Title 21—Food and Drugs

(This book contains parts 170 to 199)

Part

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

CROSS REFERENCES: Food Safety and Inspection Service, Department of Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III. Federal Trade Commission: See Commercial Practices, 16 CFR chapter I. United States Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: See Alcohol, To- bacco Products and Firearms, 27 CFR chapter I.

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(Parts 170 to 199)

EDITORIAL NOTE: The Food and Drug Administration published a document at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform effective date for compliance for regulations affecting the labeling of food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 1, 1989 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after July 1, 1986, and before January 1, 1988. At 55 FR 276, Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after January 1, 1990 and before January 1, 1992. EDITORIAL NOTE: For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994.

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (Con’t.)

Part Page 170 Food additives ...... 5 171 Food additive petitions ...... 21 172 Food additives permitted for direct addition to food for human consumption ...... 26 173 Secondary direct food additives permitted in food for human consumption ...... 112 174 Indirect food additives: General ...... 142 175 Indirect food additives: Adhesives and components of coatings ...... 143 176 Indirect food additives: Paper and paperboard components ...... 185 177 Indirect food additives: Polymers ...... 223 178 Indirect food additives: Adjuvants, production aids, and sanitizers ...... 342 179 Irradiation in the production, processing and handling of food ...... 434 180 Food additives permitted in food or in contact with food on an interim basis pending additional study ...... 440 181 Prior-sanctioned food ingredients ...... 445 182 Substances generally recognized as safe ...... 449 3

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Part Page 184 Direct food substances affirmed as generally recognized as safe ...... 463 186 Indirect food substances affirmed as generally recognized as safe ...... 561 189 Substances prohibited from use in human food ...... 566 190 Dietary supplements ...... 571 191–199 [Reserved]

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PART 170—FOOD ADDITIVES (d) As used in this part, the term act means the Federal Food, Drug, and Subpart A—General Provisions Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as amended (21 U.S.C. Sec. 301–392). 170.3 Definitions. (e)(1) Food additives includes all sub- 170.6 Opinion letters on food additive status. stances not exempted by section 201(s) 170.10 Food additives in standardized foods. of the act, the intended use of which 170.15 Adoption of regulation on initiative results or may reasonably be expected of Commissioner. to result, directly or indirectly, either 170.17 Exemption for investigational use in their becoming a component of food and procedure for obtaining authoriza- or otherwise affecting the characteris- tion to market edible products from ex- tics of food. A material used in the pro- perimental animals. duction of containers and packages is 170.18 Tolerances for related food additives. 170.19 Pesticide chemicals in processed subject to the definition if it may rea- foods. sonably be expected to become a component, or to affect the characteristics, Subpart B—Food Additive Safety directly or indirectly, of food packed in the container. ‘‘Affecting the charac- 170.20 General principles for evaluating the safety of food additives. teristics of food’’ does not include such 170.22 Safety factors to be considered. physical effects, as protecting contents 170.30 Eligibility for classification as gen- of packages, preserving shape, and pre- erally recognized as safe (GRAS). venting moisture loss. If there is no 170.35 Affirmation of generally recognized migration of a packaging component as safe (GRAS) status. from the package to the food, it does 170.38 Determination of food additive sta- not become a component of the food tus. and thus is not a food additive. A sub- 170.39 Threshold of regulation for substance that does not become a compo- stances used in food-contact articles. nent of food, but that is used, for exam- Subpart C—Specific Administrative Rulings ple, in preparing an ingredient of the and Decisions food to give a different flavor, texture, or other characteristic in the food, 170.45 Fluorine-containing compounds. may be a food additive. 170.50 Glycine (aminoacetic acid) in food for (2) Uses of food additives not requiring human consumption. 170.60 Nitrites and/or nitrates in curing pre- a listing regulation. Substances used in mixes. food-contact articles (e.g., food-packaging and food-processing equipment) AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, that migrate, or may be expected to 371. migrate, into food at such negligible SOURCE: 42 FR 14483, Mar. 15, 1977, unless levels that they have been exempted otherwise noted. from regulation as food additives under EDITORIAL NOTE: Nomenclature changes to § 170.39. part 170 appear at 66 FR 56035, Nov. 6, 2001. (f) Common use in food means a substantial history of consumption of a Subpart A—General Provisions substance for food use by a significant number of consumers. § 170.3 Definitions. (g) The word substance in the defini- For the purposes of this subchapter, tion of the term ‘‘food additive’’ in- the following definitions apply: cludes a food or food component con- (a) Secretary means the Secretary of sisting of one or more ingredients. Health and Human Services. (h) Scientific procedures include those (b) Department means the Department human, animal, analytical, and other of Health and Human Services. scientific studies, whether published or (c) Commissioner means the Commis- unpublished, appropriate to establish sioner of Food and Drugs. the safety of a substance.

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(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 available tors shall be considered: for inspection at the Office of the Fed- (1) The probable consumption of the eral Register, 800 North Capitol Street, substance and of any substance formed NW., suite 700, Washington, DC 20408: in or on food because of its use. (1) Baked goods and baking mixes, in- (2) The cumulative effect of the sub- cluding all ready-to-eat and ready-to- stance in the diet, taking into account bake products, flours, and mixes re- any chemically or pharmacologically quiring preparation before serving. related substance or substances in such (2) Beverages, alcoholic, including diet. malt beverages, wines, distilled liq- (3) Safety factors which, in the opin- uors, and cocktail mix. ion of experts qualified by scientific (3) Beverages and beverage bases, training and experience to evaluate the nonalcoholic, including only special or safety of food and food ingredients, are spiced teas, soft drinks, coffee sub- generally recognized as appropriate. stitutes, and fruit and vegetable fla- (j) The term nonperishable processed vored gelatin drinks. food means any processed food not sub- (4) Breakfast cereals, including ject to rapid decay or deterioration ready-to-eat and instant and regular that would render it unfit for consump- hot cereals. tion. Examples are flour, sugar, cere- (5) Cheeses, including curd and whey als, packaged cookies, and crackers. cheeses, cream, natural, grating, proc- Not included are hermetically sealed essed, spread, dip, and miscellaneous foods or manufactured dairy products cheeses. and other processed foods requiring re- (6) Chewing gum, including all forms. frigeration. (7) Coffee and tea, including regular, (k) General recognition of safety shall decaffeinated, and instant types. be determined in accordance with (8) Condiments and relishes, includ- § 170.30. ing plain seasoning sauces and spreads, (l) Prior sanction means an explicit olives, pickles, and relishes, but not approval granted with respect to use of spices or herbs. a substance in food prior to September (9) Confections and frostings, includ- 6, 1958, by the Food and Drug Adminis- ing candy and flavored frostings, tration or the United States Depart- marshmallows, baking chocolate, and ment of Agriculture pursuant to the brown, lump, rock, maple, powdered, Federal Food, Drug, and Cosmetic Act, and raw sugars. the Poultry Products Inspection Act, (10) Dairy product analogs, including or the Meat Inspection Act. nondairy milk, frozen or liquid cream- (m) Food includes human food, sub- ers, coffee whiteners, toppings, and stances migrating to food from food- other nondairy products. contact articles, pet food, and animal (11) Egg products, including liquid, feed. frozen, or dried eggs, and egg dishes (n) The following general food cat- made therefrom, i.e., egg roll, egg foo egories are established to group spe- young, egg salad, and frozen multi- cific related foods together for the pur- course egg meals, but not fresh eggs. pose of establishing tolerances or limi- (12) Fats and oils, including mar- tations for the use of direct human garine, dressings for salads, butter, food ingredients. Individual food prod- salad oils, shortenings and cooking ucts will be included within these cat- oils.

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(13) Fish products, including all pre- jams, jellies, fruit butters, preserves, pared main dishes, salads, appetizers, and sweet spreads. frozen multicourse meals, and spreads (29) Meat products, including all containing fish, shellfish, and other meats and meat containing dishes, sal- aquatic animals, but not fresh fish. ads, appetizers, frozen multicourse (14) Fresh eggs, including cooked meat meals, and sandwich ingredients eggs and egg dishes made only from prepared by commercial processing or fresh shell eggs. using commercially processed meats (15) Fresh fish, including only fresh with home preparation. and frozen fish, shellfish, and other (30) Milk, whole and skim, including aquatic animals. only whole, lowfat, and skim fluid (16) Fresh fruits and fruit juices, in- milks. cluding only raw fruits, citrus, melons, (31) Milk products, including flavored and berries, and home-prepared ‘‘ades’’ milks and milk drinks, dry milks, top- and punches made therefrom. pings, snack dips, spreads, weight con- (17) Fresh meats, including only fresh trol milk beverages, and other milk or- or home-frozen beef or veal, pork, lamb igin products. or mutton and home-prepared fresh (32) Nuts and nut products, including meat-containing dishes, salads, appe- whole or shelled tree nuts, peanuts, co- tizers, or sandwich spreads made there- conut, and nut and peanut spreads. from. (33) Plant protein products, including (18) Fresh poultry, including only the National Academy of Sciences/Na- fresh or home-frozen poultry and game tional Research Council ‘‘reconstituted birds and home-prepared fresh poultry- vegetable protein’’ category, and meat, containing dishes, salads, appetizers, or poultry, and fish substitutes, analogs, sandwich spreads made therefrom. and extender products made from plant (19) Fresh vegetables, tomatoes, and proteins. potatoes, including only fresh and (34) Poultry products, including all home-prepared vegetables. poultry and poultry-containing dishes, salads, appetizers, frozen multicourse (20) Frozen dairy desserts and mixes, poultry meals, and sandwich ingredi- including ice cream, ice milks, sher- ents prepared by commercial proc- bets, and other frozen dairy desserts essing or using commercially processed and specialties. poultry with home preparation. (21) Fruit and water ices, including (35) Processed fruits and fruit juices, all frozen fruit and water ices. including all commercially processed (22) Gelatins, puddings, and fillings, fruits, citrus, berries, and mixtures; including flavored gelatin desserts, salads, juices and juice punches, con- puddings, custards, parfaits, pie fill- centrates, dilutions, ‘‘ades’’, and drink ings, and gelatin base salads. substitutes made therefrom. (23) Grain products and pastas, in- (36) Processed vegetables and vege- cluding macaroni and noodle products, table juices, including all commer- rice dishes, and frozen multicourse cially processed vegetables, vegetable meals, without meat or vegetables. dishes, frozen multicourse vegetable (24) Gravies and sauces, including all meals, and vegetable juices and blends. meat sauces and gravies, and tomato, (37) Snack foods, including chips, milk, buttery, and specialty sauces. pretzels, and other novelty snacks. (25) Hard candy and cough drops, in- (38) Soft candy, including candy bars, cluding all hard type candies. chocolates, fudge, mints, and other (26) Herbs, seeds, spices, seasonings, chewy or nougat candies. blends, extracts, and flavorings, includ- (39) Soups, home-prepared, including ing all natural and artificial spices, meat, fish, poultry, vegetable, and blends, and flavors. combination home-prepared soups. (27) Jams and jellies, home-prepared, (40) Soups and soup mixes, including including only home-prepared jams, commercially prepared meat, fish, jellies, fruit butters, preserves, and poultry, vegetable, and combination sweet spreads. soups and soup mixes. (28) Jams and jellies, commercial, in- (41) Sugar, white, granulated, includ- cluding only commercially processed ing only white granulated sugar.

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(42) Sugar substitutes, including Sciences/National Research Council granulated, liquid, and tablet sugar under ‘‘dough conditioner.’’ substitutes. (7) ‘‘Drying agents’’: Substances with (43) Sweet sauces, toppings, and syr- moisture-absorbing ability, used to ups, including chocolate, berry, fruit, maintain an environment of low mois- corn syrup, and maple sweet sauces and ture. toppings. (8) ‘‘Emulsifiers and emulsifier (o) The following terms describe the salts’’: Substances which modify sur- physical or technical functional effects face tension in the component phase of for which direct human food ingredi- an emulsion to establish a uniform dis- ents may be added to foods. They are persion or emulsion. adopted from the National Academy of (9) ‘‘Enzymes’’: Enzymes used to im- Sciences/National Research Council na- prove food processing and the quality tional survey of food industries, re- of the finished food. ported to the Food and Drug Adminis- (10) ‘‘Firming agents’’: Substances tration under the contract title ‘‘A added to precipitate residual pectin, Comprehensive Survey of Industry on thus strengthening the supporting tis- the Use of Food Chemicals Generally sue and preventing its collapse during Recognized as Safe’’ (September 1972), processing. which is incorporated by reference. (11) ‘‘Flavor enhancers’’: Substances Copies are available from the National added to supplement, enhance, or mod- Technical Information Service (NTIS), ify the original taste and/or aroma of a 5285 Port Royal Rd., Springfield, VA food, without imparting a char- 22161, or available for inspection at the acteristic taste or aroma of its own. Office of the Federal Register, 800 (12) ‘‘Flavoring agents and adju- North Capitol Street, NW., suite 700, vants’’: Substances added to impart or Washington, DC 20408: help impart a taste or aroma in food. (1) ‘‘Anticaking agents and free-flow agents’’: Substances added to finely (13) ‘‘Flour treating agents’’: Sub- powdered or crystalline food products stances added to milled flour, at the to prevent caking, lumping, or agglom- mill, to improve its color and/or baking eration. qualities, including bleaching and ma- (2) ‘‘Antimicrobial agents’’: Sub- turing agents. stances used to preserve food by pre- (14) ‘‘Formulation aids’’: Substances venting growth of microorganisms and used to promote or produce a desired subsequent spoilage, including fungi- physical state or texture in food, in- stats, mold and rope inhibitors, and the cluding carriers, binders, fillers, plasti- effects listed by the National Academy cizers, film-formers, and tableting aids, of Sciences/National Research Council etc. under ‘‘preservatives.’’ (15) ‘‘Fumigants’’: Volatile sub- (3) ‘‘Antioxidants’’: Substances used stances used for controlling insects or to preserve food by retarding deteriora- pests. tion, rancidity, or discoloration due to (16) ‘‘Humectants’’: Hygroscopic sub- oxidation. stances incorporated in food to pro- (4) ‘‘Colors and coloring adjuncts’’: mote retention of moisture, including Substances used to impart, preserve, or moisture-retention agents and anti- enhance the color or shading of a food, dusting agents. including color stabilizers, color fixa- (17) ‘‘Leavening agents’’: Substances tives, color-retention agents, etc. used to produce or stimulate produc- (5) ‘‘Curing and pickling agents’’: tion of carbon dioxide in baked goods Substances imparting a unique flavor to impart a light texture, including and/or color to a food, usually pro- yeast, yeast foods, and calcium salts ducing an increase in shelf life sta- listed by the National Academy of bility. Sciences/National Research Council (6) ‘‘Dough strengtheners’’: Sub- under ‘‘dough conditioners.’’ stances used to modify starch and glu- (18) ‘‘Lubricants and release agents’’: ten, thereby producing a more stable Substances added to food contact sur- dough, including the applicable effects faces to prevent ingredients and fin- listed by the National Academy of ished products from sticking to them.

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(19) ‘‘Non-nutritive sweeteners’’: Sub- ping agents, foaming agents, and de- stances having less than 2 percent of foaming agents, etc. the caloric value of sucrose per equiva- (30) ‘‘Surface-finishing agents’’: Sub- lent unit of sweetening capacity. stances used to increase palatability, (20) ‘‘Nutrient supplements’’: Sub- preserve gloss, and inhibit discolora- stances which are necessary for the tion of foods, including glazes, polishes, body’s nutritional and metabolic proc- waxes, and protective coatings. esses. (31) ‘‘Synergists’’: Substances used to (21) ‘‘Nutritive sweeteners’’: Sub- act or react with another food ingre- stances having greater than 2 percent dient to produce a total effect different of the caloric value of sucrose per or greater than the sum of the effects equivalent unit of sweetening capacity. produced by the individual ingredients. (22) ‘‘Oxidizing and reducing agents’’: (32) ‘‘Texturizers’’: Substances which Substances which chemically oxidize affect the appearance or feel of the or reduce another food ingredient, food. thereby producing a more stable product, 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, July 17, 1995] under ‘‘dough conditioners.’’ (23) ‘‘pH control agents’’: Substances § 170.6 Opinion letters on food addi- added to change or maintain active tive status. acidity or basicity, including buffers, acids, alkalies, and neutralizing (a) Over the years the Food and Drug agents. Administration has given informal (24) ‘‘Processing aids’’: Substances written opinions to inquiries as to the used as manufacturing aids to enhance safety of articles intended for use as the appeal or utility of a food or food components of, or in contact with, component, including clarifying food. Prior to the enactment of the agents, clouding agents, catalysts, floc- Food Additives Amendment of 1958 culents, filter aids, and crystallization (Pub. L. 85–929; Sept. 6, 1958), these inhibitors, etc. opinions were given pursuant to sec- (25) ‘‘Propellants, aerating agents, tion 402(a)(1) of the Federal Food, and gases’’: Gases used to supply force Drug, and Cosmetic Act, which reads in to expel a product or used to reduce the part: ‘‘A food shall be deemed to be amount of oxygen in contact with the adulterated if it bears or contains any food in packaging. poisonous or deleterious substance (26) ‘‘Sequestrants’’: Substances which may render it injurious to which combine with polyvalent metal health’’. ions to form a soluble metal complex, (b) Since enactment of the Food Ad- to improve the quality and stability of ditives Amendment, the Food and Drug products. Administration has advised such in- (27) ‘‘Solvents and vehicles’’: Sub- quirers that an article: stances used to extract or dissolve an- (1) Is a food additive within the other substance. meaning of section 201(s) of the act; or (28) ‘‘Stabilizers and thickeners’’: (2) Is generally recognized as safe Substances used to produce viscous so- (GRAS); or lutions or dispersions, to impart body, (3) Has prior sanction or approval improve consistency, or stabilize emul- under that amendment; or sions, including suspending and body- (4) Is not a food additive under the ing agents, setting agents, jellying conditions of intended use. agents, and bulking agents, etc. (c) In the interest of the public (29) ‘‘Surface-active agents’’: Sub- health, such articles which have been stances used to modify surface prop- considered in the past by the Food and erties of liquid food components for a Drug Administration to be safe under variety of effects, other than emulsi- the provisions of section 402(a)(1), or to fiers, but including solubilizing agents, be generally recognized as safe for dispersants, detergents, wetting their intended use, or to have prior agents, rehydration enhancers, whip- sanction or approval, or not to be food

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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, Drug Administration are hereby re- and the petitioner fails to designate it voked. as such, the Commissioner, upon deter- (e) The prior opinions of the kind de- mining that the petition includes a scribed in paragraph (c) of this section proposal for a food-additive regulation, will be replaced by qualified and cur- shall so notify the petitioner and shall rent opinions if the recipient of each thereafter proceed in accordance with such letter forwards a copy of each to the regulations in this part. the Department of Health and Human (c) A regulation will not be issued al- Services, Food and Drug Administra- lowing the use of a food additive in a tion, Center for Food Safety and Ap- food for which a definition and stand- plied Nutrition, 5100 Paint Branch ard of identity is established, unless its Pkwy., College Park, MD 20740, along issuance is in conformity with section with a copy of his letter of inquiry, on 401 of the Act or with the terms of a or before July 23, 1970. (f) This section does not apply to food temporary permit issued under § 130.17 additive status opinion letters per- of this chapter. When the contemplated taining to articles that were considered use of such additive complies with the by the Food and Drug Administration terms of a temporary permit, the food to be food additives nor to articles in- additive regulation will be conditioned cluded in regulations in parts 170 on such compliance and will expire through 189 of this chapter if the arti- with the expiration of the temporary cles are used in accordance with the re- permit. quirements of such regulations. § 170.15 Adoption of regulation on ini- [42 FR 14483, Mar. 15, 1977, as amended at 54 tiative of Commissioner. FR 24896, June 12, 1989] (a) The Commissioner upon his own § 170.10 Food additives in standard- initiative may propose the issuance of ized foods. a regulation prescribing, with respect to any particular use of a food additive, (a) The inclusion of food ingredients the conditions under which such addi- in parts 170 through 189 of this chapter tive may be safely used. Notice of such does not imply that these ingredients proposal shall be published in the FED- may be used in standardized foods un- ERAL REGISTER and shall state the rea- less they are recognized as optional in- sons for the proposal. gredients in applicable food standards. Where a petition is received for the (b) Action upon a proposal made by issuance or amendment of a regulation the Commissioner shall proceed as pro- establishing a definition and standard vided in part 10 of this chapter. of identity for a food under section 401 [42 FR 14486, Mar. 15, 1977, as amended at 42 of the Act, which proposes the inclu- FR 15673, Mar. 22, 1977]

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§ 170.17 Exemption for investigational having additive toxic effects and will use and procedure for obtaining au- be considered as related food additives. thorization to market edible prod- (b) Tolerances established for such ucts from experimental animals. related food additives may limit the A food additive or food containing a amount of a common component that food additive intended for investiga- may be present, or may limit the tional use by qualified experts shall be amount of biological activity (such as exempt from the requirements of sec- cholinesterase inhibition) that may be tion 409 of the Act under the following present or may limit the total amount conditions: of related food additives that may be (a) If intended for investigational use present. in vitro or in laboratory research ani- (c) Where food additives from two or mals, it bears a label which states more chemicals in the same class are prominently, in addition to the other present in or on a food, the tolerance information required by the act, the for the total of such additives shall be warning: the same as that for the additive having the lowest numerical tolerance in Caution. Contains a new food additive for this class, unless there are available investigational use only in laboratory re- methods that permit quantitative de- search animals or for tests in vitro. Not for termination of the amount of each food use in humans. additive present or unless it is shown (b) If intended for use in animals that a higher tolerance is reasonably other than laboratory research animals required for the combined additives to and if the edible products of the ani- accomplish the physical or technical mals are to be marketed as food, per- effect for which such combined addi- mission for the marketing of the edible tives are intended and that the higher products as food has been requested by tolerance will be safe. the sponsor, and authorization has (d) Where residues from two or more been granted by the Food and Drug Ad- additives in the same class are present ministration in accordance with § 511.1 in or on a food and there are available of this chapter or by the Department of methods that permit quantitative de- Agriculture in accordance with 9 CFR termination of each residue, the quan- 309.17, and it bears a label which states tity of combined residues that are prominently, in addition to the other within the tolerance may be deter- information required by the Act, the mined as follows: warning: (1) Determine the quantity of each residue present. Caution. Contains a new food additive for (2) Divide the quantity of each res- use only in investigational animals. Not for use in humans. idue by the tolerance that would apply Edible products of investigational animals if it occurred alone, and multiply by are not to be used for food unless authoriza- 100 to determine the percentage of the tion has been granted by the U.S. Food and permitted amount of residue present. Drug Administration or by the U.S. Depart- (3) Add the percentages so obtained ment of Agriculture. for all residues present. (c) If intended for nonclinical labora- (4) The sum of the percentage shall tory studies in food-producing animals, not exceed 100 percent. the study is conducted in compliance § 170.19 Pesticide chemicals in proc- with the regulations set forth in part 58 essed foods. of this chapter. When pesticide chemical residues [42 FR 14483, Mar. 15, 1977, as amended at 43 occur in processed foods due to the use FR 60021, Dec. 22, 1978] of raw agricultural commodities that bore or contained a pesticide chemical § 170.18 Tolerances for related food ad- in conformity with an exemption ditives. granted or a tolerance prescribed under (a) Food additives that cause similar section 408 of the Act, the processed or related pharmacological effects will food will not be regarded as adulter- be regarded as a class, and in the ab- ated so long as good manufacturing sence of evidence to the contrary, as practice has been followed in removing

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any residue from the raw agricultural lined procedures. In reaching a deci- commodity in the processing (such as sion, the Commissioner will give due by peeling or washing) and so long as weight to the anticipated levels and the concentration of the residue in the patterns of consumption of the additive processed food when ready to eat is not specified or reasonably inferrable. For greater than the tolerance prescribed the purposes of this section, the prin- for the raw agricultural commodity. ciples for evaluating safety of additives But when the concentration of residue set forth in the abovementioned publi- in the processed food when ready to eat cations will apply to any substance is higher than the tolerance prescribed that may properly be classified as a for the raw agricultural commodity, food additive as defined in section the processed food is adulterated unless 201(s) of the Act. the higher concentration is permitted (b) Upon written request describing by a tolerance obtained under section the proposed use of an additive and the 409 of the Act. For example, if fruit proposed experiments to determine its bearing a residue of 7 parts per million safety, the Commissioner will advise a of DDT permitted on the raw agricul- person who wishes to establish the tural commodity is dried and a residue safety of a food additive whether he be- in excess of 7 parts per million of DDT lieves the experiments planned will results on the dried fruit, the dehydrated fruit is adulterated unless the yield data adequate for an evaluation higher tolerance for DDT is authorized of the safety of the additive. by the regulations in this part. Food § 170.22 Safety factors to be consid- that is itself ready to eat, and which ered. contains a higher residue than allowed for the raw agricultural commodity, In accordance with section may not be legalized by blending or 409(c)(5)(C) of the Act, the following mixing with other foods to reduce the safety factors will be applied in deter- residue in the mixed food below the tol- mining whether the proposed use of a erance prescribed for the raw agricul- food additive will be safe: Except where tural commodity. evidence is submitted which justifies use of a different safety factor, a safety Subpart B—Food Additive Safety factor in applying animal experimen- tation data to man of 100 to 1, will be § 170.20 General principles for evalu- used; that is, a food additive for use by ating the safety of food additives. man will not be granted a tolerance (a) In reaching a decision on any pe- that will exceed 1⁄100th of the maximum tition filed under section 409 of the amount demonstrated to be without Act, the Commissioner will give full harm to experimental animals. consideration to the specific biological properties of the compound and the § 170.30 Eligibility for classification as adequacy of the methods employed to generally recognized as safe (GRAS). demonstrate safety for the proposed use, and the Commissioner will be (a) General recognition of safety may guided by the principles and procedures be based only on the views of experts for establishing the safety of food addi- qualified by scientific training and ex- tives stated in current publications of perience to evaluate the safety of sub- the National Academy of Sciences-Na- stances directly or indirectly added to tional Research Council. A petition food. The basis of such views may be ei- will not be denied, however, by reason ther (1) scientific procedures or (2) in of the petitioner’s having followed pro- the case of a substance used in food cedures other than those outlined in prior to January 1, 1958, through expe- the publications of the National Acad- rience based on common use in food. emy of Sciences-National Research General recognition of safety requires Council if, from available evidence, the common knowledge about the sub- Commissioner finds that the proce- stance throughout the scientific com- dures used give results as reliable as, munity knowledgeable about the safety or more reliable than, those reasonably of substances directly or indirectly to be expected from the use of the out- added to food.

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(b) General recognition of safety (d) The food ingredients listed as based upon scientific procedures shall GRAS in part 182 of this chapter or af- require the same quantity and quality firmed as GRAS in part 184 or § 186.1 of of scientific evidence as is required to this chapter do not include all sub- obtain approval of a food additive regu- stances that are generally recognized lation for the ingredient. General rec- as safe for their intended use in food. ognition of safety through scientific Because of the large number of sub- procedures shall ordinarily be based stances the intended use of which re- upon published studies which may be sults or may reasonably be expected to corroborated by unpublished studies result, directly or indirectly, in their and other data and information. becoming a component or otherwise af- (c)(1) General recognition of safety fecting the characteristics of food, it is through experience based on common impracticable to list all such sub- use in food prior to January 1, 1958, stances that are GRAS. A food ingre- may be determined without the quan- dient of natural biological origin that tity or quality of scientific procedures has been widely consumed for its nutri- required for approval of a food additive ent properties in the United States regulation. General recognition of safe- prior to January 1, 1958, without known ty through experience based on com- detrimental effects, which is subject mon use in food prior to January 1, only to conventional processing as 1958, shall be based solely on food use practiced prior to January 1, 1958, and of the substance prior to January 1, for which no known safety hazard ex- 1958, and shall ordinarily be based upon ists, will ordinarily be regarded as generally available data and informa- GRAS without specific inclusion in tion. An ingredient not in common use part 182, part 184 or § 186.1 of this chap- in food prior to January 1, 1958, may ter. achieve general recognition of safety (e) Food ingredients were listed as only through scientific procedures. GRAS in part 182 of this chapter during (2) A substance used in food prior to 1958–1962 without a detailed scientific January 1, 1958, may be generally rec- review of all available data and infor- ognized as safe through experience mation relating to their safety. Begin- based on its common use in food when ning in 1969, the Food and Drug Admin- that use occurred exclusively or pri- istration has undertaken a systematic marily outside of the United States if review of the status of all ingredients the information about the experience used in food on the determination that establishes that the use of the sub- they are GRAS or subject to a prior stance is safe within the meaning of sanction. All determinations of GRAS the act (see § 170.3(i)). Common use in status or food additive status or prior food prior to January 1, 1958, that oc- sanction status pursuant to this review curred outside of the United States shall be handled pursuant to §§ 170.35, shall be documented by published or 170.38, and 180.1 of this chapter. Affir- other information and shall be corrobo- mation of GRAS status shall be an- rated by information from a second, nounced in part 184 or § 186.1 of this independent source that confirms the chapter. history and circumstances of use of the (f) The status of the following food substance. The information used to ingredients will be reviewed and af- document and to corroborate the his- firmed as GRAS or determined to be a tory and circumstances of use of the food additive or subject to a prior sanc- substance must be generally available; tion pursuant to § 170.35, § 170.38, or that is, it must be widely available in § 180.1 of this chapter: the country in which the history of use (1) Any substance of natural biologi- has occurred and readily available to cal origin that has been widely con- interested qualified experts in this sumed for its nutrient properties in the country. Persons claiming GRAS sta- United States prior to January 1, 1958, tus for a substance based on its com- without known detrimental effect, for mon use in food outside of the United which no health hazard is known, and States should obtain FDA concurrence which has been modified by processes that the use of the substance is GRAS. first introduced into commercial use

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after January 1, 1958, which may rea- Office of the Federal Register, 800 sonably be expected significantly to North Capitol Street, NW., suite 700, alter the composition of the substance. Washington, DC 20408. (2) Any substance of natural biologi- (2) It performs an appropriate func- cal origin that has been widely con- tion in the food or food-contact article sumed for its nutrient properties in the in which it is used. United States prior to January 1, 1958, (3) It is used at a level no higher than without known detrimental effect, for necessary to achieve its intended pur- which no health hazard is known, that pose in that food or, if used as a compo- has had significant alteration of com- nent of a food-contact article, at a position by breeding or selection after level no higher than necessary to January 1, 1958, where the change may achieve its intended purpose in that ar- be reasonably expected to alter the nu- ticle. tritive value or the concentration of toxic constituents. (i) If a substance is affirmed as GRAS (3) Distillates, isolates, extracts, and in part 184 or § 186.1 of this chapter with concentration of extracts of GRAS sub- no limitation other than good manu- stances. facturing practice, it shall be regarded (4) Reaction products of GRAS sub- as GRAS if its conditions of use are not stances. significantly different from those re- (5) Substances not of a natural bio- ported in the regulation as the basis on logical origin, including those for which the GRAS status of the sub- which evidence is offered that they are stance was affirmed. If the conditions identical to a GRAS counterpart of of use are significantly different, such natural biological origin. use of the substance may not be GRAS. (6) Substances of natural biological In such a case a manufacturer may not origin intended for consumption for rely on the regulation as authorizing other than their nutrient properties. the use but must independently estab- (g) A food ingredient that is not lish that the use is GRAS or must use GRAS or subject to a prior sanction re- the substance in accordance with a quires a food additive regulation pro- food additive regulation. mulgated under section 409 of the act (j) If an ingredient is affirmed as before it may be directly or indirectly GRAS in part 184 or § 186.1 of this chap- added to food. ter with specific limitation(s), it may (h) A food ingredient that is listed as be used in food only within such limi- GRAS in part 182 of this chapter or af- tation(s) (including the category of firmed as GRAS in part 184 or § 186.1 of food(s), the functional use(s) of the in- this chapter shall be regarded as GRAS gredient, and the level(s) of use). Any only if, in addition to all the require- use of such an ingredient not in full ments in the applicable regulation, it compliance with each such established also meets all of the following require- limitation shall require a food additive ments: regulation. (1) It complies with any applicable food grade specifications of the Food (k) Pursuant to § 170.35, a food ingre- Chemicals Codex, 2d Ed. (1972), or, if dient may be affirmed as GRAS in part specifically indicated in the GRAS af- 184 or § 186.1 of this chapter for a spe- firmation regulation, the Food Chemi- cific use(s) without a general evalua- cals Codex, 3d Ed. (1981), which are in- tion of use of the ingredient. In addi- corporated by reference, except that tion to the use(s) specified in the regu- any substance used as a component of lation, other uses of such an ingredient articles that contact food and affirmed may also be GRAS. Any affirmation of as GRAS in § 186.1 of this chapter shall GRAS status for a specific use(s), with- comply with the specifications therein, out a general evaluation of use of the or in the absence of such specifications, ingredient, is subject to reconsider- shall be of a purity suitable for its in- ation upon such evaluation. tended use. Copies may be obtained (l) New information may at any time from the National Academy Press, 2101 require reconsideration of the GRAS Constitution Ave. NW., Washington, status of a food ingredient. Any change DC 20418, or may be examined at the in part 182, part 184, or § 186.1 of this

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chapter shall be accomplished pursuant forth in § 170.30 (b) or (c) have been met, to § 170.38. in the following form: (i) Description of the substance, in- [42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, cluding: 1988] (a) Common or usual name. (b) Chemical name. § 170.35 Affirmation of generally recog- (c) Chemical Abstract Service (CAS) nized as safe (GRAS) status. registry number. (a) The Commissioner, either on his (d) Empirical formula. initiative or on the petition of an in- (e) Structural formula. terested person, may affirm the GRAS (f) Specifications for food grade ma- status of substances that directly or terial, including arsenic and heavy indirectly become components of food. metals. (Recommendation for any (b)(1) If the Commissioner proposes change in the Food Chemicals Codex on his own initiative that a substance monograph should be included where is entitled to affirmation as GRAS, he applicable.) will place all of the data and informa- (g) Quantitative compositions. tion on which he relies on public file in (h) Manufacturing process (excluding the office of the Dockets Management any trade secrets). Branch and will publish in the FEDERAL (ii) Use of the substance, including: REGISTER a notice giving the name of (a) Date when use began. the substance, its proposed uses, and (b) Information and reports or other any limitations proposed for purposes data on past uses in food. other than safety. (c) Foods in which used, and levels of (2) The FEDERAL REGISTER notice will use in such foods, and for what pur- allow a period of 60 days during which poses. any interested person may review the (iii) Methods for detecting the sub- data and information and/or file com- stance in food, including: ments with the Dockets Management (a) References to qualitative and Branch. Copies of all comments re- quantitative methods for determining ceived shall be made available for ex- the substance(s) in food, including the amination in the Dockets Management type of analytical procedures used. Branch’s office. (b) Sensitivity and reproducibility of (3) The Commissioner will evaluate such method(s). all comments received. If he concludes (iv) Information to establish the safe- that there is convincing evidence that ty and functionality of the substance the substance is GRAS as described in in food. Published scientific literature, § 170.30, he will publish a notice in the evidence that the substance is identical FEDERAL REGISTER listing the sub- to a GRAS counterpart of natural bio- stance as GRAS in part 182, part 184, or logical origin, and other data may be part 186 of this chapter, as appropriate. submitted to support safety. Any ad- (4) If, after evaluation of the com- verse information or consumer comments, the Commissioner concludes plaints shall be included. Complete bib- that there is a lack of convincing evi- liographic references shall be provided dence that the substance is GRAS and where a copy of the article is not pro- that it should be considered a food ad- vided. ditive subject to section 409 of the Act, (v) A statement signed by the person he shall publish a notice thereof in the responsible for the petition that to the FEDERAL REGISTER in accordance with best of his knowledge it is a represent- § 170.38. ative and balanced submission that in- (c)(1) Persons seeking the affirmation cludes unfavorable information, as well of GRAS status of substances as pro- as favorable information, known to vided in § 170.30(e), except those subject him pertinent to the evaluation of the to the NAS/NRC GRAS list survey (36 safety and functionality of the sub- FR 20546; October 23, 1971), shall submit stance. a petition for GRAS affirmation pursu- (vi) If nonclinical laboratory studies ant to part 10 of this chapter. Such pe- are involved, additional information tition shall contain information to es- and data submitted in support of filed tablish that the GRAS criteria as set petitions shall include, with respect to

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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 Dockets Management ISTER in accordance with § 170.38. Branch and will publish a notice of fil- (7) The notice of filing in the FED- ing in the FEDERAL REGISTER giving ERAL REGISTER will request submission the name of the petitioner and a brief of proof of any applicable prior sanc- description of the petition including tion for use of the ingredient under the name of the substance, its proposed conditions different from those pro- use, and any limitations proposed for posed to be determined to be GRAS. reasons other than safety. A copy of The failure of any person to come for- the notice will be mailed to the peti- ward with proof of such an applicable tioner at the time the original is sent prior sanction in response to the notice to the FEDERAL REGISTER. of filing will constitute a waiver of the (3)(i) If intended uses of the sub- right to assert or rely on such sanction stance include uses in meat, meat food at any later time. The notice of filing product, or poultry product subject to will also constitute a proposal to estab- regulation by the U.S. Department of lish a regulation under part 181 of this Agriculture (USDA) under the Poultry chapter, incorporating the same provi- Products Inspection Act (PPIA) (21 sions, in the event that such a regula- U.S.C. 451 et seq.) or Federal Meat In- tion is determined to be appropriate as spection Act (FMIA) (21 U.S.C. 601 et a result of submission of proof of such seq.), FDA shall, upon filing of the peti- an applicable prior sanction in re- tion, forward a copy of the petition or sponse to the notice of filing. relevant portions thereof to the Food (Information collection requirements were Safety and Inspection Service, USDA, approved by the Office of Management and for simultaneous review under the Budget under control number 0910–0132) PPIA and FMIA. [42 FR 14488, Mar. 15, 1977, as amended at 50 (ii) FDA will ask USDA to advise FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, whether the proposed meat and poultry 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, uses comply with the FMIA and PPIA July 29, 1997; 65 FR 51762, Aug. 25, 2000] or, if not, whether use of the substance would be permitted in products under § 170.38 Determination of food addi- USDA jurisdiction under specified con- tive status. ditions or restrictions. (a) The Commissioner may, in ac- (4) The notice of filing in the FED- cordance with § 170.35(b)(4) or (c)(5), ERAL REGISTER will allow a period of 60 publish a notice in the FEDERAL REG- days during which any interested per- ISTER determining that a substance is son may review the petition and/or file not GRAS and is a food additive sub- comments with the Dockets Manage- ject to section 409 of the Act. ment Branch. Copies of all comments (b)(1) The Commissioner, on his own received shall be made available for ex- initiative or on the petition of any in- amination in the Dockets Management terested person, pursuant to part 10 of Branch’s office. this chapter, may issue a notice in the (5) The Commissioner will evaluate FEDERAL REGISTER proposing to deter- the petition and all available informa- mine that a substance is not GRAS and

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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 Dockets constitutes a determination that ex- Management Branch and will include cluded uses would result in adultera- in the FEDERAL REGISTER notice the tion of the food in violation of section name of the substance, its known uses, 402 of the Act, and the failure of any and a summary of the basis for the de- person to come forward with proof of termination. 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 Dockets Management to establish a regulation under part 181 Branch. Copies of all comments shall of this chapter, incorporating the same be made available for examination in provisions, in the event that such a the Dockets Management Branch’s of- regulation is determined to be appro- fice. priate as a result of submission of proof (3) The Commissioner will evaluate of such an applicable prior sanction in all comments received. If he concludes response to the proposal. that there is a lack of convincing evidence that the substance is GRAS or is [42 FR 14488, Mar. 15, 1977, as amended at 42 otherwise exempt from the definition FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, of a food additive in section 201(s) of 1989] the Act, he will publish a notice there- § 170.39 Threshold of regulation for of in the FEDERAL REGISTER. If he con- substances used in food-contact ar- cludes that there is convincing evi- ticles. dence that the substance is GRAS, he will publish an order in the FEDERAL (a) A substance used in a food-con- REGISTER listing the substance as tact article (e.g., food-packaging or GRAS in part 182, part 184, or part 186 food-processing equipment) that mi- of this chapter, as appropriate. grates, or that may be expected to mi- (c) A FEDERAL REGISTER notice deter- grate, into food will be exempted from mining that a substance is a food addi- regulation as a food additive because it tive shall provide for the use of the ad- becomes a component of food at levels ditive in food or food contact surfaces that are below the threshold of regula- as follows: tion if: (1) It may promulgate a food additive (1) The substance has not been shown regulation governing use of the addi- to be a carcinogen in humans or ani- tive. mals, and there is no reason, based on (2) It may promulgate an interim the chemical structure of the sub- food additive regulation governing use stance, to suspect that the substance is of the additive. a carcinogen. The substance must also (3) It may require discontinuation of not contain a carcinogenic impurity or, the use of the additive. if it does, must not contain a carcino- (4) It may adopt any combination of genic impurity with a TD50 value based the above three approaches for dif- on chronic feeding studies reported in ferent uses or levels of use of the addi- the scientific literature or otherwise tive. available to the Food and Drug Admin- (d) If the Commissioner of Food and istration of less than 6.25 milligrams Drugs is aware of any prior sanction per kilogram bodyweight per day (The for use of the substance, he will con- TD50, for the purposes of this section, is currently propose a separate regulation the feeding dose that causes cancer in covering such use of the ingredient 50 percent of the test animals when under part 181 of this chapter. If the corrected for tumors found in control Commissioner is unaware of any such animals. If more than one TD50 value 17

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has been reported in the scientific lit- (2) Detailed information on the con- erature for a substance, the Food and ditions of use of the substance (e.g., Drug Administration will use the low- temperature, type of food with which est appropriate TD50 value in its re- the substance will come into contact, view.); the duration of the contact, and wheth- (2) The substance presents no other er the food-contact article will be for health or safety concerns because: repeated or single use applications); (i) The use in question has been (3) A clear statement as to whether shown to result in or may be expected the request for exemption from regula- to result in dietary concentrations at tion as a food additive is based on the or below 0.5 parts per billion, cor- fact that the use of the substance in responding to dietary exposure levels the food-contact article results in a di- at or below 1.5 micrograms/person/day etary concentration at or below 0.5 (based on a diet of 1,500 grams of solid parts per billion, or on the fact that it food and 1,500 grams of liquid food per involves the use of a regulated direct person per day); or food additive for which the dietary ex- (ii) The substance is currently regu- posure is at or below 1 percent of the lated for direct addition into food, and acceptable dietary intake (ADI); the dietary exposure to the substance (4) Data that will enable the Food resulting from the proposed use is at or and Drug Administration to estimate below 1 percent of the acceptable daily the daily dietary concentration result- intake as determined by safety data in ing from the proposed use of the sub- the Food and Drug Administration’s stance. These data should be in the files or from other appropriate sources; form of: (3) The substance has no technical ef- (i) Validated migration data obtained fect in or on the food to which it mi- under worst-case (time/temperature) grates; and intended use conditions utilizing ap- (4) The substance use has no signifi- propriate food simulating solvents; cant adverse impact on the environ- (ii) Information on the amount of the ment. substance used in the manufacture of (b) Notwithstanding paragraph (a) of the food-contact article; or this section, the Food and Drug Admin- (iii) Information on the residual level istration reserves the right to decline of the substance in the food-contact ar- to grant an exemption in those cases in ticle. For repeat-use articles, an esti- which available information estab- mate of the amount of food that con- lishes that the proposed use may pose a tacts a specific unit of surface area public health risk. The reasons for the over the lifetime of the article should agency’s decision to decline to grant an also be provided. (In cases where data exemption will be explained in the are provided only in the form of manu- Food and Drug Administration’s re- facturing use levels or residual levels sponse to the requestor. of the substance present in the food- (c) A request for the Food and Drug contact article, the Food and Drug Ad- Administration to exempt a use of a ministration will calculate a worst- substance from regulation as a food ad- case dietary concentration level as- ditive shall include three copies of the suming 100 percent migration.) A de- following information (If part of the tailed description of the analytical submitted material is in a foreign lan- method used to quantify the substance guage, it must be accompanied by an should also be submitted along with English translation verified to be com- data used to validate the detection plete and accurate in accordance with limit. § 10.20(c)(2) of this chapter): (iv) In cases where there is no detect- (1) The chemical composition of the able migration into food or food substance for which the request is simulants, or when no residual level of made, including, whenever possible, a substance is detected in the food-con- the name of the chemical in accord- tact article by a suitable analytical ance with current Chemical Abstract method, the Food and Drug Adminis- Service (CAS) nomenclature guidelines tration will, for the purposes of esti- and a CAS registry number, if avail- mating the dietary concentration, con- able; sider the validated detection limit of

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the method used to analyze for the sub- Interested persons may also obtain a stance. copy of the list of exempted substances (5) The results of an analysis of exist- by contacting the Food and Drug Ad- ing toxicological information on the ministration’s Office of Premarket Ap- substance and its impurities. This in- proval (HFS–200), 5100 Paint Branch formation on the substance is needed Pkwy., College Park, MD 20740. For ac- to show whether an animal carcinogen tions requiring an environmental as- bioassay has been carried out, or sessment, the agency’s finding of no whether there is some other basis for significant impact and the evidence suspecting that the substance is a car- supporting that finding, contained in cinogen or potent toxin. This type of the petitioner’s environmental assess- information on the impurities is need- ment, also will be available for public ed to show whether any of them are inspection at the Dockets Management carcinogenic, and, if carcinogenic, Branch in accordance with § 25.51(b)(2) whether their TD50 values are greater of this chapter. Requests for copies of than 6.25 milligrams per kilogram releasable information contained in bodyweight per day in accordance with submissions requesting exemptions paragraph (a)(1) of this section. from the food additive regulations will (6) Information on the environmental be handled in accordance with the Food impact that would result from the pro- and Drug Administration’s Freedom of posed use of the substance. The request Information Act procedures, as de- should contain either a claim for cat- scribed in part 20 of this chapter. In egorical exclusion as specified in § 25.32 particular, data and information that of this chapter or an environmental as- fall within the definitions of a trade se- sessment as specified in § 25.40 of this cret or confidential commercial or fi- chapter. nancial information are not available (d) Data to be reviewed under this for public disclosure in accordance section shall be submitted to the Food with § 20.61(c) of this chapter. and Drug Administration’s Office of (f) If the request for an exemption Premarket Approval (HFS–200), 5100 from regulation as a food additive is Paint Branch Pkwy., College Park, MD not granted, the requestor may submit 20740. a petition to the Food and Drug Ad- (e) The Food and Drug Administra- ministration for reconsideration of the tion will inform the requestor by letter decision in accordance with the provi- whether the specific food-contact ap- sions of § 10.33 of this chapter. plication is exempt from regulation as (g) If the Food and Drug Administra- a food additive or not. Although a sub- tion receives significant new informa- stance that migrates to food at a level tion that raises questions about the di- that results in a dietary concentration etary concentration or the safety of a at or below the threshold of regulation substance that the agency has exempt- will not be the subject of a regulation ed from regulation, the Food and Drug published in the FEDERAL REGISTER Administration may reevaluate the and will not appear in the Code of Fed- substance. If the Food and Drug Ad- eral Regulations, the Food and Drug ministration tentatively concludes Administration will maintain a list of that the information that is available substances exempted from regulation about the substance no longer supports as food additives under this section on an exemption for the use of the food- display at the Dockets Management contact material from the food addi- Branch. This list will include the name tive regulations, the agency will notify of the company that made the request, any persons that requested an exemp- the chemical name of the substance, tion for the substance of its tentative the specific use for which it has re- decision. The requestors will be given ceived an exemption from regulation as an opportunity to show why the use of a food additive, and any appropriate the substance should not be regulated limitations on its use. The list will not under the food additive provisions of include any trade names. This list will the act. If the requestors fail to ade- enable interested persons to see the quately respond to the new evidence, types of uses of food-contact materials the agency will notify them that fur- being exempted under the regulation. ther use of the substance in question

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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 § 103.35(d) of this chapter, and (c) to the Dockets Management Branch as that authorized by regulations (40 CFR part of the file of uses of substances ex- part 180) under section 408 of the Act. empted from regulation as food additives. The Food and Drug Administra- § 170.50 Glycine (aminoacetic acid) in tion recognizes that manufacturers food for human consumption. other than those that actually made a (a) Heretofore, the Food and Drug request for exemption may also be Administration has expressed the opin- using exempted substances in food-con- ion in trade correspondence that gly- tact articles under conditions of use cine is generally recognized as safe for (e.g., use levels, temperature, type of certain technical effects in human food food contacted, etc.) that are similar to when used in accordance with good those for which the exemption was manufacturing practice; however: issued. Because only requestors will be (1) Reports in scientific literature in- notified as part of the revocation proc- dicate that adverse effects were found ess described in this section, the Food in cases where high levels of glycine and Drug Administration plans to no- were administered in diets of experi- tify other manufacturers by means of a mental animals. notice published in the FEDERAL REG- (2) Current usage information indi- ISTER of its decision to revoke an ex- cates that the daily dietary intake of emption issued for a specific use of a glycine by humans may be substan- substance in a food contact article. tially increasing due to changing use (h) Guidance documents to assist re- patterns in food technology. questors in the preparation of submis- Therefore, the Food and Drug Adminis- sions seeking exemptions from the food tration no longer regards glycine and additive regulations are available from its salts as generally recognized as safe the Food and Drug Administration’s for use in human food and all out- Office of Premarket Approval (HFS– standing letters expressing sanction for 200), 5100 Paint Branch Pkwy., College such use are rescinded. Park, MD 20740. Interested persons are (b) The Commissioner of Food and encouraged to obtain specific guidance Drugs concludes that by May 8, 1971, from the Food and Drug Administra- manufacturers: tion on the appropriate protocols to be (1) Shall reformulate food products used for obtaining migration data, on for human use to eliminate added gly- the validation of the analytical meth- cine and its salts; or ods used to quantify migration levels, (2) Shall bring such products into on the procedures used to relate migra- compliance with an authorizing food tion data to dietary exposures, and on additive regulation. A food additive pe- any other issue not specifically covered tition supported by toxicity data is re- in the Food and Drug Administration’s quired to show that any proposed level guidance documents. of glycine or its salts added to foods for [60 FR 36595, July 17, 1995, as amended at 62 human consumption will be safe. FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, (c) The status of glycine as generally 2000] recognized as safe for use in animal feed, as prescribed in § 582.5049 of this Subpart C—Specific Administra- chapter, remains unchanged because tive Rulings and Decisions the additive is considered an essential nutrient in certain animal feeds and is § 170.45 Fluorine-containing com- safe for such use under conditions of pounds. good feeding practice. The Commissioner of Food and Drugs has concluded that it is in the interest § 170.60 Nitrites and/or nitrates in cur- of the public health to limit the addi- ing premixes. tion of fluorine compounds to foods (a) (a) Nitrites and/or nitrates are food to that resulting from the fluoridation additives when combined in curing pre- of public water supplies as stated in mixes with spices and/or other fla- § 250.203 of this chapter, (b) to that re- voring or seasoning ingredients that

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contain or constitute a source of sec- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. ondary or tertiary amines, including SOURCE: 42 FR 14489, Mar. 15, 1977, unless but not limited to essential oils, diso- otherwise noted. dium inosinate, disodium guanylate, hydrolysates of animal or plant origin Subpart A—General Provisions (such as hydrolyzed vegetable protein), oleoresins of spices, soy products, and § 171.1 Petitions. spice extractives. Such food additives (a) Petitions to be filed with the may be used only after the establish- Commissioner under the provisions of ment of an authorizing food additive section 409(b) of the Federal Food, regulation. A food additive petition Drug, and Cosmetic Act (the act) shall submitted pursuant to §§ 171.1 and be submitted in triplicate (quadru- 171.100 of this chapter, supported by plicate, if intended uses include use in data demonstrating that nitrosamines meat, meat food product, or poultry are not formed in curing premixes con- product). If any part of the material taining such food additives, is required submitted is in a foreign language, it to establish safety. shall be accompanied by an accurate (b) Nitrites and/or nitrates, when and complete English translation. The packaged separately from flavoring petition shall state petitioner’s post of- and seasoning in curing premixes, may fice address to which published notices continue to be used under prior sanc- or orders issued or objections filed pur- tions in the commercial curing of meat suant to section 409 of the Act may be and meat products and poultry prod- sent. ucts and in accordance with the provi- (b) Pertinent information may be in- sions of §§ 172.170 and 172.175 of this corporated in, and will be considered as chapter that apply to meat curing part of, a petition on the basis of spe- preparations for the home curing of cific reference to such information sub- meat and meat products, including mitted to and retained in the files of poultry and wild game. To assure safe the Food and Drug Administration. use of such ingredients the labeling of However, any reference to unpublished the premixes shall bear instructions to information furnished by a person the user that such separately packaged other than the applicant will not be ingredients are not to be combined considered unless use of such informa- until just prior to use. Encapsulating tion is authorized in a written state- or coating some or all of the ingredi- ment signed by the person who sub- ents does not constitute separate pack- mitted it. Any reference to published aging. information offered in support of a food additive petition should be accom- PART 171—FOOD ADDITIVE panied by reprints or photostatic cop- PETITIONS ies of such references. (c) Petitions shall include the fol- Subpart A—General Provisions lowing data and be submitted in the following form: Sec. 171.1 Petitions. (Date) 171.6 Amendment of petition. Name of petitioner lllllllllllll 171.7 Withdrawal of petition without preju- Post-office address lllllllllllll dice. Date lllllllllllllllllllll 171.8 Threshold of regulation for substances Name of food additive and proposed use ll used in food-contact articles. llllllllllllllllllllllll Petitions Control Branch Subpart B—Administrative Actions on Food and Drug Administration Applications Department of Health and Human Services Washington, DC 20204. 171.100 Regulation based on petition. DEAR SIRS: 171.102 Effective date of regulation. The undersigned, lllll submits this 171.110 Procedure for objections and hear- petition pursuant to section 409(b)(1) of the ings. Federal Food, Drug, and Cosmetic Act with 171.130 Procedure for amending and repeal- respect to lllll ing tolerances or exemptions from tolerances. (Name of the food additive and proposed use)

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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 the characteristics of the substance or the D. A description of practicable methods to reliability of the controls may be specified. determine the amount of the food additive in If the food additive is a mixture of chemi- the raw, processed, and/or finished food and cals, the petition shall supply a list of all of any substance formed in or on such food substances used in the synthesis, extraction, because of its use. The test proposed shall be or other method of preparation, regardless of one that can be used for food-control pur- whether they undergo chemical change in poses and that can be applied with consistent the process. Each substance should be identi- results by any properly equipped and trained fied by its common English name and com- laboratory personnel. plete chemical name, using structural for- E. Full reports of investigations made with mulas when necessary for specific identifica- respect to the safety of the food additive. tion. If any proprietary preparation is used (A petition may be regarded as incomplete as a component, the proprietary name should unless it includes full reports of adequate be followed by a complete quantitative tests reasonably applicable to show whether statement of composition. Reasonable alter- or not the food additive will be safe for its natives for any listed substance may be spec- intended use. The reports ordinarily should ified. include detailed data derived from appro- If the petitioner does not himself perform priate animal and other biological experi- all the manufacturing, processing, and pack- ments in which the methods used and the re- ing operations for a food additive, the peti- sults obtained are clearly set forth. The petition shall identify each person who will per- tion shall not omit without explanation any form a part of such operations and designate reports of investigations that would bias an the part. evaluation of the safety of the food additive.) The petition shall include stability data, F. Proposed tolerances for the food addi- and, if the data indicate that it is needed to tive, if tolerances are required in order to in- insure the identity, strength, quality, or pu- sure its safety. A petitioner may include a rity of the additive, the expiration date that proposed regulation. will be employed. G. If submitting petition to modify an ex- B. The amount of the food additive pro- isting regulation issued pursuant to section posed for use and the purposes for which it is 409(c)(1)(A) of the Act, full information on proposed, together with all directions, rec- each proposed change that is to be made in ommendations, and suggestions regarding the original regulation must be submitted. the proposed use, as well as specimens of the The petition may omit statements made in labeling proposed for the food additive and the original petition concerning which no any labeling that will be required by applica- change is proposed. A supplemental petition ble provisions of the Federal Food, Drug, and must be submitted for any change beyond Cosmetic Act on the finished food by reason the variations provided for in the original of the use of the food additive. If the additive petition and the regulation issued on the results or may reasonably be expected to re- basis of the original petition.

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H. The petitioner is required to submit ei- (ii) A protocol for a test or study, un- ther a claim for categorical exclusion under less it is shown to fall within the ex- § 25.30 or 25.32 of this chapter or an environ- emption established for trade secrets mental assessment under § 25.40 of this chap- and confidential commercial informa- ter. tion in § 20.61 of this chapter. Yours very truly, (iii) Adverse reaction reports, prod- Petitioner llllllllllllllllll uct experience reports, consumer com- By llllllllllllllllllllll plaints, and other similar data and in- (Indicate authority) formation, after deletion of: (d) The petitioner will be notified of (a) Names and any information that the date on which his petition is filed; would identify the person using the and an incomplete petition, or one that product. has not been submitted in triplicate, (b) Names and any information that will usually be retained but not filed as would identify any third party involved a petition under section 409 of the Act. with the report, such as a physician or The petitioner will be notified in what hospital or other institution. respects his petition is incomplete. (iv) A list of all ingredients contained (e) The petition must be signed by in a food additive, whether or not it is the petitioner or by his attorney or in descending order of predominance. A agent, or (if a corporation) by an au- particular ingredient or group of ingre- thorized official. dients shall be deleted from any such (f) The data specified under the sev- list prior to public disclosure if it is eral lettered headings should be sub- shown to fall within the exemption es- mitted on separate sheets or sets of tablished in § 20.61 of this chapter, and sheets, suitably identified. If such data a notation shall be made that any such have already been submitted with an ingredient list is incomplete. earlier application, the present peti- (v) An assay method or other analyt- tion may incorporate it by specific ref- ical method, unless it serves no regu- erence to the earlier. If part of the data latory or compliance purpose and is have been submitted by the manufac- shown to fall within the exemption es- turer of the food additive as a master tablished in § 20.61 of this chapter. file, the petitioner may refer to the (2) The following data and informa- master file if and to the extent he ob- tion in a food additive petition are not tains the manufacturer’s written per- available for public disclosure unless mission to do so. The manufacturer they have been previously disclosed to may authorize specific reference to the the public as defined in § 20.81 of this data without disclosure to the peti- chapter or they relate to a product or tioner. Nothing herein shall prevent ingredient that has been abandoned reference to published data. and they no longer represent a trade (g) A petition shall be retained but secret or confidential commercial or fi- shall not be filed if any of the data pre- nancial information as defined in § 20.61 scribed by section 409(b) of the Act are of this chapter: lacking or are not set forth so as to be (i) Manufacturing methods or proc- readily understood. esses, including quality control proce- (h)(1) The following data and infor- dures. mation in a food additive petition are (ii) Production, sales, distribution, available for public disclosure, unless and similar data and information, ex- extraordinary circumstances are cept that any compilation of such data shown, after the notice of filing of the and information aggregated and pre- petition is published in the FEDERAL pared in a way that does not reveal REGISTER or, if the petition is not data or information which is not avail- promptly filed because of deficiencies able for public disclosure under this in it, after the petitioner is informed provision is available for public disclo- that it will not be filed because of the sure. deficiencies involved: (iii) Quantitative or semiquantita- (i) All safety and functionality data tive formulas. and information submitted with or in- (3) All correspondence and written corporated by reference in the petition. summaries of oral discussions relating

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to a food additive petition are avail- (j) The Commissioner may request a able for public disclosure in accordance full description of the methods used in, with the provisions of part 20 of this and the facilities and controls used for, chapter when the food additive regula- the production of the food additive, or tion is published in the FEDERAL REG- a sample of the food additive, articles ISTER. used as components thereof, or of the (4) For purposes of this regulation, food in which the additive is proposed safety and functionality data include to be used, at any time while a petition all studies and tests of a food additive is under consideration. The Commis- on animals and humans and all studies sioner shall specify in the request for a and tests on a food additive for iden- sample of the food additive, or articles tity, stability, purity, potency, per- used as components thereof, or of the formance, and usefulness. food in or on which the additive is pro- (i)(1) Within 15 days after receipt, the posed to be used, a quantity deemed Commissioner will notify the peti- adequate to permit tests of analytical tioner of acceptance or nonacceptance methods to determine quantities of the of a petition, and if not accepted the food additive present in foods for which reasons therefor. If accepted, the date it is intended to be used or adequate of the notification letter sent to peti- for any study or investigation reason- tioner becomes the date of filing for ably required with respect to the safety the purposes of section 409(b)(5) of the of the food additive or the physical or Act. If the petitioner desires, he may technical effect it produces. The date supplement a deficient petition after used for computing the 90-day limit for being notified regarding deficiencies. If the purposes of section 409(c)(2) of the the supplementary material or expla- Act shall be moved forward 1 day for nation of the petition is deemed ac- each day after the mailing date of the ceptable, petitioner shall be notified. request taken by the petitioner to sub- The date of such notification becomes mit the sample. If the information or the date of filing. If the petitioner does sample is requested a reasonable time not wish to supplement or explain the in advance of the 180 days, but is not petition and requests in writing that it submitted within such 180 days after be filed as submitted, the petition shall filing of the petition, the petition will be filed and the petitioner so notified. be considered withdrawn without prej- The date of such notification becomes udice. the date of filing. (k) If nonclinical laboratory studies (2) The Commissioner will publish in are involved, petitions filed with the the FEDERAL REGISTER within 30 days Commissioner under section 409(b) of from the date of filing of such petition, the act shall include, with respect to a notice of the filing, the name of the each nonclinical study contained in the petitioner, and a brief description of petition, either a statement that the the proposal in general terms. In the study has been, or will be, conducted in case of a food additive which becomes a compliance with the good laboratory component of food by migration from practice regulations as set forth in part packaging material, the notice shall 58 of this chapter, or, if any such study include the name of the migratory sub- was not conducted in compliance with stance, and where it is different from such regulations, a brief statement of that of one of the original components, the reason for the noncompliance. the name of the parent component, the (l) [Reserved] maximum quantity of the migratory (m) If clinical investigations involv- substance that is proposed for use in ing human subjects are involved, peti- food, and the physical or other tech- tions filed with the Commissioner nical effect which the migratory sub- under section 409(b) of the Act shall instance or its parent component is include statements regarding each such tended to have in the packaging mate- clinical investigation relied upon in rial. A copy of the notice will be the petition that it either was con- mailed to the petitioner when the ducted in compliance with the require- original is forwarded to the FEDERAL ments for institutional review set forth REGISTER for publication. in part 56 of this chapter, or was not

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subject to such requirements in accord- forth in part 58 of this chapter, or, if ance with § 56.104 or § 56.105, and that it the study was not conducted in compli- was conducted in compliance with the ance with such regulations, a brief requirements for informed consent set statement of the reason for the non- forth in part 50 of this chapter. compliance. (n)(1) If intended uses of the food ad- [50 FR 7492, Feb. 22, 1985, as amended at 50 ditive include uses in meat, meat food 16668, Apr. 26, 1985] product, or poultry product subject to regulation by the U.S. Department of § 171.7 Withdrawal of petition without Agriculture (USDA) under the Poultry prejudice. Products Inspection Act (PPIA) (21 (a) In some cases the Commissioner U.S.C. 451 et seq.) or the Federal Meat will notify the petitioner that the peti- Inspection Act (FMIA) (21 U.S.C. 601 et tion, while technically complete, is in- seq.), FDA shall, upon filing of the peti- adequate to justify the establishment tion, forward a copy of the petition or of a regulation or the regulation re- relevant portions thereof to the Food quested by petitioner. This may be due Safety and Inspection Service, USDA, to the fact that the data are not suffi- for simultaneous review under the ciently clear or complete. In such PPIA and FMIA. cases, the petitioner may withdraw the (2) FDA will ask USDA to advise petition pending its clarification or the whether the proposed meat and poultry obtaining of additional data. This with- uses comply with the FMIA and PPIA, drawal will be without prejudice to a or if not, whether use of the substance future filing. Upon refiling, the time would be permitted in products under limitation will begin to run anew from USDA jurisdiction under specified con- the date of refiling. ditions or restrictions. (b) At any time before the order pro- [42 FR 14489, Mar. 15, 1977, as amended at 42 vided for in § 171.100(a) has been for- FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, warded to the FEDERAL REGISTER for 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, publication, the petitioner may with- 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, draw the petition without prejudice to Aug. 25, 2000] a future filing. Upon refiling the time EFFECTIVE DATE NOTE: At 65 FR 51763, Aug. limitation will begin to run anew. 25, 2000, § 171.1 was amended in paragraph (a) by revising the first sentence, in paragraph § 171.8 Threshold of regulation for (c) in the petition by revising the introduc- substances used in food-contact ar- tory paragraph preceding paragraph A., and ticles. by adding paragraph (n). The revised and added text contains information collection Substances used in food-contact arti- and recordkeeping requirements and will not cles (e.g., food-packaging or food-proc- become effective until approval has been essing equipment) that migrate or that given by the Office of Management and may be expected to migrate into food Budget. at negligible levels may be reviewed under § 170.39 of this chapter. The Food § 171.6 Amendment of petition. and Drug Administration will exempt After a petition has been filed, the substances whose uses it determines petitioner may submit additional in- meet the criteria in § 170.39 of this formation or data in support thereof. chapter from regulation as food addi- In such cases, if the Commissioner de- tives and, therefore, a food additive pe- termines that the additional informa- tition will not be required for the ex- tion or data amount to a substantive empted use. amendment, the petition as amended will be given a new filing date, and the [60 FR 36596, July 17, 1995] time limitation will begin to run anew. If nonclinical laboratory studies are in- Subpart B—Administrative Actions volved, additional information and on Applications data submitted in support of filed petitions shall include, with respect to § 171.100 Regulation based on petition. each nonclinical study, either a state- (a) The Commissioner will forward ment that the study was conducted in for publication in the FEDERAL REG- compliance with the requirements set ISTER, within 90 days after filing of the

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petition (or within 180 days if the time § 171.130 Procedure for amending and is extended as provided for in section repealing tolerances or exemptions 409(c)(2) of the Act), a regulation pre- from tolerances. scribing the conditions under which (a) The Commissioner, on his own the food additive may be safely used initiative or on the petition of any in- (including, but not limited to, speci- terested person, pursuant to part 10 of fications as to the particular food or this chapter, may propose the issuance classes of food in or on which such ad- of a regulation amending or repealing a ditive may be used, the maximum regulation pertaining to a food additive quantity that may be used or per- or granting or repealing an exception mitted to remain in or on such food, for such additive. the manner in which such additive may (b) Any such petition shall include an be added to or used in or on such food, assertion of facts, supported by data, and any directions or other labeling or showing that new information exists packaging requirements for such addi- with respect to the food additive or tive deemed necessary by him to assure that new uses have been developed or the safety of such use), and prior to the old uses abandoned, that new data are available as to toxicity of the chem- forwarding of the order to the FEDERAL ical, or that experience with the exist- REGISTER for publication shall notify ing regulation or exemption may jus- the petitioner of such order and the tify its amendment or repeal. New data reasons for such action; or by order shall be furnished in the form specified deny the petition, and shall notify the in §§ 171.1 and 171.100 for submitting pe- petitioner of such order and of the rea- titions. sons for such action. (b) The regulation shall describe the [42 FR 14491, Mar. 15, 1977, as amended at 42 conditions under which the substance FR 15674, Mar. 22, 1977] may be safely used in any meat product, meat food product, or poultry PART 172—FOOD ADDITIVES PER- product subject to the Federal Meat In- MITTED FOR DIRECT ADDITION TO spection Act (FMIA) (21 U.S.C. 601 et FOOD FOR HUMAN CONSUMP- seq.) or the Poultry Products Inspec- TION tion Act (PPIA) (21 U.S.C. 451 et seq.). (c) If the Commissioner determines Subpart A—General Provisions that additional time is needed to study Sec. and investigate the petition, he shall 172.5 General provisions for direct food ad- by written notice to the petitioner ex- ditives. tend the 90-day period for not more than 180 days after the filing of the pe- Subpart B—Food Preservatives tition. 172.105 Anoxomer. 172.110 BHA. [42 FR 14489, Mar. 15, 1977, as amended at 65 172.115 BHT. FR 51763, Aug. 25, 2000] 172.120 Calcium disodium EDTA. 172.130 Dehydroacetic acid. § 171.102 Effective date of regulation. 172.133 Dimethyl dicarbonate. A regulation published in accordance 172.135 Disodium EDTA. 172.140 Ethoxyquin. with § 171.100(a) shall become effective 172.145 Heptylparaben. upon publication in the FEDERAL REG- 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- ISTER. phenol. 172.155 Natamycin (pimaricin). § 171.110 Procedure for objections and 172.160 Potassium nitrate. hearings. 172.165 Quaternary ammonium chloride combination. Objections and hearings relating to 172.170 Sodium nitrate. food additive regulations under section 172.175 Sodium nitrite. 409 (c), (d), or (h) of the Act shall be 172.177 Sodium nitrite used in processing governed by part 12 of this chapter. smoked chub. 172.180 Stannous chloride. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.185 TBHQ. FR 15674, Mar. 22, 1977] 172.190 THBP.

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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. 172.695 Xanthan gum. 172.255 Polyacrylamide. 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. 172.715 Calcium lignosulfonate. Subpart D—Special Dietary and Nutritional 172.720 Calcium lactobionate. Additives 172.723 Epoxidized soybean oil. 172.725 Gibberellic acid and its potassium 172.310 Aluminum nicotinate. salt. 172.315 Nicotinamide-ascorbic acid complex. 172.730 Potassium bromate. 172.320 Amino acids. 172.735 Glycerol ester of wood rosin. 172.325 Bakers yeast protein. 172.755 Stearyl monoglyceridyl citrate. 172.330 Calcium pantothenate, calcium chlo- 172.765 Succistearin (stearoyl propylene gly- ride double salt. col hydrogen succinate). 172.335 D-Pantothenamide. 172.770 Ethylene oxide polymer. 172.340 Fish protein isolate. 172.775 Methacrylic acid-divinylbenzene co- 172.345 Folic acid (folacin). polymer. 172.350 Fumaric acid and salts of fumaric acid. Subpart I—Multipurpose Additives 172.365 Kelp. 172.800 Acesulfame potassium. 172.370 Iron-choline citrate complex. 172.802 Acetone peroxides. 172.372 N-Acetyl-L-methionine. 172.804 Aspartame. 172.375 Potassium iodide. 172.806 Azodicarbonamide. 172.385 Whole fish protein concentrate. 172.808 Copolymer condensates of ethylene 172.395 Xylitol. oxide and propylene oxide. 172.399 Zinc methionine sulfate. 172.809 Curdlan. 172.810 Dioctyl sodium sulfosuccinate. Subpart E—Anticaking Agents 172.811 Glyceryl tristearate. 172.812 Glycine. 172.410 Calcium silicate. 172.814 Hydroxylated lecithin. 172.430 Iron ammonium citrate. 172.816 Methyl glucoside-coconut oil ester. 172.480 Silicon dioxide. 172.818 Oxystearin. 172.490 Yellow prussiate of soda. 172.820 Polyethylene gylcol (mean molecular weight 200–9,500). Subpart F—Flavoring Agents and Related 172.822 Sodium lauryl sulfate. Substances 172.824 Sodium mono- and dimethyl naphthalene sulfonates. 172.510 Natural flavoring substances and 172.826 Sodium stearyl fumarate. natural substances used in conjunction 172.828 Acetylated monoglycerides. with flavors. 172.830 Succinylated monoglycerides. 172.515 Synthetic flavoring substances and 172.831 Sucralose. adjuvants. 172.832 Monoglyceride citrate. 172.520 Cocoa with dioctyl sodium sulfo- 172.833 Sucrose acetate isobutyrate (SAIB). succinate for manufacturing. 172.834 Ethoxylated mono- and diglycerides. 172.530 Disodium guanylate. 172.836 Polysorbate 60. 172.535 Disodium inosinate. 172.838 Polysorbate 65. 172.540 DL-Alanine. 172.840 Polysorbate 80. 172.560 Modified hop extract. 172.841 Polydextrose. 172.575 Quinine. 172.842 Sorbitan monostearate. 172.580 Safrole-free extract of sassafras. 172.844 Calcium stearoyl-2-lactylate. 172.585 Sugar beet extract flavor base. 172.846 Sodium stearoyl lactylate. 172.590 Yeast-malt sprout extract. 172.848 Lactylic esters of fatty acids.

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172.850 Lactylated fatty acid esters of glyc- (2) Any substance intended for use in erol and propylene glycol. or on food is of appropriate food grade 172.852 Glyceryl-lacto esters of fatty acids. and is prepared and handled as a food 172.854 Polyglycerol esters of fatty acids. 172.856 Propylene glycol mono- and diesters ingredient. of fats and fatty acids. (b) The existence of a regulation pre- 172.858 Propylene glycol alginate. scribing safe conditions of use for a 172.859 Sucrose fatty acid esters. food additive shall not be construed to 172.860 Fatty acids. relieve the use of the substance from 172.861 Cocoa butter substitute from coco- compliance with any other provision of nut oil, palm kernel oil, or both oils. the Act. 172.862 Oleic acid derived from tall oil fatty acids. (c) The existence of any regulation 172.863 Salts of fatty acids. prescribing safe conditions of use for a 172.864 Synthetic fatty alcohols. nutrient substance does not constitute 172.866 Synthetic glycerin produced by the a finding that the substance is useful hydrogenolysis of carbohydrates. or required as a supplement to the diet 172.867 Olestra. of humans. 172.868 Ethyl cellulose. 172.870 Hydroxypropyl cellulose. 172.872 Methyl ethyl cellulose. Subpart B—Food Preservatives 172.874 Hydroxypropyl methylcellulose. 172.876 Castor oil. § 172.105 Anoxomer. 172.878 White mineral oil. 172.880 Petrolatum. Anoxomer as identified in this sec- 172.882 Synthetic isoparaffinic petroleum tion may be safely used in accordance hydrocarbons. with the following conditions: 172.884 Odorless light petroleum hydro- (a) Anoxomer is 1,4-benzenediol, 2- carbons. (1,1-dimethylethyl)-polymer with 172.886 Petroleum wax. 172.888 Synthetic petroleum wax. diethenylbenzene, 4-(1,1-dimethyl- 172.890 Rice bran wax. ethyl)phenol, 4- methoxyphenol, 4,4′-(1- 172.892 Food starch-modified. methylethylidene)bis(phenol) and 4- 172.894 Modified cottonseed products in- methylphenol (CAS Reg. No. 60837–57–2) tended for human consumption. prepared by condensation polymeriza- 172.896 Dried yeasts. tion of divinylbenzene (m- and p-) with 172.898 Bakers yeast glycan. tert-butylhydroquinone, tert-butyl- AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, phenol, hydroxyanisole, p-cresol and 379e. 4,4′-isopropylidenediphenol. SOURCE: 42 FR 14491, Mar. 15, 1977, unless (b) The polymeric antioxidant meets otherwise noted. the following specifications: EDITORIAL NOTE: Nomenclature changes to (1) Polymer, not less than 98.0 per- part 172 appear at 61 FR 14482, Apr. 2, 1996, 66 cent as determined by an ultraviolet FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. method entitled ‘‘Ultraviolet Assay, 27, 2001. ‘‘1982, which is incorporated by reference. Copies are available from the Subpart A—General Provisions Center for Food Safety and Applied Nu- trition (HFS–200), Food and Drug Ad- § 172.5 General provisions for direct ministration, 5100 Paint Branch Pkwy., food additives. College Park, MD 20740, or available for (a) Regulations prescribing condi- inspection at the Office of the Federal tions under which food additive sub- Register, 800 North Capitol Street, stances may be safely used predicate NW., suite 700, Washington, DC 20408. usage under conditions of good manu- (2) Molecular weight: Total mono- facturing practice. For the purposes of mers, dimers and trimers below 500 not this part, good manufacturing practice more than 1 percent as determined by a shall be defined to include the fol- method entitled ‘‘Low Molecular lowing restrictions. Weight Anoxomer Analysis,’’ 1982, (1) The quantity of the substance which is incorporated by reference. added to food does not exceed the Copies are available from the Center amount reasonably required to accom- for Food Safety and Applied Nutrition plish its intended physical, nutritive, (HFS–200), Food and Drug Administra- or other technical effect in food. tion, 5100 Paint Branch Pkwy., College

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Park, MD 20740, or available for inspec- Limitations tion at the Office of the Federal Reg- (total BHA Food and BHT) ister, 800 North Capitol Street, NW., parts per suite 700, Washington, DC 20408. million (3) Phenol content: Not less than 3.2 Sweet potato flakes ...... 50 milliequivalent/gram and not more 1 BHA only. than 3.8 milliequivalent/gram as determined by a method entitled ‘‘Total (c) To assure safe use of the additive: Phenols,’’ 1982, which is incorporated (1) The label of any market package by reference. Copies are available from of the additive shall bear, in addition the Center for Food Safety and Applied to the other information required by Nutrition (HFS–200), Food and Drug the Act, the name of the additive. Administration, 5100 Paint Branch (2) When the additive is marketed in Pkwy., College Park, MD 20740, or a suitable carrier, in addition to meet- available for inspection at the Office of ing the requirement of paragraph (c)(1) the Federal Register, 800 North Capitol of this section, the label shall declare Street, NW., suite 700, Washington, DC the percentage of the additive in the 20408. mixture. (4) Heavy metals as lead (as Pb), not (3) The label or labeling of dry mixes more than 10 parts per million. Arsenic for beverages and desserts shall bear (as As), not more than 3 parts per mil- adequate directions for use to provide lion. Mercury (as Hg), not more than 1 that beverages and desserts prepared part per million. from the dry mixes contain no more (c) Anoxomer may be safely used as than 2 parts per million BHA. an antioxidant in food at a level of not more than 5,000 parts per million based § 172.115 BHT. on fat and oil content of the food. The food additive BHT (butylated hydroxytoluene), alone or in combination [48 FR 18798, Apr. 26, 1983, as amended at 54 with other antioxidants permitted in FR 24896, June 12, 1989] this subpart B may be safely used in or § 172.110 BHA. on specified foods, as follows: (a) The BHT meets the following The food additive BHA (butylated hy- specification: Assay (total BHT) 99 per- droxyanisole) alone or in combination cent minimum. with other antioxidants permitted in (b) The BHT is used alone or in com- food for human consumption in this bination with BHA, as an antioxidant subpart B may be safely used in or on in foods, as follows: specified foods, as follows: (a) The BHA meets the following Limitations (total BHA specification: Food and BHT) parts per Assay (total BHA), 98.5 percent minimum. million Melting point 48 °C minimum. Dehydrated potato shreds ...... 50 (b) The BHA is used alone or in com- Dry breakfast cereals ...... 50 bination with BHT, as an antioxidant Emulsion stabilizers for shortenings ...... 200 in foods, as follows: Potato flakes ...... 50 Potato granules ...... 10 Sweetpotato flakes ...... 50 Limitations (total BHA Food and BHT) (c) To assure safe use of the additive: parts per million (1) The label of any market package of the additive shall bear, in addition Dehydrated potato shreds ...... 50 to the other information required by Active dry yeast ...... 1 1,000 Beverages and desserts prepared from dry the Act, the name of the additive. mixes ...... 1 2 (2) When the additive is marketed in Dry breakfast cereals ...... 50 a suitable carrier, in addition to meet- Dry diced glazed fruit ...... 1 32 ing the requirement of paragraph (c)(1) Dry mixes for beverages and desserts ...... 1 90 of this section, the label shall declare Emulsion stabilizers for shortenings ...... 200 Potato flakes ...... 50 the percentage of the additive in the Potato granules ...... 10 mixture.

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§ 172.120 Calcium disodium EDTA. Limita- tion The food additive calcium disodium Food (parts Use per mil- EDTA (calcium disodium ethylene- lion) diaminetetraacetate) may be safely used in designated foods for the pur- Shrimp (cooked 250 Retard struvite forma- canned) . tion; promote color poses and in accordance with the condi- retention. tions prescribed, as follows: Spice extractives in 60 Promote color and fla- (a) The additive contains a minimum soluble carriers . vor retention. of 99 percent by weight of either the di- Spreads, artificially col- 100 Promote color retention. ored and lemon-fla- hydrate C10H12O8N2CaNa2·2H2O or the vored or orange-fla- trihydrate C10H12O8N2CaNa2·3H2O, or vored . any mixture of the two. 1 By weight of egg yolk portion. (b) It is used or intended for use as (2) With disodium EDTA (disodium follows: ethylenediaminetetraacetate) in the (1) Alone, in the following foods at following foods at not to exceed, in not to exceed the levels prescribed, cal- combination, the levels prescribed, calculated as the anhydrous compound: culated as anhydrous C10H12O8N2CaNa2: Limita- tion Limita- Food (parts Use tion per mil- Food (parts Use lion) per million) Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. Dressings, nonstandardized .... 75 Preservative. Canned carbonated soft 33 Promote flavor reten- French dressing ...... 75 Do. drinks . tion. Mayonnaise ...... 75 Do. Canned white potatoes 110 Promote color retention. Salad dressing ...... 75 Do. Clams (cooked canned) 340 Promote color retention. Sandwich spread ...... 100 Do. Crabmeat (cooked 275 Retard struvite forma- Sauces ...... 75 Do. canned) . tion; promote color retention. (c) To assure safe use of the additive: Cucumbers pickled ...... 220 Promote color, flavor, (1) The label and labeling of the addi- and texture retention. Distilled alcoholic bev- 25 Promote stability of tive container shall bear, in addition to erages . color, flavor, and/or the other information required by the product clarity. Act, the name of the additive. Dressings, nonstandard- 75 Preservative. (2) The label or labeling of the addi- ized . Dried lima beans 310 Promote color retention. tive container shall bear adequate use (cooked canned) . directions to provide a final food prod- Egg product that is 1 200 Preservative. uct that complies with the limitations hard-cooked and consists, in a cylindrical provided in paragraph (b) of this sec- shape, of egg white tion. with an inner core of (d) In the standardized foods listed in egg yolk . paragraph (b) of this section, the addi- Fermented malt bev- 25 Antigushing agent. erages . tives are used only in compliance with French dressing ...... 75 Preservative. the applicable standards of identity for Legumes (all cooked 365 Promote color retention. such foods. canned, other than dried lima beans, pink [42 FR 14491, Mar. 15, 1977, as amended at 48 beans, and red FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, beans) . 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Mayonnaise ...... 75 Do. Aug. 8, 2000] Mushrooms (cooked 200 Promote color retention. canned) . Oleomargarine ...... 75 Preservative. § 172.130 Dehydroacetic acid. Pecan pie filling ...... 100 Promote color retention. The food additive dehydroacetic acid Pink beans (cooked 165 Promote color retention. canned) . and/or its sodium salt may be safely Potato salad ...... 100 Preservative. used in accordance with the following Processed dry pinto 800 Promote color retention. prescribed conditions: beans . Red beans (cooked 165 Promote color retention. (a) The food additive meets the fol- canned) . lowing specifications: Salad dressing ...... 75 Preservative. Sandwich spread ...... 100 Do. Dehydroacetic acid: Melting point, 109 °C–111 Sauces ...... 75 Do. °C; assay, minimum 98 percent (dry basis).

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Sodium salt of dehydroacetic acid: Assay, CALCULATION minimum 98 percent (dry basis). ()− × (b) It is used or intended for use as a ba 13. 4 = preservative for cut or peeled squash, % DMDC and is so used that no more than 65 W parts per million expressed as dehydro- NOTE: For adding the diisobutylamine so- acetic acid remains in or on the pre- lution, always use the same pipette and wait pared squash. for a further three drops to fall when the flow has stopped. (c) The label or labeling of any pack- (2) The additive contains not more age of the additive intended for use in than 2,000 ppm (0.2 percent) dimethyl food shall bear adequate directions for carbonate as determined by a method use to insure compliance with this sec- entitled ‘‘Gas Chromatography Method tion. for Dimethyl Carbonate Impurity in § 172.133 Dimethyl dicarbonate. Dimethyl Dicarbonate,’’ whichis incorporated by reference in accordance Dimethyl dicarbonate (CAS Reg. No. with 5 U.S.C. 552(a). Copies are avail- 4525–33–1) may be safely used in food in able from the Center for Food Safety accordance with the following pre- and Applied Nutrition (HFS–200), 5100 scribed conditions: Paint Branch Pkwy., College Park, MD (a) The additive meets the following 20740, or available for inspection at the specifications: Office of the Federal Register, 800 (1) The additive has a purity of not North Capitol Street, NW., suite 700, less than 99.8 percent as determined by Washington, DC 20408. the following titration method: (b) The additive is used or intended for use as a microbial control agent in PRINCIPLES OF METHOD the following beverages under normal Dimethyl dicarbonate (DMDC) is mixed circumstances of bottling, canning, or with excess diisobutylamine with which it other forms of final packaging, where reacts quantitatively. The excess amine is the viable microbial load has been re- backtitrated with acid. duced to 500 microorganisms per milli- APPARATUS liter or less by current good manufacturing practices such as heat treat- 250-milliliter (mL) Beaker ment, filtration, or other technologies 100-mL Graduate cylinder prior to the use of dimethyl dicar- 25-mL Pipette bonate: 10-mL Burette (automatic, eg., Metrohm burette) (1) In wine, dealcoholized wine, and Stirrer low alcohol wine in an amount not to Device for potentiometric titration exceed 200 parts per million. Reference electrode (2) In ready-to-drink teas in an Glass electrode amount not to exceed 250 parts per million. unflavored beverages containing REAGENTS added electrolytes (5–20 milli- Acetone, analytical-grade equivalents/liter sodium ion (Na+) and Solution of 1 N diisobutylamine in chloro- 3–7 milliequivalents/liter potassium ion benzene, distilled (K+)) in an amount not to exceed 250 1 N Acetic Acid parts per million. (4) In carbonated, dilute beverages PROCEDURE containing juice, fruit flavor, or both, Accurately weigh in about 2 grams of the with juice content not to exceed 50 per- sample (W) and dissolve in 100 mL acetone. cent, in an amount not to exceed 250 Add accurately 25 mL of the 1 N diisobutyl- parts per million. amine solution by pipette and allow to stand (c) To ensure the safe use of the food for 5 minutes. Subsequently, titrate the re- additive, the label of the package con- action mixture potentiometrically with 1 N hydrochloric acid (consumption=a mL) while taining the additive shall bear, in addi- stirring. For determining the blank con- tion to other information required by sumption, carry out the analysis without a the Federal Food, Drug, and Cosmetic sample (consumption=b mL). Act:

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(1) The name of the additive ‘‘di- (2) With calcium disodium EDTA methyl dicarbonate.’’ (calcium disodium ethylenediamine- (2) The intended use of the additive. tetraacetate; calcium disodium (3) Adequate directions for use to en- (ethylenedinitrilo) tetraacetate), in the sure compliance with this section. following foods at not to exceed, in combination, the levels prescribed, cal- [53 FR 41329, Oct. 21, 1988, as amended at 58 culated as anhydrous C H O N CaNa : FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; 10 12 8 2 2 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, Limita- 1996; 66 FR 13653, Mar. 7, 2001] tion Food (parts Use per mil- § 172.135 Disodium EDTA. lion) The food additive disodium EDTA Dressings, nonstandardized 75 Preservative. (disodium ethylenediaminetetraace- French dressing ...... 75 Do. tate) may be safely used in designated Mayonnaise ...... 75 Do. foods for the purposes and in accord- Salad dressing ...... 75 Do. ance with the following prescribed con- Sandwich spread ...... 100 Do. ditions: Sauces ...... 75 Do. (a) The additive contains a minimum of 99 percent disodium ethylenedia- (3) Alone, as a sequestrant in the minetetraacetate dihydrate nonnutritive sweeteners that are listed (C H O N Na ·2H O). in § 180.37 of this chapter and that, in 10 14 8 2 2 2 addition, are designed for aqueous solu- (b) It is used or intended for use as tion: That the amount of the follows: Provided, additive, calculated as anhydrous cal- (1) Alone, in the following foods at cium disodium EDTA, does not exceed not to exceed the levels prescribed, cal- 0.1 percent by weight of the dry non- culated as anhydrous calcium disodium nutritive sweetener. EDTA: (c) To assure the safe use of the addi- Limita- tive: tion Food (parts Use (1) The label and labeling of the addi- per mil- tive container shall bear, in addition to lion) the other information required by the Aqueous multivitamin prep- 150 With iron salts as a act, the name of the additive. arations . stabilizer for vita- (2) The label or labeling of the addi- min B 12 in liquid tive container shall bear adequate use multivitamin preparations. directions to provide a final food prod- Canned black-eyed peas .... 145 Promote color re- uct that complies with the limitations tention. provided in paragraph (b) of this sec- Canned kidney beans ...... 165 Preservative. tion. Canned strawberry pie filling 500 Promote color retention. (d) In the standardized foods listed in Cooked sausage ...... 36 As a cure accel- paragraphs (b) (1) and (2) of this section erator with so- the additives are used only in compli- dium ascorbate or ascorbic acid. ance with the applicable standards of Dressings, nonstandardized 75 Preservative. identity for such foods. French dressing ...... 75 Do. Frozen white potatoes in- 100 Promote color re- [42 FR 14491, Mar. 15, 1977, as amended at 65 cluding cut potatoes . tention. FR 48379, Aug. 8, 2000] Gefilte fish balls or patties in 1 50 Inhibit discoloration. packing medium . § 172.140 Ethoxyquin. Legumes (all cooked 165 Promote color re- canned, other than black- tention. (a) Ethoxyquin (1,2-dihydro-6-ethoxy- eyed peas) . 2,2,4-trimethylquinoline) may be safely Mayonnaise ...... 75 Preservative. 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

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for residues of ethoxyquin in or on edi- Heavy metals (as Pb): Not more than 20 parts ble products of animals as follows: per million. 5 parts per million in or on the uncooked fat (c) The additive may be applied on of meat from animals except poultry. cheese, as an antimycotic, in amounts 3 parts per million in or on the uncooked not to exceed 20 milligrams per kilo- liver and fat of poultry. gram (20 parts per million) in the fin- 0.5 part per million in or on the uncooked ished product as determined by Inter- muscle meat of animals. national Dairy Federation (IDF) Stand- 0.5 part per million in poultry eggs. ard 140A:1992, ‘‘Cheese and Cheese Zero in milk. Rind-Determination of Natamycin Con- tent-Method by Molecular Absorption § 172.145 Heptylparaben. Spectrometry and by High-Perform- (a) The food additive heptylparaben ance Liquid Chromatography,’’ which is the chemical n-heptyl p-hydroxy- is incorporated by reference. The Di- benzoate. rector of the Office of the Federal Reg- (b) It may be safely used to inhibit ister approves this incorporation by microbiological spoilage in accordance reference in accordance with 5 U.S.C. with the following prescribed condi- 552(a) and 1 CFR part 51. Copies are tions: available from the Division of Product (1) In fermented malt beverages in Policy (HFS–206), Center for Food Safe- amounts not to exceed 12 parts per mil- ty and Applied Nutrition, Food and lion. Drug Administration, 5100 Paint (2) In noncarbonated soft drinks and Branch Pkwy., College Park, MD 20740, fruit-based beverages in amounts not or may be examined at the Center for to exceed 20 parts per million, when Food Safety and Applied Nutrition’s standards of identity established under Library, 200 C St. SW., Washington, section 401 of the Act (21 U.S.C. 341) do DC, or at the Office of the Federal Reg- not preclude such use. ister, 800 North Capitol St. NW., suite 700, Washington, DC. § 172.150 4-Hydroxymethyl-2,6-di-tert- butylphenol. [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, The food additive 4-hydroxymethyl- 1998; 66 FR 13847, Mar. 8, 2001] 2,6-di-tert-butylphenol may be safely used in food in accordance with the fol- § 172.160 Potassium nitrate. lowing prescribed conditions: The food additive potassium nitrate (a) The additive has a solidification may be safely used as a curing agent in point of 140 °C–141 °C. the processing of cod roe, in an amount (b) The additive is used as an anti- not to exceed 200 parts per million of oxidant alone or in combination with the finished roe. other permitted antioxidants. (c) The total amount of all anti- § 172.165 Quaternary ammonium chlo- oxidants added to such food shall not ride combination. exceed 0.02 percent of the oil or fat con- The food additive, quaternary ammo- tent of the food, including the essential nium chloride combination, may be (volatile) oil content of the food. safely used in food in accordance with § 172.155 Natamycin (pimaricin). the following conditions: (a) The additive contains the fol- (a) Natamycin (CAS Reg. No. 7681–93– lowing compounds: n-dodecyl dimethyl 8), also known as pimaricin, is a pol- benzyl ammonium chloride (CAS Reg. yene macrolide antimycotic substance No. 139–07–1); n-dodecyl dimethyl ethyl- possessing an empirical formula of benzyl ammonium chloride (CAS Reg. C33H47NO13 and a molecular weight of No. 27479–28–3); n-hexadecyl dimethyl 665.7. benzyl ammonium chloride (CAS Reg. (b) The additive shall conform to the No. 122–18–9); n-octadecyl dimethyl following specifications: benzyl ammonium chloride (CAS Reg. Purity: 97 percent ±2 percent on an anhy- No. 122–19–0); n-tetradecyl dimethyl drous basis. benzyl ammonium chloride (CAS Reg. Arsenic: Not more than 1 part per million. No. 139–08–2); n-tetradecyl dimethyl

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ethylbenzyl ammonium chloride (CAS (b) To assure safe use of the additive, Reg. No. 27479–29–4). in addition to the other information re- (b) The additive meets the following quired by the Act: specifications: pH (5 percent active so- (1) The label of the additive or of a lution) 7.0–8.0; total amines, maximum mixture containing the additive shall 1 percent as combined free amines and bear: amine hydrochlorides. (i) The name of the additive. (c) The additive is used as an anti- (ii) A statement of the concentration microbial agent, as defined in of the additive in any mixture. § 170.3(o)(2) of this chapter, in raw sugar (2) If in a retail package intended for cane juice. It is added prior to clari- household use, the label and labeling of fication when further processing of the the additive, or of a mixture con- sugar cane juice must be delayed. taining the additive, shall bear ade- (d) The additive is applied to the quate directions for use to provide a sugar juice in the following quantities, final food product that complies with based on the weight of the raw cane: the limitations prescribed in paragraph Parts per (a) of this section. Component million (3) If in a retail package intended for household use, the label of the additive n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 n-Dodecyl dimethyl ethylbenzyl ammonium or of a mixture containing the addi- chloride ...... 3.4–13.5 tive, shall bear the statement ‘‘Keep n-Hexadecyl dimethyl benzyl ammonium chlo- out of the reach of children’’. ride ...... 1.5–6.0 n-Octadecyl dimethyl benzyl ammonium chloride ...... 0.25–1.0 § 172.175 Sodium nitrite. n-Tetradecyl dimethyl benzyl ammonium chlo- The food additive sodium nitrite may ride ...... 3.0–12.0 n-Tetradecyl dimethyl ethylbenzyl ammonium be safely used in or on specified foods chloride ...... 1.6–6.5 in accordance with the following prescribed conditions: [50 FR 3890, Jan. 29, 1985] (a) It is used or intended for use as follows: § 172.170 Sodium nitrate. (1) As a color fixative in smoked The food additive sodium nitrate cured tunafish products so that the may be safely used in or on specified level of sodium nitrite does not exceed foods in accordance with the following 10 parts per million (0.001 percent) in prescribed conditions: the finished product. (a) It is used or intended for use as (2) As a preservative and color fixa- follows: tive, with or without sodium nitrate, (1) As a preservative and color fixa- in smoked, cured sablefish, smoked, tive, with or without sodium nitrite, in cured salmon, and smoked, cured shad smoked, cured sablefish, smoked, cured so that the level of sodium nitrite does salmon, and smoked, cured shad, so not exceed 200 parts per million and the that the level of sodium nitrate does level of sodium nitrate does not exceed not exceed 500 parts per million and the 500 parts per million in the finished level of sodium nitrite does not exceed product. 200 parts per million in the finished (3) As a preservative and color fixa- product. tive, with sodium nitrate, in meat-cur- (2) As a preservative and color fixa- ing preparations for the home curing of tive, with or without sodium nitrite, in meat and meat products (including meat-curing preparations for the home poultry and wild game), with directions curing of meat and meat products (infor use which limit the amount of so- cluding poultry and wild game), with dium nitrite to not more than 200 parts directions for use which limit the per million in the finished meat prod- amount of sodium nitrate to not more uct, and the amount of sodium nitrate than 500 parts per million in the fin- to not more than 500 parts per million ished meat product and the amount of in the finished meat product. sodium nitrite to not more than 200 (b) To assure safe use of the additive, parts per million in the finished meat in addition to the other information re- product. quired by the Act:

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(1) The label of the additive or of a further cooled to a temperature of 38 °F mixture containing the additive shall or below within 12 hours after smoking. bear: A temperature of 38 °F or below shall (i) The name of the additive. be maintained during all subsequent (ii) A statement of the concentration storage and distribution. All shipping of the additive in any mixture. containers, retail packages, and ship- (2) If in a retail package intended for ping records shall indicate with appro- household use, the label and labeling of priate notice the perishable nature of the additive, or of a mixture con- the product and specify that the prod- taining the additive, shall bear ade- uct shall be held under refrigeration (38 quate directions for use to provide a °F or below) until consumed. final food product which complies with (e) To assure safe use of the additive: the limitations prescribed in paragraph (1) The label and labeling of the addi- (a) of this section. tive container shall bear, in addition to (3) If in a retail package intended for the other information required by the household use, the label of the addi- Act, the name of the additive. tive, or of a mixture containing the ad- (2) The label or labeling of the addi- ditive, shall bear the statement ‘‘Keep tive container shall bear adequate di- out of the reach of children’’. rections to assure use in compliance with the provisions of this section. § 172.177 Sodium nitrite used in processing smoked chub. § 172.180 Stannous chloride. The food additive sodium nitrite may The food additive stannous chloride be safely used in combination with salt may be safely used for color retention (NaCl) to aid in inhibiting the out- in asparagus packed in glass, with lids growth and toxin formation from Clos- lined with an inert material, in an tridium botulinum type E in the com- amount not to exceed 20 parts per mil- mercial processing of smoked chub in lion calculated as tin (Sn). accordance with the following prescribed conditions: § 172.185 TBHQ. (a) All fish in smoking establish- ments shall be clean and wholesome The food additive TBHQ, which is the and shall be expeditiously processed, chemical 2-(1,1-dimethylethyl)-1,4-benz- packed, and stored under adequate san- enediol (Chemical Abstracts Service itary conditions in accordance with Registry Number 1948–33–0), also known good manufacturing practice. as tertiary butylhydroquinone, may be (b) The brining procedure is con- safely used in food in accordance with trolled in such a manner that the the following prescribed conditions: water phase portion of the edible por- (a) The food additive has a melting ° ° tion of the finished smoked product has point of 126.5 C–128.5 C. a salt (NaCl) content of not less than (b) It is used as an antioxidant alone 3.5 percent, as measured in the loin or in combination with BHA and/or muscle, and the sodium nitrite content BHT. of the edible portion of the finished (c) The total antioxidant content of a smoked product is not less than 100 food containing the additive will not parts per million and not greater than exceed 0.02 percent of the oil or fat con- 200 parts per million, as measured in tent of the food, including the essential the loin muscle. (volatile) oil content of the food. (c) Smoked chub shall be heated by a controlled heat process which provides § 172.190 THBP. a monitoring system positioned in as The food additive THBP (2,4,5-tri- many strategic locations in the smoke- hydroxybutyrophenone) may be safely house as necessary to assure a contin- used in food in accordance with the fol- uous temperature throughout each fish lowing prescribed conditions: of at least 160 °F for a minimum of 30 (a) The food additive has a melting minutes. point of 149 °C–153 °C. (d) The finished product shall be (b) It is used as an antioxidant alone cooled to a temperature of 50 °F or or in combination with other permitted below within 3 hours after smoking and antioxidants.

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(c) The total antioxidant content of a accordance with the following condi- food containing the additive will not tions: exceed 0.02 percent of the oil or fat con- (a) The coating is applied in the min- tent of the food, including the essential imum amount required to accomplish (volatile) oil content of the food. the intended effect. (b) The coating may be formulated from the following components, each Subpart C—Coatings, Films and used in the minimum quantity required Related Substances to accomplish the intended effect: (1) Substances generally recognized § 172.210 Coatings on fresh citrus fruit. as safe for the purpose or previously Coatings may be applied to fresh cit- sanctioned for the purpose. rus fruit for protection of the fruit in (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, 1916 Race St., Phila- delphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408) using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene- ethyl alcohol in a 2:1 ratio. Sodium lauryl sulfate ...... Complying with § 172.822. As a film former. Wood rosin ...... Color of K or paler.

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

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]

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§ 172.215 Coumarone-indene resin. § 172.225 Methyl and ethyl esters of fatty acids produced from edible The food additive coumarone-indene fats and oils. resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and Methyl esters and ethyl esters of tangerines in accordance with the fol- fatty acids produced from edible fats lowing prescribed conditions: and oils may be safely used in food, (a) The food additive is manufactured subject to the following prescribed con- by the polymerization of a crude, ditions: heavy coal-tar solvent naphtha meet- (a) The additive consists of a mixture ing the following specifications: of either methyl or ethyl esters of (1) It is a mixture of indene, indan fatty acids produced from edible fats (hydrindene), substituted benzenes, and and oils and meets the following speci- related compounds. fications: (2) It contains no more than 0.25 per- (1) Not less than 90 percent methyl or cent tar bases. ethyl esters of fatty acids. (3) 95 percent distills in the range 167 (2) Not more than 1.5 percent unsa- °C–184 °C. ponifiable matter. (b) The food additive meets the fol- (b) The additive is used or intended lowing specifications: for use at the level not to exceed 3 percent by weight in an aqueous emulsion (1) Softening point, ring and ball: 126 in dehydrating grapes to produce rai- °C minimum as determined by ASTM sins, whereby the residue of the addi- method E28–67 (Reapproved 1982), tive on the raisins does not exceed 200 ‘‘Standard Test Method for Softening parts per million. Point by Ring-and-Ball Apparatus,’’ which is incorporated by reference. [57 FR 12711, Apr. 13, 1992] Copies may be obtained from the Amer- ican Society for Testing Materials, 1916 § 172.230 Microcapsules for flavoring Race St., Philadelphia, PA 19103, or substances. may be examined at the Office of the Microcapsules may be safely used for Federal Register, 800 North Capitol encapsulating discrete particles of fla- Street, NW., suite 700, Washington, DC voring substances that are generally 20408. recognized as safe for their intended (2) Refractive index (n 25/D) 1.63–1.64. use or are regulated under this part, in (c) It is used or intended for use as a accordance with the following condi- protective coating for grapefruit, lem- tions: ons, limes, oranges, tangelos, and tan- (a) The microcapsules may be formu- gerines whereby the maximum amount lated from the following components, of the resin remaining on the fruit does each used in the minimum quantity re- not exceed 200 parts per million on a quired to accomplish the intended ef- fresh-weight basis. fect: (d) To assure safe use of the additive: (1) Substances generally recognized (1) The label of the market package as safe for the purpose. or any intermediate premix of the ad- (2) One or more of the following com- ditive shall bear, in addition to the ponents: other information required by the act: COMPONENT AND LIMITATIONS (i) The name of the additive, coumarone-indene resin. Succinylated gelatin—Not to exceed 15 per- (ii) A statement of the concentration cent by combined weight of the microcapsule and flavoring oil. Succinic acid con- of the additive therein. tent of the gelatin is 4.5 to 5.5 percent. (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 [42 FR 14491, Mar. 15, 1977, as amended at 49 paragraph (a)(2) of this section, the fol- FR 10103, Mar. 19, 1984] lowing components:

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COMPONENT AND LIMITATIONS § 172.250 Petroleum naphtha. Glutaraldehyde—As cross-linking agent for Petroleum naphtha may be safely insolubilizing a coacervate of gum arabic used in food in accordance with the fol- and gelatin. lowing conditions: n-Octyl alcohol—As a defoamer. (a) The additive is a mixture of liquid (4) In lieu of the components listed in hydrocarbons, essentially paraffinic paragraphs (a)(2) and (3) of this section, and naphthenic in nature obtained the following component: from petroleum, (b) The additive is refined to meet COMPONENT AND LIMITATIONS the following specifications when subjected to the procedures described in Petroleum wax—Complying with § 172.886. this paragraph. Not to exceed 50 percent by combined (1) Boiling-point range: 175 °F–300 °F. weight of the microcapsule and spice-flavoring substance. (2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum. (b) The microcapsules produced from (3) Ultraviolet absorbance limits, as the components listed in paragraphs (a) follows: (1), (2), and (3) of this section may be Maximum used for encapsulating authorized fla- absorb- voring oils for use, in accordance with ance per Wavelength (milli-microns) centimeter good manufacturing practice, in foods optical for which standards of identity estab- pathlength lished under section 401 of the Act do 280–289 ...... 0.15 not preclude such use, except that 290–299 ...... 13 microcapsules formulated from compo- 300–359 ...... 08 nents listed in paragraph (a)(2) of this 360–400 ...... 02 section may be used only for encapsulating lemon oil, distilled lime oil, ANALYTICAL SPECIFICATION FOR PETROLEUM orange oil, peppermint oil, and spear- NAPHTHA mint oil for use in dry mixes for pud- GENERAL INSTRUCTIONS dings and gelatin desserts. All glassware should be scrupulously (c) The microcapsules produced from cleaned to remove all organic matter such as the components listed in paragraphs (a) oil, grease, detergent residues, etc. Examine (1) and (4) of this section may be used all glassware, including stoppers and stop- only for encapsulating authorized cocks, under ultraviolet light to detect any spice-flavoring substances for use, in residual fluorescent contamination. As a pre- accordance with good manufacturing cautionary measure, it is recommended practice to rinse all glassware with purified iso- practice, in frozen pizzas which are to octane immediately before use. No grease is be further processed by heat. Such piz- to be used on stopcocks or joints. Great care zas shall bear labels or labeling includ- to avoid contamination of petroleum naph- ing adequate directions for use to en- tha samples in handling and to assure ab- sure heating to temperatures which sence of any extraneous material arising will melt the wax to release the spice- from inadequate packaging is essential. Be- flavoring substances. cause some of the polynuclear hydrocarbons sought in this test are very susceptible to [45 FR 48123, July 18, 1980] photo-oxidation, the entire procedure is to be carried out under subdued light. § 172.235 Morpholine. APPARATUS Morpholine may be safely used as a Separatory funnels. 250-milliliter, and 2,000- component of food, subject to the fol- milliliter capacity, equipped with tetra- lowing restrictions. fluoroethylene polymer stopcocks. (a) It is used as the salt(s) of one or Erlenmeyer flask. 125-milliliter with 24/40 more of the fatty acids meeting the re- standard taper neck. quirements of § 172.860, as a component Evaporation flask. 250-milliliter capacity of protective coatings applied to fresh all-glass flask equipped with 24/40 standard taper stopper having inlet and outlet tubes fruits and vegetables. to permit passage of nitrogen across the sur- (b) It is used at a level not in excess face of the container liquid to be evaporated. of that reasonably required to produce Condenser. 24/40 joints, fitted with drying its intended effect. tube, length optional.

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Spectrophotometric cells. Fused quartz cells, length should be 0.00 between 280–400 mµ. optical path length in the range of 5,000 cen- Methyl alcohol may be purified by simple timeters ±0.005 centimeter; also for checking distillation or by refluxing in the presence of spectrophotometer performance only, optical potassium hydroxide (10 grams/2 liters) and path length in the range 1,000 centimeter zinc dust (25 grams/2 liters) for 3 hours fol- ±0.005 centimeter. With distilled water in the lowed by distillation. cells, determine any absorbance difference. n-Hexadecane, 99 percent olefin-free. Dilute Spectrophotometer. Spectral range 250–400 1.0 milliliter of n-hexadecane to 25 milliliters mµ with spectral slit width of 2 mµ or less; with isooctane and determine the absorbance under instrument operating conditions for in a 5-centimeter cell compared to isooctane these absorbance measurements, the spectro- as reference between 280–400 mµ. The absorb- photometer shall also meet the following ance per centimeter path length shall not ex- performance requirements: ceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel Absorbance repeatability, ±0.01 at 0.4 absorb- or by distillation. ance. Sodium borohydride. 98 percent. 1 ± Absorbance accuracy, 0.05 at 0.4 absorb- Water. All distilled water must be ex- ance. ± tracted with isooctane before use. A series of Wavelength repeatability, 0.2 millimicron. three successive extracts of 1.5 liters of dis- Wavelength accuracy, ±1.0 millimicron. tilled water with 100-milliliter portions of Ultraviolet lamp. Long wavelength (3400– isooctane is satisfactory. 3800A°). PROCEDURE REAGENTS Determination of ultraviolet absorbance. Add Isooctane (2,2,4-trimethylpentane). Use 180 a 25-milliliter aliquot of the hydrocarbon milliliters in a 250-milliliter Erlenmeyer solvent together with 1 milliliter of hexa- flask, add 1 milliliter of purified n-hexadecane to the 125-milliliter Erlenmeyer decane, insert the head assembly, allow ni- flask. While flushing with nitrogen, evapo- trogen gas to flow into the inlet tube and rate to 1 milliliter on a steam bath. Nitrogen connect the outlet tube to a solvent trap and is admitted through a 8±1-milliliter outer-di- vacuum line in such a way as to prevent any ameter tube, drawn out into a 2±1-centimeter back flow of condensate into the flask. The long and 1±0.5-millimeter inner-diameter contents of the flask are evaporated on a capillary tip. This is positioned so that the steam bath until 1 milliliter of residue re- capillary tip extends 4 centimeters into the mains. Dissolve the 1 milliliter of hexa- flask. The nitrogen flow rate is such that the decane residue in isooctane and make up to surface of the liquid is barely disturbed. 25 milliliters. Determine the absorbance in a After the volume is reduced to that of the 1 5-centimeter path length cell compared to milliliter of hexadecane, the flask is left on isooctane as reference. The absorbance the steam bath for 10 more minutes before should not exceed 0.01 per centimeter path removing. Add 10 milliliters of purified iso- length between 280–400 mµ. If necessary, isooctane to the flask and reevaporate the solu- octane may be purified by passage through a tion to a 1-milliliter volume in the same column of activated silica gel (Grade 12, Da- manner as described above, except do not vidson Chemical Co., Baltimore, Md., or heat for an added 10 minutes. Repeat this op- equivalent) or by distillation. eration twice more. Let the flask cool. Methyl alcohol, A.C.S. reagent grade. Use 10 Add 10 milliliters of methyl alcohol and milliliters and proceed as with isooctane. about 0.3 gram of sodium borohydride. (Mini- The absorbance per centimeter of path mize exposure of the borohydride to the atmosphere; a measuring dipper may be used.) Immediately fit a water-cooled condenser 1 As determined by procedure using potas- equipped with a 24/40 joint and with a drying sium chromate for reference standard and tube into the flask, mix until the sodium described in National Bureau of Standards borohydride is dissolved, and allow to stand Circular 484, Spectrophotometry, U.S. De- for 30 minutes at room temperature, with partment of Commerce, (1949). The accuracy intermittent swirling. At the end of this is to be determined by comparison with the time, disconnect the flask and evaporate the standard values at 290, 345, and 400 milli- methyl alcohol on the steam bath under ni- microns. The procedure is incorporated by trogen until sodium borohydride begins to reference. Copies of the material incor- drop out of solution. Remove the flask and porated by reference are available from the let it cool. Center for Food Safety and Applied Nutri- Add 6 milliliters of isooctane to the flask tion (HFS–200), Food and Drug Administra- and swirl to wash the crystalline slurry. tion, 5100 Paint Branch Pkwy., College Park, Carefully transfer the isooctane extract to a MD 20740, or available for inspection at the 250-milliliter separatory funnel. Dissolve the Office of the Federal Register, 800 North Cap- crystals in the flask with about 25 milliliters itol Street, NW., suite 700, Washington, DC of distilled water and pour this also into the 20408. separatory funnel. Adjust the water volume

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in the separatory funnel to about 100 milli- (c) Petroleum naphtha containing liters and shake for 1 minute. After separa- antioxidants shall meet the specified tion of the layers, draw off the aqueous layer ultraviolet absorbance limits after cor- into a second 250-milliliter separatory fun- rection for any absorbance due to the nel. Transfer the hydrocarbon layer in the antioxidants. Petroleum naphtha may first funnel to a 25-milliliter volumetric contain antioxidants authorized for use flask. Carefully wash the Erlenmeyer flask with in food in an amount not to exceed an additional 6 milliliters of isooctane, swirl, that reasonably required to accomplish and transfer to the second separatory funnel. the intended effect or to exceed any Shake the funnel for 1 minute. After separa- prescribed limitations. tion of the layers, draw off the aqueous layer (d) Petroleum naphtha is used or in- into the first separatory funnel. Transfer the tended for use as a solvent in protec- isooctane in the second funnel to the volu- tive coatings on fresh citrus fruit in metric flask. Again wash the Erlenmeyer compliance with § 172.210. flask with an additional 6 milliliters of isooctane, swirl, and transfer to the first sepa- [42 FR 14491, Mar. 15, 1977, as amended at 47 ratory funnel. Shake the funnel for 1 minute. FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, After separation of the layers, draw off the 1984; 54 FR 24896, June 12, 1989] aqueous layer and discard. Transfer the isooctane layer to the volumetric flask and ad- § 172.255 Polyacrylamide. just the volume to 25 milliliters of isooctane. Polyacrylamide containing not more Mix the contents well, then transfer to the than 0.2 percent of acrylamide mon- first separatory funnel and wash twice with omer may be safely used as a film 50-milliliter portions of distilled water. Dis- former in the imprinting of soft-shell card the aqueous layers after each wash. gelatin capsules when the amount used Determine the ultraviolet absorbance of is not in excess of the minimum re- the isooctane extract in 5-centimeter path length cells compared to isooctane as ref- quired to produce the intended effect. erence between 280–400 mµ. Determine a reagent blank concurrently with the sample, § 172.260 Oxidized polyethylene. using 25 milliliters of purified isooctane in- Oxidized polyethylene may be safely stead of a solvent sample and measuring the used as a component of food, subject to ultraviolet absorbance of the blank between the following restrictions: 280–400mµ. (a) Oxidized polyethylene is the basic The reagent blank absorbance should not resin produced by the mild air oxida- exceed 0.04 per centimeter path length be- µ µ tion of polyethylene. The polyethylene tween 280–289 m ; 0.020 between 290–359 m ; used in the oxidation process conforms and 0.010 between 360–400 mµ. Determination of boiling-point range. Use to the density, maximum n-hexane ex- ASTM method D86–82, ‘‘Standard Method for tractable fraction, and maximum xy- Distillation of Petroleum Products,’’ which lene soluble fraction specifications pre- is incorporated by reference. Copies may be scribed in item 2.3 of the table in obtained from the American Society for § 177.1520(c) of this chapter. The Testing Materials, 1916 Race St., Philadel- oxidized polyethylene has a minimum phia, PA 19103, or may be examined at the number average molecular weight of Office of the Federal Register, 800 North Cap- 1,200, as determined by high tempera- itol Street, NW., suite 700, Washington, DC ture vapor pressure osmometry; con- 20408. tains a maximum of 5 percent by Determination of nonvolatile residue. For hydrocarbons boiling below 121 °C, determine weight of total oxygen; and has an acid the nonvolatile residue by ASTM method value of 9 to 19. D1353–78, ‘‘Standard Test Method for Non- (b) The additive is used or intended volatile Matter in Volatile Solvents for Use for use as a protective coating or com- in Paint, Varnish, Lacquer, and Related ponent of protective coatings for fresh Products;’’ for those boiling above 121 °C, use avocados, bananas, beets, coconuts, ASTM method D381–80, ‘‘Standard Test eggplant, garlic, grapefruit, lemons, Method for Existent Gum in Fuels by Jet limes, mango, muskmelons, onions, or- Evaporation,’’ which methods are incor- anges, papaya, peas (in pods), pine- porated by reference. Copies may be obtained from the American Society for Testing Ma- apple, plantain, pumpkin, rutabaga, terials, 1916 Race St., Philadelphia, PA 19103, squash (acorn), sweetpotatoes, tan- or may be examined at the Office of the Fed- gerines, turnips, watermelon, Brazil eral Register, 800 North Capitol Street, NW., nuts, chestnuts, filberts, hazelnuts, pe- suite 700, Washington, DC 20408. cans, and walnuts (all nuts in shells).

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(c) The additive is used in accordance ular weights of 600 and 260, respec- with good manufacturing practice and tively. in an amount not to exceed that re- (b) The additive meets the following quired to produce the intended effect. specifications: Molecular weight, 880– 930; melting point, 215°–217 °F; acid § 172.270 Sulfated butyl oleate. number, 43–47; and saponification num- Sulfate butyl oleate may be safely ber, 75–78. used in food, subject to the following (c) It is used or intended for use as a prescribed conditions: protective coating or component of (a) The additive is prepared by sul- protective coatings for fresh grape- fation, using concentrated sulfuric fruit, lemons, limes, muskmelons, or- acid, of a mixture of butyl esters pro- anges, sweetpotatoes, and tangerines. duced by transesterification of an edi- (d) It is used in an amount not to ex- ble vegetable oil using 1-butanol. Fol- ceed that required to produce the in- lowing sulfation, the reaction mixture tended effect. is washed with water and neutralized with aqueous sodium or potassium hy- § 172.280 Terpene resin. droxide. Prior to sulfation, the butyl The food additive terpene resin may oleate reaction mixture meets the fol- be safely used in accordance with the lowing specifications: following prescribed conditions: (1) Not less than 90 percent butyl ole- (a) The food additive is the beta- ate. pinene polymer obtained by polym- (2) Not more than 1.5 percent unsa- erizing terpene hydrocarbons derived ponifiable matter. from wood. It has a softening point of (b) The additive is used or intended 112 °C–118 °C, as determined by ASTM for use at a level not to exceed 2 per- method E28–67 (Reapproved 1982), cent by weight in an aqueous emulsion ‘‘Standard Test Method for Softening in dehydrating grapes to produce rai- Point By Ring-and-Ball Apparatus,’’ sins, whereby the residue of the addi- which is incorporated by reference. tive on the raisins does not exceed 100 Copies may be obtained from the Amer- parts per million. ican Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or [57 FR 12711, Apr. 13, 1992] may be examined at the Office of the Federal Register, 800 North Capitol § 172.275 Synthetic paraffin and suc- Street, NW., suite 700, Washington, DC cinic derivatives. 20408. Synthetic paraffin and succinic de- (b) It is used or intended for use as rivatives identified in this section may follows: be safely used as a component of food, (1) As a moisture barrier on soft gela- subject to the following restrictions: tin capsules in an amount not to ex- (a) The additive is prepared with 50 ceed 0.07 percent of the weight of the percent Fischer-Tropsch process syn- capsule. thetic paraffin, meeting the definition (2) As a moisture barrier on powders and specifications of § 172.615, and 50 of ascorbic acid or its salts in an percent of such synthetic paraffin to amount not to exceed 7 percent of the which is bonded succinic anhydride and weight of the powder. succinic acid derivatives of isopropyl alcohol, polyethylene glycol, and poly- [42 FR 14491, Mar. 15, 1977, as amended at 49 propylene glycol. It consists of a mix- FR 10104, Mar. 19, 1984] ture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic anhy- Subpart D—Special Dietary and dride, alkyl succinic anhydride iso- Nutritional Additives propyl half ester, dialkyl succinic anhydride polyethylene glycol half ester, § 172.310 Aluminum nicotinate. and dialkyl succinic anhydride poly- Aluminum nicotinate may be safely propylene glycol half ester, where the used as a source of niacin in foods for alkane (alkyl) has a chain length of 30– special dietary use. A statement of the 70 carbon atoms and the polyethylene concentration of the additive, ex- and polypropylene glycols have molec- pressed as niacin, shall appear on the

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label of the food additive container or itol Street, NW., suite 700, Washington, on that of any intermediate premix DC 20408) for the following: prepared therefrom. L-Alanine L-Arginine § 172.315 Nicotinamide-ascorbic acid L-Arginine Monohydrochloride complex. L-Cysteine Monohydrochloride Nicotinamide-ascorbic acid complex L-Cystine may be safely used in accordance with Aminoacetic acid (glycine) the following prescribed conditions: L-Leucine DL-Methionine (a) The additive is the product of the L-Methionine controlled reaction between ascorbic L-Tryptophan acid and nicotinamide, melting in the L-Phenylalanine range 141 °C to 145 °C. L-Proline (b) It is used as a source of ascorbic L-Serine acid and nicotinamide in multivitamin L-Threonine preparations. Glutamic Acid Hydrochloride L-Isoleucine § 172.320 Amino acids. L-Lysine Monohydrochloride Monopotassium L-glutamate The food additive amino acids may L-Tyrosine be safely used as nutrients added to L-Valine foods in accordance with the following (2) As found in ‘‘Specifications and conditions: Criteria for Biochemical Compounds,’’ (a) The food additive consists of one NAS/NRC Publication, 3rd Ed. (1972), or more of the following individual which is incorporated by reference amino acids in the free, hydrated or an- (copies are available from the Center hydrous form or as the hydrochloride, for Food Safety and Applied Nutrition sodium or potassium salts: (HFS–200), Food and Drug Administra- L-Alanine tion, 5100 Paint Branch Pkwy., College L-Arginine Park, MD 20740, or available for inspec- L-Asparagine tion at the Office of the Federal Reg- L-Aspartic acid ister, 800 North Capitol Street, NW., L-Cysteine suite 700, Washington, DC 20408) for the L-Cystine following: L-Glutamic acid L-Glutamine L-Asparagine Aminoacetic acid (glycine) L-Aspartic acid L-Histidine L-Glutamine L-Isoleucine L-Histidine L-Leucine (c) The additive(s) is used or intended L-Lysine DL-Methionine (not for infant foods) for use to significantly improve the bi- L-Methionine ological quality of the total protein in L-Phenylalanine a food containing naturally occurring L-Proline primarily-intact protein that is consid- L-Serine ered a significant dietary protein L-Threonine source, provided that: L-Tryptophan (1) A reasonable daily adult intake of L-Tyrosine the finished food furnishes at least 6.5 L-Valine grams of naturally occurring primarily (b) The food additive meets the fol- intact protein (based upon 10 percent of lowing specifications: the daily allowance for the ‘‘reference’’ (1) As found in ‘‘Food Chemicals adult male recommended by the Na- Codex,’’ National Academy of Sciences/ tional Academy of Sciences in ‘‘Rec- National Research Council (NAS/NRC), ommended Dietary Allowances,’’ NAS 3d Ed. (1981), which is incorporated by Publication No. 1694, 7th Ed. (1968), reference (copies may be obtained from which is incorporated by reference. the National Academy Press, 2101 Con- Copies are available from the Center stitution Ave. NW., Washington, DC for Food Safety and Applied Nutrition 20418, or may be examined at the Office (HFS–200), Food and Drug Administra- of the Federal Register, 800 North Cap- tion, 5100 Paint Branch Pkwy., College

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Park, MD 20740, or available for inspec- the Association of Official Analytical tion at the Office of the Federal Reg- Chemists,’’ 13th Ed. (1980), which is in- ister, 800 North Capitol Street, NW., corporated by reference. Copies may be suite 700, Washington, DC 20408. obtained from the Association of Offi- (2) The additive(s) results in a pro- cial Analytical Chemists International, tein efficiency ratio (PER) of protein 481 North Frederick Ave., suite 500, in the finished ready-to-eat food equiv- Gaithersburg, MD 20877–2504, or may be alent to casein as determined by the examined at the Office of the Federal method specified in paragraph (d) of Register, 800 North Capitol Street, this section. NW., suite 700, Washington, DC 20408. (3) Each amino acid (or combination Each manufacturer or person employ- of the minimum number necessary to ing the additive(s) under the provisions achieve a statistically significant increase) added results in a statistically of this section shall keep and maintain significant increase in the PER as de- throughout the period of his use of the termined by the method described in additive(s) and for a minimum of 3 paragraph (d) of this section. The min- years thereafter, records of the tests imum amount of the amino acid(s) to required by this paragraph and other achieve the desired effect must be used records required to assure effectiveness and the increase in PER over the pri- and compliance with this regulation marily-intact naturally occurring pro- and shall make such records available tein in the food must be substantiated upon request at all reasonable hours by as a statistically significant difference any officer or employee of the Food with at least a probability (P) value of and Drug Administration, or any other less than 0.05. officer or employee acting on behalf of (4) The amount of the additive added the Secretary of Health and Human for nutritive purposes plus the amount Services and shall permit such officer naturally present in free and combined or employee to conduct such inven- (as protein) form does not exceed the tories of raw and finished materials on following levels of amino acids ex- hand as he deems necessary and other- pressed as percent by weight of the wise to check the correctness of such total protein of the finished food: records. Percent by (e) To assure safe use of the additive, weight of the label and labeling of the additive total protein (ex- and any premix thereof shall bear, in pressed as 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 L-Isoleucine ...... 6.6 (3) Adequate directions for use to 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 L-Phenylalanine ...... 5.8 of this section. L-Proline ...... 4.2 (f) The food additive amino acids L-Serine ...... 8.4 L-Threonine ...... 5.0 added as nutrients to special dietary L-Tryptophan ...... 1.6 foods that are intended for use solely L-Tyrosine ...... 4.3 under medical supervision to meet nu- L-Valine ...... 7.4 tritional requirements in specific med- (d) Compliance with the limitations ical conditions and comply with the re- concerning PER under paragraph (c) of quirements of part 105 of this chapter this section shall be determined by the are exempt from the limitations in method described in sections 43.212– paragraphs (c) and (d) of this section 43.216, ‘‘Official Methods of Analysis of and may be used in such foods at levels

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not to exceed good manufacturing formation required by the Act, the fol- practices. lowing: [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. (1) The name of the additive ‘‘cal- 28, 1977, as amended at 47 FR 11836, Mar. 19, cium chloride double salt of d-calcium 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, pantothenate’’ or ‘‘calcium chloride June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR double salt of dl-calcium panto- 14480, Apr. 2, 1996] thenate’’, whichever is appropriate. (2) A statement of the appropriate § 172.325 Bakers yeast protein. concentration of the additive, ex- Bakers yeast protein may be safely pressed as pantothenic acid. used in food in accordance with the following conditions: § 172.335 D-Pantothenamide. (a) Bakers yeast protein is the insol- The food additive D-pantothenamide uble proteinaceous material remaining as a source of pantothenic acid activ- after the mechanical rupture of yeast ity, may be safely used in foods for spe- cells of Saccharomyces cerevisiae and re- cial dietary use in an amount not in moval of whole cell walls by cen- excess of that reasonably required to trifugation and separation of soluble produce its intended effect. cellular materials. (b) The additive meets the following § 172.340 Fish protein isolate. specifications on a dry weight basis: (1) Zinc salts less than 500 parts per (a) The food additive fish protein iso- million (ppm) as zinc. late may be safely used as a food sup- (2) Nucleic acid less than 2 percent. plement in accordance with the following prescribed conditions: (3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05 ppm mer- (1) The additive shall consist prin- cury, and 0.3 ppm selenium. cipally of dried fish protein prepared (c) The viable microbial content of from the edible portions of fish after the finished ingredient is: removal of the heads, fins, tails, bones, (1) Less than 10,000 organisms/gram scales, viscera, and intestinal contents. by aerobic plate count. (2) The additive shall be derived only (2) Less than 10 yeasts and molds/ from species of bony fish that are gen- gram. erally recognized by qualified sci- (3) Negative for Salmonella, E. coli, entists as safe for human consumption coagulase positive Staphylococci, Clos- and that can be processed as prescribed tridium perfringens, Clostridium botu- to meet the required specifications. linum, or any other recognized micro- (3) Only wholesome fresh fish other- bial pathogen or any harmful microbial wise suitable for human consumption toxin. may be used. The fish shall be handled (d) The ingredient is used in food as expeditiously under sanitary condi- a nutrient supplement as defined in tions. These conditions shall be in ac- § 170.3(o)(20) of this chapter. cordance with recognized good manufacturing practice for fish to be used as § 172.330 Calcium pantothenate, cal- human food. cium chloride double salt. (4) The additive shall be prepared by The food additive calcium chloride extraction with hexane and food-grade double salt of calcium pantothenate ethanol to remove fat and moisture. may be safely used in foods for special Solvent residues shall be reduced by dietary uses in accordance with good drying. manufacturing practice and under the (b) The food additive meets the fol- following prescribed conditions: lowing specifications: (Where methods (a) The food additive is of the d (dex- of determination are specified, they are trorotatory) or the dl (racemic) form. Association of Official Analytical (b) To assure safe use of the additive, Chemists Methods, 13th ed., 1980, which the label and labeling of the food addi- are incorporated by reference). 1 tive container, or that of any intermediate premixes prepared therefrom, 1 Copies are available from: Association of shall bear, in addition to the other in- Official Analytical Chemists International,

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(1) Protein content, as N × 6.25, shall (c) Folic acid may be added to foods not be less than 90 percent by weight of subject to a standard of identity estab- the final product, as determined by the lished under section 401 of the Federal method described in section 2.057, Im- Food, Drug, and Cosmetic Act (the act) proved Kjeldahl Method for Nitrate- when the standard of identity specifi- Free Samples (20)—Official Final Ac- cally provides for the addition of folic tion. acid. (2) Moisture content shall not be (d) Folic acid may be added, at levels more than 10 percent by weight of the not to exceed 400 micrograms (µg) per final product, as determined by the serving, to breakfast cereals, as defined method described in section 24.003, Air under § 170.3(n)(4) of this chapter, and Drying (1)—Official First Action. to corn grits at a level such that each (3) Fat content shall not be more pound of corn grits contains not more than 0.5 percent by weight of the final than 1.0 milligram of folic acid. product, as determined by the method (e) Folic acid may be added to infant described in section 24.005, Crude Fat formula in accordance with section or Ether Extract—Official Final Ac- 412(i)(1) of the act or with regulations tion. issued under section 412(i)(2) of the act which are codified in § 107.100 of this (4) Solvent residues in the final prod- chapter. uct shall not be more than 5 parts per (f) Folic acid may be added to a med- million of hexane and 3.5 percent eth- ical food, as defined in section 5(b)(3) of anol by weight. the Orphan Drug Act (21 U.S.C. [46 FR 38072, July 24, 1981, as amended at 47 360ee(b)(3)), at levels not to exceed the FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, amount necessary to meet the distinc- 1989] tive nutritional requirements of the disease or condition for which the food § 172.345 Folic acid (folacin). is formulated. Folic acid (CAS Reg. No. 59–30–3), (g) Folic acid may be added to food also known as folacin or folate, may be for special dietary use at levels not to safely used in food as a nutrient in ac- exceed the amount necessary to meet cordance with the following prescribed the special dietary needs for which the conditions: food is formulated. (a) Folic acid is the chemical N-[4- (h) Folic acid may be added to foods [[(2-amino-1,4-dihydro-4-oxo-6-pteri- represented as meal-replacement prod- dinyl)methyl]amino]benzoyl]-L-glu- ucts, in amounts not to exceed: tamic acid. (1) Four hundred µg 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 µ 4th ed. (1996), pp. 157–158, which is in- (2) Two hundred g 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 § 172.350 Fumaric acid and salts of fu- the Center for Food Safety and Applied maric acid. Nutrition’s Library, Food and Drug Ad- Fumaric acid and its calcium, fer- ministration, 200 C St. SW., Wash- rous, magnesium, potassium, and so- ington, DC, or at the Office of the Fed- dium salts may be safely used in food eral Register, 800 North Capitol St. in accordance with the following pre- NW., suite 700, Washington, DC. scribed conditions: (a) The additives meet the following specifications: 481 North Frederick Ave., suite 500, Gaithers- burg, MD 20877–2504, or examined at the Of- (1) Fumaric acid contains a minimum fice of the Federal Register, 800 North Cap- of 99.5 percent by weight of fumaric itol Street, NW., suite 700, Washington, DC acid, calculated on the anhydrous 20408. basis.

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(2) The calcium, magnesium, potas- accordance with the following condi- sium, and sodium salts contain a min- tions: imum of 99 percent by weight of the re- (a) N-Acetyl-L-methionine (Chemical spective salt, calculated on the anhy- Abstracts Service Registry No. 65–82–7) drous basis. Ferrous fumarate contains is the derivative of the amino acid me- a minimum of 31.3 percent total iron thionine formed by addition of an and not more than 2 percent ferric acetyl group to the alpha-amino group iron. of methionine. It may be in the free, (b) With the exception of ferrous fu- hydrated or anhydrous form, or as the marate, fumaric acid and the named sodium or potassium salts. salts are used singly or in combination (b) The additive meets the following in food at a level not in excess of the specifications: amount reasonably required to accom- (1) Purity assay, on a dry basis: Min- plish the intended effect. imum 99 percent. (c) Ferrous fumarate is used as a (2) Residue on ignition: Maximum 0.1 source of iron in foods for special die- percent. tary use, when the use is consistent (3) Specific optical rotation 20 with good nutrition practice. [alpha] D: Between ¥19° and ¥23°. (4) The additive may contain residues § 172.365 Kelp. of not more than 500 ppm ethyl acetate; 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 § 172.370 Iron-choline citrate complex. described in paragraph (d) of this section. 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

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weight of the total protein of the fin- requirements of part 105 of this chap- ished food, including the amount natu- ter, the food additive is exempt from rally present in free and combined (as the limitations in paragraphs (c)(1) protein) form. through (4) and (d) of this section and (5) The additive shall not be added to may be used in those foods at levels infant foods or to foods containing not to exceed good manufacturing added nitrites/nitrates. practices. (d) Compliance with the limitations [43 FR 27784, June 27, 1978, as amended at 46 concerning PER under paragraph (c) of FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, the section shall be determined by the 1984; 54 FR 24897, June 12, 1989] method described in sections 43.212– 43.216, ‘‘Official Methods of Analysis of § 172.375 Potassium iodide. the Association of Official Analytical The food additive potassium iodide Chemists,’’ 13th Ed. (1980), which is in- may be safely used in accordance with corporated by reference. Copies may be the following prescribed conditions: obtained from the Association of Offi- cial Analytical Chemists International, (a) Potassium iodide may be safely 481 North Frederick Ave., suite 500, added to a food as a source of the es- Gaithersburg, MD 20877–2504, or may be sential mineral iodine, provided the examined at the Office of the Federal maximum intake of the food as may be Register, 800 North Capitol Street, consumed during a period of one day, NW., suite 700, Washington, DC 20408. or as directed for use in the case of a Each manufacturer or person employ- dietary supplement, will not result in ing the additive under the provisions of daily ingestion of the additive so as to this section shall keep and maintain provide a total amount of iodine in ex- throughout the period of use of the ad- cess of 225 micrograms for foods labeled ditive and for a minimum of 3 years without reference to age or physio- thereafter, records of the tests required logical state; and when age or the con- by this paragraph and other records re- ditions of pregnancy or lactation are quired to assure effectiveness and com- specified, in excess of 45 micrograms pliance with this regulation. Those for infants, 105 micrograms for children records shall be made available upon under 4 years of age, 225 micrograms request at all reasonable hours by any for adults and children 4 or more years officer or employee acting on behalf of of age, and 300 micrograms for preg- the Secretary of Health and Human nant or lactating women. Services. Those officers or employees (b) To assure safe use of the additive, shall be permitted to conduct inven- in addition to the other information re- tories of raw and finished materials on quired by the Act, the label of the addi- hand as are deemed necessary to verify tive shall bear: the 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- § 172.385 Whole fish protein con- quired by the Act, the following: centrate. (1) The name of the additive con- The food additive whole fish protein tained therein. concentrate may be safely used as a (2) The amounts of additive and each food supplement in accordance with amino acid contained in any mixture. the following prescribed conditions: (3) Adequate directions for use to (a) The additive is derived from provide a finished food meeting the whole, wholesome hake and hakelike limitations prescribed by paragraph (c) fish, herring of the genera Clupea, men- of this section. haden, and anchovy of the species En- (f) When the food additive is added as graulis mordax, handled expeditiously a nutrient to special dietary foods that and under sanitary conditions in ac- are intended for use solely under med- cordance with good manufacturing ical supervision to meet nutritional re- practices recognized as proper for fish quirements in specific medical condi- that are used in other forms for human tions and these foods comply with the food.

