

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. 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 copolymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene types from distillates of cracked petroleum stocks). Phenol ...... For use as preservative only. Phenol-coumarone-indene resin. Phenolic resins as described in § 175.300(b)(3)(vi). Phenothiazine ...... For use only as polymerization-control agent. Phenyl-b-naphthylamine (free of b-naphthylamine). o-Phenylphenol ...... For use as preservative only. o-Phthalic acid. Pimaric acid ...... Pine oil. Piperazine. Piperidinium pentamethylenedithiocarbamate. Poly(acrylamide-[2-acrylamide-2-methylpropylsulfonate]-dimethylidiallyl ammonium chloride) sodium salt (CAS Reg. No. 72275-68-4). Polyamides derived from reaction of one or more of the following acids with one or more of the following amines: Acids: Azelaic acid. Dimerized vegetable oil acids. Amines: Bis(hexamethylene) triamine and higher homologues. Diethylenetriamine. Diphenylamine. Ethylenediamine. Hexamethylenediamine. Poly(oxypropylene)diamine (weight average molecular weight 2010) (CAS Reg. No. 9046–10–0). Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046–10–0).

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Substances Limitations

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 glycol 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 prepared 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. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dimethyl-a-methylstyrene. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethyl acrylate. Ethylene.

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Substances Limitations

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 formaldehyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide and/or propylene oxide). Poly(oxycaproyl) diols and triols (minimum molecular weight 500). Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt. Polyoxyethylene (20 mol)—anhydrous lanolin adduct. Polyoxyethylene (molecular weight 200) dibenzoate. Polyoxyethylene (molecular weight 200–600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil). Polyoxyethylene (15 moles) ester of rosin. Polyoxyethylene (4–5 moles) ether of phenol. Polyoxyethylene (25 moles)—glycerol adduct. Polyoxyethylene (40 moles) stearate. Polyoxyethylene (5–15 moles) tridecyl alcohol. Polyoxypropylene (3 moles) tridecyl alcohol sulfate. Polyoxypropylene (20 moles) butyl ether. Polyoxypropylene (40 moles) butyl ether. Polyoxypropylene (20 moles) oleate butyl ether. Polyoxypropylene-polyoxyethylene condensate (minimum molecular weight 1,900). Polypropylene glycol (minimum molecular weight 150). Polypropylene glycol (3–4 moles) triether with 2-ethyl-2-(hydroxymethyl)- 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245–46–6) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Polypropylene, noncrystalline. Polysiloxanes: Diethyl polysiloxane.

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Substances Limitations

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. Polytretrafluoroethylene. Polyurethane resins produced by: (1) reacting diisocyanates with one or more of the polyols or polyesters named in this paragraph, or (2) reacting 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 polypropylene 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 percent of comonomer units derived from 1-alkenes having 12 to 20 carbon 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. 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.

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Substances Limitations

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 thereof, 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, stabilizer, or preservative. Total fluoride for all sources not to exceed 1 percent by weight of the finished adhesive. Sodium formaldehyde sulfoxylate. Sodium formate. Sodium heptadecylsulfate. Sodium hypochlorite. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate. Sodium N-lauroyl sarcosinate. Sodium metaborate. Sodium a-naphthalene sulfonate. Sodium nitrate. Sodium nitrite. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ...... For use as preservative only. Sodium perborate.

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Substances Limitations

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 percent 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 disodium 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, disodium 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 molecular 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 condensates with phenol, formaldehyde, coumarone, and/or indene. Terphenyl. Terphenyl, hydrogenated. Terpineol. Tetraethylene pentamine. Tetraethylthiuram disulfide. Tetrahydrofuran. Tetrahydrofurfuryl alcohol. Tetra-isopropyl titanate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] methane.

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Substances Limitations

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 molecular weight approximately 500. Tri(nonylphenyl) phosphite-formaldehyde resins ...... As identified in § 177.2600(c)(4)(iii) of this chapter. For use only as a stabilizer. Triphenylphosphate. Tripropylene glycol monomethyl ether. 1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H)- trione. Tris (p-tertiary butyl phenyl) phosphate. Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane. Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139– 89–9). Turpentine. Urea-formaldehyde resins as described in § 175.300(b)(3)(xii). Vegetable oil, sulfonated or sulfated, potassium salt. Vinyl acetate-maleic anhydride copolymer, sodium salt. Waxes, petroleum. Wax, petroleum, chlorinated (40% to 70% chlorine). Waxes, synthetic paraffin (Fischer-Tropsch process). 3-(2-Xenolyl)-1,2-epoxypropane.

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Substances Limitations

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

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Butadiene-acrylonitrile-styrene copolymer. form to molded virgin fiber and heat- Butadiene-styrene copolymer. cured to an insoluble resin. Butyl rubber. (b) Optional substances used in the Butylated reaction product of p-cresol and preparation of the polymer and in the dicyclopentadiene produced by reacting p- preparation and application of the cresol and dicyclopentadiene in an approximate mole ratio of 1.5 to 1.0, respectively, emulsion may include substances followed by alkylation with isobutylene so named in this paragraph, in an amount that the butyl content of the final product not to exceed that required to accom- is not less than 18 percent, for use at levels plish the desired technical effect and not to exceed 1.0 percent by weight of the subject to any limitation prescribed: adhesive formulation. Provided, however, That any substance Chlorinated natural rubber. named in this paragraph and covered Isobutylene-styrene copolymer. by a specific regulation in subchapter Petrolatum. Polybutene-1. B of this chapter must meet any speci- Polybutene, hydrogenated; complying with fications in such regulation. the identity prescribed under § 178.3740(b) of List of substances Limitations this chapter. Polyisobutylene. Aluminum stearate. cis-1,4-Polyisoprene. Ammonium lauryl sulfate. Polystyrene. Borax ...... Not to exceed the Propyl gallate. amount required as a preservative in emul- Rapeseed oil, vulcanized. sion defoamer. Rosins and rosin derivatives as provided in Disodium hydrogen phosphate ..... Do. § 178.3870 of this chapter. Formaldehyde. Rubber hydrochloride. Glyceryl monostearate. Rubber (natural latex solids or crepe, Methyl cellulose. smoked or unsmoked). Mineral oil. Paraffin wax. Terpene resins (a- and b-pinene), Potassium hydroxide. homopolymers, copolymers, and conden- Potassium persulfate. sates with phenol, formaldehyde, cou- Tallow. marone, and/or indene. Tetrasodium pyrophosphate. Tetrasodium ethylenediaminetetraacetate. Titanium dioxide. Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more (c) The coating in the form in which than 1 percent by weight of it contacts food meets the following triisopropanolamine). tests: (1) An appropriate sample when ex- (c) Acrylonitrile copolymers identi- posed to distilled water at 212 °F for 30 fied in this section shall comply with minutes shall yield total chloroform- the provisions of § 180.22 of this chap- soluble extractables not to exceed 0.5 ter. milligram per square inch. [42 FR 14534, Mar. 15, 1977, as amended at 42 (2) An appropriate sample when ex- FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, posed to n-heptane at 120 °F for 30 min- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, utes shall yield total chloroform-solu- Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] ble extractables not to exceed 0.5 milligram per square inch. Subpart C—Substances for Use as Components of Coatings § 175.230 Hot-melt strippable food coatings. § 175.210 Acrylate ester copolymer Hot-melt strippable food coatings coating. may be safely applied to food, subject Acrylate ester copolymer coating to the provisions of this section. may safely be used as a food-contact (a) The coatings are applied to and surface of articles intended for pack- used as removable coatings for food. aging and holding food, including heat- (b) The coatings may be prepared, as ing of prepared food, subject to the pro- mixtures, from the following sub- visions of this section: stances: (a) The acrylate ester copolymer is a (1) Substances generally recognized fully polymerized copolymer of ethyl as safe in food. acrylate, methyl methacrylate, and (2) Substances identified in this sub- methacrylic acid applied in emulsion paragraph.

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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- NARA, call 202–741–6030, or go to: http:// ponent of hot-melt strippable food coat- www.archives.gov/federallregister/ ings applied to frozen codeloflfederallregulations/ meats and complying ibrllocations.html. with § 172.878 of this (2) Oil content. The substance has an chapter. oil content not exceeding 2.5 percent as determined by ASTM method D721–56T, § 175.250 Paraffin (synthetic). ‘‘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- (3) Absorptivity. The substance has an ing food in accordance with the fol- absorptivity at 290 millimicrons in lowing prescribed conditions: decahydronaphthalene at 88 °C not ex- (a) The additive is synthesized by the ceeding 0.01 as determined by ASTM Fischer-Tropsch process from carbon method E131–81a, ‘‘Standard Defini- monoxide and hydrogen, which are cat- tions of Terms and Symbols Relating alytically converted to a mixture of to Molecular-Spectroscopy,’’ which is paraffin hydrocarbons. Lower molec- incorporated by reference. See para- ular-weight fractions are removed by graph (b)(1) of this section for avail- distillation. The residue is hydro- ability of the incorporation by ref- genated and may be further treated by erence. percolation through activated char- (c) The provisions of this section are coal. This mixture can be fractionated not applicable to synthetic paraffin into its components by a solvent sepa- used in food-packaging adhesives com- ration method, using synthetic plying with § 175.105. isoparaffinic petroleum hydrocarbons [42 FR 14534, Mar. 15, 1977, as amended at 47 complying with § 178.3530 of this chap- FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, ter. 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, (b) Synthetic paraffin shall conform Aug. 3, 1995] to the following specifications: (1) Congealing point. There is no speci- § 175.260 Partial phosphoric acid fication for the congealing point of esters of polyester resins. synthetic paraffin components, except Partial phosphoric acid esters of pol- those components that have a con- yester resins identified in this section gealing point below 50 °C when used in and applied on aluminum may be safely contact with food Types III, IVA, V, used as food-contact coatings, in ac- VIIA, and IX identified in table 1 of cordance with the following prescribed § 176.170(c) of this chapter and under conditions: conditions of use E, F, and G described (a) For the purpose of this section, in table 2 of § 176.170(c) of this chapter partial phosphoric acid esters of poly- shall be limited to a concentration not ester resins are prepared by the reac- exceeding 15 percent by weight of the tion of trimellitic anhydride with 2,2- finished coating. The congealing point dimethyl-1,3-propanediol followed by shall be determined by ASTM method reaction of the resin thus produced D938–71 (Reapproved 1981), ‘‘Standard with phosphoric acid anhydride to Test Method for Congealing Point of produce a resin having an acid number Petroleum Waxes, Including Petro- of 81 to 98 and a phosphorus content of latum,’’ which is incorporated by ref- 4.05 to 4.65 percent by weight. erence. Copies may be obtained from (b) The coating is chemically bonded the American Society for Testing Ma- to the metal and cured at temperatures terials, 100 Barr Harbor Dr., West exceeding 450 °F.

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(c) The finished food-contact coating, (4) Viscometer. Cannon-Ubbelohde size when extracted with the solvent or sol- 50 semimicro dilution viscometer (or vents characterizing the type of food equivalent). and under the conditions of time and (5) Calculation. The calculation meth- temperature characterizing the condi- od used is that described in appendix X tions of its intended use, as determined 1.3 (ASTM method D1243–79, ‘‘Standard from tables 1 and 2 of § 175.300(d), yields Test Method for Dilute Solution Vis- total extractives in each extracting cosity of Vinyl Chloride Polymers,’’ solvent not to exceed 0.3 milligrams which is incorporated by reference; see per square inch of food-contact surface, paragraph (b) of this section for avail- as determined by the methods de- ability of the incorporation by ref- scribed in § 175.300(e), and the coating erence) with the reduced viscosity de- yields 2,2-dimethyl-1,3-propanediol in termined for three concentration levels each extracting solvent not to exceed not greater than 0.5 gram per deciliter 0.3 micrograms per square inch of food- and extrapolated to zero concentration contact surface. In testing the finished for intrinsic viscosity. The following food-contact articles, a separate test formula is used for determining re- sample is to be used for each required duced viscosity: 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 programs 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 polymerization 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 tional Archives and Records Adminis- repeated food-contact use and is ap- tration (NARA). For information on plied to any suitable substrate as a the availability of this material at continuous film or enamel that serves NARA, call 202–741–6030, or go to: http:// as a functional barrier between the www.archives.gov/federallregister/ food and the substrate. The coating is codeloflfederallregulations/ characterized by one or more of the fol- ibrllocations.html. lowing descriptions: (1) Solvent. N,N-Dimethylacetamide, (1) Coatings cured by oxidation. technical grade. (2) Coatings cured by polymerization, (2) Solution. Powdered resin and sol- condensation, and/or cross-linking vent are heated at 120 °C until the resin without oxidation. is dissolved. (3) Coatings prepared from prepoly- (3) Temperature. Flow times of the merized substances. solvent and solution are determined at (b) The coatings are formulated from 110 °C. optional substances that may include:

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(1) Substances generally recognized (iii) Synthetic drying oils, as the as safe in food. basic polymer: (2) Substances the use of which is Butadiene and methylstyrene copolymer. permitted by regulations in this part Butadiene and styrene copolymer, blown or or which are permitted by prior sanc- unblown. tion or approval and employed under Maleic anhydride adduct of butadiene sty- the specific conditions, if any, of the rene. prior sanction or approval. Polybutadiene. (3) Any substance employed in the (iv) Natural fossil resins, as the basic production of resinous and polymeric resin: coatings that is the subject of a regulation in subchapter B of this chapter Copal. and conforms with any specification in Damar. Elemi. such regulation. Substances named in Gilsonite. this paragraph (b)(3) and further identi- Glycerol ester of damar, copal, elemi, and fied as required: sandarac. (i) Drying oils, including the Sandarac. triglycerides or fatty acids derived Shellac. therefrom: Utah coal resin. Beechnut. (v) Rosins and rosin derivatives, with Candlenut. or without modification by polymeriza- Castor (including dehydrated). tion, isomerization, incidental Chinawood (tung). decarboxylation, and/or hydrogenation, Coconut. as follows: Corn. (a) Rosins, refined to color grade of K Cottonseed. or paler: Fish (refined). Hempseed. Gum rosin. Linseed. Tall oil rosin. Oiticica. Wood rosin. Perilla. (b) Rosin esters formed by reacting Poppyseed. rosin (paragraph (b)(3)(v)(a) of this sec- Pumpkinseed. Safflower. tion) with: Sesame. 4,4′-sec-Butylidenediphenol-epichlorohydrin Soybean. (epoxy). Sunflower. Diethylene glycol. Tall oil. Ethylene glycol. Walnut. Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin The oils may be raw, heat-bodied, or (epoxy). blown. They may be refined by filtra- Methyl alcohol. tion, degumming, acid or alkali wash- Pentaerythritol. ing, bleaching, distillation, partial de- (c) Rosin esters (paragraph (b)(3)(v)(b) hydration, partial polymerization, or of this section) modified by reaction solvent extraction, or modified by com- with: bination with maleic anhydride. (ii) Reconstituted oils from Maleic anhydride. triglycerides or fatty acids derived o-, m-, and p-substituted phenol-formalde- from the oils listed in paragraph hydes listed in paragraph (b)(3)(vi) of this (b)(3)(i) of this section to form esters section. Phenol-formaldehyde. with: (d) Rosin salts: Butylene glycol. Ethylene glycol. Calcium resinate (limed rosin). Pentaerythritol. Zinc resinate. Polyethylene glycol. Polypropylene glycol. (vi) Phenolic resins as the basic poly- Propylene glycol. mer formed by reaction of phenols with Sorbitol. formaldehyde: Trimethylol ethane. (a) Phenolic resins formed by reac- Trimethylol propane. tion of formaldehyde with:

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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. Phenyl o-cresol. (d) Monohydric alcohols: p-Phenylphenol. Cetyl alcohol. Xylenol. Decyl alcohol. (b) Adjunct for phenolic resins: Alu- Lauryl alcohol. minum butylate. Myristyl alcohol. (vii) Polyester resins (including Octyl alcohol. alkyd-type), as the basic polymers, Stearyl alcohol. formed as esters of acids listed in para- (e) Catalysts: graph (b)(3)(vii) (a) and (b) of this section by reaction with alcohols in para- Dibutyltin oxide (CAS Reg. No. 818–08–6), not 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- (a) Polybasic acids: ester resin. 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). Dimerized fatty acids derived from oils listed (viii) Epoxy resins, catalysts, and ad- in paragraph (b)(3)(i) of this section. juncts: Fumaric. (a) Epoxy resins, as the basic poly- Isophthalic. Maleic. mer: 2,6-Naphthalenedicarboxylic. (Alkoxy C10-C16)-2,3-epoxypropane, in which 2,6-Naphthalenedicarboxylic, dimethyl ester. the alkyl groups are even numbered and Orthophthalic. consist of a maximum of 1 percent C10 car- Sebacic. bon atoms and a minimum of 48 percent C12 Terephthalic. carbon atoms and a minimum of 18 percent Terpene-maleic acid adduct. C14 carbon atoms, for use only in coatings Trimellitic. that are intended for contact with dry bulk (b) Monobasic acids: foods at room temperature. 4,4′-sec-Butylidenediphenol-epichlorohydrin. Benzoic acid. 4,4′-sec-Butylidenediphenol-epichlorohydrin 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. reacted with one or more of the drying oils tert-Butyl benzoic acid. or fatty acids listed in paragraph (b)(3)(i) Fatty acids derived from oils listed in para- of this section. graph (b)(3)(i) of this section. 4,4′-sec-Butylidenediphenol-epichlorohydrin Rosins listed in paragraph (b)(3)(v)(a) of this chemically treated with one or more of section, for use only as reactants in oil- the following substances: based or fatty acid-based alkyd resins. Allyl ether of mono-, di-, or trimethylol (c) Polyhydric alcohols: phenol. 4,4′-sec-Butylidenediphenol-formaldehyde. Butylene glycol. 4,4′-Isopropylidenediphenol-formaldehyde. Diethylene glycol. Melamine-formaldehyde. 2,2-Dimethyl-1,3-propanediol for use only in Phenol-formaldehyde. forming polyester resins for coatings in- Urea-formaldehyde. tended for use in contact with non-alco- Epoxidized polybutadiene. holic foods. Glycidyl ethers formed by reacting Ethylene glycol. phenolnovolak resins with Glycerol. epichlorohydrin. Mannitol. 4,4′-Isopropylidenediphenol-epichlorohydrin. a-Methyl glucoside. 4,4′-Isopropylidenediphenol-epichlorohydrin Pentaerythritol. reacted with one or more of the drying oils

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or fatty acids listed in paragraph (b)(3)(i) Catalysts and cross-linking agents for epoxy of this section. resins: 4,4′-Isopropylidenediphenol-epichlorohydrin 3-Aminomethyl-3,5,5- chemically treated with one or more of trimethylcyclohexylamine (CAS Reg. No. the following substances: 2855–0913–092). Allyl ether of mono-, di-, or trimethylol Cyanoguanidine. phenol. Dibutyl phthalate, for use only in coatings 4,4′-sec-Butylidenediphenol-formaldehyde. for containers having a capacity of 1,000 4,4′-Isopropylidenediphenol-formaldehyde. gallons or more when such containers are Melamine-formaldehyde. 2,2′-[(1-methylethylidene)bis[4,1- intended for repeated use in contact with phenyleneoxy[1-(butoxymethyl)-2,1- alcoholic beverages containing up to 8 per- ethanediyl]oxymethylene]]bisoxirane, cent of alcohol by volume. CAS Reg. No. 71033–08–4, for use only in 3-Diethylaminopropylamine (CAS Reg. No. coatings intended for contact with bulk 104–78–9), for use in coatings at a level not dry foods at temperatures below 100 °F. to exceed 6 percent by weight of the resin Phenol-formaldehyde. when such coatings are intended for re- Urea-formaldehyde. peated use in contact with foods only of the types identified in paragraph (d) of this (b) Catalysts and cross-linking agents section, table 1, under Types I, II, and III, for epoxy resins: under conditions of use C, D, E, or F as de- 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- scribed in table 2 of paragraph (d) of this amine reacted with phenol and formalde- section; or when such coatings are in- hyde in a ratio of 2.6:1.0:2.0, for use only in tended for repeated use in contact with coatings intended for repeated use in con- foods of the types identified in paragraph tact with foods only of the types identified (d) of this section, table 1, under Types V, in paragraph (d) of this section, table 1, VI, VII, and VIII, under conditions of use E under Category I and Category VIII, at or F as described in table 2 of paragraph (d) temperatures not exceeding 88 °C (190 °F). of this section. Use shall be limited to N-Beta-(aminoethyl)-gamma-aminopropyltri- coatings for tanks of capacity greater than methoxysilane (CAS Reg. No. 1760–24–3), for 530,000 gallons. use only in coatings at a level not to ex- Diethylenetriamine. ceed 1.3 percent by weight of the resin Diphenylamine. when such coatings are intended for repeated use in contact with foods only of Ethylenediamine. the types identified in paragraph (d) of this Isophthalyl dihydrazide for use only in coat- section, table 1, under Types I, II, and III, ings subject to the provisions of paragraph under conditions of use C, D, E, or F as de- (c) (3) or (4) of this section. scribed in table 2 of paragraph (d) of this 4,4′-Methylenedianiline, for use only in coat- section; or when such coatings are in- ings for containers having a capacity of tended for repeated use in contact with 1,000 gallons or more when such containers foods of the types identified in paragraph are intended for repeated use in contact (d) of this section, table 1, under Types V, with alcoholic beverages containing up to 8 VI, VII, and VIII, under conditions of use E percent of alcohol by volume. or F as described in table 2 of paragraph (d) N-Oleyl-1,3-propanediamine with not more of this section. Use shall be limited to than 10 percent by weight of coatings for tanks of capacity greater than diethylaminoethanol. 530,000 gallons. 3-Pentadecenyl phenol mixture (obtained Benzyl alcohol (CAS Reg. No. 100–51–6), for from cashew nutshell liquid) reacted with use only in coatings at a level not to ex- formaldehyde and ethylenediamine in a ceed 4 percent by weight of the resin when such coatings are intended for repeated use ratio of 1:2:2 (CAS Reg. No. 68413–28–5). in contact with foods only of the types Polyamine produced when 1 mole of the identified in paragraph (d) of this section, chlorohydrin diether of polyethylene gly- table 1, under Types I, II, and III, under col 400 is made to react under conditions of use C, D, E, or F as described dehydrohalogenating conditions with 2 in table 2 of paragraph (d) of this section; moles of N-octadecyltrimethylenediamine or when such coatings are intended for re- for use only in coatings that are subject to peated use in contact with foods of the the provisions of paragraph (c) (3) or (4) of types identified in paragraph (d) of this this section and that contact food at tem- section, table 1, under Types V, VI, VII, peratures not to exceed room temperature. and VIII, under conditions of use E or F as Polyethylenepolyamine (CAS Reg. No. 68131– described in table 2 of paragraph (d) of this 73–7), for use only in coatings intended for section. Use shall be limited to coatings repeated use in contact with food, at tem- for tanks of capacity greater than 530,000 peratures not to exceed 180 °F (82 °C). gallons.

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Salicylic acid, for use only in coatings for Meta-Xylylenediamine (1,3-benzenedi- containers having a capacity of 1,000 gal- methanamine, CAS Reg. No. 1477–55–0), for lons or more when such containers are in- use only in coatings at a level not to extended for repeated use in contact with al- ceed 3 percent by weight of the resin when coholic beverages containing up to 8 per- such coatings are intended for repeated use cent of alcohol by volume. in contact with foods only of the types Salicylic acid (CAS Reg. No. 69–72–7), for use identified in paragraph (d) of this section, only in coatings at a level not to exceed table 1, under Types I, II, and III, under 0.35 percent by weight of the resin when conditions of use C, D, E or F as described such coatings are intended for repeated use in table 2 of paragraph (d) of this section; in contact with foods only of the types or when such coatings are intended for re- identified in paragraph (d) of this section, peated use in contact with foods of the table 1, under Types I, II, and III, under types identified in paragraph (d) of this conditions of use C, D, E, or F as described section, table 1, under Types V, VI, VII, in table 2 of paragraph (d) of this section; and VIII, under conditions of use E or F as or when such coatings are intended for re- described in table 2 of paragraph (d) of this peated use in contact with foods of the section. Use shall be limited to coatings types identified in paragraph (d) of this for tanks of capacity greater than 530,000 section, table 1, under Types V, VI, VII, gallons. and VIII, under conditions of use E or F as Para-Xylylenediamine (1,4 benzenedimethan- described in table 2 of paragraph (d) of this amine, CAS Reg. No. 539–48–0), for use only section. Use shall be limited to coatings in coatings at a level not to exceed 0.6 per- for tanks of capacity greater than 530,000 cent by weight of the resin when such coat- gallons. ings are intended for repeated use in con- Stannous 2-ethylhexanoate for use only as a tact with foods only of the types identified catalyst at a level not to exceed 1 percent in paragraph (d) of this section, table 1, by weight of the resin used in coatings that under Types I, II, III, under conditions of are intended for contact with food under use C, D, E, or F as described in table 2 of conditions of use D, E, F, and G described paragraph (d) of this section; or when such in table 2 of paragraph (d) of this section. coatings are intended for repeated use in Styrene oxide, for use only in coatings for contact with foods of the types identified containers having a capacity of 1,000 gal- in paragraph (d) of this section, table 1, lons or more when such containers are in- under Types V, VI, VII, and VIII, under tended for repeated use in contact with al- conditions of use E and F as described in coholic beverages containing up to 8 per- table 2 of paragraph (d) of this section. Use cent of alcohol by volume. shall be limited to coatings for tanks of ca- Tetraethylenepentamine. pacity greater than 530,000 gallons. Tetraethylenepentamine reacted with (c) Adjuncts for epoxy resins: equimolar quantities of fatty acids. Tri(dimethylaminomethyl) phenol and its Aluminum butylate. salts prepared from the fatty acid moieties Benzoic acid, for use as a component in of the salts listed in paragraph epoxy resins for coatings not exceeding a (b)(3)(xxii)(b) of this section, for use only coating weight of 4 milligrams per square in coatings subject to the provisions of inch and that are intended for contact paragraph (c) (3) or (4) of this section. under conditions of use D, E, F or G de- Triethylenetetramine. scribed in table 2 of paragraph (d) of this Trimellitic anhydride (CAS Reg. No. 552–30– section with alcoholic beverages con- 7) for use only as a cross-linking agent at taining less than 8 percent alcohol. a level not to exceed 15 percent by weight Polyamides from dimerized vegetable oils of the resin in contact with food under all and the amine catalysts listed in para- conditions of use, except that resins in- graph (b)(3)(viii)(b) of this section, as the tended for use with foods containing more basic polymer. than 8 percent alcohol must contact such Silane coupled silica, prepared from the re- food only under conditions of use D, E, F, action of microcrystalline quartz with N- and G described in table 2 of paragraph (d) beta-(N-vinylbenzylamino) ethyl-gamma- of this section. aminopropyltrimethoxy silane, mono- Trimellitic anhydride adducts of ethylene hydrogen chloride, for use only in coatings glycol and glycerol, prepared by the reac- intended for repeated use in contact with tion of 1 mole of trimellitic anhydride with foods only of the types identified in para- 0.4–0.6 mole of ethylene glycol and 0.04–0.12 graph (d) of this section, table 1, under mole of glycerol, for use only as a cross- Category I and Category VIII, at tempera- linking agent at a level not to exceed 10 tures not exceeding 88 °C (190 °F). percent by weight of the cured coating, Succinic anhydride, for use as a component provided that the cured coating only con- in epoxy resins for coatings not exceeding tacts food containing not more than 8 per- a coating weight of 4 milligrams per square cent alcohol. inch, and that are intended for contact

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under conditions of use D, E, F or G de- (xiv) Modifiers (for oils and alkyds, scribed in table 2 of paragraph (d) of this including polyesters), as the basic poly- section with alcoholic beverages con- mer: taining less than 8 percent alcohol. Butyl methacrylate. (ix) Coumarone-indene resin, as the Cyclopentadiene. basic polymer. Methyl, ethyl, butyl, or octyl esters of acryl- (x) Petroleum hydrocarbon resin ic acid. (cyclopentadiene type), as the basic Methyl methacrylate. polymer. Styrene. (xi) Terpene resins, as the basic poly- Vinyl toluene. mer, from one or more of the following: (xv) Vinyl resinous substance, as the basic polymers: Dipentene. Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl acetate. 106168–39–2). For use only with coatings in Polyvinyl alcohol. contact with acidic and aqueous foods. Polyvinyl butyral. Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl chloride. dipentene copolymer resin (CAS Reg. No. Polyvinyl formal. 106168–37–0). For use only with coatings in Polyvinylidene chloride. contact with acidic and aqueous foods. Polyvinyl pyrrolidone. a-Pinene. Polyvinyl stearate. b-Pinene. Vinyl chloride-acetate-2,3-epoxypropyl methacrylate copolymers containing not more (xii) Urea-formaldehyde, resins and than 10 weight percent of total polymer their curing catalyst: units derived from 2,3-epoxypropyl meth- (a) Urea-formaldehyde resins, as the acrylate and not more than 0.1 weight per- basic polymer: cent of unreacted 2,3-epoxypropyl methacrylate monomer for use in coatings for Urea-formaldehyde. containers. Urea-formaldehyde chemically modified with Vinyl chloride-acetate, hydroxyl-modified methyl, ethyl, propyl, isopropyl, butyl, or copolymer. isobutyl alcohol. Vinyl chloride-acetate, hydroxyl-modified Urea-formaldehyde chemically modified with copolymer, reacted with trimellitic anhy- one or more of the amine catalysts listed dride. in paragraph (b)(3)(viii)(b) of this section. Vinyl chloride copolymerized with acrylamide and ethylene in such a manner that (b) Curing (cross-linking) catalyst for the finished copolymers have a minimum urea-formaldehyde resins: weight average molecular weight of 30,000 Dodecyl benzenesulfonic acid (C.A. Registry and contain not more than 3.5 weight per- No. 27176–87–0). cent of total polymer units derived from acrylamide; the acrylamide portion may or (xiii) Triazine-formaldehyde resins may not be subsequently partially and their curing catalyst: hydrolyzed. (a) Triazine-formaldehyde resins, as Vinyl chloride copolymerized with one or the basic polymer: more of the following substances: Acrylonitrile. Benzoguanamine-formaldehyde. Fumaric acid and/or its methyl, ethyl, Melamine-formaldehyde. propyl, butyl, amyl, hexyl, heptyl, or octyl Melamine-formaldehyde chemically modified esters. with one or more of the following amine Maleic acid and/or its methyl, ethyl, propyl, catalysts: butyl, amyl, hexyl, heptyl, or octyl esters. Amine catalysts listed in paragraph 5-Norbornene-2,3-dicarboxylic acid, mono-n- (b)(3)(viii)(b) of this section. butyl ester; for use such that the finished Dimethylamine-2-methyl-1-propanol. vinyl chloride copolymers contain not Methylpropanolamine. more than 4 weight percent of total polymer units derived from this comonomer. Triethanolamine. Vinyl acetate. Melamine-formaldehyde chemically modified Vinylidene chloride. with methyl, ethyl, propyl, isopropyl, Vinyl chloride-vinylidene chloride-2,3- butyl, or isobutyl alcohol. epoxypropyl methacrylate copolymers con- (b) Curing (cross-linking) catalyst for taining not more than 10 weight percent of triazine-formaldehyde resins: total polymer units derived from 2,3- epoxypropyl methacrylate and not more Dodecyl benzenesulfonic acid (C.A. Registry than 0.05 weight percent of unreacted 2,3- No. 27176–87–0). epoxypropyl methacrylate monomer based

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

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Acrylic acid. Lithium. Ethyl acrylate. Magnesium. Methyl acrylate. Manganese. n-Butyl acrylate-styrene-methacrylic acid- Zinc. hydroxyethyl methacrylate copolymers Zirconium. containing no more than 2 weight percent of total polymer units derived from meth- (b) Salts: acrylic acid and containing no more than Caprate. 9.5 weight percent of total polymer units Caprylate. derived from hydroxyethyl methacrylate; Isodecanoate. for use only in coatings in contact with dry Linoleate. food (food type VIII in table 1 of paragraph Naphthenate. (d) of this section). 2-(Dimethylamino) ethanol (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. (xxiii) Waxes: The styrene and alpha methyl styrene, individually, 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 (Mn) 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 Acetyl tributyl citrate. 250. The monomer content shall be less Acetyl triethyl citrate. than 0.5 percent. The polymers are for use Butyl phthalyl butyl glycolate. only in contact with food of Types IV-A, V, Butyl stearate. VII in table 1 of paragraph (d) of this sec- p-tert-Butyl phenyl salicylate. tion, under use conditions E through G in Dibutyl sebacate. table 2 of paragraph (d), and with food of Diethyl phthalate. Type VIII without use temperature restric- Diisobutyl adipate. tion. Diisooctyl phthalate. (xxi) Elastomers, as the basic poly- Epoxidized soybean oil (iodine number max- mer: imum 14; oxirane oxygen content 6% minimum), as the basic polymer. Butadiene-acrylonitrile copolymer. Ethyl phthalyl ethyl glycolate. Butadiene-acrylonitrile-styrene copolymer. 2-Ethylhexyl diphenyl phosphate. Butadiene-styrene copolymer. di-2-Ethylhexyl phthalate. Butyl rubber. Glycerol. Chlorinated rubber. Glyceryl monooleate. 2-Chloro-1,3-butadiene (neoprene). Glyceryl triacetate. Natural rubber (natural latex or natural Monoisopropyl citrate. latex solids, smoked or unsmoked). Propylene glycol. Polyisobutylene. Sorbitol. Rubber hydrochloride. Mono-, di-, and tristearyl citrate. Styrene-isobutylene copolymer. 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. this section with acid, to form the salt (xxv) Release agents, as the basic listed in paragraph (b)(3)(xxii)(b) of this polymer, when applicable: section: ′ (a) Metals: N,N -Dioleoylethylenediamine (CAS Reg. No. 110–31–6) for use only in ionomeric resins Aluminum. complying with § 177.1330 of this chapter Calcium. and in ethylene vinyl acetate copolymers Cerium. complying with § 177.1350 of this chapter at Cobalt. a level not to exceed 0.0085 milligram per Iron. square centimeter (0.055 milligram per

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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 loxane resins solids): methylphenylpolysiloxanes. The methylphenylpolysiloxanes 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- (xxix) Surface active agents: cosity): Dimethylpolysiloxanes and/or 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 D1243–79, ‘‘Standard Test Method for Dilute (xxvi) Colorants used in accordance Solution Viscosity of Vinyl Chloride Poly- with § 178.3297 of this chapter. mers,’’ which is incorporated by reference (xxvii) Surface lubricants: (Copies may be obtained from the Amer- ican Society for Testing Materials, 100 Cottonseed oil and other edible oils. Barr Harbor Dr., West Conshohocken, Dibutyl sebacate. Philadelphia, PA 19428-2959, or may be ex- Dioctyl sebacate. amined at the National Archives and Glyceryl monostearate. Records Administration (NARA). For in- Lanolin. 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 chloride copolymers and limited to use at (xxviii) Silicones and their curing levels not to exceed 0.1 percent by weight catalysts: of the copolymers. (a) Silicones as the basic polymer: Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate Siloxane resins originating from methyl hy- Sodium lauryl sulfate. drogen polysiloxane, dimethyl 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. polysiloxane, and methylphenyl Reg. No. 126-86-3), for use only in can coat- polysiloxane. ings which are subsequently dried and Siloxane resins originating from the plat- cured at temperatures of at least 193 °C (380 inum-catalyzed reaction product of vinyl- °F) for 4 minutes. containing dimethylpolysiloxane (CAS Reg. No. 68083–18–1 and CAS Reg. No. 68083– (xxx) Antioxidants: 19–2) with methylhydrogen polysiloxane Butylated hydroxyanisole. (CAS Reg. No. 63148–57–2) and Butylated hydroxytoluene. dimethylmethylhydrogen polysiloxane Gum guaiac. (CAS Reg. No. 68037–59–2), where the plat- Dilauryl thiodipropionate. inum content does not exceed 150 parts per Nordihydroguaiaretic acid. million. The following substances may be Propyl gallate. used as optional polymerization inhibitors: Distearyl thiodipropionate. 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. Thiodipropionic acid. 107–54–0), at a level not to exceed 0.53 2,4,5-Trihydroxybutyrophenone. weight-percent; 1-Ethynylcyclohexene (CAS Reg. No. 931–49– (xxxi) Can end cements (sealing com- 7), at a level not to exceed 0.64 weight-per- pounds used for sealing can ends only): cent; In addition to the substances listed in

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paragraph (b) of this section and those 4,4′-Bis(alpha,alpha-dimethyl- listed in § 177.1210(b)(5) of this chapter, benzyl)diphenylamine, CAS Reg. No. 10081– the following may be used: 67–1. Ethyl toluene sulfonamide. Butadiene-styrene-divinylbenzene copolymer N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- (CAS Reg. No. 26471–45–4) for use only at hydroxyhydrocinnamide), CAS Reg. No. levels not to exceed 23.8 percent by weight 23128–74–7. of the cement solids in can end cements. Polyamides consisting of the following: Butadiene-styrene-fumaric acid copolymer. Copolymer of omega-laurolactam and 4,4′-Butylidenebis (6-tert-butyl-m-cresol). espilon-caprolactam, CAS Reg. No. 25191– Dibenzamido phenyl disulfide. 04–2 (Nylon 12/6). Di-b-naphthyl phenylenediamine. Homopolymer of omega-aminododecanoic Dipentamethylene thiuram tetrasulfide. acid, CAS Reg. No. 24937–16–4. Isobutylene-isoprene-divinylbenzene copoly- Homopolymer of omega-laurolactam, CAS mers for use only at levels not to exceed 15 Reg. No. 25038–74–8 (Nylon 12). percent by weight of the dry cement com- Polyamides derived from the following acids position. and amines: Naphthalene sulfonic acid-formaldehyde con- Acids: densate, sodium salt, for use only at levels Adipic. not to exceed 0.6 percent by weight of the Azelaic. cement solids in can end cements for con- Sebacic. tainers having a capacity of not less than Vegetable oil acids (with or without 5 gallons. dimerization). Sodium decylbenzene sulfonate. Amines: Sodium nitrite for use only at levels not to Diethylenetriamine. exceed 0.3 percent by weight of the cement Diphenylamine. solids in can end cements for containers Ethylenediamine. having a capacity of not less than 5 gal- Hexamethylenediamine. lons. Tetraethylenepentamine. Sodium pentachlorophenate for use as a pre- Triethylenetetramine. servative at 0.1 percent by weight in can- Polypropylene glycol CAS Reg. No. 25322–69– sealing compounds on containers having a 4. capacity of 5 gallons or more. Sodium pentachlorophenate for use as a pre- Sodium phenylphenate. servative at 0.1 percent by weight in can- Styrene-maleic anhydride resin, partial sealing compounds on containers having a methyl and butyl (sec- or iso-) esters, for capacity of 5 gallons or more. use only at levels not in excess of 3 percent Tetrakis [methylene(3,5-di-tert-butyl-4- of the cement solids in can end cement for- hydroxyhydrocinnamate)]methane, CAS mulations. Reg. No. 6683–19–8. Tetrasodium EDTA (tetrasodium ethylene- Toluene sulfonamide formaldehyde resin diaminetetraacetate). (basic polymer). Tri (mixed mono- and dinonylphenyl) Triethylene glycol methacrylate for use only phosphite. as polymerization cross-linking agent in Zinc dibutyldithiocarbamate. side seam cements for containers intended (xxxii) Side seam cements: In addi- for use in contact with food only of the tion to the substances listed in para- types identified in paragraph (d) of this section, table 1, under Categories I, II, and graph (b)(3) (i) to (xxx), inclusive, of VI. this section, the following may be used. Urea. p-tert-Butyl perbenzoate as a catalyst for (xxxiii) Miscellaneous materials: epoxy resin. epsilon-Caprolactam-(ethylene-ethyl acry- Ammonium citrate. late) graft polymer. Ammonium potassium phosphate. Dicumyl peroxide for use only as polymeriza- Bentonite, modified by reaction with benzyl tion catalyst. dimethyl alkyl ammonium chloride, where 4–(Diiodomethylsulfonyl) toluene (CAS Reg. the alkyl groups are derived from hydro- No. 20018–09–1) for use as a preservative at genated tallow (CAS Reg. No. 71011–24–0). a level not to exceed 0.3 percent by weight For use only as a rheological agent in coat- in can-sealing cements. ings intended to contact food under re- Diisodecyl phthalate for use only as plasti- peated use conditions. cizer in side seam cements for containers Bentonite, modified by reaction with sodium intended for use in contact with food only stearate and benzyl dimethyl alkyl ammo- of the types identified in paragraph (d) of nium chloride, where the alkyl groups are this section, table 1, under Categories I, II, derived from hydrogenated tallow (CAS and VI. Reg. No. 121888–68–4). For use as a

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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 derived 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. ASTM method D2503–82, ‘‘Standard Test Sodium pyrophosphate. Method for Molecular Weight (Relative Stannous chloride. Molecular Mass) of Hydrocarbons by Ther- Stannous stearate. moelectric Measurement of Vapor Pres- Stannous sulfate. sure,’’ which is incorporated by reference. Stearyl alcohol. Copies may be obtained from the American 2-Sulfoethyl methacrylate, sodium salt (CAS Society for Testing Materials, 100 Barr Reg. No. 1804–87–1). For use only in copoly- Harbor Dr., West Conshohocken, Philadel- mer coatings on metal under conditions of

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use E, F, and G described in table 2 of para- (xxxvii) Polymeric resin as a coating graph (d) of this section, and limited to use component prepared from terephthalic at a level not to exceed 2.0 percent by acid, isophthalic acid, succinic anhy- weight of the dry copolymer coating. dride, ethylene glycol, diethylene gly- Tetrasodium pyrophosphate. col, and 2,2-dimethyl-1,3-propanediol Tridecyl alcohol produced from tetrapropylene by the oxo process, for use for use in contact with aqueous foods only as a processing aid in polyvinyl chlo- and alcoholic foods containing not 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 (c) The coating in the finished form maleate are copolymerized with or without in which it is to contact food, when ex- one of the monomers: Acrylic acid or 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 ture characterizing the conditions of copolymers shall contain at least 50 its intended use as determined from ta- weight-percent of polymer units derived bles 1 and 2 of paragraph (d) of this sec- from vinyl acetate and shall contain no tion, shall yield chloroform-soluble ex- more than 5 weight-percent of total poly- tractives, corrected for zinc extractives mer units derived from acrylic acid or glycidyl methacrylate. as zinc oleate, not to exceed the following: (xxxiv) Polyamide resins derived (1) From a coating intended for or from dimerized vegetable oil acids employed as a component of a con- (containing not more than 20 percent of tainer not to exceed 1 gallon and in- monomer acids) and ethylenediamine, tended for one-time use, not to exceed as the basic resin, for use only in coat- 0.5 milligram per square inch nor to ex- ings that contact food at temperatures ceed that amount as milligrams per not to exceed room temperature. square inch that would equal 0.005 per- (xxxv) Polyamide resins having a cent of the water capacity of the con- maximum acid value of 5 and a max- tainer, in milligrams, divided by the imum amine value of 8.5 derived from area of the food-contact surface of the dimerized vegetable oil acids (con- container in square inches. From a fab- taining not more than 10 percent of ricated container conforming with the monomer acids), ethylenediamine, and description in this paragraph (c)(1), the 4,4-bis (4-hydroxyphenyl) pentanoic extractives shall not exceed 0.5 milli- acid (in an amount not to exceed 10 gram per square inch of food-contact percent by weight of said polyamide surface nor exceed 50 parts per million resins); as the basic resin, for use only of the water capacity of the container in coatings that contact food at tem- as determined by the methods provided peratures not to exceed room tempera- in paragraph (e) of this section. ture provided that the concentration of (2) From a coating intended for or the polyamide resins in the finished employed as a component of a con- food-contact coating does not exceed 5 tainer having a capacity in excess of 1 milligrams per square inch of food-con- gallon and intended for one-time use, tact surface. not to exceed 1.8 milligrams per square (xxxvi) Methacrylonitrile grafted inch nor to exceed that amount as mil- polybutadiene copolymers containing ligrams per square inch that would no more than 41 weight percent of total equal 0.005 percent of the water capac- polymer units derived from ity of the container in milligrams, di- methacrylonitrile; for use only in coat- vided by the area of the food-contact ings that are intended for contact, surface of the container in square under conditions of use D, E, F, or G inches. described in table 2 of paragraph (d) of (3) From a coating intended for or this section, with food containing no employed as a component of a con- more than 8 percent of alcohol. tainer for repeated use, not to exceed

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

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

Extractant Types of food (see Condition of use 1,2 8 percent alcohol table 1) Water (time and Heptane (time (time and tempera- temperature) and temperature) ture)

A. High temperature heat-sterilized I, IV-B ...... 250 °F, 2 hr ...... (e.g., over 212 °F). III, IV-A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water sterilized ...... II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteurized above 150 II, IV-B ...... Fill boiling, cool to °F. 100 °F. III, IV-A ...... do ...... V ...... 120 °F, 15 min...... do. D. Hot filled or pasteurized below 150 II, IV-B, VI-B ...... 150 °F, 2 hr ...... °F. III, IV-A ...... do ...... 100 °F, 30 min. 150 °F, 2 hr V ...... do ...... VI-A ...... E. Room temperature filled and stored I, II, IV-B, VI-B ...... 120 °F, 24 hr ...... (no thermal treatment in the con- III, IV-A ...... do ...... 70 °F, 30 min. 120 °F, 24 hr tainer). V, VII ...... do ...... VI-A ...... F. Refrigerated storage, no thermal I, II, III, IV-A, IV-B, 70 °F, 48 hr ...... treatment in the container). VI-B, VII. 70 °F, 48 hr VI-A ...... G. Frozen storage (no thermal treat- I, II, III, IV-B, VII .... 70 °F, 24 hr. ment in the container). H. Frozen storage: Ready-prepared foods intended to be reheated in container at time of use:. 1. Aqueous or oil in water emulsion I, II, IV-B ...... 212 °F, 30 min. of high or low fat. 2. Aqueous, high or low free oil or III, IV-A, VII ...... do ...... 120 °F, 30 min. fat. 1 Heptane extractant not to be used on wax-lined containers. 2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.

(e) Analytical methods—(1) Selection of (paragraph (d) of this section), select extractability conditions. First ascertain the food-simulating solvent or solvents the type of food product (table 1, para- (demineralized distilled water, graph (d) of this section) that is being heptane, and/or 8 percent ethyl alcohol) packed commercially in the test con- and the time-temperature exaggera- tainer and the normal conditions of tions of the container-use conditions. thermal treatment used in packaging Aqueous products (Types I, II, IV-B, the type of food involved. Using table 2 and VI-B) require only a water-

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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. perature of 190 °F–200 °F before starting Insert a thermometer in the water and to rinse the container. Invert the con- allow the uncovered container to stand tainer over the top of the fountain and in a room at 70 °F–85 °F. When the tem- direct a strong stream of hot water perature reads 100 °F, composite the against the bottom and all sides for 1 water from each replicate immediately minute, drain, and allow to dry. in a clean Pyrex flask or beaker. Pro- (4) Exposure conditions—(i) Water (250 ceed with the determination of the °F for 2 hours), simulating high-tempera- amount of extractives by the method ture heat sterilization. Fill the container described in paragraph (e)(5) of this within 1⁄4-inch of the top with a meas- section. ured volume of demineralized distilled (iv) Water (150° for 2 hours), simulating water. Cover the container with clean hot fill or pasteurization below 150 °F. aluminum foil and place the container Preheat demineralized distilled water on a rack in a pressure cooker. Add a to 150 °F in a clean Pyrex flask. Fill small amount of demineralized dis- the container within 1⁄4-inch of the top tilled water to the pressure cooker, but with a measured volume of the 150 °F

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water and cover with clean aluminum tainer. Fill the container to within 1⁄4- foil. Place the test container in an inch of the top with a measured volume oven maintained at 150 °F. After 2 of boiling, demineralized distilled hours, remove the test container from water. Cover the container with clean the oven and immediately composite aluminum foil and place the container the water of each replicate in a clean 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- Fill the container within 1⁄4-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 aluminum foil. Place the test container in termination of the amount of extrac- an incubator or oven maintained at 120 tives by the method described in para- °F. After 24 hours, remove the test con- graph (e)(5) of this section. tainer from the incubator and imme- (ix) Heptane (150 °F for 2 hours) simu- diately composite the water of each lating high-temperature heat sterilization replicate in a clean Pyrex flask or for fatty foods only. Preheat redistilled beaker. Proceed with the determina- reagent-grade heptane (boiling point tion of the amount of extractives by 208 °F) carefully in a clean Pyrex flask the method described in paragraph on a water bath or nonsparking hot (e)(5) of this section. plate in a well-ventilated hood to 150 (vi) Water (70 °F for 48 hours), simu- °F. At the same time preheat a pres- lating refrigerated storage. Bring sure cooker or equivalent to 150 °F in demineralized distilled water to 70 °F an incubator. This pressure cooker is in a clean Pyrex flask. Fill the con- to serve only as a container for the tainer within 1⁄4-inch of the top with a heptane-containing test package inside measured volume of the 70 °F water, the incubator in order to minimize the and cover with clean aluminum foil. danger of explosion. Fill the test con- Place the test container in a suitable tainer within 1⁄4-inch of the top with a room maintained at 70 °F. After 48 measured volume of the 150 °F heptane hours, immediately composite the and cover with clean aluminum foil. water of each replicate in a clean Place the test container in the Pyrex flask or beaker. Proceed with preheated pressure cooker and then put the determination of the amount of ex- the assembly into a 150 °F incubator. tractives by the method described in After 2 hours, remove the pressure paragraph (e)(5) of this section. cooker from the incubator, open the as- (vii) ( ° ), Water 70 F for 24 hours simu- sembly, and immediately composite lating frozen storage. Bring the heptane of each replicate in a clean demineralized distilled water to 70 °F Pyrex flask or beaker. Proceed with in a clean Pyrex flask. Fill the con- the determination of the amount of ex- tainer within 1⁄4-inch of the top with a measured volume of the 70 °F water tractives by the method described in and cover with clean aluminum foil. paragraph (e)(5) of this section. Place the container in a suitable room (x) Heptane (120 °F for 30 minutes), sim- maintained at 70 °F. After 24 hours, im- ulating boiling water sterilization of fatty mediately composite the water of each foods only. Preheat redistilled reagent- replicate in a clean Pyrex flask or grade heptane (boiling point 208 °F) beaker. Proceed with the determina- carefully in a clean Pyrex flask on a tion of the amount of extractives by water bath or nonsparking hot plate in the method described in paragraph a well-ventilated hood to 120 °F. At the (e)(5) of this section. same time, preheat a pressure cooker (viii) Water (212 °F for 30 minutes), sim- or equivalent to 120 °F in an incubator. ulating frozen foods reheated in the con- This pressure cooker is to serve only as

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

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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 = clean aluminum foil and place in an per square inch s oven or incubator maintained at 120 °F. Ex= e a After 24 hours, remove the container = ( )( )(1000) from the oven or incubator and imme- Extractives residue diately composite the alcohol from ()()cs 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 section. ()()sF (xvii) Alcohol—8 percent (70 °F for 48 Ex= e a hours), simulating alcoholic beverages in = ( )( )(1000) refrigerated storage. Bring 8 percent (by Extractives residue volume) ethyl alcohol in demineralized ()()()csF distilled water to 70 °F in a clean Pyrex where: flask. Fill the test container within 1⁄4- Ex=Extractives residue in ppm for any con- inch of the top with a measured volume tainer size. of the 8 percent alcohol. Cover the con- e=Milligrams extractives per sample tested. tainer with clean aluminum foil. Place a=Total coated area, including closure in the test container in a suitable room square inches. maintained at 70 °F. After 48 hours, im- c=Water capacity of container, in grams. mediately composite the alcohol from s=Surface of coated area tested, in square each replicate into a clean Pyrex flask. inches. Proceed with the determination of the F=Five, the ratio of the amount of extrac- amount of extractives by the method tives removed from a coated container by heptane under exaggerated time-tempera- described in paragraph (e)(5) of this ture test conditions compared to the section. amount extracted by a fat or oil from a NOTE: The tests specified in paragraph container tested under exaggerated condi- (e)(4) (i) through (xvii) of this section are ap- tions of thermal sterilization and use. plicable to flexible packages consisting of e′=Chloroform-soluble extractives residue. coated metal contacting food, in which case ee′=Zinc corrected chloroform-soluble ex- the closure end is double-folded and clamped tractive residue. with metal spring clips by which the package e′ or ee′ is substituted for e in the above equa- can be suspended. tions when necessary.

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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 resin 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- Rinsing equipment, soda fountain pressure- ently low blank) to the dried and 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 rack, 12.5 inches inside diameter × 11 inches the chloroform extraction, washing the inside height, 20 pounds per square inch safe filter paper with this second portion of operating pressure. chloroform. Add this filtrate to the Oven, mechanical convection, range to in- original filtrate and evaporate the 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) 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion platinum dish in a desiccator for 30 proof (water bath may be substituted). minutes and weigh to the nearest 0.1 Constant-temperature room or chamber 70 milligram to get the chloroform-solu- °F±2 °F minimum inside dimensions 19″ × 19″ ble extractives residue (e′). This e′ is × 19″. substituted for e in the equations in Hot plate, nonsparking (explosion proof), paragraph (e)(5)(i) (a) and (b) of this 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 minimum. lion or the extractives in milligrams All glass, Pyrex or equivalent. per square inch exceed the limitations prescribed in paragraph (c) of this sec- (2) Reagents. tion for the particular container size, Water, all water used in extraction proce- proceed as follows to correct for zinc dure should be freshly demineralized (deion- extractives (‘‘C’’ enamels only): Ash ized) distilled water. the residue in the platinum dish by Heptane, reagent grade, freshly redistilled heating gently over a Meeker-type before use, using only material boiling at 208 ° burner to destroy organic matter and F. Alcohol, 8 percent (by volume), prepared hold at red heat for about 1 minute. from undenatured 95 percent ethyl alcohol Cool in the air for 3 minutes, and place diluted with demineralized or distilled the platinum dish in the desiccator for water. 30 minutes and weigh to the nearest 0.1 Chloroform, reagent grade, freshly redis- milligram. Analyze this ash for zinc by tilled before use, or a grade having an estab- standard Association of Official Agri- lished, consistently low blank. cultural Chemists methods or equiva- Filter paper, Whatman No. 41 or equivalent. Calculate the zinc in the ash as lent. zinc oleate, and subtract from the (g) In accordance with good manufac- weight of chloroform-soluble extrac- turing practice, finished coatings in- tives residue (e′) to obtain the zinc-cor- tended for repeated food-contact use

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shall be thoroughly cleansed prior to (a) The coating is applied as a contin- their first use in contact with food. uous film over one or both sides of a (h) Acrylonitrile copolymers identi- base film produced from one or more of fied in this section shall comply with the basic olefin polymers complying the provisions of § 180.22 of this chap- with § 177.1520 of this chapter. The base ter. polyolefin film may contain optional [42 FR 14534, Mar. 15, 1977] adjuvant substances permitted for use in polyolefin film by applicable regula- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 175.300, see the List of CFR tions in parts 170 through 189 of this Sections Affected, which appears in the chapter. Finding Aids section of the printed volume (b) The coatings are formulated from and at www.fdsys.gov. optional substances which are: § 175.320 Resinous and polymeric coat- (1) Substances generally recognized ings for polyolefin films. as safe for use in or on food. Resinous and polymeric coatings (2) Substances the use of which is may be safely used as the food-contact permitted under applicable regulations surface of articles intended for use in in parts 170 through 189 of this chapter, producing, manufacturing, packing, by prior sanctions, or approvals. processing, preparing, treating, pack- (3) Substances identified in this para- aging, transporting, or holding food, in graph (b)(3) and subject to such limita- accordance with the following pre- tions as are provided: scribed conditions:

List of substances Limitations

(i) Resins and polymers: Acrylic acid polymer and its ethyl or methyl esters. Acrylamide copolymerized with ethyl acrylate and/or styrene and/or methacrylic acid, and the copolymer subsequently 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 methacrylate, 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 molecular weight 900. Melamine-formaldehyde as the basic polymer or chemically modified with methyl alcohol. Methacrylic acid and its ethyl or methyl esters copolymerized with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. a-Methyl styrene polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio For use only in coatings that contact food under conditions of 1 a-methylstyrene to 3 vinyltoluene). use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, provided that the concentration of a-methylstyrene- vinyltoluene copolymer resins in the finished food-contact coating does not exceed 1.0 milligram per square inch of food-contact surface. Petroleum alicyclic hydrocarbon resins ...... As defined in § 176.170 of this chapter. Blended with butyl rubber 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 coating 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.

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List of substances Limitations

Azelaic acid (CAS Reg. No. 123–99–9) in an amount not to exceed 3.7 percent by weight of the polyamide 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 polyamide 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 conditions 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 chapter, table 1, under Category VIII, and under conditions of use E, F, or G described in table 2 of § 176.170(c) of this chapter. Polyhydric alcohols: 1,3-Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. Mannitol. a-Methyl glucoside. Pentaerythritol. Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. Polyethylenimine ...... For use only as a primer subcoat to anchor epoxy surface coatings to the base sheet. Polystyrene. Polyvinyl acetate. Polyvinyl chloride ...... Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million. vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083– 18–1 and CAS Reg. No. 68083–19–2) with methylhydrogen polysiloxane (CAS Reg. No. 63148–57–2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037– 59–2). The following substances may be used as optional polymerization inhibitors:. 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107–54–0), at a level not to exceed 0.53 weight percent;.

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List of substances Limitations

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 chapter, 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, individually, 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 permeation chromatography). The acid number of the polymer 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-pinene, 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 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 maleic acid-modified copolymer. Vinyl chloride copolymerized with one or more of the following: Acrvlonitrile. Vinyl acetate. Vinylidene chloride. Vinylidene chloride copolymerized with one or more of the following: Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Acrylonitrile. Itaconic acid. Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Methacrylonitrile. Vinyl chloride.

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List of substances Limitations

(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 aluminum, 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 complying with § 177.1350 of this chapter at a level not to exceed 0.0085 milligram per square centimeter (0.055 milligram 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 concentration) in the dry coating.

(c) The coating in the finished form shall yield net chloroform-soluble ex- in which it is to contact food, when extractives not to exceed 0.5 milligram tracted with the solvent or solvents per square inch of coated surface. characterizing the type of food, and (d) Acrylonitrile copolymers identi- under conditions of time and tempera- fied in this section shall comply with ture characterizing the conditions of its intended use as determined from tables 1 and 2 of § 176.17(c) of this chapter,

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the provisions of § 180.22 of this chap- tilled water at 120 °F for 24 hours does ter. 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 film obtained with n-heptane at 70 °F 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 for 30 minutes does not exceed 0.5 milli- FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, 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- polyolefin films intended for packaging mer coatings for nylon film. food, subject to the provisions of this Vinylidene chloride copolymer coat- section. ings identified in this section and ap- (a) The copolymer may contain added plied on nylon film may be safely used optional substances to impart desired as food-contact surfaces, in accordance properties. with the following prescribed condi- (b) The quantity of any optional sub- tions: stance does not exceed the amount reasonably required to accomplish the in- (a) The coating is applied as a contin- tended physical or technical effect nor uous film over one or both sides of a any limitations further provided. base film produced from nylon resins (c) Any optional substance that is complying with § 177.1500 of this chap- the subject of a regulation in parts 174, ter. 175, 176, 177, 178, and § 179.45 of this (b) The coatings are prepared from chapter conforms with any specifica- vinylidene chloride copolymers pro- tions in such regulation. duced by copolymerizing vinylidene (d) Optional substances as provided chloride with one or more of the mono- in paragraph (a) of this section include: mers acrylic acid, acrylonitrile, ethyl (1) Substances generally recognized acrylate, methacrylic acid, methyl ac- as safe in food. rylate, methyl methacrylate (CAS Reg. (2) Substances subject to prior sanc- No. 80–62–6; maximum use level 6 tion or approval for uses with a copoly- weight percent) and 2-sulfoethyl meth- mer of vinyl acetate and crotonic acid acrylate (CAS Reg. No. 10595–80–9; max- and used in accordance with such sanc- imum use level 1 weight percent). The tion or approval. finished copolymers contain at least 50 (3) Substances identified in this sub- weight percent of polymer units de- paragraph and subject to such limita- rived from vinylidene chloride. The fin- tions as are provided: ished coating produced from vinylidene List of substances Limitations chloride copolymers produced by copolymerizing vinylidene chloride with Silica. methyl methacrylate and/or 2- Japan wax. sulfoethyl methacrylate, or with meth- (e) Copolymer of vinyl acetate and yl methacrylate and/or 2-sulfoethyl crotonic acid used as a coating or as a methacrylate together with one or component of a coating conforming more of the other monomers from this with the specifications of paragraph section, is restricted to use at or below (e)(1) of this section are used as pro- room temperature. vided in paragraph (e)(2) of this sec- (c) Optional adjuvant substances em- tion. ployed in the production of the coat- (1) Specifications. (i) The chloroform- ings or added thereto to impart desired soluble portion of the water extractives properties may include sodium of the coated film obtained with dis- dodecylbenzenesulfonate.

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(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 food-contact coating for articles in- FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, 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 dodecylbenzenesulfonate in addition to food meets the following extractives substances described in § 174.5(d) of this limitations when tested by the meth- chapter. ods provided in § 175.300(e): (d) The coating in the finished form (1) The coating when extracted with in which it is to contact food, when ex- distilled water at 180 °F for 24 hours tracted with the solvent or solvents yields total extractives not to exceed characterizing the type of food, and 0.05 milligram per square inch of food- under the conditions of time and tem- contact surface. perature characterizing the conditions (2) The coating when extracted with 8 of its intended use as determined from percent (by volume) ethyl alcohol in tables 1 and 2 of § 176.170(c) of this chap- distilled water at 160 °F for 4 hours ter, shall yield net chloroform-soluble yields total extractives not to exceed

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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 coatings. Subpart A [Reserved] Zinc-silicon dioxide matrix coatings Subpart B—Substances for Use Only as may be safely used as the food-contact Components of Paper and Paperboard surface of articles intended for use in producing, manufacturing, packing, Sec. processing, preparing, treating, pack- 176.110 Acrylamide-acrylic acid resins. aging, transporting, or holding food, 176.120 Alkyl ketene dimers. subject to the provisions of this sec- 176.130 Anti-offset substances. tion; 176.150 Chelating agents used in the manu- (a) The coating is applied to a metal facture of paper and paperboard. surface, cured, and washed with water 176.160 Chromium (Cr III) complex of N- ethyl-N-heptadecylfluoro-octane sulfonyl to remove soluble substances. glycine. (b) The coatings are formulated from 176.170 Components of paper and paperboard optional substances which include: in contact with aqueous and fatty foods. (1) Substances generally recognized 176.180 Components of paper and paperboard as safe. in contact with dry food. (2) Substances for which safe condi- 176.200 Defoaming agents used in coatings. tions of use have been prescribed in 176.210 Defoaming agents used in the manu- § 175.300. facture of paper and paperboard. (3) Substances identified in para- 176.230 3,5-Dimethyl-1,3,5,2H- graph (c) of this section, subject to the tetrahydrothiadiazine-2-thione. limitations prescribed. 176.250 Poly-1,4,7,10,13-pentaaza-15- hydroxyhexadecane. (c) The optional substances per- 176.260 Pulp from reclaimed fiber. mitted are as follows: 176.300 Slimicides. 176.320 Sodium nitrate-urea complex. List of substances Limitations 176.350 Tamarind seed kernel powder. Ethylene glycol ...... As a solvent removed by water washing. AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. Iron oxide. SOURCE: 42 FR 14554, Mar. 15, 1977, unless Lithium hydroxide ...... Removed by water washing. otherwise noted. Methyl orange ...... As an acid-base indicator. Potassium dichromate ...... Removed by water washing. EDITORIAL NOTE: Nomenclature changes to Silica gel. part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 Sodium silicate. FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. Zinc, as particulate metal. 1, 2005.

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Subpart A [Reserved] used to prevent the transfer of inks employed in printing and decorating Subpart B—Substances for Use paper and paperboard used for food 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 resins. paper or paperboard in an amount not 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 accordance 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. effect and not to exceed 2 percent by Industrial starch—modified .... Complying with § 178.3520 of 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 and oils. List of substances Limitations (b) The alkyl ketene dimers are used Ammonium fructoheptonate. as an adjuvant in the manufacture of Ammonium glucoheptonate. paper and paperboard under such condi- Disodium ethylenediamine tetraacetate. tions that the alkyl ketene dimers and Pentasodium salt of diethylenetriamine pentaacetate. their hydrolysis products dialkyl Sodium fructoheptonate. ketones do not exceed 0.4 percent by Sodium glucoheptonate. weight of the paper or paperboard. Tetrasodium ethylenediamine tetra- (c) The alkyl ketene dimers may be acetate. Trisodium N-hydroxyethyl ethylene- used in the form of an aqueous emul- diamine triacetate. sion which may contain sodium lignosulfonate as a dispersant. (b) Any one or any combination of the substances named is used or in- § 176.130 Anti-offset substances. tended for use as chelating agents. Substances named in paragraphs (b) (c) The substances are added in an and (c) of this section may be safely amount not greater than that required

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

List of Substances Limitations

Acetyl peroxide ...... For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet- taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper- monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper- percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and termined by LVG-series Brookfield viscometer (or equivalent) paperboard. using a No. 2 spindle at 30 r.p.m.

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List of Substances Limitations

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 determined 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 percent 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 paperboard 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 paragraph (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 suspension is used as a component of coatings for paper and paperboard 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 fluorine 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 described in table 2 of paragraph (c) of this section, with nonalcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX described in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional baking. 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 percent N-methyldiethanolamine and not less than 90 mole percent dimethylolpropionic acid. The final product is a 15 to 20 percent by weight aqueous solution, having a Brookfield viscosity 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 aniline 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 accordance 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 information 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 operation 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 paperboard 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 percent by weight aqueous solution (active polymer) has a viscosity of more than 22 centipoises at 22 °C (72 °F) as determined 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 determined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).

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List of Substances Limitations

Diallyldiethylammonium chloride polymer with acrylamide, and diallyldimethylammonium chloride, produced by copolymerizing acrylamide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride, respectively, in the following weight ratios and having viscosities determined at 22 °C, by LVF-series Brookfield viscometer using a No. 1 spindle 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 percent 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 paperboard. 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 paperboard. 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) acrylamide, 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 centipoises 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 determined 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 paperboard and coatings for paper and paperboard. 2,5-Di-tert-butyl hydroquinone ...... For use only as an antioxidant for fatty based coating adjuvants 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 without correction for any fluorine which might be present in the untreated paper or paperboard, when such paper or paperboard 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-series 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 adjuvants 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 paperboard 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 paperboard 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-diethylaminoethyl 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 adjuvants 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 dioxide. The finished paper and paperboard will be used in contact 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 paragraph (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 material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.); and maximum weight loss not to exceed 3% when distilled to 371° C, nor to exceed an additional 1.1% when further distilled between 371° C and thermal decomposition. 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-formaldehyde 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 paperboard 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 finished 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 aqueous 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 peracid 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 viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method). 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 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 viscometer using a No. 1H spindle at 50 r.p.m. (or equivlent method). 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 produced 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 viscometer 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 spindle 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 solution 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 paragraph (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 spindle 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 paperboard. Polymethacrylic acid, sodium salt, having a viscosity in 30-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 125–325 centipoises at when used at a level not to exceed 0.3% by weight of coat- 25 °C as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 60 r.p.m. Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity cent-by-weight aqueous solution of 400–700 centipoises at when used at a level not to exceed 0.1% by weight of coat- 25 °C, as determined by LV-series Brookfield viscometer (or ing solids. equivalent) using a No. 2 spindle at 30 r.p.m. Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro- For use only as a retention aid employed prior to the sheet- duced by reaction of 1:1 molar ratio of methylamine and forming operation in such an amount that finished paper and epichlorohydrin so that a 31-percent aqueous solution at 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 information 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 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.). The following formula is used for determining 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 condensed 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 release 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 manufacture 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, provided 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 styrene-butadiene with one or more of the monomers: acrylamide, 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 contain 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 exceed 0.02 pct by weight of finished paper and paperboard. Triethanolamine ...... For use only to adjust pH during the manufacture of amino resins permitted for use as components of paper and paperboard. 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 paperboard 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 percent 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 formaldehyde 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 finished 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 acrylate, 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 methacrylate, 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 copolymers 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 polymer 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, binders, pigment slurries, and sizing solutions at a level not to exceed 0.006 percent by weight of the coating, solution, slurry or emulsion.

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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 paragraph (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 paperboard 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 million (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 anhydride. Dihydroxy dichlorodiphenyl methane ...... For use only as preservative for coating formulations. Dimethylpolysiloxane, 100 centistokes viscosity. Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane copolymer (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 methacrylate, 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 solids under conditions described in paragraph (c) of this section, 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 coating 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 copolymerization of ethylene and acrylic acid and/or their partial ammonium 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 information 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 reaction product will not consist of more than 70 percent modified 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 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.). Specific gravity 0.96–0.99 (20 °C/20 °C). Such petroleum hydrocarbon resins are produced by the catalytic polymerization of dienes and olefins from low-boiling distillates of cracked petroleum 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 glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C–92 °C., and a color of K or paler. 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 modified 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 paperboard. 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 described 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 paperboard. 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 average molecular weight (Mn) shall be at least 2,000 (as determined 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 copolymers have a minimum number average molecular weight greater than 100,000 and a level of residual styrene monomer in the polymer not to exceed 0.1 percent by weight. Styrene-butadiene copolymers produced by copolymerizing styrene-butadiene with one or more of the monomer: acrylamide, 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 polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid and methacrylic acid, and shall contain not more than 2 weight percent of polymer units derived 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 combination 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 derived 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 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 material 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 paragraph (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 conditions 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, conditions 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 acetate 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 propionate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight percent 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 acrylate, 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 conditions 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, conditions of use C, D, E, F, and G. Vinyl chloride copolymers produced by copolymerizing vinyl chloride with one or more of the monomers acrylonitrile; fumaric 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 anhydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl ester; vinyl acetate-and vinylidene chloride. The finished copolymers 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 reacted with trimellitic anhydride. Vinylidene chloride copolymers produced by copolymerizing vinylidene chloride with one or more of the monomers acrylamide acrylic acid, acrylonitrile, butyl acrylate, butyl methacrylate ethyl acrylate, ethyl methacrylate, fumaric acid, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, octadecyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride and vinyl sulfonic acid. The finished 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 sulfonic 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 included 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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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, freshly 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 equation, 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 percent 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 ethylenediamine 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 sodium 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, sodium salt.. Methylated poly(N-1,2-dihydroxyethylene-1,3-imidazolidin-2- For use only only as an in solubilizer for starch. one). Modified polyacrylamide resulting from an epichlorohydrin addi- For use only as a dry strength and pigment retention aid agent tion to a condensate of formaldehyde-dicyandiamide- employed prior to the sheetforming operation in the manu- diethylene triamine and which product is then reacted with facture of paper and paperboard and used at a level not to polyacrylamide and urea to produce a resin having a nitro- exceed 1 percent by weight of dry fibers. gen content of 5.6 to 6.3 percent and having a minimum viscosity in 56 percent-by-weight aqueous solution of 200 centipoises at 25 °C, as determined by LVT-series Brookfield viscometer 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 polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum 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 molecular 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 prescribed 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 dioxide, 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, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles.. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl or p-nonylphenyl]-omega- hydroxypoly (oxyethylene) where nonyl group is a propylene trimer isomer.. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl sulfosuccinamate.. Toluene.. Triethanolamine.. Triethylenetetramine ...... Polymerization cross-linking agent. Triethylenetetramine monoacetate, partially stearoylated.. Urea-formaldehyde chemically modified with: Alcohol (methyl, ethyl, butyl, isobutyl, propyl, or isopropyl). Aminomethylsulfonic acid. Diaminobutane. Diaminopropane. Diethylenetriamine. N,N′-Dioleoylethylenediamine. Diphenylamine. N,N′-Distearoylethylenediamine. Ethylenediamine. Guanidine. Imino-bis-butylamine. Imino-bis-ethylamine. Imino-bis-propylamine. N-Oleoyl-N′-stearoylethylenediamine. Polyamines made by reacting ethylenediamine or triethylenediamine with dichloroethane or dichloropropane. Tetraethylenepentamine. Triethylenetetramine. Xylene.. Xylene sulfonic acid-formaldehyde condensate, sodium salt.. Zinc stearate..

[42 FR 14554, Mar. 15, 1977]

EDITORIAL NOTE: For 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 limitations 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 infor shipping or handling any such sub- tended for use in contact with food in stance. an amount not to exceed that necessary 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 chlorine).. 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 temperatures 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 acrylonitrile-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 copolymers. 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 acrylate 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 copolymer 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 following 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 alcohol; 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-distilled 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 acceptable 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 spectrophotometer 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 polarographic 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 identified 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 milligram 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 residual acrylonitrile 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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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 molecular 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/styrene elastomer. (b) Adjuvants. The modified copolymer 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 determination 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 availability 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- the limitations of § 177.1010(b) of this ministration (NARA). For information chapter, when prepared as strips, as de- on the availability of this material at scribed in § 177.1010(c)(2) of this chapter. NARA, call 202–741–6030, or go to: http:// (2) The n-alkylglutarimide/acrylic copolymers shall not be used as polymer www.archives.gov/federallregister/ modifiers in vinyl chloride homo- or codeloflfederallregulations/ copolymers. ibrllocations.html. (e) Conditions of use. The n- (f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers fied in this section shall comply with are used as articles or components of the provisions of § 180.22 of this chap- articles (other than articles composed ter. of vinyl chloride homo- or copolymers) (g) Acrylonitrile copolymers identi- intended for use in contact with all fied in this section are not authorized foods except beverages containing to be used to fabricate beverage con- more than 8 percent alcohol under containers. ditions of use D, E, F, and G as de- [42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter. 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, [54 FR 20382, May 11, 1989, as amended at 58 June 12, 1989] FR 17098, Apr. 1, 1993]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

TABLE 1

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

Arachidy-l-behenyl amide (C20-C22fatty acid amides) ...... 5 percent. Azodicarbonamide ...... 1. 2 percent. 2. 5 percent; for use only in the manufacture of polyethylene complying with item 2.1 in § 177.1520(c) of this chapter. Balata rubber. Benzyl alcohol ...... 1 percent. Brominated isobutylene-isoprene copolymers, produced when isobutylene-isoprene copolymers complying with § 177.1420(a)(2) are modified by bromination with not more than 2.3 weight-percent of bromine and having a Mooney Viscosity (ML 1+8 (125 °C)) of 27 or higher. The viscosity is determined by the American Society for Testing and Mate- rials (ASTM) method D 1646–81, ‘‘Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Moon- ey Viscometer),’’ which is incorporated by reference in accordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504 and the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 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.. 1,3-Butanediol. Calcium tin stearate ...... 2 percent. Calcium zinc stearate ...... Do. Carbon, activated ...... 1 percent. Castor oil, hydrogenated ...... 2 percent. Chlorinated isobutylene-isoprene copolymers complying with § 177.1420. Coco amide (coconut oil fatty acids amides) ...... 2 percent. Cork (cleaned, granulated). Diebenzamide phenyl disulfide ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Di(C7, C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter; except that, there is no limitation on polymer thickness. Di-2-ethylhexyl adipate. Di-2-ethylhexyl sebacate ...... 2 percent. Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per hundred by weight of permitted vinyl chloride homo- and/or copolymer resins used in contact with food of Types I, II, IV- B, VI-A, VI-B, VI-C (up to 15 percent alcohol by volume), VII- B, and VIII described in § 176.170(c) of this chapter, table 1, and under conditions of use A through H described in § 176. 170 (c) of this chapter, table 2. Dihexyl ester of sodium sulfosuccinate ...... 1 percent. Diisodecyl phthalate ...... No limitation on amount used but for use only in closure-sealing gasket compositions used in contact with non-fatty foods containing no more than 8 percent of alcohol. Di-b-naphthyl-p-phenylenediamine ...... 1 percent. Dipentamethylenethiurametetrasulfide ...... 0.4 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Eicosane (technical grade) (water-white mixture of predominantly straight-chain paraffin hydrocarbons averaging 20 carbon atoms per molecule). Epoxidized linseed oil. Epoxidized linseed oil modified with trimellitic anhydride. Epoxidized safflower oil. Epoxidized safflower oil modified with trimellitic anhydride. Epoxidized soybean oil modified with trimellitic anhydride.

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TABLE 1—Continued

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

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

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TABLE 1—Continued

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

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

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

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

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

Extractant Types of food Conditions of use (see table 3) 8 percent Water 2 Heptane 1,2 alcohol 2

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

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

§ 177.1211 Cross-linked polyacrylate may contain optional adjuvant sub- copolymers. stances required in the production of Cross-linked polyacrylate copoly- such copolymers. The optional adju- mers identified in paragraph (a) of this vant substances may include sub- section may be safely used as articles stances permitted for such use by regu- or components of articles intended for lations in parts 170 through 179 of this use in contact with food in accordance chapter, substances generally recog- with the following prescribed condi- nized as safe in food, and substances tions: used in accordance with a prior sanc- (a) Identity. For the purpose of this tion or approval. section, the cross-linked polyacrylate (c) Extractives limitations. The copoly- copolymers consist of: mers identified in paragraph (a) of this (1) The grafted copolymer of cross- section, in the finished form in which linked sodium polyacrylate identified they will contact food, must yield low as 2-propenoic acid, polymers with N,N- molecular weight (less than 1,000 Dal- di-2-propenyl-2-propen-1-amine and tons) extractives of no more than 0.15 hydrolyzed polyvinyl acetate, sodium percent by weight of the total polymer salts, graft (CAS Reg. No. 166164–74–5); when extracted with 0.2 percent by or weight of aqueous sodium chloride so- (2) 2-propenoic acid, polymer with 2- lution at 20 °C for 24 hours. The low ethyl-2-(((1-oxo-2-pro- molecular weight extractives shall be penyl)oxy)methyl)-1,3-propanediyl di-2- determined using size exclusion chro- propenoate and sodium 2-propenoate matography or an equivalent method. (CAS Reg. No. 76774–25–9). When conducting the extraction test, (b) Adjuvants. The copolymers identi- the copolymer, with no other absorp- fied in paragraph (a) of this section tive media, shall be confined either in

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a finished absorbent pad or in any suit- (d) Substances employed in the pro- able flexible porous article, (such as a duction of the copolymer include: ‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized pressure of 0.15 pounds per square inch as safe in food. (for example, a 4×6 inch square pad is (2) Substances subject to prior sanc- subjected to a 1.6 kilograms applied tion or approval for use in the copoly- mass). The solvent used shall be at mer and used in accordance with such least 60 milliliters aqueous sodium sanction or approval. chloride solution per gram of copoly- (3) Substances which by regulation in mer. parts 174, 175, 176, 177, 178 and § 179.45 of (d) Conditions of use. The copolymers this chapter may be safely used as identified in paragraph (a)(1) of this components of resinous or polymeric section are limited to use as a fluid ab- coatings and film used as food-contact sorbent in food-contact materials used surfaces, subject to the provisions of in the packaging of frozen or refrig- such regulation. erated poultry. The copolymers identi- (e) The copolymer conforms with the fied in paragraph (a)(2) of this section following specifications: are limited to use as a fluid absorbent (1) The copolymer, when extracted in food-contact materials used in the with distilled water at reflux tempera- packaging of frozen or refrigerated ture for 2 hours, yields total extrac- meat and poultry. tives not to exceed 0.05 percent. (2) The copolymer, when extracted [64 FR 28098, May 25, 1999, as amended at 65 with ethyl acetate at reflux tempera- FR 16817, Mar. 30, 2000] ture for 2 hours, yields total extrac- § 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent. dimethylene terephthalate and 1,4- (3) The copolymer, when extracted cyclohexylene dimethylene with n-hexane at reflux temperature isophthalate copolymer. for 2 hours, yields total extractives not Copolymer of 1,4-cyclohexylene to exceed 0.05 percent. dimethylene terephthalate and 1,4- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, cyclohexylene dimethylene isophtha- 1984, as amended at 55 FR 34555, Aug. 23, 1990] late may be safely used as an article or component of articles used in pro- § 177.1310 Ethylene-acrylic acid co- ducing, manufacturing, packing, proc- polymers. essing, preparing, treating, packaging, The ethylene-acrylic acid copolymers transporting, or holding food, subject identified in paragraph (a) of this sec- to the provisions of this section: tion may be safely used as components (a) The copolymer is a basic poly- of articles intended for use in contact ester produced by the catalytic con- with food subject to the provisions of densation of dimethyl terephthalate this section. and dimethyl isophthalate with 1,4- (a) The ethylene-acrylic acid copoly- cyclohexanedimethanol, to which may mers consist of basic copolymers pro- have been added certain optional sub- duced by the copolymerization of stances required in its production or ethylene and acrylic acid such that the added to impart desired physical and finished basic copolymers contain no technical properties. more than: (b) The quantity of any optional sub- (1) 10 weight-percent of total polymer stance employed in the production of units derived from acrylic acid when the copolymer does not exceed the used in accordance with paragraph (b) amount reasonably required to accom- of this section; and plish the intended physical or technical (2) 25 weight-percent of total polymer effect or any limitation further pro- units derived from acrylic acid when vided. used in accordance with paragraph (c) (c) Any substance employed in the of this section. production of the copolymer that is the (b) The finished food-contact articles subject of a regulation in parts 174, 175, made with no more than 10 percent 176, 177, 178 and § 179.45 of this chapter total polymer units derived from acryl- conforms with any specification in ic acid, when extracted with the sol- such regulation. vent or solvents characterizing the

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type of food and under the conditions contact with food subject to the provi- of its intended use as determined from sions of this section. tables 1 and 2 of § 176.170(c) of this chap- (a) Identity. For the purposes of this ter, yield net acidified chloroform-solu- section, ethylene-carbon monoxide co- ble extractives not to exceed 0.5 milli- polymers (CAS Reg. No. 25052–62–4) con- gram per square inch of food-contact sist of the basic polymers produced by surface when tested by the methods the copolymerization of ethylene and prescribed in § 177.1330(e)(1), (3)(i) carbon monoxide such that the copoly- through (iv), (4), (5), and (6), except mers contain not more than 30 weight- that percent of polymer units derived from (1) The total residue method using 3 carbon monoxide. percent acetic acid, as prescribed in (b) Conditions of use. (1) The polymers § 177.1330(e)(6)(i)(a), does not apply, and may be safely used as components of (2) The net acidified chloroform-solu- the food-contact or interior core layer ble extractives from paper and paper- of multilaminate food-contact articles. board complying with § 176.170 of this (2) The polymers may be safely used chapter may be corrected for wax, pet- as food-contact materials at tempera- rolatum, and mineral oil as provided in tures not to exceed 121 °C (250 °F). § 176.170(d)(5)(iii)(b) of this chapter. (c) Specifications. (1) Food-contact If the finished food-contact article is layers formed from the basic copoly- itself the subject of a regulation in mer identified in paragraph (a) of this parts 174, 175, 176, 177, 178, and § 179.45 of section shall be limited to a thickness this chapter, it shall also comply with of not more than 0.01 centimeter (0.004 any specifications and limitations pre- inch). scribed for it by that regulation. (2) The copolymers identified in paragraph (a) of this section shall have a (c) The finished food-contact layer melt index not greater than 500 as de- made with basic copolymers containing termined by ASTM method D1238–82, more than 10 weight-percent but no condition E ‘‘Standard Test Method for more than 25 weight-percent of total Flow Rates of Thermoplastics by Ex- polymer units derived from acrylic trusion Plastometer,’’ which is incor- acid and with a maximum thickness of porated by reference in accordance 0.0025 inch (2.5 mils) may be used in with 5 U.S.C. 552(a) and 1 CFR part 51. contact with food types I, II, IVB, VIA, Copies may be obtained from the Amer- VIB, VIIB, and VIII identified in table ican Society for Testing Materials, 100 1 of § 176.170(c) of the chapter under Barr Harbor Dr., West Conshohocken, conditions of use B through H as de- Philadelphia, PA 19428-2959, or may be scribed in table 2 of § 176.170(c) of this examined at the Center for Food Safety chapter, and in contact with food types and Applied Nutrition (HFS–200), Food III, IVA, V, VIIA, and IX identified in and Drug Administration, 5100 Paint table 1 of § 176.170(c) of this chapter Branch Pkwy., College Park, MD 20740, under conditions of use E through G as or at the National Archives and described in table 2 of § 176.170(c) of this Records Administration (NARA). For chapter. information on the availability of this (d) The provisions of this section are material at NARA, call 202–741–6030, or not applicable to ethylene-acrylic acid go to: http://www.archives.gov/ copolymers used in food-packaging ad- federallregister/ hesives complying with § 175.105 of this codeloflfederallregulations/ chapter. ibrllocations.html. [42 FR 14572, Mar. 15, 1977, as amended at 51 (3) The basic copolymer identified in FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, paragraph (a) of this section, when ex- 1988] tracted with the solvent or solvents characterizing the type of food and § 177.1312 Ethylene-carbon monoxide under the conditions of time and tem- copolymers. perature characterizing the conditions The ethylene-carbon monoxide co- of its intended use, as determined from polymers identified in paragraph (a) of tables 1 and 2 of § 176.170(c) of this chap- this section may be safely used as com- ter, yields net chloroform-soluble ex- ponents of articles intended for use in tractives in each extracting solvent

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not to exceed 0.5 milligram per square (a) Identity. For the purposes of this inch of food-contact surface when test- section, ethylene-1,4-cyclohexylene ed by methods described in § 176.170(d) dimethylene terephthalate copolymers of this chapter. (1,4-benzene dicarboxylic acid, di- (4) The provisions of this section are methyl ester, polymerized with 1,4- not applicable to ethylene-carbon mon- cyclohexanedimethanol and 1,2- oxide copolymers complying with ethanediol) (CAS Reg. No. 25640–14–6) or § 175.105 of this chapter. (1,4-benzenedicarboxylic acid, polym- [57 FR 32422, July 22, 1992] erized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. § 177.1315 Ethylene-1, 4-cyclohexylene 25038–91–9) are basic copolymers meet- dimethylene terephthalate copolymers. ing the specifications prescribed in paragraph (b) of this section, to which Ethylene-1, 4-cyclohexylene may have been added certain optional dimethylene terephthalate copolymer substances required in their production may be safely used as articles or com- or added to impart desired physical or ponents of articles intended for use in contact with food subject to provisions technical properties. of this section and of part 174 of this (b) Specifications: chapter.

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

1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in- ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con- dimethylene cent solution of per square inch) of food-containing not more than terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol- mer is the reaction phenol- with water added at 82.2 °C ume) aqueous alcohol, product of dimethyl tetrachloroetha- (180 °F) and allowed to cool excluding carbonated terephthalate or ter- ne (60:40 ratio to 48.9 °C (120 °F) in con- beverages and beer. ephthalic acid with a wt/wt) solvent is tact with the food-contact ar- Conditions of hot fill mixture containing 99 not less than ticle. not to exceed 82.2 °C to 66 mole percent of 0.669 as deter- (180 °F), storage at ethylene glycol and 1 mined by using temperatures not in to 34 mole percent of a Wagner vis- excess of 48.9 °C 1,4-cyclo- cometer (or (120 °F). No thermal hexanedimethanol (70 equivalent) and treatment in the con- percent trans isomer, calculated from tainer. 30 percent cls isomer). the following equation: Inher- ent viscosity = (Natural loga- rithm of (Nr)/(c) where: Nr=Ratio of flow time of the polymer solution to that of the solvent, and c=concentration of the test solution expressed in grams per 100 milliliters...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-contact surface when extracted with 3 percent (by volume) aqueous acetic acid added at 82.2 °C (180 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article.

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...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-contact surface when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5...... do ...... (4) 0.16 microgram per square ...... do ...... Do. centimeter (1.0 microgram per square inch) of food-contact surface when extracted for 24 hours with 25 percent (by volume) aqueous ethanol at 48.9 °C (120 °F). 2. Oriented ethylene-1,4- ...... do ...... (1) 0.23 microgram per square When extracted In contact with non- cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ- dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev- terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor- terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9 mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther- to 85 mole percent ticle. meter (0.60 mal treatment in the ethylene glycol and 1 microgram per container. to 15 mole percent of square inch) of 1,4-cyclohexane-di- food-contact methanol (70 percent surface. trans isomer, 30 percent cls isomer)...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-contact surface of oriented copolymer when extracted with 3 percent (by volume) aqueous acetic acid added at 87.8 °C (190 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-contact surface of oriented copolymer when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5...... do ...... (4) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 20 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of thermal 20 percent (by volume) treatment in the con- aqueous ethanol heated to tainer not exceeding 65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for utes and allowed to cool to 20 minutes. Storage at 48.9 °C (120 °F) in contact temperatures not in with the food-contact article. excess of 48.9 °C (120 °F).

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

(c) Analytical method for determination § 177.1320 Ethylene-ethyl acrylate co- of extractability. The total extracted polymers. terephthaloyl moieties can be deter- Ethylene-ethyl acrylate copolymers mined in the extracts, without evapo- may be safely used to produce pack- ration of the solvent, by measuring the aging materials, containers, and equip- ultraviolet (UV) absorbance at 240 ment intended for use in producing, nanometers. The spectrophotometer manufacturing, packing, processing, (Varian 635–D, or equivalent) is zeroed preparing, treating, packaging, trans- with a sample of the solvent taken porting, or holding food, in accordance from the same lot used in the extrac- with the following prescribed condition tests. The concentration of the tions: total terephthaloyl moieties in water, 3 (a) Ethylene-ethyl acrylate copoly- percent acetic acid, and in 8 percent mers consist of basic resins produced aqueous alcohol is calculated as bis(2- by the catalytic copolymerization of hydroxyethyl terephthalate) by ref- ethylene and ethyl acrylate, to which erence to standards prepared in the ap- may have been added certain optional propriate solvent. Concentration of the substances to impart desired techno- terephthaloyl moieties in heptane is logical properties to the resin. Subject calculated as cyclic trimer to any limitations prescribed in this (C6H4CO2C2H4CO2)3, by reference to section, the optional substances may standards prepared in 95:5 percent (v/v) include: heptane: tetrahydrofuran. (1) Substances generally recognized as safe in food and food packaging. [45 FR 39252, June 10, 1980, as amended at 47 (2) Substances the use of which is FR 24288, June 4, 1982; 49 FR 25629, June 22, permitted under applicable regulations 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov. 24, 1995] in parts 170 through 189 of this chapter, prior sanction, or approvals. (b) The ethyl acrylate content of the copolymer does not exceed 8 percent by

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weight unless it is blended with poly- used in contact with food except as a ethylene or with one or more olefin co- component of articles used for pack- polymers complying with § 177.1520 or aging or holding food during cooking with a mixture of polyethylene and one provided they meet the following or more olefin copolymers, in such pro- extractability limits: portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3 tent of the blend does not exceed 8 per- percent in xylene after refluxing and cent by weight, or unless it is used in subsequent cooling to 25 °C. a coating complying with § 175.300 or (ii) Maximum extractable fraction of § 176.170 of this chapter, in such propor- 5.5 percent when extracted with n- tions that the ethyl acrylate content hexane at 50 °C. does not exceed 8 percent by weight of (d) The provisions of paragraphs (b) the finished coating. and (c)(2) of this section are not appli- (c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co- mers or the blend shall conform to the polymers used in the formulation of ad- specifications prescribed in paragraph hesives complying with § 175.105 of this (c)(1) of this section and shall meet the chapter. ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49 scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984] and the extractability limits prescribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins. tion, when tested by the methods pre- Ionomeric resins manufactured from scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co- (1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal- fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium, polymers can be identified by their and/or zinc partial salts), ethylene- characteristic infrared spectra. methacrylic acid-vinyl acetate copoly- (ii) Quantitative determination of ethyl mers (and/or their ammonium, cal- acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium, be determined by the infrared spectra. and/or zinc partial salts,), or meth- Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po- at 11.6 microns and divide by the tassium, sodium and/or zinc partial plaque thickness to obtain absorbance salts) may be safely used as articles or per mil. From a previously prepared components of articles intended for use calibration curve, obtain the amount of in contact with food, in accordance ethyl acrylate present. with the following prescribed condi- (iii) Specific gravity. Ethylene-ethyl tions: acrylate copolymers have a specific (a) For the purpose of this section, gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly- than 0.935, as determined by ASTM mers consist of basic copolymers pro- method D1505–68 (Reapproved 1979), duced by the copolymerization of ‘‘Standard Test Method for Density of ethylene and methacrylic acid such Plastics by the Density-Gradient Tech- that the copolymers contain no more nique,’’ which is incorporated by ref- than 20 weight percent of polymer erence. Copies may be obtained from units derived from methacrylic acid, the American Society for Testing Ma- and the ethylene-methacrylic acid- terials, 100 Barr Harbor Dr., West vinyl acetate copolymers consist of Conshohocken, Philadelphia, PA 19428- basic copolymers produced by the co- 2959, or may be examined at the Na- polymerization of ethylene, meth- tional Archives and Records Adminis- acrylic acid, and vinyl acetate such tration (NARA). For information on that the copolymers contain no more the availability of this material at than 15 weight percent of polymer NARA, call 202–741–6030, or go to: http:// units derived from methacrylic acid. www.archives.gov/federallregister/ (b) For the purpose of this section, codeloflfederallregulations/ the methacrylic acid copolymers with ibrllocations.html. ethylene and isobutyl acrylate consist (2) Limitations. Ethylene-ethyl acry- of basic copolymers produced by the late copolymers or the blend may be copolymerization of methacrylic acid,

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

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(e) Analytical methods—(1) Selection of the net chloroform-soluble extractives extractability conditions for ionomeric res- are unchanging within experimental ins. First ascertain the type of food error appropriate to the method as de- (table 1 of § 176.170(c) of this chapter) scribed in paragraphs (d) (1)(i) and (2)(i) that is being packed or used in contact of this section. Should equilibrium not with the finished food-contact article be demonstrated over the above time described in paragraph (a) of this sec- series, extraction times must be ex- tion, and also ascertain the normal tended until three successive unchang- conditions of thermal treatment used ing values for extractives are obtained. in packaging or contacting the type of In the case where intended uses involve food involved. Using table 2 of § 176.170 temporary food contact above 120 °F, (c) of this chapter, select the food-sim- the food-simulating solvent is to be ulating solvent or solvents and the contacted with the food-contact article time-temperature test conditions that under conditions of time and tempera- correspond to the intended use of the ture that duplicate the actual condi- finished food-contact article. Having tions in the intended use. Subsequently selected the appropriate food-simu- the extraction is to be continued for lating solvent or solvents and time- the time period and under the condi- temperature exaggeration over normal tions specified in the above table. use, follow the applicable extraction (3) Reagents—(i) Water. All water used procedure. in extraction procedures should be (2) Selection of extractability conditions freshly demineralized (deionized) dis- for ionomeric resins. Using table I of tilled water. paragraph (f) of this section ascertain (ii) n-Heptane. Reagent grade, freshly the type of food that is being packed or redistilled before use, using only mate- used in contact with the finished food- rial boiling at 208 °F (97.8 °C). contact article described in paragraph (iii) Alcohol. 8 or 50 percent (by vol- (b) of this section, and also ascertain ume), prepared from undenatured 95 the food-simulating solvent or solvents percent ethyl alcohol diluted with that correspond to the intended use of demineralized (deionized), distilled the finished food-contact article. water. (i) Abbreviated test. For intended use (iv) Chloroform. Reagent grade, fresh- involving food contact at or below 120 ly redistilled before use, or a grade °F (49 °C), the appropriate food-simu- having an established, consistently low lating solvent is to contact the food- blank. contact film for the time and tempera- (v) Acetic acid. 3 percent (by weight), tures as follows: prepared from glacial acetic acid diluted with demineralized (deionized), Solvent Time Temperature distilled water. n-Heptane ...... 1 2 120 °F (49 °C). (4) Selection of test method. The fin- Water, 3% acetic acid, or 8%/ 1 48 120 °F (49 °C). ished food-contact articles shall be 50% ethanol. tested either by the extraction cell de- 1 Hours scribed in the Journal of the Association (ii) Equilibrium test. For intended use of Official Agricultural Chemists, Vol. 47, involving food contact at or below 120 No. 1, p. 177–179 (February 1964), also °F (49 °C), the appropriate food-simu- described in ASTM method F34–76 (Re- lating solvent is to contact the food- approved 1980), ‘‘Standard Test Method contact film at a temperature of 120 °F for Liquid Extraction of Flexible Bar- until equilibrium is demonstrated. rier Materials,’’ which are incorporated by reference, or by adapting the in-con- Minimum tainer methods described in § 175.300(e) extraction Solvent times of this chapter. Copies of the material (hours) incorporated by reference are available n-Heptane ...... 8, 10, 12 from the Center for Food Safety and Water, 3% acetic acid, or 8%/50% ethanol ...... 72, 96, Applied Nutrition (HFS–200), Food and 120 Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, The results from a series of extraction and the American Society for Testing times demonstrate equilibrium when Materials, 100 Barr Harbor Dr., West

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Conshohocken, Philadelphia, PA 19428- If when calculated by the equations in 2959, respectively, or may be examined paragraphs (e)(6)(i) (a) and (b) of this at the National Archives and Records section, the extractives in milligrams Administration (NARA). For informa- per square inch exceed the limitations tion on the availability of this mate- prescribed in paragraphs (c) or (d) of rial at NARA, call 202–741–6030, or go this section, proceed to paragraph to: http://www.archives.gov/ (e)(6)(ii) of this section (method for de- federallregister/ termining the amount of acidified chlo- codeloflfederallregulations/ roform-soluble extractives residue). ibr locations.html. l (ii) Acidified chloroform-soluble extrac- (5) Selection of samples. Quadruplicate tives residue. Add 3 milliliters of 37 per- samples should be tested, using for each replicate sample the number of cent ACS reagent grade hydrochloric finished articles with a food-contact acid and 3 milliliters of distilled water surface nearest to 100 square inches. to the evaporating dish containing the (6) Determination of amount of extrac- dried and weighed residue, e, obtained tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section. the exposure period, remove the test Mix well so every portion of the residue container or test cell from the oven, if is wetted with the hydrochloric acid any, and combine the solvent for each solution. Then add 50 milliliters of replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter lent) flask or beaker, being sure to through Whatman No. 41 filter paper rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva- small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a rate the food-simulating solvents to clean separatory funnel. Shake for 1 about 100 milliliters in the flask, and minute, then draw off the chloroform transfer to a clean, tared evaporating layer into a clean tared evaporating dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the flask three times with small portions chloroform extraction, washing the of solvent used in the extraction proce- dish, the filter paper, and the sepa- dure, and evaporate to a few milliliters ratory funnel with this second portion on a nonsparking, low-temperature of chloroform. Add this filtrate to the hotplate. The last few milliliters original filtrate and evaporate the should be evaporated in an oven main- total down to a few milliliters on a ° tained at a temperature of 221 F (105 low-temperature hotplate. The last few °C). Cool the evaporating dish in a des- milliliters should be evaporated in an iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30 Calculate the extractives in milligrams per square inch of the container or ma- minutes and weigh to the nearest 0.1 terial surface. milligram to get the acidified chloro- ′ (a) Water, 3 percent acetic acid, and 8 form-soluble extractives residue, e . ′ percent and 50 percent alcohol. Milli- This e is substituted for e in the equa- grams extractives per square inch=e/s. tions in paragraphs (e)(6)(i) (a) and (b) (b) Heptane. Milligrams extractives of this section. per square inch=(e)/(s)(F) (f) The types of food and appropriate solvents are as follows: where: e=Milligrams extractives per sample tested. TABLE 1 s=Surface area tested, in square inches. F=Five, the ratio of the amount of extrac- Types of food Appropriate solvent tives removed by heptane under exaggerated time-temperature test conditions 1. Nonacid (pH above 5.0), aque- Water, n-heptane. compared to the amount extracted by a fat ous products; may contain salt or oil under exaggerated conditions of or sugar or both, and including thermal sterilization and use. oil-in-water emulsions of low- or e′=Acidified chloroform-soluble extractives high-fat content. ′ 2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% residue. e is substituted for e in the above ous products; may contain salt acetic acid. equations when necessary (See paragraph or sugar or both, and including (e)(6)(ii) of this section for method to ob- oil-in-water emulsions of low- or tain e′). high-fat content.