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(b) The additive consists essentially may be used to reduce residues of the of a dried fish protein processed from solvents used in the extraction process. the whole fish without removal of (6) The additive shall contain not in heads, fins, tails, viscera, or intestinal excess of 100 parts per million fluorides contents. It is prepared by solvent ex- (expressed as F). traction of fat and moisture with iso- (7) The additive shall be free of Esch- propyl alcohol or with ethylene dichlo- erichia coli and pathogenic organisms, ride followed by isopropyl alcohol, ex- including Salmonella, and shall have a cept that the additive derived from total bacterial plate count of not more herring, menhaden and anchovy is pre- than 10,000 per gram. pared by solvent extraction with iso- (8) The additive shall have no more propyl alcohol alone. Solvent residues than a faint characteristic fish odor are reduced by conventional heat dry- and taste. ing and/or microwave radiation and (d) When the additive is used or in- there is a partial removal of bone. tended for use in the household as a protein supplement in food for regular (c) The food additive meets the fol- consumption by children up to 8 years lowing specifications: × of age, the amount of the additive from (1) Protein content (N 6.25) shall this source shall not exceed 20 grams not be less than 75 percent by weight of per day (about one heaping table- the final product, as determined by the spoon). method described in section 2.057 in (e) When the additive is used as a ‘‘Official Methods of Analysis of the protein supplement in manufactured Association of Official Analytical food, the total fluoride content (ex- Chemists’’ (AOAC), 13th Ed. (1980). Pro- pressed as F) of the finished food shall tein quality shall not be less than 100, not exceed 8 ppm based on the dry as determined by the method described weight of the food product. in sections 43.212–43.216 of the AOAC. (f) To assure safe use of the additive, The 13th Ed. is incorporated by refin addition to the other information re- erence, and copies may be obtained quired by the Act: from the Association of Official Ana- (1) The label of consumer-sized or lytical Chemists International, 481 bulk containers of the additive shall North Frederick Ave., suite 500, Gai- bear the name ‘‘whole fish protein con- thersburg, MD 20877–2504, or may be ex- centrate’’. amined at the Office of the Federal (2) The label or labeling of containers Register, 800 North Capitol Street, of the additive shall bear adequate di- NW., suite 700, Washington, DC 20408. rections for use to comply with the (2) Moisture content shall not exceed limitations prescribed by paragraphs 10 percent by weight of the final prod- (d) and (e) of this section. uct, as determined by the method de- (3) Labels of manufactured foods con- scribed in section 24.003 of the AOAC. taining the additive shall bear, in the See paragraph (c)(1) of this section for ingredient statement, the name of the availability of the material incor- additive, ‘‘whole fish protein con- porated by reference. centrate’’ in the proper order of de- (3) Fat content shall not exceed 0.5 creasing predominance in the finished percent by weight of the final product, food. as determined by the method described [42 FR 14491, Mar. 15, 1977, as amended at 49 in section 24.005 of the AOAC. See para- FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, graph (c)(1) of the this section for 1989] availability of the material incorporated by reference. § 172.395 Xylitol. (4) The additive may contain residues Xylitol may be safely used in foods of isopropyl alcohol and ethylene di- for special dietary uses, provided the chloride not in excess of 250 parts per amount used is not greater than that million and 5 parts per million, respec- required to produce its intended effect. tively, when used as solvents in the extraction process. § 172.399 Zinc methionine sulfate. (5) Microwave radiation meeting the Zinc methionine sulfate, CAS Reg. requirements of § 179.30 of this chapter No. 56329–42–1, may be safely used in

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accordance with the following pre- § 172.480 Silicon dioxide. scribed conditions: The food additive silicon dioxide may (a) The additive is the product of the be safely used in food in accordance reaction between equimolar amounts of with the following conditions: zinc sulfate and DL-methionine in puri- (a) The food additive is manufactured fied water. by vapor phase hydrolysis or by other (b) The additive meets the following means whereby the particle size is such specifications: as to accomplish the intended effect. (b) It is used as an anticaking agent, Zinc content—19 to 22 percent. subject to the following conditions: C H NO S ‘‘DL-methionine’’—46 to 50 per- 5 11 2 (1) It is used in only those foods in cent. which the additive has been dem- Cadmium—not more than 0.05 part per million. onstrated to have an anticaking effect. (2) It is used in an amount not in ex- (c) The additive is used in tablet form cess of that reasonably required to as a source of dietary zinc. produce its intended effect. (3) [Reserved] [46 FR 58297, Dec. 1, 1981] (4) It is used in an amount not to exceed 2 percent by weight of the food. Subpart E—Anticaking Agents (c) It is used or intended for use as a stabilizer in the production of beer, and § 172.410 Calcium silicate. is removed from the beer by filtration Calcium silicate, including synthetic prior to final processing. calcium silicate, may be safely used in (d) It is used or intended for use as an food in accordance with the following adsorbent for dl-a-tocopheryl acetate prescribed conditions: and pantothenyl alcohol in tableted (a) It is used as an anticaking agent foods for special dietary use, in an in food in an amount not in excess of amount not greater than that required that reasonably required to produce its to accomplish the intended physical or technical effect. intended effect. (b) It will not exceed 2 percent by § 172.490 Yellow prussiate of soda. weight of the food, except that it may (a) The food additive yellow prussiate be present up to 5 percent by weight of of soda (sodium ferrocyanide decahy- baking powder. drate; Na4Fe(CN)6·10H2O contains a minimum of 99 percent by weight of so- § 172.430 Iron ammonium citrate. dium ferrocyanide decahydrate. Iron ammonium citrate may be safe- (b) The additive is used or intended ly used in food in accordance with the for use as an anticaking agent in salt following prescribed conditions: and as an adjuvant in the production of (a) The additive is the chemical dendritic crystals of salt in an amount green ferric ammonium citrate. needed to produce its intended effect (b) The additive is used, or intended but not in excess of 13 parts per million for use as an anticaking agent in salt calculated as anhydrous sodium ferro- for human consumption so that the cyanide. level of iron ammonium citrate does [42 FR 14491, Mar. 15, 1977, as amended at 58 not exceed 25 parts per million (0.0025 FR 17098, Apr. 1, 1993] percent) in the finished salt. (c) To assure safe use of the additive Subpart F—Flavoring Agents and the label or labeling of the additive Related Substances shall bear, in addition to the other information required by the Act: § 172.510 Natural flavoring substances (1) The name of the additive. and natural substances used in conjunction with flavors. (2) Adequate directions to provide a final product that complies with the Natural flavoring substances and limitations prescribed in paragraph (b) natural adjuvants may be safely used of this section. in food in accordance with the following conditions.

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(a) They are used in the minimum resins, oleoresins, waxes, and dis- quantity required to produce their in- tillates) they consist of one or more of tended physical or technical effect and the following, used alone or in com- in accordance with all the principles of bination with flavoring substances and good manufacturing practice. adjuvants generally recognized as safe (b) In the appropriate forms (plant in food, previously sanctioned for such parts, fluid and solid extracts, con- use, or regulated in any section of this cretes, absolutes, oils, gums, balsams, part.

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 free1 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 free1 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. 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 .

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Common name Scientific name Limitations

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 . Olibanum ...... Boswellia carteri Birdw. and other Boswellia spp . Opopanax (bisabolmyrrh) ...... Opopanax chironium Koch (true opopanax) of Commiphora erythraea Engl. var. Llabrescens. Orris root ...... Iris germanica L. (including its variety florentina Dykes) and I. pallida Lam . Pansy ...... Viola tricolor L ...... In alcoholic beverages only Passion flower ...... Passiflora incarnata L . Patchouly ...... Pogostemon cablin Benth. and P. heyneanus Benth . Peach leaves ...... Prunus persica (L.) Batsch ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Pennyroyal, American ...... Hedeoma pulegioides (L.) Pers . Pennyroyal, European ...... Mentha pulegium L . Pine, dwarf, needles and twigs ...... Pinus mugo Turra var. pumilio (Haenke) Zenari . Pine, Scotch, needles and twigs ...... Pinus sylvestris L . Pine, white, bark ...... Pinus strobus L ...... In alcoholic beverages only Pine, white oil ...... Pinus palustris Mill., and other Pinus spp . Poplar buds ...... Populus balsamifera L. (P. tacamahacca Mill.), P. Do. candicans Ait., or P. nigra L . Quassia ...... Picrasma excelsa (Sw.) Planch, or Quassia amara L . Quebracho bark ...... Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii (Quebrachia lorentzii (Griseb)) . (Griseb.) Engl.

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Common name Scientific name Limitations

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 free1 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 free1 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 Association of Official Analytical Chemists International, 481 North Frederic Ave., suite 500, Gaithersburg, MD 20877–2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408 [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]

§ 172.515 Synthetic flavoring sub- accordance with the following condi- stances and adjuvants. tions. Synthetic flavoring substances and adjuvants may be safely used in food in

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

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Butyl valerate. γ-Decalactone; 5-hydroxy-decanoic acid, δ- 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-γ-butyrolactone; 4,4-dibutyl-4-hy- cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- droxy-butyric acid, γ-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 [8.2.0.04, 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. γ-Dodecalactone; 4-hydroxydodecanoic acid γ- Citronellyl butyrate. lactone. Citronellyl formate. 2-Dodecenal. Citronellyl isobutyrate. Estragole. Citronellyl phenylacetate. ρ-Ethoxybenzaldehyde. Citronellyl propionate. Ethyl acetoacetate. Citronellyl valerate. Ethyl 2-acetyl-3-phenylpropionate; ethyl- p-Cresol. benzyl acetoacetate. Cuminaldehyde; cuminal; p-isopropyl benz- Ethyl aconitate, mixed esters. aldehyde. Ethyl acrylate. Cyclohexaneacetic acid. Ethyl ρ-anisate. Cyclohexaneethyl acetate. Ethyl anthranilate. Cyclohexyl acetate. Ethyl benzoate. Cyclohexyl anthranilate. Ethyl benzoylacetate. Cyclohexyl butyrate. a-Ethylbenzyl butyrate; a-phenylpropyl bu- Cyclohexyl cinnamate. tyrate. Cyclohexyl formate. Ethyl brassylate; tridecanedioic acid cyclic Cyclohexyl isovalerate. ethylene glycol diester; cyclo 1,13-ethyl- Cyclohexyl propionate. enedioxytridecan-1,13-dione. p-Cymene. 2-Ethylbutyl acetate. γ-Decalactone; 4-hydroxy-decanoic acid, γ- 2-Ethylbutyraldehyde. lactone. 2-Ethylbutyric acid.

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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)-δ9,10-octahydroazulene acetate. Ethyl heptanoate. γ-Heptalactone; 4-hydroxyheptanoic acid, γ- 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. ω-6-Hexadecenlactone; 16-hydroxy-6- Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, ω-lactone; cinnamate. ambrettolide. Ethyl propionate. γ-Hexalactone; 4-hydroxyhexanoic acid, γ-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. Formic acid Hexyl isovalerate. (2-Furyl)-2-propanone; furyl acetone. Hexyl 2-methylbutyrate. 1-Furyl-2-propanone; furyl acetone. Hexyl octanoate. Fusel oil, refined (mixed amyl alcohols). Hexyl phenylacetate; n-hexyl phenylacetate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Hexyl propionate. octadien-1-yl acetoacetate. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- Geranyl acetone; 6,10-dimethyl-5,9- octanal. undecadien-2-one. Hydroxycitronellal diethyl acetal. Geranyl benzoate. Hydroxycitronellal dimethyl acetal. Geranyl butyrate. Hydroxycitronellal; 3,7-dimethyl-1,7- Geranyl formate. octanediol. Geranyl hexanoate N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Geranyl isobutyrate. pelargonyl vanillylamide. Geranyl isovalerate. 5-Hydroxy-4-octanone; butyroin. Geranyl phenylacetate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Geranyl propionate. benzyl acetone.

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Indole. Isojasmone; mixture of 2-hexylidenecyclo- a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- pentanone and 2-hexyl-2-cyclopenten-1-one. yl)-3-buten-2-one. a-Isomethylionone; 4-(2,6,6-trimethyl-2- b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- cyclohexen-1-yl)-3-methyl-3-buten-2-one; yl)-3-buten-2-one. methyl γ-ionone. a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Isopropyl acetate. 1-yl)-3-buten-2-one; 6-methylionone. ρ-Isopropylacetophenone. Isoamyl acetate. Isopropyl alcohol; isopropanol. Isoamyl acetoacetate. Isopropyl benzoate. Isoamyl alcohol; isopentyl alcohol; 3-methyl- ρ-Isopropylbenzyl alcohol; cuminic alcohol; 1-butanol. ρ-cymen-7-ol. Isoamyl benzoate. 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- ρ-Isopropylphenylacetaldehyde; ρ-cymen-7- furylacetate. carboxaldehyde. Isoamyl hexanoate. Isopropyl phenylacetate. Isoamyl isobutyrate. 3-(ρ-Isopropylphenyl)-propionaldehyde; ρ-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. Isoamyl salicylate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- Isoborneol. penten-1-one. Isobornyl acetate. Lauric aldehyde; dodecanal. Isobornyl formate. Lauryl acetate. Isobornyl isovalerate. Lauryl alcohol; 1-dodecanol. Isobornyl propionate. Lepidine; 4-methylquinoline. Isobutyl acetate. Levulinic acid. Isobutyl acetoacetate. Linalool oxide; cis- and trans-2-vinyl-2-meth- Isobutyl alcohol. yl-5-(1′-hydroxy-1′-methylethyl) tetra- Isobutyl angelate; isobutyl cis-2-methyl-2- hydrofuran. butenoate. Linalyl anthranilate; 3,7-dimethyl-1,6- Isobutyl anthranilate. octadien-3-yl anthranilate. Isobutyl benzoate. Linalyl benzoate. Isobutyl butyrate. Linalyl butyrate. Isobutyl cinnamate. Linalyl cinnamate. Isobutyl formate. Linalyl formate. Isobutyl 2-furanpropionate. Linalyl hexanoate. Isobutyl heptanoate. Linalyl isobutyrate. Isobutyl hexanoate. Linalyl isovalerate. Isobutyl isobutyrate. Linalyl octanoate. a-Isobutylphenethyl alcohol; isobutyl benzyl Linalyl propionate. carbinol; 4-methyl-1-phenyl-2-pentanol. Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. Isobutyl phenylacetate. Menthadienol; p-mentha-1,8(10)-dien-9-ol. Isobutyl propionate. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Isobutyl salicylate. Menthadienyl acetate; p-mentha-1,8(10)-dien- 2-Isobutylthiazole. 9-yl acetate. Isobutyraldehyde. p-Menth-3-en-1-ol. Isobutyric acid. 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl Isoeugenol; 2-methoxy-4-propenylphenol. acetate. Isoeugenyl acetate. Menthol; 2-isopropyl-5-methylcyclohexanol. Isoeugenyl benzyl ether; benzyl isoeugenol. Menthone; p-menthan-3-one. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- Menthyl acetate; p-menth-3-yl acetate. anisole; ethyl isoeugenol. Menthyl isovalerate; p-menth-3-yl iso- Isoeugenyl formate. valerate. Isoeugenyl methyl ether; 4-propenyl- o-Methoxybenzaldehyde. veratrole; methyl isoeugenol. p-Methoxybenzaldehyde; p-anisaldehyde. Isoeugenyl phenylacetate. o-Methoxycinnamaldehyde.

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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- -Methylbenzyl butyrate; styralyl butyrate. a cohol. -Methylbenzyl isobutyrate; styralyl iso- a 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. 2-Methylbutyl isovalerate. dimethylphenyl ethylcarbinyl isobutyrate. Methyl p-tert-butylphenylacetate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl 2-Methylbutyraldehyde; methyl ethyl acetal- phenylacetaldehyde. dehyde. Methyl 4-phenylbutyrate. 3-Methylbutyraldehyde; isovaleraldehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- Methyl butyrate. butyl ketone. 2-Methylbutyric acid. Methyl 3-phenylpropionate; methyl hydro- a-Methylcinnamaldehyde. cinnamate. p-Methylcinnamaldehyde. Methyl propionate. Methyl cinnamate. 3-Methyl-5-propyl-2-cyclohexen-1-one. 2-Methyl-1,3-cyclohexadiene. Methyl sulfide. Methylcyclopentenolone; 3-methylcyclopen- 3-Methylthiopropionaldehyde; methional. tane-1,2-dione. 2-Methyl-3-tolylpropionaldehyde, mixed o-, Methyl disulfide; dimethyl disulfide. m-, p-. Methyl ester of rosin, partially hydrogenated 2-Methylundecanal; methyl nonyl acetal- (as defined in § 172.615); methyl dehyde. dihydroabietate. Methyl 9-undecenoate. Methyl heptanoate. Methyl 2-undecynoate; methyl decyne car- 2-Methylheptanoic acid. bonate. 6-Methyl-3,5-heptadien-2-one. Methyl valerate. Methyl-5-hepten-2-ol. 2-Methylvaleric acid. 6-Methyl-5-hepten-2-one. Myrcene; 7-methyl-3-methylene-1,6-octa- Methyl hexanoate. diene. Methyl 2-hexanoate. Myristaldehyde; tetradecanal. Methyl p-hydroxybenzoate; methylparaben. d-Neomenthol; 2-isopropyl-5-methylcyclo- Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclohexanol. hexen-1-yl)-4-penten-3-one. Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo- Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- hexen-1-yl)-4-penten-3-one. 3-ol. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo- Neryl acetate. hexen-1-yl-)-4-penten-3-one. Neryl butyrate. Methyl isobutyrate. Neryl formate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- Neryl isobutyrate. hyde; a-methyl-p-isopropylhydro- Neryl isovalerate. cinnamaldehyde; cyclamen aldehyde. Neryl propionate. Methyl isovalerate. 2,6-Nonadien-1-ol.

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γ-Nonalactone; 4-hydroxynonanoic acid, γ- 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. γ-Octalactone; 4-hydroxyoctanoic acid, γ-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. ω-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, ω-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; ρ-mentha-1,5-diene. monolaurate. Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan Phenethyl alcohol; b-phenylethyl alcohol. monostereate. Phenethyl anthranilate. Polysorbate 80; polyoxyethylene (20) sorbitan Phenethyl benzoate. monooleate. Phenethyl butyrate. Potassium acetate. Phenethyl cinnamate. Propenylguaethol; 6-ethoxy-m-anol. Phenethyl formate. Propionaldehyde. Phenethyl isobutyrate. Propyl acetate. Phenethyl isovalerate. Propyl alcohol; 1-propanol. Phenethyl 2-methylbutyrate. p-Propyl anisole; dihydroanethole. Phenethyl phenylacetate. Propyl benzoate. Phenethyl propionate. Propyl butyrate. Phenethyl salicylate. Propyl cinnamate. Phenethyl senecioate; phenethyl 3,3-di- Propyl disulfide. methylacrylate. Propyl formate. Phenethyl tiglate. Propyl 2-furanacrylate. Phenoxyacetic acid. Propyl heptanoate.

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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. γ-Undecalactone; 4-hydroxyundecanoic acid Propyl phenylacetate. γ-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. Rum ether; ethyl oxyhydrate. (c) D-Decalactone and D- Salicylaldehyde. dodecalactone when used separately or Santalol, a and b. in combination in oleomargarine are Santalyl acetate. used at levels not to exceed 10 parts per Santalyl phenylacetate. Skatole. million and 20 parts per million, re- Sorbitan monostearate. spectively, in accordance with § 166.110 Styrene. of this chapter. Sucrose octaacetate. (d) BHA (butylated hydroxyanisole) a-Terpinene. may be used as an antioxidant in fla- γ-Terpinene. voring substances whereby the additive a-Terpineol; p-menth-1-en-8-ol. does not exceed 0.5 percent of the es- b-Terpineol. Terpinolene; p-menth-1,4(8)-diene. sential (volatile) oil content of the fla- Terpinyl acetate. voring substance. Terpinyl anthranilate. [42 FR 14491, Mar. 15, 1977, as amended at 42 Terpinyl butyrate. FR 23148, May 6, 1977; 43 FR 19843, May 9, Terpinyl cinnamate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, Terpinyl formate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR Terpinyl isobutyrate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; Terpinyl isovalerate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, Terpinyl propionate. 1989; 61 FR 14245, Apr. 1, 1996] 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 Tetramethyl ethylcyclohexenone; mixture of chapter and § 172.810, is used or in- 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- tended for use as a flavoring substance one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one. in dry beverage mixes whereby the 2-Thienyl mercaptan; 2-thienylthiol. amount of dioctyl sodium sulfo- Thymol. succinate does not exceed 75 parts per Tolualdehyde glyceryl acetal, mixed o, m, p. million of the finished beverage. The Tolualdehydes, mixed o, m, p. labeling of the dry beverage mix shall p-Tolylacetaldehyde. bear adequate directions to assure use o-Tolyl acetate; o-cresyl acetate. in compliance with this section. p-Tolyl acetate; p-cresyl acetate. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- § 172.530 Disodium guanylate. tone. p-Tolyl isobutyrate. Disodium guanylate may be safely p-Tolyl laurate. used as a flavor enhancer in foods, at a

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

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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 residue limitations as prescribed in sugar and glutamic acid have been re- paragraph (b)(5) of this section, and a covered, and which has been subjected boron content level not in excess of 300 to ion exchange to minimize the con- parts per million (0.0300 percent), cal- centration of naturally occurring trace culated as boron. minerals. (8) The additive is manufactured (b) It is used as a flavor in food. from hops as a nonisomerizable nonvolatile hop resin by an initial extrac- § 172.590 Yeast-malt sprout extract. tion and fractionation using one or Yeast-malt sprout extract, as de- more of the solvents listed in para- scribed in this section, may be safely graph (b)(5) of this section followed by used in food in accordance with the fol- a sequence of aqueous extractions and lowing prescribed conditions:

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(a) The additive is produced by par- units and arabinose units in the ap- tial hydrolysis of yeast extract (de- proximate ratio of six to one. rived from Saccharomyces cereviseae, (b) It is used in the following foods in Saccharomyces fragilis, or Candida utilis) the minimum quantity required to using the sprout portion of malt barley produce its intended effect as an emul- as the source of enzymes. The additive sifier, stabilizer, binder, or bodying ′ contains a maximum of 6 percent 5 nu- agent: Essential oils, nonnutritive cleotides by weight. sweeteners, flavor bases, nonstandard- (b) The additive may be used as a fla- ized dressings, and pudding mixes. vor enhancer in food at a level not in excess of that reasonably required to § 172.615 Chewing gum base. produce the intended effect. The food additive chewing gum base Subpart G—Gums, Chewing Gum may be safely used in the manufacture Bases and Related Substances of chewing gum in accordance with the following prescribed conditions: § 172.610 Arabinogalactan. (a) The food additive consists of one Arabinogalactan may be safely used or more of the following substances in food in accordance with the fol- that meet the specifications and limi- lowing conditions: tations prescribed in this paragraph, (a) Arabinogalactan is a poly- used in amounts not to exceed those re- saccharide extracted by water from quired to produce the intended physical Western larch wood, having galactose 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. Natural rubber (smoked sheet and latex sol- Hevea brasiliensis. ids) .

Synthetic Specifications

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

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

Family Genus and species

Paraffin ...... Synthesized by Fischer-Tropsch process from carbon monoxide and 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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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 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. 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).

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.

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

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

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the Xanthan Gum monograph, the (d) The additive meets the following ‘‘Food Chemicals Codex,’’ 4th ed. (1996), specifications: pp. 437–438, which is incorporated by (1) Residual isopropyl alcohol not to reference in accordance with 5 U.S.C. exceed 750 parts per million. 552(a) and 1 CFR part 51. Copies are (2) An aqueous solution containing 1 available from the National Academy percent of the additive and 1 percent of Press, Box 285, 2101 Constitution Ave. potassium chloride stirred for 2 hours NW., Washington, DC 20055 (Internet has a minimum viscosity of 600 centi- address ‘‘http://www.nap.edu’’), or may poises at 75 °F, as determined by be examined at the Center for Food Brookfield Viscometer, Model LVF (or Safety and Applied Nutrition’s Li- equivalent), using a No. 3 spindle at 60 brary, Food and Drug Administration, r.p.m., and the ratio of viscosities at 75 200 C St. SW., Washington, DC, or at °F and 150 °F is in the range of 1.02 to the Office of the Federal Register, 800 1.45. North Capitol St. NW., suite 700, Wash- (3) Positive for xanthan gum when ington, DC. 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 used in foods where standards of iden- to be tested. Add the blend slowly (approxi- tity established under section 401 of mately 1⁄2 minute) at the point of maximum the Federal Food, Drug, and Cosmetic agitation to a stirred solution of 200 milliliters of distilled water previously heated to Act do not preclude such use. 80 °C in a 400-milliliter beaker. Continue me- (f) To assure safe use of the additive: chanical stirring until the mixture is in solu- (1) The label of its container shall tion, but stir for a minimum time of 30 min- bear, in addition to other information utes. Do not allow the water temperature to required by the Federal Food, Drug, drop below 60 °C. and Cosmetic Act, the name of the ad- Set the beaker and its contents aside to ditive and the designation ‘‘food cool in the absence of agitation. Allow a grade’’. minimum time of 2 hours for cooling. Exam- ine the cooled beaker contents for a firm (2) The label or labeling of the food rubbery gel formation after the temperature additive container shall bear adequate drops below 40 °C. directions for use. In the event that a gel is obtained, make up a 1 percent solution of the polysaccharide [55 FR 39614, Sept. 28, 1990, as amended at 57 to be tested in 200 milliliters of distilled FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, water previously heated to 80 °C (omit the lo- 1999] cust bean gum). Allow the solution to cool without agitation as before. Formation of a § 172.695 Xanthan gum. gel on cooling indicates that the sample is a The food additive xanthan gum may gelling polysaccharide and not xanthan gum. be safely used in food in accordance Record the sample as ‘‘positive’’ for xan- with the following prescribed condi- than gum if a firm, rubbery gel forms in the tions: presence of locust bean gum but not in its absence. Record the sample as ‘‘negative’’ for (a) The additive is a polysaccharide xanthan gum if no gel forms or if a soft or gum derived from Xanthomonas brittle gel forms both with locust bean gum campestris by a pure-culture fermenta- and in a 1 percent solution of the sample tion process and purified by recovery (containing no locust bean gum). with isopropyl alcohol. It contains D- (4) Positive for xanthan gum when glucose, D-mannose, and D-glucuronic subjected to the following procedure: acid as the dominant hexose units and is manufactured as the sodium, potas- PYRUVIC ACID TEST sium, or calcium salt. (b) The strain of Xanthomonas Pipet 10 milliliters of an 0.6 percent solu- campestris is nonpathogenic and tion of the polysaccharide in distilled water (60 milligrams of water-soluble gum) into a nontoxic in man or other animals. 50-milliliter flask equipped with a standard (c) The additive is produced by a taper glass joint. Pipet in 20 milliliters of 1N process that renders it free of viable hydrochloric acid. Weigh the flask. Reflux cells of Xanthomonas campestris. the mixture for 3 hours. Take precautions to

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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 Compare the results with a curve of the op- added to the herbicide atrazine for applica- tical density versus concentration of an au- tion to corn. thentic sample of pyruvic acid that has been a-(p-Dodecylphenyl)-omega-hydroxypoly run through the procedure starting with the (oxyethylene) produced by the condensation preparation of the hydrazone. of 1 mole of dodecylphenol (dodecyl group is Record the percent by weight of pyruvic a proplyene tetramer isomer) with an aver- acid in the test polysaccharide. Note ‘‘posi- age of 4–14 or 30–70 moles of ethylene oxide; tive’’ for xanthan gum if the sample contains if a blend of products is used, the average more than 1.5 percent of pyruvic acid and number of moles of ethylene oxide reacted to ‘‘negative’’ for xanthan gum if the sample produce any product that is a component of contains less than 1.5 percent of pyruvic acid the blend shall be in the range of 4–14 or 30– by weight. 70. Ethylene dichloride. (e) The additive is used or intended Polyglyceryl phthalate ester of coconut oil for use in accordance with good manu- fatty acids. facturing practice as a stabilizer, emul- a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- sifier, thickener, suspending agent, omega-hydroxypoly(oxyethylene) produced bodying agent, or foam enhancer in by the condensation of 1 mole of p-(1,1,3,3- tetramethylbutyl) phenol with an average of foods for which standards of identity 4–14 or 30–70 moles of ethylene oxide; if a established under section 401 of the Act blend of products is used, the average num- do not preclude such use. ber of moles of ethylene oxide reacted to (f) To assure safe use of the additive: produce any product that is a component of (1) The label of its container shall the blend shall be in the range of 4–14 or 30– bear, in addition to other information 70. required by the Act, the name of the a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- omega-hydroxypoly(oxyethylene) produced additive and the designation ‘‘food by the condensation of 1 mole of p-(1,1,3,3- grade’’. tetramethylbutyl) phenol with 1 mole of (2) The label or labeling of the food ethylene oxide. additive container shall bear adequate Sodium acrylate and acrylamide copoly- directions for use. mer with a minimum average molecular weight of 10,000,000 in which 30 percent of the polymer is comprised of acrylate units and 70 Subpart H—Other Specific Usage percent acrylamide units, for use as a drift Additives control agent in herbicide formulations applied to crops at a level not to exceed 0.5 § 172.710 Adjuvants for pesticide use ounces of the additive per acre. dilutions. The following surfactants and related § 172.712 1,3-Butylene glycol. adjuvants may be safely added to pes- The food additive 1,3-butylene glycol ticide use dilutions by a grower or ap- (CAS Reg. No. 107–88–0) may be safely plicant prior to application to the used in food in accordance with the fol- growing crop: lowing prescribed conditions:

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(a) It is prepared by the aldol con- § 172.723 Epoxidized soybean oil. densation of acetaldehyde followed by Epoxidized soybean oil may be safely catalytic hydrogenation. used in accordance with the following (b) The food additive shall conform prescribed conditions: to the identity and specifications listed (a) The additive is prepared by react- in the monograph entitled ‘‘1,3-Butyl- ing soybean oil in toluene with hydro- ene Glycol’’ in the Food Chemicals gen peroxide and formic acid. Codex, 4th ed. (1996), p. 52, which is in- (b) It meets the following specifica- corporated by reference in accordance tions: with 5 U.S.C. 552(a) and 1 CFR part 51. (1) Epoxidized soybean oil contains Copies are available from the Office of oxirane oxygen, between 7.0 and 8.0 per- Premarket Approval, Center for Food cent, as determined by the American Safety and Applied Nutrition, 5100 Oil Chemists’ Society (A.O.C.S.) meth- Paint Branch Pkwy., College Park, MD od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- 20740, or may be examined at the Cen- approved 1989, which is incorporated by ter for Food Safety and Applied Nutri- reference in accordance with 5 U.S.C tion’s Library, Food and Drug Admin- 552(a) and 1 CFR part 51. Copies are istration, 200 C St. SW., Washington, available from the American Oil Chem- DC, or at the Office of the Federal Reg- ists’ Society, P. O. Box 3489, Cham- ister, 800 North Capitol St. NW., suite paign, IL 61826–3489, or may be exam- 700, Washington, DC. ined at the Division of Petition Control (c) It is used in the manufacture of (HFS–215), Center for Food Safety and sausage casings as a formulation aid as Applied Nutrition, Food and Drug Ad- defined in § 170.3(o)(14) of this chapter ministration, 1110 Vermont Ave. NW., and as a processing aid as defined in suite 1200, Washington, DC, or at the § 170.3(o)(24) of this chapter. Office of the Federal Register, 800 [62 FR 26228, May 13, 1997] North Capitol St. NW., suite 700, Wash- ington, DC. § 172.715 Calcium lignosulfonate. (2) The maximum iodine value is 3.0, Calcium lignosulfonate may be safely as determined by A.O.C.S. method Cd used in or on food, subject to the provi- 1–25, ‘‘Iodine Value of Fats and Oils sions of this section. Wijs Method,’’ revised 1993, which is in- (a) Calcium lignosulfonate consists of corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. sulfonated lignin, primarily as calcium The availability of this incorporation and sodium salts. by reference is given in paragraph (b) It is used in an amount not to ex- (b)(1) of this section. ceed that reasonably required to ac- (3) The heavy metals (as Pb) content complish the intended physical or tech- cannot be more than 10 parts per mil- nical effect when added as a dispersing lion, as determined by the ‘‘Heavy Met- agent and stabilizer in pesticides for als Test,’’ of the ‘‘Food Chemicals preharvest or postharvest application Codex,’’ 4th ed. (1996), pp. 760–761, Meth- to bananas. od II (with a 2-gram sample and 20 § 172.720 Calcium lactobionate. microgram of lead ion in the control), which is incorporated by reference in The food additive calcium accordance with 5 U.S.C. 552(a) and 1 lactobionate may be safely used in food CFR part 51. Copies are available from in accordance with the following pre- the National Academy Press, Box 285, scribed conditions: 2101 Constitution Ave. NW., Wash- (a) The food additive is the calcium ington, DC 20055 (Internet address salt of lactobionic acid (4-(b,D- ‘‘http://www.nap.edu’’), or may be ex- galactosido)-D-gluconic acid) produced amined at the Center for Food Safety by the oxidation of lactose. and Applied Nutrition’s Library, Food (b) It is used or intended for use as a and Drug Administration, 200 C St. firming agent in dry pudding mixes at SW., Washington, DC, or at the Office a level not greater than that required of the Federal Register, 800 North Cap- to accomplish the intended effect. itol St. NW., suite 700, Washington, DC.

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(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 labeled as described in paragraph (d) of § 172.725 Gibberellic acid and its po- this section. tassium salt. (d) To insure the safe use of the addi- The food additives gibberellic acid tive the label of the treated malt shall and its potassium salt may be used in bear, in addition to the other informa- the malting of barley in accordance tion required by the Act, the state- with the following prescribed condiments: tions: (1) ‘‘Contains not more than 2 parts (a) The additives meet the following per million lll’’, the blank being specifications: filled in with the words ‘‘gibberellic (1) The gibberellic acid is produced acid’’ or ‘‘potassium gibberellate’’, by deep-culture fermentation of a suit- whichever is appropriate; and able nutrient medium by a strain of (2) ‘‘Brewer’s malt—To be used in the Fusarium moniliforme or a selection of production of fermented malt bev- this culture. erages only’’ or ‘‘Distiller’s malt—To (2) The gibberellic acid produced is of be used in the production of distilled 80 percent purity or better. spirits only’’, whichever is appropriate. (3) The empirical formula of gibberellic acid is represented by § 172.730 Potassium bromate. C H O . 19 22 6 The food additive potassium bromate (4) Potassium gibberellate is the po- may be safely used in the malting of tassium salt of the specified gibberellic barley under the following prescribed acid. conditions: (5) The potassium gibberellate is of 80 percent purity or better. (a)(1) It is used or intended for use in (6) The gibberellic acid or potassium the malting of barley under conditions gibberellate may be diluted with sub- whereby the amount of the additive stances generally recognized as safe in present in the malt from the treatment foods or with salts of fatty acids con- does not exceed 75 parts per million of forming to § 172.863. bromate (calculated as Br), and the (b) They are used or intended for use treated malt is used only in the pro- in the malting of barley under condi- duction of fermented malt beverages or tions whereby the amount of either or distilled spirits. both additives present in the malt is (2) The total residue of inorganic bro- not in excess of 2 parts per million ex- mides in fermented malt beverages, re- pressed as gibberellic acid, and the sulting from the use of the treated treated malt is to be used in the pro- malt plus additional residues of inor- duction of fermented malt beverages or ganic bromides that may be present distilled spirits only, whereby the fin- from uses in accordance with other reg- ished distilled spirits contain none and ulations in this chapter promulgated the finished malt beverage contains under sections 408 and/or 409 of the act, not more than 0.5 part per million of does not exceed 25 parts per million of gibberellic acid. bromide (calculated as Br). No toler- (c) To insure the safe use of the food ance is established for bromide in dis- additives the label of the package shall tilled spirits because there is evidence bear, in addition to the other informa- that inorganic bromides do not pass tion required by the Act: over in the distillation process. (1) The name of the additive, (b) To assure safe use of the additive, ‘‘gibberellic acid’’ or ‘‘potassium the label or labeling of the food addi- gibberellate’’, whichever is appro- tive shall bear, in addition to the other priate. information required by the Act, the (2) An accurate statement of the con- following: centration of the additive contained in (1) The name of the additive. the package. (2) Adequate directions for use.

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(c) To assure safe use of the additive, with shortenings containing emulsi- the label or labeling of the treated fiers. malt shall bear, in addition to other information required by the Act, the § 172.765 Succistearin (stearoyl pro- statement, ‘‘Brewer’s Malt—To be used pylene glycol hydrogen succinate). in the production of fermented malt The food additive succistearin (ste- beverages only’’, or ‘‘Distiller’s Malt— aroyl propylene glycol hydrogen succi- To be used in the production of dis- nate) may be safely used in food in ac- tilled spirits only’’, whichever is the cordance with the following prescribed case. conditions: (a) The additive is the reaction prod- § 172.735 Glycerol ester of wood rosin. uct of succinic anhydride, fully hydro- Glycerol ester of wood rosin may be genated vegetable oil (predominantly safely used in food in accordance with C16 or C18 fatty acid chain length), and the following prescribed conditions: propylene glycol. (b) The additive meets the following (a) It has an acid number of 3 to 9, a specifications: drop-softening point of 88 °C–96 °C; and a color of N or paler as determined in Acid number 50–150. accordance with Official Naval Stores Hydroxyl number 15–50. Standards of the United States. It is Succinated ester content 45–75 percent. purified by countercurrent steam dis- (c) The additive is used or intended tillation. for use as an emulsifier in or with (b) It is used to adjust the density of shortenings and edible oils intended for citrus oils used in the preparation of use in cakes, cake mixes, fillings, beverages whereby the amount of the icings, pastries, and toppings, in ac- additive does not exceed 100 parts per cordance with good manufacturing million of the finished beverage. practice.

§ 172.755 Stearyl monoglyceridyl cit- § 172.770 Ethylene oxide polymer. rate. The polymer of ethylene oxide may The food additive stearyl be safely used as a foam stabilizer in monoglyceridyl citrate may be safely fermented malt beverages in accord- used in food in accordance with the fol- ance with the following conditions. lowing provisions: (a) It is the polymer of ethylene (a) The additive is prepared by con- oxide having a minimum viscosity of trolled chemical reaction of the fol- 1,500 centipoises in a 1 percent aqueous lowing: solution at 25 °C. (b) It is used at a level not to exceed Reactant Limitations 300 parts per million by weight of the fermented malt beverage. Citric acid ...... (c) The label of the additive bears di- Monoglycerides of fatty Prepared by the glycerolysis of ed- acids . ible fats and oils or derived from rections for use to insure compliance fatty acids conforming with with paragraph (b) of this section. § 172.860. Stearyl alcohol ...... Derived from fatty acids con- § 172.775 Methacrylic acid- forming with § 172.860, or de- divinylbenzene copolymer. rived synthetically in conformity with § 172.864. Methacrylic acid-divinylbenzene copolymer may be safely used in food in (b) The additive stearyl accordance with the following pre- monoglyceridyl citrate, produced as scribed conditions: described under paragraph (a) of this (a) The additive is produced by the section, meets the following specifica- polymerization of methacrylic acid and tions: divinylbenzene. The divinylbenzene functions as a cross-linking agent and Acid number 40 to 52. constitutes a minimum of 4 percent of Total citric acid 15 to 18 percent. the polymer. Saponification number 215–255. (b) Aqueous extractives from the ad- (c) The additive is used or intended ditive do not exceed 2 percent (dry for use as an emulsion stabilizer in or basis) after 24 hours at 25 °C.

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(c) The additive is used as a carrier of (7) Confections, hard candy, and soft vitamin B12 in foods for special dietary candy. use. (8) Baked goods and baking mixes, including frostings, icings, toppings, and Subpart I—Multipurpose Additives fillings for baked goods. (9) Yogurt and yogurt-type products. § 172.800 Acesulfame potassium. (10) Frozen and refrigerated desserts. Acesulfame potassium (CAS Reg. No. (11) Sweet sauces, toppings, and syr- 55589–62–3), also known as acesulfame ups. K, may be safely used as a sweetening (12) Alcoholic beverages. agent in food in accordance with the (13) Nonalcoholic beverages, includ- following prescribed conditions: ing beverage bases. (a) Acesulfame potassium is the po- (d) If the food containing the additive tassium salt of 6-methyl-1,2,3- is represented to be for special dietary oxathiazine-4(3H)-one-2,2-dioxide. uses, it shall be labeled in compliance (b) The additive meets the following with part 105 of this chapter. specifications: (e) The additive shall be used in ac- (1) Purity is not less than 99 percent cordance with current good manufac- on a dry basis. The purity shall be de- turing practice in an amount not to ex- termined by a method titled ceed that reasonably required to ac- ‘‘Acesulfame Potassium Assay,’’ which complish the intended effect. is incorporated by reference. Copies are [53 FR 28382, July 28, 1988, as amended at 57 available from the Center for Food FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, Safety and Applied Nutrition (HFS– Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 200), Food and Drug Administration, 36362, July 6, 1998] 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at § 172.802 Acetone peroxides. the Office of the Federal Register, 800 The food additive acetone peroxides North Capitol Street, NW., suite 700, may be safely used in flour, and in Washington, DC 20408. bread and rolls where standards of (2) Fluoride content is not more than identity do not preclude its use, in ac- 30 parts per million, as determined by cordance with the following prescribed method III of the Fluoride Limit Test conditions: of the Food Chemicals Codex, 3d Ed. (a) The additive is a mixture of (1981), p. 511, which is incorporated by monomeric and linear dimeric acetone reference. Copies are available from peroxide, with minor proportions of the National Academy Press, 2101 Con- higher polymers, manufactured by re- stitution Ave. NW., Washington, DC action of hydrogen peroxide and ace- 20418, or available for inspection at the tone. Office of the Federal Register, 800 (b) The additive may be mixed with North Capitol Street, NW., suite 700, an edible carrier to give a concentra- Washington, DC 20408. tion of: (1) 3 grams to 10 grams of hy- (c) The additive may be used in the drogen peroxide equivalent per 100 following foods when standards of iden- grams of the additive, plus carrier, for tity established under section 401 of use in flour maturing and bleaching; or the Federal Food, Drug, and Cosmetic (2) approximately 0.75 gram of hydro- Act do not preclude such use: gen peroxide equivalent per 100 grams (1) Sugar substitute, including granu- of the additive, plus carrier, for use in lated, powdered, liquid, and tablet dough conditioning. form. (c) It is used or intended for use: (1) (2) [Reserved] In maturing and bleaching of flour in a (3) Chewing gum. quantity not more than sufficient for (4) Dry bases for beverages, instant such effect; and (2) as a dough-condi- coffee, and instant tea. tioning agent in bread and roll produc- (5) Dry bases for gelatins, puddings, tion at not to exceed the quantity of and pudding desserts. hydrogen peroxide equivalent nec- (6) Dry bases for dairy product essary for the artificial maturing ef- analogs. fect.

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(d) To insure safe use of the additive, ener in the final baked product. The the label of the food additive container level of aspartame used in these prod- and any intermediate premix thereof ucts is determined by an analytical shall bear, in addition to the other in- method entitled ‘‘Analytical Method formation required by the act: for the Determination of Aspartame (1) The name of the additive, ‘‘ace- and Diketopiperazine in Baked Goods tone peroxides’’. and Baking Mixes,’’ October 8, 1992, (2) The concentration of the additive which was developed by the Nutrasweet expressed in hydrogen peroxide equiva- Co. Copies are available from the Office lents per 100 grams. of Premarket Approval (HFS–200), Cen- (3) Adequate use directions to provide ter for Food Safety and Applied Nutri- a final product that complies with the tion, 5100 Paint Branch Pkwy., College limitations prescribed in paragraph (c) Park, MD 20740, or are available for in- of this section. spection at the Center for Food Safety and Applied Nutrition’s Library, Food § 172.804 Aspartame. and Drug Administration, 200 C St. The food additive aspartame may be SW., Washington, DC 20204, and the Of- safely used in food in accordance with fice of the Federal Register, 800 North good manufacturing practice as a Capitol St. NW., suite 700, Washington, sweetening agent and a flavor enhancer DC. in foods for which standards of identity (d) To assure safe use of the additive, established under section 401 of the act in addition to the other information re- do not preclude such use under the fol- quired by the Act: lowing conditions: (1) The principal display panel of any (a) Aspartame is the chemical 1- intermediate mix of the additive for methyl N-L-a-aspartyl-L-phenylalanine manufacturing purposes shall bear a (C14H18N2O5). statement of the concentration of the (b) The additive meets the specifica- additive contained therein; tions of the ‘‘Food Chemicals Codex,’’ (2) The label of any food containing 3d Ed. (1981) pp. 28–29 and First Supple- the additive shall bear, either on the ment p. 5, which is incorporated by ref- principal display panel or on the infor- erence in accordance with 5 U.S.C. mation panel, the following statement: 552(a). Copies are available from the PHENYLKETONURICS: CONTAINS National Academy Press, 2101 Constitu- PHENYLALANINE tion Ave. NW., Washington, DC 20418, or may be examined at the Center for The statement shall appear in the la- Food Safety and Applied Nutrition’s beling prominently and conspicuously Library, Food And Drug Administra- as compared to other words, state- tion, 200 C St. SW., Washington, DC, or ments, designs or devices and in bold at the Office of the Federal Register, type and on clear contrasting back- 800 North Capitol St. NW., suite 700, ground in order to render it likely to Washington, DC. be read and understood by the ordinary (c)(1) When aspartame is used as a individual under customary conditions sugar substitute tablet for sweetening of purchase and use. hot beverages, including coffee and tea, (3) When the additive is used in a L-leucine may be used as a lubricant in sugar substitute for table use, its label the manufacture of such tablets at a shall bear instructions not to use in level not to exceed 3.5 percent of the cooking or baking. weight of the tablet. (4) Packages of the dry, free-flowing (2) When aspartame is used in baked additive shall prominently display the goods and baking mixes, the amount of sweetening equivalence in teaspoons of the additive is not to exceed 0.5 percent sugar. by weight of ready-to-bake products or (e) If the food containing the additive of finished formulations prior to bak- purports to be or is represented for spe- ing. Generally recognized as safe cial dietary uses, it shall be labeled in (GRAS) ingredients or food additives compliance with part 105 of this chap- approved for use in baked goods shall ter. be used in combination with aspartame EDITORIAL NOTE: For FEDERAL REGISTER ci- to ensure its functionality as a sweet- tations affecting § 172.804, see the List of CFR

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Sections Affected, which appears in the block copolymer, having a minimum Finding Aids section of the printed volume average molecular weight of 1900 and a and on GPO Access. minimum cloud point of 9 °C–12 °C in 10 percent aqueous solution. § 172.806 Azodicarbonamide. (4) a-Hydro-omega-hydroxy-poly(ox- The food additive azodicarbonamide yethylene) poly (oxypropylene)-(51–57 may be safely used in food in accord- moles) poly(oxyethylene) block copoly- ance with the following prescribed con- mer, having an average molecular ditions: weight of 14,000 and a cloud point above (a) It is used or intended for use: 100 °C in 1 percent aqueous solution. (1) As an aging and bleaching ingre- (b) The additive is used or intended dient in cereal flour in an amount not for use as follows: to exceed 2.05 grams per 100 pounds of (1) The additive identified in para- flour (0.0045 percent; 45 parts per mil- graph (a)(1) of this section is used in lion). practice as a solubilizing and stabi- (2) As a dough conditioner in bread lizing agent in flavor concentrates baking in a total amount not to exceed (containing authorized flavoring oils) 0.0045 percent (45 parts per million) by for use in foods for which standards of weight of the flour used, including any identity established under section 401 quantity of azodicarbonamide added to of the Act do not preclude such use, flour in accordance with paragraph provided that the weight of the addi- (a)(1) of this section. tive does not exceed the weight of the (b) To assure safe use of the additive: flavoring oils in the flavor concentrate. (1) The label and labeling of the addi- (2) The additive identified in para- tive and any intermediate premix pre- graph (a)(2) of this section is used as a pared therefrom shall bear, in addition processing aid and wetting agent in to the other information required by combination with dioctyl sodium sulfo- the Act, the following: succinate for fumaric acid as pre- (i) The name of the additive. scribed in § 172.810. (ii) A statement of the concentration (3) The additive identified in para- or the strength of the additive in any graph (a)(3) of this section is used: intermediate premixes. (i) As a surfactant and defoaming (2) The label or labeling of the food agent, at levels not to exceed 0.05 per- additive shall also bear adequate direc- cent by weight, in scald baths for poul- tions for use. try defeathering, followed by potable § 172.808 Copolymer condensates of water rinse. The temperatures of the ethylene oxide and propylene oxide. scald baths shall be not less than 125 °F. Copolymer condensates of ethylene (ii) As a foam control and rinse adju- oxide and propylene oxide may be safe- vant in hog dehairing machines at a ly used in food under the following pre- use level of not more than 5 grams per scribed conditions: hog. (a) The additive consists of one of the (4) The additive identified in para- following: graph (a)(4) of this section is used as a (1) -Hydro-omega-hydroxy-poly (oxy- a dough conditioner in yeast-leavened ethylene) poly(oxypropylene)-(55–61 bakery products for which standards of moles)poly(oxyethylene) block copoly- identity established under section 401 mer, having a molecular weight range of the Act do not preclude such use, of 9,760–13,200 and a cloud point above provided that the amount of the addi- 100 °C in 1 percent aqueous solution. tive dose not exceed 0.5 percent by (2) a-Hydro-omega-hydroxy-poly (oxyethylene)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- 73

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glucan; CAS Reg. No. 54724–00–4) pro- § 172.810 Dioctyl sodium sulfosuc- duced by pure culture fermentation cinate. from the nonpathogenic and The food additive dioctyl sodium nontoxicogenic bacterium Alcaligenes sulfosuccinate, which meets the speci- faecalis var. myxogenes. fications of the Food Chemicals Codex, (b) Curdlan meets the following spec- 3d Ed. (1981), pp. 102–104, which is incor- ifications when it is tested according porated by reference (copies may be ob- to the methods described or referenced tained from the National Academy in the document entitled ‘‘Analytical Press, 2101 Constitution Ave. NW., Methods for Specification Tests for Washington, DC 20418, or may be exam- Curdlan,’’ by Takeda Chemical Indus- ined at the Office of the Federal Reg- tries, Ltd., 12–10 Nihonbashi, 2–Chome, ister, 800 North Capitol Street, NW., Chuo-ku, Tokyo, 103, Japan, 1996, which suite 700, Washington, DC 20408), may is incorporated by reference in accord- be safely used in food in accordance ance with 5 U.S.C. 552(a) and 1 CFR with the following prescribed condi- part 51. Copies are available from the tions: Division of Petition Control (HFS–215), Center for Food Safety and Applied Nu- (a) As a wetting agent in the fol- trition, Food and Drug Administration, lowing fumaric acid-acidulated foods: 5100 Paint Branch Pkwy., College Park, Dry gelatin dessert, dry beverage base, MD 20740, or may be examined at the and fruit juice drinks, when standards Center for Food Safety and Applied Nu- of identity do not preclude such use. trition’s Library, Food and Drug Ad- The labeling of the dry gelatin dessert ministration, 200 C St. SW., Wash- and dry beverage base shall bear ade- ington, DC, or at the Office of the Fed- quate directions for use, and the addi- eral Register, 800 North Capitol St. tive shall be used in such an amount NW., suite 700, Washington, DC. that the finished gelatin dessert will (1) Positive for curdlan. contain not in excess of 15 parts per million of the additive and the finished (2) Assay for curdlan (calculated as beverage or fruit juice drink will con- anhydrous glucose), not less than 80 tain not in excess of 10 parts per mil- percent. lion of the additive. (3) pH of 1 percent aqueous suspension, 6.0–7.5. (b) As a processing aid in sugar fac- tories in the production of unrefined (4) Lead, not more than 0.5 mg/kg. cane sugar, in an amount not in excess (5) Heavy metals (as Pb), not more of 0.5 part per million of the additive than 0.002 percent. per percentage point of sucrose in the (6) Total nitrogen, not more than 0.2 juice, syrup, or massecuite being proc- percent. essed, and so used that the final molas- (7) Loss on drying, not more than 10 ses will contain no more than 25 parts percent. per million of the additive. (8) Residue on ignition, not more (c) As a solubilizing agent on gums than 6 percent. and hydrophilic colloids to be used in (9) Gel strength of 2 percent aqueous food as stabilizing and thickening 3 suspension, not less than 600x10 dyne agents, when standards of identity do per square centimeter. not preclude such use. The additive is (10) Aerobic plate count, not more used in an amount not to exceed 0.5 3 than 10 per gram. percent by weight of the gums or hy- (11) Coliform bacteria, not more than drophilic colloids. 3 per gram. (d) As an emulsifying agent for cocoa (c) Curdlan is used or intended for fat in noncarbonated beverages con- use in accordance with good manufac- taining cocoa, whereby the amount of turing practice as a formulation aid, the additive does not exceed 25 parts processing aid, stabilizer and thick- per million of the finished beverage. ener, and texturizer in foods for which (e) As a dispersing agent in ‘‘cocoa standards of identity established under with dioctyl sodium sulfosuccinate for section 401 of the act do not preclude manufacturing’’ that conforms to the such use. provisions of § 163.117 of this chapter [61 FR 65941, Dec. 16, 1996] and the use limitations prescribed in

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§ 172.520, in an amount not to exceed 0.4 Uses Limitations percent by weight thereof. 2. As a formulation aid as de- Not to exceed 0.5 percent. (f) As a processing aid and wetting fined in § 170.3(o)(14) of this agent in combination with a-hydro- chapter, lubricant and release omega -hydroxy - poly(oxyethylene) - agent as defined in § 170.3(o)(18) of this chapter, poly-(oxypropylene) (53–59 moles) and surface-finishing agent as poly(oxyethylene) (14–16 moles) block defined in § 170.3(o)(30) of copolymer, having a molecular weight this chapter in food . 3. As a formulation aid as de- Not to exceed 3.0 percent range of 3,500–4,125 and a cloud point of fined in § 170.3(o)(14) of this of the combined weight 9 °C–12 °C in 10 percent aqueous solu- chapter in confections . of the formulation. tion, for fumaric acid used in fumaric 4. As a formulation aid as de- Not to exceed 1.0 percent fined in § 170.3(o)(14) of this of the combined weight acid-acidulated dry beverage base and chapter in fats and oils as de- of the formulation. in fumaric acid-acidulated fruit juice fined in § 170.3 (n)(12) of this drinks, when standards of identity do chapter . 5. As a winterization and frac- Not to exceed 0.5 percent not preclude such use. The labeling of tionation aid in fat and oil by weight of the proc- the dry beverage base shall bear ade- processing . essed fat or oil. quate directions for use, and the additives shall be used in such an amount (d) To assure safe use of the additive: that the finished beverage or fruit juice (1) In addition to the other informa- drink will contain not in excess of a tion required by the act, the label or total of 10 parts per million of the labeling of the additive shall bear the dioctyl sodium sulfosuccinate-block name of the additive. copolymer combination. (2) The label of the additive shall bear adequate directions to provide a [42 FR 14491, Mar. 15, 1977, as amended at 49 final product that complies with the FR 10105, Mar. 19, 1984] limitations prescribed in paragraph (c) § 172.811 Glyceryl tristearate. of this section. The food additive glyceryl tristearate [53 FR 21632, June 9, 1988, as amended at 59 may be safely used in food in accord- FR 24924, May 13, 1994] ance with the following prescribed con- § 172.812 Glycine. ditions: (a) The food additive (CAS Reg. No. The food additive glycine may be 555–43–1) is prepared by reacting stearic safely used for technological purposes acid with glycerol in the presence of a in food in accordance with the fol- suitable catalyst. lowing prescribed conditions: (b) The food additive meets the fol- (a) The additive complies with the lowing specifications: specifications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), p. 140, which is in- Acid number: Not to exceed 1.0. corporated by reference. Copies may be Iodine number: Not to exceed 1.0. obtained from the National Academy Saponification number: 186–192. Press, 2101 Constitution Ave. NW., Hydroxyl number: Not to exceed 5.0. Washington, DC 20418, or may be exam- Free glycerol content: Not to exceed 0.5 per- ined at the Office of the Federal Reg- cent. ister, 800 North Capitol Street, NW., Unsaponifiable matter: Not to exceed 0.5 per- suite 700, Washington, DC 20408. cent. (b) The additive is used or intended ° ° Melting point (Class II): 69 C–73 C. for use as follows: (c) The additive is used or intended for use as follows when standards of Uses Limitations identity established under section 401 As a masking agent for the Not to exceed 0.2 percent in of the Act do not preclude such use: bitter aftertaste of sac- the finished beverage. charin used in manufactured beverages and bev- Uses Limitations erage bases . 1. As a crystallization accel- Not to exceed 1 percent of As a stabilizer in mono- and Not to exceed 0.02 percent of erator in cocoa products, in the combined weight of diglycerides prepared by the mono- and imitation chocolate, and in the formulation. the glycerolysis of edible diglycerides. compound coatings . fats or oils .

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(c) To assure safe use of the additive, (b) It is used or intended for use as in addition to the other information re- follows: quired by the Act: (1) As an aid in crystallization of su- (1) The labeling of the additive shall crose and dextrose at a level not to ex- bear adequate directions for use of the ceed the minimum quantity required to additive in compliance with the provi- produce its intended effect. sions of this section. (2) As a surfactant in molasses at a (2) The labeling of beverage bases level not to exceed 320 parts per million containing the additive shall bear ade- in the molasses. quate directions for use to provide that beverages prepared therefrom shall § 172.818 Oxystearin. contain no more than 0.2 percent gly- The food additive oxystearin may be cine. safely used in foods, when such use is not precluded by standards of identity [42 FR 14491, Mar. 15, 1977, as amended at 49 in accordance with the following condi- FR 10105, Mar. 19, 1984] tions: (a) The additive is a mixture of the § 172.814 Hydroxylated lecithin. glycerides of partially oxidized stearic The food additive hydroxylated and other fatty acids obtained by heat- lecithin may be safely used as an emul- ing hydrogenated cottonseed or soy- sifier in foods in accordance with the bean oil under controlled conditions, in following conditions: the presence of air and a suitable cata- (a) The additive is obtained by the lyst which is not a food additive as so treatment of lecithin in one of the fol- defined. The resultant product meets lowing ways, under controlled condi- the following specifications: tions whereby the separated fatty acid Acid number: Maximum 15. fraction of the resultant product has Iodine number: Maximum 15. an acetyl value of 30 to 38: Saponification number: 225–240. (1) With hydrogen peroxide, benzoyl Hydroxyl number: 30–45. peroxide, lactic acid, and sodium hy- Unsaponifiable material: Maximum 0.8 per- droxide. cent. ± ° (2) With hydrogen peroxide, acetic Refractive index (butyro): 60 1 at 48 C. acid, and sodium hydroxide. (b) It is used or intended for use as a (b) It is used or intended for use, in crystallization inhibitor in vegetable accordance with good manufacturing oils and as a release agent in vegetable practice, as an emulsifier in foods, ex- oils and vegetable shortenings, where- cept for those standardized foods that by the additive does not exceed 0.125 do not provide for such use. percent of the combined weight of the (c) To assure safe use of the additive, oil or shortening. the label of the food additive container (c) To insure safe use of the additive, shall bear, in addition to the other in- the label and labeling of the additive formation required by the Act: container shall bear, in addition to the (1) The name of the additive, other information required by the Act: ‘‘hydroxylated lecithin’’. (1) The name of the additive. (2) Adequate directions for its use. (2) Adequate directions to provide an oil or shortening that complies with § 172.816 Methyl glucoside-coconut oil the limitations prescribed in paragraph ester. (b) of this section. Methyl glucoside-coconut oil ester § 172.820 Polyethylene glycol (mean may be safely used in food in accord- molecular weight 200–9,500). ance with the following conditions: Polyethylene glycol identified in this (a) It is the methyl glucoside-coconut section may be safely used in food in oil ester having the following specifica- accordance with the following pre- tions: scribed conditions: Acid number: 10–20 (a) Identity. (1) The additive is an ad- Hydroxyl number: 200–300 dition polymer of ethylene oxide and pH (5% aqueous): 4.8–5.0 water with a mean molecular weight of Saponification number: 178–190 200 to 9,500.

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(2) It contains no more than 0.2 per- 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 milliliter (for example 10 milligrams diluted to graph (b) of this section. volume in a 10-milliliter volumetric flask is (b) Analytical method. (1) The analyt- equivalent to 1 milligram per milliliter). ical method prescribed in the National Formulary XV (1980), page 1244, for pol- STANDARDIZATION yethylene glycol 400 shall be used to Inject a 2-microliter aliquot of the glycol determine the total ethylene and standard into the gas chromatograph em- diethylene glycol content of poly- ploying the conditions described above. ethylene glycols having mean molec- Measure the net peak heights for the ethyl- ular weights of 450 or higher. ene glycol and for the diethylene glycol. (2) The following analytical method Record the values as follows: shall be used to determine the total A=Peak height in millimeters of the ethyl- ethylene and diethylene glycol content ene glycol peak. B=milligrams of ethylene glycol per milli- of polyethylene glycols having mean liter of standard solution. molecular weights below 450. 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 × sam- liters per minute. ple 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. Syringe: 10-microliter (Hamilton 710 N or for food. 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. SX850, or equivalent) 12 percent in H2O by (3) As an adjuvant in dispersing vita- weight on 60–80 mesh nonacid washed diato- min and/or mineral preparations. maceous earth (Chromosorb W. Johns-Man- (4) As a coating on sodium nitrite to ville, or equivalent). inhibit hygroscopic properties. REAGENTS AND MATERIALS (d) Limitations. (1) It is used in an Carrier gas, nitrogen: Commercial grade in amount not greater than that required cylinder equipped with reducing regulator to to produce the intended physical or provide 50 p.s.i.g. to the gas chromatograph. technical effect. Ethylene glycol: Commercial grade. Purify (2) A tolerance of zero is established if necessary, by distillation. for residues of polyethylene glycol in Diethylene glycol: Commercial grade. Pu- milk. rify, if necessary, by distillation. Glycol standards: Prepare [42 FR 14491, Mar. 15, 1977, as amended at 49 chromatographic standards by dissolving FR 10105, Mar. 19, 1984]

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§ 172.822 Sodium lauryl sulfate. limitations prescribed in paragraph (b) of this section. The food additive sodium lauryl sulfate may be safely used in food in ac- [42 FR 14491, Mar. 15, 1977, as amended at 43 cordance with the following conditions: FR 18668, May 2, 1978] (a) The additive meets the following § 172.824 Sodium mono- and dimethyl specifications: naphthalene sulfonates. (1) It is a mixture of sodium alkyl sulfates consisting chiefly of sodium The food additive sodium mono- and lauryl sulfate [CH (CH ) CH OSO Na]. dimethyl naphthalene sulfonates may 2 2 10 2 2 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 or intended for use in potable water (2) As a whipping agent at a level not systems to reduce hardness and aid in to exceed 0.5 percent by weight of gela- sedimentation and coagulation by rais- tine used in the preparation of marsh- ing the pH for the efficient utilization mallows. of other coagulation materials. (3) As a surfactant in: (2) As an anticaking agent in sodium (i) Fumaric acid-acidulated dry bev- nitrite at a level not in excess of 0.1 erage base whereby the additive does percent by weight thereof for author- not exceed 25 parts per million of the ized uses in cured fish and meat. finished beverage and such beverage (c) In addition to the general labeling base is not for use in a food for which requirements of the Act: a standard of identity established (1) Sodium carbonate produced in ac- under section 401 of the Act precludes cordance with paragraph (b)(1) of this such use. section shall be labeled to show the (ii) Fumaric acid-acidulated fruit presence of the additive and its label or juice drinks whereby the additive does labeling shall bear adequate directions not exceed 25 parts per million of the for use. finished fruit juice drink and it is not (2) Sodium nitrite produced in ac- used in a fruit juice drink for which a cordance with paragraph (b)(2) of this standard of identity established under section shall bear the labeling required section 401 of the Act precludes such by § 172.175 and a statement declaring use. the presence of sodium mono- and di- (4) As a wetting agent at a level not methyl naphthalene sulfonates. to exceed 10 parts per million in the [42 FR 14491, Mar. 15, 1977, as amended at 63 partition of high and low melting frac- FR 7069, Feb. 12, 1998] tions of crude vegetable oils and animal fats, provided that the partition § 172.826 Sodium stearyl fumarate. step is followed by a conventional re- Sodium stearyl fumarate may be fining process that includes alkali neu- safely used in food in accordance with tralization and deodorization of the the following conditions: fats and oils. (a) It contains not less than 99 per- (c) To insure the safe use of the addi- cent sodium stearyl fumarate cal- tive, the label of the food additive con- culated on the anhydrous basis, and tainer shall bear, in addition to the not more than 0.25 percent sodium ste- other information required by the Act: aryl maleate. (1) The name of the additive, sodium (b) The additive is used or intended lauryl sulfate. for use: (2) Adequate use directions to provide (1) As a dough conditioner in yeast- a final product that complies with the leavened bakery products in an amount

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not to exceed 0.5 percent by weight of succinylation of a product obtained by the flour used. the glycerolysis of edible fats and oils, (2) As a conditioning agent in dehy- or by the direct esterification of glyc- drated potatoes in an amount not to erol with edible fat-forming fatty exceed 1 percent by weight thereof. acids. (3) As a stabilizing agent in (b) The additive meets the following nonyeast-leavened bakery products in specifications: an amount not to exceed 1 percent by weight of the flour used. Succinic acid content: 14.8%–25.6% (4) As a conditioning agent in proc- Melting point: 50 °C–60 °C. essed cereals for cooking in an amount Acid number: 70–120 not to exceed 1 percent by weight of (c) The additive is used or intended the dry cereal, except for foods for for use in the following foods: which standards of identity preclude (1) As an emulsifier in liquid and such use. plastic shortenings at a level not to ex- (5) As a conditioning agent in starch- ceed 3 percent by weight of the short- thickened or flour-thickened foods in ening. an amount not to exceed 0.2 percent by (2) As a dough conditioner in bread weight of the food. baking, when such use is permitted by § 172.828 Acetylated monoglycerides. an appropriate food standard, at a level not to exceed 0.5 percent by weight of The food additive acetylated the flour used. monoglycerides may be safely used in or on food in accordance with the fol- § 172.831 Sucralose. lowing prescribed conditions: (a) The additive is manufactured by: (a) Sucralose is the chemical 1,6- β (1) The interesterification of edible dichloro-1,6-dideoxy- -D- α fats with triacetin and in the presence fructofuranosyl-4-chloro-4-deoxy- -D- of catalytic agents that are not food galactopyranoside (CAS Reg. No. 56038– additives or are authorized by regula- 13–2). tion, followed by a molecular distilla- (b) The additive meets the specification or by steam stripping; or tions of the ‘‘Food Chemicals Codex,’’ (2) The direct acetylation of edible 4th ed. (1996), pp. 398–400, which is in- monoglycerides with acetic anhydride corporated by reference in accordance without the use of catalyst or molec- with 5 U.S.C. 552(a) and 1 CFR part 51. ular distillation, and with the removal Copies are available from the the Divi- by vacuum distillation, if necessary, of sion of Product Policy (HFS–206), Cen- the acetic acid, acetic anhydride, and ter for Food Safety and Applied Nutri- triacetin. tion, Food and Drug Administration, (b) The food additive has a Reichert- 5100 Paint Branch Pkwy., College Park, Meissl value of 75–200 and an acid value MD 20740, or may be examined at the of less than 6. Center for Food Safety and Applied Nu- (c) The food additive is used at a trition’s Library, 200 C St. SW., Wash- level not in excess of the amount rea- ington, DC 20204–0001, or the Office of sonably required to produce its in- the Federal Register, 800 North Capitol tended effect in food, or in food-proc- St. NW., suite 700, Washington, DC. essing, food-packing, or food-storage (c) The additive may be used as a equipment. sweetener in foods generally, in accordance with current good manufacturing [42 FR 14491, Mar. 15, 1977, as amended at 50 practice in an amount not to exceed FR 3508, Jan. 25, 1985] that reasonably required to accomplish § 172.830 Succinylated monoglycerides. the intended effect. The food additive succinylated (d) If the food containing the additive monoglycerides may be safely used in purports to be or is represented to be food in accordance with the following for special dietary use, it shall be la- prescribed conditions: beled in compliance with part 105 of (a) The additive is a mixture of semi- this chapter. and neutral succinic acid esters of [63 FR 16433, Apr. 3, 1998, as amended at 64 mono- and diglycerides produced by the FR 43909, Aug. 12, 1999]

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§ 172.832 Monoglyceride citrate. Specifications, Addendum 4, Food and A food additive that is a mixture of Agriculture Organization of the United glyceryl monooleate and its citric acid Nations (FAO), Food and Nutrition monoester manufactured by the reac- Paper 5, Revision 2’’ (1991), pp. 203 and tion of glyceryl monooleate with citric 204, which is incorporated by reference, acid under controlled conditions may in accordance with 5 U.S.C. 552(a) and 1 be safely used as a synergist and solu- CFR part 51. Copies are available from bilizer for antioxidants in oils and fats, the Office of Premarket Approval, Cen- when used in accordance with the con- ter for Food Safety and Applied Nutri- ditions prescribed in this section. tion (HFS–200), Food and Drug Admin- (a) The food additive meets the fol- istration, 5100 Paint Branch Pkwy., lowing specifications: College Park, MD 20740, or may be examined at the Center for Food Safety Acid number, 70–100. and Applied Nutrition’s Library, 200 C Total citric acid (free and combined), 14 per- St. SW., Washington, DC, or at the Of- cent–17 percent. fice of the Federal Register, 800 North (b) It is used, or intended for use, in Capitol St. NW., suite 700, Washington, antioxidant formulations for addition DC. to oils and fats whereby the additive (3) Acid value: Not to exceed 0.20 de- does not exceed 200 parts per million of termined using 50 grams of sample by the combined weight of the oil or fat the ‘‘Guide to Specifications for Gen- and the additive. eral Notices, General Analytical Tech- (c) To assure safe use of the additive: niques, Identification Tests, Test Solu- (1) The container label shall bear, in tions, and Other Reference Materials,’’ addition to the other information re- in the ‘‘Compendium of Food Additive quired by the Act, the name of the ad- Specifications, Addendum 4, FAO Food ditive. and Nutrition Paper 5, Revision 2,’’ p. (2) The label or accompanying label- 189 (1991), which is incorporated by ref- ing shall bear adequate directions for erence; see paragraph (b)(2) of this sec- the use of the additive which, if fol- tion for availability of the incorpora- lowed, will result in a food that com- tion by reference. plies with the requirements of this sec- (4) Lead: Not to exceed 1.0 milli- tion. grams/kilogram determined by the ‘‘Atomic Absorption § 172.833 Sucrose acetate isobutyrate Spectrophotometric Graphite Furnace (SAIB). Method, Method I,’’ in the ‘‘Food Sucrose acetate isobutyrate may be Chemicals Codex,’’ 4th ed. (1996), pp. 763 safely used in foods in accordance with and 764, with an attached modification the following prescribed conditions: to the sample digestion section in Ap- (a) Sucrose acetate isobutyrate (CAS pendix III.B (July 1996), which is incor- Reg. No. 27216–37–1), or SAIB, is the porated by reference. Copies are avail- chemical alpha-D-glucopyranoside, O- able from the National Academy Press, acetyl-tris-O-(2-methyl-1-oxopropyl)- 2101 Constitution Ave. NW., Box 285, beta-D-fructofuranosyl, acetate tris(2- Washington, DC 20055 (Internet ‘‘http:// methyl propanoate). www.nap.edu’’), or may be examined at (b) SAIB, a pale, straw-colored liquid, the Center for Food Safety and Applied meets the following specifications: (1) Nutrition’s Library, 200 C St. SW., Assay: Not less than 98.8 percent and Washington, DC, or at the Office of the not more than 101.9 percent, based on Federal Register, 800 North Capitol St. the following formula: NW., suite 700, Washington, DC. Assay = ((SV 0.10586) ÷ 56.1) x 100 (5) Triacetin: Not to exceed 0.10 per- Where SV = Saponification value cent determined by gas chroma- (2) Saponification value: 524–540 de- tography as described in the ‘‘Guide to termined using 1 gram of sample by the Specifications for General Notices, ‘‘Guide to Specifications for General General Analytical Techniques, Identi- Notices, General Analytical Tech- fication Tests, Test Solutions, and niques, Identification Tests, Test Solu- Other Reference Materials,’’ in the tions, and Other Reference Materials,’’ ‘‘Compendium of Food Additive Speci- in the ‘‘Compendium of Food Additive fications, Addendum 4, FAO Food and

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Nutrition Paper 5, Revision 2,’’ (1991), Use Limitations pp. 13–26, which is incorporated by ref- 3. As an emulsifier in Not to exceed 0.45 percent erence; see paragraph (b)(2) of this sec- whipped vegetable oil top- by weight of the finished tion for availability of the incorpora- pings and topping mixes . whipped vegetable oil top- tion by reference. pings. 4. As an emulsifier in icings Not to exceed 0.5 percent by (c) The food additive is used as a sta- and icing mixes . weight of the finished bilizer (as defined in § 170.3(o)(28) of this icings. chapter) of emulsions of flavoring oils 5. As an emulsifier in frozen Not to exceed 0.2 percent by in nonalcoholic beverages. desserts . weight of the finished frozen desserts. (d) The total SAIB content of a bev- 6. As an emulsifier in edible Not to exceed 0.4 percent by erage containing the additive does not vegetable fat-water emul- weight of the finished vege- exceed 300 milligrams/kilogram of the sions intended for use as table fat-water emulsions. substitutes for milk or finished beverage. cream in beverage coffee . [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999] (d) When the name ‘‘polyglycerate 60’’ is used in labeling it shall be fol- § 172.834 Ethoxylated mono- and lowed by either ‘‘polyoxyethylene (20) diglycerides. mono-and diglycerides of fatty acids’’ The food additive ethoxylated mono- or ‘‘ethoxylated mono- and and diglycerides (polyoxyethylene (20) diglycerides’’ in parentheses. mono- and diglycerides of fatty acids) [42 FR 14491, Mar. 15, 1977, as amended at 42 (polyglycerate 60) may be safely used FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, in food in accordance with the fol- 1985] lowing prescribed conditions: (a) The food additive is manufactured § 172.836 Polysorbate 60. by: The food additive polysorbate 60 (1) Glycerolysis of edible fats pri- (polyoxyethylene (20) sorbitan mono- marily composed of stearic, palmitic, stearate) which is a mixture of and myristic acids; or polyoxyethylene ethers of mixed par- (2) Direct esterification of glycerol tial stearic and palmitic acid esters of with a mixture of primarily stearic, sorbitol anhydrides and related com- palmitic, and myristic acids; pounds, may be safely used in food in accordance with the following pre- to yield a product with less than 0.3 scribed conditions: acid number and less than 0.2 percent (a) The food additive is manufactured water, which is then reacted with by reacting stearic acid (usually con- ethylene oxide. taining associated fatty acids, chiefly (b) The additive meets the following palmitic) with sorbitol to yield a prod- specifications: uct with a maximum acid number of 10 Saponification number, 65–75. and a maximum water content of 0.2 Acid number, 0–2. percent, which is then reacted with Hydroxyl number, 65–80. ethylene oxide. Oxyethylene content, 60.5–65.0 percent. (b) The food additive meets the following specifications: (c) The additive is used or intended for use in the following foods when Saponification number 45–55. standards of identity established under Acid number 0–2. section 401 of the Act do not preclude Hydroxyl number 81–96. such use: Oxyethylene content 65 percent–69.5 percent.

Use Limitations (c) It is used or intended for use as follows: 1. As an emulsifier in pan-re- Not to exceed levels required (1) As an emulsifier in whipped edible lease agents for and as a to produce the intended ef- dough conditioner in yeast- fects, total not to exceed oil topping with or without one or a leavened bakery products . 0.5 percent by weight of combination of the following: the flour used. (i) Sorbitan monostearate; 2. As an emulsifier in cakes Not to exceed 0.5 percent by and cake mixes . weight of the dry ingredi- (ii) Polysorbate 65; ents. (iii) Polysorbate 80;

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whereby the maximum amount of the When used alone, the maximum additive or additives used does not ex- amount of polysorbate 60 shall not exceed 0.4 percent of the weight of the ceed 0.46 percent of the weight of the finished whipped edible oil topping; ex- cake icings and cake fillings. When cept that a combination of the additive used with polysorbate 65 and/or sorbi- with sorbitan monostearate may be tan monostearate, it shall not exceed used in excess of 0.4 percent, provided 0.46 percent, nor shall the polysorbate that the amount of the additive does 65 exceed 0.32 percent or the sorbitan not exceed 0.77 percent and the amount monostearate exceed 0.7 percent, and of sorbitan monostearate does not ex- no combination of these emulsifiers ceed 0.27 percent of the weight of the shall exceed 1 percent of the weight of finished whipped edible oil topping. the cake icing or cake filling. (2) As an emulsifier in cakes and cake (6) To impart greater opacity to mixes, with or without one or a com- sugar-type confection coatings where- bination of the following: by the maximum amount of the addi- (i) Polysorbate 65. tive does not exceed 0.2 percent of the (ii) Sorbitan monostearate. weight of the finished sugar coating. (7) As an emulsifier in nonstandard- When used alone, the maximum ized dressings whereby the maximum amount of polysorbate 60 shall not ex- amount of the additive does not exceed ceed 0.46 percent of the cake or cake 0.3 percent of the weight of the finished mix, on a dry-weight basis. When used dressings. with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 0.46 (8) As an emulsifier, alone or in com- percent, nor shall the polysorbate 65 bination with polysorbate 80, in exceed 0.32 percent or the sorbitan shortenings and edible oils intended for monostearate exceed 0.61 percent, and use in foods as follows, when standards no combination of these emulsifiers of identity established under section shall exceed 0.66 percent of the cake or 401 of the act do not preclude such use: cake mix, all calculated on a dry- (i) It is used alone in an amount not weight basis. to exceed 1 percent of the weight of the (3) As an emulsifier, alone or in com- finished shortening or oil. bination with sorbitan monostearate, (ii) It is used with polysorbate 80 in in nonstandardized confectionery coat- any combination providing no more ings and standardized cacao products than 1 percent of polysorbate 60 and no specified in §§ 163.123, 163.130, 163.135, more than 1 percent of polysorbate 80, 163.140, 163.145, and 163.150 of this chap- provided that the total combination ter, as follows: does not exceed 1 percent of the fin- (i) It is used alone in an amount not ished shortening or oil. to exceed 0.5 percent of the weight of (iii) The 1–percent limitation speci- the finished nonstandardized confec- fied in paragraph (c)(8) (i) and (ii) of tionery coating or standardized cacao this section may be exceeded in premix product. concentrates of shortening or edible oil (ii) It is used with sorbitan mono- if the labeling complies with the re- stearate in any combination of up to quirements of paragraph (d) of this sec- 0.5 percent of polysorbate 60 and up to tion. 1 percent of sorbitan monostearate: (9) As an emulsifier in solid-state, ed- Provided, That the total combination ible vegetable fat-water emulsions in- does not exceed 1 percent of the weight tended for use as substitutes for milk of the finished nonstandardized confec- or cream in beverage coffee, with or tionery coating or standardized cacao without one or a combination of the product. following: (4) [Reserved] (i) Polysorbate 65. (5) As an emulsifier in cake icings (ii) Sorbitan monostearate. and cake fillings, with or without one The maximum amount of the additive or a combination of the following: or additives shall not exceed 0.4 per- (i) Polysorbate 65. cent by weight of the finished edible (ii) Sorbitan monostearate. vegetable fat-water emulsion.

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(10) As a foaming agent in non- (1) The label of the additive and any alcoholic mixes, to be added to alco- intermediate premixes shall bear: holic beverages in the preparation of (i) The name of the additive. mixed alcoholic drinks, at a level not (ii) A statement of the concentration to exceed 4.5 percent by weight of the or strength of the additive in any in- nonalcoholic mix. termediate premixes. (11) As a dough conditioner in yeast- (2) The label or labeling shall bear leavened bakery products in an amount adequate directions to provide a final not to exceed 0.5 percent by weight of product that complies with the limita- the flour used. tions prescribed in paragraph (c) of this (12) As an emulsifier, alone or in section. combination with sorbitan monostea- [42 FR 14491, Mar. 15, 1977, as amended at 43 rate, in the minimum quantity re- FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, quired to accomplish the intended ef- 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, fect, in formulations of white mineral Oct. 28, 1999] oil conforming with § 172.878 and/or petroleum wax conforming with § 172.886 § 172.838 Polysorbate 65. for use as protective coatings on raw The food additive polysorbate 65 fruits and vegetables. (polyoxyethylene (20) sorbitan (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 mixes in an amount not to exceed 0.5 Saponification number 88–98. 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 exceed 3.6 percent by weight of the mix. (c) The additive is used, or intended (iv) In sugar-based pudding mixes in for use, as follows: an amount not to exceed 0.5 percent by (1) As an emulsifier in ice cream, fro- weight of the mix. zen custard, ice milk, fruit sherbet and (v) In artificially sweetened pudding nonstandardized frozen desserts when mixes in an amount not to exceed 0.5 used alone or in combination with percent by weight of the mix. polysorbate 80, whereby the maximum (16) As an emulsifier in ice cream, amount of the additives, alone or in frozen custard, fruit sherbet, and non- combination, does not exceed 0.1 per- standardized frozen desserts when used cent of the finished frozen dessert. alone or in combination with poly- (2) As an emulsifier in cakes and cake sorbate 65 and/or polysorbate 80, where- mixes, with or without one or a com- by the maximum amount of the addi- bination of the following: tives, alone or in combination, does not (i) Sorbitan monostearate. exceed 0.1 percent of the finished frozen (ii) Polysorbate 60. dessert. When used alone, the maximum (d) To assure safe use of the additive, amount of polysorbate 65 shall not ex- in addition to the other information re- ceed 0.32 percent of the cake or cake quired by the Act: mix, on a dry-weight basis. When used

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with sorbitan monostearate and/or (2) The label or labeling shall bear polysorbate 60, it shall not exceed 0.32 adequate directions to provide a final percent, nor shall the sorbitan mono- product that complies with the limita- stearate exceed 0.61 percent or the tions prescribed in paragraph (c) of this polysorbate 60 exceed 0.46 percent, and section. no combination of these emulsifiers [42 FR 14491, Mar. 15, 1977, as amended at 43 shall exceed 0.66 percent of the cake or FR 2871, Jan. 20, 1978] cake mix, all calculated on a dry- weight basis. § 172.840 Polysorbate 80. (3) As an emulsifier in whipped edible The food additive polysorbate 80 oil topping with or without one or a (polyoxyethylene (20) sorbitan combination of the following: monooleate), which is a mixture of (i) Sorbitan monostearate; polyoxyethylene ethers of mixed par- (ii) Polysorbate 60; tial oleic acid esters of sorbitol anhy- (iii) Polysorbate 80; drides and related compounds, may be whereby the maximum amount of the safely used in food in accordance with additive or additives used does not ex- the following prescribed conditions: ceed 0.4 percent of the weight of the (a) The food additive is manufactured finished whipped edible oil topping. by reacting oleic acid (usually con- (4) As an emulsifier in solid-state, ed- taining associated fatty acids) with ible vegetable fat-water emulsions in- sorbitol to yield a product with a max- tended for use as substitutes for milk imum acid number of 7.5 and a max- or cream in beverage coffee, with or imum water content of 0.5 percent, without one or a combination of the which is then reacted with ethylene following: oxide. (i) Sorbitan monostearate. (b) The food additive meets the fol- (ii) Polysorbate 60. lowing specifications: The maximum amount of the additive Saponification number 45–55. 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. (5) As an emulsifier in cake icings (c) The additive is used or intended and cake fillings, with or without one for use as follows: or a combination of the following: (1) An emulsifier in ice cream, frozen (i) Sorbitan monostearate. custard, ice milk, fruit sherbet, and (ii) Polysorbate 60. nonstandardized frozen desserts, when used alone or in combination with When used alone, the maximum polysorbate 65 whereby the maximum amount of polysorbate 65 shall not ex- amount of the additives, alone or in ceed 0.32 percent of the weight of the combination, does not exceed 0.1 per- cake icing or cake filling. When used cent of the finished frozen dessert. with sorbitan monostearate and/or (2) In yeast-defoamer formulations polysorbate 60, it shall not exceed 0.32 whereby the maximum amount of the percent, nor shall the sorbitan mono- additive does not exceed 4 percent of stearate exceed 0.7 percent or the poly- the finished yeast defoamer and the sorbate 60 exceed 0.46 percent, and no maximum amount of the additive in combination of these emulsifiers shall the yeast from such use does not ex- exceed 1 percent of the weight of the ceed 4 parts per million. cake icing or cake filling. (3) As a solubilizing and dispersing (d) To assure safe use of the additive, agent in pickles and pickle products, in addition to the other information re- whereby the maximum amount of the quired by the Act: additive does not exceed 500 parts per (1) The label of the additive and any million. intermediate premixes shall bear: (4) As a solubilizing and dispersing (i) The name of the additive. agent in: (ii) A statement of the concentration (i) Vitamin-mineral preparations or strength of the additive in any in- containing calcium caseinate in the ab- termediate premixes. sence of fat-soluble vitamins, whereby

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the maximum intake of polysorbate 80 (i) Sorbitan monostearate; shall not exceed 175 milligrams from (ii) Polysorbate 60; the recommended daily dose of the (iii) Polysorbate 65; preparations. whereby the maximum amount of the (ii) Fat-soluble vitamins in vitamin additive or additives used does not ex- and vitamin-mineral preparations con- ceed 0.4 percent of the weight of the taining no calcium caseinate, whereby finished whipped edible oil topping. the maximum intake of polysorbate 80 (10) It is used as a wetting agent in shall not exceed 300 milligrams from scald water for poultry defeathering, the recommended daily dose of the followed by potable water rinse. The preparations. concentration of the additive in the (iii) In vitamin-mineral preparations scald water does not exceed 0.0175 per- containing both calcium caseinate and cent. fat-soluble vitamins, whereby the max- (11) As a dispersing agent in gelatin imum intake of polysorbate 80 shall desserts and in gelatin dessert mixes, not exceed 475 milligrams from the rec- whereby the amount of the additive ommended daily dose of the prepara- does not exceed 0.082 percent on a dry- tions. weight basis. (5) As a surfactant in the production (12) As an adjuvant added to herbi- of coarse crystal sodium chloride cide use and plant-growth regulator whereby the maximum amount of the use dilutions by a grower or applicator 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]

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§ 172.841 Polydextrose. (13) Tablespreads. Polydextrose as identified in this sec- (d) If the food containing the additive tion may be safely used in food in ac- purports to be or is represented for spe- cordance with the following prescribed cial dietary uses, it shall be labeled in conditions: compliance with part 105 of this chap- (a)(1) Polydextrose (CAS Reg. No. ter. 68424–04–4) is a partially metabolizable (e) The label and labeling of food a water-soluble polymer prepared by the single serving of which would be ex- condensation of a melt which consists pected to exceed 15 grams of the addi- either of approximately 89 percent D- tive shall bear the statement: ‘‘Sen- glucose, 10 percent sorbitol, and 1 per- sitive individuals may experience a cent citric acid or of approximately 90 laxative effect from excessive con- percent D-glucose, 10 percent sorbitol, sumption of this product’’. and 0.1 percent phosphoric acid, on a [46 FR 30081, June 5, 1981, as amended at 59 weight basis. FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, (2) Polydextrose may be partially 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, neutralized with potassium hydroxide, June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR or partially reduced by transition 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000] metal catalytic hydrogenation in aqueous solution. § 172.842 Sorbitan monostearate. (b) The additive meets the specifica- The food additive sorbitan monostea- tions of the ‘‘Food Chemicals Codex,’’ rate, which is a mixture of partial ste- 4th ed. (1996), pp. 297–300, which is in- aric and palmitic acid esters of sorbitol corporated by reference in accordance anhydrides, may be safely used in or on with 5 U.S.C. 552(a) and 1 CFR part 51. food in accordance with the following Copies are available from the National prescribed conditions: Academy Press, 2101 Constitution Ave. (a) The food additive is manufactured NW., Washington, DC 20418, or may be by reacting stearic acid (usually con- examined at the Center for Food Safety taining associated fatty acids, chiefly and Applied Nutrition’s Library, Food palmitic) with sorbitol to yield essen- and Drug Administration, 200 C St. tially a mixture of esters. SW., Washington, DC, or at the Office (b) The food additive meets the fol- of the Federal Register, 800 North Cap- lowing specifications: itol St. NW., suite 700, Washington, DC. (c) Polydextrose is used in accord- Saponification number, 147–157 ance with current good manufacturing Acid number, 5–10 practices as a bulking agent, formula- Hydroxyl number, 235–260 tion aid, humectant, and texturizer in (c) It is used or intended for use, the following foods when standards of alone or in combination with poly- identity established under section 401 sorbate 60 as follows: of the act do not preclude such use: (1) As an emulsifier in whipped edible (1) Baked goods and baking mixes (re- oil topping with or without one or a stricted to fruit, custard, and pudding- combination of the following: filled pies, cakes, cookies, and similar (i) Polysorbate 60; baked products); (ii) Polysorbate 65; (2) Chewing gum; (iii) Polysorbate 80; (3) Confections and frostings; (4) Dressings for salads; whereby the maximum amount of the (5) Film coatings on single and mul- additive or additives used does not ex- tiple vitamin and mineral supplement ceed 0.4 percent of the weight of the tablets; finished whipped edible oil topping; ex- (6) Frozen dairy desserts and mixes; cept that a combination of the additive (7) Fruit and water ices; with polysorbate 60 may be used in ex- (8) Fruit spreads; cess of 0.4 percent: Provided, That the (9) Gelatins, puddings and fillings; amount of the additive does not exceed (10) Hard and soft candy; 0.27 percent and the amount of poly- (11) Peanut spread; sorbate 60 does not exceed 0.77 percent (12) Sweet sauces, toppings, and syr- of the weight of the finished whipped ups; edible oil topping.

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

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(1) As a dough conditioner in yeast- tablished under section 401 of the Act leavened bakery products and prepared do not preclude such use: mixes for yeast-leavened bakery prod- (1) As a dough strengthener, emulsi- ucts in an amount not to exceed 0.5 fier, or processing aid in baked prod- part for each 100 parts by weight of ucts, pancakes, and waffles, in an flour used. amount not to exceed 0.5 part for each (2) As a whipping agent in: 100 parts by weight of flour used. (i) Liquid and frozen egg white at a (2) As a surface-active agent, emulsi- level not to exceed 0.05 percent. fier, or stabilizer in icings, fillings, (ii) Dried egg white at a level not to puddings, and toppings, at a level not exceed 0.5 percent. to exceed 0.2 percent by weight of the (iii) Whipped vegetable oil topping at finished food. a level not to exceed 0.3 percent of the (3) As an emulsifier or stabilizer in weight of the finished whipped vege- liquid and solid edible fat-water emul- table oil topping. (3) As a conditioning agent in dehy- sions intended for use as substitutes drated potatoes in an amount not to for milk or cream in beverage coffee, at exceed 0.5 percent by weight thereof. a level not to exceed 0.3 percent by (d) To assure safe use of the additive: weight of the finished edible fat-water (1) The label and labeling of the food emulsion. additive and any intermediate premix (4) As a formulation aid, processing prepared therefrom shall bear, in addi- aid, or surface-active agent in dehy- tion to the other information required drated potatoes, in an amount not to by the act, the following: exceed 0.5 percent of the dry weight of (i) The name of the additive. the food. (ii) A statement of the concentration (5) As an emulsifier, stabilizer, or or strength of the additive in any in- texturizer in snack dips, at a level not termediate premixes. to exceed 0.2 percent by weight of the (2) The label or labeling of the food finished product. additive shall also bear adequate direc- (6) As an emulsifier, stabilizer, or tions of use to provide a finished food texturizer in cheese substitutes and that complies with the limitations pre- imitations and cheese product sub- scribed in paragraph (c) of this section. stitutes and imitations, at a level not to exceed 0.2 percent by weight of the § 172.846 Sodium stearoyl lactylate. finished food. The food additive sodium stearoyl (7) As an emulsifier, stabilizer, or lactylate (CAS Reg. No. 25–383–997) may texturizer in sauces or gravies, and the be safely used in food in accordance products containing the same, in an with the following prescribed condi- amount not to exceed 0.25 percent by tions: weight of the finished food. (a) The additive, which is a mixture (8) In prepared mixes for each of the of sodium salts of stearoyl lactylic foods listed in paragraphs (c) (1) acids and minor proportions of sodium through (7) of this section, provided the salts of related acids, is manufactured additive is used only as specified in by the reaction of stearic acid and lac- each of those paragraphs. tic acid and conversion to the sodium (9) As an emulsifier, stabilizer, or salts. texturizer in cream liqueur drinks, at a (b) The additive meets the specifica- level not to exceed 0.5 percent by tions of the ‘‘Food Chemicals Codex,’’ weight of the finished product. 3d Ed. (1981), pp. 300–301, which is incorporated by reference. Copies may be [45 FR 51767, Aug. 5, 1980, as amended at 49 obtained from the National Academy FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, Press, 2101 Constitution Ave. NW., 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. Washington, DC 20418, or may be exam- 27, 1986; 65 FR 60859, Oct. 13, 2000] ined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., § 172.848 Lactylic esters of fatty acids. suite 700, Washington, DC 20408. Lactylic esters of fatty acids may be (c) It is used or intended for use as safely used in food in accordance with follows when standards of identity es- the following prescribed conditions:

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

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§ 172.856 Propylene glycol mono- and to exceed 1.1 percent by weight of the diesters of fats and fatty acids. finished product. Propylene glycol mono- and diesters (5) As an emulsifier, stabilizer, or of fats and fatty acids may be safely thickener in gelatins and puddings at a level not to exceed 0.6 percent by used in food, subject to the following weight of the finished product. prescribed conditions: (6) As a stabilizer or thickener in gra- (a) They are produced from edible vies and in sweet sauces at a level not fats and/or fatty acids in compliance to exceed 0.5 percent by weight of the with § 172.860 and/or oleic acid derived finished product. from tall oil fatty acids in compliance (7) As a stabilizer in jams and jellies with § 172.862. at a level not to exceed 0.4 percent by (b) They are used in food in amounts weight of the finished product. not in excess of that reasonably re- (8) As an emulsifier, stabilizer, or quired to produce their intended effect. thickener in condiments and relishes at a level not to exceed 0.6 percent by § 172.858 Propylene glycol alginate. weight of the finished product. The food additive propylene glycol (9) As a flavoring adjunct or adjuvant alginate (CAS Reg. No. 9005–37–2) may in seasonings and flavors at a level not be used as an emulsifier, flavoring ad- to exceed 1.7 percent by weight of the juvant, formulation aid, stabilizer, sur- finished product. factant, or thickener in foods in ac- (10) As an emulsifier, flavoring adju- cordance with the following prescribed vant, formulation aid, stabilizer or conditions: thickener, or surface active agent in (a) The additive meets the specifica- other foods, where applicable, at a tions of the Food Chemicals Codex, 3d level not to exceed 0.3 percent by Ed. (1981), p. 256, which is incorporated weight of the finished product. by reference (copies are available from (c) To ensure safe use of the additive, the National Academy Press, 2101 Con- the label of the food additive container stitution Ave. NW., Washington, DC shall bear, in addition to the other in- 20418, or available for inspection at the formation required by the act: Office of the Federal Register, 800 (1) The name of the additive, ‘‘pro- North Capitol Street, NW., suite 700, pylene glycol alginate’’ or ‘‘propylene Washington, DC 20408), and the addi- glycol ester of alginic acid’’. tional specification that it shall have (2) Adequate directions for use. up to 85 percent of the carboxylic acid [47 FR 29950, July 9, 1982] groups 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:

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(1) The total content of mono-, di-, lion as determined by a method enti- and tri-esters is not less than 80 per- tled ‘‘Determination of Dimethyl Sulf- cent as determined by a method title oxide,’’ which is incorporated by ref- ‘‘Sucrose Fatty Acid Esters, Method of erence. Copies are available from the Assay,’’ which is incorporated by ref- Center for Food Safety and Applied Nu- erence. Copies are available from the trition (HFS–200), Food and Drug Ad- Center for Food Safety and Applied Nu- ministration, 5100 Paint Branch Pkwy., trition (HFS–200), Food and Drug Ad- College Park, MD 20740, or available for ministration, 5100 Paint Branch Pkwy., inspection at the Office of the Federal College Park, MD 20740, or available for Register, 800 North Capitol Street, inspection at the Office of the Federal NW., suite 700, Washington, DC 20408. Register, 800 North Capitol Street, (11) The total isobuytl alcohol (2- NW., suite 700, Washington, DC 20408. (2) The free sucrose content is not methyl-1-propanol) content is not more more than 5 percent as determined by than 10 parts per million as determined Test S.2 in the method titled ‘‘Sucrose by a method entitled ‘‘Determination Fatty Acid Esters, Method of Assay,’’ of Isobutyl Alcohol,’’ which is incor- which is incorporated by reference. The porated by reference. Copies are avail- availability of this incorporation by able from the Center for Food Safety reference is given in paragraph (b)(1) of and Applied Nutrition (HFS–200), Food this section. and Drug Administration, 5100 Paint (3) The acid value is not more than 6. Branch Pkwy., College Park, MD 20740, (4) The residue on ignition (sulfated or available for inspection at the Office ash) is not more than 2 percent. of the Federal Register, 800 North Cap- (5) The total ethyl acetate content is itol Street, NW., suite 700, Washington, not more than 350 parts per million as DC 20408. determined by a method titled ‘‘Deter- (c) Sucrose fatty acid esters may be mination of Ethyl Acetate,’’ which is used as follows when standards of iden- incorporated by reference. Copies are tity established under section 401 of available from the Center for Food the Federal Food, Drug, and Cosmetic Safety and Applied Nutrition (HFS– Act do not preclude such use: 200), Food and Drug Administration, (1) As emulsifiers as defined in 5100 Paint Branch Pkwy., College Park, § 170.3(o)(8) of this chapter, or as stabi- MD 20740, or available for inspection at lizers as defined in § 170.3(o)(28) of this the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, chapter, in baked goods and baking Washington, DC 20408. mixes as defined in § 170.3(n)(1) of this (6) Arsenic is not more than 3 parts chapter, in chewing gum as defined in per million. § 170.3(n)(6) of this chapter, in coffee (7) Total heavy metal content (as Pb) and tea beverages with added dairy in- is not more than 50 parts per million. gredients and/or dairy product ana- (8) Lead is not more than 10 parts per logues, in confections and frostings as million. defined in § 170.3(n)(9) of this chapter, (9) The total content of methyl ethyl in dairy product analogues as defined ketone or of methanol shall not be in § 170.3(n)(10) of this chapter, in frozen more than 10 parts per million as deter- dairy desserts and mixes as defined in mined by a method titled ‘‘Methyl § 170.3(n)(20) of this chapter, and in Ethyl Ketone Test; Methyl Alcohol whipped milk products. Test,’’ which is incorporated by ref- (2) As texturizers as defined in erence. Copies are available from the § 170.3(o)(32) of this chapter in biscuit Center for Food Safety and Applied Nu- mixes, in chewing gum as defined in trition (HFS–200), Food and Drug Ad- § 170.3(n)(6) of this chapter, in confec- ministration, 5100 Paint Branch Pkwy., tions and frostings as defined in College Park, MD 20740, or available for § 170.3(n)(9) of this chapter, and in inspection at the Office of the Federal surimi-based fabricated seafood prod- Register, 800 North Capitol Street, ucts. NW., suite 700, Washington, DC 20408. (10) The total dimethyl sulfoxide con- (3) As components of protective coat- tent is not more than 2 parts per mil- ings applied to fresh apples, avocados,

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bananas, banana plantains, limes, mel- cial Analytical Chemists International, ons (honeydew and cantaloupe), pa- 481 North Frederick Ave., suite 500, paya, peaches, pears, pineapples, and Gaithersburg, MD 20877–2504, or avail- plums to retard ripening and spoiling. able for inspection at the Office of the (d) Sucrose fatty acid esters are used Federal Register, 800 North Capitol in accordance with current good manu- Street, NW., suite 700, Washington, DC facturing practice and in an amount 20408. not to exceed that reasonably required (2) Chick-edema factor shall be deter- to accomplish the intended effect. mined by the bioassay method de- [47 FR 55475, Dec. 10, 1982, as amended at 48 scribed in ‘‘Official Methods of Anal- FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, ysis of the Association of Official Ana- 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR lytical Chemists,’’ 13th Ed. (1980), sec- 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] tions 28.127–28.130, which is incor- § 172.860 Fatty acids. porated by reference. Copies may be obtained from the Association of Offi- The food additive fatty acids may be safely used in food and in the manufac- cial Analytical Chemists International, ture of food components in accordance 481 North Frederick Ave., suite 500, with the following prescribed condi- Gaithersburg, MD 20877–2504, or may be tions: examined at the Office of the Federal (a) The food additive consists of one Register, 800 North Capitol Street, or any mixture of the following NW., suite 700, Washington, DC 20408. straight-chain monobasic carboxylic (3) The gas chromatographic-electron acids and their associated fatty acids capture method for testing fatty acids manufactured from fats and oils de- for chick-edema shall be the method rived from edible sources: Capric acid, described in the ‘‘Journal of the Asso- caprylic acid, lauric acid, myristic ciation of Official Analytical Chem- acid, oleic acid, palmitic acid, and ste- ists,’’ Volume 50 (No. 1), pages 216–218 aric acid. (1967), or the modified method using a (b) The food additive meets the fol- sulfuric acid clean-up procedure, as de- lowing specifications: scribed in the ‘‘Journal of the Associa- (1) Unsaponifiable matter does not tion of the Offical Analytical Chem- exceed 2 percent. ists,’’ Volume 51 (No. 2), pages 489–490 (2) It is free of chick-edema factor: (1968), which are incorporated by ref- (i) As evidenced during the bioassay erence. See paragraph (c)(2) of this sec- method for determining the chick- edema factor as prescribed in para- tion for availability of these ref- graph (c)(2) of this section; or erences. (ii) As evidenced by the absence of (d) It is used or intended for use as chromatographic peaks with a reten- follows: tion time relative to aldrin (RA) be- (1) In foods as a lubricant, binder, tween 10 and 25, using the gas and as a defoaming agent in accordance chromatographic-electron capture with good manufacturing practice. method prescribed in paragraph (c)(3) (2) As a component in the manufac- of this section. If chromatographic ture of other food-grade additives. peaks are found with RA values be- (e) To assure safe use of the additive, tween 10 and 25, the food additive shall the label and labeling of the additive meet the requirements of the bioassay and any premix thereof shall bear, in method prescribed in paragraph (c)(2) addition to the other information re- of this section for determining chick- quired by the act, the following: edema factor. (1) The common or usual name of the (c) For the purposes of this section: acid or acids contained therein. (1) Unsaponifiable matter shall be de- (2) The words ‘‘food grade,’’ in jux- termined by the method described in the 13th Ed. (1980) of the ‘‘Official taposition with and equally as promi- Methods of Analysis of the Association nent as the name of the acid. of Official Analytical Chemists,’’ which [42 FR 14491, Mar. 15, 1977, as amended at 47 is incorporated by reference. Copies are FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, available from the Association of Offi- 1984; 54 FR 24897, June 12, 1989]

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§ 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 Office of the No. 85665–33–4), or both oils is a mixture Federal Register, 800 North Capitol of triglycerides. It is manufactured by Street, NW., suite 700, Washington, DC esterification of glycerol with food- 20408. grade fatty acids (complying with (2) The resin acid content does not § 172.860) derived from edible coconut exceed 0.01 as determined by ASTM oil, edible palm kernel oil, or both oils. method D1240–82, ‘‘Standard Test Meth- (b) The ingredient meets the fol- od for Rosin Acids in Fatty Acids,’’ lowing specifications: which is incorporated by reference. Copies may be obtained from the Amer- Acid number: Not to exceed 0.5. ican Society for Testing Materials, 1916 Saponification number: 220 to 260. Race St., Philadelphia, PA 19103, or Iodine number: Not to exceed 3. may be examined at the Office of the Melting range: 30 to 44 °C. Federal Register, 800 North Capitol (c) The ingredient is used or intended Street, NW., suite 700, Washington, DC for use as follows: 20408. (1) As coating material for sugar, (3) The requirements for absence of table salt, vitamins, citric acid, suc- chick-edema factor as prescribed in cinic acid, and spices; and § 172.860. (2) In compound coatings, cocoa (c) It is used or intended for use as creams, cocoa-based sweets, toffees, follows: caramel masses, and chewing sweets as (1) In foods as a lubricant, binder, defined in § 170.3 (n)(9) and (n)(38) of and defoaming agent in accordance this chapter, except that the ingredient with good manufacturing practice. may not be used in a standardized food (2) As a component in the manufac- unless permitted by the standard of ture of other food-grade additives. identity. (d) To assure safe use of the additive, (d) The ingredient is used in accord- the label and labeling of the additive ance with current good manufacturing and any premix thereof shall bear, in practice and in an amount not to ex- addition to the other information re- ceed that reasonably required to ac- quired by the Act, the following: complish the intended effect. (1) The common or usual name of the acid. [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992] (2) The words ‘‘food grade’’ in jux- taposition with and equally as promi- § 172.862 Oleic acid derived from tall nent as the name of the acid. oil fatty acids. [42 FR 14491, Mar. 15, 1977, as amended at 49 The food additive oleic acid derived FR 10105, Mar. 19, 1984] from tall oil fatty acids may be safely used in food and as a component in the § 172.863 Salts of fatty acids. manufacture of food-grade additives in The food additive salts of fatty acids accordance with the following pre- may be safely used in food and in the scribed conditions: manufacture of food components in ac- (a) The additive consists of purified cordance with the following prescribed oleic acid separated from refined tall conditions: oil fatty acids. (a) The additive consists of one or (b) The additive meets the following any mixture of two or more of the alu- specifications: minum, calcium, magnesium, potas- (1) Specifications for oleic acid pre- sium, and sodium salts of the fatty scribed in the ‘‘Food Chemicals acids conforming with § 172.860 and/or

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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. C2H4), and utilizing an external coolant (c) To assure safe use of the additive, such that these alcohols meet the spec- the label and labeling of the additive ifications prescribed in paragraph (a)(1) and any premix thereof shall bear, in (i) and (iii) of this section. addition to the other information re- (b) The hydrocarbon solvent used in quired by the Act, the following: the process described in paragraph (1) The common or usual name of the (a)(1) of this section is a mixture of liq- fatty acid salt or salts contained therein. uid hydrocarbons essentially paraffinic (2) The words ‘‘food grade,’’ in jux- in nature, derived from petroleum and taposition with and equally as promi- refined to meet the specifications de- nent as the name of the salt. scribed in paragraph (b)(1) of this section when subjected to the procedures § 172.864 Synthetic fatty alcohols. described in paragraph (b) (2) and (3) of Synthetic fatty alcohols may be safe- this section. ly used in food and in the synthesis of (1) The hydrocarbon solvent meets food components in accordance with the following specifications: the following prescribed conditions: (i) Boiling-point range: 175 °C–275 °C. (a) The food additive consists of any (ii) Ultraviolet absorbance limits as one of the following fatty alcohols: follows: (1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl; manufac- Maximum absorb- tured by fractional distillation of alco- Wavelength (millicrons) ance per hols obtained by a sequence of oxida- centimeter optical tion and hydrolysis of organo-alu- path length minums generated by the controlled reaction of low molecular weight 280–289 ...... 0.15 trialkylaluminum with purified ethyl- 290–299 ...... 12 300–359 ...... 05 ene (minimum 99 percent by volume 360–400 ...... 02 C2H4), and utilizing the hydrocarbon solvent as defined in paragraph (b) of (2) Use ASTM method D86–82, this section, such that: ‘‘Standard Method for Distillation of (i) Hexyl, octyl, decyl, lauryl, and Petroleum Products,’’ which is incor- myristyl alcohols contain not less than porated by reference, to determine 99 percent of total alcohols and not less boiling point range. Copies of the ma- than 96 percent of straight chain alco- terial incorporated by reference may hols. Any nonalcoholic impurities are be obtained from the American Society primarily paraffins. for Testing Materials, 1916 Race St., (ii) Cetyl and stearyl alcohols con- Philadelphia, PA 19103, or may be ex- tain not less than 98 percent of total amined at the Office of the Federal alcohols and not less than 94 percent of straight chain alcohols. Any non- Register, 800 North Capitol Street, alcoholic impurities are primarily NW., suite 700, Washington, DC 20408. paraffins. (3) The analytical method for deter- (iii) The synthetic fatty alcohols con- mining ultraviolet absorbance limits is tain no more than 0.1 weight percent of as follows: total diols as determined by a method available upon request from the Com- GENERAL INSTRUCTIONS missioner of Food and Drugs. All glassware should be scrupulously (2) Hexyl, octyl, and decyl; manufac- cleaned to remove all organic matter such as tured by fractional distillation of alco- oil, grease, detergent residues, etc. Examine hols obtained by a sequence of oxida- all glassware, including stoppers and stop- tion, hydrolysis, and catalytic hydro- cocks, under ultraviolet light to detect any

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residual fluorescent contamination. As a pre- Wavelength repeatability, ±0.2 milli- cautionary measure, it is recommended prac- micron. tice to rinse all glassware with purified iso- Wavelength accuracy, ±1.0 millimicron. octane immediately before use. No grease is Nitrogen cylinder. Water-pumped or equiva- to be used on stopcocks or joints. Great care lent purity nitrogen in cylinder equipped to avoid contamination of hydrocarbon sol- with regulator and valve to control flow at 5 vent samples in handling and to assure ab- p.s.i.g. sence of any extraneous material arising from inadequate packaging is essential. Be- REAGENTS AND MATERIALS cause some of the polynuclear hydrocarbons Organic solvents. All solvents used through- sought in this test are very susceptible to out the procedure shall meet the specifica- photo-oxidation, the entire procedure is to tions and tests described in this specifica- be carried out under subdued light. tion. The isooctane, benzene, hexane, and 1,2- APPARATUS dichloroethane designated in the list following this paragraph shall pass the fol- Chromatographic tube. 450 millimeters in lowing test: length (packing section), inside diameter 19 To the specified quantity of solvent in a ± millimeters 1 millimeter, equipped with a 250-milliliter beaker, add 1 milliliter of puri- wad of clean Pyrex brand filtering wool (Cor- fied n-hexadecane and evaporate in the vacu- ning Glass Works Catalog No. 3950 or equiva- um oven under a stream of nitrogen. Dis- lent). The tube shall contain a 250-milliliter continue evaporation when not over 1 milli- reservoir and a 2-millimeter tetrafluoro- liter of residue remains. (To the residue from ethylene polymer stopcock at the opposite benzene add a 5-milliliter portion of purified end. Overall length of the tube is 670 milli- isooctane, reevaporate, and repeat once to meters. insure complete removal of benzene.) Stainless steel rod. 2 feet in length, 2 to 4 Dissolve the 1 milliliter of hexadecane res- millimeters in diameter. idue in isooctane and make to 5 milliliters Vacuum oven. Similar to Labline No. 3610 volume. Determine the absorbance in the 1- but modified as follows: A copper tube one- centimeter path length cells compared to fourth inch in diameter and 13 inches in isooctane as reference. The absorbance of the length is bent to a right angle at the 4-inch solution of the solvent residue shall not ex- point and plugged at the opposite end; eight ceed 0.02 per centimeter path length between copper tubes one-eighth inch in diameter and 280 and 300 mµ and shall not exceed 0.01 per 5 inches in length are silver soldered in centimeter path length between 300 and 400 drilled holes (one-eighth inch in diameter) to mµ. the one-fourth-inch tube, one on each side at Isooctane (2,2,4-trimethylpentane). Use 10 the 5-, 7.5-, 10- and 12.5-inch points; the one- milliliters for the test described in the pre- eighth-inch copper tubes are bent to conform ceding paragraph. If necessary, isooctane with the inner periphery of the oven. may be purified by passage through a column Beakers. 250-milliliter and 500-milliliter ca- of activated silica gel (Grade 12, Davison pacity. Chemical Co., Baltimore, Md., or equiva- Graduated cylinders. 25-milliliter, 50-milli- lent). liter, and 150-milliliter capacity. Tuberculin syringe. 1-milliliter capacity, Benzene, spectro grade (Burdick and Jackson with 3-inch, 22-gauge needle. Laboratories, Inc., Muskegon, Mich., or equiva- Volumetric flask. 5-milliliter capacity. lent). Use 80 milliliters for the test. If nec- Spectrophotometric cells. Fused quartz essary, benzene may be purified by distilla- ground glass stoppered cells, optical path tion or otherwise. length in the range of 1.000 centimeter ±0.005 Hexane, spectro grade (Burdick and Jackson centimeter. With distilled water in the cells, Laboratories, Inc., Muskegon, Mich., or equiva- determine any absorbance difference. lent). Use 650 milliliters for the test. If nec- Spectrophotometer. Spectral range 250 milli- essary, hexane may be purified by distilla- microns—400 millimicrons with spectral slit tion or otherwise. width of 2 millimicrons or less: under instrument operating conditions for these absorb- Spectrophotometry, U.S. Department of ance measurements, the spectrophotometer Commerce, (1949). The accuracy is to be de- shall also meet the following performance termined by comparison with the standard requirements: values at 290, 345, and 400 millimicrons. Cir- ± Absorbance repeatability, 0.01 at 0.4 ab- cular 484 is incorporated by reference. Copies sorbance. are available from the Center for Food Safe- 1 ± Absorbance accuracy, 0.05 at 0.4 absorb- ty and Applied Nutrition (HFS–200), Food ance. and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available 1 As determined by using potassium chro- for inspection at the Office of the Federal mate for reference standard and described in Register, 800 North Capitol Street, NW., National Bureau of Standards Circular 484, suite 700, Washington, DC 20408.

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1,2-Dichloroethane, spectro grade (Matheson, steel rod. Take care not to get the gel above Coleman, and Bell, East Rutherford, N.J., or the liquid and onto the sides of the column. equivalent). Use 20 milliliters for test. If nec- Weigh out 40 grams ±0.1 gram of the hydro- essary, 1,2-dichloroethane may be purified by carbon solvent sample into a 250-milliliter distillation. beaker, add 50 milliliters of hexane, and pour Eluting mixtures: the solution into the column. Rinse the 1. 10 percent 1,2-dichloroethane in hexane. beaker with 50 milliliters of hexane and add Pipet 100 milliliters of 1,2-dichloroethane this to the column. Allow the hexane sample into a 1-liter glass-stoppered volumetric solution to elute into a 500-milliliter beaker flask and adjust to volume with hexane, with until the solution is about one-half inch mixing. above the gel. Rinse the column three times 2. 40 percent benzene in hexane. Pipet 400 with 50-milliliter portions of hexane. Allow milliliters of benzene into a 1-liter glass- each hexane rinse to separately elute to stoppered volumetric flask and adjust to vol- about one-half inch above the gel. Replace ume with hexane, with mixing. the eluate beaker (discard the hexane eluate) n-Hexadecane, 99 percent olefin-free. Dilute with a 250-milliliter beaker. Add two sepa- 1.0 milliliter of n-hexadecane to 5 milliliters rate 25-milliliter portions of 10 percent 1,2- with isooctane and determine the absorbance dichloroethane and allow each to separately in a 1-centimeter cell compared to isooctane elute as before. Finally, add 150 milliliters of as reference between 280 mµ-400mµ. The ab- 10 percent 1,2-dichloroethane for a total of sorbance per centimeter path length shall 200 milliliters. When the final 10 percent 1,2- not exceed 0.00 in this range. If necessary, n- dichloroethane fraction is about one-half hexadecane may be purified by percolation inch above the top of the gel bed, replace the through activated silica gel or by distilla- receiving beaker (discard the 1,2- tion. dichloroethane eluate) with a 250-milliliter Silica gel, 28–200 mesh (Grade 12, Davison beaker containing 1 milliliter of hexadecane. Chemical Co., Baltimore, Md., or equivalent). Adjust the elution rate to 2 to 3 milliliters Activate as follows: Weigh about 900 grams per minute, add two 25-milliliter portions of into a 1-gallon bottle, add 100 milliliters of 40 percent benzene and allow each to sepa- de-ionized water, seal the bottle and shake rately elute as before to within about one- and roll at intervals for 1 hour. Allow to half inch of the gel bed. Finally, add 150 mil- equilibrate overnight in the sealed bottle. liliters of 40 percent benzene for a total of 200 Activate the gel at 150 °C for 16 hours, in a milliliters. Evaporate the benzene in the 2-inch × 7-inch × 12-inch porcelain pan loose- oven with vacuum and sufficient nitrogen ly covered with aluminum foil, cool in a flow to just ripple the top of the benzene so- dessicator, transfer to a bottle and seal. lution. When the benzene is removed (as determined by a constant volume of hexa- PROCEDURE decane) add 5 milliliters of isooctane and evaporate. Repeat once to insure complete Determination of ultraviolet absorbance. Be- removal of benzene. Remove the beaker and fore proceeding with the analysis of a sample cover with aluminum foil (previously rinsed determine the absorbance in a 1-centimeter with hexane) until cool. path cell for the reagent blank by carrying Quantitatively transfer the hexadecane out the procedure without a sample. Record residue to a 5-milliliter volumetric flask and the absorbance in the wavelength range of dilute to volume with isooctane. Determine 280 to 400 millimicrons. Typical reagent the absorbance of the solution in 1-centi- blank absorbance in this range should not meter path length cells between 280 and 400 exceed 0.04 in the 280 to 299 millimicron millimicrons using isooctane as a reference. range, 0.02 in the 300 to 359 millimicron Correct the absorbance values for any ab- range, and 0.01 in the 360 to 400 millimicron sorbance derived from reagents as deter- range. If the characteristic benzene peaks in mined by carrying out the procedure without the 250 to 260 millimicron region are present, a sample. If the corrected absorbance does remove the benzene by the procedure de- not exceed the limits prescribed in para- scribed above under ‘‘Reagents and Mate- graph (b)(1)(ii) of this section, the sample rials,’’ ‘‘Organic Solvents,’’ and record ab- meets the ultraviolet absorbance specifica- sorbance again. tions for hydrocarbon solvent. Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. (c) Synthetic fatty alcohols may be Raise and drop the column on a semisoft, used as follows: clean surface for about 1 minute to settle the (1) As substitutes for the cor- gel. Pour 100 milliliters of hexane into the responding naturally derived fatty al- column with the stopcock open and allow to cohols permitted in food by existing drain to about one-half inch above the gel. Turn off the stopcock and allow the column regulations in this part or part 173 of to cool for 30 minutes. After cooling, vibrate this chapter provided that the use is in the column to eliminate air and stir the top compliance with any prescribed limita- 1 to 2 inches with a small diameter stainless tions.

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(2) As substitutes for the cor- Relative Ester Distribution of Olestra responding naturally derived fatty al- Test Material’’ dated December 19, cohols used as intermediates in the 1995, which is incorporated by reference synthesis of food additives and other in accordance with 5 U.S.C. 552(a) and 1 substances permitted in food. CFR part 51. Copies are available from the Office of Premarket Approval, Cen- [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, ter for Food Safety and Applied Nutri- 1984; 54 FR 24897, June 12, 1989] tion (HFS–200), Food and Drug Admin- istration, 5100 Paint Branch Pkwy., § 172.866 Synthetic glycerin produced College Park, MD 20740, or may be ex- by the hydrogenolysis of carbo- amined at the Center for Food Safety hydrates. and Applied Nutrition’s Library, 200 C Synthetic glycerin produced by the St. SW. Washington, DC, or at the Of- hydrogenolysis of carbohydrates may fice of the Federal Register, 800 North be safely used in food, subject to the Capitol Street, NW., suite 700, Wash- provisions of this section: ington, DC. (a) It shall contain not in excess of (3) The content of hexa-ester is not 0.2 percent by weight of a mixture of more than 1 percent as determined by butanetriols. the method listed in paragraph (b)(2) of (b) It is used or intended for use in an this section. amount not to exceed that reasonably (4) The content of penta-ester is not required to produce its intended effect. more than 0.5 percent as determined by the method listed in paragraph (b)(2) of § 172.867 Olestra. this section. Olestra, as identified in this section, (5) The unsaturated fatty acid con- may be safely used in accordance with tent is not less than 25 percent (thus the following conditions: not more than 75 percent saturated (a) Olestra is a mixture of octa-, fatty acid) and not more than 83 per- hepta-, and hexa-esters of sucrose with cent as determined by a method enti- fatty acids derived from edible fats and tled ‘‘Measurement of the Fatty Acid oils or fatty acid sources that are gen- Composition of Olestra Test Material,’’ erally recognized as safe or approved dated December 19, 1995, which is incor- for use as food ingredients. The chain porated by reference in accordance lengths of the fatty acids are no less with 5 U.S.C. 552(a) and 1 CFR part 51. than 12 carbon atoms. Copies are available from the Office of (b) Olestra meets the following speci- Premarket Approval, Center for Food fications: Safety and Applied Nutrition (HFS– (1) The total content of octa-, hepta- 200), Food and Drug Administration, , and hexa-esters is not less than 97 per- 5100 Paint Branch Pkwy., College Park, cent as determined by a method enti- MD 20740, or may be examined at the tled ‘‘Determination of Olestra by Size Center for Food Safety and Applied Nu- Exclusion Chromatography,’’ dated De- trition’s Library, 200 C St. SW., Wash- cember 19, 1995, which is incorporated ington, DC, or at the Office of the Fed- by reference in accordance with 5 eral Register, 800 North Capitol Street, U.S.C. 552(a) and 1 CFR part 51. Copies NW., suite 700, Washington, DC. are available from the Office of Pre- (6) The content of C12 and C14 fatty market Approval, Center for Food acids is each not more than 1 percent, Safety and Applied Nutrition (HFS– and total C20 and longer fatty acids is 200), Food and Drug Administration, not more than 20 percent. C16 and C18 5100 Paint Branch Pkwy., College Park, fatty acids make up the remainder MD 20740, or may be examined at the with total content not less than 78 per- Center for Food Safety and Applied Nu- cent as determined by the method list- trition’s Library, 200 C St. SW., Wash- ed in paragraph (b)(5) of this section. ington, DC, or at the Office of the Fed- (7) The free fatty acid content is not eral Register, 800 North Capitol Street, more than 0.5 percent as determined by NW., suite 700, Washington, DC. a method entitled ‘‘Free Fatty Acids’’ (2) The content of octa-ester is not published in the Official Methods and less than 70 percent as determined by a Recommended Practices of the American method entitled ‘‘Measurement of the Oil Chemists’ Society, 3d Ed. (1985) vol. 1,

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which is incorporated by reference in 1608 Broadmoor Dr., Champaign, IL accordance with 5 U.S.C. 552(a) and 1 61821, or may be examined at the Cen- CFR part 51. Copies are available from ter for Food Safety and Applied Nutri- the American Oil Chemists Society, tion’s Library, 200 C St. SW., Wash- 1608 Broadmoor Dr., Champaign, IL ington, DC, or at the Office of the Fed- 61821, or may be examined at the Cen- eral Register, 800 North Capitol Street, ter for Food Safety and Applied Nutri- NW., suite 700, Washington, DC. tion’s Library, 200 C St. SW., Wash- (13) Peroxide value is not more than ington, DC, or at the Office of the Fed- 10 meq/kg as determined by a method eral Register, 800 North Capitol Street, entitled ‘‘Peroxide Value,’’ Official NW., suite 700, Washington, DC. Methods and Recommended Practices of (8) The residue on ignition (sulfated the American Oil Chemists’ Society, 4th ash) is not more than 0.5 percent. Ed. (1989) vol. 1, which is incorporated (9) Total methanol content is not by reference in accordance with 5 more than 300 parts per million as de- U.S.C. 552(a) and 1 CFR part 51. Copies termined by the ‘‘Total Available are available from the American Oil Methanol Method,’’ dated December 19, Chemists Society, 1608 Broadmoor Dr., 1995, which is incorporated by reference Champaign, IL 61821, or may be exam- in accordance with 5 U.S.C. 552(a) and 1 ined at the Center for Food Safety and CFR part 51. Copies are available from Applied Nutrition’s Library, 200 C St. the Office of Premarket Approval, Cen- SW., Washington, DC, or at the Office ter for Food Safety and Applied Nutri- of the Federal Register, 800 North Cap- tion (HFS–200), Food and Drug Admin- itol Street, NW., suite 700, Washington, istration, 200 C St. SW., Washington, DC. DC or may be examined at the Center (14) The stiffness is not less than 50 for Food Safety and Applied Nutri- kiloPascals/second, as determined by a tion’s Library, 200 C St. SW., Wash- method entitled ‘‘Method for Measure- ington, DC, or at the Office of the Fed- ment of the Stiffness of Olestra,’’ dated eral Register, 800 North Capitol Street, December 19, 1995, which is incor- NW., suite 700, Washington, DC. porated by reference in accordance (10) The total heavy metal content with 5 U.S.C. 552(a) and 1 CFR part 51. (as Pb) is not more than 10 parts per million. Copies are available from the Office of (11) Lead is not more than 0.1 part Premarket Approval, Center for Food per million, as determined by a method Safety and Applied Nutrition (HFS– entitled ‘‘Atomic Absorption 200), Food and Drug Administration, Spectrophotometric Graphite Furnace 200 C St. SW., Washington, DC, or may Method,’’ Food Chemicals Codex, 3d Ed. be examined at the Center for Food 3d Supp. p. 168 (1992), which is incor- Safety and Applied Nutrition’s Li- porated by reference in accordance brary, 200 C St. SW., Washington, DC, with 5 U.S.C. 552(a) and 1 CFR part 51. or at the Office of the Federal Register, Copies are available from the National 800 North Capitol St. NW., suite 700, Research Council Press, 2101 Constitu- Washington, DC. tion Ave. NW., Washington, DC, or may (c) Olestra may be used in place of be examined at the Center for Food fats and oils in prepackaged ready-to- Safety and Applied Nutrition’s Li- eat savory (i.e., salty or piquant but brary, 200 C St. SW., Washington, DC, not sweet) snacks. In such foods, the or at the Office of the Federal Register, additive may be used in place of fats 800 North Capitol Street, NW., suite and oils for frying or baking, in dough 700, Washington, DC. conditioners, in sprays, in filling ingre- (12) Water is not more than 0.1 per- dients, or in flavors. cent, as determined by a method enti- (d) To compensate for any inter- tled ‘‘Moisture,’’ Official Methods and ference with absorption of fat soluble Recommended Practices of the American vitamins, the following vitamins shall Oil Chemists’ Society, 4th Ed. (1989), vol. be added to foods containing olestra: 1, which is incorporated by reference in 1.9 milligrams alpha-tocopherol equiva- accordance with 5 U.S.C. 552(a) and 1 lents per gram olestra; 51 retinol CFR part 51. Copies are available from equivalents per gram olestra (as the American Oil Chemists Society, retinyl acetate or retinyl palmitate); 12

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IU vitamin D per gram olestra; and 8 µg (iii) Utilize at least one point lead- vitamin K1 per gram olestra. ing; (e)(1) The label of a food containing (iv) Have type that is kerned so the olestra shall bear the following state- letters do not touch; ment in the manner prescribed in para- (v) Be all black or one color type, graph (e)(2) of this section: printed on a white or other neutral THIS PRODUCT CONTAINS OLESTRA. Olestra contrasting background whenever pos- may cause abdominal cramping and loose sible; stools. Olestra inhibits the absorption of (vi) Utilize a single easy-to-read type some vitamins and other nutrients. Vitamins A, D, E, and K have been added. style such as Helvetica Regular and upper and lower case letters; and (2) The statement required by para- (vii) Be in type size no smaller than graph (e)(1) of this section shall: 8 point. (i) Appear either on the principal dis- (3) The sentence ‘‘This Product Con- play panel or on the information panel of the label; tains Olestra.’’ shall be highlighted by (ii) Be enclosed by a 0.5 point box bold or extra bold type, such as rule with 2.5 points of space around the Helvetica Black. The label shall appear statement. as follows:

(4) Vitamins A, D, E, and K present in The purpose of such presentation will foods as a result of the requirement in be to receive advice from the Com- paragraph (d) of this section shall be mittee on whether there continues to declared in the listing of ingredients. be reasonable certainty that use of Such vitamins shall not be considered olestra in compliance with this regula- in determining nutrient content for the tion is not harmful. The agency will nutritional label or for any nutrient hold such additional Food Advisory claims, express or implied. Committee meetings on olestra as the (5) Olestra shall not be considered as agency determines, in its discretion, to a source of fat or calories for purposes be necessary. Based upon the results of of §§ 101.9 and 101.13 of this chapter. this entire process, the FDA will ini- (f) Consistent with its obligation to tiate any appropriate regulatory pro- monitor the safety of all additives in ceedings. the food supply, including olestra, the [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, Food and Drug Administration will re- 1996] view and evaluate all data and information bearing on the safety of olestra § 172.868 Ethyl cellulose. received by the agency after the effec- The food additive ethyl cellulose may tive date of this regulation, and will be safely used in food in accordance present such data, information, and with the following prescribed condi- evaluation to the agency’s Food Advi- tions: sory Committee within 30 months of (a) The food additive is a cellulose the effective date of this regulation. ether containing ethoxy (OC2H5) groups 99

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attached by an ether linkage and con- used in accordance with good manufac- taining on an anhydrous basis not more turing practice. than 2.6 ethoxy groups per [46 FR 50065, Oct. 9, 1981] anhydroglucose unit. (b) It is used or intended for use as § 172.872 Methyl ethyl cellulose. follows: The food additive methyl ethyl cel- (1) As a binder and filler in dry vita- lulose may be safely used in food in ac- min preparations. cordance with the following prescribed (2) As a component of protective conditions. coatings for vitamin and mineral tab- (a) The additive is a cellulose ether lets. having the general formula [C6H(10–x– (3) As a fixative in flavoring com- y)O5(CH3)x(C2H5)y]n, where x is the num- pounds. ber of methyl groups and y is the number of ethyl groups. The average value § 172.870 Hydroxypropyl cellulose. of x is 0.3 and the average value of y is 0.7. The food additive hydroxypropyl cel- (b) The additive meets the following lulose may be safely used in food, ex- specifications: cept standardized foods that do not (1) The methoxy content shall be not provide for such use, in accordance less than 3.5 percent and not more than with the following prescribed condi- 6.5 percent, calculated as OCH3, and the tions: ethoxy content shall be not less than (a) The additive consists of one of the 14.5 percent and not more than 19 per- following: cent, calculated as OC2H5, both meas- (1) A cellulose ether containing pro- ured on the dry sample. pylene glycol groups attached by an (2) The viscosity of an aqueous solu- ether linkage which contains, on an an- tion, 2.5 grams of the material in 100 hydrous basis, not more than 4.6 milliliters of water, at 20 °C, is 20 to 60 hydroxypropyl groups per centipoises. anhydroglucose unit. The additive has (3) The ash content on a dry basis has a minimum viscosity of 145 centipoises a maximum of 0.6 percent. for 10 percent by weight aqueous solu- (c) The food additive is used as an tion at 25 °C. aerating, emulsifying, and foaming (2) A cellulose ether containing pro- agent, in an amount not in excess of pylene glycol groups attached by an that reasonably required to produce its ether linkage having a hydroxypropoxy intended effect. (OC H OH) content of 5 to 16 percent 3 6 § 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

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provide a final product that complies (1) It meets the test requirements of with the limitations prescribed in para- the United States Pharmacopeia XX graph (b) of this section. (1980) for readily carbonizable sub- [42 FR 14491, Mar. 15, 1977, as amended at 47 stances (page 532). FR 38273, Aug. 31, 1982] (2) It meets the test requirements of U.S.P. XVII for sulfur compounds (page § 172.876 Castor oil. 400). The food additive castor oil may be (3) It meets the specifications pre- safely used in accordance with the fol- scribed in the ‘‘Journal of the Associa- lowing conditions: tion of Official Analytical Chemists,’’ (a) The additive meets the specifica- Volume 45, page 66 (1962), which is in- tions of the United States Pharma- corporated by reference, after correc- copeia XX (1980). tion of the ultraviolet absorbance for (b) The additive is used or intended any absorbance due to added anti- for use as follows: oxidants. Copies of the material incor- Use and Limitations porated by reference are available from Hard candy production—As a release agent the Center for Food Safety and Applied and antisticking agent, not to exceed 500 Nutrition (HFS–200), Food and Drug parts per million in hard candy. Administration, 5100 Paint Branch Vitamin and mineral tablets—As a compo- Pkwy., College Park, MD 20740, or nent of protective coatings. available for inspection at the Office of [42 FR 14491, Mar. 15, 1977, as amended at 49 the Federal Register, 800 North Capitol FR 10105, Mar. 19, 1984] Street, NW., suite 700, Washington, DC 20408. § 172.878 White mineral oil. (b) White mineral oil may contain White mineral oil may be safely used any antioxidant permitted in food by in food in accordance with the fol- regulations issued in accordance with lowing conditions: section 409 of the Act, in an amount (a) White mineral oil is a mixture of liquid hydrocarbons, essentially par- not greater than that required to affinic and naphthenic in nature ob- produce its intended effect. tained from petroleum. It is refined to (c) White mineral oil is used or in- meet the following specifications: 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.

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

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

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

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

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

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

(d) Petrolatum may contain any is incorporated by reference. Copies may be antioxidant permitted in food by regu- obtained from the American Society for lations issued in accordance with sec- Testing Materials, 1916 Race St., Philadel- tion 409 of the Act, in an amount not phia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Cap- greater than that required to produce itol Street, NW., suite 700, Washington, DC its intended effect. 20408. [42 FR 14491, Mar. 15, 1977, as amended at 49 Ultraviolet absorbance: FR 10105, Mar. 19, 1984] 260–319 millimicrons—1.5 maximum. 320–329 millimicrons—0.08 maximum. § 172.882 Synthetic isoparaffinic petro- 330–350 millimicrons—0.05 maximum. leum hydrocarbons. Nonvolatile residual: 0.002 gram per 100 milliliters maximum. Synthetic isoparaffinic petroleum Synthetic isoparaffinic petroleum hydro- hydrocarbons may be safely used in carbons containing antioxidants shall meet food, in accordance with the following the specified ultraviolet absorbance limits conditions: after correction for any absorbance due to (a) They are produced by synthesis the antioxidants. The ultraviolet absorbance from petroleum gases and consist of a shall be determined by the procedure de- mixture of liquid hydrocarbons meet- scribed for application of mineral oil, dis- ing the following specifications: regarding the last sentence of the procedure, under ‘‘Specifications’’ on page 66 of the Boiling point 93–260 °C as determined by ‘‘Journal of the Association of Official Ana- ASTM method D86–82, ‘‘Standard Method for lytical Chemists,’’ Volume 45 (February Distillation of Petroleum Products,’’ which 1962), which is incorporated by reference.

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Copies are available from the Center for or synthesized from petroleum gases. Food Safety and Applied Nutrition (HFS– The additive is chiefly paraffinic, 200), Food and Drug Administration, 5100 isoparaffinic, or naphthenic in nature. Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of (b) The additive meets the following the Federal Register, 800 North Capitol specifications: Street, NW., suite 700, Washington, DC 20408. (1) Odor is faint and not kerosenic. ° For hydrocarbons boiling below 250 F, the (2) Initial boiling point is 300 °F min- nonvolatile residue shall be determined by ASTM method D1353–78, ‘‘Standard Test imum. Method for Nonvolatile Matter in Volatile (3) Final boiling point is 650 °F max- Solvents for Use in Paint, Varnish, Lacquer, imum. and Related Products;’’ for those boiling (4) Ultraviolet absorbance limits de- ° above 121 C, ASTM method D381–80, ‘‘Stand- termined by method specified in ard Test Method for Existent Gum in Fuels by Jet Evaporation’’ shall be used. These § 178.3620(b)(1)(ii) of this chapter, as fol- methods are incorporated by reference. Cop- lows: ies may be obtained from the American Soci- ety for Testing Materials, 1916 Race St., Maximum absorb- Philadelphia, PA 19103, or may be examined µ ance per at the Office of the Federal Register, 800 Wavelength m centimeter North Capitol Street, NW., suite 700, Wash- optical pathlength ington, DC 20408. (b) Isoparaffinic petroleum hydro- 280–289 ...... 4.0 carbons may contain antioxidants au- 290–299 ...... 3.3 300–329 ...... 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 limitations. Use Limitations (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 Uses Limitations sugar and yeast . § 173.340 of this chapter. 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. fruits and vegetables . In the froth-flotation cleaning of Do. 4. As a coating on shell eggs ...... Do. vegetables . 5. As a float on fermentation Do. As a component of insecticide for- Do. fluids in the manufacture of vin- mulations used in compliance egar and wine and on brine with regulations issued in parts used in curing pickles, to pre- 170 through 189 of this chapter . vent or retard access of air, evaporation, and contamination with wild organisms during fer- § 172.886 Petroleum wax. mentation . Petroleum wax may be safely used in or on food, in accordance with the fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989] (a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in na- § 172.884 Odorless light petroleum hy- ture, derived from petroleum, and re- drocarbons. fined to meet the specifications pre- Odorless light petroleum hydro- scribed by this section. carbons may be safely used in food, in (b) Petroleum wax meets the fol- accordance with the following pre- lowing ultraviolet absorbance limits scribed conditions: when subjected to the analytical proce- (a) The additive is a mixture of liquid dure described in this paragraph. hydrocarbons derived from petroleum

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Maximum Condenser. 24/40 joints, fitted with a drying ultraviolet tube, length optional. absorbance per Evaporation flask (optional). 250–milliliter centimeter or 500–milliliter capacity all-glass flask path length equipped with standard taper stopper having inlet and outlet tubes to permit passage of 280–289 millimicrons ...... 0.15 nitrogen across the surface of contained liq- 290–299 millimicrons ...... 0.12 300–359 millimicrons ...... 0.08 uid to be evaporated. 360–400 millimicrons ...... 0.02 Vacuum distillation assembly. All glass (for purification of dimethyl sulfoxide); 2–liter distillation flask with heating mantle; ANALYTICAL SPECIFICATION FOR PETROLEUM Vigreaux vacuum-jacketed condenser (or WAX equivalent) about 45 centimeters in length GENERAL INSTRUCTIONS and distilling head with separable cold finger 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. entire procedure is to be carried out under Absorbance accuracy, 1 ±0.05 at 0.4 absorb- subdued light. ance. ± APPARATUS Wavelength repeatability, 0.2 millimicron. Separatory funnels. 250–milliliter, 500–milli- Wavelength accuracy, ±1.0 millimicron. liter, 1,000–milliliter, and preferably 2,000– Nitrogen cylinder. Water-pumped or equiva- milliliter capacity, equipped with tetra- lent purity nitrogen in cylinder equipped fluoroethylene polymer stopcocks. with regulator and valve to control flow at 5 Reservoir. 500–milliliter capacity, equipped p.s.i.g. with a 24/40 standard taper male fitting at the bottom and a suitable ball-joint at the REAGENTS AND MATERIALS top for connecting to the nitrogen supply. Organic solvents. All solvents used through- The male fitting should be equipped with out the procedure shall meet the specifica- glass hooks. tions and tests described in this specifica- Chromatographic tube. 180 millimeters in tion. The isooctane, benzene, acetone, and length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer 1 As determined by using potassium chro- stopcock, and a female 24/40 standard tapered mate for reference standard and described in fitting at the opposite end. (Overall length of National Bureau of Standards Circular 484, the column with the female joint is 235 milli- Spectrophotometry, U.S. Department of meters.) The female fitting should be Commerce, (1949). The accuracy is to be de- equipped with glass hooks. termined by comparison with the standard Disc. Tetrafluoroethylene polymer 2–inch values at 290, 345, and 400 millimicrons. Cir- diameter disc approximately 3⁄16–inch thick cular 484 is incorporated by reference. Copies with a hole bored in the center to closely fit are available from the Center for Food Safe- the stem of the chromatographic tube. ty and Applied Nutrition (HFS–200), Food Heating jacket. Conical, for 500–milliliter and Drug Administration, 5100 Paint Branch separatory funnel. (Used with variable trans- Pkwy., College Park, MD 20740, or available former heat control.) for inspection at the Office of the Federal Suction flask. 250–milliliter or 500–milliliter Register, 800 North Capitol Street, NW., filter flask. suite 700, Washington, DC 20408.

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methyl alcohol designated in the list fol- necessary, by percolation through activated lowing this paragraph shall pass the fol- silica gel or by distillation. lowing test: Methyl alcohol, A.C.S. reagent grade. Use To the specified quantity of solvent in a 10.0 milliliters of methyl alcohol. Purify, if 250–milliliter Erlenmeyer flask, add 1 milli- necessary, by distillation. liter of purified n-hexadecane and evaporate Dimethyl sulfoxide. Pure grade, clear, on the steam bath under a stream of nitro- water-white, m.p. 18° minimum. Dilute 120 gen (a) loose aluminum foil jacket around milliliters of dimethyl sulfoxide with 240 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

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paper (18.5 centimeters, Schleicher & prewash to provide such filters required in Schuell, No. 597, or equivalent). If the initial the method: Place approximately 35 grams of filtrate contains carbon fines, refilter anhydrous sodium sulfate in a 30–milliliter through the same filter until a clear filtrate coarse, fritted-glass funnel or in a 65–milli- is obtained. Protect the sulfoxide from air meter filter funnel with glass wool plug; and moisture during this operation by cov- wash with successive 15–milliliter portions of ering the solvent in the funnel and collection the indicated solvent until a 15–milliliter flask with a layer of isooctane. Transfer the portion of the wash shows 0.00 absorbance filtrate to a 2–liter separatory funnel and per centimeter path length between 280 mµ draw off the dimethyl sulfoxide into the 2– and 400 mµ when tested as prescribed under liter distillation flask of the vacuum dis- ‘‘Organic solvents.’’ Usually three portions tillation assembly and distill at approxi- of wash solvent are sufficient. mately 3–millimeter Hg pressure or less. Dis- Before proceeding with analysis of a sam- card the first 200–milliliter fraction of the distillate and replace the distillate collec- ple, determine the absorbance in a 5–centi- µ µ tion flask with a clean one. Continue the dis- meter path cell between 250 m and 400 m tillation until approximately 1 liter of the for the reagent blank by carrying out the sulfoxide has been collected. procedure, without a wax sample, at room At completion of the distillation, the rea- temperature, recording the spectra after the gent should be stored in glass-stoppered bot- extraction stage and after the complete pro- tles since it is very hygroscopic and will cedure as prescribed. The absorbance per react with some metal containers in the centimeter path length following the extrac- presence of air. tion stage should not exceed 0.040 in the Phosphoric acid. 85 percent A.C.S. reagent wavelength range from 280 mµ to 400 mµ; the grade. absorbance per centimeter path length fol- Sodium borohydride. 98 percent. lowing the complete procedure should not Magnesium oxide (Sea Sorb 43, Food Machin- exceed 0.070 in the wavelength range from 280 ery Company, Westvaco Division, distributed by mµ to 299 mµ, inclusive, nor 0.045 in the chemical supply firms, or equivalent). Place 100 wavelength range from 300 mµ to 400 mµ. If in grams of the magnesium oxide in a large either spectrum the characteristic benzene beaker, add 700 milliliters of distilled water peaks in the 250 mµ–260 mµ region are to make a thin slurry, and heat on a steam present, remove the benzene by the proce- bath for 30 minutes with intermittent stir- dure under ‘‘Organic solvents’’ and record ring. Stir well initially to insure that all the absorbance again. 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 centimeter to 2 centimeters thick. Dry for 24 dividual layers and store in glass-stoppered hours at 160 °C ±1 °C. Pulverize the magnesia flasks. with mortar and pestle. Sieve the pulverized Place a representative 1–kilogram sample absorbent between 60–180 mesh. Use the mag- of wax, or if this amount is not available, the nesia retained on the 180–mesh sieve. entire sample, in a beaker of a capacity Celite 545. Johns-Manville Company, diato- about three times the volume of the sample maceous earth, or equivalent. and heat with occasional stirring on a steam Magnesium oxide-Celite 545 mixture (2+ 1) by bath until the wax is completely melted and weight. Place the magnesium oxide (60–180 homogeneous. Weigh four 25–gram ±0.2 gram mesh) and the Celite 545 in 2 to 1 propor- portions of the melted wax in separate 100– tions, respectively, by weight in a glass- milliliter beakers. Reserve three of the por- stoppered flask large enough for adequate tions for later replicate analyses as nec- mixing. Shake vigorously for 10 minutes. essary. Pour one weighed portion imme- Transfer the mixture to a glass trough lined diately after remelting (on the steam bath) with aluminum foil (free from rolling oil) into a 500–milliliter separatory funnel con- and spread it out on a layer about 1 centi- taining 100 milliliters of the preequilibrated meter to 2 centimeters thick. Reheat the sulfoxide-phosphoric acid mixture that has mixture at 160 °C ±1 °C for 2 hours, and store been heated in the heating jacket at a tem- in a tightly closed flask. perature just high enough to keep the wax Sodium sulfate, anhydrous, A.C.S. reagent melted. (NOTE: In preheating the sulfoxide- grade, preferably in granular form. For each acid mixture, remove the stopper of the sepa- bottle of sodium sulfate reagent used, estab- ratory funnel at intervals to release the lish as follows the necessary sodium sulfate pressure.)

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Promptly complete the transfer of the liter portion of isooctane, reevaporate to 1 sample to the funnel in the jacket with por- milliliter of hexadecane, and repeat this op- tions of the preequilibrated isooctane, warm- eration once. ing the beaker, if necessary, and using a Quantitatively transfer the residue with total volume of just 50 milliliters of the sol- isooctane to a 25–milliliter volumetric flask, vent. If the wax comes out of solution during make to volume, and mix. Determine the ab- these operations, let the stoppered funnel re- sorbance of the solution in the 5–centimeter main in the jacket until the wax redissolves. path length cells compared to isooctane as (Remove stopper from the funnel at intervals reference between 280 mµ–400 mµ (take care to release pressure.) When the wax is in solu- to lose none of the solution in filling the tion, remove the funnel from the jacket and sample cell). Correct the absorbance values shake it vigorously for 2 minutes. Set up for any absorbance derived from reagents as three 250–milliliter separatory funnels with determined by carrying out the procedure each containing 30 milliliters of without a wax sample. If the corrected ab- preequilibrated isooctane. After separation sorbance does not exceed the limits pre- of the liquid phases, allow to cool until the scribed in this paragraph (b), the wax meets main portion of the wax-isooctane solution the ultraviolet absorbance specifications. If begins to show a precipitate. Gently swirl the corrected absorbance per centimeter the funnel when precipitation first occurs on path length exceeds the limits prescribed in the inside surface of the funnel to accelerate this paragraph (b), proceed as follows: this process. Carefully draw off the lower Quantitatively transfer the isooctane solu- layer, filter it slowly through a thin layer of tion to a 125–milliliter flask equipped with glass wool fitted loosely in a filter funnel into the first 250–milliliter separatory fun- 24/40 joint and evaporate the isooctane on nel, and wash in tandem with the 30–milli- the steam bath under a stream of nitrogen to liter portions of isooctane contained in the a volume of 1 milliliter of hexadecane. Add 250–milliliter separatory funnels. Shaking 10 milliliters of methyl alcohol and approxi- time for each wash is 1 minute. Repeat the mately 0.3 gram of sodium borohydride. extraction operation with two additional (Minimize exposure of the borohydride to the portions of the sulfoxide-acid mixture, re- atmosphere. A measuring dipper may be placing the funnel in the jacket after each used.) Immediately fit a water-cooled con- extraction to keep the wax in solution and denser equipped with a 24/40 joint and with a washing each extractive in tandem through drying tube into the flask, mix until the the same three portions of isooctane. borohydride is dissolved, and allow to stand Collect the successive extractives (300 mil- for 30 minutes at room temperature, with liliters total) in a separatory funnel (pref- intermittent swirling. At the end of this pe- erably 2–liter), containing 480 milliliters of riod, disconnect the flask and evaporate the distilled water, mix, and allow to cool for a methyl alcohol on the steam bath under ni- few minutes after the last extractive has trogen until the sodium borohydride begins been added. Add 80 milliliters of isooctane to to come out of the solution. Then add 10 mil- the solution and extract by shaking the fun- liliters of isooctane and evaporate to a vol- nel vigorously for 2 minutes. Draw off the ume of about 2–3 milliliters. Again, add 10 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). Weight 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 metal rod before the addition ofthe next into the flask. Add 1 milliliter of n-hexa- layer. Continue packing in this manner until decane and evaporate the isooctane on the all the 14 grams of the adsorbent is added to steam bath under nitrogen. Discontinue the tube. Level off the top of the adsorbent evaporation when not over 1 milliliter of res- by pressing down firmly with a flat glass rod idue remains. To the residue, add a 10–milli- or metal plunger to make the depth of the

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adsorbent bed approximately 12.5 centimeter path length cells compared to iso- meters in depth. Turn off the vacuum and re- octane as reference between 250 mµ–400 mµ. move the suction flask. Fit the 500–milliliter Correct for any absorbance derived from the reservoir onto the top of the reagents as determined by carrying out the chromatographic column and prewet the col- procedure without a wax sample. If either umn by passing 100 milliliters of isooctane spectrum shows the characteristic benzene through the column. Adjust the nitrogen peaks in the 250 mµ–260 mµ region, evaporate pressure so that the rate of descent of the the solution to remove benzene by the proce- isooctane coming off of the column is be- dure under ‘‘Organic Solvents.’’ Dissolve the tween 2–3 milliliters per minute. Discontinue residue, transfer quantitatively, and adjust pressure just before the last of the isooctane to volume in isooctane in a 25–milliliter vol- reaches the level of the adsorbent. (CAUTION: umetric flask. Record the absorbance again. Do not allow the liquid level to recede below If the corrected absorbance does not exceed the adsorbent level at any time.) Remove the the limits prescribed in this paragraph (b), reservoir and decant the 5–milliliter iso- the wax meets the ultraviolet absorbance octane concentrate solution onto the column specifications. and with slight pressure again allow the 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 mil- section 409 of the act. liliters of isooctane to the reservoir and con- (2) Poly(alkylacrylate) (CAS Reg. No. tinue the percolation at the 2–3 milliliter per 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 C22) methacrylate esters, having: solvent mixture reaches adsorbent level, add (i) A number average molecular 25 milliliters of 20 percent benzene in iso- weight between 40,000 and 100,000; octane to the reservoir and continue the per- (ii) A weight average molecular colation at 2–3 milliliters per minute until 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 (iii) Unreacted alkylacrylate or to the reservoir and percolate through the alkylmethacrylate monomer content column to elute the polynuclear compounds. not in excess of 14 percent, as deter- Collect the eluate in a clean 1–liter sepa- mined by a method entitled ‘‘Method ratory funnel. Allow the column to drain for Determining Weight-Average and until most of the solvent mixture is removed. 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 omer Content of Poly(alkylacrylate) small amounts of sodium chloride facilitates used as Processing Aid in Manufacture separation.) Discard the aqueous layer after of Petroleum Wax,’’ which is incor- each wash. After the final separation, filter porated by reference in accordance the residual benzene through anhydrous so- with 5 U.S.C. 552(a) and 1 CFR part 51. dium sulfate prewashed with benzene (see So- Copies are available from the Office of dium sulfate under ‘‘Reagents and Materials’’ for preparation of filter) into a 250–milliliter Premarket Approval (HFS–200), Center Erlenmeyer flask (or optionally into the for Food Safety and Applied Nutrition, evaporation flask). Wash the separatory fun- Food and Drug Administration, 5100 nel with two additional 20–milliliter portions Paint Branch Pkwy., College Park, MD of benzene which are also filtered through 20740, or may be examined at the Cen- the sodium sulfate. Add 1 milliliter of n- ter for Food Safety and Applied Nutri- hexadecane and completely remove the ben- tion’s Library, Food and Drug Admin- zene by evaporation under nitrogen, using istration, 200 C St. SW., Washington, the special procedure to eliminate benzene DC or at the Office of the Federal Reg- as previously described under ‘‘Organic Sol- vents.’’ Quantitatively transfer the residue ister, 800 North Capitol St. NW., suite with isooctane to a 25–milliliter volumetric 700, Washington, DC. Petroleum wax flask and adjust to volume. Determine the shall contain not more than 1,050 parts absorbance of the solution in the 5–centi- per million of poly(alkylacrylate) or

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poly(alkylmethacrylate) residues as Use Limitations determined by a method entitled In chewing gum base, as a In accordance with § 172.615 ‘‘Method for Determining Residual masticatory substance . in an amount not to exceed Level of Poly(alkylacrylate) in Petro- good manufacturing prac- leum Wax,’’ which is incorporated by tice. reference. Copies are available from On cheese and raw fruits and In an amount not to exceed 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 FR 10986, Mar. 9, 1994] In chewing gum base, as a mas- In an amount not to ex- 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 chapter. (a) It is the refined wax obtained 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, 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, Saponification number 75 to 120. 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 . (a) Synthetic petroleum wax is a Chewing gum ...... 21⁄2 pct ...... Plasticizing 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:

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Limitations Limitations

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

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(h) Food starch may be modified by a (2) It contains no added arsenic com- combination of the treatments pre- pound and therefore may not exceed a scribed by paragraphs (a), (b), and/or (i) maximum natural background level of of this section and any one of the 0.2 part per million total arsenic, cal- treatments prescribed by paragraph (c), culated as As. (d), (e), (f), or (g) of this section, sub- (c) To assure safe use of the additive, ject to any limitations prescribed by the label of the food additive container the paragraphs named. shall bear, in addition to other infor- (i) Food starch may be modified by mation required by the act, the name treatment with the following enzymes: of the additive as follows: (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,

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0.05 ppm mercury, 0.09 ppm selenium, PART 173—SECONDARY DIRECT and 10 ppm zinc. FOOD ADDITIVES PERMITTED IN (c) The viable microbial content of FOOD FOR HUMAN CONSUMP- the finished ingredient is: TION (1) Less than 10,000 organisms/gram by aerobic plate count. Subpart A—Polymer Substances and (2) Less than 10 yeasts and molds/ Polymer Adjuvants for Food Treatment gram. Sec. (3) Negative for Salmonella, E. coli, 173.5 Acrylate-acrylamide resins. coagulase positive Staphylococci, Clos- 173.10 Modified polyacrylamide resin. tridium perfringens, Clostridium botu- 173.20 Ion-exchange membranes. linum, or any other recognized micro- 173.21 Perfluorinated ion exchange mem- bial pathogen or any harmful microbial branes. 173.25 Ion-exchange resins. toxin. 173.40 Molecular sieve resins. (d) The additive is used or intended 173.45 Polymaleic acid and its sodium salt. for use in the following foods when 173.50 Polyvinylpolypyrrolidone. standards of identity established under 173.55 Polyvinylpyrrolidone. section 401 of the Act do not preclude 173.60 Dimethylamine-epichlorohydrin copolymer. such use: 173.65 Divinylbenzene copolymer. 173.70 Chloromethylated aminated styrene- Use Limitations divinylbenzene resin. (1) In salad dressings as an emul- Not to exceed a con- 173.73 Sodium polyacrylate. sifier and emulsifier salt as de- centration of 5 percent 173.75 Sorbitan monooleate. fined in ¤ 170.3(o)(8) of this of the finished salad chapter, stabilizer and thickener dressing. Subpart B—Enzyme Preparations and as defined in ¤ 170.3(o)(28) of Microorganisms this chapter, or texturizer as defined in ¤ 170.3(o)(32) of this 173.110 Amyloglucosidase derived from chapter . Rhizopus niveus. (2) In frozen dessert analogs as a In an amount not to ex- 173.115 Alpha-acetolactate decarboxylase ( - stabilizer and thickener as de- ceed good manufac- a fined in ¤ 170.3(o)(28) of this turing practice. ALDC) enzyme preparation derived from chapter, or texturizer as defined a recombinant Bacillus subtilis. in ¤ 170.3(o)(32) of this chapter . 173.120 Carbohydrase and cellulase derived (3) In sour cream analogs as a Do. from Aspergillus niger. stabilizer and thickener as de- 173.130 Carbohydrase derived from Rhizopus fined in ¤ 170.3(o)(28) of this oryzae. chapter, or texturizer as defined 173.135 Catalase derived from Microccocus in ¤ 170.3(o)(32) of this chapter . lysodeikticus. (4) In cheese spread analogs as Do. 173.140 Esterase-lipase derived from Mucor a stabilizer and thickener as defined in ¤ 170.3(o)(28) of this miehei. chapter, or texturizer as defined 173.145 Alpha-Galactosidase derived from in ¤ 170.3(o)(32) of this chapter . Mortierella vinaceae var. raffinoseutilizer. (5) In cheese-flavored and sour Do. 173.150 Milk-clotting enzymes, microbial. cream-flavored snack dips as a 173.160 Candida guilliermondii. stabilizer and thickener as de- 173.165 Candida lipolytica. fined in ¤ 170.3(o)(28) of this 173.170 Aminoglycoside 3′- chapter, or texturizer as defined phosphotransferase II. in ¤ 170.3(o)(32) of this chapter . Subpart C—Solvents, Lubricants, Release (e) The label and labeling of the in- Agents and Related Substances gredient shall bear adequate directions to assure that use of the ingredient 173.210 Acetone. complies with this regulation. 173.220 1,3–Butylene glycol. 173.228 Ethyl acetate. [42 FR 14491, Mar. 15, 1977, as amended at 45 173.230 Ethylene dichloride. FR 58836, Sept. 5, 1980] 173.240 Isopropyl alcohol. 173.250 Methyl alcohol residues. 173.255 Methylene chloride. 173.270 Hexane. 173.275 Hydrogenated sperm oil. 173.280 Solvent extraction process for citric acid. 173.290 Trichloroethylene.

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Subpart D—Specific Usage Additives (b) The additive contains not more than 0.05 percent of residual monomer 173.300 Chlorine dioxide. calculated as acrylamide. 173.310 Boiler water additives. 173.315 Chemicals used in washing or to as- (c) The additive is used or intended sist in the peeling of fruits and vegeta- for use as follows: bles. (1) The additive identified in para- 173.320 Chemicals for controlling micro- graph (a) (1) of this section is used as a organisms in cane-sugar and beet-sugar flocculent in the clarification of beet mills. sugar juice and liquor or cane sugar 173.322 Chemicals used in delinting cotton- juice and liquor or corn starch seed. 173.325 Acidified sodium chlorite solutions. hydrolyzate in an amount not to ex- 173.340 Defoaming agents. ceed 5 parts per million by weight of 173.342 Chlorofluorocarbon 113 and the juice or 10 parts per million by perfluorohexane. weight of the liquor or the corn starch 173.345 Chloropentafluoroethane. hydrolyzate. 173.350 Combustion product gas. (2) The additive identified in para- 173.355 Dichlorodifluoromethane. graph (a)(2) of this section is used to 173.357 Materials used as fixing agents in control organic and mineral scale in the immobilization of enzyme preparations. beet sugar juice and liquor or cane 173.360 Octafluorocyclobutane. sugar juice and liquor in an amount 173.368 Ozone. not to exceed 2.5 parts per million by 173.370 Peroxyacids. 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

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base conforming to § 177.1520 of this may include substances used in accord- chapter to polymerization with styrene ance with § 174.5 of this chapter. until the polystyrene phase of the base (c) Conditions of use. (1) is not less than 16 percent nor more Perfluorinated ion exchange mem- than 30 percent by weight. The base is branes described in paragraph (a) of then modified by reaction with this section may be used in contact chloromethyl methyl ether, and by with all types of liquid foods at tem- subsequent amination with trimethyl- peratures not exceeding 70° (158 °F). amine, dimethylamine, diethylene- (2) Maximum thickness of the copoly- triamine, or dimethylethanolamine. mer membrane is 0.007 inch (0.017 centi- (b) The ion-exchange membrane is meter). manufactured so as to comply with the (3) Perfluorinated ion exchange mem- following extraction limitations when branes shall be maintained in a sani- subjected to the described procedure: tary manner in accordance with cur- Separate square-foot samples of mem- rent good manufacturing practice so as brane weighing approximately 14 grams to prevent microbial adulteration of 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 by weight of sample. [59 FR 15623, Apr. 4, 1994] (c) The ion-exchange membrane will § 173.25 Ion-exchange resins. be used in the production of grapefruit juice to adjust the ratio of citric acid Ion-exchange resins may be safely to total solids of the grapefruit juice used in the treatment of food under the produced. following prescribed conditions: (a) The ion-exchange resins are pre- § 173.21 Perfluorinated ion exchange pared in appropriate physical form, and 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 Office of ethoxy]-1,1,2,2,-tetrafluoro-, with tetra- the Federal Register, 800 North Capitol fluoroethylene that has been subse- Street, NW., suite 700, Washington, DC quently treated to hydrolyze the 20408. sulfonyl fluoride group to the sulfonic (3) Sulfite-modified cross-linked phe- acid. The Chemical Abstracts Service nol-formaldehyde, with modification name of this polymer is ethanesulfonic resulting in sulfonic acid groups on acid, 2-[1-[difluoro-[(trifluoro- side chains. ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- (4) Methacrylic acid-divinylbenzene ethoxy]-1,1,2,2,-tetrafluoro-, polymer copolymer. with tetrafluoroethane (CAS Reg. No. (5) Cross-linked polystyrene, first 31175–20–9). chloromethylated then aminated with (b) Optional adjuvant substances. The trimethylamine, dimethylamine, dibasic polymer identified in paragraph ethylenetriamine, or dimethylethanol- (a) of this section may contain optional amine. adjuvant substances required in the (6) Diethylenetriamine, triethylene- production of such basic polymer. tetramine, or tetraethylenepentamine These optional adjuvant substances cross-linked with epichlorohydrin.

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(7) Cross-linked phenol-formaldehyde (19) Epichlorohydrin cross-linked activated with one or both of the fol- with ammonia and then quaternized lowing: Triethylene tetramine and with methyl chloride to contain not tetraethylenepentamine. more than 18 percent strong base ca- (8) Reaction resin of formaldehyde, pacity by weight of total exchange ca- acetone, and tetraethylenepentamine. pacity [Chemical Abstracts Service (9) Completely hydrolyzed copoly- name: Oxirane (chloromethyl)-, polymers of methyl acrylate and mer with ammonia, reaction product divinylbenzene. with chloromethane; CAS Reg. No. (10) Completely hydrolyzed 68036–99–7]. terpolymers of methyl acrylate, (20) Regenerated cellulose, cross- divinylbenzene, and acrylonitrile. linked and alkylated with epichloro- (11) Sulfonated terpolymers of sty- hydrin and propylene oxide, then sulfo- rene, divinylbenzene, and acrylonitrile nated whereby the amount of epi- or methyl acrylate. chlorohydrin plus propylene oxide em- (12) Methyl acrylate-divinylbenzene ployed does not exceed 250 percent by copolymer containing not less than 2 weight of the starting quantity of cel- percent by weight of divinylbenzene, lulose. aminolyzed with dimethylaminopro- (b) Ion-exchange resins are used in pylamine. the purification of foods, including po- (13) Methyl acrylate-divinylbenzene table water, to remove undesirable ions copolymer containing not less than 3.5 or to replace less desirable ions with percent by weight of divinylbenzene, one or more of the following: bicarbon- aminolyzed with dimethylaminopro- ate, calcium, carbonate, chloride, hy- pylamine. drogen, 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 acrylonitrile and methyl acrylate. this section is used only in accordance (16) Methyl acrylate-divinylbenzene- with paragraph (b)(2) of this section, diethylene glycol divinyl ether the resin identified in paragraph (a)(16) terpolymer containing not less than 3.5 of this section is used only in accord- percent by weight of divinylbenzene ance with paragraph (b)(1) or (b)(2) of and not more than 0.6 percent by this section, the ion-exchange resin weight of diethylene glycol divinyl identified in paragraph (a)(17) of this ether, aminolyzed with dimethyl- section is used only in accordance with aminopropylamine. paragraph (b)(3) of this section, the (17) Styrene-divinylbenzene cross- ion-exchange resin identified in para- linked copolymer, first graph (a)(18) of this section is used only chloromethylated then aminated with in accordance with paragraph (b)(4) of dimethylamine and oxidized with hy- this section, and the ion-exchange drogen peroxide whereby the resin con- resin identified in paragraph (a)(20) of tains not more than 15 percent by this section is used only in accordance weight of vinyl N,N-dimethylbenzyl- with paragraphs (b)(5) and (d) of this amine-N-oxide and not more than 6.5 section. percent by weight of nitrogen. (1) The ion-exchange resins identified (18) Methyl acrylate-divinylbenzene- in paragraphs (a) (12) and (16) of this diethylene glycol divinyl ether section are used to treat water for use terpolymer containing not less than 7 in the manufacture of distilled alco- percent by weight of divinylbenzene holic beverages, subject to the fol- and not more than 2.3 percent by lowing conditions: weight of diethylene glycol divinyl (i) The water is subjected to treat- ether, aminolyzed with dimethyl- ment through a mixed bed consisting of aminopropylamine and quaternized one of the resins identified in para- with methyl chloride. graph (a) (12) or (16) of this section and

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one of the strongly acidic cation-ex- only of the types identified under cat- change resins in the hydrogen form egories I, II, and VI–B in Table 1 of identified in paragraphs (a) (1), (2), and § 176.170(c) of this chapter, Provided, (11) of this section; or that either: (ii) The water is first subjected to (A) The temperature of the water or one of the resins identified in para- food passing through the resin bed is graph (a) (12) or (16) of this section and maintained at 50 °C or less and the flow is subsequently subjected to treatment rate of the water or food passing through a bed of activated carbon or through the bed is not less than 0.5 gal- one of the strongly acidic cation-ex- lon per cubic foot per minute; or change resins in the hydrogen form (B) Extracts of the resin will be found identified in paragraphs (a) (1), (2), and to contain no more than 1 milligram/ (11) of this section. kilogram dimethylaminopropylamine (iii) The temperature of the water in each of the food simulants, distilled passing through the resin beds identi- water and 10 percent ethanol, when, fied in paragraphs (b)(1) (i) and (ii) of following washing and pretreatment of this section is maintained at 30 °C or the resin in accordance with less, and the flow rate of the water § 173.25(c)(1), the resin is subjected to passing through the beds is not less the following test under conditions than 2 gallons per cubic foot per simulating the actual temperature and minute. flow rate of use: ‘‘The Determination of (iv) The ion-exchange resins identi- 3-Dimethylaminopropylamine in Food fied in paragraph (a) (12) or (16) of this Simulating Extracts of Ion Exchange section are exempted from the require- Resins,’’ February 4, 1998, which is in- ments of paragraph (c)(4) of this sec- corporated by reference in accordance tion, but the strongly acidic cation-ex- with 5 U.S.C. 552(a) and 1 CFR part 51. change resins referred to in paragraphs Copies are available from the Division (b)(1) (i) and (ii) of this section used in of Petition Control (HFS–215), Center the process meet the requirements of for Food Safety and Applied Nutrition, paragraph (c)(4) of this section, except Food and Drug Administration, 5100 for the exemption described in para- Paint Branch Pkwy., College Park, MD graph (d) of this section. 20740, or may be examined at the Cen- (2) The ion-exchange resins identified ter for Food Safety and Applied Nutri- in paragraphs (a) (13) and (16) of this tion’s Library, 200 C St. SW., Wash- section are used to treat water and ington, DC, or at the Office of the Fed- aqueous food only of the types identi- eral Register, 800 North Capitol St. fied under Categories I, II, and VI–B in NW., suite 700, Washington, DC. table 1 of § 176.170(c) of this chapter: (3) The ion-exchange resin identified Provided, That the temperature of the in paragraph (a)(17) of this section is water or food passing through the resin used only for industrial application to beds is maintained at 50 °C or less and treat bulk quantities of aqueous food, the flow rate of the water or food pass- including potable water, or for treating through the beds is not less than 0.5 ment of municipal water supplies, sub- gallon per cubic foot per minute. ject to the condition that the tempera- (i) The ion-exchange resin identified ture of the food or water passing in paragraph (a)(13) of this section is through the resin bed is maintained at used to treat water and aqueous food 25 °C or less and the flow rate of the only of the types identified under cat- food or water passing through the bed egories I, II, and VI–B in Table 1 of is not less than 2 gallons per cubic foot § 176.170(c) of this chapter: Provided, per minute. That the temperature of the water or (4) The ion-exchange resin identified food passing through the resin bed is in paragraph (a)(18) of this section is maintained at 50 °C or less and the flow used to treat aqueous sugar solutions rate of the water or food passing subject to the condition that the tem- through the bed is not less than 0.5 gal- perature of the sugar solution passing lon per cubic foot per minute. through the resin bed is maintained at (ii) The ion-exchange resin identified 82 °C (179.6 °F) or less and the flow rate in paragraph (a)(16) of this section is of the sugar solution passing through used to treat water and aqueous food the bed is not less than 46.8 liters per

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cubic meter (0.35 gallon per cubic foot) ethyl alcohol, and 5 percent (by weight) of resin bed volume per minute. acetic acid. The first liter of effluent (5) The ion-exchange resin identified from each solvent is discarded, then in paragraph (a)(20) of this section is the next 2 liters are used to determine limited to use in aqueous process organic extractives. The 2-liter sample streams for the isolation and purifi- is carefully evaporated to constant cation of protein concentrates and iso- weight at 105 °C; this is total extrac- lates under the following conditions: tives. This residue is fired in a muffle (i) For resins that comply with the furnace at 850 °C to constant weight; requirements in paragraph (d)(2)(i) of this is ash. Total extractives, minus this section, the pH range for the resin ash equals the organic extractives. If shall be no less than 3.5 and no more the organic extractives are greater than 9, and the temperatures of water than 1 part per million of the solvent and food passing through the resin bed used, a blank should be run on the sol- shall not exceed 25 °C. vent and a correction should be made (ii) For resins that comply with the by subtracting the total extractives ob- requirements in paragraph (d)(2)(ii) of tained with the blank from the total 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.

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(d)(1) The ion-exchange resins identi- rification of partially delactosed whey. fied in paragraphs (a)(1), (a)(2), (a)(11), The gel bed shall be maintained in a 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 scribed conditions: paragraph (c)(4) of this section by using (a) The additives have a weight-aver- reagent grade hydrochloric acid, di- age molecular weight in the range of luted to pH 2, as a substitute for acetic 540 to 850 and a number-average molec- acid. The resin shall be found to result ular weight in the range of 520 to 650, in no more than 25 parts per million of calculated as the acid. Molecular organic extractives obtained with each weights shall be determined by a meth- of the following solvents: Distilled od entitled ‘‘Determination of Molec- water; 15 percent alcohol; and hydro- ular Weight Distribution of chloric acid, pH 2. Blanks should be run Poly(Maleic) Acid,’’ March 17, 1992, pro- for each of the solvents, and correc- duced by Ciba-Geigy, Inc., Seven Sky- tions should be made by subtracting line Dr., Hawthorne, NY 10532–2188, the total extractives obtained with the which is incorporated by reference in blank from the total extractives ob- accordance with 5 U.S.C. 552(a) and 1 tained in the resin test. CFR part 51. Copies are available from (e) Acrylonitrile copolymers identi- the Division of Product Policy, Center fied in this section shall comply with for Food Safety and Applied Nutrition the provisions of § 180.22 of this chap- (HFS–205), Food and Drug Administra- ter. tion, 5100 Paint Branch Pkwy., College [42 FR 14526, Mar. 15, 1977, as amended at 46 Park, MD 20740, or are available for in- FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, spection at the Center for Food Safety 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, and Applied Nutrition’s Library, 200 C Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR St. SW., Washington, DC, or at the Of- 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999] fice of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, § 173.40 Molecular sieve resins. DC. Molecular sieve resins may be safely (b) The additives may be used, indi- used in the processing of food under the vidually or together, in the processing following prescribed conditions: of beet sugar juice and liquor or of cane (a) The molecular sieve resins consist sugar juice and liquor to control min- of purified dextran having an average eral scale. molecular weight of 40,000, cross-linked (c) The additives are to be used so with epichlorohydrin in a ratio of 1 that the amount of either or both addi- part of dextran to 10 parts of tives does not exceed 4 parts per mil- epichlorohydrin, to give a stable three lion (calculated as the acid) by weight dimensional structure. The resins have of the beet or cane sugar juice or liquor a pore size of 2.0 to 3.0 milliliters per process stream. gram of dry resin (expressed in terms of water regain), and a particle size of [51 FR 5315, Feb. 13, 1986, as amended at 61 10 to 300 microns. FR 386, Jan. 5, 1996] (b) The molecular sieve resins are thoroughly washed with potable water § 173.50 Polyvinylpolypyrrolidone. prior to their first use in contact with The food additive polyvinylpoly- food. pyrrolidone may be safely used in ac- (c) Molecular sieve resins are used as cordance with the following prescribed the gel filtration media in the final pu- conditions:

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

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- at 60 RPM (or by another equivalent epichlorohydrin copolymer. method). Dimethylamine-epichlorohydrin co- (3) The additive contains not more polymer (CAS Reg. No. 25988–97–0) may than 1,000 parts per million of 1,3- be safely used in food in accordance dichloro-2-propanol and not more than with the following prescribed condi- 10 parts per million epichlorohydrin. tions: The epichlorohydrin and 1,3-dichloro-2- (a) The food additive is produced by propanol content is determined by an copolymerization of dimethylamine analytical method entitled ‘‘The Deter- and epichlorohydrin in which not more mination of Epichlorohydrin and 1,3- than 5 mole-percent of dimethylamine Dichloro-2-Propanol in Dimethyl- may be replaced by an equimolar amine-Epichlorohydrin Copolymer,’’ amount of ethylenediamine, and in which is incorporated by reference. which the mole ratio of total amine to Copies are available from the Center epichlorohydrin is approximately 1:1. for Food Safety and Applied Nutrition (b) The additive meets the following (HFS–200), Food and Drug Administra- specifications: tion, 5100 Paint Branch Pkwy., College (1) The nitrogen content of the co- Park, MD 20740, or available for inspec- polymer is 9.4 to 10.8 weight percent on tion at the Office of the Federal Reg- a dry basis. ister, 800 North Capitol Street, NW., (2) A 50-percent-by-weight aqueous suite 700, Washington, DC 20408. solution of the copolymer has a min- (4) Heavy metals (as Pb), 2 parts per imum viscosity of 175 centipoises at 25 million maximum. °C as determined by LVT-series Brook- (5) Arsenic (as As), 2 parts per million field viscometer using a No. 2 spindle maximum.

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(c) The food additive is used as a de- (d) The copolymer may be used in colorizing agent and/or flocculant in contact with food only of Types I, II, the clarification of refinery sugar liq- and VI–B (excluding carbonated bev- uors and juices. It is added only at the erages) described in table 1 of para- defecation/clarification stage of sugar graph (c) of § 176.170 of this chapter. liquor refining at a concentration not [50 FR 61, Jan. 2, 1985] to exceed 150 parts per million of copolymer by weight of sugar solids. § 173.70 Chloromethylated aminated (d) To assure safe use of the additive, styrene-divinylbenzene resin. the label and labeling of the additive shall bear, in addition to other infor- Chloromethylated aminated styrene- mation required by the Act, adequate divinylbenzene copolymer (CAS Reg. directions to assure use in compliance No. 60177–39–1) may be safely used in with paragraph (c) of this section. food in accordance with the following prescribed conditions: [48 FR 37614, Aug. 19, 1983, as amended at 54 (a) The additive is an aqueous disper- FR 24897, June 12, 1989] sion of styrene-divinylbenzene copolymers, first chloromethylated then § 173.65 Divinylbenzene copolymer. aminated with trimethylamine, having Divinylbenzene copolymer may be an average particle size of not more used for the removal of organic sub- than 2.0 microns. stances from aqueous foods under the (b) The additive shall contain no following prescribed conditions: more than 3.0 percent nonvolatile, (a) The copolymer is prepared in ap- soluble extractives when tested as fol- propriate physical form and is derived lows: One hundred grams of the addi- by the polymerization of a grade of tive is centrifuged at 17,000 r/min for 2 divinylbenzene which comprises at hours. The resulting clear supernatant least 79 weight-percent divinylbenzene, is removed from the compacted solids 15 to 20 weight-percent ethylvinyl- and concentrated to approximately 10 benzene, and no more than 4 weight- grams on a steam bath. The 10-gram percent nonpolymerizable impurities. sample is again centrifuged at 17,000 r/ (b) In accordance with the manufac- min for 2 hours to remove any residual turer’s directions, the copolymer de- insoluble material. The supernatant scribed in paragraph (a) of this section from the second centrifugation is then is subjected to pre-use extraction with removed from any compacted solids a water soluble alcohol until the level and dried to constant residual weight of divinylbenzene in the extract is less using a steam bath. The percent non- than 50 parts per billion as determined volatile solubles is obtained by divid- by a method titled, ‘‘The Determina- ing the weight of the dried residue by tion of Divinylbenzene in Alcohol Ex- the weight of the solids in the original tracts of Amberlite XAD–4,’’ which is resin dispersion. incorporated by reference. Copies of (c) The additive is used as a decol- this method are available from the orizing and clarification agent for Center for Food Safety and Applied Nu- treatment of refinery sugar liquors and trition (HFS–200), Food and Drug Ad- juices at levels not to exceed 500 parts ministration, 5100 Paint Branch Pkwy., of additive solids per million parts of College Park, MD 20740, or available for sugar solids. inspection at the Office of the Federal Register, 800 North Capitol Street, [50 FR 29209, July 18, 1985] NW., suite 700, Washington, DC 20408. The copolymer is then treated with § 173.73 Sodium polyacrylate. water according to the manufacturer’s Sodium polyacrylate (CAS Reg. No. recommendation to remove the extrac- 9003–04–7) may be safely used in food in tion solvent to guarantee a food-grade accordance with the following pre- purity of the resin at the time of use, scribed conditions: in accordance with current good manu- (a) The additive is produced by the facturing practice. polymerization of acrylic acid and sub- (c) The temperature of the aqueous sequent hydrolysis of the polyacrylic food stream contacting the polymer is acid with an aqueous sodium hydroxide maintained at 79.4 °C (175 °F) or less. solution. As determined by a method

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entitled ‘‘Determination of Weight Av- Subpart B—Enzyme Preparations erage and Number Average Molecular and Microorganisms Weight of Sodium Polyacrylate,’’ which is incorporated by reference in § 173.110 Amyloglucosidase derived accordance with 5 U.S.C. 552(a), the ad- from Rhizopus niveus. ditive has— Amyloglucosidase enzyme product, (1) A weight average molecular consisting of enzyme derived from weight of 2,000 to 2,300; and Rhizopus niveus, and diatomaceous sili- (2) A weight average molecular ca as a carrier, may be safely used in weight to number average molecular food in accordance with the following weight ratio of not more than 1.3. Cop- conditions: ies of the method are available from (a) Rhizopus niveus is classified as fol- the Center for Food Safety and Applied lows: Class, Phycomycetes; order, Nutrition (HFS–200), Food and Drug Mucorales; family, Mucoraceae; genus, Rhizopus; species, niveus. Administration, 5100 Paint Branch (b) The strain of Rhizopus niveus is Pkwy., College Park, MD 20740, or nonpathogenic and nontoxic in man or available for inspection at the Office of other animals. the Federal Register, 800 North Capitol (c) The enzyme is produced by a proc- Street, NW., suite 700, Washington, DC ess which completely removes the or- 20408. ganism Rhizopus niveus from the (b) The additive is used to control amyloglucosidase. mineral scale during the evaporation of (d) The additive is used or intended beet sugar juice or cane sugar juice in for use for degrading gelatinized starch the production of sugar in an amount into constituent sugars, in the produc- not to exceed 3.6 parts per million by tion of distilled spirits and vinegar. weight of the raw juice. (e) The additive is used at a level not to exceed 0.1 percent by weight of the [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, gelatinized starch. 1988] § 173.115 Alpha-acetolactate § 173.75 Sorbitan monooleate. decarboxylase (α-ALDC) enzyme Sorbitan monooleate may be safely preparation derived from a recom- used in accordance with the following binant Bacillus subtilis. prescribed conditions: The food additive alpha-acetolactate (a) The additive is produced by the decarboxylase (a-ALDC) enzyme prepa- esterification of sorbitol with commer- ration, may be safely used in accord- cial oleic acid. ance with the following conditions: (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. (c) The additive is used or intended (b)(1) The manufacturer produces the for use as follows: additive from a pure culture fermenta- (1) As an emulsifier in polymer dis- tion of a strain of Bacillus subtilis that persions that are used in the clarifica- is nonpathogenic and nontoxigenic in tion of cane or beet sugar juice or liq- man or other animals. uor in an amount not to exceed 7.5 per- (2) The manufacturer may stabilize cent by weight in the final polymer dis- the enzyme preparation with persion. glutaraldehyde or with other suitable (2) The additive is used in an amount approved food additives or generally not to exceed 0.70 part per million in recognized as safe substances. sugar juice and 1.4 parts per million in (3) The enzyme preparation must meet the general and additional re- sugar liquor. quirements for enzyme preparations in [51 FR 11720, Apr. 7, 1986] the Food Chemicals Codex, 4th ed., 1996,

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pp. 133–134, which is incorporated by (a) Rhizopus oryzae is classified as fol- reference. The Director of the Office of lows: Class, Phycomycetes; order, the Federal Register approves this in- Mucorales; family, Mucoraceae; genus, corporation by reference in accordance Rhizopus; species, Rhizopus oryzae. with 5 U.S.C. 552(a) and 1 CFR part 51. (b) The strain of Rhizopus oryzae is Copies may be obtained from the Na- nonpathogenic and nontoxic. tional Academy Press, 2101 Constitu- (c) The carbohydrase is produced tion Ave. NW., Washington, DC 20055, under controlled conditions to main- or may be examined at the Center for tain nonpathogenicity and nontoxicity, Food Safety and Applied Nutrition, 200 including the absence of aflatoxin. C St. SW., Washington, DC, or at the (d) The carbohydrase is produced by a Office of the Federal Register, 800 North Capitol St. NW., suite 700, Wash- process which completely removes the ington, DC. organism Rhizopus oryzae from the (c) The additive is used in an amount carbohydrase product. not in excess of the minimum required (e) The carbohydrase is maintained to produce its intended effect as a proc- under refrigeration from production to essing aid in the production of alco- use and is labeled to include the neces- holic malt beverages and distilled liq- sity of refrigerated storage. uors. § 173.135 Catalase derived from Micro- [66 FR 27022, May 16, 2001] coccus lysodeikticus. § 173.120 Carbohydrase and cellulase Bacterial catalase derived from derived from Aspergillus niger. Micrococcus lysodeikticus by a pure cul- Carbohydrase and cellulase enzyme ture fermentation process may be safe- preparation derived from Aspergillus ly used in destroying and removing hy- niger may be safely used in food in ac- drogen peroxide used in the manufac- cordance with the following prescribed ture of cheese, in accordance with the conditions: following conditions. (a) Aspergillus niger is classified as (a) The organism Micrococcus follows: Class, Deuteromycetes; order, lysodeikticus from which the bacterial Moniliales; family, Moniliaceae; genus, catalase is to be derived is dem- Aspergillus; species, niger. onstrated to be nontoxic and nonpatho- (b) The strain of Aspergillus niger is genic. nonpathogenic and nontoxic in man or (b) The organism Micrococcus other animals. lysodeikticus is removed from the bac- (c) The additive is produced by a terial catalase prior to use of the bac- process that completely removes the terial catalase. organism Aspergillus niger from the (c) The bacterial catalase is used in carbohydrase and cellulase enzyme an amount not in excess of the min- product. imum required to produce its intended (d) The additive is used or intended effect. for use as follows: (1) For removal of visceral mass (bel- § 173.140 Esterase-lipase derived from lies) in clam processing. Mucor miehei. (2) As an aid in the removal of the shell from the edible tissue in shrimp Esterase-lipase enzyme, consisting of processing. enzyme derived from Mucor miehei var. (e) The additive is used in an amount Cooney et Emerson by a pure culture fer- not in excess of the minimum required mentation process, with maltodextrin to produce its intended effect. or sweet whey as a carrier, may be safely used in food in accordance with § 173.130 Carbohydrase derived from the following conditions: Rhizopus oryzae. (a) Mucor miehei var. Cooney et Emer- Carbohydrase from Rhizopus oryzae son is classified as follows: Class, may be safely used in the production of Phycomycetes; subclass, Zygomycetes; dextrose from starch in accordance order, Mucorales; family, Mucoraceae; with the following prescribed condi- genus, Mucor; species, miehei; variety tions: Cooney et Emerson.

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

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to produce its intended effect in the acid during the recovery and purifi- production of those cheeses for which cation process. it is permitted by standards of identity (d) The additive is so used that the established pursuant to section 401 of citric acid produced conforms to the the Act. specifications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), under ‘‘Citric [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 62 FR 59284, Nov. 3, acid,’’ pp. 86–87, which is incorporated 1997] by reference. Copies may be obtained from the National Academy Press, 2101 § 173.160 Candida guilliermondii. Constitution Ave. NW., Washington, The food additive Candida DC 20418, or may be examined at the guilliermondii may be safely used as the Office of the Federal Register., 800 organism for fermentation production North Capitol Street, NW., suite 700, of citric acid in accordance with the Washington, DC 20408. following conditions: [42 FR 14526, Mar. 15, 1977, as amended at 47 (a) The food additive is the enzyme FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, system of the viable organism Candida 1984; 54 FR 24897, June 12, 1989] guilliermondii and its concomitant me- tabolites produced during the fer- § 173.165 Candida lipolytica. mentation process. The food additive Candida lipolytica (b)(1) The nonpathogenic and may be safely used as the organism for nontoxicogenic organism descending fermentation production of citric acid from strain, American Type Culture in accordance with the following condi- Collection (ATCC) No. 20474,1 is classi- tions: fied as follows: (a) The food additive is the enzyme Class: Deuteromycetes. system of the organism Candida Order: Moniliales. lipolytica and its concimitant metabo- Family: Cryptococcaceae. lites produced during the fermentation Genus: Candida. process. Species: guilliermondii. (b)(1) The nonpathogenic organism is Variety: guilliermondii. classified as follows: (2) The toxonomic characteristics of Class: Deuteromycetes. the reference culture strain ATCC No. Order: Moniliales. 20474 agree in the essentials with the Family: Cryptococcaceae. standard description for Candida Genus: Candida. guilliermondii variety guilliermondii list- Species: lipolytica. ed in ‘‘The Yeasts—A Toxonomic (2) The taxonomic characteristics of Study;’’ 2d Ed. (1970), by Jacomina the culture agree in essential with the Lodder, which is incorporated by ref- standard description for Candida erence. Copies are available from the lipolytica variety lipolytica listed in Center for Food Safety and Applied Nu- ‘‘The Yeasts—A Toxonomic Study,’’ 2d trition (HFS–200), Food and Drug Ad- Ed. (1970), by Jacomina Lodder, which ministration, 5100 Paint Branch Pkwy., is incorporated by reference. Copies are College Park, MD 20740, or available for available from the Center for Food inspection at the Office of the Federal Safety and Applied Nutrition (HFS– Register, 800 North Capitol Street, 200), Food and Drug Administration, NW., suite 700, Washington, DC 20408. 5100 Paint Branch Pkwy., College Park, (c)(1) The additive is used or intended MD 20740, or available for inspection at for use as a pure culture in the fer- the Office of the Federal Register, 800 mentation process for the production North Capitol Street, NW., suite 700, of citric acid using an acceptable aque- Washington, DC 20408. ous carbohydrate substrate. (c) The additive is used or intended (2) The organism Candida for use as a pure culture in the fer- quilliermondii is made nonviable and is mentation process for the production completely removed from the citric of citric acid from purified normal alkanes. 1 Available from: American Type Culture (d) The additive is so used that the Collection, 12301 Parklawn Drive, Rockville, citric acid produced conforms to the MD 20852. specifications of the ‘‘Food Chemicals

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Codex,’’ 3d Ed. (1981), pp. 86–87, which is Absorbance repeatability, ±0.01 at 0.4 ab- incorporated by reference. Copies may sorbance. be obtained from the National Acad- Wavelength repeatability, ±0.2 nanometer. emy Press, 2101 Constitution Ave. NW., Wavelength accuracy, ±1.0 nanometer. Washington, DC 20418, or may be exam- The spectrophotometer is equipped with ined at the Office of the Federal Reg- matched 1 centimeter path length quartz microcuvettes with 0.5-milliliter volume ca- ister, 800 North Capitol Street, NW., pacity. suite 700, Wasington, DC 20408. The ad- 6. Vacuum oven, minimum inside dimen- ditive meets the following ultraviolet sions: 200 mm × 200 mm × 300 mm deep. absorbance limits when subjected to the analytical procedure described in REAGENTS AND MATERIALS this paragraph: Organic solvents. All solvents used throughout the procedure shall meet the specifica- Ultraviolet absorbance per centimeter path length Maximum tions and tests described in this specification. The methyl alcohol, isooctane, benzene, 280 to 289 millimicrons ...... 0.25 hexane and 1,2-dichloroethane designated in 290 to 299 millimicrons ...... 0.20 the list following this paragraph shall pass 300 to 359 millimicrons ...... 0.13 the following test: 360 to 400 millimicrons ...... 0.03 The specified quantity of solvent is added to a 250-milliliter round bottom flask con- ANALYTICAL PROCEDURE FOR CITRIC ACID taining 0.5 milliliter of purified n-hexa- GENERAL INSTRUCTIONS decane and evaporated on the rotary evaporator at 45 °C to constant volume. Six milli- Because of the sensitivity of the test, the liters of purified isooctane are added to this possibility of errors arising from contamina- residue and evaporated under the same con- tion is great. It is of the greatest importance ditions as above for 5 minutes. Determine that all glassware be scrupulously cleaned to the absorbance of the residue compared to remove all organic matter such as oil, purified n-hexadecane as reference. The ab- grease, detergent residues, etc. Examine all sorbance of the solution of the solvent res- glassware including stoppers and stopcocks, idue shall not exceed 0.03 per centimeter under ultraviolet light to detect any residual path length between 280 and 299 nanometers fluorescent contamination. As a pre- and 0.01 per centimeter path length between cautionary measure it is recommended prac- 300 and 400 nanometers. tice to rinse all glassware with purified iso- Methyl alcohol, A.C.S. reagent grade. Use 100 octane immediately before use. No grease is milliliters for the test described in the pre- to be used on stopcocks or joints. Great care ceding paragraph. If necessary, methyl alco- to avoid contamination of citric acid sam- hol may be purified by distillation through a ples in handling is essential to assure ab- Virgreaux column discarding the first and sence of any extraneous material arising last ten percent of the distillate or other- from inadequate packaging. Because some of wise. the polynuclear hydrocarbons sought in this Benzene, spectrograde (Burdick and Jackson test are very susceptible to photo-oxidation, Laboratories, Inc., Muskegon, Mich., or equiva- the entire procedure is to be carried out under subdued light. lent). Use 80 milliliters for the test. If necessary, benzene may be purified by distilla- APPARATUS tion or otherwise. Isooctane (2,2,4-trimethylpentane). Use 100 1. Aluminum foil, oil free. milliliters for the test. If necessary, iso- 2. Separatory funnels, 500-milliliter capac- octane may be purified by passage through a ity, equipped with tetrafluoroethylene poly- column of activated silica gel, distillation or mer stopcocks. otherwise. 3. Chromatographic tubes: (a) 80-milli- Hexane, spectrograde (Burdick and Jackson meter ID × 900-millimeter length equipped Laboratories, Inc., Muskegon, Mich., or equiva- with tetrafluoroethylene polymer stopcock lent). Use 100 milliliters for the test. If nec- and course fritted disk; (b) 18-millimeter ID essary, hexane may be purified by distilla- × 300-millimeter length equipped with tetra- tion or otherwise. fluoroethylene polymer stopcock. 4. Rotary vacuum evaporator, Buchi or 1,2-Dichloroethane, spectrograde (Matheson, equivalent. Coleman and Bell, East Rutherford, N.J., or 5. Spectrophotometer—Spectral range 250– equivalent). Use 100 milliliters for the test. If 400 nanometers with spectral slit width of 2 necessary, 1,2-dichloroethane may be puri- nanometers or less; under instrument oper- fied by distillation or otherwise. ating conditions for these absorbance meas- ELUTING MIXTURES urements, the spectrophotometer shall also meet the following performance require- 1. 10 percent 1,2-dichloroethane in hexane. ments: Prepare by mixing the purified solvents in

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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 wash with an additional 6 liters of purified column. Pour 5.5 grams of activated silica water and wash with 3,600 milliliters of puri- gel into the column. Tap the column ap- fied methyl alcohol at a relatively slow rate. proximately 20 times on a semisoft, clean Drain all of the solvents and transfer the surface to settle the silica gel. Carefully silica gel to an aluminum foil-lined drying pour 3 grams of anhydrous sodium sulfate dish. Place foil over the top of the dish. Acti- onto the top of the silica gel in the column. vate in a vacuum oven at low vacuum (ap- Carefully drain the isooctane extract of proximately 750 millimeters Mercury or 27 the citric acid solution into the column in a inches of Mercury below atmospheric pres- series of additions while the isooctane is sure) at 173° to 177 °C for at least 20 hours. draining from the column at an elution rate Cool under vacuum and store in an amber of approximately 3 milliliters per minute. bottle. Rinse the separatory funnel with 10 milli- Sodium sulfate, anhydrous, A.C.S. reagent liters of isooctane after the last portion of grade. This reagent should be washed with the extract has been applied to the column purified isooctane. Check the purity of this and add this rinse to the column. After all of reagent as described in § 172.886 of this chap- the extract has been applied to the column ter. and the solvent layer reaches the top of the Water, purified. All water used must meet sulfate bed, rinse the column with 25 milli- the specifications of the following test: liters of isooctane followed by 10 milliliters Extract 600 milliliters of water with 50 mil- of a 10-percent dichloroethane in hexane so- liliters of purified isooctane. Add 1 milliliter lution. For each rinse solution, drain the col- of purified n-hexadecane to the isooctane ex- umn until the solvent layer reaches the top tract and evaporate the resulting solution to of the sodium sulfate bed. Discard the rinse 1 milliliter. The absorbance of this residue solvents. Place a 250-milliliter round bottom shall not exceed 0.02 per centimeter path flask containing 0.5 milliliter of purified n- length between 300–400 nanometers and 0.03 hexadecane under the column. Elute the per centimeter path length between 280–299 polynuclear aromatic hydrocarbons from the nanometers. If necessary, water may be puri- column with 30 milliliters of 40-percent ben- fied by distillation, extraction with purified zene in hexane solution. Drain the eluate organic solvents, treatment with an absorb- until the 40-percent benzene in the hexane ent (e.g., activated carbon) followed by fil- solvent reaches the top of the sodium sulfate tration of the absorbent or otherwise. bed. Evaporate the 40-percent benzene in PROCEDURE hexane eluate on the rotary vacuum evapo- Separate portions of 200 milliliters of puri- rator at 45 °C until only the n-hexadecane fied water are taken through the procedure residue of 0.5 milliliter remains. Treat the n- for use as control blanks. Each citric acid hexadecane residue twice with the following sample is processed as follows: Weigh 200 wash step: Add 6 milliliters of purified iso- grams of anhydrous citric acid into a 500 mil- octane and remove the solvents by vacuum liliter flask and dissolve in 200 milliliters of evaporation at 45 °C to constant volume, i.e., pure water. Heat the solution to 60 °C and 0.5 milliliter. Cool the n-hexadecane residue transfer to a 500 milliliter separatory funnel. and transfer the solution to an 0.5-milliliter Rinse the flask with 50 milliliters of iso- microcuvette. Determine the absorbance of octane and add the isooctane to the sepa- this solution compared to purified n-hexa- ratory funnel. Gently shake the mixture 90 decane as reference. Correct the absorbance times (caution: vigorous shaking will cause values for any absorbance derived from the

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control reagent blank. If the corrected ab- (a) The substance meets the fol- sorbance does not exceed the limits pre- lowing specifications: scribed, the samples meet the ultraviolet ab- (1) 1,3-Butylene glycol content: Not sorbance specifications. less than 99 percent. The reagent blank is prepared by using 200 ° milliliters of purified water in place of the (2) Specific gravity at 20/20 C: 1.004 citric acid solution and carrying the water to 1.006. sample through the procedure. The typical (3) Distillation range: 200°–215 °C. control reagent blank should not exceed 0.03 (b) It is used in the minimum amount absorbance per centimeter path length be- required to perform its intended effect. tween 280 and 299 nanometers, 0.02 absorb- (c) It is used as a solvent for natural ance per centimeter path length between 300 and synthetic flavoring substances ex- and 359 nanometers, and 0.01 absorbance per centimeter path length between 360 and 400 cept where standards of identity issued nanometers. under section 401 of the act preclude such use. [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, § 173.228 Ethyl acetate. 1984; 54 FR 24897, June 12, 1989] Ethyl acetate (CAS Reg. No. 141–78–6) § 173.170 Aminoglycoside 3′-phospho- may be safely used in food in accord- transferase II. ance with the following conditions: The food additive aminoglycoside 3′- (a) The additive meets the specifica- phosphotransferase II may be safely tions of the Food Chemicals Codex, 1 used in the development of genetically (Ethyl Acetate; p. 372, 3d Ed., 1981), modified cotton, oilseed rape, and to- which are incorporated by reference. matoes in accordance with the fol- (b) The additive is used in accordance lowing prescribed conditions: with current good manufacturing prac- (a) The food additive is the enzyme tice as a solvent in the decaffeination aminoglycoside 3′-phosphotransferase of coffee and tea. II (CAS Reg. No. 58943–39–8) which cata- [47 FR 146, Jan. 5, 1982, as amended at 49 FR lyzes the phosphorylation of certain 28548, July 13, 1984] aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin. § 173.230 Ethylene dichloride. ′ (b) Aminoglycoside 3 -phosphotrans- A tolerance of 30 parts per million is ferase II is encoded by the kanr gene established for ethylene dichloride in originally isolated from transposon Tn5 spice oleoresins when present therein of the bacterium Escherichia coli. as a residue from the extraction of (c) The level of the additive does not spice; Provided, however, That if resi- exceed the amount reasonably required dues of other chlorinated solvents are for selection of plant cells carrying the also present the total of all residues of kanr gene along with the genetic mate- such solvents shall not exceed 30 parts rial of interest. per million. [59 FR 26711, May 23, 1994] § 173.240 Isopropyl alcohol. Subpart C—Solvents, Lubricants, Isopropyl alcohol may be present in Release Agents and Related the following foods under the condi- Substances tions specified: (a) In spice oleoresins as a residue § 173.210 Acetone. from the extraction of spice, at a level not to exceed 50 parts per million. A tolerance of 30 parts per million is (b) In lemon oil as a residue in pro- established for acetone in spice duction of the oil, at a level not to ex- oleoresins when present therein as a ceed 6 parts per million. residue from the extraction of spice.

§ 173.220 1,3-Butylene glycol. 1 Copies may be obtained from: National Academy Press, 2101 Constitution Ave. NW., 1,3-Butylene glycol (1,3-butanediol) Washington, DC 20418 or examined at the Of- may be safely used in food in accord- fice of the Federal Register, 800 North Cap- ance with the following prescribed con- itol Street, NW., suite 700, Washington, DC ditions: 20408.

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(c) In hops extract as a residue from percent) in decaffeinated roasted coffee the extraction of hops at a level not to and in decaffeinated soluble coffee ex- exceed 2.0 percent by weight: Provided, tract (instant coffee). That, (1) The hops extract is added to the § 173.270 Hexane. wort before or during cooking in the Hexane may be present in the fol- manufacture of beer. lowing foods under the conditions spec- (2) The label of the hops extract ified: specifies the presence of the isopropyl (a) In spice oleoresins as a residue alcohol and provides for the use of the from the extraction of spice, at a level hops extract only as prescribed by not to exceed 25 parts per million. paragraph (c)(1) of this section. (b) In hops extract as a residue from § 173.250 Methyl alcohol residues. the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, Methyl alcohol may be present in the That: following foods under the conditions (1) The hops extract is added to the specified: wort before or during cooking in the (a) In spice oleoresins as a residue manufacture of beer. from the extraction of spice, at a level (2) The label of the hops extract not to exceed 50 parts per million. specifies the presence of the hexane (b) In hops extract as a residue from and provides for the use of the hops ex- the extraction of hops, at a level not to tract only as prescribed by paragraph exceed 2.2 percent by weight; Provided, (b)(1) of this section. That: (1) The hops extract is added to the § 173.275 Hydrogenated sperm oil. wort before or during cooking in the manufacture of beer. The food additive hydrogenated (2) The label of the hops extract sperm oil may be safely used in accord- specifies the presence of methyl alco- ance with the following prescribed con- hol and provides for the use of the hops ditions: extract only as prescribed by para- (a) The sperm oil is derived from ren- graph (b)(1) of this section. dering the fatty tissue of the sperm whale or is prepared by synthesis of § 173.255 Methylene chloride. fatty acids and fatty alcohols derived Methylene chloride may be present in from the sperm whale. The sperm oil food under the following conditions: obtained by rendering is refined. The (a) In spice oleoresins as a residue oil is hydrogenated. from the extraction of spice, at a level (b) It is used alone or as a component not to exceed 30 parts per million; Pro- of a release agent or lubricant in bak- vided, That, if residues of other ery pans. chlorinated solvents are also present, (c) The amount used does not exceed the total of all residues of such sol- that reasonably required to accomplish vents shall not exceed 30 parts per mil- the intended lubricating effect. lion. (b) In hops extract as a residue from § 173.280 Solvent extraction process the extraction of hops, at a level not to for citric acid. exceed 2.2 percent, Provided, That: A solvent extraction process for re- (1) The hops extract is added to the covery of citric acid from conventional wort before or during cooking in the Aspergillus niger fermentation liquor manufacture of beer. may be safely used to produce food- (2) The label of the hops extract iden- grade citric acid in accordance with tifies the presence of the methylene the following conditions: chloride and provides for the use of the (a) The solvent used in the process hops extract only as prescribed by consists of a mixture of n-octyl alcohol paragraph (b)(1) of this section. meeting the requirements of § 172.864 of (c) In coffee as a residue from its use this chapter, synthetic isoparaffinic as a solvent in the extraction of caf- petroleum hydrocarbons meeting the feine from green coffee beans, at a level requirements of § 172.882 of this chap- not to exceed 10 parts per million (0.001 ter, and tridodecyl amine.

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(b) The component substances are (a) The additive is generated by one used solely as a solvent mixture and in of the following methods: Treating an a manner that does not result in for- aqueous solution of sodium chlorite mation of products not present in con- with either chlorine gas or a mixture of ventionally produced citric acid. sodium hypochlorite and hydrochloric (c) The citric acid so produced meets acid, or treating an aqueous solution of the specifications of the ‘‘Food Chemi- sodium chlorate with hydrogen per- cals Codex,’’ 3d Ed. (1981), pp. 86–87, oxide in the presence of sulfuric acid. which is incorporated by reference In either case, the generator effluent (copies may be obtained from the Na- contains at least 90 percent (by weight) tional Academy Press, 2101 Constitu- of chlorine dioxide with respect to all tion Ave. NW., Washington, DC 20418, chlorine species as determined by or may be examined at the Office of the Method 4500–ClO2 E in the ‘‘Standard Federal Register, 800 North Capitol Methods for the Examination of Water Street, NW., suite 700, Washington, DC and Wastewater,’’ 18th ed., 1992, or an 20408), and the polynuclear aromatic equivalent method. Method 4500–ClO2 E hydrocarbon specifications of § 173.165. is incorporated by reference in accord- (d) Residues of n-octyl alcohol and ance with 5 U.S.C. 552(a) and 1 CFR synthetic isoparaffinic petroleum hy- part 51. Copies are available from the drocarbons are removed in accordance Center for Food Safety and Applied Nu- with good manufacturing practice. Cur- trition (HFS–200), Food and Drug Ad- rent good manufacturing practice re- ministration, 5100 Paint Branch Pkwy., sults in residues not exceeding 16 parts College Park, MD 20740, and the Amer- per million (ppm) n-octyl alcohol and ican Public Health Association, 1015 0.47 ppm synthetic isoparaffinic petro- Fifteenth St. NW., Washington, DC leum hydrocarbons in citric acid. 20005, or may be examined at the Office (e) Tridodecyl amine may be present of the Federal Register, 800 North Cap- as a residue in citric acid at a level not itol St. NW., suite 700, Washington, DC. to exceed 100 parts per billion. (b)(1) The additive may be used as an antimicrobial agent in water used in [42 FR 14491, Mar. 15, 1977, as amended at 49 poultry processing in an amount not to FR 10106, Mar. 19, 1984] exceed 3 parts per million (ppm) residual chlorine dioxide as determined by § 173.290 Trichloroethylene. Method 4500–ClO2 E, referenced in para- Tolerances are established for resi- graph (a) of this section, or an equiva- dues of trichloroethylene resulting lent method. from its use as a solvent in the manu- (2) The additive may be used as an facture of foods as follows: antimicrobial agent in water used to Decaffeinated ground 25 parts per million. wash fruits and vegetables that are not coffee . raw agricultural commodities in an Decaffeinated soluble 10 parts per million. amount not to exceed 3 ppm residual (instant) coffee extract . chlorine dioxide as determined by Spice oleoresins ...... 30 parts per million (provided that if residues Method 4500–ClO2 E, referenced in para- of other chlorinated graph (a) of this section, or an equiva- solvents are also lent method. Treatment of the fruits present, the total of all residues of such sol- and vegetables with chlorine dioxide vents in spice shall be followed by a potable water oleoresins shall not ex- rinse or by blanching, cooking, or can- ceed 30 parts per mil- ning. lion). [60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, as amended at 61 FR Subpart D—Specific Usage 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; Additives 65 FR 34587, May 31, 2000]

§ 173.300 Chlorine dioxide. § 173.310 Boiler water additives. Chlorine dioxide (CAS Reg. No. 10049– Boiler water additives may be safely 04–4) may be safely used in food in ac- used in the preparation of steam that cordance with the following prescribed will contact food, under the following conditions: conditions:

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(a) The amount of additive is not in (b) The compounds are prepared from excess of that required for its func- substances identified in paragraphs (c) tional purpose, and the amount of and (d) of this section, and are subject steam in contact with food does not ex- to the limitations, if any, prescribed: ceed that required to produce the in- (c) List of substances: tended effect in or on the food.

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 (HFSÐ200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC . Ammonium alginate . Cobalt sulfate (as catalyst) . 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809Ð21Ð4) 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 . Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. Total not to exceed 1.5 parts per million in boiler feed water. 71050Ð62Ð9), 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. 26099Ð09Ð2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal- salt. [CAS Reg. No. 30915Ð61Ð8 or CAS Reg. No. 70247Ð culated as the acid). 90Ð4] . 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. 744Ð745, 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 Nu- trition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Reg- ister, 800 North Capitol St. NW., suite 700, Washington, DC. 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 .

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Substances Limitations

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. 306Ð307, 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, 200 C St. SW., Washington, DC, or at the Of- fice of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . Tannin (including quebracho extract) . Tetrasodium EDTA . Tetrasodium pyrophosphate .

(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:

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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) (7.5Ð8.5 moles)/poly fruit and vegetables. (oxypropylene) block copolymer having an average molecular weight of 810; a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3Ð3.7 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) (11.9Ð12.9 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. 245Ð260) Not to exceed 0.2 percent in wash water. May be used in the washing or to assist in the lye peeling of fruits and vegetables.

(3) Sodium mono- and dimethyl naph- Substance Limitations thalene sulfonates (mol. wt. 245–260) Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. may be used in the steam/scald vacuum tetraacetate . peeling of tomatoes at a level not to exceed 0.2 percent in the condensate or (5) Substances identified in this para- scald water. graph (a)(5) for use on fruits and vege- (4) Substances identified in this para- tables that are not raw agricultural graph (a)(4) for use in flume water for commodities and subject to the limita- washing sugar beets prior to the slicing tions provided: operation and subject to the limitations as are provided for the level of the substances in the flume water: Substances Limitations

Substance Limitations Hydrogen peroxide ...... Used in combination with acetic acid to form peroxyacetic acid. a-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. Not to exceed 59 ppm in wash ethylene) produced by con- water. densation of 1 mole of C11- 1-Hydroxyethylidene-1,1- May be used only with peroxy- C486315 straight chain ran- diphosphonic acid . acetic acid. Not to exceed 4.8 domly substituted secondary al- ppm in wash water. cohols with an average of 9 Peroxyacetic acid ...... Prepared by reacting acetic acid moles of ethylene oxide . with hydrogen peroxide. Not to Linear undecylbenzenesulfonic Do. exceed 80 ppm in wash water. acid . Dialkanolamide produced by con- Not to exceed 2 ppm. (b) The chemicals are used in densing 1 mole of methyl laurate with 1.05 moles of amounts not in excess of the minimum diethanolamine . required to accomplish their intended Triethanolamine ...... Do. effect. Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. (c) The use of the chemicals listed Oleic acid conforming with Do. under paragraphs (a)(1), (a)(2), and ¤ 172.860 of this chapter . Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. (a)(4) is followed by rinsing with pota- Monoethanolamine ...... Do. ble water to remove, to the extent pos- Ethylene dichloride ...... Not to exceed 0.2 ppm. sible, residues of the chemicals.

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(d) To assure safe use of the additive: Parts (1) The label and labeling of the addi- per million tive container shall bear, in addition to the other information required by the Sodium dimethyldithiocarbamate ...... 3.0 act, the name of the additive or a (ii) Disodium cyanodithioimidocarbonate ...... 2.9 Potassium N-methyldithiocarbamate ...... 4.1 statement of its composition. (2) The label or labeling of the addi- (4) Single additive for cane-sugar tive container shall bear adequate use mills and beet-sugar mills. directions to assure use in compliance with all provisions of this section. Parts per million [42 FR 14526, Mar. 15, 1977, as amended at 42 2,2-Dibromo-3-nitrilopropionamide (CAS Not more than FR 29856, June 10, 1977; 42 FR 32229, June 24, Reg. No. 10222Ð01Ð2). Limitations: By- 10.0 and not 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, product molasses, bagasse, and pulp less than 2.0. containing residues of 2,2-dibromo-3- 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; nitrilopropionamide are not authorized 64 FR 38564, July 19, 1999] for use in animal feed .

§ 173.320 Chemicals for controlling (5) Combination for cane-sugar mills: microorganisms in cane-sugar and beet-sugar mills. Parts per million Agents for controlling microorganisms in cane-sugar and beet-sugar n-Dodecyl dimethyl benzyl ammonium chlo- mills may be safely used in accordance ride ...... 0.05±0.005 n-Dodecyl dimethyl ethylbenzyl ammonium with the following conditions: chloride ...... 0.68±0.068 (a) They are used in the control of n-Hexadecyl dimethyl benzyl ammonium microorganisms in cane-sugar and/or chloride ...... 0.30±0.030 n-Octadecyl dimethyl benzyl ammonium beet-sugar mills as specified in para- chloride ...... 0.05±0.005 graph (b) of this section. n-Tetradecyl dimethyl benzyl ammonium (b) They are applied to the sugar mill chloride ...... 0.60±0.060 n-Tetradecyl dimethyl ethylbenzyl ammo- grinding, crusher, and/or diffuser sys- nium chloride ...... 0.32±0.032 tems in one of the combinations listed in paragraph (b) (1), (2), (3), or (5) of Limitations. Byproduct molasses, ba- this section or as a single agent listed gasse, and pulp containing residues of in paragraph (b) (4) or (6) of this sec- these quaternary ammonium salts are tion. Quantities of the individual addi- not authorized for use in animal feed. tives in parts per million are expressed (6) Single additive for beet-sugar in terms of the weight of the raw cane mills: or raw beets. (1) Combination for cane-sugar mills: Parts per million

Parts Glutaraldehyde (CAS Reg. No. Not more than 250. per mil- 111Ð30Ð8) . lion (c) To assure safe use of the addi- Disodium cyanodithioimidocarbonate ...... 2.5 Ethylenediamine ...... 1.0 tives, their label and labeling shall Potassium N-methyldithiocarbamate ...... 3.5 conform to that registered with the Environmental Protection Agency. (2) Combination for cane-sugar mills: [42 FR 14526, Mar. 15, 1977, as amended at 47 Parts FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, per mil- 1985; 57 FR 8065, Mar. 6, 1992] lion

Disodium ethylenebisdithiocarbamate ...... 3.0 § 173.322 Chemicals used in delinting Sodium dimethyldithiocarbamate ...... 3.0 cottonseed. Chemicals may be safely used to as- (3) Combinations for cane-sugar mills sist in the delinting of cottonseed in and beet-sugar mills: accordance with the following conditions: Parts per mil- (a) The chemicals consist of one or lion more of the following: (i) Disodium ethylenebisdithiocarbamate ...... 3.0 (1) Substances generally recognized Ethylenediamine ...... 2.0 as safe for direct addition to food.

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(2) Substances identified in this para- million (ppm), in combination with any graph and subject to such limitations GRAS acid at a level sufficient to as are provided: achieve a solution pH of 2.3 to 2.9. (3) When used in a prechiller or chill- Substances Limitations er solution, the additive is used at lev- alpha-Alkyl-omega- May be used at an applica- els that result in sodium chlorite con- hydroxypoly-(oxyethylene) tion rate not to exceed 0.3 centrations between 50 and 150 ppm, in produced by condensation percent by weight of cot- combination with any GRAS acid at of a linear primary alcohol tonseeds to enhance containing an average delinting of cottonseeds in- levels sufficient to achieve a solution chain length of 10 carbons tended for the production pH of 2.8 to 3.2. with poly(oxyethylene) hav- of cottonseed oil. Byprod- (c) The additive is used as an anti- ing an average of 5 ethyl- ucts including lint, hulls, ene oxide units . and meal may be used in microbial agent in accordance with animal feed. current industry practice in the proc- An alkanomide produced by May be used at an applica- essing of red meat, red meat parts, and condensation of coconut oil tion rate not to exceed 0.2 organs as a component of a spray or in fatty acids and dietha- percent by weight of cot- nolamine, CAS Reg. No. tonseeds to enhance the processing of red meat parts and 068603Ð42Ð9. delinting of cottonseeds in- organs as a component of a dip. Applied tended for the production as a dip or spray, the additive is used of cottonseed oil. Byprod- ucts including lint, hulls, at levels that result in sodium chlorite and meal may be used in concentrations between 500 and 1,200 animal feed. ppm in combination with any GRAS acid at levels sufficient to achieve a so- [47 FR 8346, Feb. 26, 1982] lution pH of 2.5 to 2.9. (d) The additive is used as an anti- § 173.325 Acidified sodium chlorite so- microbial agent in water and ice that lutions. are used to rinse, wash, thaw, trans- Acidified sodium chlorite solutions port, or store seafood in accordance may be safely used in accordance with with current industry standards of the following prescribed conditions: good manufacturing practice. The addi- (a) The additive is produced by mix- tive is produced by mixing an aqueous ing an aqueous solution of sodium chlo- solution of sodium chlorite with any rite (CAS Reg. No. 7758–19–2) with any GRAS acid to achieve a pH in the range generally recognized as safe (GRAS) of 2.5 to 2.9 and diluting this solution acid. with water to achieve an actual use (b)(1) The additive is used as an anti- concentration of 40 to 50 parts per mil- microbial agent in poultry processing lion (ppm) sodium chlorite. Any sea- water in accordance with current in- food that is intended to be consumed dustry practice under the following raw shall be subjected to a potable conditions: water rinse prior to consumption. (i) As a component of a carcass spray (e) The additive is used as an anti- or dip solution prior to immersion of microbial agent on raw agricultural the intact carcass in a prechiller or commodities in the preparing, packing, chiller tank; or holding of the food for commercial (ii) In a prechiller or chiller solution purposes, consistent with section for application to the intact carcass; 201(q)(1)(B)(i) of the act, and not ap- (iii) As a component of a spray or dip plied for use under section solution for application to poultry car- 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or cass parts; (q)(1)(B)(i)(III) of the act, in accordance (iv) In a prechiller or chiller solution with current industry standards of for application to poultry carcass good manufacturing practice. Applied parts; or as a dip or a spray, the additive is used (v) As a component of a post-chill at levels that result in chlorite con- carcass spray or dip solution when ap- centrations of 500 to 1200 parts per mil- plied to poultry meat, organs, or re- lion (ppm), in combination with any lated parts or trim. GRAS acid at levels sufficient to (2) When used in a spray or dip solu- achieve a pH of 2.3 to 2.9. Treatment of tion, the additive is used at levels that the raw agricultural commodities with result in sodium chlorite concentra- acidified sodium chlorite solutions tions between 500 and 1,200 parts per shall be followed by a potable water

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rinse, or by blanching, cooking, or can- Food and Drug Administration, 5100 ning. Paint Branch Pkwy., College Park, MD (f) The additive is used as an anti- 20740, or may be examined at the Cen- microbial agent on processed, ter for Food Safety and Applied Nutri- comminuted or formed meat food prod- tion’s Library, 200 C St. SW., Wash- ucts (unless precluded by standards of ington, DC 20204–0001, or the Office of identity in 9 CFR part 319) prior to the Federal Register, 800 North Capitol packaging of the food for commercial St. NW., Suite 700, Washington, DC. purposes, in accordance with current [61 FR 17829, Apr. 23, 1996, as amended at 63 industry standards of good manufac- FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, turing practice. Applied as a dip or 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, spray, the additive is used at levels Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR that result in sodium chlorite con- 22922, May 7, 2001; 66 FR 31841, June 13, 2001] centrations of 500 to 1200 ppm, in combination with any GRAS acid at levels § 173.340 Defoaming agents. sufficient to achieve a pH of 2.5 to 2.9. Defoaming agents may be safely used (g) The concentration of sodium chlo- in processing foods, in accordance with rite is determined by a method entitled the following conditions: ‘‘Determination of Sodium Chlorite: 50 (a) They consist of one or more of the ppm to 1500 ppm Concentration,’’ Sep- following: tember 13, 1995, developed by Alcide (1) Substances generally recognized Corp., Redmond, WA, which is incor- by qualified experts as safe in food or porated by reference in accordance covered by prior sanctions for the use with 5 U.S.C. 552(a) and 1 CFR part 51. prescribed by this section. Copies are available from the Division (2) Substances listed in this para- of Petition Control (HFS–215), Center graph (a)(2) of this section, subject to for Food Safety and Applied Nutrition, 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 1.400Ð1.404 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. 9003Ð11Ð6) 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 paragraph (a)(3), provided they are components of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations imposed:

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, 1,200Ð3,000. 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 .

(4) The substances listed in this para- Substances Limitations graph (a)(4), provided they are compo- n-Butoxypoly(oxyethylene)- Viscosity range, 4,850Ð5,350 nents of defoaming agents limited to poly(oxypropylene)glycol . Saybolt Universal Seconds use in processing beet sugar only, and (SUS) at 37.8 °C (100 °F). subject to the limitations imposed: The viscosity range is determined by the method ‘‘Viscosity Determination of n-butoxypoly(oxyethylene)- poly(oxypropylene) glycol’’ dated April 26, 1995, developed by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference are available from the Division of Petition Control, Center for Food Safety and Applied Nutri- tion (HFSÐ215), Food and Drug Administration, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, and may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Wash- ington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

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Substances Limitations foamed or sprayed food products, with any propellant effect being incidental Monoester of alpha-hydro- omega-hydroxy- and no more than is minimally nec- poly(oxyethylene) essary to achieve the aerating func- poly(oxypropylene) tion, except that use is not permitted poly(oxyethylene) (15 mole minimum) blocked copoly- for those standardized foods that do mer derived from low eru- not provide for such use. cic acid rapeseed oil . (c) To assure safe use of the additive (b) They are added in an amount not (1) The label of the food additive con- in excess of that reasonably required to tainer shall bear, in addition to the inhibit foaming. other information required by the act, the following: [42 FR 14526, Mar. 15, 1977, as amended at 43 (i) The name of the additive, FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, chloropentafluoroethane. Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR (ii) The percentage of the additive 29134, May 28, 1998] present in the case of a mixture. (iii) The designation ‘‘food grade’’. § 173.342 Chlorofluorocarbon 113 and perfluorohexane. (2) The label or labeling of the food additive container shall bear adequate A mixture of 99 percent directions for use. chlorofluorocarbon 113 (1,1,2-trichloro- 1,2,2-trifluoroethane) (CAS Reg. No. 76– [42 FR 14526, Mar. 15, 1977, as amended at 43 13–1, also known as fluorocarbon 113, FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, CFC 113 and FC 113) and 1 percent 1978] perfluorohexane (CAS Reg. No. 355–42– 0) may be safely used in accordance § 173.350 Combustion product gas. with the following prescribed condi- The food additive combustion prod- tions: uct gas may be safely used in the proc- (a) The additive chlorofluorocarbon essing and packaging of the foods des- 113 has a purity of not less than 99.99 ignated in paragraph (c) of this section percent. for the purpose of removing and dis- (b) The additive mixture is intended placing oxygen in accordance with the for use to quickly cool or crust-freeze following prescribed conditions: chickens sealed in intact bags composed of substances regulated in parts (a) The food additive is manufactured 174, 175, 177, 178, and § 179.45 of this by the controlled combustion in air of chapter and conforming to any limita- butane, propane, or natural gas. The tions or specifications in such regula- combustion equipment shall be pro- tions. vided with an absorption-type filter capable of removing possible toxic impu- [55 FR 8913, Mar. 9, 1990] rities, through which all gas used in § 173.345 Chloropentafluoroethane. the treatment of food shall pass; and with suitable controls to insure that The food additive any combustion products failing to chloropentafluoroethane may be safely used in food in accordance with the fol- meet the specifications provided in this lowing prescribed conditions: section will be prevented from reaching (a) The food additive has a purity of the food being treated. not less than 99.97 percent, and con- (b) The food additive meets the fol- tains not more than 200 parts per mil- lowing specifications: lion saturated fluoro compounds and 10 (1) Carbon monoxide content not to parts per million unsaturated fluoro exceed 4.5 percent by volume. compounds as impurities. (2) The ultraviolet absorbance in iso- (b) The additive is used or intended octane solution in the range 255 milli- for use alone or with one or more of the microns to 310 millimicrons not to ex- following substances: Carbon dioxide, ceed one-third of the standard ref- nitrous oxide, propane, and erence absorbance when tested as de- octafluorocyclobutane complying with scribed in paragraph (e) of this section. § 173.360, as an aerating agent for

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(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 essing, storage, or packaging of bev- such, and both inlet and vessel are so de- erage products and other food, except signed, that the gas can be bubbled through 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 combustion product gas that complies mark. with the limitations prescribed in para- Caution. The various parts of the absorption 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 microns to 310 millimicrons, under the same of isooctane in the coolant bath so that the instrumental conditions. The standard ref- solvent is completely immersed. Cool for at erence absorbance is the absorbance at 275 least 15 minutes and then pass 120 liters of millimicrons of a standard reference solution the test gas through the absorption train at of naphthalene (National Bureau of Stand- a rate of 30 liters per hour or less. Maintain ards Material No. 577 or equivalent in purity) the coolant bath at 0 °C throughout. Remove containing a concentration of 1.4 milligrams the absorption vessel from the bath, disper liter in purified isooctane, measured connect, and warm to room temperature. against isooctane of the same spectral purity Add isooctane to bring the contents of the in 5-centimeter cells. (This absorbance will absorption vessel to 60 milliliters, and mix. be approximately 0.30.) Determine the absorbance of the solution in Solvent. The solvent used is pure grade iso- the 5-centimeter cell in the range 255 milli- octane having an ultraviolet absorbance not microns to 310 millimicrons, inclusive, com- to exceed 0.05 measured against distilled pared to isooctane. The absorbance of the so- water as a reference. Upon passage of puri- lution of combustion product gas shall not fied inert gas through some isooctane under exceed that of the isooctane solvent at any the identical conditions of the test, a low- wavelength in the specified range by more ering of the absorbance value has been ob- than one-third of the standard reference ab- served. The absorbance of isooctane to be sorbance. used in this procedure shall not be more than 0.02 lower in the range 255 millimicrons to § 173.355 Dichlorodifluoromethane. 310 millimicrons, inclusive, than that of the untreated solvent as measured in a 5-centi- The food additive dichlorodi- meter cell. If necessary to obtain the pre- fluoromethane may be safely used in scribed purities, the isooctane may be passed food in accordance with the following through activated silica gel. prescribed conditions: Apparatus. To assure reproducible results, (a) The additive has a purity of not the additive is passed into the isooctane so- less than 99.97 percent. lution through a gas-absorption train consisting of the following components and nec- (b) It is used or intended for use, in essary connections: accordance with good manufacturing 1. A gas flow meter with a range up to 30 practice, as a direct-contact freezing liters per hour provided with a constant dif- agent for foods. ferential relay or other device to maintain a (c) To assure safe use of the additive: constant flow rate independent of the input (1) The label of its container shall pressure. bear, in addition to the other informa- 2. An absorption apparatus consisting of an tion required by the act, the following: inlet gas dispersion tube inserted to the bot- (i) The name of the additive, dichlo- tom of a covered cylindrical vessel with a suitable outlet on the vessel for effluent gas. rodifluoromethane, with or without the The dimensions and arrangement of tube and parenthetical name ‘‘Food Freezant vessel are such that the inlet tube introduces 12’’. the gas at a point not above 51⁄4 inches below (ii) The designation ‘‘food grade’’.

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(2) The label or labeling of the food tions in accordance with the following additive container shall bear adequate conditions: directions for use. (a) The materials consist of one or more of the following: § 173.357 Materials used as fixing (1) Substances generally recognized agents in the immobilization of en- as safe in food. zyme preparations. (2) Substances identified in this sub- Fixing agents may be safely used in paragraph and subject to such limita- the immobilization of enzyme preparations as are provided:

Substances Limitations

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. Glutaraldehyde ...... Do. Periodic acid (CAS Reg. No. 10450Ð60Ð 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. 68130Ð97Ð2) 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 (HFSÐ200), 5100 Nutrition (HFSÐ215), 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, 200 C 20740, and may be examined at the St. SW., Washington, DC, or the Office of the Federal Register, 800 North Cap- Center for Food Safety and Applied Nu- itol St. NW., suite 700, Washington, DC. trition’s Library, 200 C St. SW., Wash- ington, DC, or at the Office of the Fed- eral Register, 800 North Capitol St. NW., suite 700, Washington, DC .

(b) The fixed enzyme preparation is (b) The additive is used or intended washed to remove residues of the fixing for use alone or with one or more of the materials. following substances: Carbon dioxide, [48 FR 5716, Feb. 8, 1983, as amended at 52 FR nitrous oxide, and propane, as a propel- 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; lant and aerating agent for foamed or 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, sprayed food products, except for those 1996; 61 FR 14245, Apr. 1, 1996] standardized foods that do not provide for such use. § 173.360 Octafluorocyclobutane. (c) To assure safe use of the additive: The food additive octafluorocyclo-bu- (1) The label of the food additive con- tane may be safely used as a propellant tainer shall bear, in addition to the and aerating agent in foamed or other information required by the act, sprayed food products in accordance the following: with the following conditions: (i) The name of the additive, (a) The food additive meets the fol- octafluorocyclobutane. lowing specifications: (ii) The percentage of the additive 99.99 percent octafluorocyclobutane. present in the case of a mixture. Less than 0.1 part per million fluoroolefins, (iii) The designation ‘‘food grade’’. calculated as perfluoroisobutylene.

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(2) The label or labeling of the food § 173.370 Peroxyacids. additive container shall bear adequate Peroxyacids may be safely used in ac- directions for use. cordance with the following prescribed conditions: § 173.368 Ozone. (a) The additive is a mixture of per- Ozone (CAS Reg. No. 10028–15–6) may oxyacetic acid, octanoic acid, acetic be safely used in the treatment, stor- acid, hydrogen peroxide, age, and processing of foods, including peroxyoctanoic acid, and 1- meat and poultry (unless such use is hydroxyethylidene-1,1-diphosphonic precluded by standards of identity in 9 acid. CFR part 319), in accordance with the (b)(1) The additive is used as an anti- following prescribed conditions: microbial agent on red meat carcasses in accordance with current industry (a) The additive is an unstable, color- practice where the maximum con- less gas with a pungent, characteristic centration of peroxyacids is 220 parts odor, which occurs freely in nature. It per million (ppm) as peroxyacetic acid, is produced commercially by passing and the maximum concentration of hy- electrical discharges or ionizing radi- drogen peroxide is 75 ppm. ation through air or oxygen. (2) The additive is used as an anti- (b) The additive is used as an antimicrobial agent on poultry carcasses, microbial agent as defined in poultry parts, and organs in accord- § 170.3(o)(2) of this chapter. ance with current industry standards (c) The additive meets the specifica- of good manufacturing practice (unless tions for ozone in the Food Chemicals precluded by the U.S. Department of Codex, 4th ed. (1996), p. 277, which is in- Agriculture’s standards of identity in 9 corporated by reference. The Director CFR part 381, subpart P) where the of the Office of the Federal Register maximum concentration of approves this incorporation by ref- peroxyacids is 220 parts per million erence in accordance with 5 U.S.C. (ppm) as peroxyacetic acid, the maximum concentration of hydrogen per- 552(a) and 1 CFR part 51. Copies are oxide is 110 ppm, and the maximum available from the National Academy concentration of 1-hydroxyethylidene- Press, 2101 Constitution Ave. NW., 1,1-diphosphonic acid (HEDP) is 13 ppm. Washington, DC 20055, or may be exam- (c) The concentrations of peroxyacids ined at the Office of Premarket Ap- and hydrogen peroxide in the additive proval (HFS–200), Center for Food Safe- are determined by a method entitled ty and Applied Nutrition, Food and ‘‘Hydrogen Peroxide and Peracid (as Drug Administration, 200 C St. SW., Peracetic Acid) Content,’’ July 26, 2000, Washington, DC, and the Office of the developed by Ecolab, Inc., St. Paul, Federal Register, 800 North Capitol St. MN, which is incorporated by ref- NW., suite 700, Washington, DC. erence. The concentration of 1- (d) The additive is used in contact hydroxyethylidene-1,1-diphosphonic with food, including meat and poultry acid is determined by a method enti- (unless such use is precluded by stand- tled ‘‘Determination of 1- ards of identity in 9 CFR part 319 or 9 hydroxyethylidene-1,1-diphosphonic CFR part 381, subpart P), in the gas- acid (HEDP) Peroxyacid/Peroxide-Con- eous or aqueous phase in accordance taining Solutions,’’ August 21, 2001, de- with current industry standards of veloped by Ecolab, Inc., St. Paul, MN, good manufacturing practice. which is incorporated by reference. The (e) When used on raw agricultural Director of the Office of the Federal commodities, the use is consistent with Register approves these incorporations section 201(q)(1)(B)(i) of the Federal by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You Food, Drug, and Cosmetic Act (the act) may obtain copies of these methods and not applied for use under section from the Division of Petition Review, 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or Center for Food Safety and Applied Nu- (q)(1)(B)(i)(III) of the act. trition, Food and Drug Administration, [66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 5100 Paint Branch Pkwy., College Park, 2002] MD 20740, or you may examine a copy

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at the Center for Food Safety and Ap- (1980), which is incorporated by ref- plied Nutrition’s Library, 200 C St. erence. Copies may be obtained from SW., Washington, DC, or at the Office the Association of Official Analytical of the Federal Register, 800 North Cap- Chemists International, 481 North itol St. NW., suite 700, Washington, DC. Frederick Ave., suite 500, Gaithersburg, MD 20877–2504, or may be examined at [65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001] the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, § 173.385 Sodium methyl sulfate. Washington, DC 20408. Sodium methyl sulfate may be [43 FR 54237, Nov. 11, 1978, as amended at 49 present in pectin in accordance with FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, the following conditions. 1989] (a) It is present as the result of methylation of pectin by sulfuric acid § 173.400 Dimethyldialkylammonium chloride. and methyl alcohol and subsequent treatment with sodium bicarbonate. Dimethyldialkylammonium chloride (b) It does not exceed 0.1 percent by may be safely used in food in accord- weight of the pectin. ance with the following prescribed conditions: § 173.395 Trifluoromethane sulfonic (a) The food additive is produced by acid. one of the following methods: Trifluoromethane sulfonic acid has (1) Ammonolysis of natural tallow the empirical formula CF 3 SO 3 H (CAS fatty acids to form amines that are Reg. No. 1493–13–6). The catalyst subsequently reacted with methyl chlo- (Trifluoromethane sulfonic acid) may ride to form the quaternary ammonium safely be used in the production of compounds consisting primarily of cocoa butter substitute from palm oil dimethyldioctadecylammonium chlo- (1-palmitoyl-2-oleoyl-3-stearin) (see ride and dimethyldihexadecyl- § 184.1259 of this chapter) in accordance ammonium chloride. The additive may with the following conditions: contain residues of isopropyl alcohol (a) The catalyst meets the following not in excess of 18 percent by weight specifications: when used as a processing solvent. (2) Ammonolysis of natural tallow Appearance, Clear liquid. fatty acids to form amines that are Color, Colorless to amber. Neutralization equivalent, 147–151. then reacted with 2-ethylhexanal, re- Water, 1 percent maximum. duced, methylated, and subsequently Fluoride ion, 0.03 percent maximum. reacted with methyl chloride to form Heavy metals (as Pb), 30 parts per million the quaternary ammonium compound maximum. known as dimethyl(2-ethylhexyl) hy- Arsenic (as As), 3 parts per million max- drogenated tallow ammonium chloride imum. and consisting primarily of dimethyl(2- (b) It is used at levels not to exceed ethylhexyl)octadecylammonium chlo- 0.2 percent of the reaction mixture to ride and dimethyl(2-ethyl- catalyze the directed esterification. hexyl)hexadecylammonium chloride. (c) The esterification reaction is (b) The food additive described in quenched with steam and water and paragraph (a)(1) of this section con- the catalyst is removed with the aque- tains not more than a total of 2 percent ous phase. Final traces of catalyst are by weight of free amine and amine hy- removed by washing batches of the drochloride. The food additive de- product three times with an aqueous scribed in paragraph (a)(2) of this sec- solution of 0.5 percent sodium bicar- tion contains not more than 3 percent bonate. by weight, each, of free amine and (d) No residual catalyst may remain amine hydrochloride as determined by in the product at a detection limit of A.O.C.S. method Te 3a–64, ‘‘Acid Value 0.2 part per million fluoride as deter- and Free Amine Value of Fatty Quater- mined by the method described in ‘‘Of- nary Ammonium Chlorides,’’ 2d print- ficial Methods of Analysis of the Asso- ing including additions and revisions ciation of Official Analytical Chem- 1990, which is incorporated by reference ists,’’ sections 25.049–25.055, 13th Ed. in accordance with 5 U.S.C. 552(a) and 1

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CFR part 51. Copies are available from PART 174—INDIRECT FOOD the Center for Food Safety and Applied ADDITIVES: GENERAL Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Sec. Pkwy., College Park, MD 20740, and 174.5 General provisions applicable to indi- from the American Oil Chemists’ Soci- rect food additives. ety, P.O. Box 5037, Station A, Cham- 174.6 Threshold of regulation for substances paign, IL 61820, or available for inspec- used in food–contact articles. tion at the Office of the Federal Reg- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. ister, 800 North Capitol Street, NW., suite 700, Washington, DC. § 174.5 General provisions applicable (c) The food additive is used as a de- to indirect food additives. colorizing agent in the clarification of (a) Regulations prescribing condi- refinery sugar liquors under the fol- tions under which food additive sub- lowing limitations: stances may be safely used predicate (1) The food additive described in usage under conditions of good manu- paragraph (a)(1) of this section is added facturing practice. For the purpose of only at the defecation/clarification this part and parts 175, 176, and 177 of stage of sugar liquor refining in an this chapter, good manufacturing prac- amount not to exceed 700 parts per mil- tice shall be defined to include the fol- lion by weight of sugar solids. lowing restrictions: (2) The food additive described in (1) The quantity of any food additive paragraph (a)(2) of this section is used substance that may be added to food as under the following conditions: a result of use in articles that contact (i) The additive is adsorbed onto a food shall not exceed, where no limits support column composed of suitable are specified, that which results from polymers that are regulated for con- use of the substance in an amount not tact with aqueous food. Excess non- more than reasonably required to ac- adsorbed additive shall be rinsed away complish the intended physical or tech- with potable water prior to passage of nical effect in the food-contact article; sugar liquor through the column. shall not exceed any prescribed limita- (ii) The residue of the additive in the tions; and shall not be intended to ac- decolorized sugar liquor prior to crys- complish any physical or technical ef- tallization shall not exceed 1 part per fect in the food itself, except as such million of sugar as determined by a may be permitted by regulations in method entitled ‘‘Colorimetric Deter- parts 170 through 189 of this chapter. mination of Residual Quaternary Am- (2) Any substance used as a compo- monium Compounds (Arquad HTL8) in nent of articles that contact food shall Sugar and Sugar Solutions,’’ June 13, be of a purity suitable for its intended 1990, which is incorporated by reference use. in accordance with 5 U.S.C. 552(a) and 1 (b) The existence in the subchapter B CFR part 51. Copies are available from of a regulation prescribing safe condi- the Center for Food Safety and Applied tions for the use of a substance as an Nutrition (HFS–200), Food and Drug article or component of articles that Administration, 5100 Paint Branch contact food shall not be construed to Pkwy., College Park, MD 20740, or relieve such use of the substance or ar- available for inspection at the Office of ticle from compliance with any other the Federal Register, 800 North Capitol provision of the Federal Food, Drug, Street, NW., suite 700, Washington, DC. 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 [56 FR 42686, Aug. 29, 1991] compliance with section 402(a)(3).

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(c) The existence in this subchapter B 175.230 Hot-melt strippable food coatings. of a regulation prescribing safe condi- 175.250 Paraffin (synthetic). tions for the use of a substance as an 175.260 Partial phosphoric acid esters of pol- article or component of articles that yester resins. 175.270 Poly(vinyl fluoride) resins. contact food shall not be construed as 175.300 Resinous and polymeric coatings. implying that such substance may be 175.320 Resinous and polymeric coatings for safely used as a direct additive in food. polyolefin films. (d) Substances that under conditions 175.350 Vinyl acetate/crotonic acid copoly- of good manufacturing practice may be mer. safely used as components of articles 175.360 Vinylidene chloride copolymer coat- that contact food include the fol- ings for nylon film. 175.365 Vinylidene chloride copolymer coat- lowing, subject to any prescribed limi- ings for polycarbonate film. tations: 175.380 Xylene-formaldehyde resins con- (1) Substances generally recognized densed with 4,4′-isopropylidenediphenol- as safe in or on food. epichlorohydrin epoxy resins. (2) Substances generally recognized 175.390 Zinc-silicon dioxide matrix coatings. as safe for their intended use in food AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. packaging. (3) Substances used in accordance SOURCE: 42 FR 14534, Mar. 15, 1977, unless with a prior sanction or approval. otherwise noted. (4) Substances permitted for use by EDITORIAL NOTE: Nomenclature changes to regulations in this part and parts 175, part 175 appear at 61 FR 14482, Apr. 2, 1996, 176, 177, 178 and § 179.45 of this chapter. and 66 FR 56035, Nov. 6, 2001. [42 FR 14534, Mar. 15, 1977] Subpart A [Reserved] § 174.6 Threshold of regulation for substances used in food-contact ar- Subpart B—Substances for Use ticles. Only as Components of Adhesives Substances used in food-contact articles (e.g., food-packaging or food-proc- § 175.105 Adhesives. essing equipment) that migrate, or (a) Adhesives may be safely used as that may be expected to migrate, into components of articles intended for use food at negligible levels may be re- in packaging, transporting, or holding viewed under § 170.39 of this chapter. food in accordance with the following The Food and Drug Administration prescribed conditions: will exempt substances whose uses it (1) The adhesive is prepared from one determines meet the criteria in § 170.39 or more of the optional substances of this chapter from regulation as food named in paragraph (c) of this section, additives and, therefore, a food addi- subject to any prescribed limitations. tive petition will not be required for (2) The adhesive is either separated the exempted use. 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 adhesive that contacts packaged dry food TIVES: ADHESIVES AND COMPO- shall not exceed the limits of good NENTS OF COATINGS manufacturing practice. (ii) In fatty and aqueous foods. (a) The Subpart A [Reserved] quantity of adhesive that contacts packaged fatty and aqueous foods shall Subpart B—Substances for Use Only as not exceed the trace amount at seams Components of Adhesives and at the edge exposure between pack- Sec. aging laminates that may occur within 175.105 Adhesives. the limits of good manufacturing prac- 175.125 Pressure-sensitive adhesives. tice. (b) Under normal conditions of use Subpart C—Substances for Use as the packaging seams or laminates will Components of Coatings remain firmly bonded without visible 175.210 Acrylate ester copolymer coating. separation.

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(b) To assure safe usage of adhesives, tions of use prescribed by such sanc- the label of the finished adhesive con- tion or approval. tainer shall bear the statement ‘‘food- (3) Flavoring substances permitted packaging adhesive’’. for use in food by regulations in this (c) Subject to any limitation pre- part, provided that such flavoring sub- scribed in this section and in any other stances are volatilized from the adhe- regulation promulgated under section sives during the packaging fabrication 409 of the Act which prescribes safe process. conditions of use for substances that (4) Color additives approved for use in may be employed as constituents of ad- food. hesives, the optional substances used (5) Substances permitted for use in in the formulation of adhesives may in- adhesives by other regulations in this clude the following: subchapter and substances named in (1) Substances generally recognized this subparagraph: Provided, however, as safe for use in food or food pack- That any substance named in this aging. paragraph and covered by a specific (2) Substances permitted for use in regulation in this subchapter, must adhesives by prior sanction or approval meet any specifications in such regula- and employed under the specific condition.

Substances Limitations

Abietic acid . Acetone . Acetone-formaldehyde condensate (CAS Reg. No. 25619Ð09Ð4) . 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. 35641Ð59Ð9) . 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. 70983Ð55Ð0) . 4-[2-[2-2-(Alkoxy (C12ÐC15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate . 1-Alkyl (C6ÐC18) amino-3-amino-propane monoacetate . Alkylated (C4 and/or C8) phenols . Alkyl (C7ÐC12) benzene . Alkyl (C10ÐC20) 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 (C7ÐC12) naphthalene . alpha Olefin sulfonate [alkyl group is in the range of C10ÐC18 with not less than 50 percent C14ÐC16], ammonium, calcium, magnesium, potassium, and sodium salts . 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111Ð41Ð1) . 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.

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Substances Limitations

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. 57569Ð40Ð1) . 1,2ÐBenzisothiazolinÐ3Ðone (CAS Registry No. 2634Ð33Ð5) ...... 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. 105442Ð85Ð1) 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. 32687Ð78Ð8) . 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. 17540Ð75Ð9) . 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. 991Ð84Ð4) . Bis(tri-n-butyltin) oxide ...... For use as preservative only. Bis(trichloromethyl)sulfone C.A. Registry No. 3064Ð70Ð8 ...... Do. Borax . Boric acid . 2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52Ð51Ð7) ...... 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. 144093Ð88Ð9]). . 1,3-Butanediol . 1,4-Butanediol . 1,4-Butanediol modified with adipic acid . Butoxy polyethylene polyproplyene glycol (molecular weight 900Ð4,200) . 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 .

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Substances Limitations

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 (4Ð84 moles ethylene oxide) . Cellulose acetate butyrate . Cellulose acetate propionate . Ceresin wax (ozocerite) . Cetyl alcohol . Chloracetamide . Chloral hydrate . Chlorinated liquid n-paraffins with chain lengths of C10ÐC17, containing 40Ð70 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. 26172Ð55Ð4) and For use only as an antimicrobial agent in polymer 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682Ð20Ð4) mixture at a latex emulsions. ratio of 3 parts to 1 part, manufactured from methyl-3- mercaptopropionate (CAS Reg. No. 2935Ð90Ð2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377Ð60Ð3) 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. 35541Ð81Ð2) . Cyclohexanol . Cyclohexanone resin . Cyclohexanone-formaldehyde condensate . N-Cyclohexyl p-toluene sulfonamide . (η5-Cyclopentadienyl)-(η6-isopropylbenzene)iron(II) hexafluorophosphate For use only as a photoinitiator. (CAS Reg. No. 32760Ð80Ð8) . 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 (C12ÐC24) . 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 . 1,2ÐDibromoÐ2,4Ðdicyanobutane (CAS Registry No. 3569Ð65Ð7) ...... For use as a preservative only. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222Ð01Ð2)...... For use as a preservative only.

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Substances Limitations

Di(butoxyethyl) phthalate . 2,5-Di-tert-butylhydroquinone . Dibutyl maleate . 2,6-Di-tert-butyl-4-methylphenol ...... For use as preservative only. Di(C7, C9-alkyl)adipate . Dibutyl phthalate . Dibutyl sebacate . Dibutyltin dilaurate for use only as a catalyst for polyurethane resins . 1,2-Dichloroethylene (mixed isomers) . Dicumyl peroxide . Dicyclohexyl phthalate . Diethanolamine . Diethanolamine condensed with animal or vegetable fatty acids . Diethylamine . Diethylene glycol . Diethylene glycol adipic acid copolymer . Diethylene glycol dibenzoate . Diethylene glycol hydrogenated tallowate monoester . Diethylene glycol laurate . Diethylene glycol monobutyl ether . Diethylene glycol monobutyl ether acetate . Diethylene glycol monoethyl ether . Diethylene glycol monoethyl ether acetate . Diethylene glycol monomethyl ether . Diethylene glycol monooleate . Diethylene glycol monophenyl ether . Diethylene glycol copolymer of adipic acid and phthalic anhydride . Di(2-ethylhexyl) adipate . Di(2-ethylhexyl)hexahydrophthalate . Di(2-ethylhexyl)phthalate . Diethyl oxalate . Diethyl phthalate . Dihexyl phthalate . Dihydroabietylphthalate . Di(2-hydroxy-5-tert-butylphenyl) sulfide . 2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene) . 4,5-Dihydroxy-2-imidazolidinone . 4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018Ð09Ð01 ...... 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 ...... DipenteneÐstyrene resin (CAS Registry No. 64536Ð06Ð7) . Diphenyl-2-ethylhexyl phosphate . Diphenyl, hydrogen ated . N,N′-Diphenyl-p-phenylenediamine . Diphenyl phthalate . 1,3-Diphenyl-2-thiourea . Dipropylene glycol .

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Substances Limitations

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. 37294Ð49Ð8) . N,N′-Distearoylethylenediamine . Distearyl thiodipropionate . 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only. droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione . 4,4′-Dithiodimorpholine . n-Dodecylmercaptan . tert-Dodecylmercaptan . Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts . Elemi gum . Epichlorohydrin-4,4′-isopropylidenediphenol resin . Epichlorohydrin-4,4′-sec-butylidenediphenol resin . Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin . Epichlorohydrin-phenolformaldehyde resin . Erucamide (erucylamide) . Ethanolamine . Ethoxylated primary linear alcohols of greater than 10 percent ethylene oxide by weight having molecular weights of 390 to 7,000 (CAS Reg. No. 97953Ð22Ð5) . Ethoxypropanol butyl ether . Ethyl alcohol (ethanol) . 5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336Ð82Ð0) . Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756Ð27Ð9) . 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. 25750Ð82Ð7) . 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. 25052Ð62Ð4) 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. 26221Ð73Ð8) . Ethylene-propylene-dicyclopentadiene copolymer rubber . Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer . Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337Ð35Ð9) containing not more than 15 weight percent of units derived from carbon monoxide . 2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958Ð30Ð6) . 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. 118337Ð09Ð0) . 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 .

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Substances Limitations

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. 13822Ð56Ð5) . 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. 25791Ð96Ð2) . urethane resins in adhesives. Glyceryl borate (glycol boriborate resin) . Glyceryl ester of damar, copal, elemi, and sandarac . Glyceryl monobutyl ricinoleate . Glyceryl monohydroxy stearate . Glyceryl monohydroxy tallowate . Glyceryl polyoxypropylene triol (average molecular weight 1,000) . Glyceryl tribenzoate . Glycol diacetate . Glyoxal . Heptane . Hexamethylenetetramine . Hexane . Hexanetriols . Hexylene glycol . Hydroabietyl alcohol . Hydrocarbon resins (produced by polymerization of mixtures of mono- and di-unsaturated hydrocarbons of the aliphatic, alicyclic, and monobenzenoid type derived both from cracked petroleum and terpene stocks) (CAS Reg. No. 68239Ð99Ð6) . Hydrocarbon resins (produced by the polymerization of styrene and alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441Ð37Ð2) . 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. 106168Ð39Ð2) . Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168Ð36Ð9) . Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168Ð37Ð0) . 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 . 2ÐHydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex- Reg. No. 106797Ð53Ð9) . ceed 5 percent by weight of the adhesive. 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6ÐC17) 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 .

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Substances Limitations

2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate . 2-Imidazolidinone . 3ÐIodoÐ2Ðpropynyl-N-butyl carbamate (CAS Reg. No. 55406Ð53Ð6) ...... 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. 131298Ð44Ð77) . 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 . 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 .

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Substances Limitations

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) (1Ð2 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 6Ð9 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 1Ð40 moles of ethylene oxide . 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 . α-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. 70331Ð94Ð1) . Oxazoline . a-(oxiranylmethyl)-ω-(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. 26142Ð30Ð3) . 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. 41638Ð13Ð based resins. 5) . n-Oxydiethylene-benzothiazole . Palmitamide (palmitic acid amide) . Paraffin (C12ÐC20) sulfonate . Paraformaldehyde . Pentachlorophenol . Pentaerythritol ester of maleic anhydride . Pentaerythritol monostearate ...... For use as preservative only. Pentaerythritol tetrabenzoate [CAS Registry No. 4196Ð86Ð5] . Pentaerythritol tetrastearate . 2,4-Pentanedione . Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140Ð01Ð2) . 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.

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Substances Limitations

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. 9046Ð10Ð0) . Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046Ð10Ð0) . 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. 94Ð60Ð0) . Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975Ð82Ð1) and/or its sodium salt (CAS Reg. No. 3965Ð55Ð7) . 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. 6362Ð79Ð4) . Tetrahydrophthalic acid . Alcohols: 1,4-Cyclohexanedimethanol . 2,2-Dimethyl-1,3-propanediol . 1,6-Hexanediol (CAS Reg. No. 629Ð11Ð8) . 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 200Ð6,000) . Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413Ð26Ð6) . Polyethyleneglycol alkyl(C10ÐC12) ether sulfosuccinate, disodium salt (CAS Reg. No. 68954Ð91Ð6) . 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 .

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Substances Limitations

Allylmethacrylate (CAS Reg. No. 00096Ð05Ð09) . Butadiene . Butene . N-tert-Butylacrylamide . Butyl acrylate . 1,3-Butylene glycol dimethacrylate . Butyl methacrylate . Crotonic acid . Decyl acrylate . Diallyl fumarate . Diallyl maleate . Diallyl phthalate . Dibutyl fumarate . Dibutyl itaconate . Dibutyl maleate . Di(2-ethylhexyl) maleate . Dimethyl-a-methylstyrene . Dioctyl fumarate . Dioctyl maleate . Divinylbenzene . Ethyl acrylate . Ethylene . Ethylene cyanohydrin . 2-Ethylhexyl acrylate . Ethyl methacrylate . Fatty acids, C10-13-branched, vinyl esters (CAS Reg. No. 184785Ð 38Ð4) . Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl, heptyl and octyl esters . Glycidyl methacrylate . 1ÐHexene (CAS Reg. No. 592Ð41Ð6) . 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. 111Ð66Ð0) . 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 .

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Substances Limitations

Polyoxyethylene (molecular weight 200) dibenzoate . Polyoxyethylene (molecular weight 200Ð600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil) . Polyoxyethylene (15 moles) ester of rosin . Polyoxyethylene (4Ð5 moles) ether of phenol . Polyoxyethylene (25 moles)—glycerol adduct . Polyoxyethylene (40 moles) stearate . Polyoxyethylene (5Ð15 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 (3Ð4 moles) triether with 2-ethyl-2-(hydroxymethyl)- 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245Ð46Ð6) ...... For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Polypropylene, noncrystalline . Polysiloxanes: Diethyl polysiloxane . Dihydrogen polysiloxane . Dimethyl polysiloxane . Diphenyl polysiloxane . Ethyl hydrogen polysiloxane . Ethyl phenyl polysiloxane . Methyl ethyl polysiloxane . Methyl hydrogen polysiloxane . Methyl phenyl polysiloxane . Phenyl hydrogen polysiloxane . Polysorbate 60. Polysorbate 80. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate) . Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) . Poly[styrene-co-disodium maleate-co-a-(p-nonyl-phenyl)-omega-(p-vinyl- benzyl)poly(oxyethylene)] terpolymer . 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. 5124Ð30Ð1) with: (i) one or more of the polyols or polyesters named in this paragraph and with either N-methyldiethanolamine (CAS Reg. No. 105Ð59Ð9) and dimethyl sulfate (CAS Reg. No. 77Ð78Ð1) or dimethylolpropionic acid (CAS Reg. No. 4767Ð03Ð7) and triethylamine (CAS Reg. No. 121Ð44Ð8), or (ii) a fumaric acid-modified polypropylene glycol or fumaric acid-modified tripropylene glycol), triethylamine (CAS Reg. No. 107Ð15Ð3), and ethylenediamine (CAS Reg. No. 121Ð44Ð8), or (4) reacting meta-tetramethylxylene diisocyanate (CAS Reg. No. 2778Ð42Ð9) with one or more of the polyols and polyesters listed in this paragraph and with dimethylolpropionic acid (CAS Reg. No. 4767Ð03Ð7) and triethylamine (CAS Reg. No. 121Ð44Ð8), N-methyldiethanolamine (CAS Reg. No. 105Ð59Ð9), 2Ðdimethylaminoethanol (CAS Reg. No. 108Ð01Ð0), 2Ð dimethylaminoÐ2ÐmethylÐ1Ðpropanol (CAS Reg. No. 7005Ð47Ð2), and/or 2ÐaminoÐ2ÐmethylÐ1Ðpropanol (CAS Reg. No. 124Ð68Ð5) . 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 .

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Substances Limitations

Propyl alcohol (propanol) . Propylene carbonate . Propylene glycol and p-p′-isopropylidenediphenol diether . Propylene glycol dibenzoate (CAS Reg. No. 19224Ð26Ð1) ...... 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 (C1ÐC9) phenolformaldehyde . Ammonia . Ammonium caseinate-p-Cyclohexylphenolformaldehyde . Diethylene glycol . Dipentaerythritol . Ethylene glycol . Formaldehyde . Fumaric acid . Glycerin . Hydrogen . Isophthalic acid . 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy) . 4,4′-Isopropylidenediphenol-formaldehyde . Maleic anhydride . Methyl alcohol . Pentaerythritol . Phthalic anhydride . Polyethylene glycol . Phenol-formaldehyde . Phenyl µ-cresol-formaldehyde . p-Phenylphenol-formaldehyde . Sulfuric acid . Triethylene glycol . Xylenol-formaldehyde . Rosin salts (salts of wood, gum, and tall oil rosin, and the dimers 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 (C2ÐC13.5 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 .

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Substances Limitations

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 . 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 percentÐ80 percent stearyl and 20 percentÐ35 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 . 2Ðsulfoethyl methacrylate (CAS Registry No. 10595Ð80Ð9) ...... 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 5Ð6 moles of ethylene oxide, Chemical Abstracts Service Registry No. 039354Ð45Ð5) . 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 9Ð10 moles of ethylene oxide) (CAS Reg. No. 9040Ð38Ð4) . Sulfur . Synthetic primary linear aliphatic alcohols whose weight average molecular weight is greater than 400 (CAS Reg. No. 71750Ð71Ð5) .

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Substances Limitations

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 . 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 1Ð40 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 6Ð9 or 40 moles . Tetramethyl decanediol . Tetramethyl decynediol . Tetramethyl decynediol plus 1Ð30 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 .

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Substances Limitations

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. 139Ð 89Ð9) . Turpentine . Urea-formaldehyde resins as described in ¤ 175.300(b)(3)(xii) . Vegetable oil, sulfonated or sulfated, potassium salt . Vinyl acetate-maleic anhydride copolymer, sodium salt . Waxes, petroleum . Wax, petroleum, chlorinated (40% to 70% chlorine) . Waxes, synthetic paraffin (Fischer-Tropsch process) . 3-(2-Xenolyl)-1,2-epoxypropane . Xylene . Xylene (or toluene) alkylated with dicyclopentadiene . Zein . Zinc acetate . Zinc ammonium chloride . Zinc dibenzyl dithiocarbamate . Zinc dibutyldithiocarbamate . Zinc diethyldithiocarbamate . Zinc di(2-ethylhexoate) . Zinc formaldehyde sulfoxylate . Zinc naphthenate and dehydroabietylamine mixture . Zinc nitrate . Zinc orthophosphate . Zinc resinate . Zinc sulfide . Zineb (zinc ethylenebis-dithiocarbamate) . Ziram (zinc dimethyldithiocarbamate) .

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

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

§ 175.125 Pressure-sensitive adhesives. (3) Color additives listed for use in or on food in parts 73 and 74 of this chap- Pressure-sensitive adhesives may be ter. safely used as the food-contact surface (4) Substances identified in § 172.615 of of labels and/or tapes applied to food, this chapter other than substances in accordance with the following pre- used in accordance with paragraph scribed conditions: (a)(2) of this section. (a) Pressure-sensitive adhesives pre- (5) Polyethylene, oxidized; complying pared from one or a mixture of two or with the identity prescribed in more of the substances listed in this § 177.1620(a) of this chapter. paragraph may be used as the food-con- (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2- tact surface of labels and/or tapes ap- yl]amino]-2,6-di-tert-butylphenol (CAS plied to poultry, dry food, and proc- Reg. No. 991–84–4) as an antioxidant/ essed, frozen, dried, or partially dehy- stabilizer at a level not to exceed 1.5 drated fruits or vegetables. percent by weight of the finished pres- (1) Substances generally recognized sure-sensitive adhesive. as safe in food. (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert- (2) Substances used in accordance butylbenzoxazole) (CAS Reg. No. 7128– with a prior sanction or approval. 64–5) as an optical brightener at a level

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not to exceed 0.05 percent by weight of Rubber hydrochloride. the finished pressure-sensitive adhe- Rubber (natural latex solids or crepe, sive. smoked or unsmoked). (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) Terpene resins (a- and b-pinene), homopolymers, copolymers, and conden- phenyl]-2-methyl-1-propanone (CAS sates with phenol, formaldehyde, cou- Reg. No. 106797–53–9) as a photoinitiator marone, and/or indene. at a level not to exceed 5 percent by Tetrasodium ethylenediaminetetraacetate. weight of the pressure-sensitive adhe- Tri(mixed mono- and dinonylphenyl) sive. phosphite (which may contain not more than 1 percent by weight of (9) Butanedioic acid, sulfo-1,4-di-(C9- triisopropanolamine). C11 alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4- (c) Acrylonitrile copolymers identi- diisodecyl ester, ammonium salt [CAS fied in this section shall comply with Reg. No. 144093–88–9]) as a surface ac- the provisions of § 180.22 of this chap- tive agent at a level not to exceed 3.0 ter. percent by weight of the finished pressure-sensitive adhesive. [42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, (b) Pressure-sensitive adhesives pre- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, pared from one or a mixture of two or Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] more of the substances listed in this paragraph may be used as the food-con- Subpart C—Substances for Use as tact surface of labels and/or tapes applied to raw fruit and raw vegetables. Components of Coatings (1) Substances listed in paragraphs § 175.210 Acrylate ester copolymer (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), coating. (a)(8), and (a)(9) of this section, and those substances prescribed by para- Acrylate ester copolymer coating graph (a)(4) of this section that are not may safely be used as a food-contact identified in paragraph (b)(2) of this surface of articles intended for pack- section. aging and holding food, including heat- (2) Substances identified in this sub- ing of prepared food, subject to the pro- paragraph and subject to the limita- visions of this section: tions provided: (a) The acrylate ester copolymer is a fully polymerized copolymer of ethyl BHA. acrylate, methyl methacrylate, and BHT. methacrylic acid applied in emulsion Butadiene-acrylonitrile copolymer. form to molded virgin fiber and heat- Butadiene-acrylonitrile-styrene copolymer. Butadiene-styrene copolymer. cured to an insoluble resin. Butyl rubber. (b) Optional substances used in the Butylated reaction product of p-cresol and preparation of the polymer and in the dicyclopentadiene produced by reacting p- preparation and application of the cresol and dicyclopentadiene in an approxi- emulsion may include substances mate mole ratio of 1.5 to 1.0, respectively, named in this paragraph, in an amount followed by alkylation with isobutylene so not to exceed that required to accom- that the butyl content of the final product plish the desired technical effect and is not less than 18 percent, for use at levels 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. B of this chapter must meet any speci- Polybutene-1. fications in such regulation. Polybutene, hydrogenated; complying with 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 amount required as a Propyl gallate. 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 .

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List of substances Limitations (a) The additive is synthesized by the Fischer-Tropsch process from carbon Glyceryl monostearate . Methyl cellulose . monoxide and hydrogen, which are cat- Mineral oil . alytically converted to a mixture of Paraffin wax . paraffin hydrocarbons. Lower molec- Potassium hydroxide . Potassium persulfate . ular-weight fractions are removed by Tallow . distillation. The residue is hydro- Tetrasodium pyrophosphate . genated and may be further treated by Titanium dioxide . percolation through activated char- (c) The coating in the form in which coal. This mixture can be fractionated it contacts food meets the following into its components by a solvent sepa- tests: ration method, using synthetic (1) An appropriate sample when ex- isoparaffinic petroleum hydrocarbons posed to distilled water at 212 °F for 30 complying with § 178.3530 of this chap- minutes shall yield total chloroform- ter. soluble extractables not to exceed 0.5 (b) Synthetic paraffin shall conform milligram per square inch. to the following specifications: (2) An appropriate sample when ex- (1) Congealing point. There is no speci- posed to n-heptane at 120 °F for 30 min- fication for the congealing point of utes shall yield total chloroform-solu- synthetic paraffin components, except ble extractables not to exceed 0.5 milli- those components that have a con- gram per square inch. gealing point below 50 °C when used in contact with food Types III, IVA, V, § 175.230 Hot-melt strippable food VIIA, and IX identified in table 1 of coatings. § 176.170(c) of this chapter and under Hot-melt strippable food coatings conditions of use E, F, and G described may be safely applied to food, subject in table 2 of § 176.170(c) of this chapter to the provisions of this section. shall be limited to a concentration not (a) The coatings are applied to and exceeding 15 percent by weight of the used as removable coatings for food. finished coating. The congealing point (b) The coatings may be prepared, as shall be determined by ASTM method mixtures, from the following sub- D938–71 (Reapproved 1981), ‘‘Standard stances: Test Method for Congealing Point of (1) Substances generally recognized Petroleum Waxes, Including Petro- as safe in food. latum,’’ which is incorporated by ref- (2) Substances identified in this sub- erence. Copies may be obtained from paragraph. the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA List of substances Limitations 19103, or may be examined at the Office Acetylated monoglycerides ...... Complying with 172.828 of the Federal Register, 800 North Cap- of this chapter. itol Street, NW., suite 700, Washington, Cellulose acetate butyrate . Cellulose acetate propionate . DC 20408. Mineral oil, white ...... For use only as a com- (2) Oil content. The substance has an ponent of hot-melt oil content not exceeding 2.5 percent as strippable food coatings applied to frozen determined by ASTM method D721–56T, meats and complying ‘‘Tentative Method of Test for Oil Con- with ¤ 172.878 of this tent of Petroleum Waxes’’ (Revised chapter. 1956), which is incorporated by reference. See paragraph (b)(1) of this sec- § 175.250 Paraffin (synthetic). tion for availability of the incorpora- Synthetic paraffin may be safely tion by reference. used as an impregnant in, coating on, (3) Absorptivity. The substance has an or component of coatings on articles absorptivity at 290 millimicrons in used in producing, manufacturing, decahydronaphthalene at 88 °C not ex- packing, processing, preparing, treat- ceeding 0.01 as determined by ASTM ing, packaging, transporting, or hold- method E131–81a, ‘‘Standard Defini- ing food in accordance with the fol- tions of Terms and Symbols Relating lowing prescribed conditions: to Molecular-Spectroscopy,’’ which is

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incorporated by reference. See para- less than 5 gallons, subject to the pro- graph (b)(1) of this section for avail- visions of this section. ability of the incorporation by ref- (a) For the purpose of this section, erence. poly(vinyl fluoride) resins consist of (c) The provisions of this section are basic resins produced by the polym- not applicable to synthetic paraffin erization of vinyl fluoride. used in food-packaging adhesives com- (b) The poly(vinyl fluoride) basic res- plying with § 175.105. ins have an intrinsic viscosity of not [42 FR 14534, Mar. 15, 1977, as amended at 47 less than 0.75 deciliter per gram as de- FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, termined by ASTM method D1243–79, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, ‘‘Standard Test Method for Dilute So- Aug. 3, 1995] lution Viscosity of Vinyl Chloride Polymers,’’ which is incorporated by § 175.260 Partial phosphoric acid esters of polyester resins. reference. Copies may be obtained from the American Society for Testing Ma- Partial phosphoric acid esters of pol- terials, 1916 Race St., Philadelphia, PA yester resins identified in this section 19103, or may be examined at the Office and applied on aluminum may be safely of the Federal Register, 800 North Cap- used as food-contact coatings, in ac- itol Street, NW., suite 700, Washington, cordance with the following prescribed DC 20408. conditions: (a) For the purpose of this section, (1) Solvent. N,N-Dimethylacetamide, partial phosphoric acid esters of poly- technical grade. ester resins are prepared by the reac- (2) Solution. Powdered resin and sol- tion of trimellitic anhydride with 2,2- vent are heated at 120 °C until the resin dimethyl-1,3-propanediol followed by is dissolved. reaction of the resin thus produced (3) Temperature. Flow times of the with phosphoric acid anhydride to solvent and solution are determined at produce a resin having an acid number 110 °C. of 81 to 98 and a phosphorus content of (4) Viscometer. Cannon-Ubbelohde size 4.05 to 4.65 percent by weight. 50 semimicro dilution viscometer (or (b) The coating is chemically bonded equivalent). to the metal and cured at temperatures (5) Calculation. The calculation meth- exceeding 450 °F. od used is that described in appendix X (c) The finished food-contact coating, 1.3 (ASTM method D1243–79, ‘‘Standard when extracted with the solvent or sol- Test Method for Dilute Solution Vis- vents characterizing the type of food cosity of Vinyl Chloride Polymers,’’ and under the conditions of time and which is incorporated by reference; see temperature characterizing the condi- paragraph (b) of this section for avail- tions of its intended use, as determined ability of the incorporation by ref- from tables 1 and 2 of § 175.300(d), yields erence) with the reduced viscosity de- total extractives in each extracting termined for three concentration levels solvent not to exceed 0.3 milligrams not greater than 0.5 gram per deciliter per square inch of food-contact surface, and extrapolated to zero concentration as determined by the methods de- for intrinsic viscosity. The following scribed in § 175.300(e), and the coating formula is used for determining re- yields 2,2-dimethyl-1,3-propanediol in duced viscosity: each extracting solvent not to exceed 0.3 micrograms per square inch of food- Reduced viscosity in terms tto− contact surface. In testing the finished = food-contact articles, a separate test of deciliters per gram to× c sample is to be used for each required where: extracting solvent. t=Solution efflux time. to=Solvent efflux time. § 175.270 Poly(vinyl fluoride) resins. c=Concentration of solution in terms of Poly(vinyl fluoride) resins identified grams per deciliter. in this section may be safely used as [42 FR 14534, Mar. 15, 1977, as amended at 47 components of food-contact coatings FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, for containers having a capacity of not 1984]

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

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(b) Rosin esters formed by reacting Fumaric. rosin (paragraph (b)(3)(v)(a) of this sec- Isophthalic. tion) with: Maleic. 2,6-Naphthalenedicarboxylic. 4,4′-sec-Butylidenediphenol-epichlorohydrin 2,6-Naphthalenedicarboxylic, dimethyl ester. (epoxy). Orthophthalic. Diethylene glycol. Sebacic. Ethylene glycol. Terephthalic. Glycerol. Terpene-maleic acid adduct. 4,4′-Isopropylidenediphenol-epichlorohydrin Trimellitic. (epoxy). Methyl alcohol. (b) Monobasic acids: Pentaerythritol. Benzoic acid. (c) Rosin esters (paragraph (b)(3)(v)(b) 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. of this section) modified by reaction tert-Butyl benzoic acid. Fatty acids derived from oils listed in para- with: graph (b)(3)(i) of this section. Maleic anhydride. Rosins listed in paragraph (b)(3)(v)(a) of this o-, m-, and p-substituted phenol-formalde- section, for use only as reactants in oil- hydes listed in paragraph (b)(3)(vi) of this based or fatty acid-based alkyd resins. section. (c) Polyhydric alcohols: Phenol-formaldehyde. Butylene glycol. (d) Rosin salts: Diethylene glycol. Calcium resinate (limed rosin). 2,2-Dimethyl-1,3-propanediol for use only in Zinc resinate. forming polyester resins for coatings intended for use in contact with non-alco- (vi) Phenolic resins as the basic poly- holic foods. mer formed by reaction of phenols with Ethylene glycol. formaldehyde: Glycerol. (a) Phenolic resins formed by reac- Mannitol. tion of formaldehyde with: a-Methyl glucoside. Pentaerythritol. Alkylated (methyl, ethyl, propyl, isopropyl, Propylene glycol. butyl) phenols. Sorbitol. p-tert-Amylphenol. Triethylene glycol, for use as a component in 4,4′-sec-Butylidenediphenol. polyester resins for coatings not exceeding p-tert-Butylphenol. a coating weight of 4 milligrams per square o-, m-, and p-Cresol. inch and that are intended for contact p-Cyclohexylphenol. under conditions of use D, E, F or G de- 4,4′-Isopropylidenediphenol. scribed in table 2 of paragraph (d) of this p-Nonylphenol. section with alcoholic beverages con- p-Octylphenol. taining less than 8 percent alcohol. 3-Pentadecyl phenol mixture obtained from Trimethylol ethane. cashew nut shell liquid. Trimethylol propane. Phenol. 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. Octyl alcohol. (vii) Polyester resins (including Stearyl alcohol. alkyd-type), as the basic polymers, formed as esters of acids listed in para- (e) Catalysts: graph (b)(3)(vii) (a) and (b) of this sec- Dibutyltin oxide (CAS Reg. No. 818–08–6), not tion by reaction with alcohols in para- to exceed 0.2 percent of the polyester resin. graph (b)(3)(vii) (c) and (d) of this sec- Hydroxybutyltin oxide (CAS Reg. No. 2273– tion. 43–0), not to exceed 0.2 percent of the poly- (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:

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(a) Epoxy resins, as the basic poly- peated use in contact with foods only of mer: the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, (Alkoxy C10–C16)-2,3-epoxypropane, in which under conditions of use C, D, E, or F as de- the alkyl groups are even numbered and scribed in table 2 of paragraph (d) of this consist of a maximum of 1 percent C10 car- section; or when such coatings are in- bon atoms and a minimum of 48 percent C12 tended for repeated use in contact with carbon atoms and a minimum of 18 percent foods of the types identified in paragraph C14 carbon atoms, for use only in coatings (d) of this section, table 1, under Types V, that are intended for contact with dry bulk VI, VII, and VIII, under conditions of use E foods at room temperature. or F as described in table 2 of paragraph (d) ′ 4,4 -sec-Butylidenediphenol-epichlorohydrin. of this section. Use shall be limited to 4,4′-sec-Butylidenediphenol-epichlorohydrin coatings for tanks of capacity greater than reacted with one or more of the drying oils 530,000 gallons. or fatty acids listed in paragraph (b)(3)(i) of this section. Benzyl alcohol (CAS Reg. No. 100–51–6), for 4,4′-sec-Butylidenediphenol-epichlorohydrin use only in coatings at a level not to ex- chemically treated with one or more of ceed 4 percent by weight of the resin when the following substances: such coatings are intended for repeated use Allyl ether of mono-, di-, or trimethylol in contact with foods only of the types phenol. identified in paragraph (d) of this section, 4,4′-sec-Butylidenediphenol-formaldehyde. table 1, under Types I, II, and III, under 4,4′-Isopropylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described Melamine-formaldehyde. in table 2 of paragraph (d) of this section; Phenol-formaldehyde. or when such coatings are intended for re- Urea-formaldehyde. peated use in contact with foods of the Epoxidized polybutadiene. types identified in paragraph (d) of this Glycidyl ethers formed by reacting section, table 1, under Types V, VI, VII, phenolnovolak resins with and VIII, under conditions of use E or F as epichlorohydrin. described in table 2 of paragraph (d) of this 4,4′-Isopropylidenediphenol-epichlorohydrin. section. Use shall be limited to coatings 4,4′-Isopropylidenediphenol-epichlorohydrin for tanks of capacity greater than 530,000 reacted with one or more of the drying oils gallons. 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 phenol. Cyanoguanidine. 4,4′-sec-Butylidenediphenol-formaldehyde. Dibutyl phthalate, for use only in coatings 4,4′-Isopropylidenediphenol-formaldehyde. for containers having a capacity of 1,000 Melamine-formaldehyde. gallons or more when such containers are 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 re- Ethylenediamine.