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TABLE 1—Continued when tested by the methods described in § 176.170(d) of this chapter. If the fin- Types of food Appropriate solvent ished food-contact article is itself the 3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% subject of a regulation in parts 174, 175, ucts containing free oil or fat; acetic acid. 176, 177, 178 and § 179.45 of this chapter, may contain salt, and including it shall also comply with any specifica- water-in-oil emulsions of low- or high-fat content. tions and limitations prescribed for it 4. Dairy products and modifica- by that regulation. tions: NOTE: In testing the finished food-contact Water, n-heptane. i. Water-in-oil emulsions, high article, use a separate test sample for each or low fat. required extracting solvent. ii. Oil-in-water emulsions, high (c) The provisions of this section are or low fat. not applicable to ethylene-methyl ac- 5. Low moisture fats and oils ...... n-heptane. 6. Beverages: rylate copolymer resins used in food- i. Containing up to 8% alcohol 8% ethanol/water. packaging adhesives complying with ii. Nonalcoholic ...... 3% acetic acid. § 175.105 of this chapter. iii. Containing more than 8% 50% ethanol/water. alcohol. 7. Bakery products ...... Water, n-heptane. § 177.1345 Ethylene/1,3–phenylene oxy- 8. Dry solids (without free fat or No extraction test re- ethylene isophthalate/ oil). quired. terephthalate copolymer. 9. Dry solids (with free fat or oil) .. n-heptane. Ethylene/1, 3-phenylene oxyethylene (g) The provisions of paragraphs (c) isophthalate/terephthalate copolymer and (d) of this section are not applica- (CAS Reg. No. 87365–98–8) identified in ble to the ionomeric resins that are paragraph (a) of this section may be used in food-packaging adhesives com- safely used, subject to the provisions of plying with § 175.105 of this chapter. this section, as the non-food-contact layer of laminate structures subject to [45 FR 22916, Apr. 4, 1980, as amended at 49 FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, the provisions of § 177.1395, and in 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, blends with polyethylene terephthalate June 12, 1989] polymers complying with § 177.1630. (a) Identity. For the purpose of this § 177.1340 Ethylene-methyl acrylate co- section, ethylene/1,3-phenylene oxy- polymer resins. ethylene isophthalate/terephthalate Ethylene-methyl acrylate copolymer copolymer consists of the basic copoly- resins may be safely used as articles or mer produced by the catalytic components of articles intended for use polycondensation of isophthalic acid in contact with food, in accordance and terephthalic acid with ethylene with the following prescribed condi- glycol and 1,3-bis(2- tions: hydroxyethoxy)benzene such that the (a) For the purpose of this section, finished resin contains between 42 and the ethylene-methyl acrylate copoly- 48 mole-percent of isophthalic mer resins consist of basic copolymers moieties, between 2 and 8 mole-percent produced by the copolymerization of of terephthalic moieties, and not more ethylene and methyl acrylate such than 10 mole-percent of 1,3-bis(2- that the copolymers contain no more hydroxyethoxy)benzene moieties. than 25 weight percent of polymer (b) Specifications—(1) Density. Ethyl- units derived from methyl acrylate. ene/1,3-phenylene oxyethylene (b) The finished food-contact article, isophthalate/terephthalate copolymer when extracted with the solvent or sol- identified in paragraph (a) of this sec- vents characterizing the type of food tion has a density of 1.33±0.02 grams per and under the conditions of time and cubic centimeter measured by ASTM temperature characterizing the condi- Method D 1505–85 (Reapproved 1990), tions of its intended use as determined ‘‘Standard Test Method for Density of from tables 1 and 2 of § 176.170(c) of this Plastics by the Density-Gradient Tech- chapter, yields net chloroform-soluble nique,’’ which is incorporated by ref- extractives (corrected for zinc extrac- erence in accordance with 5 U.S.C. tives as zinc oleate) in each extracting 552(a) and 1 CFR part 51. Copies may be solvent not to exceed 0.5 milligram per obtained from the American Society square inch of food-contact surface for Testing and Materials, 100 Barr

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Harbor Dr., West Conshohocken, Phila- producing, manufacturing, packing, delphia, PA 19428-2959, or may be exam- processing, preparing, treating, pack- ined at the Center for Food Safety and aging, transporting, or holding food in Applied Nutrition’s Library, Food and accordance with the following pre- Drug Administration, 5100 Paint scribed conditions: Branch Pkwy., College Park, MD 20740, (a)(1) Ethylene-vinyl acetate copoly- and at the National Archives and mers consist of basic resins produced Records Administration (NARA). For by the catalytic copolymerization of information on the availability of this ethylene and vinyl acetate to which material at NARA, call 202–741–6030, or may have been added certain optional go to: http://www.archives.gov/ substances to impart desired techno- federallregister/ logical or physical properties to the codeloflfederallregulations/ resin. Subject to any limitations pre- ibrllocations.html. scribed in this section, the optional (2) Softening point. Ethylene/1,3–phen- substances may include: ylene oxyethylene isophthalate/ (i) Substances generally recognized terephthalate copolymer identified in as safe in food and food packaging. paragraph (a) of this section has a soft- (ii) Substances the use of which is ening point of 63±5 °C as measured by permitted under applicable regulations ASTM Method D 1525–87, ‘‘Standard Test Method for VICAT Softening Tem- in parts 170 through 189 of this chapter, perature of Plastics,’’ which is incor- prior sanction, or approvals. porated by reference in accordance (iii) Substances identified in with 5 U.S.C. 552(a) and 1 CFR part 51. § 175.300(b)(3) (xxv), (xxvii), (xxx), and The availability of this material is pro- (xxxiii) of this chapter, and colorants vided in paragraph (b)(1) of this sec- used in accordance with § 178.3297 of tion. this chapter. (c) Optional adjuvant substances. (iv) Erucamide as identified in Ethylene/1,3–phenylene oxyethylene § 178.3860 of this chapter. isophthalate/terephthalate copolymer, (v) Xanthan gum as identified in identified in paragraph (a) of this sec- § 172.695 for use as a thickening agent tion, may contain optional adjuvant at a level not to exceed 1 percent by substances required in their produc- weight of coating solids in aqueous dis- tion. The optional adjuvants may in- persions of ethylene-vinyl acetate co- clude substances used in accordance polymers, where such copolymers are with § 174.5 of this chapter. used only as coatings or a component (d) Limitations. Copolymer blends de- of coatings. scribed above shall not exceed 30 per- (vi) The copolymer of vinylidene flu- cent by weight of ethylene/1, 3-phen- oride and hexafluoropropene (CAS Reg. ylene oxyethylene isophthalate/ No. 9011–17–0), containing 65 to 71 per- terephthalate copolymer. The finished cent fluorine and having a Mooney Vis- blend may be used in contact with food cosity of at least 28, for use as a proc- only under conditions of use C through essing aid at a level not to exceed 0.2 G, as described in table 2 of § 176.170(c) percent by weight of ethylene-vinyl ac- of this chapter, except that with food etate copolymers. identified as Type III, IV-A, V, VII-A, (2) Maleic anhydride-grafted ethyl- and IX in § 176.170(c), table 1, the co- ene-vinyl acetate copolymers (CAS polymer may be used under condition Reg. No. 28064–24–6) consist of basic res- of use C at temperatures not to exceed ins produced by the catalytic copolym- 160 °F (71 °C). erization of ethylene and vinyl acetate, [57 FR 43399, Sept. 21, 1992, as amended at 59 followed by reaction with maleic anhy- FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, dride. Such polymers shall contain not 1996; 62 FR 34628, June 27, 1997] more than 11 percent of polymer units derived from vinyl acetate by weight of § 177.1350 Ethylene-vinyl acetate co- total polymer prior to reaction with polymers. maleic anhydride, and not more than 2 Ethylene-vinyl acetate copolymers percent of grafted maleic anhydride by may be safely used as articles or com- weight of the finished polymer. Op- ponents of articles intended for use in tional adjuvant substances that may be

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added to the copolymers include sub- not to exceed 17 percent by weight of stances generally recognized as safe in total polymer, subject to the limita- food and food packaging, substances tion that when contacting food of types the use of which is permitted under ap- III, IV-A, V, VI-C, VII-A, and IX, iden- plicable regulations in parts 170 tified in § 176.170(c) of this chapter, through 189 of this chapter, and sub- Table 1, the polymers shall be used stances identified in § 175.300(b)(3)(xxv), only under conditions of use C, D, E, F, (xxvii), (xxxiii), and (xxx) of this chap- and G, described in § 176.170(c) of this ter and colorants for polymers used in chapter, Table 2. accordance with the provisions of (c) The provisions of paragraph (b) of § 178.3297 of this chapter. this section are not applicable to ethyl- (b)(1) Ethylene-vinyl acetate copoly- ene-vinyl acetate copolymers used in mers, with or without the optional sub- food-packaging adhesives complying stances described in paragraph (a) of with § 175.105 of this chapter. this section, when extracted with the (d) Ethylene-vinyl acetate copoly- solvent or solvents characterizing the mers may be irradiated under the fol- type of food, and under conditions of lowing conditions to produce molecular time and temperature characterizing crosslinking of the polymers to impart the conditions of their intended use as desired properties such as increased determined from tables 1 and 2 of strength and increased ability to § 176.170(c) of this chapter, shall yield shrink when exposed to heat: net chloroform-soluble extractives cor- (1) Electron beam source of ionizing rected for zinc as zinc oleate not to ex- radiation at a maximum energy of 3 ceed 0.5 milligram per square inch of an million electron volts: Maximum ab- appropriate sample. sorbed dose not to exceed 150 kiloGray (2) Maleic anhydride grafted ethyl- (15 megarads). ene-vinyl acetate copolymers shall (2) The finished food-contact film have a melt flow index not to exceed 2.1 shall meet the extractives limitations grams per 10 minutes as determined by prescribed in paragraph (e)(2) of this ASTM method D 1238–82, ‘‘Standard section. Test Method for Flow Rates of Thermo- (3) The ethylene-vinyl acetate co- plastics by Extrusion Plastometer,’’ polymer films may be further irradi- which is incorporated by reference in ated in accordance with the provisions accordance with 5 U.S.C. 552(a). Copies of paragraph (e)(1) of this section: Pro- may be obtained from the American vided, That the total accumulated radi- Society for Testing Materials, 100 Barr ation dose from both electron beam Harbor Dr., West Conshohocken, Phila- and gamma ray radiation does not ex- delphia, PA 19428-2959, or at the Divi- ceed 150 kiloGray (15 megarads). sion of Petition Control (HFS–215), (e) Ethylene-vinyl acetate copolymer Center for Food Safety and Applied Nu- films intended for contact with food trition, Food and Drug Administration, may be irradiated to control the 5100 Paint Branch Pkwy., College Park, growth of microorganisms under the MD 20740, or may be examined at the following conditions: Center for Food Safety and Applied Nu- (1) Gamma photons emitted from a trition’s Library, 5100 Paint Branch cobalt–60 sealed source in the dose Pkwy., College Park, MD 20740, or at range of 5–50 kiloGray (0.5–5.0 the National Archives and Records Ad- megarads). ministration (NARA). For information (2) The irradiated ethylene-vinyl ace- on the availability of this material at tate copolymer films, when extracted NARA, call 202–741–6030, or go to: http:// with reagent grade n-heptane (freshly www.archives.gov/federallregister/ redistilled before use) according to codeloflfederallregulations/ methods described under § 176.170(d)(3) ibrllocations.html. Compliance of the of this chapter, at 75 °F for 30 minutes melt flow index specification shall be shall yield total extractives not to ex- determined using conditions and proce- ceed 4.5 percent by weight of the film. dures corresponding to those described [42 FR 14572, Mar. 15, 1977, as amended at 43 in the method as Condition E, Proce- FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, dure A). The copolymers shall be used 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, in blends with other polymers at levels Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999]

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§ 177.1360 Ethylene-vinyl acetate-vinyl (1) The film when extracted with dis- alcohol copolymers. tilled water at 21 °C (70 °F) for 48 hours Ethylene-vinyl acetate-vinyl alcohol yields total extractives not to exceed copolymers (CAS Reg. No. 26221–27–2) 0.0047 milligram per square centimeter (0.03 milligram per square inch) of may be safely used as articles or com- food-contact surface. ponents of articles intended for use in (2) The film when extracted with 50 contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for the following prescribed conditions: 48 hours yields total extractives not to (a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen- hol copolymers are produced by the timeter (0.04 milligram per square partial or complete alcoholysis or hy- inch) of food-contact surface. drolysis of those ethylene-vinyl acetate (c) The finished food-contact article copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003 (1) Those copolymers containing a inch) thickness and shall contact foods minimum of 55 percent ethylene and a only of the types identified in table 1 of maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories units by weight may be used in contact III, IV-A, VII-A, and IX under condi- with foods as described in paragraph (b) tions of use F and G described in table of this section. 2 of § 176.170(c) of this chapter. Film (2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch) minimum of 55 percent ethylene and a thickness representing the finished ar- maximum of 15 percent vinyl alcohol ticles shall meet the following extrac- units by weight may be used in contact tive limitation when tested by ASTM with foods as described in paragraph (c) method F34–76 (Reapproved 1980), of this section. ‘‘Standard Test Method for Liquid Ex- (3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’ 40 percent ethylene and 60 to 83 percent which is incorporated by reference. The vinyl alcohol units by weight may be availability of this incorporation by used in contact with foods as described reference is given in paragraph (b) of in paragraph (d) of this section. this section. The film when extracted (b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30 shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to inch) thickness and shall contact foods exceed 0.0078 milligram per square cen- only of the types identified in table 1 of timeter (0.05 milligram per square § 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor- I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid- conditions of use D through G de- ing by a factor of five. scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007 meter (0.005) inch thickness rep- inch) thickness and may contact all resenting the finished article shall foods, except those containing more meet the following extractive limita- than 8 percent alcohol, under condition when tested by ASTM method tions of use B through H described in F34–76 (Reapproved 1980), ‘‘Standard table 2 of § 176.170(c) of this chapter. Test Method for Liquid Extraction of Film samples of 0.018 centimeter (0.007 Flexible Barrier Materials,’’ which is inch) thickness representing the fin- incorporated by reference. Copies may ished articles shall meet the following be obtained from the American Society extractive limitation when tested by for Testing Materials, 100 Barr Harbor ASTM method F34–76 (Reapproved Dr., West Conshohocken, Philadelphia, 1980), ‘‘Standard Test Methods for Liq- PA 19428-2959, or may be examined at uid Extraction of Flexible Barrier Ma- the National Archives and Records Ad- terials,’’ which is incorporated by ref- ministration (NARA). For information erence. The availability of this incor- on the availability of this material at poration by reference is given in para- NARA, call 202–741–6030, or go to: http:// graph (b) of this section. The film when www.archives.gov/federallregister/ extracted with distilled water at 100 °C codeloflfederallregulations/ (212 °F) for 30 minutes yields ethylene- ibrllocations.html. vinyl acetate-vinyl alcohol oligomers

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not to exceed 0.093 milligram per difluoroethylene, and tetrafluoro- square centimeter (0.6 milligram per ethylene. square inch) of food contact surface as (4) Ethylene-chlorotrifluoroethylene determined by a method entitled ‘‘An- copolymer resins produced by copolym- alytical Method of Determining the erization of nominally 50 mole percent Amount of EVOH in the Extractives of ethylene and 50 mole percent of Residue of EVOH Film,’’ dated March chlorotrifluoroethylene. The copoly- 23, 1987, as developed by the Kuraray mer shall have a melting point of 239 to Co., Ltd., which is incorporated by ref- 243 °C and a melt index of less than or erence in accordance with 5 U.S.C. equal to 20 as determined by ASTM 552(a) and 1 CFR part 51. Copies may be Method D 3275–89 ‘‘Standard Specifica- obtained from the Office of Premarket tion for E-CTFE-Fluoroplastic Mold- Approval (HFS–200), Center for Food ing, Extrusion, and Coating Mate- Safety and Applied Nutrition, Food and rials,’’ which is incorporated by ref- Drug Administration, 5100 Paint erence in accordance with 5 U.S.C. Branch Pkwy., College Park, MD 20740, 552(a) and 1 CFR part 51. Copies may be or may be examined at the Center for obtained from the American Society Food Safety and Applied Nutrition’s for Testing and Materials, 1916 Race Library, 5100 Paint Branch Pkwy., Col- St., Philadelphia, PA 19013, or may be lege Park, MD 20740, or at the National examined at the National Archives and Archives and Records Administration Records Administration (NARA). For (NARA). For information on the avail- information on the availability of this ability of this material at NARA, call material at NARA, call 202–741–6030, or 202–741–6030, or go to: http:// go to: http://www.archives.gov/ www.archives.gov/federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (e) The provisions of this section are (b) Fluorocarbon resins that are iden- not applicable to ethylene-vinyl ace- tified in paragraph (a) of this section tate-vinyl alcohol copolymers used in and that comply with extractive limi- the food-packaging adhesives com- tations prescribed in paragraph (c) of plying with § 175.105 of this chapter. this section may be used as articles or components of articles intended for use [47 FR 41531, Sept. 21, 1982, as amended at 49 in contact with food as follows: FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, 2000] (1) Fluorocarbon resins that are identified in paragraphs (a)(1), (a)(2), and § 177.1380 Fluorocarbon resins. (a)(3) of this section and that comply only with the extractive limitations Fluorocarbon resins may be safely prescribed in paragraphs (c)(1) and used as articles or components of arti- (c)(2) of this section may be used when cles intended for use in contact with such use is limited to articles or com- food, in accordance with the following ponents of articles that are intended prescribed conditions: for repeated use in contact with food or (a) For the purpose of this section, that are intended for one-time use in fluorocarbon resins consist of basic res- contact with foods only of the types ins produced as follows: identified in § 176.170(c) of this chapter, (1) Chlorotrifluoroethylene resins table 1, under Types I, II, VI, VII-B, produced by the homopolymerization and VIII. of chlorotrifluoroethylene. (2) Fluorocarbon resins that are iden- (2) Chlorotrifluoroethylene-1,1- tified in paragraph (a)(4) of this section difluoroethylene copolymer resins pro- and that comply with the extractive duced by copolymerization of limitations prescribed in paragraphs chlorotrifluoroethylene and 1,1- (c)(1) and (c)(2) of this section may be difluoroethylene. used only when such use is limited to (3) Chlorotrifluoroethylene-1,1- articles or components of articles that difluoroethylene-tetrafluoroethylene are intended for repeated use in con- co-polymer resins produced by co- tact with food. polymerization of (3) In accordance with current good chlorotrifluoroethylene, 1,1- manufacturing practice, those food-

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contact articles intended for repeated food additive requirements in para- use shall be thoroughly cleansed prior graphs (c) and (d) of this section) are to their first use in contact with food. necessary to ensure proper food steri- (c) Extractives limitations are appli- lization and package integrity. Refer cable to the basic resins in the form of to parts 108, 110, 113, and 114 of this pellets that have been ground or cut chapter for details. into small particles that will pass (c) Subject to the provisions of this through a U.S. Standard Sieve No. 6 paragraph, food-contact articles pro- and that will be held on a U.S. Stand- duced from high-temperature lami- ard Sieve No. 10. nates may be safely used to package all (1) A 100-gram sample of the resin food types except those containing pellets, when extracted with 100 milli- more than 8 percent ethyl alcohol. liters of distilled water at reflux tem- (1) Polymeric films/layers. Films or lay- perature for 8 hours, shall yield total ers not separated from food by a func- extractives not to exceed 0.003 percent tional barrier must meet the following by weight of the resins. requirements: (2) A 100-gram sample of the resin (i) Films/layers may consist of the pellets, when extracted with 100 milli- following: liters of 50 percent (by volume) ethyl (a) Polyolefin resins complying with alcohol in distilled water at reflux item 2.2 or 3.2 of the table in temperature for 8 hours, shall yield § 177.1520(c). total extractives not to exceed 0.003 (b) Polymeric resin blends formu- percent by weight of the resins. lated from a base polymer complying (3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying tractives not to exceed 0.01 percent by with § 177.1350. weight of the resins. (c) Polymeric resin blends formulated [42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in § 177.1520(c) blended with no more than § 177.1390 Laminate structures for use 38 percent by weight of a homopolymer at temperatures of 250 ≥F and of isobutylene complying with above. § 177.1420(a)(1). (a) The high-temperature laminates (d) Polyethylene phthalate resins identified in this section may be safely complying with § 177.1630(e)(4) (i) and used for food contact at temperatures (ii). not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply erwise specified. These articles are lay- with item 10.3 of the table in ered constructions that are optionally § 177.1500(b) of this chapter when ex- bonded with adhesives. The interior tracted with water and heptane under (food-contact) layer(s) may be sepa- the conditions of time and temperature rated from the exterior layer(s) by a specified for condition of use A, as set functional barrier, such as aluminum forth in Table 2 of § 176.170(c) of this foil. Upon review of the physical prop- chapter. erties of a particular construction, the (f) Nylon 6⁄12 resins (CAS Reg. No. Food and Drug Administration may 25191–04–2) complying with item 13.3 of consider other layers to serve as func- the table in § 177.1500(b), for use as tional barriers. This regulation is not nonfood-contact layers of laminated intended to limit these constructions films and in rigid multilaminate con- as to shape, degree of flexibility, thick- structions with polypropylene outer ness, or number of layers. These layers layers. Laminate structures with au- may be laminated, extruded, co- thorized food-contact materials yield extruded, or fused. no more than 0.15 milligrams of epsilon- (b) When containers subject to this caprolactam and 0.04 milligrams of regulation undergo heat sterilization omega-laurolactam per square inch to produce shelf-stable foods, certain when extracted with 95 percent ethanol control measures (in addition to the at 121 °C (250 °F) for 2 hours.

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(g) Polymeric resins that comply (v) Polyester-epoxy-urethane adhe- with an applicable regulation in this sives formulated from the following: chapter which permits food type and (a) Polyester resin formed by the re- time/temperature conditions to which action of polybasic acids and the container will be exposed, includ- polyhydric alcohols listed in ing sterilization processing. § 175.300(b)(3)(vii) of this chapter. Aze- (ii) Adjuvants used in these layers laic acid may also be used as a must comply with an applicable regu- polybasic acid. lation that permits food type and time/ (b) Epoxy resin listed in temperature conditions to which the § 175.300(b)(3)(viii)(a) of this chapter and container will be exposed, including comprising no more than 30 percent by sterilization processing. weight of the cured adhesive. (2) Adhesives. The use of adhesives in (c) Urethane cross-linking agent com- these containers is optional. Adhesives prising no more than 14 percent weight may be formulated from the following of the cured adhesive and formulated substances, subject to the prescribed from 3-isocyanatomethyl-3,5.5- limitations: trimethylcyclohexyl isocyanate (i) Any substance suitable for use in cyanurate (CAS Reg. No. 53880–05–0). formulating adhesives that complies (vi) Polyurethane-polyester resin- with an applicable regulation of this epoxy adhesives formulated from the chapter which permits food type and following mixture: time/temperature conditions to which the container will be exposed, includ- (a)(1) Polyester-polyurethanediol res- ing sterilization processing. ins prepared by the reaction of a mix- (ii) Substances complying with ture of polybasic acids and polyhydric § 175.105 of this chapter may be used in alcohols listed in § 175.300(b)(3)(vii) of these constructions, provided they are this chapter and 3-isocyanatomethyl- separated from the interior (food-con- 3,5,5-trimethylcyclohexyl isocyanate tact) layer(s) by a functional barrier as (CAS Reg. No. 4098–71–9). discussed under paragraph (a) of this (2) Polyester resin formed by the re- section. action of polybasic acids and (iii) Maleic anhydride adduct of poly- polyhydric alcohols listed in propylene complying with § 175.300 of § 175.300(b)(3)(vii) of this chapter. Addi- this chapter. tionally, azelaic acid and 1,6- (iv) Polyester-urethane adhesive for hexanediol may also be used as use at temperatures not exceeding 121 reactants in lieu of a polyhydric alco- °C (250 °F) and formulated from the fol- hol. lowing: (3) Epoxy resin listed in (a) Polyester-urethanediol resin pre- § 175.300(b)(3)(viii)(a) of this chapter and pared by the reaction of a mixture of comprising not more than 5 percent by polybasic acids and polyhydric alcohols weight of the cured adhesive. listed in § 175.300(b)(3)(vii) of this chap- (4) Optional trimethoxy silane curing ter, 3-isocyanatomethyl-3,5,5- agents, containing amino, epoxy, ether, trimethylcyclohexyl isocyanate (CAS or mercapto groups not in excess of 3 Reg. No. 4098–71–9) and optional percent of the cured adhesive. trimethoxysilane coupling agents con- (b) Urethane cross-linking agent, taining amino, epoxy, ether, and/or comprising not more than 20 percent mercapto groups not to exceed 3 per- by weight of the cured adhesive, and cent by weight of the cured adhesive. formulated from trimethylol propane (b) Urethane cross-linking agent (CAS Reg. No. 77–99–6) adducts of 3– comprising not more than 25 percent isocyanatomethyl–3,5,5– by weight of the cured adhesive and trimethylcyclohexyl isocyanate (CAS formulated from 3-isocyanatomethyl- Reg. No. 4098–71–9) or 1,3- 3,5,5-trimethylcyclohexyl isocyanate bis(isocyanatomethyl)benzene (CAS (CAS Reg. No. 4098–71–9) adduct of Reg. No. 25854–16–4). trimethylol propane (Cas Reg. No. 77– (vii) Polyester-polyurethane resin- 99–6) and/or 1,3-bis(isocyanatomethyl) acid dianhydride adhesives for use at benzene (CAS Reg. No. 25854–16–4) temperatures not to exceed 121 °C (250 adduct of trimethylol propane. °F), in contact only with food Types I,

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II, VIA, VIB, VIIB, and VIII as de- in Retort Pouch Water Extracts,’’ scribed in Table I of § 176.170 of this which is incorporated by reference. chapter, and formulated from the fol- Copies are available from the Center lowing mixture: for Food Safety and Applied Nutrition (a)(1) Polyesterpolyurethanediol res- (HFS–200), Food and Drug Administra- ins prepared by the reaction of a mix- tion, 5100 Paint Branch Pkwy., College ture of polybasic acids and polyhydric Park, MD 20740, and may be examined alcohols listed in § 175.300(b)(3)(vii) of at the Center for Food Safety and Ap- this chapter and 3-isocyanatomethyl- plied Nutrition’s Library, 5100 Paint 3,5,5-trimethylcyclohexyl isocyanate Branch Pkwy., College Park, MD 20740, (CAS Reg. No. 4098–71–9). Additionally, or at the National Archives and dimethylol propionic acid and 1,6- Records Administration (NARA). For hexanediol may be used alone or in information on the availability of this combination as reactants in lieu of a material at NARA, call 202–741–6030, or polybasic acid and a polyhydric alco- go to: http://www.archives.gov/ hol. federallregister/ (2) Acid dianhydride formulated from codeloflfederallregulations/ 3a,4,5,7a-tetrahydro-7-methyl-5- ibrllocations.html. (tetrahydro-2,5-dioxo-3-furanyl)-1,3- (2) The chloroform-soluble fraction of isobenzofurandione (CAS Reg. No. the total nonvolatile extractives for 73003–90–4), comprising not more than containers using adhesives listed in one percent of the cured adhesive. paragraph (c)(2)(v) of this section shall (b) Urethane cross-linking agent, not exceed 0.016 milligram per square comprising not more than twelve per- centimeter (0.10 milligram per square cent by weight of the cured adhesive, inch) as determined by a method titled and formulated from trimethylol pro- ‘‘Determination of Non-volatile Chlo- pane (CAS Reg. No. 77–99–6) adducts of roform Soluble Residues in Retort 3-isocyanatomethyl-3,5,5- Pouch Water Extracts,’’ which is incor- trimethylcyclohexyl isocyanate (CAS porated by reference in paragraph Reg. No. 4098–71–9) and/or 1,3- (c)(3)(i)(a)(1) of this section. bis(isocyanatomethyl)benzene (CAS (b) For use at temperatures not to ex- Reg. No. 363–48–31). ceed 135 °C (275 °F): The container inte- (3) Test specifications. These specifications apply only to materials on the rior (food-contact side) shall be ex- food-contact side of a functional bar- tracted with deionized distilled water ° ° rier, if present. All tests must be per- at 135 C (275 F) for 1 hour. formed on containers made under pro- (1) The chloroform-soluble fraction of duction conditions. Laminated struc- the total nonvolatile extractives for tures submitted to extraction proce- containers using no adhesive, or adhe- dures must maintain complete struc- sives listed in paragraphs (c)(2) (i), (ii), tural integrity (particularly with re- and (iii) of this section shall not exceed gard to delamination) throughout the 0.0020 milligram per square centimeter test. (0.013 milligram per square inch) as de- (i) Nonvolatile extractives. (a) For use termined by a method titled ‘‘Deter- at temperatures not to exceed 121 °C mination of Non-volatile Chloroform (250 °F): The container interior (food- Soluble Residues in Retort Pouch contact side) shall be extracted with Water Extracts,’’ which is incorporated deionized distilled water at 121 °C (250 by reference. The availability of this °F) for 2 hours. incorporation by reference is given in (1) The chloroform-soluble fraction of paragraph (c)(3)(i)(a)(1) of this section. the total nonvolatile extractives for (2) The chloroform-soluble fraction of containers using adhesives listed in the total nonvolatile extractives for paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), containers using adhesives listed in (c)(2)(iv), and (c)(2)(vii) of this section paragraph (c)(2)(v) of this section shall shall not exceed 0.0016 milligram per not exceed 0.016 milligram per square square centimeter (0.01 milligram per centimeter (0.10 milligram per square square inch) as determined by a meth- inch) as determined by a method titled od entitled ‘‘Determination of Non- ‘‘Determination of Non-volatile Chlo- Volatile Chloroform Soluble Residues roform Soluble Residues in Retort

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Pouch Water Extracts,’’ which is incor- § 177.1395 Laminate structures for use porated by reference. The availability at temperatures between 120 ≥F and of this incorporation by reference is 250 ≥F. given in paragraph (c)(3)(i)(a)(1) of this (a) The laminates identified in this section. section may be safely used at the speci- (3) The chloroform-soluble fraction of the total nonvolatile extractives for fied temperatures. These articles are containers using adhesives listed in layered structures that are optionally paragraph (c)(2)(vi) of this section shall bonded with adhesives. In these arti- not exceed 0.008 milligram per square cles, the food-contact layer does not centimeter (0.05 milligram per square function as a barrier to migration of inch) as determined by a method enti- components from non-food-contact lay- tled, ‘‘Determination of Non-volatile ers. The layers may be laminated, ex- Chloroform Soluble Residues in Retort truded, coextruded, or fused. Pouch Water Extracts,’’ which is incor- (b) Laminate structures may be man- porated by reference in paragraph ufactured from: (c)(3)(i)(a)(1) of this section. (1) Polymers and adjuvants com- (ii) Volatiles. Volatile substances em- plying with § 177.1390 of this chapter. ployed in the manufacture of high-tem- (2) Any polymeric resin listed in perature laminates must be removed to these regulations so long as the use of the greatest extent possible in keeping the resin in the structure complies with good manufacturing practice prescribed in § 174.5(a) of this chapter. with the conditions of use (food type (d) Nylon 12/aluminum foil high-tem- and time/temperature) specified in the perature laminates: Subject to the pro- regulation for that resin. visions of this paragraph, containers (3) Optional adjuvant substances used constructed of nylon 12 laminated to in accordance with § 174.5 of this chap- aluminum foil may be safely used at ter. temperatures no greater than 250 °F (4) The following substances in non- (121 °C) in contact with all food types food-contact layers only: except those containing more than 8 percent alcohol. Substances Limitations (1) The container is constructed of Ethylene/1,3–phenylene oxy- For use only with poly- aluminum foil to which nylon 12 film is ethylene isophthalate/ ethylene terephthalate as fused. Prior to fusing the nylon 12, the terephthalate copolymer the food-contact layer, aluminum foil may be optionally (CAS Reg. No. 87365–98–8) complying with complying with § 177.1345. § 177.1630 under condi- precoated with a coating complying tions of use C through G with § 175.300 of this chapter. described in table 2 of (2) Nylon 12 resin complying with § 176.170(c) of this chap- § 177.1500 and having an average thick- ter. Laminate structures, when extracted with 8 ness not to exceed 0.0016 inch (41 mi- percent ethanol at 150 °F crons) may be used as the food-contact for 2 hours shall not yield surface of the container. m-pheny lenedioxy-O,O′- (3) Container test specifications. On diethyl isophthalate or cyclic bis(ethylene exposure to distilled water at 250 °F isophthalate) in excess of (121 °C) for 2 hours, extractives from 7.8 micrograms/square the food-contact side of the nylon 12 decimeter (0.5 microgram/square inch) of multilayered construction shall not ex- food-contact surface. ceed 0.05 milligram per square inch Nylon 6/12 resins complying For use with nonalcoholic (0.0078 milligram per square centi- with § 177.1500(b), item foods at temperatures not meter) as total nonvolatile extractives. 13.2, of this chapter (CAS to exceed 100 °C (212 Reg. No. 25191–04–2). °F). Laminate structures [45 FR 2843, Jan. 15, 1980, as amended at 47 with authorized food-con- FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; tact materials yield no 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, more than 0.15 milligram of epsilon-caprolactam 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, and 0.04 milligram of Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR omega-laurolactam per 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; square inch when ex- 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, tracted with water at 100 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668, °C (212 °F) for 5 hours. Mar. 26, 2004]

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Substances Limitations in the base sheet and coating may include: Nylon 6/66 resins complying For use only with: with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (1) Substances generally recognized of this chapter (CAS Reg. temperatures not to ex- as safe in food. 24993–04–2). ceed 82.2 °C (180 °F). (2) Substances permitted to be used Laminate structures with in water-insoluble hydroxyethyl cel- authorized food-contact materials yield no more lulose film by prior sanction or ap- than 0.15 milligram of ep- proval and under conditions specified silon-caprolactam per in such sanctions or approval, and sub- square inch when extracted with water at 82.2 stances listed in part 181, subpart B of °C (180 °F) for 5 hours. this chapter. 2. Nonalcoholic foods at (3) Substances that by any regulation temperatures not to ex- promulgated under section 409 of the ceed 100 °C (212 °F). Laminate films with au- act may be safely used as components thorized food-contact ma- of water-insoluble hydroxyethyl cel- terials yield no more than lulose film. 0.15 milligram of epsilon- caprolactam per square (4) Substances identified in and used inch when extracted with in compliance with § 177.1200(c). water at 100 °C (212 °F) (c) Any substance employed in the for 5 hours. production of the water-insoluble hy- Nylon 6/69 resins complying For use with nonalcoholic with § 177.1500(b), item 14, foods under conditions of droxyethyl cellulose film described in of this chapter (CAS Reg. use B, C, D, E, F, G, and this section that is the subject of a reg- No. 51995–62–1). H described in table 2 of ulation in parts 174, 175, 176, 177, 178 § 176.170 of this chapter. Laminate structures with and § 179.45 of this chapter conforms authorized food-contact with any specification in such regula- materials may contain tion. nylon 6/69 resins provided that the nitrogen § 177.1420 Isobutylene polymers. content of aqueous extracts of a representative Isobutylene polymers may be safely laminate (obtained at 100 used as components of articles in- °C (212 °F) for 8 hours) does not exceed 15 tended for use in producing, manufac- micrograms per square turing, packing, processing, preparing, centimeter (100 treating, packaging, transporting, or micrograms per square inch). holding food, in accordance with the following prescribed conditions: (a) For the purpose of this section, [52 FR 33575, Sept. 4, 1987, as amended at 53 isobutylene polymers are those pro- FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, duced as follows: Oct. 17, 1997] (1) Polyisobutylene produced by the homopolymerization of isobutylene § 177.1400 Hydroxyethyl cellulose film, such that the finished polymers have a water-insoluble. molecular weight of 750,000 (Flory) or Water-insoluble hydroxyethyl cel- higher. lulose film may be safely used for (2) Isobutylene-isoprene copolymers packaging food in accordance with the produced by the copolymerization of following prescribed conditions: isobutylene with not more than 3 (a) Water-insoluble hydroxyethyl cel- molar percent of isoprene such that the lulose film consists of a base sheet finished polymers have a molecular manufactured by the ethoxylation of weight of 300,000 (Flory) or higher. cellulose under controlled conditions, (3) Chlorinated isobutylene-isoprene to which may be added certain optional copolymers produced when substances of a grade of purity suitable isobutylene-isoprene copolymers (mo- for use in food packaging as constitu- lecular weight 300,000 (Flory) or higher) ents of the base sheet or as coatings are modified by chlorination with not applied to impart desired technological more than 1.3 weight-percent of chlo- properties. rine. (b) Subject to any limitations pre- (b) The polymers identified in para- scribed in parts 170 through 189 of this graph (a) of this section may contain chapter, the optional substances used optional adjuvant substances required

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in the production of the polymers. The articles intended for use in contact optional adjuvant substances required with food, subject to the provisions of in the production of the polymers may this section. include substances generally recog- (a) For the purpose of this section, nized as safe in food, substances used in isobutylene-butene copolymers consist accordance with a prior sanction or ap- of basic copolymers produced by the proval, and aluminum chloride. copolymerization of isobutylene with (c) The provisions of this section are mixtures of n-butenes such that the not applicable to polyisobutylene used finished basic copolymers contain not in food-packaging adhesives complying less than 45 weight percent of polymer with § 175.105 of this chapter. units derived from isobutylene and § 177.1430 Isobutylene-butene copoly- meet the specifications prescribed in mers. paragraph (b) of this section when test- Isobutylene-butene copolymers iden- ed by the methods described in para- tified in paragraph (a) of this section graph (c) of this section. may be safely used as components of (b) Specifications:

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

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

(c) The analytical methods for deter- for Kinematic Viscosity of Transparent mining whether isobutylene-butene co- and Opaque Liquids,’’ which is incor- polymers conform to the specifications porated by reference. The availability in paragraph (b) are as follows: of this incorporation by reference is (1) Molecular weight. Molecular given in paragraph (c)(1) of this sec- weight shall be determined by Amer- tion. ican Society for Testing and Materials (3) Maximum bromine value. Maximum (ASTM) method D2503–82, ‘‘Standard bromine value shall be determined by Test Method for Molecular Weight ASTM method D1492–78, ‘‘Standard (Relative Molecular Mass) of Hydro- Test Method for Bromine Index of Aro- carbons by Thermoelectric Measure- matic Hydrocarbons by Coulometric ment of Vapor Pressure,’’ which is in- Titration,’’ which is incorporated by corporated by reference. Copies may be obtained from the American Society reference. The availability of this infor Testing Materials, 100 Barr Harbor corporation by reference is given in Dr., West Conshohocken, Philadelphia, paragraph (c)(1) of this section. PA 19428-2959, or may be examined at (d) The provisions of this section are the National Archives and Records Ad- not applicable to isobutylene-butene ministration (NARA). For information copolymers used as provided under on the availability of this material at § 175.105 of this chapter. NARA, call 202–741–6030, or go to: http:// [52 FR 11641, Apr. 10, 1987, as amended at 63 www.archives.gov/federallregister/ FR 36175, July 2, 1998] codeloflfederallregulations/ ibrllocations.html. (2) Viscosity. Viscosity shall be determined by ASTM method D445–74, ‘‘Test

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§ 177.1440 4,4′-Isopropylidenediphenol- in other sections of subchapter B of epichlorohydrin resins minimum this chapter. molecular weight 10,000. 4,4′-Isopropylidenediphenol-epichlo- § 177.1460 Melamine-formaldehyde resins in molded articles. rohydrin resins having a minimum molecular weight of 10,000 may be safely Melamine-formaldehyde resins may used as articles or components of arti- be safely used as the food-contact sur- cles intended for use in producing, face of molded articles intended for use manufacturing, packing, processing, in producing, manufacturing, packing, preparing, treating, packaging, trans- processing, preparing, treating, pack- porting, or holding food in accordance aging, transporting, or holding food in with the following prescribed condi- accordance with the following pre- tions: scribed conditions: (a) 4,4′-Isopropylidenediphenol-ep- (a) For the purpose of this section, ichlorohydrin resins consist of basic melamine-formaldehyde resins are resins produced by the condensation of those produced when 1 mole of mel- equimolar amounts of 4,4′- amine is made to react with not more isopropylidenediphenol and than 3 moles of formaldehyde in water epichlorohydrin terminated with phe- solution. nol, to which may have been added cer- (b) The resins may be mixed with retain optional adjuvant substances refined woodpulp and the mixture may quired in the production of the resins. contain other optional adjuvant sub- (b) The optional adjuvant substances stances which may include the fol- required in the production of the resins lowing: may include substances generally rec- List of substances Limitations ognized as safe in food, substances used in accordance with a prior sanction or Colorants used in accord- approval, and the following: ance with § 178.3297 of this chapter. Dioctyl phthalate ...... For use as lubricant. List of substances Limitations Hexamethylenetetramine For use only as polymerization reaction control agent. Butyl alcohol ...... Not to exceed 300 p.p.m. as re- Phthalic acid anhydride .. Do. sidual solvent in finished resin. Zinc stearate ...... For use as lubricant. Ethyl alcohol. Toluene ...... Not to exceed 1,000 p.p.m. as residual solvent in finished resin. (c) The molded melamine-formaldehyde articles in the finished form in (c) 4,4′-Isopropylidenediphenol-ep- which they are to contact food, when ichlorohydrin resins shall meet the fol- extracted with the solvent or solvents lowing nonvolatile extractives limita- characterizing the type of food and tions: under the conditions of time and tem- (1) Maximum extractable nonvolatile perature as determined from tables 1 fraction of 2 parts per million when ex- and 2 of § 175.300(d) of this chapter, tracted with distilled water at 70 °C for shall yield net chloroform-soluble ex- 2 hours, using a volume-to-surface tractives not to exceed 0.5 milligram ratio of 2 milliliters per square inch. per square inch of food-contact surface. (2) Maximum extractable nonvolatile [42 FR 14572, Mar. 15, 1977, as amended at 56 fraction of 3 parts per million when ex- FR 42933, Aug. 30, 1991] tracted with n-heptane at 70 °C for 2 hours, using a volume-to-surface ratio § 177.1480 Nitrile rubber modified ac- of 2 milliliters per square inch. rylonitrile-methyl acrylate copoly- (3) Maximum extractable nonvolatile mers. fraction of 6 parts per million when ex- Nitrile rubber modified acrylonitrile- tracted with 10 percent (by volume) methyl acrylate copolymers identified ethyl alcohol in distilled water at 70 °C in this section may be safely used as for 2 hours, using a volume-to-surface components of articles intended for ratio of 2 milliliters per square inch. food-contact use under conditions of (d) The provisions of this section are use D, E, F, or G described in table 2 of not applicable to 4,4′-isopropylidene- § 176.170(c) of this chapter, subject to diphenol-epichlorohydrin resins listed the provisions of this section.

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(a) For the purpose of this section, the National Archives and Records Ad- nitrile rubber modified acrylonitrile- ministration (NARA). For information methyl acrylate copolymers consist of on the availability of this material at basic copolymers produced by the graft NARA, call 202–741–6030, or go to: http:// copolymerization of 73–77 parts by www.archives.gov/federallregister/ weight of acrylonitrile and 23–27 parts codeloflfederallregulations/ by weight of methyl acrylate in the ibrllocations.html.Copies are applicable presence of 8–10 parts by weight of bu- to the basic copolymers in the form of tadiene-acrylonitrile copolymers con- particles of a size that will pass taining approximately 70 percent by through a U.S. standard sieve No. 6 and weight of polymer units derived from that will be held on a U.S. standard butadiene. sieve No. 10: (b) The nitrile rubber modified acry- (i) Extracted copolymer not to ex- lonitrile-methyl acrylate basic copoly- ceed 2.0 parts per million in aqueous mers meet the following specifications extract obtained when a 100-gram sam- and extractives limitations: ple of the basic copolymers is extracted (1) Specifications. (i) Nitrogen content with 250 milliliters of demineralized is in the range 16.5–19 percent as deter- (deionized) water at reflux temperature mined by Kjeldahl analysis. for 2 hours. (ii) Intrinsic viscosity in acetonitrile (ii) Extracted copolymer not to ex- at 25 °C is not less than 0.29 deciliter ceed 0.5 part per million in n-heptane per gram as determined by ASTM extract obtained when a 100-gram sam- method D1243–79, ‘‘Standard Test Meth- ple of the basic copolymers is extracted od for Dilute Solution Viscosity of with 250 milliliters of reagent grade n- Vinyl Chloride Polymers,’’ which is in- heptane at reflux temperature for 2 corporated by reference. Copies may be hours. obtained from the American Society (c) Acrylonitrile copolymers identi- for Testing Materials, 100 Barr Harbor fied in this section shall comply with Dr., West Conshohocken, Philadelphia, the provisions of § 180.22 of this chap- PA 19428-2959, or may be examined at ter. the National Archives and Records Ad- (d) Acrylonitrile copolymers identi- ministration (NARA). For information fied in this section are not authorized on the availability of this material at to be used to fabricate beverage con- NARA, call 202–741–6030, or go to: http:// tainers. www.archives.gov/federallregister/ [42 FR 14572, Mar. 15, 1977, as amended at 42 codeloflfederallregulations/ FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, ibrllocations.html. 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, (iii) Residual acrylonitrile monomer Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR content is not more than 11 parts per 14481, Apr. 2, 1996] million as determined by gas chromatography. § 177.1500 Nylon resins. (iv) Acetonitrile-soluble fraction The nylon resins listed in paragraph after refluxing the base polymer in ace- (a) of this section may be safely used to tonitrile for 1 hour is not greater than produce articles intended for use in 95 percent by weight of the basic co- processing, handling, and packaging polymers. food, subject to the provisions of this (2) Extractives limitations. The fol- section: lowing extractive limitations are de- (a) The nylon resins are manufac- termined by an infrared tured as described in this paragraph so spectrophotometric method titled, as to meet the specifications prescribed ‘‘Infrared Spectrophotometric Deter- in paragraph (b) of this section when mination of Polymer Extracted from tested by the methods described in Borex ® 210 Resin Pellets,’’ which is in- paragraph (d) of this section. corporated by reference. Copies are (1) Nylon 66 resins are manufactured available from the Center for Food by the condensation of hexamethylene- Safety and Applied Nutrition (HFS– diamine and adipic acid. 200), Food and Drug Administration, (2) Nylon 610 resins are manufactured 5100 Paint Branch Pkwy., College Park, by the condensation of hexamethylene- MD 20740, or available for inspection at diamine and sebacic acid.

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(3) Nylon 66/610 resins are manufac- isophthalic acid (CAS Reg. No. 0121–91– tured by the condensation of equal- 5), and bis(4-amino-3-methylcycl- weight mixtures of nylon 66 salts and ohexyl)methane (CAS Reg. No. 6864–37– nylon 610 salts. 5) such that the composition in terms (4) Nylon 6/66 resins manufactured by of ingredients is 34.4±1.5 weight percent the condensation and polymerization of omega-laurolactam, 26.8±0.4 weight per- Nylon 66 salts and epsilon-caprolactam. cent isophthalic acid, and 38.8±0.5 (5) Nylon 11 resins are manufactured weight percent bis(4-amino-3- by the condensation of 11- methylcyclohexyl)-methane. aminoundecanoic acid. (12) Nylon 6I/6T resins (CAS Reg. No. (6) Nylon 6 resins are manufactured 25750–23–6) are manufactured by the by the polymerization of epsilon- condensation of caprolactam. hexamethylenediamine, terephthalic (7) Nylon 66T resins are manufac- acid, and isophthalic acid such that 65 tured by the condensation of to 80 percent of the polymer units are hexamethyl-enediamine, adipic acid, derived from hexamethylene and terephthalic acid such that com- isophthalamide. position in terms of ingredients is (13)(i) Nylon 6/12 resins (CAS Reg. No. 43.1±0.2 weight percent hexamethyl- 25191–04–2) are manufactured by the co- enediamine, 35.3±1.2 weight percent polymerization of a 1 to 1 ratio by adipic acid, and 21.6±1.2 weight percent weight of epsilon-caprolactam and terephthalic acid. omega-laurolactam. (8) Nylon 612 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No. by the condensation of 25191–04–2) are manufactured by the co- hexamethylenediamine and polymerization of a ratio of at least 80 dodecanedioic acid. weight percent of epsilon-caprolactam (9) Nylon 12 resins are manufactured and no more than 20 weight percent of by the condensation of omega- omega-laurolactam. laurolactam. (14) Nylon 6/69 resins (CAS Reg. No. (10)(i) Impact modified Nylon MXD–6 51995–62–1) are manufactured by the resins (CAS Reg. No. 59655–05–9) manu- condensation of 49.5+0.5 weight percent factured by the condensation of adipic epsilon-caprolactam, 19.4+0.2 weight acid, 1,3-benzenedimethanamine, and percent hexamethylenediamine and alpha-(3-aminopropyl)-omega-(3-amino- 31.2+0.3 weight percent azelaic acid. propoxy)polyoxyethylene under such (15) Nylon 46 resins (CAS Reg. No. conditions that the alpha-(3-amino- 50327–77–0) are manufactured by the propyl)-omega-(3-aminopropoxy) condensation of 1,4-butanediamine and polyoxyethylene monomer content adipic acid. does not exceed 7 percent by weight of (16) Nylon resins PA 6–3–T (CAS Reg- the finished resin. istry No. 26246–77–5) are manufactured (ii) Nylon MXD–6 resins (CAS Reg. by the condensation of 50 mol percent No. 25718–70–1) manufactured by the 1,4-benzenedicarboxylic acid, dimethyl condensation of adipic acid and 1,3- ester and 50 mol percent of an benzenedimethanamine. equimolar mixture of 2,2,4-trimethyl- (11) Nylon 12T resins are manufac- 1,6-hexanediamine and 2,4,4-trimethyl- tured by the condensation of omega- 1,6-hexanediamine. laurolactam (CAS Reg. No. 0947–04–6), (b) Specifications:

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

1. Nylon 66 resins ...... 1.14±.015 475–495 Dissolves in ...... 1.5 1.5 0.2 0.2 1 h. 2. Nylon 610 resins ...... 1.09±.015 405–425 Insoluble ...... 1.0 2.0 1.0 1.0 after 1 h.

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3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in ...... 1.5 2.0 1.0 1.0 1 h. 4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ...... do...... 2.0 2.0 1.5 1.5 silon-caprolactam monomer content not to exceed 0.7 percent by weight. 4.2 Nylon 6/66 resins with 1.14±.015 380–425 ...... do...... 0.8 1.0 0.5 0.5 combined caprolactam content greater than 60 percent and residual epsilon-caprolactam monomer content not to exceed 0.4 percent by weight. For use only as specified in § 177.1395 of this chapter (CAS Reg. No. 24993–04–2). 5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble ...... 30 .35 .25 .3 in articles intended for 1- after 1 h. time use or repeated use in contact with food. 5.2 Nylon 11 resins for use 1.04±.015 355–375 ...... do...... 35 1.60 .35 .40 only: a. In articles intended for repeated use in contact with food. b. In side-seam cements for articles intended for 1-time use in contact with food and which are in compliance with § 175.300 of this chapter. 6.1 Nylon 6 resins ...... 1.15±.015 392–446 Dissolves in ...... 1.0 2.0 1.0 1.0 1 h. 6.2 Nylon 6 resins for use 1.15±.015 392–446 ...... do...... 1.5 2.0 1.0 1.0 only in food-contact films having an average thickness not to exceed 0.001 in. 7. Nylon 66T resins for use 1.16±.015 482–518 Insoluble ...... 1.0 1.0 .25 .25 only in food-contact films after 1 h. having an average thickness not to exceed 0.001 in. 8. Nylon 612 resins for use 1.06±.015 406–420 ...... do...... 50 1.50 .50 .50 only in articles intended for repeated use in contact with food at temperatures not to exceed 212 °F. 9. Nylon 12 resins for use 1.01±.015 335–355 ...... do...... 1.0 2.0 1.50 1.50 only:.

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a. In food-contact films having an average thickness not to exceed 0.0016 inch intended for use in contact with nonalcoholic food under the conditions of use A (sterilization not to exceed 30 minutes at a temperature not to exceed 250 °F), and B through H of table 2 of § 176.170(c) of this chapter, except as provided in § 177.1390(d) b. In coatings intended for repeated use in contact with all food types described in table 1 of § 176.170(c) of this chapter, except those containing more than 8 percent alcohol, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 10.1 Nylon MXD–6 and im- 1.21±0.02 437–491 Dissolves in ...... 2.0 2.5 1.0 1.0 pact modified Nylon 1h. MXD–6 film having an average thickness not to exceed 40 microns (0.0016 inch) for use in processing, handling, and packaging of food of types V and IX listed in table 1 of § 176.170(c) of this chapter under conditions of use C, D, E, F, G, and H in table 2 of § 176.170(C) of this chapter. 10.2 Impact modified Nylon 1.21±0.02 437–491 do...... 2.0 2.5 1.0 1.0 MXD–6 resins for use as polymer use as polymer modifiers in Nylon 6 resin films complying with paragraph (a)(6) of this section, at levels not to exceed 13 percent by weight of films whose average thickness will not exceed 15 microns (0.6 mils). The finished film is used for packaging, transporting, or holding food, excluding beverages containing more than 8 percent alcohol (by volume) at temperatures not to exceed 49 °C (120 °F) (conditions of use E, F, and G in table 2 of § 176.170(c) of this chapter).

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10.3 Nylon MXD–6 resins 1.22±0.02 455–470 Dissolves in 1.0 1.5 0.2 0.2 for use only as nonfood- 1 h. contact layers of: (1) Mul- tilayer films and (2) rigid plastic containers composed of polypropylene food-contact and exterior layers, as defined in § 177.1520(c), item 1.1(a) and 1.1(b), of this chapter. The finished food- contact laminate, in the form in which it contacts food, when extracted with the food simulating solvent or solvents characterizing the conditions of the intended use as determined from Table 2 of § 176.170(c) of this chapter, shall yield not more than 0.5 micrograms of m-xylylenediamine-adipic acid cyclic monomer per square inch of food-contact surface, when the food simulating solvent is analyzed by any appropriate, properly validated method. 11. Nylon 12T resins for 1.06±0.015 290–310 Insoluble ...... 0.1 ...... 0.5 0.5 use in contact with all after 1 types of food except hour. those containing more than 8 percent alcohol. 12. Nylon 6I/6T resins for 1.207±0.1 N/A Insoluble ...... 0.2 1.0 0.1 0.1 use in contact with all after 1 types of food except al- hour. coholic beverages containing more than 8 percent alcohol. 13.1 Nylon 6/12 resins for 1.06±0.015 260–285 Dissolves in Greater than 140 ..... 2.0 ...... 1.5 1.5 use only in food-contact 1 hour. films having an average thickness not to exceed 51 microns (0.002 inch). The finished film is intended to contact all foods except those containing more than 8 percent ethanol under conditions of use B, C, D, E, F, G, and H listed in table 2 of § 176.170(c) of this chapter. 13.2 Nylon 6/12 resins with 1.10±0.15 380–400 Dissolves in Greater than 160 ..... 0.8 1.0 0.5 0.5 residual epsilon- 1 h. caprolactam not to exceed 0.5 percent by weight and residual omega-laurolactam not to exceed 0.1 percent by weight. For use only as specified in § 177.1395 of this chapter.

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13.3 Nylon 6/12 resins with 1.13 ±0.15 400–420 Dissolves in ...... 1.0 1.5 0.5 0.5 residual epsilon- 1 h. caprolactam not to exceed 0.8 percent by weight and residual omega-laurolactam not to exceed 0.1 percent by weight. For use only as specified in § 177.1390 of this chapter. 14. Nylon 6/69 resins for 1.09±0.02 270–277 ...... >140 using the meth- 3.0 use only as specified in od described in 21 CFR 177.1395 of this § 177.1500(c)(5)(ii) chapter. of this chapter. 15. Nylon 46 resins for use 1.18±0.015 551–592 Dissolves in ...... 0.3 0.2 0.2 0.3 only in food-contact 1 h. membrane filters intended for repeated use. The finished membrane filter is intended to contact beverages containing no more than 13 percent alcohol, under conditions of use E, F, and G listed in table 2 of § 176.170(c) of this chapter. 16. Nylon resins PA 6–3–T 1.12±0.03 NA Insoluble > 110 ...... 0.007 0.64 0.003 0 for repeated-use (exclud- after 1 h. ing bottles) in contact with food of type VIA and VIB described in table 1 of § 176.170(c) of this chapter under conditions of use D through H described in table 2 of § 176.170(c) of this chapter with a hot-fill temperature limitation of 40 °C.

(c) Nylon modifier—(1) Identity. Co- (2) Specifications. The finished copoly- polyester-graft-acrylate copolymer is ester-graft-acrylate copolymer shall the substance 1,4-benzenedicarboxylic meet the following specifications: acid, polymer with 1,4-butanediol, (E)- (i) Weight average molecular weight 2-butenedioic acid, 1,2-ethanediol, 15,000–35,000, ethyl 2-propenoate, hexanedioic acid (ii) pH 7.2 to 8.2, and and 2-propenoic acid, graft (CAS Reg. (iii) Glass transition temperature ¥ ¥ ° No. 175419–23–5), and is derived from 15 to 25 C. grafting of 25 weight percent of acrylic (3) Conditions of use. (i) Copolyester- polymer with 75 weight percent of co- graft acrylate copolymer described in paragraph (c)(1) of this section is in- polyester. The copolyester is polym- tended to improve the adhesive quali- erized terephthalic acid (55 mol%), ties of film. It is limited for use as a adipic acid (40 mol%), and fumaric acid modifier of Nylon 6 and Nylon 6 modi- (5 mol%) with ethylene glycol (40 fied with Nylon MXD–6 at a level not mol%) and 1,4-butanediol (60 mol%). to exceed 0.17 weight percent of the ad- The acrylic polymer is made from ditive in the finished film. acrylic acid (70 mol%) and ethyl acry- (ii) The finished film is used for pack- late (30 mol%). aging, transporting, or holding all types of foods under conditions of use B

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through H, described in table 2 of hours in a nitrogen atmosphere then § 176.170(c) of this chapter, except that repeat the test. in the case of Nylon 6 films modified (3) Solubility in boiling 4.2N HCl. The with Nylon MXD–6 (complying with test shall be run on a sample approxi- § 177.1500, item 10.2), the use complies mately the size of a 1⁄8-inch cube in at with the conditions of use specified in least 25 milliliters of 4.2 normal hydro- table 2. chloric acid. (iii) Extractives. Food contact films (4) Maximum extractable fraction in se- described in paragraphs (c)(1) of this lected solvents. The procedure for deter- section, when extracted with solvent or mining the maximum extractable frac- solvents prescribed for the type of food tion of the nylon resins in selected sol- and under conditions of time and tem- vents is as follows: perature specified for the intended use, (i) Film should be cut with ordinary shall yield total extractives not to ex- scissors into pieces of a convenient size ceed 0.5 milligram per inch squared of such as 1⁄4-inch squares, for the extrac- food-contact surface when tested by tion tests described in this section. The the methods described in § 176.170(d) of granules of nylon molding powders are this chapter. in the proper form for the extraction (iv) Optional adjuvant substances. The tests. Samples of fabricated articles substances employed in the production such as pipe, fittings, and other similar of Nylon modifiers listed in paragraph articles must be cut to approximately (c)(1) of this section may include: the size of the molding powder. This can be done conveniently by using a (A) Substances generally recognized small-scale commercial plastics as safe for use in food and food pack- granulator and cutting the sample aging; through a screen having 1⁄4-inch mesh. (B) Substances subject to prior sanc- Fine particles should be separated from tion or approval for use in Nylon resins the cut resin by screening through a 20- and used in accordance with such sanc- mesh screen. The material retained on tions or approval; and the screen is suitable for the extraction (C) Optional substances required in tests. the production of the additive identi- (ii) The organic solvents must be of fied in this paragraph and other op- American Chemical Society analytical tional substances that may be required reagent grade; distilled water is used. to accomplish the intended physical or Approximately 30 grams of the pre- technical effect. pared sample is weighed to the nearest (d) Analytical methods—(1) Specific milligram. The weighed resin is trans- gravity. Specific gravity shall be deter- ferred to a 500-milliliter round-bottom mined by weighing a 1-gram to 5-gram flask equipped with a reflux condenser. sample first in air and then in freshly Approximately 300-milliliters of sol- boiled distilled water at 23 °C±2 °C. vent is added to the flask and the con- (2) Melting point. The melting point tents refluxed gently for 8 hours with a shall be determined as follows: Use a heating mantle. The solvent is then fil- hot-stage apparatus. The use of crossed tered off immediately while still hot, nicol prisms with a microscope hot using a Buchner funnel approximately stage and reading of the thermometer 5 inches in diameter, a suction flask, when the birefringence disappears in- and a hardened filter paper (Whatman creases the accuracy. If the crossed No. 50 or equivalent). The paper is wet nicol apparatus is not available, use with the solvent and a slight suction the lowest temperature at which the applied just before starting the filtra- sample becomes transparent or the tion. The resin is washed twice with sharp edges or corners of the sample approximately 100-milliliter portions of become rounded as the melting point. solvent and the combined filtrate and In case of doubt as to the onset of washings are reduced to approximately melting, the sample is prodded with a 25 milliliters by evaporation at reduced sharp instrument. If it sticks to the pressure (50 millimeters to 100 millime- heating block, it is considered to have ters of mercury, absolute), heating as melted. If the melting point is low, dry necessary. The contents of the flask the sample in an oven at 85 °C for 24 are transferred to an evaporation dish

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(which has been held in a vacuum des- (a) For the purpose of this section, iccator over anhydrous calcium sulfate olefin polymers are basic polymers until constant weight has been at- manufactured as described in this para- tained) and carefully evaporated to graph, so as to meet the specifications dryness. The weight of the solid residue prescribed in paragraph (c) of this sec- is determined by difference after hold- tion, when tested by the methods de- ing in a vacuum desiccator over anhy- scribed in paragraph (d) of this section. drous calcium sulfate until constant (1)(i) Polypropylene consists of basic weight has been attained. The percent polymers manufactured by the cata- of solids extracted is calculated by di- lytic polymerization of propylene. viding the weight of the solid residue (ii) Propylene homopolymer consists by the weight of the sample and multi- of basic polymers manufactured by the plying by 100. catalytic polymerization of propylene (5) Viscosity number (VN). (i) The vis- with a metallocene catalyst. cosity number (VN) for Nylon 6/12 resin (2)(i) Polyethylene consists of basic in a 96 percent sulfuric acid solution (5 polymers manufactured by the cata- milligrams resin per milliliter) shall be lytic polymerization of ethylene. determined at 25 °C (77 °F) by method (ii) Fumaric acid-grafted poly- ISO 307–1984(E), ‘‘Plastics-Polyamides- ethylene (CAS Reg. No. 26877–81–6) con- Determination of Viscosity Number,’’ sists of basic polymers manufactured which is incorporated by reference. by the catalytic polymerization of Copies are available from the Center ethylene followed by reaction with fu- for Food Safety and Applied Nutrition maric acid in the absence of free rad- (HFS–200), Food and Drug Administra- ical initiators. Such polymers shall tion, 5100 Paint Branch Pkwy., College contain grafted fumaric acid at levels Park, MD 20740, or available for inspec- not to exceed 2 percent by weight of tion at the National Archives and the finished polymer. Records Administration (NARA). For (3) Olefin basic copolymers consist of information on the availability of this basic copolymers manufactured by the material at NARA, call 202–741–6030, or catalytic copolymerization of: go to: http://www.archives.gov/ (i) Two or more of the 1-alkenes hav- federallregister/ ing 2 to 8 carbon atoms. Such olefin codeloflfederallregulations/ basic copolymers contain not less than ibrllocations.html. 96 weight-percent of polymer units de- (ii) The viscosity number (VN) for rived from ethylene and/or propylene, Nylon 6/69 and Nylon PA–6–3–T resins except that: in a 99 percent cresol solution (5 milli- (a)(1) Olefin basic copolymers manu- grams resin per milliliter) shall be de- factured by the catalytic copolym- ° ° termined at 25 C (77 F) by method ISO erization of ethylene and hexene-1 or 307–1984(E), ‘‘Plastics-Polyamides-De- ethylene and octene-1 shall contain not termination of Viscosity Number,’’ less than 90 weight-percent of polymer which is incorporated by reference. The units derived from ethylene; availability of this incorporation by (2) Olefin basic copolymers manufac- reference is given in paragraph (d)(5)(i) tured by the catalytic copolymeriza- of this section. tion of ethylene and hexene-1 shall con- [42 FR 14572, Mar. 15, 1977] tain not less than 80 but not more than 90 weight percent of polymer units de- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 177.1500, see the List of rived from ethylene. CFR Sections Affected, which appears in the (3) Olefin basic copolymers manufac- Finding Aids section of the printed volume tured by the catalytic copolymeriza- and at www.fdsys.gov. tion of ethylene and pentene-1 shall contain not less than 90 weight-percent § 177.1520 Olefin polymers. of polymer units derived from ethyl- The olefin polymers listed in para- ene. graph (a) of this section may be safely (4) Olefin basic copolymers manufac- used as articles or components of arti- tured by the catalytic polymerization cles intended for use in contact with of ethylene and octene-1 shall contain food, subject to the provisions of this not less than 50 weight-percent of poly- section. mer units derived from ethylene.

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(b) Olefin basic copolymers manufac- derived by copolymerization with 1,4- tured by the catalytic copolymeriza- hexadiene. tion of ethylene and 4-methylpentene-1 (v) Ethylene and butene-1 copolymers shall contain not less than 89 weight- (CAS Reg. No. 25087–34–7) that shall percent of polymer units derived from contain not less than 80 weight percent ethylene; of polymer units derived from ethyl- (c)(1) Olefin basic copolymers manu- ene. factured by the catalytic copolym- (vi) Olefin basic copolymers (CAS erization of two or more of the mono- Reg. No. 61615–63–2) manufactured by mers ethylene, propylene, butene-1, 2- the catalytic copolymerization of methylpropene-1, and 2,4,4- ethylene and propylene with 1,4- trimethylpentene-1 shall contain not hexadiene, followed by reaction with less than 85 weight-percent of polymer fumaric acid in the absence of free rad- units derived from ethylene and/or pro- ical initiators. Such polymers shall pylene; contain not more than 4.5 percent of (2) Olefin basic copolymers manufac- polymer units deriving from 1,4- tured by the catalytic copolymeriza- hexadiene by weight of total polymer tion of propylene and butene-1 shall prior to reaction with fumaric acid and contain greater than 15 but not greater not more than 2.2 percent of grafted fu- than 35 weight percent of polymer maric acid by weight of the finished units derived from butene-1 with the polymer. remainder being propylene. (vii) Ethylene and 2-norbornene (CAS (d) Olefin basic terpolymers manufac- Reg. No. 26007–43–2) copolymers that tured by the catalytic copolymeriza- shall contain not less than 30 and not tion of ethylene, hexene-1, and either more than 70 mole percent of polymer propylene or butene-1, shall contain units derived from 2-norbornene. not less than 85 weight percent poly- (4) Poly(methylpentene) consists of mer units derived from ethylene. basic polymers manufactured by the (e) Olefin basic copolymers manufac- catalytic polymerization of 4- tured by the catalytic polymerization methylpentene-1. of ethylene and octene-1, or ethylene, (5) Polyethylene graft copolymers octene-1, and either hexene-1, butene-1, consist of polyethylene complying with propylene, or 4-methylpentene-1 shall item 2.2 of paragraph (c) of this section contain not less than 80 weight percent which subsequently has 3a,4,7,7a- of polymer units derived from ethyl- tetrahydromethyl-4,7- ene. methanoisobenzofuran-1,3-dione graft- (ii) 4-Methylpentene-1 and 1-alkenes ed onto it at a level not to exceed 1.7 having from 6 to 18 carbon atoms. Such percent by weight of the finished co- olefin basic copolymers shall contain polymer. not less than 95 molar percent of poly- (6) Ethylene-maleic anhydride co- mer units derived from 4- polymers (CAS Reg. No. 9006–26–2) con- methylpentene-1, except that copoly- taining no more than 2 percent by mers manufactured with 1-alkenes hav- weight of copolymer units derived from ing from 12 to 18 carbon atoms shall maleic anhydride. contain not less than 97 molar percent (b) The basic olefin polymers identi- of polymer units derived from 4- fied in paragraph (a) of this section methylpentene-1; or may contain optional adjuvant sub- (iii) Ethylene and propylene that stances required in the production of may contain as modifiers not more such basic olefin polymers. The op- than 5 weight-percent of total polymer tional adjuvant substances required in units derived by copolymerization with the production of the basic olefin poly- one or more of the following monomers or finished food-contact articles mers: may include substances permitted for such use by applicable regulations in 5-Ethylidine-2-norbornene. parts 170 through 189 of this chapter, 5-Methylene-2-norbornene. substances generally recognized as safe (iv) Ethylene and propylene that may in food and food packaging, substances contain as a modifier not more than 4.5 used in accordance with a prior sanc- weight percent of total polymer units tion or approval, and the following:

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Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para- erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV-B, VI-A through 220 °C (428 °F), and the subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified in table 1 of § 176.170(c) of of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de- ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV-A, V, VII-A, and IX identified in table 1 of ‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap- as determined by ASTM Method D 611–82, ‘‘Standard Test ter. Methods for Aniline Point and Mixed Aniline Point of Petro- leum Products and Hydrocarbon Solvents,’’ both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 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.. Colorants used in accordance with § 178.3297 of this chapter. 2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene 63–7). homopolymer complying with § 177.1520(c), item 1.1 and olefin copolymers complying with § 177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the maximum concentration of tert-butyl alcohol in the polymer does not exceed 100 parts per million, as determined by a method titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 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. Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section, polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene. 14–7), and polypropylene (CAS Reg. No. 9003–07–0), resulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as determined by a method entitled, ‘‘Determination of the Total Acrylic in PP-MMA/BA Polymers,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Li- brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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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Substance Limitations

Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con- °C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin- approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I, by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of 3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap- parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi- rials,’’ both of which are incorporated by reference in accord- fied in table 1 of § 176.170(c) of this chapter and under con- ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are ditions of use D through G described in table 2 of available from the American Society for Testing and Mate- § 176.170(c) of this chapter. rials, 100 Barr Harbor Dr., West Conshohocken, Philadel- phia, PA 19428-2959, or from the Center For Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records Ad- ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin 79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev- rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de- Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi- Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H. incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 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.. Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin 68937–54–2). polymers that comply with § 177.1520(c) at levels not to exceed 0.3 percent by weight of the polymer. The finished polymer is used in contact with foods under conditions of use B through H described in table 2 of § 176.170 of this chapter. Triisopropanolamine (CAS Reg. No. 122–20–3) ...... For use as a Zeigler-Natta-type catalyst deactivator and antioxidant in the production of olefin polymers complying with § 177.1520(c), items 2.1, 2.2, and 2.3, and having a minimum density of 0.94 grams per cubic centimeter, and copolymers complying with § 177.1520(c), items 3.1 and 3.2, for use in contact with all foods under the following conditions of use: (a) films with a maximum thickness of 0.102 millimeter (0.004 inch) may be used under conditions A through H defined in table 2 of § 176.170(c) of this chapter; and (b) articles with thickness greater than 0.102 millimeter (0.004 inch) may be used under conditions C through G defined in table 2 of § 176.170(c) of this chapter. Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers. more than 6 percent.

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Substance Limitations

Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap- by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H. available from the Center for Food Safety and Applied Nutri- tion (HFS–200), Food and Drug Administration, 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.. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev- less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de- 100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi- 3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H. Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 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..

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

1.1a. Polypropylene described in para- 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C graph (a)(1)(i) of this section temperature 1.1b. Propylene homopolymer described 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C in paragraph (a)(1)(ii) of this section temperature 1.2. Polypropylene, noncrystalline; for use 0.80–0.88 only to plasticize polyethylene described under items 2.1 and 2.2 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polyethylene 1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C. only: To plasticize polypropylene described by item 1.1 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polypropylene, and further provided that such plasticized polypropylene contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV-B, VI-B, VII-B, and VIII; and for use at levels not to exceed 50 pct by weight of any mixture employed as a food- contact coating provided such coatings contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV-B, VI-B, VII-B, and VIII 2.1. Polyethylene for use in articles that con- 0.85–1.00 ...... 5.5 pct at 50 °C 11.3 pct at 25 °C tact food except for articles used for packing or holding food during cooking

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2.2. Polyethylene for use in articles used for 0.85–1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3. Polyethylene for use only as component 0.85–1.00 ...... 53 pct at 50 °C 75 pct at 25 °C of food-contact coatings at levels up to and including 50 percent by weight of any mixture employed as a food-contact coating 2.4. Olefin polymers described in paragraph (a)(2)(ii) of this section, having a melt flow index not to exceed 17 grams/per 10 minutes as determined by the method described in paragraph (d)(7) of this section, for use in blends with other polymers at levels not to exceed 20 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV-A, V, VI-C, VII-A, and IX identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.1a. Olefin copolymers described in para- 0.85–1.00 ...... 5.5 pct at 50 °C 30 pct at 25 °C graph (a)(3)(i) of this section for use in articles that contact food except for articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(a)(3) of this section and listed in item 3.1c of this table and olefin copolymers described in paragraph (a)(3)(i)(e) of this section and listed in item 3.1b of this table 3.1b. Olefin copolymers described in para- 0.9–1.00 ...... Do Do. graph (a)(3)(i)(e) of this section for use in contact with food only under conditions of use D, E, F, G, and H described in § 176.170(c) of this chapter, table 2 3.1c. Olefin copolymers described in para- Not less than 0.92 graph (a)(3)(i)(a)(3) of this section for use in contact with food only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2; except that such copolymers when used in contact with food of the types identified in § 176.170(c), table 1, under types III, IVA, V, VIIA, and IX, shall be used only under conditions of use D, E, F, and G described in § 176.170(c) of this chapter, table 2

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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(2) Melt-viscosity. (i) The perfluoro- this material at NARA, call 202–741– carbon resins identified in paragraph 6030, or go to: http://www.archives.gov/ (a)(1) of this section shall have a melt federallregister/ viscosity of not less than 104 poises at codeloflfederallregulations/ 380 °C (716 °F) as determined by ASTM ibrllocations.html. The requirements of method D1238–82, ‘‘Standard Test Meth- this paragraph do not apply to poly- od for Flow Rates of Thermoplastics by tetrafluoroethylene resin lubricant Extrusion Plastometer,’’ which is in- powders described in paragraph (c) of corporated by reference. Copies may be this section. obtained from the American Society (e) Limitations. 1 (1) Perfluorocarbon- for Testing Materials, 100 Barr Harbor molded articles having a surface area Dr., West Conshohocken, Philadelphia, of 6.45 square decimeters (100 square PA 19428-2959, or may be examined at inches) or more and at least 1.27 milli- the National Archives and Records Ad- meters (0.05 inch) thick shall be ex- ministration (NARA). For information tracted at reflux temperatures for 2 on the availability of this material at hours separately with distilled water, NARA, call 202–741–6030, or go to: http:// 50 percent ethanol, n-heptane, and www.archives.gov/federallregister/ ethyl acetate. codeloflfederallregulations/ (2) Perfluorocarbon resins identified ibrllocations.html. The melt viscosity in paragraphs (a)(1) and (2) of this sec- of the perfluorocarbon resins identified tion and intended for use as coatings or in paragraph (a)(1) of this section shall components of coatings shall meet not vary more than 50 percent within extractability limits prescribed in one-half hour at 380 °C (716 °F). paragraph (e)(3) of this section when (ii) Perfluorocarbon resins identified the resins in the form of coatings de- in paragraph (a)(2) of this section shall scribed in paragraphs (e)(2) (i) and (ii) have a melt viscosity of not less than of this section are extracted at reflux 104 poises at 372 °C (702 °F) as deter- temperatures for 2 hours separately mined by a more detailed method ti- with distilled water, 8 percent ethanol, tled ‘‘Determination of Melt Viscosity, and n-heptane: Molecular Weight Distribution Index (i) Perfluorocarbon resin coatings and Viscosity Stability,’’ which is in- based on resins identified in paragraph corporated by reference. Copies are (a)(1) of this section shall be applied to available from the Center for Food both sides of a 0.025-millimeter (0.001 Safety and Applied Nutrition (HFS– inch) thick aluminum foil to a thick- 200), Food and Drug Administration, ness of 0.025 millimeter (0.001 inch) 5100 Paint Branch Pkwy., College Park, after thermal curing at 399 °C (750 °F) MD 20740, or available for inspection at for 10 minutes. If a primer is used, the the National Archives and Records Ad- total thickness of the primer plus top- ministration (NARA). For information coat shall equal 0.025 millimeter (0.001 on the availability of this material at inch) after heat curing. NARA, call 202–741–6030, or go to: http:// (ii) Perfluorocarbon resin coatings www.archives.gov/federallregister/ based on resins identified in paragraph codeloflfederallregulations/ (a)(2) of this section shall be applied to ibrllocations.html. both sides of a 0.025-millimeter (0.001 (3) Thermal instability index. The thermal instability index of the tetra- 1 A more detailed procedure of extraction fluoroethylene homopolymer shall not conditions is entitled, ‘‘Preparation of Ex- exceed 50 as determined by ASTM tracts,’’ which is incorporated by reference. method D1457–56T, ‘‘Test for Thermal Copies are available from the Center for Instablility index of Tetrafluoro- Food Safety and Applied Nutrition (HFS– ethylene Homopolymer’’ (Revised 1956), 200), Food and Drug Administration, 5100 which is incorporated by reference. Paint Branch Pkwy., College Park, MD 20740, Copies are available from University or available for inspection at the National Microfilms International, 300 N. Zeeb Archives and Records Administration (NARA). For information on the availability Rd., Ann Arbor, MI 48106, or available of this material at NARA, call 202–741–6030, for inspection at the National Archives or go to: http://www.archives.gov/ and Records Administration (NARA). federallregister/codeloflfederallregulations/ For information on the availability of ibrllocations.html.

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

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

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

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paragraph (a)(1) and (3) of this section extractives not to exceed 0.15 percent may include substances generally rec- by weight of the resins. ognized as safe in food, substances used [42 FR 14572, Mar. 15, 1977, as amended at 46 in accordance with a prior sanction or FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, approval, and the following: 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994] List of substances Limitations

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

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(c) Polyestercarbonate resins shall ethyl alcohol in distilled water at conform to the specifications pre- reflux temperature for 6 hours, shall scribed in paragraph (c)(1) of this sec- yield total nonvolatile extractives not tion and shall meet the extractive lim- to exceed 0.005 percent by weight of the itations prescribed in paragraph (c)(2) resins. of this section. (iii) Polyestercarbonate resins, when (1) Specifications. Polyestercarbonate extracted with n-heptane at reflux resins identified in paragraph (a) of temperature for 6 hours, shall yield this section can be identified by their total nonvolatile extractives not to ex- characteristic infrared spectrum. The ceed 0.002 percent by weight of the res- resins shall comply with either or both ins. of the following specifications: (3) Residual methylene chloride levels in (i) The solution intrinsic viscosity of polyestercarbonate resins. Polyester- the polyestercarbonate resins shall be carbonate resin articles in the finished a minimum of 0.44 deciliter per gram, form shall not contain residual meth- as determined by a method entitled ylene chloride in excess of 5 parts per ‘‘Intrinsic Viscosity (IV) of Lexan ® million as determined by a method ti- Polyestercarbonate Resin by a Single tled ‘‘Analytical Method for Deter- Point Method Using Dichloromethane mination of Residual Methylene Chlo- as the Solvent,’’ developed by the Gen- ride in Polyestercarbonate Resin,’’ de- eral Electric Co., September 20, 1985, veloped by the General Electric Co., which is incorporated by reference in July 23, 1991, which is incorporated by accordance with 5 U.S.C. 552(a) and 1 reference in accordance with 5 U.S.C. CFR part 51. Copies are available from 552(a) and 1 CFR part 51. Copies are the Office of Premarket Approval, Cen- available from the Center for Food ter for Food Safety and Applied Nutri- Safety and Applied Nutrition (HFS– tion (HFS–215), Food and Drug Admin- 200), Food and Drug Administration, istration, 5100 Paint Branch Pkwy., 5100 Paint Branch Pkwy., College Park, College Park, MD 20740, or may be ex- MD 20740, or may be examined at the amined at the Center for Food Safety National Archives and Records Admin- and Applied Nutrition’s Library, Food istration (NARA). For information on and Drug Administration, 5100 Paint the availability of this material at Branch Pkwy., College Park, MD 20740, NARA, call 202–741–6030, or go to: http:// or at the National Archives and www.archives.gov/federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [57 FR 3940, Feb. 3, 1992, as amended at 64 FR federallregister/ 27178, May 19, 1999] codeloflfederallregulations/ § 177.1590 Polyester elastomers. ibrllocations.html. (ii) A minimum weight-average mo- The polyester elastomers identified lecular weight of 27,000, as determined in paragraph (a) of this section may be by gel permeation chromatography safely used as the food-contact surface using polystyrene standards. of articles intended for use in contact (2) Extractives limitations. The with bulk quantities of dry food of the polyestercarbonate resins to be tested type identified in § 176.170(c) of this shall be ground or cut into small par- chapter, table 1, under Type VIII, in ac- ticles that will pass through a U.S. cordance with the following prescribed standard sieve No. 6 and that will be conditions: held on U.S. standard sieve No. 10. (a) For the purpose of this section, (i) Polyestercarbonate resins, when polyester elastomers are those pro- extracted with distilled water at reflux duced by the ester exchange reaction temperature for 6 hours, shall yield when one or more of the following total nonvolatile extractives not to ex- phthalates—dimethyl terephthalate, ceed 0.005 percent by weight of the res- dimethyl orthophthalate, and dimethyl ins. isophthalate—is made to react with (ii) Polyestercarbonate resins, when alpha-hydroomega-hydroxypoly extracted with 50 percent (by volume) (oxytetramethylene) and/or 1,4-

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butanediol such that the finished elas- this section may contain optional adju- tomer has a number average molecular vant substances required in the produc- weight between 20,000 and 30,000. tion of basic resins or finished food- (b) Optional adjuvant substances em- contact articles. The optional adjuvant ployed in the production of the poly- substances required in the production ester elastomers or added thereto to of the basic polymer may include sub- impart desired technical or physical stances permitted for such use by ap- properties may include the following plicable regulations as set forth in part substances: 174 of this chapter. (c) Specifications and extractives limita- List of substances Limitations tions—(1) Specifications. Polyetherimide 4,4′ - Bis (alpha, alpha-di- For use only as an anti- resin identified in paragraph (a) of this methyl-benzyl) oxidant. section shall have an intrinsic vis- diphenylamine. cosity in chloroform at 25 °C (77 °F) of Tetrabutyl titanate ...... For use only as a catalyst. not less than 0.35 deciliter per gram as determined by a method titled ‘‘In- (c) An appropriate sample of the fin- trinsic Viscosity of ULTEM ished polyester elastomer in the form Polyetherimide Using Chloroform as in which it contacts food when sub- the Solvent,’’ which is incorporated by jected to ASTM method D968–81, reference. Copies are available from ‘‘Standard Test Methods for Abrasion the Center for Food Safety and Applied Resistance of Organic Coatings by the Nutrition (HFS–200), Food and Drug Falling Abrasive Tester,’’ which is in- Administration, 5100 Paint Branch corporated by reference (Copies may be Pkwy., College Park, MD 20740, or obtained from the American Society available for inspection at the National for Testing Materials, 100 Barr Harbor Archives and Records Administration Dr., West Conshohocken, Philadelphia, (NARA). For information on the avail- PA 19428-2959, or may be examined at ability of this material at NARA, call the National Archives and Records Ad- 202–741–6030, or go to: http:// ministration (NARA). For information www.archives.gov/federallregister/ on the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federallregister/ (2) Extractive limitations. Extractive codeloflfederallregulations/ limitations are applicable to the basic ibrllocations.html.), using No. 50 emery polyetherimide resin in the form of abrasive in lieu of Ottawa sand, shall molded discs of thickness 0.16 centi- exhibit an abrasion coefficient of not meter (0.063 inch). The resin discs when less than 100 liters per mil of thickness. extracted with distilled water at 121 °C [42 FR 14572, Mar. 15, 1977, as amended at 49 (250 °F) for 2 hours yield total nonvola- FR 10109, Mar. 19, 1984] tile extractives of not more than 12.3 micrograms per square centimeter. § 177.1595 Polyetherimide resin. [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. The polyetherimide resin identified 3, 1985] in this section may be safely used as an article or component of an article in- § 177.1600 Polyethylene resins, tended for use in contact with food, carboxyl modified. subject to the provisions of this sec- Carboxyl-modified polyethylene res- tion. ins may be safely used as the food-con- (a) Identity. For the purpose of this tact surface of articles intended for use section, the polyetherimide resin is 1,3- in contact with food in accordance isobenzofurandione, 5,5′[(1-methyl- with the following prescribed condi- ethylidene)bis(4,1-phenyleneoxy)] bis- tions: polymer with 1,3-benzenediamine (CAS (a) For the purpose of this section, Reg. No. 61128–46–9), and is derived from carboxyl-modified polyethylene resins the condensation reaction of m- consist of basic polymers produced phenylenediamine and bisphenol A- when ethylene-methyl acrylate basic dianhydride. copolymers, containing no more than (b) Optional adjuvants. The basic 25 weight percent of polymer units de- polymer identified in paragraph (a) of rived from methyl acrylate, are made

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

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

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polyethylene phthalate plastics does Ethylene-1,4-cyclohexylene dimethylene not exceed the amount reasonably re- terephthalate copolyesters described in quired to accomplish the intended § 177.1315(b)(3). physical or technical effect or any lim- Ethylene terephthalate polymer: Prepared by the condensation of dimethyl itations further provided. Any sub- terephthalate and ethylene glycol. stance employed in the production of Ethylene terephthalate polymer: Prepared polyethylene phthalate plastics that is by the condensation of terephthalic acid the subject of a regulation in parts 174, and ethylene glycol. 175, 176, 177, 178 and 179 of this chapter (iii) Coatings: conforms with any specification in Acrylic copolymers (CAS Reg. No. 30394–86– such regulation. 6): Prepared by reaction of ethyl acrylate (e) Substances employed in the pro- (CAS Reg. No. 140–88–5), methyl methacry- duction of polyethylene phthalate plas- late (CAS Reg. No. 80–62–6), and tics include: methacrylamide (CAS Reg. No. 79–39–0) (1) Substances generally recognized blended with melamine-formaldehyde resin as safe in food. (CAS Reg. No. 68002–20–0). For use in coat- (2) Substances subject to prior sanc- ings for polyethylene phthalate films com- tion or approval for use in poly- plying with paragraph (a) of this section.— ethylene phthalate plastics and used in Ethylene azelate-terephthalate copolymer: The copolymer, dissolved in 1,1,2-trichloro- accordance with such sanction or ap- ethane and/or methylene chloride, may be proval. used as a heat-activated sealant on poly- (3) Substances which by regulation in ethylene terephthalate film intended for parts 174, 175, 176, 177, 178 and § 179.45 of sealing polyethylene terephthalate pouch- this chapter may be safely used as es that are used as containers of either components of resinous or polymeric nonalcoholic beverages or alcoholic bev- food-contact surfaces subject to the erages containing not more than 15 percent provisions of such regulation. ethyl alcohol. The copolymer has a (4) Substances identified in this para- terephthalate/azelate molecular ratio of 1.25/1.00 and a relative viscosity of not less graph (e)(4) subject to the limitations than 1.5 as determined by a method title prescribed: ‘‘General Procedure of Determining the Relative Viscosity of Resin Polymers,’’ LIST OF SUBSTANCES AND LIMITATIONS which is incorporated by reference. Copies (i) Base sheet: are available from the Center for Food Safety and Applied Nutrition (HFS–200), Ethylene terephthalate copolymers: Pre- Food and Drug Administration, 5100 Paint pared by the condensation of dimethyl Branch Pkwy., College Park, MD 20740, or terephthalate or terephthalic acid with available for inspection, at the National ethylene glycol, modified with one or more Archives and Records Administration of the following: Azelaic acid, dimethyl (NARA). For information on the avail- azelate, dimethyl sebacate, sebacic acid. Ethylene terephthalate copolymers: Pre- ability of this material at NARA, call 202– pared by the condensation of dimethyl 741–6030, or go to: http://www.archives.gov/ terephthalate or terephthalic acid with federallregister/ ethylene glycol, modified with one or more codeloflfederallregulations/ of the following: Azelaic acid, dimethyl ibrllocations.html. Total residual copoly- azelate, dimethyl sebacate, sebacic acid, mer solvent (1,1,2-trichloroethane and/or pyromellitic dianhydride. The level of methylene chloride) shall not exceed 0.13 pyromellitic dianhydride shall not exceed milligram per square inch of film, and food 0.5 percent by weight of the finished co- contact of the film shall be limited to not polymer which may be used under condi- more than 1 square inch per 250 grams of tions of use E through H as described in beverage. table 2 of § 176.170(c) of this chapter. 2-Ethylhexyl acrylate copolymerized with Ethylene terephthalate-isophthalate copoly- one or more of the following: mers: Prepared by the condensation of Acrylonitrile. dimethyl terephthalate or terephthalic Methacrylonitrile. acid and dimethyl isophthalate or iso- Methyl acrylate. phthalic acid with ethylene glycol. The Methyl methacrylate. finished copolymers contain either: Itaconic acid. (a) 77 to 83 weight percent or Vinylidene chloride copolymerized with one (b) At least 97 weight percent of polymer or more of the following: units derived from ethylene Methacrylic acid and its methyl, ethyl, terephthalate. propyl, butyl, or octyl esters. Acrylic acid and its methyl, ethyl, propyl, (ii) Base sheet and base polymer: butyl, or octyl esters.

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

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(1) Specifications. (i) The food contact including filtration, at temperatures surface meets the specifications in not exceeding 212 °F. paragraph (f)(1) of this section; and (iii) Filtration of bulk alcoholic bev- (ii) The food contact surface when ex- erages, not exceeding 50 percent alco- posed to 50 percent ethyl alcohol at 120 hol by volume, at temperatures not ex- °F for 24 hours, yields chloroform-solu- ceeding 120 °F. ble extractives not to exceed 0.5 mg/in2 (j) Polyethylene phthalate plastics, of food contact surface exposed to the composed of ethylene terephthalate- solvent. isophthalate containing a minimum of (2) Conditions of use. The plastics are 98 weight percent of polymer units de- used for packaging, transporting, or rived from ethylene terephthalate, or holding alcoholic beverages that do not ethylene-1,4-cyclohexylene exceed 50 percent alcohol by volume. dimethylene terephthalate copoly- (h) Uncoated polyethylene phthalate esters described in § 177.1315(b)(3), con- plastics consisting of a base sheet or forming with the specifications pre- base polymer prepared as prescribed scribed in paragraph (j)(1) of this sec- from substances identified in para- tion, are used as provided in paragraph graphs (e)(4)(i) and (ii) of this section (j)(2) of this section. and conforming with the specifications (1) Specifications. (i) The food contact prescribed in paragraph (h)(1) of this surface meets the specifications in section are used as provided in para- paragraph (f)(1) of this section and graph (h)(2) of this section: (ii)(a) Containers with greater than 500 (1) Specifications. (i) The food contact mL capacity. The food-contact surface surface, when exposed to distilled when exposed to 95 percent ethanol at ° water at 250 °F for 2 hours yields chlo- 120 F for 24 hours should not yield roform-soluble extractives not to ex- chloroform-soluble extractives in ex- 2 ceed 0.02 milligram/inch 2 of food con- cess of 0.005 mg/in . tact surface exposed to the solvent; and (b) Containers with less than or equal to (ii) The food contact surface, when 500 mL capacity. The food contact sur- exposed to n-heptane at 150 °F for 2 face when exposed to 95 percent eth- ° hours, yields chloroform-soluble ex- anol at 120 F for 24 hours should not tractives not to exceed 0.02 milligram/ yield chloroform-soluble extractives in 2 inch 2 of food contact surface exposed excess of 0.05 mg/in . to the solvent. (2) Conditions of use. The plastics are (2) Conditions of use. The plastics are used for packaging, transporting, or used to contain foods during oven bak- holding alcoholic foods that do not ex- ing or oven cooking at temperatures ceed 95 percent alcohol by volume. above 250 °F. [42 FR 14572, Mar. 15, 1977, as amended at 42 (i) Polyethylene phthalate fabric, FR 18611, Apr. 8, 1977; 44 FR 40886, July 13, identified in paragraph (c) of this sec- 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, tion and conforming with the specifica- Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR tions prescribed in paragraph (i)(1) of 30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984; 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, this section, is used only as provided in 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, paragraph (i)(2) of this section. Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR (1) Specifications. Chloroform-soluble 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995; extractives shall not exceed 0.2 milli- 61 FR 46718, Sept. 5, 1996] gram/inch 2 of food-contact surface when exposed to the following solvents § 177.1632 Poly (phenyleneterephthala- at temperatures and times indicated: mide) resins. (i) Distilled water at 212 °F for 2 Poly(phenyleneterephthalamide) res- hours. ins identified in paragraph (a) of this (ii) n-Heptane at 150 °F for 2 hours. section may be safely used as articles (iii) 50 percent ethyl alcohol at 120 °F or components of articles intended for for 24 hours. repeated contact with food. (2) Conditions of use. The plastics are (a) Identity. For the purpose of this intended for: section, the poly(phenylene- (i) Dry food contact. terephthalamide) resins (CAS Reg. No. (ii) Bulk food (excluding alcoholic 26125–61–1) are produced by the polym- beverages) repeated use applications, erization of terephthalolyl chloride

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

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this section may contain optional adju- (a)(1) and (a)(2), respectively, of this vant substances required in the produc- section shall be used in contact with tion of such basic polymers. Such op- food only under conditions of use B tional adjuvant substances may in- through H set forth in table 2 of clude substances permitted for such § 176.170(c) of this chapter. use by applicable regulations in this [48 FR 31384, July 8, 1983, as amended at 54 chapter, substances generally recog- FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, nized as safe in food, substances gen- 1990] erally recognized as safe in indirect additives, and substances used in accord- § 177.1637 Poly(oxy-1,2- ance with prior sanction or approval. ethanediyloxycarbonyl-2,6- (c) Specifications. (1) Poly(p- naphthalenediylcarbonyl) resins. methylstyrene) basic polymers identi- Poly(oxy-1,2-ethanediyloxycarbonyl- fied in paragraph (a)(1) of this section 2,6-naphthalenediylcarbonyl) resins shall contain not more than 1 weight identified in paragraph (a) of this sec- percent of total residual p- tion may be safely used as articles or methystyrene monomer, as determined components of articles intended for use by a gas chromatographic method ti- in contact with food in accordance tled, ‘‘Gas Chromatographic Deter- with the following conditions: mination of PMS and PET in PPMS (a) Identity. For the purpose of this Basic Polymers,’’ which is incorporated section, poly(oxy-1,2- by reference. Copies are available from ethanediyloxycarbonyl-2,6- the Center for Food Safety and Applied naphthalenediylcarbonyl) resins (CAS Nutrition (HFS–200), Food and Drug Reg. No. 24968–11–4) are polymers Administration, 5100 Paint Branch formed by catalytic transesterification Pkwy., College Park, MD 20740, or of 2,6-dimethylnaphthalene available for inspection at the National dicarboxylate with ethylene glycol fol- Archives and Records Administration lowed by catalytic polycondensation. (NARA). For information on the avail- (b) Specifications—(1) Density. The ability of this material at NARA, call density of poly(oxy-1,2- 202–741–6030, or go to: http:// ethanediyloxycarbonyl-2,6- www.archives.gov/federallregister/ naphthalenediylcarbonyl) resins shall codeloflfederallregulations/ be between 1.33 and 1.40 grams per ibrllocations.html. cubic centimeter. (2) Rubber-modified poly(p- (2) Inherent viscosity. The finished methylstyrene) basic polymers identi- food-contact article shall have a min- fied in paragraph (a)(2) of this section imum inherent viscosity of 0.55 deci- shall contain not more than 0.5 weight liter per gram in a solution of 0.1 gram percent of total residual p- of polymer in 100 milliliters of a 25/40/ methylstyrene monomer, as deter- 35 (weight/weight/weight) solution of p- mined by the method identified in chlorophenol/tetrachloroethane/phenol. paragraph (c)(1) of this section The viscosity is determined by East- (d) Other specifications and limitations. man Chemical Co.’s method ECD-A-AC- The poly(p-methylstyrene) and rubber- G-V-1-5, ‘‘Determination of Dilute So- modified poly(p-methylstyrene) identi- lution Viscosity of Polyesters,’’ dated fied in and complying with this sec- May 31, 1988, which is incorporated by tion, when used as components of the reference in accordance with 5 U.S.C. food-contact surface of any article that 552(a) and 1 CFR part 51. Copies are is the subject of a regulation in parts available from the Office of Premarket 175, 176, 177, 178 and § 179.45 of this chap- Approval, Center for Food Safety and ter, shall comply with any specifica- Applied Nutrition (HFS–215), Food and tions and limitations prescribed by Drug Administration, 5100 Paint such regulation for the article in the Branch Pkwy., College Park, MD 20740, finished form in which it is to contact or may be examined at the Center for food. Food Safety and Applied Nutrition’s (e) Conditions of use. Poly(p- Library, Food and Drug Administra- methylstyrene) basic polymers and tion, 5100 Paint Branch Pkwy., College rubber-modified poly(p-methylstyrene) Park, MD 20740, or at the National Ar- basic polymers identified in paragraphs chives and Records Administration

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(NARA). For information on the avail- less than 75 weight percent of total ability of this material at NARA, call polymer units derived from styrene 202–741–6030, or go to: http:// monomer. www.archives.gov/federallregister/ (b) Optional adjuvants. The basic codeloflfederallregulations/ polymers identified in paragraph (a) of ibrllocations.html. this section may contain optional adju- (c) Extraction limitations. A 0.5 milli- vant substances required in the produc- meter (0.02 inch) thick sheet of resin tion of such basic polymers. Such op- when extracted with water at 121 °C tional adjuvant substances may in- (250 °F) for 2 hours shall yield total clude substances permitted for such nonvolatile extractives not exceeding use by regulations in parts 170 through 2.0 micrograms per square inch of ex- 189 of this chapter, substances gen- posed resin surface. erally recognized as safe in food, and (d) Conditions of use. The finished substances used in accordance with a food contact article shall be: prior sanction or approval. (1) Used in contact only with food of (c) Specifications. (1) Polystyrene Types I, II, IVB, VIA, VIB, VIIB, and basic polymers identified in paragraph VIII identified in table 1 of § 176.170(c) (a)(1) of this section shall contain not of this chapter, under conditions of use more than 1 weight percent of total re- A through H described in table 2 of sidual styrene monomer, as determined § 176.170(c) of this chapter; and with by the method described in paragraph food of Types III, IVA, V, VIC, VIIA, (d) of this section, except that when and IX identified in table 1 of used in contact with fatty foods of § 176.170(c) of this chapter, under condi- Types III, IV-A, V, VII-A, and IX de- tions of use C through H described in scribed in table 1 of § 176.170(c) of this table 2 of § 176.170(c) of this chapter; chapter, such polystyrene basic poly- and mers shall contain not more than 0.5 (2) Identified in a manner that will weight percent of total residual sty- differentiate the article from articles rene monomer. made of other polymeric resins to fa- (2) Rubber-modified polystyrene cilitate collection and sorting. basic polymers identified in paragraph [61 FR 14965, Apr. 4, 1996] (a)(2) of this section shall contain not more than 0.5 weight percent of total § 177.1640 Polystyrene and rubber- residual styrene monomer, as deter- modified polystyrene. mined by the method described in para- Polystyrene and rubber-modified pol- graph (d) of this section. ystyrene identified in this section may (d) Analytical method for determination be safely used as components of arti- of total residual styrene monomer con- cles intended for use in contact with tent—(1) Scope. This method is suitable food, subject to the provisions of this for the determination of residual sty- section. rene monomer in all types of styrene (a) Identity. For the purposes of this polymers. section, polystyrene and rubber-modi- (2) Principle. The sample is dissolved fied polystyrene are basic polymers in methylene chloride. An aliquot of manufactured as described in this para- the solution is injected into a gas chro- graph so as to meet the specifications matograph. The amount of styrene prescribed in paragraph (c) of this sec- monomer present is determined from tion when tested by the method de- the area of the resulting peak. scribed in paragraph (d) of this section. (3) Apparatus—(i) Gas chromatograph. (1) Polystyrene consists of basic poly- Beckman GC-2A gas chromatograph mers produced by the polymerization with hydrogen flame detector or appa- of styrene. ratus of equivalent sensitivity. (2) Rubber-modified polystyrene con- (ii) Chromatograph column. One-quar- sists of basic polymers produced by ter inch outside diameter stainless combining styrene-butadiene copoly- steel tubing (0.028 inch wall thickness), mers and/or polybutadiene with poly- 4 feet in length, packed with 20 percent styrene, either during or after polym- polyethylene glycol (20,000 molecular erization of the polystyrene, such that weight) on alkaline treated 60–80 mesh the finished basic polymers contain not firebrick.