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Isophthalyl dihydrazide for use only in coat- Tetraethylenepentamine reacted with ings subject to the provisions of paragraph equimolar quantities of fatty acids. (c) (3) or (4) of this section. Tri(dimethylaminomethyl) phenol and its 4,4′-Methylenedianiline, for use only in coat- salts prepared from the fatty acid moieties ings for containers having a capacity of of the salts listed in paragraph 1,000 gallons or more when such containers (b)(3)(xxii)(b) of this section, for use only are intended for repeated use in contact in coatings subject to the provisions of with alcoholic beverages containing up to 8 paragraph (c) (3) or (4) of this section. percent of alcohol by volume. Triethylenetetramine. N-Oleyl-1,3-propanediamine with not more Trimellitic anhydride (CAS Reg. No. 552–30– than 10 percent by weight of 7) for use only as a cross-linking agent at diethylaminoethanol. a level not to exceed 15 percent by weight 3-Pentadecenyl phenol mixture (obtained of the resin in contact with food under all from cashew nutshell liquid) reacted with conditions of use, except that resins in- formaldehyde and ethylenediamine in a tended for use with foods containing more ratio of 1:2:2 (CAS Reg. No. 68413–28–5). than 8 percent alcohol must contact such Polyamine produced when 1 mole of the food only under conditions of use D, E, F, chlorohydrin diether of polyethylene gly- and G described in table 2 of paragraph (d) col 400 is made to react under of this section. dehydrohalogenating conditions with 2 Trimellitic anhydride adducts of ethylene moles of N-octadecyltrimethylenediamine glycol and glycerol, prepared by the reac- for use only in coatings that are subject to tion of 1 mole of trimellitic anhydride with the provisions of paragraph (c) (3) or (4) of 0.4–0.6 mole of ethylene glycol and 0.04–0.12 this section and that contact food at tem- mole of glycerol, for use only as a cross- peratures not to exceed room temperature. linking agent at a level not to exceed 10 Polyethylenepolyamine (CAS Reg. No. 68131– percent by weight of the cured coating, 73–7), for use only in coatings intended for provided that the cured coating only con- repeated use in contact with food, at tem- tacts food containing not more than 8 per- peratures not to exceed 180 °F (82 °C). cent alcohol. 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.

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(c) Adjuncts for epoxy resins: Dodecyl benzenesulfonic acid (C.A. Registry No. 27176–87–0). Aluminum butylate. Benzoic acid, for use as a component in (xiii) Triazine-formaldehyde resins epoxy resins for coatings not exceeding a and their curing catalyst: coating weight of 4 milligrams per square (a) Triazine-formaldehyde resins, as inch and that are intended for contact the basic polymer: under conditions of use D, E, F or G described in table 2 of paragraph (d) of this Benzoguanamine-formaldehyde. section with alcoholic beverages con- Melamine-formaldehyde. taining less than 8 percent alcohol. Melamine-formaldehyde chemically modified Polyamides from dimerized vegetable oils with one or more of the following amine and the amine catalysts listed in para- catalysts: graph (b)(3)(viii)(b) of this section, as the Amine catalysts listed in paragraph basic polymer. (b)(3)(viii)(b) of this section. Silane coupled silica, prepared from the re- Dimethylamine-2-methyl-1-propanol. action of microcrystalline quartz with N- Methylpropanolamine. beta-(N-vinylbenzylamino) ethyl-gamma- Triethanolamine. aminopropyltrimethoxy silane, mono- Melamine-formaldehyde chemically modified hydrogen chloride, for use only in coatings with methyl, ethyl, propyl, isopropyl, intended for repeated use in contact with butyl, or isobutyl alcohol. foods only of the types identified in paragraph (d) of this section, table 1, under (b) Curing (cross-linking) catalyst for Category I and Category VIII, at tempera- triazine-formaldehyde resins: tures not exceeding 88 °C (190 °F). Succinic anhydride, for use as a component Dodecyl benzenesulfonic acid (C.A. Registry in epoxy resins for coatings not exceeding No. 27176–87–0). a coating weight of 4 milligrams per square (xiv) Modifiers (for oils and alkyds, inch, and that are intended for contact under conditions of use D, E, F or G de- including polyesters), as the basic poly- scribed in table 2 of paragraph (d) of this mer: section with alcoholic beverages con- Butyl methacrylate. taining less than 8 percent alcohol. Cyclopentadiene. (ix) Coumarone-indene resin, as the Methyl, ethyl, butyl, or octyl esters of acryl- basic polymer. ic acid. (x) Petroleum hydrocarbon resin Methyl methacrylate. (cyclopentadiene type), as the basic Styrene. Vinyl toluene. polymer. (xi) Terpene resins, as the basic poly- (xv) Vinyl resinous substance, as the mer, from one or more of the following: basic polymers: Dipentene. Polyvinyl acetate. Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl alcohol. 106168–39–2). For use only with coatings in Polyvinyl butyral. contact with acidic and aqueous foods. Polyvinyl chloride. Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl formal. dipentene copolymer resin (CAS Reg. No. Polyvinylidene chloride. 106168–37–0). For use only with coatings in Polyvinyl pyrrolidone. contact with acidic and aqueous foods. Polyvinyl stearate. a-Pinene. Vinyl chloride-acetate-2,3-epoxypropyl meth- b-Pinene. acrylate copolymers containing not more (xii) Urea-formaldehyde, resins and than 10 weight percent of total polymer their curing catalyst: units derived from 2,3-epoxypropyl methacrylate and not more than 0.1 weight per- (a) Urea-formaldehyde resins, as the cent of unreacted 2,3-epoxypropyl meth- basic polymer: acrylate monomer for use in coatings for 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

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and contain not more than 3.5 weight per- (xix) Polypropylene as the basic poly- cent of total polymer units derived from mer: acrylamide; the acrylamide portion may or may not be subsequently partially Polypropylene. hydrolyzed. Maleic anhydride adduct of polypropylene Vinyl chloride copolymerized with one or The polypropylene used in the manufac- more of the following substances: ture of the adduct complies with Acrylonitrile. § 177.1520(c), item 1.1; and the adduct has a Fumaric acid and/or its methyl, ethyl, maximum combined maleic anhydride con- propyl, butyl, amyl, hexyl, heptyl, or octyl tent of 0.8 percent and a minimum intrin- ° esters. sic viscosity of 0.9, determined at 135 C on a 0.1 percent solution of the modified poly- Maleic acid and/or its methyl, ethyl, propyl, propylene in decahydronaphthalene as de- butyl, amyl, hexyl, heptyl, or octyl esters. termined by a method titled ‘‘Method for 5-Norbornene-2,3-dicarboxylic acid, mono- n- Determination of Intrinsic Viscosity of butyl ester; for use such that the finished Maleic Anhydride Adduct of Poly- vinyl chloride copolymers contain not propylene,’’ which is incorporated by ref- more than 4 weight percent of total poly- erence. Copies are available from the Cen- mer units derived from this comonomer. ter for Food Safety and Applied Nutrition Vinyl acetate. (HFS–200), Food and Drug Administration, Vinylidene chloride. 5100 Paint Branch Pkwy., College Park, Vinyl chloride-vinylidene chloride-2,3- MD 20740, or available for inspection at the epoxypropyl methacrylate copolymers con- Office of the Federal Register, 800 North taining not more than 10 weight percent of Capitol Street, NW., suite 700, Washington, total polymer units derived from 2,3- DC 20408. epoxypropyl methacrylate and not more than 0.05 weight percent of unreacted 2,3- (xx) Acrylics and their copolymers, epoxypropyl methacrylate monomer based as the basic polymer: on polymer solids for use only in coatings Acrylamide with ethylacrylate and/or sty- for containers intended for contact with rene and/or methacrylic acid, subsequently foods under conditions B, C, D, E, F, G, or reacted with formaldehyde and butanol. H described in table 2 of paragraph (d) of Acrylic acid and the following esters thereof: this section. Ethyl. (xvi) Cellulosics, as the basic poly- Methyl. mer: Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate copolymers con- Carboxymethylcellulose. taining no more than 20 weight percent of Cellulose acetate. total polymer units derived from meth- Cellulose acetate-butyrate. acrylic acid and containing no more than 7 Cellulose acetate-propionate. weight percent of total polymer units de- Ethylcellulose. rived from hydroxyethyl methacrylate; for Ethyl hydroxyethylcellulose. use only in coatings that are applied by electrodeposition to metal substrates. Hydroxyethylcellulose. Butyl acrylate-styrene-methacrylic acid- Hydroxypropyl methylcellulose. hydroxypropyl methacrylate copolymers Methylcellulose. containing no more than 20 weight percent Nitrocellulose. of total polymer units derived from meth- (xvii) Styrene polymers, as the basic acrylic acid and containing no more than 7 polymer: weight percent of total polymer units derived from hydroxypropyl methacrylate; Polystyrene. for use only in coatings that are applied by a-Methyl styrene polymer. electrodeposition to metal substrates and Styrene copolymerized with one or more of that are intended for contact, under condi- the following: tion of use D, E, F, or G described in table Acrylonitrile. 2 of paragraph (d) of this section, with food a-Methylstyrene. containing no more than 8 percent of alcohol. (xviii) Polyethylene and its copoly- Ethyl acrylate-styrene-methacrylic acid co- mers as the basic polymer: polymers for use only as modifiers for epoxy resins listed in paragraph Ethylene-ethyl acrylate copolymer. (b)(3)(viii)(a) of this section. Ethylene-isobutyl acrylate copolymers con- Ethyl acrylate-methyl methacrylate-sty- taining no more than 35 weight percent of rene-methacrylic acid copolymers for use total polymer units derived from isobutyl only as modifiers for epoxy resins listed in acrylate. paragraph (b)(3)(viii)(a) of this section. Ethylene-vinyl acetate copolymer. 2-Ethylhexyl acrylate-ethyl acrylate copoly- Polyethylene. mers prepared by copolymerization of 2-

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ethylhexyl acrylate and ethyl acrylate in a Butadiene-acrylonitrile copolymer. 7/3 weight ratio and having a number aver- Butadiene-acrylonitrile-styrene copolymer. age molecular weight range of 5,800 to 6,500 Butadiene-styrene copolymer. and a refractive index, nD25° (40 percent in Butyl rubber. 2,2,4-trimethyl pentane) of 1.4130–1.4190; for Chlorinated rubber. use as a modifier for nylon resins com- 2-Chloro-1,3-butadiene (neoprene). plying with § 177.1500 of this chapter and for Natural rubber (natural latex or natural phenolic and epoxy resins listed in para- latex solids, smoked or unsmoked). graph (b)(3) (vi) and (viii) of this section, Polyisobutylene. respectively, at a level not to exceed 1.5 Rubber hydrochloride. percent of the coating. Styrene-isobutylene copolymer. 2-Ethylhexyl acrylate-methyl methacrylate- (xxii) Driers made by reaction of a acrylic acid copolymers for use only as modifiers for epoxy resins listed in para- metal from paragraph (b)(3)(xxii)(a) of graph (b)(3)(viii) of this section. this section with acid, to form the salt Methacrylic acid and the following esters listed in paragraph (b)(3)(xxii)(b) of this thereof: section: Butyl. (a) Metals: Ethyl. Aluminum. Methyl. Calcium. Methacrylic acid or its ethyl and methyl Cerium. esters copolymerized with one or more of Cobalt. the following: Iron. Acrylic acid. Lithium. Ethyl acrylate. Magnesium. Methyl acrylate. Manganese. n-Butyl acrylate-styrene-methacrylic acid- Zinc. hydroxyethyl methacrylate copolymers 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) eth- Neodecanoate. anol (C.A.S. Registry No. 108–01–0) may be Octoate (2-ethylhexoate). employed as an optional adjuvant sub- Oleate. stance limited to no more than 2 weight Palmitate. percent based on polymer solids in the Resinate. coating emulsion. Ricinoleate. Styrene polymers made by the polymeriza- Soyate. tion of any combination of styrene or Stearate. alpha methyl styrene with acrylic acid, Tallate. methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. (xxiii) Waxes: The styrene and alpha methyl styrene, in- Paraffin, Type I. dividually, may constitute from 0 to 80 Paraffin, Type II. weight percent of the polymer. The other Polyethylene. monomers, individually, may be from 0 to Sperm oil. 40 weight percent of the polymer. The poly- Spermaceti. mer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel (xxiv) Plasticizers: permeation chromatography). The acid 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. Epoxidized soybean oil (iodine number max- (xxi) Elastomers, as the basic poly- imum 14; oxirane oxygen content 6% min- mer: imum), as the basic polymer.

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Ethyl phthalyl ethyl glycolate. (a) Silicones as the basic polymer: 2-Ethylhexyl diphenyl phosphate. di-2-Ethylhexyl phthalate. Siloxane resins originating from methyl hy- Glycerol. drogen polysiloxane, dimethyl Glyceryl monooleate. polysiloxane, and methylphenyl Glyceryl triacetate. polysiloxane. Monoisopropyl citrate. Siloxane resins originating from the plat- Propylene glycol. inum-catalyzed reaction product of vinyl- Sorbitol. containing dimethylpolysiloxane (CAS Mono-, di-, and tristearyl citrate. Reg. No. 68083–18–1 and CAS Reg. No. 68083– Triethyl citrate. 19–2) with methylhydrogen polysiloxane Triethylene glycol. (CAS Reg. No. 63148–57–2) and 3-(2-Xenolyl)-1,2-epoxypropane. dimethylmethylhydrogen polysiloxane (xxv) Release agents, as the basic (CAS Reg. No. 68037–59–2), where the plat- polymer, when applicable: inum content does not exceed 150 parts per million. The following substances may be N,N′-Dioleoylethylenediamine (CAS Reg. No. used as optional polymerization inhibitors: 110–31–6) for use only in ionomeric resins 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. complying with § 177.1330 of this chapter 107–54–0), at a level not to exceed 0.53 and in ethylene vinyl acetate copolymers weight-percent; complying with § 177.1350 of this chapter at 1-Ethynylcyclohexene (CAS Reg. No. 931–49– a level not to exceed 0.0085 milligram per 7), at a level not to exceed 0.64 weight-per- square centimeter (0.055 milligram per cent; square inch) in the finished food-contact Bis(methoxymethyl)ethyl maleate (CAS Reg. article. No. 102054–10–4), at a level not to exceed 1.0 ′ N,N -Distearoyl ethylenediamine. weight-percent; Linoleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No. Oleic acid amide. 68082–23–5); and Palmitic acid amide. Petrolatum. Tetramethyltetravinylcyclotetrasiloxane Polyethylene wax. (CAS Reg. No. 2554–06–5). Polyoxyethylene glycol monooleate (mol. (b) Curing (cross-linking) catalysts wt. of the polyoxyethylene glycol moiety for silicones (the maximum amount of greater than 300). Polytetrafluoroethylene. tin catalyst used shall be that required Silicones (not less than 300 centistokes vis- to effect optimum cure but shall not cosity): Dimethylpolysiloxanes and/or exceed 1 part of tin per 100 parts of si- methylphenylpolysiloxanes. The methyl- loxane resins solids): phenylpolysiloxanes contain not more than 2.0 percent by weight of cyclosiloxanes Dibutyltin dilaurate. having up to and including 4 siloxy units. Stannous oleate. Silicones (not less than 100 centistokes vis- Tetrabutyl titanate. cosity): Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use (xxix) Surface active agents: only on metal substrates. The Ethylene oxide adduct of 2,4,7,9-tetramethyl- methylphenylpolysiloxanes contain not 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). more than 2.0 percent by weight of cyclosiloxanes having up to and including 4 Poly[2-(diethylamino) ethyl methacrylate] siloxy units. phosphate (minimum intrinsic viscosity in water at 25 °C is not less than 9.0 deciliters (xxvi) Colorants used in accordance per gram as determined by ASTM method with § 178.3297 of this chapter. D1243–79, ‘‘Standard Test Method for Dilute (xxvii) Surface lubricants: Solution Viscosity of Vinyl Chloride Poly- mers,’’ which is incorporated by reference Cottonseed oil and other edible oils. (copies may be obtained from the Amer- Dibutyl sebacate. ican Society for Testing Materials, 1916 Dioctyl sebacate. Race St., Philadelphia, PA 19103, or may be Glyceryl monostearate. examined at the Office of the Federal Reg- Lanolin. ister, 800 North Capitol Street, NW., suite Mineral oil, white. 700, Washington, DC 20408), for use only as Palm oil. a suspending agent in the manufacture of Paraffin, Type I. vinyl chloride copolymers and limited to Paraffin, Type II. use at levels not to exceed 0.1 percent by Petrolatum. weight of the copolymers. Stearic acid. Sodium dioctyl sulfosuccinate. (xxviii) Silicones and their curing Sodium dodecylbenzenesulfonate catalysts: Sodium lauryl sulfate.

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2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. graph (b)(3) (i) to (xxx), inclusive, of Reg. No. 126-86-3), for use only in can coat- this section, the following may be used. ings which are subsequently dried and cured at temperatures of at least 193 °C (380 p-tert-Butyl perbenzoate as a catalyst for °F) for 4 minutes. epoxy resin. epsilon-Caprolactam-(ethylene-ethyl acry- (xxx) Antioxidants: late) graft polymer. Butylated hydroxyanisole. Dicumyl peroxide for use only as polymeriza- Butylated hydroxytoluene. tion catalyst. Gum guaiac. 4–(Diiodomethylsulfonyl) toluene (CAS Reg. Dilauryl thiodipropionate. No. 20018–09–1) for use as a preservative at Nordihydroguaiaretic acid. a level not to exceed 0.3 percent by weight Propyl gallate. in can–sealing cements. Distearyl thiodipropionate. Diisodecyl phthalate for use only as plasti- Thiodipropionic acid. cizer in side seam cements for containers 2,4,5-Trihydroxybutyrophenone. intended for use in contact with food only of the types identified in paragraph (d) of (xxxi) Can end cements (sealing com- this section, table 1, under Categories I, II, pounds used for sealing can ends only): and VI. In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl- paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081– listed in § 177.1210(b)(5) of this chapter, 67–1. Ethyl toluene sulfonamide. the following may be used: N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No. (CAS Reg. No. 26471–45–4) for use only at 23128–74–7. levels not to exceed 23.8 percent by weight Polyamides consisting of the following: of the cement solids in can end cements. Copolymer of omega-laurolactam and Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191– 4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6). Dibenzamido phenyl disulfide. Homopolymer of omega-aminododecanoic Di-b-naphthyl phenylenediamine. acid, CAS Reg. No. 24937–16–4. Dipentamethylene thiuram tetrasulfide. Homopolymer of omega-laurolactam, CAS Isobutylene-isoprene-divinylbenzene copoly- Reg. No. 25038–74–8 (Nylon 12). mers for use only at levels not to exceed 15 Polyamides derived from the following acids percent by weight of the dry cement com- and amines: position. Acids: Naphthalene sulfonic acid-formaldehyde con- Adipic. densate, sodium salt, for use only at levels Azelaic. not to exceed 0.6 percent by weight of the Sebacic. cement solids in can end cements for con- Vegetable oil acids (with or without tainers having a capacity of not less than dimerization). 5 gallons. Amines: Sodium decylbenzene sulfonate. Diethylenetriamine. Sodium nitrite for use only at levels not to Diphenylamine. exceed 0.3 percent by weight of the cement Ethylenediamine. solids in can end cements for containers Hexamethylenediamine. having a capacity of not less than 5 gal- Tetraethylenepentamine. lons. Triethylenetetramine. Sodium pentachlorophenate for use as a pre- Polypropylene glycol CAS Reg. No. 25322–69– servative at 0.1 percent by weight in can- 4. sealing compounds on containers having a Sodium pentachlorophenate for use as a pre- capacity of 5 gallons or more. servative at 0.1 percent by weight in can- Sodium phenylphenate. sealing compounds on containers having a Styrene-maleic anhydride resin, partial capacity of 5 gallons or more. methyl and butyl (sec- or iso-) esters, for Tetrakis [methylene(3,5-di-tert-butyl-4- use only at levels not in excess of 3 percent hydroxyhydrocinnamate)]methane, CAS of the cement solids in can end cement for- Reg. No. 6683–19–8. mulations. Toluene sulfonamide formaldehyde resin Tetrasodium EDTA (tetrasodium ethylene- (basic polymer). diaminetetraacetate). Triethylene glycol methacrylate for use only Tri (mixed mono- and dinonylphenyl) as polymerization cross-linking agent in phosphite. side seam cements for containers intended Zinc dibutyldithiocarbamate. for use in contact with food only of the types identified in paragraph (d) of this (xxxii) Side seam cements: In addi- section, table 1, under Categories I, II, and tion to the substances listed in para- VI.

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Urea. sion-based silicone coatings at a level not to exceed 50 milligrams per kilogram (xxxiii) Miscellaneous materials: (based on isothiazolone active ingredient) Ammonium citrate. in the coating formulations. Ammonium potassium phosphate. Cyclohexanone-formaldehyde resin produced Bentonite, modified by reaction with benzyl when 1 mole of cyclohexanone is made to dimethyl alkyl ammonium chloride, where react with 1.65 moles of formaldehyde such the alkyl groups are derived from hydro- that the finished resin has an average mo- genated tallow (CAS Reg. No. 71011–24–0). lecular weight of 600–610 as determined by For use only as a rheological agent in coat- ASTM method D2503–82, ‘‘Standard Test ings intended to contact food under re- Method for Molecular Weight (Relative peated use conditions. Molecular Mass) of Hydrocarbons by Ther- Bentonite, modified by reaction with sodium moelectric Measurement of Vapor Pres- stearate and benzyl dimethyl alkyl ammo- sure,’’ which is incorporated by reference. nium chloride, where the alkyl groups are Copies may be obtained from the American derived from hydrogenated tallow (CAS Society for Testing Materials, 1916 Race Reg. No. 121888–68–4). For use as a St., Philadelphia, PA 19103, or may be ex- rheological agent only in coatings in- amined at the Office of the Federal Reg- tended to contact dry food under repeated- ister, 800 North Capitol Street, NW., suite use conditions. 700, Washington, DC 20408. For use only in Calcium acetate. contact with nonalcoholic and nonfatty Calcium ethyl acetoacetate. foods under conditions of use E, F, and G, Calcium glycerophosphate. described in table 2 of paragraph (d) this Calcium, sodium, and potassium oleates. section. Calcium, sodium, and potassium Decyl alcohol. ricinoleates. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. Calcium, sodium, and potassium stearates. 35691–65–7). For use as an antimicrobial Castor oil, hydrogenated. agent at levels not to exceed 500 milli- Castor oil, hydrogenated polymer with ethyl- grams per kilogram in emulsion-based sili- enediamine, 12-hydroxyoctadecanoic acid cone coatings. and sebacic acid (CAS Reg. No. 68604–06–8). Disodium hydrogen phosphate. The condensation product formed by the Ethyl acetoacetate. reaction of hydrogenated castor oil with Hectorite, modified by reaction with a mix- polyamide derived from ethylenediamine, ture of benzyl methyl dialkyl ammonium sebacic acid and 12-hydroxystearic acid, for chloride and dimethyl dialkyl ammonium use only in coatings at a level not to ex- chloride, where the alkyl groups are de- ceed 3.2 percent by weight of the resin rived from hydrogenated tallow (CAS Reg. when such coatings are intended for re- No. 121888–67–3). For use as a rheological peated use in contact with foods only of agent only in coatings intended to contact the types identified in paragraph (d) of this dry food under repeated-use conditions. section, table 1, under Types I, II, and III, under conditions of use C, D, E, or F as de- Lauryl alcohol. scribed in table 2 of paragraph (d) of this Lecithin. section; or when such coatings are in- Magnesium, sodium, and potassium citrate. tended for repeated use in contact with Magnesium glycerophosphate. foods of the types identified in paragraph Magnesium stearate. (d) of this section, table 1, under Types V, Mono-, di-, and tricalcium phosphate. VI, VII, and VIII, under conditions of use E Monodibutylamine pyrophosphate as or F as described in table 2 of paragraph (d) sequestrant for iron. of this section. Use shall be limited to Mono-, di-, and trimagnesium phosphate. coatings for tanks of capacity greater than Myristyl alcohol. 530,000 gallons. Octyl alcohol. Castor oil, sulfated, sodium salt (CAS Reg. Phosphoric acid. No. 68187–76–8), for use only in coatings for Polybutene, hydrogenated; complying with containers intended for repeated use. the identity and limitations prescribed by Cetyl alcohol. § 178.3740 of this chapter. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Poly(ethylene oxide). Reg. No. 26172–55–4) and 2-methyl-4- Siloxanes and silicones, dimethyl, 3- isothiazolin-3-one (CAS Reg. No. 2682–20–4) hydroxypropyl group-terminated, diesters mixture, at a ratio of 3 parts to 1 part, re- with poly(2-oxepanone), diacetates (CAS spectively, manufactured from methyl-3- Reg. No. 116810–47–0) at a level not to ex- mercaptopropionate (CAS Reg. No. 2935–90– ceed 0.025 weight percent of the finished 2) and optionally containing magnesium coating having no greater than a 0.5 mil nitrate (CAS Reg. No. 10377–60–3) at a con- thickness for use as a component of poly- centration equivalent to the isothiazolone ester, epoxy, and acrylic coatings com- active ingredients (weight/weight). For use plying with paragraphs (b)(3)(vii), (viii), only as an antimicrobial agent in emul- and (xx) of this section, respectively.

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Silver chloride-coated titanium dioxide for milligrams per square inch of food-con- use only as a preservative in latex emul- tact surface. sions at a level not to exceed 2.2 parts per (xxxvi) Methacrylonitrile grafted million (based on silver ion concentration) polybutadiene copolymers containing in the dry coating. no more than 41 weight percent of total Sodium pyrophosphate. Stannous chloride. polymer units derived from Stannous stearate. methacrylonitrile; for use only in coat- Stannous sulfate. ings that are intended for contact, Stearyl alcohol. under conditions of use D, E, F, or G 2-Sulfoethyl methacrylate, sodium salt (CAS described in table 2 of paragraph (d) of Reg. No. 1804–87–1). For use only in copoly- this section, with food containing no mer coatings on metal under conditions of more than 8 percent of alcohol. 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 for use in contact with aqueous foods tetrapropylene by the oxo process, for use 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

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gallon and intended for one-time use, a component of a container, not to ex- not to exceed 1.8 milligrams per square ceed 18 milligrams per square inch of inch nor to exceed that amount as mil- coated surface. ligrams per square inch that would (d) Tables: equal 0.005 percent of the water capacity of the container in milligrams, di- TABLE 1—TYPES OF FOOD vided by the area of the food-contact I. Nonacid (pH above 5.0), aqueous products; may contain surface of the container in square salt or sugar or both, and including oil-in-water emulsions inches. of low- or high-fat content. II. Acidic (pH 5.0 or below), aqueous products; may contain (3) From a coating intended for or salt or sugar or both, and including oil-in-water emulsions employed as a component of a con- of low- or high-fat content. tainer for repeated use, not to exceed III. Aqueous, acid or nonacid products containing free oil or 18 milligrams per square inch nor to fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content. exceed that amount as milligrams per IV. Dairy products and modifications: square inch that would equal 0.005 per- A. Water-in-oil emulsion, high- or low-fat. cent of the water capacity of the con- B. Oil-in-water emulsion, high- or low-fat. tainer in milligrams, divided by the V. Low moisture fats and oils. area of the food-contact surface of the VI. Beverages: A. Containing alcohol. container in square inches. B. Nonalcoholic. (4) From coating intended for re- VII. Bakery products. peated use, and employed other than as 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 Condition of use Types of food (see 8 percent alcohol table 1) Water (time and Heptane (time and (time and tempera- temperature) temperature) ture)

A. High temperature heat-sterilized I, IVÐB ...... 250 °F, 2 hr ...... (e.g., over 212 °F) . III, IVÐA, 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, IVÐB ...... Fill boiling, cool to ...... °F . 100 °F . III, IVÐA ...... do ...... V ...... 120 °F, 15 min ...... do ...... D. Hot filled or pasteurized below 150 II, IVÐB, VIÐB ...... 150 °F, 2 hr ...... °F . III, IVÐA ...... do ...... 100 °F, 30 min . 150 °F, 2 hr V ...... do ...... VIÐA ...... E. Room temperature filled and stored I, II, IVÐB, VIÐB ..... 120 °F, 24 hr ...... (no thermal treatment in the con- III, IVÐA ...... do ...... 70 °F, 30 min . 120 °F, 24 hr tainer) . V, VII ...... do ...... VIÐA ...... F. Refrigerated storage, no thermal I, II, III, IVÐA, IVÐB, 70 °F, 48 hr ...... treatment in the container) . VIÐB, VII . 70 °F, 48 hr VIÐA ...... G. Frozen storage (no thermal treat- I, II, III, IVÐB, 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, IVÐB ...... 212 °F, 30 min . of high or low fat . 2. Aqueous, high or low free oil or III, IVÐA, 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 packed commercially in the test con- extractability conditions. First ascertain tainer and the normal conditions of the type of food product (table 1, para- thermal treatment used in packaging graph (d) of this section) that is being the type of food involved. Using table 2

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(paragraph (d) of this section), select ture heat sterilization. Fill the container the food-simulating solvent or solvents within 1⁄4-inch of the top with a meas- (demineralized distilled water, ured volume of demineralized distilled heptane, and/or 8 percent ethyl alcohol) water. Cover the container with clean and the time-temperature exaggera- aluminum foil and place the container tions of the container-use conditions. on a rack in a pressure cooker. Add a Aqueous products (Types I, II, IV–B, small amount of demineralized dis- and VI–B) require only a water- tilled water to the pressure cooker, but extractability test at the temperature do not allow the water to touch the and time conditions shown for the bottom of the container. Close the most severe ‘‘conditions of use.’’ Aque- cooker securely and start to heat over ous products with free oil or fat, and a suitable burner. When a steady water-oil emulsions (types III, IV–A, stream of steam emerges from the and VII) will require determinations of vent, close the vent and allow the pres- both water extractability and heptane sure to rise to 15 pounds per square extractability. Low-moisture fats and inch (250 °F) and continue to maintain oils (type V with no free water) require this pressure for 2 hours. Slowly re- only the heptane extractability. Alco- lease the pressure, open the pressure holic beverages (type VI–A) require cooker when the pressure reads zero, only the 8 percent alcohol extractant. and composite the water of each rep- Having selected the appropriate ex- licate immediately in a clean Pyrex tractant or extractants simulating var- flask or beaker. Proceed with the de- ious types of foods and beverages and termination of the amount of extrac- the time-temperature exaggerations tives by the method described in para- over normal use, follow the applicable graph (e)(5) of this section. extraction procedure. Adapt the proce- (ii) Water (212 °F for 30 minutes), simu- dure, when necessary, for containers lating boiling water sterilization. Fill the having a capacity of over 1 gallon. container within 1⁄4-inch of the top (2) Selection of coated-container sam- with a measured volume of boiling, ples. For consumer-sized containers up demineralized distilled water. Cover to 1 gallon, quadruplicate samples of the container with clean aluminum foil representative containers (using for and place the container on a rack in a each replicate sample the number of pressure cooker in which a small containers nearest to an area of 180 amount of demineralized distilled square inches) should be selected from water is boiling. Do not close the pres- the lot to be examined. sure vent, but operate at atmospheric (3) Cleaning procedure preliminary to pressure so that there is a continuous determining the amount of extractables escape of a small amount of steam. from coated containers. Quadruplicate Continue to heat for 30 minutes, then samples of representative containers remove the test container and com- should be selected from the lot to be posite the contents of each replicate examined and must be carefully rinsed immediately in a clean Pyrex flask or to remove extraneous material prior to beaker. Proceed with the determina- the actual extraction procedure. Soda tion of the amount of extractives by fountain pressure-type hot water rins- the method described in paragraph ing equipment, consisting in its sim- (e)(5) of this section. plest form of a 1⁄8-inch–1⁄4-inch internal (iii) Water (from boiling to 100 °F), sim- diameter metal tube attached to a hot ulating hot fill or pasteurization above 150 water line and bent so as to direct a °F. Fill the container within 1⁄4-inch of stream of water upward, may be used. the top with a measured volume of Be sure hot water has reached a tem- boiling, demineralized distilled water. 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

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

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

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

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e′=Chloroform-soluble extractives residue. cultural Chemists methods or equiva- ee′=Zinc corrected chloroform-soluble ex- lent. Calculate the zinc in the ash as tractive residue. zinc oleate, and subtract from the e′ or ee′ is substituted for e in the above equations when necessary. weight of chloroform-soluble extractives residue (e′) to obtain the zinc-cor- If when calculated by the equations in rected chloroform-soluble extractives paragraph (e)(5)(i) (a) and (b) of this residue (ee′). This ee′ is substituted for section, the concentration of extrac- e in the formulas in paragraph (e)(5)(i) tives residue (Ex) exceeds 50 parts per (a) and (b) of this section. To comply million or the extractives in milli- with the limitations in paragraph (c) of grams per square inch exceed the limi- this section, the chloroform-soluble ex- tations prescribed in paragraph (c) of tractives residue (but after correction this section for the particular con- for the zinc extractives in case of ‘‘C’’ tainer size, proceed to paragraph enamels) must not exceed 50 parts per (e)(5)(ii) of this section (method for de- million and must not exceed in milli- termining the amount of chloroform- grams per square inch the limitations soluble extractives residue). for the particular article as prescribed (ii) Chloroform-soluble extractives 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 × the chloroform extraction, washing the rack, 12.5 inches inside diameter 11 inches 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′′, con- low-temperature hotplate. The last few stant temperature to ±2 °F (water bath may milliliters should be evaporated in an be substituted). oven maintained at 212 °F. Cool the Incubator, inside dimensions (minimum) ′′ × ′′ × ′′ ° ± ° platinum dish in a desiccator for 30 19 19 19 for use at 100 F 2 F explosion 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 min- lion or the extractives in milligrams imum. 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. hold at red heat for about 1 minute. Alcohol, 8 percent (by volume), prepared Cool in the air for 3 minutes, and place from undenatured 95 percent ethyl alcohol 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.

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

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.

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List of substances Limitations

Polyamide resins (CAS Reg. No. 68139Ð70Ð8), as the For use only in coatings for polypropylene films that contact basic resin, derived from: food at temperatures not to exceed room temperature. Dimerized vegetable oil or tall oil acids containing not more than 20 percent of monomer acids . Azelaic acid (CAS Reg. No. 123Ð99Ð9) in an amount not to exceed 3.7 percent by weight of the polyamide resin . Ethylenediamine (CAS Reg. No. 107Ð15Ð3) . Piperazine (CAS Reg. No. 110Ð85Ð0) 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 ......

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List of substances Limitations

Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million. vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083Ð 18Ð1 and CAS Reg. No. 68083Ð19Ð2) with methylhydrogen polysiloxane (CAS Reg. No. 63148Ð57Ð2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037Ð 59Ð2). The following substances may be used as optional polymerization inhibitors: . 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107Ð54Ð0), at a level not to exceed 0.53 weight percent; . 1-Ethynylcyclohexene (CAS Reg. No. 931Ð49Ð7), at a level not to exceed 0.64 weight percent; . Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054Ð10Ð4), at a level not to exceed 1.0 weight percent; . Methylvinyl cyclosiloxane (CAS Reg. No. 68082Ð23Ð5); and . Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554Ð06Ð5). . 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: 68083Ð19Ð2 and 68083Ð18Ð1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts polysiloxane (CAS Reg. No. 63148Ð57Ð2). Dimethyl maleate food only of the types identified in ¤ 176.170(c) of this chap- (CAS Reg. No. 624Ð48Ð6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VIIÐB when used 108Ð05Ð4) may be used as optional polymerization inhibitors . under 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, VIIÐA, 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. 68083Ð19Ð2 and 68083Ð18Ð1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148Ð57Ð2). Dimethyl maleate (CAS Reg. No. 624Ð48Ð6), vinyl acetate (CAS Reg. No. 108Ð05Ð4), dibutyl maleate (CAS Reg. No. 105Ð76Ð0) and diallyl maleate (CAS Reg. No. 999Ð21Ð3) may be used as optional polymerization inhibitors. The polymer may also contain C16ÐC18 olefins (CAS Reg. No. 68855Ð60Ð7) 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 IVÐA, 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. 1804Ð87Ð1] . 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 .

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List of substances Limitations

Vinylidene chloride copolymerized with one or more of the following: Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters . Acrylonitrile . Itaconic acid . Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters . Methacrylonitrile . Vinyl chloride . (ii) Plasticizers: Acetyl tributyl citrate . Acetyl triethyl citrate . Butyl phthalyl butyl glycolate . Butyl stearate . Dibutyl sebacate . Diethyl phthalate . 2-Ethylhexyl diphenyl phosphate . Ethyl phthalyl ethyl glycolate . Glycerol monooleate ...... Glycerol triacetate . Triethyl citrate . (iii) Adjuvants (release agents, waxes, and dispersants): Acetone . Amides (unsubstituted) of fatty acids from vegetable or animal oils . n-Butyl acetate . n-Butyl alcohol . Candelilla wax . Carnauba wax . 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172Ð For use only as an antimicrobial agent in emulsion-based sili- 55Ð4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. cone coatings at a level not to exceed 50 milligrams per kilo- 2682Ð20Ð4) 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. 2935Ð90Ð2) and optionally containing magnesium nitrate (CAS Reg. No. 10377Ð60Ð3) at a concentration equivalent to the isothiazolone active ingredients (weight/ weight). . 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691Ð65Ð 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. 110Ð31Ð6) .. 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- 87Ð100. 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.

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

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

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food meets the following extractives (c) The optional substances per- limitations when tested by the meth- mitted are as follows: ods provided in § 175.300(e): (1) The coating when extracted with List of substances Limitations distilled water at 180 °F for 24 hours Ethylene glycol ...... As a solvent removed by yields total extractives not to exceed water washing. Iron oxide . 0.05 milligram per square inch of food- Lithium hydroxide ...... Removed by water washing. contact surface. Methyl orange ...... As an acid-base indicator. (2) The coating when extracted with 8 Potassium dichromate ...... Removed by water washing. Silica gel . percent (by volume) ethyl alcohol in Sodium silicate . distilled water at 160 °F for 4 hours Zinc, as particulate metal . yields total extractives not to exceed 0.05 milligram per square inch of food- (d) The coating in the finished form contact surface. in which it is to contact food, when ex- (c) The resins identified in paragraph tracted with the solvent or solvents (a) of this section may be used as a characterizing the type of food, and food-contact coating for articles in- under the conditions of its intended use tended for contact at temperatures not as shown in table 1 and 2 of § 175.300(d) to exceed room temperature with food (using 20 percent alcohol as the solvent of Type VI–C described in table 1 of when the type of food contains approxi- § 176.170(c) of this chapter provided the mately 20 percent alcohol) shall yield coating in the finished form in which it total extractives not to exceed those is to contact food meets the following prescribed in § 175.300(c)(3); lithium ex- extractives limitations when tested by tractives not to exceed 0.025 milligram the methods provided in § 175.300(e): per square inch of surface; and chro- (1) The coating when extracted with mium extractives not to exceed 0.05 distilled water at 180 °F for 24 hours microgram per square inch of surface. yields total extractives not to exceed (e) The coatings are used as food-con- 0.05 milligram per square inch of food- tact surfaces for bulk reusable con- contact surface. tainers intended for storing, handling, (2) The coating when extracted with and transporting food. 50 percent (by volume) ethyl alcohol in distilled water at 180 °F for 24 hours PART 176—INDIRECT FOOD ADDI- yields total extractives not to exceed TIVES: PAPER AND PAPERBOARD 0.05 milligram per square inch. COMPONENTS

§ 175.390 Zinc-silicon dioxide matrix Subpart A [Reserved] coatings. Zinc-silicon dioxide matrix coatings Subpart B—Substances for Use Only as may be safely used as the food-contact Components of Paper and Paperboard surface of articles intended for use in Sec. producing, manufacturing, packing, 176.110 Acrylamide-acrylic acid resins. processing, preparing, treating, pack- 176.120 Alkyl ketene dimers. aging, transporting, or holding food, 176.130 Anti-offset substances. subject to the provisions of this sec- 176.150 Chelating agents used in the manu- tion; facture of paper and paperboard. (a) The coating is applied to a metal 176.160 Chromium (Cr III) complex of N- surface, cured, and washed with water ethyl-N-heptadecylfluoro-octane sulfonyl glycine. to remove soluble substances. 176.170 Components of paper and paperboard (b) The coatings are formulated from in contact with aqueous and fatty foods. optional substances which include: 176.180 Components of paper and paperboard (1) Substances generally recognized in contact with dry food. as safe. 176.200 Defoaming agents used in coatings. (2) Substances for which safe condi- 176.210 Defoaming agents used in the manu- tions of use have been prescribed in facture of paper and paperboard. 176.230 3,5-Dimethyl-1,3,5,2H- § 175.300. tetrahydrothiadiazine-2-thione. (3) Substances identified in para- 176.250 Poly-1,4,7,10,13-pentaaza-15- graph (c) of this section, subject to the hydroxyhexadecane. limitations prescribed. 176.260 Pulp from reclaimed fiber.

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176.300 Slimicides. ketones do not exceed 0.4 percent by 176.320 Sodium nitrate-urea complex. weight of the paper or paperboard. 176.350 Tamarind seed kernel powder. (c) The alkyl ketene dimers may be AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. used in the form of an aqueous emul- SOURCE: 42 FR 14554, Mar. 15, 1977, unless sion which may contain sodium otherwise noted. lignosulfonate as a dispersant. EDITORIAL NOTE: Nomenclature changes to § 176.130 Anti-offset substances. part 176 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001. Substances named in paragraphs (b) and (c) of this section may be safely Subpart A [Reserved] used to prevent the transfer of inks employed in printing and decorating paper and paperboard used for food Subpart B—Substances for Use packaging in accordance with the pro- Only as Components of Paper visions of this section: and Paperboard (a) The substances are applied to the nonfood contact, printed side of the § 176.110 Acrylamide-acrylic acid res- paper or paperboard in an amount not ins. greater than that required to accom- Acrylamide-acrylic acid resins may plish the technical effect nor greater be safely used as components of arti- than any specific limitations, where cles intended for use in producing, such are provided. manufacturing, packing, processing, (b) Anti-offset powders are prepared preparing, treating, packaging, trans- from substances that are generally rec- porting, or holding food, subject to the ognized as safe in food, substances for provisions of this section. which prior sanctions or approvals (a) Acrylamide-acrylic acid resins are were granted and which are used in ac- produced by the polymerization of 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 . Industrial starch—modified .... Complying with ¤ 178.3520 of effect and not to exceed 2 percent by this chapter. weight of the paper or paperboard. Stannous oleate . Zinc-2-ethyl hexoate . § 176.120 Alkyl ketene dimers. Alkyl ketene dimers may be safely § 176.150 Chelating agents used in the used as a component of articles in- manufacture of paper and paper- tended for use in producing, manufac- board. turing, packing, processing, preparing, The substances named in paragraph treating, packaging, transporting, or (a) of this section may be safely used in holding food, subject to the provisions the manufacture of paper and paper- of this section. board, in accordance with the condi- (a) The alkyl ketene dimers are man- tions prescribed in paragraphs (b) and ufactured by the dehydrohalogenation (c) of this section: of the acyl halides derived from the (a) Chelating agents: fatty acids of animal or vegetable fats 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 . Pentasodium salt of diethylenetriamine tions that the alkyl ketene dimers and pentaacetate . their hydrolysis products dialkyl Sodium fructoheptonate .

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

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List of Substances Limitations

Acetyl peroxide ...... For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet- taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper- monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper- percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and termined by LVG-series Brookfield viscometer (or equivalent) paperboard. using a No. 2 spindle at 30 r.p.m . Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl For use only as a retention aid and flocculant employed prior sulfate copolymer resins containing not more than 10 molar to the sheet-forming operation in the manufacture of paper percent of b-methacrylyloxyethyltrimethylammonium methyl and paperboard. sulfate and containing less than 0.2% of residual acrylamide monomer . Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl For use only in paper mill boilers. ether (CAS Reg. No. 86830Ð15Ð1) . 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. 40623Ð75Ð4) 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 75Ð150 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 22.5Ð25.0 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 1,000Ð 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 7.4Ð8.3 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, IVÐB, and VIIÐB 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 C15ÐC21 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(C12ÐC20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheetÐforming Reg. No. 27401Ð06Ð5) . operation in the manufacture of paper and paperboard.

tert-Alkyl(C8ÐC16)mercaptans ...... For use only as polymerization-control agent. Aluminum acetate . 2-Amino-2-methyl-1-propanol (CAS Reg. No. 124Ð68Ð5) ...... 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. 32535Ð84Ð5) 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. 149564Ð62Ð5), For use as insolubilizers with protein binders in coatings for ammonium zirconium lactate-citrate (CAS Reg. No. 149564Ð paper and paperboard, at a level not to exceed 1.4 percent 64Ð7), ammonium zirconium lactate (CAS Reg. No. 149564Ð by weight of coating solids. 63Ð6) . 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) . 9,10ÐAnthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of 84Ð65Ð1) 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. 88526Ð47Ð0), 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 28Ð67 (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 611Ð82, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC . Azo-bisisobutyronitrile ...... For use only as polymerization catalyst. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634Ð33Ð5) ...... 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 (C12ÐC18)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 5.8Ð6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op- No. 68412Ð27Ð1) . 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, IVÐB, VI, VIIÐB, and VIII described in table 1 of paragraph (c) of this section. 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52Ð51Ð7) ...... 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. 144093Ð88Ð9]). . 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(C16ÐC18)carbamoyl chloride (CAS Reg. No. 41319Ð54Ð 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. 25136Ð75Ð8) . Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior No. 26590Ð05Ð6). 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 50Ð50 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: 50Ð2.5Ð47.5. 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: 25Ð2.5Ð72.5. 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: 80Ð2.5Ð17.5. 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 50Ð 2.5Ð47.5, 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 47.8Ð 2.2Ð2.5Ð47.5, 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.10222Ð01Ð2). 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. [26796Ð75Ð8] having 90Ð95 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. 73347Ð80Ð5) . 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. 111Ð30Ð8) ...... 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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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, IVÐB, VIÐB, VIIÐB, and VIII of table I in par. (c) of this section. N, N, N′,N′,N′′,N′′-Hexakis (methoxymethyl)-1,3,5-triazine- For use only as a water-repellent applied to the surface of 2,4,6-triamine polymer with stearyl alcohol, a-octadecenyl- paper and paperboard at levels not to exceed 1 percent by omega-hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20+) al- weight of the finished dry paperboard fibers. The finished cohols (CAS Reg. No. 130328Ð24Ð4) . 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. 27636Ð For use only as a preservative in clay-type fillers at a level not 82Ð4), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms dimethylhydantoin (CAS Reg. No. 6440Ð58Ð0) . 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. 70142Ð34Ð6) 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, 2Ð(C17 and C17-unsaturated alkyl)-1Ð For use only at a level not to exceed 0.5 percent by weight of [2Ð(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749Ð55Ð4). . 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. 113221Ð69Ð5) 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. 25751Ð For use only as a boiler water additive at a level not to exceed 21Ð7) . 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 61791Ð41Ð1) . 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. 68130Ð71Ð2) . paper and paperboard. Monoglyceride citrate . Monoisopropanolamine (CAS Reg. No. 78Ð96Ð6) ...... 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, 10.9Ð12.2% 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, 4,4Ðbis [(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. 71608Ð61Ð2) . 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. 92265Ð81Ð1) 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, IVÐA, V, VIIÐA, 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 D36Ð76, ‘‘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 D5Ð73 (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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408); 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. 53800Ð41Ð2), produced by react- agent employed prior to the sheet-forming operation in the ing 9.6Ð16.4 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 13Ð16 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. 68583Ð79Ð9] 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 IVÐB and under condi- Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or tions of use described in paragraph (c) of this section, table equivalent method) . 2, 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. 96387Ð48Ð3) 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. 167678Ð45Ð7) .

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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 10.9Ð11.9 percent and a chlorine content of 13.8Ð 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 [27029Ð41Ð0], 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 4Ð6) 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 5.0Ð5.3 percent; a chlorine content of 29.7Ð31.3 percent; and a phosphorus content of 2.0Ð2.2 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 13.0Ð 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 10.9Ð12.4 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. 26062Ð For use only: 79Ð3) 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- 26062Ð79Ð3) 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. 4767Ð03Ð7) 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 200Ð600 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 VIIÐB 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 125Ð325 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 400Ð700 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 D1545Ð76 (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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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. D1243Ð79, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408). 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. 110224Ð99Ð2) . 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. Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1- For use only as a component of polyolefin coatings with methyl-C9Ð49-alkyl (CAS Reg. No. 144635Ð08Ð5) . ¤ 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 VIÐA and VIÐB 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.

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List of Substances Limitations

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. 118632Ð For use only in paper mill boilers. 18Ð1) . Sodium zinc potassium polyphosphate (CAS Reg. No. 65997Ð For use only as a pigment dispersant in coatings at a level not 17Ð3) . 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. 53504Ð31Ð7). 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. 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, IVÐB, VI, VIIÐB 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 .

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List of Substances Limitations

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 56136Ð14Ð2) . 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 4.7Ð4.9 percent and viscosity of 350Ð700 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 - octadecylsulfoÐsuc- 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. 7779Ð For use only as an antimicrobial agent for coating, binder, pig- 27Ð3) . 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. 68989Ð22Ð0) ...... 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.

(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.

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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. 35641Ð59Ð9) . 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 C10ÐC18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings cent C14ÐC16). . 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. Butylbenzyl phthalate ...... Complying with ¤ 178.3740 of this chapter. Butyl oleate, sulfated, ammonium, potassium, or sodium salt . Butyraldehyde . Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2- For use only as a mold- and mildew-proofing agent in coatings dicarboximide) . intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Type I, II, VIÐB, and VIII. Castor Oil, polyoxyethylated (42 moles ethylene oxide) ...... For use only as an emulsifier in nitrocellulose coatings for paper and paperboard intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Types IV A, V, VII A, VIII, and IX; and limited to use at a level not to exceed 8 percent by weight of the coating solids. 1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only: (CAS Reg. No. 4080Ð31Ð3) . 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.

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List of substances Limitations

5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172Ð For use only: 55Ð4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in 2682Ð20Ð4) 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 2935Ð90Ð2). The mixture may contain magnesium nitrate coating formulation. (CAS Reg. No. 10377Ð60Ð3) 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 E28Ð67 (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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), 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 (HFSÐ 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691Ð65Ð7) .. 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. 120Ð55Ð8) ...... 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 . N,N′-Diphenyl-p-phenylenediamine ...... For use only as polymerization inhibitor in 2-sulfoethyl methacrylate, sodium salt. Dipropylene glycol dibenzoate (CAS Reg. No. 27138Ð31Ð4) ..... 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.

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List of substances Limitations

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 D1238Ð82, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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. 1344Ð00Ð9) is produced For use only as a component of coatings in paper and paper- by the reaction of sodium silicate (CAS Reg. No. 1344Ð09Ð board products at a level not to exceed 9 percent by weight 8) and kaolinite clay (CAS Reg. No. 1332Ð58Ð7) 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. 46236Ð15Ð1) 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 E28Ð67 (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 D611Ð82, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408). Specific gravity 0.96Ð0.99 (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 °CÐ92 °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. 68083Ð19Ð2 and 68083Ð18Ð1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating polysiloxane (CAS Reg. No. 63148Ð57Ð2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of yl hydrogen) polysiloxane (CAS Reg. No. 68037Ð59Ð2). this section, table 1, under Types I, II, VI, and VIIÐB when Diallyl maleate (CAS Reg No. 999Ð21Ð3), dimethyl maleate used under conditions of use E, F, and G described in table (CAS Reg. No. 624Ð48Ð6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section. Reg. No. 78Ð27Ð3) and vinyl acetate (CAS Reg. No. 108Ð 2. In coatings for paper and paperboard provided the coating 05Ð4) 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, VIIÐA, VIII, and IX when used under conditions of use A through H described in table 2 of paragraph (c) of this section. 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. 68083Ð19Ð2 and 68083Ð18Ð1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148Ð57Ð2). Dimethyl maleate (CAS Reg. No. 624Ð48Ð6), vinyl acetate (CAS Reg. No. 108Ð05Ð4), dibutyl maleate (CAS Reg. No. 105Ð76Ð0) and diallyl maleate (CAS Reg. No. 999Ð21Ð3) may be used as optional polymerization inhibitors. The polymer may also contain C16ÐC18 olefins (CAS Reg. No. 68855Ð60Ð7) as a control release agent . Sodium decylbenzenesulfonate . Sodium dihexyl sulfosuccinate .

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List of substances Limitations

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 IVÐA, 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. 1300Ð72Ð7) ...... 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 IVÐA, 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. 25950Ð40Ð7 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 . 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 D2503Ð82, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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, IVÐB, VIÐB, VIIÐB, 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.

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List of substances Limitations

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. 1804Ð87Ð1] . 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, VIÐB, 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 . 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.

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List of substances Limitations

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. 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. 147Ð14Ð 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 and under conditions of time and tem- paper and paperboard in the finished perature characterizing the conditions form in which it is to contact food, of its intended use as determined from when extracted with the solvent or sol- tables 1 and 2 of this paragraph, shall vents characterizing the type of food,

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yield net chloroform-soluble extrac- TABLE 1—TYPES OF RAW AND PROCESSED tives (corrected for wax, petrolatum, FOODS—Continued mineral oil and zinc extractives as zinc IV. Dairy products and modifications: oleate) not to exceed 0.5 milligram per A. Water-in-oil emulsions, high- or low-fat. square inch of food-contact surface as B. Oil-in-water emulsions, high- or low-fat. determined by the methods described V. Low-moisture fats and oil. VI. Beverages: in paragraph (d) of this section. A. Containing up to 8 percent of alcohol. B. Nonalcoholic. TABLE 1—TYPES OF RAW AND PROCESSED C. Containing more than 8 percent alcohol. FOODS VII. Bakery products other than those included under Types I. Nonacid, aqueous products; may contain salt or sugar or VIII or IX of this table: both (pH above 5.0). A. Moist bakery products with surface containing free fat II. Acid, aqueous products; may contain salt or sugar or or oil. both, and including oil-in-water emulsions of low- or high- B. Moist bakery products with surface containing no free fat content. fat or oil. III. Aqueous, acid or nonacid products containing free oil or VIII. Dry solids with the surface containing no free fat or oil fat; may contain salt, and including water-in-oil emulsions (no end test required). of low- or high-fat content. 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

Types of food Water Heptane 8 percent al- 50 percent al- 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, IVÐB, VIIÐB ..... 250 °F, 2 hr ...... over 212 °F) . III, IVÐA, VIIÐA ...... do ...... 150 °F, 2 hr ...... B. Boiling water sterilized ...... II, VIIÐB ...... 212 °F, 30 ...... min . III, VIIÐA ...... do ...... 120 °F, 30 ...... min . C. Hot filled or pasteurized above 150 °F .... II, IVÐB, VIIÐB .... Fill boiling, ...... cool to 100 °F . III, IVÐA, VIIÐA ...... do ...... 120 °F, 15 ...... min . V, IX ...... do ...... D. Hot filled or pasteurized below 150 °F ..... II, IVÐB, VIÐB, ...... VIIÐB ...... 150 °F, 2 hr ...... III, IVÐA, VIIÐA ...... do ...... 100 °F, 30 ...... min . V, IX ...... do ...... VIÐA ...... 150 °F, 2 hr ...... VIÐC ...... 150 °F, 2 hr. E. Room temperature filled and stored (no I, II, IVÐB, VIÐB, 120 °F, 24 hr ...... thermal treatment in the container) . VIIÐB . III, IVÐA, VIIÐA ...... do ...... 70 °F, 30 ...... min . V, IX ...... do ...... VIÐA ...... 120 °F, 24 hr ...... VIÐC ...... 120 °F, 24 hr. F. Refrigerated storage (no thermal treat- III, IVÐA, VIIÐA ... 70 °F, 48 hr 70 °F, 30 ...... ment in the container) . min . I, II, IVÐB, VIÐB, ...... do ...... VIIÐB . VIÐA ...... 70 °F, 48 hr ...... VIÐC ...... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in I, II, IVÐB, VIIÐB 70 °F, 24 hr ...... the container) . III, VIIÐA ...... 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, IVÐB, VIIÐB 212 °F, 30 ...... high- or low-fat . min .

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

Food-simulating solvents

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

2. Aqueous, high- or low-free oil or fat .. III, IVÐA, VIIÐA, ...... do ...... 120 °F, 30 ...... IX . 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 Chemists International, 481 North extractability conditions. First ascertain Frederick Ave., suite 500, Gaithersburg, the type of food product (table 1, para- MD 20877–2504, or may be examined at graph (c) of this section) that is being the Office of the Federal Register, 800 packed commercially in the paper or North Capitol Street, NW., suite 700, paperboard and the normal conditions Washington, DC 20408); also described of thermal treatment used in pack- in ASTM method F34–76 (Reapproved aging the type of food involved. Using 1980), ‘‘Standard Test Method for Liq- table 2, paragraph (c) of this section, uid Extraction of Flexible Barrier Ma- select the food-simulating solvent or terials,’’ which is incorporated by ref- solvents and the time-temperature ex- erence (copies may be obtained from aggerations of the paper or paperboard the American Society for Testing Ma- use conditions. Having selected the ap- terials, 1916 Race St., Philadelphia, PA propriate food-simulating solvent or 19103, or may be examined at the Office solvents and the time-temperature ex- of the Federal Register, 800 North Cap- aggeration over normal use, follow the itol Street, NW., suite 700, Washington, applicable extraction procedure. DC 20408), except that formed paper and (2) Reagents—(i) Water. All water used paperboard products may be tested in in extraction procedures should be the container by adapting the in-con- freshly demineralized (deionized) dis- tainer methods described in § 175.300(e) tilled water. of this chapter. Formed paper and pa- (ii) n-Heptane. Reagent grade, freshly perboard products such as containers redistilled before use, using only mate- and lids, that cannot be tested satisfac- rial boiling at 208 °F. torily by any of the above methods (iii) Alcohol. 8 or 50 percent (by vol- may be tested in specially designed ex- ume), prepared from undenatured 95 traction equipment, usually consisting percent ethyl alcohol diluted with of clamping devices that fit the closure demineralized (deionized) distilled or container so that the food-contact water. surface can be tested, or, if flat sam- (iv) Chloroform. Reagent grade, fresh- ples can be cut from the formed paper ly redistilled before use, or a grade or paperboard products without de- having an established consistently low stroying the integrity of the food-con- blank. tact surface, they may be tested by (3) Selection of test method. Paper or adapting the following ‘‘sandwich’’ paperboard ready for use in packaging method: shall be tested by use of the extraction (i) Apparatus. (a) Thermostated (±1.0 cell described in ‘‘Official Methods of °F) water bath, variable between 70 °F Analysis of the Association of Official and 120 °F water bath cover capable of Analytical Chemists,’’ 13th Ed. (1980), holding at least one 800-milliliter beak- sections 21.010–21.015, under ‘‘Exposing er partially submersed in bath. Flexible Barrier Materials for Extrac- (b) Analytical balance sensitive to 0.1 tion,’’ which is incorporated by ref- milligram with an approximate capac- erence (copies may be obtained from ity of 100 grams. the Association of Official Analytical (c) Tongs.

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(d) Hood and hot-plate facilities. container or test cell from the oven (e) Forced draft oven. and combine the solvent for each rep- For each extraction, the following ad- licate in a clean Pyrex (or equivalent) ditional apparatus is necessary: flask or beaker being sure to rinse the (f) One No. 2 paper clip. test container or cell with a small (g) One 800-milliliter beaker with quantity of clean solvent. Evaporate watch-glass cover. the food-simulating solvents to about (h) One 250-milliliter beaker. 100 milliliters in the flask or beaker, and transfer to a clean, tared (i) Five 21⁄2-inch-square aluminum screens (standard aluminum window evaporating dish (platinum or Pyrex), screening is acceptable). washing the flask three times with (j) One wire capable of supporting small portions of solvent used in the sample stack. extraction procedure, and evaporate to (ii) Procedure. (a) For each extrac- a few milliliters on a nonsparking, low- temperature hotplate. The last few tion, accurately cut eight 21⁄2-inch- square samples from the formed paper milliliters should be evaporated in an or paperboard product to be tested. oven maintained at a temperature of approximately 221 °F. Cool the (b) Carefully stack the eight 21⁄2-inch- evaporating dish in a desiccator for 30 square samples and the five 21⁄2-inch- square aluminum screens in sandwich minutes and weigh the residue to the form such that the food-contact side of nearest 0.1 milligram, (e). Calculate the each sample is always next to an alu- extractives in milligrams per square minum screen, as follows: Screen, sam- inch of the container or sheeted paper ple, sample, screen, sample, sample, or paperboard surface. screen, etc. Clip the sandwich together (a) Water and 8- and 50-percent alcohol. Milligrams extractives per square carefully with a No. 2 paper clip, leav- inch=(e)/(s). ing just enough space at the top to slip (b) Heptane. Milligrams extractives a wire through. per square inch=(e)/(s)(F) (c) Place an 800-milliliter beaker containing 100-milliliters of the appro- where: priate food-simulating solvent into the e=Milligrams extractives per sample tested. constant temperature bath, cover with s=Surface area tested, in square inches. a watch glass and condition at the de- F=Five, the ratio of the amount of extractives removed by heptane under exagger- sired temperature. ated time-temperature test conditions (d) After conditioning, carefully compared to the amount extracted by a lower the sample sandwich with tongs fat or oil under exaggerated conditions of into the beaker. thermal sterilization and use. (e) At the end of the extraction pe- e′=Chloroform-soluble extractives residue. riod, using the tongs, carefully lift out ee′=Corrected chloroform-soluble extractives the sample sandwich and hang it over residue. e′ or ee′ is substituted for e in the above equa- the beaker with the wire. tions when necessary. (f) After draining, pour the food-simulating solvent solution into a tared If when calculated by the equations in 250-milliliter beaker. Rinse the 800-mil- paragraph (d)(5)(i) (a) and (b) of this liliter beaker three times, using a total section, the extractives in milligrams of not more than 50 milliliters of the per square inch exceeds the limitations required solvent. prescribed in paragraph (c) of this sec- (g) Determine total nonvolatile ex- tion, proceed to paragraph (d)(5)(ii) of tractives in accordance with paragraph this section (method for determining (d)(5) of this section. the amount of chloroform-soluble ex- (4) Selection of samples. Quadruplicate tractives residues). samples should be tested, using for (ii) Chloroform-soluble extractives res- each replicate sample the number of idue. Add 50 milliliters of chloroform 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

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through Whatman No. 41 filter paper the column (or buret) may be option- (or equivalent) in a Pyrex (or equiva- ally fitted with a 100-millimeter sol- lent) funnel, collecting the filtrate in a vent reservoir. clean, tared evaporating dish (platinum (2) Preparation of column. Place a or Pyrex). Repeat the chloroform ex- snug pledget of fine glass wool in the traction, washing the filter paper with bottom of the column (or buret) if the this second portion of chloroform. Add column (or buret) is not equipped with this filtrate to the original filtrate and integral coarse, fritted glass disc. Over- evaporate the total down to a few mil- lay the glass wool pledget (or fritted liliters on a low-temperature hotplate. glass disc) with a 15–20 millimeter deep The last few milliliters should be evap- layer of fine sand. Measure in a grad- orated in an oven maintained at ap- uated cylinder 15 milliliters of proximately 221 °F. Cool the chromatographic grade aluminum evaporating dish in a desiccator for 30 oxide (80–200 mesh) that has been tight- minutes and weigh to the nearest 0.1 ly settled by tapping the cylinder. milligram to get the chloroform-solu- Transfer the aluminum oxide to the ble extractives residue (′). This ′ is sub- chromatographic tube, tapping the stituted for e in the equations in para- tube during and after the transfer so as graph (d)(5)(i) (a) and (b) of this sec- to tightly settle the aluminum oxide. tion. If the chloroform-soluble extrac- Overlay the layer of aluminum oxide tives in milligrams per square inch with a 1.0–1.5 centimeter deep layer of still exceeds the limitation prescribed anhydrous sodium sulfate and on top of in paragraph (c) of this section, proceed this place an 8–10 millimeter thick plug to paragraph (d)(5)(iii) of this section of fine glass wool. Next carefully add (method for determining corrected about 25 milliliters of heptane to the chloroform-soluble extractives res- column with stopcock open, and allow idue). the heptane to pass through the col- (iii) Corrected chloroform-soluble ex- umn until the top level of the liquid tractives residue—(a) Correction for zinc just passes into the top glass wool plug extractives. Ash the residue in the in the column, and close stopcock. evaporating dish by heating gently (3) Chromatographing of sample ex- over a Meker-type burner to destroy tract—(i) For chloroform residues weigh- organic matter and hold at red heat for ing 0.5 gram or less. To the dried and about 1 minute. Cool in the air for 3 weighed chloroform-soluble extract minutes, and place the evaporating residue in the evaporating dish, ob- dish in the desiccator for 30 minutes tained in paragraph (d)(5)(ii) of this and weigh to the nearest 0.1 milligram. section, add 20 milliliters of heptane Analyze this ash for zinc by standard and stir. If necessary, heat carefully to Association of Official Agricultural dissolve the residue. Additional Chemists methods or equivalent. Cal- heptane not to exceed a total volume of culate the zinc in the ash as zinc ole- 50 milliliters may be used if necessary ate, and subtract from the weight of to complete dissolving. Cool to room chloroform-soluble extractives residue temperature. (If solution becomes (′) to obtain the zinc-corrected chloro- cloudy, use the procedure in paragraph form-soluble extractives residue (e′). (d)(5)(iii)(b)(3)(ii) of this section to ob- This e′ is substituted for e in the equa- tain an aliquot of heptane solution cal- tions in paragraph (d)(5)(i) (a) and (b) of culated to contain 0.1–0.5 gram of chlo- this section. roform-soluble extract residue.) Trans- (b) Correction for wax, petrolatum, and fer the clear liquid solution to the col- mineral oil—(1) Apparatus. Standard 10 umn (or buret). Rinse the dish with 10 millimeter inside diameter × 60 centi- millimeters of additional heptane and meter chromatographic column (or add to column. Allow the liquid to pass 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

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filtrate with an additional 10–15 milli- soluble extracts which contain high liters of heptane and add to the col- melting waxes (melting point greater umn. Wash (elute) the column with than 170 °F), it may be necessary to di- more heptane collecting about 100 mil- lute the heptane solution further so liliters of total eluate including that that a 50-milliliter aliquot will contain already collected in the evaporating only 0.1–0.2 gram of the chloroform- dish. Evaporate the combined eluate in soluble extract residue.) the evaporating dish to dryness on a (e) Acrylonitrile copolymers identi- steam bath. Dry the residue for 15 min- fied in this section shall comply with utes in an oven maintained at a tem- the provisions of § 180.22 of this chap- perature of approximately 221 °F. Cool ter, except where the copolymers are the evaporating dish in a desiccator for restricted to use in contact with food 30 minutes and weigh the residue to the only of the type identified in paragraph nearest 0.1 milligram. Subtract the (c), table 1 under Category VIII. weight of the residue from the weight [42 FR 14554, Mar. 15, 1977] of chloroform-soluble extractives residue (′) to obtain the wax-, petrolatum- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 176.170, see the List of CFR , and mineral oil-corrected chloroform- Sections Affected, which appears in the soluble extractives residue (e′). This e′ Finding Aids section of the printed volume is substituted for e in the equations in and on GPO Access. paragraph (d)(5)(i) (a) and (b) of this section. § 176.180 Components of paper and pa- (ii) For chloroform residues weighing perboard in contact with dry food. more than 0.5 gram. Redissolve the The substances listed in this section dried and weighed chloroform-soluble may be safely used as components of extract residue as described in para- the uncoated or coated food-contact graph (d)(5)(iii)(b)(3)(i) of this section surface of paper and paperboard in- using proportionately larger quantities tended for use in producing, manufac- of heptane. Transfer the heptane solu- turing, packing, processing, preparing, tion to an appropriate-sized volumetric treating, packaging, transporting, or flask (i.e., a 250-milliliter flask for holding dry food of the type identified about 2.5 grams of residue) and adjust in § 176.170(c), table 1, under Type VIII, to volume with additional heptane. Pi- subject to the provisions of this sec- pette out an aliquot (about 50 milli- tion. liters) calculated to contain 0.1–0.5 (a) The substances are used in gram of the chloroform-soluble extract amounts not to exceed that required to residue and analyze accomplish their intended physical or chromatographically as described in technical effect, and are so used as to paragraph (d)(5)(iii)(b)(3)(i) of this sec- accomplish no effect in food other than tion. In this case the weight of the that ordinarily accomplished by pack- dried residue from the heptane eluate aging. must be multiplied by the dilution fac- (b) The substances permitted to be tor to obtain the weight of wax, petro- used include the following: latum, and mineral oil residue to be (1) Substances that by § 176.170 and subtracted from the weight of chloro- other applicable regulations in parts form-soluble extractives residue (′) to 170 through 189 of this chapter may be obtain the wax-, petrolatum-, and min- safely used as components of the eral oil-corrected chloroform-soluble uncoated or coated food-contact sur- extractives residue (e′). This e′ is sub- face of paper and paperboard, subject stituted for e in the equations in para- to the provisions of such regulation. graph (d)(5)(i) (a) and (b) of this sec- (2) Substances identified in the fol- tion. (Note: In the case of chloroform- 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. 38193Ð60Ð1) . 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. 70983Ð55Ð0). .

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List of substances Limitations

4-[2-[2-(2-Alkoxy(C12ÐC15) 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 C10ÐC18 with not less than 50 percent C14ÐC16). . 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. 2634Ð33Ð5) ...... 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. 3064Ð70Ð8 ...... For use only as a preservative in coatings. Borax ...... For use as preservative in coatings. Boric acid ...... Do. 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 . Diethanolamine. . Diethylene glycol dibenzoate (CAS Reg. No. 120Ð55Ð8) ...... 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°Ð228 °F, as determined by ASTM method D127Ð60, and an acid value of 10 maximum. ASTM Method D127Ð60 ‘‘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 Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. . Diphenylamine. . Dipropylene glycol dibenzoate (CAS Reg. No. 27138Ð31Ð4) ..... 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 (C12ÐC18) diethanolamide. . Fish oil fatty acids, hydrogenated, potassium salt. . Formaldehyde. . Glyceryl monocaprate. . Glyceryl tribenzoate (CAS Reg. No. 614Ð33Ð5) ...... For use only as a plasticizer in polymeric coatings. Glyoxal. . Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013Ð For use as an insolubilizer for starch in coatings. 01Ð0) 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. 53037Ð34Ð6) ...... For use as an insolubilizer for starch.

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List of substances Limitations

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, 2Ð(C17 and C17-unsaturated alkyl)-1Ð For use only at levels not to exceed 0.5 percent by weight of [2Ð(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard. methyl, methyl sulfates (CAS Reg. No. 72749Ð55Ð4). . 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 esters of mono-, di-, and tripropylene glycol. . Methyl napthalene sulfonic acid-formaldehyde condensate, sodium salt. . Methylated poly(NÐ1,2-dihydroxyethylene-1,3-imidazolidinÐ2Ð 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 C15ÐC21 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. 68412Ð pounds per ton of paper. 14Ð6), and the acetate salts thereof (CAS Reg. No. 68784Ð 21Ð4), which may be emulsified with ethoxylated tallow alkyl amines (CAS Reg. No. 61791Ð26Ð2) . 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-(C16ÐC18) 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). .

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List of substances Limitations

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 11Ð15 percent and chlorine level of 20Ð23 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. 114133Ð44Ð7) or a sulfate (CAS Reg. No. 167678Ð43Ð5), having a weight-average molecular weight of 1,300,000 and a number-average molecular weight of 16,000. . Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No. 115340Ð77Ð7), 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. 150413Ð26Ð6) . 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.

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List of substances Limitations

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. 106569Ð82Ð8) . perboard coatings. Polyoxyethylene (minimum 12 moles) ester of tall oil (30%Ð 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 0.20Ð0.25 micron, a length-to-diameter ratio of approximately 25:1 or greater, and consist principally of K2Ti4O9 and K2Ti 6O13. . 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 6Ð9 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.

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List of substances Limitations

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 on GPO Access.

§ 176.200 Defoaming agents used in effect in the defoaming agents or any coatings. limitation further provided. (c) Any substance employed in the The defoaming agents described in production of defoaming agents and this section may be safely used as com- which is the subject of a regulation in ponents of articles intended for use in parts 174, 175, 176, 177, 178 and § 179.45 of producing, manufacturing, packing, this chapter conforms with any speci- processing, preparing, treating, pack- fication in such regulation. aging, transporting, or holding food, (d) Substances employed in the for- subject to the provisions of this sec- mulation of defoaming agents include: tion. (1) Substances generally recognized (a) The defoaming agents are pre- as safe in food. pared as mixtures of substances de- (2) Substances subject to prior sanc- scribed in paragraph (d) of this section. tion or approval for use in defoaming (b) The quantity of any substance agents and used in accordance with employed in the formulation of de- such sanction or approval. foaming agents does not exceed the (3) Substances identified in this para- amount reasonably required to accom- graph (d)(3) and subject to such limita- plish the intended physical or technical tions as are provided:

List of substances Limitations

n-Butyl alcohol . tert-Butyl alcohol . Butyl stearate . Castor oil, sulfated, ammonium, potassium, or sodium salt . Cetyl alcohol . Cyclohexane . Cyclohexanol . Diethylene glycol monolaurate . Diethylene glycol monostearate . Dimers and trimers of unsaturated C18 fatty acids derived from: For use only at levels not to exceed 0.1% by weight of total coating solids. Animal and vegetable fats and oils. Tall oil. Dimethylpolysiloxane . a-(Dinonylphenyl)-ω-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. 9014Ð93Ð1) . 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 .

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List of substances Limitations

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 . 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 (1) The quantity of defoaming agent follows: or agents used shall not exceed the

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amount reasonably required to accom- Rapeseed oil. plish the intended effect, which is to Ricebran oil. prevent or control the formation of Soybean oil. Sperm oil. foam. Tall oil. (2) The defoaming agents are used in the preparation and application of (2) Fatty triglycerides, and marine coatings for paper and paperboard. oils, and the fatty acids and alcohols derived therefrom (paragraph (d)(1) of [42 FR 14554, Mar. 15, 1977, as amended at 62 this section) reacted with one or more FR 39772, July 24, 1997] of the following, with or without dehy- § 176.210 Defoaming agents used in the dration, to form chemicals of the cat- manufacture of paper and paper- egory indicated in parentheses: board. Aluminum hydroxide (soaps). Defoaming agents may be safely used Ammonia (amides). in the manufacture of paper and paper- Butanol (esters). board intended for use in packaging, Butoxy-polyoxypropylene, molecular weight transporting, or holding food in accord- 1,000–2,500 (esters). Butylene glycol (esters). ance with the following prescribed con- Calcium hydroxide (soaps). ditions: Diethanolamine (amides). (a) The defoaming agents are pre- Diethylene glycol (esters). pared from one or more of the sub- Ethylene glycol (esters). stances named in paragraph (d) of this Ethylene oxide (esters and ethers). section, subject to any prescribed limi- Glycerin (mono- and diglycerides). tations. Hydrogen (hydrogenated compounds). Hydrogen (amines). (b) The defoaming agents are used to Isobutanol (esters). prevent or control the formation of Isopropanol (esters). foam during the manufacture of paper Magnesium hydroxide (soaps). and paperboard prior to and during the Methanol (esters). sheet-forming process. Morpholine (soaps). (c) The quantity of defoaming agent Oxygen (air-blown oils). or agents added during the manufac- Pentaerythritol (esters). Polyoxyethylene, molecular weights 200, 300, turing process shall not exceed the 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 amount necessary to accomplish the (esters). intended technical effect. Polyoxypropylene, molecular weight 200– (d) Substances permitted to be used 2,000 (esters). in the formulation of defoaming agents Potassium hydroxide (soaps). include substances subject to prior Propanol (esters). sanctions or approval for such use and Propylene glycol (esters). employed subject to the conditions of Propylene oxide (esters). Sodium hydroxide (soaps). such sanctions or approvals, substances Sorbitol (esters). generally recognized as safe for use in Sulfuric acid (sulfated and sulfonated com- food, substances generally recognized pounds). as safe for use in paper and paperboard, Triethanolamine (amides and soaps). and substances listed in this para- Triisopropanolamine (amides and soaps). graph, subject to the limitations, if Trimethylolethane (esters). any, prescribed. Zinc hydroxide (soaps). (1) Fatty triglycerides, and the fatty (3) Miscellaneous: acids, alcohols, and dimers derived Alcohols and ketone alcohols mixture (still- therefrom: bottom product from C12–C18 alcohol manu- Beef tallow. facturing process). Castor oil. Amyl alcohol. Coconut oil. Butoxy polyethylene polypropylene glycol Corn oil. molecular weight 900–4,200. Cottonseed oil. Butoxy-polyoxypropylene molecular weight Fish oil. 1,000–2,500. Lard oil. Butylated hydroxyanisole. Linseed oil. Butylated hydroxytoluene. Mustardseed oil. Calcium lignin sulfonate. Palm oil. Capryl alcohol. Peanut oil. p-Chlorometacresol.

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Cyclohexanol. Reg. No. 97–88–1), isobutyl methacrylate Diacetyltartaric acid ester of tallow mono- (CAS Reg. No. 97–86–9) and methyl meth- glyceride. acrylate (CAS Reg. No. 80–62–6); the com- 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. bined polymer contains no more than 5 35691–65–7), for use as a preservative at a weight percent of polymer units derived level not to exceed 0.05 weight-percent of from N-vinyl pyrrolidone and is present at the defoaming agent. a level not to exceed 7 parts per million by Diethanolamine. weight of the finished dry paper and paper- Diethylene triamine. board fibers. Di-(2-ethylhexyl) phthalate. Polyoxyethylene (4 mols) decyl phosphate. 2,6-Dimethyl heptanol-4 (nonyl alcohol). Polyoxyethylene (4 mols) di(2-ethyl hexano- Dimethylpolysiloxane. ate). Di-tert-butyl hydroquinone. Polyoxyethylene (15 mols) ester of rosin. Dodecylbenzene sulfonic acids. Polyoxyethylene (3–15 mols) tridecyl alcohol. Ethanol. Polyoxypropylene, molecular weight 200– 2-Ethylhexanol. 2,000. Ethylenediamine tetraacetic acid tetra- Polyoxypropylene-polyoxethylene conden- sodium salt. sate, minimum molecular weight 950. Formaldehyde. Polyoxypropylene-ethylene oxide condensate Heavy oxo-fraction (a still-bottom product of of ethylene diamine, molecular weight iso-octyl alcohol manufacture, of approxi- 1,700–3,800. mate composition: Octyl alcohol 5 percent Polyvinyl pyrrolidone, molecular weight nonyl alcohol 10 percent, decyl and higher 40,000. alcohols 35 percent, esters 45 percent, and soaps 5 percent). Potassium distearyl phosphate. 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2- Potassium pentachlorophenate. oxazoline. Potassium trichlorophenate. Hexylene glycol (2-methyl-2-4-pentanediol). Rosins and rosin derivatives identified in 12-Hydroxystearic acid. § 175.105(c)(5) of this chapter. Isobutanol. Silica. Isopropanol. Siloxanes and silicones, dimethyl, methylhy- Isopropylamine salt of dodecylbenzene sul- drogen, reaction products with poly- fonic acid. ethylene-polypropylene glycol monoallyl Kerosine. ether (CAS Reg. No. 71965–38–3). Lanolin. Sodium alkyl (C9–C15) benzene-sulfonate. Methanol. Sodium dioctyl sulfosuccinate. Methyl 12-hydroxystearate. Sodium distearyl phosphate. Methyl taurine-oleic acid condensate, molec- Sodium lauryl sulfate. ular weight 486. Sodium lignin sulfonate. a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu- Sodium 2-mercaptobenzothiazole. tyl)-o-phenylene]]bis[omega-hydroxypoly Sodium naphthalenesulfonic acid (3 mols) (oxyethylene)] having 6–7.5 moles of ethyl- condensed with formaldehyde (2 mols). ene oxide per hydroxyl group. Sodium orthophenylphenate. Mineral oil. Sodium pentachlorophenate. Mono-, di-, and triisopropanolamine. Sodium petroleum sulfonate, molecular Mono- and diisopropanolamine stearate. weight 440–450. Monobutyl ether of ethylene glycol. Sodium trichlorophenate. Monoethanolamine. Stearyl alcohol. 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. o-Phenylphenol. moles of ethylene oxide. Pine oil. Tetrahydrofurfuryl alcohol. Polybutene, hydrogenated; complying with Tributoxyethyl phosphate. the identity prescribed under § 178.3740(b) of Tributyl phosphate. this chapter. Tridecyl alcohol. Polyethylene. Triethanolamine. Polyethylene, oxidized (air-blown). Triethylene glycol di(2-ethyl hexanoate). Polymer derived from N-vinyl pyrrolidone Tri-(2-ethylhexyl) phosphate. and copolymers derived from the mixed Tristearyl phosphate. alkyl (C12-C15, C16, C18, C20, and C22) meth- Wax, petroleum, Type I and Type II. acrylate esters, butyl methacrylate (CAS Wax, petroleum (oxidized).

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Wax (montan). § 176.260 Pulp from reclaimed fiber. [42 FR 14554, Mar. 15, 1977, as amended at 47 (a) Pulp from reclaimed fiber may be FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, safely used as a component of articles 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, used in producing, manufacturing, June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR packing, processing, preparing, treat- 14246, Apr. 1, 1996] ing, packaging, transporting, or holding food, subject to the provisions of § 176.230 3,5-Dimethyl-1,3,5,2H- paragraph (b) of this section. tetrahydrothiadiazine-2-thione. (b) Pulp from reclaimed fiber is pre- 3,5-Dimethyl-1,3,5,2H-tetrahydrothi- pared from the paper and paperboard adiazine-2-thione may safely be used as products described in paragraphs (b) (1) a preservative in the manufacture and and (2) of this section, by repulping coating of paper and paperboard in- with water to recover the fiber with tended for use in contact with food in the least possible amount of nonfibrous accordance with the following pre- substances. scribed conditions: (1) Industrial waste from the manu- (a) It is used as follows: facture of paper and paperboard prod- (1) In the manufacture of paper and ucts excluding that which bears or con- paperboard as a preservative for sub- tains any poisonous or deleterious substance which is retained in the recov- stances added to the pulp suspension ered pulp and that migrates to the prior to the sheet-forming operation food, except as provided in regulations provided that the preservative is vola- promulgated under sections 406 and 409 tilized by heat in the drying and fin- of the Federal Food, Drug, and Cos- ishing of the paper and paperboard. metic Act. (2) As a preservative for coatings for (2) Salvage from used paper and pa- paper and paperboard, Provided, That perboard excluding that which (i) bears the preservative is volatilized by heat or contains any poisonous or delete- in the drying and finishing of the coat- rious substance which is retained in ed paper or paperboard. the recovered pulp and that migrates (b) The quantity used shall not ex- to the food, except as provided in regu- ceed the least amount reasonably re- lations promulgated under sections 406 quired to accomplish the intended and 409 of the act or (ii) has been used technical effect and shall not be infor shipping or handling any such sub- tended to nor, in fact, accomplish any stance. physical or technical effect in the food § 176.300 Slimicides. itself. (c) The use of a preservative in any (a) Slimicides may be safely used in substance or article subject to any reg- the manufacture of paper and paper- ulation in parts 174, 175, 176, 177, 178 board that contact food, in accordance and § 179.45 of this chapter must comply with the following prescribed conditions: with any specifications and limitations (1) Slimicides are used as anti- prescribed by such regulation for the microbial agents to control slime in substance or article. the manufacture of paper and paperboard. § 176.250 Poly-1,4,7,10,13-pentaaza-15- hydroxyhexadecane. (2) Subject to any prescribed limitations, slimicides are prepared from one Poly-1,4,7,10,13-pentaaza-15-hydrox- or more of the slime-control substances yhexadecane may be safely used as a named in paragraph (c) of this section retention aid employed prior to the to which may be added optional adju- sheet-forming operation in the manu- vant substances as provided for under facture of paper and paperboard in- paragraph (d) of this section. tended for use in contact with food in (3) Slimicides are added to the proc- an amount not to exceed that nec- ess water used in the production of essary to accomplish the intended paper or paperboard, and the quantity physical or technical effect and not to added shall not exceed the amount nec- exceed 6 pounds per ton of finished essary to accomplish the intended paper or paperboard. technical effect.

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(b) To insure safe usage, the label or slimicides include substances subject labeling of slimicides shall bear ade- to prior sanction or approval for such quate directions for use. use and the following: (c) Slime-control substances permitted for use in the preparation of

List of substances Limitations

Acrolein . Alkenyl (C16ÐC18) dimethylethyl-ammonium bromide . n-Alkyl (C12ÐC18) 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. 3785Ð34Ð0] 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. 52Ð51Ð7) ...... 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 . n-Dialkyl (C12ÐC18) benzylmethylammonium chloride . 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691Ð65Ð7) .. 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. 1192Ð52Ð5) ...... 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. 20018Ð09Ð01). 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. 34911Ð46Ð1) . 2-Hydroxypropyl methanethiol sulfonate . 2-Mercaptobenzothiazole . Methylenebisbutanethiolsulfonate . Methylenebisthiocyanate . 2-Nitrobutyl bromoacetate [CA Reg. No. 32815Ð96Ð6] ...... 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 55566Ð30Ð8) . 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 .

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(d) Adjuvant substances permitted to tended technical effect or exceed 15 be used in the preparation of slimicides percent by weight of the finished paper. include substances generally recog- (2) Conditions of use. The glassine and nized as safe for use in food, substances greaseproof papers are used for pack- generally recognized as safe for use in aging dry food or as the food-contact paper and paperboard, substances per- surface for dry food. mitted to be used in paper and paperboard by other regulations in this § 176.350 Tamarind seed kernel pow- chapter, and the following: der. Tamarind seed kernel powder may be Acetone. safely used as a component of articles Butlylene oxide. Dibutyl phthalate. intended for use in producing, manu- Didecyl phthalate. facturing, packing, processing, pre- N,N-Dimethylformamide. paring, treating, packaging, trans- Dodecyl phthalate. porting, or holding food, subject to the Ethanolamine. provisions of this section. Ethylene glycol. (a) Tamarind seed kernel powder is Ethylenediamine. the ground kernel of tamarind seed N-methyl-2-pyrrolidone (CAS Reg. No. 872– (Tamarindus indica L.) after removal of 50–4). the seed coat. a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbutyl)-o-phenylene]] bis[omega-hydroxypoly (b) It is used in the manufacture of (oxyethylene)] having 6–7.5 moles of ethyl- paper and paperboard. ene oxide per hydroxyl group. Monomethyl ethers of mono-, di-, and tri- PART 177—INDIRECT FOOD propylene glycol. ADDITIVES: POLYMERS Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide. Octylphenol reaction product with 25 mol- Subpart A [Reserved] ecules of propylene oxide and 40 molecules of ethylene oxide. Subpart B—Substances for Use as Basic Components of Single and Repeated [42 FR 14554, Mar. 15, 1977, as amended at 42 Use Food Contact Surfaces FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Sec. Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR 177.1010 Acrylic and modified acrylic plas- 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989; tics, semirigid and rigid. 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24, 177.1020 Acrylonitrile/butadiene/styrene co– 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, polymer. June 30, 2000; 65 FR 70790, Nov. 28, 2000] 177.1030 Acrylonitrile/butadiene/styrene/ methyl methacrylate copolymer. § 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer. Sodium nitrate-urea complex may be 177.1050 Acrylonitrile/styrene copolymer 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. (a) Sodium nitrate-urea complex is a 177.1211 Cross-linked polyacrylate copoly- clathrate of approximately two parts mers. 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. this section. 177.1315 Ethylene-1,4-cyclohexylene (1) Limitations. (i) It is used as a plas- dimethylene terephthalate copolymers. 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.

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177.1345 Ethylene/1,3-phenylene oxyethylene 177.1950 Vinyl chloride-ethylene copoly- isophthalate/terephthalate copolymer. mers. 177.1350 Ethylene-vinyl acetate copolymers. 177.1960 Vinyl chloride-hexene-1 copoly- 177.1360 Ethylene-vinyl acetate-vinyl alco- mers. hol copolymers. 177.1970 Vinyl chloride-lauryl vinyl ether 177.1380 Fluorocarbon resins. copolymers. 177.1390 Laminate structures for use at tem- 177.1980 Vinyl chloride-propylene copoly- peratures of 250 °F and above. mers. 177.1395 Laminate structures for use at tem- 177.1990 Vinylidene chloride/methyl acry- ° ° peratures between 120 F and 250 F. late copolymers. 177.1400 Hydroxyethyl cellulose film, water- 177.2000 Vinylidene chloride/methyl acry- insoluble. late/methyl methacrylate polymers. 177.1420 Isobutylene polymers. 177.1430 Isobutylene-butene copolymers. Subpart C—Substances for Use Only as 177.1440 4,4′-Isopropylidenediphenol- epichlorohydrin resins minimum molec- Components of Articles Intended for ular weight 10,000. Repeated Use 177.1460 Melamine-formaldehyde resins in molded articles. 177.2210 Ethylene polymer, chlorosulfonated. 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers. 177.2250 Filters, microporous polymeric. 177.1500 Nylon resins. 177.2260 Filters, resin-bonded. 177.1520 Olefin polymers. 177.2280 4,4′-Isopropylidenediphenol- 177.1550 Perfluorocarbon resins. epichlorohydrin thermosetting epoxy 177.1555 Polyarylate resins. resins. 177.1556 Polyaryletherketone resins. 177.2355 Mineral reinforced nylon resins. 177.1560 Polyarylsulfone resins. 177.2400 Perfluorocarbon cured elastomers. 177.1570 Poly-1-butene resins and butene/ 177.2410 Phenolic resins in molded articles. ethylene copolymers. 177.2415 Poly(aryletherketone) resins. 177.1580 Polycarbonate resins. 177.2420 Polyester resins, cross-linked. 177.1585 Polyestercarbonate resins. 177.2430 Polyether resins, chlorinated. 177.1590 Polyester elastomers. 177.2440 Polyethersulfone resins. 177.1595 Polyetherimide resin. 177.2450 Polyamide-imide resins. 177.1600 Polyethylene resins, carboxyl modified. 177.2460 Poly(2,6-dimethyl-1,4-phenylene) 177.1610 Polyethylene, chlorinated. oxide resins. 177.1615 Polyethylene, fluorinated. 177.2465 Polymethylmethacrylate/poly(tri 177.1620 Polyethylene, oxidized. methoxysilylpropyl) methacrylate co- 177.1630 Polyethylene phthalate polymers. polymers. 177.1632 Poly (phenyleneterephthalamide) 177.2470 Polyoxymethylene copolymer. resins. 177.2480 Polyoxymethylene homopolymer. 177.1635 Poly(p-methylstyrene) and rubber- 177.2490 Polyphenylene sulfide resins. modified poly(p-methylstyrene). 177.2500 Polyphenylene sulfone resins. 177.1637 Poly(oxy-1,2- 177.2510 Polyvinylidene fluoride resins. ethanediyloxycarbonyl-2,6- 177.2550 Reverse osmosis membranes. naphthalenediylcarbonyl) resins. 177.2600 Rubber articles intended for re- 177.1640 Polystyrene and rubber-modified peated use. polystyrene. 177.2710 Styrene-divinylbenzene resins, 177.1650 Polysulfide polymer-polyepoxy res- cross-linked. ins. 177.2800 Textiles and textile fibers. 177.1655 Polysulfone resins. 177.1660 Poly (tetramethylene 177.2910 Ultra-filtration membranes. terephthalate). AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. 177.1670 Polyvinyl alcohol film. 177.1680 Polyurethane resins. SOURCE: 42 FR 14572, Mar. 15, 1977, unless 177.1810 Styrene block polymers. otherwise noted. 177.1820 Styrene-maleic anhydride copoly- EDITORIAL NOTE: Nomenclature changes to mers. part 177 appear at 61 FR 14482, Apr. 2, 1996, 66 177.1830 Styrene-methyl methacrylate co- FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. polymers. 27, 2001. 177.1850 Textryls. 177.1900 Urea-formaldehyde resins in molded articles. Subpart A [Reserved]

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Subpart B—Substances for Use as (3) Polymers identified in paragraphs Basic Components of Single (a)(1) and (2) of this section containing and Repeated Use Food Con- no more than 5 weight-percent of total polymer units derived by copolym- tact Surfaces erization with one or more of the § 177.1010 Acrylic and modified acrylic monomers listed in paragraph (a)(3)(i) plastics, semirigid and rigid. and (ii) of this section. Monomers listed in paragraph (a)(3)(ii) of this section Semirigid and rigid acrylic and modi- are limited to use only in plastic arti- fied acrylic plastics may be safely used cles intended for repeated use in con- as articles intended for use in contact tact with food. with food, in accordance with the fol- (i) List of minor monomers: lowing prescribed conditions. The acrylic and modified acrylic polymers Acrylamide. or plastics described in this section Acrylic acid also may be safely used as components 1,3-Butylene glycol dimethacrylate. 1,4-Butylene glycol dimethacrylate. of articles intended for use in contact Diethylene glycol dimethacrylate. with food. Diproplylene glycol dimethacrylate. (a) The optional substances that may Divinylbenzene. be used in the formulation of the Ethylene glycol dimethacrylate. semirigid and rigid acrylic and modi- Itaconic acid. fied acrylic plastics, or in the formula- Methacrylic acid. tion of acrylic and modified acrylic N-Methylolacrylamide. N-Methylolmethacrylamide. components of articles, include sub- 4-Methyl-1,4-pentanediol dimethacrylate. stances generally recognized as safe in Propylene glycol dimethacrylate. food, substances used in accordance Trivinylbenzene. with a prior sanction or approval, sub- (ii) List of minor monomers limited stances permitted for use in such plas- to use only in plastic articles intended tics by regulations in parts 170 through for repeated use in contact with food: 189 of this chapter, and substances identified in this paragraph. At least 50 Allyl methacrylate [Chemical Abstracts weight-percent of the polymer content Service Registry No. 96–05–9] of the acrylic and modified acrylic ma- tert-Butyl acrylate. terials used as finished articles or as tert-Butylaminoethyl methacrylate. sec-Butyl methacrylate. components of articles shall consist of tert-Butyl methacrylate. polymer units derived from one or Cyclohexyl methacrylate. more of the acrylic or methacrylic Dimethylaminoethyl methacrylate. monomers listed in paragraph (a)(1) of 2-Ethylhexyl methacrylate. this section. Hydroxyethyl methacrylate. (1) Homopolymers and copolymers of Hydroxyethyl vinyl sulfide. the following monomers: Hydroxypropyl methacrylate. Isobornyl methacrylate. n-Butyl acrylate. Isobutyl methacrylate. n-Butyl methacrylate. Isopropyl acrylate. Ethyl acrylate. Isopropyl methacrylate. 2-Ethylhexyl acrylate. Methacrylamide. Ethyl methacrylate. Methacrylamidoethylene urea. 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. mixed: Styrene. Vinyl chloride. Butadiene-acrylonitrile copolymers. Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers.

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Butadiene-acrylonitrile-styrene-methyl from tables 1 and 2 of § 176.170(c) of this methacrylic copolymers. chapter, shall yield extractives not to Butadiene-styrene copolymers. exceed the following, when tested by Butyl rubber. Natural rubber. the methods prescribed in paragraph Polybutadiene. (c) of this section. The acrylic and Poly (3-chloro-1,3-butadiene). modified acrylic polymers or plastics Polyester identified in § 175.300(b)(3)(vii) of intended to be used as components of this chapter. articles also shall yield extractives not Polyvinyl chloride. to exceed the following limitations Vinyl chloride copolymers complying with when prepared as strips as described in § 177.1980. Vinyl chloride-vinyl acetate copolymers. paragraph (c)(2) of this section: (1) Total nonvolatile extractives not (5) Antioxidants and stabilizers iden- to exceed 0.3 milligram per square inch tified in § 175.300(b)(3)(xxx) of this chap- of surface tested. ter and the following: (2) Potassium permanganate oxidiz- Di-tert-butyl-p-cresol. able distilled water and 8 and 50 per- 2-Hydroxy-4-methoxybenzophenone. cent alcohol extractives not to exceed 2-Hydroxy-4-methoxy-2- an absorbance of 0.15. carboxybenzophenone. (3) Ultraviolet-absorbing distilled 3-Hydroxyphenyl benzoate. water and 8 and 50 percent alcohol ex- p-Methoxyphenol. tractives not to exceed an absorbance Methyl salicylate. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro- of 0.30. cinnamate (CAS Reg. No. 2082–79–3): For (4) Ultraviolet-absorbing n-heptane use only: (1) At levels not exceeding 0.2 extractives not to exceed an absorb- percent by weight in semirigid and rigid ance of 0.10. acrylic and modified acrylic plastics, (c) Analytical methods—(1) Selection of where the finished articles contact foods extractability conditions. These are to be containing not more than 15 percent alco- chosen as provided in § 176.170(c) of this hol; and (2) at levels not exceeding 0.01 per- chapter. cent by weight in semirigid and rigid acrylic and modified acrylic plastics in- (2) Preparation of samples. Sufficient tended for repeated food-contact use where samples to allow duplicates of all ap- the finished article may be used for foods plicable tests shall be cut from the ar- containing more than 15 percent alcohol. ticles or formed from the plastic com- Phenyl salicylate. position under tests, as strips about 2.5 (6) Release agents: Fatty acids de- inches by about 0.85-inch wide by about rived from animal and vegetable fats 0.125-inch thick. The total exposed sur- ± and oils, and fatty alcohols derived face should be 5 square inches 0.5- from such acids. square inch. The samples, after prepa- (7) Surface active agent: Sodium ration, shall be washed with a clean dodecylbenzenesulfonate. brush under hot tapwater, rinsed under (8) Miscellaneous materials: running hot tapwater (140 °F minimum), rinsed with distilled water, and Di(2-ethylhexyl) phthalate, for use only as a air-dried in a dust-free area or in a des- flow promoter at a level not to exceed 3 iccator. weight-percent based on the monomers. Dimethyl phthalate. (3) Preparation of solvents. The water Oxalic acid, for use only as a polymerization used shall be double-distilled water, catalyst aid. prepared in a still using a block tin Tetraethylenepentamine, for use only as a condenser. The 8 and 50 percent (by vol- catalyst activator at a level not to exceed ume) alcohol solvents shall be prepared 0.5 weight-percent based on the monomers. from ethyl alcohol meeting the speci- Toluene. fications of the United States Pharma- Xylene. copeia XX and diluted with double-dis- (b) The semirigid and rigid acrylic tilled water that has been prepared in a and modified acrylic plastics, in the still using a tin block condenser. The finished form in which they are to con- n-heptane shall be spectrophotometric tact food, when extracted with the sol- grade. Adequate precautions must be vent or solvents characterizing the taken to keep all solvents dust-free. type of food and under the conditions (4) Blank values on solvents. (i) Dupli- of time and temperature as determined cate determinations of residual solids

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shall be run on samples of each solvent be determined by preparing duplicate that have been exposed to the tempera- permanganate test blanks according to ture-time conditions of the extraction paragraph (c)(7)(iv) of this section. For test without the plastic sample. Sixty this test, the directions referring to milliliters of exposed solvent is the sample extract shall be dis- pipetted into a clean, weighed plat- regarded. The blanks shall be scanned inum dish, evaporated to 2–5 milliliters in 5-centimeter silica on a nonsparking, low-temperature hot spectrophotometric cells in the spec- plate and dried in 212 °F oven for 30 trophotometer versus the appropriate minutes. The residue for each solvent solvent as reference. The absorbance in shall be determined by weight and the distilled water in the wavelength re- average residue weight used as the gion of 544 to 552 mµ should be 1.16 but blank value in the total solids deter- must not be less than 1.05 nor more mination set out in paragraph (c)(6) of than 1.25. The absorbance in the 8 and this section. The residue for an accept- 50 percent alcohol must not be less able solvent sample shall not exceed 0.5 than 0.85 nor more than 1.15. milligram per 60 milliliters. (v) Duplicate permanganate test de- (ii) For acceptability in the ultra- terminations shall be run on samples of violet absorbers test, a sample of each distilled water and 8 and 50 percent al- solvent shall be scanned in an ultra- cohol solvents that have been exposed violet spectrophotometer in 5-centi- to the temperature-time conditions of meter silica spectrophotometric ab- the extraction test without the plastic sorption cells. The absorbance of the sample. The procedure shall be as de- distilled water when measured versus scribed in paragraph (c)(7)(iv) of this air in the reference cell shall not ex- section, except that the appropriate exceed 0.03 at any point in the wave- posed solvent shall be substituted length region of 245 to 310 mµ. The ab- where the directions call for sample ex- sorbance of the 8 percent alcohol when tract. The average difference in the measured versus distilled water in the absorbances in the region of 544 to 552 reference cell shall not exceed 0.01 at mµ shall be used as a blank correction any point in the wavelength region of for the determination of permanganate 245 to 310 mµ. The absorbance of the 50 percent alcohol when measured versus oxidizable extractives according to distilled water in the reference cell paragraph (c)(7)(iv) of this section. shall not exceed 0.05 at any point in the (5) Extraction procedure. For each ex- wavelength region of 245 to 310 mµ. The traction, place a plastic sample in a × absorbance of the heptane when meas- clean 25 millimeters 200 millimeters ured versus distilled water in the ref- hard-glass test tube and add solvent erence cell shall not exceed 0.15 at 245, equal to 10 milliliters of solvent per 0.09 at 260, 0.04 at 270, and 0.02 at any square inch of plastic surface. This point in the wavelength region of 280 to amount will be between 45 milliliters 310 mµ. and 55 milliliters. The solvent must be (iii) Duplicate ultraviolet blank de- preequilibrated to the temperature of terminations shall be run on samples of the extraction test. Close the test tube each solvent that has been exposed to with a ground-glass stopper and expose the temperature-time conditions of the to the specified temperature for the extraction test without the plastic specified time. Cool the tube and con- sample. An aliquot of the exposed sol- tents to room temperature if nec- vent shall be measured versus the un- essary. exposed solvent in the reference cell. (6) Determination of total nonvolatile The average difference in the extractives. Remove the plastic strip absorbances at any wavelength in the from the solvent with a pair of clean region of 245 to 310 mµ shall be used as forceps and wash the strip with 5 milli- a blank correction for the ultraviolet liters of the appropriate solvent, add- absorbers measured at the same wave- ing the washings to the contents of the length according to paragraph (c)(8)(ii) test tube. Pour the contents of the test of this section. tube into a clean, weighed platinum (iv) The acceptability of the solvents dish. Wash the tube with 5 milliliters for use in the permanganate test shall of the appropriate solvent and add the

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solvent to the platinum dish. Evapo- million of p-methoxyphenol (melting rate the solvent to 2–5 milliliters on a point 54–56 °C, Eastman grade or equiv- nonsparking, low-temperature alent). Pipette 25 milliliters of this p- hotplate. Complete the evaporation in methoxyphenol solution into a rinsed a 212 °F oven for 30 minutes. Cool the Erlenmeyer flask. Pipette exactly 3.0 dish in a desiccator for 30 minutes and milliliters of 154 parts per million weigh to the nearest 0.1 milligram. Cal- aqueous potassium permanganate solu- culate the total nonvolatile extractives tion into the p-methoxyphenol and ex- as follows: actly 3.0 milliliters into the blank, in eb− that order. Swirl both flasks to mix the Milligrams extractives = contents and then transfer aliquots per square inch s from each flask into matched 5-centimeter spectrophotometric absorption Extractives in parts eb cells. The cells are placed in the spec- =×100 per million trophotometer cell compartment with s the p-methoxyphenol solution in the where: reference beam. Spectrophotometric e=Total increase in weight of the dish, in measurement is conducted as in para- milligrams. graph (c)(7)(iv) of this section. The ab- b=Blank value of the solvent in milligrams, as determined in paragraph (c)(4)(i) of sorbance reading in the region 544–552 this section. mµ should be 0.24 but must be not less s=Total surface of the plastic sample in than 0.12 nor more than 0.36. This test square inches. shall be run in duplicate. For the pur- (7) Determination of potassium per- pose of ascertaining compliance with manganate oxidizable extractives. (i) Pi- the limitations in paragraph (b)(2) of pette 25 milliliters of distilled water this section, the absorbance measure- into a clean 125-milliliter Erlenmeyer ments obtained on the distilled water flask that has been rinsed several extracts according to paragraph times with aliquots of distilled water. (c)(7)(iv) of this section shall be multi- This is the blank. Prepare a distilled plied by a correction factor, calculated water solution containing 1.0 part per 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

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(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 nate was added to the solutions. The extracts. Pipette 25 milliliters of the ap- height of the absorbance peak shall be propriate solvent into a clean, 125-mil- measured, corrected for the blank as liliter Erlenmeyer flask that has been determined in paragraph (c)(4)(v) of rinsed several times with aliquots of this section, and multiplied by the ap- the same solvent. This is the blank. propriate correction factor determined Into another similarly rinsed flask, pi- according to paragraph (c)(7) (i), (ii), pette 25 milliliters of the sample ex- and (iii) of this section. This test shall tract that has been exposed under the be run in duplicate and the two results conditions specified in paragraph (c)(5) averaged. of this section. Pipette exactly 3.0 mil- (8) Determination of ultraviolet-absorb- liliters of 154 parts per million aqueous ing extractives. (i) A distilled water so- potassium permanganate solution into lution containing 1.0 part per million the sample and exactly 3.0 milliliters of p-methoxyphenol (melting point 54 into the blank, in that order. Before °C–56 °C. Eastman grade or equivalent) use, the potassium permanganate solution shall be checked as in paragraph shall be scanned in the region 360 to 220 µ (c)(7)(i) of this section. Both flasks are m in 5-centimeter silica spectrophoto- swirled to mix the contents, and then metric absorption cells versus a dis- aliquots from each flask are trans- tilled water reference. The absorbance ferred to matched 5-centimeter at the wavelength of maximum absorb- spectrophotometric absorption cells. ance (should be about 285 mµ) is about Both cells are placed in the spectro- 0.11 but must be not less than 0.08 nor photometer cell compartment with the more than 0.14. This test shall be run in sample solution in the reference beam. duplicate. For the purpose of The spectrophotometer is adjusted for ascertaining compliance with the limi- 0 and 100 percent transmittance at 700 tations prescribed in paragraph (b) (3) mµ. The spectrum is scanned on the ab- and (4) of this section, the absorbance sorbance scale from 700 mµ to 500 mµ in obtained on the extracts according to such a way that the region 544 mµ to paragraph (c)(8)(ii) of this section shall 552 mµ is scanned within 5 minutes to be multiplied by a correction factor, 10 minutes of the time that permanga- 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

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(ii) An aliquot of the extract that has lonitrile and 22 to 27 parts by weight of been exposed under the conditions styrene; and specified in paragraph (c)(5) of this sec- (2) Eleven to sixteen parts by weight tion is scanned in the wavelength re- of a grafted rubber consisting of (i) 8 to gion 360 to 220 mµ versus the appro- 13 parts of butadiene/styrene elastomer priate solvent reference in matched 5- containing 72 to 77 parts by weight of centimeter silica spectrophotometric butadiene and 23 to 28 parts by weight absorption cells. The height of any ab- of styrene and (ii) 3 to 8 parts by sorption peak shall be measured, cor- weight of a graft polymer having the rected for the blank as determined in same composition range as the matrix paragraph (c)(4)(iii) of this section, and polymer. multiplied by the correction factor de- (b) Adjuvants. The copolymer identi- termined according to paragraph fied in paragraph (a) of this section (c)(8)(i) of this section. may contain adjuvant substances re- (d) In accordance with current good quired in its production. Such adju- manufacturing practice, finished vants may include substances gen- semirigid and rigid acrylic and modi- erally recognized as safe in food, sub- fied acrylic plastics, and articles con- stances used in accordance with prior taining these polymers, intended for sanction, substances permitted in this repeated use in contact with food shall part, and the following: be thoroughly cleansed prior to their first use in contact with food. Substance Limitations (e) Acrylonitrile copolymers identi- 2-Mercapto- ethanol ...... The finished copolymer shall fied in this section shall comply with contain not more than 100 the provisions of § 180.22 of this chap- ppm 2-mercaptoethanol ac- ter. rylonitrile adduct as determined by a method titled (f) The acrylic and modified acrylic ‘‘Analysis of Cycopac polymers identified in and complying Resin for Residual b-(2- with this section, when used as compo- Hydroxyethylmercapto) pro- nents of the food-contact surface of an pionitrile,’’ which is incorporated by reference. Cop- article that is the subject of a regula- ies are available from the tion in this part and in parts 174, 175, Bureau of Foods (HFSÐ 176, and 178 of this chapter, shall com- 200), Food and Drug Ad- ministration, 5100 Paint ply with any specifications and limita- Branch Pkwy., College tions prescribed by such regulation for Park, MD 20740, or avail- the article in the finished form in able for inspection at the which it is to contact food. Office of the Federal Reg- ister, 800 North Capitol [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. Street, NW., suite 700, 28, 1977, as amended at 43 FR 54927, Nov. 24, Washington, DC 20408. 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR (c) Specifications. (1) Nitrogen content 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985] of the copolymer is in the range of 16 to 18.5 percent as determined by Micro- § 177.1020 Acrylonitrile/butadiene/sty- Kjeldahl analysis. rene co-polymer. (2) Residual acrylonitrile monomer Acrylonitrile/butadiene/styrene co- content of the finished copolymer arti- polymer identified in this section may cles is not more than 11 parts per mil- be safely used as an article or compo- lion as determined by a gas nent of articles intended for use with chromatographic method titled ‘‘De- all foods, except those containing alco- termination of Residual Acrylonitrile hol, under conditions of use E, F, and G and Styrene Monomers-Gas described in table 2 of § 176.170(c) of this Chromatographic Internal Standard chapter. Method,’’ which is incorporated by ref- (a) Identity. For the purpose of this erence. Copies are available from the section, the acrylonitrile/butadiene/ Center for Food Safety and Applied Nu- styrene copolymer consists of: trition (HFS–200), Food and Drug Ad- (1) Eighty-four to eighty-nine parts ministration, 5100 Paint Branch Pkwy., by weight of a matrix polymer con- College Park, MD 20740, or available for taining 73 to 78 parts by weight of acry- inspection at the Office of the Federal

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Register, 800 North Capitol Street, of a matrix polymer containing 64 to 69 NW., suite 700, Washington, DC 20408. parts by weight of acrylonitrile, 25 to (d) Extractive limitations. (1) Total 30 parts by weight of styrene and 4 to nonvolatile extractives not to exceed 6 parts by weight of methyl methacry- 0.0005 milligram per square inch sur- late; and (2) 21 to 27 parts by weight of face area when the finished food con- a grafted rubber consisting of (i) 16 to tact article is exposed to distilled 20 parts of butadiene/styrene/elastomer water, 3 percent acetic acid, or n- containing 72 to 77 parts by weight of ° heptane for 8 days at 120 F. butadiene and 23 to 28 parts by weight (2) The finished food-contact article of styrene and (ii) 5 to 10 parts by shall yield not more than 0.0015 milli- weight of a graft polymer having the gram per square inch of acrylonitrile same composition range as the matrix monomer when exposed to distilled water and 3 percent acetic acid at 150 polymer. °F for 15 days when analyzed by a po- (b) Adjuvants. The copolymer identi- larographic method titled ‘‘Extracted fied in paragraph (a) of this section Acrylonitrile by Differential Pulse Po- may contain adjuvant substances re- larography,’’ which is incorporated by quired in its production. Such adju- reference. Copies are available from vants may include substances gen- the Center for Food Safety and Applied erally recognized as safe in food, sub- Nutrition (HFS–200), Food and Drug stances used in accordance with prior Administration, 5100 Paint Branch sanction, substances permitted under Pkwy., College Park, MD 20740, or applicable regulations in this part, and available for inspection at the Office of the following: the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC Substances Limitations 20408. 2ÐMercaptoethanol ...... The finished copolymer shall (e) Acrylonitrile copolymers identi- contain not more than 800 fied in this section shall comply with ppm 2Ðmercaptoethanol the provisions of § 180.22 of this chap- acrylonitrile adduct as determined by a method titled ter. ‘‘Analysis of Cycopac (f) Acrylonitrile copolymers identi- Resin for Residual bÐ(2Ð fied in this section are not authorized Hydroxyethylmercapto) propionitrile,’’ which is incor- to be used to fabricate beverage con- porated by reference. Cop- tainers. ies are available from the Bureau of Foods (HFSÐ [42 FR 14572, Mar. 15, 1977, as amended at 42 200), Food and Drug Ad- FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, ministration, 5100 Paint 1982; 54 FR 24897, June 12, 1989] Branch Pkwy., College Park, MD 20740, or avail- § 177.1030 Acrylonitrile/butadiene/sty- able for inspection at the rene/methyl methacrylate copoly- Office of the Federal Reg- ister, 800 North Capitol mer. Street, NW., suite 700, Acrylonitrile/butadiene/styrene/ Washington, DC 20408. methyl methacrylate copolymer identified in this section may be safely (c) Specifications. (1) Nitrogen content used as an article or component of arti- of the copolymer is in the range of 13.0 cles intended for use with food identi- to 16.0 percent as determined by Micro- fied in table 1 of § 176.170(c) of this Kjeldahl analysis. chapter as Type I, II, III, IVA, IVB, V, (2) Residual acrylonitrile monomer VIB, (except bottles intended to hold content of the finished copolymer arti- carbonated beverages), VIIA, VIIB, VIII cles is not more than 11 parts per mil- and IX, under conditions of use C, D, E, lion as determined by a gas F, and G described in table 2 of chromatographic method titled ‘‘De- § 176.170(c) of this chapter with a high termination of Residual Acrylonitrile temperature limitation of 190 °F. and Styrene Monomers-Gas (a) Identity. For the purpose of this Chromatographic Internal Standard section, acrylonitrile/butadiene/sty- Method,’’ which is incorporated by ref- rene/methyl methacrylate copolymer erence. Copies are available from the consists of: (1) 73 to 79 parts by weight

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Center for Food Safety and Applied Nu- to be used to fabricate beverage con- trition (HFS–200), Food and Drug Ad- tainers. ministration, 5100 Paint Branch Pkwy., [42 FR 14572, Mar. 15, 1977, as amended at 42 College Park, MD 20740, or available for FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, inspection at the Office of the Federal 1982; 54 FR 24898, June 12, 1989] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 177.1040 Acrylonitrile/styrene copoly- (d) Extractive limitations. (1) Total mer. nonvolatile extractives not to exceed Acrylonitrile/styrene copolymers 0.0005 milligram per square inch sur- identified in this section may be safely face area of the food-contact article used as a component of packaging ma- when exposed to distilled water, 3 per- terials subject to the provisions of this cent acetic acid, 50 percent ethanol, section. and n-heptane for 10 days at 120 °F. (a) Identity. For the purposes of this section acrylonitrile/styrene copoly- (2) The finished food-contact article mers are basic copolymers meeting the shall yield not more than 0.0025 milli- specifications prescribed in paragraph gram per square inch of acrylonitrile (c) of this section. monomer when exposed to distilled (b) Adjuvants. (1) The copolymers water, 3 percent acetic acid and n- identified in paragraph (c) of this sec- heptane at 190 °F for 2 hours, cooled to tion may contain adjuvant substances 120 °F (80 to 90 minutes) and main- required in their production, with the tained at 120 °F for 10 days when ana- exception that they shall not contain lyzed by a polarographic method titled mercaptans or other substances which ‘‘Extracted Acrylonitrile by Differen- form reversible complexes with acryl- tial Pulse Polarography,’’ which is in- onitrile monomer. Permissible adju- corporated by reference. Copies are vants may include substances gen- available from the Center for Food erally recognized as safe in food, sub- Safety and Applied Nutrition (HFS– stances used in accordance with prior 200), Food and Drug Administration, sanction, substances permitted under 5100 Paint Branch Pkwy., College Park, applicable regulations in this part, and MD 20740, or available for inspection at those authorized in paragraph (b)(2) of the Office of the Federal Register, 800 this section. North Capitol Street, NW., suite 700, (2) The optional adjuvants for the ac- Washington, DC 20408. rylonitrile/styrene copolymer identi- (e) Acrylonitrile copolymers identified in paragraphs (c) (1) and (3) of this section are as follows: fied in this section shall comply with the provisions of § 180.22 of this chap- Substances Limitation ter. Condensation polymer of toluene 0.15 pct maximum. (f) Acrylonitrile copolymers identi- sulfonamide and formaldehyde . fied in this section are not authorized (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 66Ð area of the food contact article weight is 30,000.1 72 parts by weight of acrylo- when exposed to distilled water nitrile and 28Ð34 parts by weight and 3 pct acetic acid for 10 d at of styrene; for use with food of 66 °C (150 °F) . Type VIÐB 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.

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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 45Ð heptane extract obtained when °C (77 °F) is 10cP.1 65 parts by weight of acrylo- 100 g sample of the basic co- nitrile and 35Ð55 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 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 66Ð 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 28Ð34 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 VIÐA and VIÐB identified rylonitrile The extracted copolymer shall not in 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 (HFSÐ200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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 (HFSÐ200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction by ASTM method DÐ1434Ð82, ‘‘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 (HFSÐ200), 5100 Paint Branch Pkwy., College Park, MD 20740, and the American Society for Testing Materials, 1916 Race Street, Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

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

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4–6 parts by weight of a graft copoly- Gas Chromatographic Internal Stand- mer consisting of 70–77 parts by weight ard Method,’’ which is incorporated by of acrylonitrile and 23–30 parts by reference. Copies are available from weight of styrene. the Center for Food Safety and Applied (b) Adjuvants. The modified copoly- Nutrition (HFS–200), Food and Drug mer identified in paragraph (a) of this Administration, 5100 Paint Branch section may contain adjuvant sub- Pkwy., College Park, MD 20740, or stances required in its production. available for inspection at the Office of Such adjuvants may include substances the Federal Register, 800 North Capitol generally recognized as safe in food, Street, NW., suite 700, Washington, DC substances used in accordance with 20408. prior sanction, substances permitted (d) Extractives limitations. The fol- under applicable regulations in this lowing extractives limitations are depart, and the following: termined by an infrared spectrophotometric method titled ‘‘Infrared Substances Limitations Spectrophotometric Determination of n-Dodecylmercaptan ...... The finished copolymer shall Polymer Extracted from Borex 210 contain not more than 500 Resin Pellets,’’ which is incorporated parts per million (ppm) dodecylmercaptan as by reference. Copies are available from dodecylmercapto- the Center for Food Safety and Applied propionitrile as determined Nutrition (HFS–200), Food and Drug by the method titled, ‘‘De- Administration, 5100 Paint Branch termination of b-Dodecyl- mercaptopropionitrile in Pkwy., College Park, MD 20740, or NRÐ16 Polymer,’’ which is available for inspection at the Office of incorporated by reference. the Federal Register, 800 North Capitol Copies are available from the Center for Food Safety Street, NW., suite 700, Washington, DC and Applied Nutrition 20408, and are applicable to the modi- (HFSÐ200), Food and Drug fied copolymers in the form of particles Administration, 5100 Paint of a size that will pass through a U.S. Branch Pkwy., College Park, MD 20740, or avail- Standard Sieve No. 6 and that will be able for inspection at the held on a U.S. Standard Sieve No. 10: Office of the Federal Reg- (1) The extracted copolymer shall not ister, 800 North Capitol Street, NW., suite 700, exceed 2.0 ppm in aqueous extract ob- Washington, DC 20408. tained when a 100-gram sample of copolymer is extracted with 250 milli- (c) Specifications. (1) Nitrogen content liters of freshly distilled water at of the modified copolymer is in the reflux temperature for 2 hours. range of 17.7–19.8 percent. (2) The extracted copolymer shall not (2) Intrinsic viscosity of the matrix exceed 0.5 ppm in n-heptane when a 100- copolymer in butyrolactone is not less gram sample of the basic copol-ymer is than 0.5 deciliter/gram at 35 °C, as de- extracted with 250 milliliters spectral termined by the method titled ‘‘Molec- grade n-heptane at reflux temperature ular Weight of Matrix Copolymer by for 2 hours. Solution Viscosity,’’ which is incor- (e) Accelerated extraction end test. The porated by reference. Copies are avail- modified copolymer shall yield acrylo- able from the Center for Food Safety nitrile monomer not in excess of 0.4 and Applied Nutrition (HFS–200), Food ppm when tested as follows: and Drug Administration, 5100 Paint (1) The modified copolymer shall be Branch Pkwy., College Park, MD 20740, in the form of eight strips 1⁄2 inch by 4 or available for inspection at the Office inches by .03 inch. of the Federal Register, 800 North Cap- (2) The modified copolymer strips itol Street, NW., suite 700, Washington, shall be immersed in 225 milliliters of 3 DC 20408. percent acetic acid in a Pyrex glass (3) Residual acrylonitrile monomer pressure bottle. content of the modified copolymer ar- (3) The pyrex glass pressure bottle is ticles is not more than 11 ppm as deter- then sealed and heated to 150 °F in ei- mined by a gas chromatographic meth- ther a circulating air oven or a thermo- od titled ‘‘Determination of Residual stat controlled bath for a period of 8 Acrylonitrile and Styrene Monomers- days.

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(4) The Pyrex glass pressure bottle is (c) Specifications. Maximum nitrogen then removed from the oven or bath content of the copolymer determined and cooled to room temperature. A by micro-Kjeldahl analysis, shall not sample of the extracting solvent is exceed 8 percent. then withdrawn and analyzed for acry- (d) Limitations. (1) The n-alkylglutar- lonitrile monomer by a gas imide/acrylic copolymers in the fin- chromatographic method titled ‘‘Gas- ished form in which they shall contact Solid Chromatographic Procedure for food, when extracted with the solvent Determining Acrylonitrile Monomer in or solvents characterizing the type of Acrylonitrile-Containing Polymers and food and under the conditions of time Food Simulating Solvents,’’ which is and temperature described in tables 1 incorporated by reference. Copies, are and 2 of § 176.170(c) of this chapter, available from the Center for Food shall yield extractives not to exceed Safety and Applied Nutrition (HFS– the limitations of § 177.1010(b) of this 200), Food and Drug Administration, chapter, when prepared as strips, as de- 5100 Paint Branch Pkwy., College Park, scribed in § 177.1010(c)(2) of this chapter. MD 20740, or available for inspection at (2) The n-alkylglutarimide/acrylic co- the Office of the Federal Register, 800 polymers shall not be used as polymer North Capitol Street, NW., suite 700, modifiers in vinyl chloride homo- or copolymers. Washington, DC 20408. (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. such use by applicable regulations, as (3) Substances that by any regulation set forth in part 174 of this chapter. promulgated under section 409 of the

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act may be safely used as components (4) Substances named in this section of cellophane. and further identified as required. (c) List of substances:

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 (C12ÐC18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of fatty acid (C12ÐC18) diethanolamine soap, and cellulose pulp used in the manufacture of cellophane base diethanolamine mixture having total alkali (calculated as po- sheet. tassium hydroxide) of 16Ð18% and having an acid number of 25Ð35. 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 (C8ÐC18) 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°Ð228 °F., as determined by ASTM method D127Ð60 (‘‘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 Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408), 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. 62362Ð49Ð6) . 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 percentÐ12.2 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 . N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl- aminoethyl)oleamide) . Paraffin, synthetic, complying with ¤ 175.250 of this chapter . Pentaerythritol tetrastearate ...... 0.1 percent.

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

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 2,000Ð10,200; For use only as an adjuvant in vinylidene chloride copolymer bromine number range 210Ð320) . 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 °CÐ92 °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 1,900Ð9,000) . 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 . 2-Stearamido-ethyl stearate . Stearyl alcohol . Styrene-maleic anhydride resins ...... As the basic polymer. Terpene resins identified in ¤ 172.615 of this chapter .

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

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

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(5) Substances that may be employed in the manufacture of closure-sealing gaskets include:

TABLE 1

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

Arachidy-l-behenyl amide (C20ÐC22fatty 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 1646Ð81, ‘‘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 Association of Official Analytical Chemists International, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504 and the Center for Food Safety and Applied Nutrition (HFSÐ200), Food and Drug Ad- ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC . 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. 006422Ð86Ð2). .... 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, IVÐ B, VIÐA, VIÐB, VIÐC (up to 15 percent alcohol by volume), VIIÐB, 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 . Erucylamide ...... 5 percent. Ethylene-propylene copolymer .

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TABLE 1—Continued

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

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. 68411Ð46Ð1) ... 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. 2750Ð3000. 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 26375Ð23Ð5). . gasket compositions used in contact with food types VIÐA and VIÐC (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. 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.

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TABLE 1—Continued

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

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, organisol, mechanical dis- the analytical method described in persion, or latex ...... 50 500 50 § 175.300 of this chapter, adapting the 2. Preformed overall discs procedural details to make the method or annular rings of plasticized polymers, including applicable to closures; such as, for ex- 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 vulcanized plasticized polymers, with the solvent. including natural or synthetic rubber ...... 50 50 50 TABLE 3—TYPES OF FOOD 4. Preformed overall discs I. Nonacid (pH above 5.0), aqueous products; may contain or annular rings of poly- salt or sugar or both, and including oil-in-water emulsions meric or resinous-coated of low- or high-fat content. paper, paperboard, plas- II. Acidic (pH 5.0 or below), aqueous products; may contain tic, or metal foil substrates 50 250 50 5. Closures with sealing salt or sugar or both, and including oil-in-water emulsions gaskets or sealing com- of low- or high-fat content. positions as described in III. Aqueous, acid or nonacid products containing free oil or 1, 2, 3, and 4, and includ- fat; may contain salt, and including water-in-oil emulsions ing paper, paperboard, of low- or high-fat content. and glassine used for dry IV. Dairy products and modifications: foods only ...... (1) (1) (1) A. Water-in-oil emulsions, high- or low-fat. B. Oil-in-water emulsions, high- or low-fat. 1 Extractability tests not applicable. V. Low-moisture fats and oils. (c) The closure assembly to include VI. Beverages: the sealing gasket or sealing com- A. Containing alcohol. B. Nonalcoholic. pound, together with any polymeric or VII. Bakery products. resinous coating, film, foil, natural VIII. Dry solids (no end-test required).