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

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List of substances Limitations lecular weight of 15,000, as determined by osmotic pressure in Sodium dibutyl naphthalene Wetting agent. sulfonate. monochlorobenzene; or Sodium hydrosulfide. (2) 1,1′-Sulfonylbis[4-chlorobenzene] Sodium polysulfide. polymer with 4,4′-(1- b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent. ether. methylethylidene)bis[phenol] (min- Titanium dioxide. imum 92 percent) and 4,4′- Toluene ...... Solvent. sulfonylbis[phenol] (maximum 8 per- Trichloroethane ...... Cross-linking agent. 1,2,3-Trichloropropane ...... Do. cent) (CAS Reg. No. 88285–91–0) pro- Urea-formaldehyde resins. duced when a mixture of 4,4′- Xylene ...... Solvent. isopropylidenediphenol (minimum 92 ′ (b) The resins are used as the food- percent) and 4,4 -sulfonylbis[phenol] contact surface for dry food. (maximum 8 percent) is made to react ′ (c) An appropriate sample of the fin- with 4,4 -dichlorodiphenyl sulfone in ished resin in the form in which it con- such a way that the finished resin has tacts food, when subjected to ASTM a minimum number average molecular method D968–81, ‘‘Standard Test Meth- weight of 26,000, as determined by os- ods for Abrasion Resistance of Organic motic pressure in dimethylformamide. Coatings by the Falling Abrasive Test- (b) The basic polysulfone resins iden- er,’’ which is incorporated by reference tified in paragraph (a) of this section (Copies may be obtained from the may contain optional adjuvant sub- American Society for Testing Mate- stances required in the production of rials, 100 Barr Harbor Dr., West such basic resins. The optional adju- Conshohocken, Philadelphia, PA 19428- vant substances required in the produc- 2959, or may be examined at the Na- tion of the basic polysulfone resins tional Archives and Records Adminis- may include substances described in tration (NARA). For information on § 174.5(d) of this chapter and the fol- the availability of this material at lowing: NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ List of substances Limitations codeloflfederallregulations/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as ibrllocations.html.), using No. 50 Emery residual solvent in finished basic abrasive in lieu of Ottawa sand, shall resin in paragraph (a)(1) of this exhibit and abrasion coefficient of not section. Monochlorobenzene .. Not to exceed 500 parts per million less than 20 liters per mil of film thick- as residual solvent in finished ness. basic resin in paragraph (a)(1) of this section. [42 FR 14572, Mar. 15, 1977, as amended at 49 N-methyl-2- Not to exceed 0.01 percent (100 FR 10110, Mar. 19, 1984] pyrrolidone. parts per million) as residual solvent in finished basic resin in para- § 177.1655 Polysulfone resins. graph (a)(2) of this section. Polysulfone resins identified in paragraph (a) of this section may be safely (c) Polysulfone resins, when ex- used as articles or components of arti- tracted at reflux temperatures for 6 cles intended for use in contact with hours with the solvents—distilled food, in accordance with the following water, 50 percent (by volume) ethyl al- prescribed conditions: cohol in distilled water, 3 percent ace- (a) For the purpose of this section, tic acid in distilled water, and n- polysulfone resins are: heptane, yield total extractives in each (1) Poly(oxy-p-phenylenesulfonyl-p- extracting solvent not to exceed 0.0078 phenyleneoxy-p- milligram per square centimeter (0.05 phenyleneisopropylidene-p-phenylene) milligram per square inch) of resin sur- resins (CAS Reg. No. 25154–01–2) con- face. Note: In testing the finished sisting of basic resins produced when polysulfone resins, use a separate resin the disodium salt of 4,4′- test sample for each required extract- isopropylidenediphenol is made to ing solvent. react with 4,4′-dichlorodiphenyl sulfone (d) Polysulfone resins intended for re- in such a way that the finished resins peated use in contact with food may be have a minimum number average mo- used under conditions of use A through

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

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

List of substances Limitations

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

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List of substances Limitations

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

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

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

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

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

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

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Barr Harbor Dr., West Conshohocken, (3) Maximum extractable fractions in Philadelphia, PA 19428-2959, or avail- distilled water and 50 percent ethanol and able for inspection at the National Ar- the maximum net residue solubles in chlo- chives and Records Administration roform. The maximum extractable frac- (NARA). For information on the avail- tions in distilled water and 50 percent ability of this material at NARA, call ethanol, and the maximum net residue 202–741–6030, or go to: http:// solubles in chloroform, shall be deter- www.archives.gov/federallregister/ mined in accordance with § 176.170(d)(3) codeloflfederallregulations/ of this chapter using a sandwich form ibrllocations.html.) modified by using a of the finished copolymer of the speci- forced resonant vibration instead of a fied thickness and for the time and fixed vibration and by using fre- temperature specified in paragraph (b) quencies of 25 to 40 cycles per second of this section. instead of 0.1 to 10 cycles per second. (d) The provisions of this section are (ii) Direct reading viscoelastometric not applicable to butadiene-styrene co- method titled ‘‘Direct Reading Viscoelastrometric Method for Deter- polymers listed in other sections of mining Glass Transition Points of Sty- this subpart. rene Block Polymers’’ (which is incor- (e) The provisions of this section are porated by reference; copies are avail- not applicable to styrene block poly- able from the Center for Food Safety mers with 1,3-butadiene listed in and Applied Nutrition (HFS–200), Food § 175.105 of this chapter. and Drug Administration, 5100 Paint [42 FR 14572, Mar. 15, 1977, as amended at 42 Branch Pkwy., College Park, MD 20740, FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, or available for inspection at the Na- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, tional Archives and Records Adminis- June 12, 1989; 58 FR 65546, Dec. 15, 1993] tration (NARA). For information on the availability of this material at § 177.1820 Styrene-maleic anhydride NARA, call 202–741–6030, or go to: http:// copolymers. www.archives.gov/federallregister/ Styrene-maleic anhydride copoly- codeloflfederallregulations/ mers identified in paragraph (a) of this ibrllocations.html.), by which the glass section may be safely used as articles transition points are determined in the or components of articles intended for tensile mode of deformation at a fre- use in contact with food, subject to quency of 35 hertz using a Rheovibron provisions of this section. Model DDV-II (or equivalent) Direct Reading Viscoelastometer. Take maxi- (a) For the purpose of this section, ma in the out-of-phase component of styrene-maleic anhydride copolymers the complex modulus as the glass tran- are those produced by the polymeriza- sition points. For block polymers of tion of styrene and maleic anhydride so low styrene content or for simple block that the finished polymers meet the polymers, the polymer may be treated specifications prescribed in paragraph with 0.3 part per hundred dicumyl per- (b) of this section, when tested by the oxide and cured for 30 minutes at 153 °C methods described in paragraph (c) of to accentuate the upper transition this section. point. (b) Specifications:

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

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

(c) The analytical methods for deter- codeloflfederallregulations/ mining conformance with specifica- ibrllocations.html. tions for styrene-maleic anhydride co- (d) The provisions of this section are polymers prescribed in this section are not applicable to styrene-maleic anhy- as follows: dride copolymers listed in other sec- (1) Molecular weight. Molecular tions of this subpart. weight shall be determined by membrane osmometry. [42 FR 14572, Mar. 15, 1977, as amended at 47 (2) Residual styrene monomer content. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, Residual styrene monomer content 1982; 54 FR 24898, June 12, 1989] shall be determined by the method de- § 177.1830 Styrene-methyl methacry- scribed in § 177.1640(d). late copolymers. (3) Residual maleic anhydride monomer content. Residual maleic anhydride Styrene-methyl methacrylate comonomer content shall be determined polymers identified in this section may by a gas chromatographic method ti- be safely used as components of plastic tled ‘‘Determination of Residual Ma- articles intended for use in contact leic Anhydride in Polymers by Gas with food, subject to the provisions of Chromatography,’’ which is incor- this section. porated by reference. Copies are avail- (a) For the purpose of this section, able from the Center for Food Safety styrene-methyl methacrylate copoly- and Applied Nutrition (HFS–200), Food mers consist of basic copolymers pro- and Drug Administration, 5100 Paint duced by the copolymerization of sty- Branch Pkwy., College Park, MD 20740, rene and methyl methacrylate such or available for inspection at the Na- that the finished basic copolymers con- tional Archives and Records Adminis- tain more than 50 weight percent of tration (NARA). For information on polymer units derived from styrene. the availability of this material at (b) The finished plastic food-contact NARA, call 202–741–6030, or go to: http:// article, when extracted with the sol- www.archives.gov/federallregister/ vent or solvents characterizing the

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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(f) The provisions of this section are (2) The weight average molecular not applicable to vinyl chloride-pro- weight of the copolymer is not less pylene copolymers used in food-pack- than 50,000 when determined by gel per- aging adhesives complying with meation chromatography using tetra- § 175.105 of this chapter. hydrofuran as the solvent. The gel permeation chromatograph is calibrated [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984] with polystyrene standards. The basic gel permeation chromatographic meth- § 177.1990 Vinylidene chloride/methyl od is described in ANSI/ASTM D3536–76, acrylate copolymers. ‘‘Standard Test Method for Molecular The vinylidene chloride/methyl acry- Weight Averages and Molecular Weight late copolymers (CAS Reg. No. 25038– Distribution of Polystyrene by Liquid 72–6) identified in paragraph (a) of this Exclusion Chromatography (Gel Per- section may be safely used as an article meation Chromatography-GPC),’’ or as a component of an article in- which is incorporated by reference. tended for use in contact with food sub- Copies are available from University ject to the provisions of this section. Microfilms International, 300 North Zeeb Rd., Ann Arbor, MI 48106, or avail- (a) Identity. For the purposes of this section vinylidene chloride/methyl ac- able for inspection at the National Ar- rylate copolymers consist of basic co- chives and Records Administration polymers produced by the copolym- (NARA). For information on the avail- erization of vinylidene chloride and ability of this material at NARA, call methyl acrylate such that the copoly- 202–741–6030, or go to: http:// mers contain not more than 15 weight- www.archives.gov/federallregister/ percent of polymer units derived from codeloflfederallregulations/ methyl acrylate. ibrllocations.html. (b) Optional adjuvant substances. The (3) Residual vinylidene chloride and basic vinylidene chloride/methyl acry- residual methyl acrylate in the copoly- late copolymers identified in paragraph mer in the form in which it will con- (a) of this section may contain optional tact food (unsupported film, barrier adjuvant substances required in the layer, or as a copolymer for blending) production of such basic copolymers. will not exceed 10 parts per million and These optional adjuvant substances 5 parts per million, respectively, as de- may include substances permitted for termined by either a gas such use by regulations in parts 170 chromatographic method titled ‘‘De- through 179 of this chapter, substances termination of Residual Vinylidene generally recognized as safe in food, Chloride and Methyl Acrylate in Vinyl- and substances used in accordance with idene Chloride/Methyl Acrylate Co- a prior sanction or approval. polymer Resins and Films,’’ or, alter- (c) Specifications. (1) The methyl acry- natively, ‘‘Residual Methyl Acrylate late content is determined by an infra- and Vinylidene Chloride Monomers in red spectrophotometric method titled Saran MA/VDC Resins and Pellets by ‘‘Determination of Copolymer Ratio in Headspace Gas Chromatography,’’ Vinylidene Chloride/Methyl Acrylate dated March 3, 1986, which are incor- Copolymers,’’ which is incorporated by porated by reference in accordance reference. Copies are available from with 5 U.S.C. 552(a). Copies are avail- the Center for Food Safety and Applied able from the Center for Food Safety Nutrition (HFS–200), Food and Drug and Applied Nutrition (HFS–200), Food Administration, 5100 Paint Branch and Drug Administration, 5100 Paint Pkwy., College Park, MD 20740, or Branch Pkwy., College Park, MD 20740, available for inspection at the National or available for inspection at the Na- Archives and Records Administration tional Archives and Records Adminis- (NARA). For information on the avail- tration (NARA). For information on ability of this material at NARA, call the availability of this material at 202–741–6030, or go to: http:// NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ www.archives.gov/federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html.

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

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2959, or available for inspection at the Methods for the specifications in this National Archives and Records Admin- paragraph (b), titled ‘‘Chlorine and istration (NARA). For information on Bromine—Coulometric Titration Meth- the availability of this material at od by Aminco Chloridometer,’’ NARA, call 202–741–6030, or go to: http:// ‘‘Hypolon ® Synthetic Rubber—Deter- www.archives.gov/federallregister/ mination of Sulfur by Parr Bomb,’’ and codeloflfederallregulations/ ASTM method D2857–70 (Reapproved ibrllocations.html. 1977), ‘‘Standard Test Method for Di- (3) The basic polymer or food-contact lute Solution Viscosity of Polymers,’’ article described in paragraph (a) of are incorporated by reference. Copies this section, when extracted with the of the ASTM method may be obtained solvent or solvents characterizing the from the American Society for Testing type of food and under the conditions Materials, 100 Barr Harbor Dr., West of time and temperature characterizing Conshohocken, Philadelphia, PA 19428- the conditions of its intended use as de- 2959. Copies of the other two methods termined from tables 1 and 2 of are available from the Center for Food § 176.170(c) of this chapter, yields net Safety and Applied Nutrition (HFS– chloroform-soluble extractives in each 200), Food and Drug Administration, extracting solvent not to exceed .08 5100 Paint Branch Pkwy., College Park, milligram per square centimeter (0.5 MD 20740. Copies of all three methods milligram per square inch) of food-con- may be examined at the National Ar- tact surface when tested by the meth- chives and Records Administration ods described in § 176.170(d). If the fin- (NARA). For information on the avail- ished food-contact article is itself the ability of this material at NARA, call subject of a regulation in parts 174 202–741–6030, or go to: http:// through 178 and § 179.45 of this chapter, www.archives.gov/federallregister/ it shall also comply with any specifica- codeloflfederallregulations/ tions and limitations prescribed for it ibrllocations.html. by the regulation. (c) The additive is used as the article, or a component of articles, intended for [49 FR 29578, July 23, 1984] use as liners and covers for reservoirs intended for the storage of water for Subpart C—Substances for Use drinking purposes. Only as Components of Arti- (d) Substances permitted by § 177.2600 cles Intended for Repeated may be employed in the preparation of Use ethylene polymers, chlorosulfonated, subject to any limitations prescribed § 177.2210 Ethylene polymer, chloro- therein. sulfonated. (e) The finished ethylene copolymers, Ethylene polymer, chlorosulfonated chlorosulfonated shall conform to as identified in this section may be § 177.2600(e) and (g). safely used as an article or component [42 FR 14572, Mar. 15, 1977, as amended at 49 of articles intended for use in contact FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, with food, subject to the provisions of 1989] this section. (a) Ethylene polymer, chloro- § 177.2250 Filters, microporous poly- sulfonated is produced by chloro- meric. sulfonation of a carbon tetrachloride Microporous polymeric filters identi- solution of polyethylene with chlorine fied in paragraph (a) of this section and sulfuryl chloride. may be safely used, subject to the pro- (b) Ethylene polymer, chloro- visions of this section, to remove par- sulfonated shall meet the following ticles of insoluble matter in producing, specifications: manufacturing, processing, and pre- (1) Chlorine not to exceed 25 percent paring bulk quantities of liquid food. by weight. (a) Microporous polymeric filters (2) Sulfur not to exceed 1.15 percent consist of a suitably permeable, contin- by weight. uous, polymeric matrix of polyvinyl (3) Molecular weight is in the range chloride, vinyl chloride-propylene, or of 95,000 to 125,000. vinyl chloride-vinyl acetate, in which

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

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

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

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

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subject to any limitations prescribed (2) Fluoride extractives calculated as therein. fluorine not to exceed 0.47 milligram (4) Substances identified in this para- per square decimeter (0.03 milligram graph (b)(4) subject to such limitations per square inch). as are provided: (e) Conditions of use. In accordance with current good manufacturing prac- Substances Limitations tice, finished food contact articles con- Carbon black (channel proc- Not to exceed 15 parts per taining the perfluorocarbon cured ess of furnace combustion 100 parts of the elastomers shall be thoroughly cleaned process) (CAS Reg. No. terpolymer. 1333–86–4). prior to their first use in contact with Magnesium oxide (CAS Reg. Not to exceed 5 parts per food. No. 1309–48–4). 100 parts of the terpolymer. [49 FR 43050, Oct. 26, 1984]

(c) Specifications—(1) Infrared identi- § 177.2410 Phenolic resins in molded fication. Perfluorocarbon cured articles. elastomers may be identified by the Phenolic resins identified in this sec- characteristic infrared spectra of the tion may be safely used as the food- pyrolysate breakdown product that is contact surface of molded articles in- obtained by heating and decomposing tended for repeated use in contact with the elastomer using the method enti- nonacid food (pH above 5.0), in accord- tled ‘‘Qualitative Identification of ance with the following prescribed con- Kalrez ® by Infrared Examination of ditions: Pyrolysate.’’ This method is incor- (a) For the purpose of this section, porated by reference. Copies of the the phenolic resins are those produced method are available from the Center when one or more of the phenols listed for Food Safety and Applied Nutrition in paragraph (a)(1) of this section are (HFS–200), Food and Drug Administra- made to react with one or more of the tion, 5100 Paint Branch Pkwy., College aldehydes listed in paragraph (a)(2) of Park, MD 20740, or available for inspec- this section, with or without aniline tion at the National Archives and and/or anhydro-formaldehyde aniline Records Administration (NARA). For (hexahydro-1, 3,5-triphenyl-s-triazine): information on the availability of this (1) Phenols: material at NARA, call 202–741–6030, or p-tert-Amylphenol. go to: http://www.archives.gov/ p-tert-Butylphenol. federallregister/ o-, m-, and p-Cresol. codeloflfederallregulations/ p-Octylphenol. ibrllocations.html. Phenol. (2) Thermogravimetry. Perfluorocarbon o- and p-Phenylethylphenol mixture pro- cured elastomers have a major decom- duced when phenol is made to react with position peak occurring at 490 ° ±15 °C styrene in the presence of sulfuric acid cat- (914 °F). Less than 1.5 percent of the alyst. elastomers will volatilize below 400 °C (2) Aldehydes: (752 °F) when run under nitrogen at a 10 ° ° Acetaldehyde. C or 18 F per minute heating rate Formaldehyde. using a Du Pont Thermal Analyzer Paraldehyde. Model 1099 with Model 951 TGA unit or the equivalent. (b) Optional adjuvant substances em- (d) Extractive limitations. Articles fab- ployed in the production of the phe- ricated from perfluorocarbon cured nolic resins or added thereto to impart elastomers having a thickness of at desired technical or physical properties least 1.0 millimeter (0.039 inch) when include the following: extracted at reflux temperatures for 2 Asbestos fiber. hours separately with distilled water, Barium hydroxide ...... For use as catalyst. 50 percent ethanol, and n-heptane, Calcium stearate ...... For use as lubricant. Carbon black (channel proc- shall meet the following extractability ess). limits: Diatomaceous earth. (1) Total extractives not to exceed 3.1 Glass fiber. Hexamethylenetetramine ...... For use as curing agent. milligrams per square decimeter (0.2 Mica. milligrams per square inch). Oxalic acid ...... For use as catalyst.

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Zinc stearate ...... For use as lubricant. Substance Limitations

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

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

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

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

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

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

(c) The cross-linked polyester resins, ins shall be thoroughly cleansed prior with or without the optional sub- to their first use in contact with food. stances described in paragraph (b) of this section, and in the finished form in § 177.2440 Polyethersulfone resins. which they are to contact food, when Polyethersulfone resins identified in extracted with the solvent or solvents paragraph (a) of this section may be characterizing the type of food and safely used as articles or components under the conditions of time and tem- of articles intended for repeated use in perature characterizing the conditions contact with food in accordance with of their intended use, as determined the following prescribed conditions: from tables 1 and 2 of § 176.170(c) of this (a) For the purpose of this section, chapter, shall meet the following ex- polyethersulfone resins are: tractives limitations: (1) Poly(oxy-p-phenylenesulfonyl-p- (1) Net chloroform-soluble extrac- phenylene) resins (CAS Reg. No. 25667– tives not to exceed 0.1 milligram per 42–9), which have a minimum number square inch of food-contact surface average molecular weight of 16,000. tested when the prescribed food-simu- (2) 1,1′-sulfonylbis[4-chlorobenzene] lating solvent is water or 8 or 50 per- polymer with 4,4′-(1-methylethyl- cent alcohol. idene)bis[phenol] (maximum 8 percent) (2) Total nonvolatile extractives not and 4,4′-sulfonylbis[phenol] (minimum to exceed 0.1 milligram per square inch 92 percent) (CAS Reg. No. 88285–91–0), of food-contact surface tested when the which have a minimum number aver- prescribed food-simulating solvent is age molecular weight of 26,000. heptane. (3) In paragraphs (a)(1) and (a)(2) of (d) In accordance with good manufac- this section, the minimum number av- turing practice, finished articles con- erage molecular weight is determined taining the cross-linked polyester res- by reduced viscosity in dimethyl form- ins shall be thoroughly cleansed prior amide in accordance with ASTM meth- to their first use in contact with food. od D2857–70 (Reapproved 1977), ‘‘Stand- ard Test Method for Dilute Solution [42 FR 14572, Mar. 15, 1977, as amended at 48 Viscosity of Polymers,’’ which is incor- FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, porated by reference. Copies may be 1989] obtained from the American Society for Testing Materials, 100 Barr Harbor § 177.2430 Polyether resins, Dr., West Conshohocken, Philadelphia, chlorinated. PA 19428-2959, or may be examined at Chlorinated polyether resins may be the Division of Petition Control (HFS– safely used as articles or components 215), Center for Food Safety and Ap- of articles intended for repeated use in plied Nutrition, 1110 Vermont Ave. producing, manufacturing, packing, NW., suite 1200, Washington, DC, or at processing, preparing, treating, pack- the National Archives and Records Ad- aging, transporting, or holding food, in ministration (NARA). For information accordance with the following pre- on the availability of this material at scribed conditions: NARA, call 202–741–6030, or go to: http:// (a) The chlorinated polyether resins www.archives.gov/federallregister/ are produced by the catalytic polym- codeloflfederallregulations/ erization of 3,3-bis(chloromethyl)- ibrllocations.html. oxetane, and shall contain not more (b) The basic resins identified in than 2 percent residual monomer. paragraphs (a)(1) and (a)(2) of this sec- (b) In accordance with good manufac- tion may contain optional adjuvant turing practice, finished articles con- substances described in § 174.5(d) of this taining the chlorinated polyether res- chapter and the following:

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List of substances Limitations tent of not less than 7.8 weight percent and not more than 8.2 weight percent. Diphenylsulfone ...... Not to exceed 0.2 percent as residual solvent in the finished Polyamide-imide resins identified in basic resin described in para- paragraph (a)(2) of this section shall graph (a)(1) of this section. have a nitrogen content of not less Dimethyl sulfoxide ...... Not to exceed 0.01 percent as residual solvent in the finished than 7.5 weight percent and not more basic resin described in para- than 7.8 weight percent. Nitrogen con- graph (a)(1) of this section. tent is determined by the Dumas Nitro- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as residual solvent in the finished gen Determination as set forth in the basic resin described in para- ‘‘Official Methods of Analysis of the graph (a)(2) of this section. Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections (c) The finished food-contact article, 7.016–7.020, which is incorporated by when extracted at reflux temperatures for 2 hours with the following four sol- reference in accordance with 5 U.S.C. vents, yields net chloroform-soluble ex- 552(a). Copies may be obtained from the tractives in each extracting solvent AOAC INTERNATIONAL, 481 North not to exceed 0.02 milligram per square Frederick Ave., suite 500, Gaithersburg, inch of food-contact surface: distilled MD 20877, or may be examined at the water, 50 percent (by volume) ethyl al- National Archives and Records Admin- cohol in distilled water, 3 percent ace- istration (NARA). For information on tic acid in distilled water, and n- the availability of this material at heptane. (Note: In testing the finished NARA, call 202–741–6030, or go to: http:// food-contact article, use a separate www.archives.gov/federallregister/ test sample for each required extract- codeloflfederallregulations/ ing solvent.) ibrllocations.html. (d) In accordance with good manufac- (2) Polyamide-imide resins identified turing practice, finished food-contact in paragraph (a)(1) of this section shall articles containing the have a solution viscosity of not less polyethersulfone resins shall be thor- than 1.200. Polyamide-imide resins oughly cleansed before their first use identified in paragraph (a)(2) of this in contact with food. section shall have a solution viscosity [44 FR 34493, June 15, 1979, as amended at 47 of not less than 1.190. Solution vis- FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, cosity shall be determined by a method 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, titled ‘‘Solution Viscosity’’ which is in- Sept. 20, 1995] corporated by reference in accordance with 5 U.S.C. 552(a). Copies are avail- § 177.2450 Polyamide-imide resins. able from the Center for Food Safety Polyamide-imide resins identified in and Applied Nutrition (HFS–200), Food paragraph (a) of this section may be and Drug Administration, 5100 Paint safely used as components of articles Branch Pkwy., College Park, MD 20740, intended for repeated use in contact or available for inspection at the Na- with food, in accordance with the fol- tional Archives and Records Adminis- lowing prescribed conditions: tration (NARA). For information on (a) Identity. (1) For the purpose of the availability of this material at this section the polyamide-imide resins NARA, call 202–741–6030, or go to: are derived from the condensation re- http:// action of substantially equimolar parts www.archives.gov/federallregister/ of trimellitic anhydride and p,p′- codeloflfederallregulations/ diphenylmethane diisocyanate. ibrllocations.html. (2) The polyamide-imide resins (CAS (3) The polyamide-imide resins iden- Reg. No. 31957–38–7) derived from the tified in paragraph (a)(1) of this section condensation reaction of equimolar are heat cured at 600 °F for 15 minutes parts of benzoyl chloride-3,4- when prepared for extraction tests and dicarboxylic anhydride and 4,4′- the residual monomers: p,p- diphenylmethanediamine. diphenylmethane diisocyanate should (b) Specifications. (1) Polyamide-imide not be present at greater than 100 parts resins identified in paragraph (a)(1) of per million and trimellitic anhydride this section shall have a nitrogen con- should not be present at greater than

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500 parts per million. Residual mono- cleansed prior to their first use in con- mers are determined by gas chroma- tact with food. tography (the gas chromatography [42 FR 14572, Mar. 15, 1977, as amended at 47 method titled ‘‘Amide-Imide Polymer FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, Analysis—Analysis of Monomer Con- 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, tent,’’ is incorporated by reference in Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR accordance with 5 U.S.C. 552(a). Copies 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] are available from the Center for Food § 177.2460 Poly(2,6-dimethyl-1,4-phen- Safety and Applied Nutrition (HFS– ylene) oxide resins. 200), Food and Drug Administration, The poly(2,6-dimethyl-1,4-phenylene) 5100 Paint Branch Pkwy., College Park, oxide resins identified in paragraph (a) MD 20740, or available for inspection at of this section may be used as an arti- the National Archives and Records Ad- cle or as a component of an article in- ministration (NARA). For information tended for use in contact with food sub- on the availability of this material at ject to the provisions of this section. NARA, call 202–741–6030, or go to: http:// (a) Identity. For the purposes of this www.archives.gov/federallregister/ section, poly(2,6-dimethyl-1,4-phen- codeloflfederallregulations/ ylene) oxide resins consist of basic res- ibrllocations.html.). ins produced by the oxidative coupling (c) Extractive limitations are appli- of 2,6-xylenol such that the finished cable to the polyamide-imide resins basic resins meet the specifications identified in paragraphs (a) (1) and (2) and extractives limitations prescribed of this section in the form of films of 1 in paragraph (c) of this section. mil uniform thickness after coating (b) Optional adjuvant substances. The and heat curing at 600 °F for 15 minutes basic poly(2,6-dimethyl-1,4-phenylene) on stainless steel plates, each having oxide resins identified in paragraph (a) such resin-coated surface area of 100 of this section may contain optional square inches. The cured-resin film adjuvant substances required in the coatings shall be extracted in accord- production of such basic resins. The op- ance with the method described in tional adjuvant substances required in the production of the basic poly(2,6-di- § 176.170(d)(3) of this chapter, using a methyl-1,4-phenylene) oxide resins may plurality of spaced, coated stainless include substances permitted for such steel plates, exposed to the respective use by regulations in parts 170 through food simulating solvents. The resin 189 of this chapter, substances gen- shall meet the following extractive erally recognized as safe in food, sub- limitations under the corresponding stances used in accordance with a prior extraction conditions: sanction or approval, and the fol- (1) Distilled water at 250 °F for 2 lowing: hours: Not to exceed 0.01 milligram per Limitations (expressed as square inch. List of substances percent by weight of finished (2) Three percent acetic acid at 212 °F basic resin) for 2 hours: Not to exceed 0.05 milli- Diethylamine ...... Not to exceed 0.16 percent gram per square inch. as residual catalyst. (3) Fifty percent ethyl alcohol at 160 Methyl alcohol ...... Not to exceed 0.02 percent as residual solvent. °F for 2 hours: Not to exceed 0.03 milli- Toluene ...... Not to exceed 0.2 percent as gram per square inch. residual solvent. (4) n-Heptane at 150 °F for 2 hours: Not to exceed 0.05 milligram per square (c) Specifications and extractives limita- inch. tions. The poly(2,6-dimethyl-1,4-phenylene) oxide basic resins meet the fol- (d) In accordance with good manufac- lowing: turing practice, those food contact ar- (1) Specifications. Intrinsic viscosity ticles, having as components the poly- is not less than 0.30 deciliter per gram amide-imide resins identified in para- as determined by ASTM method D1243– graph (a) of this section and intended 79, ‘‘Standard Test Method for Dilute for repeated use shall be thoroughly Solution Viscosity of Vinyl Chloride Polymers,’’ which is incorporated by

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

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§ 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec- mer. ular weight of the copolymer is 15,000 Polyoxymethylene copolymer identi- as determined by a method titled fied in this section may be safely used ‘‘Number Average Molecular Weight,’’ as an article or component of articles which is incorporated by reference. intended for food-contact use in ac- Copies are available from the Center cordance with the following prescribed for Food Safety and Applied Nutrition conditions: (HFS–200), Food and Drug Administra- (a) Identity. For the purpose of this tion, 5100 Paint Branch Pkwy., College section, polyoxymethylene copolymers Park, MD 20740, or available for inspec- are identified as the following: The re- tion at the National Archives and action product of trioxane (cyclic Records Administration (NARA). For trimer of formaldehyde) and ethylene information on the availability of this oxide (CAS Reg. No. 24969–25–3) or the material at NARA, call 202–741–6030, or reaction product of trioxane (cyclic go to: http://www.archives.gov/ trimer of formaldehyde) and a max- federallregister/ imum of 5 percent by weight of codeloflfederallregulations/ butanediol formal (CAS Reg. No. 25214 ibrllocations.html. 85–1). Both copolymers may have cer- (d) Extractive limitations. (1) Polyoxy- tain optional substances added to impart desired technological properties to methylene copolymer in the finished the copolymer. form in which it is to contact food, (b) Optional adjuvant substances. The when extracted with the solvent or sol- polyoxymethylene copolymer identi- vents characterizing the type of food fied in paragraph (a) of this section and under conditions of time and tem- may contain optional adjuvant sub- perature as determined from tables 1 stances required in its production. The and 2 of § 175.300(d) of this chapter, quantity of any optional adjuvant sub- shall yield net chloroform-soluble ex- stance employed in the production of tractives not to exceed 0.5 milligram the copolymer does not exceed the per square inch of food-contact surface. amount reasonably required to accom- (2) Polyoxymethylene copolymer plish the intended technical or physical with or without the optional sub- effect. Such adjuvants may include stances described in paragraph (b) of substances generally recognized as safe this section, when ground or cut into in food, substances used in accordance particles that pass through a U.S.A. with prior sanction, substances per- Standard Sieve No. 6 and that are re- mitted under applicable regulations in tained on a U.S.A. Standard Sieve No. parts 170 through 189 of this chapter, 10, shall yield total extractives as fol- and the following: lows: (1) Stabilizers (total amount of stabi- (i) Not to exceed 0.20 percent by lizers not to exceed 2.0 percent and amount of any one stabilizer not to ex- weight of the copolymer when exceed 1.0 percent of polymer by weight) tracted for 6 hours with distilled water at reflux temperature. Calcium ricinoleate. (ii) Not to exceed 0.15 percent by Cyanoguanidine. Hexamethylene bis(3,5-di-tert-butyl-4- weight of the copolymer when ex- hydroxyhydrocinnamate) (CAS Reg. No. tracted for 6 hours with n-heptane at 35074–77–2). reflux temperature. Melamine-formaldehyde resin. (e) Conditions of use. (1) The 2,2′-Methylenebis(4-methyl-6-tert-butyl- polyoxymethylene copolymer is for use phenol). as articles or components of articles Nylon 6/66, weight ratio 2/3. Tetrakis [methylene (3,5-di-tert-butyl-4- intended for repeated use. hydroxyhydrocinnamate)] methane. (2) Use temperature shall not exceed 250 °F. (2) Lubricant: N,N′Distearoylethyl- enediamine. (3) In accordance with good manufac- (c) Specifications. (1) Polyoxymeth- turing practice, finished articles con- ylene copolymer can be identified by taining polyoxymethylene copolymer its characteristic infrared spectrum.

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

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the finished form which is to contact cleansed prior to first use in contact food, when extracted with the solvent with food. or solvents characterizing the type of [42 FR 14572, Mar. 15, 1977, as amended at 43 food and under conditions of time and FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, temperature characterizing the condi- 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, tions of intended use under paragraphs Mar. 19, 1984; 54 FR 24898, June 12, 1989] (c)(3) and (d) of § 175.300 of this chapter and as limited by paragraph (e) of this § 177.2490 Polyphenylene sulfide resins. section, shall yield net chloroform- soluble extractives not to exceed 0.5 Polyphenylene sulfide resins milligram per square inch of food-con- (poly(1,4-phenylene sulfide) resins) may tact surface. be safely used as coatings or components of coatings of articles intended (2) Polyoxymethylene homopolymer, for repeated use in contact with food, with or without the optional adjuvant in accordance with the following pre- substances described in paragraph (b) scribed conditions. of this section, when ground or cut into (a) Polyphenylene sulfide resins con- particles that pass through a U.S.A. sist of basic resins produced by the re- Standard Sieve No. 6 and that are reaction of equimolar parts of p- tained on a U.S.A. Standard Sieve No. dichlorobenzene and sodium sulfide, 10, shall yield extractives as follows: such that the finished resins meet the (i) Formaldehyde not to exceed 0.0050 following specifications as determined percent by weight of homopolymer as by methods titled ‘‘Oxygen Flask Com- determined by a method titled ‘‘Form- bustion-Gravimetric Method for Deter- aldehyde Release and Formaldehyde mination of Sulfur in Organic Com- Analysis,’’ which is incorporated by pounds,’’ ‘‘Determination of the Inher- reference. Copies are available from ent Viscosity of Polyphenylene Sul- Center for Food Safety and Applied Nu- fide,’’ and ‘‘Analysis for trition (HFS–200) Food and Drug Ad- Dichlorobenzene in Ryton ministration, 5100 Paint Branch Pkwy., Polyphenylene Sulfide,’’ which are in- College Park, MD 20740, or available for corporated by reference. Copies are inspection at the National Archives available from the Center for Food and Records Administration (NARA). Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, For information on the availability of 5100 Paint Branch Pkwy., College Park, this material at NARA, call 202–741– MD 20740, or available for inspection at 6030, or go to: http://www.archives.gov/ the National Archives and Records Ad- federallregister/ ministration (NARA). For information codeloflfederallregulations/ on the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (ii) Total extractives not to exceed www.archives.gov/federallregister/ 0.20 percent by weight of homopolymer codeloflfederallregulations/ when extracted for 6 hours with dis- ibrllocations.html. tilled water at reflux temperature and (1) Sulfur content: 28.2–29.1 percent 0.15 percent by weight of homopolymer by weight of finished resin. when extracted for 6 hours with n- (2) Minimum inherent viscosity: 0.13 heptane at reflux temperature. deciliters per gram. (e) Conditions of use. (1) Polyoxy- (3) Maximum residual p- methylene homopolymer is for use as dichlorobenzene: 0.8 ppm. articles or components of articles in- (b) Subject to any limitations pre- tended for repeated use. scribed in parts 170 through 189 of this (2) Use temperature shall not exceed chapter, the following optional sub- 250 °F. stances may be added to the polyphenylene sulfide basic resins in an (3) In accordance with good manufac- amount not to exceed that reasonably turing practice, finished articles con- required to accomplish the intended taining polyoxymethylene physical or technical effect. homopolymer shall be thoroughly (1) Substances generally recognized as safe in food.

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

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

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(2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with tion may be used in contact with all any specification in such regulation. types of liquid food, except food con- (i) Elastomers. taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer. temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers (3) Reverse osmosis membranes shall complying with § 177.1210. be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol accordance with current good manufac- dimethacrylate copolymers containing not turing practice so as to prevent micro- more than 5 weight percent of polymer bial adulteration of food. units derived from ethylene glycol dimethacrylate. (4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co- osmosis membranes and their supports polymer. shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly- their first use in accordance with cur- mer. rent good manufacturing practice. Chloroprene polymers. Chlorotrifluoroethylene-vinylidene fluoride [49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer. FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5 Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units derived from 5-methylene-2-norbornene and/ § 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene. repeated use. Ethylene-propylene-dicyclopentadiene co- Rubber articles intended for repeated polymer. use may be safely used in producing, Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8 weight manufacturing, packing, processing, percent of total polymer units derived preparing, treating, packaging, trans- from 1,4-hexadiene. porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co- provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro- (a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly- from natural and/or synthetic polymers mers are modified by hydrogenation of the and adjuvant substances as described olefinic unsaturation to leave either: (1) Not more than 10 percent trans olefinic in paragraph (c) of this section. unsaturation and no a, b-olefinic (b) The quantity of any substance unsaturation as determined by a method employed in the production of rubber entitled ‘‘Determination of Residual a, b- articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1, quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South fect in the rubber article and shall not Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 percent to 20 percent olefinic be intended to accomplish any effect in unsaturation and Mooney viscosities great- food. er than 45 (ML 1 + 4 @ 100 °C), as deter- (c) Substances employed in the prep- mined by ASTM Standard Method D1646– aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber— following, subject to any limitations Viscosity and Vulcanization Characteris- prescribed: tics (Mooney Viscometer),’’ which are both (1) Substances generally recognized incorporated by reference in accordance as safe for use in food or food pack- with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- ies of these methods may be obtained from aging. the Division of Petition Control (HFS–215), (2) Substances used in accordance Center for Food Safety and Applied Nutri- with the provisions of a prior sanction tion, Food and Drug Administration, 5100 or approval. Paint Branch Pkwy., College Park, MD (3) Substances that by regulation in 20740, or may be examined at the Center for parts 170 through 189 of this chapter Food Safety and Applied Nutrition’s Li- may be safely used in rubber articles, brary, 5100 Paint Branch Pkwy., College subject to the provisions of such regu- Park, MD 20740, or at the National Ar- chives and Records Administration lation. (NARA). For information on the avail- (4) Substances identified in this para- ability of this material at NARA, call 202– graph (c)(4), provided that any sub- 741–6030, or go to: http://www.archives.gov/ stance that is the subject of a regula- federallregister/

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

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

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

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

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

List of substances Limitations

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

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List of substances Limitations

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

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

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178.3450 Esters of stearic and palmitic acids. Subpart B—Substances Utilized To 178.3480 Fatty alcohols, synthetic. Control the Growth of Micro- 178.3500 Glycerin, synthetic. 178.3505 Glyceryl tri-(12-acetoxystearate). organisms 178.3520 Industrial starch-modified. § 178.1005 Hydrogen peroxide solution. 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic. Hydrogen peroxide solution identi- 178.3570 Lubricants with incidental food fied in this section may be safely used contact. to sterilize polymeric food-contact sur- 178.3600 Methyl glucoside-coconut oil ester. faces identified in paragraph (e)(1) of 178.3610 a-Methylstyrene-vinyltoluene res- this section. ins, hydrogenated. (a) Identity. For the purpose of this 178.3620 Mineral oil. section, hydrogen peroxide solution is 178.3650 Odorless light petroleum hydro- an aqueous solution containing not carbons. more than 35 percent hydrogen per- 178.3690 Pentaerythritol adipate-stearate. oxide (CAS Reg. No. 7722–84–1) by 178.3700 Petrolatum. weight, meeting the specifications pre- 178.3710 Petroleum wax. scribed in paragraph (c) of this section. 178.3720 Petroleum wax, synthetic. (b) Optional adjuvant substances. Hy- 178.3725 Pigment dispersants. drogen peroxide solution identified in 178.3730 Piperonyl butoxide and pyrethrins paragraph (a) of this section may con- as components of bags. tain substances generally recognized as 178.3740 Plasticizers in polymeric sub- safe in or on food, substances generally stances. recognized for their intended use in 178.3750 Polyethylene glycol (mean molec- food packaging, substances used in ac- ular weight 200–9,500). cordance with a prior sanction or ap- 178.3760 Polyethylene glycol (400) proval, and substances permitted by monolaurate. applicable regulations in parts 174 178.3770 Polyhydric alcohol esters of through 179 of this chapter. oxidatively refined (Gersthofen process) (c) Specifications. Hydrogen peroxide montan wax acids. solution shall meet the specifications 178.3780 Polyhydric alcohol esters of long of the ‘‘Food Chemicals Codex,’’ 3d Ed. chain monobasic acids. (1981), pp. 146–147, which is incorporated 178.3790 Polymer modifiers in semirigid and by reference (Copies may be obtained rigid vinyl chloride plastics. from the National Academy Press, 2101 178.3800 Preservatives for wood. Constitution Ave. NW., Washington, 178.3850 Reinforced wax. DC 20418, or may be examined at the 178.3860 Release agents. 178.3870 Rosins and rosin derivatives. National Archives and Records Admin- 178.3900 Sodium pentachlorophenate. istration (NARA). For information on 178.3910 Surface lubricants used in the man- the availability of this material at ufacture of metallic articles. NARA, call 202–741–6030, or go to: http:// 178.3930 Terpene resins. www.archives.gov/federallregister/ 178.3940 Tetraethylene glycol di-(2-ethyl- codeloflfederallregulations/ hexoate). ibrllocations.html.), and the United 178.3950 Tetrahydrofuran. States Pharmacopeia XX (1980), except that hydrogen peroxide may exceed the AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. concentration specified therein. SOURCE: 42 FR 14609, Mar. 15, 1977, unless (d) Limitations. No use of hydrogen otherwise noted. peroxide solution in the sterilization of food packaging material shall be con- EDITORIAL NOTE: Nomenclature changes to part 178 appear at 61 FR 14482, Apr. 2, 1996, 66 sidered to be in compliance if more FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, than 0.5 part per million of hydrogen 2001, 68 FR 15355, Mar. 31, 2003, and 70 FR peroxide can be determined in distilled 72074, Dec. 1, 2005. water packaged under production conditions (assay to be performed immediately after packaging). Subpart A [Reserved] (e) Conditions of use. (1) Hydrogen peroxide solution identified in and complying with the specifications in this section may be used by itself or in

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combination with other processes to utensils, and on other food-contact ar- treat food-contact surfaces to attain ticles as specified in this section, with- commercial sterility at least equiva- in the following prescribed conditions: lent to that attainable by thermal (a) Such sanitizing solutions are processing for metal containers as pro- used, followed by adequate draining, vided for in part 113 of this chapter. before contact with food. Food-contact surfaces include the fol- (b) The solutions consist of one of the lowing: following, to which may be added components generally recognized as safe Substances Limitations and components which are permitted Ethylene-acrylic acid Complying with § 177.1310 of this by prior sanction or approval. copolymers. chapter. (1) An aqueous solution containing Ethylene-carbon mon- Complying with § 177.1312 of this oxide copolymers. chapter. potassium, sodium, or calcium hypo- Ethylene-methyl acry- Complying with § 177.1340 of this chlorite, with or without the bromides late copolymer resins. chapter. of potassium, sodium, or calcium. Ethylene-vinyl acetate Complying with § 177.1350 of this copolymers. chapter. (2) An aqueous solution containing Ionomeric resins ...... Complying with § 177.1330 of this dichloroisocyanuric acid, chapter. trichloroisocyanuric acid, or the so- Isobutylene polymers... Complying with § 177.1420 (a)(1) dium or potassium salts of these acids, and (a)(2) of this chapter. Olefin polymers ...... Complying with § 177.1520 of this with or without the bromides of potas- chapter. sium, sodium, or calcium. Polycarbonate resins ... Complying with § 177.1580 of this (3) An aqueous solution containing chapter. Polyethylene- Complying with § 177.1630 of this potassium iodide, sodium p- terephthalate poly- chapter (excluding polymers de- toluenesulfonchloroamide, and sodium mers. scribed in § 177.1630(c)) of this lauryl sulfate. chapter. Poly-l-butene resins Complying with § 177.1570 of this (4) An aqueous solution containing and butene/ethylene chapter. iodine, butoxy monoether of mixed copolymers. (ethylene-propylene) polyalkylene gly- Polystryrene and rub- Complying with § 177.1640 of this col having a cloudpoint of 90°–100 °C in ber-modified poly- chapter. styrene polymers. 0.5 percent aqueous solution and an av- Vinylidene chloride/ Complying with § 177.1990 of this erage molecular weight of 3,300, and methyl acrylate co- chapter. ethylene glycol monobutyl ether. Addi- polymers. tionally, the aqueous solution may (2) The packaging materials identi- contain diethylene glycol monoethyl fied in paragraph (e)(1) of this section ether as an optional ingredient. may be used for packaging all commer- (5) An aqueous solution containing cially sterile foods except that the elemental iodine, hydriodic acid, a-(p- olefin polymers may be used in articles nonylphenyl)-omega-hydroxypoly-(oxy- for packaging foods only of the types ethylene) (complying with the identity identified in § 176.170(c) of this chapter, prescribed in § 178.3400(c) and having a table 1, under Categories I, II, III, IV-B, maximum average molecular weight of V, and VI. 748) and/or polyoxyethylene- (3) Processed foods packaged in the polyoxypropylene block polymers (hav- materials identified in paragraph (e)(1) ing a minimum average molecular of this section shall conform with parts weight of 1,900). Additionally, the aque- 108, 110, 113, and 114 of this chapter as ous solution may contain isopropyl al- applicable. cohol as an optional ingredient. (6) An aqueous solution containing [46 FR 2342, Jan. 9, 1981, as amended at 49 FR elemental iodine, sodium iodide, so- 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; dium dioctylsulfosuccinate, and 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, polyoxyethylene-polyoxypropylene Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR block polymers (having a minimum av- 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 erage molecular weight of 1,900). FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, (7) An aqueous solution containing 1992] dodecylbenzenesulfonic acid and either isopropyl alcohol or polyoxyethylene- § 178.1010 Sanitizing solutions. polyoxypropylene block polymers (hav- Sanitizing solutions may be safely ing a minimum average molecular used on food-processing equipment and weight of 2,800). In addition to use on

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food-processing equipment and uten- utensils, this solution may be used on sils, this solution may be used on glass glass bottles and other glass containers bottles and other glass containers in- intended for holding milk. All equip- tended for holding milk. ment, utensils, glass bottles, and other (8) An aqueous solution containing glass containers treated with this sani- elemental iodine, butoxy monoether of tizing solution shall have a drainage mixed (ethylene-propylene) period of 15 minutes prior to use in polyalkylene glycol having a minimum contact with food. average molecular weight of 2,400 and (13) An aqueous solution containing a-lauroyl-omega-hydroxypoly (oxy- elemental iodine and alkyl (C12-C15) ethylene) with an average 8–9 moles of monoether of mixed (ethylene-pro- ethylene oxide and an average molec- pylene) polyalkylene glycol, having a ular weight of 400. In addition to use on cloud-point of 70°–77 °C in 1 percent food-processing equipment and uten- aqueous solution and an average mo- sils, this solution may be used on bev- lecular weight of 807. erage containers, including milk con- (14) An aqueous solution containing tainers or equipment. Rinse water iodine, butoxy monoether of mixed treated with this solution can be recir- (ethylene-propylene) polyalkylene gly- culated as a preliminary rinse. It is not col, having a cloud-point of 90°–100 °C to be used as final rinse. in 0.5 percent aqueous solution and an (9) An aqueous solution containing n- average molecular weight of 3,300, and alkyl (C12-C18) benzyldimethylam- polyoxyethylene-polyoxypropylene monium chloride compounds having block polymers (having a minimum av- average molecular weights of 351 to 380. erage molecular weight of 2,000). The alkyl groups consist principally of (15) An aqueous solution containing groups with 12 to 16 carbon atoms and lithium hypochlorite. contain not more than 1 percent each of groups with 8 and 10 carbon atoms. (16) An aqueous solution containing Additionally, the aqueous solution may equal amounts of n-alkyl (C12-C18) ben- contain either ethyl alcohol or iso- zyl dimethyl ammonium chloride and propyl alcohol as an optional ingre- n-alkyl (C12-C14) dimethyl ethylbenzyl dient. ammonium chloride (having average (10) An aqueous solution containing molecular weights of 377 to 384), with trichloromelamine and either sodium the optional adjuvant substances lauryl sulfate or dodecyl- tetrasodium ethylenediaminetetra- benzenesulfonic acid. In addition to use acetate and/or alpha-(p-nonylphenol)- on food-processing equipment and omega-hydroxy poly (oxyethylene) hav- utensils and other food-contact arti- ing an average poly- (oxyethylene) con- cles, this solution may be used on bev- tent of 11 moles. Alpha-hydro-omega- erage containers except milk con- hydroxypoly-(oxyethylene) tainers or equipment. poly(oxypropoylene) (15 to 18 mole (11) An aqueous solution containing minimum) poly (oxyethylene) block copolymer, having a minimum molecular equal amounts of n-alkyl (C12-C18) benzyl dimethyl ammonium chloride and weight of 1,900 (CAS Registry No. 9003– 11–6) may be used in lieu of alpha- (p- n-alkyl (C12-C18) dimethyl ethylbenzyl ammonium chloride (having an average nonylphenol)-omega-hydroxy- molecular weight of 384). In addition to poly(oxyethylene) having an average use on food-processing equipment and poly(oxyethylene) content of 11 moles. utensils, this solution may be used on In addition to use on food-processing food-contact surfaces in public eating equipment and utensils, this solution places. may be used on food-contact surfaces (12) An aqueous solution containing in public eating places. the sodium salt of sulfonated oleic (17) An aqueous solution containing acid, polyoxyethylene- di-n-alkyl(C8-C10)dimethyl ammonium polyoxypropylene block polymers (hav- chlorides having average molecular ing an average molecular weight of weights of 332–361 and either ethyl al- 2,000 and 27 to 31 moles of cohol or isopropyl alcohol. In addition polyoxypropylene). In addition to use to use on food-processing equipment on food-processing equipment and and utensils, this solution may be used

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on food-contact surfaces in public eat- poly(oxypropylene)] (having an average ing places. molecular weight of 965). (18) An aqueous solution containing (25) An aqueous solution containing n-alkyl(C12-C18) benzyldimethylammo- elemental iodine (CAS Reg. No. 7553–56– nium chloride, sodium metaborate, 2), potassium iodide (CAS Reg. No. alpha-terpineol and alpha[p-(1,1,3,3- 7681–11–0), and isopropanol (CAS Reg. tetramethylbutyl)phenyl] -omega-hy- No. 67–63–0). In addition to use on food droxy-poly (oxyethylene) produced processing equipment and utensils, this with one mole of the phenol and 4 to 14 solution may be used on beverage con- moles ethylene oxide. tainers, including milk containers and (19) An aqueous solution containing equipment and on food-contact sur- sodium dichloroisocyanurate and faces in public eating places. tetrasodium ethylenediaminetetraacetate. In addition to use on food- (26) [Reserved] processing equipment and utensils, this (27) An aqueous solution containing solution may be used on food-contact decanoic acid (CAS Reg. No. 334–48–5), surfaces in public eating places. octanoic acid (CAS Reg. No. 124–07–2), (20) An aqueous solution containing and sodium 1-octanesulfonate (CAS ortho-phenylphenol, ortho-benzyl-para- Reg. No. 5324–84–5). Additionally, the chlorophenol, para- aqueous solution may contain iso- tertiaryamylphenol, sodium -alpha- propyl alcohol (CAS Reg. No. 67–63–0) alkyl(C12-C15)-omega-hydroxypoly (oxy- as an optional ingredient. ethylene) sulfate with the (28) An aqueous solution containing poly(oxyethylene) content averaging sulfonated 9-octadecenoic acid (CAS one mole, potassium salts of coconut Reg. No. 68988–76–1) and sodium oil fatty acids, and isopropyl alcohol or xylenesulfonate (CAS Reg. No. 1300–72– hexylene glycol. 7). (21) An aqueous solution containing (29) An aqueous solution containing sodium dodecylbenzenesulfonate. In ad- dodecyldiphenyloxidedisulfonic acid dition to use on food-processing equip- (CAS Reg. No. 30260–73–2), sulfonated ment and utensils, this solution may tall oil fatty acid (CAS Reg. No. 68309– be used on glass bottles and other glass 27–3), and neo-decanoic acid (CAS Reg. containers intended for holding milk. (22) An aqueous solution containing No. 26896–20–8). In addition to use on food-processing equipment and uten- (1) di-n-alkyl(C8-C10) dimethylammonium chloride com- sils, this solution may be used on glass pounds having average molecular bottles and other glass containers intended for holding milk. weights of 332–361, (2) n-alkyl (C12-C18) benzyldimethylammonium chloride (30) An aqueous solution containing compounds having average molecular hydrogen peroxide (CAS Reg. No. 7722– weights of 351–380 and consisting prin- 84–1), peracetic acid (CAS Reg. No. 79– cipally of alkyl groups with 12 to 16 21–0), acetic acid (CAS Reg. No. 64–19– carbon atoms with or without not over 7), and 1-hydroxyethylidene-1,1- 1 percent each of groups with 8 and 10 diphosphonic acid (CAS Reg. No. 2809– carbon atoms, and (3) ethyl alcohol. 21–4). The ratio of compound (1) to compound (31) An aqueous solution containing (2) is 60 to 40. elemental iodine, alpha-alkyl(C10-C14)- (23) An aqueous solution containing omega-hydroxypoly(oxyethylene)poly- n-alkyl (C12-C16) benzyl- (oxypropylene) of average molecular dimethylammonium chloride and weight between 768 and 837, and alpha- didecyldimethylammonium chloride. alkyl(C -C )-omega- (24) An aqueous solution containing 12 18 hydroxypoly(oxyethylene) elemental iodine (CAS Reg. No. 7553–56– poly(oxypropylene) of average molec- 2), alpha-[p-(1,1,3,3-tetramethylbutyl)- phenyl]-omega-hydroxypoly-(oxy- ular weight between 950 and 1,120. In ethylene) produced with one mole of addition to use on food-processing the phenol and 4 to 14 moles ethylene equipment and utensils, this solution may be used on food-contact surfaces oxide, and alpha-alkyl(C12-C15)-omega- hydroxy[poly(oxyethylene) in public eating places.

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(32) An aqueous solution containing 2) and a mixture of the sodium salt of (i) di-n-alkyl(C8-C10)dimethyl- ammo- naphthalenesulfonic acid (CAS Reg. nium chloride compounds having aver- No. 1321–69–3); the methyl, dimethyl, age molecular weights of 332 to 361, (ii) and trimethyl dervatives of the sodium n-alkyl(C12-C18)benzyldimethylammo- salt of naphthalenesulfonic acid; and a nium chloride compounds having aver- mixture of the sodium salt of age molecular weights of 351 to 380 and naphthalenesulfonic acid, and the consisting principally of alkyl groups methyl, dimethyl, and trimethyl de- with 12 to 16 carbon atoms with no rivatives of the sodium salt of more than 1 percent of groups with 8 naphthalenesulfonic acid alkylated at 3 and 10, (iii) ethyl alcohol, and (iv) percent by weight with C6-C9 linear alpha-(p-nonylphenyl)-omega- olefins, as components of a sanitizing hydroxypoly(oxyethylene) produced by solution to be used on food-processing the condensation of 1 mole of p- equipment and utensils. The methyl nonylphenol with 9 to 12 moles of and dimethyl substituted derivatives ethylene oxide. The ratio of compound (described within this paragraph (i) to compound (ii) is 3 to 2. (b)(35)) constitute no less than 70 per- (33) An aqueous solution containing cent by weight of the mixture of (i) di-n-alkyl-(C8-C10)- naphthalenesulfonates. dimethylammonium chloride com- (36) The sanitizing solution contains pounds having average molecular decanoic acid (CAS Reg. No. 334–48–5); weights of 332 to 361; (ii) n-alkyl(C12- octanoic acid (CAS Reg. No. 124–07–2); C18) -benzyldimethylammonium chlo- lactic acid (CAS Reg. No. 050–21–5); ride compounds having molecular phosphoric acid (CAS Reg. No. 7664–38– weights of 351 to 380 and consisting 2); a mixture of 1-octanesulfonic acid principally of alkyl groups with 12 to 16 (CAS Reg. No. 3944–72–7), and 1- carbon atoms with no more than 1 per- octanesulfonic-2-sulfinic acid (CAS cent of the groups with 8 to 10; and (iii) Reg. No. 113652–56–5) or 1,2- tetrasodium ethylenediamine octanedisulfonic acid (CAS Reg. No. tetraacetate. Additionally, the aqueous 113669–58–2); the condensate of four solution contains either alpha-(p- moles of nonylphenyl)-omega-hydroxypoly-(oxy- poly(oxyethylene)poly(oxypropylene) ethylene) or alpha-alkyl(C11-C15)-omega- block copolymers with one mole of hydroxypoly-(oxyethylene), each pro- ethylenediamine (CAS Reg. No. 11111– duced with 9 to 13 moles of ethylene 34–5); and the optional ingredient oxide. The ratio of compound (i) to FD&C Yellow No. 5 (CAS Reg. No. compound (ii) is 3 to 2. 001934210). In addition to use on food- (34) An aqueous solution of an equi- processing equipment and utensils, this librium mixture of oxychloro species solution may be used on dairy-proc- (predominantly chlorite, chlorate, and essing equipment. chlorine dioxide) generated either (i) (37) The sanitizing solution contains by directly metering a concentrated sodium hypochlorite (CAS Reg. No. chlorine dioxide solution, prepared just 7681–52–9), trisodium phosphate (CAS prior to use, into potable water to pro- Reg. No. 7601–54–9), sodium lauryl sul- vide the concentration of available fate (CAS Reg. No. 151–21–3), and potas- chlorine dioxide stated in paragraph sium permanganate (CAS Reg. No. (c)(29) of this section, or (ii) by acidifi- 7722–64–7). Magnesium oxide (CAS Reg. cation of an aqueous alkaline solution No. 1309–48–4) and potassium bromide of oxychloro species (predominantly (CAS Reg. No. 7758–02–3) may be added chlorite and chlorate) followed by dilu- as optional ingredients to this sani- tion with potable water to provide the tizing solution. In addition to use on concentration of available chlorine di- food-processing equipment and uten- oxide described in paragraph (c)(29) of sils, this solution may be used on food- this section. contact surfaces in public eating (35) An aqueous solution containing places. decanoic acid (CAS Reg. No. 334–48–5), (38) An aqueous solution containing octanoic acid (CAS Reg. No. 124–07–2), hydrogen peroxide (CAS Reg. No. 7722– lactic acid (CAS Reg. No. 050–21–5), 84–1); peroxyacetic acid (CAS Reg. No. phosphoric acid (CAS Reg. No. 7664–38– 79–21–0); acetic acid (CAS Reg. No. 64–

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19–7); sulfuric acid (CAS Reg. No. 7664– phosphoric acid (CAS Reg. No. 7664–38– 93–9); and 2,6-pyridinedicarboxylic acid 2), propionic acid (CAS Reg No. 79–09– (CAS Reg. No. 499–83–2). In addition to 04), and sodium 1-octanesulfonate (CAS use on food-processing equipment and Reg. No. 5324–84–5). Sulfuric acid (CAS utensils, this solution may be used on Reg. No. 7664–93–9) may be added as an dairy-processing equipment. optional ingredient. In addition to use (39) An aqueous solution containing on food-processing equipment and phosphoric acid (CAS Reg. No. 7664–38– utensils, this solution may be used on 2); octenyl succinic acid (CAS Reg. No. dairy-processing equipment. 28805–58–5); N,N-dimethyloctanamine (43) An aqueous solution of iodine (CAS Reg. No. 7378–99–6); and a mixture and hypochlorous acid generated by of n-carboxylic acids (C6-C12, consisting the dilution of an aqueous acidic (21.5 of not less than 56 percent octanoic percent nitric acid) solution of iodine acid and not less than 40 percent deca- monochloride. In addition to use on noic acid). This solution may be used food-processing equipment and uten- on food-processing equipment and sils, this solution may be used on utensils, including dairy-processing dairy-processing equipment. equipment. (44) An aqueous solution of citric (40) An aqueous solution prepared by acid, disodium ethylenediaminetetra- combining elemental iodine (CAS Reg. acetate, sodium lauryl sulfate, and No. 7553–56–2); hydriodic acid (CAS Reg. monosodium phosphate. In addition to No. 10034–85–2); sodium N-cyclohexyl-N- use on food-processing equipment and palmitoyl taurate (CAS Reg. No. 132– utensils, this solution may be used on 43–4); chloroacetic acid, sodium salt re- dairy-processing equipment. action products with 4,5-dihydro-2- (45) An aqueous solution of hydrogen undecyl-1H-imidazole-1-ethanol and so- peroxide, acetic acid, peroxyacetic dium hydroxide (CAS Reg. No. 68608–66– acid, octanoic acid, peroxyoctanoic 2); dodecylbenzene sulfonic acid (CAS acid, sodium 1-octanesulfonate, and 1- Reg. No. 27176–87–0); phosphoric acid hydroxyethylidene-1,1-diphosphonic (CAS Reg. No. 7664–38–2); isopropyl alcohol (CAS Reg. No. 67–63–0); and cal- acid. In addition to use on food-proc- cium chloride (CAS Reg. No. 10043–52– essing equipment and utensils, this so- 4). In addition to use on food-proc- lution may be used on food-contact essing equipment and utensils, this so- surfaces in public eating places, sub- lution may be used on dairy-processing ject to the limitations in paragraph equipment. (c)(39) of this section. (41) An aqueous solution containing (46) An aqueous solution of chlorine dioxide and related oxychloro species n-alkyl(C12- generated by acidification of an aque- C16)benzyldimethylammonium chloride, having average molecular weights ous solution of sodium chlorite with a ranging from 351 to 380 wherein the solution of sodium gluconate, citric alkyl groups contain principally 12 to acid, phosphoric acid, and sodium 16 carbons and not more than 1 percent mono- and each of the groups with 8 and 10 carbon didodecylphenoxybenzenedisulfonate. atoms; ammonium chloride (CAS Reg. In addition to use on food-processing No. 12125–02–9); calcium stearate (CAS equipment and utensils, this solution Reg. No. 1592–23–0); sodium bicarbonate may be used on dairy-processing equip- (CAS Reg. No. 144–55–8); starch or ment. dextrin, or both starch and dextrin (c) The solutions identified in para- (CAS Reg. No. 9004–53–9); and the op- graph (b) of this section will not exceed tional ingredient methylene blue (CAS the following concentrations: Reg. No. 61–73–4). In addition to use on (1) Solutions identified in paragraph food-processing equipment and uten- (b)(1) of this section will provide not sils, this solution may be used on food- more than 200 parts per million of contact surfaces in public eating available halogen determined as avail- places. able chlorine. (42) An aqueous solution containing (2) Solutions identified in paragraph decanoic acid (CAS Reg. No. 334–48–5), (b)(2) of this section will provide not nonanoic acid (CAS Reg. No. 112–05–0), more than 100 parts per million of

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available halogen determined as avail- available chlorine and not more than 30 able chlorine. ppm lithium. (3) Solution identified in paragraph (11) Solutions identified in paragraph (b)(3) of this section will provide not (b)(16) of this section shall provide not more than 25 parts per million of ti- more than 200 parts per million of ac- tratable iodine. The solutions will con- tive quaternary compound. tain the components potassium iodide, (12) Solutions identified in paragraph sodium p-toluenesulfonchloramide and (b)(17) of this section shall provide, sodium lauryl sulfate at a level not in when ready to use, a level of 150 parts excess of the minimum required to per million of the active quaternary produce their intended functional ef- compound. fect. (13) Solutions identified in paragraph (4) Solutions identified in paragraph (b)(18) of this section shall provide not (b)(4), (5), (6), (8), (13), and (14) of this more than 200 parts per million of ac- section will contain iodine to provide tive quaternary compound and not not more than 25 parts per million of more than 66 parts per million of titratable iodine. The adjuvants used alpha[p-(1,1,3,3-tetramethylbutyl) with the iodine will not be in excess of phenyl]-omega-hydroxypoly (oxy- the minimum amounts required to ac- ethylene). complish the intended technical effect. (14) Solutions identified in paragraph (b)(19) of this section shall provide, (5) Solutions identified in paragraph when ready to use, a level of 100 parts (b)(7) of this section will provide not per million of available chlorine. more than 400 parts per million (15) Solutions identified in paragraph dodecylbenzenesulfonic acid and not (b)(20) of this section are for single use more than 80 parts per million of applications only and shall provide, polyoxyethylene-polyoxypropylene when ready to use, a level of 800 parts block polymers (having a minimum av- per million of total active phenols con- erage molecular weight of 2,800) or not sisting of 400 parts per million ortho- more than 40 parts per million of iso- phenylphenol, 320 parts per million propyl alcohol. ortho-benzyl-para-chlorophenol and 80 (6) Solutions identified in paragraph parts per million para- (b)(9) of this section shall provide when tertiaryamylphenol. ready to use no more than 200 parts per (16) Solution identified in paragraph million of the active quaternary com- (b)(21) of this section shall provide not pound. more than 430 parts per million and not (7) Solutions identified in paragraph less than 25 parts per million of sodium (b)(10) of this section shall provide not dodecylbenzenesulfonate. more than sufficient (17) Solutions identified in paragraph trichloromelamine to produce 200 parts (b)(22) of this section shall provide, per million of available chlorine and ei- when ready to use, at least 150 parts ther sodium lauryl sulfate at a level per million and not more than 400 parts not in excess of the minimum required per million of active quaternary com- to produce its intended functional ef- pound. fect or not more than 400 parts per mil- (18) Solutions identified in paragraph lion of dodecylbenzenesulfonic acid. (b)(23) of this section shall provide at (8) Solutions identified in paragraph least 150 parts per million and not (b)(11) of this section shall provide, more than 200 parts per million of the when ready to use, not more than 200 active quaternary compound. parts per million of active quaternary (19) Solutions identified in para- compound. graphs (b)(24), (b)(25), and (b)(43) of this (9) The solution identified in para- section shall provide at least 12.5 parts graph (b)(12) of this section shall proper million and not more than 25 parts vide not more than 200 parts per mil- per million of titratable iodine. The ad- lion of sulfonated oleic acid, sodium juvants used with the iodine shall not salt. be in excess of the minimum amounts (10) Solutions identified in paragraph required to accomplish the intended (b)(15) of this section will provide not technical effect. more than 200 parts per million of (20)–(21) [Reserved]

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(22) Solutions identified in paragraph the amounts required to accomplish (b)(27) of this section shall provide, the intended technical effect. when ready to use, at least 109 parts (28) Solutions identified in paragraph per million and not more than 218 parts (b)(33) of this section shall provide, per million of total active fatty acids when ready to use, at least 150 parts and at least 156 parts per million and per million and not more than 400 parts not more than 312 parts per million of per million of active quaternary com- the sodium 1-octanesulfonate. pounds. The adjuvants used with the (23) Solutions identified in paragraph quaternary compounds shall not exceed (b)(28) of this section shall provide, the amounts required to accomplish when ready to use, at least 156 parts the intended technical effect. per million and not more than 312 parts Tetrasodium ethylenediamine per million of sulfonated 9- tetraacetate shall be added at a min- octadecenoic acid, at least 31 parts per imum level of 60 parts per million. Use million and not more then 62 parts per of these sanitizing solutions shall be million of sodium xylenesulfonate. limited to conditions of water hardness (24) Solutions identified in paragraph not in excess of 300 parts per million. (b)(29) of this section will provide at (29) Solutions identified in paragraph least 237 parts per million and not (b)(34) of this section should provide, more than 474 parts per million when ready to use, at least 100 parts dodecyldiphenyloxidedisulfonic acid, at per million and not more than 200 parts least 33 parts per million and not more per million available chlorine dioxide than 66 parts per million sulfonated as determined by the method titled tall oil fatty acid, and at least 87 parts ‘‘Iodometric Method for the Deter- per million and not more than 174 parts mination of Available Chlorine Dioxide per million neo-decanoic acid. (50–250 ppm available ClO2),’’ which is incorporated by reference. Copies are (25) Solutions identified in paragraph available from the Center for Food (b)(30) of this section shall provide, Safety and Applied Nutrition (HFS– when ready to use, not less than 550 200), Food and Drug Administration, parts per million and not more than 5100 Paint Branch Pkwy., College Park, 1,100 parts per million hydrogen per- MD 20740, or available for inspection at oxide, not less than 100 parts per mil- the National Archives and Records Ad- lion and not more than 200 parts per ministration (NARA). For information million peracetic acid, not less than 150 on the availability of this material at parts per million and not more than 300 NARA, call 202–741–6030, or go to: http:// parts per million acetic acid, and not www.archives.gov/federallregister/ less than 15 parts per million and not codeloflfederallregulations/ more than 30 parts per million 1- ibrllocations.html. hydroxyethylidene-1,1-diphosphonic (30) Solutions identified in paragraph acid. (b)(35) of this section shall provide, (26) The solution identified in para- when ready for use, at least 117 parts graph (b)(31) of this section shall proper million and not more than 234 parts vide, when ready to use, at least 12.5 per million of total fatty acids and at parts per million and not more than 25 least 166 parts per million and not parts per million of titratable iodine. more than 332 parts per million of a The adjuvants used with the iodine will mixture of naphthalenesulfonates. The not be in excess of the minimum adjuvants phosphoric acid and lactic amounts required to accomplish the in- acid, used with decanoic acid, octanoic tended technical effect. acid, and sodium naphthalenesulfonate (27) Solutions identified in paragraph and its alkylated derivatives, will not (b)(32) of this section shall provide, be in excess of the minimum amounts when ready to use, at least 150 parts required to accomplish the intended per million and no more than 400 parts technical effects. per million of active quarternary com- (31) Solutions identified in paragraph pounds in solutions containing no more (b)(36) of this section shall provide, than 600 parts per million water hard- when ready for use, at least 29 parts per ness. The adjuvants used with the million and not more than 58 parts per quarternary compounds will not exceed million decanoic acid; at least 88 parts

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per million and not more than 176 parts (33) Solutions identified in paragraph per million of octanoic acid; at least 69 (b)(38) of this section shall provide parts per million and not more than 138 when ready for use not less than 300 parts per million of lactic acid; at least parts per million and not more than 465 256 parts per million and not more than parts per million of hydrogen peroxide; 512 parts per million of phosphoric not less than 200 parts per million and acid; at least 86 parts per million and not more than 315 parts per million of not more than 172 parts per million of peroxyacetic acid; not less than 200 1-octanesulfonic acid; at least 51 parts parts per million and not more than 340 per million and not more than 102 parts parts per million of acetic acid; not per million of 1-octanesulfonic-2- less than 10 parts per million and not sulfinic acid or 1,2-octanedisulfonic more than 20 parts per million of sul- acid; and at least 10 parts per million furic acid; and not less than 0.75 parts and not more than 20 parts per million per million and not more than 1.2 parts of the condensate of four moles of per million of 2,6-pyridinedicarboxylic poly(oxyethylene)poly(oxypropylene) acid. block copolymers with one mole of (34) Solutions identified in paragraph ethylenediamine. The colorant adju- (b)(39) of this section shall provide vant FD&C Yellow No. 5 shall not be when ready for use not less than 460 used in excess of the minimum amount parts per million and not more than 625 required to accomplish the intended parts per million of phosphoric acid, technical effect. and all components shall be present in (32)(i) The solution identified in para- the following proportions: 1 part phos- graph (b)(37) of this section without po- phoric acid to 0.25 octenyl succinic acid tassium bromide shall provide, when to 0.18 part N,N-dimethyloctanamine to ready to use, at least 100 parts per mil- 0.062 part of a mixture of n-carboxylic lion and not more than 200 parts per acids (C6-C12, consisting of not less million of available halogen deter- than 56 percent octanoic acid and not mined as available chlorine; at least less than 40 percent decanoic acid). 2,958 parts per million and not more (35) Solutions identified in paragraph than 5,916 parts per million of tri- (b)(40) of this section shall provide sodium phosphate; at least 1 part per when ready for use not less than 12.5 million and not more than 3 parts per parts per million and not more than million of sodium lauryl sulfate; and at 25.0 parts per million of titratable io- least 0.3 part per million and not more dine; and not less than 2.7 parts per than 0.7 part per million on potassium million and not more than 5.5 parts per permanganate. million of dodecylbenzene sulfonic (ii) The solution identified in para- acid. All components shall be present graph (b)(37) of this section with potas- in the following proportions: 1.0 part sium bromide shall provide, when dodecylbenzene sulfonic acid to 43 ready to use, at least 25 parts per mil- parts sodium N-cyclohexyl-N-palmitoyl lion and not more than 200 parts per taurate to 7.7 parts chloroacetic acid, million of available halogen deter- sodium salt, reaction products with 4,5- mined as available chlorine; at least 15 dihydro-2-undecyl-1H-imidazole-1-eth- parts per million and not more than 46 anol and sodium hydroxide to 114 parts parts per million of potassium bro- phosphoric acid to 57 parts isopropyl mide; at least 690 parts per million and alcohol to 3.0 parts calcium chloride. not more than 2,072 parts per million of (36) Solutions identified in paragraph trisodium phosphate; at least 0.3 part (b)(41) of this section shall provide, per million and not more than 1 part when ready for use, not less than 150 per million of sodium lauryl sulfate; parts per million and not more than 200 and at least 0.1 part per million and parts per million of n-alkyl(C12- not more than 0.3 part per million of C16)benzyldimethylammonium chlo- potassium permanganate. ride; and not more than 0.4 part per (iii) Magnesium oxide when used in million of the colorant methylene blue. paragraph (c)(32) (i) or (ii) of this sec- Components shall be present in the tion shall not be used in excess of the product used to prepare the solution in minimum amount required to accom- the following proportions: 1 part n- plish its intended technical effect. alkyl(C12- 368

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C16)benzyldimethylammonium chloride per million of octanoic acid (including to 0.24 part ammonium chloride to 0.08 peroxyoctanoic acid); at least 281 parts part calcium stearate to 0.60 part so- per million and not more than 686 parts dium bicarbonate to 0.08 part starch or per million of acetic acid; at least 7 dextrin, or a combination of starch and parts per million and not more than 34 dextrin. parts per million of 1- (37)(i) The solution identified in para- hydroxyethylidene-1,1-diphosphonic graph (b)(42) of this section not con- acid; and at least 36 parts per million taining sulfuric acid shall provide when and not more than 109 parts per million ready for use not less than 45 parts per of sodium 1-octanesulfonate. million and not more than 90 parts per (ii) The solution identified in para- million of decanoic acid; and all com- graph (b)(45) of this section, when used ponents shall be present in the fol- on food-contact equipment and utensils lowing proportions (weight/weight (w/ in warewashing machines, including w)): 1 part decanoic acid to 1 part nona- warewashing machines in public eating noic acid to 9.5 parts phosphoric acid to places, at temperatures no less than 120 3.3 parts propionic acid to 3.3 parts so- °F (49 °C) shall provide when ready for dium 1-octanesulfonate. use at least 30 parts per million and (ii) The solution identified in para- not more than 91 parts per million of graph (b)(42) of this section containing hydrogen peroxide; at least 19 parts per sulfuric acid shall provide when ready million and not more than 58 parts per for use not less than 45 parts per mil- million of peroxyacetic acid; at least 17 lion and not more than 90 parts per parts per million and not more than 52 million of decanoic acid; and all com- parts per million of octanoic acid (in- ponents shall be present in the fol- cluding peroxyoctanoic acid); at least lowing proportions (w/w): 1 part deca- 119 parts per million and not more than noic acid to 1 part nonanoic acid to 2.8 290 parts per million of acetic acid; at parts phosphoric acid to 3.3 parts propi- least 3 parts per million and not more onic acid to 3.3 parts sodium 1- than 14 parts per million of 1- octanesulfonate to 3.2 parts sulfuric hydroxyethylidene-1,1-diphosphonic acid. acid; and at least 15 parts per million (38) The solution identified in para- and not more than 46 parts per million graph (b)(44) of this section shall proof sodium 1-octanesulfonate. vide, when ready for use, at least 16,450 (iii) The solution identified in para- parts per million and not more than graph (b)(45) of this section, when used 32,900 parts per million of citric acid; at on dairy or beverage containers, shall least 700 parts per million and not provide when ready for use at least 36 more than 1,400 parts per million of di- parts per million and not more than 108 sodium ethylenediaminetetraacetate; parts per million of hydrogen peroxide; at least 175 parts per million and not at least 23 parts per million and not more than 350 parts per million of so- more than 69 parts per million of per- dium lauryl sulfate; and at least 175 oxyacetic acid; at least 20 parts per parts per million and not more than 350 million and not more than 61 parts per parts per million of monosodium phos- million of octanoic acid (including phate. peroxyoctanoic acid); at least 140 parts (39)(i) The solution identified in para- per million and not more than 343 parts graph (b)(45) of this section, when used per million of acetic acid; at least 3 on food processing equipment and uten- parts per million and not more than 17 sils, including dairy and beverage-proc- parts per million of 1- essing equipment but excluding food- hydroxyethylidene-1,1-diphosphonic contact surfaces in public eating places acid; and at least 18 parts per million and dairy and beverage containers, and not more than 55 parts per million shall provide when ready for use at of sodium 1-octanesulfonate. least 72 parts per million and not more (40) The solution identified in para- than 216 parts per million of hydrogen graph (b)(46) of this section shall pro- peroxide; at least 46 parts per million vide, when ready for use, at least 100 and not more than 138 parts per million parts per million and not more than 200 of peroxyacetic acid; at least 40 parts parts per million of chlorine dioxide as per million and not more than 122 parts determined by the method developed

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by Bio-cide International, Inc., enti- (d) Sanitizing agents for use in ac- tled, ‘‘Iodometric Method for the De- cordance with this section will bear la- termination of Available Chlorine Di- beling meeting the requirements of the oxide (50–250 ppm Available ClO2),’’ Federal Insecticide, Fungicide, and dated June 11, 1987, which is incor- Rodenticide Act. porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. [42 FR 14609, Mar. 16, 1977] Copies of this method are available EDITORIAL NOTE: For FEDERAL REGISTER ci- from the Division of Petition Control, tations affecting § 178.1010, see the List of Center for Food Safety and Applied Nu- CFR Sections Affected, which appears in the trition (HFS–215), Food and Drug Ad- Finding Aids section of the printed volume ministration, 5100 Paint Branch Pkwy., and at www.fdsys.gov. College Park, MD 20740, and may be examined at the Center for Food Safety Subpart C—Antioxidants and and Applied Nutrition’s Library, Food and Drug Administration, 5100 Paint Stabilizers Branch Pkwy., College Park, MD 20740, § 178.2010 Antioxidants and/or stabi- or at the National Archives and lizers for polymers. Records Administration (NARA). For information on the availability of this The substances listed in paragraph material at NARA, call 202–741–6030, or (b) of this section may be safely used as go to: http://www.archives.gov/ antioxidants and/or stabilizers in poly- federallregister/ mers used in the manufacture of arti- codeloflfederallregulations/ cles or components of articles intended ibrllocations.html; at least 380 parts per for use in producing, manufacturing, million and not more than 760 parts per packing, processing, preparing, treat- million of sodium gluconate; and at ing, packaging, transporting, or hold- least 960 parts per million and not ing food, subject to the provisions of more than 1,920 parts per million of so- this section: dium mono- and (a) The quantity used shall not ex- didodecylphenoxybenzenedisulfonate. ceed the amount reasonably required Other components listed under para- to accomplish the intended technical graph (b)(46) of this section shall be effect. used in the minimum amount nec- (b) List of substances: essary to produce the intended effect.

Substances Limitations

N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only: trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with §§ 175.105 and numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter. content is in the range 5.4–5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, butadiene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings complying with § 175.300, § 176.170, or § 175.320 of this chapter. The average thickness of such coatings and closure-sealing gaskets shall not exceed 0.004 inch. Alkylthiophenolics: ...... For use only: 1. Acid-catalyzed condensation reaction products 1. At levels not to exceed 2 percent by weight of adhesives complying with of 4-nonylphenol, formaldehyde, and 1- § 175.105 of this chapter, of pressure-sensitive adhesives complying with dodecanethiol (CAS Reg. No. 164907–73–7).. § 175.125 of this chapter, and of rubber articles complying with § 177.2600 of this chapter. 2. Acid-catalyzed condensation reaction products 2. Do. of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 203742–97–6).. p-tert-Amylphenolformaldehyde resins produced For use only at levels not to exceed 2.1 percent by weight of polyamide when one mole of p-tert-amylphenol is made to resins that are: react under acid conditions with one mole of 1. Derived from dimerized vegetable oil acids (containing not more than 20 formaldehyde. percent of monomer acids) and ethylenediamine. 2. Used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter.

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only: tert-butylphenol (CAS Reg. No. 991–84–4). 1. At levels not to exceed 0.5 percent by weight: in styrene block copolymers complying with § 177.1810 of this chapter; in rosins and rosin derivatives complying with § 175.300(b)(3)(v) of this chapter; in can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter; in side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter; in petroleum alicyclic hydrocarbon resins and terpene resins complying with § 175.320(b)(3) of this chapter; in rosin and rosin derivatives complying with § 176.170(a)(5) of this chapter; in petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with § 176.170(b)(2) of this chapter; in terpene resins complying with § 175.300(b)(2)(xi) of this chapter, when such terpene resins are used in accordance with § 176.170(b)(1) of this chapter; in resins and polymers complying with § 176.180(b) of this chapter; in closures with sealing gaskets complying with § 177.1210 of this chapter; in petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b) of this chapter; and in reinforced wax complying with § 178.3850 of this chapter. 2. At levels not to exceed 0.2 percent by weight of the finished cellophane complying with § 177.1200 of this chapter. 3. At levels not to exceed 0.1 percent by weight in polystyrene and rubber- modified polystyrene complying with § 177.1640 of this chapter: Provided, That the finished polystyrene and rubber-modified polystyrene polymer contact food only under conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 4. In adhesives complying with § 175.105 of this chapter; in pressure-sensitive adhesives complying with § 175.125 of this chapter; and as provided in § 177.2600 of this chapter. 4,4′-Bis(a,a-dimethylbenzyl)diphenylamine (CAS For use at levels not to exceed 0.3 percent by weight of polypropylene Reg. No. 10081–67–1). complying with § 177.1520(c) of this chapter. The polypropylene articles are limited to use in contact with non-fatty foods only. Boric acid (CAS Reg. No. 10043–35–3) ...... For use only at levels not to exceed 0.16 percent by weight of ethylene- vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3) and (d) of this chapter. 1,3–Butanediol. Butylated reaction product of p-cresol and For use only: dicyclopentadiene produced by reacting p-cresol 1. As components of nonfood articles complying with §§ 175.105 and and dicyclopentadiene in an approximate mole 177.2600(c)(4)(iii) of this chapter. ratio of 1.5 to 1, respectively, followed by 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/ alkylation with isobutylene so that the butyl con- styrene copolymers. The finished copolymers may be used in contact tent of the final product is not less than 18 per- with food of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under conditions cent. of use B through H, as described in tables 1 and 2 of § 176.170(c) of this chapter, and with food of Types III, IV-A, V, VI-C, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176. 170(c) of this chapter.

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

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Substances Limitations

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

[42 FR 14609, Mar. 15, 1977]

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

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

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

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dichloride shall not exceed 0.02 percent. cover at least three equilibrium peri- p odic determinations, as follows: (6) Beta-carbobutoxyethyltin (i) The exposure time for the first de- tris(isooctylmercaptoacetate) (CAS termination shall be at least 72 hours Reg. No. 63438–80–2) is an estertin for aqueous solvents, and at least 6 chemical having 13.0 to 14.0 percent by hours for heptane. weight of tin (Sn) and having 10.5 to (ii) Subsequent determinations shall 11.5 percent by weight of mercapto sul- be at a minimum of 24-hour intervals fur. It is made from beta- for aqueous solvents, and 2-hour inter- carbobutoxyethyltin trichloride. The vals for heptane. These tests shall yield isooctyl radical in the mercaptoacetate total octylin stabilizers not to exceed is derived from oxo process primary 0.5 parts per million as determined by octyl alcohol. The beta- analytical method entitled ‘‘Atomic carbobutoxyethyltin trichloride has an Absorption Spectrometric Determina- organotin composition that is not less tion of Sub-part-per-Million Quantities than 95 percent by weight of beta- of Tin in Extracts and Biological Mate- carbobutoxyethyltin trichloride and rials with Graphite Furnace,’’ Analyt- not more than 5 percent total of ical Chemistry, Vol. 49, p. 1090–1093 triestertin chloride and diestertin chlo- (1977), which is incorporated by ref- ride. erence. Copies are available from the (7) The dodecyltin stabilizer is a mix- Center for Food Safety and Applied Nu- ture of 50 to 60 percent by weight of n- trition (HFS–200), Food and Drug Ad- dodecyltin S,S′,S″- ministration, 5100 Paint Branch Pkwy., tris(isooctylmercaptoacetate) (CAS College Park, MD 20740, or available for Reg. No. 67649–65–4) and 40 to 50 percent inspection at the National Archives by weight of di(n-dodecyl)tin S,S′- di(isooctylmercaptoacetate) (CAS Reg. and Records Administration (NARA). No. 84030–61–5) having 13 to 14 percent For information on the availability of by weight of tin (Sn) and having 8 to 9 this material at NARA, call 202–741– percent by weight of mercapto sulfur. 6030, or go to: http://www.archives.gov/ It is made from a mixture of dodecyltin federallregister/ trichloride and di(dodecyl)tin dichlo- codeloflfederallregulations/ ride which has not more than 0.2 per- ibrllocations.html. cent by weight of dodecyltin tri- (iii) Subsequent determinations for chloride, not more than 2 percent by the dodecyltin mixture described in weight of dodecylbutyltin dichloride paragraph (a)(7) of this section shall be and not more than 3 percent by weight at a minimum of 24-hour intervals for of tri(dodecyl)tin chloride. The aqueous solvents and 2-hour intervals isooctyl radical in the mercaptoacetate for heptane. These tests shall yield is derived from oxo process primary di(n-octyl)tin S,S′- octyl alcohols. bis(isooctylmercaptoacetate), or di(n- (b) The vinyl chloride plastic con- octyl)tin maleate polymer, or (C10-C16)- tainers, film or panels in the finished alkylmercaptoacetate reaction prod- form in which they are to contact food, ucts with dichlorodioctylstannane and shall meet the following limitations: trichlorooctylstannane, or n-octyltin (1) The finished plastics intended for S,S′,S″-tris(isooctylmercaptoacetate), contact with foods of the types listed tris(isooctylmercaptoacetate) and di(n- in this section shall be extracted with dodecyl)tin the solvent or solvents characterizing bis(isooctylmercaptoacetate) or any those types of foods as determined combination thereof, not to exceed 0.5 from table 2 of § 176.170(c) of this chap- parts per million as determined by an ter at the temperature reflecting the analytical method entitled ‘‘Atomic conditions of intended use as deter- Absorption Spectrophotometric Deter- mined therein. Additionally, extrac- mination of Sub-part-per-Million Quan- tion tests for acidic foods shall be in- tities of Tin in Extracts and Biological cluded and simulated by 3-percent ace- Materials with Graphite Furnace,’’ An- tic acid at temperatures specified for alytical Chemistry, Vol. 49, pp. 1090–1093 water in table 2 of § 176.170(c) of this (1977), which is incorporated by ref- chapter. The extraction tests shall erence in accordance with 5 U.S.C.

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

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List of substances Limitations

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

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

List of substances Limitations

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

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List of substances Limitations

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

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

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

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

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List of substances Limitations

N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only: (C1-C18) are derived from tallow. 1. As an antistatic agent at levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of food-contact surface in vinylidene chloride copolymer coatings complying with § 175.320, § 177.1200, or § 177.1630 of this chapter, provided that such coatings contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV, VII, VIII, and IX under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter. The finished copolymers shall contain at least 70 weight pct of polymer units derived from vinylidene chloride; and shall contain not more than 5 weight pct of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid. N,N-Bis(2-hydroxyethyl)dodecanamide produced when For use only: diethanolamine is made to react with methyl laurate such 1. As an antistatic agent at levels not to exceed 0.5 percent by that the finished product: Has a minimum melting point of 36 weight of molded or extruded polyethylene containers in- °C; has a minimum amide assay of 90 percent; contains no tended for contact with honey, chocolate syrup, liquid sweet- more than 2 percent by weight of free diethanolamine; and eners, condiments, flavor extracts and liquid flavor con- contains no more than 0.5 percent by weight of N,N, bis(2- centrates, grated cheese, light and heavy cream, yogurt, and hydroxyethyl)piperazine, as determined by paper chroma- foods of Type VIII as described in table 1 of § 176.170(c) of tography method. this chapter. 2. As an antistatic agent at levels not to exceed 0.2 percent by weight in polypropylene films complying with § 177.1520 of this chapter, and used in contact with food of Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. The average thickness of such polypropylene film shall not exceed 0.001 inches (30 micrometers). N,N-Bis(2-hydroxyethyl) dodecanamide produced when For use only as an antistatic agent at levels not to exceed 0.5 diethanolamine is made to react with methyl laurate such percent by weight of molded or extruded polyethylene con- that the finished product: Has a minimum melting point of 36 tainers intended for contact with honey, chocolate syrup, liq- °C; has a minimum amide assay of 90 percent; contains no uid sweeteners, condiments, flavor extracts and liquid flavor more than 2 percent by weight of free diethanolamine; and concentrates, grated cheese, light and heavy cream, yogurt, contains no more than 0.5 percent by weight of N,N′-bis(2- and foods of Type VIII as described in table 1 of hydroxyethyl) piperazine, as determined by paper chroma- § 176.170(c) of this chapter. tography method. N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts For use only as an antistatic agent at levels not to exceed 0.45 Service Registry No. 10213–78–2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of Service Registry No. 66810–88–6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use salt), Chemical Abstracts Service Registry No. 24170–14–7, B through H described in table 2 of § 176.170(c). The aver- as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed ethylene oxide with octadecylamine and further reacting this 0.002 inch. product with sodium monochloroacetate and sodium hydroxide, such that the final product has: A nitrogen content of 3.3–3.8 percent; a melting point of 42°–50 °C; and a pH of 10.0–11.5 in a 1 percent by weight aqueous solution. a-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by For use only as an antistatic agent at levels not to exceed 0.2 the condensation of 1 mole of n-dodecanol with an average pct by weight in low-density polyethylene film having an av- of 9.5 moles of ethylene oxide to form a condensate having erage thickness not exceeding 0.005 inch. a hydroxyl content of 2.7 to 2.9 pct and having a cloud point of 80 °C to 92 °C in 1 pct by weight aqueous solution. Glycerol ester mixtures of ricinoleic acid, containing not more As an antifogging agent at levels not exceeding 1.5 pct by than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct weight of permitted plasticized vinyl chloride homo-and/or triricinoleate, and 3.3 pct free glycerine. copolymers. N-Methacryloyloxyethyl-N, N-dimethylammonium-a-N-methyl For use only as an antistatic agent at levels not to exceed 0.2 carboxylate chloride sodium salt, octadecyl methacrylate, percent by weight of polyolefin films that contact foods under ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2- the conditions of use B through H described in table 2 of pyrrolidone copolymer (CAS Reg. No. 66822–60–4). § 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch).

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List of substances Limitations

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

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

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

Use Limitations

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

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

§ 178.3290 Chromic chloride com- nor exceed 7 micrograms of chromium plexes. per square inch of closure area. Myristo chromic chloride complex (b) The packaging container which and stearato chromic chloride complex has its closure area treated with the may be safely used as release agents in release agent shall have a capacity of the closure area of packaging con- not less than 120 grams of food per tainers intended for use in producing, square inch of such treated closure manufacturing, packing, processing, area. preparing, treating, packaging, transporting, or holding food, subject to the § 178.3295 Clarifying agents for poly- provisions of this section: mers. (a) The quantity used shall not ex- Clarifying agents may be safely used ceed that reasonably required to ac- in polymers that are articles or compo- complish the intended technical effect nents of articles intended for use in

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contact with food, subject to the provisions of this section:

Substances Limitations

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

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Substances Limitations

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

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

§ 178.3297 Colorants for polymers. (b) The colorant must be used in accordance with current good manufac- The substances listed in paragraph turing practice, including use levels (e) of this section may be safely used as which are not in excess of those reason- colorants in the manufacture of arti- ably required to accomplish the in- cles or components of articles intended tended coloring effect. for use in producing, manufacturing, (c) Colorants in this section must packing, processing, preparing, treat- conform to the description and speci- ing, packaging, transporting, or hold- fications indicated. If a polymer de- ing food, subject to the provisions and scribed in this section is itself the sub- definitions set forth in this section: ject of a regulation promulgated under (a) The term colorant means a dye, section 409 of the Federal Food, Drug, pigment, or other substance that is and Cosmetic Act, it shall also comply used to impart color to or to alter the with any specifications and limitations color of a food-contact material, but prescribed by that regulation. Extrac- that does not migrate to food in tion testing guidelines to conduct stud- amounts that will contribute to that ies for additional uses of colorants food any color apparent to the naked under this section are available from eye. For the purpose of this section, the term ‘‘colorant’’ includes sub- the Food and Drug Administration free stances such as optical brighteners and of charge from the Center for Food fluorescent whiteners, which may not Safety and Applied Nutrition, (HFS– themselves be colored, but whose use is 200) Food and Drug Administration, intended to affect the color of a food- 5100 Paint Branch Pkwy., College Park, contact material. MD 20740.

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

Substances Limitations

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

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

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Substances Limitations

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

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Substances Limitations

High-purity furnace black (CAS Reg. No. 1333–86–4) con- For use at levels not to exceed 2.5 percent by weight of the taining total polynuclear aromatic hydrocarbons not to ex- polymer. ceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled ‘‘Determination of PAH Content of Carbon Black,’’ dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Premarket Approval (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Li- brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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.. Iron oxides. Kaolin-modified, produced by treating kaolin with a reaction For use only in olefin polymers complying with § 177.1520 of product of isopropyl titanate and oleic acid in which 1 mole this chapter at levels not to exceed 40 percent by weight of of isopropyl titanate is reacted with 1 to 2 moles of oleic olefin polymer. acid. The reaction product will not exceed 8 percent of the modified kaolin. The oleic acid used shall meet the requirements specified in § 172.860 of this chapter. Magnesium oxide. Magnesium silicate (talc). Manganese Violet (manganese ammonium pyrophosphate; For use at levels not to exceed 2 percent by weight of poly- CAS Reg. No. 10101–66–3).. mers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter. Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo- benzoxazolyl)stilbene (CAS Registry No. 5242–49–9) and ride and not to exceed 0.03 percent by weight in all other lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used benzoxazolyl)stilbene (CAS Registry No. 2397–00–4) and only under conditions of use D, E, F, and G described in 4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533–45– table 2 of § 176.170(c) of this chapter. 5). 7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in: No. 3333–62–8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter and a nitrogen content of 10.7 to 11.2 percent. only at levels such that the product of concentration of the optical brightener (expressed in parts per million by weight of the olefin polymer) multiplied by the thickness of the olefin polymer (expressed in thousandths of an inch and limited to no more than 0.400 inch) shall not exceed 500; provided that the level of the brightener shall not exceed 20 parts per million by weight of the olefin polymer, and further that the olefin polymers shall comply with specifications for items 1.1, 2.1, 3.1, 3.3, and 4 of § 177.1520(c) of this chapter. The polymer may be used under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use E, F, and G. 2. Polyethylene terephthalate specified in § 177.2800(d)(5)(i) of this chapter at a level not to exceed 0.035 percent by weight of the finished fibers. Nickel antimony titanium yellow rutile (C.I. Pigment Yellow 53, For use at levels not to exceed 1 percent by weight of poly- CAS Reg. No. 8007–18–9). mers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. 1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly- anthracenedione (CAS Reg. No. 4118–16–5). ethylene phthalate polymers that comply with § 177.1630 of this chapter. The finished articles are to contact food only under conditions of use E, F, and G described in table 2, § 176.170(c) of this chapter, except, when such articles are used with food types III, IV-A, and V, described in table 1, § 176.170(c) of this chapter, the finished articles are to contact food only under conditions of use D, E, F, and G. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–8). Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260). C.I. Pigment red 38 (C.I. No. 21120) ...... For use only in rubber articles for repeated use complying with § 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article.

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Substances Limitations

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

[48 FR 46775, Oct. 14, 1983]

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

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

List of substances Limitations

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

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List of substances Limitations

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

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

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List of substances Limitations

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

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List of substances Limitations

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

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

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(a) They are used or intended for use www.archives.gov/federallregister/ as plasticizers or lubricants in poly- codeloflfederallregulations/ styrene intended for use in contact ibrllocations.html. with food. (1) Synthetic fatty alcohols. (i) Hexyl, (b) They are added to the formulated octyl, decyl, lauryl, myristyl, cetyl, polymer prior to extrusion. and stearyl alcohols meeting the speci- (c) The quantity used shall not ex- fications and definition prescribed in ceed that required to accomplish the § 172.864 of this chapter, except that intended technical effect. they may contain not more than 0.8 weight percent total diols. § 178.3480 Fatty alcohols, synthetic. (ii) Lauryl, myristyl, cetyl, and ste- Synthetic fatty alcohols may be safe- aryl alcohols manufactured by the ly used as components of articles in- process described in § 172.864(a)(2) of tended for use in contact with food, this chapter such that lauryl and and in synthesizing food additives and myristyl alcohols meet the specifica- other substances permitted for use as tions in § 172.864(a)(1)(i) of this chapter, components of articles intended for use and cetyl and stearyl alcohols meet the in contact with food in accordance specifications in § 172.864(a)(1)(ii) of this with the following prescribed condi- chapter. tions: (2) Conditions of use. (i) Synthetic (a) The food additive consists of fatty fatty alcohols as substitutes for the alcohols meeting the specifications and corresponding naturally derived fatty definition prescribed in § 172.864 of this alcohols permitted for use in compli- chapter, except as provided in para- ance with § 178.3910. graph (c) of this section. (ii) Synthetic lauryl alcohol as a sub- (b) It is used or intended for use as stitute for the naturally derived lauryl follows: alcohol permitted as an intermediate (1) As substitutes for the cor- in the synthesis of sodium lauryl sul- responding naturally derived fatty al- fate used in compliance with § 178.3400. cohols permitted for use as components of articles intended for use in contact [42 FR 14609, Mar. 15, 1977, as amended at 47 with food by existing regulations in FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, parts 174, 175, 176, 177, 178 and § 179.45 of 1989] this chapter: Provided, That the use is § 178.3500 Glycerin, synthetic. in compliance with any prescribed limitations. Synthetic glycerin may be safely (2) As substitutes for the cor- used as a component of articles in- responding naturally derived fatty al- tended for use in packaging materials cohols used as intermediates in the for food, subject to the provisions of synthesis of food additives and other this section: substances permitted for use as compo- (a) It is produced by the hydro- nents of food-contact articles. genolysis of carbohydrates, and shall (c) Synthetic fatty alcohols identi- contain not in excess of 0.2 percent by fied in paragraph (c)(1) of this section weight of a mixture of butanetriols. may contain not more than 0.8 weight (b) It is used in a quantity not to ex- percent of total diols as determined by ceed that amount reasonably required a method titled ‘‘Diols in Monohydroxy to produce its intended physical or Alcohol by Miniature Thin Layer Chro- technical effect, and in accordance matography (MTLC),’’ which is incor- with any limitations prescribed by ap- porated by reference. Copies are avail- plicable regulations in parts 174, 175, able from the Center for Food Safety 176, 177, 178 and 179 of this chapter. It and Applied Nutrition (HFS–200), Food shall not be intended to, nor in fact ac- and Drug Administration, 5100 Paint complish, any direct physical or tech- Branch Pkwy., College Park, MD 20740, nical effect in the food itself. or available for inspection at the Na- tional Archives and Records Adminis- § 178.3505 Glyceryl tri-(12-acetoxy- tration (NARA). For information on stearate). the availability of this material at Glyceryl tri-(12-acetoxystearate) NARA, call 202–741–6030, or go to: http:// (CAS Reg. No. 139–43–5) may be safely

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

List of reactants Limitations

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

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

List of reactants Limitations

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

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List of reactants Limitations

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

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

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

Substances Limitations

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

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Substances Limitations

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

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

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§ 178.3600 Methyl glucoside-coconut oil this chapter may be used as a compo- ester. nent of nonfood articles provided such Methyl glucoside-coconut oil ester use complies with any applicable limi- identified in § 172.816(a) of this chapter tations in parts 170 through 189 of this may be safely used as a processing aid chapter. The use of white mineral oil in (filter aid) in the manufacture of or on food itself, including the use of starch, including industrial starch- white mineral oil as a protective coat- modified complying with § 178.3520, in- ing or release agent for food, is subject tended for use as a component of arti- to the provisions of § 172.878 of this cles that contact food. chapter. (b) Technical white mineral oil iden- § 178.3610 ù-Methylstyrene- tified in paragraph (b)(1) of this section vinyltoluene resins, hydrogenated. may be used as provided in paragraph Hydrogenated a-methylstyrene- (b)(2) of this section. vinyltoluene copolymer resins having a (1) Technical white mineral oil con- molar ratio of 1 a-methylstyrene to 3 sists of specially refined distillates of vinyltoluene may be safely used as virgin petroleum or of specially refined components of polyolefin film intended distillates that are produced syn- for use in contact with food, subject to thetically from petroleum gases. Tech- the following provisions: nical white mineral oil meets the fol- (a) Hydrogenated a-methylstyrene- lowing specifications: vinyltoluene copolymer resins have a (i) Saybolt color 20 minimum as de- drop-softening point of 125° to 165 °C termined by ASTM method D156–82, and a maximum absorptivity of 0.17 ‘‘Standard Test Method for Saybolt liter per gram centimeter at 266 nano- Color of Petroleum Products (Saybolt meters, as determined by methods ti- Chromometer Method),’’ which is in- tled ‘‘Determination of Softening Point corporated by reference. Copies may be (Drop Method)’’ and ‘‘Determination of obtained from the American Society Unsaturation of Resin 1977,’’ which are for Testing Materials, 100 Barr Harbor incorporated by reference. Copies are Dr., West Conshohocken, Philadelphia, available from the Center for Food PA 19428-2959, or may be examined at Safety and Applied Nutrition (HFS– the National Archives and Records Ad- 200), Food and Drug Administration, ministration (NARA). For information 5100 Paint Branch Pkwy., College Park, on the availability of this material at MD 20740, or available for inspection at NARA, call 202–741–6030, or go to: http:// the National Archives and Records Ad- www.archives.gov/federallregister/ ministration (NARA). For information codeloflfederallregulations/ on the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (ii) Ultraviolet absorbance limits as www.archives.gov/federallregister/ follows: codeloflfederallregulations/ ibrllocations.html. Maximum absorb- (b) The polyolefin film is produced μ ance per from olefin polymers complying with Wavelength (m ) centimeter optical § 177.1520 of this chapter, and the aver- pathlength age thickness of the film in the form in which it contacts food does not exceed 280 to 289 ...... 4.0 290 to 299 ...... 3.3 0.002 inch. 300 to 329 ...... 2.3 [42 FR 14609, Mar. 15, 1977, as amended at 47 330 to 350 ...... 0.8 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989] Technical white mineral oil containing antioxidants shall meet the specified § 178.3620 Mineral oil. ultraviolet absorbance limits after cor- Mineral oil may be safely used as a rection for any absorbance due to the component of nonfood articles intended antioxidants. The ultraviolet absorb- for use in contact with food, subject to ance shall be determined by the proce- the provisions of this section: dure described for application to min- (a) White mineral oil meeting the eral oil under ‘‘Specification’’ on page specifications prescribed in § 172.878 of 66 of the ‘‘Journal of the Association of

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Official Agricultural Chemists,’’ Vol- reference is given in paragraph (b)(1)(i) ume 45 (February 1962) (which is incor- of this section. porated by reference; copies are avail- (iii) Ultraviolet absorbance limits as able from the Center for Food Safety follows as determined by the analytical and Applied Nutrition (HFS–200), Food method described in paragraph (c)(3) of and Drug Administration, 5100 Paint this section: Branch Pkwy., College Park, MD 20740, or available for inspection at the Na- Maximum absorb- tional Archives and Records Adminis- Wavelength (mμ) ance per tration (NARA). For information on centimeter optical the availability of this material at pathlength NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ 280 to 289 ...... 0.7 290 to 299 ...... 0.6 codeloflfederallregulations/ 300 to 359 ...... 0.4 ibrllocations.html.), disregarding the 360 to 400 ...... 09 last two sentences of that procedure and substituting therefor the fol- (2) The mineral oil may be used wher- lowing: Determine the absorbance of ever mineral oil is permitted for use as the mineral oil extract in a 10-milli- a component of nonfood articles com- meter cell in the range from 260–350 plying with §§ 175.105 and 176.210 of this mμ, inclusive, compared to the solvent chapter and § 178.3910 (for use only in control. If the absorbance so measured rolling of metallic foil and sheet exceeds 2.0 at any point in range 280–350 stock), §§ 176.200, 177.2260, 177.2600, and mμ, inclusive, dilute the extract and 177.2800 of this chapter. the solvent control, respectively, to (3) The analytical method for deter- twice their volume with dimethyl sulf- mining ultraviolet absorbance limit is oxide and remeasure the absorbance. as follows: Multiply the remeasured absorbance values by 2 to determine the absorb- GENERAL INSTRUCTIONS ance of the mineral oil extract per cen- Because of the sensitivity of the test, the timeter optical pathlength. possibility of errors arising from contamina- (2) Technical white mineral oil may tion is great. It is of the greatest importance be used wherever mineral oil is per- that all glassware be scrupulously cleaned to mitted for use as a component of remove all organic matter such as oil, nonfood articles complying with grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, §§ 175.105, 176.200, 176.210, 177.2260, under ultraviolet light to detect any residual 177.2600, and 177.2800 of this chapter and fluorescent contamination. As a pre- §§ 178.3570 and 178.3910. cautionary measure it is recommended prac- (3) Technical white mineral oil may tice to rinse all glassware with purified iso- contain any antioxidant permitted in octane immediately before use. No grease is food by regulations issued in accord- to be used on stopcocks or joints. Great care ance with section 409 of the Act, in an to avoid contamination of oil samples in amount not greater than that required handling and to assure absence of any extraneous material arising from inadequate to produce its intended effect. packaging is essential. Because some of the (c) Mineral oil identified in para- polynuclear hydrocarbons sought in this test graph (c)(1) of this section may be used are very susceptible to photo-oxidation, the as provided in paragraph (c)(2) of this entire procedure is to be carried out under section. subdued light. (1) The mineral oil consists of virgin petroleum distillates refined to meet APPARATUS the following specifications: Separatory funnels. 250-milliliter, 500-milli- (i) Initial boiling point of 450 °F min- liter, 1,000-milliliter, and preferably 2,000- imum. milliliter capacity, equipped with tetra- (ii) Color 5.5 maximum as determined fluoroethylene polymer stopcocks. by ASTM method D1500–82, ‘‘Standard Reservoir. 500-milliliter capacity, equipped with a 24/40 standard taper male fitting at Test Method for ASTM Color of Petro- the bottom and a suitable ball-joint at the leum Products (ASTM Color Scale),’’ top for connecting to the nitrogen supply. which is incorporated by reference. The The male fitting should be equipped with availability of this incorporation by glass hooks.

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Chromatographic tube. 180 millimeters in REAGENTS AND MATERIALS length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, frit- Organic solvents. All solvents used through- ted-glass disc, a tetrafluoroethylene polymer out the procedure shall meet the specifica- stopcock, and a female 24/40 standard tapered tions and tests described in this specifica- fitting at the opposite end. (Overall length of tion. The isooctane, benzene, acetone, and the column with the female joint is 235 milli- methyl alcohol designated in the list fol- meters.) The female fitting should be lowing this paragraph shall pass the fol- equipped with glass hooks. lowing test: Disc. Tetrafluoroethylene polymer 2-inch To the specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milli- diameter disk approximately 3⁄16-inch thick with a hole bored in the center to closely fit liter of purified n-hexadecane and evaporate the stem of the chromatographic tube. on the steam bath under a stream of nitro- Suction flask. 250-milliliter or 500-milliliter gen (a loose aluminum foil jacket around the filter flask. flask will speed evaporation). Discontinue Condenser. 24/40 joints, fitted with a drying evaporation when not over 1 milliliter of res- tube, length optional. idue remains. (To the residue from benzene Evaporation flask (optional). 250-milliliter or add a 10-milliliter portion of purified iso- 500-milliliter capacity all-glass flask octane, reevaporate, and repeat once to in- equipped with standard taper stopper having sure complete removal of benzene.) inlet and outlet tubes to permit passage of Alternatively, the evaporation time can be nitrogen across the surface of contained liq- reduced by using the optional evaporation uid to be evaporated. flask. In this case the solvent and n-hexa- Spectrophotometric cells. Fused quartz cells, decane are placed in the flask on the steam optical path length in the range of 5,000 cen- bath, the tube assembly is inserted, and a timeter ±0.005 centimeter; also for checking stream of nitrogen is fed through the inlet spectrophotometer performance only, optical tube while the outlet tube is connected to a path length in the range 1,000 centimeter solvent trap and vacuum line in such a way ±0.005 centimeter. With distilled water in the as to prevent any flow-back of condensate cells, determine any absorbance differences. into the flask. Spectrophotometer. Spectral range 250 milli- Dissolve the 1 milliliter of hexadecane res- microns—400 millimicrons with spectral slit idue in isooctane and make to 25 milliliters width of 2 millimicrons or less; under instru- volume. Determine the absorbance in the 5- ment operating conditions for these absorb- centimeter path length cells compared to ance measurements, the spectrophotometer isooctane as reference. The absorbance of the shall also meet the following performance solution of the solvent residue (except for requirements: methyl alcohol) shall not exceed 0.01 per cen- Absorbance repeatability, ±0.01 at 0.4 ab- timeter path length between 280 and 400 mμ. sorbance. For methyl alcohol this absorbance value Absorbance accuracy 1 ±0.05 at 0.4 absorb- shall be 0.00. ance. Isooctane (2,2,4-trimethylpentane). Use 180 Wavelength accuracy, ±1.0 millimicron. milliliters for the test described in the pre- Nitrogen cylinder. Water-pumped or equiva- ceding paragraph. Purify, if necessary, by lent purity nitrogen in cylinder equipped passage through a column of activated silica with regulator and valve to control flow at 5 gel (Grade 12, Davison Chemical Company, p.s.i.g. Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter. 1 As determined by procedure using potassium chromate for reference standard and Benzene, A.C.S. reagent grade. Use 150 milli- described in National Bureau of Standards liters for the test. Purify, if necessary, by Circular 484, Spectrophotometry, U.S. De- distillation or otherwise. partment of Commerce (1949). The accuracy Acetone, A.C.S. reagent grade. Use 200 milli- is to be determined by comparison with the liters for the test. Purify, if necessary, by standard values at 290, 345, and 400 milli- distillation. microns. Circular 484 is incorporated by ref- Eluting mixtures: erence. Copies are available from the Center 1. 10 percent benzene in isooctane. Pipet 50 for Food Safety and Applied Nutrition (HFS– milliliters of benzene into a 250-milliliter 200), Food and Drug Administration, 5100 glass-stoppered volumetric flask and adjust Paint Branch Pkwy., College Park, MD 20740, to volume with isooctane, with mixing. or available for inspection at the National 2. 20 percent benzene in isooctane. Pipet 50 Archives and Records Administration milliliters of benzene into a 250-milliliter (NARA). For information on the availability glass-stoppered volumetric flask and adjust of this material at NARA, call 202–741–6030, to volume with isooctane, with mixing. or go to: http://www.archives.gov/ 3. Acetone-benzene-water mixture. Add 20 federallregister/codeloflfederallregulations/ milliliters of water to 380 milliliters of ace- ibrllocations.html. tone and 200 milliliters of benzene, and mix.

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

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

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

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

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

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

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

Use Limitations

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

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

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

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Substances Limitations

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

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

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

Substances Limitations

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

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Substances Limitations

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

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

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Substances Limitations

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

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Substances Limitations

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

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

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

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are very susceptible to photo-oxidation, the Absorbance accuracy, 1 ±0.05 at 0.4 absorb- entire procedure is to be carried out under ance. subdued light. Wavelength repeatability, ±0.2 millimicron. APPARATUS Wavelength accuracy, ±1.0 millimicron. Separatory funnels. 250-milliliter, 500-milli- Recording time, 50 seconds. liter, 1,000-milliliter, and preferably 2,000- Time constant, 0.6 second. milliliter capacity, equipped with tetra- Sensitivity, 30. fluoroethylene polymer stopcocks. Ordinate scale, 90–100 percent transmission Reservoir. 1,000-milliliter capacity, through scale. equipped with a 24/40 standard taper male fit- Abscissa scale, 8X. ting at the bottom and a suitable balljoint at Nitrogen cylinder. Water-pumped or equiva- the top. lent purity nitrogen in cylinder equipped Chromatographic tube. 1,200 millimeters in with regulator and valve to control flow at 5 length, inside diameter to be 16.5 millimeters p.s.i.g. ±0.5 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer REAGENTS AND MATERIALS stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of Organic solvents. All solvents used through- the column with the female joint is 1,255 mil- out the procedure shall meet the specifica- limeters.) The female fitting should be tions and tests described in this specifica- equipped with glass hooks. tion. The isooctane and benzene designated Disc. Tetrafluoroethylene polymer 2-inch in the list following this paragraph shall diameter disc approximately 3⁄16-inch thick pass the following test: with a hole bored in the center to closely fit To be specified quantity of solvent in a 250- the stem of the chromatographic tube. milliliter Erlenmeyer flask, add 1 milliliter Heating jackets. Conical, for 500-milliliter of purified n-hexadecane and evaporate on and 1,000-milliliter separatory funnels. (Used the steam bath under a stream of nitrogen (a with variable transformer heat control.) loose aluminum foil jacket around the flask Suction flask. 250-milliliter or 500-milliliter will speed evaporation). Discontinue evapo- filter flask. ration when not over 1 milliliter of residue Condenser. 24⁄40 joints, fitted with a drying remains. (To the residue from benzene add a tube, length optional. 10-milliliter portion of purified isooctane, re- Evaporation flasks (optional). A 250-milli- evaporate, and repeat once to insure com- liter or 500-milliliter capacity and a 1-liter plete removal of benzene.) capacity all-glass flask equipped with stand- Alternatively, the evaporation time can be ard taper stopper having inlet and outlet reduced by using the optional evaporation tubes to permit passage of nitrogen across flask. In this case the solvent and n-hexa- the surface of contained liquid to be evapo- decane are placed in the flask on the steam rated. bath, the tube assembly is inserted, and a Vacuum distillation assembly. All glass (for stream of nitrogen is fed through the inlet purification of dimethyl sulfoxide) 2-liter tube while the outlet tube is connected to a distillation flask with heating mantle; solvent trap and vacuum line in such a way Vigreaux vacuum-jacketed condenser (or as to prevent any flow-back of condensate equivalent) about 45 centimeters in length into the flask. and distilling head with separable cold finger condenser. Use of tetrafluoroethylene poly- 1 As determined by procedure using potas- mer sleeves on the glass joints will prevent sium chromate for reference standard and freezing. Do not use grease on stopcocks or described in National Bureau of Standards joints. Circular 484, Spectrometry, U.S. Department ° Oil bath. Capable of heating to 90 C. of Commerce (1949). The accuracy is to be de- Spectrophotometric cells. Fused quartz cells, termined by comparison with the standard optical pathlength in the range 1.000 centi- values at 290, 345, and 400 millimicrons. Cir- ± meter 0.005 centimeter. With distilled water cular 484 is incorporated by reference. Copies in the cells, determine any absorbance dif- are available from the Center for Food Safe- ferences. ty and Applied Nutrition (HFS–200), Food Spectrophotometer. Spectral range 250 milli- and Drug Administration, 5100 Paint Branch microns-400 millimicrons with spectral slit Pkwy., College Park, MD 20740, or available width of 0.2 millimicron or less; under infor inspection at the National Archives and strument operating conditions for these ab- Records Administration (NARA). For infor- sorbance measurements. The spectrophotom- mation on the availability of this material eter shall also meet the following perform- at NARA, call 202–741–6030, or go to: http:// ance requirements: www.archives.gov/federallregister/ Absorbance repeatability, ±0.01 at 0.4 ab- codeloflfederallregulations/ sorbance. ibrllocations.html.

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

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

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

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

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neutralized with calcium hydroxide to reference. Copies are available from produce a composition having up to 2 American Association of Oil Chemists, percent by weight calcium. The alpha- 36 East Wacker Drive, Chicago, IL olefins, obtained from the polymeriza- 60601, or available for inspection at the tion of ethylene, have 20 to 50 carbon National Archives and Records Admin- atoms and contain a minimum of 75 istration (NARA). For information on percent by weight straight chain alpha- the availability of this material at olefins and not more than 25 percent NARA, call 202–741–6030, or go to: http:// vinylidene compounds. www.archives.gov/federallregister/ (b) Specifications. The polyhydric al- codeloflfederallregulations/ cohol esters have the following speci- ibrllocations.html. fications: (4) Ultraviolet absorbance as speci- (1) Melting point of 60–80 °C for the fied in § 178.3770(a)(4) of this chapter ethylene glycol ester and 90–105 °C for when tested by the analytical method the glycerol ester as determined by the described therein. Fisher Johns method as described in [42 FR 14609, Mar. 15, 1977, as amended at 47 ‘‘Semimicro Qualitative Organic Anal- FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, ysis—The Systematic Identification of 1989; 61 FR 14481, Apr. 2, 1996] Organic Compounds,’’ by Cheronis and Entrikin, 2d Ed., Interscience Pub- § 178.3790 Polymer modifiers in lishers, NY, which is incorporated by semirigid and rigid vinyl chloride reference. Copies are available from plastics. the Center for Food Safety and Applied The polymers identified in paragraph Nutrition (HFS–200), Food and Drug (a) of this section may be safely Administration, 5100 Paint Branch admixed, alone or in mixture with Pkwy., College Park, MD 20740, or other permitted polymers, as modifiers available for inspection at the National in semirigid and rigid vinyl chloride Archives and Records Administration plastic food-contact articles prepared (NARA). For information on the avail- from vinyl chloride homopolymers and/ ability of this material at NARA, call or from vinyl chloride copolymers com- 202–741–6030, or go to: http:// plying with § 177.1950, § 177.1970, and/or www.archives.gov/federallregister/ § 177.1980 of this chapter, in accordance codeloflfederallregulations/ with the following prescribed condi- ibrllocations.html. tions: (2) Acid value 15–25 for each ester as (a) For the purpose of this section, determined by the A.O.C.S. method the polymer modifiers are identified as Trla-64T ‘‘Titer Test,’’ which is incor- follows: porated by reference. Copies are avail- (1) Acrylic polymers identified in this able from American Association of Oil subparagraph provided that such poly- Chemists, 36 East Wacker Drive, Chi- mers contain at least 50 weight-percent cago, IL 60601, or available for inspec- of polymer units derived from one or tion at the National Archives and more of the monomers listed in para- Records Administration (NARA). For graph (a)(1)(i) of this section. information on the availability of this (i) Homopolymers and copolymers of material at NARA, call 202–741–6030, or the following monomers: go to: http://www.archives.gov/ n-Butyl acrylate. federallregister/ n-Butyl methacrylate. codeloflfederallregulations/ Ethyl acrylate. ibrllocations.html. The method is modi- Methyl methacrylate. fied to use as the acid solvent a 1:1 vol- (ii) Copolymers produced by co- ume mixture of anhydrous isopropyl al- polymerizing one or more of the mono- cohol and toluene. The solution is mers listed in paragraph (a)(1)(i) of this titrated with 0.1N methanolic sodium section with one or more of the fol- hydroxide. lowing monomers: (3) Saponification value 120–160 for Acrylonitrile. the ethylene glycol ester and 90–130 for Butadiene. the glycerol ester as determined the a-Methylstyrene. A.O.C.S. method Trla-64T ‘‘Saponifica- Styrene. tion Value,’’ which is incorporated by Vinylidene chloride.

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

List of substances Limitations

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

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List of substances Limitations

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

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

List of substances Limitations

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

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List of substances Limitations

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

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

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

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

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(c) The use in any substance or arti- (4) Viscosity: Viscosity in poises cle that is the subject of a regulation shall be as determined by ASTM meth- in parts 174, 175, 176, 177, 178 and § 179.45 od D1824–66 (Reapproved 1980), ‘‘Stand- of this chapter shall conform with any ard Test Method for Apparent Vis- specifications and limitations pre- cosity of Plastisols and Organosols at scribed by such regulation for the fin- Low Shear Rates by Brookfield Vis- ished form of the substance or article. cometer,’’ and in Saybolt seconds by (d) The provisions of this section are ASTM method D88–81, ‘‘Standard Test not applicable to rosins and rosin de- Method for Saybolt Viscosity,’’ which rivatives identified in § 175.300(b)(3)(v) are incorporated by reference. The of this chapter and used in resinous availability of this incorporation by and polymeric coatings complying with reference is given in paragraph (f)(1) of § 175.300 of this chapter. this section. (e) The provisions of this section are (5) Softening point: Softening point not applicable to rosins and rosin de- shall be as determined by ASTM meth- rivatives identified in § 175.105(c)(5) of od E28–67, ‘‘Standard Test Method for this chapter and used in defoaming Softening Point by Ring and Ball Ap- agents complying with § 176.210 of this paratus’’ (Reapproved 1977), which is chapter, food-packaging adhesives incorporated by reference. Copies are complying with § 175.105 of this chapter, available from American Society for and rubber articles complying with Testing and Materials (ASTM), 100 § 177.2600 of this chapter. Barr Harbor Dr., West Conshohocken, (f) The analytical methods for deter- Philadelphia, PA 19428-2959, or avail- mining whether rosins and rosin derivatives conform to the specifications able for inspection at the National Ar- prescribed in paragraph (a) of this sec- chives and Records Administration tion are as follows: (NARA). For information on the avail- (1) Color: Color shall be as deter- ability of this material at NARA, call mined by ASTM method D509–70 (Re- 202–741–6030, or go to: http:// approved 1981), ‘‘Standard Methods of www.archives.gov/federallregister/ Sampling and Grading Rosin,’’ which is codeloflfederallregulations/ incorporated by reference. Copies may ibrllocations.html. be obtained from the American Society (6) Analytical methods for deter- for Testing Materials, 100 Barr Harbor mining drop-softening point, saponi- Dr., West Conshohocken, Philadelphia, fication number, and any other speci- PA 19428-2959, or may be examined at fications not listed under paragraphs the National Archives and Records Ad- (f)(1) through (5) of this section, titled: ministration (NARA). For information (i) ‘‘Determination of Abeitic Acid and on the availability of this material at Dehydroabietic Acid in Rosins’’; (ii) NARA, call 202–741–6030, or go to: http:// ‘‘Determination of Softening Point of www.archives.gov/federallregister/ Solid Resins’’; (iii) ‘‘Determination of codeloflfederallregulations/ Saponification Number of Rosin ibrllocations.html. Esters,’’ and (iv) ‘‘Determination of (2) Refractive index: Refractive index Phenolic Modification of Rosin Deriva- shall be as determined by ASTM meth- tives,’’ which are incorporated by ref- od D1747–62 (Reapproved 1978), ‘‘Stand- erence. Copies are available from the ard Test Method for Refractive Index of Center for Food Safety and Applied Nu- Viscous Materials,’’ which is incor- trition (HFS–200), Food and Drug Ad- porated by reference. The availability ministration, 5100 Paint Branch Pkwy., of this incorporation by reference is College Park, MD 20740, or available for given in paragraph (f)(1) of this section. inspection at the National Archives (3) Acid number: Acid number shall and Records Administration (NARA). be as determined by ASTM method For information on the availability of D465–82, ‘‘Standard Test Methods for this material at NARA, call 202–741– Acid Number of Rosin,’’ which is incor- 6030, or go to: http://www.archives.gov/ porated by reference. The availability federallregister/ of this incorporation by reference is given in paragraph (f)(1) of this section.

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

List of substances Limitations

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

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List of substances Limitations

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

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

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material at NARA, call 202–741–6030, or under ultraviolet light to detect any residual go to: http://www.archives.gov/ fluorescent contamination. As a pre- federallregister/ cautionary measure it is recommended prac- codeloflfederallregulations/ tice to rinse all glassware with purified isooctane immediately before use. No grease is ibrllocations.html. to be used on stopcocks or joints. Great care (b) Nonvolatile residue is 0.005 gram to avoid contamination of oil samples in per 100 milliliters, maximum, as deter- handling and to assure absence of any extra- mined by ASTM method D381–80, neous material arising from inadequate ‘‘Standard Test Method for Existent packaging is essential. Because some of the Gum in Fuels by Jet Evaporation,’’ polynuclear hydrocarbons sought in this test when the final boiling point is 121 °C or are very susceptible to photo-oxidation, the above and by ASTM method D1353–78, entire procedure is to be carried out under subdued light. ‘‘Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in APPARATUS Paint, Varnish, Lacquer, and Related Separatory funnels. 250-milliliter, 500-milli- Products,’’ when the final boiling point liter, 1,000-milliliter, and preferably 2,000- is below 121 °C. These ASTM methods milliliter capacity, equipped with tetra- are incorporated by reference. The fluoroethylene polymer stopcocks. availability of these incorporations by Evaporation flask (optional). 250-milliliter or reference is given in paragraph 500-milliliter capacity all-glass flask (a)(4)(i)(a) of this section. equipped with standard-taper stopper having (c) Saybolt color 20 minimum as de- inlet and outlet tubes to permit passage of termined by ASTM method D156–82, nitrogen across the surface of contained liquid to be evaporated. ‘‘Standard Test Method for Saybolt Spectrophotometric cells. Fused quartz cells, Color of Petroleum Products (Saybolt optical path length in the range of 5,000 cen- Chromometer Method),’’ which is in- timeters ±0.005 centimeter; also for checking corporated by reference. The avail- spectrophotometer performance only, optical ability of this incorporation by ref- path length in the range 1.000 centimeter erence is given in paragraph (a)(4)(i)(a) ±0.005 centimeter. With distilled water in the of this section. cells, determine any absorbance differences. (d) Aromatic component content Spectrophotometer. Special range 250 millicrons-400 millimicrons with spectral slit shall not exceed 32 percent. width of 2 millimicrons or less; under instru- (e) Conforms with ultraviolet absorb- ment operating conditions for these absorbance limits prescribed in § 178.3620(c) as ance measurements, the spectrophotometer determined by the analytical method shall also meet the following performance described therein. requirements: (ii) Ultraviolet absorbance limits on Absorbance repeatability, ±0.01 at 0.4 ab- residual lubricants are as follows: sorbance. Absorbance accuracy, 1 ±0.05 at 0.4 absorb- Maximum ance. absorb- Wavelength repeatability, ±0.2 milli- ance per 5 Wavelength (mμ) centi- micron. meters op- Wavelength accuracy, ±1.0 millimicron. tical pathlength 1 As determined by procedure using potas- 280–289 ...... 0.7 sium chromate for reference standard and 290–299 ...... 6 described in National Bureau of Standards 300–359 ...... 4 Circular 484, Spectrometry, U.S. Department 360–400 ...... 09 of Commerce (1949), which is incorporated by (iii) The analytical method for deter- reference. Copies are available from the Cen- ter for Food Safety and Applied Nutrition mining ultraviolet absorbance limits (HFS–200), Food and Drug Administration, on residual lubricants is as follows: 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Na- GENERAL INSTRUCTIONS tional Archives and Records Administration Because of the sensitivity of the test, the (NARA). For information on the availability possibility of errors arising from contamina- of this material at NARA, call 202–741–6030, tion is great. It is of the greatest importance or go to: http://www.archives.gov/ that all glassware be scrupulously cleaned to federallregister/codeloflfederallregulations/ remove all organic matter such as oil, ibrllocations.html. The accuracy is to be de- grease, detergent, residues, etc. Examine all termined by comparison with the standard glassware including stoppers and stopcocks, values at 210, 345, and 400 millimicrons.

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

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

List of substances Limitations

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

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List of substances Limitations

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

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

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scale as measured in 50 percent mineral Subpart C—Packaging Materials for spirits solution. Irradiated Foods

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

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

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permitted by paragraph (a)(4) of this Use Limitations section. 7. For the sterilization of frozen, pack- Minimum dose 44 (4) X rays generated from machine aged meats used solely in the Na- kGy (4.4 Mrad). sources using tantalum or gold as the tional Aeronautics and Space Admin- Packaging mate- target material and using energies not istration space flight programs. rials used need to exceed 7.5 (MeV). not comply with § 179.25(c) pro- (b) Limitations. vided that their use is otherwise Use Limitations permitted by applicable regula- 1. For control of Trichinella spiralis in Minimum dose 0.3 tions in parts 174 pork carcasses or fresh, non-heat- kiloGray (kGy) through 186 of processed cuts of pork carcasses. (30 kilorad this chapter. (krad)); maximum 8. For control of foodborne pathogens Not to exceed 4.5 dose not to ex- in, and extension of the shelf-life of, kGy maximum ceed 1 kGy (100 refrigerated or frozen, uncooked for refrigerated krad). 2. For growth and maturation inhibition Not to exceed 1 products that are meat within the products; not to of fresh foods. kGy (100 krad). meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy 3. For disinfestation of arthropod pests Do. byproducts within the meaning of 9 maximum for fro- in food. CFR 301.2(tt), or meat food products zen products. 4. For microbial disinfection of dry or Not to exceed 10 within the meaning of 9 CFR dehydrated enzyme preparations (in- kGy (1 megarad 301.2(uu), with or without nonfluid cluding immobilized enzymes). (Mrad)). seasoning, that are otherwise com- 5. For microbial disinfection of the fol- Not to exceed 30 posed solely of intact or ground lowing dry or dehydrated aromatic kGy (3 Mrad). meat, meat byproducts, or both meat vegetable substances when used as and meat byproducts. ingredients in small amounts solely 9. For control of Salmonella in fresh Not to exceed 3.0 for flavoring or aroma: culinary herbs, shell eggs.. kGy. seeds, spices, vegetable seasonings 10. For control of microbial pathogens Not to exceed 8.0 that are used to impart flavor but that on seeds for sprouting.. kGy. are not either represented as, or ap- 11. For the control of Vibrio bacteria Not to exceed 5.5 pear to be, a vegetable that is eaten and other foodborne microorganisms kGy. for its own sake, and blends of these in or on fresh or frozen molluscan aromatic vegetable substances. Tur- shellfish.. meric and paprika may also be irradi- 12. For control of food-borne pathogens Not to exceed 4.0 ated when they are to be used as and extension of shelf-life in fresh kGy. color additives. The blends may con- iceberg lettuce and fresh spinach.. tain sodium chloride and minor amounts of dry food ingredients ordinarily used in such blends. (c) Labeling. (1) The label and label- 6. For control of food-borne pathogens Not to exceed 3 ing of retail packages of foods irradi- in fresh or frozen, uncooked poultry kGy (300 krad); ated in conformance with paragraph (b) products that are: (1) Whole car- any packaging casses or disjointed portions of such used shall not of this section shall bear the following carcasses that are ‘‘ready-to-cook exclude oxygen. logo along with either the statement poultry’’ within the meaning of 9 CFR 381.1(b)(44), or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses).

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‘‘Treated with radiation’’ or the when shipped to a food manufacturer statement ‘‘Treated by irradiation’’ in or processor for further processing, la- addition to information required by beling, or packing. other regulations. The logo shall be [51 FR 13399, Apr. 18, 1986, as amended at 53 placed prominently and conspicuously FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, in conjunction with the required state- 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, ment. The radiation disclosure state- Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR ment is not required to be more promi- 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 nent than the declaration of ingredi- FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, ents required under § 101.4 of this chap- 2000; 65 FR 64607, Oct. 30, 2000; 69 FR 76846, ter. As used in this provision, the term Dec. 23, 2004; 70 FR 48072, Aug. 16, 2005; 73 FR ‘‘radiation disclosure statement’’ 49603, Aug. 22, 2008] means the written statement that dis- closes that a food has been inten- § 179.30 Radiofrequency radiation for the heating of food, including tionally subject to irradiation. microwave frequencies. (2) For irradiated foods not in package form, the required logo and phrase Radiofrequency radiation, including ‘‘Treated with radiation’’ or ‘‘Treated microwave frequencies, may be safely by irradiation’’ shall be displayed to used for heating food under the fol- the purchaser with either (i) the label- lowing conditions: ing of the bulk container plainly in (a) The radiation source consists of view or (ii) a counter sign, card, or electronic equipment producing radio other appropriate device bearing the waves with specific frequencies for this information that the product has been purpose authorized by the Federal treated with radiation. As an alter- Communications Commission. native, each item of food may be indi- (b) The radiation is used or intended vidually labeled. In either case, the infor use in the production of heat in formation must be prominently and food wherever heat is necessary and ef- conspicuously displayed to purchasers. fective in the treatment or processing The labeling requirement applies only of food. to a food that has been irradiated, not to a food that merely contains an irra- § 179.39 Ultraviolet radiation for the diated ingredient but that has not processing and treatment of food. itself been irradiated. Ultraviolet radiation for the proc- (3) For a food, any portion of which is essing and treatment of food may be irradiated in conformance with para- safely used under the following condi- graph (b) of this section, the label and tions: labeling and invoices or bills of lading (a) The radiation sources consist of shall bear either the statement low pressure mercury lamps emitting ‘‘Treated with radiation—do not irra- 90 percent of the emission at a wave- diate again’’ or the statement ‘‘Treated length of 253.7 nanometers (2,537 by irradiation—do not irradiate again’’ Angstroms).

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(b) The ultraviolet radiation is used or intended for use as follows:

Irradiated food Limitations Use

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

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

§ 179.41 Pulsed light for the treatment (b) The following packaging mate- of food. rials may be subjected to a dose of ra- Pulsed light may be safely used for diation, not to exceed 10 kilograys, un- treatment of foods under the following less otherwise indicated, incidental to conditions: the use of gamma, electron beam, or X- (a) The radiation sources consist of radiation in the radiation treatment of xenon flashlamps designed to emit prepackaged foods: broadband radiation consisting of (1) Nitrocellulose-coated or vinyli- wavelengths covering the range of 200 dene chloride copolymer-coated cello- to 1,100 nanometers (nm), and operated phane complying with § 177.1200 of this so that the pulse duration is no longer chapter. than 2 milliseconds (msec); (2) Glassine paper complying with (b) The treatment is used for surface § 176.170 of this chapter. microorganism control; (3) Wax-coated paperboard complying (c) Foods treated with pulsed light with § 176.170 of this chapter. shall receive the minimum treatment (4) Polyolefin film prepared from one reasonably required to accomplish the or more of the basic olefin polymers intended technical effect; and complying with § 177.1520 of this chap- (d) The total cumulative treatment ter. The finished film may contain: shall not exceed 12.0 Joules/square cen- (i) Adjuvant substances used in com- timeter (J/cm2.) pliance with §§ 178.3740 and 181.22 through 181.30 of this chapter, sodium [61 FR 42383, Aug. 15, 1996] citrate, sodium lauryl sulfate, polyvinyl chloride, and materials as listed Subpart C—Packaging Materials in paragraph (d)(2)(i) of this section. for Irradiated Foods (ii) Coatings comprising a vinylidene chloride copolymer containing a min- § 179.45 Packaging materials for use imum of 85 percent vinylidene chloride during the irradiation of pre- with one or more of the following co- packaged foods. monomers: Acrylic acid, acrylonitrile, The packaging materials identified itaconic acid, methyl acrylate, and in this section may be safely subjected methyl methacrylate. to irradiation incidental to the radi- (5) Kraft paper prepared from un- ation treatment and processing of pre- bleached sulfate pulp to which rosin, packaged foods, subject to the provi- complying with § 178.3870 of this chap- sions of this section and to the require- ter, and alum may be added. The kraft ment that no induced radioactivity is paper is used only as a container for detectable in the packaging material flour and is irradiated with a dose not itself: exceeding 500 grays. (a) The radiation of the food itself (6) Polyethylene terephthalate film shall comply with regulations in this prepared from the basic polymer as depart. scribed in § 177.1630(e)(4)(i) and (ii) of

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

Substances Limitations

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

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(ii) Polyethylene terephthalate film 180.30 Brominated vegetable oil. prepared from the basic polymer as de- 180.37 Saccharin, ammonium saccharin, cal- scribed in § 177.1630(e)(4)(ii) of this cium saccharin, and sodium saccharin. chapter. The finished film may contain AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; one or more of the added substances 42 U.S.C. 241. listed in paragraph (d)(2)(i) of this sec- EDITORIAL NOTE: Nomenclature changes to tion. part 180 appear at 61 FR 14482, Apr. 2, 1996, (iii) Nylon 6 films prepared from the and 66 FR 56035, Nov. 6, 2001. nylon 6 basic polymer as described in § 177.1500(a)(6) of this chapter and meet- Subpart A—General Provisions ing the specifications of item 6.1 of the table in § 177.1500(b) of this chapter. § 180.1 General. The finished film may contain one or (a) Substances having a history of more of the added substances listed in use in food for human consumption or paragraph (d)(2)(i) of this section. in food contact surfaces may at any (iv) Vinyl chloride-vinyl acetate co- time have their safety or functionality polymer film prepared from the basic brought into question by new informa- copolymer containing 88.5 to 90.0 tion that in itself is not conclusive. An weight percent of vinyl chloride with interim food additive regulation for 10.0 to 11.5 weight percent of vinyl ace- the use of any such substance may be tate and having a maximum volatility promulgated in this subpart when new of not over 3.0 percent (1 hour at 105 °C) information raises a substantial ques- and viscosity not less than 0.30 deter- tion about the safety or functionality mined by ASTM method D1243–79, of the substance but there is a reason- ‘‘Standard Test Method for Dilute So- able certainty that the substance is lution Viscosity of Vinyl Chloride not harmful and that no harm to the Polymers,’’ Method A, which is incor- public health will result from the con- porated by reference. The availability tinued use of the substance for a lim- of this incorporation by reference is ited period of time while the question given in paragraph (b)(9) of this sec- raised is being resolved by further tion. The finished film may contain study. one or more of the added substances (b) No interim food additive regula- listed in paragraph (d)(2)(i) of this section may be promulgated if the new in- tion. formation is conclusive with respect to (e) Acrylonitrile copolymers identi- the question raised or if there is a rea- fied in this section shall comply with sonable likelihood that the substance the provisions of § 180.22 of this chap- is harmful or that continued use of the ter. substance will result in harm to the [42 FR 14635, Mar. 15, 1977, as amended at 49 public health. FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, (c) The Commissioner, on his own ini- 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, tiative or on the petition of any inter- Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR ested person, pursuant to part 10 of this 10575, Feb. 16, 2001] chapter, may propose an interim food additive regulation. A final order pro- PART 180—FOOD ADDITIVES PER- mulgating an interim food additive MITTED IN FOOD OR IN CON- regulation shall provide that continued TACT WITH FOOD ON AN IN- use of the substance in food is subject TERIM BASIS PENDING ADDI- to each of the following conditions: TIONAL STUDY (1) Use of the substance in food or food contact surfaces must comply with whatever limitations the Commis- Subpart A—General Provisions sioner deems to be appropriate under Sec. the circumstances. 180.1 General. (2) Within 60 days following the effective date of the regulation, an inter- Subpart B—Specific Requirements for ested person shall satisfy the Commis- Certain Food Additives sioner in writing that studies adequate 180.22 Acrylonitrile copolymers. and appropriate to resolve the ques- 180.25 Mannitol. tions raised about the substance have

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been undertaken, or the Food and Drug will require elimination of the sub- Administration may undertake the stance from the food supply. studies. The Commissioner may extend (e) The Commissioner may consult this 60-day period if necessary to re- with advisory committees, professional view and act on proposed protocols. If organizations, or other experts in the no such commitment is made, or ade- field, in evaluating: quate and appropriate studies are not (1) Whether an interim food additive undertaken, an order shall imme- regulation is justified, diately be published in the FEDERAL (2) The type of studies necessary and REGISTER revoking the interim food ad- appropriate to resolve questions raised ditive regulation effective upon publi- about a substance, cation. (3) Whether interim results indicate (3) A progress report shall be filed on the reasonable likelihood that a health the studies every January 1 and July 1 hazard exists, or until completion. If the progress report (4) Whether the data available at the is inadequate or if the Commissioner conclusion of those studies justify a concludes that the studies are not food additive regulation. being pursued promptly and diligently (f) Where appropriate, an emergency or if interim results indicate a reason- action level may be issued for a sub- able likelihood that a health hazard ex- stance subject to paragraph (a) of this ists, an order will promptly be pub- section that is not an approved food ad- lished in the FEDERAL REGISTER revok- ditive, pending the issuance of a final ing the interim food additive regula- interim food additive regulation. Such tion effective upon publication. an action level shall be issued pursuant (4) If nonclinical laboratory studies to sections 306 and 402(a) of the act to are involved, studies filed with the identify, based upon available data, a Commissioner shall include, with re- safe level of use for the substance. spect to each study, either a statement Such an action level shall be issued in that the study has been or will be con- a notice published in the FEDERAL REG- ducted in compliance with the good ISTER and shall be followed as soon as laboratory practice regulations as set practicable by a proposed interim food forth in part 58 of this chapter, or, if additive regulation. Where the avail- any such study was not conducted in able data do not permit establishing an compliance with such regulations, a action level for the safe use of a sub- brief statement of the reason for the stance, use of the substance may be noncompliance. prohibited. The identification of a pro- (5) [Reserved] hibited substance may be made in part (6) If clinical investigations involving 189 of this chapter when appropriate. human subjects are involved, such in- [42 FR 14636, Mar. 15, 1977, as amended at 42 vestigations filed with the Commis- FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, sioner shall include, with respect to 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, each investigation, a statement that Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR the investigation either was conducted 39634, Sept. 27, 1989] in compliance with the requirements for institutional review set forth in Subpart B—Specific Requirements part 56 of this chapter, or was not sub- for Certain Food Additives ject to such requirements in accordance with §§ 56.104 or 56.105, and that it § 180.22 Acrylonitrile copolymers. has been or will be conducted in com- Acrylonitrile copolymers may be pliance with the requirements for in- safely used on an interim basis as arti- formed consent set forth in part 50 of cles or components of articles intended this chapter. for use in contact with food, in accord- (d) Promptly upon completion of the ance with the following prescribed con- studies undertaken on the substance, ditions: the Commissioner will review all avail- (a) Limitations for acrylonitrile able data, will terminate the interim monomer extraction for finished food- food additive regulation, and will ei- contact articles, determined by a ther issue a food additive regulation or method of analysis titled ‘‘Gas-Solid

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Chromatographic Procedure for Deter- Such testing shall include determina- mining Acrylonitrile Monomer in Ac- tion of the rate of decomposition of the rylonitrile-Containing Polymers and complex at temperatures of 100 °F, 160 Food Simulating Solvents,’’ which is °F, and 212 °F using 3 percent acetic incorporated by reference. Copies are acid as the hydrolic agent. Acrylo- available from the Center for Food nitrile monomer levels, acrylonitrile/ Safety and Applied Nutrition (HFS– mercaptan complex levels, acrylo- 200), Food and Drug Administration, nitrile oligomer levels, descriptions of 5100 Paint Branch Pkwy., College Park, the analytical methods used to deter- MD 20740, or available for inspection at mine the complex and the acrylonitrile the National Archives and Records Ad- migration, and validation studies of ministration (NARA). For information these analytical methods shall be sub- on the availability of this material at mitted by June 9, 1977, to the Center NARA, call 202–741–6030, or go to: http:// for Food Safety and Applied Nutrition www.archives.gov/federallregister/ (HFS–200), Food and Drug Administra- codeloflfederallregulations/ tion, 5100 Paint Branch Pkwy., College ibrllocations.html. Park, MD 20740, unless an extension is (1) In the case of single-use articles granted by the Food and Drug Admin- having a volume to surface ratio of 10 istration for good cause shown. Analyt- milliliters or more per square inch of ical methods for the determination of food contact surface—0.003 milligram/ acrylonitrile complexes with n- square inch when extracted to equi- dodecyl-mercaptan, n-octyl mercaptan, librium at 120 °F with food-simulating and 2-mercaptoethanol, titled ‘‘Deter- solvents appropriate to the intended mination of b-Dodecyl- conditions of use. mercaptopropionitrile in NR–16R Aque- (2) In the case of single-use articles ous Extracts’’ and ‘‘Measurement of b- having a volume to surface ratio of less (2-Hdroxyethylmercapto) Propionitrile than 10 milliliters per square inch of in Heptane Food-Simulating Solvent,’’ food contact surface—0.3 part per mil- are incorporated by reference. Copies lion calculated on the basis of the vol- are available from the Center for Food ume of the container when extracted to Safety and Applied Nutrition (HFS– equilibrium at 120 °F with food-simu- 200), Food and Drug Administration, lating solvents appropriate to the in- 5100 Paint Branch Pkwy., College Park, tended conditions of use. MD 20740, or available for inspection at (3) In the case of repeated-use arti- the National Archives and Records Ad- cles—0.003 milligram/square inch when ministration (NARA). For information extracted at a time equivalent to ini- on the availability of this material at tial batch usage utilizing food-simu- NARA, call 202–741–6030, or go to: http:// lating solvents and temperatures ap- www.archives.gov/federallregister/ propriate to the intended conditions of codeloflfederallregulations/ use. ibrllocations.html. The food-simulating solvents shall in- (c) The following data shall be pro- clude, where applicable, distilled vided for finished food-contact articles water, 8 percent or 50 percent ethanol, intended for repeated use: 3 percent acetic acid, and either n- (1) Qualitative and quantitative mi- heptane or an appropriate oil or fat. gration values at a time equivalent to (b) Where necessary, current regula- initial batch usage, utilizing solvents tions permitting the use of acrylo- and temperatures appropriate to the nitrile copolymers shall be revised to intended conditions of use. specify limitations on acrylonitrile/ (2) Qualitative and quantitative mi- mercaptan complexes utilized in the gration values at the time of equi- production of acrylonitrile copolymers. librium extractions, utilizing solvents Such copolymers, if they contain re- and temperatures appropriate to the versible acrylonitrile/mercaptan com- intended conditions of use. plexes and are used in other than re- (3) Data on the volume and/or weight peated-use conditions, shall be tested of food handled during the initial batch to determine the identity of the com- time period(s), during the equilibrium plex and the level of the complex test period, and over the estimated life present in the food-contact article. of the food-contact surface.

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(d) Where acrylonitrile copolymers the user in good faith believed the use represent only a minor component of a to be prior-sanctioned. The Commis- polymer system, calculations based on sioner of Food and Drugs shall, by no- 100 percent migration of the acrylo- tice in the FEDERAL REGISTER, identify nitrile component may be submitted in any use of acrylonitrile copolymers not lieu of the requirements of paragraphs in accordance with this paragraph. (a), (b), and (c) of this section in sup- Those uses are thereafter unapproved port of the continued safe use of acry- food additives and consequently unlaw- lonitrile copolymers. ful. (e) On or before September 13, 1976, (2) Any use of acrylonitrile copoly- any interested person shall satisfy the mers subject to paragraph (f)(1) of this Commissioner of Food and Drugs that section shall be the subject of a peti- toxicological feeding studies adequate tion submitted on or before December and appropriate to establish safe condi- 13, 1976, in accordance with § 171.1 of tions for the use of acrylonitrile co- this chapter, unless an extension of polymers have been, or soon will be, time is granted by the Food and Drug undertaken. Toxicity studies of acrylo- Administration for good cause shown. nitrile monomer shall include: (1) Life- Any application for extension shall be time feeding studies with a mamma- by petition submitted in accordance lian species, preferably with animals with the requirements of part 10 of this exposed in utero to the chemical, (2) chapter. If a petition is denied, in studies of multigeneration reproduc- whole or in part, those uses subject to tion with oral administration of the the denial are thereafter unapproved test material, (3) assessment of food additives and consequently unlaw- teratogenic and mutagenic potentials, ful. (4) subchronic oral administration in a (3) Any use of acrylonitrile copoly- nonrodent mammal, (5) tests to deter- mers subject to paragraph (f)(1) of this mine any synergistic toxic effects be- section shall meet the acrylonitrile tween acrylonitrile monomer and cya- monomer extraction limitation set nide ion, and (6) a literature search on forth in paragraph (a) of this section the effects of chronic ingestion of hy- and shall be subject to the require- drogen cyanide. Data on levels of acryl- ments of paragraph (b) of this section. amide extractable from acrylonitrile (g) In addition to the requirements of copolymers shall also be submitted. this section, the use of acrylonitrile co- Protocols of testing should be sub- polymers shall comply with all applica- mitted for review to the Center for ble requirements in other regulations Food Safety and Applied Nutrition in this part. (HFS–200), Food and Drug Administra- [42 FR 14636, Mar. 15, 1977, as amended at 47 tion, 5100 Paint Branch Pkwy., College FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, Park, MD 20740. 1989; 61 FR 14246, Apr. 1, 1996] (f) Acrylonitrile copolymers may be used in contact with food only if au- § 180.25 Mannitol. thorized in parts 174 through 179 or (a) Mannitol is the chemical § 181.32 of this chapter, except that 1,2,3,4,5,6,-hexanehexol (C6H14O6) a other uses of acrylonitrile copolymers hexahydric alcohol, differing from sor- in use prior to June 14, 1976, may con- bitol principally by having a different tinue under the following conditions: optical rotation. Mannitol is produced (1) On or before August 13, 1976, each by one of the following processes: use of acrylonitrile copolymers in a (1) The electrolytic reduction or manner not authorized by § 181.32 of transition metal catalytic hydro- this chapter or parts 174 through 179 of genation of sugar solutions containing this chapter shall be the subject of a glucose or fructose. notice to the Center for Food Safety (2) The fermentation of sugars or and Applied Nutrition (HFS–200), Food sugar alcohols such as glucose, sucrose, and Drug Administration, 5100 Paint fructose, or sorbitol using the yeast Branch Pkwy., College Park, MD 20740. Zygosaccharomyces rouxii. Such notice shall be accompanied by a (3) A pure culture fermentation of statement of the basis, including any sugars such as fructose, glucose, or articles and correspondence, on which maltose using the nonpathogenic,

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nontoxicogenic bacterium Lactobacillus stance. Continued uses of this ingre- intermedius (fermentum). dient are contingent upon timely and (b) The ingredient meets the speci- adequate progress reports of such tests, fications of the ‘‘Food Chemicals and no indication of increased risk to Codex,’’ 3d Ed. (1981), pp. 188–190, which public health during the test period. is incorporated by reference. Copies (g) Prior sanctions for this ingredient may be obtained from the National different from the uses established in Academy Press, 2101 Constitution Ave. this regulation do not exist or have NW., Washington, DC 20418, or may be been waived. examined at the National Archives and [42 FR 14636, Mar. 15, 1977, as amended at 49 Records Administration (NARA). For FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996; information on the availability of this 69 FR 65542, Nov. 15, 2004] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 180.30 Brominated vegetable oil. federallregister/ The food additive brominated vege- codeloflfederallregulations/ table oil may be safely used in accord- ibrllocations.html. ance with the following prescribed con- (c) The ingredient is used as an ditions: anticaking agent and free-flow agent as (a) The additive complies with speci- defined in § 170.3(o)(1) of this chapter, fications prescribed in the ‘‘Food formulation aid as defined in § 170.3(o) Chemicals Codex,’’ 3d Ed. (1981), pp. 40– (14) of this chapter, firming agent as 41, which is incorporated by reference, defined in § 170.3(o)(10) of this chapter, except that free fatty acids (as oleic) flavoring agent and adjuvant as defined shall not exceed 2.5 percent and iodine in § 170.3(o)(12) of this chapter, lubri- value shall not exceed 16. Copies of the cant and release agent as defined in material incorporated by reference § 170.3(o)(18) of this chapter, nutritive may be obtained from the National sweetener as defined in § 170.3(o)(21) of Academy Press, 2101 Constitution Ave. this chapter, processing aid as defined NW., Washington, DC 20418, or may be in § 170.3(o)(24) of this chapter, sta- examined at the National Archives and bilizer and thickener as defined in Records Administration (NARA). For § 170.3(o)(28) of this chapter, surface-fin- information on the availability of this ishing agent as defined in § 170.3(o)(30) material at NARA, call 202–741–6030, or of this chapter, and texturizer as de- go to: http://www.archives.gov/ fined in § 170.3(o)(32) of this chapter. federallregister/ (d) The ingredient is used in food at codeloflfederallregulations/ levels not to exceed 98 percent in ibrllocations.html. pressed mints and 5 percent in all other (b) The additive is used on an interim hard candy and cough drops as defined basis as a stabilizer for flavoring oils in § 170.3(n)(25) of this chapter, 31 per- used in fruit-flavored beverages, for cent in chewing gum as defined in which any applicable standards of iden- § 170.3(n)(6) of this chapter, 40 percent tity do not preclude such use, in an in soft candy as defined in § 170.3(n)(38) amount not to exceed 15 parts per mil- of this chapter, 8 percent in confections lion in the finished beverage, pending and frostings as defined in § 170.3(n)(9) the outcome of additional toxicological of this chapter, 15 percent in non- studies on which periodic reports at 6- standardized jams and jellies, commer- month intervals are to be furnished cial, as defined in § 170.3(n)(28) of this and final results submitted to the Food chapter, and at levels less than 2.5 per- and Drug Administration promptly cent in all other foods. after completion of the studies. (e) The label and labeling of food [42 FR 14636, Mar. 15, 1977, as amended at 49 whose reasonably foreseeable consump- FR 5610, Feb. 14, 1984] tion may result in a daily ingestion of 20 grams of mannitol shall bear the § 180.37 Saccharin, ammonium sac- statement ‘‘Excess consumption may charin, calcium saccharin, and so- have a laxative effect’’. dium saccharin. (f) In accordance with § 180.1, ade- The food additives saccharin, ammo- quate and appropriate feeding studies nium saccharin, calcium saccharin, and have been undertaken for this sub- sodium saccharin may be safely used as

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sweetening agents in food in accord- (1) To reduce bulk and enhance fla- ance with the following conditions, if vors in chewable vitamin tablets, the substitution for nutritive sweet- chewable mineral tablets, or combina- eners is for a valid special dietary pur- tions thereof. pose and is in accord with current spe- (2) To retain flavor and physical cial dietary food regulations and poli- properties of chewing gum. cies or if the use or intended use is for (3) To enhance flavor of flavor chips an authorized technological purpose used in nonstandardized bakery prod- other than calorie reduction: ucts. (a) Saccharin is the chemical, 1,2- (f) To assure safe use of the additives, benzisothiazolin-3-one - 1,1 - dioxide in addition to the other information re- (C7H5NO3S). The named salts of sac- quired by the Act: charin are produced by the additional (1) The label of the additive and any neutralization of saccharin with the intermediate mixes of the additive for proper base to yield the desired salt. manufacturing purposes shall bear: (b) The food additives meet the speci- (i) The name of the additive. fications of the ‘‘Food Chemicals (ii) A statement of the concentration Codex,’’ 3d Ed. (1981), pp. 22, 62, 266–267, of the additive, expressed as saccharin, 297–299, which is incorporated by refin any intermediate mix. erence. Copies may be obtained from (iii) Adequate directions for use to the National Academy Press, 2101 Con- provide a final food product that com- stitution Ave. NW., Washington, DC plies with the limitations prescribed in 20418, or may be examined at the Na- paragraphs (d) and (e) of this section. tional Archives and Records Adminis- (2) The label of any finished food tration (NARA). For information on product containing the additive shall the availability of this material at bear: NARA, call 202–741–6030, or go to: http:// (i) The name of the additive. www.archives.gov/federallregister/ (ii) The amount of the additive, cal- codeloflfederallregulations/ culated as saccharin, as follows: ibrllocations.html. (a) For beverages, in milligrams per (c) Authority for such use shall ex- fluid ounce; pire when the Commissioner receives (b) For cooking or table use products, the final reports on the ongoing studies in milligrams per dispensing unit; in Canada and publishes an order on (c) For processed foods, in terms of the safety of saccharin and its salts the weight or size of a serving which based on those reports and other avail- shall be that quantity of the food con- able data. taining 30 milligrams or less of the ad- (d) The additives are used or intended ditive. for use as a sweetening agent only in (iii) When the additive is used for cal- special dietary foods, as follows: orie reduction, such other labeling as is (1) In beverages, fruit juice drinks, required by part 105 of this chapter. and bases or mixes when prepared for [42 FR 14636, Mar. 15, 1977, as amended at 49 consumption in accordance with direc- FR 5610, Feb. 14, 1984; 72 FR 10357, Mar. 8, tions, in amounts not to exceed 12 mil- 2007] ligrams of the additive, calculated as saccharin, per fluid ounce. PART 181—PRIOR-SANCTIONED (2) As a sugar substitute for cooking or table use, in amounts not to exceed FOOD INGREDIENTS 20 milligrams of the additive, calculated as saccharin, for each ex- Subpart A—General Provisions pressed teaspoonful of sugar sweet- Sec. ening equivalency. 181.1 General. (3) In processed foods, in amounts not 181.5 Prior sanctions. to exceed 30 milligrams of the additive, calculated as saccharin, per serving of Subpart B—Specific Prior-Sanctioned Food designated size. Ingredients (e) The additives are used or intended 181.22 Certain substances employed in the for use only for the following techno- manufacture of food-packaging mate- logical purposes: rials.

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181.23 Antimycotics. ISTER and shall be followed as soon as 181.24 Antioxidants. practicable by a proposed regulation in 181.25 Driers. 181.26 Drying oils as components of finished accordance with paragraph (b) of this resins. section. Where the available data dem- 181.27 Plasticizers. onstrate that the substance may be in- 181.28 Release agents. jurious at any level, use of the sub- 181.29 Stabilizers. stance may be prohibited. The identi- 181.30 Substances used in the manufacture fication of a prohibited substance may of paper and paperboard products used in food packaging. be made in part 189 of this chapter 181.32 Acrylonitrile copolymers and resins. when appropriate. 181.33 Sodium nitrate and potassium nitrate. [42 FR 14638, Mar. 15, 1977, as amended at 42 181.34 Sodium nitrite and potassium nitrite. FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, 1989] AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14638, Mar. 15, 1977, unless § 181.5 Prior sanctions. otherwise noted. (a) A prior sanction shall exist only EDITORIAL NOTE: Nomenclature changes to for a specific use(s) of a substance in part 181 appear at 61 FR 14482, Apr. 2, 1996, food, i.e., the level(s), condition(s), and 66 FR 56035, Nov. 6, 2001. product(s), etc., for which there was explicit approval by the Food and Drug Subpart A—General Provisions Administration or the United States § 181.1 General. Department of Agriculture prior to September 6, 1958. (a) An ingredient whose use in food (b) The existence of a prior sanction or food packaging is subject to a prior exempts the sanctioned use(s) from the sanction or approval within the meaning of section 201(s)(4) of the Act is ex- food additive provisions of the Act but empt from classification as a food addi- not from the other adulteration or the tive. The Commissioner will publish in misbranding provisions of the Act. this part all known prior sanctions. (c) All known prior sanctions shall be Any interested person may submit to the subject of a regulation published in the Commissioner a request for publi- this part. Any such regulation is sub- cation of a prior sanction, supported by ject to amendment to impose whatever evidence to show that it falls within limitation(s) or condition(s) may be section 201(s)(4) of the Act. necessary for the safe use of the ingre- (b) Based upon scientific data or in- dient, or revocation to prohibit use of formation that shows that use of a the ingredient, in order to prevent the prior-sanctioned food ingredient may adulteration of food in violation of sec- be injurious to health, and thus in vio- tion 402 of the Act. lation of section 402 of the Act, the (d) In proposing, after a general eval- Commissioner will establish or amend uation of use of an ingredient, regula- an applicable prior sanction regulation tions affirming the GRAS status of to impose whatever limitations or con- substances added directly to human ditions are necessary for the safe use of food in part 184 of this chapter or sub- the ingredient, or to prohibit use of the stances in food-contact surfaces in part ingredient. 186 of this chapter, or establishing a (c) Where appropriate, an emergency action level may be issued for a prior- food additive regulation for substances sanctioned substance, pending the added directly to human food in parts issuance of a final regulation in ac- 172 and 173 of this chapter or food addi- cordance with paragraph (b) of this sec- tives in food-contact surfaces in parts tion. Such an action level shall be 174, 175, 176, 177, 178 and § 179.45 of this issued pursuant to section 402(a) of the chapter, the Commissioner shall, if he Act to identify, based upon available is aware of any prior sanction for use data, conditions of use of the substance of the ingredient under conditions dif- that may be injurious to health. Such ferent from those proposed in the regu- an action level shall be issued in a no- lation, concurrently propose a separate tice published in the FEDERAL REG-

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regulation covering such use of the in- ably possible, and shall not exceed any gredient under this part. If the Com- limit specified in this subpart. missioner is unaware of any such appli- [42 FR 56728, Oct. 28, 1977] cable prior sanction, the proposed regulation will so state and will require any § 181.23 Antimycotics. person who intends to assert or rely on Substances classified as such sanction to submit proof of its ex- antimycotics, when migrating from istence. Any food additive or GRAS food-packaging material shall include: regulation promulgated after a general evaluation of use of an ingredient con- Calcium propionate. stitutes a determination that excluded Methylparaben (methyl p-hydroxybenzoate). uses would result in adulteration of the Propylparaben (propyl p-hydroxybenzoate). Sodium benzoate. food in violation of section 402 of the Sodium propionate. Act, and the failure of any person to Sorbic acid. come forward with proof of such an ap- [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. plicable prior sanction in response to a 28, 1977] proposal will constitute a waiver of the right to assert or rely on such sanction § 181.24 Antioxidants. at any later time. The notice will also Substances classified as antioxidants, constitute a proposal to establish a when migrating from food-packaging regulation under this part, incor- material (limit of addition to food, porating the same provisions, in the 0.005 percent) shall include: event that such a regulation is determined to be appropriate as a result of Butylated hydroxyanisole. submission of proof of such an applica- Butylated hydroxytoluene. ble prior sanction in response to the Dilauryl thiodipropionate. Distearyl thiodipropionate. proposal. Gum guaiac. Nordihydroguairetic acid. Subpart B—Specific Prior- Propyl gallate. Sanctioned Food Ingredients Thiodipropionic acid. 2,4,5-Trihydroxy butyrophenone. § 181.22 Certain substances employed [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. in the manufacture of food-pack- 28, 1977] aging materials. § 181.25 Driers. Prior to the enactment of the food additives amendment to the Federal Substances classified as driers, when Food, Drug, and Cosmetic Act, sanc- migrating from food-packaging mate- tions were granted for the usage of the rial shall include: substances listed in §§ 181.23, 181.24, Cobalt caprylate. 181.25, 181.26, 181.27, 181.28, 181.29, and Cobalt linoleate. 181.30 in the manufacture of packaging Cobalt naphthenate. materials. So used, these substances Cobalt tallate. are not considered ‘‘food additives’’ Iron caprylate. within the meaning of section 201(s) of Iron linoleate. Iron naphthenate. the Act, provided that they are of good Iron tallate. commercial grade, are suitable for as- Manganese caprylate. sociation with food, and are used in ac- Manganese linoleate. cordance with good manufacturing Manganese naphthenate. practice. For the purpose of this sub- Manganese tallate. part, good manufacturing practice for [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. food-packaging materials includes the 28, 1977] restriction that the quantity of any of these substances which becomes a com- § 181.26 Drying oils as components of ponent of food as a result of use in finished resins. food-packaging materials shall not be Substances classified as drying oils, intended to accomplish any physical or when migrating from food-packaging technical effect in the food itself, shall material (as components of finished be reduced to the least amount reason- resins) shall include:

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Chinawood oil (tung oil). Ammonium citrate. Dehydrated castor oil. Ammonium potassium hydrogen phosphate. Linseed oil. Calcium glycerophosphate. Tall oil. Calcium phosphate. Calcium hydrogen phosphate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Calcium oleate. 28, 1977] Calcium acetate. Calcium carbonate. § 181.27 Plasticizers. Calcium ricinoleate. Substances classified as plasticizers, Calcium stearate. when migrating from food-packaging Disodium hydrogen phosphate. material shall include: Magnesium glycerophosphate. Magnesium stearate. Acetyl tributyl citrate. Magnesium phosphate. Acetyl triethyl citrate. Magnesium hydrogen phosphate. p-tert-Butylphenyl salicylate. Mono-, di-, and trisodium citrate. Butyl stearate. Mono-, di-, and tripotassium citrate. Butylphthalyl butyl glycolate. Potassium oleate. Dibutyl sebacate. Potassium stearate. Di-(2-ethylhexyl) phthalate (for foods of high Sodium pyrophosphate. water content only). Sodium stearate. Diethyl phthalate. Sodium tetrapyrophosphate. Diisobutyl adipate. Stannous stearate (not to exceed 50 parts per Diisooctyl phthalate (for foods of high water million tin as a migrant in finished food). content only). Zinc orthophosphate (not to exceed 50 parts Diphenyl-2-ethylhexyl phosphate. per million zinc as a migrant in finished Epoxidized soybean oil (iodine number max- food). imum 6; and oxirane oxygen, minimum, 6.0 Zinc resinate (not to exceed 50 parts per mil- percent). lion zinc as a migrant in finished food). Ethylphthalyl ethyl glycolate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Glycerol monooleate. 28, 1977] Monoisopropyl citrate. Mono, di-, and tristearyl citrate. § 181.30 Substances used in the manu- Triacetin (glycerol triacetate). facture of paper and paperboard Triethyl citrate. products used in food packaging. 3-(2-Xenolyl)-1,2-epoxypropane. Substances used in the manufacture [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. of paper and paperboard products used 28, 1977, as amended at 50 FR 49536, Dec. 3, in food packaging shall include: 1985] Aliphatic polyoxyethylene ethers.* § 181.28 Release agents. 1-Alkyl (C6-C18)3-amino-3-aminopropane Substances classified as release monoacetate.* Borax or boric acid for use in adhesives, agents, when migrating from food- sizes, and coatings.* packaging material shall include: Butadiene-styrene copolymer. Dimethylpolysiloxane (substantially free Chromium complex of perfluoro-octane from hydrolyzable chloride and alkoxy sulfonyl glycine for use on paper and pa- groups, no more than 18 percent loss in perboard which is waxed.* Disodium cyanodithioimidocarbamate with weight after heating 4 hours at 200 °C.; vis- ethylene diamine and potassium N-methyl cosity 300 centisokes, 600 centisokes at 25 dithiocarbamate and/or sodium 2- °C, specific gravity 0.96 to 0.97 at 25 °C, re- mercaptobenzothiazole (slimicides).* fractive index 1.400 to 1.404 at 25 °C). Ethyl acrylate and methyl methacrylate co- Linoleamide (linoleic acid amide). polymers of itaconic acid or methacrylic Oleamide (oleic acid amide). acid for use only on paper and paperboard Palmitamide (palmitic acid amide). which is waxed.* Stearamide (stearic acid amide). Hexamethylene tetramine as a setting agent [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. for protein, including casein.* 28, 1977] 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl (C6-C17) imidazolinium chloride.* § 181.29 Stabilizers. Itaconic acid (polymerized). Substances classified as stabilizers, when migrating from food-packaging *Under the conditions of normal use, these material shall include: substances would not reasonably be expected to migrate to food, based on available sci- Aluminum mono-, di-, and tristearate. entific information and data.

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Melamine formaldehyde polymer. mer—for use only as piping for han- Methyl acrylate (polymerized). dling food products and for repeated- Methyl ethers of mono-, di-, and tripropylene use articles intended to contact food. glycol.* Myristo chromic chloride complex. (ii) Acrylonitrile/styrene resin—no Nitrocellulose. restrictions. Polyethylene glycol 400. (iii) Acrylonitrile/butadiene copoly- Polyvinyl acetate. mer blended with polyvinyl chloride Potassium pentachlorophenate as a slime resin—for use only as extruded pipe. control agent.* Potassium trichlorophenate as a slime con- (b) Limitations for acrylonitrile trol agent.* monomer extraction for finished food- Resins from high and low viscosity polyvinyl contact articles, determined by using alcohol for fatty foods only. the method of analysis titled ‘‘Gas- Rubber hydrochloride. Solid Chromatographic Procedure for Sodium pentachlorophenate as a slime con- Determining Acrylonitrile Monomer in trol agent.* Sodium-trichlorophenate as a slime control Acrylonitrile-Containing Polymers and agent.* Food-Simulating Solvents,’’ which is Stearato-chromic chloride complex. incorporated by reference. Copies are Titanium dioxide.* available from the Center for Food Urea formaldehyde polymer. Safety and Applied Nutrition (HFS– Vinylidine chlorides (polymerized). 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, § 181.32 Acrylonitrile copolymers and resins. MD 20740, or available for inspection at the National Archives and Records Ad- (a) Acrylonitrile copolymers and res- ministration (NARA). For information ins listed in this section, containing on the availability of this material at less than 30 percent acrylonitrile and NARA, call 202–741–6030, or go to: http:// complying with the requirements of www.archives.gov/federallregister/ paragraph (b) of this section, may be codeloflfederallregulations/ safely used as follows: ibrllocations.html. (1) Films. (i) Acrylonitrile/butadiene/ (1) In the case of single-use articles styrene copolymers—no restrictions. having a volume to surface ratio of 10 (ii) Acrylonitrile/butadiene copoly- milliliters or more per square inch of mers—no restrictions. food-contact surface—0.003 milligram/ (iii) Acrylonitrile/butadiene copoly- square inch when extracted to equi- mer blended with vinyl chloride-vinyl librium at 120 °F with food-simulating acetate (optional at level up to 5 per- solvents appropriate to the intended cent by weight of the vinyl chloride conditions of use. resin) resin—for use only in contact (2) In the case of single-use articles with oleomargarine. having a volume to surface ratio of less (iv) Acrylonitrile/styrene copoly- than 10 milliliters per square inch of mer—no restrictions. food-contact surface—0.3 part per mil- (2) Coatings. (i) Acrylonitrile/butadiene copolymer blended with poly- lion calculated on the basis of the volume of the container when extracted to vinyl chloride resins—for use only on ° paper and paperboard in contact with equilibrium at 120 F with food-simu- meats and lard. lating solvents appropriate to the in- (ii) Polyvinyl chloride resin blended tended conditions of use. with either acrylonitrile/butadiene co- (3) In the case of repeated-use arti- polymer or acrylonitrile/butadiene sty- cles—0.003 milligram/square inch when rene copolymer mixed with neoprene, extracted at a time equivalent to ini- for use as components of conveyor tial batch usage utilizing food-simu- belts to be used with fresh fruits, vege- lating solvents and temperatures ap- tables, and fish. propriate to the intended conditions of (iii) Acrylonitrile/butadiene/styrene use. copolymer—no restrictions. The food-simulating solvents shall in- (iv) Acrylonitrile/styrene copoly- clude, where applicable, distilled mer—no restrictions. water, 8 percent or 50 percent ethanol, (3) Rigid and semirigid containers. (i) 3 percent acetic acid, and either n- Acrylonitrile/butadiene/styrene copoly- heptane or an appropriate oil or fat.

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(c) Acrylonitrile monomer may 182.90 Substances migrating to food from present a hazard to health when in- paper and paperboard products. gested. Accordingly, any food-contact 182.99 Adjuvants for pesticide chemicals. article containing acrylonitrile copoly- Subpart B—Multiple Purpose GRAS Food mers or resins that yield acrylonitrile Substances monomer in excess of that amount provided for in paragraph (b) of this sec- 182.1045 Glutamic acid. tion shall be deemed to be adulterated 182.1047 Glutamic acid hydrochloride. in violation of section 402 of the Act. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. [42 FR 14638, Mar. 15, 1977, as amended at 47 182.1087 Sodium acid pyrophosphate. FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 182.1125 Aluminum sulfate. 1989] 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. § 181.33 Sodium nitrate and potassium 182.1131 Aluminum sodium sulfate. nitrate. 182.1180 Caffeine. Sodium nitrate and potassium ni- 182.1217 Calcium phosphate. 182.1235 Caramel. trate are subject to prior sanctions 182.1320 Glycerin. issued by the U.S. Department of Agri- 182.1480 Methylcellulose. culture for use as sources of nitrite, 182.1500 Monoammonium glutamate. with or without sodium or potassium 182.1516 Monopotassium glutamate. nitrite, in the production of cured red 182.1711 Silica aerogel. meat products and cured poultry prod- 182.1745 Sodium carboxymethylcellulose. ucts. 182.1748 Sodium caseinate. 182.1778 Sodium phosphate. [48 FR 1705, Jan. 14, 1983] 182.1781 Sodium aluminum phosphate. 182.1810 Sodium tripolyphosphate. § 181.34 Sodium nitrite and potassium nitrite. Subpart C—Anticaking Agents Sodium nitrite and potassium nitrite 182.2122 Aluminum calcium silicate. are subject to prior sanctions issued by 182.2227 Calcium silicate. the U.S. Department of Agriculture for 182.2437 Magnesium silicate. use as color fixatives and preservative 182.2727 Sodium aluminosilicate. agents, with or without sodium or po- 182.2729 Sodium calcium aluminosilicate, tassium nitrate, in the curing of red hydrated. meat and poultry products. 182.2906 Tricalcium silicate. [48 FR 1705, Jan. 14, 1983] Subpart D—Chemical Preservatives 182.3013 Ascorbic acid. PART 182—SUBSTANCES 182.3041 Erythorbic acid. GENERALLY RECOGNIZED AS SAFE 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. Subpart A—General Provisions 182.3149 Ascorbyl palmitate. 182.3169 Butylated hydroxyanisole. Sec. 182.3173 Butylated hydroxytoluene. 182.1 Substances that are generally recog- 182.3189 Calcium ascorbate. nized as safe. 182.3225 Calcium sorbate. 182.10 Spices and other natural seasonings 182.3280 Dilauryl thiodipropionate. and flavorings. 182.3616 Potassium bisulfite. 182.20 Essential oils, oleoresins (solvent- 182.3637 Potassium metabisulfite. free), and natural extractives (including 182.3640 Potassium sorbate. distillates). 182.3731 Sodium ascorbate. 182.40 Natural extractives (solvent-free) 182.3739 Sodium bisulfite. used in conjunction with spices, 182.3766 Sodium metabisulfite. seasonings, and flavorings. 182.3795 Sodium sorbate. 182.50 Certain other spices, seasonings, es- 182.3798 Sodium sulfite. sential oils, oleoresins, and natural ex- 182.3862 Sulfur dioxide. tracts. 182.3890 Tocopherols. 182.60 Synthetic flavoring substances and adjuvants. Subpart E—Emulsifying Agents [Reserved] 182.70 Substances migrating from cotton and cotton fabrics used in dry food pack- Subpart F—Dietary Supplements aging. [Reserved] 469

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Subpart G—Sequestrants defined to include the following restrictions: 182.6085 Sodium acid phosphate. 182.6197 Calcium diacetate. (1) The quantity of a substance added 182.6203 Calcium hexametaphosphate. to food does not exceed the amount 182.6215 Monobasic calcium phosphate. reasonably required to accomplish its 182.6285 Dipotassium phosphate. intended physical, nutritional, or other 182.6290 Disodium phosphate. technical effect in food; and 182.6757 Sodium gluconate. (2) The quantity of a substance that 182.6760 Sodium hexametaphosphate. becomes a component of food as a re- 182.6769 Sodium metaphosphate. 182.6778 Sodium phosphate. sult of its use in the manufacturing, 182.6787 Sodium pyrophosphate. processing, or packaging of food, and 182.6789 Tetra sodium pyrophosphate. which is not intended to accomplish 182.6810 Sodium tripolyphosphate. any physical or other technical effect in the food itself, shall be reduced to Subpart H—Stabilizers the extent reasonably possible. 182.7255 Chondrus extract. (3) The substance is of appropriate food grade and is prepared and handled Subpart I—Nutrients as a food ingredient. Upon request the Commissioner will offer an opinion, 182.8013 Ascorbic acid. 182.8159 Biotin. based on specifications and intended 182.8217 Calcium phosphate. use, as to whether or not a particular 182.8223 Calcium pyrophosphate. grade or lot of the substance is of suit- 182.8250 Choline bitartrate. able purity for use in food and would 182.8252 Choline chloride. generally be regarded as safe for the 182.8778 Sodium phosphate. purpose intended, by experts qualified 182.8890 Tocopherols. to evaluate its safety. 182.8892 a-Tocopherol acetate. 182.8985 Zinc chloride. (c) The inclusion of substances in the 182.8988 Zinc gluconate. list of nutrients does not constitute a 182.8991 Zinc oxide. finding on the part of the Department 182.8994 Zinc stearate. that the substance is useful as a sup- 182.8997 Zinc sulfate. plement to the diet for humans. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. (d) Substances that are generally recognized as safe for their intended use SOURCE: 42 FR 14640, Mar. 15, 1977, unless otherwise noted. within the meaning of section 409 of the act are listed in this part. When the status of a substance has been re- Subpart A—General Provisions evaluated, it will be deleted from this § 182.1 Substances that are generally part, and will be issued as a new regu- recognized as safe. lation under the appropriate part, e.g., ‘‘affirmed as GRAS’’ under part 184 or (a) It is impracticable to list all sub- 186 of this chapter; ‘‘food additive regu- stances that are generally recognized lation’’ under parts 170 through 180 of as safe for their intended use. However, this chapter; ‘‘interim food additive by way of illustration, the Commis- regulation’’ under part 180 of this chap- sioner regards such common food inter; or ‘‘prohibited from use in food’’ gredients as salt, pepper, vinegar, bak- under part 189 of this chapter. ing powder, and monosodium glutamate as safe for their intended use. [42 FR 14640, Mar. 15, 1977, as amended at 53 This part includes additional sub- FR 44875, Nov. 7, 1988] stances that, when used for the purposes indicated, in accordance with § 182.10 Spices and other natural good manufacturing practice, are re- seasonings and flavorings. garded by the Commissioner as Spices and other natural seasonings generaly recognized as safe for such and flavorings that are generally rec- uses. ognized as safe for their intended use, (b) For the purposes of this section, within the meaning of section 409 of good manufacturing practice shall be the Act, are as follows:

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Common name Botanical name of plant source

Alfalfa herb and seed ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Ambrette seed ...... Hibiscus abelmoschus L. Angelica ...... Angelica archangelica L. or other spp. of Angelica. Angelica root ...... Do. Angelica seed ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Anise, star ...... Illicium verum Hook. f. Balm (lemon balm) ...... Melissa officinalis L. Basil, bush ...... Ocimum minimum L. Basil, sweet ...... Ocimum basilicum L. Bay ...... Laurus nobilis L. Calendula ...... Calendula officinalis L. Camomile (chamomile), English or Roman ...... Anthemis nobilis L. Camomile (chamomile), German or Hungarian ...... Matricaria chamomilla L. Capers ...... Capparis spinosa L. Capsicum ...... Capsicum frutescens L. or Capsicum annuum L. Caraway ...... Carum carvi L. Caraway, black (black cumin) ...... Nigella sativa L. Cardamom (cardamon) ...... Elettaria cardamomum Maton. Cassia, Chinese ...... Cinnamomum cassia Blume. Cassia, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia, Saigon ...... Cinnamomum loureirii Nees. Cayenne pepper ...... Capsicum frutescens L. or Capsicum annuum L. Celery seed ...... Apium graveolens L. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chives ...... Allium schoenoprasum L. Cinnamon, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon, Chinese ...... Cinnamomum cassia Blume. Cinnamon, Saigon ...... Cinnamomum loureirii Nees. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Cumin, black (black caraway) ...... Nigella sativa L. Elder flowers ...... Sambucus canadensis L. Fennel, common ...... Foeniculum vulgare Mill. Fennel, sweet (finocchio, Florence fennel) ...... Foeniculum vulgare Mill. var. duice (DC.) Alex. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Ginger ...... Zingiber officinale Rosc. Grains of paradise ...... Amomum melegueta Rosc. Horehound (hoarhound) ...... Marrubium vulgare L. Horseradish ...... Armoracia lapathifolia Gilib. Hyssop ...... Hyssopus officinalis L. Lavender ...... Lavandula officinalis Chaix. Linden flowers ...... Tilia spp. Mace ...... Myristica fragrans Houtt. Marigold, pot ...... Calendula officinalis L. Marjoram, pot ...... Majorana onites (L.) Benth. Marjoram, sweet ...... Majorana hortensis Moench. Mustard, black or brown ...... Brassica nigra (L.) Koch. Mustard, brown ...... Brassica juncea (L.) Coss. Mustard, white or yellow ...... Brassica hirta Moench. Nutmeg ...... Myristica fragrans Houtt. Oregano (oreganum, Mexican oregano, Mexican Lippia spp. sage, origan). Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, cayenne ...... Capsicum frutescens L. or Capsicum annuum L. Pepper, red ...... Do. Pepper, white ...... Piper nigrum L. Peppermint ...... Mentha piperita L. Poppy seed ...... Papayer somniferum L. Pot marigold ...... Calendula officinalis L. Pot marjoram ...... Majorana onites (L.) Benth. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Savory, summer ...... Satureia hortensis L. (Satureja).

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Common name Botanical name of plant source

Savory, winter ...... Satureia montana L. (Satureja). Sesame ...... Sesamum indicum L. Spearmint ...... Mentha spicata L. Star anise ...... Illicium verum Hook. f. Tarragon ...... Artemisia dracunculus L. Thyme ...... Thymus vulgaris L. Thyme, wild or creeping ...... Thymus serpyllum L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary ...... Curcuma zedoaria Rosc.

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

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

Common name Botanical name of plant source

Alfalfa ...... Medicago sativa L. Allspice ...... Pimenta officinalis Lindl. Almond, bitter (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Ambrette (seed) ...... Hibiscus moschatus Moench. Angelica root ...... Angelica archangelica L. Angelica seed ...... Do. Angelica stem ...... Do. Angostura (cusparia bark) ...... Galipea officinalis Hancock. Anise ...... Pimpinella anisum L. Asafetida ...... Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm) ...... Melissa officinalis L. Balsam of Peru ...... Myroxylon pereirae Klotzsch. Basil ...... Ocimum basilicum L. Bay leaves ...... Laurus nobilis L. Bay (myrcia oil) ...... Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange) ...... Citrus aurantium L. subsp. bergamia Wright et Arn. Bitter almond (free from prussic acid) ...... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch. Bois de rose ...... Aniba rosaeodora Ducke. Cacao ...... Theobroma cacao L. Camomile (chamomile) flowers, Hungarian ...... Matricaria chamomilla L. Camomile (chamomile) flowers, Roman or English Anthemis nobilis L. Cananga ...... Cananga odorata Hook. f. and Thoms. Capsicum ...... Capsicum frutescens L. and Capsicum annuum L. Caraway ...... Carum carvi L. Cardamom seed (cardamon) ...... Elettaria cardamomum Maton. Carob bean ...... Ceratonia siliqua L. Carrot ...... Daucus carota L. Cascarilla bark ...... Croton eluteria Benn. Cassia bark, Chinese ...... Cinnamomum cassia Blume. Cassia bark, Padang or Batavia ...... Cinnamomum burmanni Blume. Cassia bark, Saigon ...... Cinnamomum loureirii Nees. Celery seed ...... Apium graveolens L. Cherry, wild, bark ...... Prunus serotina Ehrh. Chervil ...... Anthriscus cerefolium (L.) Hoffm. Chicory ...... Cichorium intybus L. Cinnamon bark, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon bark, Chinese ...... Cinnamomum cassia Blume. Cinnamon bark, Saigon ...... Cinnamomum loureirii Nees. Cinnamon leaf, Ceylon ...... Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese ...... Cinnamomum cassia Blume. Cinnamon leaf, Saigon ...... Cinnamomum loureirii Nees. Citronella ...... Cymbopogon nardus Rendle. Citrus peels ...... Citrus spp. Clary (clary sage) ...... Salvia sclarea L. Clover ...... Trifolium spp. Coca (decocainized) ...... Erythroxylum coca Lam. and other spp. of Erythroxylum.

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Common name Botanical name of plant source

Coffee ...... Coffea spp. Cola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Coriander ...... Coriandrum sativum L. Cumin (cummin) ...... Cuminum cyminum L. Curacao orange peel (orange, bitter peel) ...... Citrus aurantium L. Cusparia bark ...... Galipea officinalis Hancock. Dandelion ...... Taraxacum officinale Weber and T. laevigatum DC. Dandelion root ...... Do. Dog grass (quackgrass, triticum) ...... Agropyron repens (L.) Beauv. Elder flowers ...... Sambucus canadensis L. and S. nigra I. Estragole (esdragol, esdragon, tarragon) ...... Artemisia dracunculus L. Estragon (tarragon) ...... Do. Fennel, sweet ...... Foeniculum vulgare Mill. Fenugreek ...... Trigonella foenum-graecum L. Galanga (galangal) ...... Alpinia officinarum Hance. Geranium ...... Pelargonium spp. Geranium, East Indian ...... Cymbopogon martini Stapf. Geranium, rose ...... Pelargonium graveolens L’Her. Ginger ...... Zingiber officinale Rosc. Grapefruit ...... Citrus paradisi Macf. Guava ...... Psidium spp. Hickory bark ...... Carya spp. Horehound (hoarhound) ...... Marrubium vulgare L. Hops ...... Humulus lupulus L. Horsemint ...... Monarda punctata L. Hyssop ...... Hyssopus officinalis L. Immortelle ...... Helichrysum augustifolium DC. Jasmine ...... Jasminum officinale L. and other spp. of Jasminum. Juniper (berries) ...... Juniperus communis L. Kola nut ...... Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries ...... Laurus nobilis L. Laurel leaves ...... Laurus spp. Lavender ...... Lavandula officinalis Chaix. Lavender, spike ...... Lavandula latifolia Vill. Lavandin ...... Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lemon ...... Citrus limon (L.) Burm. f. Lemon balm (see balm). Lemon grass ...... Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf. Lemon peel ...... Citrus limon (L.) Burm. f. Lime ...... Citrus aurantifolia Swingle. Linden flowers ...... Tilia spp. Locust bean ...... Ceratonia siliqua L, Lupulin ...... Humulus lupulus L. Mace ...... Myristica fragrans Houtt. Mandarin ...... Citrus reticulata Blanco. Marjoram, sweet ...... Majorana hortensis Moench. Mate´ ...... Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ...... Mentha spp. Menthyl acetate ...... Do. Molasses (extract) ...... Saccarum officinarum L. Mustard ...... Brassica spp. Naringin ...... Citrus paradisi Macf. Neroli, bigarade ...... Citrus aurantium L. Nutmeg ...... Myristica fragrans Houtt. Onion ...... Allium cepa L. Orange, bitter, flowers ...... Citrus aurantium L. Orange, bitter, peel ...... Do. Orange leaf ...... Citrus sinensis (L.) Osbeck. Orange, sweet ...... Do. Orange, sweet, flowers ...... Do. Orange, sweet, peel ...... Do. Origanum ...... Origanum spp. Palmarosa ...... Cymbopogon martini Stapf. Paprika ...... Capsicum annuum L. Parsley ...... Petroselinum crispum (Mill.) Mansf. Pepper, black ...... Piper nigrum L. Pepper, white ...... Do. Peppermint ...... Mentha piperita L. Peruvian balsam ...... Myroxylon pereirae Klotzsch. Petitgrain ...... Citrus aurantium L. Petitgrain lemon ...... Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine ...... Citrus reticulata Blanco. Pimenta ...... Pimenta officinalis Lindl.

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Common name Botanical name of plant source

Pimenta leaf ...... Pimenta officinalis Lindl. Pipsissewa leaves ...... Chimaphila umbellata Nutt. Pomegranate ...... Punica granatum L. Prickly ash bark ...... Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava- herculis L. Rose absolute ...... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of roses) ...... Do. Rose buds ...... Do. Rose flowers ...... Do. Rose fruit (hips) ...... Do. Rose geranium ...... Pelargonium graveolens L’Her. Rose leaves ...... Rosa spp. Rosemary ...... Rosmarinus officinalis L. Saffron ...... Crocus sativus L. Sage ...... Salvia officinalis L. Sage, Greek ...... Salvia triloba L. Sage, Spanish ...... Salvia lavandulaefolia Vahl. St. John’s bread ...... Ceratonia siliqua L. Savory, summer ...... Satureia hortensis L. Savory, winter ...... Satureia montana L. Schinus molle ...... Schinus molle L. Sloe berries (blackthorn berries) ...... Prunus spinosa L. Spearmint ...... Mentha spicata L. Spike lavender ...... Lavandula latifolia Vill. Tamarind ...... Tamarindus indica L. Tangerine ...... Citrus reticulata Blanco. Tarragon ...... Artemisia dracunculus L. Tea ...... Thea sinensis L. Thyme ...... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white ...... Do. Thyme, wild or creeping ...... Thymus serpyllum L. Triticum (see dog grass). Tuberose ...... Polianthes tuberosa L. Turmeric ...... Curcuma longa L. Vanilla ...... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers ...... Viola odorata L. Violet leaves ...... Do. Violet leaves absolute ...... Do. Wild cherry bark ...... Prunus serotina Ehrh. Ylang-ylang ...... Cananga odorata Hook. f. and Thoms. Zedoary bark ...... Curcuma zedoaria Rosc.

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

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

Common name Botanical name of plant source

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

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

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

Common name Derivation

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

§ 182.60 Synthetic flavoring substances ognized as safe for their intended use, and adjuvants. within the meaning of section 409 of Synthetic flavoring substances and the Act, are as follows: adjuvants that are generally recog- Beef tallow. nized as safe for their intended use, Carboxymethylcellulose. within the meaning of section 409 of Coconut oil, refined. the Act, are as follows: Cornstarch. Gelatin. Acetaldehyde (ethanal). Lard. Acetoin (acetyl methylcarbinol). Lard oil. Anethole (parapropenyl anisole). Oleic acid. Benzaldehyde (benzoic aldehyde). Peanut oil. N-Butyric acid (butanoic acid). Potato starch. d- or l-Carvone (carvol). Sodium acetate. Cinnamaldehyde (cinnamic aldehyde). Sodium chloride. Citral (2,6-dimethyloctadien-2,6-al-8, gera- Sodium silicate. nial, neral). Sodium tripolyphosphate. Decanal (N-decylaldehyde, capraldehyde, Soybean oil (hydrogenated). capric aldehyde, caprinaldehyde, aldehyde Talc. C-10). Tallow (hydrogenated). Ethyl acetate. Tallow flakes. Ethyl butyrate. Tapioca starch. 3-Methyl-3-phenyl glycidic acid ethyl ester Tetrasodium pyrophosphate. (ethyl-methyl-phenyl-glycidate, so-called Wheat starch. strawberry aldehyde, C-16 aldehyde). Zinc chloride. Ethyl vanillin. [42 FR 14640, Mar. 15, 1977, as amended at 43 Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, ol). 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, Geranyl acetate (geraniol acetate). 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; Limonene (d-, l-, and dl-). 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, ol). Linalyl acetate (bergamol). 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, Methyl anthranilate (methyl-2- July 30, 1986; 60 FR 62208, Dec. 5, 1995] aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, § 182.90 Substances migrating to food heliotropin). from paper and paperboard prod- Vanillin. ucts. [42 FR 14640, Mar. 15, 1977, as amended at 43 Substances migrating to food from FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, paper and paperboard products used in 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, food packaging that are generally rec- Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989] ognized as safe for their intended use, within the meaning of section 409 of § 182.70 Substances migrating from the Act, are as follows: cotton and cotton fabrics used in dry food packaging. Alum (double sulfate of aluminum and ammonium potassium, or sodium). Substances migrating to food from Aluminum hydroxide. cotton and cotton fabrics used in dry Aluminum oleate. food packaging that are generally rec- Aluminum palmitate.

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Casein. (c) Limitations, restrictions, or expla- Cellulose acetate. nation. This substance is generally rec- Cornstarch. ognized as safe when used as a salt sub- Diatomaceous earth filler. Ethyl cellulose. stitute in accordance with good manu- Ethyl vanillin. facturing practice. Glycerin. Oleic acid. § 182.1057 Hydrochloric acid. Potassium sorbate. (a) Product. Hydrochloric acid. Silicon dioxides. Sodium aluminate. (b) [Reserved] Sodium chloride. (c) Limitations, restrictions, or expla- Sodium hexametaphosphate. nation. This substance is generally rec- Sodium hydrosulfite. ognized as safe when used as a buffer Sodium phosphoaluminate. and neutralizing agent in accordance Sodium silicate. with good manufacturing practice. Sodium sorbate. Sodium tripolyphosphate. § 182.1073 Phosphoric acid. Sorbitol. Soy protein, isolated. (a) Product. Phosphoric acid. Starch, acid modified. (b) Conditions of use. This substance Starch, pregelatinized. is generally recognized as safe when Starch, unmodified. used in accordance with good manufac- Talc. Vanillin. turing practice. Zinc hydrosulfite. Zinc sulfate. § 182.1087 Sodium acid pyrophosphate. [42 FR 14640, Mar. 15, 1977] (a) Product. Sodium acid pyrophosphate. EDITORIAL NOTE: For additional FEDERAL (b) Conditions of use. This substance REGISTER citations affecting § 182.90, see the List of CFR Sections Affected, which appears is generally recognized as safe when in the Finding Aids section of the printed used in accordance with good manufac- volume and at www.fdsys.gov. turing practice.

§ 182.99 Adjuvants for pesticide chemi- § 182.1125 Aluminum sulfate. cals. (a) Product. Aluminum sulfate. Adjuvants, identified and used in ac- (b) Conditions of use. This substance cordance with 40 CFR 180.1001 (c) and is generally recognized as safe when (d), which are added to pesticide use di- used in accordance with good manufac- lutions by a grower or applicator prior turing practice. to application to the raw agricultural commodity, are exempt from the re- § 182.1127 Aluminum ammonium sul- quirement of tolerances under section fate. 409 of the Act. (a) Product. Aluminum ammonium sulfate. Subpart B—Multiple Purpose GRAS (b) Conditions of use. This substance Food Substances is generally recognized as safe when used in accordance with good manufac- § 182.1045 Glutamic acid. turing practice. (a) Product. Glutamic acid. (b) [Reserved] § 182.1129 Aluminum potassium sulfate. (c) Limitations, restrictions, or explanation. This substance is generally rec- (a) Product. Aluminum potassium sul- ognized as safe when used as a salt sub- fate. stitute in accordance with good manu- (b) Conditions of use. This substance facturing practice. is generally recognized as safe when used in accordance with good manufac- § 182.1047 Glutamic acid hydro- turing practice. chloride. (a) Product. Glutamic acid hydro- § 182.1131 Aluminum sodium sulfate. chloride. (a) Product. Aluminum sodium sul- (b) [Reserved] fate.

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(b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

§ 182.1180 Caffeine. § 182.1711 Silica aerogel. (a) Product. Caffeine. (a) Product. Silica aerogel as a finely (b) Tolerance. 0.02 percent. powdered microcellular silica foam (c) Limitations, restrictions, or expla- having a minimum silica content of nation. This substance is generally rec- 89.5 percent. ognized as safe when used in cola-type (b) [Reserved] beverages in accordance with good (c) Limitations, restrictions, or expla- manufacturing practice. nation. This substance is generally recognized as safe when used as a compo- § 182.1217 Calcium phosphate. nent of an anti-foaming agent in ac- (a) Product. Calcium phosphate cordance with good manufacturing (mono-, di-, and tribasic). practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1745 Sodium carboxymethylcellu- used in accordance with good manufac- lose. turing practice. (a) Product. Sodium carboxymethylcellulose is the sodium salt of § 182.1235 Caramel. carboxymethylcellulose not less than (a) Product. Caramel. 99.5 percent on a dry-weight basis, with (b) Conditions of use. This substance maximum substitution of 0.95 is generally recognized as safe when carboxymethyl groups per used in accordance with good manufac- anhydroglucose unit, and with a min- turing practice. imum viscosity of 25 centipoises for 2 percent by weight aqueous solution at § 182.1320 Glycerin. 25 °C. (a) Product. Glycerin. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice. § 182.1748 Sodium caseinate. § 182.1480 Methylcellulose. (a) Product. Sodium caseinate. (a) Product. U.S.P. methylcellulose, (b) Conditions of use. This substance except that the methoxy content shall is generally recognized as safe when not be less than 27.5 percent and not used in accordance with good manufac- more than 31.5 percent on a dry-weight turing practice. basis. (b) Conditions of use. This substance § 182.1778 Sodium phosphate. is generally recognized as safe when (a) Product. Sodium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.1500 Monoammonium glutamate. used in accordance with good manufac- (a) Product. Monoammonium glu- turing practice. tamate. (b) Conditions of use. This substance § 182.1781 Sodium aluminum phos- is generally recognized as safe when phate. used in accordance with good manufac- (a) Product. Sodium aluminum phos- turing practice. phate. (b) Conditions of use. This substance § 182.1516 Monopotassium glutamate. is generally recognized as safe when (a) Product. Monopotassium glu- used in accordance with good manufac- tamate. turing practice.