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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

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

A. High temperature heat-sterilized I, IVÐB ...... 250 °F, 2 hr ...... (e.g., over 212 °F) . III, IVÐA, 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, IVÐB ...... Fill boiling, cool to . °F . III, IVÐA ...... 100 °F . 120 °F, 15 min . V ...... do ...... do . D. Hot filled or pasteurized below 150 II, IVÐB, VIÐB ...... 150 °F, 2 hr ...... °F . III, IVÐA ...... do ...... 100 °F, 30 min . 150 °F, 2 hr V ...... do ...... VIÐA ...... E. Temperature filled and stored (no II, IVÐB, VIÐB ...... 120 °F, 24 hr ...... thermal treatment in the container) . III, IVÐA ...... do ...... 70 °F, 30 min . 120 °F, 24 hr. V ...... do ...... VIÐA ...... F. Refrigerated storage (no thermal I, II, III, IVÐA, IVÐB, 70 °F, 48 hr ...... 70 °F, 30 min ...... treatment) . VIÐB, VII . 70 °F, 48 hr. VIÐA ...... G. Frozen storage (no thermal treat- I, II, III, IVÐB, VII ... 70 °F, 24 hr ...... ment in the container) . 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]

§ 177.1211 Cross-linked polyacrylate vant substances may include sub- copolymers. stances permitted for such use by regulations in parts 170 through 179 of this Cross-linked polyacrylate copoly- chapter, substances generally recog- mers identified in paragraph (a) of this nized as safe in food, and substances section may be safely used as articles used in accordance with a prior sanc- or components of articles intended for tion or approval. use in contact with food in accordance (c) Extractives limitations. The copoly- with the following prescribed condi- mers identified in paragraph (a) of this tions: section, in the finished form in which (a) Identity. For the purpose of this they will contact food, must yield low section, the cross-linked polyacrylate molecular weight (less than 1,000 Dal- copolymers consist of: tons) extractives of no more than 0.15 (1) The grafted copolymer of cross- percent by weight of the total polymer linked sodium polyacrylate identified when extracted with 0.2 percent by as 2-propenoic acid, polymers with N,N- weight of aqueous sodium chloride so- di-2-propenyl-2-propen-1-amine and lution at 20 °C for 24 hours. The low hydrolyzed polyvinyl acetate, sodium molecular weight extractives shall be salts, graft (CAS Reg. No. 166164–74–5); determined using size exclusion chro- or matography or an equivalent method. (2) 2-propenoic acid, polymer with 2- When conducting the extraction test, ethyl-2-(((1-oxo-2-pro- the copolymer, with no other absorp- penyl)oxy)methyl)-1,3-propanediyl di-2- tive media, shall be confined either in propenoate and sodium 2-propenoate a finished absorbent pad or in any suit- (CAS Reg. No. 76774–25–9). able flexible porous article, (such as a (b) Adjuvants. The copolymers identi- ‘‘tea bag’’ or infuser), under an applied fied in paragraph (a) of this section pressure of 0.15 pounds per square inch may contain optional adjuvant sub- (for example, a 4x6 inch square pad is stances required in the production of subjected to a 1.6 kilograms applied such copolymers. The optional adju- mass). The solvent used shall be at

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least 60 milliliters aqueous sodium mer and used in accordance with such chloride solution per gram of copoly- sanction or approval. mer. (3) Substances which by regulation in (d) Conditions of use. The copolymers parts 174, 175, 176, 177, 178 and § 179.45 of identified in paragraph (a)(1) of this this chapter may be safely used as section are limited to use as a fluid ab- components of resinous or polymeric sorbent in food-contact materials used coatings and film used as food-contact in the packaging of frozen or refrig- surfaces, subject to the provisions of erated poultry. The copolymers identi- such regulation. fied in paragraph (a)(2) of this section (e) The copolymer conforms with the are limited to use as a fluid absorbent following specifications: in food-contact materials used in the (1) The copolymer, when extracted packaging of frozen or refrigerated with distilled water at reflux tempera- meat and poultry. ture for 2 hours, yields total extractives not to exceed 0.05 percent. [64 FR 28098, May 25, 1999, as amended at 65 (2) The copolymer, when extracted FR 16817, Mar. 30, 2000] with ethyl acetate at reflux temperature for 2 hours, yields total extrac- § 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent. dimethylene terephthalate and 1,4- cyclohexylene dimethylene (3) The copolymer, when extracted isophthalate copolymer. with n-hexane at reflux temperature for 2 hours, yields total extractives not Copolymer of 1,4-cyclohexylene to exceed 0.05 percent. dimethylene terephthalate and 1,4- cyclohexylene dimethylene isophtha- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, late may be safely used as an article or 1984, as amended at 55 FR 34555, Aug. 23, 1990] component of articles used in pro- § 177.1310 Ethylene-acrylic acid co- ducing, manufacturing, packing, proc- polymers. essing, preparing, treating, packaging, transporting, or holding food, subject The ethylene-acrylic acid copolymers to the provisions of this section: identified in paragraph (a) of this section 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 (d) Substances employed in the pro- type of food and under the conditions duction of the copolymer include: of its intended use as determined from (1) Substances generally recognized tables 1 and 2 of § 176.170(c) of this chap- as safe in food. ter, yield net acidified chloroform-solu- (2) Substances subject to prior sanc- ble extractives not to exceed 0.5 milli- tion or approval for use in the copoly- gram per square inch of food-contact

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surface when tested by the methods carbon monoxide such that the copoly- prescribed in § 177.1330(e)(1), (3)(i) mers contain not more than 30 weight- through (iv), (4), (5), and (6), except percent of polymer units derived from that carbon monoxide. (1) The total residue method using 3 (b) Conditions of use. (1) The polymers percent acetic acid, as prescribed in may be safely used as components of § 177.1330(e)(6)(i)(a), does not apply, and the food-contact or interior core layer (2) The net acidified chloroform-solu- of multilaminate food-contact articles. ble extractives from paper and paperboard complying with § 176.170 of this (2) The polymers may be safely used chapter may be corrected for wax, pet- as food-contact materials at tempera- ° ° rolatum, and mineral oil as provided in tures not to exceed 121 C (250 F). § 176.170(d)(5)(iii)(b) of this chapter. (c) Specifications. (1) Food-contact If the finished food-contact article is layers formed from the basic copoly- itself the subject of a regulation in mer identified in paragraph (a) of this parts 174, 175, 176, 177, 178, and § 179.45 of section shall be limited to a thickness this chapter, it shall also comply with of not more than 0.01 centimeter (0.004 any specifications and limitations pre- inch). scribed for it by that regulation. (2) The copolymers identified in para- (c) The finished food-contact layer graph (a) of this section shall have a made with basic copolymers containing melt index not greater than 500 as de- more than 10 weight-percent but no termined by ASTM method D1238–82, more than 25 weight-percent of total condition E ‘‘Standard Test Method for polymer units derived from acrylic Flow Rates of Thermoplastics by Ex- acid and with a maximum thickness of trusion Plastometer,’’ which is incor- 0.0025 inch (2.5 mils) may be used in porated by reference in accordance contact with food types I, II, IVB, VIA, with 5 U.S.C. 552(a) and 1 CFR part 51. VIB, VIIB, and VIII identified in table Copies may be obtained from the Amer- 1 of § 176.170(c) of the chapter under ican Society for Testing Materials, 1916 conditions of use B through H as de- Race St., Philadelphia, PA 19103, or scribed in table 2 of § 176.170(c) of this chapter, and in contact with food types may be examined at the Center for III, IVA, V, VIIA, and IX identified in Food Safety and Applied Nutrition table 1 of § 176.170(c) of this chapter (HFS–200), Food and Drug Administra- under conditions of use E through G as tion, 200 C St. SW., Washington, DC, or described in table 2 of § 176.170(c) of this at the Office of the Federal Register, chapter. 800 North Capitol St. NW., suite 700, (d) The provisions of this section are Washington, DC. not applicable to ethylene-acrylic acid (3) The basic copolymer identified in copolymers used in food-packaging ad- paragraph (a) of this section, when ex- hesives complying with § 175.105 of this tracted with the solvent or solvents chapter. characterizing the type of food and [42 FR 14572, Mar. 15, 1977, as amended at 51 under the conditions of time and tem- FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, perature characterizing the conditions 1988] of its intended use, as determined from tables 1 and 2 of § 176.170(c) of this chap- § 177.1312 Ethylene-carbon monoxide ter, yields net chloroform-soluble ex- copolymers. tractives in each extracting solvent The ethylene-carbon monoxide co- not to exceed 0.5 milligram per square polymers identified in paragraph (a) of inch of food-contact surface when test- this section may be safely used as com- ed by methods described in § 176.170(d) ponents of articles intended for use in of this chapter. contact with food subject to the provi- (4) The provisions of this section are sions of this section. not applicable to ethylene-carbon mon- (a) Identity. For the purposes of this section, ethylene-carbon monoxide co- oxide copolymers complying with polymers (CAS Reg. No. 25052–62–4) con- § 175.105 of this chapter. sist of the basic polymers produced by [57 FR 32422, July 22, 1992] the copolymerization of ethylene and

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§ 177.1315 Ethylene-1, 4-cyclohexylene methyl ester, polymerized with 1,4- dimethylene terephthalate copoly- cyclohexanedimethanol and 1,2- mers. ethanediol) (CAS Reg. No. 25640–14–6) or Ethylene-1, 4-cyclohexylene (1,4-benzenedicarboxylic acid, polym- dimethylene terephthalate copolymer erized with 1,4-cyclohexanedimethanol may be safely used as articles or com- and 1,2-ethanediol) (CAS Reg. No. ponents of articles intended for use in 25038–91–9) are basic copolymers meet- contact with food subject to provisions ing the specifications prescribed in of this section and of part 174 of this paragraph (b) of this section, to which chapter. may have been added certain optional (a) Identity. For the purposes of this substances required in their production section, ethylene-1,4-cyclohexylene or added to impart desired physical or dimethylene terephthalate copolymers technical properties. (1,4-benzene dicarboxylic acid, di- (b) Specifications:

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-tet with water added at 82.2 °C ume) aqueous alcohol, product of dimethyl rachloroethane (180 °F) and allowed to cool excluding carbonated terephthalate or ter- (60:40 ratio wt/ to 48.9 °C (120 °F) in con- beverages and beer. ephthalic acid with a 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- (i) Maximum soluble fraction of 11.3 ethylene or with one or more olefin co- percent in xylene after refluxing and polymers complying with § 177.1520 or subsequent cooling to 25 °C. with a mixture of polyethylene and one (ii) Maximum extractable fraction of or more olefin copolymers, in such pro- 5.5 percent when extracted with n- portions that the ethyl acrylate con- hexane at 50 °C. tent of the blend does not exceed 8 per- (d) The provisions of paragraphs (b) cent by weight, or unless it is used in and (c)(2) of this section are not appli- a coating complying with § 175.300 or cable to ethylene-ethyl acrylate co- § 176.170 of this chapter, in such propor- polymers used in the formulation of ad- tions that the ethyl acrylate content hesives complying with § 175.105 of this does not exceed 8 percent by weight of chapter. the finished coating. [42 FR 14572, Mar. 15, 1977, as amended at 49 (c) Ethylene-ethyl acrylate copoly- FR 10108, Mar. 19, 1984] mers or the blend shall conform to the specifications prescribed in paragraph § 177.1330 Ionomeric resins. (c)(1) of this section and shall meet the Ionomeric resins manufactured from ethyl acrylate content limits pre- either ethylene-methacrylic acid co- scribed in paragraph (b) of this section, polymers (and/or their ammonium, cal- and the extractability limits pre- cium, magnesium, potassium, sodium, scribed in paragraph (c)(2) of this sec- and/or zinc partial salts), ethylene- tion, when tested by the methods pre- methacrylic acid-vinyl acetate copoly- scribed for polyethylene in § 177.1520. mers (and/or their ammonium, cal- (1) Specifications—(i) Infrared identi- cium, magnesium, potassium, sodium, fication. Ethylene-ethyl acrylate co- and/or zinc partial salts,), or meth- polymers can be identified by their acrylic acid polymers with ethylene characteristic infrared spectra. and isobutyl acrylate (and/or their po- (ii) Quantitative determination of ethyl tassium, sodium and/or zinc partial acrylate content. The ethyl acrylate can salts) may be safely used as articles or be determined by the infrared spectra. components of articles intended for use Prepare a scan from 10.5 microns to 12.5 in contact with food, in accordance microns. Obtain a baseline absorbance with the following prescribed condi- at 11.6 microns and divide by the tions: plaque thickness to obtain absorbance (a) For the purpose of this section, per mil. From a previously prepared the ethylene-methacrylic acid copoly- calibration curve, obtain the amount of mers consist of basic copolymers pro- ethyl acrylate present. duced by the copolymerization of (iii) Specific gravity. Ethylene-ethyl ethylene and methacrylic acid such acrylate copolymers have a specific that the copolymers contain no more gravity of not less than 0.920 nor more than 20 weight percent of polymer than 0.935, as determined by ASTM units derived from methacrylic acid, method D1505–68 (Reapproved 1979), and the ethylene-methacrylic acid- ‘‘Standard Test Method for Density of vinyl acetate copolymers consist of Plastics by the Density-Gradient Tech- basic copolymers produced by the co- nique,’’ which is incorporated by ref- polymerization of ethylene, meth- erence. Copies may be obtained from acrylic acid, and vinyl acetate such the American Society for Testing Ma- that the copolymers contain no more terials, 1916 Race St., Philadelphia, PA than 15 weight percent of polymer 19103, or may be examined at the Office units derived from methacrylic acid. of the Federal Register, 800 North Cap- (b) For the purpose of this section, itol Street, NW., suite 700, Washington, the methacrylic acid copolymers with DC 20408. 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, used in contact with food except as a ethylene, and isobutyl acrylate such component of articles used for pack- that the copolymers contain no less aging or holding food during cooking than 70 weight percent of polymer provided they meet the following units derived from ethylene, no more extractability limits: than 15 weight percent of polymer

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

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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, 1916 Race St., Philadelphia, the net chloroform-soluble extractives PA 19103, respectively, or may be exam- are unchanging within experimental ined at the Office of the Federal Reg- error appropriate to the method as de- ister, 800 North Capitol Street, NW., scribed in paragraphs (d) (1)(i) and (2)(i) suite 700, Washington, DC 20408. of this section. Should equilibrium not (5) Selection of samples. Quadruplicate be demonstrated over the above time samples should be tested, using for series, extraction times must be ex- each replicate sample the number of tended until three successive unchang- finished articles with a food-contact ing values for extractives are obtained. surface nearest to 100 square inches.

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(6) Determination of amount of extrac- dried and weighed residue, e, obtained tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section. the exposure period, remove the test Mix well so every portion of the residue container or test cell from the oven, if is wetted with the hydrochloric acid any, and combine the solvent for each solution. Then add 50 milliliters of replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter lent) flask or beaker, being sure to through Whatman No. 41 filter paper rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva- small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a rate the food-simulating solvents to clean separatory funnel. Shake for 1 about 100 milliliters in the flask, and minute, then draw off the chloroform transfer to a clean, tared evaporating layer into a clean tared evaporating dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the flask three times with small portions chloroform extraction, washing the of solvent used in the extraction proce- dish, the filter paper, and the sepa- dure, and evaporate to a few milliliters ratory funnel with this second portion on a nonsparking, low-temperature of chloroform. Add this filtrate to the hotplate. The last few milliliters original filtrate and evaporate the should be evaporated in an oven main- total down to a few milliliters on a tained at a temperature of 221 °F (105 low-temperature hotplate. The last few °C). Cool the evaporating dish in a des- milliliters should be evaporated in an iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30 Calculate the extractives in milligrams minutes and weigh to the nearest 0.1 per square inch of the container or ma- milligram to get the acidified chloro- terial surface. form-soluble extractives residue, e′. (a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa- percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i) (a) and (b) grams extractives per square inch=e/s. of this section. (b) Heptane. Milligrams extractives (f) The types of food and appropriate per square inch=(e)/(s)(F) solvents are as follows:

where: TABLE 1 e=Milligrams extractives per sample tested. s=Surface area tested, in square inches. Types of food Appropriate solvent F=Five, the ratio of the amount of extrac- 1. Nonacid (pH above 5.0), aque- Water, n-heptane. tives removed by heptane under exagger- ous products; may contain salt ated time-temperature test conditions or sugar or both, and including compared to the amount extracted by a oil-in-water emulsions of low- or fat or oil under exaggerated conditions of high-fat content . thermal sterilization and use. 2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% e′=Acidified chloroform-soluble extractives ous products; may contain salt acetic acid. residue. e′ is substituted for e in the or sugar or both, and including oil-in-water emulsions of low- or above equations when necessary (See high-fat content . paragraph (e)(6)(ii) of this section for 3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% method to obtain e′). ucts containing free oil or fat; acetic acid. may contain salt, and including If when calculated by the equations in water-in-oil emulsions of low- or paragraphs (e)(6)(i) (a) and (b) of this high-fat content . 4. Dairy products and modifica- section, the extractives in milligrams tions: per square inch exceed the limitations Water, n-heptane . prescribed in paragraphs (c) or (d) of i. Water-in-oil emulsions, high or low fat . this section, proceed to paragraph ii. Oil-in-water emulsions, high (e)(6)(ii) of this section (method for de- or low fat . termining the amount of acidified chlo- 5. Low moisture fats and oils ...... n-heptane. roform-soluble extractives residue). 6. Beverages: i. Containing up to 8% alcohol 8% ethanol/water. (ii) Acidified chloroform-soluble extrac- ii. Nonalcoholic ...... 3% acetic acid. tives residue. Add 3 milliliters of 37 per- iii. Containing more than 8% 50% ethanol/water. cent ACS reagent grade hydrochloric alcohol . 7. Bakery products ...... Water, n-heptane. acid and 3 milliliters of distilled water 8. Dry solids (without free fat or No extraction test re- to the evaporating dish containing the oil) . quired.

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TABLE 1—Continued § 177.1345 Ethylene/1,3–phenylene oxyethylene isophthalate/ Types of food Appropriate solvent terephthalate copolymer. 9. Dry solids (with free fat or oil) .. n-heptane. Ethylene/1, 3-phenylene oxyethylene isophthalate/terephthalate copolymer (g) The provisions of paragraphs (c) (CAS Reg. No. 87365–98–8) identified in and (d) of this section are not applica- paragraph (a) of this section may be ble to the ionomeric resins that are safely used, subject to the provisions of used in food-packaging adhesives com- this section, as the non-food-contact plying with § 175.105 of this chapter. layer of laminate structures subject to [45 FR 22916, Apr. 4, 1980, as amended at 49 the provisions of § 177.1395, and in FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, blends with polyethylene terephthalate 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, polymers complying with § 177.1630. June 12, 1989] (a) Identity. For the purpose of this section, ethylene/1,3-phenylene oxy- § 177.1340 Ethylene-methyl acrylate co- ethylene isophthalate/terephthalate polymer resins. copolymer consists of the basic copoly- Ethylene-methyl acrylate copolymer mer produced by the catalytic resins may be safely used as articles or polycondensation of isophthalic acid components of articles intended for use and terephthalic acid with ethylene in contact with food, in accordance glycol and 1,3-bis(2- with the following prescribed condi- hydroxyethoxy)benzene such that the tions: finished resin contains between 42 and (a) For the purpose of this section, 48 mole-percent of isophthalic the ethylene-methyl acrylate copoly- moieties, between 2 and 8 mole-percent mer resins consist of basic copolymers of terephthalic moieties, and not more produced by the copolymerization of than 10 mole-percent of 1,3-bis(2- ethylene and methyl acrylate such hydroxyethoxy)benzene moieties. that the copolymers contain no more (b) Specifications—(1) Density. Ethyl- than 25 weight percent of polymer ene/1,3-phenylene oxyethylene units derived from methyl acrylate. isophthalate/terephthalate copolymer (b) The finished food-contact article, identified in paragraph (a) of this sec- when extracted with the solvent or sol- tion has a density of 1.33±0.02 grams per vents characterizing the type of food cubic centimeter measured by ASTM and under the conditions of time and Method D 1505–85 (Reapproved 1990), temperature characterizing the condi- ‘‘Standard Test Method for Density of tions of its intended use as determined Plastics by the Density-Gradient Tech- from tables 1 and 2 of § 176.170(c) of this nique,’’ which is incorporated by ref- chapter, yields net chloroform-soluble erence in accordance with 5 U.S.C. extractives (corrected for zinc extrac- 552(a) and 1 CFR part 51. Copies may be tives as zinc oleate) in each extracting obtained from the American Society solvent not to exceed 0.5 milligram per for Testing and Materials, 1916 Race square inch of food-contact surface St., Philadelphia, PA 19103, or may be when tested by the methods described examined at the Center for Food Safety in § 176.170(d) of this chapter. If the fin- and Applied Nutrition’s Library, Food ished food-contact article is itself the and Drug Administration, 5100 Paint subject of a regulation in parts 174, 175, Branch Pkwy., College Park, MD 20740, 176, 177, 178 and § 179.45 of this chapter, and the Office of the Federal Register, it shall also comply with any specifica- 800 North Capitol St. NW., suite 700, tions and limitations prescribed for it Washington, DC. by that regulation. (2) Softening point. Ethylene/1,3–phen- NOTE: In testing the finished food-contact ylene oxyethylene isophthalate/ article, use a separate test sample for each terephthalate copolymer identified in required extracting solvent. paragraph (a) of this section has a soft- (c) The provisions of this section are ening point of 63±5 °C as measured by not applicable to ethylene-methyl ac- ASTM Method D 1525–87, ‘‘Standard rylate copolymer resins used in food- Test Method for VICAT Softening Tem- packaging adhesives complying with perature of Plastics,’’ which is incor- § 175.105 of this chapter. porated by reference in accordance

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with 5 U.S.C. 552(a) and 1 CFR part 51. (xxxiii) of this chapter, and colorants The availability of this material is pro- used in accordance with § 178.3297 of vided in paragraph (b)(1) of this sec- this chapter. tion. (iv) Erucamide as identified in (c) Optional adjuvant substances. § 178.3860 of this chapter. Ethylene/1,3–phenylene oxyethylene (v) Xanthan gum as identified in isophthalate/terephthalate copolymer, § 172.695 for use as a thickening agent identified in paragraph (a) of this sec- at a level not to exceed 1 percent by tion, may contain optional adjuvant weight of coating solids in aqueous dis- substances required in their produc- persions of ethylene-vinyl acetate co- tion. The optional adjuvants may include 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 copolymers. total polymer prior to reaction with 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 producing, manufacturing, packing, tional adjuvant substances that may be processing, preparing, treating, pack- added to the copolymers include sub- aging, transporting, or holding food in stances generally recognized as safe in accordance with the following pre- food and food packaging, substances scribed conditions: the use of which is permitted under ap- (a)(1) Ethylene-vinyl acetate copoly- plicable regulations in parts 170 mers consist of basic resins produced through 189 of this chapter, and sub- by the catalytic copolymerization of stances identified in § 175.300(b)(3)(xxv), ethylene and vinyl acetate to which (xxvii), (xxxiii), and (xxx) of this chap- may have been added certain optional ter and colorants for polymers used in substances to impart desired techno- accordance with the provisions of logical or physical properties to the § 178.3297 of this chapter. resin. Subject to any limitations pre- (b)(1) Ethylene-vinyl acetate copoly- scribed in this section, the optional mers, with or without the optional sub- substances may include: stances described in paragraph (a) of (i) Substances generally recognized this section, when extracted with the as safe in food and food packaging. solvent or solvents characterizing the (ii) Substances the use of which is type of food, and under conditions of permitted under applicable regulations time and temperature characterizing in parts 170 through 189 of this chapter, the conditions of their intended use as prior sanction, or approvals. (iii) Substances identified in determined from tables 1 and 2 of § 175.300(b)(3) (xxv), (xxvii), (xxx), and § 176.170(c) of this chapter, shall yield

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net chloroform-soluble extractives cor- (2) The finished food-contact film rected for zinc as zinc oleate not to ex- shall meet the extractives limitations ceed 0.5 milligram per square inch of an prescribed in paragraph (e)(2) of this appropriate sample. section. (2) Maleic anhydride grafted ethyl- (3) The ethylene-vinyl acetate co- ene-vinyl acetate copolymers shall polymer films may be further irradi- have a melt flow index not to exceed 2.1 ated in accordance with the provisions grams per 10 minutes as determined by of paragraph (e)(1) of this section: Pro- ASTM method D 1238–82, ‘‘Standard vided, That the total accumulated radi- Test Method for Flow Rates of Thermo- ation dose from both electron beam plastics by Extrusion Plastometer,’’ and gamma ray radiation does not ex- which is incorporated by reference in ceed 150 kiloGray (15 megarads). accordance with 5 U.S.C. 552(a). Copies (e) Ethylene-vinyl acetate copolymer may be obtained from the American films intended for contact with food Society for Testing Materials, 1916 may be irradiated to control the Race St., Philadelphia, PA 19103, or at growth of microorganisms under the the Division of Petition Control (HFS– following conditions: 215), Center for Food Safety and Ap- (1) Gamma photons emitted from a plied Nutrition, Food and Drug Admin- cobalt–60 sealed source in the dose istration, 5100 Paint Branch Pkwy., range of 5–50 kiloGray (0.5–5.0 College Park, MD 20740, or may be ex- megarads). amined at the Center for Food Safety (2) The irradiated ethylene-vinyl ace- and Applied Nutrition’s Library, 200 C tate copolymer films, when extracted St. SW., Washington, DC, or at the Of- with reagent grade n-heptane (freshly fice of the Federal Register, 800 North redistilled before use) according to Capitol St. NW., suite 700, Washington, methods described under § 176.170(d)(3) DC. Compliance of the melt flow index of this chapter, at 75 °F for 30 minutes specification shall be determined using shall yield total extractives not to ex- conditions and procedures cor- ceed 4.5 percent by weight of the film. responding to those described in the [42 FR 14572, Mar. 15, 1977, as amended at 43 method as Condition E, Procedure A). FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, The copolymers shall be used in blends 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, with other polymers at levels not to Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999] exceed 17 percent by weight of total polymer, subject to the limitation that § 177.1360 Ethylene-vinyl acetate-vinyl when contacting food of types III, IV– alcohol copolymers. A, V, VI–C, VII–A, and IX, identified in Ethylene-vinyl acetate-vinyl alcohol § 176.170(c) of this chapter, Table 1, the copolymers (CAS Reg. No. 26221–27–2) polymers shall be used only under con- may be safely used as articles or com- ditions of use C, D, E, F, and G, de- ponents of articles intended for use in scribed in § 176.170(c) of this chapter, contact with food, in accordance with Table 2. the following prescribed conditions: (c) The provisions of paragraph (b) of (a) Ethylene-vinyl acetate-vinyl alco- this section are not applicable to ethyl- hol copolymers are produced by the ene-vinyl acetate copolymers used in partial or complete alcoholysis or hy- food-packaging adhesives complying drolysis of those ethylene-vinyl acetate with § 175.105 of this chapter. copolymers complying with § 177.1350. (d) Ethylene-vinyl acetate copoly- (1) Those copolymers containing a mers may be irradiated under the fol- minimum of 55 percent ethylene and a lowing conditions to produce molecular maximum of 30 percent vinyl alcohol crosslinking of the polymers to impart units by weight may be used in contact desired properties such as increased with foods as described in paragraph (b) strength and increased ability to of this section. shrink when exposed to heat: (2) Those copolymers containing a (1) Electron beam source of ionizing minimum of 55 percent ethylene and a radiation at a maximum energy of 3 maximum of 15 percent vinyl alcohol million electron volts: Maximum ab- units by weight may be used in contact sorbed dose not to exceed 150 kiloGray with foods as described in paragraph (c) (15 megarads). of this section.

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(3) Those copolymers containing 17 to with n-heptane at 38 °C (100 °F) for 30 40 percent ethylene and 60 to 83 percent minutes yields total extractives not to vinyl alcohol units by weight may be exceed 0.0078 milligram per square cen- used in contact with foods as described timeter (0.05 milligram per square in paragraph (d) of this section. inch) of food-contact surface, after cor- (b) The finished food-contact article recting the total extractives by divid- shall not exceed 0.013 centimeter (0.005 ing by a factor of five. inch) thickness and shall contact foods (d) The finished food-contact article only of the types identified in table 1 of shall not exceed 0.018 centimeter (0.007 § 176.170(c) of this chapter in Categories inch) thickness and may contact all I, II, IV–B, VI, VII–B, and VIII under foods, except those containing more conditions of use D through G de- than 8 percent alcohol, under condi- scribed in table 2 of § 176.170(c) of this tions of use B through H described in chapter. Film samples of 0.013 centi- table 2 of § 176.170(c) of this chapter. meter (0.005) inch thickness rep- Film samples of 0.018 centimeter (0.007 resenting the finished article shall inch) thickness representing the fin- meet the following extractive limita- ished articles shall meet the following tion when tested by ASTM method extractive limitation when tested by F34–76 (Reapproved 1980), ‘‘Standard ASTM method F34–76 (Reapproved Test Method for Liquid Extraction of 1980), ‘‘Standard Test Methods for Liq- Flexible Barrier Materials,’’ which is uid Extraction of Flexible Barrier Ma- incorporated by reference. Copies may terials,’’ which is incorporated by ref- be obtained from the American Society erence. The availability of this incor- for Testing Materials, 1916 Race St., poration by reference is given in para- Philadelphia, PA 19103, or may be ex- graph (b) of this section. The film when amined at the Office of the Federal extracted with distilled water at 100 °C Register, 800 North Capitol Street, (212 °F) for 30 minutes yields ethylene- NW., suite 700, Washington, DC 20408. vinyl acetate-vinyl alcohol oligomers (1) The film when extracted with dis- not to exceed 0.093 milligram per ° ° tilled water at 21 C (70 F) for 48 hours square centimeter (0.6 milligram per yields total extractives not to exceed square inch) of food contact surface as 0.0047 milligram per square centimeter determined by a method entitled ‘‘An- (0.03 milligram per square inch) of alytical Method of Determining the food-contact surface. Amount of EVOH in the Extractives (2) The film when extracted with 50 Residue of EVOH Film,’’ dated March percent ethyl alcohol at 21 °C (70 °F) for 23, 1987, as developed by the Kuraray 48 hours yields total extractives not to Co., Ltd., which is incorporated by ref- exceed 0.0062 milligram per square cen- erence in accordance with 5 U.S.C. timeter (0.04 milligram per square 552(a) and 1 CFR part 51. Copies may be inch) of food-contact surface. obtained from the Office of Premarket (c) The finished food-contact article Approval (HFS–200), Center for Food shall not exceed 0.0076 centimeter (0.003 Safety and Applied Nutrition, Food and inch) thickness and shall contact foods Drug Administration, 5100 Paint only of the types identified in table 1 of § 176.170(c) of this chapter in Categories Branch Pkwy., College Park, MD 20740, III, IV–A, VII–A, and IX under condi- or may be examined at the Center for tions of use F and G described in table Food Safety and Applied Nutrition’s 2 of § 176.170(c) of this chapter. Film Library, 200 C St. SW., Washington, samples of 0.0076 centimeter (0.003 inch) DC, or at the Office of the Federal Reg- thickness representing the finished ar- ister, 800 North Capitol St. NW., suite ticles shall meet the following extrac- 700, Washington, DC. tive limitation when tested by ASTM (e) The provisions of this section are method F34–76 (Reapproved 1980), not applicable to ethylene-vinyl ace- ‘‘Standard Test Method for Liquid Ex- tate-vinyl alcohol copolymers used in traction of Flexible Barrier Materials,’’ the food-packaging adhesives com- which is incorporated by reference. The plying with § 175.105 of this chapter. availability of this incorporation by [47 FR 41531, Sept. 21, 1982, as amended at 49 reference is given in paragraph (b) of FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, this section. The film when extracted 2000]

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§ 177.1380 Fluorocarbon resins. for repeated use in contact with food or Fluorocarbon resins may be safely that are intended for one-time use in used as articles or components of arti- contact with foods only of the types cles intended for use in contact with identified in § 176.170(c) of this chapter, food, in accordance with the following table 1, under Types I, II, VI, VII–B, prescribed conditions: and VIII. (a) For the purpose of this section, (2) Fluorocarbon resins that are iden- fluorocarbon resins consist of basic res- tified in paragraph (a)(4) of this section ins produced as follows: and that comply with the extractive (1) Chlorotrifluoroethylene resins limitations prescribed in paragraphs produced by the homopolymerization (c)(1) and (c)(2) of this section may be of chlorotrifluoroethylene. used only when such use is limited to (2) Chlorotrifluoroethylene-1,1- articles or components of articles that difluoroethylene copolymer resins pro- are intended for repeated use in con- duced by copolymerization of tact with food. chlorotrifluoroethylene and 1,1- (3) In accordance with current good difluoroethylene. manufacturing practice, those food- (3) Chlorotrifluoroethylene-1,1- contact articles intended for repeated difluoroethylene-tetrafluoroethylene use shall be thoroughly cleansed prior co-polymer resins produced by co- to their first use in contact with food. polymerization of (c) Extractives limitations are appli- chlorotrifluoroethylene, 1,1- cable to the basic resins in the form of difluoroethylene, and tetrafluoro- pellets that have been ground or cut ethylene. into small particles that will pass (4) Ethylene-chlorotrifluoroethylene through a U.S. Standard Sieve No. 6 copolymer resins produced by copolym- and that will be held on a U.S. Stand- erization of nominally 50 mole percent ard Sieve No. 10. of ethylene and 50 mole percent of (1) A 100-gram sample of the resin chlorotrifluoroethylene. The copoly- pellets, when extracted with 100 milli- mer shall have a melting point of 239 to liters of distilled water at reflux tem- 243 °C and a melt index of less than or perature for 8 hours, shall yield total equal to 20 as determined by ASTM extractives not to exceed 0.003 percent Method D 3275–89 ‘‘Standard Specifica- by weight of the resins. tion for E–CTFE–Fluoroplastic Mold- (2) A 100-gram sample of the resin ing, Extrusion, and Coating Mate- pellets, when extracted with 100 milli- rials,’’ which is incorporated by ref- liters of 50 percent (by volume) ethyl erence in accordance with 5 U.S.C. alcohol in distilled water at reflux 552(a) and 1 CFR part 51. Copies may be temperature for 8 hours, shall yield obtained from the American Society total extractives not to exceed 0.003 for Testing and Materials, 1916 Race percent by weight of the resins. St., Philadelphia, PA 19013, or may be (3) A 100-gram sample of the resin examined at the Office of the Federal pellets, when extracted with 100 milli- Register, 800 North Capitol Street, liters of n-heptane at reflux tempera- NW., suite 700, Washington, DC. ture for 8 hours, shall yield total ex- (b) Fluorocarbon resins that are iden- tractives not to exceed 0.01 percent by tified in paragraph (a) of this section weight of the resins. and that comply with extractive limi- [42 FR 14572, Mar. 15, 1977, as amended at 57 tations prescribed in paragraph (c) of FR 185, Jan. 3, 1992] this section may be used as articles or components of articles intended for use § 177.1390 Laminate structures for use in contact with food as follows: at temperatures of 250 ≥F and (1) Fluorocarbon resins that are iden- above. tified in paragraphs (a)(1), (a)(2), and (a) The high-temperature laminates (a)(3) of this section and that comply identified in this section may be safely only with the extractive limitations used for food contact at temperatures prescribed in paragraphs (c)(1) and not exceeding 135 °C (275 °F) unless oth- (c)(2) of this section may be used when erwise specified. These articles are lay- such use is limited to articles or com- ered constructions that are optionally ponents of articles that are intended bonded with adhesives. The interior

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(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. food additive requirements in para- (ii) Adjuvants used in these layers graphs (c) and (d) of this section) are must comply with an applicable regu- necessary to ensure proper food steri- lation that permits food type and time/ lization and package integrity. Refer temperature conditions to which the to parts 108, 110, 113, and 114 of this container will be exposed, including chapter for details. sterilization processing. (c) Subject to the provisions of this (2) Adhesives. The use of adhesives in paragraph, food-contact articles pro- these containers is optional. Adhesives duced from high-temperature lami- may be formulated from the following nates may be safely used to package all substances, subject to the prescribed food types except those containing limitations: more than 8 percent ethyl alcohol. (1) Polymeric films/layers. Films or lay- (i) Any substance suitable for use in ers not separated from food by a func- formulating adhesives that complies tional barrier must meet the following with an applicable regulation of this requirements: chapter which permits food type and (i) Films/layers may consist of the time/temperature conditions to which following: the container will be exposed, includ- (a) Polyolefin resins complying with ing sterilization processing. item 2.2 or 3.2 of the table in (ii) Substances complying with § 177.1520(c). § 175.105 of this chapter may be used in (b) Polymeric resin blends formu- these constructions, provided they are lated from a base polymer complying separated from the interior (food-con- with item 2.2 or 3.2 of the table in tact) layer(s) by a functional barrier as § 177.1520(c) blended with no more than discussed under paragraph (a) of this 10 percent by weight of a copolymer of section. ethylene and vinyl acetate complying (iii) Maleic anhydride adduct of poly- with § 177.1350. propylene complying with § 175.300 of (c) Polymeric resin blends formulated this chapter. from a base polymer complying with (iv) Polyester-urethane adhesive for item 2.2 or 3.2 of the table in use at temperatures not exceeding 121 § 177.1520(c) blended with no more than °C (250 °F) and formulated from the fol- 38 percent by weight of a homopolymer lowing: of isobutylene complying with (a) Polyester-urethanediol resin pre- § 177.1420(a)(1). pared by the reaction of a mixture of (d) Polyethylene phthalate resins polybasic acids and polyhydric alcohols complying with § 177.1630(e)(4) (i) and listed in § 175.300(b)(3)(vii) of this chap- (ii). ter, 3-isocyanatomethyl-3,5,5- (e) Nylon MXD–6 resins that comply trimethylcyclohexyl isocyanate (CAS with item 10.3 of the table in Reg. No. 4098–71–9) and optional § 177.1500(b) of this chapter when ex- trimethoxysilane coupling agents con- tracted with water and heptane under taining amino, epoxy, ether, and/or

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mercapto groups not to exceed 3 per- formulated from trimethylol propane cent by weight of the cured adhesive. (CAS Reg. No. 77–99–6) adducts of 3– (b) Urethane cross-linking agent isocyanatomethyl–3,5,5– comprising not more than 25 percent trimethylcyclohexyl isocyanate (CAS by weight of the cured adhesive and Reg. No. 4098–71–9) or 1,3- formulated from 3-isocyanatomethyl- bis(isocyanatomethyl)benzene (CAS 3,5,5-trimethylcyclohexyl isocyanate Reg. No. 25854–16–4). (CAS Reg. No. 4098–71–9) adduct of (vii) Polyester-polyurethane resin- trimethylol propane (Cas Reg. No. 77– acid dianhydride adhesives for use at 99–6) and/or 1,3-bis(isocyanatomethyl) temperatures not to exceed 121 °C (250 benzene (CAS Reg. No. 25854–16–4) °F), in contact only with food Types I, adduct of trimethylol propane. II, VIA, VIB, VIIB, and VIII as de- (v) Polyester-epoxy-urethane adhe- scribed in Table I of § 176.170 of this sives formulated from the following: chapter, and formulated from the fol- (a) Polyester resin formed by the re- lowing mixture: action of polybasic acids and (a)(1) Polyesterpolyurethanediol res- polyhydric alcohols listed in ins prepared by the reaction of a mix- § 175.300(b)(3)(vii) of this chapter. Aze- ture of polybasic acids and polyhydric laic acid may also be used as a alcohols listed in § 175.300(b)(3)(vii) of polybasic acid. this chapter and 3-isocyanatomethyl- (b) Epoxy resin listed in 3,5,5-trimethylcyclohexyl isocyanate § 175.300(b)(3)(viii)(a) of this chapter and (CAS Reg. No. 4098–71–9). Additionally, comprising no more than 30 percent by dimethylol propionic acid and 1,6- weight of the cured adhesive. hexanediol may be used alone or in (c) Urethane cross-linking agent com- combination as reactants in lieu of a prising no more than 14 percent weight polybasic acid and a polyhydric alco- of the cured adhesive and formulated hol. from 3-isocyanatomethyl-3,5.5- (2) Acid dianhydride formulated from trimethylcyclohexyl isocyanate 3a,4,5,7a-tetrahydro-7-methyl-5- cyanurate (CAS Reg. No. 53880–05–0). (vi) Polyurethane-polyester resin- (tetrahydro-2,5-dioxo-3-furanyl)-1,3- epoxy adhesives formulated from the isobenzofurandione (CAS Reg. No. following mixture: 73003–90–4), comprising not more than (a)(1) Polyester-polyurethanediol res- one percent of the cured adhesive. ins prepared by the reaction of a mix- (b) Urethane cross-linking agent, ture of polybasic acids and polyhydric comprising not more than twelve per- alcohols listed in § 175.300(b)(3)(vii) of cent by weight of the cured adhesive, this chapter and 3-isocyanatomethyl- and formulated from trimethylol pro- 3,5,5-trimethylcyclohexyl isocyanate pane (CAS Reg. No. 77–99–6) adducts of (CAS Reg. No. 4098–71–9). 3-isocyanatomethyl-3,5,5- (2) Polyester resin formed by the re- trimethylcyclohexyl isocyanate (CAS action of polybasic acids and Reg. No. 4098–71–9) and/or 1,3- polyhydric alcohols listed in bis(isocyanatomethyl)benzene (CAS § 175.300(b)(3)(vii) of this chapter. Addi- Reg. No. 363–48–31). tionally, azelaic acid and 1,6- (3) Test specifications. These specifica- hexanediol may also be used as tions apply only to materials on the reactants in lieu of a polyhydric alco- food-contact side of a functional bar- hol. rier, if present. All tests must be per- (3) Epoxy resin listed in formed on containers made under pro- § 175.300(b)(3)(viii)(a) of this chapter and duction conditions. Laminated struc- comprising not more than 5 percent by tures submitted to extraction proce- weight of the cured adhesive. dures must maintain complete struc- (4) Optional trimethoxy silane curing tural integrity (particularly with reagents, containing amino, epoxy, ether, gard to delamination) throughout the or mercapto groups not in excess of 3 test. percent of the cured adhesive. (i) Nonvolatile extractives. (a) For use (b) Urethane cross-linking agent, at temperatures not to exceed 121 °C comprising not more than 20 percent (250 °F): The container interior (food- by weight of the cured adhesive, and contact side) shall be extracted with

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deionized distilled water at 121 °C (250 paragraph (c)(2)(v) of this section shall °F) for 2 hours. not exceed 0.016 milligram per square (1) The chloroform-soluble fraction of centimeter (0.10 milligram per square the total nonvolatile extractives for inch) as determined by a method titled containers using adhesives listed in ‘‘Determination of Non-volatile Chlo- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), roform Soluble Residues in Retort (c)(2)(iv), and (c)(2)(vii) of this section Pouch Water Extracts,’’ which is incor- shall not exceed 0.0016 milligram per porated by reference. The availability square centimeter (0.01 milligram per of this incorporation by reference is square inch) as determined by a meth- given in paragraph (c)(3)(i)(a)(1) of this od entitled ‘‘Determination of Non- Volatile Chloroform Soluble Residues section. in Retort Pouch Water Extracts,’’ (3) The chloroform-soluble fraction of which is incorporated by reference. the total nonvolatile extractives for Copies are available from the Center containers using adhesives listed in for Food Safety and Applied Nutrition paragraph (c)(2)(vi) of this section shall (HFS–200), Food and Drug Administra- not exceed 0.008 milligram per square tion, 5100 Paint Branch Pkwy., College centimeter (0.05 milligram per square Park, MD 20740, and may be examined inch) as determined by a method enti- at the Center for Food Safety and Ap- tled, ‘‘Determination of Non-volatile plied Nutrition’s Library, 200 C St. Chloroform Soluble Residues in Retort SW., Washington, DC, or at the Office Pouch Water Extracts,’’ which is incor- of the Federal Register, 800 North Cap- porated by reference in paragraph itol St. NW., suite 700, Washington, DC (c)(3)(i)(a)(1) of this section. 20408. (ii) Volatiles. Volatile substances em- (2) The chloroform-soluble fraction of ployed in the manufacture of high-tem- the total nonvolatile extractives for perature laminates must be removed to containers using adhesives listed in paragraph (c)(2)(v) of this section shall the greatest extent possible in keeping not exceed 0.016 milligram per square with good manufacturing practice pre- centimeter (0.10 milligram per square scribed in § 174.5(a) of this chapter. inch) as determined by a method titled (d) Nylon 12/aluminum foil high-tem- ‘‘Determination of Non-volatile Chlo- perature laminates: Subject to the pro- roform Soluble Residues in Retort visions of this paragraph, containers Pouch Water Extracts,’’ which is incor- constructed of nylon 12 laminated to porated by reference in paragraph aluminum foil may be safely used at (c)(3)(i)(a)(1) of this section. temperatures no greater than 250 °F (b) For use at temperatures not to ex- (121 °C) in contact with all food types ceed 135 °C (275 °F): The container inte- except those containing more than 8 rior (food-contact side) shall be ex- percent alcohol. tracted with deionized distilled water (1) The container is constructed of ° ° at 135 C (275 F) for 1 hour. aluminum foil to which nylon 12 film is (1) The chloroform-soluble fraction of fused. Prior to fusing the nylon 12, the the total nonvolatile extractives for aluminum foil may be optionally containers using no adhesive, or adhesives listed in paragraphs (c)(2) (i), (ii), precoated with a coating complying and (iii) of this section shall not exceed with § 175.300 of this chapter. 0.0020 milligram per square centimeter (2) Nylon 12 resin complying with (0.013 milligram per square inch) as de- § 177.1500 and having an average thick- termined by a method titled ‘‘Deter- ness not to exceed 0.0016 inch (41 mi- mination of Non-volatile Chloroform crons) may be used as the food-contact Soluble Residues in Retort Pouch surface of the container. Water Extracts,’’ which is incorporated (3) Container test specifications. On by reference. The availability of this exposure to distilled water at 250 °F incorporation by reference is given in (121 °C) for 2 hours, extractives from paragraph (c)(3)(i)(a)(1) of this section. the food-contact side of the nylon 12 (2) The chloroform-soluble fraction of multilayered construction shall not ex- the total nonvolatile extractives for ceed 0.05 milligram per square inch containers using adhesives listed in

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(0.0078 milligram per square centi- Substances Limitations meter) as total nonvolatile extractives. Nylon 6/12 resins complying For use with nonalcoholic [45 FR 2843, Jan. 15, 1980, as amended at 47 with ¤ 177.1500(b), item foods at temperatures not 13.2, of this chapter (CAS to exceed 100 °C (212 FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; Reg. No. 25191Ð04Ð2) . °F). Laminate structures 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, with authorized food-con- 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, tact materials yield no Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR more than 0.15 milligram 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; of epsilon-caprolactam and 0.04 milligram of 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, omega-laurolactam per 1999; 64 FR 46272, Aug. 25, 1999] square inch when extracted with water at 100 § 177.1395 Laminate structures for use °C (212 °F) for 5 hours. at temperatures between 120 ≥F and Nylon 6/66 resins complying For use only with: 250 ≥F. with ¤ 177.1500(b), item 4.2 1. Nonalcoholic foods at of this chapter (CAS Reg. temperatures not to ex- (a) The laminates identified in this 24993Ð04Ð2) . ceed 82.2 cC (180 cF). Laminate structures with section may be safely used at the speci- authorized food-contact fied temperatures. These articles are materials yield no more layered structures that are optionally than 0.15 milligram of epsilon-caprolactam per bonded with adhesives. In these arti- square inch when ex- cles, the food-contact layer does not tracted with water at 82.2 function as a barrier to migration of cC (180 cF) for 5 hours. 2. Nonalcoholic foods at components from non-food-contact lay- temperatures not to ex- ers. The layers may be laminated, exceed 100 cC (212 cF). truded, coextruded, or fused. Laminate films with authorized food-contact ma- (b) Laminate structures may be man- terials yield no more than ufactured from: 0.15 milligram of epsilon- (1) Polymers and adjuvants com- caprolactam per square inch when extracted with plying with § 177.1390 of this chapter. water at 100 cC (212 cF) (2) Any polymeric resin listed in for 5 hours. these regulations so long as the use of Nylon 6/69 resins complying For use with nonalcoholic with ¤ 177.1500(b), item 14, foods under conditions of the resin in the structure complies of this chapter (CAS Reg. use B, C, D, E, F, G, and with the conditions of use (food type No. 51995Ð62Ð1) . H described in table 2 of and time/temperature) specified in the ¤ 176.170 of this chapter. Laminate structures with regulation for that resin. authorized food-contact (3) Optional adjuvant substances used materials may contain nylon 6/69 resins pro- in accordance with § 174.5 of this chap- vided that the nitrogen ter. content of aqueous ex- (4) The following substances in non- tracts of a representative laminate (obtained at 100 food-contact layers only: °C (212 °F) for 8 hours) does not exceed 15 Substances Limitations micrograms per square centimeter (100 Ethylene/1,3Ðphenylene oxy- For use only with poly- micrograms per square ethylene isophthalate/ ethylene terephthalate as inch). terephthalate copolymer the food-contact layer, (CAS Reg. No. 87365Ð98Ð8) complying with complying with ¤ 177.1345. ¤ 177.1630 under condi- [52 FR 33575, Sept. 4, 1987, as amended at 53 tions of use C through G FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, described in table 2 of 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, ¤ 176.170(c) of this chapter. Laminate structures, Oct. 17, 1997] when extracted with 8 percent ethanol at 150 °F § 177.1400 Hydroxyethyl cellulose film, for 2 hours shall not yield water-insoluble. m-pheny lenedioxy-O,O′- diethyl isophthalate or cy- Water-insoluble hydroxyethyl cel- clic bis(ethylene lulose film may be safely used for isophthalate) in excess of packaging food in accordance with the 7.8 micrograms/square decimeter (0.5 following prescribed conditions: microgram/square inch) of (a) Water-insoluble hydroxyethyl cel- food-contact surface. lulose film consists of a base sheet

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manufactured by the ethoxylation of molecular weight of 750,000 (Flory) or cellulose under controlled conditions, higher. to which may be added certain optional (2) Isobutylene-isoprene copolymers substances of a grade of purity suitable produced by the copolymerization of for use in food packaging as constitu- isobutylene with not more than 3 ents of the base sheet or as coatings molar percent of isoprene such that the applied to impart desired technological finished polymers have a molecular properties. weight of 300,000 (Flory) or higher. (b) Subject to any limitations pre- (3) Chlorinated isobutylene-isoprene scribed in parts 170 through 189 of this copolymers produced when chapter, the optional substances used isobutylene-isoprene copolymers (mo- in the base sheet and coating may in- lecular weight 300,000 (Flory) or higher) clude: are modified by chlorination with not (1) Substances generally recognized more than 1.3 weight-percent of chlo- as safe in food. rine. (2) Substances permitted to be used (b) The polymers identified in para- in water-insoluble hydroxyethyl cel- graph (a) of this section may contain lulose film by prior sanction or ap- optional adjuvant substances required proval and under conditions specified in the production of the polymers. The in such sanctions or approval, and sub- optional adjuvant substances required stances listed in part 181, subpart B of in the production of the polymers may this chapter. include substances generally recog- (3) Substances that by any regulation nized as safe in food, substances used in promulgated under section 409 of the accordance with a prior sanction or ap- act may be safely used as components proval, and aluminum chloride. of water-insoluble hydroxyethyl cellulose film. (c) The provisions of this section are (4) Substances identified in and used not applicable to polyisobutylene used in compliance with § 177.1200(c). in food-packaging adhesives complying (c) Any substance employed in the with § 175.105 of this chapter. production of the water-insoluble hydroxyethyl cellulose film described in § 177.1430 Isobutylene-butene copolymers. this section that is the subject of a regulation in parts 174, 175, 176, 177, 178 Isobutylene-butene copolymers iden- and § 179.45 of this chapter conforms tified in paragraph (a) of this section with any specification in such regula- may be safely used as components of tion. articles intended for use in contact with food, subject to the provisions of § 177.1420 Isobutylene polymers. this section. Isobutylene polymers may be safely (a) For the purpose of this section, used as components of articles in- isobutylene-butene copolymers consist tended for use in producing, manufac- of basic copolymers produced by the turing, packing, processing, preparing, copolymerization of isobutylene with treating, packaging, transporting, or mixtures of n-butenes such that the holding food, in accordance with the finished basic copolymers contain not following prescribed conditions: less than 45 weight percent of polymer (a) For the purpose of this section, units derived from isobutylene and isobutylene polymers are those pro- meet the specifications prescribed in duced as follows: paragraph (b) of this section when test- (1) Polyisobutylene produced by the ed by the methods described in para- homopolymerization of isobutylene graph (c) of this section. such that the finished polymers have a (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 .

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

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- § 177.1440 4,4′-Isopropylidenediphenol- mining whether isobutylene-butene co- epichlorohydrin resins minimum polymers conform to the specifications molecular weight 10,000. in paragraph (b) are as follows: 4,4′-Isopropylidenediphenol-epichlo- (1) Molecular weight. Molecular rohydrin resins having a minimum mo- weight shall be determined by Amer- lecular weight of 10,000 may be safely ican Society for Testing and Materials used as articles or components of arti- (ASTM) method D2503–82, ‘‘Standard cles intended for use in producing, Test Method for Molecular Weight manufacturing, packing, processing, (Relative Molecular Mass) of Hydro- preparing, treating, packaging, trans- carbons by Thermoelectric Measure- porting, or holding food in accordance ment of Vapor Pressure,’’ which is in- with the following prescribed condi- corporated by reference. Copies may be tions: ′ obtained from the American Society (a) 4,4 -Isopropylidenediphenol-ep- for Testing Materials, 1916 Race St., ichlorohydrin resins consist of basic resins produced by the condensation of Philadelphia, PA 19103, or may be ex- equimolar amounts of 4,4′- amined at the Office of the Federal isopropylidenediphenol and Register, 800 North Capitol Street, epichlorohydrin terminated with phe- NW., suite 700, Washington, DC 20408. nol, to which may have been added cer- (2) Viscosity. Viscosity shall be deter- tain optional adjuvant substances re- mined by ASTM method D445–74, ‘‘Test quired in the production of the resins. for Kinematic Viscosity of Transparent (b) The optional adjuvant substances and Opaque Liquids,’’ which is incor- required in the production of the resins porated by reference. The availability may include substances generally rec- of this incorporation by reference is ognized as safe in food, substances used given in paragraph (c)(1) of this sec- in accordance with a prior sanction or tion. approval, and the following: (3) Maximum bromine value. Maximum bromine value shall be determined by List of substances Limitations ASTM method D1492–78, ‘‘Standard Butyl alcohol ...... Not to exceed 300 p.p.m. as re- Test Method for Bromine Index of Aro- sidual solvent in finished resin. Ethyl alcohol . matic Hydrocarbons by Coulometric Toluene ...... Not to exceed 1,000 p.p.m. as re- Titration,’’ which is incorporated by sidual solvent in finished resin. reference. The availability of this incorporation by reference is given in (c) 4,4′-Isopropylidenediphenol-ep- paragraph (c)(1) of this section. ichlorohydrin resins shall meet the fol- (d) The provisions of this section are lowing nonvolatile extractives limitations: not applicable to isobutylene-butene (1) Maximum extractable nonvolatile copolymers used as provided under fraction of 2 parts per million when ex- § 175.105 of this chapter. tracted with distilled water at 70 °C for [52 FR 11641, Apr. 10, 1987, as amended at 63 2 hours, using a volume-to-surface FR 36175, July 2, 1998] ratio of 2 milliliters per square inch.

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(2) Maximum extractable nonvolatile tractives not to exceed 0.5 milligram fraction of 3 parts per million when ex- per square inch of food-contact surface. tracted with n-heptane at 70 °C for 2 [42 FR 14572, Mar. 15, 1977, as amended at 56 hours, using a volume-to-surface ratio FR 42933, Aug. 30, 1991] of 2 milliliters per square inch. (3) Maximum extractable nonvolatile § 177.1480 Nitrile rubber modified ac- fraction of 6 parts per million when ex- rylonitrile-methyl acrylate copoly- tracted with 10 percent (by volume) mers. ethyl alcohol in distilled water at 70 °C Nitrile rubber modified acrylonitrile- for 2 hours, using a volume-to-surface methyl acrylate copolymers identified ratio of 2 milliliters per square inch. in this section may be safely used as (d) The provisions of this section are components of articles intended for not applicable to 4,4′-isopropylidene- food-contact use under conditions of diphenol-epichlorohydrin resins listed use D, E, F, or G described in table 2 of in other sections of subchapter B of § 176.170(c) of this chapter, subject to this chapter. the provisions of this section. (a) For the purpose of this section, § 177.1460 Melamine-formaldehyde res- nitrile rubber modified acrylonitrile- ins in molded articles. methyl acrylate copolymers consist of Melamine-formaldehyde resins may basic copolymers produced by the graft be safely used as the food-contact sur- copolymerization of 73–77 parts by face of molded articles intended for use weight of acrylonitrile and 23–27 parts in producing, manufacturing, packing, by weight of methyl acrylate in the processing, preparing, treating, pack- presence of 8–10 parts by weight of bu- aging, transporting, or holding food in tadiene-acrylonitrile copolymers con- accordance with the following pre- taining approximately 70 percent by scribed conditions: weight of polymer units derived from (a) For the purpose of this section, butadiene. melamine-formaldehyde resins are (b) The nitrile rubber modified acry- those produced when 1 mole of mel- lonitrile-methyl acrylate basic copoly- amine is made to react with not more mers meet the following specifications than 3 moles of formaldehyde in water and extractives limitations: solution. (1) Specifications. (i) Nitrogen content (b) The resins may be mixed with re- is in the range 16.5–19 percent as deter- fined woodpulp and the mixture may mined by Kjeldahl analysis. contain other optional adjuvant sub- (ii) Intrinsic viscosity in acetonitrile stances which may include the fol- at 25 °C is not less than 0.29 deciliter lowing: per gram as determined by ASTM method D1243–79, ‘‘Standard Test Meth- List of substances Limitations od for Dilute Solution Viscosity of Vinyl Chloride Polymers,’’ which is in- Colorants used in accordance with ¤ 178.3297 corporated by reference. Copies may be of this chapter . obtained from the American Society Dioctyl phthalate ...... For use as lubricant. for Testing Materials, 1916 Race St., Hexamethylenetetramine For use only as polymerization reaction control agent. Philadelphia, PA 19103, or may be ex- Phthalic acid anhydride .. Do. amined at the Office of the Federal Zinc stearate ...... For use as lubricant. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The molded melamine-formalde- (iii) Residual acrylonitrile monomer hyde articles in the finished form in content is not more than 11 parts per which they are to contact food, when million as determined by gas chroma- extracted with the solvent or solvents tography. characterizing the type of food and (iv) Acetonitrile-soluble fraction under the conditions of time and tem- after refluxing the base polymer in ace- perature as determined from tables 1 tonitrile for 1 hour is not greater than and 2 of § 175.300(d) of this chapter, 95 percent by weight of the basic co- shall yield net chloroform-soluble ex- polymers.

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(2) Extractives limitations. The fol- in paragraph (b) of this section when lowing extractive limitations are de- tested by the methods described in termined by an infrared paragraph (c) of this section. spectrophotometric method titled, (1) Nylon 66 resins are manufactured ‘‘Infrared Spectrophotometric Deter- by the condensation of hexamethylene- mination of Polymer Extracted from diamine and adipic acid. Borex 210 Resin Pellets,’’ which is in- (2) Nylon 610 resins are manufactured corporated by reference. Copies are by the condensation of hexamethylene- available from the Center for Food diamine and sebacic acid. Safety and Applied Nutrition (HFS– (3) Nylon 66/610 resins are manufac- 200), Food and Drug Administration, tured by the condensation of equal- 5100 Paint Branch Pkwy., College Park, weight mixtures of nylon 66 salts and MD 20740, or available for inspection at nylon 610 salts. the Office of the Federal Register, 800 (4) Nylon 6/66 resins manufactured by North Capitol Street, NW., suite 700, the condensation and polymerization of Washington, DC 20408, and are applica- Nylon 66 salts and epsilon-caprolactam. ble to the basic copolymers in the form (5) Nylon 11 resins are manufactured of particles of a size that will pass by the condensation of 11- through a U.S. standard sieve No. 6 and aminoundecanoic acid. that will be held on a U.S. standard (6) Nylon 6 resins are manufactured sieve No. 10: by the polymerization of epsilon- (i) Extracted copolymer not to ex- caprolactam. ceed 2.0 parts per million in aqueous (7) Nylon 66T resins are manufac- extract obtained when a 100-gram sam- tured by the condensation of ple of the basic copolymers is extracted hexamethyl-enediamine, adipic acid, with 250 milliliters of demineralized and terephthalic acid such that com- (deionized) water at reflux temperature position in terms of ingredients is for 2 hours. 43.1±0.2 weight percent hexamethyl- (ii) Extracted copolymer not to ex- enediamine, 35.3±1.2 weight percent ceed 0.5 part per million in n-heptane adipic acid, and 21.6±1.2 weight percent extract obtained when a 100-gram sam- terephthalic acid. ple of the basic copolymers is extracted (8) Nylon 612 resins are manufactured with 250 milliliters of reagent grade n- by the condensation of heptane at reflux temperature for 2 hexamethylenediamine and hours. dodecanedioic acid. (c) Acrylonitrile copolymers identi- (9) Nylon 12 resins are manufactured fied in this section shall comply with by the condensation of omega- the provisions of § 180.22 of this chap- laurolactam. ter. (10)(i) Impact modified Nylon MXD–6 (d) Acrylonitrile copolymers identi- resins (CAS Reg. No. 59655–05–9) manu- fied in this section are not authorized factured by the condensation of adipic to be used to fabricate beverage con- acid, 1,3-benzenedimethanamine, and tainers. T3alpha-(3-aminopropyl)-omega-(3- [42 FR 14572, Mar. 15, 1977, as amended at 42 amino-propoxy)polyoxyethylene FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, under such conditions that the alpha- 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, (3-amino-propyl)-omega-(3- Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR aminopropoxy) polyoxyethylene mon- 14481, Apr. 2, 1996] omer content does not exceed 7 percent by weight of the finished resin. § 177.1500 Nylon resins. (ii) Nylon MXD–6 resins (CAS Reg. The nylon resins listed in paragraph No. 25718–70–1) manufactured by the (a) of this section may be safely used to condensation of adipic acid and 1,3- produce articles intended for use in benzenedimethanamine. processing, handling, and packaging (11) Nylon 12T resins are manufac- food, subject to the provisions of this tured by the condensation of omega- section: laurolactam (CAS Reg. No. 0947–04–6), (a) The nylon resins are manufac- isophthalic acid (CAS Reg. No. 0121–91– tured as described in this paragraph so 5), and bis(4-amino-3-methylcycl- as to meet the specifications prescribed ohexyl)methane (CAS Reg. No. 6864–37–

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5) such that the composition in terms weight percent of epsilon-caprolactam of ingredients is 34.4±1.5 weight percent and no more than 20 weight percent of omega-laurolactam, 26.8±0.4 weight per- omega-laurolactam. cent isophthalic acid, and 38.8±0.5 (14) Nylon 6/69 resins (CAS Reg. No. weight percent bis(4-amino-3- 51995–62–1) are manufactured by the methylcyclohexyl)-methane. condensation of 49.5+0.5 weight percent (12) Nylon 6I/6T resins (CAS Reg. No. epsilon-caprolactam, 19.4+0.2 weight 25750–23–6) are manufactured by the percent hexamethylenediamine and condensation of 31.2+0.3 weight percent azelaic acid. hexamethylenediamine, terephthalic (15) Nylon 46 resins (CAS Reg. No. acid, and isophthalic acid such that 65 50327–77–0) are manufactured by the to 80 percent of the polymer units are condensation of 1,4-butanediamine and derived from hexamethylene adipic acid. isophthalamide. (16) Nylon resins PA 6–3–T (CAS Reg- (13)(i) Nylon 6/12 resins (CAS Reg. No. istry No. 26246–77–5) are manufactured 25191–04–2) are manufactured by the co- by the condensation of 50 mol percent polymerization of a 1 to 1 ratio by 1,4-benzenedicarboxylic acid, dimethyl weight of epsilon-caprolactam and ester and 50 mol percent of an omega-laurolactam. equimolar mixture of 2,2,4-trimethyl- (ii) Nylon 6/12 resins (CAS Reg. No. 1,6-hexanediamine and 2,4,4-trimethyl- 25191–04–2) are manufactured by the co- 1,6-hexanediamine. polymerization of a ratio of at least 80 (b) Specifications:

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

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the size of the molding powder. This Copies are available from the Center can be done conveniently by using a for Food Safety and Applied Nutrition small-scale commercial plastics (HFS–200), Food and Drug Administra- granulator and cutting the sample tion, 5100 Paint Branch Pkwy., College through a screen having 1⁄4-inch mesh. Park, MD 20740, or available for inspec- Fine particles should be separated from tion at the Office of the Federal Reg- the cut resin by screening through a 20- ister, 800 North Capitol Street, NW., mesh screen. The material retained on suite 700, Washington, DC 20408. the screen is suitable for the extraction (ii) The viscosity number (VN) for tests. Nylon 6/69 and Nylon PA–6–3–T resins (ii) The organic solvents must be of in a 99 percent cresol solution (5 milli- American Chemical Society analytical grams resin per milliliter) shall be de- reagent grade; distilled water is used. termined at 25 °C (77 °F) by method ISO Approximately 30 grams of the pre- 307–1984(E), ‘‘Plastics-Polyamides-De- pared sample is weighed to the nearest termination of Viscosity Number,’’ milligram. The weighed resin is trans- which is incorporated by reference. The ferred to a 500-milliliter round-bottom availability of this incorporation by flask equipped with a reflux condenser. reference is given in paragraph (d)(5)(i) Approximately 300-milliliters of sol- of this section. vent is added to the flask and the contents refluxed gently for 8 hours with a [42 FR 14572, Mar. 15, 1977] heating mantle. The solvent is then fil- EDITORIAL NOTE: ForFEDERAL REGISTER ci- tered off immediately while still hot, tations affecting § 177.1500, see the List of using a Buchner funnel approximately CFR Sections Affected, which appears in the 5 inches in diameter, a suction flask, Finding Aids section of the printed volume and on GPO Access. and a hardened filter paper (Whatman No. 50 or equivalent). The paper is wet § 177.1520 Olefin polymers. with the solvent and a slight suction applied just before starting the filtra- The olefin polymers listed in para- tion. The resin is washed twice with graph (a) of this section may be safely approximately 100-milliliter portions of used as articles or components of arti- solvent and the combined filtrate and cles intended for use in contact with washings are reduced to approximately food, subject to the provisions of this 25 milliliters by evaporation at reduced section. pressure (50 millimeters to 100 millime- (a) For the purpose of this section, ters of mercury, absolute), heating as olefin polymers are basic polymers necessary. The contents of the flask manufactured as described in this para- are transferred to an evaporation dish graph, so as to meet the specifications (which has been held in a vacuum des- prescribed in paragraph (c) of this sec- iccator over anhydrous calcium sulfate tion, when tested by the methods de- until constant weight has been at- scribed in paragraph (d) of this section. tained) and carefully evaporated to (1)(i) Polypropylene consists of basic dryness. The weight of the solid residue polymers manufactured by the cata- is determined by difference after hold- lytic polymerization of propylene. ing in a vacuum desiccator over anhy- (ii) Propylene homopolymer consists drous calcium sulfate until constant of basic polymers manufactured by the weight has been attained. The percent catalytic polymerization of propylene of solids extracted is calculated by di- with a metallocene catalyst. viding the weight of the solid residue (2)(i) Polyethylene consists of basic by the weight of the sample and multi- polymers manufactured by the cata- plying by 100. lytic polymerization of ethylene. (5) Viscosity number (VN). (i) The vis- (ii) Fumaric acid-grafted poly- cosity number (VN) for Nylon 6/12 resin ethylene (CAS Reg. No. 26877–81–6) con- in a 96 percent sulfuric acid solution (5 sists of basic polymers manufactured milligrams resin per milliliter) shall be by the catalytic polymerization of determined at 25 °C (77 °F) by method ethylene followed by reaction with fu- ISO 307–1984(E), ‘‘Plastics-Polyamides- maric acid in the absence of free rad- Determination of Viscosity Number,’’ ical initiators. Such polymers shall which is incorporated by reference. contain grafted fumaric acid at levels

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not to exceed 2 percent by weight of propylene or butene-1, shall contain the finished polymer. not less than 85 weight percent poly- (3) Olefin basic copolymers consist of mer units derived from ethylene. basic copolymers manufactured by the (e) Olefin basic copolymers manufac- catalytic copolymerization of: tured by the catalytic polymerization (i) Two or more of the 1-alkenes hav- of ethylene and octene-1, or ethylene, ing 2 to 8 carbon atoms. Such olefin octene-1, and either hexene-1, butene-1, basic copolymers contain not less than propylene, or 4-methylpentene-1 shall 96 weight-percent of polymer units de- contain not less than 80 weight percent rived from ethylene and/or propylene, of polymer units derived from ethyl- except that: ene. (a)(1) Olefin basic copolymers manu- (ii) 4-Methylpentene-1 and 1-alkenes factured by the catalytic copolym- having from 6 to 18 carbon atoms. Such erization of ethylene and hexene-1 or olefin basic copolymers shall contain ethylene and octene-1 shall contain not not less than 95 molar percent of poly- less than 90 weight-percent of polymer mer units derived from 4- units derived from ethylene; methylpentene-1, except that copoly- (2) Olefin basic copolymers manufac- mers manufactured with 1-alkenes hav- tured by the catalytic copolymeriza- ing from 12 to 18 carbon atoms shall tion of ethylene and hexene-1 shall con- contain not less than 97 molar percent tain not less than 80 but not more than of polymer units derived from 4- 90 weight percent of polymer units de- methylpentene-1; or rived from ethylene. (iii) Ethylene and propylene that (3) Olefin basic copolymers manufac- may contain as modifiers not more tured by the catalytic copolymeriza- than 5 weight-percent of total polymer tion of ethylene and pentene-1 shall units derived by copolymerization with contain not less than 90 weight-percent one or more of the following mono- of polymer units derived from ethyl- mers: ene. (4) Olefin basic copolymers manufac- 5-Ethylidine-2-norbornene. tured by the catalytic polymerization 5-Methylene-2-norbornene. of ethylene and octene-1 shall contain not less than 50 weight-percent of poly- (iv) Ethylene and propylene that may mer units derived from ethylene. contain as a modifier not more than 4.5 (b) Olefin basic copolymers manufac- weight percent of total polymer units tured by the catalytic copolymeriza- derived by copolymerization with 1,4- tion of ethylene and 4-methylpentene-1 hexadiene. shall contain not less than 89 weight- (v) Ethylene and butene-1 copolymers percent of polymer units derived from (CAS Reg. No. 25087–34–7) that shall ethylene; contain not less than 80 weight percent (c)(1) Olefin basic copolymers manu- of polymer units derived from ethyl- factured by the catalytic copolym- ene. erization of two or more of the mono- (vi) Olefin basic copolymers (CAS mers ethylene, propylene, butene-1, 2- Reg. No. 61615–63–2) manufactured by methylpropene-1, and 2,4,4- the catalytic copolymerization of trimethylpentene-1 shall contain not ethylene and propylene with 1,4- less than 85 weight-percent of polymer hexadiene, followed by reaction with units derived from ethylene and/or pro- fumaric acid in the absence of free rad- pylene; ical initiators. Such polymers shall (2) Olefin basic copolymers manufac- contain not more than 4.5 percent of tured by the catalytic copolymeriza- polymer units deriving from 1,4- tion of propylene and butene-1 shall hexadiene by weight of total polymer contain greater than 15 but not greater prior to reaction with fumaric acid and than 35 weight percent of polymer not more than 2.2 percent of grafted fu- units derived from butene-1 with the maric acid by weight of the finished remainder being propylene. polymer. (d) Olefin basic terpolymers manufac- (vii) Ethylene and 2-norbornene (CAS tured by the catalytic copolymeriza- Reg. No. 26007–43–2) copolymers that tion of ethylene, hexene-1, and either shall contain not less than 30 and not

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

Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent Reg. No. 88526Ð47Ð0), 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, IVÐB, VIÐA through 220 °C (428 °F), and the subsequent catalytic hydrogenation VIÐC, VIIÐB, 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 28Ð67 (Reapproved 1982), food Types III, IVÐA, V, VIIÐA, 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 611Ð82, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or from the Center for Food Safety and Applied Nutrition (HFSÐ200), Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . Colorants used in accordance with ¤ 178.3297 of this chapter . 2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78Ð For use as an initiator in the production of propylene 63Ð7) . 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 (HFSÐ 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

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Substance Limitations

Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section, polypropylene (CAS Reg. No. 121510Ð09Ð6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852Ð37Ð plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011Ð 85 weight-percent of polymer units derived from propylene. 14Ð7), and polypropylene (CAS Reg. No. 9003Ð07Ð0), 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 PPÐMMA/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 (HFSÐ200), 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, 200 C. St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132Ð00Ð3) 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 C4ÐC5 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 28Ð67 (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, IVÐB, VIÐA, VIÐB, VIIÐB, 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 3236Ð88, ‘‘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, IVÐA, V, VIÐC, VIIÐA, and IX iden- rials,’’ both of which are incorporated by reference in accord- tified in table 1 of ¤ 176.170(c) of this chapter and under ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are conditions 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, 1916 Race St., Philadelphia, PA 19103, or from the Center For Food Safety and Applied Nutrition (HFSÐ200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . Polymethylsilsesquioxane (CAS Reg. No. 68554Ð70Ð1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937Ð For use only as a processing aid in the production of olefin 79Ð9), 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 3835Ð79 (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 (HFSÐ200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC . Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin 68937Ð54Ð2) . 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.

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Substance Limitations

Triisopropanolamine (CAS Reg. No. 122Ð20Ð3) ...... 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. 108Ð75Ð8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462Ð84Ð6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591Ð22Ð0), juvant is used at a level not to exceed 20 parts per million not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers. more than 6 percent . Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded No. 9011Ð17Ð0) 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 (HFSÐ200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC . Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin No. 9011Ð17Ð0), 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- 3835Ð79 (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 (HFSÐ200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408.

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 polymer) in xy- gradeÐ Nhexane at speci- lene at specified fied temperatures temperatures

1.1a. Polypropylene described in paragraph 0.880Ð0.913 MP: 160°Ð180 °C 6.4 pct at reflux 9.8 pct at 25 °C (a)(1)(i) of this section temperature 1.1b. Propylene homopolymer described in 0.880Ð0.913Ð MP: 150°Ð180 °C 6.4 pct at reflux 9.8 pct at 25 °C paragraph (a)(1)(ii) of this section temperature 1.2. Polypropylene, noncrystalline; for use 0.80Ð0.88 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

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1.3. Polypropylene, noncrystalline, for use 0.80Ð0.88 SP:115°Ð138 °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, IVÐB, VIÐB, VIIÐB, 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, IVÐB, VIÐB, VIIÐB, and VIII 2.1. Polyethylene for use in articles that con- 0.85Ð1.00 ...... 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 2.2. Polyethylene for use in articles used for 0.85Ð1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3. Polyethylene for use only as component 0.85Ð1.00 ...... 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, IVÐA, V, VIÐC, VIIÐA, 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- 0.85Ð1.00 ...... 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- 0.9Ð1.00 ...... 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- 0.85Ð1.00 ...... 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- 0.85Ð0.92 ...... 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 para- ...... graph (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- 0.85Ð0.90 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- 0.85Ð0.90 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, IVÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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) 0.82Ð0.85 MP: 235°Ð250 °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 2 hours and filtered at the boiling approximately 1-inch squares by any point. The filtrate is evaporated and convenient method that avoids con- the total residue weighed as a measure tamination by dust, dirt, or grease of the solvent extractable fraction. (NOTE: Do not touch samples with bare (a) Apparatus. (1) Erlenmeyer flasks, fingers—use forceps to hold or transfer 250-milliliter, with ground joint. samples). (2) Condensers, Allihn, 400-millimeter (1) Density. Density shall be deter- jacket, with ground joint. mined by ASTM method D1505–68 (Re- (3) Funnels, ribbed 75-millimeter di- approved 1979), ‘‘Standard Test Method ameter, stem cut to 40 millimeters. for Density of Plastics by the Density- (4) Funnels, Buchner type, with Gradient Technique,’’ which is incor- coarse-porosity fritted disc, 60-milli- porated by reference. Copies may be meter diameter. obtained from the American Society (5) Bell jar for vacuum filtration into for Testing Materials, 1916 Race St., beaker. Philadelphia, PA 19103, or may be ex- (b) Reagent. n-Hexane, commercial amined at the Office of the Federal grade, specific gravity 0.663–0.667 (20 °C/ Register, 800 North Capitol Street, 20 °C), boiling range 66 °C-69 °C, or NW., suite 700, Washington, DC 20408. equivalent. (2) Melting point or softening point—(i) (c) Procedure. Weigh 1 gram of sample Melting point. The melting point shall accurately and place in a 250-milliliter be determined by ASTM method D2117– Erlenmeyer flask containing two or 82, ‘‘Standard Test Method for Melting three boiling stones. Add 100 milliliters Point of Semicrystalline Polymers by of solvent, attach the flask to the con- the Hot Stage Microscopy Method,’’ denser (use no grease), and reflux the which is incorporated by reference. The mixture for 2 hours. Remove the flask availability of this incorporation by from the heat, disconnect the con- reference is given in paragraph (d)(1) of denser, and filter rapidly, while still this section. hot, through a small wad of glass wool (ii) Softening point. The softening packed in a short-stem funnel into a point shall be determined by ASTM tared 150-millimeter beaker. Rinse the method E28–67 (Reapproved 1982), flask and filter with two 10-milliliter ‘‘Standard Test Method for Softening portions of the hot solvent, and add the Point by Ring-and-Ball Apparatus,’’ rinsings to the filtrate. Evaporate the which is incorporated by reference. The filtrate on a stream bath with the aid availability of this incorporation by of a stream of nitrogen. Dry the res- reference is given in paragraph (d)(1) of idue in a vacuum oven at 110 °C for 2 this section. hours, cool in a desiccator, and weigh (3) Maximum extractable fraction in n- to the nearest 0.0001 gram. Determine hexane—(i) Olefin copolymers described the blank on 120 milliliters of solvent in paragraph (a)(3)(ii) of this section, evaporated in a tared 150-milliliter polypropylene, and poly(methylpentene). beaker. Correct the sample residue for A sample is refluxed in the solvent for this blank if significant. Calculation:

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

(ii) Olefin copolymers described in para- the extraction period to give a measure graph (a)(3)(i) of this section and poly- of the solvent extractable fraction. The ethylene. A preweighed sample is ex- maximum n-hexane-extractable frac- tracted at 50 °C for 2 hours and filtered. tion may be determined by the meth- The filtrate is evaporated and the total ods set forth in paragraphs (d)(3)(ii)(a) residue weighed as a measure of the through (d)(3)(ii)(i) of this section. solvent extractable fraction. Alter- (a) Extraction apparatus. Two-liter, natively, the sample is reweighed after straight-walled, Pyrex (or equivalent)

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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 vent, adding the remainder of the fil- an outlet tube located 1 inch off center. trate from the Erlenmeyer flask as the Nitrogen is fed from the supply source evaporation proceeds. When the volume through a coil of 1⁄4-inch stainless steel of the solvent has been reduced to tubing immersed in the same steam about 50 milliliters, transfer the con- bath used to supply heat for solvent centrated liquid to a previously tared evaporation. All connections are made weighing dish of suitable size. Wash the with flexible tetrafluoroethylene tub- beaker twice with 20–30 milliliter por- ing. tions of warm solvent, adding the (c) Reagents—(1) n-Hexane. Spectro- washings to the weighing dish while grade n-hexane. continuing to evaporate the remainder (2) Nitrogen. High-purity dry nitrogen of the solvent under the gas cover with containing less than 10 parts per mil- its flow of warm nitrogen directed to- lion of oxygen. ward the center of the dish. In the (d) Procedure. Transfer 2.5 grams (ac- event that an insoluble residue that curately weighed to nearest 0.001 gram) cannot be removed with warm solvent of the polymer to the resin kettle. Add remains in the beaker, it may be nec- 1 liter of solvent and clamp top in posi- essary to heat with a small amount of tion. Start water flowing through jack- a higher boiling solvent such as ben- et of the reflux condenser and apply air zene or toluene, transferring these pressure to the stirring motor to washings to the weighing dish before produce vigorous agitation. Turn on final evaporation to dryness. Transfer heating jacket with transformer set at the weighing dish with its residue to a a predetermined voltage to bring the vacuum desiccator, and allow it to re- temperature of the contents to 50 °C main overnight (at least 12 hours), within 20–25 minutes. As the thermom- after which the net weight of the dry eter reading approaches 45 °C–47 °C, re- residue is determined to the nearest duce the voltage to the predetermined 0.0001 gram. Correct the result for any setting that will just maintain the solvent blank equivalent to the non- temperature at 50 °C. Do not overshoot volatile matter determined to be con- the prescribed temperature. Should tained in the amount of solvents used this occur discard the test and start in the test. afresh. Exactly 2 hours after the sol- (e) Extraction apparatus for alternate vent temperature has reached 50 °C, method. Two-liter extraction vessel, disconnect the heater, remove the resin such as a resin kettle or round bottom kettle from the heating jacket, and de- flask, fitted with an Allihn condenser cant the solvent, while still warm, (size C), a 45/50 male joint with a Teflon through a coarse filter paper placed on sleeve, and a Teflon coated stir bar. top of a fritted-glass funnel, collecting Water bath maintained at 49.5 °C ±0.5

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

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

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

(ii) Olefin copolymers described in para- and the total residue weighed as a graph (a)(3)(i) of this section and poly- measure of soluble fraction. ethylene. A sample is extracted in xy- (a) Apparatus—(1) Extraction appa- lene at reflux temperature for 2 hours ratus. Two-liter, straight-walled Pyrex and filtered. The filtrate is evaporated (or equivalent) resin kettles, fitted

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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. reflux condenser and apply full voltage Avoid any charring of the residue. (115 volts) to the heating mantle. When Transfer the weighing dish to a vacu- the xylene starts to boil, reduce the um desiccator at room temperature voltage to a level just sufficient to and allow to remain under reduced maintain reflux. After refluxing for at pressure for at least 12 hours (over- least 2 hours, disconnect the power night), after which determine the net source to the mantle, remove the ket- weight of the residue to the nearest tle, and allow to cool in air until the 0.0001 gram. Correct the result for non- temperature of the contents drops to 50 volatile solvent blank obtained by °C, after which the kettle may be rap- evaporating the equivalent amount of

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xylene under identical conditions. Cal- test conditions and procedures are as culate the weight of residue originally follows: present in the total weight of solvent (840 grams), using the appropriate fac- List of polymers Conditions/procedures tor based on the weight of filtrate Olefin copolymers described in para- Condition L, proce- evaporated. graph (a)(3)(i)(c)(2) of this section . dure A. (5) Viscosity average molecular weight Olefin copolymers described in para- Condition E, proce- olefin copolymers described in paragraphs graph (a)(3)(v) of this section . dure A. Olefin polymers described in para- Condition E, proce- (a)(3) (iii) and (iv) of this section. The graph (a)(2)(ii) of this section . dure A. viscosity average molecular weight Olefin polymers described in para- Condition E, proce- shall be determined from the kine- graph (a)(3)(vi) of this section . dure A. matic viscosity (using ASTM method D445–74, ‘‘Test for Kinematic Viscosity (8) Melting peak temperature. The melt of Transparent and Opaque Liquids’’ temperature of the olefin polymers de- (Revised 1974), which is incorporated by scribed in paragraph (a)(3)(ii) of this reference; copies are available from section shall be determined by ASTM American Society for Testing and Ma- method D 3418–82, ‘‘Standard Test terials (ASTM), 1916 Race Street, Method for Transition Temperatures of Philadelphia, PA 19103, or available for Polymers by Thermal Analysis,’’ which inspection at the Office of the Federal is incorporated by reference in accord- Register, 800 North Capitol Street, ance with 5 U.S.C. 552(a). The avail- NW., suite 700, Washington, DC 20408) of ability of this incorporation by ref- solutions of the copolymers in solvents erence is given in paragraph (d)(1) of and at temperatures as follows: this section. (i) Olefin polymers described in para- (9) Intrinsic viscosity. The intrinsic graph (a)(3)(iii) of this section in viscosity of the olefin polymers de- ° decahydronaphthalene at 135 C. scribed in paragraph (a)(3)(ii) of this (ii) Olefin polymers described in section shall be determined by ASTM paragraph (a)(3)(iv) of this section in method D 1601–78, ‘‘Standard Test ° tetrachloroethylene at 30 C. Method for Dilute Solution Viscosity (6) Mooney viscosity—olefin copolymers of Ethylene Polymers,’’ which is incor- described in paragraph (a)(3)(iii) of this porated by reference in accordance section. Mooney viscosity is determined with 5 U.S.C. 552(a). The availability of by ASTM method D1646–81, ‘‘Standard this incorporation by reference is given Test Method for Rubber—Viscosity and in paragraph (d)(1) of this section. Vulcanization Characteristics (Mooney Viscometer),’’ which is incorporated by (e) Olefin copolymers described in reference (the availability of this in- paragraph (a)(3) (i) of this section and corporation by reference is given in polyethylene, alone or in combination, paragraph (d)(1) of this section), using may be subjected to irradiation bom- the large rotor at a temperature of 100 bardment from a source not to exceed °C, except that a temperature of 127 °C 2.3 million volts intensity to cause mo- shall be used for those copolymers lecular crosslinking of the polymers to whose Mooney viscosity cannot be de- impart desired properties, such as in- termined at 100 °C. The apparatus con- creased strength and increased ability taining the sample is warmed for 1 to shrink when exposed to heat. minute, run for 8 minutes, and vis- (f) The olefin polymers identified in cosity measurements are then made. and complying with this section, when (7) Melt flow index. The melt flow used as components of the food-contact index of olefin polymers described surface of any article that is the sub- below shall be determined by ASTM ject of a regulation in parts 174, 175, method D–1238–82, ‘‘Standard Test 176, 177, 178, and § 179.45 of this chapter, Method for Flow Rates of Thermo- shall comply with any specifications plastics by Extrusion Plastometer,’’ and limitations prescribed by such reg- which is incorporated by reference in ulation for the article in the finished accordance with 5 U.S.C. 552(a). The form in which it is to contact food. availability of this incorporation by (g) The provisions of this section are reference is given in paragraph (d)(1) of not applicable to olefin polymers iden- this section. The olefin polymers and tified in § 175.105(c) (5) of this chapter

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and used in food-packaging adhesives List of substances Limitations complying with § 175.105 of this chapter. Lithium polysilicate containing For use only as a compo- [42 FR 14572, Mar. 15, 1977] not more than 20 weight per- nent of repeated-use cent silica, not more than 2.1 coatings not exceeding EDITORIAL NOTE: For FEDERAL REGISTER ci- percent lithium oxide and 0.030 millimeter (0.0012 tations affecting § 177.1520, see the List of having a maximum mole inch) in thickness where CFR Sections Affected, which appears in the ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally cured at minimum sinter- Finding Aids section of the printed volume ing temperatures of 371 and on GPO Access. °C (700 °F). Lithium extractives shall not exceed § 177.1550 Perfluorocarbon resins. 1.55 milligrams per square decimeter (0.1 Perfluorocarbon resins identified in milligram per square inch) this section may be safely used as arti- of coating surface when tested in accordance with cles or components of articles intended paragraph (e)(2) of this to contact food, subject to the provi- section. sions of this section: Naphthalene sulfonic acid For use only: formaldehyde condensate, 1. As a component of re- (a) Identity. For the purpose of this sodium salt . peated-use coatings, section, perfluorocarbon resins are based on the those produced by: (1) The perfluorocarbon resin identified in paragraph homopolymerization and/or copolym- (a)(1) of this section, not erization of hexafluoropropylene and to exceed 0.030 milli- tetrafluoroethylene, and (2) the cometer (0.0012 inch) in thickness, and at a level polymerization of not to exceed 0.4 weight perfluoropropylvinylether and tetra- percent of the coating. fluoroethylene (CAS Reg. No. 26655–00– 2. As a component of repeated-use coatings, 5). The resins shall meet the extrac- based on the tives limitations in paragraph (d) of perfluorocarbon resin identified in paragraph this section. (a)(2) of this section, not (b) Optional components. The to exceed 0.10 millimeter perfluorocarbon resins identified in (0.004 inch) in thickness, and at a level not to ex- paragraph (a) of this section as well as ceed 0.4 weight percent articles or coating made from these of the coating. resins may include the following optional components except that the (c) Optional processing. Poly- tetra- resin identified in paragraph (a)(2) of fluoroethylene resins may be irradi- this section may not be used with the ated by either a cobalt-60 sealed optional component, lithium source, at a maximum dose of gamma polysilicate, mentioned in paragraph radiation not to exceed 7.5 megarads, (b)(4) of this section. or an electron beam at energy levels (1) Substances generally recognized not to exceed 2.5 million electron volts with a maximum dosage of 7.5 as safe (GRAS) in food or food pack- megarads, to produce lubricant pow- aging subject to any limitations cited ders having a particle diameter of not on their use. more than 20 microns for use only as (2) Substances used in accordance components of articles intended for re- with a prior sanction or approval, sub- peated use in contact with food. ject to any limitations cited in the (d) Specifications—(1) Infrared identi- prior sanction or approval. fication. Perfluorocarbon resins can be (3) Substances authorized under ap- identified by their characteristic infra- plicable regulations in this part and in red spectra. parts 175 and 178 of this chapter and (2) Melt-viscosity. (i) The perfluoro- subject to any limitations prescribed carbon resins identified in paragraph therein. (a)(1) of this section shall have a melt (4) The following substances, subject viscosity of not less than 104 poises at to any limitations prescribed: 380 °C (716 °F) as determined by ASTM

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method D1238–82, ‘‘Standard Test Meth- of 6.45 square decimeters (100 square od for Flow Rates of Thermoplastics by inches) or more and at least 1.27 milli- Extrusion Plastometer,’’ which is in- meters (0.05 inch) thick shall be ex- corporated by reference. Copies may be tracted at reflux temperatures for 2 obtained from the American Society hours separately with distilled water, for Testing Materials, 1916 Race St., 50 percent ethanol, n-heptane, and Philadelphia, PA 19103, or may be ex- ethyl acetate. amined at the Office of the Federal (2) Perfluorocarbon resins identified Register, 800 North Capitol Street, in paragraphs (a)(1) and (2) of this sec- NW., suite 700, Washington, DC 20408. tion and intended for use as coatings or The melt viscosity of the perfluorocarbon resins identified in components of coatings shall meet paragraph (a)(1) of this section shall extractability limits prescribed in not vary more than 50 percent within paragraph (e)(3) of this section when one-half hour at 380 °C (716 °F). the resins in the form of coatings de- (ii) Perfluorocarbon resins identified scribed in paragraphs (e)(2) (i) and (ii) in paragraph (a)(2) of this section shall of this section are extracted at reflux have a melt viscosity of not less than temperatures for 2 hours separately 104 poises at 372 °C (702 °F) as deter- with distilled water, 8 percent ethanol, mined by a more detailed method ti- and n-heptane: tled ‘‘Determination of Melt Viscosity, (i) Perfluorocarbon resin coatings Molecular Weight Distribution Index based on resins identified in paragraph and Viscosity Stability,’’ which is in- (a)(1) of this section shall be applied to corporated by reference. Copies are both sides of a 0.025-millimeter (0.001 available from the Center for Food inch) thick aluminum foil to a thick- Safety and Applied Nutrition (HFS– ness of 0.025 millimeter (0.001 inch) 200), Food and Drug Administration, after thermal curing at 399 °C (750 °F) 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at for 10 minutes. If a primer is used, the the Office of the Federal Register, 800 total thickness of the primer plus top- North Capitol Street, NW., suite 700, coat shall equal 0.025 millimeter (0.001 Washington, DC 20408. inch) after heat curing. (3) Thermal instability index. The ther- (ii) Perfluorocarbon resin coatings mal instability index of the tetra- based on resins identified in paragraph fluoroethylene homopolymer shall not (a)(2) of this section shall be applied to exceed 50 as determined by ASTM both sides of a 0.025-millimeter (0.001 method D1457–56T, ‘‘Test for Thermal inch) thick aluminum foil to a thick- Instablility index of Tetrafluoro- ness of 0.10 millimeter (0.004 inch) after ethylene Homopolymer’’ (Revised 1956), thermal curing at 427 °C (800 °F) for 10 which is incorporated by reference. minutes. If a primer is used, the total Copies are available from University thickness of the primer plus topcoat Microfilms International, 300 N. Zeeb shall equal 0.10 millimeter (0.004 inch) Rd., Ann Arbor, MI 48106, or available after heat curing. for inspection at the Office of the Fed- (3) The extracted surfaces shall meet eral Register, 800 North Capitol Street, the following extractability limits: NW., suite 700, Washington, DC 20408. (i) Total extractives not to exceed 3.1 The requirements of this paragraph do not apply to polytetrafluoroethylene milligrams per square decimeter (0.2 resin lubricant powders described in milligram per square inch). paragraph (c) of this section. (ii) Fluoride extractives calculated as (e) Limitations. 1 (1) Perfluorocarbon- fluorine not to exceed 0.46 milligram molded articles having a surface area per square decimeter (0.03 milligram per square inch). 1 A more detailed procedure of extraction (f) Conditions of use. Perfluorocarbon conditions is entitled, ‘‘Preparation of Ex- resins identified in paragraph (a)(2) of tracts,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– or available for inspection at the Office of 200), Food and Drug Administration, 5100 the Federal Register, 800 North Capitol Paint Branch Pkwy., College Park, MD 20740, Street, NW., suite 700, Washington, DC 20408.

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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 minimum weight average molecular (c) Extractive limitations. The finished weight of 20,000. food-contact article yields net total ex- (3) Polyarylate resins may be identi- tractives in each extracting solvent fied by their characteristic infrared not to exceed 0.052 milligram per spectra. square inch (corresponding to 0.008 mil- (c) Extractive limitations. The finished ligram per square centimeter) of food- polyarylate resins in sheet form at contact surface, when extracted at least 0.5 millimeter (0.020 inch) thick, reflux temperature for 2 hours with the when extracted with water at 121 °C following solvents: Distilled water, 50 (250 °F) for 2 hours, shall yield total percent (by volume) ethyl alcohol in nonvolatile extractives not to exceed distilled water, 3 percent acetic acid 2.33 micrograms per square centimeter (by weight) in distilled water, and n- (15 micrograms per square inch) of the heptane. exposed resin surface. (d) In testing the finished food-con- (d) Limitations. Polyarylate resin ar- tact article made of ticles may be used in contact with all polyaryletherketone resin, use a sepa- foods except beverages containing rate test sample for each required ex- more than 8 volume percent ethanol tracting solvent. under conditions of use A through H, [61 FR 42381, Aug. 15, 1996] described in table 2 of § 176.170(c) of this chapter. § 177.1560 Polyarylsulfone resins. [52 FR 35540, Sept. 22, 1987] Polyarylsulfone resins (CAS Reg. No. 79293–56–4) may be safely used as arti- § 177.1556 Polyaryletherketone resins. cles or components of articles intended The poly(oxy-1,4-phenylenecarbonyl- for use in contact with food, at tem- 1,4-phenyleneoxy-1,4- peratures up to and including normal phenylenecarbonyl-1,4- baking temperatures, in accordance

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with the following prescribed condi- NOTE: In testing the finished polyaryl- tions: sulfone resin use a separate test sample for (a) Identity. Polyarylsulfone resins each required extracting solvent. are copolymers containing not more [50 FR 31046, July 24, 1985] than 25 percent of oxy-p-phenyleneoxy-p-phenylenesulfonyl-p-phenylene § 177.1570 Poly-1-butene resins and polymer units and not less than 75 per- butene/ethylene copolymers. cent of oxy-p-phenylenesulfonyl-p- The poly-1-butene resins and butene/ phenylene-oxy-p-phenylenesulfonyl-p- ethylene copolymers identified in this phenylene polymer units. The copoly- section may be safely used as articles mers have a minimum reduced vis- or components of articles intended for cosity of 0.40 deciliter per gram in 1- use in contact with food subject to the methyl-2-pyrrolidinone in accordance provisions of this section. with ASTM method D2857–70 (Re- (a) Identity. Poly-1-butene resins are approved 1977), ‘‘Standard Test Method produced by the catalytic polymeriza- for Dilute Solution Viscosity of Poly- tion of 1-butene liquid monomer. mers,’’ which is incorporated by ref- Butene/ethylene copolymers are pro- erence. Copies may be obtained from duced by the catalytic polymerization the American Society for Testing and of 1-butene liquid monomer in the pres- Materials, 1916 Race St., Philadelphia, ence of small amounts of ethylene PA 19103, or may be examined at the monomer so as to yield no higher than Office of the Federal Register, 800 a 6-weight percent concentration of North Capitol Street, NW., suite 700, polymer units derived from ethylene in Washington, DC 20408. the copolymer. (b) Poly- (b) Optional adjuvant substances. The Specifications and limitations. 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 paragraph and further identified as re- an intrinsic viscosity 1.0 to 3.2 as deter- quired: mined by ASTM method D1601–78, Substances Limitations ‘‘Standard Test Method for Dilute So- lution Viscosity of Ethylene Poly- Sulfolane ..... Not to exceed 0.15 percent as residual sol- mers,’’ which is incorporated by ref- vent in the finished basic resin. erence. Copies may be obtained from the American Society for Testing Ma- (c) Extractive limitations. The finished terials, 1916 Race St., Philadelphia, PA polyarylsulfone resin when extracted 19103, or may be examined at the Office for 2 hours with the following solvents of the Federal Register, 800 North Cap- at the specified temperatures yields itol Street, NW., suite 700, Washington, total extractives in each extracting DC 20408. solvent not to exceed 0.008 milligram (iii) Density. Poly-1-butene resins per square centimeter of food-contact have a density of 0.904 to 0.920 gms/cm3, surface: distilled water at 121 °C (250 and butene/ethylene copolymers have a °F), 50 percent (by volume) ethyl alco- density of 0.890 to 0.916 gms/cm3 as de- hol in distilled water at 71.1 °C (160 °F), termined by ASTM method D1505–68 3 percent acetic acid in distilled water (Reapproved 1979), ‘‘Standard Test at 100 °C (212 °F), and n-heptane at 65.6 Method for Density of Plastics by the °C (150 °F). Density-Gradient Technique,’’ which is

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incorporated by reference. The avail- § 177.1580 Polycarbonate resins. ability of this incorporation by ref- Polycarbonate resins may be safely erence is given in paragraph (b)(1)(ii) of used as articles or components of arti- this section. cles intended for use in producing, (iv) Melt index. Poly-1-butene resins manufacturing, packing, processing, have a melt index of 0.1 to 24 and the preparing, treating, packaging, trans- butene/ethylene copolymers have a porting, or holding food, in accordance melt index of 0.1 to 20 as determined by with the following prescribed condi- ASTM method D1238–82, condition E, tions: ‘‘Standard Test Method for Flow Rates (a) Polycarbonate resins are poly- of Thermoplastics by Extrusion Plas- esters produced by: tometer,’’ which is incorporated by ref- (1) The condensation of 4,4′-iso- erence. The availability of this incor- propylidenediphenol and carbonyl chlo- poration by reference is given in para- ride to which may have been added cer- graph (b)(1)(ii) of this section. tain optional adjuvant substances re- (2) Limitations. Poly-1-butene resins quired in the production of the resins; and butene/ethylene copolymers for use or by in articles that contact food, and for (2) The reaction of molten 4,4′-iso- articles used for packing or holding propylidenediphenol with molten di- food during cooking shall yield no phenyl carbonate in the presence of the more than the following extractables: ′ (i) Poly-1-butene resins may be used disodium salt of 4,4 -isopro- as articles or components of articles pylidenediphenol. (3) The condensation of 4,4′-isopro- intended for use in contact with food, pylidenediphenol, carbonyl chloride, provided that the maximum and 0.5 percent weight maximum of extractables do not exceed 2.5 percent a2,a6-bis (6-hydroxy-m-tolyl) mesitol to by weight of the polymer when film or which may have been added certain op- molded samples are tested for 2 hours tional adjuvant substances required in at 50 °C (122 °F) in n-heptane. (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 contact with food under conditions of paragraph (a)(1) and (3) of this section use B, C, D, E, F, G, or H described in may include substances generally rec- table 2 of § 176.170(c) of this chapter, ognized as safe in food, substances used subject to the provisions of this section in accordance with a prior sanction or and provided that the maximum approval, and the following: extractables from test films 0.1 to 0.2 List of substances Limitations millimeter (0.004 to 0.008 inch) in thickness do not exceed 0.80 percent by p-tert-Butylphenol ...... Chloroform ...... weight of the polymer when extracted p-Cumylphenol (CAS Reg. For use only as a chain ter- in a soxhlet extractor for 6 hours with No. 599Ð64Ð4) . minator at a level not to ex- refluxing 95 percent ethanol. ceed 5 percent by weight of the resin. (iii) Poly-1-butene resins may be used Ethylene dichloride . as articles or components of articles Heptane . intended for packaging or holding food Methylene chloride . during cooking, provided that the Monochlorobenzene ...... Not to exceed 500 p.p.m. as residual solvent in finished thickness of such polymers in the form resin. in which they contact food shall not Pentaerythritol tetrastearate For use only as a mold re- exceed 0.1 millimeter (0.004 inch) and (CAS Reg. No. 115Ð83Ð3) . lease agent, at a level not to exceed 0.5 percent by yield maximum extractables of not weight of the finished resin. more than 2.5 percent by weight of the Phenol (CAS Reg. No. 108Ð polymer when films are extracted for 2 95Ð2) . hours at 50 °C (122 °F) in n-heptane. Pyridine . Toluene: (CAS Reg. No. Not to exceed 800 parts per [42 FR 14572, Mar. 15, 1977, as amended at 49 108Ð88Ð3) . million as residual solvent FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, in finished resin. Triethylamine . 1985]

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(c) Polycarbonate resins shall con- by CAS Reg. No. 114096–64–9 when pro- form to the specification prescribed in duced with the use of greater than 2 paragraph (c)(1) of this section and but not greater than 5 weight percent shall meet the extractives limitations p-cumylphenol (CAS Reg. No. 599–64–4), prescribed in paragraph (c)(2) of this as an optional adjuvant substance in section. accordance with paragraph (b)(2) of (1) Specification. Polycarbonate resins this section. can be identified by their char- (b) Optional adjuvants. The optional acteristic infrared spectrum. adjuvant substances required in the (2) Extractives limitations. The production of resins identified in para- polycarbonate resins to be tested shall graph (a) of this section may include: be ground or cut into small particles (1) Substances used in accordance that will pass through a U.S. standard with § 174.5 of this chapter. sieve No. 6 and that will be held on a (2) Substances identified in U.S. standard sieve No. 10. (i) Polycarbonate resins, when ex- § 177.1580(b). tracted with distilled water at reflux (3) Substances regulated in temperature for 6 hours, shall yield § 178.2010(b) of this chapter for use in total extractives not to exceed 0.15 per- polycarbonate resins complying with cent by weight of the resins. § 177.1580: (ii) Polycarbonate resins, when ex- Provided, That the substances are used tracted with 50 percent (by volume) in accordance with any limitation on ethyl alcohol in distilled water at concentration, conditions of use, and reflux temperature for 6 hours, shall food types specified in § 178.2010(b) of yield total extractives not to exceed this chapter. 0.15 percent by weight of the resins. (c) Polyestercarbonate resins shall (iii) Polycarbonate resins, when ex- conform to the specifications pre- tracted with n-heptane at reflux tem- scribed in paragraph (c)(1) of this sec- perature for 6 hours, shall yield total tion and shall meet the extractive lim- extractives not to exceed 0.15 percent itations prescribed in paragraph (c)(2) by weight of the resins. of this section. [42 FR 14572, Mar. 15, 1977, as amended at 46 (1) Specifications. Polyestercarbonate FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, resins identified in paragraph (a) of 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, this section can be identified by their Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994] characteristic infrared spectrum. The § 177.1585 Polyestercarbonate resins. resins shall comply with either or both of the following specifications: Polyestercarbonate resins may be (i) The solution intrinsic viscosity of safely used as articles or components the polyestercarbonate resins shall be of articles intended for use in producing, manufacturing, packing, proc- a minimum of 0.44 deciliter per gram, essing, preparing, treating, packaging, as determined by a method entitled  or holding food, in accordance with the ‘‘Intrinsic Viscosity (IV) of Lexan following prescribed conditions: Polyestercarbonate Resin by a Single (a) Polyestercarbonate resins (CAS Point Method Using Dichloromethane Reg. No. 71519–80–7) are produced by the as the Solvent,’’ developed by the Gen- condensation of 4,4′- eral Electric Co., September 20, 1985, isopropylidenediphenol, carbonyl chlo- which is incorporated by reference in ride, terephthaloyl chloride, and accordance with 5 U.S.C. 552(a) and 1 isophthaloyl chloride such that the fin- CFR part 51. Copies are available from ished resins are composed of 45 to 85 the Office of Premarket Approval, Cen- molepercent ester, of which up to 55 ter for Food Safety and Applied Nutri- mole-percent is the terephthaloyl iso- tion (HFS–215), Food and Drug Admin- mer. The resins are manufactured istration, 5100 Paint Branch Pkwy., using a phthaloyl chloride/carbonyl College Park, MD 20740, or may be ex- chloride mole ratio of 0.81 to 5.7/1 and amined at the Center for Food Safety isophthaloyl chloride/terephthaloyl and Applied Nutrition’s Library, Food chloride mole ratio of 0.81/1 or greater. and Drug Administration, 200 C St. The resins are also properly identified SW., Washington, DC, or at the Office

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of the Federal Register, 800 North Cap- safely used as the food-contact surface itol St. NW., suite 700, Washington, DC; of articles intended for use in contact or with bulk quantities of dry food of the (ii) A minimum weight-average mo- type identified in § 176.170(c) of this lecular weight of 27,000, as determined chapter, table 1, under Type VIII, in ac- by gel permeation chromatography cordance with the following prescribed using polystyrene standards. conditions: (2) Extractives limitations. The (a) For the purpose of this section, polyestercarbonate resins to be tested polyester elastomers are those pro- shall be ground or cut into small par- duced by the ester exchange reaction ticles that will pass through a U.S. when one or more of the following standard sieve No. 6 and that will be phthalates—dimethyl terephthalate, held on U.S. standard sieve No. 10. dimethyl orthophthalate, and dimethyl (i) Polyestercarbonate resins, when isophthalate—is made to react with extracted with distilled water at reflux alpha-hydroomega-hydroxypoly temperature for 6 hours, shall yield (oxytetramethylene) and/or 1,4- total nonvolatile extractives not to ex- butanediol such that the finished elas- ceed 0.005 percent by weight of the res- tomer has a number average molecular ins. weight between 20,000 and 30,000. (ii) Polyestercarbonate resins, when extracted with 50 percent (by volume) (b) Optional adjuvant substances em- ethyl alcohol in distilled water at ployed in the production of the poly- reflux temperature for 6 hours, shall ester elastomers or added thereto to yield total nonvolatile extractives not impart desired technical or physical to exceed 0.005 percent by weight of the properties may include the following resins. substances: (iii) Polyestercarbonate resins, when List of substances Limitations extracted with n-heptane at reflux temperature for 6 hours, shall yield 4,4′ - Bis (alpha, alpha-di- For use only as an anti- total nonvolatile extractives not to ex- methyl-benzyl) oxidant. ceed 0.002 percent by weight of the res- diphenylamine . Tetrabutyl titanate ...... For use only as a catalyst. ins. (3) Residual methylene chloride levels in (c) An appropriate sample of the fin- polyestercarbonate resins. Polyester- ished polyester elastomer in the form carbonate resin articles in the finished in which it contacts food when sub- form shall not contain residual meth- jected to ASTM method D968–81, ylene chloride in excess of 5 parts per ‘‘Standard Test Methods for Abrasion million as determined by a method ti- Resistance of Organic Coatings by the tled ‘‘Analytical Method for Deter- Falling Abrasive Tester,’’ which is in- mination of Residual Methylene Chlo- corporated by reference (copies may be ride in Polyestercarbonate Resin,’’ de- obtained from the American Society veloped by the General Electric Co., for Testing Materials, 1916 Race St., July 23, 1991, which is incorporated by reference in accordance with 5 U.S.C. Philadelphia, PA 19103, or may be ex- 552(a) and 1 CFR part 51. Copies are amined at the Office of the Federal available from the Center for Food Register, 800 North Capitol Street, Safety and Applied Nutrition (HFS– NW., suite 700, Washington, DC 20408), 200), Food and Drug Administration, using No. 50 emery abrasive in lieu of 5100 Paint Branch Pkwy., College Park, Ottawa sand, shall exhibit an abrasion MD 20740, or may be examined at the coefficient of not less than 100 liters Office of the Federal Register, 800 per mil of thickness. North Capitol Street, NW., suite 700, [42 FR 14572, Mar. 15, 1977, as amended at 49 Washington, DC. FR 10109, Mar. 19, 1984] [57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999] § 177.1595 Polyetherimide resin. The polyetherimide resin identified § 177.1590 Polyester elastomers. in this section may be safely used as an The polyester elastomers identified article or component of an article in- in paragraph (a) of this section may be tended for use in contact with food,

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subject to the provisions of this sec- with the following prescribed condition. tions: (a) Identity. For the purpose of this (a) For the purpose of this section, section, the polyetherimide resin is 1,3- carboxyl-modified polyethylene resins isobenzofurandione, 5,5′[(1-methyl- consist of basic polymers produced ethylidene)bis(4,1-phenyleneoxy)] bis- when ethylene-methyl acrylate basic polymer with 1,3-benzenediamine (CAS copolymers, containing no more than Reg. No. 61128–46–9), and is derived from 25 weight percent of polymer units de- the condensation reaction of m- rived from methyl acrylate, are made phenylenediamine and bisphenol A- to react in an aqueous medium with dianhydride. one or more of the following sub- (b) Optional adjuvants. The basic stances: polymer identified in paragraph (a) of this section may contain optional adju- Ammonium hydroxide. vant substances required in the produc- Calcium carbonate. tion of basic resins or finished food- Potassium hydroxide. contact articles. The optional adjuvant Sodium hydroxide. substances required in the production (b) The finished food-contact article, of the basic polymer may include sub- when extracted with the solvent or sol- stances permitted for such use by ap- vents characterizing the type of food plicable regulations as set forth in part and under the conditions of time and 174 of this chapter. temperature characterizing the condi- (c) Specifications and extractives limi- tions of its intended use as determined tations—(1) Specifications. from tables 1 and 2 of § 176.170(c) of this Polyetherimide resin identified in chapter, yields total extractives in paragraph (a) of this section shall have each extracting solvent not to exceed an intrinsic viscosity in chloroform at 0.5 milligram per square inch of food- 25 °C (77 °F) of not less than 0.35 deciliter per gram as determined by a contact surface as determined by the method titled ‘‘Intrinsic Viscosity of methods described in § 176.170(d) of this ULTEM Polyetherimide Using Chloro- chapter; and if the finished food-conform as the Solvent,’’ which is incor- tact article is itself the subject of a porated by reference. Copies are avail- regulation in parts 174, 175, 176, 177, 178, able from the Center for Food Safety and § 179.45 of this chapter, it shall also and Applied Nutrition (HFS–200), Food comply with any specifications and and Drug Administration, 5100 Paint limitations prescribed for it by that Branch Pkwy., College Park, MD 20740, regulation. In testing the finished food- or available for inspection at the Office contact articles, a separate test sample of the Federal Register, 800 North Cap- is to be used for each required extract- itol Street, NW., suite 700, Washington, ing solvent. DC 20408. (c) The provisions of paragraph (b) of (2) Extractive limitations. Extractive this section are not applicable to limitations are applicable to the basic carboxyl-modified polyethylene resins polyetherimide resin in the form of used in food-packaging adhesives com- molded discs of thickness 0.16 centi- plying with § 175.105 of this chapter. meter (0.063 inch). The resin discs when extracted with distilled water at 121 °C § 177.1610 Polyethylene, chlorinated. (250 °F) for 2 hours yield total nonvola- Chlorinated polyethylene identified tile extractives of not more than 12.3 in this section may be safely used as micrograms per square centimeter. articles or components of articles that [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. contact food, except for articles used 3, 1985] for packing or holding food during cooking, subject to the provisions of § 177.1600 Polyethylene resins, this section. carboxyl modified. (a) For the purpose of this section, Carboxyl-modified polyethylene res- chlorinated polyethylene consists of ins may be safely used as the food-con- basic polymers produced by the direct tact surface of articles intended for use chlorination of polyethylene con- in contact with food in accordance forming to the density, maximum n-

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hexane extractable fraction, and max- limitations of § 177.1520(c), items 2.1 and imum xylene soluble fraction specifica- 3.1. tions prescribed under item 2.1 of the (c) The finished food-contact article, table in § 177.1520(c). Such chlorinated when extracted with the solvent or sol- polyethylene contains a maximum of 60 vents characterizing the type of food percent by weight of total chlorine, as and under conditions of time and tem- determined by ASTM 1method D1303–55 perature characterizing the conditions (Reapproved 1979), ‘‘Standard Test of its intended use as determined from Method for Total Chlorine in Vinyl tables 1 and 2 of § 176.170(c) of this chap- Chloride Polymers and Copolymers,’’ ter, yields fluoride ion not to exceed 5 which is incorporated by reference parts per million calculated on the (copies may be obtained from the basis of the volume of food held by the American Society for Testing Mate- food-contact article. rials, 1916 Race St., Philadelphia, PA [48 FR 39057, Aug. 29, 1983] 19103, or may be examined at the Office of the Federal Register, 800 North Cap- § 177.1620 Polyethylene, oxidized. itol Street, NW., suite 700, Washington, Oxidized polyethylene identified in DC 20408), and has a 7.0 percent max- paragraph (a) of this section may be imum extractable fraction in n-hexane safely used as a component of food-con- at 50 °C, as determined by the method tact articles, in accordance with the described in § 177.1520(d)(3)(ii). following prescribed conditions: (b) Chlorinated polyethylene may be (a) Oxidized polyethylene is the basic used in contact with all types of food, resin produced by the mild air oxida- except that when used in contact with tion of polyethylene conforming to the fatty food of Types III, IV–A, V, VII–A, density, maximum n-hexane extract- and IX described in table 1 of § 176.170(c) able fraction, and maximum xylene of this chapter, chlorinated poly- soluble fraction specifications pre- ethylene is limited to use only as a scribed under item 2.3 of the table in modifier admixed at levels not exceed- § 177.1520(c). Such oxidized polyethylene ing 15 weight percent in plastic articles has a minimum number average molec- prepared from polyvinyl chloride and/ ular weight of 1,200, as determined by or from vinyl chloride copolymers com- high temperature vapor pressure os- plying with § 177.1980. mometry, contains a maximum of 5 [42 FR 14572, Mar. 15, 1977, as amended at 49 percent by weight of total oxygen, and FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, has an acid value of 9 to 19. 1994] (b) The finished food-contact article, when extracted with the solvent or sol- § 177.1615 Polyethylene, fluorinated. vents characterizing the type of food Fluorinated polyethylene, identified and under the conditions of time and in paragraph (a) of this section, may be temperature characterizing the condi- safely used as food-contact articles in tions of its intended use as determined accordance with the following pre- from tables 1 and 2 of § 176.170(c) of this scribed conditions: chapter, yields net acidified chloro- (a) Fluorinated polyethylene food- form-soluble extractives not to exceed contact articles are produced by modi- 0.5 milligram per square inch of food- fying the surface of polyethylene arti- contact surface when tested by the cles through action of fluorine gas in methods described in § 177.1330(c), ex- combination with gaseous nitrogen as cept that net acidified chloroform-solu- an inert diluent. Such modification af- ble extractives from paper and paper- fects only the surface of the polymer, board complying with § 176.170 of this leaving the interior unchanged. chapter may be corrected for wax, pet- Fluorinated polyethylene articles are rolatum, and mineral oil as provided in manufactured from basic resins con- § 176.170(d) (5)(iii)(b) of this chapter. If taining not less than 85 weight-percent the finished food-contact article is of polymer units derived from ethylene itself the subject of a regulation in and identified in § 177.1520 (a)(2) and parts 174, 175, 176, 177, 178 and § 179.45 of (3)(i). this chapter, it shall also comply with (b) Fluorinated polyethylene articles any specifications and limitations pre- conform to the specifications and use scribed for it by such regulations.

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(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 used as provided in §§ 175.105 and 176.210 polyethylene phthalate plastics does of this chapter, and § 177.2800. The pro- not exceed the amount reasonably revisions of paragraph (b) of this section quired to accomplish the intended are not applicable to oxidized poly- physical or technical effect or any lim- ethylene used as provided in §§ 175.125 itations further provided. Any sub- and 176.170(a)(5) of this chapter and stance employed in the production of § 177.1200. polyethylene phthalate plastics that is the subject of a regulation in parts 174, § 177.1630 Polyethylene phthalate 175, 176, 177, 178 and 179 of this chapter polymers. conforms with any specification in Polyethylene phthalate polymers such regulation. identified in this section may be safely (e) Substances employed in the pro- used as, or components of plastics duction of polyethylene phthalate plas- (films, articles, or fabric) intended for tics include: use in contact with food in accordance (1) Substances generally recognized with the following prescribed condi- as safe in food. tions: (2) Substances subject to prior sanc- (a) Polyethylene phthalate films con- tion or approval for use in poly- sist of a base sheet of ethylene ethylene phthalate plastics and used in terephthalate polymer, ethylene accordance with such sanction or ap- terephthalate-isophthalate copolymer, proval. or ethylene-1,4-cyclohexylene (3) Substances which by regulation in dimethylene terephthalate copoly- parts 174, 175, 176, 177, 178 and § 179.45 of esters described in § 177.1315(b)(3), to this chapter may be safely used as which have been added optional sub- components of resinous or polymeric stances, either as constituents of the food-contact surfaces subject to the base sheet or as constituents of coat- provisions of such regulation. ings applied to the base sheet. (4) Substances identified in this para- (b) Polyethylene phthalate articles graph (e)(4) subject to the limitations prescribed: consist of a base polymer of ethylene terephthalate polymer, or ethylene-1,4- LIST OF SUBSTANCES AND LIMITATIONS cyclohexylene dimethylene terephthalate copolyesters described in (i) Base sheet: § 177.1315(b)(3), to which have been Ethylene terephthalate copolymers: Pre- added optional substances, either as pared by the condensation of dimethyl constituents of the base polymer or as terephthalate or terephthalic acid with ethylene glycol, modified with one or more constituents of coatings applied to the of the following: Azelaic acid, dimethyl base polymer. azelate, dimethyl sebacate, sebacic acid. (c)(1) Polyethylene phthalate Ethylene terephthalate copolymers: Pre- spunbonded nonwoven fabric consist of pared by the condensation of dimethyl continuous filaments of ethylene terephthalate or terephthalic acid with terephthalate polymer and ethylene ethylene glycol, modified with one or more terephthalate-isophthalate copolymer of the following: Azelaic acid, dimethyl azelate, dimethyl sebacate, sebacic acid, to which may have been added optional pyromellitic dianhydride. The level of adjuvant substances required in their pyromellitic dianhydride shall not exceed preparation and finishing. 0.5 percent by weight of the finished co- (2) The ethylene terephthalate- polymer which may be used under condi- isophthalate copolymer component of tions of use E through H as described in the fabric shall not exceed 25 percent table 2 of § 176.170(c) of this chapter. by weight. The filaments may be blend- Ethylene terephthalate-isophthalate copolymers: Prepared by the condensation of di- ed with other fibers regulated for the methyl terephthalate or terephthalic acid specific use and the spunbonded fabric and dimethyl isophthalate or isophthalic may be further bonded by application acid with ethylene glycol. The finished co- of heat and/or pressure. polymers contain either:

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(a) 77 to 83 weight percent or Acrylic acid and its methyl, ethyl, propyl, (b) At least 97 weight percent of polymer butyl, or octyl esters. units derived from ethylene Acrylonitrile. terephthalate. Methacrylonitrile. Vinyl chloride. (ii) Base sheet and base polymer: Itaconic acid. Ethylene-1,4-cyclohexylene dimethylene Styrene-maleic anhydride resin, partial 2- terephthalate copolyesters described in butoxyethyl ester, ammonium salt (CAS § 177.1315(b)(3). Reg. No. 68890–80–2). For use only as a coat- Ethylene terephthalate polymer: Prepared ing for polyethylene phthalate films com- by the condensation of dimethyl plying with paragraph (a) of this section, terephthalate and ethylene glycol. at levels not to exceed 0.025 gram per Ethylene terephthalate polymer: Prepared square meter (0.016 milligram per square by the condensation of terephthalic acid inch) of the film, in contact with food of and ethylene glycol. types VIII and IX in table 1 of § 176.170(c) of this chapter, under use conditions E, F, (iii) Coatings: and G in table 2 of § 176.170(c) of this chap- Acrylic copolymers (CAS Reg. No. 30394–86– ter. 6): Prepared by reaction of ethyl acrylate (CAS Reg. No. 140–88–5), methyl methacry- (iv) Emulsifiers: late (CAS Reg. No. 80–62–6), and Sodium dodecylbenzenesulfonate: As an ad- methacrylamide (CAS Reg. No. 79–39–0) juvant in the application of coatings to the blended with melamine-formaldehyde resin base sheet or base polymer. (CAS Reg. No. 68002–20–0). For use in coat- Sodium lauryl sulfate: As an adjuvant in the ings for polyethylene phthalate films com- application of coatings to the base sheet or plying with paragraph (a) of this section.– base polymer. Ethylene azelate-terephthalate copolymer: 2-Sulfoethyl methacrylate, sodium salt (CAS The copolymer, dissolved in 1,1,2-trichloro- Reg. No. 1804–87–1). For use only in copoly- ethane and/or methylene chloride, may be mer coatings on polyethylene phthalate used as a heat-activated sealant on poly- film under conditions of use E, F, and G de- ethylene terephthalate film intended for scribed in table 2 of § 175.300(d) of this chap- sealing polyethylene terephthalate pouch- ter, and limited to use at a level not to ex- es that are used as containers of either ceed 2.0 percent by weight of the dry co- nonalcoholic beverages or alcoholic bev- polymer coating. erages containing not more than 15 percent (v) Modifier: ethyl alcohol. The copolymer has a 1,4-Benzenedicarboxylic acid, dimethyl ester, terephthalate/azelate molecular ratio of polymer with 1,4-butanediol and a-hydro- 1.25/1.00 and a relative viscosity of not less omega-hydroxypoly(oxy-1,4-butanediyl) than 1.5 as determined by a method title CAS Reg. No. 9078–71–1) meeting the fol- ‘‘General Procedure of Determining the lowing specifications: Relative Viscosity of Resin Polymers,’’ Melting point: 200° to 215 °C as determined which is incorporated by reference. Copies by ASTM method D2117–82, ‘‘Standard are available from the Center for Food Test Method for Melting Point of Safety and Applied Nutrition (HFS–200), Semicrystalline Polymers by the Hot Food and Drug Administration, 5100 Paint Stage Microscopy Method,’’ which is in- Branch Pkwy., College Park, MD 20740, or corporated by reference. Copies may be available for inspection, at the Office of obtained from the American Society for the Federal Register, 800 North Capitol Testing Materials, 1916 Race St., Phila- Street, NW., suite 700, Washington, DC delphia, PA 19103, or may be examined at 20408. Total residual copolymer solvent the Office of the Federal Register, 800 (1,1,2-trichloroethane and/or methylene North Capitol Street, NW., suite 700, chloride) shall not exceed 0.13 milligram Washington, DC 20408. per square inch of film, and food contact of Density: 1.15 to 1.20 as determined by ASTM the film shall be limited to not more than method D1505–68 (Reapproved 1979), 1 square inch per 250 grams of beverage. ‘‘Standard Test Method for Density of 2-Ethylhexyl acrylate copolymerized with Plastics by the Density-Gradient Tech- one or more of the following: nique,’’ which is incorporated by ref- Acrylonitrile. erence. Copies may be obtained from the Methacrylonitrile. American Society for Testing Materials, Methyl acrylate. 1916 Race St., Philadelphia, PA 19103, or Methyl methacrylate. may be examined at the Office of the Itaconic acid. Federal Register, 800 North Capitol Vinylidene chloride copolymerized with one Street, NW., suite 700, Washington, DC or more of the following: 20408. Methacrylic acid and its methyl, ethyl, The modifier is used at a level not to ex- propyl, butyl, or octyl esters. ceed 5 percent by weight of polyethylene

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terephthalate film. The average thick- of food contact surface exposed to the ness of the finished film shall not exceed solvent. 0.016 millimeter (0.0006 inch). (2) Conditions of use. The plastics are Hexanedioic acid polymer with 1,3- benzenedimethanamine (CAS Reg. No. used for packaging, transporting, or 25718–70–1) meeting the specifications in holding alcoholic beverages that do not § 177.1500(b), item 10, when tested by the exceed 50 percent alcohol by volume. methods given in § 177.1500(c). The modi- (h) Uncoated polyethylene phthalate fier is used in polyethylene terephthalate plastics consisting of a base sheet or at a level not to exceed 30 percent by base polymer prepared as prescribed weight of the polyethylene from substances identified in para- terephthalate. Chloroform-soluble extractives shall not graphs (e)(4)(i) and (ii) of this section exceed 0.08 milligram/centimeter 2 (0.5 and conforming with the specifications milligram/inch 2) of food-contact surface prescribed in paragraph (h)(1) of this of the modified polyethylene section are used as provided in para- terephthalate article when exposed to graph (h)(2) of this section: the following solvents at temperatures (1) Specifications. (i) The food contact and times indicated: ° ° surface, when exposed to distilled (a) Distilled water at 49 C (120 F) for 24 ° hours; water at 250 F for 2 hours yields chlo- (b) n-Heptane at 49 °C (120 °F) for 24 hours; roform-soluble extractives not to ex- (c) 8 percent ethyl alcohol at 49 °C (120 °F) ceed 0.02 milligram/inch 2 of food con- for 24 hours. tact surface exposed to the solvent; and For use in contact with all types of foods (ii) The food contact surface, when except (a) those containing more than 8 exposed to n-heptane at 150 °F for 2 percent alcohol, or (b) those at temperatures over 49 °C (120 °F). hours, yields chloroform-soluble extractives not to exceed 0.02 milligram/ (f) Polyethylene phthalate plastics inch 2 of food contact surface exposed conforming with the specifications pre- to the solvent. scribed in paragraph (f)(1) of this sec- (2) Conditions of use. The plastics are tion are used as provided in paragraph used to contain foods during oven bak- (f)(2) of this section: ing or oven cooking at temperatures (1) Specifications. (i) The food contact above 250 °F. surface, when exposed to distilled (i) Polyethylene phthalate fabric, ° water at 250 F for 2 hours, yields chlo- identified in paragraph (c) of this sec- roform-soluble extractives not to ex- tion and conforming with the specifica- 2 ceed 0.5 mg/in of food contact surface tions prescribed in paragraph (i)(1) of exposed to the solvent; and this section, is used only as provided in (ii) The food contact surface, when paragraph (i)(2) of this section. exposed to n-heptane at 150 °F for 2 (1) Specifications. Chloroform-soluble hours, yields chloroform-soluble ex- extractives shall not exceed 0.2 milli- tractives not to exceed 0.5 mg/in 2 of gram/inch 2 of food-contact surface food contact surface exposed to the sol- when exposed to the following solvents vent. at temperatures and times indicated: (2) Conditions of use. The plastics are (i) Distilled water at 212 °F for 2 used for packaging, transporting, or hours. holding food, excluding alcoholic bev- ° erages, at temperatures not to exceed (ii) n-Heptane at 150 F for 2 hours. ° 250 °F. (iii) 50 percent ethyl alcohol at 120 F (g) Polyethylene phthalate plastics for 24 hours. conforming with the specifications pre- (2) Conditions of use. The plastics are scribed in paragraph (g)(1) of this sec- intended for: tion are used as provided in paragraph (i) Dry food contact. (g)(2) of this section. (ii) Bulk food (excluding alcoholic (1) Specifications. (i) The food contact beverages) repeated use applications, surface meets the specifications in including filtration, at temperatures paragraph (f)(1) of this section; and not exceeding 212 °F. (ii) The food contact surface when ex- (iii) Filtration of bulk alcoholic bev- posed to 50 percent ethyl alcohol at 120 erages, not exceeding 50 percent alco- °F for 24 hours, yields chloroform-solu- hol by volume, at temperatures not ex- ble extractives not to exceed 0.5 mg/in 2 ceeding 120 °F.

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(j) Polyethylene phthalate plastics, (b) Optional adjuvant substances. The composed of ethylene terephthalate- poly(phenyleneterephthalamide) resins isophthalate containing a minimum of identified in paragraph (a) of this sec- 98 weight percent of polymer units de- tion may contain the following op- rived from ethylene terephthalate, or tional adjuvant substances, subject to ethylene-1,4-cyclohexylene any limitation on their use: dimethylene terephthalate copoly- (1) Optional adjuvant substances au- esters described in § 177.1315(b)(3), con- thorized for this use in accordance with forming with the specifications pre- § 174.5 of this chapter. scribed in paragraph (j)(1) of this sec- (2) Optional finish components, total tion, are used as provided in paragraph weight not to exceed 1 percent by (j)(2) of this section. weight of the base polymer, as follows: (1) Specifications. (i) The food contact surface meets the specifications in List of substances Limitations paragraph (f)(1) of this section and Diundecylphthalate (CAS (ii)(a) Containers with greater than 500 Reg. No. 3648Ð20Ð2). Mono- and dipotassium salts mL capacity. The food-contact surface of lauryl phosphate (CAS when exposed to 95 percent ethanol at Reg. No. 39322Ð78Ð6). 120 °F for 24 hours should not yield o-Phenylphenol (CAS Reg. For use as a fungicide for fin- No. 90Ð43Ð7) . ish coating materials. Not chloroform-soluble extractives in ex- to exceed 0.01 percent by cess of 0.005 mg/in 2. weight of the base poly- (b) Containers with less than or equal to mer. Poly(oxyethylene/ 500 mL capacity. The food contact sur- oxypropylen- face when exposed to 95 percent eth- e)monobutylether (CAS anol at 120 °F for 24 hours should not Reg. No. 9038Ð95Ð3). yield chloroform-soluble extractives in Poly(oxyethylene) mono(nonylphenyl)ether 2 excess of 0.05 mg/in . (CAS Reg. No. 9019Ð45Ð (2) Conditions of use. The plastics are 9). used for packaging, transporting, or Polyvinyl methylether (CAS Reg. No. 9003Ð09Ð2). holding alcoholic foods that do not ex- Poly(oxyethylene) sorbitol ceed 95 percent alcohol by volume. monolaurate tetraoleate (CAS Reg. No. 71243Ð28Ð [42 FR 14572, Mar. 15, 1977, as amended at 42 2). FR 18611, Apr. 8, 1977; 44 FR 40886, July 13, Poly(oxyethylene) sorbitol 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, hexaoleate (CAS Reg. No. Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 57171Ð56Ð9). ′ 30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984; 4,4 -Butylidenebis (6-tert- For use only as an oxidation butyl-m-cresol) (CAS Reg. inhibitor for finish coating 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, No. 85Ð60Ð9) . materials. Not to exceed 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, 0.01 percent by weight of Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR the base polymer. 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995; 61 FR 46718, Sept. 5, 1996] (c) Specifications. (1) Poly(phenyleneterephthalamide) resins § 177.1632 Poly (phenyleneterephthala- in the form of continuous filament mide) resins. yarns or fibers that have been scoured Poly(phenyleneterephthalamide) resin accordance with paragraph (d)(1) of ins identified in paragraph (a) of this this section, when refluxed in a 50 per- section may be safely used as articles cent ethanol/water mixture for 24 or components of articles intended for hours, yields total extractables not ex- repeated contact with food. ceeding 0.5 percent by weight of the (a) Identity. For the purpose of this sample. section, the poly(phenylene- (2) Poly(phenyleneterephthalamide) terephthalamide) resins (CAS Reg. No. resins in the form of pulp, when 26125–61–1) are produced by the polym- refluxed in a 50 percent ethanol/water erization of terephthalolyl chloride mixture for 24 hours, yields total with p-phenylenediamine. The extractables not exceeding 0.65 percent poly(phenyleneterephthalamide) resin by weight of the sample. fibers and yarns may contain optional (d) Conditions of use. (1) adjuvant substances required in their Poly(phenyleneterephthalamide) resins preparation and finishing. in the form of continuous filament

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yarns and fibers may be used as compo- nized as safe in food, substances gen- nents of articles intended for repeated erally recognized as safe in indirect ad- use in contact with food at tempera- ditives, and substances used in accord- tures not to exceed 260 °C (500 °F). All ance with prior sanction or approval. items are scoured prior to use by agita- (c) Specifications. (1) Poly(p- tion in a water bath containing 0.5 methylstyrene) basic polymers identi- gram/liter of tetrasodium fied in paragraph (a)(1) of this section pyrophosphate and 0.5 percent deter- shall contain not more than 1 weight ° gent. The items are agitated at 80 C percent of total residual p- ° (180 F) for 20 minutes, and then sub- methystyrene monomer, as determined jected to a cold water rinse. by a gas chromatographic method ti- (2) Poly(phenyleneterephthalamide) tled, ‘‘Gas Chromatographic Deter- resins in the form of pulp may be used mination of PMS and PET in PPMS as gaskets and packing for food proc- Basic Polymers,’’ which is incorporated essing equipment at temperatures not to exceed 260 °C (500 °F). by reference. Copies are available from the Center for Food Safety and Applied [57 FR 3125, Jan. 28, 1992] Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch § 177.1635 Poly(p-methylstyrene) and Pkwy., College Park, MD 20740, or rubber-modified poly(p-methylstyrene). available for inspection at the Office of the Federal Register, 800 North Capitol Poly(p-methylstyrene) and rubber- Street, NW., suite 700, Washington, DC modified poly(p-methylstyrene) identi- 20408. fied in this section may be safely used as components of articles intended for (2) Rubber-modified poly(p- use in contact with food, subject to the methylstyrene) basic polymers identi- provisions of this section: fied in paragraph (a)(2) of this section (a) Identity. For the purposes of this shall contain not more than 0.5 weight section, poly(p-methylstyrene) and percent of total residual p- rubber-modified poly(p-methylstyrene) methylstyrene monomer, as deter- are basic polymers, manufactured as mined by the method identified in described in this paragraph, meeting paragraph (c)(1) of this section the specifications prescribed in para- (d) Other specifications and limitations. graph (c) of this section. The poly(p-methylstyrene) and rubber- (1) Poly(p-methylstyrene) (CAS Reg. modified poly(p-methylstyrene) identi- No. 24936–41–2) polymer produced by the fied in and complying with this sec- polymerization of p-methylstyrene. tion, when used as components of the (2) Rubber-modified poly(p- food-contact surface of any article that methylstyrene) (CAS Reg. No. 33520–88– is the subject of a regulation in parts 6) polymer produced by combining sty- 175, 176, 177, 178 and § 179.45 of this chap- rene-butadiene copolymer and/or ter, shall comply with any specifica- polybutadiene with poly(p- tions and limitations prescribed by methylstyrene), either during or after such regulation for the article in the polymerization of the poly(p- finished form in which it is to contact methylstyrene), such that the finished food. polymers contain not less than 75 (e) Conditions of use. Poly(p- weight percent of total polymer units methylstyrene) basic polymers and derived from p-methylstyrene) mon- rubber-modified poly(p-methylstyrene) omer. basic polymers identified in paragraphs (b) Optional adjuvants. The basic (a)(1) and (a)(2), respectively, of this polymers identified in paragraph (a) of section shall be used in contact with this section may contain optional adju- food only under conditions of use B vant substances required in the production of such basic polymers. Such op- through H set forth in table 2 of tional adjuvant substances may in- § 176.170(c) of this chapter. clude substances permitted for such [48 FR 31384, July 8, 1983, as amended at 54 use by applicable regulations in this FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, chapter, substances generally recog- 1990]

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§ 177.1637 Poly(oxy-1,2- (d) Conditions of use. The finished ethanediyloxycarbonyl-2,6- food contact article shall be: naphthalenediylcarbonyl) resins. (1) Used in contact only with food of Poly(oxy-1,2-ethanediyloxycarbonyl- Types I, II, IVB, VIA, VIB, VIIB, and 2,6-naphthalenediylcarbonyl) resins VIII identified in table 1 of § 176.170(c) identified in paragraph (a) of this sec- of this chapter, under conditions of use tion may be safely used as articles or A through H described in table 2 of § 176.170(c) of this chapter; and with components of articles intended for use food of Types III, IVA, V, VIC, VIIA, in contact with food in accordance and IX identified in table 1 of with the following conditions: § 176.170(c) of this chapter, under condi- (a) Identity. For the purpose of this tions of use C through H described in section, poly(oxy-1,2- table 2 of § 176.170(c) of this chapter; ethanediyloxycarbonyl-2,6- and naphthalenediylcarbonyl) resins (CAS (2) Identified in a manner that will Reg. No. 24968–11–4) are polymers differentiate the article from articles formed by catalytic transesterification made of other polymeric resins to fa- of 2,6-dimethylnaphthalene cilitate collection and sorting. dicarboxylate with ethylene glycol followed by catalytic polycondensation. [61 FR 14965, Apr. 4, 1996] (b) Specifications—(1) Density. The § 177.1640 Polystyrene and rubber- density of poly(oxy-1,2- modified polystyrene. ethanediyloxycarbonyl-2,6- Polystyrene and rubber-modified pol- naphthalenediylcarbonyl) resins shall ystyrene identified in this section may be between 1.33 and 1.40 grams per be safely used as components of arti- cubic centimeter. cles intended for use in contact with (2) Inherent viscosity. The finished food, subject to the provisions of this food-contact article shall have a min- section. imum inherent viscosity of 0.55 deci- (a) Identity. For the purposes of this liter per gram in a solution of 0.1 gram section, polystyrene and rubber-modi- of polymer in 100 milliliters of a 25/40/ fied polystyrene are basic polymers 35 (weight/weight/weight) solution of p- manufactured as described in this para- chlorophenol/tetrachloroethane/phenol. graph so as to meet the specifications The viscosity is determined by East- prescribed in paragraph (c) of this sec- man Chemical Co.’s method ECD-A-AC- tion when tested by the method de- G-V-1-5, ‘‘Determination of Dilute So- scribed in paragraph (d) of this section. lution Viscosity of Polyesters,’’ dated (1) Polystyrene consists of basic poly- May 31, 1988, which is incorporated by mers produced by the polymerization reference in accordance with 5 U.S.C. of styrene. 552(a) and 1 CFR part 51. Copies are (2) Rubber-modified polystyrene con- available from the Office of Premarket sists of basic polymers produced by Approval, Center for Food Safety and combining styrene-butadiene copoly- Applied Nutrition (HFS–215), Food and mers and/or polybutadiene with poly- Drug Administration, 5100 Paint styrene, either during or after polym- Branch Pkwy., College Park, MD 20740, erization of the polystyrene, such that or may be examined at the Center for the finished basic polymers contain not Food Safety and Applied Nutrition’s less than 75 weight percent of total Library, Food and Drug Administra- polymer units derived from styrene tion, 200 C St. SW., Washington, DC, or monomer. at the Office of the Federal Register, (b) Optional adjuvants. The basic 800 North Capitol St. NW., Washington, polymers identified in paragraph (a) of DC. 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

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substances used in accordance with a (ii) The hydrogen burner is operated prior sanction or approval. with 15 pounds per square inch of air (c) Specifications. (1) Polystyrene pressure and 7 pounds per square inch basic polymers identified in paragraph of hydrogen pressure. (a)(1) of this section shall contain not (iii) The attenuation of the hydrogen more than 1 weight percent of total re- flame detector is set at 2×102. sidual styrene monomer, as determined (6) Standardization. (i) Prepare a by the method described in paragraph standard solution by weighing accu- (d) of this section, except that when rately 15 to 20 milligrams of styrene used in contact with fatty foods of monomer into a 2-ounce bottle con- Types III, IV-A, V, VII-A, and IX de- taining 25.0 milliliters of methylene scribed in table 1 of § 176.170(c) of this chloride. Cap the bottle tightly and chapter, such polystyrene basic poly- shake to thoroughly mix the solution. mers shall contain not more than 0.5 (ii) By means of a microliter syringe, weight percent of total residual sty- inject 1 microliter of the standard solu- rene monomer. tion into the gas chromatograph. Meas- (2) Rubber-modified polystyrene ure the area of the styrene monomer basic polymers identified in paragraph peak which emerges after approxi- (a)(2) of this section shall contain not mately 12 minutes. more than 0.5 weight percent of total (7) Procedure. (i) Transfer 1 gram of residual styrene monomer, as deter- sample (accurately weighed to the mined by the method described in para- nearest 0.001 gram to a 2-ounce bottle graph (d) of this section. and add several glass beads. Pipette (d) Analytical method for determination 25.0 milliliters of methylene chloride of total residual styrene monomer con- into the bottle. Cap the bottle tightly tent—(1) Scope. This method is suitable and place on a mechanical shaker. for the determination of residual sty- Shake until the polymer is completely rene monomer in all types of styrene dissolved. If any insoluble residue re- polymers. mains, allow the bottle to stand (or (2) Principle. The sample is dissolved centrifuge at a low speed) until a clear in methylene chloride. An aliquot of supernatant layer appears. the solution is injected into a gas chro- (ii) By means of a microliter syringe, matograph. The amount of styrene inject 3 microliters of the clear super- monomer present is determined from natant liquid into the gas chro- the area of the resulting peak. matograph. (3) Apparatus—(i) Gas chromatograph. (iii) Measure the area of the resulting Beckman GC-2A gas chromatograph styrene monomer peak. Compare the with hydrogen flame detector or appa- sample peak area with the area pro- ratus of equivalent sensitivity. duced by the standard styrene mon- (ii) Chromatograph column. One-quar- omer solution. Calculation: ter inch outside diameter stainless steel tubing (0.028 inch wall thickness), Percent residual styrene 4 feet in length, packed with 20 percent monomer=Milligrams monomer in stand- polyethylene glycol (20,000 molecular ard×peak area of sample/Peak area of mon- × × weight) on alkaline treated 60–80 mesh omer standard sample weight in grams 30 firebrick. (e) Other specifications and limitations. (iii) Recorder. Millivolt range of 0–1, The polystyrene and rubber-modified chart speed of 30 inches per hour. polystyrene identified in and com- (4) Reagents. Compressed air, purified; plying with this section, when used as helium gas; hydrogen gas; methylene components of the food-contact surface chloride, redistilled; and styrene mon- of any article that is the subject of a omer, redistilled. regulation in parts 174, 175, 176, 177, 178 (5) Operating conditions for the gas and § 179.45 of this chapter, shall com- chromatograph. (i) The column is oper- ply with any specifications and limita- ated at a temperature of 100 °C with a tions prescribed by such regulation for helium flow rate of 82 milliliters per the article in the finished form in minute. which it is to contact food.

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(f) Nonapplicability. The provisions of List of substances Limitations this section are not applicable to polystyrene and rubber-modified poly- Xylene ...... Solvent. styrene used in food-packaging adhe- (b) The resins are used as the food- sives complying with § 175.105 of this contact surface for dry food. chapter. (c) An appropriate sample of the fin- § 177.1650 Polysulfide polymer- ished resin in the form in which it con- polyepoxy resins. tacts food, when subjected to ASTM method D968–81, ‘‘Standard Test Meth- Polysulfide polymer-polyepoxy res- ods for Abrasion Resistance of Organic ins may be safely used as the food-con- Coatings by the Falling Abrasive Test- tact surface of articles intended for er,’’ which is incorporated by reference packaging, transporting, holding, or (copies may be obtained from the otherwise contacting dry food, in ac- American Society for Testing Mate- cordance with the following prescribed rials, 1916 Race St., Philadelphia, PA conditions: 19103, or may be examined at the Office (a) Polysulfide polymer-polyepoxy of the Federal Register, 800 North Cap- resins are the reaction products of liq- itol Street, NW., suite 700, Washington, uid polysulfide polymers and DC 20408), using No. 50 Emery abrasive polyfunctional epoxide resins, cured in lieu of Ottawa sand, shall exhibit with the aid of and abrasion coefficient of not less tri(dimethylaminomethyl) phenol, to than 20 liters per mil of film thickness. which have been added certain optional substances to impart desired techno- [42 FR 14572, Mar. 15, 1977, as amended at 49 logical properties to the resins. Subject FR 10110, Mar. 19, 1984] to any limitations prescribed in this section, the optional substances may § 177.1655 Polysulfone resins. include: Polysulfone resins identified in para- (1) Substances generally recognized graph (a) of this section may be safely as safe in food and food packaging. used as articles or components of arti- (2) Substances the use of which is cles intended for use in contact with permitted under applicable regulations food, in accordance with the following in this part, prior sanctions, or approv- prescribed conditions: als. (a) For the purpose of this section, (3) Substances named in this subpara- polysulfone resins are: graph and further identified as re- (1) Poly(oxy-p-phenylenesulfonyl-p- quired: phenyleneoxy-p- phenyleneisopropylidene-p-phenylene) List of substances Limitations resins (CAS Reg. No. 25154–01–2) con- Bis(2-chloroethyl) formal . sisting of basic resins produced when Bis(dichloropropyl) formal ...... Cross-linking agent. the disodium salt of 4,4′- Butyl alcohol ...... Solvent. Carbon black (channel process) . isopropylidenediphenol is made to Chlorinated paraffins ...... Cross-linking agent. react with 4,4′-dichlorodiphenyl sulfone Epoxidized linseed oil . in such a way that the finished resins Epoxidized soybean oil . Epoxy resins (as listed in have a minimum number average mo- ¤ 175.300(b)(3)(viii)(a) of this chap- lecular weight of 15,000, as determined ter). . by osmotic pressure in Ethylene glycol monobutyl ether ...... Solvent. Magnesium chloride . monochlorobenzene; or Methyl isobutyl ketone ...... Solvent. (2) 1,1′-Sulfonylbis[4-chlorobenzene] Naphthalene sulfonic acid-formalde- polymer with 4,4′-(1- hyde condensate, sodium salt . Sodium dibutyl naphthalene Wetting agent. methylethylidene)bis[phenol] (min- sulfonate . imum 92 percent) and 4,4′- Sodium hydrosulfide . sulfonylbis[phenol] (maximum 8 per- Sodium polysulfide . cent) (CAS Reg. No. 88285–91–0) pro- b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent. ether . duced when a mixture of 4,4′- Titanium dioxide . isopropylidenediphenol (minimum 92 Toluene ...... Solvent. percent) and 4,4′-sulfonylbis[phenol] Trichloroethane ...... Cross-linking agent. 1,2,3-Trichloropropane ...... Do. (maximum 8 percent) is made to react Urea-formaldehyde resins . with 4,4′-dichlorodiphenyl sulfone in

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such a way that the finished resin has articles or components of articles in- a minimum number average molecular tended to contact food, in accordance weight of 26,000, as determined by os- with the following prescribed condi- motic pressure in dimethylformamide. tions: (b) The basic polysulfone resins iden- (a) Identity. For the purpose of this tified in paragraph (a) of this section section, poly (tetramethylene may contain optional adjuvant sub- terephthalate) is the reaction product stances required in the production of of dimethyl terephthalate with 1,4- such basic resins. The optional adju- butanediol to which may have been vant substances required in the produc- added certain optional substances to tion of the basic polysulfone resins impart desired technological properties may include substances described in to the polymer. § 174.5(d) of this chapter and the fol- (b) Optional adjuvant substances. lowing: Poly(tetramethylene terephthalate) identified in paragraph (a) of this sec- List of substances Limitations tion may contain optional adjuvant Dimethyl sulfoxide ..... Not to exceed 50 parts per million as substances. The quantity of any op- residual solvent in finished basic tional adjuvant substance employed in resin in paragraph (a)(1) of this the production of the polymer does not section. Monochlorobenzene .. Not to exceed 500 parts per million exceed the amount reasonably required as residual solvent in finished to accomplish the intended technical basic resin in paragraph (a)(1) of or physical effect. Such adjuvants may this section. N-methyl-2- Not to exceed 0.01 percent (100 include substances generally recog- pyrrolidone . parts per million) as residual sol- nized as safe in food, substances used in vent in finished basic resin in para- accordance with prior sanction, and graph (a)(2) of this section. substances permitted under applicable regulations in this part. (c) Polysulfone resins, when ex- (c) Specifications. (1) Inherent vis- tracted at reflux temperatures for 6 cosity of a 0.50 percent solution of the hours with the solvents—distilled polymer in phenol/tetrachloroethane water, 50 percent (by volume) ethyl al- (60/40 weight ratio) solvent is not less cohol in distilled water, 3 percent ace- than 0.6 as determined using a Wagner tic acid in distilled water, and n- viscometer (or equivalent) and cal- heptane, yield total extractives in each culated from the following equation: extracting solvent not to exceed 0.0078 milligram per square centimeter (0.05 (natural log arithm of N ) milligram per square inch) of resin sur- Inherent = r viscos ity face. Note: In testing the finished (c) polysulfone resins, use a separate resin test sample for each required extract- where: ing solvent. Nr=Ratio of flow time of the polymer solu- (d) Polysulfone resins intended for re- tion to that of the solvent and c=polymer concentration of the test solution in peated use in contact with food may be grams per 100 milliliters. used under conditions of use A through (2) Poly(tetramethylene H in table 2 of § 176.170(c) of this chap- terephthalate) in the finished form in ter. The resins intended for single-serv- which it is to contact food shall yield ice food-contact use may be used only total extractives as follows: under condition of use H described in (i) Not to exceed 0.08 milligram per table 2 of § 176.170(c) of this chapter. 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 square inch of food contact surface terephthalate). 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.

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(iv) Not to exceed 0.02 milligram per cordance with the following prescribed square inch of food contact surface conditions: when extracted for 2 hours at 65.6 °C (a) For the purpose of this section, (150 °F) with 50 percent ethanol. polyurethane resins are those produced when one or more of the isocyanates [42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985; 52 FR 20069, May 29, listed in paragraph (a)(1) of this section 1987] is made to react with one or more of the substances listed in paragraph § 177.1670 Polyvinyl alcohol film. (a)(2) of this section: Polyvinyl alcohol film may be safely (1) Isocyanates: used in contact with food of the types Bis(isocyanatomethyl) benzene (CAS Reg. identified in § 176.170(c) of this chapter, No. 25854–16–4). table 1, under Types V, VIII, and IX, in Bis(isocyanatomethyl) cyclohexane (CAS accordance with the following pre- Reg. No. 38661–72–2). ′ ′ scribed conditions: 4,4 -Diisocyanato-3,3 -dimethylbiphenyl (bi- tolylene diisocyanate). (a) The polyvinyl alcohol film is pro- Diphenylmethane diisocyanate. duced from polyvinyl alcohol having a Hexamethylene diisocyanate. minimum viscosity of 4 centipoises 3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- when a 4-percent aqueous solution is hexyl isocyanate. tested at 20 °C. 4,4-Methylenebis(cyclohexyl isocyanate). (b) The finished food-contact film for Toluene diisocyanate. use in contact with Food Types V or (2) List of substances: IX, when extracted with the solvent characterizing the type of food and Adipic acid. under the conditions of time and tem- 1,4-Butanediol. perature characterizing its intended 1,3-Butylene glycol. 1,4–Cyclohexane dimethanol (CAS Reg. No. use as determined from tables 1 and 2 105–08–8). of § 176.170(c) of this chapter, yields 2,2-Dimethyl-1,3-propanediol. total extractives not to exceed 0.078 Ethylene glycol. milligram per square centimeter (0.5 1,6–Hexanediol (CAS Reg. No. 629–11–8).a– milligram per square inch) of food-con- Hydro–οµεγα–hydroxypoly(oxy–1,4– tact surface when tested by ASTM butanediyl) (CAS Reg. No. 25190–06–1). method F34–76 (Reapproved 1980), a-Hydro-omega-hydroxypoly (oxytetra- ‘‘Standard Test Method for Liquid Ex- methylene). ′ traction of Flexible Barrier Materials,’’ a,a -(Isopropylidenedi-p-phenylene)bis[omega- hydroxypoly (oxypropylene)(3–4 moles)], which is incorporated by reference. average molecular weight 675. Copies may be obtained from the Amer- Maleic anhydride. ican Society for Testing Materials, 1916 Methyl oxirane polymer with oxirane (CAS Race St., Philadelphia, PA 19103, or Reg. No. 9003–11–6). may be examined at the Office of the Methyl oxirane polymer with oxirane, ether Federal Register, 800 North Capitol with 1,2,3–propanetriol (CAS Reg. No. 9082– Street, NW., suite 700, Washington, DC 00–2). ′ ′′ ′′′ 20408. a,a a ,a -Neopentanetetrayltetrakis [omega- hydroxypoly (oxypropylene) (1–2 moles)], (c) The finished food-contact film average molecular weight 400. shall not be used as a component of Pentaerythritol-linseed oil alcoholysis prod- food containers intended for use in con- uct. tact with water. Phthalic anhydride. Polybutylene glycol. [42 FR 14572, Mar. 15, 1977, as amended at 49 Polyethyleneadipate modified with ethanol- FR 10110, Mar. 19, 1984] amine with the molar ratio of the amine to the adipic acid less than 0.1 to 1. § 177.1680 Polyurethane resins. Poly(oxycarbonylpentamethylene). The polyurethane resins identified in Polyoxypropylene ethers of 4.4′-isopropyl- paragraph (a) of this section may be idenediphenol (containing an average of 2– safely used as the food-contact surface 4 moles of propylene oxide). Polypropylene glycol. of articles intended for use in contact a,a′,a′′-1,2,3-Propanetriyltris [omega- with bulk quantities of dry food of the hydroxypoly (oxypropylene) (15–18 moles)], type identified in § 176.170(c) of this average molecular weight 3,000. chapter, table 1, under Type VIII, in ac- Propylene glycol.

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a,a′,a′′-[Propylidynetris (methylene)] tris (b) Optional adjuvant substances em- [omega-hydroxypoly (oxypropylene) (min- ployed in the production of the poly- imum 1.5 moles)], minimum molecular urethane resins or added thereto to im- weight 400. a-[ρ(1,1,3,3-Tetramethylbutyl) - phenyl]- part desired technical or physical prop- omega-hydroxypoly(oxyethylene) (5 moles), erties may include the following sub- average molecular weight 425. stances: Trimethylol propane.

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) (136Ð170 moles)], average molecular weight 15,000. 4,4′-Methylenedianiline ...... As a curing agent. 1,1′,1′′-Nitrilotri-2-propanol ...... Do. 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 [methyleneÐ(2,5Ðdi-tert-butyl-4-hydroxyhydrocinna- Stabilizer. mate)]methane (CAS Reg. No. 6683Ð19Ð8) . 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. 57609Ð64Ð0) .

(c) An appropriate sample of the fin- components of articles intended for use ished resin in the form in which it con- in contact with food, subject to provi- tacts food, when subjected to ASTM sions of this section. method D968–81, ‘‘Standard Test Meth- (a) For the purpose of this section, ods for Abrasion Resistance of Organic styrene block polymers are basic poly- Coatings by the Falling Abrasive Test- mers manufactured as described in this er,’’ which is incorporated by reference paragraph, so that the finished poly- (copies may be obtained from the mers meet the specifications prescribed American Society for Testing Mate- in paragraph (b) of this section, when rials, 1916 Race St., Philadelphia, PA tested by the methods described in 19103, or may be examined at the Office paragraph (c) of this section. of the Federal Register, 800 North Cap- (1) Styrene block polymers with 1,3- itol Street, NW., suite 700, Washington, butadiene are those produced by the DC 20408), using No. 50 Emery abrasive catalytic solution polymerization of in lieu of Ottawa sand, shall exhibit an styrene and 1,3-butadiene. abrasion coefficient of not less than 20 (2) Styrene block polymers with 2- liters per mil of film thickness. methyl-1,3-butadiene are those pro- [42 FR 14572, Mar. 15, 1977, as amended at 46 duced by the catalytic solution polym- FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, erization of styrene and 2-methyl-1,3- 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, butadiene. Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] (3) Styrene block polymers with 1,3- butadiene, hydrogenated are those pro- § 177.1810 Styrene block polymers. duced by the catalytic solution polym- The styrene block polymers identi- erization of styrene and 1,3-butadiene, fied in paragraph (a) of this section and subsequently hydrogenated. may be safely used as articles or as (b) Specifications:

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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, IVÐB, VI, VIIÐB, (¥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 . (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, IVÐB, VI, VIIÐB, 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 (¥85 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 yl-1,3-butadiene; for use as articles °F) to ¥47 mg/in2) of sur- mg/in2) of sur- or as components of articles that °C (¥53 face at reflux face at 66 °C contact food of Types I, II, IVÐB, VI, °F) and 86 temperature for 2 (150 °F) for 2 hr VIIÐB, and VIII identified in table 1 in °C (187 hr on a 0.071 cm on a 0.071 cm ¤ 176.170(c) of this chapter . °F) to 122 (0.028 in) thick (0.028 in) thick °C (252 sample. (Option- sample. (Option- °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 (-58 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 butadiene, hydrogenated (CAS Reg. °F) to -30 mg/in2) of sur- mg/in2) of sur- No. 66070Ð58Ð4): for use as articles °C (-22 °F) face at reflux face at 66 °C or as components of articles that and 92 °C temperature for 2 (150 °F) for 2 hr contact food of Types I, II, IVÐB, VI, (198 °F) to hr on a 0.071 cm on a 0.071 cm VIIÐB, and VIII identified in table 1 in 98 °C (208 (0.028 in) thick (0.028 in) thick ¤ 176.170(c) of this chapter . °F) . sample . sample. (ii) Styrene block polymers with 1,3-bu- 16,000 ...... do ...... do ...... do ...... Do. tadiene, hydrogenated (CAS Reg. No. 66070Ð58Ð4): 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, IVÐA, V, VIIÐA, 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- and are applicable to the finished poly- mining whether styrene block polymer. mers conform to the specifications prescribed in this section are as follows

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(1) Molecular weight. Molecular cured for 30 minutes at 153 °C to accen- weight shall be determined by intrinsic tuate the upper transition point. viscosity (or other suitable method). (3) Maximum extractable fractions in (2) Glass transition points. The glass distilled water and 50 percent ethanol and transition points shall be determined the maximum net residue solubles in chlo- by either of the following methods: roform. The maximum extractable frac- (i) ASTM method D2236–70 (‘‘Stand- tions in distilled water and 50 percent ard Method of Test for Dynamic Me- ethanol, and the maximum net residue chanical Properties of Plastics by solubles in chloroform, shall be deter- Means of Torsional Pendulum,’’ which mined in accordance with § 176.170(d)(3) is incorporated by reference; copies are of this chapter using a sandwich form available from American Society for of the finished copolymer of the speci- Testing and Materials (ASTM), 1916 fied thickness and for the time and Race Street, Philadelphia, PA 19103, or temperature specified in paragraph (b) available for inspection at the Office of of this section. the Federal Register, 800 North Capitol (d) The provisions of this section are Street, NW., suite 700, Washington, DC not applicable to butadiene-styrene co- 20408) modified by using a forced reso- polymers listed in other sections of nant vibration instead of a fixed vibra- this subpart. tion and by using frequencies of 25 to 40 (e) The provisions of this section are cycles per second instead of 0.1 to 10 not applicable to styrene block poly- cycles per second. mers with 1,3-butadiene listed in (ii) Direct reading viscoelastometric § 175.105 of this chapter. method titled ‘‘Direct Reading Viscoelastrometric Method for Deter- [42 FR 14572, Mar. 15, 1977, as amended at 42 mining Glass Transition Points of Sty- FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, rene Block Polymers’’ (which is incor- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, porated by reference; copies are avail- June 12, 1989; 58 FR 65546, Dec. 15, 1993] able from the Center for Food Safety and Applied Nutrition (HFS–200), Food § 177.1820 Styrene-maleic anhydride copolymers. and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, Styrene-maleic anhydride copoly- or available for inspection at the Office mers identified in paragraph (a) of this of the Federal Register, 800 North Cap- section may be safely used as articles itol Street, NW., suite 700, Washington, or components of articles intended for DC 20408), by which the glass transition use in contact with food, subject to points are determined in the tensile provisions of this section. mode of deformation at a frequency of (a) For the purpose of this section, 35 hertz using a Rheovibron Model styrene-maleic anhydride copolymers DDV–II (or equivalent) Direct Reading are those produced by the polymeriza- Viscoelastometer. Take maxima in the tion of styrene and maleic anhydride so out-of-phase component of the complex that the finished polymers meet the modulus as the glass transition points. specifications prescribed in paragraph For block polymers of low styrene con- (b) of this section, when tested by the tent or for simple block polymers, the methods described in paragraph (c) of polymer may be treated with 0.3 part this section. per hundred dicumyl peroxide and (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- eptane at specified Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, 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, IVÐA, IVÐB, V, VIÐB (except that will pass U.S. standard carbonated beverages), VIIÐA, VIIÐB, 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. 27288Ð99Ð9) 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, IVÐA, IVÐB, V, U.S. standard sieve No. 20. VI, VIIÐA, VIIÐB, VIII, and IX identi- sieve No. 20. fied 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- dride copolymers listed in other sec- mining conformance with specifications of this subpart. tions for styrene-maleic anhydride copolymers prescribed in this section are [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, as follows: 1982; 54 FR 24898, June 12, 1989] (1) Molecular weight. Molecular weight shall be determined by mem- § 177.1830 Styrene-methyl methacry- brane osmometry. late copolymers. (2) Residual styrene monomer content. Residual styrene monomer content Styrene-methyl methacrylate co- shall be determined by the method de- polymers identified in this section may scribed in § 177.1640(d). be safely used as components of plastic (3) Residual maleic anhydride monomer articles intended for use in contact content. Residual maleic anhydride with food, subject to the provisions of monomer content shall be determined this section. by a gas chromatographic method ti- (a) For the purpose of this section, tled ‘‘Determination of Residual Ma- styrene-methyl methacrylate copoly- leic Anhydride in Polymers by Gas mers consist of basic copolymers pro- Chromatography,’’ which is incor- duced by the copolymerization of sty- porated by reference. Copies are avail- rene and methyl methacrylate such able from the Center for Food Safety that the finished basic copolymers con- and Applied Nutrition (HFS–200), Food tain more than 50 weight percent of and Drug Administration, 5100 Paint polymer units derived from styrene. Branch Pkwy., College Park, MD 20740, (b) The finished plastic food-contact or available for inspection at the Office article, when extracted with the sol- of the Federal Register, 800 North Cap- vent or solvents characterizing the itol Street, NW., suite 700, Washington, type of food and under the conditions DC 20408. of time and temperature characterizing (d) The provisions of this section are the conditions of intended use as deter- not applicable to styrene-maleic anhy- mined from tables 1 and 2 of § 176.170(c)

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of this chapter, yields extractives not this section are used as prescribed in to exceed the following when tested by paragraph (d)(2) of this section. the methods prescribed in § 177.1010(c); (1) Conditions of test. Textryls, when (1) Total nonvolatile extractives not extracted with distilled water at reflux to exceed 0.3 milligram per square inch temperature for 1 hour, yield total ex- of surface tested. tractives not to exceed 1 percent. (2) Potassium permanganate oxidiz- (2) Uses. Textryls are used for pack- able distilled water and 8 and 50 per- aging or holding food at ordinary tem- cent alcohol extractives not to exceed peratures and in the brewing of hot an absorbance of 0.15. beverages. (3) Ultraviolet-absorbing distilled water and 8 and 50 percent alcohol ex- § 177.1900 Urea-formaldehyde resins in tractives not to exceed an absorbance molded articles. of 0.30. Urea-formaldehyde resins may be (4) Ultraviolet-absorbing n-heptane safely used as the food-contact surface extractives not to exceed an absorb- of molded articles intended for use in ance of 0.40. contact with food, in accordance with the following prescribed conditions: § 177.1850 Textryls. (a) For the purpose of this section, Textryls identified in this section urea-formaldehyde resins are those may be safely used as articles or com- produced when 1 mole of urea is made ponents of articles, intended for use in to react with not more than 2 moles of producing, manufacturing, packing, formaldehyde in water solution. processing, preparing, treating, pack- (b) The resins may be mixed with re- aging, transporting or holding food, fined wood pulp and the mixture may subject to the provisions of this sec- contain other optional adjuvant sub- tion. stances which may include the fol- (a) Textryls are nonwoven sheets pre- lowing: pared from natural or synthetic fibers, bonded with fibryl (Fibryl consists of a List of substances Limitations polymeric resin in fibrous form com- Hexamethylenetetramine ...... For use only as polymeriza- mingled with fiber to facilitate sheet tion-control agent. formation and subsequently heat cured Tetrachlorophthalic acid an- Do. to fuse the fibryl and effect bonding). hydride . (b) Textryls are prepared from the fi- Zinc stearate ...... For use as lubricant. bers, fibryls, and adjuvants identified (c) The finished food-contact article, in paragraph (c) of this section, and when extracted with the solvent or sol- subject to limitations prescribed in vents characterizing the type of food that paragraph, provided that any sub- and under the conditions of time and stance that is the subject of a regula- temperature characterizing the condition in parts 174, 175, 176, 177, 178 and tions of its intended use as determined § 179.45 of this chapter conforms with from tables 1 and 2 of § 175.300(d) of this any specifications in such regulation chapter, yields total extractives in for that substance as a component of each extracting solvent not to exceed polymeric resins used as food contact 0.5 milligram per square inch of food- surfaces. contact surface as determined by the (c) The fibers, fibryls, and adjuvants methods described in § 175.300(e) of this permitted are as follows: chapter. Substances Limitations NOTE: In testing the finished food-contact article, use a separate test sample for each (1) Fibers prepared from pol- Conforming with ¤ 177.1630. required extracting solvent. yethylene terephthalate resins . (2) Fibryls prepared from As the basic polymer. § 177.1950 Vinyl chloride-ethylene co- vinyl chloride-vinyl acetate polymers. copolymer . (3) Adjuvant substance, As a solvent in the prepara- The vinyl chloride-ethylene copoly- dimethylformamide . tion of fibryl. mers identified in paragraph (a) of this section may be safely used as compo- (d) Textryls meeting the conditions nents of articles intended for contact of test prescribed in paragraph (d)(1) of with food, under conditions of use D, E,

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F, or G described in table 2 of § 176.170 (iii) Total extractives obtained by ex- (c) of this chapter, subject to the provi- tracting with water at 150 °F for 2 sions of this section. hours contain no more than 0.5 milli- (a) For the purpose of this section, gram of vinyl chloride-ethylene copol- vinyl chloride-ethylene copolymers ymer per 100 grams of sample tested as consist of basic copolymers produced determined from the organic chlorine by the copolymerization of vinyl chlo- content. The organic chlorine content ride and ethylene such that the fin- is determined as described in paragraph ished basic copolymers meet the speci- (d)(3) of this section. fications and extractives limitations (d) Analytical methods: The analyt- prescribed in paragraph (c) of this sec- ical methods for determining whether tion, when tested by the methods de- vinyl chloride-ethylene basic copoly- scribed in paragraph (d) of this section. mers conform to the extractives limi- (b) The basic vinyl chloride-ethylene tations prescribed in paragraph (c) of copolymers identified in paragraph (a) this section are as follows and are ap- of this section may contain optional plicable to the basic copolymers in adjuvant substances required in the powder form having a particle size such production of such basic copolymers. that 100 percent will pass through a The optional adjuvant substances re- U.S. Standard Sieve No. 40 and 80 per- quired in the production of the basic cent will pass through a U.S. Standard vinyl chloride-ethylene copolymers Sieve No. 80: may include substances permitted for (1) Reagents—(i) Water. All water used such use by regulations in parts 170 in these procedures shall be through 189 of this chapter, substances demineralized (deionized), freshly dis- generally recognized as safe in food, tilled water. and substances used in accordance with a prior sanction or approval. (ii) n-Heptane. Reagent grade, freshly (c) The vinyl chloride-ethylene basic distilled n-heptane shall be used. copolymers meet the following speci- (2) Determination of total amount of ex- fications and extractives limitations: tractives. All determinations shall be (1) Specifications. (i) Total chlorine done in duplicate using duplicate content is in the range of 53 to 56 per- blanks. Approximately 400 grams of cent as determined by any suitable an- sample (accurately weighed) shall be alytical procedure of generally accept- placed in a 2-liter Erlenmeyer flask. ed applicability. Add 1,200 milliliters of solvent and (ii) Intrinsic viscosity in cover the flask with aluminum foil. cyclohexanone at 30 °C is not less than The covered flask and contents are sus- 0.50 deciliter per gram as determined pended in a thermostated bath and are by ASTM method D1243–79, ‘‘Standard kept, with continual shaking at 150 °F Test Method for Dilute Solution Vis- for 2 hours. The solution is then fil- cosity of Vinyl Chloride Polymers,’’ tered through a No. 42 Whatman filter which is incorporated by reference. paper, and the filtrate is collected in a Copies may be obtained from the Amer- graduated cylinder. The total amount ican Society for Testing Materials, 1916 of filtrate (without washing) is meas- Race St., Philadelphia, PA 19103, or ured and called A milliliters. The fil- may be examined at the Office of the trate is transferred to a Pyrex (or Federal Register, 800 North Capitol equivalent) beaker and evaporated on a Street, NW., suite 700, Washington, DC steam bath under a stream of nitrogen 20408. to a small volume (approximately 50–60 (2) Extractives limitations. The fol- milliliters). The concentrated filtrate lowing extractives limitations are de- is then quantitatively transferred to a termined by the methods described in tared 100-milliliter Pyrex beaker using paragraph (d) of this section: small, fresh portions of solvent and a (i) Total extractives do not exceed rubber policeman to effect the transfer. 0.10 weight-percent when extracted The concentrated filtrate is evaporated with n-heptane at 150 °F for 2 hours. almost to dryness on a hotplate under (ii) Total extractives do not exceed nitrogen, and is then transferred to a 0.03 weight-percent when extracted drying oven at 230 °F in the case of the with water at 150 °F for 2 hours. aqueous extract or to a vacuum oven at

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150 °F in the case of the heptane extract, it is overnight under vacuum at tract. In the case of the aqueous ex- 150 °F. The residue is weighed and cor- tract, the evaporation to constant rected for the solvent blank. Calcula- weight is completed in 15 minutes at tion: 230 °F; and in the case of heptane ex-

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 evaporated carefully on a steam plate content of aqueous extract—(i) Principle. to a volume of approximately 50 milli- The vinyl chloride-ethylene copolymer liters and then transferred quan- content of the aqueous extract can be titatively, a little at a time, to a clean determined by determining the organic 22-milliliter Parr cup, also on the chlorine content and calculating the steam plate. The solution is evaporated amount of copolymer equivalent to the to dryness. Next 0.25 gram of sucrose organic chlorine content. and 0.5 gram of benzoic acid are added (ii) Total organic chlorine content. A to the cup. One scoop (approximately weighed sample of approximately 400 15 grams) of sodium peroxide is then grams is extracted with 1,200 milliliters added to the cup. The bomb is assem- of water at 150 °F for 2 hours, filtered, bled and ignition is conducted in the and the volume of filtrate is measured usual fashion. (A milliliters) as described in para- (d) After the bomb has cooled, it is graph (d)(2) of this section. rinsed thoroughly with distilled water (a) A slurry of Amberlite IRA–400, or and disassembled. The top of the bomb equivalent, is made with distilled is rinsed into a 250-milliliter beaker water in a 150-milliliter beaker. The with distilled water. The beaker is slurry is added to a chromatographic placed on the steam plate. The bomb column until it is filled to about half cup is placed in the beaker and care- its length. This should give a volume of resin of 15–25 milliliters. The liquid fully tipped over to allow the water to must not be allowed to drain below the leach out the combustion mixture. top of the packed column. After the bubbling has stopped, the cup (b) The column is regenerated to the is removed from the beaker and rinsed basic (OH) form by slowly passing thoroughly. The solution is cooled to through it (10–15 milliliters per minute) room temperature and cautiously neu- 10 grams of sodium hydroxide dissolved tralized with concentrated nitric acid in 200 milliliters of water. The column by slowly pouring the acid down a stir- is washed with distilled water until the ring rod until the bubbling ceases. The effluent is neutral to phenolphthalein. solution is cooled and an equal volume One drop of methyl red indicator is of acetone is added. added to the A milliliters of filtered (e) The solution is titrated with 0.005 aqueous extract and, if on the basic N silver nitrate using standard poten- side (yellow), nitric acid is added drop tiometric titration techniques with a by drop until the solution turns pink. silver electrode as indicator and a po- (c) The extract is deionized by pass- tassium nitrate modified calomel elec- ing it through the exchange column at trode as a reference electrode. An ex- a rate of 10–15 milliliters per minute. panded scale recording titrimeter. The column is washed with 200 milli- Metrohm Potentiograph 2336 or equiva- liters of distilled water. The deionized lent, should be used; a complete blank extract and washings are collected in a must be run in duplicate. 1,500-milliliter beaker. The solution is (iii) Calculations.

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

where: (1) Specifications. (i) Total chlorine T=Milliliters of silver nitrate (sample minus content is 53 to 56 percent as deter- blank)×normality of silver nitrate. mined by any suitable analytical pro- F=1,200/A (as defined above) cedure of generally accepted applica- (e) The vinyl chloride-ethylene co- bility. polymers identified in and complying (ii) Inherent viscosity in ° with this section, when used as compo- cyclohexanone at 30 C is not less than nents of the food-contact surface of 0.59 deciliters per gram as determined any article that is the subject of a reg- by ASTM method D1243–79, ‘‘Standard ulation in parts 174, 175, 176, 177, 178 Test Method for Dilute Solution Vis- and § 179.45 of this chapter, shall com- cosity of Vinyl Chloride Polymers,’’ ply with any specifications and limita- which is incorporated by reference. tions prescribed by such regulation for Copies may be obtained from the Amer- the article in the finished form in ican Society for Testing Materials, 1916 which it is to contact food. Race St., Philadelphia, PA 19103, or (f) The provisions of this section are may be examined at the Office of the not applicable to vinyl chloride-ethyl- Federal Register, 800 North Capitol ene copolymers used as provided in Street, NW., suite 700, Washington, DC §§ 175.105 and 176.180 of this chapter. 20408. (2) Extractives limitations. The fol- [42 FR 14572, Mar. 15, 1977, as amended at 49 lowing extractives limitations are de- FR 10110, Mar. 19, 1984] termined by the methods prescribed in § 177.1970(d). § 177.1960 Vinyl chloride-hexene-1 copolymers. (i) Total extractives do not exceed 0.01 weight percent when extracted The vinyl chloride-hexene-1 copoly- with water at 150 °F for 2 hours. mers identified in paragraph (a) of this (ii) Total extractives do not exceed section or as components of articles in- 0.30 weight percent when extracted tended for use in contact with food, with n-heptane at 150 °F for 2 hours. under conditions of use D, E, F, or G (c) Other specifications and limitations. described in table 2 of § 176.170(c) of this The vinyl chloride-hexene-1 copoly- chapter, subject to the provisions of mers identified in and complying with this section. this section, when used as components (a) Identity. For the purposes of this of the food-contact surface of any arti- section vinyl chloride-hexene-1 copoly- cle that is subject to a regulation in mers consist of basic copolymers pro- parts 174, 175, 176, 177, 178 and § 179.45 of duced by the copolymerization of vinyl this chapter, shall comply with any chloride and hexene-1 such that the fin- specifications and limitations pre- ished copolymers contain not more scribed by such regulation for the arti- than 3 mole-percent of polymer units cle in the finished form in which it is derived from hexene-1 and meet the to contact food. specifications and extractives limitations prescribed in paragraph (b) of this [42 FR 14572, Mar. 15, 1977, as amended at 49 section. The copolymers may option- FR 10110, Mar. 19, 1984] ally contain hydroxypropyl methylcellulose and trichloroethylene used as § 177.1970 Vinyl chloride-lauryl vinyl a suspending agent and chain transfer ether copolymers. agent, respectively, in their produc- The vinyl chloride-lauryl vinyl ether tion. copolymers identified in paragraph (a) (b) Specifications and limitations. The of this section may be used as an arti- vinyl chloride-hexene-1 basic copoly- cle or as a component of an article in- mers meet the following specifications tended for use in contact with food sub- and extractives limitations: ject to the provisions of this section.

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(a) Identity. For the purposes of this (d) Analytical methods. The analytical section vinyl chloride-lauryl vinyl methods for determining total extrac- ether copolymers consist of basic co- tives are applicable to the basic copolymers produced by the copolym- polymers in powder form having a par- erization of vinyl chloride and lauryl ticle size such that 100 percent will vinyl ether such that the finished co- pass through a U.S. Standard Sieve No. polymers contain not more than 3 40 and such that not more than 10 per- weight-percent of polymer units de- cent will pass through a U.S. Standard rived from lauryl vinyl ether and meet Sieve No. 200. the specifications and extractives limi- (1) Reagents—(i) Water. All water used tations prescribed in paragraph (c) of in these procedures shall be this section. demineralized (deionized), freshly dis- (b) Optional adjuvant substances. The tilled water. basic vinyl chloride-lauryl vinyl ether (ii) n-Heptane. Reagent grade, freshly copolymers identified in paragraph (a) distilled n-heptane shall be used. of this section may contain optional (2) Determination of total amount of ex- adjuvant substances required in the tractives. Place an accurately weighed production of such basic copolymers. sample of suitable size in a clean These optional adjuvant substances borosilicate flask, and for each gram of may include substances permitted for sample add 3 milliliters of solvent pre- such use by regulations in parts 170 viously heated to 150 °F. Maintain the through 189 of this chapter, substances temperature of the contents of the generally recognized as safe in food, flask at 150 °F for 2 hours using a hot and substances used in accordance with plate while also maintaining gentle a prior sanction or approval. mechanical agitation. Filter the con- (c) Specifications and limitations. The tents of the flask rapidly through No. vinyl chloride-lauryl vinyl ether basic 42 Whatman filter paper with the aid of copolymers meet the following speci- suction. Transfer the filtrate to flat fications and extractives limitations: glass dishes that are warmed on a hot (1) Specifications. (i) Total chlorine plate and evaporate the solvent with content is 53 to 56 percent as deter- the aid of a stream of filtered air. When mined by any suitable analytical pro- the volume of the filtrate has been re- cedure of generally accepted applica- duced to 10 to 15 milliliters, transfer bility. the filtrate to tared 50-milliliter (ii) Inherent viscosity in borosilicate glass beakers and com- ° cylcoHhexanone at 30 C is not less plete evaporation to a constant weight than 0.60 deciliter per gram as deter- in a 140 °F vacuum oven. Carry out a mined by ASTM method D1243–79, corresponding blank determination ‘‘Standard Test Method for Dilute So- with each solvent. Determine the lution Viscosity of Vinyl Chloride weight of the residue corrected for the Polymers,’’ which is incorporated by solvent blank and calculate the result reference. Copies may be obtained from as percent of the initial weight of the the American Society for Testing Ma- resin sample taken for analysis. terials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office (e) Other specifications and limitations. of the Federal Register, 800 North Cap- The vinyl chloride-lauryl vinyl ether itol Street, NW., suite 700, Washington, copolymers identified in and complying DC 20408. with this section, when used as compo- (2) Extractives limitations. The fol- nents of the food-contact surface of lowing extractives limitations are de- any article that is subject to a regula- termined by the method described in tion in parts 174, 175, 176, 177, 178 and paragraph (d) of this section: § 179.45 of this chapter, shall comply (i) Total extractives do not exceed with any specifications and limitations 0.03 weight-percent when extracted prescribed by such regulation for the with water at 150 °F for 2 hours. article in the finished form in which it is to contact food. (ii) Total extractives do not exceed 0.60 weight-percent when extracted [42 FR 14572, Mar. 15, 1977, as amended at 49 with n-heptane at 150 °F for 2 hours. FR 10110, Mar. 19, 1984]

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§ 177.1980 Vinyl chloride-propylene co- (i) Total extractives do not exceed polymers. 0.10 weight-percent when extracted The vinyl chloride-propylene copoly- with n-heptane at 150 °F for 2 hours. mers identified in paragraph (a) of this (ii) Total extractives do not exceed section may be safely used as compo- 0.03 weight-percent when extracted nents of articles intended for contact with water at 150 °F for 2 hours. with food, subject to the provisions of (iii) Total extractives obtained by ex- this section. tracting with water at 150 °F for 2 (a) For the purpose of this section, hours contain no more than 0.17 milli- vinyl chloride-propylene copolymers gram of vinyl chloride-propylene co- consist of basic copolymers produced polymer per 100 grams of sample tested by the copolymezation of vinyl chlo- as determined from the organic chloride and propylene such that the fin- rine content. For the purpose of this ished basic copolymers meet the speci- section, the organic chlorine content is fications and extractives limitations the difference between the total chlo- prescribed in paragraph (c) of this sec- rine and ionic chlorine contents deter- tion, when tested by the methods de- mined as described in paragraph (d) of scribed in paragraph (d) of this section. this section. (b) The basic vinyl chloride-pro- (d) Analytical methods: The analyt- pylene copolymers identified in para- ical methods for determining whether graph (a) of this section may contain vinyl chloride-propylene basic copoly- optional adjuvant substances required mers conform to the extractives limi- in the production of such basic copoly- tations prescribed in paragraph (c) of mers. The optional adjuvant sub- this section are as follows and are ap- stances required in the production of plicable to the basic copolymers in the basic vinyl chloride-propylene co- powder form having a particle size such polymers may include substances per- that 100 percent will pass through a mitted for such use by regulations in U.S. Standard Sieve No. 40 and 80 per- parts 170 through 189 of this chapter, cent will pass through a U.S. Standard substances generally recognized as safe Sieve No. 80: in food, and substances used in accord- (1) Reagents—(i) Water. All water used ance with a prior sanction or approval. in these procedures shall be (c) The vinyl chloride-propylene demineralized (deionized), freshly dis- basic copolymers meet the following tilled water. specifications and extractives limita- (ii) n-Heptane. Reagent grade, freshly tions: distilled n-heptane shall be used. (1) Specifications. (i) Total chlorine (2) Determination of total amount of ex- content is in the range of 53 to 56 per- tractives. All determinations shall be cent as determined by any suitable an- done in duplicate using duplicate alytical procedure of generally accept- blanks. Approximately 400 grams of ed applicability. sample (accurately weighed) shall be (ii) Intrinsic viscosity in cyclo- placed in a 2-liter Erlenmeyer flask. hexanone at 30 °C is not less than 0.50 Add 1,200 milliliters of solvent and deciliter per gram as determined by cover the flask with aluminum foil. ASTM method D1243–79, ‘‘Standard The covered flask and contents are sus- Test Method for Dilute Solution Vis- pended in a thermostated bath and are cosity of Vinyl Chloride Polymers,’’ kept, with continual shaking, at 150 °F which is incorporated by reference. for 2 hours. The solution is then fil- Copies may be obtained from the Amer- tered through a No. 42 Whatman filter ican Society for Testing Materials, 1916 paper, and the filtrate is collected in a Race St., Philadelphia, PA 19103, or graduated cylinder. The total amount may be examined at the Office of the of filtrate (without washing) is meas- Federal Register, 800 North Capitol ured and called A milliliters. The fil- Street, NW., suite 700, Washington, DC trate is transferred to a Pyrex (or 20408. equivalent) beaker and evaporated on a (2) Extractives limitations. The fol- steam bath under a stream of nitrogen lowing extractives limitations are de- to a small volume (approximately 50–60 termined by the methods described in milliliters). The concentrated filtrate paragraph (d) of this section: is then quantitatively transferred to a

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

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 ducted in the usual fashion using a content of aqueous extract—(i) Principle. Meeker burner. The heating is contin- The vinyl chloride-propylene copoly- ued for 1 minute after the water at the mer content of the aqueous extract can top has evaporated. The bomb is be determined by determining the or- quenched in water, rinsed with distilled ganic chlorine content and calculating water, and placed in a 400-milliliter the amount of copolymer equivalent to beaker. The bomb cover is rinsed with the organic chlorine content. The or- water, catching the washings in the ganic chlorine content is the difference same 400-milliliter beaker. The bomb is between the total chlorine content and covered with distilled water and a the ionic chlorine content. watch glass and heated until the melt (ii) Total chlorine content. A weighed has dissolved. The bomb is removed, sample is extracted with water at 150 rinsed, catching the rinsings in the °F for 2 hours, filtered, and the volume beaker, and the solution is acidified of filtrate is measured (A milliliters) as with concentrated nitric acid using described in paragraph (d)(2) of this section. Two drops of 50 percent by methyl purple as an indicator. The weight sodium hydroxide solution are beaker is covered with a watch glass, added to prevent loss of chloride from and the contents are boiled gently for ammonium chloride, if present, and the 10–15 minutes. After cooling to room solution is evaporated to approxi- temperature the solution is made mately 15 milliliters. The concentrated slightly alkaline with 50 percent by filtrate is quantitatively transferred to weight sodium hydroxide solution, a 22-milliliter Parr bomb fusion cup then acidified with dilute (1:5) nitric and gently evaporated to dryness. To acid. Then 1.5 milliliters of 2 N nitric the contents of the cup are added 3.5 acid per 100 milliliters of solution is grams of granular sodium peroxide, 0.1 added and the solution is titrated with gram of powdered starch, and 0.02 gram 0.005 N silver nitrate to the equivalence potassium nitrate; and the contents potential end point using an expanded are mixed thoroughly. The bomb is as- scale pH meter (Beckman Model 76, or sembled, water is added to the recess at equivalent). A complete blank must be the top of the bomb and ignition is con- 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: A=volume of filtrate obtained in extraction.

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B=milliliters of silver nitrate solution used mately 150 milliliters. The solution is in sample titration×normality of silver quantitatively transferred to a 250-mil- nitrate solution. liliter beaker, methyl purple indicator C=milliliters of silver nitrate solution used in blank titration×normality of silver ni- is added, and the solution is neutral- trate solution. ized with 0.1 N nitric acid. For each 100 milliliters of solution is added 1.5 mil- (iii) Ionic chlorine content. A weighed sample is extracted with water at 150 liliters of 2 N nitric acid. The solution °F for 2 hours, filtered, and the volume is titrated with 0.005 N silver nitrate to of filtrate is measured (A milliliters) as the equivalence potential end point, in paragraph (d)(2) of this section. Two using the expanded scale pH meter de- drops of 50 percent by weight sodium scribed in paragraph (d)(3)(ii) of this hydroxide solution are added and the section. A complete blank must be run solution is evaporated to approxi- 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: (e) The vinyl chloride-propylene co- A=volume of filtrate obtained in extraction. polymers identified in and complying D=milliliters of silver nitrate solution used with this section, when used as compo- in sample titration×normality of silver nents of the food-contact surface of nitrate solution. any article that is the subject of a reg- E=milliliters of silver nitrate solution used ulation in parts 174, 175, 176, 177, 178 in blank titration×normality of silver ni- and § 179.45 of this chapter, shall com- trate solution. ply with any specifications and limita- (iv) Organic chlorine content and vinyl tions prescribed by such regulation for chloride-propylene copolymer content of the article in the finished form in which it is to contact food. aqueous extract. The organic chlorine (f) The provisions of this section are content and the vinyl chloride pro- not applicable to vinyl chloride-propylene copolymer content of the aque- pylene copolymers used in food-pack- ous extract is calculated as follows: aging adhesives complying with (a) Organic chlorine content. Milli- § 175.105 of this chapter. equivalents of organic chlorine in aqueous extract of 100 grams of sample [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984] equal milliequivalents of total chlorine in aqueous extract of 100 grams of sam- § 177.1990 Vinylidene chloride/methyl ple (as calculated in paragraph (d)(3)(ii) acrylate copolymers. of this section) minus milliequivalents The vinylidene chloride/methyl acry- of ionic chlorine in aqueous extract of late copolymers (CAS Reg. No. 25038– 100 grams of sample (as calculated in 72–6) identified in paragraph (a) of this paragraph (d)(3)(iii) of this section). section may be safely used as an article (b) Vinyl chloride-propylene copolymer or as a component of an article in- content. Milligrams of vinyl chloride- tended for use in contact with food sub- propylene copolymer in aqueous ex- ject to the provisions of this section. tract of 100 grams of sample equal (a) Identity. For the purposes of this milliequivalents of organic chlorine in section vinylidene chloride/methyl ac- aqueous extract of 100 grams of sample rylate copolymers consist of basic co- (as calculated in paragraph (d)(3)(iv) (a) polymers produced by the copolym- of this section) multiplied by 84.5. erization of vinylidene chloride and NOTE: The conversion factor, 84.5, is de- methyl acrylate such that the copoly- rived from the equivalent weight of chlorine mers contain not more than 15 weight- divided by the chlorine content of the percent of polymer units derived from heptane extractable fraction.) methyl acrylate.

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(b) Optional adjuvant substances. The termination of Residual Vinylidene basic vinylidene chloride/methyl acry- Chloride and Methyl Acrylate in Vinyl- late copolymers identified in paragraph idene Chloride/Methyl Acrylate Co- (a) of this section may contain optional polymer Resins and Films,’’ or, alter- adjuvant substances required in the natively, ‘‘Residual Methyl Acrylate production of such basic copolymers. and Vinylidene Chloride Monomers in These optional adjuvant substances Saran MA/VDC Resins and Pellets by may include substances permitted for Headspace Gas Chromatography,’’ such use by regulations in parts 170 dated March 3, 1986, which are incor- through 179 of this chapter, substances porated by reference in accordance generally recognized as safe in food, with 5 U.S.C. 552(a). Copies are avail- and substances used in accordance with able from the Center for Food Safety a prior sanction or approval. and Applied Nutrition (HFS–200), Food (c) Specifications. (1) The methyl acry- and Drug Administration, 5100 Paint late content is determined by an infra- Branch Pkwy., College Park, MD 20740, red spectrophotometric method titled or available for inspection at the Office ‘‘Determination of Copolymer Ratio in of the Federal Register, 800 North Cap- Vinylidene Chloride/Methyl Acrylate Copolymers,’’ which is incorporated by itol Street, NW., suite 700, Washington, reference. Copies are available from DC 20408. the Center for Food Safety and Applied (d) Extractives limitations. The basic Nutrition (HFS–200), Food and Drug copolymer resin in the form of granules Administration, 5100 Paint Branch that will pass through a U.S. Standard Pkwy., College Park, MD 20740, or Sieve No. 45 (350 microns) shall meet available for inspection at the Office of the following extractives limitations: the Federal Register, 800 North Capitol (1) 10-gram samples of the resin, Street, NW., suite 700, Washington, DC when extracted separately with 100 20408. milliliters of distilled water at 121 °C (2) The weight average molecular (250 °F) for 2 hours, and 100 milliliters weight of the copolymer is not less of n-heptane at 66 °C (150 °F) for 2 than 50,000 when determined by gel per- hours, shall yield total nonvolatile ex- meation chromatography using tetra- tractives not to exceed 0.5 percent by hydrofuran as the solvent. The gel per- weight of the resin. meation chromatograph is calibrated (2) The basic copolymer in the form with polystyrene standards. The basic of film when extracted separately with gel permeation chromatographic meth- distilled water at 121 °C (250 °F) for 2 od is described in ANSI/ASTM D3536–76, hours shall yield total nonvolatile ex- ‘‘Standard Test Method for Molecular tractives not to exceed 0.047 milligram Weight Averages and Molecular Weight per square centimeter (0.3 milligram Distribution of Polystyrene by Liquid per square inch). Exclusion Chromatography (Gel Per- (e) Conditions of use. The copolymers meation Chromatography-GPC),’’ which is incorporated by reference. may be safely used as articles or com- Copies are available from University ponents of articles intended for use in Microfilms International, 300 North producing, manufacturing, processing, Zeeb Rd., Ann Arbor, MI 48106, or avail- preparing, treating, packaging, trans- able for inspection at the Office of the porting, or holding food, including Federal Register, 800 North Capitol processing of packaged food at tem- Street, NW., suite 700, Washington, DC peratures not to exceed 135 °C (275 °F). 20408. (f) Other specifications and limitations. (3) Residual vinylidene chloride and The vinylidene chloride-methyl acry- residual methyl acrylate in the copoly- late copolymers identified in and commer in the form in which it will con- plying with this section, when used as tact food (unsupported film, barrier components of the food contact surface layer, or as a copolymer for blending) of any article that is subject to a regu- will not exceed 10 parts per million and lation in parts 174 through 178 and 5 parts per million, respectively, as de- § 179.45 of this chapter, shall comply termined by either a gas with any specifications and limitations chromatographic method titled ‘‘De- prescribed by such regulation for the

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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 polymer units derived from methyl [48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 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, 1916 Race St., Philadelphia, PA consist of basic polymers produced by 19103, or available for inspection at the the copolymerization of vinylidene Office of the Federal Register, 800 chloride/methyl acrylate/methyl meth- North Capitol Street, NW., suite 700, acrylate such that the basic polymers Washington, DC 20408. or the finished food-contact articles (3) The basic polymer or food-contact meet the specifications prescribed in article described in paragraph (a) of paragraph (d) of this section. this section, when extracted with the (b) Optional adjuvant substances. The solvent or solvents characterizing the basic vinylidene chloride/methyl acry- type of food and under the conditions late/methyl methacrylate polymers of time and temperature characterizing identified in paragraph (a) of this sec- the conditions of its intended use as de- tion may contain optional adjuvant termined from tables 1 and 2 of substances required in the production § 176.170(c) of this chapter, yields net of such basic polymers. These optional chloroform-soluble extractives in each adjuvant substances may include sub- extracting solvent not to exceed .08 stances permitted for such use by regu- milligram per square centimeter (0.5 lations in parts 170 through 179 of this milligram per square inch) of food-con- chapter, substances generally recog- tact surface when tested by the meth- nized as safe in food, and substances ods described in § 176.170(d). If the fin- used in accordance with a prior sanc- ished food-contact article is itself the tion of approval. subject of a regulation in parts 174 (c) Conditions of use. The polymers through 178 and § 179.45 of this chapter, may be safely used as articles or as it shall also comply with any specifica- components of articles intended for use tions and limitations prescribed for it in producing, manufacturing, proc- by the regulation. essing, preparing, treating, packaging, [49 FR 29578, July 23, 1984] transporting, or holding food, including processing of packaged food at temperatures up to 121 °C (250 °F). Subpart C—Substances for Use (d) Specifications and limitations. The Only as Components of Arti- vinylidene chloride/methyl acrylate/ cles Intended for Repeated methyl methacrylate basic polymers Use and/or finished food-contact articles meet the following specifications and § 177.2210 Ethylene polymer, chloro- limitations: sulfonated. (1)(i) The basic vinylidene chloride/ Ethylene polymer, chlorosulfonated methyl acrylate/methyl methacrylate as identified in this section may be polymers contain not more than 2 safely used as an article or component weight percent of polymer units de- of articles intended for use in contact

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with food, subject to the provisions of § 177.2250 Filters, microporous poly- this section. meric. (a) Ethylene polymer, chloro- Microporous polymeric filters identi- sulfonated is produced by chloro- fied in paragraph (a) of this section sulfonation of a carbon tetrachloride may be safely used, subject to the pro- solution of polyethylene with chlorine visions of this section, to remove par- and sulfuryl chloride. ticles of insoluble matter in producing, (b) Ethylene polymer, chloro- manufacturing, processing, and pre- sulfonated shall meet the following paring bulk quantities of liquid food. specifications: (a) Microporous polymeric filters (1) Chlorine not to exceed 25 percent consist of a suitably permeable, contin- by weight. uous, polymeric matrix of polyvinyl (2) Sulfur not to exceed 1.15 percent chloride, vinyl chloride-propylene, or by weight. vinyl chloride-vinyl acetate, in which finely divided silicon dioxide is embed- (3) Molecular weight is in the range ded. Cyclohexanone may be used as a of 95,000 to 125,000. solvent in the production of the filters. Methods for the specifications in this (b) Any substance employed in the paragraph (b), titled ‘‘Chlorine and production of microporous polymeric Bromine—Coulometric Titration Meth- filters that is the subject of a regula- od by Aminco Chloridometer,’’ tion in parts 170 through 189 of this ‘‘Hypolon Synthetic Rubber—Deter- chapter must conform with any speci- mination of Sulfur by Parr Bomb,’’ and fication in such regulation. ASTM method D2857–70 (Reapproved (c) Cyclohexanone when used as a sol- 1977), ‘‘Standard Test Method for Di- vent in the production of the filters lute Solution Viscosity of Polymers,’’ shall not exceed 0.35 percent by weight are incorporated by reference. Copies of the microporous polymeric filters. of the ASTM method may be obtained (d) The microporous polymeric filters may be colored with colorants used in from the American Society for Testing accordance with § 178.3297 of this chap- Materials, 1916 Race St., Philadelphia, ter. PA 19103. Copies of the other two meth- (e) The temperature of food being ods are available from the Center for processed through the microporous pol- Food Safety and Applied Nutrition ymeric filters shall not exceed 180 °F. (HFS–200), Food and Drug Administra- (f) The microporous polymeric filters tion, 5100 Paint Branch Pkwy., College shall be maintained in a sanitary man- Park, MD 20740. Copies of all three ner in accordance with good manufac- methods may be examined at the Office turing practice so as to prevent poten- of the Federal Register, 800 North Cap- tial microbial adulteration of the food. itol Street, NW., suite 700, Washington, (g) To assure safe use of the micro- DC 20408. porous polymeric filters, the label or (c) The additive is used as the article, labeling shall include adequate direc- or a component of articles, intended for tions for a pre-use treatment, con- use as liners and covers for reservoirs sisting of washing with a minimum of intended for the storage of water for 2 gallons of potable water at a tem- drinking purposes. perature of 180 °F for each square foot (d) Substances permitted by § 177.2600 of filter, prior to the filter’s first use in may be employed in the preparation of contact with food. ethylene polymers, chlorosulfonated, [42 FR 14572, Mar. 15, 1977, as amended at 56 subject to any limitations prescribed FR 42933, Aug. 30, 1991] therein. (e) The finished ethylene copolymers, § 177.2260 Filters, resin-bonded. chlorosulfonated shall conform to Resin-bonded filters may be safely § 177.2600(e) and (g). used in producing, manufacturing, processing, and preparing food, subject [42 FR 14572, Mar. 15, 1977, as amended at 49 to the provisions of this section. FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, (a) Resin-bonded filters are prepared 1989] from natural or synthetic fibers to

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which have been added substances re- Ammonium. quired in their preparation and fin- Calcium. ishing, and which are bonded with res- Magnesium. ins prepared by condensation or polym- Potassium. 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 (c) Any substance employed in the at a usage level not to exceed 10 percent by production of resin-bonded filters that weight of the lubricant formulations. is the subject of a regulation in parts Ricebran oil. 174, 175, 176, 177, 178 and § 179.45 of this Titanium dioxide. chapter conforms with any specifica- (3) Resins: tion in such regulation. (d) Substances employed in the pro- Acrylic polymers produced by polymerizing ethyl acrylate alone or with one or more of duction of resin-bonded filters include the monomers: Acrylic acid, acrylonitrile, the following, subject to any limita- N-methylolacrylamide, and styrene. The tions provided: finished copolymers shall contain at least 70 weight percent of polymer units derived LIST OF SUBSTANCES AND LIMITATIONS from ethyl acrylate, no more than 2 weight percent of total polymer units derived (1) Fibers: from acrylic acid, no more than 10 weight Cellulose pulp. percent of total polymer units derived Cotton. from acrylonitrile, no more than 2 weight Nylon. (From nylon resins complying with percent of total polymer units derived the provisions of applicable regulations in from N-methylolacrylamide, and no more subchapter B of this chapter. than 25 weight percent of total polymer Polyethylene terephthalate complying in units derived from styrene. For use only as composition with the provisions of provided in paragraph (m) of this section. § 177.1630; for use in inline filtration only as Melamine-formaldehyde. provided for in paragraphs (e) and (f) of Melamine-formaldehyde chemically modified this section. with one or more of the amine catalysts Rayon (viscose). identified in § 175.300(b)(3)(xiii) of this chapter. (2) Substances employed in fiber fin- Melamine-formaldehyde chemically modified ishing: with methyl alcohol. BHT. Melamine-formaldehyde chemically modified Butyl (or isobutyl) palmitate or stearate. with urea; for use only as provided for in 2,5-Di-tert-butyl hydroquinone for use only in paragraphs (e), (f), (g), (h), and (i) of this lubricant formulations for rayon fiber fin- section. ishing and at a usage level not to exceed Phenol-formaldehyde resins. 0.1 percent by weight of the lubricant for- Polyvinyl alcohol. mulations. Polyvinyl alcohol with the copolymer of Dimethylpolysiloxane. acrylic acid-allyl sucrose. 4-Ethyl-4-hexadecyl morpholinium ethyl sul- Polyvinyl alcohol with melamine formalde- fate for use only as a lubricant in the man- hyde. ufacture of polyethylene terephthalate fi- Polyvinyl acetate with melamine formalde- bers specified in paragraph (d)(1) of this hyde. p- section at a level not to exceed 0.03 percent -Toluenesulfonamide-formaldehyde chemi- by weight of the finished fibers. cally modified with one or more of the amine catalysts identified in § 175.300 Fatty acid (C10-C18) diethanolamide condensates. (b)(3)(xiii) of this chapter. Fatty acids derived from animal or vegetable (4) Adjuvant substances: fats and oils, and salts of such acids, single or mixed, as follows: Dimethyl polysiloxane with methylcellulose Aluminum. and sorbic acid (as an antifoaming agent).

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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 (f) Resin-bonded filters conforming with the specifications of paragraph (f) aqueous food, yields total extractives (1) of this section are used as provided not to exceed 4 percent, by weight, of in paragraph (e)(2) of this section: the filter. (1) Total extractives. The finished fil- (2) Conditions of use. It is used in com- ter, when exposed to distilled water at mercial filtration of bulk quantities of 145 °F for 2 hours, yields total extrac- nonalcoholic, aqueous foods having a tives not to exceed 4 percent by weight pH of 5.0 or below. of the filter. (k) Resin-bonded filters conforming (2) Conditions of use. It is used to fil- with the specifications of paragraph (k) ter milk or potable water at operating (1) of this section are used as provided temperatures not to exceed 145 °F. in paragraph (k)(2) of this section: (g) Resin-bonded filters conforming (1) Total extractives. The finished fil- with the specifications of paragraph (g) ter, when exposed to 8 percent (by vol- (1) of this section are used as provided ume) ethyl alcohol in distilled water in paragraph (g)(2) of this section: for 2 hours at a temperature equivalent (1) Total extractives. The finished fil- to, or higher than, the filtration tem- ter, when exposed to n-hexane at reflux perature of the alcoholic beverage, temperature for 2 hours, yields total yields total extractives not to exceed 4 extractives not to exceed 0.5 percent by weight of the filter. percent, by weight, of the filter. (2) Conditions of use. It is used to fil- (2) Conditions of use. It is used in com- ter edible oils. mercial filtration of bulk quantities of (h) Resin-bonded filters conforming alcoholic beverages containing not with the specifications of paragraph (h) more than 8 percent alcohol. (1) of this section are used as provided (l) Resin-bonded filters conforming in paragraph (h)(2) of this section: with the specifications of paragraph (l) (1) Total extractives. The finished fil- (1) of this section are used as provided ter, when exposed to distilled water at in paragraph (l)(2) of this section: 212 °F for 2 hours, yields total extrac- (1) Total extractives. The finished fil- tives not to exceed 4 percent by weight ter, when exposed to 50 percent (by vol- of the filter. ume) ethyl alcohol in distilled water (2) Conditions of use. It is used to fil- for 2 hours at a temperature equivalent ter milk, coffee, tea, and potable water to, or higher than, the filtration tem- ° at temperatures not to exceed 212 F. perature of the alcoholic beverage, (i) Resin-bonded filters conforming yields total extractives not to exceed 4 with the specifications of paragraph (i) percent, by weight, of the filter. (1) of this section are used as provided in paragraph (i)(2) of this section: (2) Conditions of use. It is used in com- (1) Total extractives. The finished fil- mercial filtration of bulk quantities of ter, when exposed to distilled water for alcoholic beverages containing more 2 hours at a temperature equivalent to, than 8 percent alcohol. or higher than, the filtration tempera- (m) Resin-bonded filters fabricated ture of the aqueous food, yields total from acrylic polymers as provided in

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paragraph (d)(3) of this section to- 4,4′-Isopropylidenediphenol ... Do. 4,4′-Methylenedianiline ...... Do. gether with other substances as pro- m-Phenylenediamine ...... Do. vided in paragraph (d), (1), (2), and (4) Tetrahydrophthalic anhydride Do. of this section may be used as follows: (1) The finished filter may be used to (c) In accordance with good manufac- filter milk or potable water at oper- turing practice, finished articles con- ating temperatures not to exceed 100 taining the resins shall be thoroughly °F, provided that the finished filter cleansed prior to their first use in con- when exposed to distilled water at 100 tact with food. °F for 2 hours yields total extractives (d) The provisions of this section are not to exceed 1 percent by weight of not applicable to 4,4′-isopropylidenedi- the filter. phenol-epichlorohydrin resins listed in (2) The finished filter may be used to other sections of parts 174, 175, 176, 177, filter milk or potable water at oper- 178 and 179 of this chapter. ating temperatures not to exceed 145 ° [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, F, provided that the finished filter 1984] when exposed to distilled water at 145 °F for 2 hours yields total extractives § 177.2355 Mineral reinforced nylon not to exceed 1.2 percent by weight of resins. the filter. Mineral reinforced nylon resins iden- (n) Acrylonitrile copolymers identi- tified in paragraph (a) of this section fied in this section shall comply with may be safely used as articles or com- the provisions of § 180.22 of this chap- ponents of articles intended for re- ter. peated use in contact with nonacidic [42 FR 14572, Mar. 15, 1977, as amended at 56 food (pH above 5.0) and at use tempera- FR 42933, Aug. 30, 1991] tures not exceeding 212 °F. in accordance with the following prescribed con- § 177.2280 4,4′-Isopropylidenediphenol- ditions: epichlorohydrin thermosetting (a) For the purpose of this section epoxy resins. the mineral reinforced nylon resins 4,4′-Isopropylidenediphenol-epichlo- consist of nylon 66, as identified in and rohydrin thermosetting epoxy resins complying with the specifications of may be safely used as articles or com- § 177.1500, reinforced with up to 40 ponents of articles intended for re- weight percent of calcium silicate and peated use in producing, manufac- up to 0.5 weight percent 3- turing, packing, processing, preparing, (triethoxysilyl) propylamine (Chemical treating, packaging, transporting, or Abstracts Service Registry No. holding food, in accordance with the 000919302) based on the weight of the following prescribed conditions: calcium silicate. (a) The basic thermosetting epoxy (b) The mineral reinforced nylon res- resin is made by reacting 4,4′- ins may contain up to 0.2 percent by isopropylidenediphenol with epichloro- weight of titanium dioxide as an op- hydrin. tional adjuvant substance. (b) The resin may contain one or (c) The mineral reinforced nylon res- more of the following optional sub- ins with or without the optional substances provided the quantity used stance described in paragraph (b) of does not exceed that reasonably re- this section, and in the form of 1⁄8-inch quired to accomplish the intended ef- molded test bars, when extracted with fect: the solvents, i.e., distilled water and 50 percent (by volume) ethyl alcohol in Allyl glycidyl ether ...... As curing system additive. Di- and tri-glycidyl ester mix- As modifier at levels not to distilled water, at reflux temperature ture resulting from the re- exceed equal parts by for 24 hours using a volume-to-surface action of epichlorohydrin weight of the 4,4′- ratio of 2 milliliters of solvent per with mixed dimers and isopropylidenediphenol- square inch of surface tested, shall trimers of unsaturated C18 epichlorohydrin basic resin monobasic fatty acids de- and limited to use in con- meet the following extractives limita- rived from animal and veg- tact with alcoholic bev- tions: etable fats and oils . erages containing not more (1) Total extractives not to exceed 5.0 than 8 percent of alcohol. 1,2-Epoxy-3-phenoxypropane As curing system additive. milligrams per square inch of food-con- Glyoxal ...... Do. tact surface tested for each solvent.

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(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 subject to any limitations prescribed § 177.2400 Perfluorocarbon cured therein. elastomers. (4) Substances identified in this para- Perfluorocarbon cured elastomers graph (b)(4) subject to such limitations identified in paragraph (a) of this sec- as are provided:

tion may be safely used as articles or Substances Limitations components of articles intended for repeated use in contact with nonacid Carbon black (channel proc- Not to exceed 15 parts per ess of furnace combustion 100 parts of the food (pH above 5.0), subject to the pro- process) (CAS Reg. No. terpolymer. visions of this section. 1333Ð86Ð4) . (a) Identity. (1) For the purpose of Magnesium oxide (CAS Reg. Not to exceed 5 parts per No. 1309Ð48Ð4) . 100 parts of the this section, perfluorocarbon cured terpolymer. elastomers are produced by terpolymerizing tetrafluorethylene (c) Specifications—(1) Infrared identi- (CAS Reg. No. 116–14–3), fication. Perfluorocarbon cured perfluoromethyl vinyl ether (CAS Reg. elastomers may be identified by the No. 1187–93–5), and perfluoro-2- characteristic infrared spectra of the phenoxypropyl vinyl ether (CAS Reg. pyrolysate breakdown product that is No. 24520–19–2) and subsequent curing of obtained by heating and decomposing the terpolymer (CAS Reg. No. 26658–70– the elastomer using the method enti- 8) using the crosslinking agent, phenol, tled ‘‘Qualitative Identification of 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl) Kalrez by Infrared Examination of ethylidene] bis-,dipotassium salt (CAS Pyrolysate.’’ This method is incor- Reg. No. 25088–69–1) and accelerator, porated by reference. Copies of the 1,4,7,10,13,16-hexaoxacyclooctadecane method are available from the Center (CAS Reg. No. 17455–13–9). for Food Safety and Applied Nutrition (2) The perfluorocarbon base polymer (HFS–200), Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College shall contain no less than 40 weight- Park, MD 20740, or available for inspec- percent of polymer units derived from tion at the Office of the Federal Reg- tetrafluoroethylene, no less than 40 ister, 800 North Capitol Street, NW., weight-percent of polymer units de- suite 700, Washington, DC 20408. rived from perfluoromethyl vinyl ether (2) Thermogravimetry. Perfluorocarbon and no more than 5 weight-percent cured elastomers have a major decom- polymer units derived from perfluoro-2- position peak occurring at 490 ° ±15 °C phenoxy-propyl vinyl ether. (914 °F). Less than 1.5 percent of the (3) The composition limitations of elastomers will volatilize below 400 °C the cured elastomer, calculated as (752 °F) when run under nitrogen at a 10 parts per 100 parts of terpolymer, are °C or 18 °F per minute heating rate as follows: using a Du Pont Thermal Analyzer Phenol, 4,4′-[2,2,2-trifluoro-1- Model 1099 with Model 951 TGA unit or (trifluoromethyl)-ethylidene] bis- the equivalent. ,dipotassium salt—not to exceed 5 parts. (d) Extractive limitations. Articles fab- 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not ricated from perfluorocarbon cured to exceed 5 parts. elastomers having a thickness of at

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least 1.0 millimeter (0.039 inch) when desired technical or physical properties extracted at reflux temperatures for 2 include the following: hours separately with distilled water, 50 percent ethanol, and n-heptane, Asbestos fiber . shall meet the following extractability Barium hydroxide ...... For use as catalyst. Calcium stearate ...... For use as lubricant. limits: Carbon black (channel proc- (1) Total extractives not to exceed 3.1 ess) . milligrams per square decimeter (0.2 Diatomaceous earth . Glass fiber . milligrams per square inch). Hexamethylenetetramine ...... For use as curing agent. (2) Fluoride extractives calculated as Mica . fluorine not to exceed 0.47 milligram Oxalic acid ...... For use as catalyst. per square decimeter (0.03 milligram Zinc stearate ...... For use as lubricant. per square inch). (e) Conditions of use. In accordance (c) The finished food-contact article, with current good manufacturing prac- when extracted with distilled water at tice, finished food contact articles con- reflux temperature for 2 hours, using a taining the perfluorocarbon cured volume-to-surface ratio of 2 milliliters elastomers shall be thoroughly cleaned of distilled water per square inch of prior to their first use in contact with surface tested, shall meet the following food. extractives limitations: (1) Total extractives not to exceed [49 FR 43050, Oct. 26, 1984] 0.15 milligram per square inch of food- contact surface. § 177.2410 Phenolic resins in molded (2) Extracted phenol not to exceed articles. 0.005 milligram per square inch of food- Phenolic resins identified in this sec- contact surface. tion may be safely used as the food- (3) No extracted aniline when tested contact surface of molded articles in- by a spectrophotometric method sen- tended for repeated use in contact with sitive to 0.006 milligram of aniline per- nonacid food (pH above 5.0), in accord- square inch of food-contact surface. ance with the following prescribed con- (d) In accordance with good manufac- ditions: turing practice, finished molded arti- (a) For the purpose of this section, cles containing the phenolic resins the phenolic resins are those produced shall be thoroughly cleansed prior to when one or more of the phenols listed their first use in contact with food. in paragraph (a)(1) of this section are made to react with one or more of the § 177.2415 Poly(aryletherketone) res- aldehydes listed in paragraph (a)(2) of ins. this section, with or without aniline Poly(aryletherketone) resins identi- and/or anhydro-formaldehyde aniline fied in paragraph (a) of this section (hexahydro-1, 3,5-triphenyl-s-triazine): may be safely used as articles or com- (1) Phenols: ponents of articles intended for re- p-tert-Amylphenol. peated use in contact with food subject p-tert-Butylphenol. to the provisions of this section. o-, m-, and p-Cresol. (a) Identity. For the purposes of this p-Octylphenol. section, poly(aryletherketone) resins Phenol. are poly(p-oxyphenylene p- o- and p-Phenylethylphenol mixture pro- oxyphenylene p-carboxyphenylene) res- duced when phenol is made to react with ins (CAS Reg. No. 29658–26–2) produced styrene in the presence of sulfuric acid cat- by the polymerization of hydroquinone alyst. and 4,4′-difluorobenzophenone, and (2) Aldehydes: have a minimum weight-average molecular weight of 12,000, as determined Acetaldehyde. by gel permeation chromatography in Formaldehyde. comparison with polystyrene stand- Paraldehyde. ards, and a minimum mid-point glass (b) Optional adjuvant substances em- transition temperature of 142 °C, as de- ployed in the production of the phe- termined by differential scanning nolic resins or added thereto to impart calorimetry.

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(b) Optional adjuvant substances. The Fatty acids, and dimers thereof, from nat- basic resins identified in paragraph (a) ural sources. may contain optional adjuvant sub- Fumaric. stances used in their production. These Isophthalic. Maleic. adjuvants may include substances de- Methacrylic. scribed in § 174.5(d) of this chapter and Orthophthalic. the following: Sebacic. Terephthalic. Trimellitic.

Substance Limitations (2) Polyols and polyepoxides:

Diphenyl sulfone ...... Not to exceed 0.2 percent Butylene glycol. by weight as a residual Diethylene glycol. solvent in the finished 2,2-Dimethyl-1,3-propanediol. basic resin. Dipropylene glycol. Ethylene glycol. (c) Extractive limitations. The finished Glycerol. food contact article, when extracted at 4,4′-Isopropylidenediphenol-epichlorohydrin. reflux temperatures for 2 hours with Mannitol. a-Methyl glucoside. the following four solvents, yields in Pentaerythritol. each extracting solvent net chloroform Polyoxypropylene ethers of 4,4′-isopropylide- soluble extractives not to exceed 0.05 nediphenol (containing an average of 2–7.5 milligrams per square inch of food con- moles of propylene oxide). tact surface: Distilled water, 50 percent Propylene glycol. (by volume) ethanol in distilled water, Sorbitol. 3 percent acetic acid in distilled water, Trimethylol ethane. and n-heptane. In testing the final food Trimethylol propane. 2,2,4-Trimethyl-1,3-pentanediol. contact article, a separate test sample shall be used for each extracting sol- (3) Cross-linking agents: vent. Butyl acrylate. [63 FR 20315, Apr. 24, 1998] Butyl methacrylate. Ethyl acrylate. § 177.2420 Polyester resins, cross- Ethylhexyl acrylate. linked. Methyl acrylate. Methyl methacrylate. Cross-linked polyester resins may be Styrene. safely used as articles or components Triglycidyl isocyanurate (CAS Reg. No. 2451– of articles intended for repeated use in 62–9), for use only in coatings contacting contact with food, in accordance with bulk quantities of dry food of the type the following prescribed conditions: identified in § 176.170(c) of this chapter, table 1, under type VIII. (a) The cross-linked polyester resins Vinyl toluene. are produced by the condensation of one or more of the acids listed in para- (b) Optional adjuvant substances em- graph (a)(1) of this section with one or ployed to facilitate the production of more of the alcohols or epoxides listed the resins or added thereto to impart in paragraph (a)(2) of this section, fol- desired technical or physical properties lowed by copolymerization with one or include the following, provided that more of the cross-linking agents listed the quantity used does not exceed that in paragraph (a)(3) of this section: reasonably required to accomplish the (1) Acids: intended physical or technical effect and does not exceed any limitations Adipic. 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 .

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

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. 818Ð08Ð6) ...... 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. 2273Ð43Ð0) ...... 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. 23850Ð For use in the polycondensation reaction at levels not to ex- 94Ð4) . 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 . Polyethylene glycol 6000. Silicon dioxide . Wax, petroleum ...... Complying with ¤ 178.3710 of this chapter.

(c) The cross-linked polyester resins, tested when the prescribed food-simu- with or without the optional sub- lating solvent is water or 8 or 50 per- stances described in paragraph (b) of cent alcohol. this section, and in the finished form in (2) Total nonvolatile extractives not which they are to contact food, when to exceed 0.1 milligram per square inch extracted with the solvent or solvents of food-contact surface tested when the characterizing the type of food and prescribed food-simulating solvent is under the conditions of time and tem- heptane. perature characterizing the conditions (d) In accordance with good manufac- of their intended use, as determined turing practice, finished articles con- from tables 1 and 2 of § 176.170(c) of this taining the cross-linked polyester res- chapter, shall meet the following ex- ins shall be thoroughly cleansed prior tractives limitations: to their first use in contact with food. (1) Net chloroform-soluble extrac- [42 FR 14572, Mar. 15, 1977, as amended at 48 tives not to exceed 0.1 milligram per FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, square inch of food-contact surface 1989]

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§ 177.2430 Polyether resins, 800 North Capitol St. NW., suite 700, chlorinated. Washington, DC. Chlorinated polyether resins may be (b) The basic resins identified in safely used as articles or components paragraphs (a)(1) and (a)(2) of this sec- of articles intended for repeated use in tion may contain optional adjuvant producing, manufacturing, packing, substances described in § 174.5(d) of this processing, preparing, treating, pack- chapter and the following: aging, transporting, or holding food, in List of substances Limitations accordance with the following prescribed conditions: Diphenylsulfone ...... Not to exceed 0.2 percent as re- (a) The chlorinated polyether resins sidual solvent in the finished basic resin described in para- are produced by the catalytic polym- graph (a)(1) of this section. erization of 3,3-bis(chloromethyl)- Dimethyl sulfoxide ...... Not to exceed 0.01 percent as oxetane, and shall contain not more residual solvent in the finished than 2 percent residual monomer. basic resin described in paragraph (a)(1) of this section. (b) In accordance with good manufac- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as turing practice, finished articles con- residual solvent in the finished taining the chlorinated polyether res- basic resin described in para- ins shall be thoroughly cleansed prior graph (a)(2) of this section. to their first use in contact with food. (c) The finished food-contact article, § 177.2440 Polyethersulfone resins. when extracted at reflux temperatures for 2 hours with the following four sol- Polyethersulfone resins identified in vents, yields net chloroform-soluble ex- paragraph (a) of this section may be tractives in each extracting solvent safely used as articles or components not to exceed 0.02 milligram per square of articles intended for repeated use in inch of food-contact surface: distilled contact with food in accordance with water, 50 percent (by volume) ethyl al- the following prescribed conditions: cohol in distilled water, 3 percent ace- (a) For the purpose of this section, tic acid in distilled water, and n- polyethersulfone resins are: heptane. (Note: In testing the finished (1) Poly(oxy-p-phenylenesulfonyl-p- food-contact article, use a separate phenylene) resins (CAS Reg. No. 25667– test sample for each required extract- 42–9), which have a minimum number ing solvent.) average molecular weight of 16,000. (d) In accordance with good manufac- ′ (2) 1,1 -sulfonylbis[4-chlorobenzene] turing practice, finished food-contact ′ polymer with 4,4 -(1-methylethyl- articles containing the idene)bis[phenol] (maximum 8 percent) polyethersulfone resins shall be thor- and 4,4′-sulfonylbis[phenol] (minimum oughly cleansed before their first use 92 percent) (CAS Reg. No. 88285–91–0), in contact with food. which have a minimum number average molecular weight of 26,000. [44 FR 34493, June 15, 1979, as amended at 47 (3) In paragraphs (a)(1) and (a)(2) of FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, this section, the minimum number av- 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, erage molecular weight is determined Sept. 20, 1995] by reduced viscosity in dimethyl form- § 177.2450 Polyamide-imide resins. amide in accordance with ASTM method D2857–70 (Reapproved 1977), ‘‘Stand- Polyamide-imide resins identified in ard Test Method for Dilute Solution paragraph (a) of this section may be Viscosity of Polymers,’’ which is incor- safely used as components of articles porated by reference. Copies may be intended for repeated use in contact obtained from the American Society with food, in accordance with the fol- for Testing Materials, 1916 Race St., lowing prescribed conditions: Philadelphia, PA 19103, or may be ex- (a) Identity. (1) For the purpose of amined at the Division of Petition Con- this section the polyamide-imide resins trol (HFS–215), Center for Food Safety are derived from the condensation re- and Applied Nutrition, 1110 Vermont action of substantially equimolar parts Ave. NW., suite 1200, Washington, DC, of trimellitic anhydride and p,p′- or at the Office of the Federal Register, diphenylmethane diisocyanate.

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(2) The polyamide-imide resins (CAS 500 parts per million. Residual mono- Reg. No. 31957–38–7) derived from the mers are determined by gas chroma- condensation reaction of equimolar tography (the gas chromatography parts of benzoyl chloride-3,4- method titled ‘‘Amide-Imide Polymer dicarboxylic anhydride and 4,4′- Analysis—Analysis of Monomer Con- diphenylmethanediamine. tent,’’ is incorporated by reference in (b) Specifications. (1) Polyamide-imide accordance with 5 U.S.C. 552(a). Copies resins identified in paragraph (a)(1) of are available from the Center for Food this section shall have a nitrogen con- Safety and Applied Nutrition (HFS– tent of not less than 7.8 weight percent 200), Food and Drug Administration, and not more than 8.2 weight percent. 5100 Paint Branch Pkwy., College Park, Polyamide-imide resins identified in MD 20740, or available for inspection at paragraph (a)(2) of this section shall the Office of the Federal Register, 800 have a nitrogen content of not less North Capitol Street, NW., suite 700, than 7.5 weight percent and not more Washington, DC). than 7.8 weight percent. Nitrogen content is determined by the Dumas Nitro- (c) Extractive limitations are appli- gen Determination as set forth in the cable to the polyamide-imide resins ‘‘Official Methods of Analysis of the identified in paragraphs (a) (1) and (2) Association of Official Analytical of this section in the form of films of 1 Chemists,’’ 13th Ed. (1980), sections mil uniform thickness after coating ° 7.016–7.020, which is incorporated by and heat curing at 600 F for 15 minutes reference in accordance with 5 U.S.C. on stainless steel plates, each having 552(a). Copies may be obtained from the such resin-coated surface area of 100 Association of Official Analytical square inches. The cured-resin film Chemists International, 481 North coatings shall be extracted in accord- Frederick Ave., suite 500, Gaithersburg, ance with the method described in MD 20877–2504, or may be examined at § 176.170(d)(3) of this chapter, using a the Office of the Federal Register, 800 plurality of spaced, coated stainless North Capitol Street, NW., suite 700, steel plates, exposed to the respective Washington, DC. food simulating solvents. The resin (2) Polyamide-imide resins identified shall meet the following extractive in paragraph (a)(1) of this section shall limitations under the corresponding have a solution viscosity of not less extraction conditions: than 1.200. Polyamide-imide resins (1) Distilled water at 250 °F for 2 identified in paragraph (a)(2) of this hours: Not to exceed 0.01 milligram per section shall have a solution viscosity square inch. of not less than 1.190. Solution vis- (2) Three percent acetic acid at 212 °F cosity shall be determined by a method for 2 hours: Not to exceed 0.05 milli- titled ‘‘Solution Viscosity’’ which is in- gram per square inch. corporated by reference in accordance (3) Fifty percent ethyl alcohol at 160 with 5 U.S.C. 552(a). Copies are avail- °F for 2 hours: Not to exceed 0.03 milli- able from the Center for Food Safety gram per square inch. and Applied Nutrition (HFS–200), Food (4) n-Heptane at 150 °F for 2 hours: and Drug Administration, 5100 Paint Not to exceed 0.05 milligram per square Branch Pkwy., College Park, MD 20740, inch. or available for inspection at the Office of the Federal Register, 800 North Cap- (d) In accordance with good manufac- itol Street, NW., suite 700, Washington, turing practice, those food contact ar- DC. ticles, having as components the poly- (3) The polyamide-imide resins iden- amide-imide resins identified in para- tified in paragraph (a)(1) of this section graph (a) of this section and intended are heat cured at 600 °F for 15 minutes for repeated use shall be thoroughly when prepared for extraction tests and cleansed prior to their first use in con- the residual monomers: p,p- tact with food. diphenylmethane diisocyanate should [42 FR 14572, Mar. 15, 1977, as amended at 47 not be present at greater than 100 parts FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, per million and trimellitic anhydride 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, should not be present at greater than Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996]

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§ 177.2460 Poly(2,6-dimethyl-1,4-phen- (i) Solvent: Chloroform, reagent grade ylene) oxide resins. containing 0.01 percent tert- The poly(2,6-dimethyl-1,4-phenylene) butylcatechol. oxide resins identified in paragraph (a) (ii) Resin sample: Powdered resin ob- of this section may be used as an arti- tained from production prior to mold- cle or as a component of an article in- ing or extrusion. tended for use in contact with food sub- (iii) Viscometer: Cannno-Ubbelohde se- ject to the provisions of this section. ries 25 dilution viscometer (or equiva- (a) Identity. For the purposes of this lent). section, poly(2,6-dimethyl-1,4-phen- (iv) Calculation: The calculation ylene) oxide resins consist of basic res- method used is that described in appen- ins produced by the oxidative coupling dix X.1.3 (ASTM method D1243–79, cited of 2,6-xylenol such that the finished and incorporated by reference in para- basic resins meet the specifications graph (c)(1) of this section) with the re- and extractives limitations prescribed duced viscosity determined for three in paragraph (c) of this section. concentration levels (0.4, 0.2, and 0.1 (b) Optional adjuvant substances. The gram per deciliter) and extrapolated to basic poly(2,6-dimethyl-1,4-phenylene) zero concentration for intrinisic vis- oxide resins identified in paragraph (a) cosity. The following formula is used of this section may contain optional for determining reduced viscosity: adjuvant substances required in the − production of such basic resins. The op- Reduced viscosity in terms = tto tional adjuvant substances required in of deciliters per gram × the production of the basic poly(2,6-di- tco methyl-1,4-phenylene) oxide resins may where: include substances permitted for such t=Solution efflux time. use by regulations in parts 170 through to=Solvent efflux time. 189 of this chapter, substances gen- c=Concentration of solution in terms of erally recognized as safe in food, sub- grams per deciliter. stances used in accordance with a prior (2) Extractives limitations. Total resin sanction or approval, and the fol- extracted not to exceed 0.02 weight-per- lowing: cent when extracted with n-heptane at 160 °F for 2 hours as determined using Limitations (expressed as List of substances percent by weight of finished 200 milliliters of reagent grade n- basic resin) heptane which has been freshly dis- Diethylamine ...... Not to exceed 0.16 percent tilled before use and 25 grams of poly as residual catalyst. (2,-6-dimethyl-1,4-phenylene) oxide Methyl alcohol ...... Not to exceed 0.02 percent resin. The resin as tested is in pellet as residual solvent. Toluene ...... Not to exceed 0.2 percent as form having a particle size such that residual solvent. 100 percent of the pellets will pass through a U.S. Standard Sieve No. 6 (c) Specifications and extractives limita- and 100 percent of the pellets will be tions. The poly(2,6-dimethyl-1,4-phen- held on a U.S. Standard Sieve No. 10. ylene) oxide basic resins meet the fol- (d) Other limitations. The poly(2,6-di- lowing: methyl-1,4-phenylene) oxide resins (1) Specifications. Intrinsic viscosity identified in and complying with this is not less than 0.30 deciliter per gram section, when used as components of as determined by ASTM method D1243– the food-contact surface of any article 79, ‘‘Standard Test Method for Dilute that is the subject of a regulation in Solution Viscosity of Vinyl Chloride parts 174, 175, 176, 177, 178 and § 179.45 of Polymers,’’ which is incorporated by this chapter, shall comply with any reference, modified as follows. Copies specifications and limitations pre- of the incorporation by reference may scribed by such regulation for the arti- be obtained from the American Society cle in the finished form in which it is for Testing Materials, 1916 Race St., to contact food. Philadelphia, PA 19103, or may be ex- (e) Uses. The poly(2,6-dimethyl-1,4- amined at the Office of the Federal phenylene) oxide resins identified in Register, 800 North Capitol Street, and complying with the limitations in NW., suite 700, Washington, DC 20408. this section may be used as articles or

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components of articles intended for re- trimer of formaldehyde) and a max- peated food-contact use or as articles imum of 5 percent by weight of or components of articles intended for butanediol formal (CAS Reg. No. 25214 single-service food-contact use only 85–1). Both copolymers may have cer- under the conditions described in tain optional substances added to im- § 176.170(c) of this chapter, table 2, con- part desired technological properties to ditions of use H. the copolymer. (b) Optional adjuvant substances. The [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, polyoxymethylene copolymer identi- 1998] fied in paragraph (a) of this section may contain optional adjuvant sub- § 177.2465 Polymethylmethacrylate/ stances required in its production. The poly(trimethoxysilylpropyl)meth- quantity of any optional adjuvant sub- acrylate copolymers. stance employed in the production of Polymethylmethacrylate/ the copolymer does not exceed the poly(trimethoxysilylpropyl) methacry- amount reasonably required to accom- late copolymers (CAS Reg. No. 26936– plish the intended technical or physical 30–1) may be safely used as components effect. Such adjuvants may include of surface primers used in conjunction substances generally recognized as safe with silicone polymers intended for re- in food, substances used in accordance peated use and complying with § 175.300 with prior sanction, substances per- of this chapter and § 177.2600, in accord- mitted under applicable regulations in ance with the following prescribed con- parts 170 through 189 of this chapter, ditions. and the following: (a) Identity. For the purpose of this (1) Stabilizers (total amount of stabi- section, polymethylmethacrylate/ lizers not to exceed 2.0 percent and poly(trimethoxysilylpropyl)methacry- amount of any one stabilizer not to ex- late copolymers are produced by the ceed 1.0 percent of polymer by weight) polymerization of methylmethacrylate Calcium ricinoleate. and Cyanoguanidine. trimethoxysilylpropylmethacrylate. Hexamethylene bis(3,5-di-tert-butyl-4- (b) Conditions of use. (1) The hydroxyhydrocinnamate) (CAS Reg. No. polymethylmethacrylate/ 35074–77–2). poly(trimethoxysilylpropyl)methacry- Melamine-formaldehyde resin. ′ late copolymers are used at levels not 2,2 -Methylenebis(4-methyl-6-tert-butylphenol). to exceed 6.0 percent by weight of the Nylon 6/66, weight ratio 2/3. primer formulation. Tetrakis [methylene (3,5-di-tert-butyl-4- (2) The copolymers may be used in hydroxyhydrocinnamate)] methane. food contact applications with all food ′ types under conditions of use B (2) Lubricant: N,N Distearoylethyl- through H as described in table 2 of enediamine. (c) (1) Polyoxymeth- § 176.170(c) of this chapter. Specifications. ylene copolymer can be identified by [59 FR 5948, Feb. 9, 1994] its characteristic infrared spectrum. (2) Minimum number average molec- § 177.2470 Polyoxymethylene copoly- ular weight of the copolymer is 15,000 mer. as determined by a method titled Polyoxymethylene copolymer identi- ‘‘Number Average Molecular Weight,’’ fied in this section may be safely used which is incorporated by reference. as an article or component of articles Copies are available from the Center intended for food-contact use in ac- for Food Safety and Applied Nutrition cordance with the following prescribed (HFS–200), Food and Drug Administra- conditions: tion, 5100 Paint Branch Pkwy., College (a) Identity. For the purpose of this Park, MD 20740, or available for inspec- section, polyoxymethylene copolymers tion at the Office of the Federal Reg- are identified as the following: The re- ister, 800 North Capitol Street, NW., action product of trioxane (cyclic suite 700, Washington, DC 20408. trimer of formaldehyde) and ethylene (d) Extractive limitations. (1) Polyoxy- oxide (CAS Reg. No. 24969–25–3) or the methylene copolymer in the finished reaction product of trioxane (cyclic form in which it is to contact food,

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when extracted with the solvent or sol- (b) Optional adjuvant substances. The vents characterizing the type of food polyoxymethylene homopolymer iden- and under conditions of time and tem- tified in paragraph (a) of this section perature as determined from tables 1 may contain optional adjuvant sub- and 2 of § 175.300(d) of this chapter, stances in its production. The quantity shall yield net chloroform-soluble ex- of any optional adjuvant substance em- tractives not to exceed 0.5 milligram ployed in the production of the per square inch of food-contact surface. homopolymer does not exceed the (2) Polyoxymethylene copolymer amount reasonably required to accom- with or without the optional sub- plish the intended effect. Such adju- stances described in paragraph (b) of vants may include substances gen- this section, when ground or cut into erally recognized as safe in food, sub- particles that pass through a U.S.A. stances used in accordance with prior Standard Sieve No. 6 and that are retained on a U.S.A. Standard Sieve No. sanction, substances permitted under 10, shall yield total extractives as fol- applicable regulations in this part, and lows: the following: (i) Not to exceed 0.20 percent by (1) Stabilizers. The homopolymer may weight of the copolymer when ex- contain one or more of the following tracted for 6 hours with distilled water stabilizers. The total amount of stabi- at reflux temperature. lizers shall not exceed 1.9 percent of (ii) Not to exceed 0.15 percent by homopolymer by weight, and the quan- weight of the copolymer when ex- tity of individual stabilizer used shall tracted for 6 hours with n-heptane at not exceed the limitations set forth reflux temperature. below: (e) Conditions of use. (1) The polyoxymethylene copolymer is for use Substances Limitations as articles or components of articles Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- intended for repeated use. butyl-4-hydroxy-hydro- cent by weight of (2) Use temperature shall not exceed cinnamate) (CAS Reg. No. homopolymer. The finished 250 °F. 35074Ð77Ð2) . articles shall not be used for foods containing more (3) In accordance with good manufac- than 8 percent alcohol. turing practice, finished articles con- 2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5 taining polyoxymethylene copolymer tert-butylphenol) . percent by weight of shall be thoroughly cleansed before homopolymer. Nylon 66/610/6 terpolymer, At a maximum level of 1.5 their first use in contact with food. respective proportions of percent by weight of [42 FR 14572, Mar. 15, 1977, as amended at 48 nylon polymers by weight homopolymer. are: 3/2/4. FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, Nylon 612/6 copolymer (CAS Do. 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Reg. No. 51733-10-9), May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR weight ratio 6/1. 24898, June 12, 1989] Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5 butyl-4-hydroxy-hydro- percent by weight of § 177.2480 Polyoxymethylene cinnamate)] methane . homopolymer. 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.

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1979), ‘‘Standard Test Method for Den- (ii) Total extractives not to exceed sity of Plastics by the Density-Gra- 0.20 percent by weight of homopolymer dient Technique,’’ which is incor- when extracted for 6 hours with dis- porated by reference. Copies may be tilled water at reflux temperature and obtained from the American Society 0.15 percent by weight of homopolymer for Testing Materials, 1916 Race St., when extracted for 6 hours with n- Philadelphia, PA 19103, or may be ex- heptane at reflux temperature. amined at the Office of the Federal (e) Conditions of use. (1) Polyoxy- Register, 800 North Capitol Street, methylene homopolymer is for use as NW., suite 700, Washington, DC 20408. articles or components of articles in- (4) Melting point is between 172 °C tended for repeated use. and 184 °C as determined by ASTM (2) Use temperature shall not exceed method D2133–66, ‘‘Specifications for 250 °F. Acetal Resin Injection Molding and Ex- (3) In accordance with good manufac- trusion Materials’’ (Revised 1966), turing practice, finished articles con- which is incorporated by reference. taining polyoxymethylene Copies are available from American So- homopolymer shall be thoroughly ciety for Testing and Materials cleansed prior to first use in contact (ASTM), 1916 Race Street, Philadel- with food. phia, PA 19103, or available for inspection at the Office of the Federal Reg- [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, ister, 800 North Capitol Street, NW., 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, suite 700, Washington, DC 20408. Mar. 19, 1984; 54 FR 24898, June 12, 1989] (d) Extractive limitations. (1) Polyoxymethylene homopolymer, in § 177.2490 Polyphenylene sulfide res- the finished form which is to contact ins. food, when extracted with the solvent Polyphenylene sulfide resins or solvents characterizing the type of (poly(1,4-phenylene sulfide) resins) may food and under conditions of time and be safely used as coatings or compo- temperature characterizing the condi- nents of coatings of articles intended tions of intended use under paragraphs for repeated use in contact with food, (c)(3) and (d) of § 175.300 of this chapter in accordance with the following pre- and as limited by paragraph (e) of this scribed conditions. section, shall yield net chloroform- (a) Polyphenylene sulfide resins con- soluble extractives not to exceed 0.5 sist of basic resins produced by the re- milligram per square inch of food-con- action of equimolar parts of p- tact surface. dichlorobenzene and sodium sulfide, (2) Polyoxymethylene homopolymer, such that the finished resins meet the with or without the optional adjuvant following specifications as determined substances described in paragraph (b) by methods titled ‘‘Oxygen Flask Com- of this section, when ground or cut into bustion-Gravimetric Method for Deter- particles that pass through a U.S.A. mination of Sulfur in Organic Com- Standard Sieve No. 6 and that are re- pounds,’’ ‘‘Determination of the Inher- tained on a U.S.A. Standard Sieve No. ent Viscosity of Polyphenylene Sul- 10, shall yield extractives as follows: fide,’’ and ‘‘Analysis for (i) Formaldehyde not to exceed 0.0050 Dichlorobenzene in Ryton percent by weight of homopolymer as Polyphenylene Sulfide,’’ which are in- determined by a method titled ‘‘Form- corporated by reference. Copies are aldehyde Release and Formaldehyde available from the Center for Food Analysis,’’ which is incorporated by Safety and Applied Nutrition (HFS– reference. Copies are available from 200), Food and Drug Administration, Center for Food Safety and Applied Nu- 5100 Paint Branch Pkwy., College Park, trition (HFS–200) Food and Drug Ad- MD 20740, or available for inspection at ministration, 5100 Paint Branch Pkwy., the Office of the Federal Register, 800 College Park, MD 20740, or available for North Capitol Street, NW., suite 700, inspection at the Office of the Federal Washington, DC 20408. Register, 800 North Capitol Street, (1) Sulfur content: 28.2–29.1 percent NW., suite 700, Washington, DC 20408. by weight of finished resin.

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(2) Minimum inherent viscosity: 0.13 § 177.2500 Polyphenylene sulfone res- deciliters per gram. ins. (3) Maximum residual p- The polyphenylene sulfone resins dichlorobenzene: 0.8 ppm. (CAS Reg. No. 31833–61–1) identified in (b) Subject to any limitations pre- paragraph (a) of this section may be scribed in parts 170 through 189 of this safely used as articles or components chapter, the following optional sub- of articles intended for repeated use in stances may be added to the contact with food, subject to the provi- polyphenylene sulfide basic resins in an sions of this section. amount not to exceed that reasonably (a) Identity. For the purpose of this required to accomplish the intended section, polyphenylene sulfone resins physical or technical effect. consist of basic resin produced by re- (1) Substances generally recognized acting polyphenylene sulfide with per- as safe in food. acetic acid such that the finished res- (2) Substances used in accordance ins meet the specifications set forth in with prior sanction or approval. paragraph (c) of this section. The (3) Substances the use of which is polyphenylene sulfide used to manufac- permitted in coatings under regula- ture polyphenylene sulfone is prepared tions in parts 170 through 189 of this by the reaction of sodium sulfide and p- chapter. (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 [65 FR 15058, Mar. 21, 2000] in contact with food at temperatures up to and including normal baking and § 177.2510 Polyvinylidene fluoride res- frying temperatures; provided that the ins. finished cured coating, when extracted Polyvinylidene fluoride resins may at reflux temperatures for 2 hours sepa- be safely used as articles or compo- rately with distilled water, 50 percent nents of articles intended for repeated ethanol in water, 3 percent acetic acid use in contact with food, in accordance and heptane, yields total extractives in with the following prescribed condi- each extracting solvent not to exceed tions: 0.2 milligram per square inch of surface (a) For the purpose of this section, and when extracted at reflux tempera- the polyvinylidene fluoride resins con- ture for 1 hour with diphenyl ether sist of basic resins produced by the po- yields total extractives not to exceed lymerization of vinylidene fluoride. 4.5 milligrams per square inch of sur- (b) The finished food-contact article, face. when extracted at reflux temperatures [42 FR 14572, Mar. 15, 1977, as amended at 47 for 2 hours with the solvents distilled FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, water, 50 percent (by volume) ethyl al- 1989] cohol in distilled water, and n-heptane,

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yields total extractives in each ex- square inch) as a thin film composite tracting solvent not to exceed 0.01 mil- on a suitable support. The maximum ligram per square inch of food-contact weight of the 2,4-toluenediisocyanate surface tested; and if the finished food- component of the thin film composite contact article is itself the subject of a is 0.47 milligrams per square decimeter regulation in parts 174, 175, 176, 177, 178 (0.03 milligrams per square inch). and § 179.45 of this chapter, it shall also (3) For the purpose of this section, comply with any specifications and the reverse osmosis membrane consists limitations prescribed for it by that of a polyaramide identified as 2,4- regulation. (NOTE: In testing the fin- diaminobenzenesulfonic acid, calcium ished food-contact article, use a sepa- salt (2:1) polymer with 1,3- rate test sample for each required ex- benzenediamine, 1,3-benzenedicarbonyl tracting solvent.) (c) In accordance with good manufac- dichloride, and 1,4-benzenedicarbonyl turing practice, finished food-contact dichloride (CAS Reg. No. 39443–76–0). articles containing the polyvinylidene The membrane is the food contact sur- fluoride resins shall be thoroughly face and may be applied as a film on a cleansed prior to their first use in con- suitable support. Its maximum weight tact with food. is 512 milligrams per square decimeter (33 milligrams per square inch). § 177.2550 Reverse osmosis mem- (4) A cross-linked high molecular branes. weight polyamide reaction product of Substances identified in paragraph poly(N-vinyl-N-methylamine) (CAS (a) of this section may be safely used as Reg. No. 31245–56–4), N,N′-bis(3- reverse osmosis membranes intended aminopropyl)ethylenediamine (CAS for use in processing bulk quantities of Reg. No. 10563–26–5), 1,3- liquid food to separate permeate from benzenedicarbonyl dichloride (CAS food concentrate or in purifying water Reg. No. 99–63–8) and 1,3,5- for food manufacturing under the fol- benzenetricarbonyl trichloride (CAS lowing prescribed conditions: Reg. No. 4422–95–1). The membrane is (a) Identity. For the purpose of this the food-contact surface. Its maximum section, reverse osmosis membranes weight is 20 milligrams per square deci- may consist of either of the following meter (1.3 milligrams per square inch) formulations: as a thin film composite on a suitable (1) A cross-linked high molecular support. weight polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride (5) A polyamide reaction product of with 1,3-benzenediamine (CAS Reg. No. 1,3,5-benzenetricarbonyl trichloride 83044–99–9) or piperazine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with 110–85–0). The membrane is on the food- piperazine (CAS Reg. No. 110–85–0) and contact surface, and its maximum 1,2-diaminoethane (CAS Reg. No. 107– weight is 62 milligrams per square deci- 15–3). The membrane is the food-con- meter (4 milligrams per square inch) as tact layer and may be applied as a film a thin film composite on a suitable on a suitable support. Its maximum support. weight is 15 milligrams per square deci- (2) A cross-linked polyetheramine meter (1 milligram per square inch). (CAS Reg. No. 101747–84–6), identified as (b) Optional adjuvant substances. The the copolymer of epichlorohydrin, 1,2- basic polymer identified in paragraph ethanediamine and 1,2-dichloroethane, (a) of this section may contain optional whose surface is the reaction product adjuvant substances required in the of this copolymer with 2,4- production of such basic polymer. toluenediisocyanate (CAS Reg. No. of These optional adjuvant substances the final polymer is 99811–80–0) for use may include substances permitted for as the food-contact surface of reverse such use by regulations in parts 170 osmosis membranes used in processing through 186 of this chapter, substances liquid food. The composite membrane generally recognized as safe in food, is on the food-contact surface and its maximum weight is 4.7 milligrams per and substances used in accordance with square decimeter (0.3 milligrams per a prior sanction or approval.

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(c) Supports. Suitable supports for re- (1) Substances generally recognized verse osmosis membranes are mate- as safe for use in food or food pack- rials permitted for such use by regula- aging. tions in parts 170 through 186 of this (2) Substances used in accordance chapter, substances generally recog- with the provisions of a prior sanction nized as safe in food, and substances or approval. used in accordance with a prior sanc- (3) Substances that by regulation in tion or approval. parts 170 through 189 of this chapter (d) Conditions of use. (1) Reverse os- may be safely used in rubber articles, mosis membranes described in para- subject to the provisions of such regu- graphs (a)(1), (a)(2), (a)(3), and (a)(5) of lation. this section may be used in contact (4) Substances identified in this para- with all types of liquid food at tem- graph (c)(4), provided that any sub- peratures up to 80 °C (176 °F). stance that is the subject of a regula- (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) in paragraph (c) of this section. Not more than 10 percent trans olefinic 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 be intended to accomplish any effect in 7MI; or (2) 0.4 percent to 20 percent olefinic food. unsaturation and Mooney viscosities greater 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

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incorporated by reference in accordance Silicone (Si) elastomers containing methyl with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- groups. ies of these methods may be obtained from Silicone (Psi) elastomers containing meth- the Division of Petition Control (HFS–215), yl and phenyl groups. Center for Food Safety and Applied Nutri- Silicone (Vsi) elastomers containing meth- tion, Food and Drug Administration, 5100 yl and vinyl groups. Paint Branch Pkwy., College Park, MD Silicone (Fsi) elastomers containing meth- 20740, or may be examined at the Center for yl and fluorine groups. Food Safety and Applied Nutrition’s Li- Silicone (PVsi) elastomers containing brary, 200 C St. SW., Washington, DC, or at phenyl, methyl, and vinyl groups. the Office of the Federal Register, 800 Styrene-butadiene copolymer. North Capitol St. NW., suite 700, Wash- Vinylidene fluoride-hexafluoropropylene co- ington, DC. A copy of ASTM Standard polymers (minimum number average mo- Method D1646–92 may also be obtained from lecular weight 70,000 as determined by os- the American Society for Testing and Ma- motic pressure in methyl ethyl ketone). terials, 100 Barr Harbor Dr., West Vinylidene fluoride-hexafluoropropylene- Conshohocken, PA 19428–2959. tetrafluoroethylene copolymers (minimum Isobutylene-isoprene copolymer. number average molecular weight 100,000 Polyamide/polyether block copolymers (CAS as determined by osmotic pressure in Reg. No. 77402–38–1 prepared by reacting a methyl ethyl ketone). copolymer of omega-laurolactam and adipic acid with poly(tetramethylene ether gly- (ii) Vulcanization materials—(a) Vul- col). The polyamide and polyether compo- canizing agents. nents are reacted in ratios such that the 4,4′-Bis(aminocyclohexyl)methane carbamate polyamide component constitutes a min- for use only as cross-linking agent in the imum of 30 weight-percent of total polymer vulcanization of vinylidene units. The copolymers may be used in con- fluoridehexafluoropropylene copolymer tact with foods of Types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of and vinylidene fluoride- § 176.170(c) of this chapter at temperatures hexafluoropropylene-tetrafluoroethylene not to exceed 150 °F except that those co- copolymer elastomers identified under polymers prepared with less than 50 paragraph (c)(4)(i) of this section and lim- weight-percent of polyamide are limited to ited to use at levels not to exceed 2.4 per- use in contact with such foods at tempera- cent by weight of such copolymers. tures not to exceed 100 °F. Diisopropyl xanthogen polysulfide (a 1:2:1 Polybutadiene. mixture of O,O-di(1-methylethyl)trithio- Polyester elastomers derived from the reac- bis-thioformate, O,O-di(1- tion of dimethyl terephthalate, 1,4- methylethyl)tetrathio-bis-thioformate, butanediol, and a-hydro-omega- and O,O-di(1-methylethyl)pentathio-bis- hydroxypoly (oxytetramethylene). Addi- thioformate) for use as a cross linking tionally, trimethyl trimellitate may be agent in the vulcanization of natural rub- used as a reactant. The polyester ber, styrene-butadiene copolymer, acrylo- elastomers may be used only in contact nitrile-butadiene copolymer, and ethylene- with foods containing not more than 8 per- propylene terpolymers identified under cent alcohol and limited to use in contact paragraph (c)(4)(i) of this section and lim- with food at temperatures not exceeding ited to use at levels not to exceed 2.4 per- 150 °F. cent by weight of such copolymers. Polyisoprene. Hexamethylenediamine carbamate for use Polyurethane resins (CAS Reg. Nos. 37383–28– only as cross-linking agent in the vul- 1 or 9018–04–6) derived from the reaction of canization of vinylidene fluoride- diphenylmethane diisocyanate with 1,4- hexafluoropropylene copolymer and vinyli- butanediol and polytetramethylene ether dene fluoride-hexafluoropropylene-tetra- glycol. fluoroethylene copolymer elastomers iden- Polyurethane resins derived from reactions tified under paragraph (c)(4)(i) of this sec- of diphenylmethane diisocyanate with tion and limited to use at levels not to ex- adipic acid and 1,4-butanediol. ceed 1.5 percent by weight of such copoly- Rubber, natural. mers. Silicone basic polymer as described in ASTM Sulfur, ground. method D1418–81, ‘‘Standard Practice for (b) Accelerators (total not to exceed 1.5 Rubber and Rubber Latices—Nomen- percent by weight of rubber product). clature,’’ which is incorporated by reference. Copies may be obtained from the 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- American Society for Testing Materials, fide. 1916 Race St., Philadelphia, PA 19103, or Benzoyl peroxide. may be examined at the Office of the Fed- 1,3-Bis(2-benzothiazolylmercaptomethyl) eral Register, 800 North Capitol Street, urea. NW., suite 700, Washington, DC 20408. N-tert-Butyl-2-benzothiazole sulfenamide.

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Butyraldehyde-aniline resin (iodine number Zinc butyl xanathate. 670–705). Zinc dibenzyl dithiocarbamate. Carbon disulfide-1,1′-methylenedipiperidine Zinc dibutyldithiocarbamate. reaction product. Zinc diethyldithiocarbamate. Copper dimethyldithiocarbamate. Zinc 2-mercaptobenzothiazole. N-Cyclohexyl-2-benzothiazole sulfenamide. Ziram (zinc dimethyldithiocarbamate). Dibenzoyl-p-quinone dioxime. Dibenzylamine. (c) Retarders (total not to exceed 10 per- Diisopropyl xanthogen polysulfide (a 1:2:1 cent of weight of rubber product). 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 Reg. No. 971–15–3). (iii) Antioxidants and antiozonants Diphenylguanidine. (total not to exceed 5 percent by weight of Diphenylguanidine phthalate. rubber product). 1,3-Diphenyl-2-thiourea. 2,2′-Dithiobis[benzothiazole]. Aldol-a-naphthylamine. 4,4′-Dithiodimorpholine. Alkylated (C4 and/or C8) phenols. N,N′-Di-o-tolylguanidine. BHT (butylated hydroxytoluene). Di-o-tolylguanidine salt of 4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]- pyrocatecholborate. 2,6-di-tert-butylphenol (CAS Reg. No. 991– Ethylenediamine carbamate. 84–4) for use only as a stabilizer at levels Heptaldehyde-aniline resin (iodine number not to exceed 0.5 percent by weight of the 430–445). finished rubber product. 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.

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N,N′-Disalicylalpropylenediamine. Dibutyl sebacate. N,N′-Di-o-tolylethylenediamine. Didecyl adipate. Hydroquinone monobenzyl ether. Didecyl phthalate. Isopropoxydiphenylamine. Diisodecyl adipate. N-Isopropyl-N′-phenyl-p-phenylenediamine. Diisodecyl phthalate. 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol). Diisooctyl adipate. 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.

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(v) Fillers. Diethyl xanthogen disulfide. 4-(Diiodomethylsulfonyl) toluene, Chemical Aluminum hydroxide. Abstracts Service Registry No. 20018–09–01, Aluminum silicate. for use as an antifungal preservative at Asbestos fiber, chrysotile or crocidolite. levels not to exceed 0.3 percent by weight Barium sulfate. of the sealants and caulking materials. 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. (vii) Lubricants (total not to exceed 2 Phenothiazine. 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. Thioxylenois as peptizing agents. Rosins and rosin-derivatives identified in Tridecyl mercaptan. § 175.105(c)(5) of this chapter. Zinc 4-tert-butylthiophenate as peptizing Sodium decylbenzenesulfonate agent. Sodium dodecylbenzenesulfonate 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. (e) Rubber articles intended for re- Animal glue as described in § 178.3120 of this peated use in contact with aqueous chapter. 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. tives not to exceed 20 milligrams per 1,2-Benzisothiazolin-3-one (CAS Reg. No. 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 polymeriza- shall meet the following specifications: tion catalyst for polybutadiene. The food-contact surface of the rubber 4-tert-Butyl-o-thiocresol as peptizing agent. 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

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175 milligrams per square inch during (c) In accordance with good manufac- the first 7 hours of extraction, nor to turing practice, finished articles con- exceed 4 milligrams per square inch taining the resins shall be thoroughly during the succeeding 2 hours of ex- cleansed prior to their first use in con- traction. tact with food. (g) In accordance with good manufacturing practice finished rubber articles § 177.2800 Textiles and textile fibers. intended for repeated use in contact Textiles and textile fibers may safely with food shall be thoroughly cleansed be used as articles or components of ar- prior to their first use in contact with ticles intended for use in producing, food. manufacturing, packing, processing, (h) The provisions of this section are preparing, treating, packaging, trans- not applicable to rubber nursing-bottle porting, or holding food, subject to the nipples. provisions of this section. (i) Acrylonitrile copolymers identi- (a) The textiles and textile fibers are fied in this section shall comply with prepared from one or more of the fibers the provisions of § 180.22 of this chap- identified in paragraph (d) of this sec- ter. tion and from certain other adjuvant substances required in the production [42 FR 14572, Mar. 15, 1977] of the textiles or textile fibers or added EDITORIAL NOTE: For FEDERAL REGISTER ci- to impart desired properties. tations affecting § 177.2600, see the List of (b) The quantity of any adjuvant sub- CFR Sections Affected, which appears in the stance employed in the production of Finding Aids section of the printed volume textiles or textile fibers does not ex- and on GPO Access. ceed the amount reasonably required to accomplish the intended physical or § 177.2710 Styrene-divinylbenzene resins, cross-linked. technical effect or any limitation further provided. Styrene-divinylbenzene cross-linked (c) Any substance employed in the copolymer resins may be safely used as production of textiles or textile fibers articles or components of articles in- that is the subject of a regulation in tended for repeated use in producing, parts 174, 175, 176, 177, 178 and § 179.45 of manufacturing, packing, processing, this chapter conforms with any speci- preparing, treating, packaging, trans- fication in such regulation. porting, or holding food, in accordance (d) Substances employed in the pro- with the following prescribed condi- duction of or added to textiles and tex- tions: tile fibers may include: (a) The resins are produced by the co- (1) Substances generally recognized polymerization of styrene with as safe in food. divinylbenzene. (2) Substances subject to prior sanc- (b) The resins meet the extractives tion or approval for use in textiles and limitations prescribed in this para- textile fibers and used in accordance graph: with such sanction or approval. (1) The resins to be tested are ground (3) Substances generally recognized or cut into small particles that will as safe for use in cotton and cotton fab- pass through a U.S. standard sieve No. rics used in dry-food packaging. 3 and that will be held on a U.S. stand- (4) Substances that by regulation in ard sieve No. 20. this part may safely be used in the pro- (2) A 100-gram sample of the resins, duction of or as a component of tex- when extracted with 100 milliliters of tiles or textile fibers and subject to ethyl acetate at reflux temperature for provisions of such regulation. 1 hour, yields total extractives not to (5) Substances identified in this para- exceed 1 percent by weight of the res- graph (d)(5), subject to such limitations ins. as are provided:

List of substances Limitations

(i) Fibers: Cotton .

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List of substances Limitations

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 . 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 preceding 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 400Ð3,000) . 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 .

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List of substances Limitations

Ultramarine blue . Waxes, petroleum . Zinc hydrosulfite .

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

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Subpart D—Certain Adjuvants and EDITORIAL NOTE: Nomenclature changes to Production Aids part 178 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. 178.3010 Adjuvant substances used in the 27, 2001. manufacture of foamed plastics. 178.3120 Animal glue. 178.3125 Anticorrosive agents. Subpart A [Reserved] 178.3130 Antistatic and/or antifogging agents in food-packaging materials. Subpart B—Substances Utilized To 178.3280 Castor oil, hydrogenated. 178.3290 Chromic chloride complexes. Control the Growth of Micro- 178.3295 Clarifying agents for polymers. organisms 178.3297 Colorants for polymers. 178.3300 Corrosion inhibitors used for steel § 178.1005 Hydrogen peroxide solution. or tinplate. 178.3400 Emulsifiers and/or surface-active Hydrogen peroxide solution identi- agents. fied in this section may be safely used 178.3450 Esters of stearic and palmitic acids. to sterilize polymeric food-contact sur- 178.3480 Fatty alcohols, synthetic. faces identified in paragraph (e)(1) of 178.3500 Glycerin, synthetic. this section. 178.3505 Glyceryl tri-(12-acetoxystearate). (a) Identity. For the purpose of this 178.3520 Industrial starch-modified. section, hydrogen peroxide solution is 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic. an aqueous solution containing not 178.3570 Lubricants with incidental food more than 35 percent hydrogen per- contact. oxide (CAS Reg. No. 7722–84–1) by 178.3600 Methyl glucoside-coconut oil ester. weight, meeting the specifications pre- 178.3610 a-Methylstyrene-vinyltoluene res- scribed in paragraph (c) of this section. ins, hydrogenated. (b) Optional adjuvant substances. Hy- 178.3620 Mineral oil. drogen peroxide solution identified in 178.3650 Odorless light petroleum hydrocarbons. paragraph (a) of this section may con- 178.3690 Pentaerythritol adipate–stearate. tain substances generally recognized as 178.3700 Petrolatum. safe in or on food, substances generally 178.3710 Petroleum wax. recognized for their intended use in 178.3720 Petroleum wax, synthetic. food packaging, substances used in ac- 178.3725 Pigment dispersants. cordance with a prior sanction or ap- 178.3730 Piperonyl butoxide and pyrethrins proval, and substances permitted by as components of bags. 178.3740 Plasticizers in polymeric sub- applicable regulations in parts 174 stances. through 179 of this chapter. 178.3750 Polyethylene glycol (mean molec- (c) Specifications. Hydrogen peroxide ular weight 200–9,500). solution shall meet the specifications 178.3760 Polyethylene glycol (400) of the ‘‘Food Chemicals Codex,’’ 3d Ed. monolaurate. (1981), pp. 146–147, which is incorporated 178.3770 Polyhydric alcohol esters of by reference (copies may be obtained oxidatively refined (Gersthofen process) montan wax acids. from the National Academy Press, 2101 178.3780 Polyhydric alcohol esters of long Constitution Ave. NW., Washington, chain monobasic acids. DC 20418, or may be examined at the 178.3790 Polymer modifiers in semirigid and Office of the Federal Register, 800 rigid vinyl chloride plastics. North Capitol Street, NW., suite 700, 178.3800 Preservatives for wood. Washington, DC 20408), and the United 178.3850 Reinforced wax. States Pharmacopeia XX (1980), except 178.3860 Release agents. 178.3870 Rosins and rosin derivatives. that hydrogen peroxide may exceed the 178.3900 Sodium pentachlorophenate. concentration specified therein. 178.3910 Surface lubricants used in the man- (d) Limitations. No use of hydrogen ufacture of metallic articles. peroxide solution in the sterilization of 178.3930 Terpene resins. food packaging material shall be con- 178.3940 Tetraethylene glycol di-(2-ethyl- sidered to be in compliance if more hexoate). than 0.5 part per million of hydrogen 178.3950 Tetrahydrofuran. peroxide can be determined in distilled AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. water packaged under production con- SOURCE: 42 FR 14609, Mar. 15, 1977, unless ditions (assay to be performed imme- otherwise noted. diately after packaging).

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

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polyoxypropylene block polymers (hav- 2,000 and 27 to 31 moles of ing a minimum average molecular polyoxypropylene). In addition to use weight of 2,800). In addition to use on on food-processing equipment and food-processing equipment and uten- utensils, this solution may be used on sils, this solution may be used on glass glass bottles and other glass containers bottles and other glass containers in- intended for holding milk. All equip- tended for holding milk. ment, utensils, glass bottles, and other (8) An aqueous solution containing glass containers treated with this sani- elemental iodine, butoxy monoether of tizing solution shall have a drainage mixed (ethylene-propylene) period of 15 minutes prior to use in polyalkylene glycol having a minimum contact with food. average molecular weight of 2,400 and (13) An aqueous solution containing a-lauroyl-omega-hydroxypoly (oxy- elemental iodine and alkyl (C12-C15) ethylene) with an average 8–9 moles of monoether of mixed (ethylene-pro- ethylene oxide and an average molec- pylene) polyalkylene glycol, having a ular weight of 400. In addition to use on cloud-point of 70°–77 °C in 1 percent food-processing equipment and uten- aqueous solution and an average mo- sils, this solution may be used on bev- lecular weight of 807. erage containers, including milk con- (14) An aqueous solution containing tainers or equipment. Rinse water iodine, butoxy monoether of mixed treated with this solution can be recir- (ethylene-propylene) polyalkylene gly- culated as a preliminary rinse. It is not col, having a cloud-point of 90°–100 °C to be used as final rinse. in 0.5 percent aqueous solution and an (9) An aqueous solution containing n- average molecular weight of 3,300, and alkyl (C12-C18) benzyldimethylam- polyoxyethylene-polyoxypropylene monium chloride compounds having block polymers (having a minimum av- average molecular weights of 351 to 380. erage molecular weight of 2,000). The alkyl groups consist principally of (15) An aqueous solution containing groups with 12 to 16 carbon atoms and lithium hypochlorite. contain not more than 1 percent each (16) An aqueous solution containing of groups with 8 and 10 carbon atoms. equal amounts of n-alkyl (C12-C18) ben- Additionally, the aqueous solution may zyl dimethyl ammonium chloride and contain either ethyl alcohol or iso- n-alkyl (C12-C14) dimethyl ethylbenzyl propyl alcohol as an optional ingre- ammonium chloride (having average dient. molecular weights of 377 to 384), with (10) An aqueous solution containing the optional adjuvant substances trichloromelamine and either sodium tetrasodium ethylenediaminetetra- lauryl sulfate or dodecyl- acetate and/or alpha-(p-nonylphenol)- benzenesulfonic acid. In addition to use omega-hydroxy poly (oxyethylene) hav- on food-processing equipment and ing an average poly- (oxyethylene) con- utensils and other food-contact arti- tent of 11 moles. Alpha-hydro-omega- cles, this solution may be used on bev- hydroxypoly-(oxyethylene) erage containers except milk con- poly(oxypropoylene) (15 to 18 mole tainers or equipment. minimum) poly (oxyethylene) block co- (11) An aqueous solution containing polymer, having a minimum molecular equal amounts of n-alkyl (C12-C18) ben- weight of 1,900 (CAS Registry No. 9003– zyl dimethyl ammonium chloride and 11–6) may be used in lieu of alpha- (p- n-alkyl (C12-C18) dimethyl ethylbenzyl nonylphenol)-omega-hydroxy- ammonium chloride (having an average poly(oxyethylene) having an average molecular weight of 384). In addition to poly(oxyethylene) content of 11 moles. use on food-processing equipment and In addition to use on food-processing utensils, this solution may be used on equipment and utensils, this solution food-contact surfaces in public eating may be used on food-contact surfaces places. in public eating places. (12) An aqueous solution containing (17) An aqueous solution containing the sodium salt of sulfonated oleic di-n-alkyl(C8-C10)dimethyl ammonium acid, polyoxyethylene- chlorides having average molecular polyoxypropylene block polymers (hav- weights of 332–361 and either ethyl al- ing an average molecular weight of cohol or isopropyl alcohol. In addition

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to use on food-processing equipment oxide, and alpha-alkyl(C12-C15)-omega- and utensils, this solution may be used hydroxy[poly(oxyethylene) on food-contact surfaces in public eat- poly(oxypropylene)] (having an average ing places. molecular weight of 965). (18) An aqueous solution containing (25) An aqueous solution containing n-alkyl(C12-C18) benzyldimethylammo- elemental iodine (CAS Reg. No. 7553–56– nium chloride, sodium metaborate, 2), potassium iodide (CAS Reg. No. alpha-terpineol and alpha[p-(1,1,3,3- 7681–11–0), and isopropanol (CAS Reg. tetramethylbutyl)phenyl] -omega-hy- No. 67–63–0). In addition to use on food droxy-poly (oxyethylene) produced processing equipment and utensils, this with one mole of the phenol and 4 to 14 solution may be used on beverage con- moles ethylene oxide. tainers, including milk containers and (19) An aqueous solution containing equipment and on food-contact sur- sodium dichloroisocyanurate and faces in public eating places. tetrasodium ethylenediaminetetra- (26) [Reserved] acetate. In addition to use on food- (27) An aqueous solution containing processing equipment and utensils, this decanoic acid (CAS Reg. No. 334–48–5), solution may be used on food-contact octanoic acid (CAS Reg. No. 124–07–2), surfaces in public eating places. and sodium 1-octanesulfonate (CAS (20) An aqueous solution containing Reg. No. 5324–84–5). Additionally, the ortho-phenylphenol, ortho-benzyl-para- aqueous solution may contain iso- chlorophenol, para- propyl alcohol (CAS Reg. No. 67–63–0) tertiaryamylphenol, sodium -alpha- as an optional ingredient. alkyl(C12-C15)-omega-hydroxypoly (oxyethylene) 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. No. 26896–20–8). In addition to use on (22) An aqueous solution containing food-processing equipment and uten- (1) di-n-alkyl(C8-C10) sils, this solution may be used on glass dimethylammonium chloride com- bottles and other glass containers in- pounds having average molecular tended for holding milk. weights of 332–361, (2) n-alkyl (C12-C18) (30) An aqueous solution containing benzyldimethylammonium chloride hydrogen peroxide (CAS Reg. No. 7722– compounds having average molecular 84–1), peracetic acid (CAS Reg. No. 79– weights of 351–380 and consisting prin- 21–0), acetic acid (CAS Reg. No. 64–19– cipally of alkyl groups with 12 to 16 7), and 1-hydroxyethylidene-1,1- carbon atoms with or without not over diphosphonic acid (CAS Reg. No. 2809– 1 percent each of groups with 8 and 10 21–4). carbon atoms, and (3) ethyl alcohol. (31) An aqueous solution containing The ratio of compound (1) to compound elemental iodine, alpha-alkyl(C10-C14)- (2) is 60 to 40. omega-hydroxypoly(oxyethylene)poly- (23) An aqueous solution containing (oxypropylene) of average molecular n-alkyl (C12-C16) benzyl- weight between 768 and 837, and alpha- dimethylammonium chloride and alkyl(C12-C18)-omega- didecyldimethylammonium chloride. hydroxypoly(oxyethylene) (24) An aqueous solution containing poly(oxypropylene) of average molec- elemental iodine (CAS Reg. No. 7553–56– ular weight between 950 and 1,120. In 2), alpha-[p-(1,1,3,3-tetramethylbutyl)- addition to use on food-processing phenyl]-omega-hydroxypoly-(oxy- equipment and utensils, this solution ethylene) produced with one mole of may be used on food-contact surfaces the phenol and 4 to 14 moles ethylene 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 1934210); the condensate of four moles solution contains either alpha-(p- 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 Office of the Federal Register, 800 lion and not more than 200 parts per North Capitol Street, NW., suite 700, million peracetic acid, not less than 150 Washington, DC 20408. parts per million and not more than 300 (30) Solutions identified in paragraph parts per million acetic acid, and not (b)(35) of this section shall provide, less than 15 parts per million and not when ready for use, at least 117 parts more than 30 parts per million 1- per million and not more than 234 parts hydroxyethylidene-1,1-diphosphonic per million of total fatty acids and at acid. least 166 parts per million and not (26) The solution identified in para- more than 332 parts per million of a graph (b)(31) of this section shall pro- mixture of naphthalenesulfonates. The vide, when ready to use, at least 12.5 adjuvants phosphoric acid and lactic parts per million and not more than 25 acid, used with decanoic acid, octanoic parts per million of titratable iodine. acid, and sodium naphthalenesulfonate The adjuvants used with the iodine will and its alkylated derivatives, will not not be in excess of the minimum be in excess of the minimum amounts amounts required to accomplish the in- required to accomplish the intended tended technical effect. technical effects. (27) Solutions identified in paragraph (31) Solutions identified in paragraph (b)(32) of this section shall provide, (b)(36) of this section shall provide, when ready to use, at least 150 parts when ready for use, at least 29 parts per per million and no more than 400 parts million and not more than 58 parts per per million of active quarternary com- million decanoic acid; at least 88 parts pounds in solutions containing no more per million and not more than 176 parts than 600 parts per million water hard- per million of octanoic acid; at least 69 ness. The adjuvants used with the parts per million and not more than 138 quarternary compounds will not exceed parts per million of lactic acid; at least

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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 than million of available halogen deter- 56 percent octanoic acid and not less mined as available chlorine; at least 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- (33) Solutions identified in paragraph C16)benzyldimethylammonium chloride (b)(38) of this section shall provide to 0.24 part ammonium chloride to 0.08 when ready for use not less than 300 part calcium stearate to 0.60 part so- parts per million and not more than 465 dium bicarbonate to 0.08 part starch or

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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 per million of octanoic acid (including by Bio-cide International, Inc., enti- peroxyoctanoic acid); at least 281 parts tled, ‘‘Iodometric Method for the De- per million and not more than 686 parts termination of Available Chlorine Di- per million of acetic acid; at least 7 oxide (50–250 ppm Available ClO2),’’ 352

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dated June 11, 1987, which is incor- Federal Insecticide, Fungicide, and porated by reference in accordance Rodenticide Act. with 5 U.S.C. 552(a) and 1 CFR part 51. [42 FR 14609, Mar. 16, 1977] Copies of this method are available from the Division of Petition Control, EDITORIAL NOTE: For FEDERAL REGISTER citations 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 on GPO Access. College Park, MD 20740, and may be examined at the Center for Food Safety Subpart C—Antioxidants and and Applied Nutrition’s Library, Food Stabilizers and Drug Administration, 200 C St. SW., Washington, DC, or at the Office § 178.2010 Antioxidants and/or stabi- of the Federal Register, 800 North Cap- lizers for polymers. itol St. NW., suite 700, Washington, DC; The substances listed in paragraph at least 380 parts per million and not (b) of this section may be safely used as more than 760 parts per million of so- antioxidants and/or stabilizers in poly- dium gluconate; and at least 960 parts mers used in the manufacture of arti- per million and not more than 1,920 cles or components of articles intended parts per million of sodium mono- and for use in producing, manufacturing, didodecylphenoxybenzenedisulfonate. packing, processing, preparing, treat- Other components listed under para- ing, packaging, transporting, or hold- graph (b)(46) of this section shall be ing food, subject to the provisions of used in the minimum amount nec- this section: essary to produce the intended effect. (a) The quantity used shall not exceed the amount reasonably required (d) Sanitizing agents for use in ac- to accomplish the intended technical cordance with this section will bear la- effect. beling meeting the requirements of the (b) List of substances:

Substances Limitations

N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only: trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with ¤¤ 175.105 and numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter. content is in the range 5.4Ð5.6 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. 164907Ð73Ð7). . ¤ 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. 203742Ð97Ð6). . p-tert-Amylphenolformaldehyde resins produced For use only at levels not to exceed 2.1 percent by weight of polyamide when one mole of p-tert-amylphenol is made to resins that are: react under acid conditions with one mole of 1. Derived from dimerized vegetable oil acids (containing not more than 20 formaldehyde . percent of monomer acids) and ethylenediamine. 2. Used in compliance with regulations in parts 174, 175, 176, 177, 178 and ¤ 179.45 of this chapter. 1,4-Benzenedicarboxylic acid, bis[2-(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin poly- dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hy- mers complying with ¤ 177.1520 of this chapter. droxy-5-methylphenyl]methyl]-4-methylphenyl]ester (CAS Reg. No. 57569Ð40Ð1) . 2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only: phenylethyl)phenol (CAS Reg. No. 70321Ð86Ð7) . 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.