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§ 182.1810 Sodium tripolyphosphate. § 182.2906 Tricalcium silicate. (a) Product. Sodium (a) Product. Tricalcium silicate. tripolyphosphate. (b) Tolerance. 2 percent. (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in table salt turing practice. in accordance with good manufacturing practice. Subpart C—Anticaking Agents Subpart D—Chemical § 182.2122 Aluminum calcium silicate. Preservatives (a) Product. Aluminum calcium silicate. § 182.3013 Ascorbic acid. (b) Tolerance. 2 percent. (a) Product. Ascorbic acid. (c) Limitations, restrictions, or expla- (b) Conditions of use. This substance nation. This substance is generally rec- is generally recognized as safe when ognized as safe when used in table salt used in accordance with good manufac- in accordance with good manufacturing turing practice. practice. § 182.3041 Erythorbic acid. § 182.2227 Calcium silicate. (a) Product. Erythorbic acid. (a) Product. Calcium silicate. (b) Conditions of use. This substance (b) Tolerance. 2 percent and 5 percent. is generally recognized as safe when (c) Limitations, restrictions, or expla- used in accordance with good manufac- nation. This substance is generally rec- turing practice. ognized as safe when used at levels not exceeding 2 percent in table salt and 5 § 182.3089 Sorbic acid. percent in baking powder in accordance (a) Product. Sorbic acid. with good manufacturing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.2437 Magnesium silicate. used in accordance with good manufac- (a) Product. Magnesium silicate. turing practice. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla- § 182.3109 Thiodipropionic acid. nation. This substance is generally rec- (a) Product. Thiodipropionic acid. ognized as safe when used in table salt (b) Tolerance. This substance is gen- in accordance with good manufacturing erally recognized as safe for use in food practice. when the total content of antioxidants is not over 0.02 percent of fat or oil § 182.2727 Sodium aluminosilicate. content, including essential (volatile) (a) Product. Sodium aluminosilicate oil content of the food, provided the (sodium silicoaluminate). substance is used in accordance with (b) Tolerance. This substance is gen- good manufacturing practice. erally recognized as safe for use at a level not exceeding 2 percent in accord- § 182.3149 Ascorbyl palmitate. ance with good manufacturing prac- (a) Product. Ascorbyl palmitate. tice. (b) Conditions of use. This substance is generally recognized as safe when § 182.2729 Sodium calcium used in accordance with good manufac- aluminosilicate, hydrated. turing practice. (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium § 182.3169 Butylated hydroxyanisole. silicoaluminate). (a) Product. Butylated hydroxy- (b) Tolerance. This substance is gen- anisole. erally recognized as safe for use at a (b) Tolerance. This substance is gen- level not exceeding 2 percent in accord- erally recognized as safe for use in food ance with good manufacturing prac- when the total content of antioxidants tice. is not over 0.02 percent of fat or oil

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content, including essential (volatile) § 182.3637 Potassium metabisulfite. oil content of food, provided the sub- (a) Product. Potassium metabisulfite. stance is used in accordance with good manufacturing practice. (b) [Reserved] (c) Limitations, restrictions, or expla- § 182.3173 Butylated hydroxytoluene. nation. This substance is generally recognized as safe when used in accord- (a) Product. Butylated hydroxytoluene. ance with good manufacturing prac- (b) Tolerance. This substance is gen- tice, except that it is not used in erally recognized as safe for use in food meats; in food recognized as a source of when the total content of antioxidants vitamin B1; on fruits and vegetables in- is not over 0.02 percent of fat or oil tended to be served raw to consumers content, including essential (volatile) or sold raw to consumers, or to be pre- oil content of food, provided the sub- sented to consumers as fresh. stance is used in accordance with good [42 FR 14640, Mar. 15, 1977, as amended at 51 manufacturing practice. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] § 182.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. § 182.3640 Potassium sorbate. (b) Conditions of use. This substance (a) Product. Potassium sorbate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. § 182.3225 Calcium sorbate. (a) Product. Calcium sorbate. § 182.3731 Sodium ascorbate. (b) Conditions of use. This substance (a) Product. Sodium ascorbate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. § 182.3280 Dilauryl thiodipropionate. (a) Product. Dilauryl § 182.3739 Sodium bisulfite. thiodipropionate. (a) Product. Sodium bisulfite. (b) Tolerance. This substance is gen- (b) [Reserved] erally recognized as safe for use in food (c) Limitations, restrictions, or expla- when the total content of antioxidants is not over 0.02 percent of fat or oil nation. This substance is generally rec- content, including essential (volatile) ognized as safe when used in accord- oil content of the food, provided the ance with good manufacturing prac- substance is used in accordance with tice, except that it is not used in good manufacturing practice. meats; in food recognized as a source of vitamin B1; on fruits or vegetables in- § 182.3616 Potassium bisulfite. tended to be served raw to consumers or sold raw to consumers, or to be pre- (a) Product. Potassium bisulfite. (b) [Reserved] sented to the consumer as fresh. (c) Limitations, restrictions, or expla- [42 FR 14640, Mar. 15, 1977, as amended at 51 nation. This substance is generally rec- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, ognized as safe when used in accord- 1990; 59 FR 65939, Dec. 22, 1994] ance with good manufacturing practice, except that it is not used in § 182.3766 Sodium metabisulfite. meats; in food recognized as a source of (a) Product. Sodium metabisulfite. vitamin B1; on fruits and vegetables in- (b) [Reserved] tended to be served raw to consumers (c) Limitations, restrictions, or expla- or sold raw to consumers, or to be pre- nation. This substance is generally rec- sented to consumers as fresh. ognized as safe when used in accord- [42 FR 14640, Mar. 15, 1977, as amended at 51 ance with good manufacturing prac- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, tice, except that it is not used in 1990; 59 FR 65939, Dec. 22, 1994] meats; in food recognized as a source of

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vitamin B1; on fruits or vegetables in- Subpart F—Dietary Supplements tended to be served raw to consumers [Reserved] or sold raw to consumers, or to be pre- sented to consumers as fresh. Subpart G—Sequestrants 1 [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, § 182.6085 Sodium acid phosphate. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Sodium acid phosphate. § 182.3795 Sodium sorbate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Sodium sorbate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.6197 Calcium diacetate. turing practice. (a) Product. Calcium diacetate. § 182.3798 Sodium sulfite. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Sodium sulfite. used in accordance with good manufac- (b) [Reserved] turing practice. (c) Limitations, restrictions, or explanation. This substance is generally rec- § 182.6203 Calcium ognized as safe when used in accord- hexametaphosphate. ance with good manufacturing prac- (a) Calcium tice, except that it is not used in Product. hexametaphosphate. meats; in food recognized as a source of (b) Conditions of use. This substance vitamin B1; on fruits or vegetables intended to be served raw to consumers is generally recognized as safe when or sold raw to consumers, or to be pre- used in accordance with good manufac- sented to consumers as fresh. turing practice. [42 FR 14640, Mar. 15, 1977, as amended at 51 § 182.6215 Monobasic calcium phos- FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, phate. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Monobasic calcium phosphate. § 182.3862 Sulfur dioxide. (b) Conditions of use. This substance (a) Product. Sulfur dioxide. is generally recognized as safe when (b) [Reserved] used in accordance with good manufac- (c) Limitations, restrictions, or expla- turing practice. nation. This substance is generally recognized as safe when used in accord- § 182.6285 Dipotassium phosphate. ance with good manufacturing prac- (a) Product. Dipotassium phosphate. tice, except that it is not used in (b) Conditions of use. This substance meats; in food recognized as a source of is generally recognized as safe when vitamin B ; on fruits or vegetables in- 1 used in accordance with good manufac- tended to be served raw to consumers turing practice. or sold raw to consumers, or to be pre- sented to consumers as fresh. § 182.6290 Disodium phosphate. [42 FR 14640, Mar. 15, 1977, as amended at 51 (a) Product. Disodium phosphate. FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, (b) Conditions of use. This substance 1990; 59 FR 65939, Dec. 22, 1994] is generally recognized as safe when used in accordance with good manufac- § 182.3890 Tocopherols. turing practice. (a) Product. Tocopherols. (b) Conditions of use. This substance § 182.6757 Sodium gluconate. is generally recognized as safe when (a) Product. Sodium gluconate. used in accordance with good manufacturing practice. 1 For the purpose of this subpart, no attempt has been made to designate those Subpart E—Emulsifying Agents sequestrants that may also function as [Reserved] chemical preservatives. 480

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§ 182.6760 Sodium Subpart I—Nutrients hexametaphosphate. (a) Product. Sodium SOURCE: 45 FR 58838, Sept. 5, 1980, unless hexametaphosphate. otherwise noted. (b) Conditions of use. This substance is generally recognized as safe when § 182.8013 Ascorbic acid. used in accordance with good manufac- (a) Product. Ascorbic acid. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6769 Sodium metaphosphate. used in accordance with good manufac- (a) Product. Sodium metaphosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.8159 Biotin. used in accordance with good manufac- (a) Product. Biotin. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6778 Sodium phosphate. used in accordance with good manufac- (a) Product. Sodium phosphate turing practice. (mono-, di-, and tribasic). (b) Conditions of use. This substance § 182.8217 Calcium phosphate. is generally recognized as safe when (a) Product. Calcium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6787 Sodium pyrophosphate. used in accordance with good manufac- (a) Product. Sodium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.8223 Calcium pyrophosphate. used in accordance with good manufac- (a) Product. Calcium pyrophosphate. turing practice. (b) Conditions of use. This substance is generally recognized as safe when § 182.6789 Tetra sodium used in accordance with good manufac- pyrophosphate. turing practice. (a) Product. Tetra sodium pyrophosphate. § 182.8250 Choline bitartrate. (b) Conditions of use. This substance (a) Product. Choline bitartrate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufacturing practice. § 182.6810 Sodium tripolyphosphate. (a) Product. Sodium § 182.8252 Choline chloride. tripolyphosphate. (a) Product. Choline chloride. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice.

Subpart H—Stabilizers § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate § 182.7255 Chondrus extract. (mono-, di-, and tribasic). (a) Product. Chondrus extract (b) Conditions of use. This substance (carrageenin). is generally recognized as safe when

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used in accordance with good manufac- PART 184—DIRECT FOOD SUB- turing practice. STANCES AFFIRMED AS GEN- § 182.8890 Tocopherols. ERALLY RECOGNIZED AS SAFE (a) Product. Tocopherols. Subpart A—General Provisions (b) Conditions of use. This substance Sec. is generally recognized as safe when 184.1 Substances added directly to human used in accordance with good manufac- food affirmed as generally recognized as turing practice. safe (GRAS).

§ 182.8892 ù-Tocopherol acetate. Subpart B—Listing of Specific Substances Affirmed as GRAS (a) Product. a-Tocopherol acetate. (b) Conditions of use. This substance 184.1005 Acetic acid. is generally recognized as safe when 184.1007 Aconitic acid. used in accordance with good manufac- 184.1009 Adipic acid. 184.1011 Alginic acid. turing practice. 184.1012 a-Amylase enzyme preparation from Bacillus stearothermophilus. § 182.8985 Zinc chloride. 184.1021 Benzoic acid. (a) Product. Zinc chloride. 184.1024 Bromelain. (b) Conditions of use. This substance 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease is generally recognized as safe when enzyme product. used in accordance with good manufac- 184.1033 Citric acid. turing practice. 184.1034 Catalase (bovine liver). 184.1061 Lactic acid. § 182.8988 Zinc gluconate. 184.1063 Enzyme-modified lecithin. 184.1065 Linoleic acid. (a) Product. Zinc gluconate. 184.1069 Malic acid. (b) Conditions of use. This substance 184.1077 Potassium acid tartrate. is generally recognized as safe when 184.1081 Propionic acid. used in accordance with good manufac- 184.1090 Stearic acid. 184.1091 Succinic acid. turing practice. 184.1095 Sulfuric acid. 184.1097 Tannic acid. § 182.8991 Zinc oxide. 184.1099 Tartaric acid. (a) Product. Zinc oxide. 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides. (b) Conditions of use. This substance 184.1115 Agar-agar. is generally recognized as safe when 184.1120 Brown algae. used in accordance with good manufac- 184.1121 Red algae. turing practice. 184.1133 Ammonium alginate. 184.1135 Ammonium bicarbonate. § 182.8994 Zinc stearate. 184.1137 Ammonium carbonate. 184.1138 Ammonium chloride. (a) Product. Zinc stearate prepared 184.1139 Ammonium hydroxide. from stearic acid free from chickedema 184.1140 Ammonium citrate, dibasic. factor. 184.1141a Ammonium phosphate, monobasic. (b) Conditions of use. This substance 184.1141b Ammonium phosphate, dibasic. 184.1143 Ammonium sulfate. is generally recognized as safe when 184.1148 Bacterially-derived carbohydrase used in accordance with good manufac- enzyme preparation. turing practice. 184.1150 Bacterially-derived protease enzyme preparation. § 182.8997 Zinc sulfate. 184.1155 Bentonite. 184.1157 Benzoyl peroxide. (a) Product. Zinc sulfate. 184.1165 n-Butane and iso-butane. (b) Conditions of use. This substance 184.1185 Calcium acetate. is generally recognized as safe when 184.1187 Calcium alginate. used in accordance with good manufac- 184.1191 Calcium carbonate. turing practice. 184.1193 Calcium chloride. 184.1195 Calcium citrate. 184.1199 Calcium gluconate. 184.1201 Calcium glycerophosphate.

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184.1205 Calcium hydroxide. 184.1408 Licorice and licorice derivatives. 184.1206 Calcium iodate. 184.1409 Ground limestone. 184.1207 Calcium lactate. 184.1415 Animal lipase. 184.1210 Calcium oxide. 184.1420 Lipase enzyme preparation derived 184.1212 Calcium pantothenate. from Rhizopus niveus. 184.1221 Calcium propionate. 184.1425 Magnesium carbonate. 184.1229 Calcium stearate. 184.1426 Magnesium chloride. 184.1230 Calcium sulfate. 184.1428 Magnesium hydroxide. 184.1240 Carbon dioxide. 184.1431 Magnesium oxide. 184.1245 Beta-carotene. 184.1434 Magnesium phosphate. 184.1250 Cellulase enzyme preparation de- 184.1440 Magnesium stearate. rived from Trichoderma longibrachi- 184.1443 Magnesium sulfate. atum. 184.1443a Malt. 184.1257 Clove and its derivatives. 184.1444 Maltodextrin. 184.1259 Cocoa butter substitute. 184.1445 Malt syrup (malt extract). 184.1260 Copper gluconate. 184.1446 Manganese chloride. 184.1261 Copper sulfate. 184.1449 Manganese citrate. 184.1262 Corn silk and corn silk extract. 184.1452 Manganese gluconate. 184.1265 Cuprous iodide. 184.1461 Manganese sulfate. 184.1271 L-Cysteine. 184.1472 Menhaden oil. 184.1272 L-Cysteine monohydrochloride. 184.1490 Methylparaben. 184.1277 Dextrin. 184.1498 Microparticulated protein product. 184.1278 Diacetyl. 184.1505 Mono- and diglycerides. 184.1282 Dill and its derivatives. 184.1521 Monosodium phosphate derivatives 184.1287 Enzyme-modified fats. of mono- and diglycerides. 184.1293 Ethyl alcohol. 184.1530 Niacin. 184.1295 Ethyl formate. 184.1535 Niacinamide. 184.1296 Ferric ammonium citrate. 184.1537 Nickel. 184.1297 Ferric chloride. 184.1538 Nisin preparation. 184.1298 Ferric citrate. 184.1540 Nitrogen. 184.1301 Ferric phosphate. 184.1545 Nitrous oxide. 184.1304 Ferric pyrophosphate. 184.1553 Peptones. 184.1307 Ferric sulfate. 184.1555 Rapeseed oil. 184.1307a Ferrous ascorbate. 184.1560 Ox bile extract. 184.1307b Ferrous carbonate. 184.1563 Ozone. 184.1307c Ferrous citrate. 184.1583 Pancreatin. 184.1307d Ferrous fumarate. 184.1585 Papain. 184.1308 Ferrous gluconate. 184.1588 Pectins. 184.1311 Ferrous lactate. 184.1595 Pepsin. 184.1315 Ferrous sulfate. 184.1610 Potassium alginate. 184.1316 Ficin. 184.1613 Potassium bicarbonate. 184.1317 Garlic and its derivatives. 184.1619 Potassium carbonate. 184.1318 Glucono delta-lactone. 184.1622 Potassium chloride. 184.1321 Corn gluten. 184.1625 Potassium citrate. 184.1322 Wheat gluten. 184.1631 Potassium hydroxide. 184.1323 Glyceryl monooleate. 184.1634 Potassium iodide. 184.1324 Glyceryl monostearate. 184.1635 Potassium iodate. 184.1328 Glyceryl behenate. 184.1639 Potassium lactate. 184.1329 Glyceryl palmitostearate. 184.1643 Potassium sulfate. 184.1330 Acacia (gum arabic). 184.1655 Propane. 184.1333 Gum ghatti. 184.1660 Propyl gallate. 184.1339 Guar gum. 184.1666 Propylene glycol. 184.1343 Locust (carob) bean gum. 184.1670 Propylparaben. 184.1349 Karaya gum (sterculia gum). 184.1676 Pyridoxine hydrochloride. 184.1351 Gum tragacanth. 184.1685 Rennet (animal-derived) and 184.1355 Helium. chymosin preparation (fermentation-de- 184.1366 Hydrogen peroxide. rived). 184.1370 Inositol. 184.1695 Riboflavin. 184.1372 Insoluble glucose isomerase enzyme 184.1697 Riboflavin-5′-phosphate (sodium). preparations. 184.1698 Rue. 184.1375 Iron, elemental. 184.1699 Oil of rue. 184.1386 Isopropyl citrate. 184.1702 Sheanut oil. 184.1387 Lactase enzyme preparation from 184.1721 Sodium acetate. Candida pseudotropicalis. 184.1724 Sodium alginate. 184.1388 Lactase enzyme preparation from 184.1733 Sodium benzoate. Kluyveromyces lactis. 184.1736 Sodium bicarbonate. 184.1400 Lecithin. 184.1742 Sodium carbonate.

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184.1751 Sodium citrate. poses and under the conditions pre- 184.1754 Sodium diacetate. scribed. The regulations in this part 184.1763 Sodium hydroxide. shall sufficiently describe each ingre- 184.1764 Sodium hypophosphite. 184.1768 Sodium lactate. dient to identify the characteristics of 184.1769a Sodium metasilicate. the ingredient that has been affirmed 184.1784 Sodium propionate. as GRAS and to differentiate it from 184.1792 Sodium sesquicarbonate. other possible versions of the ingre- 184.1801 Sodium tartrate. dient that have not been affirmed as 184.1804 Sodium potassium tartrate. GRAS. Ingredients affirmed as GRAS 184.1807 Sodium thiosulfate. in this part are also GRAS as indirect 184.1835 Sorbitol. 184.1845 Stannous chloride (anhydrous and human food ingredients, subject to any dihydrated). limitations prescribed in parts 174, 175, 184.1848 Starter distillate. 176, 177, 178 or § 179.45 of this chapter or 184.1851 Stearyl citrate in part 186 of this chapter. The purity 184.1854 Sucrose. specifications in this part do not apply 184.1857 Corn sugar. when the ingredient is used in indirect 184.1859 Invert sugar. applications. However, when used in in- 184.1865 Corn syrup. direct applications, the ingredient 184.1866 High fructose corn syrup. 184.1875 Thiamine hydrochloride. must be of a purity suitable for its in- 184.1878 Thiamine mononitrate. tended use in accordance with 184.1890 a-Tocopherols. § 170.30(h)(1) of this chapter. 184.1901 Triacetin. (b) Any ingredient affirmed as GRAS 184.1903 Tributyrin. in this part shall be used in accordance 184.1911 Triethyl citrate. with current good manufacturing prac- 184.1914 Trypsin. tice. For the purpose of this part, cur- 184.1923 Urea. 184.1924 Urease enzyme preparation from rent good manufacturing practice in- Lactobacillus fermentum. cludes the requirements that a direct 184.1930 Vitamin A. human food ingredient be of appro- 184.1945 Vitamin B12. priate food grade; that it be prepared 184.1950 Vitamin D. and handled as a food ingredient; and 184.1973 Beeswax (yellow and white). that the quantity of the ingredient 184.1976 Candelilla wax. added to food does not exceed the 184.1978 Carnauba wax. 184.1979 Whey. amount reasonably required to accom- 184.1979a Reduced lactose whey. plish the intended physical, nutri- 184.1979b Reduced minerals whey. tional, or other technical effect in 184.1979c Whey protein concentrate. food. 184.1983 Bakers yeast extract. (1) If the ingredient is affirmed as 184.1984 Zein. GRAS with no limitations on its condi- 184.1985 Aminopeptidase enzyme preparations of use other than current good tion derived from lactococcus lactis. manufacturing practice, it shall be re- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. garded as GRAS if its conditions of use SOURCE: 42 FR 14653, Mar 15, 1977, unless are consistent with the requirements of otherwise noted. paragraph (b), (c), and (d) of this section. When the Food and Drug Admin- EDITORIAL NOTE: Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001, 66 istration (FDA) determines that it is FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, appropriate, the agency will describe 2003, 69 FR 13717, Mar. 24, 2004, 70 FR 40880, one or more current good manufac- July 15, 2005, and 70 FR 67651, Nov. 8, 2005. turing practice conditions of use in the regulation that affirms the GRAS sta- Subpart A—General Provisions tus of the ingredient. For example, when the safety of an ingredient has § 184.1 Substances added directly to been evaluated on the basis of limited human food affirmed as generally conditions of use, the agency will de- recognized as safe (GRAS). scribe in the regulation that affirms (a) The direct human food ingredi- the GRAS status of the ingredient, one ents listed in this part have been re- or more of these limited conditions of viewed by the Food and Drug Adminis- use, which may include the category of tration and determined to be generally food(s), the technical effect(s) or func- recognized as safe (GRAS) for the pur- tional use(s) of the ingredient, and the

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level(s) of use. If the ingredient is used promulgated pursuant to this section under conditions that are significantly constitutes a determination that ex- different from those described in the cluded uses would result in adultera- regulation, that use of the ingredient tion of the food in violation of section may not be GRAS. In such a case, a 402 of the Act, and the failure of any manufacturer may not rely on the reg- person to come forward with proof of ulation as authorizing that use but such an applicable prior sanction in re- shall independently establish that that sponse to the proposal will constitute a use is GRAS or shall use the ingredient waiver of the right to assert or rely on in accordance with a food additive reg- such sanction at any later time. The ulation. Persons seeking FDA approval notice will also constitute a proposal of an independent determination that a to establish a regulation under part 181 use of an ingredient is GRAS may sub- of this chapter, incorporating the same mit a GRAS petition in accordance provisions, in the event that such a with § 170.35 of this chapter. regulation is determined to be appro- (2) If the ingredient is affirmed as priate as a result of submission of proof GRAS with specific limitation(s), it of such an applicable prior sanction in shall be used in food only within such response to the proposal. limitation(s), including the category of (f) The label and labeling of the in- food(s), the functional use(s) of the ingredient and any intermediate mix of gredient, and the level(s) of use. Any the ingredient for use in finished food use of such an ingredient not in full shall bear, in addition to the other la- compliance with each such established beling required by the Act: limitation shall require a food additive (1) The name of the ingredient, ex- regulation. cept where exempted from such label- (3) If the ingredient is affirmed as ing in part 101 of this chapter. GRAS for a specific use, without a gen- (2) A statement of concentration of eral evaluation of use of the ingredient, the ingredient in any intermediate other uses may also be GRAS. mix; or other information to permit a (c) The listing of a food ingredient in food processor independently to deter- this part does not authorize the use of mine that use of the ingredients will be such substance in a manner that may in accordance with any limitations and lead to deception of the consumer or to good manufacturing practice gudelines any other violation of the Federal prescribed. Food, Drug, and Cosmetic Act (the (3) Adequate directions for use to Act). provide a final food product that complies with any limitations prescribed (d) The listing of more than one infor the ingredient(s). gredient to produce the same technological effect does not authorize use of [42 FR 14653, Mar. 15, 1977, as amended at 42 a combination of two or more ingredi- FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. ents to accomplish the same techno- 19, 1983; 62 FR 15110, Mar. 31, 1997] logical effect in any one food at a combined level greater than the highest Subpart B—Listing of Specific level permitted for one of the ingredi- Substances Affirmed as GRAS ents. (e) If the Commissioner of Food and § 184.1005 Acetic acid.

Drugs is aware of any prior sanction (a) Acetic acid (C2H4O2, CAS Reg. No. for use of an ingredient under condi- 64–19–7) is known as ethanoic acid. It tions different from those proposed to occurs naturally in plant and animal be affirmed as GRAS, he will concur- tissues. It is produced by fermentation rently propose a separate regulation of carbohydrates or by organic syn- covering such use of the ingredient thesis. The principal synthetic meth- under part 181 of this chapter. If the ods currently employed are oxidation Commissioner is unaware of any such of acetaldehyde derived from ethylene, applicable prior sanction, the proposed liquid phase oxidation of butane, and regulation will so state and will re- reaction of carbon monoxide with quire any person who intends to assert methanol derived from natural gas. or rely on such sanction to submit (b) The ingredient meets the speci- proof of its existence. Any regulation fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 8, which is incorporated CAS Reg. No. 000499–12–7) occurs in the by reference. Copies are available from leaves and tubers of Aconitum napellus the National Academy Press, 2101 Con- L. and other Ranunculaceae. stitution Ave. NW., Washington, DC Transaconitic acid can be isolated dur- 20418, or available for inspection at the ing sugarcane processing, by precipita- National Archives and Records Admin- tion as the calcium salt from cane istration (NARA). For information on sugar or molasses. It may be syn- the availability of this material at thesized by sulfuric acid dehydration of NARA, call 202–741–6030, or go to: http:// citric acid, but not by the www.archives.gov/federallregister/ methanesulfonic acid method. codeloflfederallregulations/ (b) The ingredient meets the fol- ibrllocations.html. lowing specifications: (c) The ingredient is used as a curing (1) Assay. Not less than 98.0 percent and pickling agent as defined in of C3H3(COOH)3, using the ‘‘Food § 170.3(o)(5) of this chapter; flavor Chemicals Codex,’’ 4th ed. (1996), pp. enhancer as defined in § 170.3(o)(11) of 102–103, test for citric acid, which is in- this chapter; flavoring agent and adju- corporated by reference in accordance vant as defined in § 170.3(o)(12) of this with 5 U.S.C. 552(a) and 1 CFR part 51, chapter; pH control agent as defined in and a molecular weight of 174.11. Copies § 170.3(o)(23) of this chapter; as a sol- of the material incorporated by ref- vent and vehicle as defined in erence are available from the National § 170.3(o)(27) of this chapter; and as a Academy Press, Box 285, 2101 Constitu- boiler water additive complying with tion Ave. NW., Washington, DC 20055 § 173.310 of this chapter. (Internet address http://www.nap.edu), (d) The ingredient is used in food at or may be examined at the Center for levels not to exceed current good man- Food Safety and Applied Nutrition’s ufacturing practice in accordance with Library, Food and Drug Administra- § 184.1(b)(1). Current good manufac- tion, 5100 Paint Branch Pkwy., College turing practice results in a maximum Park, MD 20740, or at the National Ar- level as served, of 0.25 percent for chives and Records Administration baked goods as defined in § 170.3(n)(1) of (NARA). For information on the avail- this chapter; 0.8 percent for cheeses as ability of this material at NARA, call defined in § 170.3(n)(5) of this chapter 202–741–6030, or go to: http:// and dairy product analogs as defined in www.archives.gov/federallregister/ § 170.3(n)(10) of this chapter; 0.5 percent codeloflfederallregulations/ for chewing gum as defined in ibrllocations.html. § 170.3(n)(6) of this chapter; 9.0 percent (2) Melting point. Not less than 195 °C for condiments and relishes as defined and the determination results in de- in § 170.3(n)(8) of this chapter; 0.5 per- composition of aconitic acid. cent for fats and oils as defined in (3) Heavy metals (as Pb). Not more § 170.3(n)(12) of this chapter; 3.0 percent than 10 parts per million. for gravies and sauces as defined in (4) Arsenic (as As). Not more than 3 § 170.3(n)(24) of this chapter; 0.6 percent parts per million. for meat products as defined in (5) Oxalate. Passes test. § 170.3(n)(29) of this chapter; and 0.15 (6) Readily carbonizable substances. percent or less for all other food cat- Passes the test for citric acid of the egories. The ingredient may also be ‘‘Food Chemicals Codex,’’ 4th ed. (1996), used in boiler water additives at levels pp. 102–103, which is incorporated by not to exceed current good manufac- reference in accordance with 5 U.S.C. turing practice. 552(a) and 1 CFR part 51. The avail- (e) Prior sanctions for this ingredient ability of this incorporation by ref- different from the uses established in erence is given in paragraph (b)(1) of this section do not exist or have been this section. waived. (7) Residue on ignition. Not more than [47 FR 27814, June 25, 1982] 0.1 percent as determined by the ‘‘Food Chemicals Codex,’’ 4th ed. (1996), pp. § 184.1007 Aconitic acid. 102–103, test for citric acid, which is in- (a) Aconitic acid (1,2,3- corporated by reference in accordance propenetricarboxylic acid (C6H6O6), with 5 U.S.C. 552(a) and 1 CFR part 51. 486

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The availability of this incorporation ester. The ester is purified by recrys- by reference is given in paragraph tallization from ethanol. The melting (b)(1) of this section. range of the ester is 153° to 154 °C. (c) The ingredient is used as a fla- (c) The ingredient is used as a flavoring substance and adjuvant as de- voring agent as defined in § 170.3(o)(12) fined in § 170.3(o)(12) of this chapter. of this chapter; leavening agent as de- (d) The ingredient is used in food, in fined in § 170.3(o)(17) of this chapter; accordance with § 184.1(b)(1), at levels and pH control agent as defined in not to exceed good manufacturing § 170.3(o)(23) of this chapter. practice. Current good manufacturing (d) The ingredient is used in foods at practice results in a maximum level, as levels not to exceed current good man- served, of 0.003 percent for baked goods ufacturing practice in accordance with as defined in § 170.3(n)(1) of this chap- § 184.1(b)(1). Current good manufac- ter, 0.002 percent for alcoholic bev- turing practice results in maximum erages as defined in § 170.3(n)(2) of this levels, as served, of 0.05 percent for chapter, 0.0015 percent for frozen dairy baked goods as defined in § 170.3(n)(1) of products as defined in § 170.3(n)(20) of this chapter; 0.005 percent for non- this chapter, 0.0035 percent for soft alcoholic beverages as defined in candy as defined in § 170.3(n)(38) of this § 170.3(n)(3) of this chapter; 5.0 percent chapter, and 0.0005 percent or less for for condiments and relishes as defined all other food categories. in § 170.3(n)(8) of this chapter; 0.45 per- (e) Prior sanctions for this ingredient cent for dairy product analogs as de- different from the uses established in fined in § 170.3(n)(10) of this chapter; 0.3 this section do not exist or have been percent for fats and oil as defined in waived. § 170.3(n)(12) of this chapter; 0.0004 percent for frozen dairy desserts as defined [43 FR 47724, Oct. 17, 1978, as amended at 49 in § 170.3(n)(20) of this chapter; 0.55 per- FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999] cent for gelatin and puddings as defined in § 170.3(n)(22) of this chapter; 0.1 § 184.1009 Adipic acid. percent for gravies as defined in § 170.3(n)(24) of this chapter; 0.3 percent (a) Adipic acid (C6H10O4, CAS Reg. No. 00124–04–9) is also known as 1,4- for meat products as defined in § 170.3(n)(29) of this chapter; 1.3 percent butanedicarboxylic acid or hexane- for snack foods as defined in dioic acid. It is prepared by nitric acid § 170.3(n)(37) of this chapter; and 0.02 oxidation of cyclohexanol or percent or less for all other food cat- cyclohexanone or a mixture of the two. egories. (b) The ingredient meets the speci- (e) Prior sanctions for adipic acid dif- fications of the Food Chemicals Codex, ferent from the uses established in this 3d Ed. (1981), p. 11, which is incor- section do not exist or have been porated by reference (Copies are avail- waived. able from the National Academy Press, 2101 Constitution Ave., NW., Wash- [47 FR 27810, June 25, 1982] ington, DC 20418, or available for inspection at the National Archives and § 184.1011 Alginic acid. Records Administration (NARA). For (a) Alginic acid is a colloidal, hydro- information on the availability of this philic polysaccharide obtained from material at NARA, call 202–741–6030, or certain brown algae by alkaline extrac- go to: http://www.archives.gov/ tion. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications of the Food Chemicals Codex, ibrllocations.html.), and the following 3d Ed. (1981), p. 13, which is incor- additional specifications: porated by reference. Copies are avail- (1) The adipic acid is converted to its able from the National Academy Press, corresponding amide. The amide is pu- 2101 Constitution Ave. NW., Wash- rified by recrystallization from water ington, DC 20418, or available for in- or aqueous ethanol. The melting range spection at the National Archives and of the amide is 219° to 220 °C. Records Administration (NARA). For (2) The adipic acid is converted to its information on the availability of this corresponding bis-p-p-bromophenacyl material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ codeloflfederallregulations/ federallregister/ ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. the ingredient is used in food with no (c) In accordance with § 184.1(b)(2), limitation other than current good the ingredient is used in food only manufacturing practices. The affirma- within the following specific limitation of this ingredient as GRAS as a ditions: rect human food ingredient is based upon the following current good manu- Maximum level of facturing practice conditions of use: Category of food use in food (as Functional use (1) The ingredient is used as an en- served) zyme, as defined in § 170.3(o)(9) of this Soup and soup Not to exceed cur- Emulsifier, emulsi- chapter, in the hydrolysis of edible mixes, rent good manu- fier salt, starch to produce maltodextrins and § 170.3(n) (40) facturing prac- § 170.3(o)(8) of of this chapter. tice. this chapter; for- nutritive carbohydrate sweeteners. mulation aid, (2) The ingredient is used at levels § 170.3(o)(14) of not to exceed current good manufac- this chapter; sta- turing practices. bilizer, thickener, § 170.3(o)(28) of [60 FR 55789, Nov. 3, 1995] this chapter. § 184.1021 Benzoic acid. (d) Prior sanctions for this ingredient (a) Benzoic acid is the chemical different from the use established in benzenecarboxylic acid (C7H6O2), occur- this section do not exist or have been ring in nature in free and combined waived. forms. Among the foods in which ben- [47 FR 47375, Oct. 26, 1982] zoic acid occurs naturally are cran- berries, prunes, plums, cinnamon, ripe § 184.1012 ù-Amylase enzyme prepara- cloves, and most berries. Benzoic acid tion from Bacillus is manufactured by treating molten stearothermophilus. phthalic anhydride with steam in the (a) a-Amylase enzyme preparation is presence of a zinc oxide catalyst, by obtained from the culture filtrate that the hydrolysis of benzotrichloride, or results from a pure culture fermenta- by the oxidation of toluene with nitric tion of a nonpathogenic and acid or sodium bichromate or with air in the presence of a transition metal nontoxicogenic strain of Bacillus salt catalyst. stearothermophilus. Its characterizing (b) The ingredient meets the speci- enzyme activity is a-amylase (1,4 a-D fications of the ‘‘Food Chemicals glucan glucanohydrolase (E.C. 3.2.1.1)). Codex,’’ 3d Ed. (1981), p. 35, which is in- (b) The ingredient meets the general corporated by reference. Copies may be and additional requirements for en- obtained from the National Academy zyme preparations in the ‘‘Food Chemi- Press, 2101 Constitution Ave. NW., cals Codex,’’ 3d ed. (1981), pp. 107–110, Washington, DC 20418, or may be exam- which is incorporated by reference in ined at the National Archives and accordance with 5 U.S.C. 552(a) and 1 Records Administration (NARA). For CFR part 51. Copies are available from information on the availability of this the National Academy Press, 2101 Con- material at NARA, call 202–741–6030, or stitution Ave. NW., Washington, DC go to: http://www.archives.gov/ 20418, or may be examined at the Office federallregister/ of Premarket Approval (HFS–200), Cen- codeloflfederallregulations/ ter for Food Safety and Applied Nutri- ibrllocations.html. tion, Food and Drug Administration, (c) The ingredient is used as an anti- 1110 Vermont Ave. NW., suite 1200, microbial agent as defined in Washington, DC, or at the National Ar- § 170.3(o)(2) of this chapter, and as a fla- chives and Records Administration voring agent and adjuvant as defined in (NARA). For information on the avail- § 170.3(o)(12) of this chapter. ability of this material at NARA, call (d) The ingredient is used in food at 202–741–6030, or go to: http:// levels not to exceed good manufac- www.archives.gov/federallregister/ turing practice. Current usage results

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in a maximum level of 0.1 percent in § 184.1025 Caprylic acid. food. (The Food and Drug Administra- (a) Caprylic acid [CH (CH ) COOH, tion has not determined whether sig- 3 2 6 nificantly different conditions of use CAS Reg. No. 124–07–2] is the chemical would be GRAS). name for octanoic acid. It is considered (e) Prior sanctions for this ingredient to be a short or medium chain fatty different from those uses established in acid. It occurs normally in various this section, or different from that set foods and is commercially prepared by forth in part 181 of this chapter, do not oxidation of n-octanol or by fermenta- exist or have been waived. tion and fractional distillation of the volatile fatty acids present in coconut [42 FR 14653, Mar. 15, 1977, as amended at 49 oil. FR 5610, Feb. 14, 1984] (b) The ingredient meets the speci- § 184.1024 Bromelain. fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), p. 207, which is in- (a) Bromelain (CAS Reg. No. 9001–00– 7) is an enzyme preparation derived corporated by reference. Copies may be from the pineapples Ananas comosus obtained from the National Academy and A. bracteatus L. It is a white to Press, 2101 Constitution Ave. NW., light tan amorphous powder. Its char- Washington, DC 20418, or may be exam- acterizing enzyme activity is that of a ined at the National Archives and peptide hydrolase (EC 3.4.22.32). Records Administration (NARA). For (b) The ingredient meets the general information on the availability of this requirements and additional require- material at NARA, call 202–741–6030, or ments for enzyme preparations in the go to: http://www.archives.gov/ Food Chemicals Codex, 3d ed. (1981), p. federallregister/ 110, which is incorporated by reference codeloflfederallregulations/ in accordance with 5 U.S.C. 552(a) and 1 ibrllocations.html. CFR part 51. Copies are available from (c) The ingredient is used as a fla- the National Academy Press, 2101 Con- voring agent and adjuvant as defined in stitution Ave. NW., Washington, DC, or § 170.3(o)(12) of this chapter. may be examined at the Office of Pre- (d) The ingredient is used in foods in market Approval (HFS–200), Food and accordance with § 184.1(b)(1), at levels Drug Administration, 5100 Paint not to exceed good manufacturing Branch Pkwy., College Park, MD 20740, practice. Current good manufacturing and at the National Archives and practices result in maximum levels, as Records Administration (NARA). For served, of: 0.013 percent for baked goods information on the availability of this as defined in § 170.3(n)(1) of this chap- material at NARA, call 202–741–6030, or ter; 0.04 percent for cheeses as defined go to: http://www.archives.gov/ in § 170.3(n)(5) of this chapter; 0.005 per- federallregister/ cent for fats and oils as defined in codeloflfederallregulations/ § 170.3(n)(12) of this chapter, for frozen ibrllocations.html. dairy desserts as defined in § 170.3(n)(20) (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no of this chapter, for gelatins and pud- limitation other than current good dings as defined in § 170.3(n)(22) of this manufacturing practice. The affirma- chapter, for meat products as defined tion of this ingredient as GRAS as a di- in § 170.3(n)(29) of this chapter, and for rect food ingredient is based upon the soft candy as defined in § 170.3(n)(38) of following current good manufacturing this chapter; 0.016 percent for snack practice conditions of use: foods as defined in § 170.3(n)(37) of this (1) The ingredient is used as an en- chapter; and 0.001 percent or less for all zyme as defined in § 170.3(o)(9) of this other food categories. chapter to hydrolyze proteins or (e) Prior sanctions for this ingredient polypeptides. different from the uses established in (2) The ingredient is used in food at this section do not exist or have been levels not to exceed current good man- waived. ufacturing practice. [43 FR 19843, May 9, 1978, as amended at 49 [60 FR 32910, June 26, 1995] FR 5611, Feb. 14, 1984]

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§ 184.1027 Mixed carbohydrase and tion using Candida spp., described in protease enzyme product. §§ 173.160 and 173.165 of this chapter; and (a) Mixed carbohydrase and protease by the solvent extraction process de- enzyme product is an enzyme prepara- scribed in § 173.280 of this chapter for tion that includes carbohydrase and the recovery of citric acid from Asper- protease activity. It is obtained from gillus niger fermentation liquor. the culture filtrate resulting from a (b) The ingredient meets the specifications of the Food Chemicals Codex, pure culture fermentation of a non- 3d ed. (1981), pp. 86–87, and its third sup- pathogenic strain of B. licheniformis. plement (March 1992), pp. 107–108, which (b) The ingredient meets the speci- are incorporated by reference in ac- fications of the Food Chemicals Codex, cordance with 5 U.S.C. 552(a) and 1 CFR 3d Ed. (1981), p. 107, which is incor- part 51. Copies are available from the porated by reference. Copies are avail- National Academy Press, 2101 Constitu- able from the National Academy Press, tion Ave. NW., Washington, DC 20418, 2101 Constitution Ave. NW., Wash- and the Center for Food Safety and Ap- ington, DC 20418, or available for in- plied Nutrition (HFS–200), 5100 Paint spection at the National Archives and Branch Pkwy., College Park, MD 20740, Records Administration (NARA). For or may be examined at the National information on the availability of this Archives and Records Administration material at NARA, call 202–741–6030, or (NARA). For information on the avail- go to: http://www.archives.gov/ ability of this material at NARA, call federallregister/ 202–741–6030, or go to: http:// codeloflfederallregulations/ www.archives.gov/federallregister/ ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitations other than current good tion of this ingredient as generally rec- manufacturing practice. ognized as safe as a direct human food (d) Prior sanctions for this ingredient ingredient is based upon the following different from the uses established in current good manufacturing practice this section do not exist or have been conditions of use: waived. (1) The ingredient is used as an enzyme, as defined in § 170.3(o)(9) of this [59 FR 63895, Dec. 12, 1994] chapter, to hydrolyze proteins or car- § 184.1034 Catalase (bovine liver). bohydrates. (2) The ingredient is used in the fol- (a) Catalase (bovine liver) (CAS Reg. lowing foods at levels not to exceed No. 81457–95–6) is an enzyme prepara- current good manufacturing practice: tion obtained from extracts of bovine alcoholic beverages, as defined in liver. It is a partially purified liquid or § 170.3(n)(2) of this chapter, candy, nu- powder. Its characterizing enzyme ac- tritive sweeteners, and protein tivity is catalase (EC 1.11.1.6). hydrolyzates. (b) The ingredient meets the general requirements and additional require- [48 FR 240, Jan. 4, 1983] ments for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. § 184.1033 Citric acid. 110, which is incorporated by reference (a) Citric acid (C6H8O7, CAS Reg. No. in accordance with 5 U.S.C. 552(a) and 1 77–92–9) is the compound 2-hydroxy- CFR part 51. Copies are available from 1,2,3-propanetricarboxylic acid. It is a the National Academy Press, 2101 Con- naturally occurring constituent of stitution Ave., NW., Washington, DC plant and animal tissues. It occurs as 20418, or may be examined at the Office colorless crystals or a white powder of Premarket Approval (HFS–200), Food and may be anhydrous or contain one and Drug Administration, 5100 Paint mole of water per mole of citric acid. Branch Pkwy., College Park, MD 20740, Citric acid may be produced by recov- and at the National Archives and ery from sources such as lemon or pine- Records Administration (NARA). For apple juice; by mycological fermenta- information on the availability of this

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material at NARA, call 202–741–6030, or the following current good manufac- go to: http://www.archives.gov/ turing practice conditions of use: federallregister/ (1) The ingredient is used as an anti- codeloflfederallregulations/ microbial agent as defined in ibrllocations.html. § 170.3(o)(2) of this chapter; a curing and (c) In accordance with § 184.1(b)(1), pickling agent as defined in § 170.3(o)(5) the ingredient is used in food with no of this chapter; a flavor enhancer as de- limitation other than current good fined in § 170.3(o)(11) of this chapter; a manufacturing practice. The affirma- flavoring agent and adjuvant as defined tion of this ingredient as GRAS as a di- in § 170.3(o)(12) of this chapter; a pH rect food ingredient is based upon the control agent as defined in § 170.3(o)(23) following current good manufacturing of this chapter; and a solvent and vehi- practice conditions of use: cle as defined in § 170.3(o)(27) of this (1) The ingredient is used as an en- chapter. zyme as defined in § 170.3(o)(9) of this (2) The ingredient is used in food, ex- chapter to decompose hydrogen per- cept in infant foods and infant for- oxide. mulas, at levels not to exceed current (2) The ingredient is used in food at good manufacturing practice. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. different from the uses established in [60 FR 32910, June 26, 1995, as amended at 69 this section do not exist or have been FR 24512, May 4, 2004] waived.

§ 184.1061 Lactic acid. [49 FR 35367, Sept. 7, 1984]

(a) Lactic acid (C3H6O3, CAS Reg. § 184.1063 Enzyme-modified lecithin. Nos.: DL mixture, 598–82–3; L-isomer, 79– (a) Enzyme-modified lecithin is pre- 33–4; D-isomer, 10326–41–7), the chemical 2-hydroxypropanoic acid, occurs natu- pared by treating lecithin with either rally in several foods. It is produced phospholipase A2 (EC 3.1.1.4) or pan- commercially either by fermentation creatin. of carbohydrates such as glucose, su- (b) The ingredient meets the speci- crose, or lactose, or by a procedure in- fications in paragraphs (b)(1) through volving formation of lactonitrile from (b)(8) of this section. Unless otherwise acetaldehyde and hydrogen cyanide noted, compliance with the specifica- and subsequent hydrolysis to lactic tions listed below is determined ac- acid. cording to the methods set forth for (b) The ingredient meets the speci- lecithin in the Food Chemicals Codex, fications of the Food Chemicals Codex, 4th ed. (1996), pp. 220–221, which are in- 3d Ed. (1981), p. 159, which is incor- corporated by reference in accordance porated by reference. Copies are avail- with 5 U.S.C. 552(a) and 1 CFR part 51. able from the National Academy Press, Copies are available from the National 2101 Constitution Avenue, NW., Wash- Academy Press, 2101 Constitution Ave. ington, DC 20418, or available for in- NW., Washington DC 20418, or may be spection at the National Archives and examined at the Center for Food Safety Records Administration (NARA). For and Applied Nutrition’s Library, 5100 information on the availability of this Paint Branch Pkwy., College Park, MD material at NARA, call 202–741–6030, or 20740, or at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (1) Acetone-insoluble matter tion of this ingredient as generally rec- (phosphatides), not less than 50.0 per- ognized as safe (GRAS) as a direct cent. human food ingredient is based upon (2) Acid value, not more than 40.

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(3) Lead, not more than 1.0 part per method, low pressure splitting with million, as determined by atomic ab- catalyst, continuous high pressure sorption spectroscopy. counter current splitting, and medium (4) Heavy metals (as Pb), not more pressure autoclave splitting with cata- than 20 parts per million. lyst. (5) Hexane-insoluble matter, not (b) The ingredient must be of a pu- more than 0.3 percent. rity suitable for its intended use. The (6) Peroxide value, not more than 20. ingredient must also meet the speci- (7) Water, not more than 4.0 percent. fications in § 172.860(b) of this chapter. (8) Lysolecithin, 50 to 80 mole percent (c) In accordance with § 184.1(b)(1), of total phosphatides as determined by the ingredient is used in food with no ‘‘Determination of Lysolecithin Con- limitation other than current good tent of Enzyme-Modified Lecithin: manufacturing practice. The affirma- Method I,’’ dated 1985, which is incor- tion of this ingredient as generally rec- porated by reference in accordance ognized as safe (GRAS) as a direct with 5 U.S.C. 552(a) and 1 CFR part 51. human food ingredient is based upon Copies are available from the Division the following current good manufac- of Petition Control, Center for Food turing practice conditions of use: Safety and Applied Nutrition (HFS– (1) The ingredient is used as a fla- 215), Food and Drug Administration, voring agent and adjuvant as defined in 5100 Paint Branch Pkwy., College Park, § 170.3(o)(12) of this chapter and as a nu- MD 20740, or may be examined at the trient supplement as defined in Center for Food Safety and Applied Nu- § 170.3(o)(20) of this chapter. trition’s Library, 5100 Paint Branch (2) The ingredient is used in foods at Pkwy., College Park, MD 20740, or at levels not to exceed current good man- the National Archives and Records Ad- ufacturing practice. The ingredient ministration (NARA). For information may be used in infant formula in ac- on the availability of this material at cordance with section 412(g) of the Fed- NARA, call 202–741–6030, or go to: http:// eral Food, Drug, and Cosmetic Act (the www.archives.gov/federallregister/ act) or with regulations promulgated codeloflfederallregulations/ under section 412(a)(2) of the act. ibrllocations.html. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [49 FR 48534, Dec. 13, 1984, as amended at 73 tion of this ingredient as generally rec- FR 8606, Feb. 14, 2008] ognized as safe as a direct human food ingredient is based upon the following § 184.1069 Malic acid. current good manufacturing practice (a) Malic acid (C H O , CAS Reg. No. conditions of use: 4 6 5 of L-form 97–67–6, CAS Reg. No. of DL- (1) The ingredient is used as an emul- form 617–48–1) is the common name for sifier as defined in § 170.3(o)(8) of this 1-hydroxy-1, 2-ethanedicarboxylic acid. chapter. L (+) malic acid, referred to as L-malic (2) The ingredient is used at levels acid, occurs naturally in various foods. not to exceed current good manufac- Racemic DL-malic acid does not occur turing practice. naturally. It is made commercially by [61 FR 45889, Aug. 30, 1996] hydration of fumaric acid or maleic acid. § 184.1065 Linoleic acid. (b) The ingredient meets the speci- (a) Linoleic acid ((Z, Z)–9, 12-octadec- fications of the ‘‘Food Chemicals adienoic acid (C17H31COOH) (CAS Reg. Codex,’’ 3d Ed. (1981), pp. 183–184, which No. 60–33–3)), a straight chain unsatu- is incorporated by reference. Copies rated fatty acid with a molecular may be obtained from the National weight of 280.5, is a colorless oil at Academy Press, 2101 Constitution Ave. room temperature. Linoleic acid may NW., Washington, DC 20418, or may be be prepared from edible fats and oils by examined at the National Archives and various methods including hydrolysis Records Administration (NARA). For and saponification, the Twitchell information on the availability of this

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material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) The ingredients are used as a fla- (c) In accordance with § 184.1(b)(1), vor enhancer as defined in § 170.3(o)(11) the ingredient is used in food with no of this chapter, flavoring agent and ad- limitation other than current good juvant as defined in § 170.3(o)(12) of this manufacturing practice. The affirma- chapter, and pH control agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(23) of this chapter. ognized as safe (GRAS) as a direct (d) The ingredients are used in food, human food ingredient is based upon except baby food, at levels not to ex- the following current good manufac- ceed good manufacturing practice in turing practice conditions of use: accordance with § 184.1(b)(1). Current good manufacturing practice results in (1) The ingredient is used as an a maximum level, as served, of 3.4 per- anticaking agent as defined in cent for nonalcoholic beverages as de- § 170.3(o)(1) of this chapter; an anti- fined in § 170.3(n)(3) of this chapter; 3.0 microbial agent as defined in percent for chewing gum as defined in § 170.3(o)(2) of this chapter; a formula- § 170.3(n)(6) of this chapter; 0.8 percent tion aid as defined in § 170.3(o)(14) of for gelatins, puddings, and fillings as this chapter; a humectant as defined in defined in § 170.3(n)(22) of this chapter; § 170.3(o)(16) of this chapter; a leavening 6.9 percent for hard candy as defined in agent as defined in § 170.3(o)(17) of this § 170.3(n)(25) of this chapter; 2.6 percent chapter; A pH control agent as defined for jams and jellies as defined in in § 170.3(o)(23) of this chapter; a proc- § 170.3(n)(28) of this chapter; 3.5 percent essing aid as defined in § 170.3(o)(24) of for processed fruits and fruit juices as this chapter; a stabilizer and thickener defined in § 170.3(n)(35) of this chapter; as defined in § 170.3(o)(28) of this chap- 3.0 percent for soft candy as defined in ter; and a surface-active agent as de- § 170.3(n)(38) of this chapter; and 0.7 per- fined in § 170.3(o)(29) of this chapter. cent for all other food categories. (2) The ingredient is used in the fol- (e) Prior sanctions for malic acid dif- lowing foods at levels not to exceed ferent from the uses established in this current good manufacturing practice: section do not exist or have been baked goods as defined in § 170.3(n)(1) of waived. this chapter; confections and frostings [44 FR 20656, Apr. 6, 1979, as amended at 49 as defined in § 170.3(n)(9) of this chap- FR 5611, Feb. 14, 1984] ter; gelatins and puddings as defined in § 170.3(n)(22) of this chapter; hard candy § 184.1077 Potassium acid tartrate. as defined in § 170.3(n)(25) of this chap-

(a) Potassium acid tartrate (C4H5KO6, ter; jams and jellies as defined in CAS Reg. No. 868–14–4) is the potassium § 170.3(n)(28) of this chapter; and soft acid salt of L¥(+)¥tartaric acid and is candy as defined in § 170.3(n)(38) of this also called potassium bitartrate or chapter. cream of tartar. It occurs as colorless (d) Prior sanctions for this ingredient or slightly opaque crystals or as a different from the uses established in white, crystalline powder. It has a this section do not exist or have been pleasant, acid taste. It is obtained as a waived. byproduct of wine manufacture. (b) The ingredient meets the speci- [48 FR 52446, Nov. 18, 1983] fications of the Food Chemicals Codex, § 184.1081 Propionic acid. 3d Ed. (1981), P. 238, which is incorporated by reference. Copies are avail- (a) Propionic acid (C3H6O2, CAS Reg. able from the National Academy Press, No. 79–09–4) is an oily liquid having a 2101 Constitution Ave. NW., Wash- slightly pungent, rancid odor. It is ington, DC 20418, or available for in- manufactured by chemical synthesis or spection at the National Archives and by bacterial fermentation. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 254, which is incor- and Records Administration (NARA). porated by reference. Copies are avail- For information on the availability of able from the National Academy Press, this material at NARA, call 202–741– 2101 Constitution Ave. NW., Wash- 6030, or go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as a fla- tion of this ingredient as generally rec- voring agent and adjuvant as defined in ognized as safe (GRAS) as a direct § 170.3(o)(12) of this chapter. human food ingredient is based upon (2) The ingredient is used in foods at the following current good manufac- levels not to exceed current good man- turing practice conditions of use: ufacturing practice. (1) The ingredient is used as an antimicrobial agent as defined in (d) Prior sanctions for this ingredient § 170.3(o)(2) of this chapter and a fla- different from the uses established in voring agent as defined in § 170.3(o)(12) this section do not exist or have been of this chapter. waived. (2) The ingredient is used in foods at [48 FR 52445, Nov. 18, 1983, as amended at 50 levels not to exceed current good man- FR 49536, Dec. 3, 1985; 69 FR 24512, May 4, ufacturing practice. 2004] (d) Prior sanctions for this ingredient different from the uses established in § 184.1091 Succinic acid. this section do not exist or have been (a) Succinic acid (C4H6O4, CAS Reg. waived. No. 110–15–6), also referred to as amber [49 FR 13141, Apr. 3, 1984] acid and ethylenesuccinic acid, is the chemical 1,4-butanedioic acid. It is § 184.1090 Stearic acid. commercially prepared by hydrogenation of maleic or fumaric acid. It (a) Stearic acid (C18H36O2, CAS Reg. No. 57–11–4) is a white to yellowish can also be produced by aqueous alkali white solid. It occurs naturally as a or acid hydrolysis of succinonitrile. glyceride in tallow and other animal or (b) The ingredient meets the speci- vegetable fats and oils and is a prin- fications of the ‘‘Food Chemicals cipal constituent of most commercially Codex,’’ 3d Ed. (1981), pp. 314–315, which hydrogenated fats. It is produced com- is incorporated by reference. Copies mercially from hydrolyzed tallow de- may be obtained from the National rived from edible sources or from Academy Press, 2101 Constitution Ave. hydrolyzed, completely hydrogenated NW., Washington, DC 20418, or may be vegetable oil derived from edible examined at the National Archives and sources. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 313, which is incor- go to: http://www.archives.gov/ porated by reference, and the require- federallregister/ ments of § 172.860(b)(2) of this chapter. codeloflfederallregulations/ Copies of the Food Chemicals Codex ibrllocations.html. are available from the National Acad- (c) The ingredient is used as a flavor emy Press, 2101 Constitution Ave. NW., enhancer as defined in § 170.3(o)(11) of Washington, DC 20418, or available for this chapter and pH control agent as inspection at the National Archives defined in § 170.3(o)(23) of this chapter.

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(d) The ingredient is used in food at § 170.3(n)(2) of this chapter and 0.0003 levels not to exceed good manufac- percent for cheeses as defined in turing practice in accordance with § 170.3(n)(5) of this chapter. § 184.1(b)(1). Current good manufac- (e) Prior sanctions for this ingredient turing practice results in a maximum different from the uses established in level, as served, of 0.084 percent in con- this section do not exist or have been diments and relishes as defined in waived. § 170.3(n)(8) of this chapter and 0.0061 percent in meat products as defined in [45 FR 6085, Jan. 25, 1980, as amended at 49 § 170.3(n)(29) of this chapter. FR 5611, Feb. 14, 1984] (e) Prior sanctions for this ingredient different from the uses established in § 184.1097 Tannic acid. this section do not exist or have been (a) Tannic acid (CAS Reg. No. 1401– waived. 55–4), or hydrolyzable gallotannin, is a complex polyphenolic organic struc- [44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984] ture that yields gallic acid and either glucose or quinic acid as hydrolysis § 184.1095 Sulfuric acid. products. It is a yellowish-white to light brown substance in the form of an (a) Sulfuric acid (H2SO4, CAS Reg. No. 7664–93–9), also known as oil of vit- amorphous, bulky powder, glistening riol, is a clear, colorless, oily liquid. It scales, or spongy masses. It is also is prepared by reacting sulfur dioxide ordorless, or has a faint characteristic (SO ) with oxygen and mixing the re- odor, and has an astringent taste. Tan- 2 nic acid is obtained by solvent extrac- sultant sulfur trioxide (SO3) with water, or by reacting nitric oxide (NO) tion of nutgalls or excrescences that with sulfur dioxide and water. form on the young twigs of Quercus (b) The ingredient meets the speci- infectoria Oliver and related species of fications of the ‘‘Food Chemicals Quercus. Tannic acid is also obtained Codex,’’ 3d Ed. (1981), pp. 317–318, which by solvent extraction of the seed pods is incorporated by reference. Copies of Tara (Caesalpinia spinosa) or the may be obtained from the National nutgalls of various sumac species, in- Academy Press, 2101 Constitution Ave. cluding Rhus semialata, R. coriaria, R. NW., Washington, DC 20418, or may be galabra, and R. typhia. examined at the National Archives and (b) The ingredient meets the speci- Records Administration (NARA). For fications of the Food Chemicals Codex, information on the availability of this 3d Ed. (1981), p. 319, which is incor- material at NARA, call 202–741–6030, or porated by reference. Copies are avail- go to: http://www.archives.gov/ able from the National Academy Press, federallregister/ 2101 Constitution Ave. NW., Wash- codeloflfederallregulations/ ington, DC 20418, or available for in- ibrllocations.html. spection at the National Archives and (c) The ingredient is used as a pH Records Administration (NARA). For control agent as defined in § 170.3(o)(23) information on the availability of this of this chapter and processing aid as material at NARA, call 202–741–6030, or defined in § 170.3(o)(24) of this chapter. go to: http://www.archives.gov/ (d) The ingredient is used in food at federallregister/ levels not to exceed good manufac- codeloflfederallregulations/ turing practice in accordance with ibrllocations.html. § 184.1(b)(1). Current good manufac- (c)(1) In accordance with § 184.1(b)(2), turing practice results in a maximum the ingredient is used in food only level, as served, of 0.014 percent for al- within the following specific limita- coholic beverages as defined in tions:

Maximum level of use Category of food in food (as Functional use served) (percent)

Baked goods and baking mixes, § 170.3(n)(1) of this 0.01 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. chapter.

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Maximum level of use Category of food in food (as Functional use served) (percent)

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

(2) Tannic acid may be used in ren- the following current good manufac- dered animal fat in accordance with 9 turing practice conditions of use: CFR 318.7. (1) The ingredient is used as a firm- (d) Prior sanctions for this ingredient ing agent as defined in § 170.3(o)(10) of different from the uses established in this chapter; a flavor enhancer as de- this section do not exist or have been fined in § 170.3(o)(11) of this chapter; a waived. flavoring agent as defined in [50 FR 21043, May 22, 1985] § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this § 184.1099 Tartaric acid. chapter; and a pH control agent as de- (a) Food grade tartaric acid (C4H6O6, fined in § 170.3(o)(23) of this chapter. CAS Reg. No. 87–69–4) has the L con- (2) The ingredient is used in foods at figuration. The L form of tartaric acid levels not to exceed current good man- is dextrorotatory in solution and is ufacturing practice. ¥ ¥ also known as L (+) tartaric acid. (d) Prior sanctions for this ingredient Tartaric acid occurs as colorless or different from the uses established in translucent crystals or as a white, this section do not exist or have been crystalline powder. It is odorless and waived. has an acid taste. It is obtained as a byproduct of wine manufacture. [48 FR 52447, Nov. 18, 1983, as amended at 50 (b) The ingredient meets the speci- FR 49536, Dec. 3, 1985] fications of the Food Chemicals Codex, 3d Ed. (1981), P. 320, which is incor- § 184.1101 Diacetyl tartaric acid esters porated by reference. Copies are avail- of mono- and diglycerides. able from the National Academy Press, (a) Diacetyl tartaric acid esters of 2101 Constitution Ave. NW., Wash- mono- and diglycerides, also know as ington, DC 20418, or available for in- DATEM, are composed of mixed esters spection at the National Archives and of glycerin in which one or more of the Records Administration (NARA). For hydroxyl groups of glycerin has been information on the availability of this esterified by diacetyl tartaric acid and material at NARA, call 202–741–6030, or by fatty acids. The ingredient is pre- go to: http://www.archives.gov/ federallregister/ pared by the reaction of diacetyl tar- codeloflfederallregulations/ taric anhydride with mono- and ibrllocations.html. diglycerides that are derived from edi- (c) In accordance with § 184.1(b)(1), ble sources. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d. Ed. (1981), pp. 98–99, which is incor- tion of this ingredient as generally rec- porated by reference in accordance ognized as safe (GRAS) as a direct with 5 U.S.C. 552(a). Copies are avail- human food ingredient is based upon able from the National Academy Press,

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

MAXIMUM USAGE LEVELS PERMITTED

Foods (as served) Percent Functions

Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Confections and frostings, § 170.3(n)(9) of this chapter ...... 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter; surface finisher, § 170.3(o)(30) of this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 25 Flavoring agent, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for this ingredient § 184.1120 Brown algae. different from the uses established in (a) Brown algae are seaweeds of the this section do not exist or have been species Analipus japonicus, Eisenia waived. bicyclis, Hizikia fusiforme, Kjellmaniella [44 FR 19391, Apr. 3, 1979, as amended at 49 gyrata, Laminaria angustata, Laminaria FR 5611, Feb. 14, 1984]

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claustonia, Laminaria digitata, Lam- ters. The material is dried and ground inaria japonica, Laminaria longicruris, or chopped for use in food. Laminaria longissima, Laminaria (b) The ingredient meets the speci- ochotensis, Laminaria saccharina, fications for kelp in the Food Chemi- Macrocystis pyrifera, Petalonia fascia, cals Codex, 3d Ed. (1981), p. 157, which is Scytosiphon lomentaria and Undaria incorporated by reference, except that pinnatifida. They are harvested prin- the loss on drying is not more than 20 cipally in coastal waters of the north- percent and the maximum allowable ern Atlantic and Pacific oceans. The level for iodine is 0.05 percent. Copies material is dried and ground or are available from the National Acad- chopped for use in food. emy Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci- Washington, DC 20418, or available for fications for kelp in the Food Chemi- inspection at the National Archives cals Codex, 3d Ed. (1981), p. 157, which is and Records Administration (NARA). incorporated by reference. Copies are For information on the availability of available from the National Academy this material at NARA, call 202–741– Press, 2101 Constitution Ave. NW., 6030, or go to: http://www.archives.gov/ Washington, DC 20418, or available for federallregister/ inspection at the National Archives codeloflfederallregulations/ and Records Administration (NARA). ibrllocations.html. For information on the availability of (c) In accordance with § 184.1(b)(2), this material at NARA, call 202–741– the ingredient is used in food only 6030, or go to: http://www.archives.gov/ within the following specific limita- federallregister/ tions: codeloflfederallregulations/ Maximum level of ibrllocations.html. Category of food use in food (as Functional use (c) In accordance with § 184.1(b)(2), served) the ingredient is used in food only Spices, Not to exceed cur- Flavor enhancer, within the following specific limita- seasonings, and rent good manu- § 170.3(o)(11) of flavorings, facturing prac- this chapter; fla- tions: § 170.3(n) (26) tice. vor adjuvant, of this chapter. § 170.3(o)(12) of Maximum level of this chapter. Category of food use in food (as Functional use served) (d) Prior sanctions for this ingredient Spices, Not to exceed cur- Flavor enhancer, different from the use established in seasonings, and rent good manu- § 170.3(o)(11) of this section do not exist or have been flavorings, facturing prac- this chapter; fla- § 170.3(n) (26) tice. vor adjuvant, waived. of this chapter. § 170.3(o)(12) of this chapter. [47 FR 47376, Oct. 26, 1982]

(d) Prior sanctions for this ingredient § 184.1133 Ammonium alginate. different from the use established in (a) Ammonium alginate (CAS Reg. this section do not exist or have been No. 9005–34–9) is the ammonium salt of waived. alginic acid, a natural polyuronide constituent of certain brown algae. Ammo- [47 FR 47376, Oct. 26, 1982] nium alginate is prepared by the neutralization of purified alginic acid with § 184.1121 Red algae. appropriate pH control agents. (a) Red algae are seaweeds of the spe- (b) The ingredient meets the speci- cies Gloiopeltis furcata, Porphyra fications of the Food Chemicals Codex, crispata, Porphyra deutata, Porphyra 3d Ed. (1981), p. 18, which is incor- perforata, Porphyra suborbiculata, porated by reference. Copies are avail- Porphyra tenera and Rhodymenia able from the National Academy Press, palmata. Porphyra and Rhodymenia are 2101 Constitution Ave. NW., Wash- harvested principally along the coasts ington, DC 20418, or available for in- of Japan, Korea, China, Taiwan, and spection at the National Archives and the East and West coasts of the United Records Administration (NARA). For States. Gloiopeltis is harvested prin- information on the availability of this cipally in southern Pacific coastal wa- material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(2), (c) In accordance with § 184.1(b)(1), the ingredient is used in food only the ingredient is used in food with no within the following specific limita- limitation other than current good tions: manufacturing practice. The affirmation of this ingredient as generally rec- Maximum level of ognized as safe (GRAS) as a direct use in human food ingredient is based upon Category of food food (as Functional use served) the following current good manufac- (percent) turing practice conditions of use: (1) The ingredient is used as a dough Confections, frostings, 0.4 Stabilizer, thickener, § 170.3(n)(9) of this § 170.3(o)(28) of this strengthener as defined in § 170.3(o)(6) chapter. chapter. of this chapter; a leavening agent as Fats and oils, 0.5 Do. defined in § 170.3(o)(17) of this chapter; § 170.3(n)(12) of this chapter. a pH control agent as defined in Gelatins, puddings, 0.5 Do. § 170.3(o)(23) of this chapter; and a § 170.3(n)(22) of this texturizer as defined in § 170.3(o)(32) of chapter. this chapter. Gravies and sauces, 0.4 Do. § 170.3(n)(24) of this (2) The ingredient is used in food at chapter. levels not to exceed current good man- Jams and jellies, 0.4 Do. ufacturing practice. § 170.3(n)(28) of this chapter. (d) Prior sanctions for this ingredient Sweet sauces, 0.5 Do. different from the uses established in § 170.3(n)(43) of this this section do not exist or have been chapter. All other food cat- 0.1 Humectant, waived. egories. § 170.3(o)(16) of this [48 FR 52439, Nov. 18, 1983] chapter; stabilizer, thickener, § 170.3(o)(28) of this § 184.1137 Ammonium carbonate. chapter. (a) Ammonium carbonate ((NH4)2CO3, CAS Reg. No. 8000–73–5) is a mixture of (d) Prior sanctions for ammonium al- ammonium bicarbonate (NH HCO ) and ginate different from the uses estab- 4 3 ammonium carbamate (NH COONH ). lished in this section do not exist or 2 4 It is prepared by the sublimation of a have been waived. mixture of ammonium sulfate and cal- [47 FR 29950, July 9, 1982] cium carbonate and occurs as a white powder or a hard, white or translucent § 184.1135 Ammonium bicarbonate. mass. (a) Ammonium bicarbonate (b) The ingredient meets the speci- (NH4HCO3, CAS Reg. No. 1066–33–7) is fications of the Food Chemicals Codex, prepared by reacting gaseous carbon di- 3d Ed. (1981), p. 19, which is incor- oxide with aqueous ammonia. Crystals porated by reference. Copies are avail- of ammonium bicarbonate are precip- able from the National Academy Press, itated from solution and subsequently 2101 Constitution Ave. NW., Wash- washed and dried. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the National Archives and fications of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 19, which is incor- information on the availability of this porated by reference. Copies are avail- material at NARA, call 202–741–6030, or able from the National Academy Press, go to: http://www.archives.gov/ 2101 Constitution Ave. NW., Wash- federallregister/ ington, DC 20418, or available for in- codeloflfederallregulations/ spection at the National Archives and ibrllocations.html. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food with no material at NARA, call 202–741–6030, or limitation other than current good

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manufacturing practice. The affirma- of this chapter; a flavor enhancer as de- tion of this ingredient as generally rec- fined in § 170.3(o)(11) of this chapter; a ognized as safe (GRAS) as a direct leavening agent as defined in human food ingredient is based upon § 170.3(o)(17) of this chapter; and a proc- the following current good manufac- essing aid as defined in § 107.3(o)(24) of turing practice conditions of use: this chapter. (1) The ingredient is used as a leav- (2) The ingredient is used in food at ening agent as defined in § 170.3(o)(17) of levels not to exceed current good man- this chapter and a pH control agent as ufacturing practice. defined in § 170.3(o)(23) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in food at different from the uses established in levels not to exceed current good man- this section do not exist or have been ufacturing practice. waived. (d) Prior sanctions for this ingredient [48 FR 52439, Nov. 18, 1983] different from the uses established in this section do not exist or have been § 184.1139 Ammonium hydroxide. waived. (a) Ammonium hydroxide (NH4OH, [48 FR 52439, Nov. 18, 1983] CAS Reg. No. 1336–21–6) is produced by passing ammonia gas into water. § 184.1138 Ammonium chloride. (b) The ingredient meets the speci- (a) Ammonium chloride (NH4Cl, CAS fications of the Food Chemicals Codex, Reg. No. 12125–02–9) is produced by the 3d Ed. (1981), p. 20, which is incor- reaction of sodium chloride and an am- porated by reference. Copies are avail- monium salt in solution. The less solu- able from the National Academy Press, ble sodium salt separates out at ele- 2101 Constitution Ave. NW., Wash- vated temperatures, and ammonium ington, DC 20418, or available for in- chloride is recovered from the filtrate spection at the National Archives and on cooling. Alternatively, hydrogen Records Administration (NARA). For chloride formed by the burning of hy- information on the availability of this drogen in chlorine is dissolved in water material at NARA, call 202–741–6030, or and then reacted with gaseous ammo- go to: http://www.archives.gov/ nia. Ammonium chloride is crystallized federallregister/ from the solution. codeloflfederallregulations/ (b) The ingredient meets the speci- ibrllocations.html. fications of the Food Chemicals Codex, (c) In accordance with § 184.1(b)(1), 3d Ed. (1981), p. 20, which is incor- the ingredient is used in food with no porated by reference. Copies are avail- limitation other than current good able from the National Academy Press, manufacturing practice. The affirma- 2101 Constitution Ave, NW., Wash- tion of this ingredient as generally rec- ington, DC 20418, or available for in- ognized as safe (GRAS) as a direct spection at the National Archives and human food ingredient is based upon Records Administration (NARA). For the following current good manufac- information on the availability of this turing practice conditions of use: material at NARA, call 202–741–6030, or (1) The ingredient is used as a leav- go to: http://www.archives.gov/ ening agent as defined in § 170.3(o)(17) of federallregister/ this chapter; a pH control agent as de- codeloflfederallregulations/ fined in § 170.3(o)(23) of this chapter; a ibrllocations.html. surface-finishing agent as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(30) of this chapter; and as a the ingredient is used in food with no boiler water additive complying with limitation other than current good § 173.310 of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as generally rec- levels not to exceed current good man- ognized as safe (GRAS) as a direct ufacturing practice. The ingredient human food ingredient is based upon may also be used as a boiler water ad- the following current good manufac- ditive at levels not to exceed current turing practice conditions of use: good manufacturing practice. (1) The ingredient is used as a dough (d) Prior sanctions for this ingredient strengthener as defined in § 170.3(o)(6) different from the uses established in

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this section do not exist or have been go to: http://www.archives.gov/ waived. federallregister/ codeloflfederallregulations/ [48 FR 52440, Nov. 18, 1983, as amended at 59 FR 14551, Mar. 29, 1994] ibrllocations.html. (c) In accordance with § 184.1(b)(1), § 184.1140 Ammonium citrate, dibasic. the ingredient is used in food with no limitation other than current good (a) Ammonium citrate, dibasic manufacturing practice. The affirma- ((NH4)2HC6H5O7, CAS Reg. No. 3012–65–5) tion of this ingredient as generally rec- is the diammonium salt of citric acid. ognized as safe (GRAS) as a direct It is prepared by partially neutralizing human food ingredient is based upon citric acid with ammonia. the following current good manufac- (b) The ingredient must be of a pu- turing practice conditions of use: rity suitable for its intended use. (1) The ingredient is used as a dough (c) In accordance with § 184.1(b)(1), strengthener as defined in § 170.3(o)(6) the ingredient is used in food with no of this chapter and a pH control agent limitation other than current good as defined in § 170.3(o)(23) of this chap- manufacturing practice. The affirma- ter. tion of this ingredient as generally rec- (2) The ingredient is used in food at ognized as safe (GRAS) as a direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a flavor this section do not exist or have been enhancer as defined in § 170.3(o)(11) of waived. this chapter and as a pH control agent as defined in § 170.3(o)(23) of this chap- [48 FR 52440, Nov. 18, 1983] ter. § 184.1141b Ammonium phosphate, di- (2) The ingredient is used in non- basic. alcoholic beverages as defined in (a) Ammonium phosphate, dibasic § 170.3(n)(3) of this chapter and in ((NH ) HPO , CAS Reg. No. 7783–28–0) is cheeses as defined in § 170.3(n)(5) of this 4 2 4 manufactured by reacting ammonia chapter at levels not to exceed current with phosphoric acid at a pH above 5.8. good manufacturing practice. (b) The ingredient meets the speci- (d) Prior sanctions for this ingredient fications of the Food Chemicals Codex, different from the uses established in 3d Ed. (1981), p. 21, which is incor- this section, or different from those set porated by reference. Copies are avail- forth in part 181 of this chapter, do not able from the National Academy Press, exist or have been waived. 2101 Constitution Ave. NW., Wash- [59 FR 63896, Dec. 12, 1994, as amended at 73 ington, DC 20418, or available for in- FR 8606, Feb. 14, 2008] spection at the National Archives and Records Administration (NARA). For § 184.1141a Ammonium phosphate, information on the availability of this monobasic. material at NARA, call 202–741–6030, or (a) Ammonium phosphate, monobasic go to: http://www.archives.gov/ (NH4H2PO4, CAS Reg. No. 7722–76–1) is federallregister/ manufactured by reacting ammonia codeloflfederallregulations/ with phosphoric acid at a pH below 5.8. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d Ed. (1981), p. 21, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The affirma- able from the National Academy Press, tion of this ingredient as generally rec- 2101 Constitution Ave. NW., Wash- ognized as safe (GRAS) as a direct ington, DC 20418, or available for in- human food ingredient is based upon spection at the National Archives and the following current good manufac- Records Administration (NARA). For turing practice conditions of use: information on the availability of this (1) The ingredient is used as a dough material at NARA, call 202–741–6030, or strengthener as defined in § 170.3(o)(6)

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of this chapter; a firming agent as de- this section do not exist or have been fined in § 170.3(o)(10) of this chapter; a waived. leavening agent as defined in [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, § 170.3(o)(17) of this chapter; a pH con- 1980, as amended at 49 FR 5611, Feb. 14, 1984] trol agent as defined in § 170.3(o)(23) of this chapter; and a processing aid as § 184.1148 Bacterially-derived defined in § 170.3(o)(24) of this chapter. carbohydrase enzyme preparation. (2) The ingredient is used in food at (a) Bacterially-derived carbohydrase levels not to exceed current good man- enzyme preparation is obtained from ufacturing practice. the culture filtrate resulting from a (d) Prior sanctions for this ingredient pure culture fermentation of a non- different from the uses established in pathogenic and nontoxigenic strain of this section do not exist or have been Bacillus subtilis or B. amyloliquefaciens. waived. The preparation is characterized by the presence of the enzymes a-amylase (EC [48 FR 52440, Nov. 18, 1983] 3.2.1.1) and b-glucanase (EC 3.2.1.6), § 184.1143 Ammonium sulfate. which catalyze the hydrolysis of O- glycosyl bonds in carbohydrates. (a) Ammonium sulfate ((NH4)2SO4, (b) The ingredient meets the general CAS Reg. No. 7783–20–2) occurs natu- requirements and additional require- rally and consists of colorless or white, ments in the monograph on enzyme odorless crystals or granules. It is pre- preparations in the Food Chemicals pared by the neutralization of sulfuric Codex, 4th ed. (1996), pp. 128–135, which acid with ammonium hydroxide. is incorporated by reference in accord- (b) The ingredient meets the speci- ance with 5 U.S.C. 552(a) and 1 CFR fications of the ‘‘Food Chemicals part 51. Copies are available from the Codex,’’ 3d Ed. (1981), pp. 22–23, which is National Academy Press, 2101 Constitu- incorporated by reference. Copies may tion Ave. NW., Washington, DC 20418, be obtained from the National Acad- or may be examined at the Center for emy Press, 2101 Constitution Ave. NW., Food Safety and Applied Nutrition’s Washington, DC 20418, or may be exam- Library, 5100 Paint Branch Pkwy., Col- ined at the National Archives and lege Park, MD 20740, or at the National Records Administration (NARA). For Archives and Records Administration information on the availability of this (NARA). For information on the avail- material at NARA, call 202–741–6030, or ability of this material at NARA, call go to: http://www.archives.gov/ 202–741–6030, or go to: http:// federallregister/ www.archives.gov/federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. In addition, anti- (c) The ingredient is used as a dough biotic activity is absent in the enzyme strengthener as defined in § 170.3(o)(6) preparation when determined by an ap- of this chapter, firming agent as de- propriate validated method such as the fined in § 170.3(o)(10) of this chapter, method ‘‘Determination of antibiotic activity’’ in the Compendium of Food and processing aid as defined in Additive Specifications, vol. 2, Joint § 170.3(o)(24) of this chapter. FAO/WHO Expert Committee on Food (d) The ingredient is used in food at Additives (JECFA), Food and Agri- levels not to exceed good manufac- culture Organization of the United Na- turing practice in accordance with tions, Rome, 1992. Copies are available § 184.1(b)(1). Current good manufac- from Bernan Associates, 4611–F Assem- turing practice results in a maximum bly Dr., Lanham, MD 20706, or from The level, as served, of 0.15 percent for United Nations Bookshop, General As- baked goods as defined in § 170.3(n)(1) of sembly Bldg., rm. 32, New York, NY this chapter and 0.1 percent for gela- 10017, or by inquiries sent to http:// tins and puddings as defined in www.fao.org. Copies may be examined § 170.1(n)(22) of this chapter. at the Center for Food Safety and Ap- (e) Prior sanctions for this ingredient plied Nutrition’s Library, 5100 Paint different from the uses established in Branch Pkwy., College Park, MD 20740.

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(c) In accordance with § 184.1(b)(1), culture Organization of the United Na- the ingredient is used in food with no tions, Rome, 1992. Copies are available limitation other than current good from Bernan Associates, 4611–F Assem- manufacturing practice. The affirma- bly Dr., Lanham, MD 20706, or from The tion of this ingredient as GRAS as a di- United Nations Bookshop, General As- rect food ingredient is based upon the sembly Bldg., rm. 32, New York, NY following current good manufacturing 10017, or by inquiries sent to http:// practice conditions of use: www.fao.org. Copies may be examined (1) The ingredient is used as an en- at the Center for Food Safety and Ap- zyme as defined in § 170.3(o)(9) of this plied Nutrition’s Library, 5100 Paint chapter to hydrolyze polysaccharides (e.g., starch). Branch Pkwy., College Park, MD 20740. (2) The ingredient is used in food at (c) In accordance with § 184.1(b)(1), levels not to exceed current good man- the ingredient is used in food with no ufacturing practice. limitation other than current good manufacturing practice. The affirma- [64 FR 19894, Apr. 23, 1999] tion of this ingredient as GRAS as a di- § 184.1150 Bacterially-derived protease rect food ingredient is based upon the enzyme preparation. following current good manufacturing (a) Bacterially-derived protease en- practice conditions of use: zyme preparation is obtained from the (1) The ingredient is used as an en- culture filtrate resulting from a pure zyme as defined in § 170.3(o)(9) of this culture fermentation of a nonpatho- chapter to hydrolyze proteins or genic and nontoxigenic strain of Bacil- polypeptides. lus subtilis or B. amyloliquefaciens. The (2) The ingredient is used in food at preparation is characterized by the levels not to exceed current good man- presence of the enzymes subtilisin (EC ufacturing practice. 3.4.21.62) and neutral proteinase (EC 3.4.24.28), which catalyze the hydrolysis [64 FR 19895, Apr. 23, 1999] of peptide bonds in proteins. (b) The ingredient meets the general § 184.1155 Bentonite. requirements and additional require- (a) Bentonite (Al2O34SiO2nH2O, CAS ments in the monograph on enzyme Reg. No. 1302–0978–099) is principally a preparations in the Food Chemicals colloidal hydrated aluminum silicate. Codex, 4th ed. (1996), pp. 128–135, which Bentonite contains varying quantities is incorporated by reference in accord- of iron, alkalies, and alkaline earths in ance with 5 U.S.C. 552(a) and 1 CFR the commercial products. Depending on part 51. Copies are available from the the cations present, natural deposits of National Academy Press, 2101 Constitu- bentonite range in color from white to tion Ave. NW., Washington, DC 20418, gray, yellow, green, or blue. or may be examined at the Center for Bentonite’s fine particles provide large Food Safety and Applied Nutrition’s total surface area and, hence, pro- Library, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, or at the National nounced adsorptive capability. Archives and Records Administration (b) The ingredient must be of a pu- (NARA). For information on the avail- rity suitable for its intended use. ability of this material at NARA, call (c) In accordance with § 184.1(b)(1), 202–741–6030, or go to: http:// the ingredient is used in food with no www.archives.gov/federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. In addition, anti- tion of this ingredient as generally rec- biotic activity is absent in the enzyme ognized as safe (GRAS) as a direct preparation when determined by an ap- human food ingredient is based upon propriate validated method such as the the following current good manufac- method ‘‘Determination of antibiotic turing practice conditions of use: activity’’ in the Compendium of Food (1) The ingredient is used as a proc- Additive Specifications, vol. 2, Joint essing aid as defined in § 170.3(o)(24) of FAO/WHO Expert Committee on Food this chapter. Additives (JECFA), Food and Agri-

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(2) The ingredient is used in food at chapter; and annatto-colored whey, levels not to exceed current good man- such that the final bleached product ufacturing practice. Current good man- conforms to the descriptions and speci- ufacturing practice results in no sig- fications for whey, concentrated whey, nificant residue in foods. or dried whey in § 184.1979(a) (1), (2), or (d) Prior sanctions for this ingredient (3), respectively. different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been [47 FR 43367, Oct. 1, 1982, as amended at 73 FR waived. 8606, Feb. 14, 2008] [51 FR 27173, July 30, 1986]

§ 184.1157 Benzoyl peroxide. § 184.1165 n-Butane and iso-butane. (a) Benzoyl peroxide ((C6H5CO)2O2, (a) n-Butane and iso-butane (empir- CAS Reg. No. 94–36–0) is a colorless, ical formula C4H10, CAS Reg. Nos. 106– rhombic crystalline solid. It is pre- 97–8 and 75–28–5, respectively) are color- pared by reaction of benzoyl chloride, less, odorless, flammable gases at nor- sodium hydroxide, and hydrogen per- mal temperatures and pressures. They oxide. are easily liquefied under pressure at (b) The ingredient meets the speci- room temperature and are stored and fications of the Food Chemicals Codex, shipped in the liquid state. The butanes 3d Ed. (1981), p. 35, which is incor- are obtained from natural gas by frac- porated by reference. Copies are avail- tionation following absorption in oil, able from the National Academy Press, adsorption to surface-active agents, or 2101 Constitution Ave. NW., Wash- refrigeration. ington, DC 20418, or available for in- (b) The ingredients must be of a pu- spection at the National Archives and rity suitable for their intended use. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this these ingredients are used in food with material at NARA, call 202–741–6030, or no limitations other than current good go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of these ingredients as generally codeloflfederallregulations/ recognized as safe (GRAS) as direct ibrllocations.html. human food ingredients is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredients are used as pro- manufacturing practice. The affirma- pellants, aerating agents, and gases as tion of this ingredient as generally rec- defined in § 170.3(o)(25) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredients are used in food human food ingredient is based upon at levels not to exceed current good the following current good manufac- manufacturing practice. turing practice conditions of use: (d) Prior sanctions for these ingredi- (1) The ingredient is used as a bleach- ents different from the uses established ing agent in food. (2) The ingredient is used in the fol- in this section do not exist or have lowing foods at levels not to exceed been waived. current good manufacturing practice: [48 FR 57270, Dec. 29, 1983, as amended at 73 flour; milk used for production of FR 8607, Feb. 14, 2008] Asiago fresh and Asiago soft cheese (§ 133.102), Asiago medium cheese § 184.1185 Calcium acetate. (§ 133.103), Asiago old cheese (§ 133.104), (a) Calcium acetate (Ca (C2H3O2)2, Blue cheese (§ 133.106), Caciocavallo CAS Reg. No. 62–54–4), also known as siciliano chesse (§ 133.111), Gorgonzola acetate of lime or vinegar salts, is the cheese (§ 133.141), Parmesan and calcium salt of acetic acid. It may be reggiano cheese (§ 133.165), Provolone produced by the calcium hydroxide cheese (§ 133.181), Romano cheese neutralization of acetic acid. (§ 133.183), and Swiss and emmentaler (b) The ingredient meets the speci- cheese (§ 133.195) in part 133 of this fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 44, which is incorporated by reference. Copies are avail- porated by reference. Copies are available from the National Academy Press, able from the National Academy Press, 2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- ington, DC 20418, or available for inspection at the National Archives and spection at the National Archives and Records Administration (NARA). For Records Administration (NARA). For information on the availability of this information on the availability of this material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(2), (c) The ingredient is used as a firm- the ingredient is used in food only ing agent as defined in § 170.3(o)(10) of within the following specific limita- this chapter; pH control agent as de- tions: fined in § 170.3(o)(23) of this chapter; processing aid as defined in § 170.3(o)(24) Maximum level of of this chapter; sequestrant as defined use in in § 170.3(o)(26) of this chapter; sta- Category of food food (as Functional use served) bilizer and thickener as defined in (percent) § 170.3(o)(28) of this chapter; and texturizer as defined in § 170.3(o)(32) of Baked goods, 0.002 Stabilizer, thickener, § 170.3(n)(1) of this § 170.3(o)(28) of this this chapter. chapter. chapter. (d) The ingredient is used in food at Alcoholic beverages, 0.4 Do. levels not to exceed current good man- § 170.3(n)(2) of this ufacturing practices in accordance chapter. Confections and 0.4 Do. with § 184.1(b)(1). Current good manu- frostings, facturing practices result in a max- § 170.3(n)(9) of this imum level, as served, of 0.2 percent for chapter. baked goods as defined in § 170.3(n)(1) of Egg products, 0.6 Do. § 170.3(n)(11) of this this chapter; 0.02 percent for cheese as chapter. defined in § 170.3(n)(5) of this chapter; Fats and oils, 0.5 Do. 0.2 percent for gelatins, puddings, and § 170.3(n)(12) of this fillings as defined in § 170.3(n)(22) of chapter. Gelatins, puddings, 0.25 Do. this chapter; 0.15 percent for sweet § 170.3(n)(22) of this sauces, toppings, and syrups as defined chapter. in § 170.3(n)(43) of this chapter; and Gravies and sauces, 0.4 Do. 0.0001 percent for all other food cat- § 170.3(n)(24) of this chapter. egories. Jams and jellies, 0.5 Do. (e) Prior sanctions for this ingredient § 170.3(n)(28) of this different from the uses established in chapter. this section or in part 181 of this chap- Sweet sauces, 0.5 Do. § 170.3(n)(43) of this ter do not exist or have been waived. chapter. [47 FR 27807, June 25, 1982] All other food cat- 0.3 Do. egories. § 184.1187 Calcium alginate. (d) Prior sanctions for calcium algi- (a) Calcium alginate (CAS Reg. No. nate different from the uses established 9005–35–0) is the calcium salt of alginic in this section do not exist or have acid, a natural polyuronide constituent been waived. of certain brown algae. Calcium alginate is prepared by the neutralization [47 FR 29951, July 9, 1982] of purified alginic acid with appropriate pH control agents, or from so- § 184.1191 Calcium carbonate. dium alginate by metathesis with ap- (a) Calcium carbonate (CaCO3, CAS propriate calcium salts. Reg. No. 471–34–1) is prepared by three (b) The ingredient meets the speci- common methods of manufacture: fications of the Food Chemicals Codex, (1) As a byproduct in the ‘‘Lime soda 3d Ed. (1981), p. 45, which is incor- process’’;

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(2) By precipitation of calcium car- (c) The ingredient is used as an bonate from calcium hydroxide in the anticaking agent as defined in ‘‘Carbonation process’’; or § 170.3(o)(1) of this chapter; anti- (3) By precipitation of calcium car- microbial agent as defined in bonate from calcium chloride in the § 170.3(o)(2) of this chapter; curing or ‘‘Calcium chloride process’’. pickling agent as defined in § 170.3(o)(5) (b) The ingredient meets the speci- of this chapter; firming agent as de- fications of the Food Chemicals Codex, fined in § 170.3(o)(10) of this chapter; 3d Ed. (1981), p. 46, which is incor- flavor enhancer as defined in porated by reference. Copies are avail- § 170.3(o)(11) of this chapter; humectant able from the National Academy Press, as defined in § 170.3(o)(16) of this chap- 2101 Constitution Ave. NW., Wash- ter; nutrient supplement as defined in ington, DC 20418, or available for in- § 170.3(o)(20) of this chapter; pH control spection at the National Archives and agent as defined in § 170.3(o)(23) of this Records Administration (NARA). For chapter; processing aid as defined in information on the availability of this § 170.3(o)(24) of this chapter; stabilizer material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ and thickener as defined in § 170.3(o)(28) federallregister/ of this chapter; surface-active agent as codeloflfederallregulations/ defined in § 170.3(o)(29) of this chapter; ibrllocations.html. synergist as defined in § 170.3(o)(31) of (c) In accordance with § 184.1(b)(1), this chapter; and texturizer as defined the ingredient is used in food with no in § 170.3(o)(32) of this chapter. limitation other than current good (d) The ingredient is used in foods at manufacturing practice. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practices in accordance different from the uses established in with § 184.1(b)(1). Current good manu- this section, or different from that set facturing practices result in a max- forth in part 181 of this chapter, do not imum level, as served, of 0.3 percent for exist or have been waived. baked goods as defined in § 170.3(n)(1) of [48 FR 52441, Nov. 18, 1983] this chapter and for dairy product analogs as defined in § 170.3(n)(10) of § 184.1193 Calcium chloride. this chapter; 0.22 percent for nonalcoholic beverages and beverage bases (a) Calcium chloride (CaCl2·2H2O, CAS Reg. No. 10035–04–8) or anhydrous as defined in § 170.3(n)(3) of this chapter; 0.2 percent for cheese as defined in calcium chloride (CaCl2, CAS Reg. No. 10043–52–4) may be commercially ob- § 170.3(n)(5) of this chapter and for proc- tained as a byproduct in the ammonia- essed fruit and fruit juices as defined in soda (Solvay) process and as a joint § 170.3(n)(35) of this chapter; 0.32 per- product from natural salt brines, or it cent for coffee and tea as defined in may be prepared by substitution reac- § 170.3(n)(7) of this chapter; 0.4 percent tions with other calcium and chloride for condiments and relishes as defined salts. in § 170.3(n)(8) of this chapter; 0.2 per- (b) The ingredient meets the speci- cent for gravies and sauces as defined fications of the Food Chemicals Codex, in § 170.3(n)(24) of this chapter; 0.1 per- 3d Ed. (1981), p. 47, which is incor- cent for commercial jams and jellies as porated by reference. Copies are avail- defined in § 170.3(n)(28) of this chapter; able from the National Academy Press, 0.25 percent for meat products as de- 2101 Constitution Ave. NW., Wash- fined in § 170.3(n)(29) of this chapter; 2.0 ington, DC 20418, or available for in- percent for plant protein products as spection at the National Archives and defined in § 170.3(n)(33) of this chapter; Records Administration (NARA). For 0.4 percent for processed vegetables and information on the availability of this vegetable juices as defined in material at NARA, call 202–741–6030, or § 170.3(n)(36) of this chapter; and 0.05 go to: http://www.archives.gov/ percent for all other food categories. federallregister/ (e) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html.

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this section do not exist or have been 3d Ed. (1981), p. 51, which is incor- waived. porated by reference. Copies are available from the National Academy Press, [47 FR 27808, June 25, 1982, as amended at 61 FR 14247, Apr. 1, 1996] 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- § 184.1195 Calcium citrate. spection at the National Archives and (a) Calcium citrate Records Administration (NARA). For information on the availability of this (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– 0994–095) is the calcium salt of citric material at NARA, call 202–741–6030, or acid. It is prepared by neutralizing cit- go to: http://www.archives.gov/ ric acid with calcium hydroxide or cal- federallregister/ cium carbonate. It occurs as a fine codeloflfederallregulations/ white, odorless powder and usually ibrllocations.html. contains four moles of water per mole (c) The ingredient is used as a firm- of calcium citrate. ing agent as defined in § 170.3(o)(10) of (b) The ingredient meets the speci- this chapter; formulation aid as defined fications of the Food Chemicals Codex, in § 170.3(o)(14) of this chapter; 3d ed. (1981), pp. 49 and 50, which is in- sequestrant as defined in § 170.3(o)(26) of corporated by reference in accordance this chapter; stabilizer or thickener as with 5 U.S.C. 552(a) and 1 CFR part 51. defined in § 170.3(o)(28) of this chapter; Copies are available from the National and texturizer as defined in § 170.3(o)(32) Academy Press, 2101 Constitution Ave. of this chapter. NW., Washington, DC 20418, and the (d) The ingredient is used in foods at Center for Food Safety and Applied Nu- levels not to exceed current good man- trition (HFS–200), 5100 Paint Branch ufacturing practices in accordance Pkwy., College Park, MD 20740, or may with § 184.1(b)(1). Current good manu- be examined at the National Archives facturing practices result in a max- and Records Administration (NARA). imum level, as served, of 1.75 percent For information on the availability of for baked goods as defined in this material at NARA, call 202–741– § 170.3(n)(1) of this chapter; 0.4 percent 6030, or go to: http://www.archives.gov/ for dairy product analogs as defined in federallregister/ § 170.3(n)(10) of this chapter; 4.5 percent codeloflfederallregulations/ for gelatins and puddings as defined in ibrllocations.html. § 170.3(n)(22) of this chapter; and 0.01 (c) In accordance with § 184.1(b)(1), percent for sugar substitutes as defined the ingredient is used in food with no in § 170.3(n)(42) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. Calcium cit- different from the uses established in rate may also be used in infant formula this section do not exist or have been in accordance with section 412(g) of the waived. Federal Food, Drug, and Cosmetic Act [47 FR 27808, June 25, 1982] (the act) or with regulations promulgated under section 412(a)(2) of the act. § 184.1201 Calcium glycerophosphate. (d) Prior sanctions for this ingredient (a) Calcium glycerophosphate different from the uses established in (C H CaO P, CAS Reg. No. 27214–00–2) is this section do not exist or have been 3 7 6 a fine, white, odorless, almost taste- waived. less, slightly hygroscopic powder. It is [59 FR 63896, Dec. 12, 1994] prepared by neutralizing glycero- phosphoric acid with calcium hydrox- § 184.1199 Calcium gluconate. ide or calcium carbonate. The commer- (a) Calcium gluconate cial product is a mixture of calcium b- ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. , and D-, and L-a-glycerophosphate. 299–28–5) is the calcium salt of gluconic (b) The ingredient meets the speci- acid which may be produced by neu- fications of the ‘‘Food Chemicals tralization of gluconic acid with lime Codex,’’ 3d Ed. (1981), pp. 51–52, which is or calcium carbonate. incorporated by reference in accord- (b) The ingredient meets the speci- ance with 5 U.S.C. 552(a) and 1 CFR fications of the Food Chemicals Codex, part 51. Copies may be obtained from

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the National Academy Press, 2101 Con- this section do not exist or have been stitution Ave. NW., Washington, DC waived. 20418, or may be examined at the Na- [49 FR 26714, June 29, 1984] tional Archives and Records Adminis- tration (NARA). For information on § 184.1206 Calcium iodate. the availability of this material at (a) Calcium iodate [Ca(IO ) ·H O, CAS NARA, call 202–741–6030, or go to: http:// 3 2 2 Reg. No. 7789–80–2], also referred to as www.archives.gov/federallregister/ lautarite, does not occur naturally but codeloflfederallregulations/ can be prepared by passing chlorine ibrllocations.html. into a hot solution of lime (CaCO ) in (c) In accordance with § 184.1(b)(1), 3 which iodine has been dissolved. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the ‘‘Food Chemicals manufacturing practice. The affirma- Codex,’’ 3d Ed. (1981), p. 53, which is in- tion of this ingredient as generally rec- corporated by reference. Copies may be ognized as safe (GRAS) as a direct obtained from the National Academy human food ingredient is based upon Press, 2101 Constitution Ave. NW., the following current good manufac- Washington, DC 20418, or may be exam- turing practice conditions of use: ined at the National Archives and (1) The ingredient is used as a nutri- Records Administration (NARA). For ent supplement as defined in information on the availability of this § 170.3(o)(20) of this chapter. material at NARA, call 202–741–6030, or (2) The ingredient is used in gelatins, go to: http://www.archives.gov/ puddings, and fillings as defined in federallregister/ § 170.3(n)(22) of this chapter. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) The ingredient is used as a dough this section or different from that as strengthener as defined in § 170.3(o)(6) set forth in part 181 of this chapter, do of this chapter. not exist or have been waived. (d) The ingredient is used in the man- [57 FR 10813, Mar. 31, 1992] ufacture of bread in accordance with § 184.1(b)(2) of this chapter in an § 184.1205 Calcium hydroxide. amount not to exceed 0.0075 percent based on the weight of the flour. (a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305–62–0) is also known as (e) Prior sanctions for this ingredient slaked lime or calcium hydrate. It is different from the uses established in produced by the hydration of lime. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, [43 FR 11699, Mar. 21, 1978, as amended at 49 3d Ed. (1981), p. 52, which is incor- FR 5611, Feb. 14, 1984] porated by reference. Copies are available from the National Academy Press, § 184.1207 Calcium lactate.

2101 Constitution Ave. NW., Wash- (a) Calcium lactate (C6H10CaO6.xH2O, ington, DC 20418, or available for in- where x is any integer up to 5, CAS spection at the National Archives and Reg. No. 814–80–2) is prepared commer- Records Administration (NARA). For cially by the neutralization of lactic information on the availability of this acid with calcium carbonate or cal- material at NARA, call 202–741–6030, or cium hydroxide. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), p. 53, which is incor- ibrllocations.html. porated by reference. Copies are avail- (c) In accordance with § 184.1(b)(1), able from the National Academy Press, the ingredient is used in food with no 2101 Constitution Avenue NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. spection at the National Archives and (d) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this

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material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. federallregister/ (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no limitation other than current good [49 FR 26714, June 29, 1984] manufacturing practice. The affirma- § 184.1212 Calcium pantothenate. tion of this ingredient as generally recognized as safe (GRAS) as a direct (a) Calcium pantothenate human food ingredient is based upon ((C9H16NO5)2Ca, CAS Reg. No. of the D- the following current good manufac- isomer, 137–08–6) is a salt of panto- turing practice conditions of use: thenic acid, one of the vitamins of the (1) The ingredient is used as a firm- B complex. Only the D-isomer of panto- ing agent as defined in § 170.3(o)(10) of thenic acid has vitamin activity, al- this chapter; a flavor enhancer as de- though both the D-isomer and the DL- fined in § 170.3(o)(11) of this chapter; a racemic mixture of calcium panto- flavoring agent or adjuvant as defined thenate are used in food. Commercial in § 170.3(o)(12) of this chapter; a leav- calcium pantothenate is prepared syn- ening agent as defined in § 170.3(o)(17) of thetically from isobutyraldehyde and this chapter; a nutrient supplement as formaldehyde via 1,1-dimethyl-2-hy- defined in § 170.3(o)(20) of this chapter; droxy-propionaldehyde and and a stabilizer and thickener as de- pantolactone. fined in § 170.3(o)(28) of this chapter. (b) Calcium pantothenate meets the (2) The ingredient is used in food, ex- specifications of the Food Chemicals cept in infant foods and infant for- Codex, 3d Ed. (1981), p. 56, which is in- mulas, at levels not to exceed current corporated by reference. Copies are good manufacturing practice. available from the National Academy (d) Prior sanctions for this ingredient Press, 2101 Constitution Ave. NW., different from the uses established in Washington, DC 20418, or available for this section do not exist or have been inspection at the National Archives waived. and Records Administration (NARA). [49 FR 35367, Sept. 7, 1984] For information on the availability of this material at NARA, call 202–741– § 184.1210 Calcium oxide. 6030, or go to: http://www.archives.gov/ (a) Calcium oxide (CaO, CAS Reg. No. federallregister/ 1305–78–8) is also known as lime, quick codeloflfederallregulations/ lime, burnt lime, or calx. It is produced ibrllocations.html. from calcium carbonate, limestone, or (c) In accordance with § 184.1(b)(1), oyster shells by calcination at tem- the ingredient is used in food with no peratures of 1,700–2,450 °F. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 55, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter. information on the availability of this (2) The ingredient is used in foods at material at NARA, call 202–741–6030, or levels not to exceed current good mango to: http://www.archives.gov/ ufacturing practice. Calcium panto- federallregister/ thenate may be used in infant formula codeloflfederallregulations/ in accordance with section 412(g) of the ibrllocations.html. Federal Food, Drug, and Cosmetic Act (c) In accordance with § 184.1(b)(1), (the act) or with regulations promul- the ingredient is used in food with no gated under section 412(a)(2) of the Act.

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(d) Prior sanctions for this ingredient § 184.1229 Calcium stearate. different from the uses established in (a) Calcium stearate (Ca(C17H35COO)2, this section do not exist or have been CAS Reg. No. 1529–23–0) is the calcium waived. salt of stearic acid derived from edible [48 FR 51908, Nov. 15, 1983] sources. It is prepared as a white precipitate by mixing calcium chloride § 184.1221 Calcium propionate. and sodium stearate in aqueous solu-

(a) Calcium propionate (C6H10CaO4, tion. CAS Reg. No. 4075–81–4) is the calcium (b) The ingredient meets the speci- salt of propionic acid. It occurs as fications of the Food Chemicals Codex, white crystals or a crystalline solid, 3d Ed. (1981), p. 64, which is incor- possessing not more than a faint odor porated by reference, and the require- of propionic acid. It is prepared by neu- ments of § 172.860(b)(2) of this chapter. tralizing propionic acid with calcium Copies of the Food Chemicals Codex hydroxide. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave. NW., fications of the Food Chemicals Codex, Washington, DC 20418, or available for 3d Ed. (1981), p. 60, which is incor- inspection at the National Archives porated by reference. Copies are avail- and Records Administration (NARA). able from the National Academy Press, For information on the availability of 2101 Constitution Ave. NW., Wash- this material at NARA, call 202–741– ington, DC 20418, or available for in- 6030, or go to: http://www.archives.gov/ spection at the National Archives and federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a fla- ognized as safe (GRAS) as a direct voring agent and adjuvant as defined in human food ingredient is based upon § 170.3(o)(12) of this chapter; a lubricant the following current good manufac- and release agent as defined in turing practice conditions of use: § 170.3(o)(18) of this chapter; and a sta- (1) The ingredient is used as an anti- bilizer and thickener as defined in microbial agent as defined in § 170.3(o)(28) of this chapter. § 170.3(o)(2) of this chapter. (2) The ingredient is used in foods at (2) The ingredient is used in the fol- levels not to exceed current good man- lowing foods at levels not to exceed ufacturing practice. current good manufacturing practice: (d) Prior sanctions for this ingredient baked goods as defined in § 170.3(n)(1) of different from the uses established in this chapter; cheeses as defined in this section do not exist or have been § 170.3(n)(5) of this chapter; confections waived. and frostings as defined in § 170.3(n)(9) [48 FR 52445, Nov. 18, 1983] of this chapter; gelatins, puddings, and fillings as defined in § 170.3(n)(22) of § 184.1230 Calcium sulfate. this chapter; and jams and jellies as de- (a) Calcium sulfate (CaSO , CAS Reg. fined in § 170.3(n)(28) of this chapter. 4 No. 7778–18–9 or CaSO4·2H2O, CAS Reg. (d) Prior sanctions for this ingredient No. 10101–41–4), also known as plaster of different from the uses established in Paris, anhydrite, and gypsum, occurs this section do not exist or have been naturally and exists as a fine, white to waived. slightly yellow-white odorless powder. [49 FR 13141, Apr. 3, 1984] The anhydrous form is prepared by

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complete dehydration of gypsum, below and 0.07 percent or less for all other 300 °C, in an electric oven. food categories. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), p. 66, which is in- this section do not exist or have been corporated by reference. Copies may be waived. obtained from the National Academy [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, Press, 2101 Constitution Ave. NW., 1980, as amended at 49 FR 5611, Feb. 14, 1984] Washington, DC 20418, or may be examined at the National Archives and § 184.1240 Carbon dioxide. Records Administration (NARA). For (a) Carbon dioxide (empirical formula information on the availability of this CO , CAS Reg. No. 124–38–9) occurs as a material at NARA, call 202–741–6030, or 2 colorless, odorless, noncombustible gas go to: http://www.archives.gov/ at normal temperatures and pressures. federallregister/ The solid form, dry ice, sublimes under codeloflfederallregulations/ atmospheric pressure at a temperature ibrllocations.html. of ¥78.5 °C. Carbon dioxide is prepared (c) The ingredient is used as an as a byproduct of the manufacture of anticaking agent as defined in lime during the ‘‘burning’’ of lime- § 170.3(o)(1) of this chapter, color and stone, from the combustion of carbo- coloring adjunct as defined in naceous material, from fermentation § 170.3(o)(4) of this chapter, dough processes, and from gases found in cer- strengthener as defined in § 170.3(o)(6) tain natural springs and wells. of this chapter, drying agent as defined (b) The ingredient must be of a pu- in § 170.3(o)(7) of this chapter, firming rity suitable for its intended use. agent as defined in § 170.3(o)(10) of this (c) In accordance with § 184.1(b)(1), chapter, flour treating agent as defined the ingredient is used in food with no in § 170.3(o)(13) of this chapter, formula- limitations other than current good tion aid as defined in § 170.3(o)(14) of manufacturing practice. The affirma- this chapter, leavening agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(17) of this chapter, nu- ognized as safe (GRAS) as a direct trient supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter, pH control the following current good manufac- agent as defined in § 170.3(o)(23) of this turing practice conditions of use: chapter, processing aid as defined in (1) The ingredient is used as a leav- § 170.3(o)(24) of this chapter, stabilizer ening agent as defined in § 170.3(o)(17) of and thickener as defined in § 170.3(o)(28) this chapter; a processing aid as de- of this chapter, synergist as defined in fined in § 170.3(o)(24) of this chapter; § 170.3(o)(31) of this chapter, and and a propellant, aerating agent, and texturizer as defined in § 170.3(o)(32) of gas as defined in § 170.3(o)(25) of this this chapter. chapter. (d) The ingredient is used in food at (2) The ingredient is used in food at levels not to exceed good manufac- levels not to exceed current good man- turing practice in accordance with ufacturing practice. § 184.1(b)(1). Current good manufac- (d) Prior sanctions for this ingredient turing practice results in a maximum different from the uses established in level, as served, of 1.3 percent for baked this section do not exist or have been goods as defined in § 170.3(n)(1) of this waived. chapter, 3.0 percent for confections and frostings as defined in § 170.3(n)(9) of [48 FR 57270, Dec. 29, 1983, as amended at 73 this chapter, 0.5 percent for frozen FR 8607, Feb. 14, 2008] dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, 0.4 percent § 184.1245 Beta-carotene. for gelatins and puddings as defined in (a) Beta-carotene (CAS Reg. No. 7235– § 170.3(n)(22) of this chapter, 0.5 percent 40–7) has the molecular formula C40H56. for grain products and pastas as de- It is synthesized by saponification of fined in § 170.3(n)(23) of this chapter, vitamin A acetate. The resulting alco- 0.35 percent for processed vegetables as hol is either reacted to form vitamin A defined in § 170.3(n)(36) of this chapter, Wittig reagent or oxidized to vitamin A

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aldehyde. Vitamin A Wittig reagent linkages in cellulose. It is obtained and vitamin A aldehyde are reacted to- from the culture filtrate resulting from gether to form beta-carotene. a pure culture fermentation process. (b) The ingredient meets the speci- (b) The ingredient meets the general fications of the Food Chemicals Codex, and additional requirements for en- 3d Ed. (1981), p. 73, which is incor- zyme preparations in the monograph porated by reference. Copies are avail- specifications on enzyme preparations able from the National Academy Press, in the ‘‘Food Chemicals Codex,’’ 4th ed. 2101 Constitution Ave. NW., (1996), pp. 129 to 134, which is incor- Washingtion, DC 20418, or available for porated by reference in accordance inspection at the National Archives with 5 U.S.C. 552(a) and 1 CFR part 51. and Records Administration (NARA). Copies are available from the National For information on the availability of Academy Press, 2101 Constitution Ave. this material at NARA, call 202–741– NW., Box 285, Washington, DC 20055 6030, or go to: http://www.archives.gov/ (Internet http://www.nap.edu), or may federallregister/ be examined at the Center for Food codeloflfederallregulations/ ibrllocations.html. Safety and Applied Nutrition’s Li- (c) In accordance with § 184.1(b)(1), brary, 5100 Paint Branch Pkwy., Col- the ingredient is used in food with no lege Park, MD 20740, or at the National limitation other than current good Archives and Records Administration manufacturing practice. The affirma- (NARA). For information on the avail- tion of this ingredient as generally rec- ability of this material at NARA, call ognized as safe (GRAS) as a direct 202–741–6030, or go to: http:// human food ingredient is based upon www.archives.gov/federallregister/ the following current good manufac- codeloflfederallregulations/ turing practice conditions of use: ibrllocations.html. (1) The ingredient is used as a nutri- (c) In accordance with § 184.1(b)(1), ent supplement as defined in the ingredient is used in food with no § 170.3(o)(20) of this chapter. limitation other than current good (2) The ingredient is used in the fol- manufacturing practice. The affirma- lowing foods at levels not to exceed tion of this ingredient as generally rec- current good manufacturing practice: ognized as safe (GRAS) as a direct dairy product analogs as defined in human food ingredient is based upon § 170.3(n)(10) of this chapter; fats and the following current good manufac- oils as defined in § 170.3(n)(12) of this turing practice conditions of use: chapter; and processed fruits and fruit (1) The ingredient is used in food as juices as defined in § 170.3(n)(35) of this an enzyme as defined in § 170.3(o)(9) of chapter. Beta-carotene may be used in this chapter for the breakdown of cel- infant formula as a source of vitamin A lulose. in accordance with section 412(g) of the (2) The ingredient is used in food at Federal Food, Drug, and Cosmetic Act levels not to exceed current good man- or with regulations promulgated under ufacturing practice. section 412(g) of the act. (d) Prior sanctions for this ingredient [64 FR 28361, May 26, 1999] different from the uses established in this section do not exist or have been § 184.1257 Clove and its derivatives. waived. (a) Cloves are the dried unopened [52 FR 25211, July 6, 1987] flower buds and calyx tubes, harvested before the flowers have opened, of the § 184.1250 Cellulase enzyme prepara- clove tree Eugenia caryophyllata tion derived from Trichoderma Thunberg, native to tropical Asia. longibrachiatum. Their derivatives include essential oils (a) Cellulase enzyme preparation is (cloves, CAS Reg. No. 8000–34–8; buds; derived from a nonpathogenic, leaves, CAS Reg. No. 8015–97–2; stems, nontoxicogenic strain of Trichoderma CAS Reg. No. 8015–98–3; and eugenol, longibrachiatum (formerly T. reesei). The CAS Reg. No. 97–53–0), oleoresins, and enzyme, cellulase, catalyzes the natural extractives obtained from endohydrolysis of 1,4-beta-glycosidic clove buds, leaves, and stems.

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(b) Clove bud oil, clove leaf oil, clove in this section do not exist or have stem oil, and eugenol meet the speci- been waived. fications of the ‘‘Food Chemicals [44 FR 3964, Jan 19, 1979, as amended at 47 FR Codex,’’ 4th ed. (1996), pp. 104–105, which 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; is incorporated by reference in accord- 64 FR 1759, Jan. 12, 1999] ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the § 184.1259 Cocoa butter substitute. National Academy Press, Box 285, 2101 (a) The common or usual name for Constitution Ave. NW., Washington, the triglyceride 1-palmitoyl-2-oleoyl-3- DC 20055 (Internet address http:// stearin is ‘‘cocoa butter substitute pri- www.nap.edu), or may be examined at marily from palm oil.’’ The common or the Center for Food Safety and Applied usual name for the triglyceride 1-3- Nutrition’s Library, Food and Drug Ad- distearoyl-2-olein is ‘‘cocoa butter sub- ministration, 5100 Paint Branch Pkwy., stitute primarily from high-oleic saf- College Park, MD 20740, or at the Na- flower or sunflower oil.’’ tional Archives and Records Adminis- (1) The ingredient 1-palmitoyl-2-ole- tration (NARA). For information on oyl-3-stearin is manufactured by: the availability of this material at (i) Directed esterification of fully NARA, call 202–741–6030, or go to: http:// saturated 1,3-diglycerides (derived from www.archives.gov/federallregister/ palm oil) with the anhydride of food- codeloflfederallregulations/ grade oleic acid in the presence of the ibrllocations.html. As determined by catalyst trifluoromethane sulfonic acid analytical methods in the ‘‘Food (§ 173.395 of this chapter), or Chemicals Codex,’’ clove oleoresin or (ii) By interesterification of partially other natural extractives (other than saturated 1,2,3-triglycerides (derived clove oils) meet the ‘‘Food Chemicals from palm oil) with ethyl stearate in Codex’’ specifications for clove (clove the presence of a suitable lipase enzyme preparation that is either gen- bud) oil and the following modifica- erally recognized as safe (GRAS) or has tions: food additive approval for such use. (1) The assay for phenols, as eugenol, (2) The ingredient 1-3-distearoyl-2- by the ‘‘Food Chemicals Codex’’ test, olein is manufactured by 4th ed. (pp. 104–105), or the volatile oils interesterification of partially unsatu- content by the ‘‘Food Chemicals rated 1,2,3-triglycerides (derived from Codex’’ test, 4th ed. (pp. 104–105) should high-oleic safflower or sunflower oil) conform to the representation of the with ethyl stearate or stearic acid in vendor; the presence of a suitable lipase en- (2) Optical rotation of the volatile oil zyme preparation that is either GRAS between ¥2° and 0°; or has food additive approval for such (3) Refractive index of the volatile oil use. between 1.527 and 1.538 at 20 °C; (b) The ingredient meets the fol- (4) Specific gravity of the volatile oil lowing specifications: between 1.036 and 1.060; and (1) Over 90 percent triglycerides, not (5) Residual solvent free, except those more than 7 percent diglycerides, not solvents that are GRAS or within tol- more than 1 percent monoglycerides, erance levels as specified in part 173, and not more than 1 percent free fatty subpart C, of this chapter. acids. (c) Clove and its derivatives are used (2) Total glycerides—98 percent min- as flavoring agents and adjuvants as imum. defined in § 170.3(0)(12) of this chapter. (3) Heavy metals (as lead), not more than 10 milligrams per kilogram, as de- (d) The ingredients are used in food termined by the Heavy Metals Test of at levels not to exceed good manufac- the ‘‘Food Chemicals Codex,’’ 4th ed. turing practice in accordance with (1996), pp. 760–761, which is incorporated § 184.1(b)(1). by reference in accordance with 5 (e) Prior sanctions for these ingredi- U.S.C. 552(a) and 1 CFR part 51. Copies ents different from the uses established are available from the National Acad- emy Press, Box 285, 2101 Constitution

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Ave. NW., Washington, DC 20055 (Inter- information on the availability of this net address http://www.nap.edu), or may material at NARA, call 202–741–6030, or be examined at the Center for Food go to: http://www.archives.gov/ Safety and Applied Nutrition’s Li- federallregister/ brary, Food and Drug Administration, codeloflfederallregulations/ 5100 Paint Branch Pkwy., College Park, ibrllocations.html. MD 20740, or at the National Archives (9) Hexane—not more than 5 parts per and Records Administration (NARA). million as determined by the method of For information on the availability of Dupuy et al., ‘‘Rapid Quantitative De- this material at NARA, call 202–741– termination of Residual Hexane in Oils 6030, or go to: http://www.archives.gov/ by Direct Gas Chromatography,’’ pub- federallregister/ lished in the ‘‘Journal of the American code of federal regulations/ l l l Oil Chemists’ Society,’’ Vol. 52, p. 118– ibrllocations.html. 120, 1975, which is incorporated by ref- (4) Color—clear, bright, and free from erence. Copies are available from the suspended matter. (5) Odor and taste—free from foreign Division of Food and Color Additives, and rancid odor and taste. Center for Food Safety and Applied Nu- (6) Residual catalyst (‘‘Official Meth- trition (HFS–200), Food and Drug Ad- ods of Analysis of the Association of ministration, 5100 Paint Branch Pkwy., Official Analytical Chemists,’’ 13th Ed. College Park, MD 20740, or available for (1980), sections 25.049–25.055, which is inspection at the National Archives incorporated by reference), residual and Records Administration (NARA). fluorine; limit of detection 0.2 part per For information on the availability of million F; multiply fluoride result by this material at NARA, call 202–741– 2.63 to convert to residual catalyst. 6030, or go to: http://www.archives.gov/ Copies of the material incorporated by federallregister/ reference may be obtained from the codeloflfederallregulations/ AOAC INTERNATIONAL, 481 North ibrllocations.html. Frederick Ave., suite 500, Gaithersburg, (c) In accordance with § 184.1(b)(1), MD 20877, or may be examined at the the ingredient is used in the following National Archives and Records Admin- food categories at levels not to exceed istration (NARA). For information on current good manufacturing practice: the availability of this material at Confections and frostings as defined in NARA, call 202–741–6030, or go to: http:// § 170.3(n)(9) of this chapter; coatings of www.archives.gov/federallregister/ soft candy as defined in § 170.3(n)(38) of codeloflfederallregulations/ this chapter; and sweet sauces and top- ibrllocations.html. The ingredient shall pings as defined in § 170.3(n)(43) of this be washed three times in batches with chapter; except that the ingredient 0.5 percent sodium bicarbonate to re- may not be used in a standardized food move catalyst residuals in accordance unless permitted by the standard of with good manufacturing practice. identity. (7) Residual methanol—5 parts per (d) The ingredient is used in food in million maximum. accordance with § 184.1(b)(1) at levels (8) Residual fatty acid ethyl esters— not to exceed good manufacturing not more than 20 parts per million as practice. determined by a ‘‘Modification of Japan Institute of Oils and Fats: Anal- [43 FR 54239, Nov. 11, 1978, as amended at 47 ysis Method of Residual Ethyl Esters of FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, Fatty Acids’’ issued by the Fuji Oil 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Co., which is incorporated by reference. Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR Copies are available from the Division 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999] of Food and Color Additives, Center for § 184.1260 Copper gluconate. Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- (a) Copper gluconate (cupric gluco- tion, 5100 Paint Branch Pkwy., College nate (CH2OH(CHOH)4COO)2Cu, CAS Park, MD 20740, or available for inspec- Reg. No. 527–09–3) is a substance that tion at the National Archives and occurs as light blue to bluish-green, Records Administration (NARA). For odorless crystals, or as a fine, light

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blue powder. It is prepared by the reac- (c) In accordance with § 184.1(b)(1), tion of gluconic acid solutions with cu- the ingredient is used in food with no pric oxide or basic cupric carbonate. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 90, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC. 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter and as a information on the availability of this processing aid as defined in § 170.3(o)(24) material at NARA, call 202–741–6030, or of this chapter. go to: http://www.archives.gov/ (2) The ingredient is used in food at federallregister/ levels not to exceed current good man- codeloflfederallregulations/ ufacturing practice. Copper sulfate ibrllocations.html. may be used in infant formula in ac- (c) In accordance with § 184.1(b)(1), cordance with section 412(g) of the Fed- the ingredient is used in food with no eral Food, Drug, and Cosmetic Act (the limitation other than current good Act) or with regulations promulgated manufacturing practice. The affirma- under section 412(a)(2) of the Act. tion of this ingredient as generally rec- (d) Prior sanctions for this ingredient ognized as safe (GRAS) as a direct different from the uses established in human food ingredient is based upon this section do not exist or have been the following current good manufac- waived. turing practice conditions of use: [49 FR 24119, June 12, 1984, as amended at 73 (1) The ingredient is used as a nutri- FR 8607, Feb. 14, 2008] ent supplement as defined in § 170.3(o)(20) of this chapter and as a § 184.1262 Corn silk and corn silk ex- synergist as defined in § 170.3(o)(31) of tract. this chapter. (a) Corn silk is the fresh styles and (2) The ingredient is used in food at stigmas of Zea mays L. collected when levels not to exceed current good man- the corn is in milk. The filaments are ufacturing practice. Copper gluconate extracted with dilute ethanol to may be used in infant formula in ac- produce corn silk extract. The extract cordance with section 412(g) of the Fed- may be concentrated at a temperature eral Food, Drug, and Cosmetic Act (the not exceeding 60 °C. Act) or with regulations promulgated (b) The ingredient must be of a pu- under section 412(a)(2) of the Act. rity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(2), different from the uses established in the ingredients are used in food only this section do not exist or have been within the following specific limita- waived. tions: [49 FR 24119, June 12, 1984] Maximum level of Category of food use in Functional use § 184.1261 Copper sulfate. food (as served) 1 (a) Copper sulfate (cupric sulfate, Baked goods and bak- 30 Flavoring agent, CuSO4·5H2O, CAS Reg. No. 7758–98–7) ing mixes, § 170.3(o)(12) of this usually is used in the pentahydrate § 170.3(n)(1) of this chapter. form. This form occurs as large, deep chapter. blue or ultramarine, triclinic crystals; Nonalcoholic bev- 20 Do. as blue granules, or as a light blue pow- erages, § 170.3(n)(3) of this chapter. der. The ingredient is prepared by the Frozen dairy desserts, 10 Do. reaction of sulfuric acid with cupric § 170.3(n)(20) of this oxide or with copper metal. chapter. Soft candy, 20 Do. (b) The ingredient must be of a pu- § 170.3(n)(38) of this rity suitable for its intended use. chapter.

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Maximum codeloflfederallregulations/ level of ibr locations.html. Category of food use in Functional use l food (as (c) The ingredient is used to supply served) 1 up to 0.009 part of total L-cysteine per All other food cat- 4 Do. 100 parts of flour in dough as a dough egories. strengthener as defined in § 170.3(o)(6) 1 Parts per million. of this chapter in yeast-leavened baked goods and baking mixes as defined in (d) Prior sanctions for this ingredient § 170.3(n)(1) of this chapter. different from the uses established in (d) This regulation is issued prior to this section do not exist or have been a general evaluation of use of this in- waived. gredient in order to affirm as GRAS [47 FR 29953, July 9, 1982, as amended at 73 the specific use named. FR 8607, Feb. 14, 2008] [42 FR 14653, Mar. 15, 1977, as amended at 49 § 184.1265 Cuprous iodide. FR 5612, Feb. 14, 1984] (a) Cuprous iodide (copper (I) iodide, § 184.1272 L-Cysteine CuI, CAS Reg. No. 7681–65–4) is a pure monohydrochloride. white crystalline powder. It is prepared by the reaction of copper sulfate with (a) L-Cysteine monohydrochloride is potassium iodide under slightly acidic the chemical L-2-amino-3- conditions. mercaptopropanoic acid (b) The ingredient must be of a pu- monohydrochloride monohydrate rity suitable for its intended use. (C3H7O2NS HCl H2O). (c) In accordance with § 184.1(b)(2), (b) The ingredient meets the speci- the ingredient is used in food only fications of the ‘‘Food Chemicals within the following specific limita- Codex,’’ 3d Ed. (1981), pp. 92–93, which is tions: incorporated by reference. Copies may be obtained from the National Acad- Cat- emy Press, 2101 Constitution Ave. NW., egory Maximum treatment Functional use of food level in food Washington, DC 20418, or may be examined at the National Archives and Table 0.01 percent ...... Source of dietary iodine. Records Administration (NARA). For salt. information on the availability of this (d) Prior sanctions for this ingredient material at NARA, call 202–741–6030, or different from the uses established in go to: http://www.archives.gov/ this section do not exist or have been federallregister/ waived. codeloflfederallregulations/ ibrllocations.html. [49 FR 24119, June 12, 1984, as amended at 73 (c) The ingredient is used to supply FR 8607, Feb. 14, 2008] up to 0.009 part of total L-cysteine per § 184.1271 L-Cysteine. 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) (a) L-Cysteine is the chemical L-2- of this chapter in yeast-leavened baked amino-3-mercaptopropanoic acid goods and baking mixes as defined in (C3H7O2NS). § 170.3(n)(1) of this chapter. (b) The ingredient meets the appro- (d) This regulation is issued prior to priate part of the specification set a general evaluation of use of this in- forth in the ‘‘Food Chemicals Codex,’’ gredient in order to affirm as GRAS 3d Ed. (1981), pp. 92–93, which is incor- the specific use named. porated by reference. Copies may be obtained from the National Academy [42 FR 14653, Mar. 15, 1977, as amended at 49 Press, 2101 Constitution Ave. NW., FR 5612, Feb. 14, 1984] Washington, DC 20418, or may be examined at the National Archives and § 184.1277 Dextrin. Records Administration (NARA). For (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. information on the availability of this No. 9004–53–9) is an incompletely material at NARA, call 202–741–6030, or hydrolyzed starch. It is prepared by dry go to: http://www.archives.gov/ heating corn, waxy maize, waxy milo, federallregister/ potato, arrowroot, wheat, rice, tapioca,

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or sago starches, or by dry heating the 3d Ed. (1981), p. 368, which is incor- starches after: (1) Treatment with safe porated by reference. Copies are avail- and suitable alkalis, acids, or pH con- able from the National Academy Press, trol agents and (2) drying the acid or 2101 Constitution Ave. NW., Wash- alkali treated starch. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the National Archives and fication of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 96, which is incor- information on the availability of this porated by reference. Copies are avail- material at NARA, call 202–741–6030, or able from the National Academy Press, go to: http://www.archives.gov/ 2101 Constitution Ave. NW., Wash- federallregister/ ington, DC 20418, or available for in- codeloflfederallregulations/ spection at the National Archives and ibrllocations.html. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food with no material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of this ingredient as generally rec- codeloflfederallregulations/ ognized as safe (GRAS) as a direct ibrllocations.html. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as a fla- manufacturing practice. The affirma- voring agent and adjuvant as defined in tion of this ingredient as generally rec- § 170.3(o)(12) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredient is used in food at human food ingredient is based upon levels not to exceed current good man- the following current good manufac- ufacturing practice. turing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as a formu- different from the uses established in lation aid as defined in § 170.3(o)(14) of this section do not exist or have been this chapter; as a processing aid as de- waived. fined in § 170.3(o)(24) of this chapter; as [48 FR 51907, Nov. 15, 1983] a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; and as a § 184.1282 Dill and its derivatives. surface-finishing agent as defined in (a) Dill (American or European) is § 170.3(o)(30) of this chapter. the herb and seeds from Anethum (2) The ingredient is used in food at graveolens L., and dill (Indian) is the levels not to exceed current good man- herb and seeds from Anethum sowa, ufacturing practice. D.C. Its derivatives include essential (d) Prior sanctions for this ingredient oils, oleoresins, and natural extractives different from the uses established in obtained from these sources of dill. this section do not exist or have been (b) Dill oils meet the description and waived. specifications of the ‘‘Food Chemicals [48 FR 51909, Nov. 15, 1983] Codex,’’ 4th ed. (1996), pp. 122–123, which is incorporated by reference in accord- § 184.1278 Diacetyl. ance with 5 U.S.C. 552(a) and 1 CFR (a) Diacetyl (C4H6O2, CAS Reg. No. part 51. Copies are available from the 431–03–8) is a clear yellow to yellowish National Academy Press, Box 285, 2101 green liquid with a strong pungent Constitution Ave. NW., Washington, odor. It is also known as 2,3- DC 20055 (Internet address http:// butanedione and is chemically syn- www.nap.edu), or may be examined at thesized from methyl ethyl ketone. It the Center for Food Safety and Applied is miscible in water, glycerin, alcohol, Nutrition’s Library, Food and Drug Ad- and ether, and in very dilute water so- ministration, 5100 Paint Branch Pkwy., lution, it has a typical buttery odor College Park, MD 20740, or at the Na- and flavor. tional Archives and Records Adminis- (b) The ingredient meets the speci- tration (NARA). For information on fications of the Food Chemicals Codex, the availability of this material at

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NARA, call 202–741–6030, or go to: http:// in this section do not exist or have www.archives.gov/federallregister/ been waived. codeloflfederallregulations/ [52 FR 25976, July 10, 1987, as amended at 73 ibrllocations.html. FR 8607, Feb. 14, 2008] (c) Dill and its derivatives are used as flavoring agents and adjuvants as de- § 184.1293 Ethyl alcohol. fined in § 170.3(o)(12) of this chapter. (d) The ingredients are used in food (a) Ethyl alcohol (ethanol) is the at levels not to exceed good manufac- chemical C2H5OH. turing practice. (b) The ingredient meets the speci- (e) [Reserved] fications of the ‘‘Food Chemicals (f) Prior sanctions for these ingredi- Codex,’’ 4th ed. (1996), p. 136, which is ents different from the uses established incorporated by reference in accord- in this section do not exist or have ance with 5 U.S.C. 552(a) and 1 CFR been waived. part 51. Copies are available from the National Academy Press, Box 285, 2101 [42 FR 14653, Mar. 15, 1977, as amended at 42 Constitution Ave. NW., Washington, FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, DC 20055 (Internet address http:// 1984; 64 FR 1760, Jan. 12, 1999] www.nap.edu), or may be examined at § 184.1287 Enzyme-modified fats. the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Ad- (a) Enzyme-modified refined beef fat, ministration, 5100 Paint Branch Pkwy., enzyme-modified butterfat, and en- College Park, MD 20740, or at the Na- zyme-modified steam-rendered chicken tional Archives and Records Adminis- fat are prepared from refined beef fat; tration (NARA). For information on butterfat or milkfat; and steam-ren- the availability of this material at dered chicken fat, respectively, with NARA, call 202–741–6030, or go to: http:// enzymes that are generally recognized www.archives.gov/federallregister/ as safe (GRAS). Enzyme-modified milk codeloflfederallregulations/ powder may be prepared with GRAS ibrllocations.html. enzymes from reconstituted milk pow- (c) The ingredient is used as an anti- der, whole milk, condensed or con- microbial agent as defined in centrated whole milk, evaporated § 170.3(o)(2) of this chapter on pizza milk, or milk powder. The lipolysis is crusts prior to final baking at levels maintained at a temperature that is not to exceed 2.0 percent by product optimal for the action of the enzyme weight. until appropriate acid development is attained. The enzymes are then inac- (d) This regulation is issued prior to tivated. The resulting product is con- general evaluation of use of this ingre- centrated or dried. dient in order to affirm as GRAS the specific use named. (b) The ingredients must be of a purity suitable for their intended use. [42 FR 14653, Mar. 15, 1977, as amended at 49 (c) In accordance with § 184.1(b)(1), FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, the ingredients are used in food with 1999] no limitation other than current good manufacturing practice. The affirma- § 184.1295 Ethyl formate.

tion of these ingredients as generally (a) Ethyl formate (C3H6O2, CAS Reg. recognized as safe (GRAS) as direct No. 109–94–4) is also referred to as ethyl human food ingredients is based upon methanoate. It is an ester of formic the following current good manufac- acid and is prepared by esterification turing practice conditions of use: of formic acid with ethyl alcohol or by (1) The ingredients are used as fla- distillation of ethyl acetate and formic voring agents and adjuvants as defined acid in the presence of concentrated in § 170.3(o)(12) of this chapter. sulfuric acid. Ethyl formate occurs (2) The ingredients are used in food naturally in some plant oils, fruits, and at levels not to exceed current good juices but does not occur naturally in manufacturing practice. the animal kingdom. (d) Prior sanctions for these ingredi- (b) The ingredient meets the speci- ents different from the uses established fications of the ‘‘Food Chemicals

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Codex,’’ 3d Ed. (1981), p. 376, which is in- (2) Ferric ammonium citrate (iron corporated by reference. Copies may be (III) ammonium citrate, CAS Reg. No. obtained from the National Academy 1333–00–2) is a complex salt of undeter- Press, 2101 Constitution Ave. NW., mined structure composed of 14.5 to 16 Washington, DC 20418, or may be exam- percent iron, approximately 7.5 percent ined at the National Archives and ammonia, and 75 percent citric acid Records Administration (NARA). For and occurs as thin transparent green information on the availability of this scales, as granules, as a powder, or as material at NARA, call 202–741–6030, or transparent green crystals. go to: http://www.archives.gov/ (b) The ingredients meet the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), pp. 116–117 (Ferric ammo- ibrllocations.html. nium citrate, brown) and p. 117 (Ferric (c) The ingredient is used as a fla- ammonium citrate, green), which is in- voring agent and adjuvant as defined in corporated by reference. Copies are § 170.3(o)(12) of this chapter. available from the National Academy (d) The ingredient is used in food at Press, 2101 Constitution Ave. NW., levels not to exceed good manufac- Washington, DC 20418, or available for turing practice in accordance with inspection at the National Archives § 184.1(b)(1). Current good manufac- and Records Administration (NARA). turing practice results in a maximum For information on the availability of level, as served, of 0.05 percent in baked this material at NARA, call 202–741– goods as defined in § 170.3(n)(1) of this 6030, or go to: http://www.archives.gov/ chapter; 0.04 percent in chewing gum as federallregister/ defined in § 170.3(n)(6), hard candy as codeloflfederallregulations/ defined in § 170.3(n)(25), and soft candy ibrllocations.html. as defined in § 170.3(n)(38) of this chap- (c) In accordance with § 184.1(b)(1), ter; 0.02 percent in frozen dairy des- the ingredients are used in food as nu- serts as defined in § 170.3(n)(20) of this trient supplements as defined in chapter; 0.03 percent in gelatins, pud- § 170.3(o)(20) of this chapter, with no dings, and fillings as defined in limitation other than current good § 170.3(n)(22) of this chapter; and 0.01 manufacturing practice. The ingredi- percent in all other food categories. ents may also be used in infant formula (e) Prior sanctions for ethyl formate in accordance with section 412(g) of the different from the uses established in Federal Food, Drug, and Cosmetic Act this section do not exist or have been (the act) (21 U.S.C. 350a(g)) or with reg- waived. ulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). [45 FR 22915, Apr. 4, 1980, as amended at 49 (d) Prior sanctions for these ingredi- FR 5612, Feb. 14, 1984] ents different from the uses established § 184.1296 Ferric ammonium citrate. in this section do not exist or have been waived. (a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared by [53 FR 16864, May 12, 1988] the reaction of ferric hydroxide with citric acid, followed by treatment with § 184.1297 Ferric chloride. ammonium hydroxide, evaporating, (a) Ferric chloride (iron (III) chlo- and drying. The resulting product oc- ride, FeC13, CAS Reg. No. 7705–08–0) curs in two forms depending on the may be prepared from iron and chlorine stoichiometry of the initial reactants. or from ferric oxide and hydrogen chlo- (1) Ferric ammonium citrate (iron ride. The pure material occurs as (III) ammonium citrate, CAS Reg. No. hydroscopic, hexagonal, dark crystals. 1332–98–5) is a complex salt of undeter- Ferric chloride hexahydrate (iron (III) mined structure composed of 16.5 to chloride hexahydrate, FeC13. 6H20, CAS 18.5 percent iron, approximately 9 per- Reg. No. 10025–77–1) is readily formed cent ammonia, and 65 percent citric when ferric chloride is exposed to mois- acid and occurs as reddish brown or ture. garnet red scales or granules or as a (b) The ingredient must be of a pu- brownish-yellowish powder. rity suitable for its intended use.

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(c) In accordance with § 184.1(b)(1) the spection at the National Archives and ingredient is used in food as a flavoring Records Administration (NARA). For agent as defined in § 170.3(o)(12) of this information on the availability of this chapter, with no limitation other than material at NARA, call 202–741–6030, or current good manufacturing practice. go to: http://www.archives.gov/ (d) Prior sanctions for this ingredient federallregister/ different from the uses established in codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food as nutri- [53 FR 16864, May 12, 1988, as amended at 73 ent supplement as defined in FR 8607, Feb. 14, 2008] § 170.3(o)(20) of this chapter, with no § 184.1298 Ferric citrate. limitation other than current good manufacturing practice. The ingre- (a) Ferric citrate (iron (III) citrate, dient may also be used in infant for- C6H5FeO7, CAS Reg. No. 2338–05–8) is mula in accordance with section 412(g) prepared from reaction of citric acid of the Federal Food, Drug, and Cos- with ferric hydroxide. It is a compound metic Act (the act) (21 U.S.C. 350a(g)) of indefinite ratio of citric acid and or with regulations promulgated under iron. section 412(a)(2) of the act (21 U.S.C. (b) The ingredient must be of a pu- 350a(a)(2)). rity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food as a nu- this section do not exist or have been trient supplement as defined in waived. § 170.3(o)(20) of this chapter, with no limitation other than current good [53 FR 16865, May 12, 1988] manufacturing practice. The ingre- § 184.1304 Ferric pyrophosphate. dient may also be used in infant formula in accordance with section 412(g) (a) Ferric pyrophosphate (iron (III) of the Federal Food, Drug, and Cos- pyrophosphate, Fe4(P207)3·xH2O, CAS metic Act (the act) (21 U.S.C. 350a(g)) Reg. No. 10058–44–3) is a tan or yel- or with regulations promulgated under lowish white colorless powder. It is pre- section 412(a)(2) of the act (21 U.S.C. pared by reacting sodium 350a(a)(2)). pyrophosphate with ferric citrate. (d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the Food Chemicals Codex, this section do not exist or have been 3d Ed. (1981), p. 120, which is incor- waived. porated by reference. Copies are available from the National Academy Press, [53 FR 16865, May 12, 1988, as amended at 73 2101 Constitution Ave. NW., Wash- FR 8607, Feb. 14, 2008] ington, DC 20418, or available for inspection at the National Archives and § 184.1301 Ferric phosphate. Records Administration (NARA). For (a) Ferric phosphate (ferric information on the availability of this orthophosphate, iron (III) phosphate, material at NARA, call 202–741–6030, or FePO4·xH2O, CAS Reg. No. 10045–86–0) is go to: http://www.archives.gov/ an odorless, yellowish-white to buff- federallregister/ colored powder and contains from one codeloflfederallregulations/ to four molecules of water of hydra- ibrllocations.html. tion. It is prepared by reaction of so- (c) In accordance with § 184.1(b)(1), dium phosphate with ferric chloride or the ingredient is used in food as a nu- ferric citrate. trient supplement as defined in (b) The ingredient meets the speci- § 170.3(o)(20) of this chapter, with no fications of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), pp. 118–120, which is incor- manufacturing practice. The ingre- porated by reference. Copies are avail- dient may also be used in infant for- able from the National Academy Press, mula in accordance with section 412(g) 2101 Constitution Ave. NW., Wash- of the Federal Food, Drug, and Cos- ington, DC 20418, or available for in- metic Act (the act) (21 U.S.C. 350a(g))

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or with regulations promulgated under this section do not exist or have been section 412(a)(2) of the act (21 U.S.C. waived. 350a(a)(2)). [53 FR 16865, May 12, 1988, as amended at 69 (d) Prior sanctions for this ingredient FR 24512, May 4, 2004; 73 FR 8607, Feb. 14, different from the uses established in 2008] this section do not exist or have been waived. § 184.1307b Ferrous carbonate. (a) Ferrous carbonate (iron (II) car- [53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988] bonate, FeCO3, CAS Reg. No. 563–71–3) is an odorless, white solid prepared by § 184.1307 Ferric sulfate. treating solutions of iron (II) salts with alkali carbonate salts. (a) Ferric sulfate (iron (III) sulfate, (b) The ingredient must be of a pu- Fe2(SO4)3 CAS Reg. No. 10028–22–5) is a rity suitable for its intended use. yellow substance that may be prepared (c) In accordance with § 184.1(b)(1), by oxidizing iron (II) sulfate or by the ingredient is used in food as a nu- treating ferric oxide or ferric hydrox- trient supplement as defined in ide with sulfuric acid. § 170.3(o)(20) of this chapter, with no (b) The ingredient must be of a pu- limitation other than current good rity suitable for its intended use. manufacturing practice. The ingre- (c) In accordance with § 184.1(b)(1), dient may also be used in infant for- the ingredient is used in food as a fla- mula in accordance with section 412(g) voring agent as defined in § 170.3(o)(12) of the Federal Foods, Drug, and Cos- of this chapter, with no limitation metic Act (the act) (21 U.S.C. 350a(g)) other than current good manufacturing or with regulations promulgated under practice. section 412(a)(2) of the act (21 U.S.C. (d) Prior sanctions for this ingredient 350a(a)(2)). different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in this section do not exist or have been waived. waived. [53 FR 16865, May 12, 1988, as amended at 73 [53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008] FR 8607, Feb. 14, 2008]

§ 184.1307a Ferrous ascorbate. § 184.1307c Ferrous citrate. (a) Ferrous ascorbate (CAS Reg. No. (a) Ferrous citrate (iron (II) citrate, 24808–52–4) is a reaction product of fer- (C6H6FeO7), CAS Reg. No. 23383–11–1) is rous hydroxide and ascorbic acid. It is a slightly colored powder or white a blue-violet product containing 16 per- crystals. It is prepared from the reac- cent iron. tion of sodium citrate with ferrous sul- (b) The ingredient must be of a pu- fate or by direct action of citric acid on rity suitable for its intended use. iron filings. (c) In accordance with § 184.1(b)(1), (b) The ingredient must be of a pu- the ingredient is used in food as a nu- rity suitable for its intended use. trient supplement as defined in (c) In accordance with § 184.1(b)(1) the § 170.3(o)(20) of this chapter, with no ingredient is used in food as a nutrient limitation other than current good supplement as defined in § 170.3(o)(20) of manufacturing practice. The ingre- this chapter, with no limitation other dient may also be used in infant for- than current good manufacturing prac- mula in accordance with section 412(g) tice. The ingredient may also be used in infant formula in accordance with of the Federal Food, Drug, and Cos- section 412(g) of the Federal Food, metic Act (the act) (21 U.S.C. 350a(g)) Drug, and Cosmetic Act (the act) (21 or with regulations promulgated under U.S.C. 350a(g)) or with regulations pro- section 412(a)(2) of the act (21 U.S.C. mulgated under section 412(a)(2) of the 350a(a)(2)). act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in

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this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemcials Codex, 3d Ed. (1981), pp. 122–123, which is incor- [53 FR 16866, May 12, 1988, as amended at 73 porated by reference. Copies are avail- FR 8607, Feb. 14, 2008] able from the National Academy Press, § 184.1307d Ferrous fumarate. 2101 Constitution Avenue NW., Wash- ington, DC 20418, or available for in- (a) Ferrous fumarate (iron (II) fuma- spection at the National Archives and rate, (C4H2FeO4), CAS Reg. No. 141–01–5) Records Administration (NARA). For is an odorless, reddish-orange to red- information on the availability of this dish-brown powder. It may contain soft material at NARA, call 202–741–6030, or lumps that produce a yellow streak go to: http://www.archives.gov/ when crushed. It is prepared by federallregister/ admixing hot solutions of ferrous sul- codeloflfederallregulations/ fate and sodium fumarate. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food as a nu- 3d Ed. (1981), pp. 120–122, which is incor- trient supplement as defined in porated by reference. Copies are avail- § 170.3(o)(20) of this chapter, with no able from the National Academy Press, limitation other than current good 2101 Constitution Ave NW., Wash- manufacturing practice. The ingre- ington, DC 20418, or available for in- dient may also be used in infant for- spection at the National Archives and mula in accordance with section 412(g) Records Administration (NARA). For of the Federal Food, Drug, and Cos- information on the availability of this metic Act (the act) (21 U.S.C. 350a(g)) material at NARA, call 202–741–6030, or or with regulations promulgated under go to: http://www.archives.gov/ section 412(a)(2) of the act (21 U.S.C. federallregister/ 350a(a)(2)). codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in this section do not exist or have been (c) In accordance with § 184.1(b)(1) the waived. ingredient is used in food as a nutrient supplement as defined in § 170.3(o)(20) of [53 FR 16866, May 12, 1988; 53 FR 20939, June this chapter, with no limitation other 7, 1988] than current good manufacturing practice. The ingredient may also be used § 184.1311 Ferrous lactate. in infant formula in accordance with (a) Ferrous lactate (iron (II) lactate, section 412(g) of the Federal Food, C6H10FeO6, CAS Reg. No. 5905–52–2) in Drug, and Cosmetic Act (the act) (21 the trihydrate form is a greenish-white U.S.C. 350a(g)), or with regulations pro- powder or crystalline mass. It is pre- mulgated under section 412(a)(2) of the pared by reacting calcium lactate or act (21 U.S.C. 350a(a)(2)). sodium lactate with ferrous sulfate, di- (d) Prior sanctions for this ingredient rect reaction of lactic acid with iron different from the uses established in filings, reaction of ferrous chloride this section do not exist or have been with sodium lactate, or reaction of fer- waived. rous sulfate with ammonium lactate. (b) The ingredient meets the speci- [53 FR 16866, May 12, 1988] fications of the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is in- § 184.1308 Ferrous gluconate. corporated by reference in accordance (a) Ferrous gluconate (iron (II) gluco- with 5 U.S.C. 552(a) and 1 CFR part 51. nate dihydrate, C12H22FeO14·2H2O, CAS Copies are available from the National Reg. No. 6047-12-7) is a fine yellowish- Academy Press, 2101 Constitution Ave. gray or pale greenish-yellow powder or NW., Washington, DC 20418, or may be granules. It is prepared by reacting hot examined at the Center for Food Safety solutions of barium or calcium gluco- and Applied Nutrition’s library, 5100 nate with ferrous sulfate or by heating Paint Branch Pkwy., College Park, MD freshly prepared ferrous carbonate with 20740, or at the National Archives and gluconic acid in aqueous solution. Records Administration (NARA). For

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information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredients are used in food as nu- go to: http://www.archives.gov/ trient supplements as defined in federallregister/ § 170.3(o)(20) of this chapter and as a codeloflfederallregulations/ processing aid as defined in § 170.3(o)(24) ibrllocations.html. of this chapter, with no limitation (c) In accordance with § 184.1(b)(1), other than current good manufacturing the ingredient is used in food as a nu- practice. The ingredients may also be trient supplement as defined in used in infant formula in accordance § 170.3(o)(20) of this chapter and as a with section 412(g) of the Federal Food, color fixative for ripe olives, with no Drug, and Cosmetic Act (the act) (21 other limitation other than current U.S.C. 350a(g)) or with regulations pro- good manufacturing practice. The in- mulgated under section 412(a)(2) of the gredient may also be used in infant for- act (21 U.S.C. 350a(a)(2)). mula in accordance with section 412(g) (d) Prior sanctions for these ingredi- of the Federal Food, Drug, and Cos- ents different from the uses established metic Act (the act) (21 U.S.C. 350a(g)) in this section do not exist or have or with regulations promulgated under been waived. section 412(a)(2) of the act (21 U.S.C. [53 FR 16866, May 12, 1988] 350a(a)(2)). (d) Prior sanctions for this ingredient § 184.1316 Ficin. different from the uses established in this section do not exist or have been (a) Ficin (CAS Reg. No. 9001–33–6) is waived. an enzyme preparation obtained from the latex of species of the genus Ficus, [53 FR 16866, May 12, 1988, as amended at 61 which include a variety of tropical fig FR 40319, Aug. 2, 1996] trees. It is a white to off-white powder. Its characterizing enzyme activity is § 184.1315 Ferrous sulfate. that of a peptide hydrolase (EC (a) Ferrous sulfate heptahydrate 3.4.22.3). (iron (II) sulfate heptahydrate, (b) The ingredient meets the general FeSO4·7H2O, CAS Reg. No. 7782–63–0) is requirements and additional require- prepared by the action of sulfuric acid ments for enzyme preparations in the on iron. It occurs as pale, bluish-green Food Chemicals Codex, 3d ed. (1981), p. crystals or granules. Progressive heat- 110, which is incorporated by reference ing of ferrous sulfate heptahydrate pro- in accordance with 5 U.S.C. 552(a) and 1 duces ferrous sulfate (dried). Ferrous CFR part 51. Copies are available from sulfate (dried) consists primarily of fer- the National Academy Press, 2101 Con- rous sulfate monohydrate (CAS Reg. stitution Ave., NW., Washington, DC No. 17375–41–6) with varying amounts of 20418, or may be examined at the Office ferrous sulfate tetrahydrate (CAS Reg. of Premarket Approval (HFS–200), Food No. 20908–72–9) and occurs as a grayish- and Drug Administration, 5100 Paint white to buff-colored powder. Branch Pkwy., College Park, MD 20740, (b) The ingredients meet the speci- and at the National Archives and fications of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 123 (Ferrous sulfate information on the availability of this heptahydrate) and p. 124 (ferrous sul- material at NARA, call 202–741–6030, or fate, dried), which is incorporated by go to: http://www.archives.gov/ reference. Copies are available from federallregister/ the National Academy Press, 2101 Con- codeloflfederallregulations/ stitution Ave., NW., Washington, DC ibrllocations.html. 20418, or available for inspection at the (c) In accordance with § 184.1(b)(1), National Archives and Records Admin- the ingredient is used in food with no istration (NARA). For information on limitation other than current good the availability of this material at manufacturing practice. The affirma- NARA, call 202–741–6030, or go to: http:// tion of this ingredient as GRAS as a di- www.archives.gov/federallregister/ rect food ingredient is based upon the codeloflfederallregulations/ following current good manufacturing ibrllocations.html. practice conditions of use:

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(1) The ingredient is used as an en- to man or other animals, or by the oxi- zyme as defined in § 170.3(o)(9) of this dation of D-glucose with enzymes de- chapter to hydrolyze proteins or rived from these microorganisms. polypeptides. (b) The ingredient meets the speci- (2) The ingredient is used in food at fications of the Food Chemicals Codex, levels not to exceed current good man- 3d Ed. (1981), p. 134, which is incor- ufacturing practice. porated by reference. Copies are available from the National Academy Press, [60 FR 32910, June 26, 1995] 2101 Constitution Ave. NW., Wash- § 184.1317 Garlic and its derivatives. ington, DC 20418, or available for inspection at the National Archives and (a) Garlic is the fresh or dehydrated Records Administration (NARA). For bulb or cloves obtained from Allium information on the availability of this sativum, a genus of the lily family. Its material at NARA, call 202–741–6030, or derivatives include essential oils, oleo- go to: http://www.archives.gov/ resins, and natural extractives ob- federallregister/ tained from garlic. codeloflfederallregulations/ (b) Garlic oil meets the specifications ibrllocations.html. of the ‘‘Food Chemicals Codex,’’ 3d Ed. (c) In accordance with § 184.1(b)(1), (1981), p. 132, which is incorporated by the ingredient is used in food with no reference. Copies may be obtained from limitation other than current good the National Academy Press, 2101 Con- manufacturing practice. The affirma- stitution Ave. NW., Washington, DC tion of this ingredient as generally rec- 20418, or may be examined at the Na- ognized as safe (GRAS) as a direct tional Archives and Records Adminis- human food ingredient is based upon tration (NARA). For information on the following current good manufac- the availability of this material at turing practice conditions of use: NARA, call 202–741–6030, or go to: http:// (1) The ingredient is used as a curing www.archives.gov/federallregister/ and pickling agent as defined in codeloflfederallregulations/ § 170.3(o)(5) of this chapter, leavening ibrllocations.html. agent as defined in § 170.3(o)(17) of this (c) Garlic and its derivatives are used chapter; pH control agent as defined in as flavoring agents and adjuvants as § 170.3(o)(23) of this chapter; and defined in § 170.3(o)(12) of this chapter. sequestrant as defined in § 170.3(o)(26) of (d) The ingredients are used in food this chapter. at levels not to exceed good manufac- (2) The ingredient is used at levels turing practice. not to exceed current good manufac- (e) [Reserved] turing practice. (f) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 [51 FR 33896, Sept. 24, 1986] FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984] § 184.1321 Corn gluten. (a) Corn gluten (CAS Reg. No. 66071– § 184.1318 Glucono delta-lactone. 96–3), also known as corn gluten meal, (a) Glucono delta-lactone (C6H10O6, is the principal protein component of CAS Reg. No. 90–80–2), also called D- corn endosperm. It consists mainly of gluconic acid delta-lactone or D- zein and glutelin. Corn gluten is a by- glucono-1,5-lactone, is the cyclic 1,5- product of the wet milling of corn for intramolecular ester of D-gluconic starch. The gluten fraction is washed acid. It is prepared by direct crys- to remove residual water soluble pro- tallization from the aqueous solution teins. Corn gluten is also produced as a of gluconic acid. Gluconic acid may be byproduct during the conversion of the produced by the oxidation of D-glucose starch in whole or various fractions of with bromine water, by the oxidation dry milled corn to corn syrups. of D-glucose by microorganisms that (b) The ingredient must be of a pu- are nonpathogenic and nontoxicogenic rity suitable for its intended use.

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(c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in ognized as safe (GRAS) as a direct this section do not exist or have been human food ingredient is based upon waived. the following current good manufacturing practice conditions of use: [50 FR 8998, Mar. 6, 1985, as amended at 73 FR (1) The ingredient is used as a nutri- 8607, Feb. 14, 2008] ent supplement as defined in § 170.3(o)(20) of this chapter and a § 184.1323 Glyceryl monooleate. texturizer as defined in § 170.3(o)(32) of (a) Glyceryl monooleate is prepared this chapter. by esterification of commerical oleic (2) The ingredient is used in food at acid that is derived either from edible levels not to exceed current good man- sources or from tall oil fatty acids ufacturing practice. meeting the requirements of § 172.862 of (d) Prior sanctions for this ingredient this chapter. It contains glyceryl different from the uses established in monooleate (C21H40O4, CAS Reg. No. this section do not exist or have been 25496–72–4) and glyceryl esters of fatty waived. acids present in commercial oleic acid. [50 FR 8998, Mar. 6, 1985, as amended at 73 FR (b) The ingredient must be of a pu- 8607, Feb. 14, 2008] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1322 Wheat gluten. the ingredient is used in food with no (a) Wheat gluten (CAS Reg. No. 8002– limitation other than current good 80–0) is the principal protein compo- manufacturing practice. The affirma- nent of wheat and consists mainly of tion of this ingredient as generally rec- gliadin and glutenin. Wheat gluten is ognized as safe (GRAS) as a direct obtained by hydrating wheat flour and human food ingredient is based upon mechanically working the sticky mass the following current good manufac- to separate the wheat gluten from the turing practice conditions of use: starch and other flour components. (1) The ingredient is used as a fla- Vital gluten is dried gluten that has re- voring agent and adjuvant as defined in tained its elastic properties. § 170.3(o)(12) of this chapter and as a (b) The ingredient must be of a pu- solvent and vehicle as defined in rity suitable for its intended use. § 170.3(o)(27) of this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in the fol- the ingredient is used in food with no lowing foods at levels not to exceed limitation other than current good current good manufacturing practice: manufacturing practice. The affirma- baked goods and baking mixes as de- tion of this ingredient as generally rec- fined in § 170.3(n)(1) of this chapter; ognized as safe (GRAS) as a direct nonalcoholic beverages and beverage human food ingredient is based upon bases as defined in § 170.3(n)(3) of this the following current good manufac- chapter; chewing gum as defined in turing practice conditions of use: § 170.3(n)(6) of this chapter; and meat (1) The ingredient is used as a dough products as defined in § 170.3(n)(29) of strengthener as defined in § 170.3(o)(6) this chapter. of this chapter; a formulation aid as (d) Prior sanctions for this ingredient defined in § 170.3(o)(14) of this chapter; different from the use established in a nutrient supplement as defined in this section do not exist or have been § 170.3(o)(20) of this chapter; a proc- waived. essing aid as defined in § 170.3(o)(24) of this chapter; a stabilizer and thickener [54 FR 7403 Feb. 21, 1989, as amended at 73 FR as defined in § 170.3(o)(28) of this chap- 8607, Feb. 14, 2008] ter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and a § 184.1324 Glyceryl monostearate. texturizing agent as defined in (a) Glyceryl monostearate, also § 170.3(o)(32) of this chapter. known as monostearin, is a mixture of

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variable proportions of glyceryl mono- (2) The ingredient is used in excipient stearate (C21H42O4, CAS Reg. No. 31566– formulations for use in tablets at levels 31–1), glyceryl monopalmitate not to exceed good manufacturing (C19H38O4, CAS Reg. No. 26657–96–5) and practice. glyceryl esters of fatty acids present in commercial stearic acid. Glyceryl [52 FR 42430, Nov. 5, 1987] monostearate is prepared by § 184.1329 Glyceryl palmitostearate. glycerolysis of certain fats or oils that are derived from edible sources or by (a) Glyceryl palmitostearate is a esterification, with glycerin, of stearic mixture of mono-, di-, and triglyceryl acid that is derived from edible esters of palmitic and stearic acids sources. made from glycerin, palmitic acid, and (b) The ingredient must be of a pu- stearic acid. rity suitable for its intended use. (b) The ingredient meets the fol- (c) In accordance with § 184.1(b)(1), lowing specifications: the ingredient is used in food with no (1) The substance is a mixture of limitation other than current good mono-, di-, and triglycerides of pal- manufacturing practice. mitic acid and stearic acid. (d) Prior sanctions for this ingredient (2) Heavy metals (as lead): Not more different from the uses established in than 10 parts per million. this section do not not exist or have (c) In accordance with § 184.1(b)(1), been waived. the ingredient is used in food with no limitation other than current good [54 FR 7403 Feb. 21, 1989, as amended at 73 FR manufacturing practice. The affirma- 8607, Feb. 14, 2008] tion of this ingredient as generally rec- § 184.1328 Glyceryl behenate. ognized as safe (GRAS) as a direct human food ingredient is based upon (a) Glyceryl behenate is a mixture of the following current good manufac- glyceryl esters of behenic acid made turing practice conditions of use: from glycerin and behenic acid (a satu- (1) The ingredient is used as a formu- rated C22 fatty acid). The mixture con- lation aid, as defined in § 170.3(o)(14) of tains predominately glyceryl this chapter. dibehenate. (2) The ingredient is used in excipient (b) The ingredient meets the fol- formulations for use in tablets at levels lowing specifications: not to exceed good manufacturing (1) 10 to 20 percent monoglyceride, 47 practice. to 59 percent diglyceride, 26 to 38 percent triglyceride, and not more than [60 FR 63621, Dec. 12, 1995] 2.5 percent free fatty acids. (2) Behenic acid. Between 80 and 90 § 184.1330 Acacia (gum arabic). percent of the total fatty acid content. (a) Acacia (gum arabic) is the dried (3) Acid value. Not more than 4. gummy exudate from stems and (4) Saponification value. Between 145 branches of trees of various species of and 165. the genus Acacia, family Leguminosae. (5) Iodine number. Not more than 3. (b) The ingredient meets the speci- (6) Heavy metals (as Pb). Not more fications of the ‘‘Food Chemicals than 10 parts per million. Codex,’’ 3d Ed. (1981), p. 7, which is in- (c) In accordance with § 184.1(b)(1) of corporated by reference. Copies may be this chapter, the ingredient is used in obtained from the National Academy food with no limitation other than cur- Press, 2101 Constitution Ave. NW., rent good manufacturing practice. The Washington, DC 20418, or may be exam- affirmation of this ingredient is gen- ined at the National Archives and erally recognized as safe (GRAS) as a Records Administration (NARA). For direct human food ingredient is based information on the availability of this upon the following current good manu- material at NARA, call 202–741–6030, or facturing practice conditions of use: go to: http://www.archives.gov/ (1) The ingredient is used as a formu- federallregister/ lation aid, as defined in § 170.3(o)(14) of codeloflfederallregulations/ this chapter. ibrllocations.html.

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, § 170.3(n)(3) of this chapter 2.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Chewing gum, §170.3(n)(6) of this chapter ...... 5.6 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Confections and frostings, § 170.3(n)(9) of this chapter ...... 12.4 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Dairy product analogs, § 170.3(n)(10) of this chapter ...... 1.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.5 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Gelatins, puddings, and fillings, § 170.3(n)(22) of this chapter 2.5 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter.; stabilizer and thickener, § 170.3(o)(28) of this chapter. Hard candy and cough drops, § 170.3(n)(25) of this chapter .. 46.5 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter. Nuts and nut products, § 170.3(n)(32) of this chapter ...... 8.3 Formulation aid, § 170.3(o)(14) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Quiescently frozen confection products ...... 6.0 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Snack foods, §170.3(n)(37) of this chapter ...... 4.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter. Soft candy, §170.3(n)(38) of this chapter ...... 85.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter, humectant, § 170.3(o)(16) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. All other food categories ...... 1.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter; texturizer, § 170.3(o)(32) of this chapter.

(d) [Reserved] in the dry deciduous forests of India (e) Prior sanctions for this ingredient and Ceylon. different from the uses established in (b) The ingredient complies with the this section do not exist or have been following specifications: waived. (1) Viscosity of a 1-percent solution. Not less than the minimum or within [42 FR 14653, Mar. 15, 1977, as amended at 42 the range claimed by the vendor. FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, (2) Limits of impurities—(i) Arsenic (as 1983; 53 FR 5766, Feb. 26, 1988] AL). Not more than 3 parts per million § 184.1333 Gum ghatti. (0.0003 percent); (ii) Ash (acid-insoluble). Not more (a) Gum ghatti (Indian gum) is an than 1.75 percent; exudate from wounds in the bark of (iii) Ash (total). Not more than 6.0 Anogeissus latifolia, a large tree found percent;

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(iv) Heavy metals (as Pb). Not more may be examined at the National Ar- than 40 parts per million (0.004 per- chives and Records Administration cent); and (NARA). For information on the avail- (v) Lead. Not more than 10 parts per ability of this material at NARA, call million (0.001 percent). 202–741–6030, or go to: http:// (3) Loss on drying. Not more than 14 www.archives.gov/federallregister/ percent dried at 105 °C for 5 hours. codeloflfederallregulations/ (4) Identification test. Add 0.2 ml of di- ibrllocations.html.), to 5 ml of a cold 1- luted lead acetate as outlined in ‘‘Offi- in-100 aqueous solution of the gum. An cial Methods of Analysis of the Asso- immediate, voluminous, opaque pre- ciation of Official Analytical Chem- cipitate indicates acacia. A small pre- ists,’’ 13th Ed. (1980), section 31.178(b), cipitate or clear solution which pro- p. 529, under ‘‘Dilute Basic Lead Ace- duces an opaque flocculent precipitate tate Standard Solution,’’ which is in- upon the addition of 1 ml of 3 N corporated by reference (Copies are ammonimum hydroxide indicates gum available from the AOAC INTER- ghatti. NATIONAL, 481 North Frederick Ave., (c) The ingredient is used in food suite 500, Gaithersburg, MD 20877, or under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

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

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

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

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

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

Soups and soup mixes, § 170.3(n)(40) of this chapter ...... 8 Do. Sweet sauces, toppings and syrups, § 170.3(n)(43) of this 1.0 Do. chapter. All other food categories ...... 5 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter.

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

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

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

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

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

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

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

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

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

(d) [Reserved] § 184.1355 Helium. (e) Prior sanctions for this ingredient (a) Helium (empirical formula He, different from the uses established in CAS Reg. No. 7440–59–7) is a colorless, this section do not exist or have been odorless, flavorless, nonflammable, waived. inert gas. It is lighter than air and is [42 FR 14653, Mar. 15, 1977, as amended at 42 produced by the liquefaction and puri- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, fication of natural gas. 1984] (b) The ingredient must be of a purity suitable for its intended use. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no

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limitations other than current good hydrogen dioxide. It is made by the manufacturing practice. The affirma- electrolytic oxidation of sulfuric acid tion of this ingredient as generally rec- or a sulfate to persulfuric acid or a ognized as safe (GRAS) as a direct persulfuric acid salt with subsequent human food ingredient is based upon hydrolysis and distillation of the hy- the following current good manufac- drogen peroxide formed; by decomposi- turing practice conditions of use: tion of barium peroxide with sulfuric (1) The ingredient is used as a proc- or phosphoric acid; by hydrogen reduc- essing aid as defined in § 170.3(o)(24) of tion of 2-ethylanthraquinone, followed this chapter. by oxidation with air, to regenerate (2) The ingredient is used in food at levels not to exceed current good man- the quinone and produce hydrogen per- ufacturing practice. oxide; or by electrical discharge (d) Prior sanctions for this ingredient through a mixture of hydrogen, oxy- different from the uses established in gen, and water vapor. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d ed. (1981), pp. 146–147, 1 which is in- [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] corporated by reference. (c) In accordance with § 184.1(b)(2), § 184.1366 Hydrogen peroxide. the ingredient is used to treat food only within the following specific limi- (a) Hydrogen peroxide (H2O2, CAS Reg. No. 7722–84–1) is also referred to as tations:

Maximum treatment Food level in food (percent) Functional use

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

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

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(d) Residual hydrogen peroxide is re- this section do not exist or have been moved by appropriate physical and waived. chemical means during the processing [47 FR 38278, Aug. 31, 1982] of food where it has been used according to paragraph (c) of this section. § 184.1372 Insoluble glucose isomerase (e) Prior sanctions for this ingredient enzyme preparations. different from the uses established in this section do not exist or have been (a) Insoluble glucose isomerase en- waived. zyme preparations are used in the production of high fructose corn syrup de- [46 FR 44439, Sept. 4, 1981, as amended at 51 scribed in § 184.1866. They are derived FR 27172, July 30, 1986] from recognized species of precisely classified nonpathogenic and § 184.1370 Inositol. nontoxicogenic microorganisms, in- (a) Inositol, or myo-inositol (C6H12O6, cluding Streptomyces rubiginosus, CAS Reg. No. 87–89–8), is cis-1,2,3,5- Actinoplanes missouriensis, Streptomyces trans-4,6-cyclohexanehexol. It occurs olivaceus, Streptomyces olivochromogenes, naturally and is prepared from an and Bacillus coagulans, that have been aqueous (0.2 percent sulfur dioxide) ex- grown in a pure culture fermentation tract of corn kernels by precipitation that produces no antibiotics. They are and hydrolysis of crude phytate. fixed (rendered insoluble) for batch (b) The ingredient meets the speci- production with GRAS ingredients or fications of the Food Chemicals Codex, may be fixed for further immobiliza- 3d Ed. (1981), p. 150, which is incor- tion with either GRAS ingredients or porated by reference. Copies are avail- materials approved under § 173.357 of able from the National Academy Press, this chapter. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the general ington, DC 20418, or available for in- and additional requirements for en- spection at the National Archives and zyme preparations in the Food Chemi- Records Administration (NARA). For cals Codex, 3d Ed. (1981), p. 107, which is information on the availability of this incorporated by reference. Copies are material at NARA, call 202–741–6030, or available from the National Academy go to: http://www.archives.gov/ Press, 2101 Constitution Ave. NW., federallregister/ Washington, DC 20418, or available for codeloflfederallregulations/ ibrllocations.html. inspection at the National Archives (c) In accordance with § 184.1(b)(1), and Records Administration (NARA). the ingredient is used in food with no For information on the availability of limitations other than current good this material at NARA, call 202–741– manufacturing practice. The affirma- 6030, or go to: http://www.archives.gov/ tion of this ingredient as generally rec- federallregister/ ognized as safe (GRAS) as a direct codeloflfederallregulations/ human food ingredient is based upon ibrllocations.html. the following current good manufac- (c) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as a nutri- limitation other than current good ent supplement as defined in manufacturing practice. The affirma- § 170.3(o)(20) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in special ognized as safe (GRAS) as a direct dietary foods as defined in part 105 of human food ingredient is based upon this chapter at levels not to exceed the following current good manufac- current good manufacturing practice. turing practice conditions of use: It may also be used in infant formula (1) The ingredient is used as an en- in accordance with section 412(g) of the zyme, as defined in § 170.3(o)(9) of this Act, or with regulations promulgated chapter, to convert glucose to fructose. under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established by

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(2) The ingredient is used in high dient may also be used in accordance fructose corn syrup, at levels not to ex- with section 412(g) of the Federal Food, ceed current good manufacturing prac- Drug, and Cosmetic Act (the act) (21 tice. U.S.C. 350a(g)) or with regulations pro- [48 FR 5720, Feb. 8, 1983, as amended at 61 FR mulgated under section 412(a)(2) of the 43450, Aug. 23, 1996] act (21 U.S.C. 350a(2)). (d) Prior sanctions for this ingredient § 184.1375 Iron, elemental. different from the uses established in (a) Iron, elemental (CAS Reg. No. this section do not exist or have been 7439–89–6) is metallic iron obtained by waived. any of the following processes: reduced [53 FR 16867, May 12, 1988] iron, electrolytic iron, and carbonyl iron. § 184.1386 Isopropyl citrate. (1) Reduced iron is prepared by react- (a) Isopropyl citrate is a mixture of ing ground ferric oxide with hydrogen the mono-, di-, and triisopropyl esters or carbon monoxide at an elevated of citric acid. It is prepared by temperature. The process results in a esterifying citric acid with grayish-black powder, all of which isopropanol. should pass through a 100-mesh sieve. (b) The ingredient must be of a pu- It is lusterless or has not more than a rity suitable for its intended use. slight luster. When viewed under a mi- (c) In accordance with § 184.1(b)(1), croscope, it appears as an amorphous the ingredient is used in food with no powder free from particles having a limitation other than current good crystalline structure. It is stable in dry manufacturing practice. The affirma- air. tion of this ingredient as generally rec- (2) Electrolytic iron is prepared by ognized as safe (GRAS) as a direct electrodeposition. It is an amorphous, human food ingredient is based upon lusterless, grayish-black powder. It is the following current good manufac- stable in dry air. (3) Carbonyl iron is prepared by the turing practice conditions of use: decomposition of iron pentacarbonyl. (1) The ingredient is used as an anti- It occurs as a dark gray powder. When oxidant as defined in § 170.3(o)(3) of this viewed under a microscope, it appears chapter; a sequestrant as defined in as spheres built up with concentric § 170.3(o)(26) of this chapter; and a sol- shells. It is stable in dry air. vent and vehicle as defined in (b) Iron, elemental (carbonyl, elec- § 170.3(o)(27) of this chapter. trolytic, or reduced) meets the speci- (2) The ingredient is used in mar- fications of the Food Chemicals Codex, garine in accordance with § 166.110 of 3d Ed. (1981) (iron, carbonyl, p. 151; this chapter; in nonalcoholic beverages iron, electrolytic, pp. 151–152; iron, re- as defined in § 170.3(n)(3) of this chap- duced; pp. 152–153), which is incor- ter; and in fats and oils as defined in porated by reference. Copies are avail- § 170.3(n)(12) of this chapter at levels able from the National Academy Press, not to exceed current good manufac- 2101 Constitution Ave. NW., Wash- turing practice. ington, DC 20418, or available for in- (d) Prior sanctions for this ingredient spection at the National Archives and different from the uses established in Records Administration (NARA). For this section, or different from those set information on the availability of this forth in part 181 of this chapter, do not material at NARA, call 202–741–6030, or exist or have been waived. go to: http://www.archives.gov/ [59 FR 63896, Dec. 12, 1994, as amended at 73 federallregister/ FR 8607, Feb. 14, 2008] codeloflfederallregulations/ ibrllocations.html. § 184.1387 Lactase enzyme preparation (c) In accordance with § 184.1(b)(1), from Candida pseudotropicalis. the ingredient is used in food as a nu- (a) This enzyme preparation is de- trient supplement as defined in rived from the nonpathogenic, § 170.3(o)(20) of this chapter, with no nontoxicogenic yeast C. limitation other than current good pseudotropicalis. It contains the enzyme manufacturing practice. The ingre- lactase (b-D-galactoside 533

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galactohydrolase, EC 3.2.1.23), which from yeast that has been grown in a converts lactose to glucose and galac- pure culture fermentation and by using tose. It is prepared from yeast that has materials that are generally recognized been grown by a pure culture fermenta- as safe or are food additives that have tion process. been approved for this use by the Food (b) The ingredient meets the general and Drug Administration. requirements and additional require- (b) The ingredient meets the general ments for enzyme preparations in the and additional requirements for en- Food Chemicals Codex, 3d ed. (1981), pp. zyme preparations in the Food Chemi- 107–110, which are incorporated by ref- cals Codex, 3d Ed. (1981), p. 107–110, erence in accordance with 5 U.S.C. which is incorporated by reference. 552(a) and 1 CFR part 51. Copies are Copies are available from the National available from the National Academy Academy Press, 2101 Constitution Ave. Press, 2101 Constitution Ave. NW., NW., Washington, DC 20418, or avail- Washington, DC 20418, or may be exam- able for inspection at the National Ar- ined at the Center for Food Safety and chives and Records Administration Applied Nutrition’s Library, 5100 Paint (NARA). For information on the avail- Branch Pkwy., College Park, MD 20740, ability of this material at NARA, call or at the National Archives and 202–741–6030, or go to: http:// Records Administration (NARA). For www.archives.gov/federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe as a direct human food limitations other than current good ingredient is based upon the following manufacturing practice. The affirma- current good manufacturing practice tion of this ingredient as generally rec- conditions of use: ognized as safe as a direct human food (1) The ingredient is used as an en- ingredient is based upon the following zyme as defined in § 170.3(o)(9) of this current good manufacturing practice chapter to convert lactose to glucose conditions of use: and galactose. (1) The ingredient is used as an en- (2) The ingredient is used in food at zyme, as defined in § 170.3(o)(9) of this levels not to exceed current good man- chapter, to convert lactose to glucose ufacturing practice. Current good man- and galactose. ufacturing practice is to use this ingre- (2) The ingredient is used in food at dient in milk to produce lactase-treat- levels not to exceed current good man- ed milk, which contains less lactose ufacturing practice. Current good man- than regular milk, or lactose-reduced ufacturing practice is limited to use of milk, which contains at least 70 per- this ingredient to reduce the lactose cent less lactose than regular milk. content in milk and milk-derived food [49 FR 47387, Dec. 4, 1984] products where food standards do not preclude such use. § 184.1400 Lecithin. [61 FR 7704, Feb. 29, 1996] (a) Commercial lecithin is a naturally occurring mixture of the § 184.1388 Lactase enzyme preparation phosphatides of choline, ethanolamine, from Kluyveromyces lactis. and inositol, with smaller amounts of (a) This enzyme preparation is de- othe lipids. It is isolated as a gum fol- rived from the nonpathogenic, lowing hydration of solvent-extracted nontoxicogenic yeast Kluyveromyces soy, safflower, or corn oils. Lecithin is lactis (previously named Saccharomyces bleached, if desired, by hydrogen per- lactis). It contains the enzyme B- oxide and benzoyl peroxide and dried galactoside galactohydrase (CAS Reg. by heating. No. CBS 683), which converts lactose to (b) The ingredient meets the speci- glucose and galactose. It is prepared fications of the Food Chemicals Codex,

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3d Ed. (1981), pp. 166–167, which is incor- the Association of Official Analytical porated by reference. Copies are avail- Chemists, 65:471–472 (1982), which are able from the National Academy Press, also incorporated by reference. Copies 2101 Constitution Ave. NW., Wash- of all of these methods are available ington, DC 20418, or available for in- from the AOAC INTERNATIONAL, 481 spection at the National Archives and North Frederick Ave., suite 500, Gai- Records Administration (NARA). For thersburg, MD 20877, or available for information on the availability of this inspection at the National Archives material at NARA, call 202–741–6030, or and Records Administration (NARA). go to: http://www.archives.gov/ For information on the availability of federallregister/ this material at NARA, call 202–741– codeloflfederallregulations/ 6030, or go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (2) Ash. Not more than 9.5 percent for manufacturing practice. licorice, 2.5 percent for ammoniated (d) Prior sanctions for this ingredient glycyrrhizin, and 0.5 percent for different from the uses established in monoammonium glycyrrhizinate on an this section do not exist or have been anhydrous basis as determined by the waived. method in the Food Chemicals Codex, [48 FR 51150, Nov. 7, 1983] 3d Ed. (1981), p. 466, which is incorporated by reference. Copies are avail- § 184.1408 Licorice and licorice deriva- able from the National Academy Press, tives. 2101 Constitution Ave. NW., Wash- (a)(1) Licorice (glycyrrhiza) root is ington, DC 20418, or available for in- the dried and ground rhizome and root spection at the National Archives and portions of Glycyrrhiza glabra or other Records Administration (NARA). For species of Glycyrrhiza. Licorice extract information on the availability of this is that portion of the licorice root that material at NARA, call 202–741–6030, or is, after maceration, extracted by boil- go to: http://www.archives.gov/ ing water. The extract can be further federallregister/ purified by filtration and by treatment codeloflfederallregulations/ with acids and ethyl alcohol. Licorice ibrllocations.html. extract is sold as a liquid, paste (3) Acid unsoluble ash. Not more than (‘‘block’’), or spray-dried powder. (2) Ammoniated glycyrrhizin is pre- 2.5 percent for licorice on an anhydrous pared from the water extract of lico- basis as determined by the method in rice root by acid precipitation followed the Food Chemicals Codex, 3d Ed. by neutralization with dilute ammonia. (1981), p. 466, which is incorporated by Monoammonium glycyrrhizinate reference. (4) Heavy metals (as Pb). Not more (C42H61O16NH45H2O, CAS Reg. No. 1407– 03–0) is prepared from ammoniated than 40 parts per million as determined glycyrrhizin by solvent extraction and by method II in the Food Chemicals separation techniques. Codex, 3d Ed. (1981), p. 512, which is in- (b) The ingredients shall meet the corporated by reference. following specifications when analyzed: (5) Arsenic (As). Not more than 3 parts (1) Assay. The glycyrrhizin content of per million as determined by the meth- each flavoring ingredient shall be de- od in the Food Chemicals Codex. 3d Ed. termined by the method in the Official (1981), p. 464, which is incorporated by Methods of Analysis of the Association reference. of Official Analytical Chemists, 13th (c) In accordance with § 184.1(b)(2), Ed., §§ 19.136–19.140, which is incor- these ingredients are used in food only porated by reference, or by methods within the following specific limita- 19.CO1 through 19.CO4 in the Journal of tions:

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Maximum level in food (percent Category of food glycyrrhizin con- Functional use tent of food) (as served)

Baked foods, § 170.3(n)(1) of this chapter ...... 0 .05 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter. Alcoholic beverages, § 170.3(n)(2) of this chapter ..... 0 .1 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; surface-active agent, § 170.3(o)(29) of this chapter. Nonalcoholic beverages, § 170.3(n)(3) of this chapter 0 .15 Do. Chewing gum, § 170.3(n)(6) of this chapter ...... 1 .1 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent, § 170.3(n)(12) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 16.0 Do. Herbs and seasonings, § 170.3(n)(26) of this chapter 0.15 Do. Plant protein products, § 170.3(n)(33) of this chapter 0 .15 Do. Soft candy, § 170.3(n)(38) of this chapter ...... 3 .1 Do. Vitamin or mineral dietary supplements ...... 0 .5 Do. All other foods except sugar substitutes, 0 .1 Do. § 170.3(n)(42) of this chapter. The ingredient is not permitted to be used as a nonnutritive sweetener in sugar substitutes.

(d) Prior sanctions for this ingredient § 184.1415 Animal lipase. different from the uses established in (a) Animal lipase (CAS Reg. No. 9001– this section do not exist or have been 62–1) is an enzyme preparation obtained waived. from edible forestomach tissue of [50 FR 21044, May 22, 1985, as amended at 54 calves, kids, or lambs, or from animal FR 24899, June 12, 1989] pancreatic tissue. The enzyme preparation may be produced as a tissue prepa- § 184.1409 Ground limestone. ration or as an aqueous extract. Its (a) Ground limestone consists essen- characterizing enzyme activity is that tially (not less than 94 percent) of cal- of a triacylglycerol hydrolase (EC cium carbonate (CaCO3) and is prepared 3.1.1.3). by the crushing, grinding, and (b) The ingredient meets the general classifying of naturally occurring lime- requirements and additional require- stone. ments for enzyme preparations in the (b) The ingredient meets the speci- Food Chemicals Codex, 3d ed. (1981), p. fications of the Food Chemicals Codex, 110, which is incorporated by reference 3d Ed. (1981), p. 173, which is incor- in accordance with 5 U.S.C. 552(a) and 1 porated by reference. Copies are avail- CFR part 51. Copies are available from able from the National Academy Press, the National Academy Press, 2101 Con- 2101 Constitution Ave. NW., Wash- stitution Ave., NW., Washington, DC ington, DC 20418, or available for in- 20418, or may be examined at the Office spection at the National Archives and of Premarket Approval (HFS–200), Food Records Administration (NARA). For and Drug Administration, 5100 Paint information on the availability of this Branch Pkwy., College Park, MD 20740, material at NARA, call 202–741–6030, or and at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as GRAS as a di- [48 FR 52442, Nov. 18, 1983] rect food ingredient is based upon the

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following current good manufacturing chapter for the interesterification of practice conditions of use: fats and oils. (1) The ingredient is used as an en- (2) The ingredient is used in food at zyme as defined in § 170.3(o)(9) of this levels not to exceed current good man- chapter to hydrolyze fatty acid ufacturing practice. glycerides. [63 FR 24419, May 4, 1998] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1425 Magnesium carbonate. ufacturing practice. (a) Magnesium carbonate (molecular [60 FR 32911, June 26, 1995] formula approximately (MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. § 184.1420 Lipase enzyme preparation 39409–82–0) is also known as magnesium derived from Rhizopus niveus. carbonate hydroxide. It is a white pow- (a) Lipase enzyme preparation con- der formed either by adding an alkaline tains lipase enzyme (CAS Reg. No. carbonate (such as sodium carbonate) 9001–62–1), which is obtained from the to a solution of magnesium sulfate or culture filtrate resulting from a pure by carbonation of a slurry of magne- culture fermentation of a nonpatho- sium hydroxide followed by boiling of genic and nontoxigenic strain of the resulting magnesium carbonate. Rhizopus niveus. The enzyme prepara- (b) The ingredient meets the speci- tion also contains diatomaceous earth fications of the Food Chemicals Codex, as a carrier. The characterizing activ- 3d Ed. (1981), p. 177, which is incor- ity of the enzyme, which catalyzes the porated by reference. Copies are avail- interesterification of fats and oils at able from the National Academy Press, the 1- and 3-positions of triglycerides, 2101 Constitution Ave. NW., Wash- is triacylglycerol lipase (EC 3.1.1.3). ington, DC 20418, or available for in- (b) The ingredient meets the general spection at the National Archives and requirements and additional require- Records Administration (NARA). For ments for enzyme preparations in the information on the availability of this monograph on Enzyme Preparations in material at NARA, call 202–741–6030, or the ‘‘Food Chemicals Codex,’’ 4th ed. go to: http://www.archives.gov/ (1996), pp. 133 and 134, which is incor- federallregister/ porated by reference in accordance codeloflfederallregulations/ with 5 U.S.C. 552(a) and 1 CFR part 51. ibrllocations.html. Copies are available from the National (c) In accordance with § 184.1(b)(1), Academy Press, 2101 Constitution Ave. the ingredient is used in food with no NW., Washington, DC 20418, or may be limitation other than current good examined at the Center for Food Safety manufacturing practice. The affirma- and Applied Nutrition’s Library, 5100 tion of this ingredient as generally rec- Paint Branch Pkwy., College Park, MD ognized as safe (GRAS) as a direct 20740, or at the National Archives and human food ingredient is based upon Records Administration (NARA). For the following current good manufac- information on the availability of this turing practice conditions of use: material at NARA, call 202–741–6030, or (1) The ingredient is used as an go to: http://www.archives.gov/ anticaking and free-flow agent as de- federallregister/ fined in § 170.3(o)(1) of this chapter; a codeloflfederallregulations/ flour treating agent as defined in ibrllocations.html. § 170.3(o)(13) of this chapter; a lubricant (c) In accordance with § 184.1(b)(1), and release agent as defined in the ingredient is used in food with no § 170.3(o)(18) of this chapter; a nutrient limitation other than current good supplement as defined in § 170.3(o)(20) of manufacturing practice. The affirma- this chapter; a pH control agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(23) of this chapter; a ognized as safe as a direct human food processing aid as defined in § 170.3(o)(24) ingredient is based upon the following of this chapter; and a synergist as de- current good manufacturing practice fined in § 170.3(o)(31) of this chapter. conditions of use: (2) The ingredient is used in foods at (1) The ingredient is used as an en- levels not to exceed current good man- zyme as defined in § 170.3(o)(9) of this ufacturing practice.

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(d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, waived. 1985] [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, § 184.1428 Magnesium hydroxide. 1985] (a) Magnesium hydroxide (Mg(OH)2, § 184.1426 Magnesium chloride. CAS Reg. No. 1309–42–8) occurs natu- (a) Magnesium chloride (MgC1 ·6H O, rally as the colorless, crystalline min- 2 2 eral brucite. It is prepared as a white CAS Reg. No. 7786–30–3) is a colorless, precipitate by the addition of sodium deliquescent, crystalline material that hydroxide to a water soluble magne- occurs naturally as the mineral sium salt or by hydration of reactive bischofite. It is prepared by dissolving grades of magnesium oxide. magnesium oxide, hydroxide, or car- (b) The ingredient meets the speci- bonate in aqueous hydrochloric acid so- fications of the Food Chemicals Codex, lution and crystallizing out magnesium 3d Ed. (1981), p. 178, which is incor- chloride hexahydrate. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the Food Chemicals Codex, 2101 Constitution Ave. NW., Wash- 3d Ed. (1981), p. 177, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the National Archives and able from the National Academy Press, Records Administration (NARA). For 2101 Constitution Ave. NW., Wash- information on the availability of this ington, DC 20418, or available for in- material at NARA, call 202–741–6030, or spection at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter; a pH con- the following current good manufac- trol agent as defined in § 170.3(o)(23) of turing practice conditions of use: this chapter; and a processing aid as (1) The ingredient is used as a fla- defined in § 170.3(o)(24) of this chapter. voring agent and adjuvant as defined in (2) The ingredient is used in foods at § 170.3(o)(12) of this chapter and a nutri- levels not to exceed current good man- ent supplement as defined in ufacturing practice. § 170.3(o)(20) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in foods at different from the uses established in levels not to exceed current good man- this section do not exist or have been ufacturing practice. The ingredient waived. also may be used in infant formula in [50 FR 13559, Apr. 5, 1985, as amended at 64 accordance with section 412(g) of the FR 405, Jan. 5, 1999] Federal Food, Drug, and Cosmetic Act (the act) or with regulations promul- § 184.1431 Magnesium oxide. gated under section 412(a)(2) of the act. (a) Magnesium oxide (MgO, CAS Reg. (d) Prior sanctions for this ingredient No. 1309–48–4) occurs naturally as the different from the uses established in colorless, crystalline mineral periclase.

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It is produced either as a bulky white this section do not exist or have been powder (light) or a relatively dense waived. white powder (heavy) by heating mag- [50 FR 13559, Apr. 5, 1985] nesium hydroxide or carbonate. Heat- ing these magnesium salts under mod- § 184.1434 Magnesium phosphate. ° ° erate conditions (400 to 900 C for a few (a) Magnesium phosphate includes hours) produces light magnesium both magnesium phosphate, dibasic, oxide. Heating the salts under more and magnesium phosphate, tribasic. ° rigorous conditions (1200 C for 12 Magnesium phosphate, dibasic hours) produces heavy magnesium (MgHPO4·3H2O, CAS Reg. No. 7782–0975– oxide. Light magnesium oxide is con- 094) occurs naturally as the white, verted to heavy magnesium oxide by crystalline mineral newberyite. It is sustained heating at high tempera- prepared commercially as a precipitate tures. formed by treating a solution of mag- (b) The ingredient meets the speci- nesium sulfate with disodium phos- fications of the Food Chemicals Codex, phate under controlled conditions. 3d Ed. (1981), p. 178, which is incor- Magnesium phosphate, tribasic porated by reference. Copies are avail- (Mg3(PO4)2·xH2O, CAS Reg. No. 7757–87– able from the National Academy Press, 1) may contain 4, 5, or 8 molecules of 2101 Constitution Ave. NW., Wash- water of hydration. It is produced as a ington, DC 20418, or available for in- precipitate from a solution of mag- spection at the National Archives and nesite with phosphoric acid. Records Administration (NARA). For (b) Magnesium phosphate, dibasic, information on the availability of this meets the specifications of the Food material at NARA, call 202–741–6030, or Chemicals Codex, 3d Ed. (1981), p. 179, go to: http://www.archives.gov/ which is incorporated by reference. federallregister/ Magnesium phosphate, tribasic, meets codeloflfederallregulations/ the specifications of the Food Chemi- ibrllocations.html. cals Codex, 3d Ed. (1981), p. 180, which is (c) In accordance with § 184.1(b)(1), incorporated by reference. Copies are the ingredient is used in food with no available from the National Academy limitation other than current good Press, 2101 Constitution Ave. NW., manufacturing practice. The affirma- Washington, DC 20418, or available for tion of this ingredient as generally rec- inspection at the National Archives ognized as safe (GRAS) as a direct and Records Administration (NARA). human food ingredient is based upon For information on the availability of the following current good manufac- this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ turing practice conditions of use: federallregister/ (1) The ingredient is used as an codeloflfederallregulations/ anticaking and free-flow agent as de- ibrllocations.html. fined in § 170.3(o)(1) of this chapter; a (c) In accordance with § 184.1(b)(1), firming agent as defined in § 170.3(o)(10) the ingredient is used in food with no of this chapter; a lubricant and release limitation other than current good agent as defined in § 170.3(o)(18) of this manufacturing practice. The affirma- chapter; a nutrient supplement as de- tion of this ingredient as generally rec- fined in § 170.3(o)(20) of this chapter; ognized as safe (GRAS) as a direct and a pH control agent as defined in human food ingredient is based upon § 170.3(o)(23) of this chapter. the following current good manufac- (2) The ingredient is used in foods at turing practice conditions of use: levels not be exceed current good man- (1) The ingredient is used as a nutri- ufacturing practice. The ingredient ent supplement as defined in also may be used in infant formula in § 170.3(o)(20) of this chapter and a pH accordance with section 412(g) of the control agent as defined in § 170.3(o)(23) Federal Food, Drug, and Cosmetic Act of this chapter. (the act) or with regulations promul- (2) The ingredient is used in foods at gated under section 412(a)(2) of the act. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. The ingredient different from the uses established in also may be used in infant formula in

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accordance with section 412(g) of the this section do not exist or have been Federal Food, Drug, and Cosmetic Act waived. (the act) or with regulations promul- [50 FR 13560, Apr. 5, 1985] gated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient § 184.1443 Magnesium sulfate. different from the uses established in (a) Magnesium sulfate (MgSO ·7H O, this section do not exist or have been 4 2 CAS Reg. No. 10034–99–8) occurs natu- waived. rally as the mineral epsomite. It is pre- [50 FR 13560, Apr. 5, 1985, as amended at 69 pared by neutralization of magnesium FR 24512, May 4, 2004] oxide, hydroxide, or carbonate with sulfuric acid and evaporating the solu- § 184.1440 Magnesium stearate. tion to crystallization. (a) Magnesium stearate (b) The ingredient meets the specifications of the Food Chemicals Codex, (Mg(C17H34COO)2, CAS Reg. No. 557–04– 0) is the magnesium salt of stearic 3d Ed. (1981), p. 183, which is incor- acid. It is produced as a white precipi- porated by reference. Copies are avail- tate by the addition of an aqueous so- able from the National Academy Press, lution of magnesium chloride to an 2101 Constitution Ave. NW., Wash- aqueous solution of sodium stearate de- ington, DC 20418, or available for in- rived from stearic acid that is obtained spection at the National Archives and from edible sources and that conforms Records Administration (NARA). For to the requirements of § 172.860(b)(2) of information on the availability of this this chapter. material at NARA, call 202–741–6030, or (b) The ingredient meets the speci- go to: http://www.archives.gov/ fications of the Food Chemicals Codex, federallregister/ 3d Ed. (1981), p. 182, which is incor- codeloflfederallregulations/ porated by reference. Copies are avail- ibrllocations.html. able from the National Academy Press, (c) In accordance with § 184.1(b)(1), 2101 Constitution Ave. NW., Wash- the ingredient is used in food with no ington, DC 20418, or available for in- limitation other than current good spection at the National Archives and manufacturing practice. The affirma- Records Administration (NARA). For tion of this ingredient as generally rec- information on the availability of this ognized as safe (GRAS) as a direct material at NARA, call 202–741–6030, or human food ingredient is based upon go to: http://www.archives.gov/ the following current good manufac- federallregister/ turing practice conditions of use: codeloflfederallregulations/ (1) The ingredient is used as a flavor ibrllocations.html. enhancer as defined in § 170.3(o)(11) of (c) In accordance with § 184.1(b)(1), this chapter; a nutrient supplement as the ingredient is used in food with no defined in § 170.3(o)(20) of this chapter; limitation other than current good and a processing aid as defined in manufacturing practice. The affirma- § 170.3(o)(24) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in foods at ognized as safe (GRAS) as a direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a lubri- this section do not exist or have been cant and release agent as defined in waived. § 170.3(o)(18) of this chapter; a nutrient [50 FR 13560, Apr. 5, 1985] supplement as defined in § 170.3(o)(20) of this chapter; and a processing aid as § 184.1443a Malt. defined in § 170.3(o)(24) of this chapter. (a) Malt is an enzyme preparation ob- (2) The ingredient is used in foods at tained from barley which has been soft- levels not to exceed current good man- ened by a series of steeping operations ufacturing practice. and germinated under controlled condi- (d) Prior sanctions for this ingredient tions. It is a brown, sweet, and viscous different from the uses established in liquid or a white to tan powder. Its

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characterizing enzyme activities are a- (1992), p. 125, which are incorporated by amylase (EC 3.2.1.1.) and b-amylase (EC reference in accordance with 5 U.S.C. 3.2.1.2). 552(a) and 1 CFR part 51. Copies are (b) The ingredient meets the general available from the National Academy requirements and additional require- Press, 2101 Constitution Ave., NW., ments for enzyme preparations in the Washington, DC 20418, or at the Divi- Food Chemicals Codex, 3d ed. (1981), p. sion of Petition Control (HFS–217), 110, which is incorporated by reference Center for Food Safety and Applied Nu- in accordance with 5 U.S.C. 552(a) and 1 trition, Food and Drug Administration, CFR part 51. Copies are available from 5100 Paint Branch Pkwy., College Park, the National Academy Press, 2101 Con- MD 20740, or may be examined at the stitution Ave., NW., Washington, DC National Archives and Records Admin- 20418, or may be examined at the Office istration (NARA). For information on of Premarket Approval (HFS–200), Food the availability of this material at and Drug Administration, 5100 Paint NARA, call 202–741–6030, or go to: http:// Branch Pkwy., College Park, MD 20740, www.archives.gov/federallregister/ and at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html.. information on the availability of this (3) Maltodextrin derived from rice material at NARA, call 202–741–6030, or starch meets the specifications of the go to: http://www.archives.gov/ Food Chemicals Codex, 4th ed. (1996), federallregister/ pp. 239 and 240, which is incorporated codeloflfederallregulations/ by reference in accordance with 5 ibrllocations.html. U.S.C. 552(a) and 1 CFR part 51. Copies (c) In accordance with § 184.1(b)(1), are available from the National Acad- the ingredient is used in food with no emy Press, 2101 Constitution Ave. NW., limitation other than current good Washington, DC 20418, or may be exam- manufacturing practice. The affirma- ined at the Center for Food Safety and tion of this ingredient as GRAS as a di- Applied Nutrition’s Library, 5100 Paint rect food ingredient is based upon the Branch Pkwy., College Park, MD 20740, following current good manufacturing or at the National Archives and practice conditions of use: Records Administration (NARA). For (1) The ingredient is used as an en- information on the availability of this zyme as defined in § 170.3(o)(9) of this material at NARA, call 202–741–6030, or chapter to hydrolyze starch or starch- go to: http://www.archives.gov/ derived polysaccharides. federallregister/ (2) The ingredient is used in food at codeloflfederallregulations/ levels not to exceed current good man- ibrllocations.html. ufacturing practice. (c) In accordance with § 184.1(b)(1), [60 FR 32911, June 26, 1995] the ingredient is used in food with no limitation other than current good § 184.1444 Maltodextrin. manufacturing practice. (d) Prior sanctions for this ingredient (a) Maltodextrin ((C6H10O5)n, CAS Reg. No. 9050–36–6) is a nonsweet nutri- different from the uses established in tive saccharide polymer that consists this section do not exist or have been of D-glucose units linked primarily by waived. a-1-4 bonds and that has a dextrose [48 FR 51911, Nov. 15, 1983; as amended at 60 equivalent (D.E.) of less than 20. It is FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, prepared as a white powder or con- 1998] centrated solution by partial hydrolysis of corn starch, potato starch, or § 184.1445 Malt syrup (malt extract). rice starch with safe and suitable acids (a) Malt is the product of barley and enzymes. (Hordeum vulgare L.) germinated under (b)(1) Maltodextrin derived from corn controlled conditions. Malt syrup and starch must be of a purity suitable for malt extract are interchangeable terms its intended use. for a viscous concentrate of water ex- (2) Maltodextrin derived from potato tract of germinated barley grain, with starch meets the specifications of the or without added safe preservative. Food Chemicals Codex, 3d ed., 3d supp. Malt syrup is usually a brown, sweet,

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and viscous liquid containing varying federallregister/ amounts of amylolytic enzymes and codeloflfederallregulations/ plant constituents. Barley is first soft- ibrllocations.html. ened after cleaning by steeping oper- (c) In accordance with § 184.1(b)(1), ations and then allowed to germinate the ingredient is used in food with no under controlled conditions. The ger- limitation other than current good minated grain then undergoes proc- manufacturing practice. The affirma- essing, such as drying, grinding, ex- tion of this ingredient as generally rec- tracting, filtering, and evaporating, to ognized as safe (GRAS) as a direct produce malt syrup (malt extract) with human food ingredient is based upon 75 to 80 percent solids or dried malt the following current good manufac- syrup with higher solids content. turing practice conditions of use: (b) The ingredient must be of a pu- (1) The ingredient is used as a nutri- rity suitable for its intended use. ent supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter. the ingredient is used in food with no (2) The ingredient may be used in in- limitation other than current good fant formulas in accordance with sec- manufacturing practice. The affirmation 412(g) of the Federal Food, Drug, tion of this ingredient as generally rec- and Cosmetic Act (the act) or with reg- ognized as safe (GRAS) as a direct ulations promulgated under section human food ingredient is based upon 412(a)(2) of the act. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a fla- this section do not exist or have been voring agent and adjuvant as defined in waived. § 170.3(o)(12) of this chapter. [50 FR 19165, May 7, 1985] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1449 Manganese citrate. ufacturing practice. (a) Manganese citrate (Mn (C H O ) , (d) Prior sanctions for this ingredient 3 6 5 7 2 CAS Reg. No. 1002–46–65) is a pale or- different from the uses established in ange or pinkish white powder. It is ob- this section do not exist or have been tained by precipitating manganese car- waived. bonate from manganese sulfate and so- [48 FR 51613, Nov. 10, 1983, as amended at 73 dium carbonate solutions. The filtered FR 8607, Feb. 14, 2008] and washed precipitate is digested first with sufficient citric acid solution to § 184.1446 Manganese chloride. form manganous citrate and then with (a) Manganese chloride (MnCl2·4H2O, sodium citrate to complete the reac- CAS Reg. No. 7773–01–5) is a pink, tion. translucent, crystalline product. It is (b) The ingredient must be of a pu- also known as manganese dichloride. It rity suitable for its intended use. is prepared by dissolving manganous (c) In accordance with § 184.1(b)(1), oxide, pyrolusite ore (MnO2), or re- the ingredient is used in food with no duced manganese ore in hydrochloric limitation other than current good acid. The resulting solution is neutral- manufacturing practice. The affirma- ized to precipitate heavy metals, fil- tion of this ingredient as generally rec- tered, concentrated, and crystallized. ognized as safe (GRAS) as a direct (b) The ingredient meets the speci- human food ingredient is based upon fications of the Food Chemicals Codex, the following current good manufac- 3d Ed. (1981), p. 186, which is incor- turing practice conditions of use: porated by reference. Copies are avail- (1) The ingredient is used as a nutri- able from the National Academy Press, ent supplement as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(20) of this chapter. ington, DC 20418, or available for in- (2) The ingredient is used in the fol- spection at the National Archives and lowing foods at levels not to exceed Records Administration (NARA). For current good manufacturing practice: information on the availability of this baked goods as defined in § 170.3(n)(1) of material at NARA, call 202–741–6030, or this chapter; nonalcoholic beverages as go to: http://www.archives.gov/ defined in § 170.3(n)(3) of this chapter;

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dairy product analogs as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(n)(10) of this chapter; fish prod- this chapter; nonalcoholic beverages as ucts as defined in § 170.3(n)(13) of this defined in § 170.3(n)(3) of this chapter; chapter; meat products as defined in dairy product analogs as defined in § 170.3(n)(29) of this chapter; milk prod- § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n)(31) of this ucts as defined in § 170.3(n)(13) of this chapter; and poultry products as de- chapter; meat products as defined in fined in § 170.3(n)(34) of this chapter. § 170.3(n)(29) of this chapter; milk prod- The ingredient may be used in infant ucts as defined in § 170.3(n)(31) of this formulas in accordance with section chapter; and poultry products as de- 412(g) of the Federal Food, Drug, and fined in § 170.3(n)(34) of this chapter. Cosmetic Act (the act) or with regula- The ingredient may be used in infant tions promulgated under section formulas in accordance with section 412(a)(2) of the act. 412(g) of the Federal Food, Drug, and (d) Prior sanctions for this ingredient Cosmetic Act (the act) or with regula- different from the uses established in tions promulgated under section this section do not exist or have been 412(a)(2) of the act. waived. (d) Prior sanctions for this ingredient different from the uses established in [50 FR 19166, May 7, 1985, as amended at 73 FR 8607, Feb. 14, 2008] this section do not exist or have been waived. § 184.1452 Manganese gluconate. [50 FR 19166, May 7, 1985] (a) Manganese gluconate (C12H22MnO14·2H2O, CAS Reg. No. 648– § 184.1461 Manganese sulfate. 0953–0998) is a slightly pink colored (a) Manganese sulfate (MnSO4·H2O, powder. It is obtained by reacting man- CAS Reg. No. 7785–0987–097) is a pale ganese carbonate with gluconic acid in pink, granular, odorless powder. It is aqueous medium and then crystallizing obtained by reacting manganese com- the product. pounds with sulfuric acid. It is also ob- (b) The ingredient meets the speci- tained as a byproduct in the manufac- fications of the Food Chemicals Codex, ture of hydroquinone. Other manufac- 3d Ed. (1981), p. 186, which is incor- turing processes include the action of porated by reference. Copies are avail- sulfur dioxide on a slurry of manganese able from the National Academy Press, dioxide in sulfuric acid, and the roast- 2101 Constitution Ave. NW., Wash- ing of pyrolusite (MnO2) ore with solid ington, DC 20418, or available for in- ferrous sulfate and coal, followed by spection at the National Archives and leaching and crystallization. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 188, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used as a nutri- the ingredient is used in food with no ent supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in the fol- tion of this ingredient as generally rec- lowing foods at levels not to exceed ognized as safe (GRAS) as a direct current good manufacturing practice: human food ingredient is based upon

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the following current good manufac- ministration, 5100 Paint Branch Pkwy., turing practice conditions of use: College Park, MD 20740, or available for (1) The ingredient is used as a nutri- inspection at the Center for Food Safe- ent supplement as defined in ty and Applied Nutrition’s Library, § 170.3(o)(20) of this chapter. Food and Drug Administration, 5100 (2) The ingredient is used in the fol- Paint Branch Pkwy., College Park, MD lowing foods at levels not to exceed 20740, or at the National Archives and current good manufacturing practice: Records Administration (NARA). For baked goods as defined in § 170.3(n)(1) of information on the availability of this this chapter; nonalcoholic beverages as material at NARA, call 202–741–6030, or defined in § 170.3(n)(3) of this chapter; go to: http://www.archives.gov/ dairy product analogs as defined in federallregister/ § 170.3(n)(10) of this chapter; fish prod- codeloflfederallregulations/ ucts as defined in § 170.3(n(13) of this ibrllocations.html. chapter; meat products as defined in (iv) Iodine number. Not less than 120 § 170.3(n)(29) of this chapter; milk prod- as determined by the American Oil ucts as defined in § 170.3(n)(31) of this Chemists’ Society Recommended Prac- chapter; and poultry products as de- tice Cd 1d–92—‘‘Iodine Value of Fats fined in § 170.3(n)(34) of this chapter. and Oils, Cyclohexane—Acetic Acid The ingredient may be used in infant Method,’’ which is incorporated by ref- formulas in accordance with section erence in accordance with 5 U.S.C. 412(g) of the Federal Food, Drug, and 552(a) and 1 CFR part 51. The avail- Cosmetic Act (the act) or with regula- ability of this incorporation by ref- tions promulgated under section erence is given in paragraph (a)(2)(iii) 412(a)(2) of the act. of this section. (d) Prior sanctions for this ingredient (v) Unsaponifiable matter. Not more different from the uses established in than 1.5 percent as determined by the this section do not exist or have been American Oil Chemists’ Society Offi- waived. cial Method Ca 6b–53—‘‘Unsaponifiable Matter’’ (reapproved 1989), which is in- [50 FR 19166, May 7, 1985] corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. § 184.1472 Menhaden oil. The availability of this incorporation (a) Menhaden oil. (1) Menhaden oil is by reference is given in paragraph prepared from fish of the genus (a)(2)(iii) of this section. Brevoortia, commonly known as menha- (vi) Free fatty acids. Not more than 0.1 den, by cooking and pressing. The re- percent as determined by the American sulting crude oil is then refined using Oil Chemists’ Society Official Method the following steps: Storage (winteriza- Ca 5a–40—‘‘Free Fatty Acids’’ (re- tion), degumming (optional), neutral- approved 1989), which is incorporated ization, bleaching, and deodorization. by reference in accordance with 5 Winterization may separate the oil and U.S.C. 552(a) and 1 CFR part 51. The produce a solid fraction. availability of this incorporation by (2) Menhaden oil meets the following reference is given in paragraph specifications: (a)(2)(iii) of this section. (i) Color and state. Yellow liquid to (vii) Peroxide value. Not more than 5 white solid. milliequivalents per kilogram of oil as (ii) Odor. Odorless to slightly fishy. determined by the American Oil Chem- (iii) Saponification value. Between 180 ists’ Society Official Method Cd 8–53— and 200 as determined by the American ‘‘Peroxide Value, Acetic Acid—Chloro- Oil Chemists’ Society Official Method form Method’’ (updated 1992) or Rec- Cd 3–25—‘‘Saponification Value’’ (re- ommended Practice Cd 8b–90—‘‘Per- approved 1989), which is incorporated oxide Value, Acetic Acid—Isooctane by reference in accordance with 5 Method’’ (updated 1992), which are in- U.S.C. 552(a) and 1 CFR part 51. Copies corporated by reference in accordance of this publication are available from with 5 U.S.C. 552(a) and 1 CFR part 51. the Office of Food Additive Safety, The availability of this incorporation Center for Food Safety and Applied Nu- by reference is given in paragraph trition (HFS–200), Food and Drug Ad- (a)(2)(iii) of this section.