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Substances Limitations

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. 3147Ð resins complying with ¤ 177.1580 of this chapter: Provided, That the fin- 75Ð9) . 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. 2725Ð22Ð6). . 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, IVÐB, VI, VIIÐB, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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. 37625Ð75Ð5); 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. 52829Ð07Ð9) . 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. 145650Ð60Ð8) . 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. 32687Ð78Ð8) . 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. 154862Ð43Ð8), 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. 122Ð20Ð3) . 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. 181314Ð48Ð7) . 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐA, V, VIÐC, VIIÐA, 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. 90498Ð90Ð1) . 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, IVÐB, VIÐA, VIÐB, VIÐC, VIIÐB, 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. 991Ð84Ð4) . 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. 10081Ð67Ð1) . 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. 10043Ð35Ð3) ...... 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. 1,3ÐButanediol . 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, IVÐB, VIÐA, VIÐB, VIIÐB, and VIII under condi- cent . tions 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, IVÐA, V, VIÐC, VIIÐA, and IX under conditions of use C through G as described in tables 1 and 2 of ¤ 176. 170(c) of this chapter. 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 13Ð25 percent by weight of butylated tions described in ¤ 176.170(c) of this chapter, table 2, under conditions m- and p-cresols, 26Ð38 percent by weight of of use C through G. styrenated m- and p-cresols, 37Ð49 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 1.5550Ð1.5650, as determined by ASTM method D1218Ð82, ‘‘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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

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Substances Limitations

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 3.8Ð4.0 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 137Ð 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, VIÐB, 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- 32509Ð66Ð3) . 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, IVÐA, V, VIIÐA, 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. 65140Ð91Ð 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. 867Ð13Ð0) . polymers complying with ¤ 177.1630 of this chapter. Cerium stereate (CAS Reg. No. 10119Ð53Ð6) ...... For use only at levels not to exceed 0.5 percent by weight in rigid and semirigid vinyl chloride homoÐ 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. 3806Ð34Ð6); 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. 3806Ð34Ð6) (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. 122Ð20Ð3)); 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°Ð62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram E324Ð79, ‘‘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 176Ð183 as determined by ASTM method D1962Ð67 (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, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408. DidodecylÐ 1,4ÐdihydroÐ2,6ÐdimethylÐ3,5Ð For use only at levels not to exceed 0.3 percenmt by weight in rigid poly- pyridinedicarboxylate (CAS Reg. No. 36265Ð41Ð 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. 1817Ð68Ð1] . 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. 134701Ð20Ð5) . 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. 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. 65447Ð77Ð0) . 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.

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Substances Limitations

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 54849Ð38Ð6) 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, 57583Ð34Ð3) 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. 26636Ð01Ð1) or dimethyltin bis(2Ð chapter at temperatures not to exceed 88 °C (190 °F). ethylhexylmercaptoacetate) (CAS Reg. No. 57583Ð35Ð4), 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°Ð52 °C as determined by ASTM method tives limitations prescribed in ¤ 176.170(c) of this chapter. E324Ð79, ‘‘Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,’’ and a saponification equivalent in the range 280Ð290 as determined by ASTM method D1962Ð67 (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 Office of the Federal Reg- ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 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. 10039Ð33Ð5] 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. 147315Ð50Ð2) . 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. 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.

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Substances Limitations

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. 178358Ð 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 58Ð2) 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. 119345Ð 1. At levels not to exceed 0.1 percent by weight of olefin polymers com- 01Ð6) 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 rubberÐmodified 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. 2,4-Di-tert-butylphenyl-3,5-di-tert-butyl-4-hydroxy- For use only: benzoate (CAS Reg. No. 4221Ð80Ð1) . 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐB, VIÐA, VIÐ B, VIIÐB, 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.

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Substances Limitations

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. 123968Ð25Ð2) . 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″′Ð1,2ÐEthanediylbis[NÐ[3Ð[[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, IVÐA, V, VIÐC, VIIÐA, and IX as described in table 1 of amine] (CAS Reg. No. 106990Ð43Ð6) . ¤ 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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 36443Ð68Ð2) . 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. 35958Ð30Ð6) . 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. 118337Ð09Ð0) . 2. In all polymers used in contact with food of types I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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, IVÐA, V, VIIÐA, 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, IVÐ A, V, VIIÐA, 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐA, V, VIIÐA, 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. 67845Ð93Ð6) . 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 23128Ð74Ð7) . 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 VIÐA and VIÐC. 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 VIÐA and VIÐC. 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. 1,6ÐHexanediamine, 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. 193098Ð40Ð7) . 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. 192268Ð64Ð7) . of the types identified in ¤ 176.170(c) of this chapter, table 1, under categories I, II, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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, IVÐB, VIÐA, VIÐB, VIIÐB, 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, IVÐA, V, VIÐC, VIIÐA, 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- 330:59Ð05Ð1. 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° Ð132 °C (258.8° Ð269.6 °F) (CAS Reg. No. chapter. 2440Ð22Ð4) . 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, VIÐA, VIÐ 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 5.2Ð5.6 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. 110553Ð27Ð0) . 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, IVÐB, VI, VIIÐB, 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. 126050Ð propylene complying with ¤ 177.1520 of this chapter. The finished poly- 54Ð2) . 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, IVÐB, VIÐB, VIIÐB, 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, IVÐA, V, VIÐA, VIÐC, VIIÐA, 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. 61167Ð58Ð6) . 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, VIÐB, 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. 68442Ð12Ð6); 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. 151436Ð98Ð5); or 3. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products with dichlorodimethylstannane, sodium sulfide, and trichloromethylstannane (CAS Reg. No. 201687Ð57Ð2);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. 59118Ð78Ð4), 1.1b 2-Mercaptoethyl tallate (CAS Reg. No. 68440Ð24Ð4), 1.1c 2-Mercaptoethyl octanoate (CAS Reg. No. 57813Ð59Ð9), 1.1d 2-Mercaptoethyl decanoate (CAS Reg. No. 68928Ð33Ð6), alone or in combination; not to exceed 40 percent by weight of the stabilizer formulation; 2.1 2-Mercaptoethanol (CAS Reg. No. 60Ð24Ð 2): Not to exceed 2 percent by weight of the stabilizer formulation. 3.1 Mineral oil (CAS Reg. No. 8012Ð95Ð1): Not to exceed 40 percent by weight of the stabilizer formulation. 4.1 Butylated hydroxytoluene (CAS Reg. No. 128Ð37Ð0): 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. 51733Ð For use only at levels not to exceed 1.5 percent by weight of 10Ð9), 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. 2082Ð 1. At levels not exceeding 0.25 percent by weight of olefin polymers com- 79Ð3) . 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, IVÐB, 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, IVÐB, VI, VIIÐ 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, IVÐB, VI, VIIÐB, 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. 202483Ð55Ð4) . 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, IVÐA, V, VIIÐ 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, IVÐA, V, VIIÐA, 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, IVÐB, 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, IVÐB, VIIÐB 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, IVÐA, V, VI, VIIÐA, 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, IVÐB, VIIÐB 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, IVÐA, V, VI, VIIÐA 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- 70331Ð94Ð1) . 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, IVÐB, VI, VIIÐB 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, IVÐA, V, VIIÐA, 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, VIIÐA, 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. 68411Ð adhesives complying with ¤ 175.125 of this chapter. 46Ð1) . Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate (CAS Reg. No. 64502Ð13Ð2) . polymers complying with ¤ 177.1630 of this chapter, such that the polymers contact foods only of Type VIÐB 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- 161717Ð32Ð4), 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. 122Ð20Ð3) . gram per cubic centimeter), and items 3.1 or 3.2, provided that the finished polymer contacts foods of types I, II, and VIÐB 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, VIÐA, VIÐC, 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, VIÐA, VIÐC, 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, VIÐA, VIÐC, 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, 26741Ð53Ð7) 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. 122Ð20Ð3) . ¤ 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. 80693Ð00Ð1) . 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/ 26741Ð53Ð7) . 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 VIIÐA 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 1,800Ð2,200, 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 ride resin where such resin constitutes not less than 98.7 percent of a averages 1.5Ð2) and produced so as to meet finished semirigid or rigid polyvinyl chloride food-contact surface, pro- the following specifications: Softening point, vided that the finished food-contact article is employed only to package 130Ð145 °C; volatile components at 150 °C, meat, cheese, and food Types I, VIII, and IX as described in table 1 of less than 1.0 percent; sulphur (sulfide) content ¤ 176.170(c) of this chapter. The finished food-contact article containing in the range 20.5Ð22.0 percent; tin content in this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48 the range 52.0Ð53.2 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. 82451Ð48Ð7) . 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 70624Ð18Ð9) . 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, IVÐA, V, VIIÐA, 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. 136504Ð96Ð6) . 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, IVÐA, V, VIIÐA, 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. 69851Ð61Ð2) . 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. 182635Ð chapter, items 1.1a, 1.1b, 1.2, and 1.3, under conditions of use D, E, F, 99Ð0) . and G, as described in Table 2 of ¤ 176.170 of this chapter. Stearoylbenzoylmethane (CAS Reg. No. 58446Ð For use only at levels not to exceed 0.5 percent by weight of vinyl chloride 52Ð9) consisting of a mixture of bÐdiketones 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. 68442Ð For use only in adhesives complying with ¤ 175.105 of this chapter and in 68Ð2) . 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- 20336Ð96Ð3) . 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, IVÐ B, VIÐB, VIIÐB, 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, IVÐA, V, VIÐA, VIÐC, VIIÐA, 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, IVÐB, VIÐA, VIÐB, VIIÐB, and VIII described in table 1, yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410Ð of ¤ 176.170(c) of this chapter, under conditions of use B through H de- 33Ð9) . scribed in table 2 of ¤ 176.170(c) of this chapter and food only of Types III, IVÐA, V, VIÐC, VIIÐA, 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. 6683Ð19Ð8) . 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, VIÐB, 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. 1709Ð 1. At levels not to exceed 0.5 percent by weight of polymers except nylon 70Ð2) . 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. 64253Ð30Ð1) . 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- 27676Ð62Ð6) . 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. 40601Ð76Ð1] . 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. 31570Ð04Ð4) . 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. 1843Ð03Ð4) . 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, IVÐB, VIÐB, VIIÐB, 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, IVÐA, V, VIÐA, VIÐC, VIIÐA, 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. 136Ð For use only: 23Ð2) . 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 on GPO Access.

§ 178.2550 4-Hydroxymethyl-2,6-di-tert- safety used alone or in combination, at butylphenol. levels not to exceed a total of 3 parts 4-Hydroxymethyl-2,6-di-tert-butyl- per hundred of resin, as stabilizers in phenol may be safely used as an anti- vinyl chloride homopolymers and co- oxidant in articles intended for use in polymers complying with the provi- contact with food, in accordance with sions of § 177.1950 or § 177.1980 of this the following prescribed conditions: chapter and that are identified for use (a) The additive has a solidification in contact with food of types I, II, III, point of 140°–141 °C. IV (except liquid milk), V, VI (except (b) The concentration of the additive malt beverages and carbonated non- and any other permitted antioxidants alcoholic beverages), VII, VIII, and IX in the finished food-contact article described in table 1 of § 176.170(c) of this does not exceed a total of 0.5 milligram chapter, except for the organotin per square inch of food-contact surface. chemical identified in paragraph (a)(3) of this section, which may be used in § 178.2650 Organotin stabilizers in contact with food of types I through IX vinyl chloride plastics. at temperatures not exceeding 75 °C The organotin chemicals identified in (167 °F), and further that the organotin paragraph (a) of this section may be chemicals identified in paragraphs (a)

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(5) and (6) of this section may be used weight of tin (Sn) and having 8.0 to 8.6 in contact with food of types I through percent by weight of mercapto sulfur. IX at temperatures not exceeding 66 °C It is made from a mixture of di(n- (150 °F), conditions of use D through G octyl)tin dichloride and (n-octyl)tin described in table 2 of § 176.170(c) of this trichloride which has an organotin chapter, and further that dodecyltin composition that is not less than 95 chemicals identified in paragraph (a)(7) percent by weight di(n-octyl)tin dichlo- of this section which may be used in ride/(n-octyl)tin trichloride, and not contact with food of types I, II, III, IV more than 1.5 percent by weight of (except liquid milk), V, VI (except malt tri(n-octyl)tin chloride. The alkyl rad- beverages and carbonated nonalcoholic ical in the mercaptoacetate is derived beverages), VII, VIII, and IX described from a mixture of saturated n-alcohols in table 1 of § 176.170(c) of this chapter which has a composition that is not at temperatures not exceeding 71 °C less than 50 percent by weight (160 °F), in accordance with the fol- tetradecyl alcohol, and that is not lowing prescribed conditions: 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 is derived from oxo process primary between 2 and 4 inclusive), having 25.2 octyl alcohols. The bis(beta- to 26.6 percent by weight of tin (Sn) carbobutoxyethyl)tin dichloride has an and having a saponification number of organotin composition that is not less 225 to 255. It is made from di(n- than 95 percent by weight of bis(beta- octyl)tin dichloride or di(n-octyl)tin carbobutoxyethyl)tin dichloride and oxide meeting the specifications pre- not more than 5 percent by weight of scribed for di(n-octyl) tin dichloride or bis(beta-carbobutoxyethyltin tri- di(n-octyl) tin oxide in paragraph (a)(1) chloride. The triestertin chloride con- of this section. tent of bis(beta-carbobutoxyethyltin) (3) C10-16-Alkyl mercaptoacetates re- dichloride shall not exceed 0.02 percent. action products with p dichlorodioctylstannane and (6) Beta-carbobutoxyethyltin trichlorooctylstannane (CAS Reg. No. tris(isooctylmercaptoacetate) (CAS 83447–69–2) is an organotin chemical Reg. No. 63438–80–2) is an estertin mixture having 10.8 to 11.8 percent by chemical having 13.0 to 14.0 percent by

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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 Office of the Federal by weight of di(n-dodecyl)tin S,S′- Register, 800 North Capitol Street, di(isooctylmercaptoacetate) (CAS Reg. NW., suite 700, Washington, DC 20408. No. 84030–61–5) having 13 to 14 percent (iii) Subsequent determinations for by weight of tin (Sn) and having 8 to 9 the dodecyltin mixture described in percent by weight of mercapto sulfur. paragraph (a)(7) of this section shall be It is made from a mixture of dodecyltin at a minimum of 24-hour intervals for trichloride and di(dodecyl)tin dichlo- aqueous solvents and 2-hour intervals ride which has not more than 0.2 per- for heptane. These tests shall yield cent by weight of dodecyltin tri- di(n-octyl)tin S,S′- chloride, not more than 2 percent by bis(isooctylmercaptoacetate), or di(n- weight of dodecylbutyltin dichloride octyl)tin maleate polymer, or (C10-C16)- and not more than 3 percent by weight alkylmercaptoacetate reaction prod- of tri(dodecyl)tin chloride. The ucts with dichlorodioctylstannane and isooctyl radical in the mercaptoacetate trichlorooctylstannane, or n-octyltin is derived from oxo process primary S,S′,S′′-tris(isooctylmercaptoacetate), octyl alcohols. tris(isooctylmercaptoacetate) and di(n- (b) The vinyl chloride plastic con- dodecyl)tin tainers, film or panels in the finished bis(isooctylmercaptoacetate) or any form in which they are to contact food, combination thereof, not to exceed 0.5 shall meet the following limitations: parts per million as determined by an (1) The finished plastics intended for analytical method entitled ‘‘Atomic contact with foods of the types listed Absorption Spectrophotometric Deter- in this section shall be extracted with mination of Sub-part-per-Million Quan- the solvent or solvents characterizing tities of Tin in Extracts and Biological those types of foods as determined Materials with Graphite Furnace,’’ An- from table 2 of § 176.170(c) of this chap- alytical Chemistry, Vol. 49, pp. 1090–1093 ter at the temperature reflecting the (1977), which is incorporated by ref- conditions of intended use as deter- erence in accordance with 5 U.S.C. mined therein. Additionally, extrac- 552(a). The availability of this incorpo- tion tests for acidic foods shall be in- ration by reference is given in para- cluded and simulated by 3-percent ace- graph (b)(1)(ii) of this section. tic acid at temperatures specified for (2) In lieu of the tests prescribed in water in table 2 of § 176.170(c) of this paragraph (b) (1) of this section, the chapter. The extraction tests shall finished plastics intended for contact cover at least three equilibrium peri- with foods only of Types II, V, VI-A odic determinations, as follows: (except malt beverages), and VI-C may (i) The exposure time for the first de- be end-tested with food-simulating sol- termination shall be at least 72 hours vents, under conditions of time and for aqueous solvents, and at least 6 temperature, as specified below, where- hours for heptane. by such tests shall yield the octyltin

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residues cited in paragraph (b)(1) of List of substances Limitations this section not in excess of 0.5 ppm: Toluene ...... For use only as a blowing agent adjuvant in polystyrene at a level not Tem- perature to exceed 0.35 percent by weight Food-simulating solvent Time (degrees of finished foamed polystyrene. (hours) Fahr- enheit) [47 FR 22090, May 21, 1982, as amended at 58 Type II ...... Acetic acid, 3 pct ...... 48 135 FR 64895, Dec. 10, 1993] Type V ...... Heptane ...... 2 100 Type VIÐA ... Ethyl alcohol, 8 pct ...... 24 120 § 178.3120 Animal glue. Type VIÐC ... Ethyl alcohol, 50 per- 24 120 cent . Animal glue may be safely used as a component of articles intended for use [42 FR 14609, Mar. 15, 1977, as amended at 47 in producing, manufacturing, packing, FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, processing, preparing, treating, pack- 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, aging, transporting, or holding food, Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR subject to the provisions of this sec- 62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR tion. 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; (a) Animal glue consists of the pro- 54 FR 24898, June 12, 1989] teinaceous extractives obtained from hides, bones, and other collagen-rich Subpart D—Certain Adjuvants and substances of animal origin (excluding Production Aids diseased or rotted animals), to which may be added other optional adjuvant § 178.3010 Adjuvant substances used in substances required in its production the manufacture of foamed plastics. or added to impart desired properties. The following substances may be (b) The quantity of any substance safely used as adjuvants in the manu- employed in the production of animal facture of foamed plastics intended for glue does not exceed the amount rea- use in contact with food, subject to any sonably required to accomplish the in- prescribed limitations: tended physical or technical effect nor any limitation further provided. List of substances Limitations (c) Any substance employed in the Azodicarbonamide ..... For use as a blowing agent in pol- production of animal glue and which is yethylene complying with item 2.1 the subject of a regulation in parts 174, in ¤ 177.1520(c) of this chapter at 175, 176, 177, 178 and § 179.45 of this chap- a level not to exceed 5 percent by ter conforms with any specification in weight of finished foamed polyethylene. such regulation. 1,1-Difluoroethane For use as a blowing agent in poly- (d) Optional adjuvant substances em- (CAS Reg. No. 75Ð styrene. ployed in the production of animal glue 37Ð6) . Isopentane ...... For use as a blowing agent in poly- include: styrene. (1) Substances generally recognized n-Pentane ...... Do. as safe in food. 1,1,2,2-Tetra- For use only as a blowing agent ad- (2) Substances subject to prior sanc- chloroethylene . juvant in polystyrene at a level not to exceed 0.3 percent by weight of tion or approval for use in animal glue finished foamed polystyrene in- and used in accordance with such sanc- tended for use in contact with food tion or approval. only of the types identified in (3) Substances identified in this para- ¤ 176.170(c) of this chapter, table 1, under Categories I, II, VI, and graph (d)(3) and subject to such limita- VIII. tions as are provided:

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.

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List of substances Limitations

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. 55799Ð dry foods. finished form of the substance or arti- 16Ð1) . 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. 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.

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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 C10ÐC18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by cent C14ÐC16) . 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. 11121Ð16Ð 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: 70955Ð14Ð5) . 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, VIÐB, VIIÐB, 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, VIIÐA, and IX, under the conditions of use C through G described in Table 2 of ¤ 176.170(c) of this chapter.

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List of substances Limitations

N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only: (C14–C18) are derived from tallow . 1. As an antistatic agent at levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in ¤ 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of ¤ 176.170(c) of this chapter provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of food-contact surface in vinylidene chloride 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- cC; 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, VIÐB, 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. 10213Ð78Ð2, 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. 66810Ð88Ð6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VIÐB, 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. 24170Ð14Ð7, 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 3.3Ð3.8 percent; a melting point of 42°Ð50 °C; and a pH of 10.0Ð11.5 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. 66822Ð60Ð4) . ¤ 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. 52497Ð24Ð2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent ene distearate (CAS Reg. No. 94945Ð28Ð5), and octadecyl additive does not exceed 16, in polypropylene films com- bis(hydroxyethyl)amine (CAS Reg. No. 10213Ð78Ð2), 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 (HFSÐ200), Food and Drug Ad- ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Wash- ington, DC 20408.

[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. (b) The packaging container which Myristo chromic chloride complex has its closure area treated with the and stearato chromic chloride complex release agent shall have a capacity of may be safely used as release agents in not less than 120 grams of food per the closure area of packaging con- square inch of such treated closure tainers intended for use in producing, area. manufacturing, packing, processing, preparing, treating, packaging, trans- § 178.3295 Clarifying agents for poly- porting, or holding food, subject to the mers. provisions of this section: Clarifying agents may be safely used (a) The quantity used shall not ex- in polymers that are articles or compo- ceed that reasonably required to ac- nents of articles intended for use in complish the intended technical effect contact with food, subject to the provisions of this section:

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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. 151841Ð65Ð5) . 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. 79072Ð96Ð1) ... 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. 54686Ð97Ð4) ...... 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. 32647Ð67Ð9) 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. 135861Ð56Ð2) 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. 25498Ð06Ð0) ...... 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. 10491Ð For use only as a clarifying agent at a level not exceeding 0.35 31Ð3) . 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. 85209Ð91Ð2) . 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, IVÐB, VIÐA, VIÐB, and VIIÐB 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, IVÐA, V, VIÐC, and VIIÐA 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 Food and Drug Administration free the term ‘‘colorant’’ includes sub- of charge from the Center for Food Safety and Applied Nutrition, (HFS– stances such as optical brighteners and 200) Food and Drug Administration, fluorescent whiteners, which may not 5100 Paint Branch Pkwy., College Park, themselves be colored, but whose use is MD 20740. intended to affect the color of a food- (d) Color additives and their lakes contact material. listed for direct use in foods, under the

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provisions of the color additive regula- chapter, may also be used as colorants tions in parts 73, 74, 81, and 82 of this for food-contact polymers. (e) List of substances:

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. 59487Ð23Ð9) . ¤ 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. 74441Ð05Ð7) . ¤ 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. 81Ð33Ð4) . 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. 116Ð75Ð6) . 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. 84632Ð65Ð5) . 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. 129423Ð54Ð7) . 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. 154946Ð66Ð4) . 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. 68186Ð90Ð3) . 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. 68186Ð91Ð4) . 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. 4051Ð63Ð2) . 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. 3089Ð17Ð6) . 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. 65212Ð77Ð3) . 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. 72102Ð mers. The finished articles are to contact food only under 84Ð2) . 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. 5521Ð31Ð3) . 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. 5280Ð80Ð8) . 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. 68259Ð05Ð2) . 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. 77804Ð81Ð0) . 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. 1533Ð45Ð5) . 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, IVÐB, VIÐA, VIÐB, VIIÐB, and VIII at temperatures not to exceed 275 °F.

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Substances Limitations

High-purity furnace black (CAS Reg. No. 1333Ð86Ð4) 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 (HFSÐ200), 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, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . 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. 10101Ð66Ð3). . 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. 5242Ð49Ð9) 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. 2397Ð00Ð4) and only under conditions of use D, E, F, and G described in 4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533Ð45Ð 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. 3333Ð62Ð8) 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. 8007Ð18Ð9) . 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. 4118Ð16Ð5) . 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, IVÐA, 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. 147Ð14Ð8) . 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. Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900) . Sienna (raw and burnt) . Silica .

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Substances Limitations

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. 106276Ð80Ð6) . 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.30125Ð47Ð4) . 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. 7128Ð64Ð5) . 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, IVÐB, VIÐA, VIÐB, VIÐC, VIIÐB, 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] use in, or to be fabricated as, food con- EDITORIAL NOTE: For FEDERAL REGISTER ci- tainers or food-processing or handling tations affecting § 178.3297, see the List of equipment, subject to the provisions of CFR Sections Affected, which appears in the this section. Finding Aids section of the printed volume (a) The corrosion inhibitors are pre- and on GPO Access. pared from substances identified in this section and used subject to the limita- § 178.3300 Corrosion inhibitors used tions prescribed. for steel or tinplate. (b) The following corrosion inhibitors Corrosion inhibitors may be safely or adjuvants are used in amounts not used for steel or tinplate intended for to exceed those reasonably required to

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accomplish the intended physical or emulsifiers and/or surface-active technical effect: agents in the manufacture of articles (1) Corrosion inhibitors (active ingre- or components of articles intended for dients) used in packaging materials for use in producing, manufacturing, pack- the packaging of steel or tinplate or ar- ing, processing, preparing, treating, ticles fabricated therefrom: packaging, transporting, or holding food, subject to the provisions of this List of substances Limitations section. Dicyclohexylamine and its salts of (a) The quantity used shall not ex- fatty acids derived from animal ceed the amount reasonably required or vegetable oil . Dicyclohexylamine nitrite . to accomplish the intended technical Morpholine and its salts of fatty effect; and the quantity that may be- acids derived from animal or come a component of food as a result of vegetable oils . such use shall not be intended to, nor in fact, accomplish any physical or (2) Adjuvants employed in the appli- technical effect in the food itself. cation and use of corrosion inhibitors: (b) The use as an emulsifier and/or List of substances Limitations surface-active agent in any substance or article that is the subject of a regu- Propylene glycol . lation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with § 178.3400 Emulsifiers and/or surface- any specifications and limitations pre- active agents. scribed by such regulation for the fin- The substances listed in paragraph ished form of the substance or article. (c) of this section may be safely used as (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. Alkyl mono- and disulfonic acids, sodium salts (produced from For use only: n-alkanes in the range of C10ÐC18 with not less than 50 per- 1. As provided in ¤ 176.170 of this chapter. cent C14ÐC16) . 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 7Ð20 moles of ethylene oxide .

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List of substances Limitations

alpha Olefin sulfonate [alkyl group is in the range of C10ÐC18 For use only: with not less than 50 percent C14ÐC16], 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. 30174Ð67Ð5) . 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 160Ð180, saponification number 210Ð of nonfood articles complying with ¤¤ 175.105, 175.300, 235, iodine number 2Ð15, and epoxy groups 0Ð0.4 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. 144093Ð88Ð9]). . a-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of di-sec-butylphenol with an average of 4Ð14 or 30Ð50 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 4Ð14 or 30Ð50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents . Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294Ð49Ð 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 103Ð111 and that are produced by the esterification of the condensation product of 1 mole of n-dodecyl alcohol with 4Ð4.5 moles of ethylene oxide . 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 4Ð14 or 30Ð50 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 4Ð14 or 30Ð50. Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only: salt (CAS Reg. No. 9084Ð06Ð4) . 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.

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List of substances Limitations

a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49Ð59 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 5.5Ð6.5 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 62Ð72 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 9Ð10 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 98Ð110 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 45Ð55 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 4Ð14 or 30Ð 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 4Ð14 or 30Ð50. 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(C10ÐC12) ether sulfosuccinate, diso- For use only at levels not to exceed 5 percent by weight of dium salt (CAS Reg. No. 68954Ð91Ð6) . 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)(4Ð12 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) (45Ð48 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 11,000Ð Such polyolefin film and polyolefin coatings shall have an av- 18,000; hydroxyl number 6.2Ð10.2; ácloud 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 40Ð50, acid number 0Ð2, hydroxyl number 60Ð108, oxyethylene content 70Ð74 pct . Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41Ð52, oxyethylene content 66Ð70.5 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 . Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meeting the following specifications: Saponification number 80Ð 95, oxyethylene content 46Ð50 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 C8–C16. Sorbitan monolaurate meeting the following specifications. Sa- ponification number 153Ð170; and hydroxyl number 330Ð360.

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List of substances Limitations

Sorbitan monooleate meeting the following specifications: Sa- ponification number 145Ð160, hydroxyl number 193Ð210. Sorbitan monopalmitate meeting the following specifications: Saponification No. 140Ð150; and hydroxyl No. 275Ð305. Sorbitan monostearate conforming to the identity prescribed in ¤ 172.842 of this chapter . Sorbitan trioleate meeting the following specifications: Saponi- fication No. 170Ð190; and hydroxyl No. 55Ð70. Sorbitan tristearate meeting the following specifications: Sa- ponification No. 176Ð188; and hydroxyl No. 66Ð80. 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. 39354Ð45Ð5) . 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 9Ð10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended ethylene oxide) (CAS Reg. No. 9040Ð38Ð4) . 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 4Ð14 or 30Ð40 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 4Ð14 or 30Ð50. 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 75Ð85 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5Ð6.5 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 58Ð70 and that are produced by the esterification of the condensation product of one mole of ‘‘oxo’’ process tridecyl alcohol with 9Ð10 moles of ethylene oxide .

(d) The provisions of this section are (b) They are added to the formulated not applicable to emulsifiers and/or polymer prior to extrusion. surface-active agents listed in (c) The quantity used shall not ex- § 175.105(c)(5) of this chapter and used in ceed that required to accomplish the food-packaging adhesives complying intended technical effect. with § 175.105 of this chapter. § 178.3480 Fatty alcohols, synthetic. EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 178.3400, see the List of Synthetic fatty alcohols may be safe- CFR Sections Affected, which appears in the ly used as components of articles in- Finding Aids section of the printed volume tended for use in contact with food, and on GPO Access. and in synthesizing food additives and § 178.3450 Esters of stearic and pal- other substances permitted for use as mitic acids. components of articles intended for use in contact with food in accordance The ester stearyl palmitate or with the following prescribed condi- palmityl stearate or mixtures thereof tions: may be safely used as adjuvants in (a) The food additive consists of fatty food-packaging materials when used in accordance with the following pre- alcohols meeting the specifications and scribed conditions: definition prescribed in § 172.864 of this (a) They are used or intended for use chapter, except as provided in para- as plasticizers or lubricants in poly- graph (c) of this section. styrene intended for use in contact (b) It is used or intended for use as with food. follows:

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(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 [42 FR 14609, Mar. 15, 1977, as amended at 47 of articles intended for use in contact FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, with food by existing regulations in 1989] parts 174, 175, 176, 177, 178 and § 179.45 of this chapter: Provided, That the use is § 178.3500 Glycerin, synthetic. in compliance with any prescribed lim- Synthetic glycerin may be safely itations. used as a component of articles in- (2) As substitutes for the cor- tended for use in packaging materials responding naturally derived fatty al- for food, subject to the provisions of cohols used as intermediates in the this section: synthesis of food additives and other (a) It is produced by the hydro- substances permitted for use as compo- genolysis of carbohydrates, and shall nents of food-contact articles. contain not in excess of 0.2 percent by weight of a mixture of butanetriols. (c) Synthetic fatty alcohols identi- (b) It is used in a quantity not to ex- fied in paragraph (c)(1) of this section ceed that amount reasonably required may contain not more than 0.8 weight to produce its intended physical or percent of total diols as determined by technical effect, and in accordance a method titled ‘‘Diols in Monohydroxy with any limitations prescribed by ap- Alcohol by Miniature Thin Layer Chro- plicable regulations in parts 174, 175, matography (MTLC),’’ which is incor- 176, 177, 178 and 179 of this chapter. It porated by reference. Copies are avail- shall not be intended to, nor in fact ac- able from the Center for Food Safety complish, any direct physical or tech- and Applied Nutrition (HFS–200), Food nical effect in the food itself. and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, § 178.3505 Glyceryl tri-(12-acetoxy- or available for inspection at the Office stearate). of the Federal Register, 800 North Cap- Glyceryl tri-(12-acetoxystearate) itol Street, NW., suite 700, Washington, (CAS Reg. No. 139–43–5) may be safely DC 20408. used as a component of articles in- (1) Synthetic fatty alcohols. (i) Hexyl, tended for use in producing, manufac- octyl, decyl, lauryl, myristyl, cetyl, turing, packing, processing, preparing, and stearyl alcohols meeting the speci- treating, packaging, transporting, or holding food, subject to the provisions fications and definition prescribed in of this section. § 172.864 of this chapter, except that (a) The additive is applied to the sur- they may contain not more than 0.8 face of calcium carbonate at a level not weight percent total diols. to exceed 1 weight-percent of the total (ii) Lauryl, myristyl, cetyl, and ste- mixture. aryl alcohols manufactured by the (b) The calcium carbonate/glyceryl process described in § 172.864(a)(2) of tri-(12-acetoxystearate) mixture is used this chapter such that lauryl and as an adjuvant in polymers in contact myristyl alcohols meet the specifica- with nonfatty foods at a level not to tions in § 172.864(a)(1)(i) of this chapter, exceed 20 weight-percent of the poly- and cetyl and stearyl alcohols meet the mer. specifications in § 172.864(a)(1)(ii) of this [50 FR 1503, Jan. 11, 1985] chapter. (2) Conditions of use. (i) Synthetic § 178.3520 Industrial starch-modified. fatty alcohols as substitutes for the Industrial starch-modified may be corresponding naturally derived fatty safely used as a component of articles alcohols permitted for use in compli- intended for use in producing, manu- ance with § 178.3910. facturing, packing, processing, pre- (ii) Synthetic lauryl alcohol as a sub- paring, treating, packaging, trans- stitute for the naturally derived lauryl porting, or holding food, subject to the alcohol permitted as an intermediate provisions of this section.

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(a) Industrial starch-modified is iden- an amount reasonably required to tified as follows: achieve the desired functional effect (1) A food starch-modified or starch but in no event in excess of any limita- or any combination thereof that has tion prescribed, with or without subse- been modified by treatment with one of quent treatment as authorized in the reactants hereinafter specified, 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) . 2. Not more than 0.20 pct residual acrylamide . 3. A minimum nitrogen content of 9.0 pct .

(b) The following adjuvants may be starch-modified,’’ and in the instance used as surface-active agents in the of an industrial starch-modified which processing of industrial starch-modi- is limited with respect to conditions of fied: use, the label of the food additive container shall contain a statement of Polyethylene glycol (400) dilaurate. such limited use. Polyethylene glycol (400) monolaurate. Polyoxyethylene (4) lauryl ether. [42 FR 14609, Mar. 15, 1977, as amended at 42 (c) To insure safe use of the indus- FR 49453, Sept. 27, 1977] trial starch-modified, the label of the food additive container shall bear the name of the additive ‘‘industrial

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§ 178.3530 Isoparaffinic petroleum hy- Method for Existent Gum in Fuels by Jet drocarbons, synthetic. Evaporation,’’ which are incorporated by reference. Copies may be obtained from the Isoparaffinic petroleum hydro- American Society for Testing Materials, 1916 carbons, synthetic, may be safely used Race St., Philadelphia, PA 19103, or may be in the production of nonfood articles examined at the Office of the Federal Reg- intended for use in producing, manu- ister, 800 North Capitol Street, NW., suite facturing, packing, processing, pre- 700, Washington, DC 20408. paring, treating, packaging, trans- (b) Isoparaffinic petroleum hydro- porting, or holding food, subject to the carbons may contain antioxidants au- provisions of this section. thorized for use in food in an amount (a) The isoparaffinic petroleum hy- not to exceed that reasonably required drocarbons, produced by synthesis from to accomplish the intended technical petroleum gases consist of a mixture of effect. liquid hydrocarbons meeting the following specifications: (c) Isoparaffinic petroleum hydrocarbons are used in the production of Boiling point 63° –260 °C, as determined by nonfood articles. The quantity used ASTM method D86–82, ‘‘Standard Method shall not exceed the amount reason- for Distillation of Petroleum Products,’’ ably required to accomplish the in- which is incorporated by reference. Copies may be obtained from the American Soci- tended technical effect, and the resid- ety for Testing Materials, 1916 Race St., ual remaining in the finished article Philadelphia, PA 19103, or may be exam- shall be the minimum amount reason- ined at the Office of the Federal Register, ably attainable. 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14609, Mar. 15, 1977, as amended at 47 Ultraviolet absorbance: FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 260–319 millimicrons—1.5 maximum. 1984] 320–329 millimicrons—0.08 maximum. 330–350 millimicrons—0.05 maximum. § 178.3570 Lubricants with incidental Nonvolatile residue 0.002 gram per 100 milli- food contact. liters maximum. Lubricants with incidental food con- Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet tact may be safely used on machinery the specified ultraviolet absorbance limits used for producing, manufacturing, after correction for any absorbance due to packing, processing, preparing, treat- the antioxidants. The ultraviolet absorbance ing, packaging, transporting, or hold- shall be determined by the procedure de- ing food, subject to the provisions of scribed for application to mineral oil under this section: ‘‘Specifications’’ on page 66 of the ‘‘Journal (a) The lubricants are prepared from of the Association of Official Agricultural Chemists,’’ Vol. 45 (February 1962), which is one or more of the following sub- incorporated by reference, disregarding the stances: last sentence of that procedure. For hydro- (1) Substances generally recognized carbons boiling below 121 °C, the nonvolatile as safe for use in food. residue shall be determined by ASTM meth- (2) Substances used in accordance od D1353–78, ‘‘Standard Test Method for Non- with the provisions of a prior sanction volatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related or approval. Products;’’ for those boiling above 121 °C, (3) Substances identified in this para- ASTM procedure D381–80, ‘‘Standard Test 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. 94270Ð86Ð7) . 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. 9038Ð95Ð3.

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Substances Limitations

a-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do. weight 1,500; Chemical Abstracts Service Registry No. 9003Ð13Ð8. 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 68953Ð58Ð2), 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. 629Ð11Ð8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14ÐC18) 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. 1809Ð14Ð9) ...... 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. 17265Ð14Ð4) ...... 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. 139Ð33Ð3) ...... 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. 56831Ð62Ð0) . 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. 95Ð38Ð5) . 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. 35074Ð77Ð2) . by weight of the lubricant. 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. 9003Ð11Ð6. 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. 110Ð For use as a corrosion inhibitor at levels not to exceed 0.5 per- 25Ð8) . 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. 68411Ð46Ð1) . 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 (C12ÐC14) primary amines (CAS Reg. No. 68187Ð inlubricants at a level not to exceed 0.5 percent by weight of 67Ð7) . the lubricant.

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Substances Limitations

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. 192268Ð65Ð8) . level not to exceed 0.5 percent by weight of the lubricant. Polyurea, having a nitrogen content of 9Ð14 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 35,000Ð140,000 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. 6683Ð19Ð8) . 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. 126019Ð82Ð7) . els not to exceed 0.5 percent by weight of the lubricant. Triphenyl phosphorothionate (CAS Reg. No. 597Ð82Ð0) ...... 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. 31570Ð For use only as a stabilizer at levels not to exceed 0.5 percent 04Ð4) . 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. 41484Ð35Ð9) . 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- starch, including industrial starch- processing equipment as a protective modified complying with § 178.3520, in- antirust film, as a release agent on gas- tended for use as a component of arti- kets or seals of tank closures, and as a cles that contact food. lubricant for machine parts and equipment in locations in which there is ex- § 178.3610 a-Methylstyrene- posure of the lubricated part to food. vinyltoluene resins, hydrogenated. The amount used is the minimum re- Hydrogenated a-methylstyrene- quired to accomplish the desired tech- vinyltoluene copolymer resins having a nical effect on the equipment, and the molar ratio of 1 -methylstyrene to 3 addition to food of any constituent a vinyltoluene may be safely used as identified in this section does not exceed the limitations prescribed. components of polyolefin film intended (c) Any substance employed in the for use in contact with food, subject to production of the lubricants described the following provisions: in this section that is the subject of a (a) Hydrogenated a-methylstyrene- regulation in parts 174, 175, 176, 177, 178 vinyltoluene copolymer resins have a and § 179.45 of this chapter conforms drop-softening point of 125° to 165 °C with any specification in such regula- and a maximum absorptivity of 0.17 tion. liter per gram centimeter at 266 nanometers, as determined by methods [42 FR 14609, Mar. 15, 1977] titled ‘‘Determination of Softening EDITORIAL NOTE: For FEDERAL REGISTER ci- Point (Drop Method)’’ and ‘‘Deter- tations affecting § 178.3570, see the List of mination of Unsaturation of Resin CFR Sections Affected, which appears in the Finding Aids section of the printed volume 1977,’’ which are incorporated by ref- and on GPO Access. erence. Copies are available from the Center for Food Safety and Applied Nu- § 178.3600 Methyl glucoside-coconut oil trition (HFS–200), Food and Drug Ad- ester. ministration, 5100 Paint Branch Pkwy., Methyl glucoside-coconut oil ester College Park, MD 20740, or available for identified in § 172.816(a) of this chapter inspection at the Office of the Federal may be safely used as a processing aid Register, 800 North Capitol Street, (filter aid) in the manufacture of NW., suite 700, Washington, DC 20408.

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(b) The polyolefin film is produced Maximum from olefin polymers complying with absorb- µ ance per § 177.1520 of this chapter, and the aver- Wavelength (m ) centimeter age thickness of the film in the form in optical pathlength which it contacts food does not exceed 0.002 inch. 300 to 329 ...... 2.3 330 to 350 ...... 0.8 [42 FR 14609, Mar. 15, 1977, as amended at 47 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 this chapter may be used as a compo- Official Agricultural Chemists,’’ Vol- nent of nonfood articles provided such ume 45 (February 1962) (which is incor- use complies with any applicable limi- porated by reference; copies are avail- tations in parts 170 through 189 of this able from the Center for Food Safety chapter. The use of white mineral oil in and Applied Nutrition (HFS–200), Food or on food itself, including the use of and Drug Administration, 5100 Paint white mineral oil as a protective coat- Branch Pkwy., College Park, MD 20740, ing or release agent for food, is subject or available for inspection at the Office to the provisions of § 172.878 of this of the Federal Register, 800 North Cap- chapter. itol Street, NW., suite 700, Washington, (b) Technical white mineral oil iden- DC 20408), disregarding the last two tified in paragraph (b)(1) of this section sentences of that procedure and sub- may be used as provided in paragraph stituting therefor the following: Deter- (b)(2) of this section. mine the absorbance of the mineral oil (1) Technical white mineral oil con- extract in a 10-millimeter cell in the sists of specially refined distillates of range from 260–350 mµ, inclusive, com- virgin petroleum or of specially refined pared to the solvent control. If the ab- distillates that are produced syn- sorbance so measured exceeds 2.0 at thetically from petroleum gases. Tech- any point in range 280–350 mµ, inclu- nical white mineral oil meets the fol- sive, dilute the extract and the solvent lowing specifications: control, respectively, to twice their (i) Saybolt color 20 minimum as de- volume with dimethyl sulfoxide and re- termined by ASTM method D156–82, measure the absorbance. Multiply the ‘‘Standard Test Method for Saybolt remeasured absorbance values by 2 to Color of Petroleum Products (Saybolt determine the absorbance of the min- Chromometer Method),’’ which is in- eral oil extract per centimeter optical corporated by reference. Copies may be pathlength. obtained from the American Society (2) Technical white mineral oil may for Testing Materials, 1916 Race St., be used wherever mineral oil is per- Philadelphia, PA 19103, or may be ex- mitted for use as a component of amined at the Office of the Federal nonfood articles complying with Register, 800 North Capitol Street, §§ 175.105, 176.200, 176.210, 177.2260, NW., suite 700, Washington, DC 20408. 177.2600, and 177.2800 of this chapter and (ii) Ultraviolet absorbance limits as §§ 178.3570 and 178.3910. follows: (3) Technical white mineral oil may contain any antioxidant permitted in Maximum absorb- food by regulations issued in accord- µ ance per ance with section 409 of the Act, in an Wavelength (m ) centimeter optical amount not greater than that required pathlength to produce its intended effect. 280 to 289 ...... 4.0 (c) Mineral oil identified in para- 290 to 299 ...... 3.3 graph (c)(1) of this section may be used

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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 APPARATUS petroleum distillates refined to meet the following specifications: Separatory funnels. 250-milliliter, 500-milli- ° liter, 1,000-milliliter, and preferably 2,000- (i) Initial boiling point of 450 F min- milliliter capacity, equipped with tetra- imum. fluoroethylene polymer stopcocks. (ii) Color 5.5 maximum as determined Reservoir. 500-milliliter capacity, equipped by ASTM method D1500–82, ‘‘Standard 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 glass hooks. availability of this incorporation by Chromatographic tube. 180 millimeters in reference is given in paragraph (b)(1)(i) length, inside diameter to be 15.7 millimeters of this section. ±0.1 millimeter, equipped with a coarse, frit- (iii) Ultraviolet absorbance limits as ted-glass disc, a tetrafluoroethylene polymer follows as determined by the analytical stopcock, and a female 24/40 standard tapered method described in paragraph (c)(3) of fitting at the opposite end. (Overall length of this section: the column with the female joint is 235 millimeters.) The female fitting should be Maximum equipped with glass hooks. absorb- Disc. Tetrafluoroethylene polymer 2-inch µ ance per diameter disk approximately 3⁄16-inch thick Wavelength (m ) centimeter optical with a hole bored in the center to closely fit pathlength the stem of the chromatographic tube. Suction flask. 250-milliliter or 500-milliliter 280 to 289 ...... 0.7 filter flask. 290 to 299 ...... 0.6 Condenser. 24/40 joints, fitted with a drying 300 to 359 ...... 0.4 tube, length optional. 360 to 400 ...... 09 Evaporation flask (optional). 250-milliliter or 500-milliliter capacity all-glass flask (2) The mineral oil may be used wher- equipped with standard taper stopper having ever mineral oil is permitted for use as inlet and outlet tubes to permit passage of a component of nonfood articles com- nitrogen across the surface of contained liq- plying with §§ 175.105 and 176.210 of this uid to be evaporated. chapter and § 178.3910 (for use only in Spectrophotometric cells. Fused quartz cells, rolling of metallic foil and sheet optical path length in the range of 5,000 cen- ± stock), §§ 176.200, 177.2260, 177.2600, and timeter 0.005 centimeter; also for checking spectrophotometer performance only, optical 177.2800 of this chapter. path length in the range 1,000 centimeter (3) The analytical method for deter- ±0.005 centimeter. With distilled water in the mining ultraviolet absorbance limit is cells, determine any absorbance differences. as follows: Spectrophotometer. Spectral range 250 millimicrons—400 millimicrons with spectral slit GENERAL INSTRUCTIONS width of 2 millimicrons or less; under instru- Because of the sensitivity of the test, the ment operating conditions for these absorb- possibility of errors arising from contamina- ance measurements, the spectrophotometer tion is great. It is of the greatest importance shall also meet the following performance that all glassware be scrupulously cleaned to requirements: ± remove all organic matter such as oil, Absorbance repeatability, 0.01 at 0.4 ab- grease, detergent residues, etc. Examine all sorbance. 1 ± glassware, including stoppers and stopcocks, Absorbance accuracy 0.05 at 0.4 absorb- under ultraviolet light to detect any residual ance. fluorescent contamination. As a pre- cautionary measure it is recommended prac- 1 As determined by procedure using potas- tice to rinse all glassware with purified iso- sium chromate for reference standard and octane immediately before use. No grease is described in National Bureau of Standards to be used on stopcocks or joints. Great care Circular 484, Spectrophotometry, U.S. De- to avoid contamination of oil samples in partment of Commerce (1949). The accuracy handling and to assure absence of any extra- is to be determined by comparison with the neous material arising from inadequate standard values at 290, 345, and 400 milli- packaging is essential. Because some of the microns. Circular 484 is incorporated by ref- polynuclear hydrocarbons sought in this test erence. Copies are available from the Center are very susceptible to photo-oxidation, the Continued

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Wavelength accuracy, ±1.0 millimicron. Eluting mixtures: Nitrogen cylinder. Water-pumped or equiva- 1. 10 percent benzene in isooctane. Pipet 50 lent purity nitrogen in cylinder equipped milliliters of benzene into a 250-milliliter with regulator and valve to control flow at 5 glass-stoppered volumetric flask and adjust p.s.i.g. to volume with isooctane, with mixing. 2. 20 percent benzene in isooctane. Pipet 50 REAGENTS AND MATERIALS milliliters of benzene into a 250-milliliter Organic solvents. All solvents used through- glass-stoppered volumetric flask and adjust out the procedure shall meet the specifica- to volume with isooctane, with mixing. tions and tests described in this specifica- 3. Acetone-benzene-water mixture. Add 20 tion. The isooctane, benzene, acetone, and milliliters of water to 380 milliliters of ace- methyl alcohol designated in the list fol- tone and 200 milliliters of benzene, and mix. lowing this paragraph shall pass the fol- n-Hexadecane, 99-percent olefin-free. Dilute lowing test: 1.0 milliliter of n-hexadecane to 25 milliliters To the specified quantity of solvent in a with isooctane and determine the absorbance 250-milliliter Erlenmeyer flask, add 1 milli- in a 5-centimeter cell compared to isooctane liter of purified n-hexadecane and evaporate as reference point between 280 mµ–400 mµ. on the steam bath under a stream of nitro- The absorbance per centimeter path length gen (a loose aluminum foil jacket around the shall not exceed 0.00 in this range. Purify, if flask will speed evaporation). Discontinue necessary, by percolation through activated evaporation when not over 1 milliliter of res- silica gel or by distillation. idue remains. (To the residue from benzene Methyl alcohol, A.C.S. reagent grade. Use add a 10-milliliter portion of purified iso- 10.0 milliliters of methyl alcohol. Purify, if octane, reevaporate, and repeat once to in- necessary, by distillation. sure complete removal of benzene.) Dimethyl sulfoxide. Spectrophotometric Alternatively, the evaporation time can be grade (Crown Zellerbach Corporation, reduced by using the optional evaporation Camas, Washington, or equivalent). Absorb- flask. In this case the solvent and n-hexa- ance (1-centimeter cell, distilled water ref- decane are placed in the flask on the steam erence, sample completely saturated with ni- bath, the tube assembly is inserted, and a trogen). stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a Absorb- solvent trap and vacuum line in such a way Wavelength ance (max- as to prevent any flow-back of condensate imum) into the flask. 261.5 ...... 1.00 Dissolve the 1 milliliter of hexadecane res- 270 ...... 20 idue in isooctane and make to 25 milliliters 275 ...... 09 volume. Determine the absorbance in the 5- 280 ...... 06 centimeter path length cells compared to 300 ...... 015 isooctane as reference. The absorbance of the solution of the solvent residue (except for There shall be no irregularities in the ab- methyl alcohol) shall not exceed 0.01 per cen- sorbance curve within these wavelengths. timeter path length between 280 and 400 mµ. Phosphoric acid. 85 percent A.C.S. reagent For methyl alcohol this absorbance value grade. shall be 0.00. Sodium borohydride. 98 percent. Isooctane (2,2,4-trimethylpentane). Use 180 Magnesium oxide (Sea Sorb 43, Food Machin- milliliters for the test described in the pre- ery Company, Westvaco Division, distributed by ceding paragraph. Purify, if necessary, by chemical supply firms, or equivalent). Place 100 passage through a column of activated silica grams of the magnesium oxide in a large gel (Grade 12, Davison Chemical Company, beaker, add 700 milliliters of distilled water Baltimore, Maryland, or equivalent) about 90 to make a thin slurry, and heat on a steam centimeters in length and 5 centimeters to 8 bath for 30 minutes with intermittent stir- centimeters in diameter. ring. Stir well initially to insure that all the Benzene, A.C.S. reagent grade. Use 150 milli- adsorbent is completely wetted. Using a liters for the test. Purify, if necessary, by Buchner funnel and a filter paper (Schleicher distillation or otherwise. & Schuell No. 597, or equivalent) of suitable Acetone, A.C.S. reagent grade. Use 200 milli- diameter, filter with suction. Continue suc- liters for the test. Purify, if necessary, by tion until water no longer drips from the distillation. funnel. Transfer the adsorbent to a glass trough lined with aluminum foil (free from for Food Safety and Applied Nutrition (HFS– rolling oil). Break up the magnesia with a 200), Food and Drug Administration, 5100 clean spatula and spread out the adsorbent Paint Branch Pkwy., College Park, MD 20740, on the aluminum foil in a layer about 1 cen- or available for inspection at the Office of timeter to 2 centimeters thick. Dry for 24 the Federal Register, 800 North Capitol hours at 160 °C ±1 °C. Pulverize the magnesia Street, NW., suite 700, Washington, DC 20408. with mortar and pestle. Sieve the pulverized

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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 meter to 2 centimeters thick. Reheat the with two additional portions of the sulf- mixture at 160 °C ±1 °C for 2 hours, and store oxide-acid mixture and wash each extractive in a tightly closed flask. in tandem through the same three portions Sodium sulfate, anhydrous, A.C.S. reagent of isooctane. grade, preferably in granular form. For each Collect the successive extractives (300 mil- bottle of sodium sulfate reagent used, estab- liliters total) in a separatory funnel (pref- lish as follows the necessary sodium sulfate erably 2-liter) containing 480 milliliters of prewash to provide such filters required in distilled water; mix, and allow to cool for a the method: Place approximately 35 grams of few minutes after the last extractive has anhydrous sodium sulfate in a 30-milliliter been added. Add 80 milliliters of isooctane to course, fritted-glass funnel or in a 65-milli- the solution and extract by shaking the fun- meter filter funnel with glass wool plug; nel vigorously for 2 minutes. Draw off the wash with successive 15-milliliter portions of lower aqueous layer into a second separatory the indicated solvent until a 15-milliliter funnel (preferably 2-liter) and repeat the ex- portion of the wash shows 0.00 absorbance traction with 80 milliliters of isooctane. per centimeter path length between 280 mµ Draw off and discard the aqueous layer. and 400 mµ when tested as prescribed under Wash each of the 80-milliliter extractives ‘‘Organic solvents.’’ Usually three portions three times with 100-milliliter portions of of wash solvent are sufficient. distilled water. Shaking time for each wash Before proceeding with analysis of a sam- is 1 minute. Discard the aqueous layers. Fil- ple, determine the absorbance in a 5-centi- ter the first extractive through anhydrous meter path cell between 250 millimicrons and sodium sulfate prewashed with isooctane (see 400 millimicrons for the reagent blank by Sodium sulfate under ‘‘Reagents and Mate- carrying out the procedure, without an oil rials’’ for preparation of filter) into a 250- sample, recording the spectra after the ex- milliliter Erlenmeyer flask (or optionally traction stage and after the complete proce- into the evaporation flask). Wash the first dure as prescribed. The absorbance per centi- separatory funnel with the second 80-millimeter pathlength following the extraction liter isooctane extractive and pass through stage should not exceed 0.02 in the wave- the sodium sulfate. Then wash the second length range from 280 mµ to 400 mµ; the ab- and first separatory funnels successively sorbance per centimeter pathlength fol- with a 20-milliliter portion of isooctane and lowing the complete procedure should not pass the solvent through the sodium sulfate exceed 0.02 in the wavelength range from 280 into the flask. Add 1 milliliter of n-hexa- mµ to 400 mµ. If in either spectrum the char- decane and evaporate the isooctane on the acteristic benzene peaks in the 250 mµ–260 steam bath under nitrogen. Discontinue mµ region are present, remove the benzene evaporation when not over 1 milliliter of res- by the procedure under ‘‘Organic solvents’’ idue remains. To the residue, add a 10-milli- and record absorbance again. liter portion of isooctane, reevaporate to 1 Place 300 milliliters of dimethyl sulfoxide milliliter of hexadecane, and repeat this opin a 1-liter separatory funnel and add 75 mil- eration once. liliters of phosphoric acid. Mix the contents Quantitatively transfer the residue with of the funnel and allow to stand for 10 min- isooctane to a 200-milliliter volumetric utes. (The reaction between the sulfoxide flask, make to volume, and mix. Determine and the acid is exothermic. Release pressure the absorbance of the solution in the 1-centi- after mixing, then keep funnel stoppered.) meter pathlength cells compared to iso- Add 150 milliliters of isooctane and shake to octane as reference between 280 mµ–400 mµ pre-equilibrate the solvents. Draw off the in- (take care to lose none of the solution in fill- dividual layers and store in glass-stoppered ing the sample cell). Correct the absorbance flasks. values for any absorbance derived from re- Weigh a 20-gram sample of the oil and agents as determined by carrying out the transfer to a 500-milliliter separatory funnel procedure without an oil sample. If the cor- containing 100 milliliters of pre-equilibrated rected absorbance does not exceed the limits sulfoxide-phosphoric acid mixture. Complete prescribed in this paragraph, the oil meets the transfer of the sample with small por- the ultraviolet absorbance specifications. If

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the corrected absorbance per centimeter sorbent level. Rapidly complete the transfer pathlength exceeds the limits prescribed in similarly with two 5–milliliter portions of this paragraph, proceed as follows: Quan- isooctane, swirling the flask repeatedly each titatively transfer the isooctane solution to time to assure adequate washing of the res- a 125-milliliter flask equipped with 24/40 idue. Just before the final 5–milliliter wash joint, and evaporate the isooctane on the reaches the top of the adsorbent, add 100 mil- steam bath under a stream of nitrogen to a liliters of isooctane to the reservoir and con- volume of 1 milliliter of hexadecane. Add 10 tinue the percolation at the 2–3 milliliters milliliters of methyl alcohol and approxi- per minute rate. Just before the last of the mately 0.3 gram of sodium borohydride. isooctane reaches the adsorbent level, add (Minimize exposure of the borohydride to the 100 milliliters of 10 percent benzene in iso- atmosphere. A measuring dipper may be octane to the reservoir and continue the per- used.) Immediately fit a water-cooled con- colation at the aforementioned rate. Just be- denser equipped with a 24/40 joint and with a fore the solvent mixture reaches adsorbent drying tube into the flask, mix until the level, add 25 milliliters of 20 percent benzene borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with in isooctane to the reservoir and continue intermittent swirling. At the end of this pe- the percolation at 2–3 milliliters per minute riod, disconnect the flask and evaporate the until all this solvent mixture has been re- methyl alcohol on the steam bath under ni- moved from the column. Discard all the trogen until the sodium borohydride begins elution solvents collected up to this point. to come out of the solution. Then add 10 mil- Add 300 milliliters of the acetone-benzene- liliters of isooctane and evaporate to a vol- water mixture to the reservoir and percolate ume of about 2–3 milliliters. Again, add 10 through the column to eluate the milliliters of isooctane and concentrate to a polynuclear compounds. Collect the eluate in volume of approximately 5 milliliters. Swirl a clean 1-liter separatory funnel. Allow the the flask repeatedly to assure adequate column to drain until most of the solvent washing of the sodium borohydride residues. mixture is removed. Wash the eluate three Fit the tetrafluoroethylene polymer disc times with 300-milliliter portions of distilled on the upper part of the stem of the water, shaking well for each wash. (The addi- chromatographic tube, then place the tube tion of small amounts of sodium chloride fa- with the disc on the suction flask and apply cilitates separation.) Discard the aqueous the vacuum (approximately 135 millimeters layer after each wash. After the final separa- Hg pressure). Weigh out 14 grams of the 2:1 tion, filter the residual benzene through an- magnesium oxide-Celite 545 mixture and hydrous sodium sulfate pre-washed with ben- pour the adsorbent mixture into the zene (see Sodium sulfate under ‘‘Reagents chromatographic tube in approximately 3- and Materials’’ for preparation of filter) into centimeter layers. After the addition of each a 250-milliliter Erlenmeyer flask (or option- layer, level off the top of the adsorbent with ally into the evaporation flask). Wash the a flat glass rod or metal plunger by pressing separatory funnel with two additional 20- down firmly until the adsorbent is well milliliter portions of benzene which are also packed. Loosen the topmost few millimeters filtered through the sodium sulfate. Add 1 of each adsorbent layer with the end of a metal rod before the addition of the next milliliter of n-hexadecane and completely re- layer. Continue packing in this manner until move the benzene by evaporation under ni- all the 14 grams of the adsorbent is added to trogen, using the special procedure to elimi- the tube. Level off the top of the adsorbent nate benzene as previously described under by pressing down firmly with a flat glass rod ‘‘Organic solvents.’’ Quantitatively transfer or metal plunger to make the depth of the the residue with isooctane to a 200-milliliter adsorbent bed approximately 12.5 centi- volumetric flask and adjust to volume. De- meters in depth. Turn off the vacuum and re- termine the absorbance of the solution in the move the suction flask. Fit the 500–milliliter 1-centimeter pathlength cells compared to reservoir onto the top of the isooctane as reference between 250 mµ–400 chromatographic column and prewet the col- mµ. Correct for any absorbance derived from umn by passing 100 milliliters of isooctane the reagents as determined by carrying out through the column. Adjust the nitrogen the procedure without an oil sample. If ei- pressure so that the rate of descent of the ther spectrum shows the characteristic ben- isooctane coming off the column is between zene peaks in the 250 mµ–260 mµ region, evap- 2–3 milliliters per minute. Discontinue pres- orate the solution to remove benzene by the sure just before the last of the isooctane procedure under ‘‘Organic solvents.’’ Dis- reaches the level of the adsorbent. (Caution: solve the residue, transfer quantitatively, Do not allow the liquid level to recede below and adjust to volume in isooctane in a 200- the adsorbent level at any time.) Remove the milliliter volumetric flask. Record the ab- reservoir and decant the 5–milliliter iso- sorbance again. If the corrected absorbance octane concentrate solution onto the column does not exceed the limits proposed in this and with slight pressure again allow the liq- paragraph, the oil meets the proposed ultra- uid level to recede to barely above the ad- violet absorbance specifications.

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(d) Mineral oil identified in para- fluoroethylene polymer stopcock. The oppo- graph (d)(1) of this section may be used site end is flanged and joined to a female 24/ as provided in paragraph (d)(2) of this 40 standard taper fitting. This provides for section. accommodating the 500-milliliter reservoir described in item I.E below. (1) The mineral oil consists of virgin D. A chromatographic column made from petroleum distillates refined to meet nominal 1.7 centimeters outside diameter × the following specifications: 115 centimeters glass tubing tapered at one (i) Distillation endpoint at 760 milli- end and joined to a 2-millimeter-bore tetra- meters pressure not to exceed 371 °C, fluoroethylene polymer stopcock. The oppo- with a maximum residue not to exceed site end is flanged and joined to a 2.5 centi- 2 percent, as determined by ASTM meters outside diameter × 9.0 centimeters method D86–82, ‘‘Standard Method for glass tube having a female 24/40 standard Distillation of Petroleum Products,’’ taper fitting. This provides for accommodating the 500-milliliter reservoir described which is incorporated by reference. The in item I. E below. availability of this incorporation by E. A 500-milliliter reservoir having a 24/40 reference is given in paragraph (b)(1)(i) standard taper male fitting at bottom and a of this section. suitable ball joint at the top for connecting (ii) Ultraviolet absorbance limits as to the nitrogen supply. The female fitting of follows as determined by the method the chromatographic columns described in described in paragraph (d)(3) of this items I. C and D above and the male fitting section. of the reservoir described in this item E should both be equipped with glass hooks.

Maximum (NOTE: Rubber stoppers are not to be used. absorb- µ ance per Stopcock grease is not to be used on ground- Wavelength (m ) centimeter glass joints in this method.) optical pathlength F. A spectrophotometer equipped to auto- matically record absorbance of liquid sam- 280 to 299 ...... 2.3 300 to 319 ...... 1.2 ples in 1-centimeter pathlength cells in the 320 to 359 ...... 8 spectral region of 280–400 mµ with a spectral 360 to 400 ...... 3 slit width of 2 mµ or less. At an absorbance level of about 0.4, absorbance measurements (iii) Pyrene content not to exceed a shall be repeatable within ±0.01 and accurate maximum of 25 parts per million as de- within ±0.05. Wavelength measurements shall ± µ termined by the method described in be repeatable with 0.2 m and accurate within ±1.0 mµ. Instrument operating condi- paragraph (d)(3) of this section. tions are selected to realize this performance (2) The mineral oil may be used only under dynamic (automatic) recording oper- in the processing of jute fiber employed ations. Accuracy of absorbance measure- in the production of textile bags in- ments are determined at 290, 345, and 400 mµ, tended for use in contact with the fol- using potassium chromate as the reference lowing types of food: Dry grains and standard. (National Bureau of Standards Cir- dry seeds (for example, beans, peas, cular 484, Spectrophotometry, U.S. Depart- rice, and lentils); whole root crop vege- ment of Commerce, 1949.) tables of the types identified in 40 CFR G. Two fused quartz cells having pathlengths of 1.00±0.005 centimeter or bet- 180.34(f); unshelled and shelled nuts (inter. cluding peanuts); and dry animal feed. II. Purity of reagents and materials. Reagent- The finished processed jute fiber shall grade chemicals shall be used in all tests. It contain no more than 6 percent by is further specified that each chemical shall weight of residual mineral oil. be tested for purity in accordance with the (3) The analytical method for deter- instruction given under ‘‘Reagents and Mate- mining ultraviolet absorbance limits rials’’ in III below. In addition, a blank run and pyrene content is as follows: by the procedure shall be made on each purified lot of reagents and materials. Unless I. Apparatus. A. Assorted beakers, sepa- otherwise indicated, references to water ratory funnels fitted with tetrafluoro- shall be understood to mean distilled water. ethylene polymer stopcocks, and graduated III. Reagents and materials— A. Organic sol- cylinders. vents. All solvents used throughout the pro- B. Volumetric flasks, 200-milliliter. cedure shall meet the specifications and C. A chromatographic column made from tests described in this section III. The iso- nominal 1.3 centimeters outside diameter × octane, benzene, cyclohexane, nitromethane, 75 centimeters glass tubing tapered at one and n-hexadecane designated shall pass the end and joined to a 2-millimeter-bore tetra- following test: To the specified quantity of

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solvent in a 150-milliliter beaker, add 1 milli- store in a vacuum desiccator. Reheating liter of purified n-hexadecane and evaporate about once a week is necessary if the silica on the steam bath under a stream of nitro- gel is repeatedly removed from the desic- gen. Discontinue evaporation when not over cator. 1 milliliter of residue remains (to the residue 5. Aluminum oxide (Aluminum Co. of America, from benzene and nitromethane add a 10-mil- Grade F-20, or equivalent grade). 80–200 mesh, liliter portion of purified isooctane, re-evap- purified and activated by the following pro- orate, and repeat once to insure complete re- cedure: Place about 1 kilogram of aluminum moval of solvent). Dissolve the 1 milliliter of oxide in a large column and wash with con- n-hexadecane residue in isooctane and make taminant-free benzene until a 200-milliliter to 10-milliliter volume. Determine the ab- sample of the benzene coming off the column sorbance in 1.0-centimeter pathlength cells will pass the ultraviolet absorption test for compared to water as reference. The absorb- benzene. This test is performed as stipulated ance of the solution of solvent residue shall under ‘‘Organic solvents’’ in A under III not exceed 0.05 between 280 and 400 mµ. above. (Caution! Remove Benzene From Ad- 1. Isooctane (2,2,4-trimethylpentane). Use 240 sorbent Under Vacuum To Minimize Explo- milliliters for the above test. Purify, if nec- sion Hazard in Subsequent Heating!) When essary, by passage through a column of acti- the aluminum oxide has been sufficiently vated silica gel. cleaned and freed of solvent, activate it be- 2. Benzene. Use 200 milliliters for the above fore use by placing the 1-kilogram batch in a test. Purify, if necessary, by distillation or shallow container in a layer no greater than otherwise. 1 inch in depth. Heat in an oven at 130 °C for 3. Cyclohexane. Use 70 milliliters for the 16 hours. Upon removal from heat, store at above test. Purify, if necessary, by distilla- atmospheric pressure over 80 percent (by tion, silica gel percolation, or otherwise. weight) sulfuric acid in a desiccator for at 4. Nitromethane. Use 125 milliliters for the least 36 hours before use. This gives alu- above test. Purify, if necessary, by distilla- minum oxide with between 6 to 9.5 percent tion or otherwise. volatiles. This is determined by heating a 5. n-Hexadecane. Determine the absorbance weighed sample of the prepared aluminum on this solvent directly. Purify, if necessary, oxide at 2,000 °F for 2 hours and then quickly by silica gel percolation or otherwise. reweighing. To insure the proper adsorptive B. Other materials—1. Pyrene standard ref- properties of the aluminum oxide, perform erence. Pyrene, reagent grade, melting point the following test: range 150–152 °C. (Organic Chemical 3627, a. Weigh 50 grams ±1 gram of the activated Eastman Kodak Co., Rochester, N.Y., or aluminum oxide and pack into the equivalent). The standard reference absorb- chromatographic column (1.3 centimeters × ance is the absorbance at 334 millimicrons of 75 centimeters) described under ‘‘Apparatus’’ a standard reference solution of pyrene con- in C under I above. Use glass wool at the col- taining a concentration of 1.0 milligram per umn exit to prevent the aluminum oxide liter in purified isooctane measured against from passing through the column. isooctane of the same spectral purity in 1.0- b. Place a 250-milliliter graduated cylinder centimeter cells. (This absorbance will be ap- under the column to measure the amount of proximately 0.28.) eluate coming from the column. 2. Chrysene solution. Prepare a solution at a c. Prewet the aluminum oxide by passing concentration of 5.0 milligrams per liter by 40 milliliters of isooctane through the col- dissolving 5.0 milligrams of chrysene in puri- umn. Adjust the nitrogen pressure so that fied isooctane in a 1-liter volumetric flask. the rate of descent of the isooctane coming Adjust to volume with isooctane. off the column is between 1.5 to 2.5 milli- 3. Nitrogen gas. Water pumped or equivalent liters per minute. purity, cylinder with regulator, and valve d. Just prior to the last of the isooctane control flow at 5 p.s.i. reaching the top of the aluminum oxide bed, 4. Silica gel. 100–200 mesh (Davison Chem- add 10 milliliters of the isooctane solution ical, Baltimore, Md., Grade 923, or equiva- containing 5.0 milligrams of chrysene per lent), purified and activated by the following liter. procedure: Place about 1 kilogram of silica e. Continue percolation until the isooctane gel in a large column and wash with con- is just above the aluminum oxide. Then add taminant-free benzene until a 200-milliliter 200 milliliters of a mixture of benzene and sample of the benzene coming off the column isooctane (331⁄3 percent benzene and 662⁄3 per- will pass the ultraviolet absorption test for cent isooctane by volume) to the reservoir benzene. This test is performed as stipulated and continue percolation. under ‘‘Organic solvents’’ in A under III f. Continue percolation, collecting the above. When the silica gel has been suffi- eluates (40 milliliters of the prewet solution, ciently cleaned, activate the gel before use 10 milliliters of the sample solution, and 200 by placing the 1-kilogram batch in a shallow milliliters of the gradient solution) in the container in a layer no greater than 1 inch in 250-milliliter graduated cylinder until the depth and heating in an oven (Caution! Ex- level of the gradient solution is just above plosion Hazard) at 130 °C. for 16 hours, and the aluminum oxide. Add 200 milliliters of

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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 tion until a 100-milliliter eluate has been ob- isooctane coming off the column is 2.0 to 3.0 tained. milliliters per minute. Be careful to main- h. Measure the amount of chrysene in this tain the level of solvent in the reservoir to 100-milliliter fraction by ultraviolet anal- prevent air from entering the aluminum ysis. If the aluminum oxide is satisfactory, oxide bed. New or additional solvent is added more than 80 percent of the original amount just before the last portion of the previous of chrysene should be found in this fraction. solvent enters the bed. To minimize possible (NOTE: If the amount of chrysene recovered photo-oxidation effects, the following proce- is less than 80 percent, the original batch of dures (steps 6 through 18) shall be carried out aluminum oxide should be sieved between in subdued light. 100–160 mesh. Activation and testing of this 6. Before the last of the isooctane reaches sieved batch should indicate a satisfactory the top of the aluminum oxide bed, release aluminum oxide for use.) the nitrogen pressure and turn off the stop- IV. Sampling. Precautions must be taken to cock on the column. Transfer the n-hexa- insure that an uncontaminated sample of the decane residue from the 150-milliliter beaker mineral oil is obtained since ultraviolet ab- from procedure step 3 above onto the col- sorption is very sensitive to small amounts umn, using several washes of isooctane (total of extraneous material contaminating the volume of washes should be no greater than sample through careless handling. 10–15 milliliters). V. Procedure. A. Blank. Before proceeding 7. Open the stopcock and continue percola- with the analysis of a sample, determine the tion until the isooctane is about 1 centi- absorbance of the solvent residues by car- meter above the top of the aluminum oxide rying out the procedure without a sample. bed. Add 200 milliliters of isooctane to the B. Sample. 1. Weigh out 20.0 grams ±0.1 reservoir, and continue the percolation at gram of the mineral oil into a beaker and the specified rate. transfer to a 250-milliliter separatory funnel 8. Just before the isooctane surface reaches fitted with a tetrafluoroethylene polymer the top of the aluminum oxide bed, add 200 stopcock, using enough cyclohexane (25 mil- milliliters of a mixture of benzene and iso- liliters) to give a final total volume of 50 octane (331⁄3 percent benzene and 662⁄3 percent milliliters (mineral oil plus cyclohexane). isooctane by volume) to the reservoir, and 2. Add 25 milliliters of nitromethane satu- continue the percolation. rated with cyclohexane and shake by hand 9. Just before the surface of this mixture vigorously for 3 minutes. Recover the lower reaches the top of the aluminum oxide bed, nitromethane layer in a 150-milliliter beaker release the nitrogen pressure, turn off the containing 1 milliliter of n-hexadecane and stopcock, and discard all the elution solvents evaporate on the steam bath under nitrogen. collected up to this point. Repeat the extraction four more times, re- 10. Add to the reservoir 300 milliliters of a covering each extract in the 150-milliliter mixture of benzene and isooctane (90 percent beaker. Exercise care not to fill the beaker benzene and 10 percent isooctane by volume), to such a capacity that solvent losses may place a 25-milliliter graduated cylinder occur. Evaporate the combined under the column, continue the percolation nitromethane extracts to 1 milliliter of n- until 20 milliliters of eluate has been col- hexadecane residue containing the lected, and then discard the eluate. nitromethane-soluble mineral oil extrac- 11. At this point, place a clean 250-milli- tives. (NOTE: Complete removal of the liter Erlenmeyer flask under the column. nitromethane is essential. This can be as- Continue the percolation and collect all the sured by two successive additions of 5 milli- remaining eluate. liters of isooctane and reevaporation.) (NOTE: Allow the column to drain com- 3. Remove the beaker from the steam bath pletely. An increase in the nitrogen pressure and allow to cool. may be necessary as the last of the solvent 4. Weigh 50 grams ±1 gram of activated alu- comes off the column.) minum oxide and pack into the 12. Place 1 milliliter of n-hexadecane into a chromatographic column (1.3 centimeters × 150-milliliter beaker. Place this onto a steam 75 centimeters) described under ‘‘Apparatus’’ bath under a nitrogen stream and transfer in in C under I above. (NOTE: A small plug of small portions the eluate from step 11 above. glass wool is placed at the column exit to Wash out the Erlenmeyer flask with small prevent the aluminum oxide from passing amounts of benzene and transfer to the evap- through the column. After adding aluminum oration beaker. Evaporate until only 1 milli- oxide, tap the column lightly to remove air liter of hexadecane residue remains. (NOTE:

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Complete removal of the benzene is essen- 18. Transfer the residue with several wash- tial. This can be assured by two successive es of isooctane into a 200-milliliter volu- additions of 5 milliliters of isooctane and re- metric flask. Add isooctane to mark. evaporation.) 19. Record the spectrum of the sample solu- 13. Remove the beaker from the steam bath tion in a 1-centimeter cell compared to iso- and cool. octane from 270 to 400 mµ. After making nec- 14. Place a sample of 113.5 grams activated essary corrections in the spectrum for cell 100- 200-mesh silica gel in a 500-milliliter differences and for the blank absorbance, glass-stoppered Erlenmeyer flask. Add to the record the maximum absorbance in each of silica gel 46.2 grams (41 milliliters) of the wavelength intervals (mµ), 280–299, 300– nitromethane. Stopper and shake the flask 319, 320–359, 360–400. vigorously until no lumps of silica gel are a. If the spectrum then shows no discern- observed and then shake occasionally during ible peak corresponding to the absorbance a period of 1 hour. The resultant maximum of the pyrene reference standard µ nitromethane-treated silica gel is 29 weight- solution at 334 m , the maximum percent nitro-methane and 71 weight-percent absorbances in the respective wavelength in- silica gel. tervals recorded shall not exceed those pre- 15. Place a small plug of glass wool in the scribed in paragraph (d)(1)(ii) of this section. b. If such a peak is evident in the spectrum tapered end of the 1.7 centimeters outside di- of the sample solution, and the spectrum as ameter × 115 centimeters column, described a whole is not incompatible with that of a under ‘‘Apparatus’’ in D of I above, adjacent pyrene contaminant yielding such a peak of to the stopcock to prevent silica gel from the observed absorbance, calculate the con- passing through the stopcock. Pack the centration of pyrene that would yield this nitromethane-treated silica gel into the col- peak (334 m) by the base-line technique de- umn, tapping lightly. The resultant silica gel scribed in ASTM method E169–63 (Re- bed should be about 95 centimeters in depth. approved 1981), ‘‘Standard Recommended Place into a flask 170 milliliters of isooctane Practices for General Techniques of Ultra- saturated with nitromethane. violet Quantitative Analysis,’’ which is in- 16. Place a 100-milliliter graduated cyl- corporated by reference. The availability of inder under the column and transfer the res- this incorporation by reference is given in idue from the beaker in procedure step 13 paragraph (b)(1)(i) of this section. Correct above with several washes of the 170 milli- each of the maximum absorbances in the re- liters of isooctane, saturated with spective specified wavelength intervals by nitromethane, onto the top of the column. subtracting the absorbance due to pyrene, (Total volume of washes should be no greater determined as follows: than 10 to 15 milliliters.) Permit isooctane solution to enter the silica gel bed until the Cp × Sa liquid level is at the top bed level. Place the Absorbance due to pyrene = remaining amount of the 170 milliliters of Sp isooctane, saturated with nitromethane, in the reservoir above the bed for percolation where: through the silica gel. Apply nitrogen pres- Cp=Calculated concentration of pyrene in sure to the top of the column, adjusting the sample solution; pressure so that the isooctane is collected at Sp=Concentration of pyrene reference stand- the rate of 2.5 to 3.5 milliliters per minute, ard solution in same units of concentra- and percolate isooctane through the bed tion; until a quantity of 75.0 milliliters of eluate is Sa=Absorbance of pyrene reference standard collected. Discard the 75 milliliters of eluate. solution at wavelength of maximum ab- Turn off the stopcock and add 250 milliliters sorbance of sample solution in the respec- of benzene to the reservoir above the bed. tive specified wavelength intervals. Use a 400-milliliter beaker to collect the re- Also calculate the pyrene content of the maining eluate. oil sample in parts per million as follows: 17. Open the stopcock, renew the pressure, Pyrene content (/200 1000 )× C and percolate the remaining isooctane and = = 10C benzene through the column eluting the re- (p.p.m.) maining aromatics. Transfer the eluate in 20/ 1000 small portions from the 400 milliliter beaker where: to a 150-milliliter beaker containing 1 milli- C=Calculated concentration of pyrene in milliter of n-hexadecane and evaporate on the ligrams per liter of sample solution. steam bath under nitrogen. Rinse the 400- c. The pyrene content so determined shall milliliter beaker well with small portions of not exceed 25 p.p.m. The maximum isooctane to obtain a complete transfer. absorbances corrected for pyrene content as (NOTE: Complete removal of the described in this step 19 for each of the speci- nitromethane and benzene is essential. This fied wavelength intervals shall not exceed can be assured by successive additions of 5 the limits prescribed in paragraph (d)(1)(ii) milliliters of isooctane and reevaporation.) of this section.

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d. If the spectrum as a whole of the sample The additive is chiefly paraffinic, solution is in any respect clearly incompat- isoparaffinic, or naphthenic in nature. ible with the presence of pyrene as the (b) The additive meets the following source of the peak at 334 mµ, then the maximum absorbances in the respective wave- specifications: length intervals without correction for any (1) Odor is faint and not kerosenic. assumed pyrene content shall not exceed the (2) Initial boiling point is 300 °F min- limits prescribed in paragraph (d)(1)(ii) of imum. this section. (3) Final boiling point is 650 °F max- [42 FR 14609, Mar. 15, 1977, as amended at 47 imum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, (4) Ultraviolet absorbance limits de- 1984; 54 FR 24898, June 12, 1989] termined by method specified in § 178.3620(b)(1)(ii), as follows: § 178.3650 Odorless light petroleum hydrocarbons. Maximum absorb- Odorless light petroleum hydro- Wavelength (Mµ) ance per carbons may be safely used, as a com- centimeter optical ponent of nonfood articles intended for pathlength use in contact with food, in accordance with the following prescribed condi- 280 to 289 ...... 4.0 290 to 299 ...... 3.3 tions: 300 to 329 ...... 2.3 (a) The additive is a mixture of liquid 330 to 360 ...... 8 hydrocarbons derived from petroleum or synthesized from petroleum gases. (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.

§ 178.3690 Pentaerythritol adipate-ste- acids (chiefly palmitic) comprising 71 arate. percent of the organic moieties. (b) Specifications. Pentaerythritol adi- Pentaerythritol adipate-stearate pate-stearate has the following speci- identified in paragraph (a) of this sec- fications: tion may be safely used as a lubricant (1) Melting point (dropping) of 55–58 in the fabrication of rigid and semi- °C as determined by ASTM method rigid polyvinyl chloride and/or vinyl D566–76 (Reapproved 1982), ‘‘Standard chloride-propylene copolymers com- Test Method for Dropping Point of Lu- plying with § 177.1980 of this chapter bricating Grease,’’ which is incor- used as articles or components of arti- porated by reference. Copies may be cles that contact food, excluding food obtained from the American Society with alcohol content greater than 8 for Testing Materials, 1916 Race St., percent under conditions of use of E, F, Philadelphia, PA 19103, or may be ex- and G described in table 2 in § 175.300(d) amined at the Office of the Federal of this chapter, subject to the provi- Register, 800 North Capitol Street, sions of this section. NW., suite 700, Washington, DC 20408. (a) Identity. For the purpose of this (2) Acid value not to exceed 15 as de- section, pentaerythritol adipate-stea- termined by ASTM method D1386–78, rate is an ester of pentaerythritol with ‘‘Standard Test Method for Saponifica- adipic acid and stearic acid and its as- tion Number (Empirical) of Synthetic sociated fatty acids (chiefly palmitic), and Natural Waxes’’ (Revised 1978), with adipic acid comprising 14 percent which is incorporated by reference. and stearic acid and its associated Copies are available from American So- ciety for Testing and Materials

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(ASTM), 1916 Race Street, Philadel- Ultraviolet absorbance per centi- phia, PA 19103, or available for inspec- meter pathlength: tion at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., Millimicrons Maximum suite 700, Washington, DC 20408. 280 to 289 ...... 0.25 (3) Saponification number of 270–280 290 to 299 ...... 20 as determined by ASTM method D1387– 300 to 359 ...... 14 78, ‘‘Standard Test Method for Acid 360 to 400 ...... 04 Number (Empirical) of Synthetic and (c) It is used or intended for use as a Natural Waxes’’ (Revised 1978), which is protective coating of the surfaces of incorporated by reference. Copies are metal or wood tanks used in fermenta- available from American Society for tion process, in an amount not in ex- Testing and Materials (ASTM), 1916 cess of that required to produce its in- Race Street, Philadelphia, PA 19103, or tended effect. available for inspection at the Office of (d) Petrolatum as defined by this sec- the Federal Register, 800 North Capitol tion may be used for the functions de- Street, NW., suite 700, Washington, DC scribed and within the limitations pre- 20408. (4) Iodine number not to exceed 2 as scribed by specific regulations in parts determined by Iodine Absorption Num- 175, 176, 177, and 178 of this chapter ber, Hanus Method, of the ‘‘Official which prescribe uses of petrolatum. Methods of Analysis of the Association For the purpose of cross-reference, of Official Analytical Chemists,’’ sec- such specific regulations include: tions 28.018–28.019, 13th Ed. (1980), which §§ 175.105, 175.125, 175.300, 176.170, 176.200, is incorporated by reference. Copies 176.210, 177.2600, 177.2800, and 178.3570 of may be obtained from the Association this chapter. of Official Analytical Chemists Inter- (e) Petrolatum may contain any anti- national, 481 North Frederick Ave., oxidant permitted in food by regula- suite 500, Gaithersburg, MD 20877–2504, tions issued pursuant to section 409 of or may be examined at the Office of the the act, in an amount not greater than Federal Register, 800 North Capitol that required to produce its intended Street, NW., suite 700, Washington, DC effect. 20408. [42 FR 14609, Mar. 15, 1977, as amended at 49 (c) The total amount of ester (cal- FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, culated as free pentaerythritol) shall 1990] not exceed 0.4 percent by weight of the polyvinyl chloride and/or the vinyl § 178.3710 Petroleum wax. chloride-propylene copolymers com- Petroleum wax may be safely used as plying with § 177.1980. a component of nonfood articles in contact with food, in accordance with the [45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; following conditions: 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. (a) Petroleum wax is a mixture of 29, 1992] solid hydrocarbons, paraffinic in nature, derived from petroleum, and re- § 178.3700 Petrolatum. fined to meet the specifications pre- Petrolatum may be safety used as a scribed in this section. component of nonfood articles in con- (b) The petroleum wax meets the fol- tact with food, in accordance with the lowing ultraviolet absorbance limits following conditions: when subjected to the analytical proce- (a) Petrolatum complies with the dure described in § 172.886(b) of this specifications set forth in the United chapter. 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

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(c) Petroleum wax may contain any 27029–57–8), as described in § 172.886(c)(2) antioxidant permitted in food by regu- of this chapter, as a processing aid in lations issued in accordance with sec- the manufacture of petroleum wax. tion 409 of the act, in an amount not greater than that required to produce [42 FR 14609, Mar. 15, 1977, as amended at 51 its intended effect. FR 19545, May 30, 1986] (d) Petroleum wax may contain a total of not more than 1 weight percent § 178.3720 Petroleum wax, synthetic. of residues of the following polymers Synthetic petroleum wax may be when such residues result from use of safely used in applications and under the polymers as processing aids (filter the same conditions where naturally aids) in the production of the petro- derived petroleum wax is permitted in leum wax: Homopolymers and/or co- subchapter B of this chapter as a com- polymers derived from one or more of ponent of articles intended to contact the mixed n-alkyl (C12, C14, C16, and C18) food, provided that the synthetic petro- methacrylate esters where the C12 and leum wax meets the definition and C14 alkyl groups are derived from coco- specifications prescribed in § 172.888 of nut oil and the C16 and C18 groups are this chapter. derived from tallow. (e) Petroleum wax may contain 2-hy- § 178.3725 Pigment dispersants. droxy-4-n-octoxybenzophenone as a stabilizer at a level not to exceed 0.01 Subject to the provisions of this reg- weight percent of the petroleum wax. ulation, the substances listed in this (f) Petroleum wax may contain section may be safely used as pigment poly(alkylacrylate) (CAS Reg. No. dispersants in food-contact materials.

Substances Limitations

Dimethylolpropionic acid (CAS Reg. No. 4767Ð03Ð7) ...... 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. 68604Ð99Ð9), 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 221281Ð21Ð6) . 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. 155419Ð59Ð3) . 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. 77Ð85Ð0) ...... 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 food in compliance with §§ 193.60 and FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 193.390 of this chapter. 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000] § 178.3740 Plasticizers in polymeric substances. § 178.3730 Piperonyl butoxide and pyrethrins as components of bags. Subject to the provisions of this regulation, the substances listed in para- Piperonyl butoxide in combination graph (b) of this section may be safely with pyrethrins may be safely used for used as plasticizers in polymeric sub- insect control on bags that are in- stances used in the manufacture of ar- tended for use in contact with dried ticles or components of articles in- feed in compliance with §§ 561.310 and tended for use in producing, manufac- 561.340 of this chapter, or that are intended for use in contact with dried turing, packing, processing, preparing,

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treating, packaging, transporting, or to accomplish the intended technical holding food. effect. (a) The quantity used shall not ex- (b) List of substances: ceed the amount reasonably required

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 (1,700Ð 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.

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.

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Substances Limitations

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 ...... 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, IVÐB, VIÐB, 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.

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Substances Limitations

Mineral oil, white . 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 D445Ð82 (‘‘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 D2161Ð82 (‘‘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 D1492Ð78 (‘‘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, 1916 Race St., Phila- delphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Polyisobutylene (mol weight 300Ð5,000) ...... 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. 25322Ð69Ð 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, VIÐB, VIIÐB, and VIII.

(c) The use of the plasticizers in any ular weight is 350 or higher and no polymeric substance or article subject more than 0.5 percent total by weight to any regulation in parts 174, 175, 176, of ethylene and diethylene glycols if its 177, 178 and 179 of this chapter must mean molecular weight is below 350, comply with any specifications and when tested by the analytical methods limitations prescribed by such regula- prescribed in § 172.820(b) of this chapter. tion for the finished form of the sub- (c) The provisions of paragraph (b) of stance or article. this section are not applicable to poly- [42 FR 14609, Mar. 15, 1977, as amended at 42 ethylene glycols used in food-pack- FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, aging adhesives complying with 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, § 175.105 of this chapter. Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] § 178.3760 Polyethylene glycol (400) § 178.3750 Polyethylene glycol (mean monolaurate. molecular weight 200–9,500). Polyethylene glycol identified in this Polyethylene glycol (400) section may be safely used as a compo- monolaurate containing not more than nent of articles intended for use in con- 0.1 percent by weight of ethylene and/ tact with food, in accordance with the or diethylene glycol may be used at a following prescribed conditions: level not to exceed 0.3 percent by (a) The additive is an addition poly- weight of twine as a finish on twine to mer of ethylene oxide and water with a be used for tying meat provided the mean molecular weight of 200 to 9,500. twine fibers are produced from nylon (b) It contains no more than 0.2 per- resins complying with § 177.1500 of this cent total by weight of ethylene and chapter. diethylene glycols if its mean molec-

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§ 178.3770 Polyhydric alcohol esters of ican Society for Testing and Materials oxidatively refined (Gersthofen (ASTM), 1916 Race Street, Philadel- process) montan wax acids. phia, PA 19103, or available for inspec- Polyhydric alcohol esters of tion at the Office of the Federal Reg- oxidatively refined (Gersthofen proc- ister, 800 North Capitol Street, NW., ess) montan wax acids identified in this suite 700, Washington, DC 20408) using section may be safely used as compo- xylene-ethyl alcohol in a 2:1 ratio in- nents of articles intended for use in stead of ethyl alcohol in preparation of contact with food in accordance with potassium hydroxide solution. the following prescribed conditions: (4) Ultraviolet absorbance limits as (a) The polyhydric alcohol esters follows, as determined by the analyt- identified in this paragraph may be ical method described in this subpara- used as lubricants in the fabrication of graph: vinyl chloride plastic food-contact ar- Ultraviolet absorbance per centi- ticles prepared from polyvinyl chloride meter pathlength. and/or from vinyl chloride copolymers complying with § 177.1980 of this chap- Millimicrons Maximum ter. Such esters meet the following specifications and are produced by par- 280 to 289 ...... 0.07 290 to 299 ...... 06 tial esterification of oxidatively re- 300 to 359 ...... 04 fined (Gersthofen process) montan wax 360 to 400 ...... 01 acids by either ethylene glycol or 1,3- butanediol with or without neutraliza- ANALYTICAL METHOD tion of unreacted carboxylic groups with calcium hydroxide: GENERAL INSTRUCTIONS ° ° (1) Dropping point 76 –105 C, as de- Because of the sensitivity of the test, the termined by ASTM method D566–76 possibility of errors arising from contamina- (Reapproved 1982), ‘‘Standard Test tion is great. It is of the greatest importance Method for Dropping Point of Lubri- that all glassware be scrupulously cleaned to cating Grease,’’ which is incorporated remove all organic matter such as oil, by reference. Copies may be obtained grease, detergent residues, etc. Examine all from the American Society for Testing glassware, including stoppers and stopcocks, Materials, 1916 Race St., Philadelphia, under ultraviolet light to detect any residual fluorescent contamination. As a pre- PA 19103, or may be examined at the cautionary measure it is recommended prac- Office of the Federal Register, 800 tice to rinse all glassware with purified iso- North Capitol Street, NW., suite 700, octane immediately before use. No grease is Washington, DC 20408. to be used on stopcocks or joints. Great care (2) Acid value 10–20, as determined by to avoid contamination of wax samples in ASTM method D1386–78 (‘‘Standard handling and to assure absence of any extra- Test Method for Acid Number (Empir- neous material arising from inadequate ical) of Synthetic and Natural Waxes’’ packaging is essential. Because some of the polynuclear hydrocarbons sought in this test (Revised 1978), which is incorporated by are very susceptible to photo-oxidation, the reference; copies are available from entire procedure is to be carried out under American Society for Testing and Ma- subdued light. terials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for APPARATUS inspection at the Office of the Federal Separatory funnels. 250-milliliter, 500-milli- Register, 800 North Capitol Street, liter, 1,000-milliliter, and preferably 2,000- NW., suite 700, Washington, DC 20408) milliliter capacity, equipped with tetra- using as solvent xylene-ethyl alcohol fluoroethylene polymer stopcocks. in a 2:1 ratio instead of toluene-ethyl Reservoir. 1,000-milliliter capacity, alcohol in a 2:1 ratio. equipped with a 24/40 standard taper male fit- (3) Saponification value 100–160, as ting at the bottom and a suitable balljoint at determined by ASTM method D1387–78 the top. (‘‘Standard Test Method for Saponi- Chromatographic tube. 1,200 millimeters in length, inside diameter to be 16.5 millimeters fication Number (Empirical) of Syn- ±0.5 millimeter, equipped with a coarse, frit- thetic and Natural Waxes’’ (Revised ted-glass disc, a tetrafluoroethylene polymer 1978), which is incorporated by ref- stopcock, and a female 24/40 standard tapered erence; copies are available from Amer- fitting at the opposite end. (Overall length of

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the column with the female joint is 1,255 mil- Wavelength accuracy, ±1.0 millimicron. limeters.) The female fitting should be Recording time, 50 seconds. equipped with glass hooks. Time constant, 0.6 second. Disc. Tetrafluoroethylene polymer 2-inch Sensitivity, 30. diameter disc approximately 3⁄16-inch thick Ordinate scale, 90–100 percent transmission with a hole bored in the center to closely fit through scale. the stem of the chromatographic tube. Abscissa scale, 8X. Heating jackets. Conical, for 500-milliliter Nitrogen cylinder. Water-pumped or equiva- and 1,000-milliliter separatory funnels. (Used lent purity nitrogen in cylinder equipped with variable transformer heat control.) with regulator and valve to control flow at 5 Suction flask. 250-milliliter or 500-milliliter p.s.i.g. filter flask. Condenser. 24⁄40 joints, fitted with a drying REAGENTS AND MATERIALS tube, length optional. Organic solvents. All solvents used through- Evaporation flasks (optional). A 250-milli- out the procedure shall meet the specifica- liter or 500-milliliter capacity and a 1-liter tions and tests described in this specifica- capacity all-glass flask equipped with stand- tion. The isooctane and benzene designated ard taper stopper having inlet and outlet in the list following this paragraph shall tubes to permit passage of nitrogen across pass the following test: the surface of contained liquid to be evapo- To be specified quantity of solvent in a 250- rated. milliliter Erlenmeyer flask, add 1 milliliter Vacuum distillation assembly. All glass (for of purified n-hexadecane and evaporate on purification of dimethyl sulfoxide) 2-liter the steam bath under a stream of nitrogen (a distillation flask with heating mantle; loose aluminum foil jacket around the flask Vigreaux vacuum-jacketed condenser (or will speed evaporation). Discontinue evapo- equivalent) about 45 centimeters in length ration when not over 1 milliliter of residue and distilling head with separable cold finger remains. (To the residue from benzene add a condenser. Use of tetrafluoroethylene poly- 10-milliliter portion of purified isooctane, re- mer sleeves on the glass joints will prevent evaporate, and repeat once to insure com- freezing. Do not use grease on stopcocks or plete removal of benzene.) joints. Alternatively, the evaporation time can be ° Oil bath. Capable of heating to 90 C. reduced by using the optional evaporation Spectrophotometric cells. Fused quartz cells, flask. In this case the solvent and n-hexa- optical pathlength in the range 1.000 centi- decane are placed in the flask on the steam ± meter 0.005 centimeter. With distilled water bath, the tube assembly is inserted, and a in the cells, determine any absorbance dif- stream of nitrogen is fed through the inlet ferences. tube while the outlet tube is connected to a Spectrophotometer. Spectral range 250 milli- solvent trap and vacuum line in such a way microns-400 millimicrons with spectral slit as to prevent any flow-back of condensate width of 0.2 millimicron or less; under in- into the flask. strument operating conditions for these ab- Dissolve the 1 milliliter of hexadecane res- sorbance measurements. The spectrophotom- idue in isooctane and make up to 25 milli- eter shall also meet the following perform- liters volume. Determine the absorbance in ance requirements: the 1-centimeter pathlength cells compared ± Absorbance repeatability, 0.01 at 0.4 ab- to isooctane as reference. The absorbance of sorbance. the solution of the solvent residue (except 1 ± Absorbance accuracy, 0.05 at 0.4 absorb- for methyl alcohol) shall not exceed 0.01 per ance. centimeter pathlength between 280 mµ and ± Wavelength repeatability, 0.2 milli- 400 mµ. micron. Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test described in the pre- 1 As determined by procedure using potas- ceding paragraph. Purify, if necessary, by sium chromate for reference standard and passage through a column of activated silica described in National Bureau of Standards gel (Grade 12, Davison Chemical Co., Balti- Circular 484, Spectrometry, U.S. Department more, Md., or equivalent) about 90 centi- of Commerce (1949). The accuracy is to be de- meters in length and 5 centimeters to 8 cen- termined by comparison with the standard timeters in diameter. values at 290, 345, and 400 millimicrons. Cir- Benzene, A.C.S. reagent grade. Use 150 milli- cular 484 is incorporated by reference. Copies liters for the test. Purify, if necessary, by are available from the Center for Food Safe- distillation or otherwise. ty and Applied Nutrition (HFS–200), Food n-Hexadecane, 99 percent olefin-free. Dilute and Drug Administration, 5100 Paint Branch 1.0 milliliter of n-hexadecane to 25 milliliters Pkwy., College Park, MD 20740, or available with isooctane and determine the absorbance for inspection at the Office of the Federal in a 1-centimeter cell compared to isooctane Register, 800 North Capitol Street, NW., as reference point between 280 mµ-400 mµ. suite 700, Washington, DC 20408. The absorbance per centimeter pathlength

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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 nitrogen. Discontinue evaporation when not remain. Allow to stand at room temperature over 1 milliliter of residue remains. To the for a period of 2 hours. At the end of this residue, add a 10-milliliter portion of iso- time the water should be evenly distributed octane and reevaporate to 1 milliliter of throughout the aluminum oxide powder, and hexadecane. Again, add 10 milliliters of iso- it should have the same free flowing prop- octane to the residue and evaporate to 1 mil- erties as the original material (flow velocity liliter of hexadecane to insure complete re- with water 0.2 milliliter per minute). At this moval of all volatile materials. Dissolve the point the aluminum oxide has an activity of 1 milliliter of hexadecane in isooctane and 1 as expressed in Brockmann degrees, and make to 25-milliliter volume. Determine the the amount of added water is 0.5 percent by absorbance in 1-centimeter pathlength cells volume. This product is used in toto and as compared to isooctane as reference. The ab- is, without further screening. sorbance of the solution should not exceed Sodium sulfate, anhydrous, A.C.S. reagent 0.02 per centimeter pathlength in the 280 mµ- grade, preferably in granular form. For each 400 mµ range. (NOTE: Difficulty in meeting bottle of sodium sulfate reagent used, estab- this absorbance specification may be due to lish as follows the necessary sodium sulfate organic impurities in the distilled water. prewash to provide such filters required in Repetition of the test omitting the dimethyl the method: Place approximately 35 grams of sulfoxide will disclose their presence. If nec- anhydrous sodium sulfate in a 30-milliliter essary to meet the specification, purify the coarse, fritted-glass funnel or in a 65-milli- water by redistillation, passage through an meter filter funnel with glass wool plug; ion-exchange resin, or otherwise.) wash with successive 15-milliliter portions of Purify, if necessary, by the following pro- the indicated solvent until a 15-milliliter cedure: To 1,500 milliliters of dimethyl sulf- portion of the wash shows 0.00 absorbance oxide in a 2-liter glass-stoppered flask, add per centimeter pathlength between 280 mµ 6.0 milliliters of phosphoric acid and 50 and 400 mµ when tested as prescribed under

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‘‘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 Before proceeding with analysis of a sam- few minutes after the last extractive has ple, determine the absorbance in a 1-centi- been added. Add 80 milliliters of isooctane to meter path cell between 250 mµ and 400 mµ the solution and extract by shaking the fun- for the reagent blank by carrying out the nel vigorously for 2 minutes. Draw off the procedure, without a wax sample, at room lower aqueous layer into a second separatory 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 the wax redissolves. (Remove stopper from chromatographic tube, then place the tube the funnel at intervals to release pressure.) with the disc on the suction flask and apply When the wax is in solution, remove the fun- the vacuum (approximately 135 millimeters nel from the jacket and shake it vigorously Hg pressure). Weigh out 180 grams of the alu- for 2 minutes. Set up three 250-milliliter minum oxide and pour the adsorbent mixture separatory funnels with each containing 30 into the chromatographic tube in approxi- milliliters of preequilibrated isooctane. mately 30-centimeter layers. After the addi- After separation of the liquid phases, allow tion of each layer, level off the top of the ad- to cool until the main portion of the wax-iso- sorbent with a flat glass rod or metal plung- octane solution begins to show a precipitate. er by pressing down firmly until the adsorb- Gently swirl the funnel when precipitation ent is well packed. Loosen the topmost few first occurs on the inside surface of the fun- millimeters of each adsorbent layer with the nel to accelerate this process. Carefully draw end of a metal rod before the addition of the off the lower layer, filter it slowly through a next layer. Continue packing in this manner thin layer of glass wool fitted loosely in a fil- until all the 180 grams of the adsorbent is ter funnel into the first 250-milliliter sepa- added to the tube. Level off the top of the ad- ratory funnel, and wash in tandem with the sorbent by pressing down firmly with a flat 30-milliliter portions of isooctane contained glass rod or metal plunger to make the depth in the 250-milliliter separatory funnels. of the adsorbent bed approximately 80 centi- Shaking time for each wash is 1 minute. Re- meters in depth. Turn off the vacuum and repeat the extraction operation with two addi- move the suction flask. Dissolve the hexa- tional portions of the sulfoxide-acid mixture, decane residue in 10 milliliters of warm ben- replacing the funnel in the jacket after each zene and decant the solution onto the col- extraction to keep the wax in solution and umn and allow the liquid level to recede to washing each extractive in tandem through barely above the adsorbent level. Rapidly the same three portions of isooctane. complete the transfer similarly with two 10-

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milliliter portions of benzene swirling the reference; copies are available from flask repeatedly each time to assure ade- American Society for Testing and Ma- quate washing of the residue. Fix the 1,000- terials (ASTM), 1916 Race Street, milliliter reservoir onto the top of the chromatographic column. Just before the Philadelphia, PA 19103, or available for final 10-milliliter wash reaches the top of the inspection at the Office of the Federal adsorbent, add 670 milliliters of benzene to Register, 800 North Capitol Street, the reservoir and continue the percolation at NW., suite 700, Washington, DC 20408) the 2–3 milliliter per minute rate until a using as solvent xylene-ethyl alcohol total of 670 milliliters of benzene has been in a 2:1 ratio instead of toluene-ethyl utilized. Collect the eluate in a clean 1-liter alcohol in a 1:2 ratio. Erlenmeyer flask (or optionally into a 1-liter (3) Saponification value 135–150, as evaporation flask). Allow the column to drain until most of the solvent mixture is re- determined by ASTM method D1387–78 moved. Add 1 milliliter of n-hexadecane and (‘‘Standard Test Method for Saponi- completely remove the benzene by evapo- fication Number (Empirical) of Syn- ration under nitrogen, using the special pro- thetic and Natural Waxes’’ (Revised cedure to eliminate benzene as previously 1978), which is incorporated by ref- described under ‘‘Organic Solvents.’’ Quan- erence; copies are available from Amer- titatively transfer the residue with isooctane ican Society for Testing and Materials to a 25-milliliter volumetric flask and adjust (ASTM), 1916 Race Street, Philadel- to volume. Determine the absorbance of the solution in the 1-centimeter pathlength cells phia, PA 19103, or available for inspec- compared to isooctane as reference between tion at the Office of the Federal Reg- 250 mµ-400 mµ. Correct for any absorbance ister, 800 North Capitol Street, NW., derived from the reagents as determined by suite 700, Washington, DC 20408) using carrying out the procedure without a wax xylene-ethyl alcohol in a 2:1 ratio in- sample. If either spectrum shows the char- stead of ethyl alcohol in preparation of acteristic benzene peaks in the 250 mµ-260 mµ potassium hydroxide solution. region, evaporate the solution to remove (4) Ultraviolet absorbance limits benzene by the procedure under ‘‘Organic Solvents.’’ Dissolve the residue, transfer specified in paragraph (a)(4) of this sec- quantitatively, and adjust to volume in iso- tion, as determined by the analytical octane in a 25-milliliter volumetric flask. method described therein. Record the absorbance again. If the cor- (c) The polyhydric alcohol esters of rected absorbance does not exceed the limits oxidatively refined (Gersthofen proc- prescribed in paragraph (a) of this section, ess) montan wax acids, identified in the wax meets the ultraviolet absorbance paragraph (a) or (b) of this section, specifications. may also be used as a component of an (b) The polyhydric alcohol esters aqueous dispersion of vinylidene chlo- identified in this paragraph may be ride copolymers, subject to the condi- used as release agents in resinous and tions described in paragraphs (c) (1) polymeric coatings for polyolefin films and (2) of this section. complying with § 175.320 of this chapter. (1) The aqueous dispersion of the ad- Such esters meet the following speci- ditive contains not more that 18 per- fications and are produced by partial cent polyhydric alcohol esters of esterification of oxidatively refined oxidatively refined (Gersthofen proc- (Gersthofen process) montan wax acids ess) montan wax acids, not more than 2 with equimolar proportions of ethylene percent poly(oxyethylene) (minimum glycol and 1,3-butanediol: 20 moles of ethylene oxide) oleyl ether (1) Dropping point 77°–82 °C, as deter- (CAS Reg. No. 9005–98–2), and not more mined by ASTM method D566–76 (Re- than 1 percent poly(oxyethylene) (min- approved 1982), ‘‘Standard Test Method imum 3 moles ethylene oxide) cetyl al- for Dropping Point of Lubricating cohols (CAS Reg. No. 9004–95–9). Grease,’’ which is incorporated by ref- (2) The aqueous dispersion described erence. The availability of this incor- in paragraph (c)(1) of this section is poration by reference is given in para- used as an additive to aqueous disper- graph (a)(1) of this section. sions of vinylidene chloride copoly- (2) Acid value 25–35, as determined by mers, regulated in §§ 175.300, 175.320, ASTM method D1386–78 (‘‘Standard 175.360, 176.170, 176,180, and 177.1630 of Test Method for Acid Number (Empir- this chapter, at levels not to exceed 1.5 ical) of Synthetic and Natural Waxes’’ percent (solids basis) in the finished (Revised 1978), which is incorporated by coating.

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(d) The polyhydric alcohol esters § 178.3780 Polyhydric alcohol esters of identified in this paragraph may be long chain monobasic acids. used as lubricants in the fabrication of Polyhydric alcohol esters of long vinyl chloride plastic food contact arti- chain monobasic acids identified in cles prepared from vinyl chloride poly- this section may be safely used as lu- mers. Such esters meet the following bricants in the fabrication of polyvinyl specifications and are produced by par- chloride and/or polyvinyl chloride co- tial esterification of oxidatively re- polymer articles complying with fined (Gersthofen process) montan wax § 177.1980 of this chapter that contact acids with glycerol followed by neu- food of Types I, II, IV-B, VI-B, VII-B, tralization: and VIII identified in table 1 in (1) Dropping point 79 to 85 °C, as de- § 176.170(c) of this chapter under condi- termined by the American Society for tions of use E, F, and G described in Testing and Materials (ASTM), Method table 2 in § 176.170(c) of this chapter, D–566–76 (Reapproved 1982), ‘‘Standard subject to the provisions of this sec- Test Method for Dropping Point of Lu- tion. bricating Grease,’’ which is incor- (a) Identity. For the purpose of this porated by reference in accordance section, polyhydric alcohol esters of with 5 U.S.C. 552(a). The availability of long chain monobasic acids consist of this incorporation by reference is given polyhydric alcohol esters having num- in paragraph (a)(1) of this section. ber average molecular weights in the range of 1,050 to 1,700. The esters are (2) Acid value 20–30, as determined by produced by the reaction of either ASTM Method D–1386–78 ‘‘Standard ethylene glycol or glycerol with long Test Method for Acid Number (Empir- chain monobasic acids containing from ical) of Synthetic and Natural Waxes’’ 9 to 49 carbon atoms obtained by the (Revised 1978) (which is incorporated by ozonization of long chain alpha-olefins, reference in accordance with 5 U.S.C. the unreacted carboxylic acids in the 552(a); the availability of this incorpo- formation of the glycerol esters being ration by reference is given in para- neutralized with calcium hydroxide to graph (a)(2) of this section), using as a produce a composition having up to 2 solvent xylene-ethyl alcohol in a 2:1 percent by weight calcium. The alpha- ratio instead of toluene-ethyl alcohol olefins, obtained from the polymeriza- in a 2:1 ratio. tion of ethylene, have 20 to 50 carbon (3) Saponification value 130–160, as atoms and contain a minimum of 75 determined by ASTM Method D–1387–78 percent by weight straight chain alpha- ‘‘Standard Test Method for Saponifica- olefins and not more than 25 percent tion Number (Empirical) of Synthetic vinylidene compounds. and Natural Waxes’’ (Revised 1978), (b) Specifications. The polyhydric al- (which is incorporated by reference in cohol esters have the following speci- accordance with 5 U.S.C. 552(a); the fications: availability of this incorporation by (1) Melting point of 60–80 °C for the ° reference is given in paragraph (a)(3) of ethylene glycol ester and 90–105 C for this section), using xylene-ethyl alco- the glycerol ester as determined by the hol in a 2:1 ratio instead of ethyl alco- Fisher Johns method as described in ‘‘Semimicro Qualitative Organic Anal- hol in the preparation of potassium hy- ysis—The Systematic Identification of droxide solution. Organic Compounds,’’ by Cheronis and (4) Ultraviolet absorbance limits Entrikin, 2d Ed., Interscience Pub- specified in paragraph (a)(4) of this sec- lishers, NY, which is incorporated by tion, as determined by the analytical reference. Copies are available from method described therein. the Center for Food Safety and Applied [42 FR 14609, Mar. 15, 1977, as amended at 47 Nutrition (HFS–200), Food and Drug FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, Administration, 5100 Paint Branch 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, Pkwy., College Park, MD 20740, or June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR available for inspection at the Office of 17512, Apr. 5, 1993] the Federal Register, 800 North Capitol

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Street, NW., suite 700, Washington, DC more of the monomers listed in para- 20408. graph (a)(1)(i) of this section. (2) Acid value 15–25 for each ester as (i) Homopolymers and copolymers of determined by the A.O.C.S. method the following monomers: Trla-64T ‘‘Titer Test,’’ which is incor- n-Butyl acrylate. porated by reference. Copies are avail- n-Butyl methacrylate. able from American Association of Oil Ethyl acrylate. Chemists, 36 East Wacker Drive, Chi- Methyl methacrylate. cago, IL 60601, or available for inspection at the Office of the Federal Reg- (ii) Copolymers produced by co- ister, 800 North Capitol Street, NW., polymerizing one or more of the mono- suite 700, Washington, DC 20408. The mers listed in paragraph (a)(1)(i) of this method is modified to use as the acid section with one or more of the fol- solvent a 1:1 volume mixture of anhy- lowing monomers: drous isopropyl alcohol and toluene. Acrylonitrile. The solution is titrated with 0.1N Butadiene. methanolic sodium hydroxide. a-Methylstyrene. (3) Saponification value 120–160 for Styrene. the ethylene glycol ester and 90–130 for Vinylidene chloride. the glycerol ester as determined the (iii) Polymers identified in para- A.O.C.S. method Trla-64T ‘‘Saponifica- graphs (a)(1) (i) and (ii) of this section tion Value,’’ which is incorporated by containing no more than 5 weight-per- reference. Copies are available from cent of total polymer units derived by American Association of Oil Chemists, copolymerization with one or more of 36 East Wacker Drive, Chicago, IL the following monomers: 60601, or available for inspection at the Office of the Federal Register, 800 Acrylic acid. North Capitol Street, NW., suite 700, 1,3-Butylene glycol dimethacrylate. Washington, DC 20408. Divinylbenzene. (4) Ultraviolet absorbance as speci- Methacrylic acid. fied in § 178.3770(a)(4) of this chapter (iv) Mixtures of polymers identified when tested by the analytical method in paragraph (a)(1) (i), (ii), and (iii) of described therein. this section; provided that no chemical reactions, other than addition reac- [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, tions, occur when they are mixed. 1989; 61 FR 14481, Apr. 2, 1996] (2) Polymers identified in paragraph (a)(1) of this section combined during § 178.3790 Polymer modifiers in their polymerization with butadiene- semirigid and rigid vinyl chloride styrene copolymers; provided that no plastics. chemical reactions, other than addi- The polymers identified in paragraph tion reactions, occur when they are (a) of this section may be safely combined. Such combined polymers admixed, alone or in mixture with may contain 50 weight-percent or more other permitted polymers, as modifiers of total polymer units derived from the in semirigid and rigid vinyl chloride butadiene-styrene copolymers. plastic food-contact articles prepared (b) The polymer content of the fin- from vinyl chloride homopolymers and/ ished plastic food-contact article con- or from vinyl chloride copolymers com- sists of: plying with § 177.1950, § 177.1970, and/or (1) Not less than 80 weight-percent of § 177.1980 of this chapter, in accordance polymer units derived from the vinyl with the following prescribed condi- chloride polymers identified in the in- tions: troduction to this section and not more (a) For the purpose of this section, than 5 weight-percent of polymer units the polymer modifiers are identified as derived from polymers identified in follows: paragraph (a)(1) of this section and (1) Acrylic polymers identified in this may optionally contain up to 15 subparagraph provided that such poly- weight-percent of polymer units de- mers contain at least 50 weight-percent rived from butadiene-styrene copoly- of polymer units derived from one or mers; or

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(2) Not less than 50 weight-percent of § 176.170(c) of this chapter, yields ex- polymer units derived from the vinyl tractives not to exceed the limits pre- chloride polymers identified in the in- scribed in § 177.1010 (b) (1), (2), (3), and troduction to this section, not more (4) of this chapter when tested by the than 50 weight-percent of polymer methods prescribed in § 177.1010 (c) of units derived from homopolymers and/ this chapter. or copolymers of ethyl acrylate and (e) Acrylonitrile copolymers identi- methyl methacrylate, and not more fied in this section shall comply with than 30 weight-percent of polymer the provisions of § 180.22 of this chap- units derived from copolymers of meth- ter. yl methacrylate, a-methylstyrene and acrylonitrile and may optionally con- § 178.3800 Preservatives for wood. tain up to 15 weight-percent of polymer units derived from butadiene-styrene Preservatives may be safely used on copolymers. wooden articles that are used or in- (c) No chemical reactions, other than tended for use in packaging, trans- addition reactions, occur among the porting, or holding raw agricultural vinyl chloride polymers and the modi- products subject to the provisions of fying polymers present in the polymer this section: mixture used in the manufacture of the (a) The preservatives are prepared finished plastic food-contact article. from substances identified in para- (d) The finished plastic food-contact graph (b) of this section and applied in article, when extracted with the sol- amounts not to exceed those necessary vent or solvents characterizing the to accomplish the technical effect of type of food and under the conditions protecting the wood from decay, mil- of time and temperature characterizing dew, and water absorption. the conditions of its intended use as de- (b) The substances permitted are as termined from tables 1 and 2 of 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. Rosins and rosin derivatives ...... As provided in ¤ 178.3870. Zinc salt of sulfonated petroleum .

§ 178.3850 Reinforced wax. physical or technical effect or any lim- Reinforced wax may be safely used as itation provided in this section. an article or component of articles in- (c) Any substance employed in the tended for use in producing, manufac- production of reinforced wax, including turing, packing, processing, trans- any optional substance, that is the sub- porting, or holding food subject to the ject of a regulation in parts 174, 175, provisions of this section. 176, 177, 178 and § 179.45 of this chapter, (a) Reinforced wax consists of petro- conforms with any specification in leum wax to which have been added such regulation. certain optional substances required in (d) The substances and optional adju- its production, or added to impart de- vant substances employed in the pro- sired physical or technical properties. duction of or added to reinforced wax (b) The quantity of any optional ad- include: juvant substance employed in the pro- (1) Substances generally recognized duction of or added to reinforced wax as safe in food. does not exceed the amount reasonably (2) Substances subject to prior sanc- required to accomplish the intended tion for use in reinforced wax and used

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in accordance with such sanction or ap- at 70 °F for 48 hours shall not exceed 0.5 proval. milligram per square inch of food-con- (3) Substances identified in this sub- tact surface. paragraph and subject to any limita- (2) It is used as a packaging material tions provided therein: or component of packaging materials for cheese and cheese products. List of substances Limitations [42 FR 14609, Mar. 15, 1977, as amended at 47 Copolymer of isobutylene modified with isoprene . FR 1288, Jan. 12, 1982] Petroleum wax, Type I and Type II . § 178.3860 Release agents. Polyethylene . Rosins and rosin derivatives as Substances listed in paragraph (b) of provided in ¤ 178.3870. this section may be safely used as re- Synthetic wax polymer as de- Not to exceed 5 percent lease agents in petroleum wax com- scribed in ¤ 176.170(a)(5) of by weight of the petro- this chapter . leum wax. plying with § 178.3710 and in polymeric resins that contact food, subject to the (e) Reinforced wax conforming with provisions of this section. the specifications in this paragraph is (a) The quantity used shall not ex- used as provided in paragraph (e)(2) of ceed the amount reasonably required this section. to accomplish the intended technical (1) The chloroform-soluble portion of effect or any limitations prescribed in the water extract obtained by exposing this section. reinforced wax to demineralized water (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. 25359Ð91Ð5) . 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). Poly(vinyl acetate/vinyl N-octadecylcarbamate) For use only in application to the backing of pressuresensitive adhesive (CAS Reg. No. 70892Ð21Ð6) 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- holding food, subject to the provisions tives. of this section. The rosins and rosin derivatives iden- (a) The rosins and rosin derivatives tified in paragraph (a) of this section are identified as follows: may safely be used in the manufacture (1) Rosins: of articles or components of articles in- (i) Gum rosin, refined to color grade tended for use in producing, manufac- of K or paler. turing, packing, processing, preparing, (ii) Wood rosin, refined to color grade treating, packaging, transporting, or of K or paler.

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(iii) Tall oil rosin, refined to color of 3 to 8, a drop-softening point of 109°– grade of K or paler. 119 °C, and a color of M or paler. (iv) Dark tall oil rosin, a fraction re- (iv) Glycerol ester of fully dimerized sulting from the refining of tall oil rosin, having an acid number of 5 to 16, rosin produced by multicolumnar dis- a drop-softening point of 165°–175 °C, tillation of crude tall oil to effect re- and a color of H or paler. moval of fatty acids and pitch compo- (v) Glycerol ester of maleic anhy- nents and having a saponification num- dride-modified wood rosin, having an ber of from 110–135 and 32 percent–44 acid number of 30 to 40, a drop-soft- percent rosin acids. ening point of 138°–146 °C, a color of M (v) Dark wood rosin, all or part of the or paler, and a saponification number residue after the volatile terpene oils less than 280. are distilled from the oleoresin ex- (vi) Methyl ester of rosin, partially tracted from pine wood. hydrogenated, purified by steam strip- (2) Modified rosins manufactured ping to have an acid number of 4 to 8, from rosins identified in paragraph a refractive index of 1.5170 to 1.5205 at (a)(1) of this section: 20 °C, and a viscosity of 23 to 66 poises (i) Partially hydrogenated rosin, cat- at 25 °C. alytically hydrogenated to a maximum (vii) Pentaerythritol ester of wood refractive index of 1.5012 at 100 °C, and rosin, having an acid number of 6 to 16, a color of WG or paler. a drop-softening point of 109°–116 °C, (ii) Fully hydrogenated rosin, cata- and a color of M or paler. lytically hydrogenated to a maximum (viii) Pentaerythritol ester of par- dehydroabietic acid content of 2 per- tially hydrogenated wood rosin, having cent, a minimum drop-softening point an acid number of 7 to 18, a drop-soft- of 79 °C, and a color of X or paler. ening point of 102°–110 °C, and a color of (iii) Partially dimerized rosin, K or paler. dimerized by sulfuric acid catalyst to a (ix) Pentaerythritol ester of maleic drop-softening point of 95°–105 °C and a anhydride-modified wood rosin, having color of WG or paler. an acid number of 8 to 16, a drop-soft- (iv) Fully dimerized rosin, dimerized ening point of 154°–162 °C, a color of M by sulfuric acid catalyst, and from or paler, and having a saponification which sufficient nondimerized rosin number less than 280. has been removed by distillation to (x) Pentaerythritol ester of maleic achieve a minimum drop-softening anhydride-modified wood rosin, having point of 143 °C, and a color of H or an acid number of 9 to 16, a drop-soft- paler. ening point of 130°–140 °C, a color of N (v) Disproportionated rosin, catalyt- or paler, and having a saponification ically disproportionated to a minimum number less than 280. dehydroabietic acid content of 35 per- (xi) Pentaerythritol ester of maleic cent, a maximum abietic acid content anhydride-modified wood rosin, having of 1 percent, a maximum content of an acid number of 134 to 145, a drop- substituted phenanthrenes (as retene) softening point of 127°–137 °C, a color of of 0.25 percent, and a color of WG or M or paler, and having a saponification paler. number less than 280. (3) Rosin esters manufactured from (xii) Pentaerythritol ester of maleic rosins and modified rosins identified in anhydride-modified wood rosin, having paragraphs (a)(1) and (2) of this section: an acid number of 30 to 40, a drop-soft- (i) Glycerol ester of wood rosin puri- ening point of 131°–137 °C, a color of N fied by steam stripping to have an acid or paler, and having a saponification number of 3 to 9, a drop-softening point number less than 280. of 88°–96 °C, and a color of N or paler. (xiii) Pentaerythritol ester of maleic (ii) Glycerol ester of partially hydro- anhydride-modified wood rosin, further genated wood rosin, having an acid modified by reaction with 4,4′-iso- number of 3 to 10, a drop-softening propyl-idenediphenol-formaldehyde point of 79°–88 °C, and a color of N or condensate, having an acid number of paler. 10 to 22, a drop-softening point of 162°– (iii) Glycerol ester of partially 172 °C, a color of K or paler, a saponi- dimerized rosin, having an acid number fication number less than 280, and a

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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. (xiv) Mixed methyl and pentaeryth- (c) The use in any substance or arti- ritol ester of maleic anhydride-modi- cle that is the subject of a regulation fied wood rosin, having an acid number in parts 174, 175, 176, 177, 178 and § 179.45 of 73 to 83, a drop-softening point of of this chapter shall conform with any 113°–123 °C, a color of M or paler, and a specifications and limitations pre- saponification number less than 280. scribed by such regulation for the fin- (xv) Triethylene glycol ester of par- ished form of the substance or article. tially hydrogenated wood rosin, having (d) The provisions of this section are an acid number of 2 to 10, a color of K not applicable to rosins and rosin de- or paler, and a viscosity of 350 to 425 rivatives identified in § 175.300(b)(3)(v) seconds Saybolt at 100 °C. of this chapter and used in resinous (xvi) Glycerol ester of maleic anhy- and polymeric coatings complying with dride-modified wood rosin, having an § 175.300 of this chapter. acid number of 17 to 23, a drop-soft- (e) The provisions of this section are ening point of 136°–140 °C, a color of M not applicable to rosins and rosin de- or paler, and a saponification number rivatives identified in § 175.105(c)(5) of less than 280. For use only in cello- this chapter and used in defoaming phane complying with § 177.1200 of this agents complying with § 176.210 of this chapter. chapter, food-packaging adhesives (xvii) Citric acid-modified glycerol complying with § 175.105 of this chapter, ester of rosin, having an acid number and rubber articles complying with less than 20, a drop-softening point of § 177.2600 of this chapter. 105°–115 °C, and a color of K or paler. (f) The analytical methods for deter- For use only as a blending agent in mining whether rosins and rosin de- coatings for cellophane complying with rivatives conform to the specifications § 177.1200 of this chapter. prescribed in paragraph (a) of this sec- (xviii) Glycerol ester of tall oil rosin, tion are as follows: purified by steam stripping to have an (1) Color: Color shall be as deter- acid number of 5–12, a softening point mined by ASTM method D509–70 (Re- of 80°–88 °C, and a color of N or paler. approved 1981), ‘‘Standard Methods of (xix) Glycerol ester of maleic anhy- Sampling and Grading Rosin,’’ which is dride-modified tall oil rosin, having an incorporated by reference. Copies may acid number of 30 to 40, a drop-soft- be obtained from the American Society ening point of 141°–146 °C, a color of N for Testing Materials, 1916 Race St., or paler, and a saponification number Philadelphia, PA 19103, or may be ex- less than 280. amined at the Office of the Federal (xx) Glycerol ester of Register, 800 North Capitol Street, disproportionated tall oil rosin, having NW., suite 700, Washington, DC 20408. an acid number of 5 to 10, a drop-soft- (2) Refractive index: Refractive index ening point of 84°–93 °C, a color of WG shall be as determined by ASTM meth- or paler, and a saponification number od D1747–62 (Reapproved 1978), ‘‘Stand- less than 180. ard Test Method for Refractive Index of (4) Rosin salts and sizes—Ammo- Viscous Materials,’’ which is incor- nium, calcium, potassium, sodium, or porated by reference. The availability zinc salts of rosin manufactured by the of this incorporation by reference is partial or complete saponification of given in paragraph (f)(1) of this section. any one of the rosins or modified rosins (3) Acid number: Acid number shall identified in paragraph (a)(1) and (2) of be as determined by ASTM method this section, or blends thereof, and D465–82, ‘‘Standard Test Methods for with or without modification by reac- Acid Number of Rosin,’’ which is incor- tion with one or more of the following: porated by reference. The availability (i) Formaldehyde. of this incorporation by reference is (ii) Fumaric acid. given in paragraph (f)(1) of this section.

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(4) Viscosity: Viscosity in poises inspection at the Office of the Federal shall be as determined by ASTM meth- Register, 800 North Capitol Street, od D1824–66 (Reapproved 1980), ‘‘Stand- NW., suite 700, Washington, DC 20408. ard Test Method for Apparent Vis- cosity of Plastisols and Organosols at [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, Low Shear Rates by Brookfield Vis- 1984; 54 FR 24899, June 12, 1989] cometer,’’ and in Saybolt seconds by ASTM method D88–81, ‘‘Standard Test § 178.3900 Sodium Method for Saybolt Viscosity,’’ which pentachlorophenate. are incorporated by reference. The Sodium pentachlorophenate may be availability of this incorporation by safely used as a preservative for ammo- reference is given in paragraph (f)(1) of nium alginate employed as a proc- this section. essing aid in the manufacture of poly- (5) Softening point: Softening point shall be as determined by ASTM meth- vinyl chloride emulsion polymers in- od E28–67, ‘‘Standard Test Method for tended for use as articles or compo- Softening Point by Ring and Ball Ap- nents of articles that contact food at paratus’’ (Reapproved 1977), which is temperatures not to exceed room tem- incorporated by reference. Copies are perature. The quantity of sodium available from American Society for pentachlorophenate used shall not ex- Testing and Materials (ASTM), 1916 ceed 0.5 percent by weight of ammo- Race St., Philadelphia, PA 19103, or nium alginate solids. available for inspection at the Office of § 178.3910 Surface lubricants used in the Federal Register, 800 North Capitol the manufacture of metallic arti- Street, NW., suite 700, Washington, DC cles. 20408. (6) Analytical methods for deter- The substances listed in this section mining drop-softening point, saponi- may be safely used in surface lubri- fication number, and any other speci- cants employed in the manufacture of fications not listed under paragraphs metallic articles that contact food, (f)(1) through (5) of this section, titled: subject to the provisions of this sec- (i) ‘‘Determination of Abeitic Acid and tion. Dehydroabietic Acid in Rosins’’; (ii) (a) The following substances may be ‘‘Determination of Softening Point of used in surface lubricants used in the Solid Resins’’; (iii) ‘‘Determination of rolling of metallic foil or sheet stock Saponification Number of Rosin provided that total residual lubricant Esters,’’ and (iv) ‘‘Determination of remaining on the metallic article in Phenolic Modification of Rosin Deriva- the form in which it contacts food does tives,’’ which are incorporated by ref- not exceed 0.015 milligram per square erence. Copies are available from the inch of metallic food-contact surface: Center for Food Safety and Applied Nu- (1) Substances identified in para- trition (HFS–200), Food and Drug Ad- graphs (b)(1) and (2) of this section. ministration, 5100 Paint Branch Pkwy., (2) Substances identified in this para- College Park, MD 20740, or available for graph.

List of substances Limitations

a-Butyl-Ω-Ðhydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038Ð95Ð3) 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. aÐButylÐΩÐhydroxypoly(oxypropylene) (CAS Reg. No. 9003- 13Ð8) having a minimum molecular weight of 1000. aÐLauroylÐΩÐhydroxpoly(oxyethylene) (CAS Reg. No. 9004Ð 81Ð3) 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. alphaÐAlkylÐomegaÐhydroxypoly(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. 6002Ð97Ð1) . Benzotriazole (CAS Reg. No. 95Ð14Ð7) ......

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List of substances Limitations

Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789Ð Not to be used in combination with sodium nitrite. 79Ð5) . Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No. 116438Ð56Ð3) . N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102Ð79Ð4) Tert-Butyl alcohol . Di(2-ethylhexyl)phthalate . Diethyl phthalate . Diethylene glycol monobutylether (CAS Reg. No. 112Ð34Ð5) .... 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 180Ð200, acid value 70Ð130, and maximum iodine value 120. Di-n-octyl sebacate . Ethylenediaminetetraacetic acid, sodium salts . Isopropyl alcohol . Isopropyl laurate (CAS Reg. No. 10233Ð13Ð3) ...... 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. 9043Ð30Ð5) . 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) . Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791Ð26Ð2) . 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 440Ð450 (CAS Reg. No. 68608Ð24Ð4) derived from naphthenic oil having a Saybolt viscosity range of 500Ð600 Saybolt Universal Seconds (SUS at 37Ð8 °C (100 °F) as determined by ASTM method D88Ð 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 Of- fice of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Synthetic alcohol mixture of straight-and branched-chain alcohols that have even numbers of carbon atoms in the range C4–C18 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, 266Ð276. 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, 283Ð296.

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List of substances Limitations

Tallow, sulfonated . Triethanolamine .

(3) Mineral oil conforming to the corporated by reference. The avail- identity prescribed in § 178.3620(c). ability of this incorporation by ref- (4) Light petroleum hydrocarbons erence is given in paragraph (a)(4)(i)(a) identified in paragraph (a)(4) (i) of this of this section. section: Provided, That the total resid- (d) Aromatic component content ual lubricant on the metallic article in shall not exceed 32 percent. the form in which it contacts food (e) Conforms with ultraviolet absorb- meets the ultraviolet absorbance lim- ance limits prescribed in § 178.3620(c) as its prescribed in paragraph (a) (4) (ii) of determined by the analytical method this section as determined by the ana- described therein. lytical method described in paragraph (ii) Ultraviolet absorbance limits on (a) (4) (iii) of this section. residual lubricants are as follows: (i) Light petroleum hydrocarbons are Maximum derived by distillation from virgin pe- absorb- troleum stocks or are synthesized from ance per 5 Wavelength (mµ) centi- petroleum gases. They are chiefly par- meters op- affinic, isoparaffinic, napthenic, or aro- tical pathlength matic in nature, and meet the following specifications: 280Ð289 ...... 0.7 (a) Initial boiling point is 24 °C min- 290Ð299 ...... 6 300Ð359 ...... 4 imum and final boiling point is 288 °C 360Ð400 ...... 09 maximum, as determined by ASTM method D86–82, ‘‘Standard Method for (iii) The analytical method for deter- Distillation of Petroleum Products,’’ mining ultraviolet absorbance limits which is incorporated by reference. on residual lubricants is as follows: Copies may be obtained from the Amer- ican Society for Testing Materials, 1916 GENERAL INSTRUCTIONS Race St., Philadelphia, PA 19103, or Because of the sensitivity of the test, the may be examined at the Office of the possibility of errors arising from contamina- Federal Register, 800 North Capitol tion is great. It is of the greatest importance Street, NW., suite 700, Washington, DC that all glassware be scrupulously cleaned to 20408. remove all organic matter such as oil, grease, detergent, residues, etc. Examine all (b) Nonvolatile residue is 0.005 gram glassware including stoppers and stopcocks, per 100 milliliters, maximum, as deter- under ultraviolet light to detect any residual mined by ASTM method D381–80, fluorescent contamination. As a pre- ‘‘Standard Test Method for Existent cautionary measure it is recommended prac- Gum in Fuels by Jet Evaporation,’’ tice to rinse all glassware with purified iso- when the final boiling point is 121 °C or octane immediately before use. No grease is above and by ASTM method D1353–78, to be used on stopcocks or joints. Great care to avoid contamination of oil samples in ‘‘Standard Test Method for Nonvolatile handling and to assure absence of any extra- Matter in Volatile Solvents for Use in neous material arising from inadequate Paint, Varnish, Lacquer, and Related packaging is essential. Because some of the Products,’’ when the final boiling point polynuclear hydrocarbons sought in this test is below 121 °C. These ASTM methods are very susceptible to photo-oxidation, the are incorporated by reference. The entire procedure is to be carried out under availability of these incorporations by subdued light. reference is given in paragraph APPARATUS (a)(4)(i)(a) of this section. (c) Saybolt color 20 minimum as de- Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000- termined by ASTM method D156–82, milliliter capacity, equipped with tetra- ‘‘Standard Test Method for Saybolt fluoroethylene polymer stopcocks. Color of Petroleum Products (Saybolt Evaporation flask (optional). 250-milliliter or Chromometer Method),’’ which is in- 500-milliliter capacity all-glass flask

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equipped with standard-taper stopper having flask. In this case the solvent and n-hexa- inlet and outlet tubes to permit passage of decane are placed in the flask on the steam nitrogen across the surface of contained liq- bath, the tube assembly is inserted, and a uid to be evaporated. stream of nitrogen is fed through the inlet Spectrophotometric cells. Fused quartz cells, tube while the outlet tube is connected to a optical path length in the range of 5,000 cen- solvent trap and vacuum line in such a way timeters ±0.005 centimeter; also for checking as to prevent any flow-back of condensate spectrophotometer performance only, optical into the flask. path length in the range 1.000 centimeter Dissolve the 1 milliliter of hexadecane res- ± 0.005 centimeter. With distilled water in the idue in isooctane and make to 25 milliliters cells, determine any absorbance differences. volume. Determine the absorbance in the 5- Spectrophotometer. Special range 250 centimeter path length cells compared to millicrons-400 millimicrons with spectral slit isooctane as reference. The absorbance of the width of 2 millimicrons or less; under instru- solution of the solvent residue shall not ex- ment operating conditions for these absorb- ceed 0.01 per centimeter path length between ance measurements, the spectrophotometer 280 and 400 mµ. Purify, if necessary, by pas- shall also meet the following performance sage through a column of activated silica gel requirements: (Grade 12, Davison Chemical Co., Baltimore, Absorbance repeatability, ±0.01 at 0.4 ab- Maryland, or equivalent) about 90 centi- sorbance. meters in length and 5 centimeters to 8 cen- Absorbance accuracy, 1 ±0.05 at 0.4 absorb- timeters in diameter. ance. Wavelength repeatability, ±0.2 milli- n-Hexadecane, 99-percent olefin-free. Dilute micron. 1.0 milliliter of n-hexadecane to 25 milliliters Wavelength accuracy, ±1.0 millimicron. with isooctane and determine the absorbance Soxhlet apparatus. 60-millimeter diameter in a 5-centimeter cell compared to isooctane body tubes fitted with condenser and 500-mil- as reference point between 280 mµ-400 mµ. liliter round-bottom boiling flask. A supply The absorbance per centimeter path length of paper thimbles to fit is required. shall not exceed 0.00 in this range. Purify, if Nitrogen cylinder. Water-pumped or equiva- necessary, by percolation through activated lent purity nitrogen in cylinder equipped silica gel or by distillation. with regulator and valve to control flow at 5 Dimethyl sulfoxide. Spectrophotometric p.s.i.g. grade (Crown Zellerbach Corp., Camas, Washington, or equivalent). Absorbance (1- REAGENTS AND MATERIALS centimeter cell, distilled water reference, Organic solvents. All solvents used through- sample completely saturated with nitrogen). out the procedure shall meet the specifications and tests described in this specifica- Absorb- Wavelength ance (max- tion. The isooctane (2,2,4-trimethylpentane) imum) shall pass the following test: Place 180 milliliters of solvent in a 250-mil- 261.5 ...... 1.00 liliter Erlenmeyer flask, add 1 milliliter of 270 ...... 20 purified n-hexadecane and evaporate on the 275 ...... 09 steam bath under a stream of nitrogen (a 280 ...... 06 loose aluminum foil jacket around the flask 300 ...... 015 will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue There shall be no irregularities in the ab- remains. sorbance curve within these wavelengths. Alternatively, the evaporation time can be Phosphoric acid. 85 percent A.C.S. reagent reduced by using the optional evaporation grade. Sodium sulfate, anhydrous, A.C.S. reagent 1 As determined by procedure using potas- grade, preferably in granular form. For each sium chromate for reference standard and bottle of sodium sulfate reagent used, estab- described in National Bureau of Standards lish as follows the necessary sodium sulfate Circular 484, Spectrometry, U.S. Department prewash to provide such filters required in of Commerce (1949), which is incorporated by the method: Place approximately 35 grams of reference. Copies are available from the Cen- anhydrous sodium sulfate in a 30-milliliter ter for Food Safety and Applied Nutrition coarse, fritted-glass funnel or in a 65-milli- (HFS–200), Food and Drug Administration, liter filter funnel with glass wool plug; wash 5100 Paint Branch Pkwy., College Park, MD with successive 15-milliliter portions of the 20740, or available for inspection at the Office indicated solvent until a 15-milliliter portion of the Federal Register, 800 North Capitol of the wash shows 0.00 absorbance per centi- Street, NW., suite 700, Washington, DC 20408. meter path length between 280 mµ and 400 mµ The accuracy is to be determined by com- when tested as prescribed under ‘‘Organic parison with the standard values at 210, 345, solvents.’’ Usually three portions of wash and 400 millimicrons. solvent are sufficient.