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(viii) Lead. Not more than 0.1 part Maximum per million as determined by the Amer- level of use in Category of food food (as ican Oil Chemists’ Society Official served) Method Ca 18c–91—‘‘Determination of Nonalcoholic beverages, § 170.3(n)(3) of this 0.5 percent Lead by Direct Graphite Furnace chapter. Atomic Absorption Spectrometry’’ (re- Nut products, § 170.3(n)(32) of this chapter .. 5.0 percent vised 1992), which is incorporated by Pastas, § 170.3(n)(23) of this chapter ...... 2.0 percent reference in accordance with 5 U.S.C. Plant protein products, § 170.3(n)(33) of this 5.0 percent 552(a) and 1 CFR part 51. The avail- chapter. Poultry products, § 170.3(n)(34) of this chap- 3.0 percent ability of this incorporation by ref- ter. erence is given in paragraph (a)(2)(iii) Processed fruit juices, § 170.3(n)(35) of this 1.0 percent of this section. chapter. Processed vegetable juices, § 170.3(n)(36) 1.0 percent (ix) Mercury. Not more than 0.5 part of this chapter. per million as determined by the meth- Snack foods, § 170.3(n)(37) of this chapter .. 5.0 percent od entitled ‘‘Biomedical Test Materials Soft candy, § 170.3(n)(38) of this chapter ..... 4.0 percent Program: Analytical Methods for the Soup mixes, § 170.3(n)(40) of this chapter ... 3.0 percent Quality Assurance of Fish Oil,’’ pub- Sugar substitutes, § 170.3(n)(42) of this 10.0 percent chapter. lished in the ‘‘NOAA Technical Memo- Sweet sauces, toppings, syrups, 5.0 percent randum NMFS-SEFC-211,’’ F. M. Van § 170.3(n)(43) of this chapter. Dolah and S. B. Galloway, editors, Na- White granulated sugar, § 170.3(n)(41) of 4.0 percent tional Marine Fisheries Service, U. S. this chapter. Department of Commerce, pages 71–88, (4) To ensure safe use of the sub- November, 1988, which is incorporated stance, menhaden oil shall not be used by reference in accordance with 5 in combination with any other added U.S.C. 552(a) and 1 CFR part 51. The oil that is a significant source of availability of this incorporation by eicosapentaenoic acid or reference is given in paragraph docosahexaenoic acid. (a)(2)(iii) of this section. (b) Hydrogenated and partially hydro- (3) In accordance with § 184.1(b)(2), genated menhaden oils. (1) Partially hy- the ingredient may be used in food only drogenated and hydrogenated menha- within the following specific limita- den oils are prepared by feeding hydro- tions to ensure that total intake of gen gas under pressure to a converter eicosapentaenoic acid or containing crude menhaden oil and a docosahexaenoic acid does not exceed nickel catalyst. The reaction is begun 3.0 grams/person/day: at 150 to 160 °C and after 1 hour the Maximum temperature is raised to 180 °C until level of use in the desired degree of hydrogenation is Category of food food (as served) reached. Hydrogenated menhaden oil is fully hydrogenated. Baked goods, baking mixes, § 170.3(n)(1) of 5.0 percent this chapter. (2) Partially hydrogenated and hy- Cereals, § 170.3(n)(4) of this chapter ...... 4.0 percent drogenated menhaden oils meet the fol- Cheese products, § 170.3(n)(5) of this chap- 5.0 percent lowing specifications: ter. (i) Color. Opaque white solid. Chewing gum, § 170.3(n)(6) of this chapter .. 3.0 percent Condiments, § 170.3(n)(8) of this chapter ..... 5.0 percent (ii) Odor. Odorless. Confections, frostings, § 170.3(n)(9) of this 5.0 percent (iii) Saponification value. Between 180 chapter. and 200. Dairy product analogs, § 170.3(n)(10) of this 5.0 percent chapter. (iv) Iodine number. Not more than 119 Egg products, § 170.3(n)(11) of this chapter 5.0 percent for partially hydrogenated menhaden Fats, oils, § 170.3(n)(12) of this chapter, but 12.0 percent oil and not more than 10 for fully hy- not in infant formula. Fish products, § 170.3(n)(13) of this chapter 5.0 percent drogenated menhaden oil. Frozen dairy desserts, § 170.3(n)(20) of this 5.0 percent (v) Unsaponifiable matter. Not more chapter. than 1.5 percent.— Gelatins, puddings, § 170.3(n)(22) of this 1.0 percent (vi) Free fatty acids. Not more than 0.1 chapter. Gravies, sauces, § 170.3(n)(24) of this chap- 5.0 percent percent. ter. (vii) Peroxide value. Not more than 5 Hard candy, § 170.3(n)(25) of this chapter .... 10.0 percent milliequivalents per kilogram of oil. Jams, jellies, § 170.3(n)(28) of this chapter .. 7.0 percent Meat products, § 170.3(n)(29) of this chapter 5.0 percent (viii) Nickel. Not more than 0.5 part Milk products, § 170.3(n)(31) of this chapter 5.0 percent per million.

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(ix) Mercury. Not more than 0.5 part this regulation do not exist or have per million. been waived. (x) Arsenic (as As). Not more than 0.1 [42 FR 14653, Mar. 15, 1977, as amended at 49 part per million. FR 5612, Feb. 14, 1984] (xi) Lead. Not more than 0.1 part per million. § 184.1498 Microparticulated protein (3) Partially hydrogenated and hy- product. drogenated menhaden oils are used as (a) Microparticulated protein product edible fats or oils, as defined in is prepared from egg whites or milk § 170.3(n)(12) of this chapter, in food at protein or a combination of egg whites levels not to exceed current good man- and milk protein. These protein ufacturing practice. sources may be used alone or in com- (4) If the fat or oil is fully hydro- bination with other safe and suitable genated, the name to be used on the ingredients to form the label of a product containing it shall microparticulated product. The mix- include the term ‘‘hydrogenated,’’ or if ture of ingredients is high-shear heat processed to achieve a smooth and it is partially hydrogenated, the name creamy texture similar to that of fat. shall include the term ‘‘partially hy- Safe and suitable ingredients used in drogenated,’’ in accordance with the preparation of the § 101.4(b)(14) of this chapter. microparticulated protein product [62 FR 30756, June 5, 1997, as amended at 70 must be used in compliance with the FR 14531, Mar. 23, 2005] limitations of the appropriate regulations in parts 172, 182, and 184 of this § 184.1490 Methylparaben. chapter. (a) Methylparaben is the chemical (b) The ingredient is used in food in methyl p-hydroxybenzoate. It is pro- accordance with § 184.1(b)(2) at levels duced by the methanol esterification of not to exceed current good manufacturing practice. The affirmation of the p-hydroxybenzoic acid in the presence use of this ingredient as generally rec- of sulfuric acid, with subsequent dis- ognized as safe (GRAS) as a direct tillation. human food ingredient is based upon (b) The ingredient meets the speci- the following conditions of use: fications of the ‘‘Food Chemicals (1) The ingredient is used in food as a Codex,’’ 3d Ed. (1981), p. 199, which is in- thickener as defined in § 170.3(o)(28) of corporated by reference. Copies may be this chapter or as a texturizer as de- obtained from the National Academy fined in § 170.3(o)(32) of this chapter. Press, 2101 Constitution Ave. NW., (2) The ingredient is used in frozen Washington, DC 20418, or may be exam- dessert-type products except that the ined at the National Archives and ingredient may not be used to replace Records Administration (NARA). For the milk fat required in standardized information on the availability of this frozen desserts. material at NARA, call 202–741–6030, or (3) The name of the ingredient used go to: http://www.archives.gov/ in the ingredient statement on both federallregister/ bulk and packaged food must include codeloflfederallregulations/ the source of the protein (e.g., ibrllocations.html. ‘‘microparticulated egg white pro- (c) The ingredient is used as an anti- tein’’), followed by a parenthetical list- microbial agent as defined in ing of each of the ingredients in the § 170.3(o)(2) of this chapter. microparticulated protein product, in (d) The ingredient is used in food at descending order of predominance. Microparticulated protein product levels not to exceed good manufac- must be used in accordance with this turing practices. Current good manu- requirement or its addition to food will facturing practice results in a max- be considered by FDA to constitute the imum level of 0.1 percent in food. use of an unapproved food additive (see (e) Prior sanctions for this ingredient § 184.1(b)(2)). different from the uses established in [55 FR 6391, Feb. 23, 1990]

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§ 184.1505 Mono- and diglycerides. agent as defined in § 170.3(o)(30) of this (a) Mono- and diglycerides consist of chapter; and a texturizer as defined in a mixture of glyceryl mono- and § 170.3(o)(32) of this chapter. diesters, and minor amounts of (2) The ingredient is used in food at triesters, that are prepared from fats levels not to exceed current good man- or oils or fat-forming acids that are de- ufacturing practice. rived from edible sources. The most (d) Prior sanctions for this ingredient prevalent fatty acids include lauric, different from the uses established in linoleic, myristic, oleic, palmitic, and this section do not exist or have been stearic. Mono- and diglycerides are waived. manufactured by the reaction of glyc- [54 FR 7403, Feb. 21, 1989, as amended at 57 erin with fatty acids or the reaction of FR 10616, Mar.27, 1992] glycerin with triglycerides in the presence of an alkaline catalyst. The prod- § 184.1521 Monosodium phosphate de- ucts are further purified to obtain a rivatives of mono- and diglycerides. mixture of glycerides, free fatty acids, (a) Monosodium phophate derivatives and free glycerin that contains at least of mono- and diglycerides are com- 90 percent-by-weight glycerides. posed of glyceride derivatives formed (b) The ingredient meets the speci- by reacting mono- and diglycerides fications of the Food Chemicals Codex, that are derived from edible sources 3d Ed. (1981), p. 201, which is incor- with phosphorus pentoxide porated by reference in accordance (tetraphosphorus decoxide) followed by with 5 U.S.C. 552(a). Copies are avail- neutralization with sodium carbonate. able from the National Academy Press, (b) The ingredient must be of a pu- 2101 Constitution Ave. NW., Wash- rity suitable for its intended use. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used in food as the ingredient is used in food with no an emulsifier and emulsifier salt as de- limitation other than current good fined in § 170.3(o)(8) of this chapter, a manufacturing practice. The affirma- lubricant and release agent as defined tion of this ingredient as generally rec- in § 170.3(o)(18) of this chapter, and as a ognized as safe (GRAS) as a direct surface-active agent as defined in human food ingredient is based upon § 170.3(o)(29) of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used in food as a current good manufacturing practice: dough strengthener as defined in dairy product analogs as defined in § 170.3(o)(6) of this chapter; an emulsi- § 170.3(n)(10) of this chapter and soft fier and emulsifier salt as defined in candy as defined in § 170.3(n)(38) of this § 170.3(o)(8) of this chapter; a flavoring chapter. agent and adjuvant as defined in (d) Prior sanctions for this ingredient § 170.3(o)(12) of this chapter; a formula- different from the uses established in tion aid as defined in § 170.3(o)(14) of this section do not exist or have been this chapter; a lubricant and release waived. agent as defined in § 170.3(o)(18) of this chapter; a solvent and vehicle as de- [54 FR 7404, Feb. 21, 1989, as amended at 73 fined in § 170.3(o)(27) of this chapter; a FR 8607, Feb. 14, 2008] stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; a surface- § 184.1530 Niacin. active agent as defined in § 170.3(o)(29) (a) Niacin (C6H5NO2, CAS Reg. No. 59– of this chapter; a surface-finishing 67–6) is the chemical 3-

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pyridinecarboxylic acid (nicotinic amide). It is a white crystalline powder acid). It is a non-hygroscopic, stable, that is soluble in water, alcohol, ether, white, crystalline solid that sublimes and glycerol. It melts between 128° and without decomposition at about 230 °C. 131 °C. It is soluble in water and alcohol. It is (b) The ingredient meets the speci- insoluble in ether. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 205, which is incor- fications of the ‘‘Food Chemicals porated by reference. Copies are avail- Codex,’’ 4th ed. (1996), p. 264, which is able from the National Academy Press, incorporated by reference in accord- 2101 Constitution Ave. NW., Wash- ance with 5 U.S.C. 552(a) and 1 CFR ington, DC 20418, or available for in- part 51. Copies are available from the spection at the National Archives and National Academy Press, Box 285, 2101 Records Administration (NARA). For Constitution Ave. NW., Washington, information on the availability of this DC 20055 (Internet address http:// material at NARA, call 202–741–6030, or www.nap.edu), or may be examined at go to: http://www.archives.gov/ the Center for Food Safety and Applied federallregister/ Nutrition’s Library, Food and Drug Ad- codeloflfederallregulations/ ministration, 5100 Paint Branch Pkwy., ibrllocations.html. College Park, MD 20740, or at the Na- (c) In accordance with § 184.1(b)(1), tional Archives and Records Adminis- the ingredient is used in food with no tration (NARA). For information on limitation other than current good the availability of this material at manufacturing practice. The affirma- NARA, call 202–741–6030, or go to: http:// tion of this ingredient as generally rec- www.archives.gov/federallregister/ ognized as safe (GRAS) as a direct codeloflfederallregulations/ human food ingredient is based upon ibrllocations.html. the following current good manufac- (c) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as a nutri- limitation other than current good ent supplement as defined in manufacturing practice. The affirma- § 170.3(o)(20) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in foods at ognized as safe (GRAS) as direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. The ingredient the following current good manufac- may also be used in infant formula in turing practice conditions of use: accordance with section 412(g) of the (1) The ingredient is used as a nutri- Federal Food, Drug, and Cosmetic Act ent supplement as defined in (the act) or with regulations promul- § 170.3(o)(20) of this chapter. gated under section 412(a)(2) of the Act. (2) The ingredient is used in foods at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. The ingredient this section do not exist or have been may also be used in infant formula in waived. accordance with section 412(g) of the [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. Federal Food, Drug, and Cosmetic Act 2, 1983] (the Act) or with regulations promulgated under section 412(a)(2) of the Act. § 184.1537 Nickel. (d) Prior sanctions for this ingredient (a) Elemental nickel (CAS Reg. No. different from the uses established in 7440–02–0) is obtained from nickel ore this section do not exist or have been by transforming it to nickel sulfide waived. (Ni3S2). The sulfide is roasted in air to [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. give nickel oxide (NiO). The oxide is 2, 1983, as amended at 64 FR 1760, Jan. 12, then reduced with carbon to give ele- 1999] mental nickel. (b) The ingredient must be of a pu- § 184.1535 Niacinamide. rity suitable for its intended use. (a) Niacinamide (C6H6N2O, CAS Reg. (c) In accordance with § 184.1(b)(1), No. 98–92–0) is the chemical 3- the ingredient is used in food with no pyridinecarboxylic acid amide (nicotin- limitation other than current good

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manufacturing practice. The affirma- (4) Zinc, not more than 25 parts per tion of this ingredient as generally rec- million. ognized as safe (GRAS) as a direct (5) Copper, zinc plus copper not more human food ingredient is based upon than 50 parts per million. the following current good manufac- (6) Total plate count, not more than turing practice conditions of use: 10 per gram. (1) The ingredient is used as a cata- (7) Escherichia coli, absent in 10 lyst as defined in § 170.3(o)(24) of this grams. chapter. (2) The ingredient is used in the hy- (8) Salmonella, absent in 10 grams. drogenation of fats and oils as defined (9) Coagulase positive staphylococci, in § 170.3(n)(12) of this chapter at levels absent in 10 grams. not to exceed current good manufac- (c) The ingredient is used as an anti- turing practice. Current good manufac- microbial agent as defined in turing practice includes the removal of § 170.3(o)(2) of this chapter to inhibit nickel from fats and oils following hy- the outgrowth of Clostridium botulinum drogenation. spores and toxin formation in pasteur- (d) Prior sanctions for this ingredient ized cheese spreads and pasteurized different from the uses established in process cheese spreads listed in this section do not exist or have been § 133.175; pasteurized cheese spread with waived. fruits, vegetables, or meats as defined [48 FR 51618, Nov. 10, 1983, as amended at 73 in § 133.176; pasteurized process cheese FR 8607, Feb. 14, 2008] spread as defined in § 133.179; pasteurized process cheese spread with fruits, § 184.1538 Nisin preparation. vegetables, or meats as defined in (a) Nisin preparation is derived from § 133.180 of this chapter. pure culture fermentations of certain (d) The ingredient is used at levels strains of Streptococcus lactis not to exceed good manufacturing Lancefield Group N. Nisin preparation practice in accordance with § 184.1(b)(1) contains nisin (CAS Reg. No. 1414–45–5), of this chapter. The current good man- a group of related peptides with anti- ufacturing practice level is the quan- biotic activity. tity of the ingredient that delivers a (b) The ingredient is a concentrate or maximum of 250 parts per million of dry material that meets the specifica- nisin in the finished product as deter- tions that follow when it is tested as mined by the British Standards Insti- described in ‘‘Specifications for Iden- tution Methods, ‘‘Methods for the Esti- tity and Purity of Some Antibiotics,’’ mation and Differentiation of Nisin in World Health Organization, FAO Nutri- Processed Cheese,’’ BS 4020 (1974), tion Meeting Report Series, No. 45A, which is incorporated by reference. 1969, which is incorporated by ref- Copies are available from the Division erence. Copies are available from the of Dockets Management (HFA–305), Division of Dockets Management Food and Drug Administration, rm. 1– (HFA–305), Food and Drug Administra- 23, 12420 Parklawn Dr., Rockville, MD tion, 5630 Fishers Lane, rm. 1061, Rock- 20857, or available for inspection at the ville, MD 20852, or available for inspec- National Archives and Records Admin- tion at the National Archives and istration (NARA). For information on Records Administration (NARA). For the availability of this material at information on the availability of this NARA, call 202–741–6030, or go to: http:// material at NARA, call 202–741–6030, or www.archives.gov/federallregister/ go to: http://www.archives.gov/ codeloflfederallregulations/ federallregister/ ibrllocations.html. codeloflfederallregulations/ ibrllocations.html. [53 FR 11250, Apr. 6, 1988, as amended at 59 (1) Nisin content, not less than 900 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, international units per milligram. 2003] (2) Arsenic, not more than 1 part per million. § 184.1540 Nitrogen. (3) Lead, not more than 2 parts per (a) Nitrogen (empirical formula N2, million. CAS Reg. No. 7727–37–9) is a colorless,

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odorless, flavorless gas that is pro- (d) Prior sanctions for this ingredient duced commercially by the fraction- different from the uses established in ation of liquid air. this section do not exist or have been (b) The ingredient must be of a pu- waived. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] the ingredient is used in food with no limitations other than current good § 184.1553 Peptones. manufacturing practice. The affirmation of this ingredient as generally rec- (a) Peptones are a variable mixture ognized as safe (GRAS) as a direct of polypeptides, oligopeptides, and human food ingredient is based upon amino acids that are produced by par- the following current good manufac- tial hydrolysis of casein, animal tissue, turing practice conditions of use: soy protein isolate, gelatin, defatted (1) The ingredient is used as a propel- fatty tissue, egg albumin, or lactal- lant, aerating agent, and gas as defined bumin (whey protein). Peptones are in § 170.3(o)(25) of this chapter. produced from these proteins using (2) The ingredient is used in food at proteolytic enzymes that either are levels not to exceed current good man- considered to be generally recognized ufacturing practice. as safe (GRAS) or are regulated as food (d) Prior sanctions for this ingredient additives. Peptones are also produced different from the uses established in by denaturing any of the proteins list- this section do not exist or have been ed in this paragraph with safe and suit- waived. able acids or heat. (b) The ingredients must be of a pu- [48 FR 57270, Dec. 29, 1983, as amended at 73 rity suitable for their intended use. FR 8607, Feb. 14, 2008] (c) In accordance with § 184.1(b)(1), § 184.1545 Nitrous oxide. these ingredients are used in food with no limitation other than current good (a) Nitrous oxide (empirical formula manufacturing practice. The affirma- N O, CAS Reg. No. 10024–97–2) is also 2 tion of these ingredients as GRAS as known as dinitrogen monoxide or direct human food ingredients is based laughing gas. It is a colorless gas, upon the following current good manu- about 50 percent heavier than air, with facturing practice conditions of use: a slightly sweet smell. It does not burn (1) These ingredients are used as nu- but will support combustion. Nitrous trient supplements as defined in oxide is manufactured by the thermal § 170.3(o)(20) of this chapter; as proc- decomposition of ammonium nitrate. essing aids as defined in § 170.3(o)(24) of Higher oxides of nitrogen are removed this chapter; and as surface-active by passing the dry gas through a series agents as defined in § 170.3(o)(29) of this of scrubbing towers. chapter. (b) The ingredient must be of a pu- (2) These ingredients are used in food rity suitable for its intended use. at levels not to exceed current good (c) In accordance with § 184.1(b)(1), manufacturing practice. the ingredient is used in food with no limitations other than current good (d) Prior sanctions for these ingredi- manufacturing practice. The affirma- ents different from the uses established tion of this ingredient as generally rec- in this section do not exist or have ognized as safe (GRAS) as a direct been waived. human food ingredient is based upon [49 FR 25430, June 21, 1984, as amended at 50 the following current good manufac- FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, turing practice conditions of use: 2008] (1) The ingredient is used as a propellant, aerating agent, and gas as defined § 184.1555 Rapeseed oil. in § 170.3(o)(25) of this chapter. (a) Fully hydrogenated rapeseed oil. (1) (2) The ingredient is used in dairy Fully hydrogenated rapeseed oil is a product analogs as defined in mixture of triglycerides in which the § 170.3(n)(10) of this chapter at levels fatty acid composition is a mixture of not to exceed current good manufac- saturated fatty acids. The fatty acids turing practice. are present in the same porportions

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which result from the full hydro- ibrllocations.html. An additional speci- genation of fatty acids occurring in fication requires the iodine number to natural rapeseed oil. The rapeseed oil be 4 or less. is obtained from the napus and (3) The ingredient is used as an emul- campestris varieties of Brassica of the sifier as defined in § 170.3(o)(8) of this family Cruciferae. It is prepared by chapter in shortenings for cake mixes. fully hydrogenating refined and The use level of the ingredient is lim- ° bleached rapeseed oil at 310–375 F, ited by good manufacturing practice using a catalyst such as nickel, until (GMP) to the minimum amount re- the iodine number is 4 or less. quired to produce the intended effect. (2) The ingredient meets the fol- Current good manufacturing practices lowing specifications: Acid value not result in a maximum level, as served, more than 6, arsenic not more than 3 parts per million, free glycerin not of 4 percent of the shortening or 0.5 more than 7 percent, heavy metals (as percent of the total weight of the cake Pb) not more than 10 parts per million, mix. iodine number not more than 4, residue (c) Low erucic acid rapeseed oil. (1) on ignition not more than 0.5 percent. Low erucic acid rapeseed oil, also (3) The ingredient is used as a sta- known as canola oil, is the fully re- bilizer and thickener as defined in fined, bleached, and deodorized edible § 170.3(o)(28) of this chapter in peanut oil obtained from certain varieties of butter. The use level of the ingredient Brassica Napus or B. Campestris of the is limited by good manufacturing prac- family Cruciferae. The plant varieties tice (GMP) to the minimum amount re- are those producing oil-bearing seeds quired to produce the intended effect. with a low erucic acid content. Chemi- Current good manufacturing practices cally, low erucic acid rapeseed oil is a result in a maximum level of 2 percent mixture of triglycerides, composed of in peanut butter. both saturated and unsaturated fatty (b) Superglycerinated fully hydro- acids, with an erucic acid content of no genated rapeseed oil. (1) more than 2 percent of the component Superglycerinated fully hydrogenated fatty acids. rapeseed oil is a mixture of mono- and (2) Low erucic acid rapeseed oil as de- diglycerides with triglycerides as a fined in paragraph (c)(1) of this section minor component. The fatty acid com- may be partially hydrogenated to re- position is a mixture of saturated fatty acids present in the same proportions duce the proportion of unsaturated as those resulting from the full hydro- fatty acids. When the partially hydrogenation of fatty acids in natural genated low erucic acid rapeseed oil is rapeseed oil. It is made by adding ex- used, it shall be referred to as partially cess glycerol to the fully hydrogenated hydrogenated low erucic acid rapeseed rapeseed oil and heating, in the pres- oil. ence of a sodium hydroxide catalyst, to (3) In addition to limiting the con- 330 °F under partial vacuum and steam tent of erucic acid to a level not ex- sparging agitation. ceeding 2 percent of the component (2) The ingredient meets the speci- fatty acids, low erucic acid rapeseed oil fications of the ‘‘Food Chemicals and partially hydrogenated low erucic Codex,’’ 3d Ed. (1981), p. 201, relating to acid rapeseed oil must be of a purity mono- and diglycerides, which is incor- suitable for their intended use. porated by reference. Copies may be (4) Low erucic acid rapeseed oil and obtained from the National Academy partially hydrogenated low erucic acid Press, 2101 Constitution Ave. NW., rapeseed oil are used as edible fats and Washington, DC 20418, or may be exam- oils in food, except in infant formula, ined at the National Archives and at levels not to exceed current good Records Administration (NARA). For manufacturing practice. information on the availability of this material at NARA, call 202–741–6030, or [42 FR 48336, Sept. 23, 1977, as amended at 49 go to: http://www.archives.gov/ FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, federallregister/ 1985; 53 FR 52682, Dec. 29, 1988; 73 FR 8608, codeloflfederallregulations/ Feb. 14, 2008]

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§ 184.1560 Ox bile extract. Maximum treat- Category of food ment level in food Functional use (a) Ox bile extract (CAS Reg. No. 8008–63–7), also known as purified Bottled water that Not to exceed cur- Antimicrobial prior to ozonation rent good man- agent, § 170.3 oxgall or sodium choleate, is a yel- meets the micro- ufacturing prac- (o)(2) of this lowish green, soft solid, with a partly biological, phys- tice. Current chapter. sweet, partly bitter, disagreeable taste. ical, chemical, good manufac- and radiological turing practice It is the purified portion of the bile of quality standards results in a an ox obtained by evaporating the alco- of § 165.110 maximum resid- hol extract of concentrated bile. (b)(2) through ual level at the (b)(5) of this time of bottling (b) Food-grade ox bile extract shall chapter. of 0.4 milligram meet the specifications of the U.S. of ozone per Pharmacopeia (USP), XIV, 1950, p. 410. 1 liter of bottled water. (c) The ingredient is used as a surfactant as defined in § 170.3 (o)(29) of this [47 FR 50210, Nov. 5, 1982, as amended at 60 chapter. FR 57130, Nov. 13, 1995] (d) The ingredient is used in food in accordance with § 184.1(b)(1) at levels § 184.1583 Pancreatin. not to exceed good manufacturing (a) Pancreatin (CAS Reg. No. 8049–47– practice. Current good manufacturing 6) is an enzyme preparation obtained practice results in a maximum level, as from porcine or bovine pancreatic tis- served, of 0.002 percent for cheese as de- sue. It is a white to tan powder. Its fined in § 170.3(n)(5) of this chapter. characterizing enzyme activity that of (e) Prior sanctions for this ingredient a peptide hydrolase (EC 3.4.21.36). different from the uses established in (b) The ingredient meets the general this section do not exist or have been requirements and additional require- waived. ments in the Food Chemicals Codex, 3d [43 FR 36064, Aug. 15, 1978. Redesignated and ed. (1981), p. 110, which is incorporated amended at 50 FR 49537, Dec. 3, 1985] by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies § 184.1563 Ozone. are available from the National Acad- (a) Ozone (O3, CAS Reg. No. 10028–15– emy Press, 2101 Constitution Ave. NW., 6) is an unstable blue gas with a pun- Washington, DC 20418, or may be exam- gent, characteristic odor, which occurs ined at the Office of Premarket Ap- freely in nature, It is produced com- proval (HFS–200), Food and Drug Ad- mercially by passing electrical dis- ministration, 5100 Paint Branch Pkwy., charges or ionizing radiation through College Park, MD 20740, and at the Na- air or oxygen. tional Archives and Records Adminis- (b) The ingredient must be of a pu- tration (NARA). For information on rity suitable for its intended use in ac- the availability of this material at cordance with § 170.30(h)(1) of this chap- NARA, call 202–741–6030, or go to: http:// ter. www.archives.gov/federallregister/ (c) In accordance with § 184.1(b)(2), codeloflfederallregulations/ the ingredient is used to treat food ibrllocations.html. only within the following specific limi- (c) In accordance with § 184.1(b)(1), tations: the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this 1 Copies may be obtained from: U.S. Pharmacopeial Convention, Inc., 12601 chapter to hydrolyze proteins or Twinbrook Parkway, Rockville, MD 20852. polypeptides.

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(2) The ingredient is used in food at § 184.1588 Pectins. levels not to exceed current good man- (a) The pectins (CAS Reg. No. 9000– ufacturing practice. 69–5) are a group of complex, high mo- [60 FR 32911, June 26, 1995] lecular weight polysaccharides found in plants and composed chiefly of par- § 184.1585 Papain. tially methylated polygalacturonic acid units. Portions of the carboxly (a) Papain (CAS Reg. No. 9001–73–4) is group occur as methyl esters, and the a proteolytic enzyme derived from remaining carboxyl groups exist in the Carica papaya L. Crude latex conform of the free acid or as its ammo- taining the enzyme is collected from nium, potassium, or sodium (CAS Reg. slashed unripe papaya. The food-grade No. 9000–59–8) salts, and in some types product is obtained by repeated filtra- as the acid amide. Thus, the pectins tion of the crude latex or an aqueous regulated in this section are the high- solution of latex or by precipitation ester pectins, low-ester pectins, from an aqueous solution of latex. The amidated pectins, pectinic acids, and resulting enzyme preparation may be pectinates. Pectin is produced commer- used in a liquid or dry form. cially by extracting citrus peel, apple (b) The ingredient meets the speci- pomace, or beet pulp with hot dilute fications of the Food Chemicals Codex, acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- 3d Ed. (1981), pp. 107–110, which is incor- tract is filtered, and pectin is then pre- porated by reference. Copies are avail- cipitated from the clear extract with able from the National Academy Press, ethanol or isopropanol, or as the copper or aluminum salt. The acid extract 2101 Constitution Ave. NW., Wash- is sometimes spray- or roller-dried, or ington, DC 20418, or available for in- it is concentrated to be sold as liquid spection at the National Archives and pectin. Records Administration (NARA). For (b) The ingredients meet the speci- information on the availability of this fications of the Food Chemical Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 215, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than currect good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. (c) In accordance with § 184.1(b)(1), turing conditions of use: the ingredients are used in food with (1) The ingredient is used as an en- no limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. The affirma- chapter; processing aid as defined in tion of these ingredients as generally § 170.3(o)(24) of this chapter; and recognized as safe (GRAS) as direct texturizer as defined in § 170.3(o)(32) of human food ingredients is based upon this chapter. the following current good manufac- (2) The ingredient is used in food at turing practice conditions of use: levels not to exceed current good man- (1) The ingredients are used as emul- ufacturing practice. sifiers as defined in § 170.3(o)(8) of this (d) Prior sanctions for this ingredient chapter and as stabilizers and thick- different from the uses established in eners as defined in § 170.3(o)(28) of this this section do not exist or have been chapter. waived. (2) The ingredients are used in food at levels not to exceed current good [48 FR 48806, Oct. 21, 1983] manufacturing practice.

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(d) Prior sanctions for these ingredi- sium alginate is prepared by the neu- ents different from the uses established tralization of purified alginic acid with in this section do not exist or have appropriate pH control agents. been waived. (b) The ingredient meets the speci- [48 FR 51149, Nov. 7, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incor- § 184.1595 Pepsin. porated by reference. Copies are available from the National Academy Press, (a) Pepsin (CAS Reg. No. 9001–75–6) is 2101 Constitution Ave. NW., Wash- an enzyme preparation obtained from ington, DC 20418, or available for in- the glandular layer of hog stomach. It spection at the National Archives and is a white to light tan powder, amber Records Administration (NARA). For paste, or clear amber to brown liquid. information on the availability of this Its characterizing enzyme activity is material at NARA, call 202–741–6030, or that of a peptide hydrolase (EC go to: http://www.archives.gov/ 3.4.23.1). federal register/ (b) The ingredient meets the general l code of federal regulations/ requirements and additional require- l l l ibr locations.html. ments for enzyme preparations in the l Food Chemicals Codex, 3d ed. (1981), p. (c) In accordance with § 184.1(b)(2), 110, which is incorporated by reference the ingredient is used in food only in accordance with 5 U.S.C. 552(a) and 1 within the following specific limita- CFR part 51. Copies are available from tions: the National Academy Press, 2101 Con- Maximum stitution Ave. NW., Washington, DC level of use in 20418, or may be examined at the Office Category of food food (as Functional use of Premarket Approval (HFS–200), Food served) and Drug Administration, 5100 Paint (percent) Branch Pkwy., College Park, MD 20740, Confections and 0.1 Stabilizer, thickener, and at the National Archives and frostings, § 170.3(o)(28) of this Records Administration (NARA). For § 170.3(n)(9) of this chapter chapter. information on the availability of this Gelatins and puddings, 0.7 Do. material at NARA, call 202–741–6030, or § 170.3(n)(22) of this go to: http://www.archives.gov/ chapter. federallregister/ Processed fruits and 0.25 Do. fruit juices, codeloflfederallregulations/ § 170.3(n)(35) of this ibrllocations.html. chapter. (c) In accordance with § 184.1(b)(1), All other food cat- 0.01 Do. the ingredient is used in food with no egories. limitation other than current good manufacturing practice. The affirma- (d) Prior sanctions for potassium al- tion of this ingredient as GRAS as a di- ginate different from the uses estab- rect food ingredient is based upon the lished in this section do not exist or following current good manufacturing have been waived. practice conditions of use: [47 FR 29951, July 9, 1982] (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this § 184.1613 Potassium bicarbonate. chapter to hydrolyze proteins or (a) Potassium bicarbonate (KHCO3, polypeptides. CAS Reg. No. 298–14–6) is made by the (2) The ingredient is used in food at following processes: levels not to exceed current good man- (1) By treating a solution of potas- ufacturing practice. sium hydroxide with carbon dioxide; [60 FR 32911, June 26, 1995] (2) By treating a solution of potassium carbonate with carbon dioxide. § 184.1610 Potassium alginate. (b) The ingredient meets the speci- (a) Potassium alginate (CAS Reg. No. fications of the Food Chemicals Codex, 9005–36–1) is the potassium salt of al- 3d Ed. (1981), p. 239, which is incor- ginic acid, a natural polyuronide con- porated by reference. Copies are avail- stituent of certain brown algae. Potas- able from the National Academy Press,

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2101 Constitution Ave. NW., Wash- Records Administration (NARA). For ington, DC 20418, or available for in- information on the availability of this spection at the National Archives and material at NARA, call 202–741–6030, or Records Administration (NARA). For go to: http://www.archives.gov/ information on the availability of this federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. the affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used in food as a the following current good manufac- flavoring agent and adjuvant as defined turing practice conditions of use: in § 170.3(o)(12) of this chapter; nutrient (1) The ingredient is used as a formu- supplement as defined in § 170.3(o)(20) of lation aid as defined in § 170.3(o)(14) of this chapter; pH control agent as de- this chapter; nutrient supplemlent as fined in § 170.3(o)(23) of this chapter; defined in § 170.3(o)(20) of this chapter; and processing aid as defined in pH control agent as defined in § 170.3(o)(24) of this chapter. § 170.3(o)(23) of this chapter; and proc- (2) The ingredient is used in food at essing aid as defined in § 170.3(o)(24) of levels not to exceed current good man- this chapter. ufacturing practice. (2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [48 FR 52442, Nov. 18, 1983] this section do not exist or have been waived. § 184.1622 Potassium chloride. [48 FR 52442, Nov. 18, 1983] (a) Potassium chloride (KCl, CAS Reg. No. 7447–40–7) is a white, odorless § 184.1619 Potassium carbonate. solid prepared from source minerals by (a) Potassium carbonate (K2CO3, CAS fractional crystallization or flotation. Reg. No. 584–08–7) is produced by the It is soluble in water and glycerol and following methods of manufacture: has a saline taste at low concentration (1) By electrolysis of potassium chlo- levels. ride followed by exposing the resultant (b) The ingredient meets the speci- potassium to carbon dioxide; fications of the Food Chemicals Codex, (2) By treating a solution of potas- 3d Ed. (1981), p. 241, which is incor- sium hydroxide with excess carbon di- porated by reference. Copies are avail- oxide to produce potassium carbonate; able from the National Academy Press, (3) By treating a solution of potas- 2101 Constitution Ave. NW., Wash- sium hydroxide with carbon dioxide to ington, DC 20418, or available for in- produce potassium bicarbonate, which spection at the National Archives and is then heated to yield potassium car- Records Administration (NARA). For bonate. information on the availability of this (b) The ingredient meets the speci- material at NARA, call 202–741–6030, or fications of the Food Chemicals Codex, go to: http://www.archives.gov/ 3d Ed. (1981), p. 240, which is incor- federallregister/ porated by reference. Copies are avail- codeloflfederallregulations/ able from the National Academy Press, ibrllocations.html. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1), ington, D.C. 20418, or available for in- the ingredient is used in food with no spection at the National Archives and limitation other than current good

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manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. (1) The ingredient is used as a flavor (d) Prior sanctions for this ingredient enhancer as defined in § 170.3(o)(11) of different from the uses established in this chapter; as a flavoring agent as de- this section, or different from those set fined in § 170.3(o)(12) of this chapter; as forth in part 181 of this chapter, do not a nutrient supplement as defined in exist or have been waived. § 170.3(o)(20) of this chapter; as a pH control agent as defined in § 170.3(o)(23) [59 FR 63896, Dec. 12, 1994] of this chapter; and as a stabilizer or thickener as defined in § 170.3(o)(28) of § 184.1631 Potassium hydroxide. this chapter. (a) Potassium hydroxide (KOH, CAS (2) The ingredient is used in food at Reg. No. 1310–58–3) is also known as levels not to exceed current good man- caustic potash, potash lye, and potassa. ufacturing practice. Potassium chlo- The empirical formula is KOH. It is a ride may be used in infant formula in white, highly deliquescent caustic accordance with section 412(g) of the solid, which is marketed in several Federal Food, Drug, and Cosmetic Act forms, including pellets, flakes, sticks, (the Act) or with regulations promul- lumps, and powders. Potassium hydrox- gated under section 412(a)(2) of the Act. ide is obtained commercially from the (d) Prior sanctions for this ingredient electrolysis of potassium chloride solu- different from the uses established in tion in the presence of a porous dia- this section do not exist or have been phragm. waived. (b) The ingredient meets the speci- [48 FR 51614, Nov. 10, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by § 184.1625 Potassium citrate. reference. Copies are available from the National Academy Press, 2101 Con- (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- stitution Ave. NW., Washington, DC tassium salt of citric acid. It is pre- 20418, or available from inspection at pared by neutralizing citric acid with the National Archives and Records Ad- potassium hydroxide or potassium car- ministration (NARA). For information bonate. It occurs as transparent crys- on the availability of this material at tals or a white granular powder, is NARA, call 202–741–6030, or go to: http:// odorless and deliquescent, and contains www.archives.gov/federallregister/ one mole of water per mole of potas- codeloflfederallregulations/ sium citrate. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d ed. (1981), p. 242, which is incor- limitation other than current good porated by reference in accordance manufacturing practice. The affirma- with 5 U.S.C. 552(a) and 1 CFR part 51. tion of this ingredient as generally rec- Copies are available from the National ognized as safe (GRAS) as a direct Academy Press, 2101 Constitution Ave. human food ingredient is based upon NW., Washington, DC 20418, and the the following current good manufac- Center for Food Safety and Applied Nu- turing practice conditions of use: trition (HFS–200), 5100 Paint Branch (1) The ingredient is used as a formu- Pkwy., College Park, MD 20740, or may lation aid as defined in § 170.3(o)(14) of be examined at the National Archives this chapter; a pH control agent as de- and Records Administration (NARA). fined in § 170.3(o)(23) of the chapter; a For information on the availability of processing aid as defined in § 170.3(o)(24) this material at NARA, call 202–741– of this chapter; and a stabilizer and 6030, or go to: http://www.archives.gov/ thickener as defined in § 170.3(o)(28) of federallregister/ this chapter.

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(2) The ingredient is used in food at Academy Press, 2101 Constitution Ave. levels not to exceed current good man- NW., Washington, DC 20418, or may be ufacturing practice. examined at the National Archives and (d) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this this section do not exist or have been material at NARA, call 202–741–6030, or waived. go to: http://www.archives.gov/ federallregister/ [48 FR 52444, Nov. 18, 1983] codeloflfederallregulations/ § 184.1634 Potassium iodide. ibrllocations.html. (c) The ingredient is used as a dough (a) Potassium iodide (KI, CAS Reg. strengthener as defined in § 170.3(o)(6) No. 7681–11–0) is the potassium salt of of this chapter. hydriodic acid. It occurs naturally in (d) The ingredient is used in the man- sea water and in salt deposits, but can ufacture of bread in accordance with be prepared by reacting hydriodic acid § 184.1(b)(2) of this chapter in an (HI) with potassium bicarbonate amount not to exceed 0.0075 percent (KHCO ). 3 based on the weight of the flour. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), pp. 246–247, which this section do not exist or have been is incorporated by reference. Copies waived. may be obtained from the National Academy Press, 2101 Constitution Ave. [43 FR 11699, Mar. 21, 1978, as amended at 49 NW., Washington, DC 20418, or may be FR 5613, Feb. 14, 1984] examined at the National Archives and Records Administration (NARA). For § 184.1639 Potassium lactate.

information on the availability of this (a) Potassium lactate (C3H5O3K, CAS material at NARA, call 202–741–6030, or Reg. No. 996–31–6) is the potassium salt go to: http://www.archives.gov/ of lactic acid. It is a hydroscopic, federallregister/ white, odorless solid and is prepared codeloflfederallregulations/ commercially by the neutralization of ibrllocations.html. lactic acid with potassium hydroxide. (c) The ingredient is used as a nutri- (b) The ingredient must be of a pu- ent supplement as defined in rity suitable for its intended use. § 170.3(o)(20) of this chapter. (c) In accordance with § 184.1(b)(1), (d) The ingredient is used in table the ingredient is used in food with no salt in accordance with § 184.1(b)(2) of limitation other than current good this chapter as a source of dietary io- manufacturing practice. This regula- dine at a maximum level of 0.01 per- tion does not authorize its use in in- cent. fant foods and infant formulas. The af- (e) Prior sanctions for this ingredient firmation of this ingredient as gen- different from the uses established in erally recognized as safe (GRAS) as a this section do not exist or have been direct human food ingredient is based waived. upon the following current good manu- [43 FR 11699, Mar. 21, 1978, as amended at 49 facturing practice conditions of use: FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, (1) The ingredient is used as a flavor 1996] enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adju- § 184.1635 Potassium iodate. vant as defined in § 170.3(o)(12) of this

(a) Potassium iodate (KIO3, CAS Reg. chapter; a humectant as defined in No. 7758–05–6) does not occur naturally § 170.3(o)(16) of this chapter; and a pH but can be prepared by reacting iodine control agent as defined in § 170.3(o)(23) with potassium hydroxide. of this chapter. (b) The ingredient meets the speci- (2) The ingredient is used in food at fications of the ‘‘Food Chemicals levels not to exceed current good man- Codex,’’ 3d Ed. (1981), pp. 245–246, which ufacturing practice. is incorporated by reference. Copies (d) Prior sanctions for this ingredient may be obtained from the National different from the uses established in

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this section do not exist or have been sorption to surface-active agents, or re- waived. frigeration. (b) The ingredient must be of a pu- [52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1643 Potassium sulfate. the ingredient is used in food with no limitations other than current good (a) Potassium sulfate (K2SO4, CAS manufacturing practice. The affirma- Reg. No. 7778–80–5) occurs naturally and tion of this ingredient as generally rec- consists of colorless or white crystals ognized as safe (GRAS) as a direct or crystalline powder having a bitter, human food ingredient is based upon saline taste. It is prepared by the neu- the following current good manufac- tralization of sulfuric acid with potas- turing practice conditions of use: sium hydroxide or potassium car- (1) The ingredient is used as a propel- bonate. lant, aerating agent, and gas as defined (b) The ingredient meets the speci- in § 170.3(o)(25) of this chapter. fications of the ‘‘Food Chemicals (2) The ingredient is used in food at Codex,’’ 3d Ed. (1981), p. 252, which is in- levels not to exceed current good man- corporated by reference. Copies may be ufacturing practice. obtained from the National Academy (d) Prior sanctions for this ingredient Press, 2101 Constitution Ave. NW., different from the uses established in Washington, DC 20418, or may be exam- this section do not exist or have been ined at the National Archives and waived. Records Administration (NARA). For information on the availability of this [48 FR 57271, Dec. 29, 1983, as amended at 73 FR 8608, Feb. 14, 2008] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 184.1660 Propyl gallate. federallregister/ (a) Propyl gallate is the n- codeloflfederallregulations/ propylester of 3,4,5-trihydroxybenzoic ibrllocations.html. (c) The ingredient is used as a fla- acid (C10H12O5). Natural occurrence of voring agent and adjuvant as defined in propyl gallate has not been reported. It § 170.3(o)(12) of this chapter. is commercially prepared by esterification of gallic acid with propyl (d) The ingredient is used in food at alcohol followed by distillation to re- levels not to exceed good manufac- move excess alcohol. turing practice in accordance with (b) The ingredient meets the speci- § 184.1(b)(1). Current good manufac- fications of the ‘‘Food Chemicals turing practice results in a maximum Codex,’’ 3d Ed. (1981), pp. 257–258, which level, as served, of 0.015 percent for is incorporated by reference. Copies nonalcoholic beverages as defined in may be obtained from the National § 170.3(n)(3) of this chapter. Academy Press, 2101 Constitution Ave. (e) Prior sanctions for this ingredient NW., Washington, DC 20418, or may be different from the uses established in examined at the National Archives and this section do not exist or have been Records Administration (NARA). For waived. information on the availability of this [45 FR 6086, Jan. 25, 1980, as amended at 49 material at NARA, call 202–741–6030, or FR 5613, Feb. 14, 1984] go to: http://www.archives.gov/ federallregister/ § 184.1655 Propane. codeloflfederallregulations/ (a) Propane (empirical formula C3H8, ibrllocations.html. CAS Reg. No. 74–98–6) is also known as (c) The ingredient is used as an anti- dimethylmethane or propyl hydrid. It oxidant as defined in § 170.3(o)(3) of this is a colorless, odorless, flammable gas chapter. at normal temperatures and pressures. (d) The ingredient is used in food at It is easily liquefied under pressure at levels not to exceed good manufac- room temperature and is stored and turing practice in accordance with shipped in the liquid state. Propane is § 184.1(b)(1). Good manufacturing prac- obtained from natural gas by fraction- tice results in a maximum total con- ation following absorption in oil, ad- tent of antioxidants of 0.02 percent of

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the fat or oil content, including the es- (d) The ingredient is used in foods at sential (volatile) oil content, of the levels not to exceed current good man- food. ufacturing practice in accordance with (e) Prior sanctions for this ingredient § 184.1(b)(1). Current good manufac- different from the uses established in turing practice results in maximum this section, or different from that levels, as served, of 5 percent for alco- stated in part 181 of this chapter, do holic beverages, as defined in not exist or have been waived. § 170.3(n)(2) of this chapter; 24 percent [42 FR 14653, Mar. 15, 1977, as amended at 44 for confections and frostings as defined FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, in § 170.3(n)(9) of this chapter; 2.5 per- 1984] cent for frozen dairy products as defined in § 170.3(n)(20) of this chapter; 97 § 184.1666 Propylene glycol. percent for seasonings and flavorings as defined in § 170.3(n)(26) of this chap- (a) Propylene glycol (C3H8O2, CAS Reg. No. 57–55–6) is known as 1,2- ter; 5 percent for nuts and nut products propanediol. It does not occur in na- as defined in § 170.3(n)(32) of this chap- ture. Propylene glycol is manufactured ter; and 2.0 percent for all other food by treating propylene with chlorinated categories. water to form the chlorohydrin which (e) Prior sanctions for this ingredient is converted to the glycol by treatment different from the uses established in with sodium carbonate solution. It is this section do not exist or have been also prepared by heating glyercol with waived. sodium hydroxide. (b) The ingredient meets the speci- [47 FR 27812, June 25, 1982] fications of the Food Chemicals Codex, § 184.1670 Propylparaben. 3d Ed. (1981), p. 255, which is incorporated by reference. Copies may be (a) Propylparaben is the chemical obtained from the National Academy propyl p-hydroxybenzoate. It is pro- Press, 2101 Constitution Ave. NW., duced by the n-propanol esterification Washington, DC 20418. It is also avail- of p-hydroxybenzoic acid in the pres- able for inspection at the National Ar- ence of sulfuric acid, with subsequent chives and Records Administration distillation. (NARA). For information on the avail- (b) The ingredient meets the speci- ability of this material at NARA, call fications of the ‘‘Food Chemicals 202–741–6030, or go to: http:// Codex,’’ 3d Ed. (1981), p. 258, which is in- www.archives.gov/federallregister/ corporated by reference. Copies may be codeloflfederallregulations/ obtained from the National Academy ibrllocations.html. Press, 2101 Constitution Ave. NW., (c) The ingredient is used as an Washington, DC 20418, or may be exam- anticaking agent as defined in ined at the National Archives and § 170.3(o)(1) of this chapter; antioxidant Records Administration (NARA). For as defined in § 170.3(o)(3) of this chap- information on the availability of this ter; dough strengthener as defined in material at NARA, call 202–741–6030, or § 170.3(o)(6) of this chapter; emulsifier go to: http://www.archives.gov/ as defined in § 170.3(o)(8) of this chap- federallregister/ ter; flavor agent as defined in codeloflfederallregulations/ § 170.3(o)(12) of this chapter; formula- ibrllocations.html. tion aid as defined in § 170.3(o)(14) of this chapter; humectant as defined in (c) The ingredient is used as an anti- § 170.3(o)(16) of this chapter; processing microbial agent as defined in aid as defined in § 170.3(o)(24) of this § 170.3(o)(2) of this chapter. chapter; solvent and vehicle as defined (d) The ingredient is used in food at in § 170.3(o)(27) of this chapter; sta- levels not to exceed good manufac- bilizer and thickener as defined in turing practices. Current good manu- § 170.3(o)(28) of this chapter; surface-ac- facturing practice results in a max- tive agent as defined in § 170.3(o)(29) of imum level of 0.1 percent in food. this chapter; and texturizer as defined (e) Prior sanctions for this ingredient in § 170.3(o)(32) of this chapter. different from the uses established in

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this regulation do not exist or have Cosmetic Act (the Act) or with regula- been waived. tions promulgated under section 412(a)(2) of the Act. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984] (d) Prior sanctions for this ingredient different from the uses established in § 184.1676 Pyridoxine hydrochloride. this section do not exist or have been (a) Pyridoxine hydrochloride waived. (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is [48 FR 51615, Nov. 10, 1983] the chemical 3-hydroxy–4,5- dihydroxymethy–2-methylpyridine hy- § 184.1685 Rennet (animal-derived) drochloride that is prepared by chem- and chymosin preparation (fer- ical synthesis. mentation-derived). (b) The ingredient meets the speci- (a)(1) Rennet and bovine rennet are fications of the Food Chemicals Codex, commercial extracts containing the ac- 3d Ed. (1981), p. 260, which is incor- tive enzyme rennin (CAS Reg. No. 9001– porated by reference. Copies are avail- 98–3), also known as chymosin (Inter- able from the National Academy Press, national Union of Biochemistry En- 2101 Constitution Ave. NW., Wash- zyme Commission (E.C.) 3.4.23.4). ington, DC 20418, or available for in- Rennet is the aqueous extract prepared spection at the National Archives and from cleaned, frozen, salted, or dried Records Administration (NARA). For fourth stomachs (abomasa) of calves, information on the availability of this kids, or lambs. Bovine rennet is the material at NARA, call 202–741–6030, or product from adults of the animals list- go to: http://www.archives.gov/ ed above. Both products are called federallregister/ rennet and are clear amber to dark codeloflfederallregulations/ brown liquid preparations or white to ibrllocations.html. tan powders. (c) In accordance with § 184.1(b)(1), (2) Chymosin preparation is a clear the ingredient is used in food with no solution containing the active enzyme limitation other than current good chymosin (E.C. 3.4.23.4). It is derived, manufacturing practice. The affirma- via fermentation, from a nonpatho- tion of this ingredient as generally rec- genic and nontoxigenic strain of Esch- ognized as safe (GRAS) as a direct erichia coli K–12 containing the human food ingredient is based upon prochymosin gene. The prochymosin is the following current good manufac- isolated as an insoluble aggregate that turing practice conditions of use: is acid-treated to destroy residual cel- (1) The ingredient is used as a nutri- lular material and, after solubilization, ent supplement as defined in is acid-treated to form chymosin. It § 170.3(o)(20) of this chapter. must be processed with materials that (2) The ingredient is used in the fol- are generally recognized as safe, or are lowing foods at levels not to exceed food additives that have been approved current good manufacturing practice: by the Food and Drug Administration baked goods as defined in § 170.3(n)(1) of for this use. this chapter; nonalcoholic beverages (3) Chymosin preparation is a clear and beverage bases as defined in solution containing the active enzyme § 170.3(n)(3) of this chapter; breakfast chymosin (E.C. 3.4.23.4). It is derived, cereals as defined in § 170.3(n)(4) of this via fermentation, from a nonpatho- chapter; dairy product analogs as de- genic and nontoxigenic strain of fined in § 170.3(n)(10) of this chapter; Kluyveromyces marxianus variety lactis, meat products as defined in containing the prochymosin gene. The § 170.3(n)(29) of this chapter; milk prod- prochymosin is secreted by cells into ucts as defined in § 170.3(n)(31) of this fermentation broth and converted to chapter; plant protein products as de- chymosin by acid treatment. All mate- fined in § 170.3(n)(33) of this chapter; rials used in the processing and formu- and snack foods as defined in lating of chymosin must be either gen- § 170.3(n)(37) of this chapter. Pyridoxine erally recognized as safe (GRAS), or be hydrochloride may be used in infant food additives that have been approved formula in accordance with section by the Food and Drug Administration 412(g) of the Federal Food, Drug, and for this use.

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(4) Chymosin preparation is a clear ter; and milk products as defined in solution containing the active enzyme § 170.3(n)(31) of this chapter. chymosin (E.C. 3.4.23.4). It is derived, (d) Prior sanctions for this ingredient via fermentation, from a nonpatho- different from the uses established in genic and nontoxigenic strain of Asper- this section do not exist or have been gillus niger van Tieghem variety waived. awamori (Nakazawa) Al-Musallam (synonym A. awamori Nakazawa) con- [55 FR 10935, Mar. 23, 1990, as amended at 57 taining the prochymosin gene. FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 1993] Chymosin is recovered from the fermentation broth after acid treatment. § 184.1695 Riboflavin. All materials used in the processing and formulating of chymosin prepara- (a) Riboflavin (C17H20N4O6, CAS Reg. tion must be either generally recog- No. 83–88–5) occurs as yellow to orange- nized as safe (GRAS) or be food addi- yellow needles that are crystallized tives that have been approved by the from 2N acetic acid, alcohol, water, or Food and Drug Administration for this pyridine. It may be prepared by chem- use. ical synthesis, biosynthetically by the (b) Rennet and chymosin preparation organism Eremothecium ashbyii, or iso- meet the general and additional related from natural sources. quirements for enzyme preparations of (b) The ingredient meets the speci- the ‘‘Food Chemicals Codex,’’ 3d Ed. fications of the Food Chemicals Codex, (1981), pp. 107–110, which is incorporated 3d Ed. (1981), p. 262, which is incor- by reference in accordance with 5 porated by reference. Copies are avail- U.S.C. 552(a). Copies are available from able from the National Academy Press, the National Academy Press, 2101 Con- 2101 Constitution Ave. NW., Wash- stitution Avenue NW., Washington, DC ington, DC 20418, or available for in- 20418, or are available for inspection at spection at the National Archives and the National Archives and Records Ad- Records Administration (NARA). For ministration (NARA). For information information on the availability of this on the availability of this material at material at NARA, call 202–741–6030, or NARA, call 202–741–6030, or go to: http:// go to: http://www.archives.gov/ www.archives.gov/federallregister/ federallregister/ code of federal regulations/ l l l codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food tion of this ingredient as generally rec- ingredient is based upon the following ognized as safe (GRAS) as a direct current good manufacturing practice human food ingredient is based upon conditions of use: the following current good manufac- (1) The ingredient is used as an en- turing practice conditions of use: zyme as defined in § 170.3(o)(9) of this (1) The ingredient is used as a nutri- chapter; a processing aid as defined in ent supplement as defined in § 170.3(o)(24) of this chapter; and a sta- § 170.3(o)(20) of this chapter. bilizer and thickener as defined in (2) The ingredient is used in foods at § 170.3(o)(28) of this chapter. levels not to exceed current good man- (2) The ingredient is used in the fol- ufacturing practice. The ingredient lowing foods at levels not to exceed may also be used in infant formula in current good manufacturing practice: accordance with section 412(g) of the In cheeses as defined in § 170.3(n)(5) of Federal Food, Drug, and Cosmetic Act this chapter; frozen dairy desserts and (the Act) or with regulations promul- mixes as defined in § 170.3(n)(20) of this gated under section 412(a)(2) of the Act. chapter; gelatins, puddings, and fillings (d) Prior sanctions for this ingredient as defined in § 170.3(n)(22) of this chap- different from the uses established in

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this section do not exist or have been § 184.1698 Rue. waived. (a) Rue is the perennial herb of sev- [48 FR 51148, Nov. 7, 1983] eral species of Ruta (Ruta montana L., Ruta graveolens L., Ruta bracteosa L., § 184.1697 Riboflavin–5′-phosphate (sodium). and Ruta calepensis L.). The leaves, buds, and stems from the top of the ′ (a) Riboflavin-5 -phosphate (sodium) plant are gathered, dried, and then (C H N O PNa·2H O, CAS Reg. No 130– 17 20 4 9 2 crushed in preparation for use, or left 40–5) occurs as the dihydrate in yellow whole. to orange-yellow crystals. It is prepared by phosphorylation of riboflavin (b) The ingredient is used in all cat- with chlorophosphoric acid, egories of food in accordance with pyrophosphoric acid, metaphosphoric § 184.1(b)(2) of this chapter at con- acid, or pyrocatechol cyclic phosphate. centrations not to exceed 2 parts per (b) The ingredient meets the speci- million. fications of the Food Chemicals Codex, (c) Prior sanctions for this ingredient 3d Ed. (1981), p. 263, which is incor- different from the uses established in porated by reference. Copies are avail- this section do not exist or have been able from the National Academy Press, waived. 2101 Constitution Ave. NW., Wash- ington DC 20418, or available for inspec- [43 FR 3705, Jan. 27, 1978] tion at the National Archives and Records Administration (NARA). For § 184.1699 Oil of rue. information on the availability of this (a) Oil of rue is the natural substance material at NARA, call 202–741–6030, or obtained by steam distillation of the go to: http://www.archives.gov/ fresh blossoming plants of rue, the pe- federallregister/ rennial herb of several species of codeloflfederallregulations/ Ruta—Ruta montana L., Ruta graveolens ibrllocations.html. L., Ruta bracteosa L., and Ruta (c) In accordance with § 184.1(b)(1), calepensis L. the ingredient is used in food with no (b) Oil of rue meets the specifications limitation other than current good of the ‘‘Food Chemicals Codex,’’ 4th ed. manufacturing practice. The affirmation of this ingredient as generally rec- (1996), pp. 342–343, which is incorporated ognized as safe (GRAS) as a direct by reference in accordance with 5 human food ingredient is based upon U.S.C. 552(a) and 1 CFR part 51. Copies the following current good manufac- are available from the National Acad- turing practice conditions of use: emy Press, Box 285, 2101 Constitution (1) The ingredient is used as a nutri- Ave. NW., Washington, DC 20055 (Inter- ent supplement as defined in net address http://www.nap.edu), or may § 170.3(o)(20) of this chapter. be examined at the Center for Food (2) The ingredient is used in milk Safety and Applied Nutrition’s Li- products, as defined in § 170.3(n)(31) of brary, Food and Drug Administration, this chapter, at levels not to exceed 5100 Paint Branch Pkwy., College Park, current good manufacturing practice. MD 20740, or at the National Archives The ingredient may also be used in in- and Records Administration (NARA). fant formulas in accordance with sec- For information on the availability of tion 412(g) of the Federal Food, Drug, this material at NARA, call 202–741– and Cosmetic Act (the Act) or with reg- 6030, or go to: http://www.archives.gov/ ulations promulgated under section federallregister/ 412(a)(2) of the Act. (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) The ingredient is used in food waived. under the following conditions: [48 FR 51148, Nov. 7, 1983]

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MAXIMUM USAGE LEVELS PERMITTED

Parts per Food (as served) million Function

Baked goods and baking mixes, § 170.3(n)(1), of 10 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. this chapter. Frozen dairy desserts and mixes, § 170.3 (n)(20) of 10 Do. this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 10 Do. All other food categories ...... 4 Do.

(d) Prior sanctions for this ingredient § 184.1721 Sodium acetate. different from the uses established in (a) Sodium acetate (C H O Na, CAS this section do not exist or have been 2 3 2 Reg. No. 127–09–3 or C H O Na·3H O, waived. 2 3 2 2 CAS Reg. No. 6131–90–4) is the sodium [42 FR 14653, Mar. 15, 1977, as amended at 49 salt of acetic acid and occurs naturally FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, in plant and animal tissues. Sodium ac- 1999] etate may occur in either the anhydrous or trihydrated form. It is pro- § 184.1702 Sheanut oil. duced synthetically by the neutraliza- (a) Sheanut oil is produced from tion of acetic acid with sodium car- sheanuts derived from the Shea tree bonate or by treating calcium acetate Butyrospermum parkii and is composed with sodium sulfate and sodium bicar- principally of triglycerides containing bonate. an oleic acid moiety at the 2-position (b) The ingredient meets the speci- and saturated fatty acids, usually ste- fications of the Food Chemicals Codex, aric or palmitic acids, at the 1- and 3- 3d Ed. (1981), pp. 272, 273 which is incor- positions. porated by reference. Copies are avail- (b) The ingredient meets the fol- able from the National Academy Press, lowing specifications when tested using 2101 Constitution Ave. NW., Wash- any appropriate validated method- ington, DC 20418, or available for in- ology: spection at the National Archives and (1) Saponification value of 185 to 195, Records Administration (NARA). For (2) Iodine value of 28 to 43, information on the availability of this (3) Unsaponifiable matter not to ex- material at NARA, call 202–741–6030, or ceed 1.5 percent, go to: http://www.archives.gov/ (4) Free fatty acids not more than 0.1 federallregister/ percent as oleic acid, codeloflfederallregulations/ (5) Peroxide value not more than 10 ibrllocations.html. milliequivalents/equivalent (meq/eq), (c) The ingredient is used as a fla- (6) Lead not more than 0.1 part per voring agent and adjuvant as defined in million (ppm), § 170.3(o)(12) of this chapter; and as a pH control agent as defined in § 170.3(o)(23) (7) Copper not more than 0.1 ppm. of this chapter. (c) In accordance with § 184.1(b)(3), (d) The ingredient is used in food at the ingredient is used in the following levels not to exceed current good man- food categories at levels not to exceed ufacturing practice in accordance with current good manufacturing practice, 184.1(b)(1). Current good manufacturing except that the ingredient may not be practice results in a maximum level, as used in a standardized food unless per- served, of 0.007 percent for breakfast mitted by the standard of identity: cereals as defined in § 170.3(n)(4) of this Confections and frostings as defined in chapter; 0.5 percent for fats and oils as § 170.3(n)(9) of this chapter, coatings of defined in § 170.3(n)(12) of this chapter; soft candy as defined in § 170.3(n)(38) of 0.6 percent for grain products and pas- this chapter, and sweet sauces and top- tas as defined in § 170.3(n)(23) of this pings as defined in § 170.3(n)(43) of this chapter and snack foods as defined in chapter. § 170.3(n)(37) of this chapter; 0.15 per- [63 FR 28895, May 27, 1998] cent for hard candy as defined in

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§ 170.3(n)(25) of this chapter; 0.12 per- nate is prepared by the neutralization cent for jams and jellies as defined in of purified alginic acid with appro- § 170.3(n)(28) of this chapter and meat priate pH control agents. products as defined in § 170.3(n)(29) of (b) The ingredient meets the speci- this chapter; 0.2 percent for soft candy fications of the Food Chemicals Codex, as defined in § 170.3(n)(38) of this chap- 3d Ed. (1981), p. 274, which is incor- ter; 0.05 percent for soups and soup porated by reference. Copies are avail- mixes as defined in § 170.3(n)(40) of this able from the National Academy Press, chapter and sweet sauces as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(43) of this chapter. ington, DC 20418, or available for in- (e) Prior sanctions for this ingredient spection at the National Archives and different from the uses established in Records Administration (NARA). For this section do not exist or have been information on the availability of this waived. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [47 FR 27815, June 25, 1982] federallregister/ codeloflfederallregulations/ § 184.1724 Sodium alginate. ibrllocations.html. (a) Sodium alginate (CAS Reg. No. (c) In accordance with § 184.1(b)(2), 9005–38–3) is the sodium salt of alginic the ingredient is used in food only acid, a natural polyuronide constituent within the following specific limita- of certain brown algae. Sodium algi- tions:

Maximum level of Category of food use in food Functional use (as served) (percent)

Condiments and relishes, § 170.3(n)(8) of this chapter, 1.0 Texturizer, § 170.3(o)(32) of this chapter, formulation aid except pimento ribbon for stuffed olives. § 170.3(o)(14) of this chapter, stabilizer, thickener, § 170.3(o)(28) of this chapter. Pimento ribbon for stuffed olives ...... 6.0 Do. Confections and frostings, § 170.3(n)(9) of this chapter .. 0.3 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Gelatins and puddings, § 170.3(n)(22) of this chapter ..... 4.0 Firming agent, § 170.3(o)(10) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 10.0 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of this 2.0 Formulation aid, §170.3(o)(14) of this chapter; chapter. texturizer, § 170.3(o)(32) of this chapter. All other food categories ...... 1.0 Emulsifier, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavor enhancer, § 170.3(o)(11) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface active agent, § 170.3(o)(29) of this chapter.

(d) Prior sanctions for sodium algi- (b) The ingredient meets the speci- nate different from the uses established fications of the ‘‘Food Chemicals in this section do not exist or have Codex,’’ 3d Ed. (1981), p. 278, which is in- been waived. corporated by reference. Copies may be obtained from the National Academy [47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1733 Sodium benzoate. ined at the National Archives and Records Administration (NARA). For (a) Sodium benzoate is the chemical information on the availability of this benzoate of soda (C H NaO ), produced 7 5 2 material at NARA, call 202–741–6030, or by the neutralization of benzoic acid go to: http://www.archives.gov/ with sodium bicarbonate, sodium car- federallregister/ bonate, or sodium hydroxide. The salt codeloflfederallregulations/ is not found to occur naturally. ibrllocations.html.

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(c) The ingredient is used as an anti- § 184.1742 Sodium carbonate. microbial agent as defined in (a) Sodium carbonate (Na2CO3, CAS § 170.3(o)(2) of this chapter, and as a fla- Reg. No. 497–19–8) is produced (1) from voring agent and adjuvant as defined in purified trona ore that has been § 170.3(o)(12) of this chapter. calcined to soda ash; (2) from trona ore (d) The ingredient is used in food at calcined to impure soda ash and then levels not to exceed good manufac- purified; or (3) synthesized from lime- turing practice. Current usage results stone by the Solvay process. in a maximum level of 0.1 percent in (b) The ingredient meets the speci- food. (The Food and Drug Administra- fications of the Food Chemicals Codex, tion has not determined whether 3d Ed. (1981), p. 280, which is incor- significally different conditions of use porated by reference. Copies are avail- would be GRAS.) able from the National Academy Press, (e) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash- different from the uses established in ington, DC 20418, or available for in- this section, or different from that set spection at the National Archives and forth in part 181 of this chapter, do not Records Administration (NARA). For exist or have been waived. information on the availability of this material at NARA, call 202–741–6030, or [42 FR 14653, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/ FR 5613, Feb. 14, 1984] federallregister/ codeloflfederallregulations/ § 184.1736 Sodium bicarbonate. ibrllocations.html.

(a) Sodium bicarbonate (NaHCO3, (c) In accordance with § 184.1(b)(1), CAS Reg. No. 144–55–8) is prepared by the ingredient is used in food with no treating a sodium carbonate or a so- limitation other than current good dium carbonate and sodium bicarbon- manufacturing practice. The affirma- ate solution with carbon dioxide. As tion of this ingredient as generally rec- carbon dioxide is absorbed, a suspen- ognized as safe (GRAS) as a direct sion of sodium bicarbonate forms. The human food ingredient is based upon slurry is filtered, forming a cake which the following current good manufacturing practice conditions of use: is washed and dried. (1) The ingredient is used in food as (b) The ingredient meets the speci- an antioxidant as defined in § 170.3(o)(3) fications of the Food Chemicals Codex, of this chapter; curing and pickling 3d Ed. (1981), p. 278, which is incor- agent as defined in § 170.3(o)(5) of this porated by reference. Copies are avail- chapter; flavoring agent and adjuvant able from the National Academy Press, as defined in § 170.3(o)(12) of this chap- 2101 Constitution Ave. NW., Wash- ter; pH control agent as defined in ington, DC 20418, or available for in- § 170.3(o)(23) of this chapter; and proc- spection at the National Archives and essing aid as defined in § 170.3(o)(24) of Records Administration (NARA). For this chapter. information on the availability of this (2) The ingredient is used in food at material at NARA, call 202–741–6030, or levels not to exceed current good mango to: http://www.archives.gov/ ufacturing practice. federallregister/ (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no [48 FR 52442, Nov. 18, 1983, as amended at 50 limitation other than current good FR 49536, Dec. 3, 1985] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1751 Sodium citrate. different from the uses established in (a) Sodium citrate (C6H5Na3O7·2H2O, this section do not exist or have been CAS Reg. No. 68–0904–092) is the sodium waived. salt of citric acid. It is prepared by neutralizing citric acid with sodium [48 FR 52442, Nov. 18, 1983] hydroxide or sodium carbonate. The

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product occurs as colorless crystals or codeloflfederallregulations/ a white crystalline powder. It may be ibrllocations.html. prepared in an anhydrous state or may (c) The ingredient is used as an anti- contain two moles of water per mole of microbial agent as defined in sodium citrate. § 170.3(o)(2) of this chapter; flavoring (b) The ingredient meets the speci- agent and adjuvant as defined in fications of the Food Chemicals Codex, § 170.3(o)(12) of this chapter; and pH 3d ed. (1981), pp. 283–284, which is incor- control agent as defined in § 170.3(o)(23) porated by reference in accordance of this chapter. with 5 U.S.C. 552(a) and 1 CFR part 51. (d) The ingredient is used in food at Copies are available from the National levels not to exceed current good man- Academy Press, 2101 Constitution Ave. ufacturing practice in accordance with NW., Washington, DC 20418, and the § 184.1(b)(1). Current good manufac- Center for Food Safety and Applied Nu- turing practice results in a maximum trition (HFS–200), 5100 Paint Branch level, as served, 0.4 percent for baked Pkwy., College Park, MD 20740, or may goods as defined in § 170.3(n)(1) of this be examined at the National Archives chapter; 0.1 percent for fats and oils as and Records Administration (NARA). defined in § 170.3(n)(12) of this chapter, For information on the availability of meat products as defined in this material at NARA, call 202–741– § 170.3(n)(29) of this chapter and soft 6030, or go to: http://www.archives.gov/ candy as defined in § 170.3(n)(38) of this federallregister/ chapter; 0.25 percent for gravies and codeloflfederallregulations/ sauces as defined in § 170.3(n)(24) of this ibrllocations.html. chapter; and 0.05 percent for snack (c) In accordance with § 184.1(b)(1), foods as defined in § 170.3(n)(37) of this the ingredient is used in food with no chapter and soups and soup mixes as defined in § 170.3(n)(40) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section, or different from those set forth in part 181 of this chapter, do not [47 FR 27815, June 25, 1982] exist or have been waived. § 184.1763 Sodium hydroxide. [59 FR 63896, Dec. 12, 1994] (a) Sodium hydroxide (NaOH, CAS Reg. No. 1310–73–2) is also known as so- § 184.1754 Sodium diacetate. dium hydrate, soda lye, caustic soda, (a) Sodium diacetate (C4H7O4Na·xH2O, white caustic, and lye. The empirical CAS Reg. No. 126–96–5) is a molecular formula is NaOH. Sodium hydroxide is compound of acetic acid, sodium ace- prepared commercially by the elec- tate, and water of hydration. The tech- trolysis of sodium chloride solution nical grade is prepared synthetically and also by reacting calcium hydroxide by reacting sodium carbonate with ace- with sodium carbonate. tic acid. Special grades are produced by (b) The ingredient meets the speci- reacting anhydrous sodium acetate and fications of the Food Chemicals Codex, acetic acid. 3d Ed. (1981), which is incorporated by (b) The ingredient meets the speci- reference. Copies are available from fications of the Food Chemicals Codex, the National Academy Press, 2101 Con- 3d Ed. (1981), p. 284, which is incor- stitution Ave. NW., Washington, DC porated by reference. Copies are avail- 20418, or available for inspection at the able from the National Academy Press, National Archives and Records Admin- 2101 Constitution Ave. NW., Wash- istration (NARA). For information on ington, DC 20418, or available for in- the availability of this material at spection at the National Archives and NARA, call 202–741–6030, or go to: http:// Records Administration (NARA). For www.archives.gov/federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no

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limitation other than current good § 184.1768 Sodium lactate. manufacturing practice. The affirma- (a) Sodium lactate (C3H5O3Na, CAS tion of this ingredient as generally rec- Reg. No. 72–17–3) is the sodium salt of ognized as safe (GRAS) as a direct lactic acid. It is prepared commercially human food ingredient is based upon by the neutralization of lactic acid the following current good manufac- with sodium hydroxide. turing practice conditions of use: (b) The ingredient must be of a pu- (1) The ingredient is used as a pH rity suitable for its intended use. control agent as defined in § 170.3(o)(23) (c) In accordance with § 184.1(b)(1), of this chapter and as a processing aid the ingredient is used in food with no as defined in § 170.3(o)(24) of this chap- limitation other than current good ter. manufacturing practice. This regula- (2) The ingredient is used in foods at tion does not authorize its use in in- levels not to exceed current good man- fant foods and infant formulas. The af- ufacturing practice. firmation of this ingredient as gen- (d) Prior sanctions for this ingredient erally recognized as safe (GRAS) as a different from the uses established in direct human food ingredient is based this section do not exist or have been upon the following current good manu- waived. facturing practice conditions of use: (1) The ingredient is used as an emul- [48 FR 52444, Nov. 18, 1983] sifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in § 184.1764 Sodium hypophosphite. § 170.3(o)(11) of this chapter; a flavoring (a) Sodium hypophosphite (NaH2PO2, agent or adjuvant as defined in CAS Reg. No. 7681–53–0) is a white, § 170.3(o)(12) of this chapter; a humec- odorless, deliquescent granular powder tant as defined in § 170.3(o)(16) of this with a saline taste. It is also prepared chapter; and a pH control agent as de- as colorless, pearly crystalline plates. fined in § 170.3(o)(23) of this chapter. It is soluble in water, alcohol, and (2) The ingredient is used in food at glycerol. It is prepared by neutraliza- levels not to exceed current good man- tion of hypophosphorous acid or by di- ufacturing practice. rect aqueous alkaline hydrolysis of (d) Prior sanctions for this ingredient white phosphorus. different from the uses established in (b) The ingredient must be of a pu- this section do not exist or have been rity suitable for its intended use. waived. (c) In accordance with § 184.1(b)(1), [52 FR 10886, Apr. 6, 1987, as amended at 73 the ingredient is used in food with no FR 8608, Feb. 14, 2008] limitations other than current good manufacturing practice. The affirma- § 184.1769a Sodium metasilicate. tion of this ingredient as generally rec- (a) Sodium metasilicate (CAS Reg. ognized as safe (GRAS) as a direct No. 6834–92–0) is a strongly alkaline human food ingredient is based upon white powder. It does not occur natu- the following current good manufac- rally but rather is synthesized by melt- turing practice conditions of use: ing sand with sodium carbonate at 1400 (1) The ingredient is used as an emul- °C. The commercially available forms sifier or stabilizer, as defined in of sodium metasilicate are the anhy- §§ 170.3(o)(8) and 170.3(o)(28) of this drous form (Na2SiO3), the pentahydrate chapter. (Na2SiO3·5H2O), and the nonahydrate (2) The ingredient is used in cod-liver (Na2SiO3·9H2O). oil emulsions at levels not to exceed (b) The ingredient must be of a pu- current good manufacturing practice. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the use established in limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [47 FR 38277, Aug. 31, 1982, as amended at 73 ognized as safe (GRAS) as a direct FR 8608, Feb. 14, 2008] human food ingredient is based upon

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the following current good manufac- (1) The ingredient is used as an anti- turing practice conditions of use: microbial agent as defined in (1) The ingredient is used as a proc- § 170.3(o)(2) of this chapter and a fla- essing aid as defined in § 170.3(o)(24) of voring agent as defined in § 170.3(o)(12) this chapter. of this chapter. (2) The ingredient is used to treat the (2) The ingredient is used in the fol- following foods at levels not to exceed lowing foods at levels not to exceed current good manufacturing practice: current good manufacturing practice: for use in washing and lye peeling of baked goods as defined in § 170.3(n)(1) of fruits, vegetables, and nuts when used this chapter; nonalcoholic beverages as in accordance with § 173.315 of this defined in § 170.3(n)(3) of this chapter; chapter; for use as a denuding agent in cheeses as defined in § 170.3(n)(5) of this tripe; for use as a hog scald agent in re- chapter; confections and frostings as moving hair; and for use as a corrosion defined in § 170.3(n)(9) of this chapter; preventative in canned and bottled gelatins, puddings, and fillings as de- water when used in accordance with fined in § 170.3(n)(22) of this chapter; § 165.110 of this chapter. jams and jellies as defined in (d) Prior sanctions for this ingredient § 170.3(n)(28) of this chapter; meat prod- different from the uses established in ucts as defined in § 170.3(n)(29) of this this section do not exist or have been chapter; and soft candy as defined in waived. § 170.3(n)(38) of this chapter. [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. (d) Prior sanctions for this ingredient 17, 1985, as amended at 72 FR 10357, Mar. 8, different from the uses established in 2007; 73 FR 8608, Feb. 14, 2008] this section do not exist or have been waived. § 184.1784 Sodium propionate. [49 FR 13142, Apr. 3, 1984] (a) Sodium propionate (C3H5NaO2, CAS Reg. No. 137–40–6) is the sodium § 184.1792 Sodium sesquicarbonate. salt of propionic acid. It occurs as colorless, transparent crystals or a (a) Sodium sesquicarbonate granular crystalline powder. It is odor- (Na2CO3·NaHCO3·2H2O, CAS Reg. No. less, or has a faint acetic-butyric acid 533–96–0) is prepared by: (1) Partial odor, and is deliquescent. It is prepared carbonation of soda ash solution fol- by neutralizing propionic acid with so- lowed by crystallization, centrifuga- dium hydroxide. tion, and drying; (2) double refining of (b) The ingredients meets the speci- trona ore, a naturally occurring im- fications of the Food Chemicals Codex, pure sodium sesquicarbonate. 3d Ed. (1981), p. 296, which is incor- (b) The ingredient meets the speci- porated by reference. Copies are avail- fications of the Food Chemicals Codex, able from the National Academy Press, 3d Ed. (1981), p. 299, which is incor- 2101 Constitution Ave. NW., Wash- porated by reference. Copies are avail- ington DC 20418, or available for inspec- able from the National Academy Press, tion at the National Archives and 2101 Constitution Ave. NW., Wash- Records Administration (NARA). For ington, DC 20418, or available for in- information on the availability of this spection at the National Archives and material at NARA, call 202–741–6030, or Records Administration (NARA). For go to: http://www.archives.gov/ information on the availability of this federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon

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the following current good manufac- and jellies as defined in § 170.3(n)(28) of turing practice conditions of use: this chapter. (1) The ingredient is used as a pH (d) Prior sanctions for this ingredient control agent as defined in § 170.3(o)(23) different from the uses established in of this chapter. this section do not exist or have been (2) The ingredient is used in cream at waived. levels not to exceed current good manufacturing practice. Current good man- [48 FR 52447, Nov. 18, 1983] ufacturing practice utilizes a level of the ingredient sufficient to control lac- § 184.1804 Sodium potassium tartrate. tic acid prior to pasteurization and (a) Sodium potassium tartrate churning of cream into butter. (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– (d) Prior sanctions for this ingredient 6) is the sodium potassium salt of different from the uses established in L¥(+)¥tartaric acid and is also called this section do not exist or have been the Rochelle salt. It occurs as colorless waived. crystals or as a white, crystalline pow- [48 FR 52443, Nov. 18, 1983] der and has a cooling saline taste. It is obtained as a byproduct of wine manu- § 184.1801 Sodium tartrate. facture.

(a) Sodium tartrate (C4H4Na2O6·2H2O, (b) The ingredient meets the speci- CAS Reg. No. 868–18–8) is the disodium fications of the Food Chemicals Codex, salt of L¥(+)¥tartaric acid. It occurs 3d Ed. (1981), p. 296, which is incor- as transparent, colorless, and odorless porated by reference. Copies are avail- crystals. It is obtained as a byproduct able from the National Academy Press, of wine manufacture. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), p. 303, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as an emul- tion of this ingredient as generally rec- sifier as defined in § 170.3(o)(8) of this ognized as safe (GRAS) as a direct chapter and as a pH control agent as human food ingredient is based upon defined in § 170.3(o)(23) of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used as an emul- current good manufacturing practice: sifier as defined in § 170.3(o)(8) of this cheeses as defined in § 170.3(n)(5) of this chapter and as a pH control agent as chapter and jams and jellies as defined defined in § 170.3(o)(23) of this chapter. in § 170.3(n)(28) of this chapter. (2) The ingredient is used in the fol- (d) Prior sanctions for this ingredient lowing foods at levels not to exceed different from the uses established in current good manufacturing practice: this section do not exist or have been cheeses as defined in§ 170.3(n)(5) of this waived. chapter; fats and oils as defined in § 170.3(n)(12) of this chapter; and jams [48 FR 52447, Nov. 18, 1983]

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§ 184.1807 Sodium thiosulfate. corporated by reference. Copies may be obtained from the National Academy (a) Sodium thiosulfate (Na S O ·5H O, 2 2 3 2 Press, 2101 Constitution Ave. NW., CAS Reg. No. 010102–0917–097) is also Washington, DC 20418, or may be exam- known as sodium hyposulfite. It is pre- ined at the National Archives and pared synthetically by the reaction of Records Administration (NARA). For sulfides and sulfur dioxide (SO ), the 2 information on the availability of this reaction of sulfur and sulfite, or the ox- material at NARA, call 202–741–6030, or idation of metal sulfides and go to: http://www.archives.gov/ hydrosulfides. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications of the ‘‘Food Chemicals ibrllocations.html. Codex,’’ 3d Ed. (1981), p. 304, which is in- (c) The ingredient is used as an corporated by reference. Copies may be anticaking agent and free-flow agent as obtained from the National Academy defined in § 170.3(o)(1) of this chapter, Press, 2101 Constitution Ave. NW., curing and pickling agent as defined in Washington, DC 20418, or may be exam- § 170.3(o)(5) of this chapter, drying ined at the National Archives and agent as defined in § 170.3(o)(7) of this Records Administration (NARA). For chapter, emulsifier and emulsifier salt information on the availability of this as defined in § 170.3(o)(8) of this chap- material at NARA, call 202–741–6030, or ter, firming agent as defined in go to: http://www.archives.gov/ § 170.3(o)(10) of this chapter, flavoring federallregister/ agent and adjuvant as defined in codeloflfederallregulations/ § 170.3(o)(12) of this chapter, formula- ibrllocations.html. tion aid as defined in § 170.3(o)(14) of (c) The ingredient is used as a formu- this chapter, humectant as defined in lation aid as defined in § 170.3(o)(14) of § 170.3(o)(16) of this chapter, lubricant this chapter and reducing agent as de- and release agent as defined in fined in § 170.3(o)(22) of this chapter. § 170.3(o)(18) of this chapter, nutritive (d) The ingredient is used in alco- sweetener as defined in § 170.3(o)(21) of holic beverages and table salt in ac- this chapter, sequestrant as defined in cordance with § 184.1(b)(1) at levels not § 170.3(o)(26) of this chapter, stabilizer to exceed good manufacturing practice. and thickener as defined in § 170.3(o)(28) Current good manufacturing practice of this chapter, surface-finishing agent results in a maximum level, as served, as defined in § 170.3(o)(30) of this chap- of 0.00005 percent for alcoholic bev- ter, and texturizer as defined in erages as defined in § 170.3(n)(2) of this § 170.3(o)(32) of this chapter. chapter and 0.1 percent for table salt as (d) The ingredient is used in food at defined in § 170.3(n)(26) of this chapter. levels not to exceed good manufac- (e) Prior sanctions for this ingredient turing practices. Current good manu- different from the uses established in facturing practice in the use of sorbitol this section do not exist or have been results in a maximum level of 99 per- waived. cent in hard candy and cough drops as [43 FR 22938, May 30, 1978, as amended at 49 defined in § 170.3(n)(25) of this chapter, FR 5613, Feb. 4, 1984] 75 percent in chewing gum as defined in § 170.3(n)(6) of this chapter, 98 percent § 184.1835 Sorbitol. in soft candy as defined in § 170.3(n)(38) (a) Sorbitol is the chemical 1,2,3,4,5,6- of this chapter, 30 percent in non- hexanehexol (C6H14O6), a hexahydric al- standardized jams and jellies, commer- cohol, differing from mannitol prin- cial, as defined in § 170.3(n)(28) of this cipally by having a different optical ro- chapter, 30 percent in baked goods and tation. Sorbitol is produced by the baking mixes as defined in § 170.3(n)(1) electrolytic reduction, or the transi- of this chapter, 17 percent in frozen tion metal catalytic hydrogenation of dairy desserts and mixes as defined in sugar solutions containing glucose or § 170.3(n)(20) of this chapter, and 12 per- fructose. cent in all other foods. (b) The ingredient meets the speci- (e) The label and labeling of food fications of the ‘‘Food Chemicals whose reasonably foreseeable consump- Codex,’’ 3d Ed. (1981), p. 308, which is in- tion may result in a daily ingestion of

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50 grams of sorbitol shall bear the § 184.1848 Starter distillate. statement: ‘‘Excess consumption may (a) Starter distillate (butter starter have a laxative effect.’’ distillate) is a steam distillate of the (f) Prior sanctions for this ingredient culture of any or all of the following different from the uses established in species of bacteria grown on a medium this regulation do not exist or have consisting of skim milk usually for- been waived. tified with about 0.1 percent citric acid: [42 FR 14653, Mar. 15, 1977, as amended at 49 Streptococcus lactis, S. cremoris, S. lactis FR 5613, Feb. 14, 1984] subsp. diacetylactis, Leuconostoc citrovorum, and L. dextranicum. The in- § 184.1845 Stannous chloride (anhy- gredient contains more than 98 percent drous and dihydrated). water, and the remainder is a mixture of butterlike flavor compounds. Diace- (a) Stannous chloride is anhydrous or tyl is the major flavor component, con- contains two molecules of water of hy- stituting as much as 80 to 90 percent of dration. Anhydrous stannous chloride the mixture of organic flavor com- (SnCl2, CAS Reg. No. 7772–99–8) is the pounds. Besides diacetyl, starter dis- chloride salt of metallic tin. It is pre- tillate contains minor amounts of acet- pared by reacting molten tin with ei- aldehyde, ethyl formate, ethyl acetate, ther chlorine or gaseous tin tetra- acetone, ethyl alcohol, 2-butanone, chloride. Dihydrated stannous chloride acetic acid, and acetoin. (SnCl2·2H2O, CAS Reg. No. 10025–0969– (b) The ingredient must be of a pu- 091) is the chloride salt of metallic tin rity suitable for its intended use. that contains two molecules of water. (c) In accordance with § 184.1(b)(1), It is prepared from granulated tin sus- the ingredient is used in food with no pended in water and hydrochloric acid limitation other than current good or chlorine. manufacturing practice. The affirma- (b) Both forms of the ingredient meet tion of this ingredient as generally rec- the specifications of the Food Chemi- ognized as safe (GRAS) as a direct cals Codex, 3d Ed. (1981), p. 312, which is human food ingredient is based upon incorporated by reference. Copies are the following current good manufac- available from the National Academy turing practice conditions of use: Press, 2101 Constitution Ave. NW., (1) The ingredient is used as a fla- Washington, DC 20418, or available for voring agent and adjuvant as defined in inspection at the National Archives § 170.3(o)(12) of this chapter. and Records Administration (NARA). (2) The ingredient is used in food at For information on the availability of levels not to exceed current good man- this material at NARA, call 202–741– ufacturing practice. 6030, or go to: http://www.archives.gov/ (d) Prior sanctions for this ingredient federallregister/ different from the uses established in codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) The ingredient is used as an anti- [48 FR 51907, Nov. 15, 1983, as amended at 73 oxidant as defined in § 170.3(o)(3) of this FR 8608, Feb. 14, 2008] chapter. § 184.1851 Stearyl citrate. (d) The ingredient is used in food at levels not to exceed current good man- (a) Stearyl citrate is a mixture of the ufacturing practice in accordance with mono-, di-, and tristearyl esters of cit- § 184.(b)(1). Current good manufacturing ric acid. It is prepared by esterifying practice results in a maximum level, as citric acid with stearyl alcohol. served, of 0.0015 percent or less; cal- (b) The ingredient must be of a pu- culated as tin, for all food categories. rity suitable for its intended use. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from those uses established in the ingredient is used in food with no limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [47 FR 27816, June 25, 1982] ognized as safe (GRAS) as a direct

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human food ingredient is based upon or enzymes, followed by refinement and the following current good manufac- crystallization from the resulting hy- turing practice conditions of use: drolysate. (1) The ingredient is used as an anti- (b) The ingredient meets the speci- oxidant as defined in § 170.3(o)(3) of this fications of the Food Chemicals Codex, chapter; an emulsifier and emulsifier 3d Ed. (1981), pp. 97–98 under the head- salt as defined in § 170.3(o)(8) of this ing ‘‘Dextrose,’’ which is incorporated chapter; a sequestrant as defined in by reference in accordance with 5 § 170.3(o)(26) of this chapter; and a sur- U.S.C. 552(a) and 1 CFR part 1. Copies face-active agent as defined in are available from the National Acad- § 170.3(o)(29) of this chapter. emy Press, 2101 Constitution Ave., NW., (2) The ingredient is used in mar- Washington, DC 20418, or available for garine in accordance with § 166.110 of inspection at the National Archives this chapter; in nonalcoholic beverages and Records Administration (NARA). as defined in § 170.3(n)(3) of this chap- For information on the availability of ter; and in fats and oils as defined in this material at NARA, call 202–741– § 170.3(n)(12) of this chapter at levels 6030, or go to: http://www.archives.gov/ not to exceed current good manufac- federallregister/ turing practice. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) In accordance with § 184.1(b)(1), this section, or different from those set the ingredient is used in food with no forth in part 181 of this chapter, do not limitation other than current good exist or have been waived. manufacturing practice. (d) Prior sanctions for this ingredient [59 FR 63897, Dec. 12, 1994, as amended at 73 FR 8608, Feb. 14, 2008] different from the uses established in this section do not exist or have been § 184.1854 Sucrose. waived.

(a) Sucrose (C12H22O11, CAS Reg. No. [53 FR 44876, Nov. 7, 1988] 57–50–11–1) sugar, cane sugar, or beet sugar is the chemical b-D- § 184.1859 Invert sugar. fructofuranosyl-a-D-glucopyranoside. (a) Invert sugar (CAS Reg. No. 8013– Sucrose is obtained by crystallization 17–0) is an aqueous solution of inverted from sugar cane or sugar beet juice or partly inverted, refined or partly re- that has been extracted by pressing or fined sucrose, the solids of which con- diffusion, then clarified and evapo- tain not more than 0.3 percent by rated. weight of ash. The solution is colorless, (b) The ingredient must be of a pu- odorless, and flavorless, except for rity suitable for its intended use. sweetness. It is produced by the hydrol- (c) In accordance with § 184.1(b)(1), ysis or partial hydrolysis of sucrose the ingredient is used in food with no with safe and suitable acids or en- limitation other than current good zymes. manufacturing practice. (b) The ingredient must be of a pu- (d) Prior sanctions for this ingredient rity suitable for its intended use. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989, as amended at 73 FR 8608, Feb. 14, 2008] (d) Prior sanctions for this ingredient different from the uses established in § 184.1857 Corn sugar. this section do not exist or have been waived. (a) Corn sugar (C6H12O6, CAS Reg. No. 50–99–7), commonly called D-glucose or [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, dextrose, is the chemical a-D- 1989, as amended at 73 FR 8608, Feb. 14, 2008] glucopyranose. It occurs as the anhydrous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of (a) Corn syrup, commonly called corn starch with safe and suitable acids ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is

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obtained by partial hydrolysis of corn go to: http://www.archives.gov/ starch with safe and suitable acids or federallregister/ enzymes. It may also occur in the de- codeloflfederallregulations/ hydrated form (dried glucose sirup). ibrllocations.html. Depending on the degree of hydrolysis, (c) In accordance with § 184.1(b)(1), corn syrup may contain, in addition to the ingredient is used in food with no glucose, maltose and higher limitation other than current good saccharides. manufacturing practice. (b) The ingredient meets the speci- [61 FR 43450, Aug.23, 1996] fications as defined and determined in § 168.120(b) or § 168.121(a) of this chapter, § 184.1875 Thiamine hydrochloride. as appropriate. (a) Thiamine hydrochloride (c) In accordance with § 184.1(b)(1), (C H C1N OS·HCl, CAS Reg. No. 67–03– the ingredient is used in food with no 12 17 4 8) is the chloride-hydrochloride salt of limitation other than current good thiamine. It occurs as hygroscopic manufacturing practice. (d) Prior sanctions for this ingredient white crystals or a white crystalline different from the uses established in powder. The usual method of preparing this section do not exist or have been this substance is by linking the waived. preformed thiazole and pyrimidine ring systems. [53 FR 44876, Nov. 7, 1988, as amended at 73 (b) The ingredient meets the speci- FR 8608, Feb. 14, 2008] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 324, which is incor- § 184.1866 High fructose corn syrup. porated by reference. Copies are avail- (a) High fructose corn syrup, a sweet, able from the National Academy Press, nutritive saccharide mixture con- 2101 Constitution Ave. NW., Wash- taining either approximately 42 or 55 ington, DC 20418, or available for in- percent fructose, is prepared as a clear spection at the National Archives and aqueous solution from high dextrose- Records Administration (NARA). For equivalent corn starch hydrolysate by information on the availability of this partial enzymatic conversion of glu- material at NARA, call 202–741–6030, or cose (dextrose) to fructose using an in- go to: http://www.archives.gov/ soluble glucose isomerase enzyme prep- federallregister/ aration described in § 184.1372. The codeloflfederallregulations/ product containing more than 50 per- ibrllocations.html. cent fructose (dry weight) is prepared (c) In accordance with § 184.1(b)(1), through concentration of the fructose the ingredient is used in food with no portion of the mixture containing less limitation other than current good than 50 percent fructose. manufacturing practice. The affirma- (b) The ingredient shall conform to tion of this ingredient as generally rec- the identity and specifications listed in ognized as safe (GRAS) as a direct the monograph entitled ‘‘High-Fruc- human food ingredient is based upon tose Corn Syrup’’ in the Food Chemi- the following current good manufac- cals Codex, 4th ed. (1996), pp. 191–192, turing practice conditions of use: which is incorporated by reference in (1) The ingredient is used as a fla- accordance with 5 U.S.C. 552(a) and 1 voring agent and adjuvant as defined in CFR part 51. Copies are available from § 170.3(o)(12) of this chapter or as a nu- the Office of Premarket Approval, Cen- trient supplement as defined in ter for Food Safety and Applied Nutri- § 170.3(o)(20) of this chapter. tion (HFS–200), Food and Drug Admin- (2) The ingredient is used in food at istration, 5100 Paint Branch Pkwy., levels not to exceed current good man- College Park, MD 20740, or may be ex- ufacturing practice. Thiamine hydro- amined at the Center for Food Safety chloride may be used in infant formula and Applied Nutrition’s Library, 5100 in accordance with section 412(g) of the Paint Branch Pkwy., College Park, MD Federal Food, Drug, and Cosmetic Act 20740, or at the National Archives and (the Act) or with regulations promul- Records Administration (NARA). For gated under section 412(a)(2) of the Act. information on the availability of this (d) Prior sanctions for this ingredient material at NARA, call 202–741–6030, or different from the uses established in

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this section do not exist or have been § 184.1890 ù-Tocopherols. waived. (a) The a-tocopherols that are the [48 FR 55124, Dec. 9, 1983] subject of this GRAS affirmation regulation are limited to the following: § 184.1878 Thiamine mononitrate. (1) d-a-Tocopherol (CAS Reg. No. 59– (a) Thiamine mononitrate 02–9) is the chemical [2R,4′R,8prime;R]- 2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl- (C12H17N5O4S, CAS Reg. No. 532–43–4) is the mononitrate salt of thiamine. It tridecyl)-6-chromanol. It occurs com- occurs as white crystals or a white mercially as a concentrate and is a red, crystalline powder and is prepared nearly odorless, viscous oil. It is ob- from thiamine hydrochloride by dis- tained by vacuum steam distillation of solving the hydrochloride salt in alka- edible vegetable oil products. line solution followed by precipitation (2) dl-a-Tocopherol (CAS Reg. No. of the nitrate half-salt with a stoichio- 10191–41–0) is a mixture of metric amount of nitric acid. stereoisomers of 2,5,7,8-tetramethyl-2- (4′,8′,12′-trimethyl-tridecyl)-6- (b) The ingredient meets the speci- chromanol. It is chemically syn- fications of the Food Chemicals Codex, thesized by condensing racemic 3d Ed. (1981), p. 325, which is incor- isophytol with trimethyl hydro- porated by reference. Copies are avail- quinone. It is a pale yellow viscous oil able from the National Academy Press, at room temperature. 2101 Constitution Ave. NW., Wash- (b) The ingredients meet the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), pp. 330–331, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(3), human food ingredient is based upon the affirmation of the ingredients as the following current good manufac- generally recognized as safe is limited turing practice conditions of use: to the following conditions of use while the agency concludes the general eval- (1) The ingredient is used as a nutri- uation of all food uses of tocopherols: ent supplement as defined in (1) The ingredients are used as inhibi- § 170.3(o)(20) of this chapter. tors of nitrosamine formation. (2) The ingredient is used in food at (2) The ingredients are used in pump- levels not to exceed current good man- cured bacon at levels not to exceed cur- ufacturing practice. Thiamine mono- rent good manufacturing practice. nitrate may be used in infant formula in accordance with section 412(g) of the [49 FR 13348, Apr. 4, 1984] Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promul- § 184.1901 Triacetin. gated under section 412(a)(2) of the Act. (a) Triacetin (C8 H14O6, CAS Reg. No. (d) Prior sanctions for this ingredient 102–76–1), also known as 1,2,3,- different from the uses established in propanetriol triacetate or glyceryl this section do not exist or have been triacetate, is the triester of glycerin waived. and acetic acid. Triacetin can be prepared by heating glycerin with acetic [48 FR 55124, Dec. 9, 1983] anhydride alone or in the presence of

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finely divided potassium hydrogen sul- (d) Prior sanctions for this ingredient fate. It can also be prepared by the re- different from the uses established in action of oxygen with a liquid-phase this section do not exist or have been mixture of allyl acetate and acetic acid waived. using a bromide salt as a catalyst. [54 FR 7404, Feb. 21, 1989] (b) The ingredient meets the specifications of the Food Chemicals Codex, § 184.1903 Tributyrin. 3d Ed. (1981), pp. 337–338, as revised by the First Supplement to the 3d Ed., (a) Tributyrin (C15H26O6, CAS Reg. which is incorporated by reference in No. 60–01–5), also known as butyrin or accordance with 5 U.S.C. 552(a). Copies glyceryl tributyrate, is the triester of are available from the National Acad- glycerin and butyric acid. It is pre- emy Press, 2102 Constitution Ave., NW., pared by esterification of glycerin with Washington, DC 20418, or available for excess butyric acid. inspection at the National Archives (b) The ingredient meets the speci- and Records Administration (NARA). fication of the Food Chemicals Codex, For information on the availability of 3d Ed. (1981), p. 416, which is incor- this material at NARA, call 202–741– porated by reference in accordance 6030, or go to: http://www.archives.gov/ with 5 U.S.C. 552(a). Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used in food as a the ingredient is used in food with no flavoring agent and adjuvant as defined limitation other than current good in § 170.3(o)(12) of this chapter; a formu- manufacturing practice. The affirma- lation aid as defined in § 170.3(o)(14) of tion of this ingredient as generaly rec- this chapter; and humectant as defined ognized as safe (GRAS) as a direct in § 170.3(o)(16) of this chapter; and a human food ingredient is based upon solvent and vehicle as defined in the following current good manufac- § 170.3(o)(27) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used in food as a lowing foods at levels not to exceed flavoring agent and adjuvant as defined current good manufacturing practice: in § 170.3(o)(12) of this chapter. baked goods and baking mixes as de- (2) The ingredient is used in the fol- fined in § 170.3(n)(1) of this chapter, al- lowing foods at levels not to exceed coholic beverages as defined in current good manufacturing practice; § 170.3(n)(2) of this chapter; non- baked goods as defined in § 170.3(n)(1) of alcoholic beverages and beverage bases this chapter; alcoholic beverages as de- as defined in § 170.3(n)(3) of this chap- fined in § 170.3(n)(2) of this chapter; ter; chewing gum as defined in nonalcoholic beverages as defined in § 170.3(n)(6) of this chapter; confections § 170.3(n)(3) of this chapter; fats and oils and frostings as defined in § 170.3(n)(9) as defined in § 170.3(n)(12) of this chap- of this chapter; frozen dairy dessert ter; frozen dairy desserts and mixes as and mixes as defined in § 170.3(n)(20) of defined in § 170.3(n)(20) of this chapter; this chapter; gelatins, puddings, and gelatins, puddings and fillngs as de- fillngs as defined in § 170.3(n)(22) of this fined in § 170.3(n)(22) of this chapter; chapter; hard candy as defined in and soft candy as defined in § 170.3(n)(25) of this chapter; and soft § 170.3(n)(38) of this chapter. candy as defined in § 170.3(n)(38) of this (d) Prior sanctions for this ingredient chapter. different from the uses established in

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this section do not exist or have been § 184.1914 Trypsin. waived. (a) Trypsin (CAS Reg. No. 9002–07–7) [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, is an enzyme preparation obtained 1989] from purified extracts of porcine or bovine pancreas. It is a white to tan § 184.1911 Triethyl citrate. amorphous powder. Its characterizing enzyme activity is that of a peptide hy- (a) Triethyl citrate (C12H20O7, CAS Reg. No. 77–93–0) is the triethyl ester of drolase (EC 3.4.21.4). citric acid. It is prepared by esterifying (b) The ingredient meets the general requirements and additional require- citric acid with ethyl alcohol and oc- ments for enzyme preparations in the curs as an odorless, practically color- Food Chemicals Codex, 3d ed. (1981), p. less, oily liquid. 110, which is incorporated by reference (b) The ingredient meets the speci- in accordance with 5 U.S.C. 552(a) and 1 fications of the Food Chemicals Codex, CFR part 51. Copies are available from 3d ed. (1981), p. 339, which is incor- the National Academy Press, 2101 Con- porated by reference in accordance stitution Ave. NW., Washington, DC with 5 U.S.C. 552(a) and 1 CFR part 51. 20418, or may be examined at the Office Copies are available from the National of Premarket Approval (HFS–200), Food Academy Press, 2101 Constitution Ave. and Drug Administration, 5100 Paint NW., Washington, DC 20418, and the Branch Pkwy., College Park, MD 20740, Center for Food Safety and Applied Nu- and at the National Archives and trition (HFS–200), 5100 Paint Branch Records Administration (NARA). For Pkwy., College Park, MD 20740, or may information on the availability of this be examined at the National Archives material at NARA, call 202–741–6030, or and Records Administration (NARA). go to: http://www.archives.gov/ For information on the availability of federallregister/ this material at NARA, call 202–741– codeloflfederallregulations/ 6030, or go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as GRAS as a di- the ingredient is used in food with no rect food ingredient is based upon the limitation other than current good following current good manufacturing manufacturing practice. The affirma- practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as an en- ognized as safe (GRAS) as a direct zyme as defined in § 170.3(o)(9) of this human food ingredient is based upon chapter to hydrolyze proteins or the following current good manufac- polypeptides. turing practice conditions of use: (2) The ingredient is used in food at (1) The ingredient is used as a fla- levels not to exceed current good man- voring agent as defined in § 170.3(o)(12) ufacturing practice. of this chapter; a solvent and vehicle as [60 FR 32911, June 26, 1995] defined in § 170.3(o)(27) of this chapter; and a surface-active agent as defined in § 184.1923 Urea. § 170.3(o)(29) of this chapter. (a) Urea (CO(NH2)2, CAS Reg. No. 57– (2) The ingredient is used in foods at 13–6) is the diamide of carbonic acid levels not to exceed current good man- and is also known as carbamide. It is a ufacturing practice. white, odorless solid and is commonly (d) Prior sanctions for this ingredient produced from CO2 by ammonolysis or different from the uses established in from cyanamide by hydrolysis. this section, or different from those set (b) The ingredient must be of a pu- forth in part 181 of this chapter, do not rity suitable for its intended use. exist or have been waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [59 FR 63897, Dec. 12, 1994] limitation other than current good

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manufacturing practice. The affirma- upon the following current good manu- tion of this ingredient as generally rec- facturing practice conditions of use: ognized as safe as a direct human food (1) The ingredient is used in wine, as ingredient is based upon the following defined in 27 CFR 2.5 and 4.10, as an en- current good manufacturing practice zyme as defined in § 170.3(o)(9) of this conditions of use: chapter to convert urea to ammonia (1) The ingredient is used as a formu- and carbon dioxide. lation aid as defined in § 170.3(o)(14) of (2) The ingredient is used in food at this chapter and as a fermentation aid. levels not to exceed current good man- (2) The ingredient is used in yeast- ufacturing practice. Current good man- raised bakery products; in alcoholic ufacturing practice is limited to use of beverages as defined in § 170.3(n)(2) of this ingredient in wine to inhibit for- this chapter; and in gelatin products. mation of ethyl carbamate. (d) Prior sanctions for this ingredient different from the uses established in [57 FR 60473, Dec. 21, 1992] this section do not exist or have been waived. § 184.1930 Vitamin A. (a)(1) Vitamin A (retinol; CAS Reg. [48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984; 73 FR 8608, Feb. 14, No. 68–26–8) is the alcohol 9,13-di- 2008] methyl-7-(1,1,5-trimethyl-6-cyclohexen- 5-yl)-7,9,11,13-nonatetraen-15-ol. It may § 184.1924 Urease enzyme preparation be nearly odorless or have a mild fishy from Lactobacillus fermentum. odor. Vitamin A is extracted from fish (a) This enzyme preparation is deliver oils or produced by total syn- rived from the nonpathogenic, thesis from b-ionone and a propargyl nontoxicogenic bacterium Lactobacillus halide. fermentum. It contains the enzyme (2) Vitamin A acetate (retinyl ace- urease (CAS Reg. No. 9002–13–5), which tate; CAS Reg. No. 127–47–9) is the ace- facilitates the hydrolysis of urea to tate ester of retinol. It is prepared by ammonia and carbon dioxide. It is pro- esterifying retinol with acetic acid. duced by a pure culture fermentation (3) Vitamin A palmitate (retinyl process and by using materials that are palmitate; CAS Reg. No. 79–81–2) is the generally recognized as safe (GRAS) or palmitate ester of retinol. It is pre- are food additives that have been ap- pared by esterifying retinol with pal- proved for this use by the Food and mitic acid. Drug Administration (FDA). (b) The ingredient meets the speci- (b) The ingredient meets the general fications for vitamin A in the Food and additional requirements for en- Chemicals Codex, 3d Ed. (1981), p. 342, zyme preparations in the ‘‘Food Chemi- which is incorporated by reference. cals Codex,’’ 3d ed. (1981), pp. 107–110, Copies are available from the National which is incorporated by reference in Academy Press, 2101 Constitution Ave. accordance with 5 U.S.C. 552(a) and 1 NW., Washington, DC 20418, or avail- CFR part 51. Copies are available from able for inspection at the National Ar- the National Academy Press, 2101 Con- chives and Records Administration stitution Ave. NW., Washington, DC (NARA). For information on the avail- 20418, or available for inspection at the ability of this material at NARA, call National Archives and Records Admin- 202–741–6030, or go to: http:// istration (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/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as GRAS as a di- the following current good manufac- rect human food ingredient is based turing practice conditions of use:

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(1) The ingredient is used in food as a (d) Prior sanctions for this ingredient nutrient supplement as defined in different from the uses established in § 170.3(o)(20) of this chapter. this section do not exist or have been (2) The ingredient is used in foods at waived. levels not to exceed current good man- [50 FR 6341, Feb. 15, 1985] ufacturing practice. Vitamin A may be used in infant formula in accordance § 184.1950 Vitamin D. with section 412(g) of the Federal Food, (a) Vitamin D is added to food as the Drug, and Cosmetic Act (the act) or following food ingredients: with regulations promulgated under (1) Crystalline vitamin D2 (C28H44O, section 412(a)(2) of the Act. CAS Reg. No. 50–14–6), also known as (d) Prior sanctions for this ingredient ergocalciferol, is the chemical 9,10- different from the uses established in seco(5Z,7E,22E)-5,7,10(19),22- this section do not exist or have been ergostatetraen-3-ol. The ingredient is waived. produced by ultraviolet irradiation of [48 FR 51610, Nov. 10, 1983] ergosterol isolated from yeast and related fungi and is purified by crys-

§ 184.1945 Vitamin B12. tallization. (2) Crystalline vitamin D (C H O, (a) Vitamin B , also known as cyano- 3 27 44 12 CAS Reg. No. 67–97–0), also known as cobalamin (C H CoN O P, CAS Reg. 63 88 14 14 cholecalciferol, is the chemical 9,10- No. 68–0919–099), is produced commer- seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- cially from cultures of Streptomyces ol. Vitamin D3 occurs in, and is iso- griseus. lated from, fish liver oils. It is also (b) The ingredient meets the speci- manufactured by ultraviolet irradia- fications of the Food Chemicals Codex, tion of 7-dehydrocholesterol produced 3d Ed. (1981), p. 343, which is incor- from cholesterol. It is purified by crys- porated by reference. Copies are avail- tallization. Vitamin D3 is the vitamin able from the National Academy Press, D form that is produced endogenously 2101 Constitution Ave. NW., Wash- in humans through sunlight activation ington, DC 20418, or available for in- of 7-dehydrocholesterol in the skin. spection at the National Archives and (3) Vitamin D2 resin and vitamin D3 Records Administration (NARA). For resin are the concentrated forms of ir- information on the availability of this radiated ergosterol (D2) and irradiated material at NARA, call 202–741–6030, or 7-dehydrocholesterol (D3) that are sepa- go to: http://www.archives.gov/ rated from the reacting materials in federallregister/ paragraphs (a) (1) and (2) of this sec- codeloflfederallregulations/ tion. The resulting products are sold as ibrllocations.html. food sources of vitamin D without fur- (c) In accordance with § 184.1(b)(1), ther purification. the ingredient is used in food with no (b) Vitamin D2 and vitamin D3 as limitation other than current good crystals meet the specifications of the manufacturing practice. The affirma- Food Chemicals Codex, 3d Ed. (1981), tion of this ingredient as generally rec- pp. 344 and 345, which is incorporated ognized as safe (GRAS) as a direct by reference. Copies are available from human food ingredient is based upon the National Academy Press, 2101 Con- the following current good manufac- stitution Ave. NW., Washington, DC turing practice conditions of use: 20418, or available for inspection at the (1) The ingredient is used as a nutri- National Archives and Records Admin- ent supplement as defined in istration (NARA). For information on § 170.3(o)(20) of this chapter. the availability of this material at (2) The ingredient is used in food at NARA, call 202–741–6030, or go to: http:// levels not to exceed current good man- www.archives.gov/federallregister/ ufacturing practice. Vitamin B12 also codeloflfederallregulationsll may be used in infant formula in ac- ibrllocations.html. Vitamin D2 resin cordance with section 412(g) of the Fed- and vitamin D3 resin must be of a pu- eral Food, Drug, and Cosmetic Act (the rity suitable for their intended use. act) or with regulations promulgated (c)(1) In accordance with § 184.1(b)(2), under section 412(a)(2) of the act. the ingredients are used in food as the

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sole source of added vitamin D only information on the availability of this within the following specific limita- material at NARA, call 202–741–6030, or tions: go to: http://www.archives.gov/ federallregister/ Maximum levels in Category of food food (as served) Functional use codeloflfederallregulations/ ibrllocations.html. Breakfast cereals, 350 (IU/100 Nutrient supple- § 170.3(n)(4) of grams). ment, (c) The ingredient is used as a fla- this chapter. § 170.3(o)(20) of voring agent and adjuvant as defined in this chapter. § 170.3(o)(12) of this chapter, as a lubri- Grain products and 90(IU/100 grams) Do. cant as defined in § 170.3(o)(18) of this pastas, § 170.3(n)(23) of chapter, and as a surface-finishing this chapter. agent as defined in § 170.3(o)(30) of this Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. chapter. of this chapter. Milk products, 89 (IU/100 grams) Do. (d) The ingredient is used in food, in § 170.3(n)(31) of accordance with § 184.1(b)(1) of this this chapter. chapter, at levels not to exceed good manufacturing practice. Current good (2) Vitamin D may be used in infant manufacturing practice results in a formula in accordance with section maximum level, as served, of: 0.065 per- 412(g) of the Federal Food, Drug, and cent for chewing gum as defined in Cosmetic Act (the act) or with regula- § 170.3(n)(6) of this chapter; 0.005 per- tions promulgated under section cent for confections and frostings as 412(a)(2) of the act. (3) Vitamin D may be used in mar- defined in § 170.3(n)(9) of this chapter; garine in accordance with § 166.110 of 0.04 percent for hard candy as defined this chapter. in § 170.3(n)(25) of this chapter; 0.1 per- (d) Prior sanctions for these ingredi- cent for soft candy as defined in ents different from the uses established § 170.3(n)(38) of this chapter; and 0.002 in this section do not exist or have percent or less for all other food cat- been waived. egories. [50 FR 30152, July 24, 1985, as amended at 73 [43 FR 14644, Apr. 7, 1978, as amended at 49 FR 8608, Feb. 14, 2008] FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, 1985] § 184.1973 Beeswax (yellow and white). § 184.1976 Candelilla wax. (a) Beeswax (CAS Reg. No. 8012–89–3) is a secretory product of honey bees (a) Candelilla wax (CAS Reg. No. used as a structural material in honey- 8006–44–8) is obtained from the can- combs. Beeswax is prepared from hon- delilla plant. It is a hard, yellowish- eycombs after removal of the honey by brown, opaque-to-translucent wax. draining or centrifuging. The combs Candelilla wax is prepared by immers- are melted in hot water or steam or ing the plants in boiling water con- with solar heat, and strained. The wax taining sulfuric acid and skimming off is refined by melting in hot water to the wax that rises to the surface. It is which sulfuric acid or alkali may be composed of about 50 percent hydro- added to extract impurities. The re- carbons with smaller amounts of esters sulting wax is referred to as yellow and free acids. beeswax. White beeswax is produced by (b) The ingredient meets the speci- bleaching the constituent pigments of fications of the Food Chemicals Codex, yellow beeswax with peroxides, or pref- 3d Ed. (1981), p. 67, which is incor- erably it is bleached by sun light. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the ‘‘Food Chemicals 2101 Constitution Ave. NW., Wash- Codex,’’ 3d Ed. (1981), pp. 34–35, which is ington, DC 20418, or available for in- incorporated by reference. Copies may spection at the National Archives and be obtained from the National Acad- Records Administration (NARA). For emy Press, 2101 Constitution Ave. NW., information on the availability of this Washington, DC 20418, or may be exam- material at NARA, call 202–741–6030, or ined at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/

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codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally rection of this ingredient as generally recognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufacturing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as a lubri- (1) The ingredient is used as an cant as defined in § 170.3(o)(18) of this anticaking agent as defined § 170.3(o)(1) chapter and as a surface-finishing of this chapter; as a formulation aid as agent as defined in § 170.3(o)(30) of this defined in § 170.3(o)(14) of this chapter; chapter. as a lubricant and release agent as de- (2) The ingredient is used in the fol- fined in § 170.3(o)(18) of this chapter; lowing foods at levels not to exceed and as a surface-finishing agent as de- current good manufacturing practice: fined in § 170.3(o)(30) of this chapter. in chewing gum as defined in (2) The ingredient is used in the fol- § 170.3(n)(6) of this chapter and in hard lowing foods at levels not to exceed candy as defined in § 170.3(n)(25) of this current good manufacturing practice: baked goods and baking mixes as de- chapter. fined in § 170.3(n)(1) of this chapter; (d) Prior sanctions for this ingredient chewing gun as defined in § 170.3(n)(6) of different from the uses established in this chapter; confections and frostings this section do not exist or have been as defined in § 170.3(n)(9) of this chap- waived. ter; fresh fruits and fruit juices as de- [48 FR 51617, Nov. 10, 1983] fined in § 170.3(n)(16) of this chapter; gravies and sauces as defined in § 184.1978 Carnauba wax. § 170.3(n)(24) of this chapter; processed (a) Carnauba wax (CAS Reg. No. 008– fruits and fruit juices as defined in 015–869) is obtained from the leaves and § 170.3(n)(35) of this chapter; and soft buds of the Brazilian wax palm candy as defined in § 170.3(n)(38) of this Copernicia cerifera Martius. The wax is chapter. hard, brittle, sparingly soluble in cold (d) Prior sanctions for this ingredient organic solvents and insoluble in different from the uses established in water. It is marketed in five grades this section do not exist or have been designated No. 1 through No. 5. Grades waived. No. 4 and No. 5 represent the bulk of [48 FR 51147, Nov. 7, 1983] the commercial trade volume. These commercial grades consist chiefly of § 184.1979 Whey. C24 to C32 normal saturated (a)(1) Whey. Whey is the liquid sub- monofunctional fatty acids and normal stance obtained by separating the co- saturated monofunctional primary al- agulum from milk, cream, or skim cohols. milk in cheesemaking. Whey obtained (b) The ingredient meets the speci- from a procedure, in which a signifi- fications of the Food Chemicals Codex, cant amount of lactose is converted to 3d Ed. (1981), p. 73, which is incor- lactic acid, or from the curd formation porated by reference. Copies are avail- by direct acidification of milk, is able from the National Academy Press, known as acid whey. Whey obtained 2101 Constitution Ave. NW., Wash- from a procedure in which there is in- ington, DC 20418, or available for insignificant conversion of lactose to lac- spection at the National Archives and tic acid is known as sweet whey. Sweet Records Administration (NARA). For whey has a maximum titratable acid- information on the availability of this ity of not more than 0.16 percent, cal- material at NARA, call 202–741–6030, or culated as lactic acid, and an alka- go to: http://www.archives.gov/ linity of ash of not more than 225 milli- federallregister/ liters of 0.1N hydrochloric acid per 100

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grams. The acidity of whey, sweet or 16.199 (dry sample), entitled ‘‘Fat in acid, may be adjusted by the addition Dried Milk (45)—Official Final Action.’’ of safe and suitable pH-adjusting ingre- (iii) Ash content, 7 to 14 percent—as dients. determined by the methods prescribed (2) Concentrated whey. Concentrated in section 16.035 (liquid sample), enti- whey is the liquid substance obtained tled ‘‘Ash (5)—Official Final Action’’ by the partial removal of water from under the heading ‘‘Total Solids,’’ or in whey, while leaving all other constitu- section 16.196 (dry sample), entitled ents in the same relative proportions ‘‘Ash—Official Final Action’’ under the as in whey. heading ‘‘Dried Milk, Nonfat Dry Milk, (3) Dry or dried whey. Dry or dried and Malted Milk.’’ whey is the dry substance obtained by (iv) Lactose content, 61 to 75 per- the removal of water from whey, while cent—as determined by the methods leaving all other constituents in the prescribed in section 16.057 (liquid sam- same relative proportions as in whey. ple), entitled ‘‘Gravimetric Method— (b) The ingredients meet the fol- Official Final Action’’ under the head- lowing specifications: ing ‘‘Lactose,’’ or in section 31.061 (dry sample), entitled ‘‘Lane-Eynon General (1) The analysis of whey, con- Volumetric Method’’ under the heading centrated whey, and dry (dried) whey, ‘‘Lactose—Chemical Methods—Official on a dry product basis, based on ana- Final Action.’’ lytical methods in the referenced sec- (v) Moisture content, 1 to 8 percent— tions of ‘‘Official Methods of Analysis as determined by the methods pre- of the Association of Official Analyt- scribed in section 16.192, entitled ical Chemists,’’ 13th ed. (1980), which is ‘‘Moisture (41)—Official Final Action’’ incorporated by reference in accord- under the heading ‘‘Dried Milk, Nonfat ance with 5 U.S.C. 552(a) and 1 CFR Dry Milk, and Malted Milk.’’ part 51, is given in paragraphs (b)(1)(i) (vi) Solids content, variable—as de- through (b)(1)(vii) of this section. Cop- termined by the methods prescribed in ies may be obtained from the AOAC section 16.032, entitled ‘‘Method I—Offi- INTERNATIONAL, 481 North Frederick cial Final Action’’ under the heading Ave., suite 500, Gaithersburg, MD 20877, ‘‘Total Solids.’’ or may be examined at the Center for (vii) Titratable Acidity, variable—as Food Safety and Applied Nutrition’s determined by the methods prescribed Library, Food and Drug Administra- in section 16.023, entitled ‘‘Acidity (2)— tion, 5100 Paint Branch Pkwy., College Official Final Action’’ under the head- Park, MD 20740, or at the National Ar- ing ‘‘Milk,’’ or by an equivalent poten- chives and Records Administration tiometric method. (NARA). For information on the avail- (2) Limits of impurities are: Heavy ability of this material at NARA, call metals (as lead). Not more than 10 202–741–6030, or go to: http:// parts per million (0.001 percent) as de- www.archives.gov/federallregister/ termined by the method described in codeloflfederallregulations/ the ‘‘Food Chemicals Codex,’’ 4th ed. ibrllocations.html. (1996), pp. 760–761, which is incorporated (i) Protein content, 10 to 15 percent— by reference in accordance with 5 as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies scribed in section 16.036 (liquid sample), are available from the National Acad- entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may sample), entitled ‘‘Kjeldahl Method’’ be examined at the Center for Food under the heading ‘‘Protein—Official Safety and Applied Nutrition’s Li- Final Action.’’ brary, Food and Drug Administration, (ii) Fat content, 0.2 to 2.0 percent—as 5100 Paint Branch Pkwy., College Park, determined by the methods prescribed MD 20740, or at the National Archives in section 16.059 (liquid sample), and Records Administration (NARA). ‘‘Reese-Gottlieb Method [Reference For information on the availability of Method] (11)—Official Final Action’’ this material at NARA, call 202–741– under the heading ‘‘Fat,’’ or in section 6030, or go to: http://www.archives.gov/

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federallregister/ INTERNATIONAL, 481 North Frederick codeloflfederallregulations/ Ave., suite 500, Gaithersburg, MD 20877, ibrllocations.html. or may be examined at the Center for (3) The whey must be derived from Food Safety and Applied Nutrition’s milk that has been pasteurized, or the Library, Food and Drug Administra- whey and modified whey product must tion, 5100 Paint Branch Pkwy., College be subjected to pasteurization tech- Park, MD 20740, or at the National Ar- niques or its equivalent before use in chives and Records Administration food. (NARA). For information on the avail- (c) Whey, concentrated whey, and dry ability of this material at NARA, call (dried) whey may be used in food in ac- 202–741–6030, or go to: http:// cordance with good manufacturing www.archives.gov/federallregister/ practice as indicated in § 184.1(b)(1). codeloflfederallregulations/ (d) The label on the whey form sold ibrllocations.html. to food manufacturers shall read as fol- (i) Protein content, 16 to 24 percent— lows: as determined by the methods pre- (1) For whey: ‘‘(Sweet or acid) whey’’ scribed in section 16.036 (liquid sample), or ‘‘whey (ll% titratable acidity). entitled ‘‘Total Nitrogen—Official (2) For concentrated whey: ‘‘Con- Final Action’’ under the heading centrated (sweet or acid) whey, % ll ‘‘Total Solids,’’ or in section 16.193 (dry solids’’ or ‘‘Concentrated whey (ll% sample), entitled ‘‘Kjeldahl Method’’ titratable acidity), ll% solids’’. under the heading ‘‘Protein—Official (3) For dry (dried) whey: ‘‘Dry (dried) Final Action.’’ (sweet or acid) whey’’ or ‘‘dry (dried) whey, (ll% titratable acidity)’’. (ii) Fat content, 1 to 4 percent—as de- (e) Whey, concentrated whey, or dry termined by the methods prescribed in (dried) whey in a finished food product section 16.059 (liquid sample), ‘‘Reese- shall be listed as ‘‘whey.’’ Gottlieb Method [Reference Method] (11)—Official Final Action’’ under the [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, heading ‘‘Fat,’’ or in section 16.199 (dry 1982, as amended at 54 FR 24899, June 12, 1989; sample), entitled ‘‘Fat in Dried Milk 64 FR 1760, Jan. 12, 1999] (45)—Official Final Action.’’ § 184.1979a Reduced lactose whey. (iii) Ash content, 11 to 27 percent—as determined by the methods prescribed (a) Reduced lactose whey is the substance obtained by the removal of lac- in section 16.035 (liquid sample), enti- tose from whey. The lactose content of tled ‘‘Ash (5)—Official Final Action’’ the finished dry product shall not ex- under the heading ‘‘Total Solids,’’ or in ceed 60 percent. Removal of the lactose section 16.196 (dry sample), entitled is accomplished by physical separation ‘‘Ash—Official Final Action’’ under the techniques such as precipitation, filtra- heading ‘‘Dried Milk, Nonfat Dry Milk, tion, or dialysis. As with whey, reduced and Malted Milk.’’ lactose whey can be used as a fluid, (iv) Lactose content, not more than concentrate, or a dry product form. 60 percent—as determined by the meth- The acidity of reduced lactose whey ods prescribed in section 16.057 (liquid may be adjusted by the addition of safe sample), entitled ‘‘Gravimetric Meth- and suitable pH-adjusting ingredients. od—Official Final Action’’ under the (b) The reduced lactose whey meets heading ‘‘Lactose,’’ or in section 31.061 the following specifications: (dry sample), entitled ‘‘Lane-Eynon (1) The analysis of reduced lactose General Volumetric Method’’ under the whey, on a dry product basis, based on heading ‘‘Lactose—Chemical Meth- analytical methods in the referenced ods—Official Final Action.’’ sections of ‘‘Official Methods of Anal- (v) Moisture content, 1 to 6 percent— ysis of the Association of Official Ana- as determined by the method pre- lytical Chemists,’’ 13th ed. (1980), which scribed in section 16.192, entitled is incorporated by reference in accord- ‘‘Moisture (41)—Official Final Action’’ ance with 5 U.S.C. 552(a) and 1 CFR under the heading ‘‘Dried Milk, Nonfat part 51, is given in paragraphs (b)(1)(i) Dry Milk, and Malted Milk.’’ through (b)(1)(vii) of this section. Cop- (vi) Solids content, variable—as de- ies may be obtained from the AOAC termined by the methods prescribed in

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section 16.032, entitled ‘‘Method I—Offi- (e) The presence of reduced lactose cial Final Action’’ under the heading whey in a finished food product shall be ‘‘Total Solids.’’ listed as ‘‘reduced lactose whey.’’ (vii) Titratable Acidity, variable—as [46 FR 44440, Sept. 4, 1981, as amended at 54 determined by the methods prescribed FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, in section 16.023, entitled ‘‘Acidity (2)— 1999] Official Final Action’’ under the heading ‘‘Milk,’’ or by an equivalent poten- § 184.1979b Reduced minerals whey. tiometric method. (a) Reduced minerals whey is the sub- (2) Limits of impurities are: Heavy stance obtained by the removal of a metals (as lead). Not more than 10 portion of the minerals from whey. The parts per million (0.001 percent), as de- dry product shall not contain more termined by the method described in than 7 percent ash. Reduced minerals the ‘‘Food Chemicals Codex,’’ 4th ed. whey is produced by physical separa- (1996), pp. 760–761, which is incorporated tion techniques such as precipitation, by reference in accordance with 5 filtration, or dialysis. As with whey, U.S.C. 552(a) and 1 CFR part 51. Copies reduced minerals whey can be used as a are available from the National Acad- fluid, concentrate, or a dry product emy Press, Box 285, 2101 Constitution form. The acidity of reduced minerals Ave. NW., Washington, DC 20055 (Inter- whey may be adjusted by the addi- net address http://www.nap.edu), or may tional of safe and suitable pH-adjusting be examined at the Center for Food ingredients. Safety and Applied Nutrition’s Li- (b) The reduced minerals whey meets brary, Food and Drug Administration, the following specifications: 5100 Paint Branch Pkwy., College Park, (1) The analysis of reduced minerals MD 20740, or at the National Archives whey, on a dry product basis, based on and Records Administration (NARA). analytical methods in the referenced For information on the availability of sections of ‘‘Official Methods of Anal- this material at NARA, call 202–741– ysis of the Association of Official Ana- lytical Chemists,’’ 13th ed. (1980), which 6030, or go to: http://www.archives.gov/ is incorporated by reference in accord- federallregister/ ance with 5 U.S.C. 552(a) and 1 CFR codeloflfederallregulations/ part 51, is given in paragraphs (b)(1)(i) ibrllocations.html. through (b)(1)(vii) of this section. Cop- (3) The reduced lactose whey shall be ies may be obtained from the AOAC derived from milk that has been pas- INTERNATIONAL, 481 North Frederick teurized, or the reduced lactose whey Ave., suite 500, Gaithersburg, MD 20877, shall be subjected to pasteurization or may be examined at the Center for techniques or its equivalent before use Food Safety and Applied Nutrition’s in food. Library, Food and Drug Administra- (c) Reduced lactose whey may be tion, 5100 Paint Branch Pkwy., College used in food in accordance with good Park, MD 20740, or at the National Ar- manufacturing practice as indicated in chives and Records Administration § 184.1(b)(1). (NARA). For information on the avail- (d) The percent of lactose present on ability of this material at NARA, call a dry product basis, i.e., ‘‘reduced lac- 202–741–6030, or go to: http:// tose whey (ll% lactose),’’ shall be de- www.archives.gov/federallregister/ clared on the label of the package sold codeloflfederallregulations/ to food manufacturers. The percent of ibrllocations.html. lactose may be declared in 5-percent (i) Protein content, 10 to 24 percent— increments, expressed as a multiple of as determined by the methods pre- 5, not greater than the actual percent- scribed in section 16.036 (liquid sample), entitled ‘‘Total Nitrogen—Official age of lactose in the product, or as an Final Action’’ under the heading actual percentage provided that an ‘‘Total Solids,’’ or in section 16.193 (dry analysis of the product on which the sample), entitled ‘‘Kjeldahl Method’’ actual percentage is based is supplied under the heading ‘‘Protein—Official to the food manufacturer. Final Action.’’

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(ii) Fat content, 1 to 4 percent—as de- 5100 Paint Branch Pkwy., College Park, termined by the methods prescribed in MD 20740, or at the National Archives section 16.059 (liquid sample), ‘‘Reese- and Records Administration (NARA). Gottlieb Method [Reference Method] For information on the availability of (11)—Official Final Action’’ under the this material at NARA, call 202–741– heading ‘‘Fat,’’ or in section 16.199 (dry 6030, or go to: http://www.archives.gov/ sample), entitled ‘‘Fat in Dried Milk federallregister/ (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, maximum 7 per- ibrllocations.html. cent—as determined by the methods (3) The reduced minerals whey shall prescribed in section 16.035 (liquid sam- be derived from milk that has been pas- ple), entitled ‘‘Ash (5)—Official Final teurized, or the reduced minerals whey Action’’ under the heading ‘‘Total Sol- shall be subjected to pasteurization ids,’’ or in section 16.196 (dry sample), techniques or its equivalent before use entitled ‘‘Ash—Official Final Action’’ in food. under the heading ‘‘Dried Milk, Nonfat (c) The reduced minerals whey may Dry Milk, and Malted Milk.’’ be used in food in accordance with good (iv) Lactose content, maximum 85 manufacturing practice as indicated in percent—as determined by the methods § 184.1(b)(1). prescribed in section 16.057 (liquid sam- (d) The percent of minerals present ple), entitled ‘‘Gravimetric Method— on a dry product basis, i.e., ‘‘reduced Official Final Action’’ under the head- minerals whey (ll% minerals),’’ shall ing ‘‘Lactose,’’ or in section 31.061 (dry be declared on the label of the package sample), entitled ‘‘Lane-Eynon General sold to food manufacturers. The per- Volumetric Method’’ under the heading cent of minerals may be declared in 2- ‘‘Lactose—Chemical Methods—Official percent increments expressed as a mul- Final Action.’’ tiple of 2, not greater than the actual (v) Moisture content, 1 to 6 percent— percentage of minerals in the product, as determined by the methods pre- or as an actual percentage provided scribed in section 16.192, entitled that an analysis of the product on ‘‘Moisture (41)—Official Final Action’’ which the actual percentage is based is under the heading ‘‘Dried Milk, Nonfat supplied to the food manufacturer. Dry Milk, and Malted Milk.’’ (e) The presence of reduced minerals (vi) Solids content, variable—as de- whey in a finished food product shall be termined by the methods prescribed in listed as ‘‘reduced minerals whey’’. section 16.032, entitled ‘‘Method I—Offi- cial Final Action’’ under the heading [46 FR 44441, Sept. 4, 1981, as amended at 54 ‘‘Total Solid.’’ FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, (vii) Titratable Acidity, variable—as 1999] determined by the methods prescribed § 184.1979c Whey protein concentrate. in section 16.023, entitled ‘‘Acidity (2)— Official Final Action’’ under the head- (a) Whey protein concentrate is the ing ‘‘Milk,’’ or by an equivalent poten- substance obtained by the removal of tiometric method. sufficient nonprotein constituents from (2) Limits of impurities are: Heavy whey so that the finished dry product metals (as lead). Not more than 10 contains not less than 25 percent pro- parts per million (0.001 percent), as de- tein. Whey protein concentrate is pro- termined by the method described in duced by physical separation tech- the ‘‘Food Chemicals Codex,’’ 4th ed. niques such as precipitation, filtration, (1996), pp. 760–761, which is incorporated or dialysis. As with whey, whey protein by reference in accordance with 5 concentrate can be used as a fluid, con- U.S.C. 552(a) and 1 CFR part 51. Copies centrate, or dry product form. The are available from the National Acad- acidity of whey protein concentrate emy Press, Box 285, 2101 Constitution may be adjusted by the addition of safe Ave. NW., Washington, DC 20055 (Inter- and suitable pH-adjusting ingredients. net address http://www.nap.edu), or may (b) The whey protein concentrate be examined at the Center for Food meets the following specifications: Safety and Applied Nutrition’s Li- (1) The analysis of whey protein con- brary, Food and Drug Administration, centrate, on a dry product basis, based

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on analytical methods in the ref- ‘‘Lactose—Chemical Methods—Official erenced sections of ‘‘Official Methods Final Action.’’ of Analysis of the Association of Offi- (v) Moisture content, 1 to 6 percent— cial Analytical Chemists,’’ 13th ed. as determined by the methods pre- (1980), which is incorporated by ref- scribed in section 16.192, entitled erence in accordance with 5 U.S.C. ‘‘Moisture (41)—Official Final Action’’ 552(a) and 1 CFR part 51, is given in under the heading ‘‘Dried Milk, Nonfat paragraphs (b)(1)(i) through (b)(1)(vii) Dry Milk, and Malted Milk.’’ of this section. Copies may be obtained (vi) Solids content, variable—as de- from the AOAC INTERNATIONAL, 481 termined by the methods prescribed in North Frederick Ave., suite 500, Gai- section 16.032, entitled ‘‘Method I—Offi- thersburg, MD 20877, or may be exam- cial Final Action’’ under the heading ined at the Center for Food Safety and ‘‘Total Solids.’’ Applied Nutrition’s Library, Food and (vii) Titratable Acidity, variable—as Drug Administration, 5100 Paint determined by the methods prescribed Branch Pkwy., College Park, MD 20740, in section 16.023, entitled ‘‘Acidity (2)— or at the National Archives and Official Final Action’’ under the head- Records Administration (NARA). For ing ‘‘Milk,’’ or by an equivalent poten- information on the availability of this tiometric method. material at NARA, call 202–741–6030, or (2) Limits of impurities are: Heavy go to: http://www.archives.gov/ metals (as lead). Not more than 10 federallregister/ parts per million (0.001 percent), as de- codeloflfederallregulations/ termined by the method described in ibrllocations.html. the ‘‘Food Chemicals Codex,’’ 4th ed. (i) Protein content, minimum 25 per- (1996), pp. 760–761, which is incorporated cent—as determined by the methods by reference in accordance with 5 prescribed in section 16.036 (liquid sam- U.S.C. 552(a) and 1 CFR part 51. Copies ple), entitled ‘‘Total Nitrogen—Offi- are available from the National Acad- cials Final Action’’ under the heading emy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may sample), entitled ‘‘Kjeldahl Method’’ be examined at the Center for Food under the heading ‘‘Protein—Official Safety and Applied Nutrition’s Li- Final Action.’’ brary, Food and Drug Administration, (ii) Fat content, 1 to 10 percent—as 5100 Paint Branch Pkwy., College Park, determined by the methods prescribed MD 20740, or at the National Archives in section 16.059 (liquid sample), and Records Administration (NARA). ‘‘Reese-Gottlieb Method [Reference For information on the availability of Method] (11)—Official Final Action’’ this material at NARA, call 202–741– under the heading ‘‘Fat,’’ or in section 6030, or go to: http://www.archives.gov/ 16.199 (dry sample), entitled ‘‘Fat in federallregister/ Dried Milk (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, 2 to 15 percent—as ibrllocations.html. determined by the methods prescribed (3) The whey protein concentrate in section 16.035 (liquid sample), enti- shall be derived from milk that has tled ‘‘Ash (5)—Official Final Action’’ been pasteurized, or the whey protein under the heading ‘‘Total Solids,’’ or in concentrate shall be subjected to pas- section 16.196 (dry sample), entitled teurization techniques or its equiva- ‘‘Ash—Official Final Action’’ under the lent before use in food. heading ‘‘Dried Milk, Nonfat Dry Milk, (c) The whey protein concentrate and Malted Milk.’’ may be used in food in accordance with (iv) Lactose content, maximum 60 good manufacturing practice as indi- percent—as determined by the methods cated in § 184.1(b)(1). prescribed in section 16.057 (liquid sam- (d) The percent of protein present on ple), entitled ‘‘Gravimetric Method— a dry product basis, i.e., ‘‘whey protein Official Final Action’’ under the head- concentrate (ll% protein),’’ shall be ing ‘‘Lactose,’’ or in section 31.061 (dry declared on the label of the package sample), entitled ‘‘Lane-Eynon General sold to food manufacturers. The per- Volumetric Method’’ under the heading cent of protein may be declared in 5-

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percent increments, expressed as a cooled, which causes the zein to pre- multiple of 5, not greater than the ac- cipitate. tual percentage of protein in the prod- (b) The ingredient must be of a pu- uct, or as an actual percentage pro- rity suitable for its intended use. vided that an analysis of the product (c) In accordance with § 184.1(b)(1), on which the actual percentage is the ingredient is used in food with no based is supplied to the food manufac- limitation other than current good turer. manufacturing practice. The affirma- (e) The presence of whey protein con- tion of this ingredient as generally rec- centrate in a finished food product ognized as safe (GRAS) as a direct shall be listed as ‘‘whey protein con- human food ingredient is based upon centrate’’. the following current good manufac- [46 FR 44441, Sept. 4, 1981, as amended at 54 turing practice conditions of use: FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, (1) The ingredient is used as a sur- 1999] face-finishing agent as defined in § 170.3(o)(30) of this chapter. § 184.1983 Bakers yeast extract. (2) The ingredient is used in food at (a) Bakers yeast extract is the food levels not to exceed current good man- ingredient resulting from concentra- ufacturing practice. tion of the solubles of mechanically (d) Prior sanctions for this ingredient ruptured cells of a selected strain of different from the uses established in yeast, Saccharomyces cerevisiae. It may this section do not exist or have been be concentrated or dried. waived. (b) The ingredient meets the fol- [50 FR 8999, Mar. 6, 1985, as amended at 73 FR lowing specifications on a dry weight 8608, Feb. 14, 2008] basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 0.2 § 184.1985 Aminopeptidase enzyme ppm lead, 0.05 ppm mercury, 0.09 ppm preparation derived from selenium, and 10 ppm zinc. lactococcus lactis. (c) The viable microbial content of (a) Aminopeptidase enzyme prepara- the finished ingredient as a con- tion is derived from the nonpathogenic centrate or dry material is: and nontoxicogenic bacterium (1) Less than 10,000 organisms/gram Lactococcus lactis (previously named by aerobic plate count. Streptococcus lactis). The preparation (2) Less than 10 yeasts and molds/ contains the enzyme aminopeptidase gram. (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and (3) Negative for Salmonella, E. coli, other peptidases that hydrolyze milk coagulase positive Staphylococci, Clos- proteins. The preparation is produced tridium perfringens, Clostridium botu- by pure culture fermentation. linum, or any other recognized micro- (b) The ingredient meets the speci- bial pathogen or any harmful microbial fications for enzyme preparations in toxin. the Food Chemicals Codex, 3d ed. (1981), (d) The ingredient is used as a fla- pp. 107–110, which are incorporated by voring agent and adjuvant as defined in reference in accordance with 5 U.S.C. § 170.3(o)(12) of this chapter at a level 552(a) and 1 CFR part 51. Copies are not to exceed 5 percent in food. available from the National Academy (e) This regulation is issued prior to Press, 2101 Constitution Ave. NW., general evaluation of use of this ingre- Washington, DC 20418, or may be exam- dient in order to affirm as GRAS the ined at the Division of Petition Control specific use named. (HFS–215), Center for Food Safety and Applied Nutrition, Food and Drug Ad- § 184.1984 Zein. ministration, 1110 Vermont Ave. NW., (a) Zein (CAS Reg. No. 9010–66–6) is suite 1200, Washington, DC, or at the one of the components of corn gluten. National Archives and Records Admin- It is produced commercially by extrac- istration (NARA). For information on tion from corn gluten with alkaline the availability of this material at aqueous isopropyl alcohol containing NARA, call 202–741–6030, or go to: http:// sodium hydroxide. The extract is then www.archives.gov/federallregister/

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codeloflfederallregulations/ Subpart A—General Provisions ibrllocations.html. (c) In accordance with § 184.1(b)(1), § 186.1 Substances added indirectly to the ingredient is used in food with no human food affirmed as generally limitations other than current good recognized as safe (GRAS). manufacturing practice. The affirma- (a) The indirect human food ingredi- tion of this ingredient as generally rec- ents listed in this part have been re- ognized as safe as a direct human food viewed by the Food and Drug Adminis- ingredient is based upon the following tration and determined to be generally current good manufacturing practice recognized as safe (GRAS) for the pur- conditions of use: poses and under the conditions prescribed, providing they comply with (1) The ingredient is used as an en- the purity specifications listed in this zyme, as defined in § 170.3(o)(9) of this part or, in the absence of purity speci- chapter, as an optional ingredient for fications, are of a purity suitable for flavor development in the manufacture their intended use in accordance with of cheddar cheese, in accordance with § 170.30(h)(1) of this chapter. Certain in- § 133.113 of this chapter, and in the gredients in this part may also be used preparation of protein hydrolysates. in food-contact surfaces in accordance (2) The ingredient is used at levels with parts 174, 175, 176, 177, 178 or not to exceed current good manufac- § 179.45 of this chapter. Ingredients af- turing practice. firmed as GRAS for direct use in part 184 of this chapter are also GRAS as in- [60 FR 54193, Oct. 20, 1995] direct human food ingredients in accordance with § 184.1(a) of this chapter. PART 186—INDIRECT FOOD SUB- (b) The regulations in this part do STANCES AFFIRMED AS GEN- not authorize direct addition of any ERALLY RECOGNIZED AS SAFE food ingredient to a food. They authorize only the use of these ingredients as Subpart A—General Provisions indirect ingredients of food, through migration from their immediate wrap- Sec. per, container, or other food-contact 186.1 Substances added indirectly to human surface. Any ingredient affirmed as food affirmed as generally recognized as GRAS in this part shall be used in ac- safe (GRAS). cordance with current good manufacturing practice. For the purpose of this Subpart B—Listing of Specific Substances part, current good manufacturing prac- Affirmed as GRAS tice includes the requirements that an 186.1093 Sulfamic acid. indirect human food ingredient be of a 186.1256 Clay (kaolin). purity suitable for its intended use, 186.1275 Dextrans. and that it be used at a level no higher 186.1300 Ferric oxide. than reasonably required to achieve its 186.1316 Formic acid. intended technical effect in the food- 186.1374 Iron oxides. contact article. 186.1551 Hydrogenated fish oil. (1) If the ingredient is affirmed as 186.1555 Japan wax. GRAS with no limitations on its condi- 186.1557 Tall oil. tions of use other than current good 186.1673 Pulp. manufacturing practice, it shall be re- 186.1750 Sodium chlorite. garded as GRAS if its conditions of use 186.1756 Sodium formate. are consistent with the requirements of 186.1770 Sodium oleate. paragraphs (b), (c), and (d) of this sec- 186.1771 Sodium palmitate. tion. When the Food and Drug Admin- 186.1797 Sodium sulfate. istration (FDA) determines that it is 186.1839 Sorbose. appropriate, the agency will describe one or more current good manufac- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. turing practice conditions of use in the SOURCE: 42 FR 14658, Mar. 15, 1977, unless regulation that affirms the GRAS sta- otherwise noted. tus of the indirect ingredient. For example, when the safety of an ingredient

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has been evaluated on the basis of lim- under part 181 of this chapter. If the ited conditions of use, the agency will Commissioner is unaware of any such describe in the regulation that affirms applicable prior sanction, the proposed the GRAS status of the indirect ingre- regulation will so state and will re- dient, one or more of these limited con- quire any person who intends to assert ditions of use, which may include the or rely on such sanction to submit category of food-contact surface(s), proof of its existence. Any regulation technical effect(s) or functional use(s) promulgated pursuant to this section of the indirect ingredient, and the constitutes a determination that ex- level(s) of use. If the ingredient is used cluded uses would result in adultera- under conditions that are significantly tion of the food in violation of section different from those described in the 402 of the Act, and the failure of any regulation, such use of a substance person to come forward with proof of may not be GRAS. In such a case, a such an applicable prior sanction in re- manufacturer may not rely on the reg- sponse to the proposal will constitute a ulation as authorizing that use but waiver of the right to assert or rely on shall independently establish that the such sanction at any later time. The use is GRAS or shall use the ingredient notice will also constitute a proposal in accordance with a food additive reg- to establish a regulation under part 181 ulation. Persons seeking FDA approval of this chapter, incorporating the same of an independent determination that a provisions, in the event that such a use of an ingredient is GRAS may sub- regulation is determined to be appro- mit a GRAS petition in accordance priate as a result of submission of proof with § 170.35 of this chapter. of such an applicable prior sanction in (2) If the ingredient is affirmed as response to the proposal. GRAS with specific limitation(s), it [42 FR 14658, Mar. 15, 1977, as amended at 48 shall be used in food-contact surfaces FR 48457, 48459, Oct. 19, 1983] only within such limitation(s), including the category of food-contact sur- Subpart B—Listing of Specific face(s), the functional use(s) of the ingredient, and the level(s) of use. Any Substances Affirmed as GRAS use of such an ingredient not in full § 186.1093 Sulfamic acid. compliance with each such established (a) Sulfamic acid (H NO S, CAS Reg. limitation shall require a food additive 3 3 No. 5329–14–6) is a white crystalline regulation. solid manufactured from urea, sulfur (3) If the ingredient is affirmed as trioxide, and sulfuric acid. It is soluble GRAS for a specific use, prior to gen- and highly ionized in water. eral evaluation of use of the ingredient, (b) In accordance with § 186.1(b)(1), other uses may also be GRAS. the ingredient is used as an indirect (c) The listing of a food ingredient in food ingredient with no limitations this part does not authorize the use of other than current good manufacturing such substance for the purpose of add- practice. The affirmation of this ingre- ing the ingredient to the food through dient as generally recognized as safe extraction from the food-contact sur- (GRAS) as an indirect human food in- face. gredient is based upon the current good (d) The listing of a food ingredient in manufacturing practice of using this this part does not authorize the use of ingredient in the manufacture of paper such substance in a manner that may and paperboard that contact food. lead to deception to the consumer or to (c) Prior sanctions for this ingredient any other violation of the Federal different from the uses established in Food, Drug, and Cosmetic Act (the this section do not exist or have been Act). waived. (e) If the Commissioner of Food and Drugs is aware of any prior sanction [47 FR 29954, July 9, 1982] for use of an ingredient under conditions different from those proposed to § 186.1256 Clay (kaolin). be affirmed as GRAS, he will concur- (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas rently propose a separate regulation Reg. No. 1332–58–7) consists of hydrated covering such use of the ingredient aluminum silicate. The commercial

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products of clay (kaolin) contain vary- § 186.1300 Ferric oxide. ing quantities of alkalies and alkaline (a) Ferric oxide (iron (III) oxide, earths. Clay (kaolin) is a white to yel- Fe2O3, CAS Reg. No. 1309–37–1) occurs lowish or grayish fine powder. There naturally as the mineral hematite. It are at least three different minerals, may be prepared synthetically by heat- kaolinite, dickite, and nacrite, classi- ing brown iron hydroxide oxide. The fied as kaolin. Kaolinite or china clay product is red-brown to black trigonal is whiter, less contaminated with ex- crystals. traneous minerals, and less plastic in (b) In accordance with § 186.1(b)(1), water. the ingredient is used as an indirect (b) In accordance with § 186.1(b)(1), human food ingredient with no limita- the ingredient is used as an indirect tion other than current good manufac- human food ingredient with no limita- turing practice. The affirmation of this tion other than current good manufac- ingredient as generally recognized as turing practice. The affirmation of this safe (GRAS) as an indirect human food ingredient as generally recognized as ingredient is based upon the following safe (GRAS) as an indirect human food current good manufacturing practice ingredient is based upon the following conditions of use: current good manufacturing practice (1) The ingredient is used as a con- conditions of use: stituent of paper and paperboard used for food packaging. (1) The ingredient is used in the man- (2) The ingredient is used at levels ufacture of paper and paperboard that not to exceed current good manufac- contact food. turing practice. (2) The ingredient is used at levels (c) Prior sanctions for this ingredient not to exceed current good manufac- different from the uses established in turing practice. this section do not exist or have been (c) Prior sanctions for this ingredient waived. different from the uses established in this regulation do not exist or have [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988] been waived. [47 FR 43367, Oct. 1, 1982] § 186.1316 Formic acid. (a) Formic acid (CH2O2, CAS Reg. No. § 186.1275 Dextrans. 64–18–6) is also referred to as methanoic (a) Dextrans (CAS Reg. No. 9004–54–0) acid or hydrogen carboxylic acid. It oc- are high molecular weight curs naturally in some insects and is polysaccharides produced by bacterial contained in the free acid state in a fermentation of sucrose. Commercially number of plants. Formic acid is pre- available dextrans are synthesized pared by the reaction of sodium formate with sulfuric acid and is isolated from sucrose by Leuconostoc by distillation. mesenteroides strain NRRL B–512(F). (b) Formic acid is used as a con- Partial depolymerization and purifi- stituent of paper and paperboard used cation of the fermented mixture shall for food packaging. produce a product that is free of viable (c) The ingredient is used at levels microorganisms. not to exceed good manufacturing (b) The ingredient is used or intended practice in accordance with § 186.1(b)(1). for use as a constituent of food-contact (d) Prior sanctions for formic acid surfaces. different from the uses established in (c) The ingredient is used at levels this section do not exist or have been not to exceed good manufacturing waived. practice. [45 FR 22915, Apr. 4, 1980] (d) Prior sanctions for this ingredient different from the uses established in § 186.1374 Iron oxides. this section do not exist or have been (a) Iron oxides (oxides of iron, CAS waived. Reg. No. 1332–37–2) are undefined mix- [43 FR 29288, July 7, 1978, as amended at 48 tures of iron (II) oxide (CAS Reg. No. FR 48457, Oct. 19, 1983] 1345–25–1, black cubic crystals) and iron

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(III) oxide (CAS Reg. No. 1309–37–1, red- (c) The ingredient is used as a con- brown to black trigonal crystals). stituent of cotton and cotton fabrics (b) In accordance with § 186.1(b)(1), used for dry food packaging. the ingredient is used as an indirect (d) The ingredient is used at levels human food ingredient with no limita- not to exceed good manufacturing tion other than current good manufac- practice in accordance with § 186.1(b)(1). turing practice. The affirmation of this (e) Prior sanctions for this ingredient ingredient as generally recognized as different from the use established in safe (GRAS) as an indirect human food this section do not exist or have been ingredient is based upon the following waived. current good manufacturing practice conditions of use: [44 FR 28323, May 15, 1979, as amended at 49 (1) The ingredient is used as a con- FR 5614, Feb. 14. 1984; 58 FR 17099, Apr. 1, stituent of paper and paperboard used 1993] for food packaging. (2) The ingredient is used at levels § 186.1555 Japan wax. not to exceed current good manufac- (a) Japan wax (CAS Reg. No. 8001–39– turing practice. 6), also known as Japan tallow or (c) Prior sanctions for this ingredient sumac wax, is a pale yellow vegetable different from the uses established in tallow, containing glycerides of the this section do not exist or have been C19-C23 dibasic acids and a high content waived. of tripalmitin. It is prepared from the [53 FR 16867, May 12, 1988; 53 FR 20939, June mesocarp by hot pressing of immature 7, 1988, as amended at 69 FR 24512, May 4, fruits of the oriental sumac, Rhus 2004] succedanea (Japan, Taiwan, and Indo- China), R. vernicifera (Japan), and R. § 186.1551 Hydrogenated fish oil. trichocarpa (China, Indo-China, India, (a) Hydrogenated fish oil (CAS Reg. and Japan). Japan wax is soluble in hot No. 91078–95–4) is a class of oils pro- alcohol, benzene, and naphtha, and induced by partial hydrogenation of oils soluble in water and in cold alcohol. expressed from fish, primarily menha- (b) In accordance with paragraph den, and secondarily herring or tuna. (b)(1) of this section, the ingredient is Hydrogenation of fish oils uses cata- used as an indirect human food ingre- lysts composed of either elemental dient with no limitation other than nickel, elemental copper, or a mixture current good manufacturing practice. of these elements. The crude hydro- The affirmation of this ingredient as genated fish oil is further processed by generally recognized as safe (GRAS) as alkali refining, bleaching, and deodori- an indirect human food ingredient is zation by steam stripping. based on the following current good (b) Hydrogenation of fish oils results manufacturing practice conditions of in a final product with a melting point use: greater than 32 °C as determined by (1) The ingredient is used as a con- Section Cc 1–25, Official and Tentative stituent of cotton and cotton fabrics Methods of the American Oil Chemists’ used for dry food packaging. Society method (reapproved 1973) or (2) The ingredient is used at levels equivalent. The product has an approx- not to exceed current good manufac- imate fatty acid composition of 30 to 45 turing practice. percent saturated fatty acids, 40 to 55 (c) Prior sanctions for this ingredient percent monoenoic fatty acids, 7 to 15 different from the uses established in percent dienoic fatty acids, 3 to 10 per- this section do not exist or have been cent trienoic fatty acids, and less than waived. 2 percent tetraenoic or higher polyenoic fatty acids. The approximate [60 FR 62208, Dec. 5, 1995] percentages of total fatty acids by carbon chain length are 15 to 30 percent § 186.1557 Tall oil. each of C16, C18, C20, C22, less than 10 (a) Tall oil (CAS Reg. No. 8002–26–4) is percent C14 or lower carbon chain essentially the sap of the pine tree. It length, and less than 1 percent C24 or is obtained commercially from the higher carbon chain length fatty acids. waste liquors of pinewood pulp mills

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and consists mainly of tall oil resin formic acid. It is produced by the reac- acids and tall oil fatty acids. tion of carbon monoxide with sodium (b) In accordance with § 186.1(b)(1), hydroxide. the ingredient is used as an indirect (b) The ingredient is used as a con- human food ingredient with no limita- stituent of paper and paperboard used tion other than current good manufac- for food packaging. turing practice. The affirmation of this (c) The ingredient is used at levels ingredient as generally recognized as not to exceed good manufacturing safe (GRAS) as an indirect human food practice in accordance with § 186.1(b)(1). ingredient is based on the following (d) Prior sanctions for sodium for- current good manufacturing practice mate different from the uses estab- conditions of use: lished in this section do not exist or (1) The ingredient is used as a con- have been waived. stituent of cotton and cotton fabrics used for dry food packaging. [45 FR 22915, Apr. 4, 1980] (2) The ingredient is used at levels § 186.1770 Sodium oleate. not to exceed current good manufacturing practice. (a) Sodium oleate (C18H33O2Na, CAS (c) Prior sanctions for this ingredient Reg. No. 143–19–1) is the sodium salt of different from the uses established in oleic acid (cis-9-octadecenoic acid). It this section, or from those listed in exists as a white to yellowish powder part 181 of this chapter, do not exist or with a slight tallow-like odor. Com- have been waived. mercially, sodium oleate is made by mixing and heating flaked sodium hy- [51 FR 16830, May 7, 1986] droxide and oleic acid. § 186.1673 Pulp. (b) In accordance with § 186.1(b)(1), the ingredient is used as a constituent (a) Pulp is the soft, spongy pith in- of paper and paperboard for food pack- side the stem of a plant such as wood, aging and as a component of lubricants straw, sugarcane, or other natural with incidental food contact in accord- plant sources. ance with § 178.3570 of this chapter, (b) The ingredient is used or intended with no limitation other than current for use as a constituent of food pack- good manufacturing practice. aging containers. (c) Prior sanctions for this ingredient (c) The ingredient is used in paper different from the uses established in and paperboard made by conventional this section do not exist or have been paper-making processes at levels not to waived. exceed good manufacturing practice. (d) Prior sanctions for this ingredient [51 FR 39372, Oct. 28, 1986] different from the uses established in this section do not exist or have been § 186.1771 Sodium palmitate.

waived. (a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408–35–5) is the sodium § 186.1750 Sodium chlorite. salt of palmitic acid (hexadecanoic (a) Sodium chlorite (NaCLO2, CAS acid). It exists as a white to yellow Reg. No. 7758–19–2) exists as slightly powder. Commercially, sodium hygroscopic white crystals or flakes. It palmitate is made by mixing and heat- is manufactured by passing chlorine di- ing flaked sodium hydroxide and pal- oxide into a solution of sodium hydrox- mitic acid. ide and hydrogen peroxide. (b) In accordance with § 186.1(b)(1), (b) the ingredient is used at levels the ingredient is used as a constituent from 125 to 250 parts per million as a of paper and paperboard for food pack- slimicide in the manufacture of paper aging with no limitation other than and paperboard that contact food. current good manufacturing practice. [45 FR 16470, Mar. 14, 1980] (c) Prior sanctions for this ingredient different from the uses established in § 186.1756 Sodium formate. this section do not exist or have been waived. (a) Sodium formate (CHNaO2, CAS Reg. No. 141–53–7) is the sodium salt of [51 FR 39372, Oct. 28, 1986]

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§ 186.1797 Sodium sulfate. PART 189—SUBSTANCES PROHIB-

(a) Sodium sulfate (Na2SO4, CAS Reg. ITED FROM USE IN HUMAN No. 7757–82–6), also known as Glauber’s FOOD salt, occurs naturally and exists as colorless crystals or as a fine, white Subpart A—General Provisions crystalline powder. It is prepared by Sec. the neutralization of sulfuric acid with 189.1 Substances prohibited from use in sodium hydroxide. human food. (b) The ingredient is used as a constituent of paper and paperboard used Subpart B—Prohibited cattle materials for food packaging, and cotton and cot- 189.5 Prohibited cattle materials. ton fabric used for dry food packaging. (c) The ingredient is used at levels Subpart C—Substances Generally Prohib- not to exceed good manufacturing ited From Direct Addition or Use as practice in accordance with § 186.1(b)(1). Human Food (d) Prior sanctions for this ingredient 189.110 Calamus and its derivatives. different from the uses established in 189.113 Cinnamyl anthranilate. this section do not exist or have been 189.120 Cobaltous salts and its derivatives. waived. 189.130 Coumarin. 189.135 Cyclamate and its derivatives. [45 FR 6086, Jan. 25, 1980] 189.140 Diethylpyrocarbonate (DEPC). 189.145 Dulcin. § 186.1839 Sorbose. 189.155 Monochloroacetic acid. 189.165 Nordihydroguaiaretic acid (NDGA). (a) Sorbose (L-sorbose, sorbinose) 189.175 P–4000. (C6H12O6, CAS Reg. No. 87–79–6) is an 189.180 Safrole. orthorhombic, bisphenoidal crystalline 189.190 Thiourea. ketohexose. It was originally identifed 189.191 Chlorofluorocarbon propellants. in the juice of mature berries from the Subpart D—Substances Prohibited From In- mountain ash (Sorbus aucuparia) where direct Addition to Human Food it occurs as the result of microbial oxi- Through Food-Contact Surfaces dation of sorbitol. It also occurs naturally in other plants. Sorbose can be 189.220 Flectol H. 189.240 Lead solders. synthesized by the catalytic hydro- 189.250 Mercaptoimidazoline and 2- genation of glucose to D-sorbitol. The mercaptoimidazoline. resulting sorbitol can be oxidized by 189.280 4,4′-Methylenebis (2-chloroanaline). Acetobacter xylinum or by Acetobacter 189.300 Hydrogenated 4,4′-isopropylidene- suboxydans. diphenolphosphite ester resins. 189.301 Tin-coated lead foil capsules for (b) The ingredient is used or intended wine bottles. for indirect food use as a constituent of cotton, cotton fabrics, paper, and pa- AUTHORITY: 21 U.S.C. 321, 342, 348, 371, 381. perboard in contact with dry food. SOURCE: 42 FR 14659, Mar. 15, 1977, unless (c) The ingredient migrates to food at otherwise noted. levels not to exceed good manufac- EDITORIAL NOTE: Nomenclature changes to turing practice. part 189 appear at 61 FR 14482, Apr. 2, 1996, 66 (d) Prior sanctions for this ingredient FR 56035, Nov. 6, 2001, 70 FR 40880, July 15, 2005, and 70 FR 67651, Nov. 8, 2005. different from the uses established in this section do not exist or have been waived. Subpart A—General Provisions [43 FR 11698, Mar. 21, 1978, as amended at 48 § 189.1 Substances prohibited from use FR 48457, Oct. 19, 1983] in human food. (a) The food ingredients listed in this section have been prohibited from use in human food by the Food and Drug Administration because of a determination that they present a potential risk to the public health or have not

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been shown by adequate scientific data passed for human consumption by the to be safe for use in human food. Use of appropriate regulatory authority, and any of these substances in violation of at the time it was inspected and this section causes the food involved to passed, it was found to be not adulter- be adulterated in violation of the act. ated. (b) This section includes only a par- (3) Mechanically Separated (MS)(Beef) tial list of substances prohibited from means a meat food product that is fine- use in human food, for easy reference ly comminuted, resulting from the me- purposes, and is not a complete list of chanical separation and removal of substances that may not lawfully be most of the bone from attached skel- used in human food. No substance may etal muscle of cattle carcasses and be used in human food unless it meets parts of carcasses that meets the speci- all applicable requirements of the act. fications contained in 9 CFR 319.5, the (c) The Commissioner of Food and regulation that prescribes the standard Drugs, either on his own initiative or of identity for MS (Species). on behalf of any interested person who (4) Nonambulatory disabled cattle has submitted a petition, may publish means cattle that cannot rise from a a proposal to establish, amend, or re- recumbent position or that cannot peal a regulation under this section on walk, including, but not limited to, the basis of new scientific evaluation those with broken appendages, severed or information. Any such petition shall tendons or ligaments, nerve paralysis, include an adequate scientific basis to fractured vertebral column, or meta- support the petition, pursuant to part bolic conditions. 10 of this chapter, and will be published (5) Specified risk material means the for comment if it contains reasonable brain, skull, eyes, trigeminal ganglia, grounds. spinal cord, vertebral column (exclud- [42 FR 14659, Mar. 15, 1977, as amended at 54 ing the vertebrae of the tail, the trans- FR 24899, June 12, 1989] verse processes of the thoracic and lumbar vertebrae, and the wings of the Subpart B—Prohibited Cattle sacrum), and dorsal root ganglia of cat- Materials tle 30 months and older and the tonsils and distal ileum of the small intestine § 189.5 Prohibited cattle materials. of all cattle. (a) Definitions. The definitions and in- (6) Tallow means the rendered fat of terpretations of terms contained in cattle obtained by pressing or by ap- section 201 of the Federal Food, Drug, plying any other extraction process to and Cosmetic Act (the act) apply to tissues derived directly from discrete such terms when used in this part. The adipose tissue masses or to other car- following definitions also apply: cass parts and tissues. Tallow must be (1) Prohibited cattle materials means produced from tissues that are not pro- specified risk materials, small intes- hibited cattle materials or must con- tine of all cattle except as provided in tain not more than 0.15 percent insol- paragraph (b)(2) of this section, mate- uble impurities as determined by the rial from nonambulatory disabled cat- method entitled ‘‘Insoluble Impurities’’ tle, material from cattle not inspected (AOCS Official Method Ca 3a-46), Amer- and passed, or mechanically separated ican Oil Chemists’ Society (AOCS), 5th (MS) (Beef). Prohibited cattle mate- Edition, 1997, incorporated by reference rials do not include the following: in accordance with 5 U.S.C. 552(a) and 1 (i) Tallow that contains no more CFR part 51, or another method equiva- than 0.15 percent insoluble impurities, lent in accuracy, precision, and sensi- tallow derivatives, hides and hide-de- tivity to AOCS Official Method Ca 3a- rived products, and milk and milk 46. You may obtain copies of the meth- products, and od from AOCS (http://www.aocs.org) 2211 (ii) Cattle materials inspected and W. Bradley Ave. Champaign, IL 61821. passed from a country designated Copies may be examined at the Center under paragraph (e) of this section. for Food Safety and Applied Nutri- (2) Inspected and passed means that tion’s Library, 5100 Paint Branch the product has been inspected and Pkwy., College Park, MD 20740, or at

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the National Archives and Records Ad- factured from, processed with, or oth- ministration (NARA). For information erwise containing, cattle material on the availability of this material at must affirm that the food was manu- NARA, call 202–741–6030, or go to http:// factured from, processed with, or oth- www.archives.gov/federallregister/ erwise contains, cattle material and codeloflfederallregulations/ must affirm that the food was manu- ibrllocations.html. factured in accordance with this sec- (7) Tallow derivative means any chem- tion. If a human food is manufactured ical obtained through initial hydrol- from, processed with, or otherwise con- ysis, saponification, or trans- tains, cattle material, then the im- esterification of tallow; chemical con- porter of record must, if requested, pro- version of material obtained by hydrol- vide within 5 days records sufficient to ysis, saponification, or trans- demonstrate that the food is not manu- esterification may be applied to obtain factured from, processed with, or does the desired product. not otherwise contain, prohibited cat- (b) Requirements. (1) No human food tle material. shall be manufactured from, processed (7) Records established or maintained with, or otherwise contain, prohibited to satisfy the requirements of this sub- cattle materials. part that meet the definition of elec- (2) The small intestine is not consid- tronic records in § 11.3(b)(6) of this ered prohibited cattle material if the chapter are exempt from the require- distal ileum is removed by a procedure ments of part 11 of this chapter. that removes at least 80 inches of the Records that satisfy the requirements uncoiled and trimmed small intestine, of this subpart but that are also re- as measured from the caeco-colic junc- quired under other applicable statutory tion and progressing proximally to- provisions or regulations remain sub- wards the jejunum, or by a procedure ject to part 11 of this chapter. that the establishment can dem- (d) Adulteration. (1) Failure of a man- onstrate is equally effective in ensur- ufacturer or processor to operate in ing complete removal of the distal compliance with the requirements of ileum. paragraphs (b) or (c) of this section (c) Records. (1) Manufacturers and renders human food adulterated under processors of a human food that is section 402(a)(4) of the act. manufactured from, processed with, or (2) Human food manufactured from, otherwise contains, material from cat- processed with, or otherwise con- tle must establish and maintain taining, prohibited cattle materials is records sufficient to demonstrate that unfit for human food and deemed adul- the food is not manufactured from, terated under section 402(a)(3) of the processed with, or does not otherwise act. contain, prohibited cattle materials. (3) Food additive status. Prohibited (2) Records must be retained for 2 cattle materials for use in human food years after the date they were created. are food additives subject to section 409 (3) Records must be retained at the of the act, except when used as dietary manufacturing or processing establish- ingredients in dietary supplements. ment or at a reasonably accessible lo- The use or intended use of any prohib- cation. ited cattle material in human food (4) The maintenance of electronic causes the material and the food to be records is acceptable. Electronic adulterated under section 402(a)(2)(C) records are considered to be reasonably of the act if the prohibited cattle mate- accessible if they are accessible from rial is a food additive, unless it is the an onsite location. subject of a food additive regulation or (5) Records required by this section of an investigational exemption for a and existing records relevant to com- food additive under § 170.17 of this chap- pliance with this section must be avail- ter. able to FDA for inspection and copy- (e) Process for designating countries. A ing. country seeking designation must send (6) When filing entry with U.S. Cus- a written request to the Director, Of- toms and Border Protection, the im- fice of the Center Director, Center for porter of record of a human food manu- Food Safety and Applied Nutrition,

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Food and Drug Administration, at the (HFS–200), Food and Drug Administra- address designated in 21 CFR 5.1100. tion, 5100 Paint Branch Pkwy., College The request shall include information Park, MD 20740, or available for inspec- about a country’s bovine spongiform tion at the National Archives and encephalopathy (BSE) case history, Records Administration (NARA). For risk factors, measures to prevent the information on the availability of this introduction and transmission of BSE, material at NARA, call 202–741–6030, or and any other information relevant to go to: http://www.archives.gov/ determining whether specified risk ma- federallregister/ terials, the small intestine of cattle ex- codeloflfederallregulations/ cept as provided in paragraph (b)(2) of ibrllocations.html. this section, material from nonambulatory disabled cattle, or MS [42 FR 14659, Mar. 15, 1977, as amended at 47 (Beef) from cattle from the country FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, should be considered prohibited cattle 1989] materials. FDA shall respond in writing to any such request and may im- § 189.113 Cinnamyl anthranilate. pose conditions in granting any such (a) The food additive cinnamyl an- request. A country designation granted thranilate (C16H15NO2, CAS Reg. No. 87– by FDA under this paragraph will be 29–6) is the ester of cinnamyl alcohol subject to future review by FDA, and and anthranilic acid. Cinnamyl an- may be revoked if FDA determines thranilate is a synthetic chemical that that it is no longer appropriate. has not been identified in natural prod- [70 FR 53068, Sept. 7, 2005, as amended at 71 ucts at levels detectable by available FR 59668, Oct. 11, 2006; 73 FR 20793, Apr. 17, methodology. It has been used as a fla- 2008] voring agent in food. (b) Food containing any added Subpart C—Substances Generally cinnamyl anthranilate is deemed to be Prohibited From Direct Addi- adulterated in violation of the act tion or Use as Human Food based upon an order published in the FEDERAL REGISTER of October 23, 1985.

SOURCE: 42 FR 14659, Mar. 15, 1977, unless [50 FR 42932, Oct. 23, 1985] otherwise noted. Redesignated at 69 FR 42273, July 14, 2004. § 189.120 Cobaltous salts and its derivatives. § 189.110 Calamus and its derivatives. (a) Cobaltous salts are the chemicals, (a) Calamus is the dried rhizome of CoC4H6O4, CoCl2, and CoSO4.They have Acorus calamus L. It has been used as a been used in fermented malt beverages flavoring compound, especially as the as a foam stabilizer and to prevent oil or extract. ‘‘gushing.’’ (b) Food containing any added (b) Food containing any added cobal- calamus, oil of calamus, or extract of tous salts is deemed to be adulterated calamus is deemed to be adulterated in in violation of the act based upon an violation of the act based upon an order published in the FEDERAL REG- order published in the FEDERAL REG- ISTER of August 12, 1966 (31 FR 8788). ISTER of May 9, 1968 (33 FR 6967). (c) The analytical method used for § 189.130 Coumarin. detecting oil of calamus (b-asarone) is in the ‘‘Journal of the Association of (a) Coumarin is the chemical 1,2- Official Analytical Chemists,’’ Volume benzopyrone, C9H6O2. It is found in 56, (Number 5), pages 1281 to 1283, Sep- tonka beans and extract of tonka tember 1973, which is incorporated by beans, among other natural sources, reference. Copies are available from and is also synthesized. It has been the AOAC INTERNATIONAL, 481 North used as a flavoring compound. Frederick Ave., suite 500, Gaithersburg, (b) Food containing any added cou- MD 20877, also from the Division of marin as such or as a constituent of Food and Color Additives, Center for tonka beans or tonka extract is deemed Food Safety and Applied Nutrition to be adulterated under the act, based

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upon an order published in the FED- codeloflfederallregulations/ ERAL REGISTER of March 5, 1954 (19 FR ibrllocations.html. 1239). [42 FR 14659, Mar. 15, 1977, as amended at 49 (c) The analytical methods used for FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, detecting coumarin in food are in sec- 1989] tions 19.016–19.024 of the ‘‘Official Meth- ods of Analysis of the Association of § 189.140 Diethylpyrocarbonate Official Analytical Chemists,’’ 13th Ed. (DEPC). (1980), which is incorporated by ref- (a) Diethylpyrocarbonate is the erence. Copies may be obtained from chemical pyrocarbonic acid diethyl the AOAC INTERNATIONAL, 481 North ester, C6H10O5. It is a synthetic chem- Frederick Ave., suite 500, Gaithersburg, ical not found in natural products at MD 20877, or may be examined at the levels detectable by available method- National Archives and Records Admin- ology and has been used as a ferment istration (NARA). For information on inhibitor in alcoholic and nonalcoholic the availability of this material at beverages. NARA, call 202–741–6030, or go to: http:// (b) Food containing any added or de- www.archives.gov/federallregister/ tectable level of DEPC is deemed to be codeloflfederallregulations/ adulterated in violation of the act ibrllocations.html. based upon an order published in the [42 FR 14659, Mar. 15, 1977, as amended at 49 FEDERAL REGISTER of August 2, 1972 (37 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, FR 15426). 1989] § 189.145 Dulcin. § 189.135 Cyclamate and its deriva- (a) Dulcin is the chemical 4- tives. ethoxyphenylurea, C9H12N2O2. It is a (a) Calcium, sodium, magnesium and synthetic chemical having a sweet potassium salts of cyclohexane sul- taste about 250 times that of sucrose, is famic acid, (C6H12NO3S)2Ca, not found in natural products at levels (C6H12NO3S)Na, (C6H12NO3S)2Mg, and detectable by the official methodology, (C6H12NO3S)K. Cyclamates are syn- and has been proposed for use as an ar- thetic chemicals having a sweet taste tificial sweetener. 30 to 40 times that of sucrose, are not (b) Food containing any added or de- found in natural products at levels detectable level of dulcin is deemed to be tectable by the official methodology, adulterated in violation of the act, and have been used as artificial sweet- based upon an order published in the eners. FEDERAL REGISTER of January 19, 1950 (b) Food containing any added or de- (15 FR 321). tectable level of cyclamate is deemed (c) The analytical methods used for to be adulterated in violation of the detecting dulcin in food are in sections act based upon an order published in 20.173–20.176 of the ‘‘Official Methods of the FEDERAL REGISTER of October 21, Analysis of the Association of Official 1969 (34 FR 17063). Analytical Chemists,’’ 13th Ed. (1980), (c) The analytical methods used for which is incorporated by reference. detecting cyclamate in food are in sec- Copies may be obtained from the AOAC tions 20.162–20.172 of the ‘‘Official Meth- INTERNATIONAL, 481 North Frederick ods of Analysis of the Association of Ave., suite 500, Gaithersburg, MD 20877, Official Analytical Chemists,’’ 13th Ed. or may be examined at the National (1980), which is incorporated by ref- Archives and Records Administration erence. Copies may be obtained from (NARA). For information on the avail- the AOAC INTERNATIONAL, 481 North ability of this material at NARA, call Frederick Ave., suite 500, Gaithersburg, 202–741–6030, or go to: http:// MD 20877, or may be examined at the www.archives.gov/federallregister/ National Archives and Records Admin- codeloflfederallregulations/ istration (NARA). For information on ibrllocations.html. the availability of this material at [42 FR 14659, Mar. 15, 1977, as amended at 49 NARA, call 202–741–6030, or go to: http:// FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, www.archives.gov/federallregister/ 1989]

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§ 189.155 Monochloroacetic acid. 20.008(b) of the ‘‘Official Methods of (a) Monochloroacetic acid is the Analysis of the AOAC INTER- NATIONAL,’’ 13th Ed. (1980), which is chemical chloroacetic acid, C2H3C1O2. It is a synthetic chemical not found in incorporated by reference. Copies may natural products, and has been pro- be obtained from the AOAC INTER- posed as a preservative in alcoholic and NATIONAL, 481 North Frederick Ave., nonalcoholic beverages. suite 500, Gaithersburg, MD 20877, or Monochloroacetic acid is permitted in may be examined at the National Ar- food package adhesives with an accept- chives and Records Administration ed migration level up to 10 parts per (NARA). For information on the avail- billion (ppb) under § 175.105 of this chap- ability of this material at NARA, call ter. The official methods do not detect 202–741–6030, or go to: http:// monochloroacetic acid at the 10 ppb www.archives.gov/federallregister/ level. codeloflfederallregulations/ (b) Food containing any added or de- ibrllocations.html. tectable level of monochloroacetic acid [42 FR 14659, Mar. 15, 1977, as amended at 49 is deemed to be adulterated in viola- FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, tion of the act based upon trade cor- 1989] respondence dated December 29, 1941 (TC–377). § 189.175 P–4000. (c) The analytical methods used for (a) P–4000 is the chemical 5-nitro-2-n- detecting monochloroacetic acid in propoxyaniline, C9H12N2O3. It is a syn- food are in sections 20.067–20.072 of the thetic chemical having a sweet taste ‘‘Official Methods of Analysis of the about 4000 times that of sucrose, is not Association of Official Analytical found in natural products at levels de- Chemists,’’ 13th Ed. (1980), which is in- tectable by the official methodology, corporated by reference. Copies may be and has been proposed for use as an ar- obtained from the AOAC INTER- tificial sweetener. NATIONAL, 481 North Frederick Ave., (b) Food containing any added or de- suite 500, Gaithersburg, MD 20877, or tectable level of P–4000 is deemed to be may be examined at the National Ar- adulterated in violation of the act chives and Records Administration based upon an order published in the (NARA). For information on the avail- FEDERAL REGISTER of January 19, 1950 ability of this material at NARA, call (15 FR 321). 202–741–6030, or go to: http:// (c) The analytical methods used for www.archives.gov/federallregister/ detecting P–4000 in food are in sections codeloflfederallregulations/ 20.177–20.181 of the ‘‘Official Methods of ibrllocations.html. Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), [42 FR 14659, Mar. 15, 1977, as amended at 49 which is incorporated by reference. FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick § 189.165 Nordihydroguaiaretic acid Ave., suite 500, Gaithersburg, MD 20877, (NDGA). or may be examined at the National (a) Nordihydroguaiaretic acid is the Archives and Records Administration chemical 4,4′-(2,3-dimethyltetrame- (NARA). For information on the availability of this material at NARA, call thylene) dipyrocatechol, C18H22O4. It occurs naturally in the resinous 202–741–6030, or go to: http:// exudates of certain plants. The com- www.archives.gov/federallregister/ mercial product, which is synthesized, codeloflfederallregulations/ has been used as an antioxidant in ibrllocations.html. foods. [42 FR 14659, Mar. 15, 1977, as amended at 49 (b) Food containing any added NDGA FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, is deemed to be adulterated in viola- 1989] tion of the act based upon an order published in the FEDERAL REGISTER of § 189.180 Safrole. April 11, 1968 (33 FR 5619). (a) Safrole is the chemical 4-allyl-1,2- (c) The analytical method used for methylenedioxy-benzene, C10H10O2. It is detecting NDGA in food is in section a natural constituent of the sassafras

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plant. Oil of sassafras is about 80 per- Copies may be obtained from the AOAC cent safrole. Isosafrole and INTERNATIONAL, 481 North Frederick dihydrosafrole are derivatives of saf- Ave., suite 500, Gaithersburg, MD 20877, role, and have been used as flavoring or may be examined at the National compounds. Archives and Records Administration (b) Food containing any added saf- (NARA). For information on the avail- role, oil of sassafras, isosafrole, or ability of this material at NARA, call dihydrosafrole, as such, or food con- 202–741–6030, or go to: http:// taining any safrole, oil of sassafras, www.archives.gov/federallregister/ isosafrole, or dihydrosafrole, e.g., sas- codeloflfederallregulations/ safras bark, which is intended solely or ibrllocations.html. primarily as a vehicle for imparting such substances to another food, e.g., [42 FR 14659, Mar. 15, 1977, as amended at 49 sassafras tea, is deemed to be adulter- FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, ated in violation of the act based upon 1989] an order published in the FEDERAL REGISTER of December 3, 1960 (25 FR § 189.191 Chlorofluorocarbon propel- 12412). lants. (c) The analytical method used for The use of chlorofluorocarbons in detecting safrole, isosafrole and human food as propellants in self-pres- dihydrosafrole is in the ‘‘Journal of the surized containers is prohibited as pro- Association of Official Analytical vided by § 2.125 of this chapter. Chemists,’’ Volume 54 (Number 4), pages 900 to 902, July 1971, which is in- [43 FR 11317, Mar. 17, 1978] corporated by reference. Copies are available from the Division of Food Subpart D—Substances Prohibited and Color Additives, Center for Food From Indirect Addition to Safety and Applied Nutrition (HFS– Human Food Through Food- 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, Contact Surfaces MD 20740, or available for inspection at the National Archives and Records Ad- SOURCE: 42 FR 14659, Mar. 15, 1977, unless ministration (NARA). For information otherwise noted. Redesignated at 69 FR 42273, on the availability of this material at July 14, 2004. NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 189.220 Flectol H. codeloflfederallregulations/ (a) Flectol H is the chemical 1,2- ibrllocations.html. dihydro-2,2,4-trimethylquinoline, po- [42 FR 14659, Mar. 15, 1977, as amended at 42 lymerized, C12H15N. It is a synthetic FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, chemical not found in natural prod- 1982; 54 FR 24900, June 12, 1989] ucts, and has been used as a component of food packaging adhesives. § 189.190 Thiourea. (b) Food containing any added or de- (a) Thiourea is the chemical tectable level of this substance is thiocarbamide, CH4N2S. It is a syn- deemed to be adulterated in violation thetic chemical, is not found in natural of the act based upon an order pub- products at levels detectable by the of- lished in the FEDERAL REGISTER of ficial methodology, and has been pro- April 7, 1967 (32 FR 5675). posed as an antimycotic for use in dip- ping citrus. [42 FR 14659, Mar.15, 1977, as amended at 58 FR 17099, Apr. 1, 1993] (b) Food containing any added or detectable level of thiourea is deemed to § 189.240 Lead solders. be adulterated under the act. (c) The analytical methods used for (a) Lead solders are alloys of metals detecting thiourea are in sections that include lead and are used in the 20.115–20.126 of the ‘‘Official Methods of construction of metal food cans. Analysis of the Association of Official (b) Food packaged in any container Analytical Chemists,’’ 13th Ed. (1980), that makes use of lead in can solder is which is incorporated by reference. deemed to be adulterated in violation

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of the Federal Food, Drug, and Cos- deemed to be adulterated and in viola- metic Act, based upon an order pub- tion of the Federal Food, Drug, and lished in the FEDERAL REGISTER of Cosmetic Act, based upon an order pub- June 27, 1995. lished in the FEDERAL REGISTER of Sep- [60 FR 33109, June 27, 1995] tember 9, 1987 (52 FR 33929).

§ 189.250 Mercaptoimidazoline and 2- [54 FR 7188, Feb. 17, 1989] mercaptoimidazoline. § 189.301 Tin-coated lead foil capsules (a) Mercaptoimidazoline and 2- for wine bottles. mercaptoimidazoline both have the (a) Tin-coated lead foil is composed molecular formula C3H6N2S. They are synthetic chemicals not found in nat- of a lead foil coated on one or both ural products and have been used in the sides with a thin layer of tin. Tin-coat- production of rubber articles that may ed lead foil has been used as a capsule come into contact with food. (i.e., as a covering applied over the (b) Food containing any added or de- cork and neck areas) on wine bottles to lectable levels of these substances is prevent insect infestation, as a barrier deemed to be adulterated in violation to oxygen, and for decorative purposes. of the act based upon an order pub- Information received by the Food and lished in the FEDERAL REGISTER of No- Drug Administration establishes that vember 30, 1973 (38 FR 33072). the use of such a capsule on wine bot- ′ tles may reasonably be expected to re- § 189.280 4,4 -Methylenebis (2-chloro- sult in lead becoming a component of analine). the wine. ′ (a) 4,4 -Methylenebis (2- (b) The capping of any bottles of wine chloroanaline) has the molecular for- after February 8, 1996, with a tin-coat- mula, C H Cl N . It is a synthetic 13 12 2 2 ed lead foil capsule renders the wine chemical not found in natural products adulterated and in violation of section and has been used as a polyurethane curing agent and as a component of 402(a)(2)(C) of the Federal Food, Drug, food packaging adhesives and poly- and Cosmetic Act because lead from urethane resins. the capsule, which is an unsafe food ad- (b) Food containing any added or de- ditive within the meaning of section tectable level of this substance is 409 of the act, may reasonably be ex- deemed to be adulterated in violation pected to become a component of the of the act based upon an order pub- wine. lished in the FEDERAL REGISTER of De- [61 FR 4820, Feb. 8, 1996] cember 2, 1969 (34 FR 19073).

§ 189.300 Hydrogenated 4,4′-isopropyl- PART 190—DIETARY SUPPLEMENTS idene-diphenolphosphite ester resins. Subpart A [Reserved] (a) Hydrogenated 4,4′-isopropylidene- diphenolphosphite ester resins are the Subpart B—New Dietary Ingredient condensation product of 1 mole of Notification triphenyl phosphite and 1.5 moles of Sec. hydrogenated 4,4′-isopropylidene- 190.6 Requirement for premarket notifica- diphenol such that the finished resins tion. have a molecular weight in the range of 2,400 to 3,000. They are synthetic AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of chemicals not found in natural prod- the Federal Food, Drug, and Cosmetic Act ucts and have been used as anti- (21 U.S.C. 321(ff), 331, 342, 350b, 371). oxidants and as stabilizers in vinyl SOURCE: 62 FR 49891, Sept. 23, 1997, unless chloride polymer resins when such otherwise noted. polymer resins are used in the manu- EDITORIAL NOTE: Nomenclature changes to facture of rigid vinyl chloride polymer part 190 appear at 66 FR 56035, Nov. 6, 2001. bottles. (b) Food containing any added or detectable levels of these substances is Subpart A [Reserved]

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Subpart B—New Dietary gested in the labeling of the dietary Ingredient Notification supplement, will reasonably be expected to be safe, including any cita- § 190.6 Requirement for premarket no- tion to published articles or other evi- tification. dence that is the basis on which the (a) At least 75 days before intro- distributor or manufacturer of the die- ducing or delivering for introduction tary supplement that contains the new into interstate commerce a dietary dietary ingredient has concluded that supplement that contains a new die- the new dietary supplement will rea- tary ingredient that has not been sonably be expected to be safe. Any ref- present in the food supply as an article erence to published information offered used for food in a form in which the in support of the notification shall be food has not been chemically altered, accompanied by reprints or photostatic the manufacturer or distributor of that copies of such references. If any part of supplement, or of the new dietary in- the material submitted is in a foreign gredient, shall submit to the Office of language, it shall be accompanied by Nutritional Products, Labeling and Di- an accurate and complete English etary Supplements (HFS–820), Center translation; and for Food Safety and Applied Nutrition, (5) The signature of the person des- Food and Drug Administration, 5100 ignated by the manufacturer or dis- Paint Branch Pkwy., College Park, MD tributor of the dietary supplement that 20740, information including any cita- contains a new dietary ingredient. tion to published articles that is the (c) FDA will acknowledge its receipt basis on which the manufacturer or of a notification made under section distributor has concluded that a die- 413 of the Federal Food, Drug, and Cos- tary supplement containing such die- metic Act (the act) and will notify the tary ingredient will reasonably be ex- submitter of the date of receipt of such pected to be safe. An original and two a notification. The date that the agen- copies of this notification shall be sub- cy receives the notification submitted mitted. under paragraph (a) of this section is (b) The notification required by para- the filing date for the notification. For graph (a) of this section shall include: 75 days after the filing date, the manu- (1) The name and complete address of facturer or distributor of a dietary sup- the manufacturer or distributor of the plement that contains a new dietary dietary supplement that contains a ingredient shall not introduce, or de- new dietary ingredient, or of the new liver for introduction, into interstate dietary ingredient; commerce the dietary supplement that (2) The name of the new dietary in- contains the new dietary ingredient. gredient that is the subject of the pre- (d) If the manufacturer or distributor market notification, including the of a dietary supplement that contains a Latin binomial name (including the au- new dietary ingredient, or of the new thor) of any herb or other botanical; dietary ingredient, provides additional (3) A description of the dietary sup- information in support of the new die- plement or dietary supplements that tary ingredient notification, the agen- contain the new dietary ingredient in- cy will review all submissions per- cluding: taining to that notification, including (i) The level of the new dietary ingre- responses made to inquiries from the dient in the dietary supplement; and agency, to determine whether they are (ii) The conditions of use rec- substantive and whether they require ommended or suggested in the labeling that the 75-day period be reset. If the of the dietary supplement, or if no con- agency determines that the new sub- ditions of use are recommended or sug- mission is a substantive amendment, gested in the labeling of the dietary FDA will assign a new filing date. FDA supplement, the ordinary conditions of will acknowledge receipt of the addi- use of the supplement; tional information and, when applica- (4) The history of use or other evi- ble, notify the manufacturer of the new dence of safety establishing that the filing date, which is the date of receipt dietary ingredient, when used under by FDA of the information that con- the conditions recommended or sug- stitutes the substantive amendment.

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(e) FDA will not disclose the exist- (f) Failure of the agency to respond ence of, or the information contained to a notification does not constitute a in, the new dietary ingredient notifica- finding by the agency that the new die- tion for 90 days after the filing date of tary ingredient or the dietary supple- the notification. After the 90th day, all ment that contains the new dietary in- information in the notification will be gredient is safe or is not adulterated placed on public display, except for any under section 402 of the act. information that is trade secret or oth- [62 FR 49891, Sept. 23, 1997, as amended at 66 erwise confidential commercial infor- FR 17359, Mar. 30, 2001] mation. PARTS 191–199 [RESERVED]

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