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Before proceeding with analysis of a sam- 250-milliliter separatory funnel and wash in ple, determine the absorbance in a 5-centi- tandem with the 30-milliliter portion of iso- meter path cell between 250 millimicrons and octane contained in the 250-milliliter sepa- 400 millimicrons for the reagent blank by ratory funnels. Shaking time for each wash carrying out the procedure, without a metal is 1 minute. Repeat the extraction operation sample. The absorbance per centimeter path with two additional portions of the sulf- length should not exceed 0.02 in the wave- oxide-acid mixture and wash each extractive length range from 280 mµ to 400 mµ. in tandem through the same three portions Place 300 milliliters of dimethyl sulfoxide of isooctane. in a 1-liter separatory funnel and add 75 mil- Collect the successive extractives (300 milliliters of phosphoric acid. Mix the contents liliters total) in a separatory funnel (pref- of the funnel and allow to stand for 10 min- erably 2-liter) containing 480 milliliters of utes. (The reaction between the sulfoxide distilled water; mix, and allow to cool for a and the acid is exothermic. Release pressure few minutes after the last extractive has after mixing, then keep funnel stoppered.) been added. Add 80 milliliters of isooctane to Add 150 milliliters of isooctane and shake to pre-equilibrate the solvents. Draw off the in- the solution and extract by shaking the fun- dividual layers and store in glass-stoppered nel vigorously for 2 minutes. Draw off the flasks. lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the ex- PROCEDURE traction with 80 milliliter of isooctane. Draw off and discard the aqueous layer. Wash each Sample. Select metal foil or sheet stock for of the 80 milliliter extractives three times the test which has not been previously con- with 100-milliliter portions distilled water. taminated by careless handling or exposure Shaking time for each wash is 1 minute. Dis- to atmospheric dust and fumes. A commer- card the aqueous layers. Filter the first ex- cial coil in the form supplied for spindle mounting in a packaging line or wrapping tractive through anhydrous sodium sulfate machine is most suitable. Strip off the out- pre-washed with isooctane (see sodium sul- side turn of metal and discard. Carefully fate under ‘‘Reagents and Materials’’ for avoid contamination or damage from han- preparation of filter) into a 250-milliliter Er- dling the metal (wear gloves). Remove a 16– lenmeyer flask (or optionally into the evapo- 18-foot length from the coil and place it on a ration flask). Wash the first separatory fun- flat surface protected by a length of new nel with the second 80-milliliter isooctane kraft paper. Cut four 15-foot strips from the extractive and pass through the sodium sul- sample, each 3 inches wide (avoid tearing the fate. Then wash the second and first sepa- edges of the strips). Using a piece of suitable ratory funnels successively with a 20-milli- glass rod, roll the strips of metal into loose liter portion of isooctane and pass the sol- coils and insert each into a Soxhlet thimble. vent through the sodium sulfate into the Each turn of coil should be visibly separated flask. Add 1 milliliter of n-hexadecane and from the adjacent turn. evaporate the isooctane on the steam bath Extraction. Fill each of the four Soxhlet under nitrogen. Discontinue evaporation tubes with purified isooctane (see under when not over 1 milliliter of residue remains. heading ‘‘Reagents and Materials,’’ above) To the residue, add a 10-milliliter portion of until siphon action occurs and then refill the isooctane, reevaporate to 1 milliliter of tube body. Supply heat to the boiling flask hexadecane, and repeat this operation once. and allow extraction to continue for at least Quantitatively transfer the residue with 8 hours or until repeated weighings of the isooctane to a 25-milliliter volumetric flask, dried and cooled coil show no further weight make to volume, and mix. Determine the ab- loss. sorbance of the solution in 5-centimeter Combine the isooctane extracts from the pathlength cells compared to isooctane as four Soxhlet units in a suitable beaker, rins- reference between 280mµ–400mµ (take care to ing each tube and flask into the beaker with lose none of the solution in filling the sam- fresh purified solvent. Evaporate the solvent ple cell). Correct the absorbance values for under an atmosphere of inert gas (nitrogen) any absorbance derived from reagents as de- to residual volume of 50–60 milliliters and termined by carrying out the procedure transfer this solution to a 500-milliliter sepa- without a metal sample. If the corrected ab- ratory funnel containing 100 milliliters of sorbance does not exceed the limits pre- pre-equilibrated sulfoxide-phosphoric acid scribed in this paragraph, the residue meets mixture. Complete the transfer of the sample the ultraviolet absorbance specifications. with small portions of pre-equilibrated isooctane to give a total volume of the residue (b) The following substances may be and solvent of 75 milliliters. Shake the fun- used in surface lubricants used to fa- nel vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each cilitate the drawing, stamping, or containing 30 milliliters of pre-equilibrated forming of metallic articles from rolled isooctane. After separation of liquid phases, foil or sheet stock by further proc- carefully draw off lower layer into the first essing provided that the total residual

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lubricant remaining on the metallic ar- (1) Antioxidants used in compliance ticle in the form in which it contacts with regulations in parts 170 through food does not exceed 0.2 milligram per 189 of this chapter. square inch of food-contact surface: (2) Substances identified in this subparagraph.

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. 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. 80939Ð62Ð4) . 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. 6683Ð19Ð8) . 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- plish the intended technical effect and graph (a)(2) of this section may be used shall not be intended to nor, in fact, in surface lubricants used to facilitate accomplish any technical effect in the the drawing, stamping, and forming of food itself. metallic articles from rolled foil and (e) The use of the surface lubricants sheet stock provided that total resid- in the manufacture of any article that ual lubricant remaining on the metal- is the subject of a regulation in parts lic article in the form in which it con- 174, 175, 176, 177, 178 and § 179.45 of this tacts food does not exceed 0.015 milli- chapter must comply with any speci- gram per square inch of food-contact fications prescribed by such regulation surface. for the finished form of the article. (d) Subject to any prescribed limita- (f) Any substance that is listed in tions, the quantity of surface lubricant this section and the subject of a regula- used in the manufacture of metallic ar- tion in parts 174, 175, 176, 177, 178 and ticles shall not exceed the least § 179.45 of this chapter shall comply amount reasonably required to accom-

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with any applicable specifications pre- erized with one another in any com- scribed by such regulation. bination, or it may be used as a solvent in the casting of film prepared from [42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; vinyl chloride copolymers complying 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. with § 177.1980 of this chapter. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, (b) The residual amount of tetra- Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR hydrofuran in the film does not exceed 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 1.5 percent by weight of film. 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999] PART 179—IRRADIATION IN THE § 178.3930 Terpene resins. PRODUCTION, PROCESSING AND The terpene resins identified in para- HANDLING OF FOOD graph (a) of this section may be safely used as components of polypropylene Subpart A [Reserved] film intended for use in contact with food, and the terpene resins identified Subpart B—Radiation and Radiation in paragraph (b) of this section may be Sources safely used as components of polyolefin Sec. film intended for use in contact with 179.21 Sources of radiation used for inspec- food; tion of food, for inspection of packaged (a) Terpene resins consisting of the food, and for controlling food processing. hydrogenated polymers of terpene hy- 179.25 General provisions for food irradia- drocarbons obtainable from sulfate tur- tion. pentine and meeting the following 179.26 Ionizing radiation for the treatment specifications: Drop-softening point of of food. ° ° 179.30 Radiofrequency radiation for the 118 –138 C; iodine value less than 20. heating of food, including microwave fre- (b) Terpene resins consisting of poly- quencies. mers of beta-pinene and meeting the 179.39 Ultraviolet radiation for the proc- following specifications: Acid value essing and treatment of food. less than 1; saponification number less 179.41 Pulsed light for the treatment of than 1; color less than 4 on the Gardner food. scale as measured in 50 percent mineral spirits solution. Subpart C—Packaging Materials for Irradiated Foods § 178.3940 Tetraethylene glycol di-(2- ethylhexoate). 179.45 Packaging materials for use during 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/ or diethylene glycols may be used at a SOURCE: 42 FR 14635, Mar. 15, 1977, unless level not to exceed 0.7 percent by otherwise noted. weight of twine as a finish on twine to be used for tying meat provided the Subpart A [Reserved] twine fibers are produced from nylon resins complying with § 177.1500 of this Subpart B—Radiation and chapter. Radiation Sources

§ 178.3950 Tetrahydrofuran. § 179.21 Sources of radiation used for Tetrahydrofuran may be safely used inspection of food, for inspection of in the fabrication of articles intended packaged food, and for controlling for packaging, transporting, or storing food processing. foods, subject to the provisions of this Sources of radiation for the purposes section. of inspection of foods, for inspection of (a) It is used as a solvent in the cast- packaged food, and for controlling food ing of film from a solution of poly- processing may be safely used under meric resins of vinyl chloride, vinyl ac- the following conditions: etate, or vinylidene chloride that have (a) The radiation source is one of the been polymerized singly or copolym- following:

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(1) X-ray tubes producing X-radiation the requirements of part 110 of this from operation of the tube source at a chapter and other applicable regula- voltage of 500 kilovolt peak or lower. tions. (2) Sealed units producing radiations (b) Food treated with ionizing radi- at energy levels of not more than 2.2 ation shall receive the minimum radi- million electron volts from one of the ation dose reasonably required to ac- following isotopes: Americium-241, ce- complish its intended technical effect sium-137, cobalt-60, iodine-125, krypton- and not more than the maximum dose 85, radium-226, and strontium-90. specified by the applicable regulation (3) Sealed units producing neutron for that use. radiation from the isotope Califor- (c) Packaging materials subjected to nium-252 (CAS Reg. No. 13981–17–4) to irradiation incidental to the radiation measure moisture in food. treatment and processing of pre- (4) Machine sources producing X-radi- packaged foods shall comply with ation at energies no greater than 10 § 179.45. million electron volts (MeV). (d) Radiation treatment of food shall (b) To assure safe use of these radi- conform to a scheduled process. A ation sources: scheduled process for food irradiation (1) The label of the sources shall is a written procedure that ensures bear, in addition to the other informa- that the radiation dose range selected tion required by the Act: by the food irradiation processor is (i) Appropriate and accurate informa- adequate under commercial processing tion identifying the source of radi- conditions (including atmosphere and ation. temperature) for the radiation to (ii) The maximum energy of radi- achieve its intended effect on a specific ation emitted by X-ray tube sources. product and in a specific facility. A (iii) The maximum energy of X-radi- food irradiation processor shall operate ation emitted by machine source. with a scheduled process established by (2) The label or accompanying label- qualified persons having expert knowl- ing shall bear: edge in radiation processing require- (i) Adequate directions for installa- ments of food and specific for that food tion and use. and for that irradiation processor’s (ii) A statement that no food shall be treatment facility. exposed to radiation sources listed in (e) A food irradiation processor shall paragraph (a) (1) and (2) of this section maintain records as specified in this so as to receive an absorbed dose in ex- section for a period of time that excess of 10 grays. ceeds the shelf life of the irradiated (iii) A statement that no food shall food product by 1 year, up to a max- be exposed to a radiation source listed imum of 3 years, whichever period is in paragraph (a)(3) of this section so as shorter, and shall make these records to receive an absorbed dose in excess of available for inspection and copy by 2 milligrays. authorized employees of the Food and (iv) A statement that no food shall be Drug Administration. Such records exposed to a radiation source listed in shall include the food treated, lot iden- paragraph (a)(4) of this section so as to tification, scheduled process, evidence receive a dose in excess of 0.5 gray of compliance with the scheduled proc- (Gy). ess, ionizing energy source, source cali- [42 FR 14635, Mar. 15, 1977, as amended at 48 bration, dosimetry, dose distribution in FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, the product, and the date of irradia- 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, tion. Apr. 10, 2001] [51 FR 13399, Apr. 18, 1986, as amended at 67 § 179.25 General provisions for food ir- FR 9585, Mar. 4, 2002] radiation. For the purposes of § 179.26, current § 179.26 Ionizing radiation for the good manufacturing practice is defined treatment of food. to include the following restrictions: Ionizing radiation for treatment of (a) Any firm that treats foods with foods may be safely used under the fol- ionizing radiation shall comply with lowing conditions:

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(a) Energy sources. Ionizing radiation Use Limitations is limited to: 6. For control of food-borne pathogens Not to exceed 3 (1) Gamma rays from sealed units of in fresh or frozen, uncooked poultry kGy (300 krad); the radionuclides cobalt-60 or cesium- products that are: (1) Whole car- any packaging 137. casses or disjointed portions of such used shall not carcasses that are ‘‘ready-to-cook exclude oxygen. (2) Electrons generated from machine poultry’’ within the meaning of 9 CFR sources at energies not to exceed 10 381.1(b)(44), or (2) mechanically sep- million electron volts. arated poultry product (a finely comminuted ingredient produced by (3) X-rays generated from machine the mechanical deboning of poultry sources at energies not to exceed 5 mil- carcasses or parts of carcasses) . 7. For the sterilization of frozen, pack- Minimum dose 44 lion electron volts. aged meats used solely in the Na- kGy (4.4 Mrad). (b) Limitations. tional Aeronautics and Space Admin- Packaging mate- istration space flight programs . rials used need Use Limitations not comply with ¤ 179.25(c) pro- 1. For control of Trichinella spiralis in Minimum dose 0.3 vided that their pork carcasses or fresh, non-heat- kiloGray (kGy) use is otherwise processed cuts of pork carcasses . (30 kilorad permitted by ap- (krad)); maximum plicable regula- dose not to ex- tions in parts 174 ceed 1 kGy (100 through 186 of krad). this chapter. 2. For growth and maturation inhibition Not to exceed 1 8. For control of foodborne pathogens Not to exceed 4.5 of fresh foods . kGy (100 krad). in, and extension of the shelf-life of, kGy maximum 3. For disinfestation of arthropod pests Do. refrigerated or frozen, uncooked for refrigerated in food . products that are meat within the products; not to meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy 4. For microbial disinfection of dry or Not to exceed 10 byproducts within the meaning of 9 maximum for fro- dehydrated enzyme preparations (in- kGy (1 megarad CFR 301.2(tt), or meat food products zen products. cluding immobilized enzymes) . (Mrad)). within the meaning of 9 CFR 5. For microbial disinfection of the fol- Not to exceed 30 301.2(uu), with or without nonfluid lowing dry or dehydrated aromatic kGy (3 Mrad). seasoning, that are otherwise com- vegetable substances when used as posed solely of intact or ground ingredients in small amounts solely meat, meat byproducts, or both meat for flavoring or aroma: culinary herbs, and meat byproducts . seeds, spices, vegetable seasonings 9. For control of Salmonella in fresh Not to exceed 3.0 that are used to impart flavor but that shell eggs. . kGy. are not either represented as, or ap- 10. For control of microbial pathogens Not to exceed 8.0 pear to be, a vegetable that is eaten on seeds for sprouting. . kGy. for its own sake, and blends of these aromatic vegetable substances. Tur- meric and paprika may also be irradi- (c) Labeling. (1) The label and label- ated when they are to be used as ing of retail packages of foods irradi- color additives. The blends may con- ated in conformance with paragraph (b) tain sodium chloride and minor amounts of dry food ingredients ordi- of this section shall bear the following narily used in such blends . logo along with either the statement

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‘‘Treated with radiation’’ or the when shipped to a food manufacturer statement ‘‘Treated by irradiation’’ in or processor for further processing, la- addition to information required by beling, or packing. other regulations. The logo shall be [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] ter. As used in this provision, the term ‘‘radiation disclosure statement’’ § 179.30 Radiofrequency radiation for means the written statement that dis- the heating of food, including microwave frequencies. closes that a food has been inten- tionally subject to irradiation. Radiofrequency radiation, including (2) For irradiated foods not in pack- microwave frequencies, may be safely age form, the required logo and phrase used for heating food under the fol- ‘‘Treated with radiation’’ or ‘‘Treated lowing conditions: by irradiation’’ shall be displayed to (a) The radiation source consists of the purchaser with either (i) the label- electronic equipment producing radio ing of the bulk container plainly in waves with specific frequencies for this view or (ii) a counter sign, card, or purpose authorized by the Federal other appropriate device bearing the Communications Commission. information that the product has been (b) The radiation is used or intended treated with radiation. As an alter- for use in the production of heat in native, each item of food may be indi- food wherever heat is necessary and ef- vidually labeled. In either case, the in- fective in the treatment or processing formation must be prominently and of food. conspicuously displayed to purchasers. The labeling requirement applies only § 179.39 Ultraviolet radiation for the to a food that has been irradiated, not processing and treatment of food. to a food that merely contains an irra- Ultraviolet radiation for the proc- diated ingredient but that has not essing and treatment of food may be itself been irradiated. safely used under the following condi- (3) For a food, any portion of which is tions: irradiated in conformance with para- (a) The radiation sources consist of graph (b) of this section, the label and low pressure mercury lamps emitting labeling and invoices or bills of lading 90 percent of the emission at a wave- shall bear either the statement length of 253.7 nanometers (2,537 ‘‘Treated with radiation—do not irra- Angstroms). diate again’’ or the statement ‘‘Treated (b) The ultraviolet radiation is used by irradiation—do not irradiate again’’ 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.

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[42 FR 14635, Mar. 15, 1977, as amended at 65 (4) Polyolefin film prepared from one FR 71057, Nov. 29, 2000] or more of the basic olefin polymers complying with § 177.1520 of this chap- § 179.41 Pulsed light for the treatment ter. The finished film may contain: of food. (i) Adjuvant substances used in com- Pulsed light may be safely used for pliance with §§ 178.3740 and 181.22 treatment of foods under the following through 181.30 of this chapter, sodium conditions: citrate, sodium lauryl sulfate, poly- (a) The radiation sources consist of vinyl chloride, and materials as listed xenon flashlamps designed to emit in paragraph (d)(2)(i) of this section. broadband radiation consisting of (ii) Coatings comprising a vinylidene wavelengths covering the range of 200 chloride copolymer containing a min- to 1,100 nanometers (nm), and operated imum of 85 percent vinylidene chloride so that the pulse duration is no longer with one or more of the following co- than 2 milliseconds (msec); monomers: Acrylic acid, acrylonitrile, (b) The treatment is used for surface itaconic acid, methyl acrylate, and microorganism control; methyl methacrylate. (c) Foods treated with pulsed light (5) Kraft paper prepared from un- shall receive the minimum treatment bleached sulfate pulp to which rosin, reasonably required to accomplish the complying with § 178.3870 of this chap- intended technical effect; and ter, and alum may be added. The kraft (d) The total cumulative treatment paper is used only as a container for shall not exceed 12.0 Joules/square cen- flour and is irradiated with a dose not timeter (J/cm2.) exceeding 500 grays. [61 FR 42383, Aug. 15, 1996] (6) Polyethylene terephthalate film prepared from the basic polymer as de- Subpart C—Packaging Materials scribed in § 177.1630(e)(4)(i) and (ii) of for Irradiated Foods this chapter. The finished film may contain: § 179.45 Packaging materials for use (i) Adjuvant substances used in com- during the irradiation of pre- pliance with §§ 178.3740 and 181.22 packaged foods. through 181.30 of this chapter, sodium The packaging materials identified citrate, sodium lauryl sulfate, poly- in this section may be safely subjected vinyl chloride, and materials as listed to irradiation incidental to the radi- in paragraph (d)(2)(i) of this section. ation treatment and processing of pre- (ii) Coatings comprising a vinylidene packaged foods, subject to the provi- chloride copolymer containing a min- sions of this section and to the require- imum of 85 percent vinylidene chloride ment that no induced radioactivity is with one or more of the following co- detectable in the packaging material monomers: Acrylic acid, acrylonitrile, itself: itaconic acid, methyl acrylate, and (a) The radiation of the food itself methyl methacrylate. shall comply with regulations in this (iii) Coatings consisting of poly- part. ethylene conforming to § 177.1520 of this (b) The following packaging mate- chapter. rials may be subjected to a dose of ra- (7) Polystyrene film prepared from diation, not to exceed 10 kilograys, un- styrene basic polymer. The finished less otherwise indicated, incidental to film may contain adjuvant substances the use of gamma, electron beam, or X- used in compliance with §§ 178.3740 and radiation in the radiation treatment of 181.22 through 181.30 of this chapter. prepackaged foods: (8) Rubber hydrochloride film pre- (1) Nitrocellulose-coated or vinyli- pared from rubber hydrochloride basic dene chloride copolymer-coated cello- polymer having a chlorine content of phane complying with § 177.1200 of this 30–32 weight percent and having a max- chapter. imum extractable fraction of 2 weight (2) Glassine paper complying with percent when extracted with n-hexane § 176.170 of this chapter. at reflux temperature for 2 hours. The (3) Wax-coated paperboard complying finished film may contain adjuvant with § 176.170 of this chapter. substances used in compliance with

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§§ 178.3740 and 181.22 through 181.30 of packaging materials may be subjected this chapter. to a dose of radiation, not to exceed 30 (9) Vinylidene chloride-vinyl chloride kilogray (3 megarads), incidental to copolymer film prepared from vinyli- the use of gamma, electron beam, or X- dene chloride-vinyl chloride basic co- radiation in the radiation treatment of polymers containing not less than 70 packaged foods. weight percent of vinylidene chloride (d) The following packaging mate- and having a viscosity of 0.50–1.50 cen- rials may be subjected to a dose of ra- tipoises as determined by ASTM meth- diation, not to exceed 60 kilograys inci- od D729–81, ‘‘Standard Specification for dental to the use of gamma, electron Vinylidene Chloride Molding Com- beam, or X-radiation in the radiation pounds,’’ which is incorporated by ref- processing of prepackaged foods: erence. Copies may be obtained from (1) Vegetable parchments, consisting the American Society for Testing Ma- terials, 1916 Race St., Philadelphia, PA of a cellulose material made from 19103, or may be examined at the Office waterleaf paper (unsized) treated with of the Federal Register, 800 North Cap- concentrated sulfuric acid, neutralized, itol Street, NW., suite 700, Washington, and thoroughly washed with distilled DC 20408. The finished film may con- water. tain adjuvant substances used in com- (2) Films prepared from basic poly- pliance with §§ 178.3740 and 181.22 mers and with or without adjuvants, as through 181.30 of this chapter. follows: (10) Nylon 11 conforming to § 177.1500 (i) Polyethylene film prepared from of this chapter. the basic polymer as described in (c) Ethylene-vinyl acetate copoly- § 177.1520(a) of this chapter. The fin- mers complying with § 177.1350 of this ished film may contain one or more of chapter. The ethylene-vinyl acetate the following added substances:

Substances Limitations

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

(ii) Polyethylene terephthalate film 10.0 to 11.5 weight percent of vinyl ace- prepared from the basic polymer as de- tate and having a maximum volatility scribed in § 177.1630(e)(4)(ii) of this of not over 3.0 percent (1 hour at 105 °C) chapter. The finished film may contain and viscosity not less than 0.30 deter- one or more of the added substances mined by ASTM method D1243–79, listed in paragraph (d)(2)(i) of this sec- ‘‘Standard Test Method for Dilute So- tion. lution Viscosity of Vinyl Chloride (iii) Nylon 6 films prepared from the Polymers,’’ Method A, which is incor- nylon 6 basic polymer as described in porated by reference. The availability § 177.1500(a)(6) of this chapter and meet- of this incorporation by reference is ing the specifications of item 6.1 of the given in paragraph (b)(9) of this sec- table in § 177.1500(b) of this chapter. tion. The finished film may contain The finished film may contain one or one or more of the added substances more of the added substances listed in paragraph (d)(2)(i) of this section. listed in paragraph (d)(2)(i) of this sec- (iv) Vinyl chloride-vinyl acetate co- tion. polymer film prepared from the basic (e) Acrylonitrile copolymers identi- copolymer containing 88.5 to 90.0 fied in this section shall comply with weight percent of vinyl chloride with

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the provisions of § 180.22 of this chap- is harmful or that continued use of the ter. substance will result in harm to the public health. [42 FR 14635, Mar. 15, 1977, as amended at 49 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: (1) Use of the substance in food or TIONAL STUDY 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 180.30 Brominated vegetable oil. been undertaken, or the Food and Drug 180.37 Saccharin, ammonium saccharin, cal- Administration may undertake the cium saccharin, and sodium saccharin. studies. The Commissioner may extend AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; this 60-day period if necessary to re- 42 U.S.C. 241. view and act on proposed protocols. If EDITORIAL NOTE: Nomenclature changes to no such commitment is made, or ade- part 180 appear at 61 FR 14482, Apr. 2, 1996, quate and appropriate studies are not and 66 FR 56035, Nov. 6, 2001. undertaken, an order shall immediately be published in the FEDERAL Subpart A—General Provisions REGISTER revoking the interim food additive regulation effective upon publi- § 180.1 General. cation. (a) Substances having a history of (3) A progress report shall be filed on use in food for human consumption or the studies every January 1 and July 1 in food contact surfaces may at any until completion. If the progress report time have their safety or functionality is inadequate or if the Commissioner brought into question by new informa- concludes that the studies are not tion that in itself is not conclusive. An being pursued promptly and diligently interim food additive regulation for or if interim results indicate a reason- the use of any such substance may be able likelihood that a health hazard ex- promulgated in this subpart when new ists, an order will promptly be pub- information raises a substantial ques- lished in the FEDERAL REGISTER revok- tion about the safety or functionality ing the interim food additive regula- of the substance but there is a reason- tion effective upon publication. able certainty that the substance is (4) If nonclinical laboratory studies not harmful and that no harm to the are involved, studies filed with the public health will result from the con- Commissioner shall include, with re- tinued use of the substance for a lim- spect to each study, either a statement ited period of time while the question that the study has been or will be con- raised is being resolved by further ducted in compliance with the good study. laboratory practice regulations as set (b) No interim food additive regula- forth in part 58 of this chapter, or, if tion may be promulgated if the new in- any such study was not conducted in formation is conclusive with respect to compliance with such regulations, a the question raised or if there is a rea- brief statement of the reason for the sonable likelihood that the substance noncompliance.

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(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 will require elimination of the sub- Chromatographic Procedure for Deter- stance from the food supply. mining Acrylonitrile Monomer in Ac- (e) The Commissioner may consult rylonitrile-Containing Polymers and with advisory committees, professional Food Simulating Solvents,’’ which is organizations, or other experts in the incorporated by reference. Copies are field, in evaluating: available from the Center for Food Safety and Applied Nutrition (HFS– (1) Whether an interim food additive 200), Food and Drug Administration, regulation is justified, 5100 Paint Branch Pkwy., College Park, (2) The type of studies necessary and MD 20740, or available for inspection at appropriate to resolve questions raised the Office of the Federal Register, 800 about a substance, North Capitol Street, NW., suite 700, (3) Whether interim results indicate Washington, DC 20408, are as follows: the reasonable likelihood that a health (1) In the case of single-use articles hazard exists, or having a volume to surface ratio of 10 (4) Whether the data available at the milliliters or more per square inch of conclusion of those studies justify a food contact surface—0.003 milligram/ food additive regulation. square inch when extracted to equi- (f) Where appropriate, an emergency librium at 120 °F with food-simulating action level may be issued for a sub- solvents appropriate to the intended stance subject to paragraph (a) of this conditions of use. section that is not an approved food ad- (2) In the case of single-use articles ditive, pending the issuance of a final having a volume to surface ratio of less interim food additive regulation. Such than 10 milliliters per square inch of an action level shall be issued pursuant food contact surface—0.3 part per mil- to sections 306 and 402(a) of the act to lion calculated on the basis of the vol- identify, based upon available data, a ume of the container when extracted to safe level of use for the substance. equilibrium at 120 °F with food-simu- Such an action level shall be issued in lating solvents appropriate to the in- a notice published in the FEDERAL REG- tended conditions of use. ISTER and shall be followed as soon as (3) In the case of repeated-use arti- practicable by a proposed interim food cles—0.003 milligram/square inch when additive regulation. Where the avail- extracted at a time equivalent to ini- able data do not permit establishing an tial batch usage utilizing food-simu- action level for the safe use of a sub- lating solvents and temperatures ap- stance, use of the substance may be propriate to the intended conditions of prohibited. The identification of a pro- use.

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The food-simulating solvents shall in- (1) Qualitative and quantitative mi- clude, where applicable, distilled gration values at a time equivalent to water, 8 percent or 50 percent ethanol, initial batch usage, utilizing solvents 3 percent acetic acid, and either n- and temperatures appropriate to the heptane or an appropriate oil or fat. intended conditions of use. (b) Where necessary, current regula- (2) Qualitative and quantitative mi- tions permitting the use of acrylo- gration values at the time of equi- nitrile copolymers shall be revised to librium extractions, utilizing solvents specify limitations on acrylonitrile/ and temperatures appropriate to the mercaptan complexes utilized in the intended conditions of use. production of acrylonitrile copolymers. (3) Data on the volume and/or weight Such copolymers, if they contain re- of food handled during the initial batch versible acrylonitrile/mercaptan com- time period(s), during the equilibrium plexes and are used in other than re- test period, and over the estimated life peated-use conditions, shall be tested of the food-contact surface. to determine the identity of the com- (d) Where acrylonitrile copolymers plex and the level of the complex represent only a minor component of a present in the food-contact article. polymer system, calculations based on 100 percent migration of the acrylo- Such testing shall include determina- nitrile component may be submitted in tion of the rate of decomposition of the lieu of the requirements of paragraphs complex at temperatures of 100 °F, 160 (a), (b), and (c) of this section in sup- °F, and 212 °F using 3 percent acetic port of the continued safe use of acry- acid as the hydrolic agent. Acrylo- lonitrile copolymers. nitrile monomer levels, acrylonitrile/ (e) On or before September 13, 1976, mercaptan complex levels, acrylo- any interested person shall satisfy the nitrile oligomer levels, descriptions of Commissioner of Food and Drugs that the analytical methods used to deter- toxicological feeding studies adequate mine the complex and the acrylonitrile and appropriate to establish safe condi- migration, and validation studies of tions for the use of acrylonitrile co- these analytical methods shall be sub- polymers have been, or soon will be, mitted by June 9, 1977, to the Center undertaken. Toxicity studies of acrylo- for Food Safety and Applied Nutrition nitrile monomer shall include: (1) Life- (HFS–200), Food and Drug Administra- time feeding studies with a mamma- tion, 5100 Paint Branch Pkwy., College lian species, preferably with animals Park, MD 20740, unless an extension is exposed in utero to the chemical, (2) granted by the Food and Drug Admin- studies of multigeneration reproduc- istration for good cause shown. Analyt- tion with oral administration of the ical methods for the determination of test material, (3) assessment of acrylonitrile complexes with n- teratogenic and mutagenic potentials, dodecyl-mercaptan, n-octyl mercaptan, (4) subchronic oral administration in a and 2-mercaptoethanol, titled ‘‘Deter- nonrodent mammal, (5) tests to determination of b-Dodecyl- mine any synergistic toxic effects be- mercaptopropionitrile in NR–16R Aque- tween acrylonitrile monomer and cya- ous Extracts’’ and ‘‘Measurement of b- nide ion, and (6) a literature search on (2-Hdroxyethylmercapto) Propionitrile the effects of chronic ingestion of hy- in Heptane Food-Simulating Solvent,’’ drogen cyanide. Data on levels of acryl- are incorporated by reference. Copies amide extractable from acrylonitrile are available from the Center for Food copolymers shall also be submitted. Safety and Applied Nutrition (HFS– Protocols of testing should be sub- 200), Food and Drug Administration, mitted for review to the Center for 5100 Paint Branch Pkwy., College Park, Food Safety and Applied Nutrition MD 20740, or available for inspection at (HFS–200, Food and Drug Administra- the Office of the Federal Register, 800 tion, 5100 Paint Branch Pkwy., College North Capitol Street, NW., suite 700, Park, MD 20740. Washington, DC 20408. (f) Acrylonitrile copolymers may be (c) The following data shall be pro- used in contact with food only if au- vided for finished food-contact articles thorized in parts 174 through 179 or intended for repeated use: § 181.32 of this chapter, except that

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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 (b) The ingredient meets the speci- statement of the basis, including any fications of the ‘‘Food Chemicals articles and correspondence, on which Codex,’’ 3d Ed. (1981), pp. 188–190, which the user in good faith believed the use is incorporated by reference. Copies to be prior-sanctioned. The Commis- may be obtained from the National sioner of Food and Drugs shall, by no- Academy Press, 2101 Constitution Ave. tice in the FEDERAL REGISTER, identify NW., Washington, DC 20418, or may be any use of acrylonitrile copolymers not examined at the Office of the Federal in accordance with this paragraph. Register, 800 North Capitol Street, Those uses are thereafter unapproved NW., suite 700, Washington, DC 20408. food additives and consequently unlaw- (c) The ingredient is used as an ful. anticaking agent and free-flow agent as (2) Any use of acrylonitrile copoly- defined in § 170.3(o)(1) of this chapter, mers subject to paragraph (f)(1) of this formulation aid as defined in § 170.3(o) section shall be the subject of a peti- (14) of this chapter, firming agent as tion submitted on or before December defined in § 170.3(o)(10) of this chapter, 13, 1976, in accordance with § 171.1 of flavoring agent and adjuvant as defined this chapter, unless an extension of in § 170.3(o)(12) of this chapter, lubri- time is granted by the Food and Drug cant and release agent as defined in Administration for good cause shown. § 170.3(o)(18) of this chapter, nutritive Any application for extension shall be sweetener as defined in § 170.3(o)(21) of by petition submitted in accordance this chapter, processing aid as defined with the requirements of part 10 of this in § 170.3(o)(24) of this chapter, sta- chapter. If a petition is denied, in bilizer and thickener as defined in whole or in part, those uses subject to § 170.3(o)(28) of this chapter, surface-fin- the denial are thereafter unapproved ishing agent as defined in § 170.3(o)(30) food additives and consequently unlaw- of this chapter, and texturizer as de- ful. fined in § 170.3(o)(32) of this chapter. (3) Any use of acrylonitrile copoly- (d) The ingredient is used in food at mers subject to paragraph (f)(1) of this levels not to exceed 98 percent in section shall meet the acrylonitrile pressed mints and 5 percent in all other monomer extraction limitation set hard candy and cough drops as defined forth in paragraph (a) of this section in § 170.3(n)(25) of this chapter, 31 per- and shall be subject to the require- cent in chewing gum as defined in ments of paragraph (b) of this section. § 170.3(n)(6) of this chapter, 40 percent (g) In addition to the requirements of in soft candy as defined in § 170.3(n)(38) this section, the use of acrylonitrile co- of this chapter, 8 percent in confections polymers shall comply with all applica- and frostings as defined in § 170.3(n)(9) ble requirements in other regulations of this chapter, 15 percent in non- in this part. standardized jams and jellies, commer- [42 FR 14636, Mar. 15, 1977, as amended at 47 cial, as defined in § 170.3(n)(28) of this FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, chapter, and at levels less than 2.5 per- 1989; 61 FR 14246, Apr. 1, 1996] cent in all other foods. (e) The label and labeling of food § 180.25 Mannitol. whose reasonably foreseeable consump- (a) Mannitol is the chemical tion may result in a daily ingestion of 1,2,3,4,5,6,-hexanehexol (C6H14O6) a 20 grams of mannitol shall bear the

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statement ‘‘Excess consumption may ance with the following conditions, if have a laxative effect’’. the substitution for nutritive sweet- (f) In accordance with § 180.1, ade- eners is for a valid special dietary pur- quate and appropriate feeding studies pose and is in accord with current spe- have been undertaken for this sub- cial dietary food regulations and poli- stance. Continued uses of this ingre- cies or if the use or intended use is for dient are contingent upon timely and an authorized technological purpose adequate progress reports of such tests, other than calorie reduction: and no indication of increased risk to (a) Saccharin is the chemical, 1,2- public health during the test period. benzisothiazolin-3-one - 1,1 - dioxide (g) Prior sanctions for this ingredient (C7H5NO3S). The named salts of sac- different from the uses established in charin are produced by the additional this regulation do not exist or have neutralization of saccharin with the been waived. proper base to yield the desired salt. [42 FR 14636, Mar. 15, 1977, as amended at 49 (b) The food additives meet the speci- FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 22, 62, 266–267, § 180.30 Brominated vegetable oil. 297–299, which is incorporated by ref- The food additive brominated vege- erence. Copies may be obtained from table oil may be safely used in accord- the National Academy Press, 2101 Con- ance with the following prescribed constitution Ave. NW., Washington, DC ditions: 20418, or may be examined at the Office (a) The additive complies with speci- of the Federal Register, 800 North Cap- fications prescribed in the ‘‘Food itol Street, NW., suite 700, Washington, Chemicals Codex,’’ 3d Ed. (1981), pp. 40– DC 20408. 41, which is incorporated by reference, (c) Authority for such use shall ex- except that free fatty acids (as oleic) pire when the Commissioner receives shall not exceed 2.5 percent and iodine the final reports on the ongoing studies value shall not exceed 16. Copies of the in Canada and publishes an order on material incorporated by reference the safety of saccharin and its salts may be obtained from the National based on those reports and other avail- Academy Press, 2101 Constitution Ave. able data. NW., Washington, DC 20418, or may be (d) The additives are used or intended examined at the Office of the Federal for use as a sweetening agent only in Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20418. special dietary foods, as follows: (b) The additive is used on an interim (1) In beverages, fruit juice drinks, basis as a stabilizer for flavoring oils and bases or mixes when prepared for used in fruit-flavored beverages, for consumption in accordance with direc- which any applicable standards of iden- tions, in amounts not to exceed 12 mil- tity do not preclude such use, in an ligrams of the additive, calculated as amount not to exceed 15 parts per mil- saccharin, per fluid ounce. lion in the finished beverage, pending (2) As a sugar substitute for cooking the outcome of additional toxicological or table use, in amounts not to exceed studies on which periodic reports at 6- 20 milligrams of the additive, cal- month intervals are to be furnished culated as saccharin, for each ex- and final results submitted to the Food pressed teaspoonful of sugar sweet- and Drug Administration promptly ening equivalency. after completion of the studies. (3) In processed foods, in amounts not to exceed 30 milligrams of the additive, [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984] calculated as saccharin, per serving of designated size. § 180.37 Saccharin, ammonium sac- (e) The additives are used or intended charin, calcium saccharin, and so- for use only for the following techno- dium saccharin. logical purposes: The food additives saccharin, ammo- (1) To reduce bulk and enhance fla- nium saccharin, calcium saccharin, and vors in chewable vitamin tablets, sodium saccharin may be safely used as chewable mineral tablets, or combina- sweetening agents in food in accord- tions thereof.

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(2) To retain flavor and physical 181.27 Plasticizers. properties of chewing gum. 181.28 Release agents. (3) To enhance flavor of flavor chips 181.29 Stabilizers. used in nonstandardized bakery prod- 181.30 Substances used in the manufacture ucts. of paper and paperboard products used in (f) To assure safe use of the additives, food packaging. in addition to the other information re- 181.32 Acrylonitrile copolymers and resins. quired by the Act: 181.33 Sodium nitrate and potassium nitrate. (1) The label of the additive and any 181.34 Sodium nitrite and potassium nitrite. intermediate mixes of the additive for manufacturing purposes shall bear: AUTHORITY: 21 U.S.C. 321, 342, 348, 371. (i) The name of the additive. SOURCE: 42 FR 14638, Mar. 15, 1977, unless (ii) A statement of the concentration otherwise noted. of the additive, expressed as saccharin, in any intermediate mix. EDITORIAL NOTE: Nomenclature changes to (iii) Adequate directions for use to part 181 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001. provide a final food product that complies with the limitations prescribed in paragraphs (d) and (e) of this section. Subpart A—General Provisions (2) The label of any finished food product containing the additive shall § 181.1 General. bear: (a) An ingredient whose use in food (i) The name of the additive. or food packaging is subject to a prior (ii) The amount of the additive, cal- sanction or approval within the mean- culated as saccharin, as follows: ing of section 201(s)(4) of the Act is ex- (a) For beverages, in milligrams per empt from classification as a food addi- fluid ounce; tive. The Commissioner will publish in (b) For cooking or table use products, this part all known prior sanctions. in milligrams per dispensing unit; Any interested person may submit to (c) For processed foods, in terms of the Commissioner a request for publi- the weight or size of a serving which cation of a prior sanction, supported by shall be that quantity of the food con- evidence to show that it falls within taining 30 milligrams or less of the ad- section 201(s)(4) of the Act. ditive. (b) Based upon scientific data or in- (iii) When the additive is used for cal- formation that shows that use of a orie reduction, such other labeling as is prior-sanctioned food ingredient may required by part 105 or § 100.130 of this be injurious to health, and thus in vio- chapter. lation of section 402 of the Act, the [42 FR 14636, Mar. 15, 1977, as amended at 49 Commissioner will establish or amend FR 5610, Feb. 14, 1984] an applicable prior sanction regulation to impose whatever limitations or con- PART 181—PRIOR-SANCTIONED ditions are necessary for the safe use of FOOD INGREDIENTS the ingredient, or to prohibit use of the ingredient. Subpart A—General Provisions (c) Where appropriate, an emergency action level may be issued for a prior- Sec. sanctioned substance, pending the 181.1 General. issuance of a final regulation in ac- 181.5 Prior sanctions. cordance with paragraph (b) of this sec- Subpart B—Specific Prior-Sanctioned Food tion. Such an action level shall be Ingredients issued pursuant to section 402(a) of the Act to identify, based upon available 181.22 Certain substances employed in the data, conditions of use of the substance manufacture of food-packaging mate- that may be injurious to health. Such rials. an action level shall be issued in a no- 181.23 Antimycotics. 181.24 Antioxidants. tice published in the FEDERAL REG- 181.25 Driers. ISTER and shall be followed as soon as 181.26 Drying oils as components of finished practicable by a proposed regulation in resins. accordance with paragraph (b) of this

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section. Where the available data dem- such sanction to submit proof of its ex- onstrate that the substance may be in- istence. Any food additive or GRAS jurious at any level, use of the sub- regulation promulgated after a general stance may be prohibited. The identi- evaluation of use of an ingredient con- fication of a prohibited substance may stitutes a determination that excluded be made in part 189 of this chapter uses would result in adulteration of the when appropriate. food in violation of section 402 of the [42 FR 14638, Mar. 15, 1977, as amended at 42 Act, and the failure of any person to FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, come forward with proof of such an ap- 1989] plicable prior sanction in response to a proposal will constitute a waiver of the § 181.5 Prior sanctions. right to assert or rely on such sanction (a) A prior sanction shall exist only at any later time. The notice will also for a specific use(s) of a substance in constitute a proposal to establish a food, i.e., the level(s), condition(s), regulation under this part, incor- product(s), etc., for which there was ex- porating the same provisions, in the plicit approval by the Food and Drug Administration or the United States event that such a regulation is deter- Department of Agriculture prior to mined to be appropriate as a result of September 6, 1958. submission of proof of such an applica- (b) The existence of a prior sanction ble prior sanction in response to the exempts the sanctioned use(s) from the proposal. food additive provisions of the Act but not from the other adulteration or the Subpart B—Specific Prior- misbranding provisions of the Act. Sanctioned Food Ingredients (c) All known prior sanctions shall be the subject of a regulation published in § 181.22 Certain substances employed this part. Any such regulation is sub- in the manufacture of food-pack- ject to amendment to impose whatever aging materials. limitation(s) or condition(s) may be Prior to the enactment of the food necessary for the safe use of the ingre- additives amendment to the Federal dient, or revocation to prohibit use of Food, Drug, and Cosmetic Act, sanc- the ingredient, in order to prevent the adulteration of food in violation of sections were granted for the usage of the tion 402 of the Act. substances listed in §§ 181.23, 181.24, (d) In proposing, after a general eval- 181.25, 181.26, 181.27, 181.28, 181.29, and uation of use of an ingredient, regula- 181.30 in the manufacture of packaging tions affirming the GRAS status of materials. So used, these substances substances added directly to human are not considered ‘‘food additives’’ food in part 184 of this chapter or sub- within the meaning of section 201(s) of stances in food-contact surfaces in part the Act, provided that they are of good 186 of this chapter, or establishing a commercial grade, are suitable for as- food additive regulation for substances sociation with food, and are used in ac- added directly to human food in parts cordance with good manufacturing 172 and 173 of this chapter or food addi- practice. For the purpose of this sub- tives in food-contact surfaces in parts part, good manufacturing practice for 174, 175, 176, 177, 178 and § 179.45 of this food-packaging materials includes the chapter, the Commissioner shall, if he restriction that the quantity of any of is aware of any prior sanction for use these substances which becomes a com- of the ingredient under conditions dif- ponent of food as a result of use in ferent from those proposed in the regu- food-packaging materials shall not be lation, concurrently propose a separate intended to accomplish any physical or regulation covering such use of the in- technical effect in the food itself, shall gredient under this part. If the Com- be reduced to the least amount reason- missioner is unaware of any such appli- ably possible, and shall not exceed any cable prior sanction, the proposed regu- limit specified in this subpart. lation will so state and will require any person who intends to assert or rely on [42 FR 56728, Oct. 28, 1977]

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§ 181.23 Antimycotics. Tall oil. Substances classified as [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. antimycotics, when migrating from 28, 1977] food-packaging material shall include: § 181.27 Plasticizers. Calcium propionate. Substances classified as plasticizers, Methylparaben (methyl p-hydroxybenzoate). when migrating from food-packaging Propylparaben (propyl p-hydroxybenzoate). material shall include: Sodium benzoate. Sodium propionate. Acetyl tributyl citrate. Sorbic acid. Acetyl triethyl citrate. p-tert-Butylphenyl salicylate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Butyl stearate. 28, 1977] Butylphthalyl butyl glycolate. Dibutyl sebacate. § 181.24 Antioxidants. Di-(2-ethylhexyl) phthalate (for foods of high Substances classified as antioxidants, water content only). when migrating from food-packaging Diethyl phthalate. material (limit of addition to food, Diisobutyl adipate. 0.005 percent) shall include: Diisooctyl phthalate (for foods of high water content only). Butylated hydroxyanisole. Diphenyl-2-ethylhexyl phosphate. Butylated hydroxytoluene. Epoxidized soybean oil (iodine number max- Dilauryl thiodipropionate. imum 6; and oxirane oxygen, minimum, 6.0 Distearyl thiodipropionate. percent). Gum guaiac. Ethylphthalyl ethyl glycolate. Nordihydroguairetic acid. Glycerol monooleate. Propyl gallate. Monoisopropyl citrate. Thiodipropionic acid. Mono, di-, and tristearyl citrate. Triacetin (glycerol triacetate). 2,4,5-Trihydroxy butyrophenone. Triethyl citrate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 3-(2-Xenolyl)-1,2-epoxypropane. 28, 1977] [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 50 FR 49536, Dec. 3, § 181.25 Driers. 1985] Substances classified as driers, when migrating from food-packaging mate- § 181.28 Release agents. rial shall include: Substances classified as release Cobalt caprylate. agents, when migrating from food- Cobalt linoleate. packaging material shall include: Cobalt naphthenate. Dimethylpolysiloxane (substantially free Cobalt tallate. from hydrolyzable chloride and alkoxy Iron caprylate. groups, no more than 18 percent loss in Iron linoleate. weight after heating 4 hours at 200 °C.; vis- Iron naphthenate. cosity 300 centisokes, 600 centisokes at 25 Iron tallate. °C, specific gravity 0.96 to 0.97 at 25 °C, re- Manganese caprylate. fractive index 1.400 to 1.404 at 25 °C). Manganese linoleate. Linoleamide (linoleic acid amide). Manganese naphthenate. Oleamide (oleic acid amide). Manganese tallate. Palmitamide (palmitic acid amide). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Stearamide (stearic acid amide). 28, 1977] [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977] § 181.26 Drying oils as components of finished resins. § 181.29 Stabilizers. Substances classified as drying oils, Substances classified as stabilizers, when migrating from food-packaging when migrating from food-packaging material (as components of finished material shall include: resins) shall include: Aluminum mono-, di-, and tristearate. Chinawood oil (tung oil). Ammonium citrate. Dehydrated castor oil. Ammonium potassium hydrogen phosphate. Linseed oil. Calcium glycerophosphate.

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

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(3) Rigid and semirigid containers. (i) article containing acrylonitrile copoly- Acrylonitrile/butadiene/styrene copolymers or resins that yield acrylonitrile mer—for use only as piping for han- monomer in excess of that amount pro- dling food products and for repeated- vided for in paragraph (b) of this sec- use articles intended to contact food. tion shall be deemed to be adulterated (ii) Acrylonitrile/styrene resin—no in violation of section 402 of the Act. restrictions. (iii) Acrylonitrile/butadiene copoly- [42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, mer blended with polyvinyl chloride 1989] resin—for use only as extruded pipe. (b) Limitations for acrylonitrile § 181.33 Sodium nitrate and potassium monomer extraction for finished food- nitrate. contact articles, determined by using Sodium nitrate and potassium ni- the method of analysis titled ‘‘Gas- trate are subject to prior sanctions Solid Chromatographic Procedure for issued by the U.S. Department of Agri- Determining Acrylonitrile Monomer in culture for use as sources of nitrite, Acrylonitrile-Containing Polymers and with or without sodium or potassium Food-Simulating Solvents,’’ which is nitrite, in the production of cured red incorporated by reference. Copies are meat products and cured poultry prod- available from the Center for Food ucts. Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, [48 FR 1705, Jan. 14, 1983] 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at § 181.34 Sodium nitrite and potassium the Office of the Federal Register, 800 nitrite. North Capitol Street, NW., suite 700, Sodium nitrite and potassium nitrite Washington, DC 20408, are as follows: are subject to prior sanctions issued by (1) In the case of single-use articles the U.S. Department of Agriculture for having a volume to surface ratio of 10 use as color fixatives and preservative milliliters or more per square inch of agents, with or without sodium or po- food-contact surface—0.003 milligram/ tassium nitrate, in the curing of red square inch when extracted to equi- meat and poultry products. ° librium at 120 F with food-simulating [48 FR 1705, Jan. 14, 1983] solvents appropriate to the intended conditions of use. (2) In the case of single-use articles PART 182—SUBSTANCES having a volume to surface ratio of less GENERALLY RECOGNIZED AS SAFE than 10 milliliters per square inch of food-contact surface—0.3 part per mil- Subpart A—General Provisions lion calculated on the basis of the vol- Sec. ume of the container when extracted to 182.1 Substances that are generally recog- equilibrium at 120 °F with food-simu- nized as safe. lating solvents appropriate to the in- 182.10 Spices and other natural seasonings tended conditions of use. and flavorings. (3) In the case of repeated-use arti- 182.20 Essential oils, oleoresins (solvent- cles—0.003 milligram/square inch when free), and natural extractives (including extracted at a time equivalent to ini- distillates). tial batch usage utilizing food-simu- 182.40 Natural extractives (solvent-free) used in conjunction with spices, lating solvents and temperatures ap- seasonings, and flavorings. propriate to the intended conditions of 182.50 Certain other spices, seasonings, es- use. sential oils, oleoresins, and natural ex- The food-simulating solvents shall in- tracts. clude, where applicable, distilled 182.60 Synthetic flavoring substances and water, 8 percent or 50 percent ethanol, adjuvants. 182.70 Substances migrating from cotton 3 percent acetic acid, and either n- and cotton fabrics used in dry food pack- heptane or an appropriate oil or fat. aging. (c) Acrylonitrile monomer may 182.90 Substances migrating to food from present a hazard to health when in- paper and paperboard products. gested. Accordingly, any food-contact 182.99 Adjuvants for pesticide chemicals.

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Subpart B—Multiple Purpose GRAS Food 182.6215 Monobasic calcium phosphate. Substances 182.6285 Dipotassium phosphate. 182.6290 Disodium phosphate. 182.1045 Glutamic acid. 182.6757 Sodium gluconate. 182.1047 Glutamic acid hydrochloride. 182.6760 Sodium hexametaphosphate. 182.1057 Hydrochloric acid. 182.6769 Sodium metaphosphate. 182.1073 Phosphoric acid. 182.6778 Sodium phosphate. 182.1087 Sodium acid pyrophosphate. 182.6787 Sodium pyrophosphate. 182.1125 Aluminum sulfate. 182.6789 Tetra sodium pyrophosphate. 182.1127 Aluminum ammonium sulfate. 182.6810 Sodium tripolyphosphate. 182.1129 Aluminum potassium sulfate. 182.1131 Aluminum sodium sulfate. Subpart H—Stabilizers 182.1180 Caffeine. 182.1217 Calcium phosphate. 182.7255 Chondrus extract. 182.1235 Caramel. 182.1320 Glycerin. Subpart I—Nutrients 182.1480 Methylcellulose. 182.8013 Ascorbic acid. 182.1500 Monoammonium glutamate. 182.8159 Biotin. 182.1516 Monopotassium glutamate. 182.8217 Calcium phosphate. 182.1711 Silica aerogel. 182.8223 Calcium pyrophosphate. 182.1745 Sodium carboxymethylcellulose. 182.8250 Choline bitartrate. 182.1748 Sodium caseinate. 182.8252 Choline chloride. 182.1778 Sodium phosphate. 182.8778 Sodium phosphate. 182.1781 Sodium aluminum phosphate. 182.8890 Tocopherols. 182.1810 Sodium tripolyphosphate. 182.8892 a-Tocopherol acetate. 182.8985 Zinc chloride. Subpart C—Anticaking Agents 182.8988 Zinc gluconate. 182.2122 Aluminum calcium silicate. 182.8991 Zinc oxide. 182.2227 Calcium silicate. 182.8994 Zinc stearate. 182.2437 Magnesium silicate. 182.8997 Zinc sulfate. 182.2727 Sodium aluminosilicate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 182.2729 Sodium calcium aluminosilicate, hydrated. SOURCE: 42 FR 14640, Mar. 15, 1977, unless 182.2906 Tricalcium silicate. otherwise noted. Subpart D—Chemical Preservatives Subpart A—General Provisions 182.3013 Ascorbic acid. § 182.1 Substances that are generally 182.3041 Erythorbic acid. recognized as safe. 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. (a) It is impracticable to list all sub- 182.3149 Ascorbyl palmitate. stances that are generally recognized 182.3169 Butylated hydroxyanisole. as safe for their intended use. However, 182.3173 Butylated hydroxytoluene. by way of illustration, the Commis- 182.3189 Calcium ascorbate. sioner regards such common food in- 182.3225 Calcium sorbate. gredients as salt, pepper, vinegar, bak- 182.3280 Dilauryl thiodipropionate. 182.3616 Potassium bisulfite. ing powder, and monosodium glu- 182.3637 Potassium metabisulfite. tamate as safe for their intended use. 182.3640 Potassium sorbate. This part includes additional sub- 182.3731 Sodium ascorbate. stances that, when used for the pur- 182.3739 Sodium bisulfite. poses indicated, in accordance with 182.3766 Sodium metabisulfite. good manufacturing practice, are re- 182.3795 Sodium sorbate. garded by the Commissioner as 182.3798 Sodium sulfite. generaly recognized as safe for such 182.3862 Sulfur dioxide. 182.3890 Tocopherols. uses. (b) For the purposes of this section, SubpartE—Emulsifying Agents [Reserved] good manufacturing practice shall be defined to include the following re- SubpartF—Dietary Supplements [Reserved] strictions: (1) The quantity of a substance added Subpart G—Sequestrants to food does not exceed the amount 182.6085 Sodium acid phosphate. reasonably required to accomplish its 182.6197 Calcium diacetate. intended physical, nutritional, or other 182.6203 Calcium hexametaphosphate. technical effect in food; and

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(2) The quantity of a substance that (d) Substances that are generally rec- becomes a component of food as a re- ognized as safe for their intended use sult of its use in the manufacturing, within the meaning of section 409 of processing, or packaging of food, and the act are listed in this part. When which is not intended to accomplish the status of a substance has been re- any physical or other technical effect evaluated, it will be deleted from this in the food itself, shall be reduced to part, and will be issued as a new regu- the extent reasonably possible. lation under the appropriate part, e.g., (3) The substance is of appropriate ‘‘affirmed as GRAS’’ under part 184 or 186 of this chapter; ‘‘food additive regu- food grade and is prepared and handled lation’’ under parts 170 through 180 of as a food ingredient. Upon request the this chapter; ‘‘interim food additive Commissioner will offer an opinion, regulation’’ under part 180 of this chap- based on specifications and intended ter; or ‘‘prohibited from use in food’’ use, as to whether or not a particular under part 189 of this chapter. grade or lot of the substance is of suitable purity for use in food and would [42 FR 14640, Mar. 15, 1977, as amended at 53 generally be regarded as safe for the FR 44875, Nov. 7, 1988] purpose intended, by experts qualified § 182.10 Spices and other natural to evaluate its safety. seasonings and flavorings. (c) The inclusion of substances in the Spices and other natural seasonings list of nutrients does not constitute a and flavorings that are generally rec- finding on the part of the Department ognized as safe for their intended use, that the substance is useful as a sup- within the meaning of section 409 of plement to the diet for humans. the Act, are as follows:

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.

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Common name Botanical name of plant source

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). 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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. 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.

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Common name Botanical name of plant source

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]

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

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food packaging that are generally rec- Sodium phosphoaluminate. ognized as safe for their intended use, Sodium silicate. within the meaning of section 409 of Sodium sorbate. Sodium tripolyphosphate. the Act, are as follows: Sorbitol. Beef tallow. Soy protein, isolated. Carboxymethylcellulose. Starch, acid modified. Coconut oil, refined. Starch, pregelatinized. Cornstarch. Starch, unmodified. Gelatin. Talc. Lard. Vanillin. Lard oil. Zinc hydrosulfite. Oleic acid. Zinc sulfate. Peanut oil. [42 FR 14640, Mar. 15, 1977] Potato starch. Sodium acetate. EDITORIAL NOTE: For additional FEDERAL Sodium chloride. REGISTER citations affecting § 182.90, see the Sodium silicate. List of CFR Sections Affected, which appears Sodium tripolyphosphate. in the Finding Aids section of the printed Soybean oil (hydrogenated). volume and on GPO Access. Talc. Tallow (hydrogenated). § 182.99 Adjuvants for pesticide chemi- Tallow flakes. cals. Tapioca starch. Adjuvants, identified and used in ac- Tetrasodium pyrophosphate. cordance with 40 CFR 180.1001 (c) and Wheat starch. (d), which are added to pesticide use di- Zinc chloride. lutions by a grower or applicator prior [42 FR 14640, Mar. 15, 1977, as amended at 43 to application to the raw agricultural FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, commodity, are exempt from the re- 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, quirement of tolerances under section 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 409 of the Act. 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, Subpart B—Multiple Purpose GRAS July 30, 1986; 60 FR 62208, Dec. 5, 1995] Food Substances § 182.90 Substances migrating to food § 182.1045 Glutamic acid. from paper and paperboard products. (a) Product. Glutamic acid. (b) [Reserved] Substances migrating to food from (c) Limitations, restrictions, or expla- paper and paperboard products used in nation. This substance is generally rec- food packaging that are generally recognized as safe when used as a salt sub- ognized as safe for their intended use, stitute in accordance with good manu- within the meaning of section 409 of facturing practice. the Act, are as follows: Alum (double sulfate of aluminum and am- § 182.1047 Glutamic acid hydro- monium potassium, or sodium). chloride. Aluminum hydroxide. (a) Product. Glutamic acid hydro- Aluminum oleate. chloride. Aluminum palmitate. (b) [Reserved] Casein. Cellulose acetate. (c) Limitations, restrictions, or expla- Cornstarch. nation. This substance is generally rec- Diatomaceous earth filler. ognized as safe when used as a salt sub- 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

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and neutralizing agent in accordance § 182.1217 Calcium phosphate. with good manufacturing practice. (a) Product. Calcium phosphate § 182.1073 Phosphoric acid. (mono-, di-, and tribasic). (a) Product. Phosphoric acid. (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. § 182.1235 Caramel. § 182.1087 Sodium acid pyrophosphate. (a) Product. Caramel. (a) Product. Sodium acid (b) Conditions of use. This substance pyrophosphate. 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. § 182.1320 Glycerin. § 182.1125 Aluminum sulfate. (a) Product. Glycerin. (a) Product. Aluminum sulfate. (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. § 182.1480 Methylcellulose. § 182.1127 Aluminum ammonium sul- (a) Product. U.S.P. methylcellulose, fate. except that the methoxy content shall (a) Product. Aluminum ammonium not be less than 27.5 percent and not sulfate. more than 31.5 percent on a dry-weight (b) Conditions of use. This substance basis. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- § 182.1129 Aluminum potassium sul- turing practice. fate. § 182.1500 Monoammonium glutamate. (a) Product. Aluminum potassium sulfate. (a) Product. Monoammonium glu- (b) Conditions of use. This substance tamate. 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. § 182.1131 Aluminum sodium sulfate. (a) Product. Aluminum sodium sul- § 182.1516 Monopotassium glutamate. fate. (a) Product. Monopotassium glu- (b) Conditions of use. This substance tamate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- § 182.1180 Caffeine. turing practice. (a) Product. Caffeine. § 182.1711 Silica aerogel. (b) Tolerance. 0.02 percent. (c) Limitations, restrictions, or expla- (a) Product. Silica aerogel as a finely nation. This substance is generally rec- powdered microcellular silica foam ognized as safe when used in cola-type having a minimum silica content of beverages in accordance with good 89.5 percent. manufacturing practice. (b) [Reserved]

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(c) Limitations, restrictions, or expla- Subpart C—Anticaking Agents nation. This substance is generally recognized as safe when used as a compo- § 182.2122 Aluminum calcium silicate. nent of an anti-foaming agent in ac- (a) Product. Aluminum calcium sili- cordance with good manufacturing cate. practice. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or expla- § 182.1745 Sodium carboxymethylcellu- nation. This substance is generally rec- lose. ognized as safe when used in table salt (a) Product. Sodium carboxy- in accordance with good manufacturing methylcellulose is the sodium salt of practice. carboxymethylcellulose not less than § 182.2227 Calcium silicate. 99.5 percent on a dry-weight basis, with maximum substitution of 0.95 (a) Product. Calcium silicate. carboxymethyl groups per (b) Tolerance. 2 percent and 5 percent. (c) Limitations, restrictions, or expla- anhydroglucose unit, and with a min- nation. This substance is generally rec- imum viscosity of 25 centipoises for 2 ognized as safe when used at levels not percent by weight aqueous solution at exceeding 2 percent in table salt and 5 ° 25 C. percent in baking powder in accordance (b) Conditions of use. This substance with good manufacturing practice. is generally recognized as safe when used in accordance with good manufac- § 182.2437 Magnesium silicate. turing practice. (a) Product. Magnesium silicate. (b) Tolerance. 2 percent. § 182.1748 Sodium caseinate. (c) Limitations, restrictions, or expla- (a) Product. Sodium caseinate. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used in table salt is generally recognized as safe when in accordance with good manufacturing used in accordance with good manufac- practice. turing practice. § 182.2727 Sodium aluminosilicate. § 182.1778 Sodium phosphate. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). (a) Product. Sodium phosphate (b) Tolerance. This substance is gen- (mono-, di-, and tribasic). erally recognized as safe for use at a (b) Conditions of use. This substance level not exceeding 2 percent in accord- is generally recognized as safe when ance with good manufacturing prac- used in accordance with good manufac- tice. turing practice. § 182.2729 Sodium calcium § 182.1781 Sodium aluminum phos- aluminosilicate, hydrated. phate. (a) Product. Hydrated sodium calcium (a) Product. Sodium aluminum phos- aluminosilicate (sodium calcium phate. silicoaluminate). (b) Tolerance. This substance is gen- (b) Conditions of use. This substance erally recognized as safe for use at a is generally recognized as safe when level not exceeding 2 percent in accord- used in accordance with good manufac- ance with good manufacturing prac- turing practice. tice.

§ 182.1810 Sodium tripolyphosphate. § 182.2906 Tricalcium silicate. (a) Product. Sodium (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.

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Subpart D—Chemical (b) Tolerance. This substance is gen- Preservatives erally recognized as safe for use in food when the total content of antioxidants § 182.3013 Ascorbic acid. is not over 0.02 percent of fat or oil (a) Product. Ascorbic acid. content, including essential (volatile) (b) Conditions of use. This substance oil content of food, provided the sub- is generally recognized as safe when stance is used in accordance with good used in accordance with good manufac- manufacturing practice. turing practice. § 182.3189 Calcium ascorbate. § 182.3041 Erythorbic acid. (a) Product. Calcium ascorbate. (a) Product. Erythorbic acid. (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. § 182.3225 Calcium sorbate. § 182.3089 Sorbic acid. (a) Product. Calcium sorbate. (a) Product. Sorbic acid. (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. § 182.3280 Dilauryl thiodipropionate. § 182.3109 Thiodipropionic acid. (a) Product. Dilauryl (a) Product. Thiodipropionic acid. thiodipropionate. (b) This substance is gen- Tolerance. (b) Tolerance. This substance is generally recognized as safe for use in food erally recognized as safe for use in food when the total content of antioxidants when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) is not over 0.02 percent of fat or oil oil content of the food, provided the content, including essential (volatile) substance is used in accordance with oil content of the food, provided the good manufacturing practice. substance is used in accordance with good manufacturing practice. § 182.3149 Ascorbyl palmitate. § 182.3616 Potassium bisulfite. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance (a) Product. Potassium bisulfite. 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- § 182.3169 Butylated hydroxyanisole. ance with good manufacturing prac- (a) Product. Butylated hydroxy- tice, except that it is not used in anisole. meats; in food recognized as a source of (b) Tolerance. This substance is gen- vitamin B1; on fruits and vegetables in- erally recognized as safe for use in food tended to be served raw to consumers when the total content of antioxidants or sold raw to consumers, or to be pre- is not over 0.02 percent of fat or oil sented to consumers as fresh. content, including essential (volatile) oil content of food, provided the sub- [42 FR 14640, Mar. 15, 1977, as amended at 51 stance is used in accordance with good FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, manufacturing practice. 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3173 Butylated hydroxytoluene. § 182.3637 Potassium metabisulfite. (a) Product. Butylated hydroxy- (a) Product. Potassium metabisulfite. toluene. (b) [Reserved]

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(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 9833, 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 vitamin B1; on fruits and vegetables in- § 182.3795 Sodium sorbate. tended to be served raw to consumers (a) Product. Sodium sorbate. or sold raw to consumers, or to be pre- (b) Conditions of use. This substance sented to consumers as fresh. is generally recognized as safe when [42 FR 14640, Mar. 15, 1977, as amended at 51 used in accordance with good manufac- FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, turing practice. 1990; 59 FR 65939, Dec. 22, 1994] § 182.3798 Sodium sulfite. § 182.3640 Potassium sorbate. (a) Product. Sodium sulfite. (a) Product. Potassium sorbate. (b) [Reserved] (b) Conditions of use. This substance (c) Limitations, restrictions, or expla- is generally recognized as safe when nation. This substance is generally rec- used in accordance with good manufac- ognized as safe when used in accord- turing practice. ance with good manufacturing practice, except that it is not used in § 182.3731 Sodium ascorbate. meats; in food recognized as a source of (a) Product. Sodium ascorbate. vitamin B1; on fruits or vegetables in- (b) Conditions of use. This substance tended 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 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, § 182.3739 Sodium bisulfite. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Sodium bisulfite. (b) [Reserved] § 182.3862 Sulfur dioxide. (c) Limitations, restrictions, or expla- (a) Product. Sulfur dioxide. nation. This substance is generally rec- (b) [Reserved] ognized as safe when used in accord- (c) Limitations, restrictions, or expla- ance with good manufacturing prac- nation. This substance is generally rec- tice, except that it is not used in ognized as safe when used in accord- meats; in food recognized as a source of ance with good manufacturing prac- vitamin B1; on fruits or vegetables in- tice, except that it is not used in tended to be served raw to consumers meats; in food recognized as a source of or sold raw to consumers, or to be pre- vitamin B1; on fruits or vegetables in- sented to the consumer as fresh. tended to be served raw to consumers or sold raw to consumers, or to be pre- [42 FR 14640, Mar. 15, 1977, as amended at 51 sented to consumers as fresh. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994] [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, § 182.3766 Sodium metabisulfite. 1990; 59 FR 65939, Dec. 22, 1994] (a) Product. Sodium metabisulfite. § 182.3890 Tocopherols. (b) [Reserved] (c) Limitations, restrictions, or expla- (a) Product. Tocopherols. nation. This substance is generally rec- (b) Conditions of use. This substance ognized as safe when used in accord- is generally recognized as safe when ance with good manufacturing prac- used in accordance with good manufac- tice, except that it is not used in turing practice. meats; in food recognized as a source of vitamin B1; on fruits or vegetables in- Subpart E—Emulsifying Agents tended to be served raw to consumers [Reserved] 460

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Subpart F—Dietary Supplements (b) Conditions of use. This substance [Reserved] is generally recognized as safe when used in accordance with good manufac- Subpart G—Sequestrants 1 turing practice. § 182.6760 Sodium § 182.6085 Sodium acid phosphate. hexametaphosphate. (a) Product. Sodium acid phosphate. (a) Product. Sodium (b) Conditions of use. This substance hexametaphosphate. 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. § 182.6197 Calcium diacetate. (a) Product. Calcium diacetate. § 182.6769 Sodium metaphosphate. (b) Conditions of use. This substance (a) Product. Sodium metaphosphate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- § 182.6203 Calcium turing practice. hexametaphosphate. § 182.6778 Sodium phosphate. (a) Product. Calcium (a) Product. Sodium phosphate hexametaphosphate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufacturing practice. turing practice. § 182.6215 Monobasic calcium phosphate. § 182.6787 Sodium pyrophosphate. (a) Product. Monobasic calcium phos- (a) Product. Sodium pyrophosphate. phate. (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. § 182.6789 Tetra sodium § 182.6285 Dipotassium phosphate. pyrophosphate. (a) Product. Dipotassium phosphate. (a) Product. Tetra sodium (b) Conditions of use. This substance pyrophosphate. 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. § 182.6290 Disodium phosphate. § 182.6810 Sodium tripolyphosphate. (a) Product. Disodium phosphate. (b) Conditions of use. This substance (a) Product. Sodium is generally recognized as safe when tripolyphosphate. 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- § 182.6757 Sodium gluconate. turing practice. (a) Product. Sodium gluconate. Subpart H—Stabilizers

1 For the purpose of this subpart, no at- § 182.7255 Chondrus extract. tempt has been made to designate those sequestrants that may also function as (a) Product. Chondrus extract chemical preservatives. (carrageenin).

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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.

Subpart I—Nutrients § 182.8890 Tocopherols. (a) Product. Tocopherols. SOURCE: 45 FR 58838, Sept. 5, 1980, unless (b) Conditions of use. This substance otherwise noted. is generally recognized as safe when used in accordance with good manufac- § 182.8013 Ascorbic acid. turing practice. (a) Product. Ascorbic acid. (b) Conditions of use. This substance § 182.8892 α-Tocopherol acetate. is generally recognized as safe when (a) Product. a-Tocopherol acetate. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when used in accordance with good manufac- § 182.8159 Biotin. turing practice. (a) Product. Biotin. (b) Conditions of use. This substance § 182.8985 Zinc chloride. is generally recognized as safe when (a) Product. Zinc chloride. used in accordance with good manufac- (b) Conditions of use. This substance turing practice. is generally recognized as safe when § 182.8217 Calcium phosphate. used in accordance with good manufacturing practice. (a) Product. Calcium phosphate (mono-, di-, and tribasic). § 182.8988 Zinc gluconate. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Zinc gluconate. 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- § 182.8223 Calcium pyrophosphate. turing practice. (a) Product. Calcium pyrophosphate. § 182.8991 Zinc oxide. (b) Conditions of use. This substance is generally recognized as safe when (a) Product. Zinc oxide. 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- § 182.8250 Choline bitartrate. turing practice. (a) Product. Choline bitartrate. (b) Conditions of use. This substance § 182.8994 Zinc stearate. is generally recognized as safe when (a) Product. Zinc stearate prepared used in accordance with good manufac- from stearic acid free from chickedema turing practice. factor. (b) Conditions of use. This substance § 182.8252 Choline chloride. is generally recognized as safe when (a) Product. Choline chloride. 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- § 182.8997 Zinc sulfate. turing practice. (a) Product. Zinc sulfate. (b) Conditions of use. This substance § 182.8778 Sodium phosphate. is generally recognized as safe when (a) Product. Sodium phosphate used in accordance with good manufac- (mono-, di-, and tribasic). turing practice.

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PART 184—DIRECT FOOD SUB- 184.1205 Calcium hydroxide. 184.1206 Calcium iodate. STANCES AFFIRMED AS GEN- 184.1207 Calcium lactate. ERALLY RECOGNIZED AS SAFE 184.1210 Calcium oxide. 184.1212 Calcium pantothenate. Subpart A—General Provisions 184.1221 Calcium propionate. 184.1229 Calcium stearate. Sec. 184.1230 Calcium sulfate. 184.1 Substances added directly to human 184.1240 Carbon dioxide. food affirmed as generally recognized as 184.1245 Beta-carotene. safe (GRAS). 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachi- Subpart B—Listing of Specific Substances atum. Affirmed as GRAS 184.1257 Clove and its derivatives. 184.1259 Cocoa butter substitute. 184.1005 Acetic acid. 184.1260 Copper gluconate. 184.1007 Aconitic acid. 184.1261 Copper sulfate. 184.1009 Adipic acid. 184.1262 Corn silk and corn silk extract. 184.1011 Alginic acid. 184.1265 Cuprous iodide. 184.1012 a-Amylase enzyme preparation 184.1271 L-Cysteine. from Bacillus stearothermophilus. 184.1272 L-Cysteine monohydrochloride. 184.1021 Benzoic acid. 184.1277 Dextrin. 184.1024 Bromelain. 184.1278 Diacetyl. 184.1025 Caprylic acid. 184.1282 Dill and its derivatives. 184.1027 Mixed carbohydrase and protease 184.1287 Enzyme-modified fats. enzyme product. 184.1293 Ethyl alcohol. 184.1033 Citric acid. 184.1295 Ethyl formate. 184.1034 Catalase (bovine liver). 184.1296 Ferric ammonium citrate. 184.1061 Lactic acid. 184.1297 Ferric chloride. 184.1063 Enzyme-modified lecithin. 184.1298 Ferric citrate. 184.1065 Linoleic acid. 184.1301 Ferric phosphate. 184.1069 Malic acid. 184.1304 Ferric pyrophosphate. 184.1077 Potassium acid tartrate. 184.1307 Ferric sulfate. 184.1081 Propionic acid. 184.1307a Ferrous ascorbate. 184.1090 Stearic acid. 184.1307b Ferrous carbonate. 184.1091 Succinic acid. 184.1307c Ferrous citrate. 184.1095 Sulfuric acid. 184.1307d Ferrous fumarate. 184.1097 Tannic acid. 184.1308 Ferrous gluconate. 184.1099 Tartaric acid. 184.1311 Ferrous lactate. 184.1101 Diacetyl tartaric acid esters of 184.1315 Ferrous sulfate. mono- and diglycerides. 184.1316 Ficin. 184.1115 Agar-agar. 184.1317 Garlic and its derivatives. 184.1120 Brown algae. 184.1318 Glucono delta-lactone. 184.1121 Red algae. 184.1321 Corn gluten. 184.1133 Ammonium alginate. 184.1322 Wheat gluten. 184.1135 Ammonium bicarbonate. 184.1323 Glyceryl monooleate. 184.1137 Ammonium carbonate. 184.1324 Glyceryl monostearate. 184.1138 Ammonium chloride. 184.1328 Glyceryl behenate. 184.1139 Ammonium hydroxide. 184.1329 Glyceryl palmitostearate. 184.1140 Ammonium citrate, dibasic. 184.1330 Acacia (gum arabic). 184.1141a Ammonium phosphate, monobasic. 184.1333 Gum ghatti. 184.1141b Ammonium phosphate, dibasic. 184.1339 Guar gum. 184.1143 Ammonium sulfate. 184.1343 Locust (carob) bean gum. 184.1148 Bacterially-derived carbohydrase 184.1349 Karaya gum (sterculia gum). enzyme preparation. 184.1351 Gum tragacanth. 184.1150 Bacterially-derived protease en- 184.1355 Helium. zyme preparation. 184.1366 Hydrogen peroxide. 184.1155 Bentonite. 184.1370 Inositol. 184.1157 Benzoyl peroxide. 184.1372 Insoluble glucose isomerase enzyme 184.1165 n–Butane and iso–butane. preparations. 184.1185 Calcium acetate. 184.1375 Iron, elemental. 184.1187 Calcium alginate. 184.1386 Isopropyl citrate. 184.1191 Calcium carbonate. 184.1387 Lactase enzyme preparation from 184.1193 Calcium chloride. Candida pseudotropicalis. 184.1195 Calcium citrate. 184.1388 Lactase enzyme preparation from 184.1199 Calcium gluconate. Kluyveromyces lactis. 184.1201 Calcium glycerophosphate. 184.1400 Lecithin.

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184.1408 Licorice and licorice derivatives. 184.1751 Sodium citrate. 184.1409 Ground limestone. 184.1754 Sodium diacetate. 184.1415 Animal lipase. 184.1763 Sodium hydroxide. 184.1420 Lipase enzyme preparation derived 184.1764 Sodium hypophosphite. from Rhizopus niveus. 184.1768 Sodium lactate. 184.1425 Magnesium carbonate. 184.1769a Sodium metasilicate. 184.1426 Magnesium chloride. 184.1784 Sodium propionate. 184.1428 Magnesium hydroxide. 184.1792 Sodium sesquicarbonate. 184.1431 Magnesium oxide. 184.1801 Sodium tartrate. 184.1434 Magnesium phosphate. 184.1804 Sodium potassium tartrate. 184.1440 Magnesium stearate. 184.1807 Sodium thiosulfate. 184.1443 Magnesium sulfate. 184.1835 Sorbitol. 184.1443a Malt. 184.1845 Stannous chloride (anhydrous and 184.1444 Maltodextrin. dihydrated). 184.1445 Malt syrup (malt extract). 184.1848 Starter distillate. 184.1446 Manganese chloride. 184.1851 Stearyl citrate 184.1449 Manganese citrate. 184.1854 Sucrose. 184.1452 Manganese gluconate. 184.1857 Corn sugar. 184.1461 Manganese sulfate. 184.1859 Invert sugar. 184.1472 Menhaden oil. 184.1865 Corn syrup. 184.1490 Methylparaben. 184.1866 High fructose corn syrup. 184.1498 Microparticulated protein product. 184.1875 Thiamine hydrochloride. 184.1505 Mono- and diglycerides. 184.1878 Thiamine mononitrate. 184.1521 Monosodium phosphate derivatives 184.1890 a-Tocopherols. of mono- and diglycerides. 184.1901 Triacetin. 184.1530 Niacin. 184.1903 Tributyrin. 184.1535 Niacinamide. 184.1911 Triethyl citrate. 184.1537 Nickel. 184.1914 Trypsin. 184.1538 Nisin preparation. 184.1923 Urea. 184.1540 Nitrogen. 184.1924 Urease enzyme preparation from 184.1545 Nitrous oxide. Lactobacillus fermentum. 184.1553 Peptones. 184.1930 Vitamin A. 184.1555 Rapeseed oil. 184.1945 Vitamin B12. 184.1560 Ox bile extract. 184.1950 Vitamin D. 184.1563 Ozone. 184.1973 Beeswax (yellow and white). 184.1583 Pancreatin. 184.1976 Candelilla wax. 184.1585 Papain. 184.1978 Carnauba wax. 184.1588 Pectins. 184.1979 Whey. 184.1595 Pepsin. 184.1979a Reduced lactose whey. 184.1610 Potassium alginate. 184.1979b Reduced minerals whey. 184.1613 Potassium bicarbonate. 184.1979c Whey protein concentrate. 184.1619 Potassium carbonate. 184.1983 Bakers yeast extract. 184.1622 Potassium chloride. 184.1984 Zein. 184.1625 Potassium citrate. 184.1985 Aminopeptidase enzyme prepara- 184.1631 Potassium hydroxide. tion derived from lactococcus lactis. 184.1634 Potassium iodide. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 184.1635 Potassium iodate. 184.1639 Potassium lactate. SOURCE: 42 FR 14653, Mar 15, 1977, unless 184.1643 Potassium sulfate. otherwise noted. 184.1655 Propane. EDITORIAL NOTE: Nomenclature changes to 184.1660 Propyl gallate. part 184 appear at 66 FR 56035, Nov. 6, 2001, 184.1666 Propylene glycol. and 66 FR 66742, Dec. 27, 2001. 184.1670 Propylparaben. 184.1676 Pyridoxine hydrochloride. 184.1685 Rennet (animal-derived) and Subpart A—General Provisions chymosin preparation (fermentation-derived). § 184.1 Substances added directly to 184.1695 Riboflavin. human food affirmed as generally 184.1697 Riboflavin-5′-phosphate (sodium). recognized as safe (GRAS). 184.1698 Rue. (a) The direct human food ingredi- 184.1699 Oil of rue. ents listed in this part have been re- 184.1702 Sheanut oil. viewed by the Food and Drug Adminis- 184.1721 Sodium acetate. 184.1724 Sodium alginate. tration and determined to be generally 184.1733 Sodium benzoate. recognized as safe (GRAS) for the pur- 184.1736 Sodium bicarbonate. poses and under the conditions pre- 184.1742 Sodium carbonate. scribed. The regulations in this part

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shall sufficiently describe each ingre- different from those described in the dient to identify the characteristics of regulation, that use of the ingredient the ingredient that has been affirmed may not be GRAS. In such a case, a as GRAS and to differentiate it from manufacturer may not rely on the reg- other possible versions of the ingre- ulation as authorizing that use but dient that have not been affirmed as shall independently establish that that GRAS. Ingredients affirmed as GRAS use is GRAS or shall use the ingredient in this part are also GRAS as indirect in accordance with a food additive reg- human food ingredients, subject to any ulation. Persons seeking FDA approval limitations prescribed in parts 174, 175, of an independent determination that a 176, 177, 178 or § 179.45 of this chapter or use of an ingredient is GRAS may sub- in part 186 of this chapter. The purity mit a GRAS petition in accordance specifications in this part do not apply with § 170.35 of this chapter. when the ingredient is used in indirect (2) If the ingredient is affirmed as applications. However, when used in in- GRAS with specific limitation(s), it direct applications, the ingredient shall be used in food only within such must be of a purity suitable for its in- limitation(s), including the category of tended use in accordance with food(s), the functional use(s) of the in- § 170.30(h)(1) of this chapter. gredient, and the level(s) of use. Any (b) Any ingredient affirmed as GRAS use of such an ingredient not in full in this part shall be used in accordance compliance with each such established with current good manufacturing prac- limitation shall require a food additive tice. For the purpose of this part, cur- regulation. rent good manufacturing practice in- (3) If the ingredient is affirmed as cludes the requirements that a direct GRAS for a specific use, without a gen- human food ingredient be of appro- eral evaluation of use of the ingredient, priate food grade; that it be prepared other uses may also be GRAS. and handled as a food ingredient; and (c) The listing of a food ingredient in that the quantity of the ingredient this part does not authorize the use of added to food does not exceed the amount reasonably required to accom- such substance in a manner that may plish the intended physical, nutri- lead to deception of the consumer or to tional, or other technical effect in any other violation of the Federal food. Food, Drug, and Cosmetic Act (the (1) If the ingredient is affirmed as Act). GRAS with no limitations on its condi- (d) The listing of more than one in- tions of use other than current good gredient to produce the same techno- manufacturing practice, it shall be re- logical effect does not authorize use of garded as GRAS if its conditions of use a combination of two or more ingredi- are consistent with the requirements of ents to accomplish the same techno- paragraph (b), (c), and (d) of this sec- logical effect in any one food at a com- tion. When the Food and Drug Admin- bined level greater than the highest istration (FDA) determines that it is level permitted for one of the ingredi- appropriate, the agency will describe ents. one or more current good manufac- (e) If the Commissioner of Food and turing practice conditions of use in the Drugs is aware of any prior sanction regulation that affirms the GRAS sta- for use of an ingredient under condi- tus of the ingredient. For example, tions different from those proposed to when the safety of an ingredient has be affirmed as GRAS, he will concur- been evaluated on the basis of limited rently propose a separate regulation conditions of use, the agency will de- covering such use of the ingredient scribe in the regulation that affirms under part 181 of this chapter. If the the GRAS status of the ingredient, one Commissioner is unaware of any such or more of these limited conditions of applicable prior sanction, the proposed use, which may include the category of regulation will so state and will re- food(s), the technical effect(s) or func- quire any person who intends to assert tional use(s) of the ingredient, and the or rely on such sanction to submit level(s) of use. If the ingredient is used proof of its existence. Any regulation under conditions that are significantly promulgated pursuant to this section

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constitutes a determination that ex- by reference. Copies are available from cluded uses would result in adultera- the National Academy Press, 2101 Con- tion of the food in violation of section stitution Ave. NW., Washington, DC 402 of the Act, and the failure of any 20418, or available for inspection at the person to come forward with proof of Office of the Federal Register, 800 such an applicable prior sanction in re- North Capitol Street, NW., suite 700, sponse to the proposal will constitute a Washington, DC 20408. waiver of the right to assert or rely on (c) The ingredient is used as a curing such sanction at any later time. The and pickling agent as defined in notice will also constitute a proposal § 170.3(o)(5) of this chapter; flavor to establish a regulation under part 181 enhancer as defined in § 170.3(o)(11) of of this chapter, incorporating the same this chapter; flavoring agent and adju- provisions, in the event that such a vant as defined in § 170.3(o)(12) of this regulation is determined to be appro- chapter; pH control agent as defined in priate as a result of submission of proof § 170.3(o)(23) of this chapter; as a sol- of such an applicable prior sanction in response to the proposal. vent and vehicle as defined in (f) The label and labeling of the in- § 170.3(o)(27) of this chapter; and as a gredient and any intermediate mix of boiler water additive complying with the ingredient for use in finished food § 173.310 of this chapter. shall bear, in addition to the other la- (d) The ingredient is used in food at beling required by the Act: levels not to exceed current good man- (1) The name of the ingredient, ex- ufacturing practice in accordance with cept where exempted from such label- § 184.1(b)(1). Current good manufac- ing in part 101 of this chapter. turing practice results in a maximum (2) A statement of concentration of level as served, of 0.25 percent for the ingredient in any intermediate baked goods as defined in § 170.3(n)(1) of mix; or other information to permit a this chapter; 0.8 percent for cheeses as food processor independently to deter- defined in § 170.3(n)(5) of this chapter mine that use of the ingredients will be and dairy product analogs as defined in in accordance with any limitations and § 170.3(n)(10) of this chapter; 0.5 percent good manufacturing practice gudelines for chewing gum as defined in prescribed. § 170.3(n)(6) of this chapter; 9.0 percent (3) Adequate directions for use to for condiments and relishes as defined provide a final food product that com- in § 170.3(n)(8) of this chapter; 0.5 per- plies with any limitations prescribed cent for fats and oils as defined in for the ingredient(s). § 170.3(n)(12) of this chapter; 3.0 percent [42 FR 14653, Mar. 15, 1977, as amended at 42 for gravies and sauces as defined in FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. § 170.3(n)(24) of this chapter; 0.6 percent 19, 1983; 62 FR 15110, Mar. 31, 1997] for meat products as defined in § 170.3(n)(29) of this chapter; and 0.15 Subpart B—Listing of Specific percent or less for all other food cat- Substances Affirmed as GRAS egories. The ingredient may also be used in boiler water additives at levels § 184.1005 Acetic acid. not to exceed current good manufac-

(a) Acetic acid (C2H4O2, CAS Reg. No. turing practice. 64–19–7) is known as ethanoic acid. It (e) Prior sanctions for this ingredient occurs naturally in plant and animal different from the uses established in tissues. It is produced by fermentation this section do not exist or have been of carbohydrates or by organic syn- waived. thesis. The principal synthetic methods currently employed are oxidation [47 FR 27814, June 25, 1982] of acetaldehyde derived from ethylene, liquid phase oxidation of butane, and § 184.1007 Aconitic acid. reaction of carbon monoxide with (a) Aconitic acid (1,2,3- methanol derived from natural gas. propenetricarboxylic acid (C6H6O6), (b) The ingredient meets the speci- CAS Reg. No. 000499–12–7) occurs in the fications of the Food Chemicals Codex, leaves and tubers of Aconitum napellus 3d Ed. (1981), p. 8, which is incorporated L. and other Ranunculaceae.

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Transaconitic acid can be isolated dur- not to exceed good manufacturing ing sugarcane processing, by precipita- practice. Current good manufacturing tion as the calcium salt from cane practice results in a maximum level, as sugar or molasses. It may be syn- served, of 0.003 percent for baked goods thesized by sulfuric acid dehydration of as defined in § 170.3(n)(1) of this chap- citric acid, but not by the ter, 0.002 percent for alcoholic bev- methanesulfonic acid method. erages as defined in § 170.3(n)(2) of this (b) The ingredient meets the fol- chapter, 0.0015 percent for frozen dairy lowing specifications: products as defined in § 170.3(n)(20) of (1) Assay. Not less than 98.0 percent this chapter, 0.0035 percent for soft of C3H3(COOH)3, using the ‘‘Food candy as defined in § 170.3(n)(38) of this Chemicals Codex,’’ 4th ed. (1996), pp. chapter, and 0.0005 percent or less for 102–103, test for citric acid, which is in- all other food categories. corporated by reference in accordance (e) Prior sanctions for this ingredient with 5 U.S.C. 552(a) and 1 CFR part 51, different from the uses established in and a molecular weight of 174.11. Copies this section do not exist or have been of the material incorporated by ref- waived. erence are available from the National [43 FR 47724, Oct. 17, 1978, as amended at 49 Academy Press, Box 285, 2101 Constitu- FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, tion Ave. NW., Washington, DC 20055 1999] (Internet address ‘‘http:// www.nap.edu’’), or may be examined at § 184.1009 Adipic acid.

the Center for Food Safety and Applied (a) Adipic acid (C6H10O4, CAS Reg. No. Nutrition’s Library, Food and Drug Ad- 00124–04–9) is also known as 1,4- ministration, 200 C St. SW., Wash- butanedicarboxylic acid or hexane- ington, DC, or at the Office of the Fed- dioic acid. It is prepared by nitric acid eral Register, 800 North Capitol St. oxidation of cyclohexanol or NW., suite 700, Washington, DC. cyclohexanone or a mixture of the two. (2) Melting point. Not less than 195 °C (b) The ingredient meets the speci- and the determination results in de- fications of the Food Chemicals Codex, composition of aconitic acid. 3d Ed. (1981), p. 11, which is incor- (3) Heavy metals (as Pb). Not more porated by reference (copies are avail- than 10 parts per million. able from the National Academy Press, (4) Arsenic (as As). Not more than 3 2101 Constitution Ave., NW., Wash- parts per million. ington, DC 20418, or available for in- (5) Oxalate. Passes test. spection at the Office of the Federal (6) Readily carbonizable substances. Register, 800 North Capitol Street, Passes the test for citric acid of the NW., suite 700, Washington, DC 20408), ‘‘Food Chemicals Codex,’’ 4th ed. (1996), and the following additional specifica- pp. 102–103, which is incorporated by tions: reference in accordance with 5 U.S.C. (1) The adipic acid is converted to its 552(a) and 1 CFR part 51. The avail- corresponding amide. The amide is pu- ability of this incorporation by ref- rified by recrystallization from water erence is given in paragraph (b)(1) of or aqueous ethanol. The melting range this section. of the amide is 219° to 220 °C. (7) Residue on ignition. Not more than (2) The adipic acid is converted to its 0.1 percent as determined by the ‘‘Food corresponding bis-p-p-bromophenacyl Chemicals Codex,’’ 4th ed. (1996), pp. ester. The ester is purified by recrys- 102–103, test for citric acid, which is in- tallization from ethanol. The melting corporated by reference in accordance range of the ester is 153° to 154 °C. with 5 U.S.C. 552(a) and 1 CFR part 51. (c) The ingredient is used as a fla- The availability of this incorporation voring agent as defined in § 170.3(o)(12) by reference is given in paragraph of this chapter; leavening agent as de- (b)(1) of this section. fined in § 170.3(o)(17) of this chapter; (c) The ingredient is used as a fla- and pH control agent as defined in voring substance and adjuvant as de- § 170.3(o)(23) of this chapter. fined in § 170.3(o)(12) of this chapter. (d) The ingredient is used in foods at (d) The ingredient is used in food, in levels not to exceed current good man- accordance with § 184.1(b)(1), at levels ufacturing practice in accordance with

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§ 184.1(b)(1). Current good manufac- Maximum level of Category of food use in food (as Functional use turing practice results in maximum served) levels, as served, of 0.05 percent for baked goods as defined in § 170.3(n)(1) of Soup and soup Not to exceed cur- Emulsifier, emulsi- mixes, rent good manu- fier salt, this chapter; 0.005 percent for non- ¤ 170.3(n) (40) facturing prac- ¤ 170.3(o)(8) of alcoholic beverages as defined in of this chapter . tice . this chapter; for- § 170.3(n)(3) of this chapter; 5.0 percent mulation aid, ¤ 170.3(o)(14) of for condiments and relishes as defined this chapter; sta- in § 170.3(n)(8) of this chapter; 0.45 per- bilizer, thickener, cent for dairy product analogs as de- ¤ 170.3(o)(28) of fined in § 170.3(n)(10) of this chapter; 0.3 this chapter. percent for fats and oil as defined in (d) Prior sanctions for this ingredient § 170.3(n)(12) of this chapter; 0.0004 per- different from the use established in cent for frozen dairy desserts as defined this section do not exist or have been in § 170.3(n)(20) of this chapter; 0.55 per- waived. cent for gelatin and puddings as defined in § 170.3(n)(22) of this chapter; 0.1 [47 FR 47375, Oct. 26, 1982] percent for gravies as defined in α § 170.3(n)(24) of this chapter; 0.3 percent § 184.1012 -Amylase enzyme preparation from Bacillus for meat products as defined in stearothermophilus. § 170.3(n)(29) of this chapter; 1.3 percent for snack foods as defined in (a) a-Amylase enzyme preparation is § 170.3(n)(37) of this chapter; and 0.02 obtained from the culture filtrate that percent or less for all other food cat- results from a pure culture fermenta- egories. tion of a nonpathogenic and (e) Prior sanctions for adipic acid dif- nontoxicogenic strain of Bacillus stearothermophilus. Its characterizing ferent from the uses established in this enzyme activity is -amylase (1,4 -D section do not exist or have been a a glucan glucanohydrolase (E.C. 3.2.1.1)). waived. (b) The ingredient meets the general [47 FR 27810, June 25, 1982] and additional requirements for enzyme preparations in the ‘‘Food Chemi- § 184.1011 Alginic acid. cals Codex,’’ 3d ed. (1981), pp. 107–110, (a) Alginic acid is a colloidal, hydro- which is incorporated by reference in philic polysaccharide obtained from accordance with 5 U.S.C. 552(a) and 1 certain brown algae by alkaline extrac- CFR part 51. Copies are available from tion. the National Academy Press, 2101 Con- (b) The ingredient meets the speci- stitution Ave. NW., Washington, DC fications of the Food Chemicals Codex, 20418, or may be examined at the Office 3d Ed. (1981), p. 13, which is incor- of Premarket Approval (HFS–200), Cen- porated by reference. Copies are avail- ter for Food Safety and Applied Nutri- able from the National Academy Press, tion, Food and Drug Administration, 2101 Constitution Ave. NW., Wash- 1110 Vermont Ave. NW., suite 1200, ington, DC 20418, or available for in- Washington, DC, or the Office of the spection at the Office of the Federal Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), 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

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upon the following current good manu- § 184.1024 Bromelain. facturing practice conditions of use: (a) Bromelain (CAS Reg. No. 9001–00– (1) The ingredient is used as an en- 7) is an enzyme preparation derived zyme, as defined in § 170.3(o)(9) of this from the pineapples Ananas comosus chapter, in the hydrolysis of edible starch to produce maltodextrins and and A. bracteatus L. It is a white to nutritive carbohydrate sweeteners. light tan amorphous powder. Its char- (2) The ingredient is used at levels acterizing enzyme activity is that of a not to exceed current good manufac- peptide hydrolase (EC 3.4.22.32). turing practices. (b) The ingredient meets the general requirements and additional require- [60 FR 55789, Nov. 3, 1995] ments for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. § 184.1021 Benzoic acid. 110, which is incorporated by reference (a) Benzoic acid is the chemical in accordance with 5 U.S.C. 552(a) and 1 benzenecarboxylic acid (C7H6O2), occur- CFR part 51. Copies are available from ring in nature in free and combined the National Academy Press, 2101 Con- forms. Among the foods in which ben- stitution Ave. NW., Washington, DC, or zoic acid occurs naturally are cran- may be examined at the Office of Pre- berries, prunes, plums, cinnamon, ripe market Approval (HFS–200), Food and cloves, and most berries. Benzoic acid Drug Administration, 200 C St. SW., is manufactured by treating molten Washington, DC, and the Office of the phthalic anhydride with steam in the Federal Register, 800 North Capitol St. presence of a zinc oxide catalyst, by NW., suite 700, Washington, DC. the hydrolysis of benzotrichloride, or (c) In accordance with § 184.1(b)(1), by the oxidation of toluene with nitric the ingredient is used in food with no acid or sodium bichromate or with air limitation other than current good in the presence of a transition metal manufacturing practice. The affirma- salt catalyst. tion of this ingredient as GRAS as a di- (b) The ingredient meets the speci- rect food ingredient is based upon the fications of the ‘‘Food Chemicals following current good manufacturing Codex,’’ 3d Ed. (1981), p. 35, which is in- practice conditions of use: corporated by reference. Copies may be (1) The ingredient is used as an en- obtained from the National Academy zyme as defined in § 170.3(o)(9) of this Press, 2101 Constitution Ave. NW., chapter to hydrolyze proteins or Washington, DC 20418, or may be exam- polypeptides. ined at the Office of the Federal Reg- (2) The ingredient is used in food at ister, 800 North Capitol Street, NW., levels not to exceed current good man- suite 700, Washington, DC 20408. ufacturing practice. (c) The ingredient is used as an antimicrobial agent as defined in [60 FR 32910, June 26, 1995] § 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as defined in § 184.1025 Caprylic acid. § 170.3(o)(12) of this chapter. (a) Caprylic acid [CH3(CH2)6COOH, (d) The ingredient is used in food at CAS Reg. No. 124–07–2] is the chemical levels not to exceed good manufac- name for octanoic acid. It is considered turing practice. Current usage results to be a short or medium chain fatty in a maximum level of 0.1 percent in acid. It occurs normally in various food. (The Food and Drug Administra- foods and is commercially prepared by tion has not determined whether sig- oxidation of n-octanol or by fermenta- nificantly different conditions of use tion and fractional distillation of the would be GRAS). volatile fatty acids present in coconut (e) Prior sanctions for this ingredient oil. different from those uses established in (b) The ingredient meets the speci- this section, or different from that set fications of the ‘‘Food Chemicals forth in part 181 of this chapter, do not Codex,’’ 3d Ed. (1981), p. 207, which is in- exist or have been waived. corporated by reference. Copies may be [42 FR 14653, Mar. 15, 1977, as amended at 49 obtained from the National Academy FR 5610, Feb. 14, 1984] Press, 2101 Constitution Ave. NW.,

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Washington, DC 20418, or may be exam- ognized as safe as a direct human food ined at the Office of the Federal Reg- ingredient is based upon the following ister, 800 North Capitol Street, NW., current good manufacturing practice suite 700, Washington, DC 20408. conditions of use: (c) The ingredient is used as a fla- (1) The ingredient is used as an en- voring agent and adjuvant as defined in zyme, as defined in § 170.3(o)(9) of this § 170.3(o)(12) of this chapter. chapter, to hydrolyze proteins or car- (d) The ingredient is used in foods in bohydrates. accordance with § 184.1(b)(1), at levels not to exceed good manufacturing (2) The ingredient is used in the fol- practice. Current good manufacturing lowing foods at levels not to exceed practices result in maximum levels, as current good manufacturing practice: served, of: 0.013 percent for baked goods alcoholic beverages, as defined in as defined in § 170.3(n)(1) of this chap- § 170.3(n)(2) of this chapter, candy, nu- ter; 0.04 percent for cheeses as defined tritive sweeteners, and protein in § 170.3(n)(5) of this chapter; 0.005 per- hydrolyzates. cent for fats and oils as defined in [48 FR 240, Jan. 4, 1983] § 170.3(n)(12) of this chapter, for frozen dairy desserts as defined in § 170.3(n)(20) § 184.1033 Citric acid. of this chapter, for gelatins and puddings as defined in § 170.3(n)(22) of this (a) Citric acid (C6H8O7, CAS Reg. No. chapter, for meat products as defined 77–92–9) is the compound 2-hydroxy- in § 170.3(n)(29) of this chapter, and for 1,2,3-propanetricarboxylic acid. It is a soft candy as defined in § 170.3(n)(38) of naturally occurring constituent of this chapter; 0.016 percent for snack plant and animal tissues. It occurs as foods as defined in § 170.3(n)(37) of this colorless crystals or a white powder chapter; and 0.001 percent or less for all and may be anhydrous or contain one other food categories. mole of water per mole of citric acid. (e) Prior sanctions for this ingredient Citric acid may be produced by recov- different from the uses established in ery from sources such as lemon or pine- this section do not exist or have been apple juice; by mycological fermenta- waived. tion using Candida spp., described in [43 FR 19843, May 9, 1978, as amended at 49 §§ 173.160 and 173.165 of this chapter; and FR 5611, Feb. 14, 1984] by the solvent extraction process described in § 173.280 of this chapter for § 184.1027 Mixed carbohydrase and the recovery of citric acid from Asper- protease enzyme product. gillus niger fermentation liquor. (a) Mixed carbohydrase and protease (b) The ingredient meets the speci- enzyme product is an enzyme prepara- fications of the Food Chemicals Codex, tion that includes carbohydrase and 3d ed. (1981), pp. 86–87, and its third sup- protease activity. It is obtained from plement (March 1992), pp. 107–108, which the culture filtrate resulting from a are incorporated by reference in ac- pure culture fermentation of a non- cordance with 5 U.S.C. 552(a) and 1 CFR pathogenic strain of B. licheniformis. part 51. Copies are available from the (b) The ingredient meets the speci- National Academy Press, 2101 Constitu- fications of the Food Chemicals Codex, tion Ave. NW., Washington, DC 20418, 3d Ed. (1981), p. 107, which is incor- and the Center for Food Safety and Ap- porated by reference. Copies are avail- plied Nutrition (HFS–200), 5100 Paint able from the National Academy Press, 2101 Constitution Ave. NW., Wash- Branch Pkwy., College Park, MD 20740, ington, DC 20418, or available for in- or may be examined at the Office of the spection at the Office of the Federal Federal Register, 800 North Capitol St. Register, 800 North Capitol Street, NW., suite 700, Washington, DC. NW., suite 700, Washington, DC 20408. (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 limitations other than current good limitation other than current good manufacturing practice. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in

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this section do not exist or have been 3d Ed. (1981), p. 159, which is incor- waived. porated by reference. Copies are available from the National Academy Press, [59 FR 63895, Dec. 12, 1994] 2101 Constitution Avenue, NW., Wash- § 184.1034 Catalase (bovine liver). ington, DC 20418, or available for inspection at the Office of the Federal (a) Catalase (bovine liver) (CAS Reg. Register, 800 North Capitol Street, No. 9001–05–2) is an enzyme preparation NW., suite 700, Washington, DC 20408. obtained from extracts of bovine liver. (c) In accordance with § 184.1(b)(1), It is a partially purified liquid or pow- the ingredient is used in food with no der. Its characterizing enzyme activity limitation other than current good is catalase (EC 1.11.1.6). manufacturing practice. The affirma- (b) The ingredient meets the general tion of this ingredient as generally rec- requirements and additional require- ognized as safe (GRAS) as a direct ments for enzyme preparations in the human food ingredient is based upon Food Chemicals Codex, 3d ed. (1981), p. the following current good manufac- 110, which is incorporated by reference turing practice conditions of use: in accordance with 5 U.S.C. 552(a) and 1 (1) The ingredient is used as an anti- CFR part 51. Copies are available from microbial agent as defined in the National Academy Press, 2101 Con- § 170.3(o)(2) of this chapter; a curing and stitution Ave., NW., Washington, DC pickling agent as defined in § 170.3(o)(5) 20418, or may be examined at the Office of this chapter; a flavor enhancer as de- of Premarket Approval (HFS–200), Food fined in § 170.3(o)(11) of this chapter; a and Drug Administration, 200 C St., flavoring agent and adjuvant as defined SW., Washington, DC, and the Office of in § 170.3(o)(12) of this chapter; a pH the Federal Register, 800 North Capitol control agent as defined in § 170.3(o)(23) St. NW., suite 700, Washington, DC. of this chapter; and a solvent and vehi- (c) In accordance with § 184.1(b)(1), cle as defined in § 170.3(o)(27) of this the ingredient is used in food with no chapter. limitation other than current good (2) The ingredient is used in food, ex- manufacturing practice. The affirma- cept in infant foods and infant for- tion of this ingredient as GRAS as a di- mulas, at levels not to exceed current rect food ingredient is based upon the good manufacturing practice. following current good manufacturing (d) Prior sanctions for this ingredient practice conditions of use: different from the uses established in (1) The ingredient is used as an en- this section do not exist or have been zyme as defined in § 170.3(o)(9) of this waived. chapter to decompose hydrogen per- [49 FR 35367, Sept. 7, 1984] oxide. (2) The ingredient is used in food at § 184.1063 Enzyme-modified lecithin. levels not to exceed current good manufacturing practice. (a) Enzyme-modified lecithin is prepared by treating lecithin with either [60 FR 32910, June 26, 1995] phospholipase A2 (EC 3.1.1.4) or pancreatin. § 184.1061 Lactic acid. (b) The ingredient meets the speci- (a) Lactic acid (C3H6O3, CAS Reg. fications in paragraphs (b)(1) through Nos.: DL mixture, 598–82–3; L-isomer, 79– (b)(8) of this section. Unless otherwise 33–4; D-isomer, 10326–41–7), the chemical noted, compliance with the specifica- 2-hydroxypropanoic acid, occurs natu- tions listed below is determined ac- rally in several foods. It is produced cording to the methods set forth for commercially either by fermentation lecithin in the Food Chemicals Codex, of carbohydrates such as glucose, su- 4th ed. (1996), pp. 220–221, which are in- crose, or lactose, or by a procedure incorporated by reference in accordance volving formation of lactonitrile from with 5 U.S.C. 552(a) and 1 CFR part 51. acetaldehyde and hydrogen cyanide Copies are available from the National and subsequent hydrolysis to lactic Academy Press, 2101 Constitution Ave. acid. NW., Washington DC 20418, or may be (b) The ingredient meets the speci- examined at the Center for Food Safety fications of the Food Chemicals Codex, and Applied Nutrition’s Library, 200 C

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St. SW., Washington, DC, or at the Of- be prepared from edible fats and oils by fice of the Federal Register, 800 North various methods including hydrolysis Capitol St. NW., suite 700, Washington, and saponification, the Twitchell DC. method, low pressure splitting with (1) Acetone-insoluble matter catalyst, continuous high pressure (phosphatides), not less than 50.0 per- counter current splitting, and medium cent. pressure autoclave splitting with cata- (2) Acid value, not more than 40. lyst. (3) Lead, not more than 1.0 part per (b) FDA is developing food-grade million, as determined by atomic ab- specifications for linoleic acid in co- sorption spectroscopy. operation with the National Academy (4) Heavy metals (as Pb), not more of Sciences. In the interim, this ingre- than 20 parts per million. dient must be of a purity suitable for (5) Hexane-insoluble matter, not its intended use. The ingredient must more than 0.3 percent. also meet the specifications in (6) Peroxide value, not more than 20. § 172.860(b) of this chapter. (7) Water, not more than 4.0 percent. (c) In accordance with § 184.1(b)(1), (8) Lysolecithin, 50 to 80 mole percent the ingredient is used in food with no of total phosphatides as determined by limitation other than current good ‘‘Determination of Lysolecithin Con- manufacturing practice. The affirma- tent of Enzyme-Modified Lecithin: tion of this ingredient as generally rec- Method I,’’ dated 1985, which is incor- ognized as safe (GRAS) as a direct porated by reference in accordance human food ingredient is based upon with 5 U.S.C. 552(a) and 1 CFR part 51. the following current good manufac- Copies are available from the Division turing practice conditions of use: of Petition Control, Center for Food (1) The ingredient is used as a fla- Safety and Applied Nutrition (HFS– voring agent and adjuvant as defined in 215), Food and Drug Administration, § 170.3(o)(12) of this chapter and as a nu- 5100 Paint Branch Pkwy., College Park, trient supplement as defined in MD 20740, or may be examined at the § 170.3(o)(20) of this chapter. Center for Food Safety and Applied Nu- (2) The ingredient is used in foods at trition’s Library, 200 C St. SW., Wash- levels not to exceed current good man- ington, DC, or at the Office of the Fed- ufacturing practice. The ingredient eral Register, 800 North Capitol St. may be used in infant formula in ac- NW., suite 700, Washington, DC. cordance with section 412(g) of the Fed- (c) In accordance with § 184.1(b)(1), eral Food, Drug, and Cosmetic Act (the the ingredient is used in food with no act) or with regulations promulgated limitation other than current good under section 412(a)(2) of the act. 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 as a direct human food this section do not exist or have been ingredient is based upon the following waived. current good manufacturing practice [49 FR 48534, Dec. 13, 1984] conditions of use: (1) The ingredient is used as an emul- § 184.1069 Malic acid. sifier as defined in § 170.3(o)(8) of this (a) Malic acid (C H O CAS Reg. No. chapter. 4 6 5, of L-form 97–67–6, CAS Reg. No. of DL- (2) The ingredient is used at levels form 617–48–1) is the common name for not to exceed current good manufac- 1-hydroxy-1, 2-ethanedicarboxylic acid. turing practice. L (+) malic acid, referred to as L-malic [61 FR 45889, Aug. 30, 1996] acid, occurs naturally in various foods. Racemic DL-malic acid does not occur § 184.1065 Linoleic acid. naturally. It is made commercially by (a) Linoleic acid ((Z, Z)–9, 12-octadec- hydration of fumaric acid or maleic adienoic acid (C17H31COOH) (CAS Reg. acid. No. 60–33–3)), a straight chain unsatu- (b) The ingredient meets the speci- rated fatty acid with a molecular fications of the ‘‘Food Chemicals weight of 280.5, is a colorless oil at Codex,’’ 3d Ed. (1981), pp. 183–184, which room temperature. Linoleic acid may is incorporated by reference. Copies

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may be obtained from the National Register, 800 North Capitol Street, Academy Press, 2101 Constitution Ave. NW., suite 700, Washington, DC 20408. NW., Washington, DC 20418, or may be (c) In accordance with § 184.1(b)(1), examined at the Office of the Federal the ingredient is used in food with no Register, 800 North Capitol Street, limitation other than current good NW., suite 700, Washington, DC 20408. manufacturing practice. The affirma- (c) The ingredients are used as a fla- tion of this ingredient as generally rec- vor enhancer as defined in § 170.3(o)(11) ognized as safe (GRAS) as a direct of this chapter, flavoring agent and ad- human food ingredient is based upon juvant as defined in § 170.3(o)(12) of this the following current good manufac- chapter, and pH control agent as de- turing practice conditions of use: fined in § 170.3(o)(23) of this chapter. (1) The ingredient is used as an (d) The ingredients are used in food, anticaking agent as defined in except baby food, at levels not to ex- § 170.3(o)(1) of this chapter; an anti- ceed good manufacturing practice in microbial agent as defined in accordance with § 184.1(b)(1). Current § 170.3(o)(2) of this chapter; a formula- good manufacturing practice results in tion aid as defined in § 170.3(o)(14) of a maximum level, as served, of 3.4 per- this chapter; a humectant as defined in cent for nonalcoholic beverages as de- § 170.3(o)(16) of this chapter; a leavening fined in § 170.3(n)(3) of this chapter; 3.0 agent as defined in § 170.3(o)(17) of this percent for chewing gum as defined in chapter; A pH control agent as defined § 170.3(n)(6) of this chapter; 0.8 percent in § 170.3(o)(23) of this chapter; a proc- for gelatins, puddings, and fillings as essing aid as defined in § 170.3(o)(24) of defined in § 170.3(n)(22) of this chapter; this chapter; a stabilizer and thickener 6.9 percent for hard candy as defined in as defined in § 170.3(o)(28) of this chap- § 170.3(n)(25) of this chapter; 2.6 percent ter; and a surface-active agent as de- for jams and jellies as defined in fined in § 170.3(o)(29) of this chapter. § 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit juices as (2) The ingredient is used in the fol- defined in § 170.3(n)(35) of this chapter; lowing foods at levels not to exceed 3.0 percent for soft candy as defined in current good manufacturing practice: § 170.3(n)(38) of this chapter; and 0.7 per- baked goods as defined in § 170.3(n)(1) of cent for all other food categories. this chapter; confections and frostings (e) Prior sanctions for malic acid dif- as defined in § 170.3(n)(9) of this chap- ferent from the uses established in this ter; gelatins and puddings as defined in section do not exist or have been § 170.3(n)(22) of this chapter; hard candy waived. as defined in § 170.3(n)(25) of this chapter; jams and jellies as defined in [44 FR 20656, Apr. 6, 1979, as amended at 49 § 170.3(n)(28) of this chapter; and soft FR 5611, Feb. 14, 1984] candy as defined in § 170.3(n)(38) of this chapter. § 184.1077 Potassium acid tartrate. (d) Prior sanctions for this ingredient (a) Potassium acid tartrate (C4H5KO6, different from the uses established in CAS Reg. No. 868–14–4) is the potassium this section do not exist or have been acid salt of L¥(+)¥tartaric acid and is waived. also called potassium bitartrate or cream of tartar. It occurs as colorless [48 FR 52446, Nov. 18, 1983] or slightly opaque crystals or as a § 184.1081 Propionic acid. white, crystalline powder. It has a pleasant, acid taste. It is obtained as a (a) Propionic acid (C3H6O2, CAS Reg. byproduct of wine manufacture. No. 79–09–4) is an oily liquid having a (b) The ingredient meets the speci- slightly pungent, rancid odor. It is fications of the Food Chemicals Codex, manufactured by chemical synthesis or 3d Ed. (1981), P. 238, which is incor- by bacterial fermentation. 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. 254, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the Office of the Federal able from the National Academy Press,

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2101 Constitution Ave. NW., Wash- human food ingredient is based upon ington, DC 20418, or available for in- the following current good manufac- spection at the Office of the Federal turing practice conditions of use: Register, 800 North Capitol Street, (1) The ingredient is used as a fla- NW., suite 700, Washington, DC 20408. voring agent and adjuvant as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(12) of this chapter. the ingredient is used in food with no (2) The ingredient is used in foods at limitation other than current good levels not to exceed current good man- manufacturing practice. The affirma- ufacturing practice. tion of this ingredient as generally recognized as safe (GRAS) as a direct (d) Prior sanctions for this ingredient human food ingredient is based upon different from the uses established in the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as an anti- [48 FR 52445, Nov. 18, 1983, as amended at 50 microbial agent as defined in FR 49536, Dec. 3, 1985] § 170.3(o)(2) of this chapter and a flavoring agent as defined in § 170.3(o)(12) § 184.1091 Succinic acid. of this chapter. (2) The ingredient is used in foods at (a) Succinic acid (C4H6O4, CAS Reg. levels not to exceed current good man- No. 110–15–6), also referred to as amber ufacturing practice. acid and ethylenesuccinic acid, is the (d) Prior sanctions for this ingredient chemical 1,4-butanedioic acid. It is different from the uses established in commercially prepared by hydro- this section do not exist or have been genation of maleic or fumaric acid. It waived. can also be produced by aqueous alkali [49 FR 13141, Apr. 3, 1984] or acid hydrolysis of succinonitrile. (b) The ingredient meets the speci- § 184.1090 Stearic acid. fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 314–315, which (a) Stearic acid (C16H36O2, CAS Reg. No. 57–11–4) is a white to yellowish is incorporated by reference. Copies white solid. It occurs naturally as a may be obtained from the National glyceride in tallow and other animal or Academy Press, 2101 Constitution Ave. vegetable fats and oils and is a prin- NW., Washington, DC 20418, or may be cipal constituent of most commercially examined at the Office of the Federal hydrogenated fats. It is produced com- Register, 800 North Capitol Street, mercially from hydrolyzed tallow de- NW., suite 700, Washington, DC 20408. rived from edible sources or from (c) The ingredient is used as a flavor hydrolyzed, completely hydrogenated enhancer as defined in § 170.3(o)(11) of vegetable oil derived from edible this chapter and pH control agent as sources. defined in § 170.3(o)(23) of this chapter. (b) The ingredient meets the speci- (d) The ingredient is used in food at fications of the Food Chemicals Codex, 3d Ed. (1981), p. 313, which is incor- levels not to exceed good manufac- porated by reference, and the require- turing practice in accordance with ments of § 172.860(b)(2) of this chapter. § 184.1(b)(1). Current good manufac- Copies of the Food Chemicals Codex turing practice results in a maximum are available from the National Acad- level, as served, of 0.084 percent in con- emy Press, 2101 Constitution Ave. NW., diments and relishes as defined in Washington, DC 20418, or available for § 170.3(n)(8) of this chapter and 0.0061 inspection at the Office of the Federal percent in meat products as defined in Register, 800 North Capitol Street, § 170.3(n)(29) of this chapter. NW., suite 700, Washington, DC 20408. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirmation of this ingredient as generally rec- [44 FR 20657, Apr. 6, 1979, as amended at 49 ognized as safe (GRAS) as a direct FR 5611, Feb. 14, 1984]

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§ 184.1095 Sulfuric acid. § 184.1097 Tannic acid.

(a) Sulfuric acid (H2SO4, CAS Reg. (a) Tannic acid (CAS Reg. No. 1401– No. 7664–93–9), also known as oil of vit- 55–4), or hydrolyzable gallotannin, is a riol, is a clear, colorless, oily liquid. It complex polyphenolic organic struc- is prepared by reacting sulfur dioxide ture that yields gallic acid and either (SO2) with oxygen and mixing the re- glucose or quinic acid as hydrolysis sultant sulfur trioxide (SO3) with products. It is a yellowish-white to water, or by reacting nitric oxide (NO) light brown substance in the form of an with sulfur dioxide and water. amorphous, bulky powder, glistening (b) The ingredient meets the specifications of the ‘‘Food Chemicals scales, or spongy masses. It is also Codex,’’ 3d Ed. (1981), pp. 317–318, which ordorless, or has a faint characteristic is incorporated by reference. Copies odor, and has an astringent taste. Tan- may be obtained from the National nic acid is obtained by solvent extrac- Academy Press, 2101 Constitution Ave. tion of nutgalls or excrescences that NW., Washington, DC 20418, or may be form on the young twigs of Quercus examined at the Office of the Federal infectoria Oliver and related species of Register, 800 North Capitol Street, Quercus. Tannic acid is also obtained NW., suite 700, Washington, DC 20408. by solvent extraction of the seed pods (c) The ingredient is used as a pH of Tara (Caesalpinia spinosa) or the control agent as defined in § 170.3(o)(23) nutgalls of various sumac species, in- of this chapter and processing aid as cluding Rhus semialata, R. coriaria, R. defined in § 170.3(o)(24) of this chapter. galabra, and R. typhia. (d) The ingredient is used in food at (b) The ingredient meets the speci- levels not to exceed good manufac- fications of the Food Chemicals Codex, turing practice in accordance with 3d Ed. (1981), p. 319, which is incor- § 184.1(b)(1). Current good manufac- porated by reference. Copies are avail- turing practice results in a maximum level, as served, of 0.014 percent for al- able from the National Academy Press, coholic beverages as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(2) of this chapter and 0.0003 ington, DC 20418, or available for in- percent for cheeses as defined in spection at the Office of the Federal § 170.3(n)(5) of this chapter. Register, 800 North Capitol Street, (e) Prior sanctions for this ingredient NW., suite 700, Washington, DC 20408. different from the uses established in (c)(1) In accordance with § 184.1(b)(2), this section do not exist or have been the ingredient is used in food only waived. within the following specific limita- [45 FR 6085, Jan. 25, 1980, as amended at 49 tions: FR 5611, Feb. 14, 1984]

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. 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 . chpater. 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.

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(2) Tannic acid may be used in ren- § 184.1101 Diacetyl tartaric acid esters dered animal fat in accordance with 9 of mono- and diglycerides. CFR 318.7. (a) Diacetyl tartaric acid esters of (d) Prior sanctions for this ingredient mono- and diglycerides, also know as different from the uses established in DATEM, are composed of mixed esters this section do not exist or have been of glycerin in which one or more of the waived. hydroxyl groups of glycerin has been [50 FR 21043, May 22, 1985] esterified by diacetyl tartaric acid and by fatty acids. The ingredient is pre- § 184.1099 Tartaric acid. pared by the reaction of diacetyl tartaric anhydride with mono- and (a) Food grade tartaric acid (C4H6O6, CAS Reg. No. 87–69–4) has the L con- diglycerides that are derived from edi- figuration. The L form of tartaric acid ble sources. is dextrorotatory in solution and is (b) The ingredient meets the speci- also known as L¥(+)¥tartaric acid. fications of the Food Chemicals Codex, Tartaric acid occurs as colorless or 3d. Ed. (1981), pp. 98–99, which is incor- translucent crystals or as a white, porated by reference in accordance crystalline powder. It is odorless and with 5 U.S.C. 552(a). Copies are avail- has an acid taste. It is obtained as a able from the National Academy Press, byproduct of wine manufacture. 2101 Constitution Avenue NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the Office of the Federal 3d Ed. (1981), P. 320, which is incor- Register, 800 North Capitol Street, porated by reference. Copies are avail- NW., suite 700, Washington, DC 20005. 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 Office of the Federal manufacturing practice. The affirma- Register, 800 North Capitol Street, tion of this ingredient as generally rec- NW., suite 700, Washington, DC 20408. 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 in food as tion of this ingredient as generally rec- an emulsifier and emulsifier salt as de- ognized as safe (GRAS) as a direct fined in § 170.3(o)(8) of this chapter and human food ingredient is based upon a flavoring agent and adjuvant as de- the following current good manufac- fined in § 170.3(o)(12) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used as a firm- lowing foods at levels not to exceed ing agent as defined in § 170.3(o)(10) of current good manufacturing practice: this chapter; a flavor enhancer as de- baked goods and baking mixes as defined in § 170.3(o)(11) of this chapter; a fined in § 170.3(n)(l) of this chapter; flavoring agent as defined in nonalcoholic beverages as defined in § 170.3(o)(12) of this chapter; a humec- § 170.3(n)(3) of this chapter; confections tant as defined in § 170.3(o)(16) of this and frostings as defined in § 170.3(n)(9) chapter; and a pH control agent as de- of this chapter; dairy product analogs fined in § 170.3(o)(23) of this chapter. as defined in § 170.3(n)(10) of this chap- (2) The ingredient is used in foods at ter; and fats and oils as defined in levels not to exceed current good man- § 170.3(n)(12) of this chapter. ufacturing practice. (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. (e) Labeling: The acronym ‘‘DATEM’’ [48 FR 52447, Nov. 18, 1983, as amended at 50 may be used on food labeling as the al- FR 49536, Dec. 3, 1985] ternate common or usual name for the

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ingredient diacetyl tartaric acid esters (b) The ingredient meets the speci- of mono- and diglycerides. fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), p. 11, which is in- [54 FR 7403, Feb. 21, 1989, as amended at 54 corporated by reference. Copies may be FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, obtained from the National Academy 1989; 60 FR 15872, Mar. 28, 1995] Press, 2101 Constitution Ave. NW., § 184.1115 Agar-agar. Washington, DC 20418, or may be examined at the Office of the Federal Reg- (a) Agar-agar (CAS Reg. No. PM 9002– ister, 800 North Capitol Street, NW., 18–0) is a dried, hydrophyllic, colloidal suite 700, Washington, DC 20408. polysaccharide extracted from one of a (c) The ingredient is used in food in number of related species of red algae accordance with § 184.1(b)(2) under the (class Rhodophyceae). following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Foods (as served) Percent Functions

Baked goods and baking mixes, ¤ 170.3(n)(1) of this 0.8 Drying agent, ¤ 170.3(o)(7) of this chapter; flavoring agent, chapter . ¤ 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 chap- 2.0 Flavoring agent, ¤ 170.3(o)(12) of this chapter; stabilizer, ter . 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.

Maximum level of § 184.1120 Brown algae. Category of food use in food (as Functional use (a) Brown algae are seaweeds of the served) species Analipus japonicus, Eisenia Spices, Not to exceed cur- Flavor enhancer, bicyclis, Hizikia fusiforme, Kjellmaniella seasonings, and rent good manu- ¤ 170.3(o)(11) of gyrata, Laminaria angustata, Laminaria flavorings, facturing prac- this chapter; fla- claustonia, Laminaria digitata, Lam- ¤ 170.3(n) (26) tice . vor adjuvant, of this chapter . ¤ 170.3(o)(12) of inaria japonica, Laminaria longicruris, this chapter. Laminaria longissima, Laminaria ochotensis, Laminaria saccharina, (d) Prior sanctions for this ingredient Macrocystis pyrifera, Petalonia fascia, different from the use established in Scytosiphon lomentaria and Undaria this section do not exist or have been pinnatifida. They are harvested prin- waived. cipally in coastal waters of the north- ern Atlantic and Pacific oceans. The [47 FR 47376, Oct. 26, 1982] material is dried and ground or chopped for use in food. § 184.1121 Red algae. (b) The ingredient meets the speci- (a) Red algae are seaweeds of the spe- fications for kelp in the Food Chemi- cies Gloiopeltis furcata, Porphyra cals Codex, 3d Ed. (1981), p. 157, which is crispata, Porphyra deutata, Porphyra incorporated by reference. Copies are perforata, Porphyra suborbiculata, available from the National Academy Porphyra tenera and Rhodymenia Press, 2101 Constitution Ave. NW., palmata. Porphyra and Rhodymenia are Washington, DC 20418, or available for harvested principally along the coasts inspection at the Office of the Federal of Japan, Korea, China, Taiwan, and

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the East and West coasts of the United within the following specific limita- States. Gloiopeltis is harvested prin- tions: cipally in southern Pacific coastal wa- Maximum ters. The material is dried and ground level of or chopped for use in food. use in Category of food food (as Functional use (b) The ingredient meets the speci- served) fications for kelp in the Food Chemi- (percent) cals Codex, 3d Ed. (1981), p. 157, which is Confections, frostings, 0.4 Stabilizer, thickener, incorporated by reference, except that ¤ 170.3(n)(9) of this ¤ 170.3(o)(28) of this the loss on drying is not more than 20 chapter . chapter. percent and the maximum allowable Fats and oils, 0.5 Do. ¤ 170.3(n)(12) of this level for iodine is 0.05 percent. Copies chapter . are available from the National Acad- Gelatins, puddings, 0.5 Do. emy Press, 2101 Constitution Ave. NW., ¤ 170.3(n)(22) of this chapter . Washington, DC 20418, or available for Gravies and sauces, 0.4 Do. inspection at the Office of the Federal ¤ 170.3(n)(24) of this Register, 800 North Capitol Street, chapter . NW., suite 700, Washington, DC 20408. Jams and jellies, 0.4 Do. ¤ 170.3(n)(28) of this (c) In accordance with § 184.1(b)(2), chapter . the ingredient is used in food only Sweet sauces, 0.5 Do. within the following specific limita- ¤ 170.3(n)(43) of this chapter . tions: All other food cat- 0.1 Humectant, egories . ¤ 170.3(o)(16) of this Maximum level of chapter; stabilizer, Category of food use in food (as Functional use thickener, served) ¤ 170.3(o)(28) of this chapter. Spices, Not to exceed cur- Flavor enhancer, seasonings, and rent good manu- ¤ 170.3(o)(11) of flavorings, facturing prac- this chapter; fla- (d) Prior sanctions for ammonium al- ¤ 170.3(n) (26) tice . vor adjuvant, ginate different from the uses estab- of this chapter . ¤ 170.3(o)(12) of lished in this section do not exist or this chapter. have been waived. (d) Prior sanctions for this ingredient [47 FR 29950, July 9, 1982] different from the use established in this section do not exist or have been § 184.1135 Ammonium bicarbonate. waived. (a) Ammonium bicarbonate (NH HCO CAS Reg. No. 1066–33–7) is [47 FR 47376, Oct. 26, 1982] 4 3, prepared by reacting gaseous carbon di- § 184.1133 Ammonium alginate. oxide with aqueous ammonia. Crystals of ammonium bicarbonate are precip- (a) Ammonium alginate (CAS Reg. itated from solution and subsequently No. 9005–34–9) is the ammonium salt of washed and dried. alginic acid, a natural polyuronide con- (b) The ingredient meets the speci- stituent of certain brown algae. Ammo- fications of the Food Chemicals Codex, nium alginate is prepared by the neu- 3d Ed. (1981), p. 19, which is incor- tralization of purified alginic acid with porated by reference. Copies are avail- appropriate pH control agents. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the Food Chemicals Codex, ington, DC 20418, or available for in- 3d Ed. (1981), p. 18, which is incor- spection at the Office of the Federal porated by reference. Copies are avail- Register, 800 North Capitol Street, able from the National Academy Press, NW., suite 700, Washington, DC 20408. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1), ington, DC 20418, or available for in- the ingredient is used in food with no spection at the Office of the Federal limitation other than current good Register, 800 North Capitol Street, manufacturing practice. The affirma- NW., suite 700, Washington, DC 20408. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(2), ognized as safe (GRAS) as a direct the ingredient is used in food only human food ingredient is based upon

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the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as a dough [48 FR 52439, Nov. 18, 1983] strengthener as defined in § 170.3(o)(6) of this chapter; a leavening agent as § 184.1138 Ammonium chloride. defined in § 170.3(o)(17) of this chapter; (a) Ammonium chloride (NH4Cl, CAS a pH control agent as defined in Reg. No. 12125–02–9) is produced by the § 170.3(o)(23) of this chapter; and a reaction of sodium chloride and an am- texturizer as defined in § 170.3(o)(32) of monium salt in solution. The less solu- this chapter. ble sodium salt separates out at ele- (2) The ingredient is used in food at vated temperatures, and ammonium levels not to exceed current good man- chloride is recovered from the filtrate ufacturing practice. on cooling. Alternatively, hydrogen (d) Prior sanctions for this ingredient chloride formed by the burning of hy- different from the uses established in drogen in chlorine is dissolved in water this section do not exist or have been and then reacted with gaseous ammo- waived. nia. Ammonium chloride is crystallized from the solution. [48 FR 52439, Nov. 18, 1983] (b) The ingredient meets the speci- § 184.1137 Ammonium carbonate. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incor- (a) Ammonium carbonate ((NH4)2CO3, porated by reference. Copies are avail- CAS Reg. No. 8000–73–5) is a mixture of able from the National Academy Press, ammonium bicarbonate (NH4HCO3) and 2101 Constitution Ave, NW., Wash- ammonium carbamate (NH2COONH4). ington, DC 20418, or available for in- It is prepared by the sublimation of a spection at the Office of the Federal mixture of ammonium sulfate and cal- Register, 800 North Capitol Street, cium carbonate and occurs as a white NW., suite 700, Washington, DC 20408. powder or a hard, white or translucent (c) In accordance with § 184.1(b)(1), mass. 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), p. 19, which is incor- tion of this ingredient as generally rec- porated by reference. Copies are avail- ognized as safe (GRAS) as a direct able from the National Academy Press, human food ingredient is based upon 2101 Constitution Ave. NW., Wash- the following current good manufac- ington, DC 20418, or available for in- turing practice conditions of use: spection at the Office of the Federal (1) The ingredient is used as a dough Register, 800 North Capitol Street, strengthener as defined in § 170.3(o)(6) NW., suite 700, Washington, DC 20408. of this chapter; a flavor enhancer as de- (c) In accordance with § 184.1(b)(1), fined in § 170.3(o)(11) of this chapter; a the ingredient is used in food with no leavening agent as defined in limitation other than current good § 170.3(o)(17) of this chapter; and a proc- manufacturing practice. The affirma- essing aid as defined in § 107.3(o)(24) of tion of this ingredient as generally rec- 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 leav- different from the uses established in ening agent as defined in § 170.3(o)(17) of this section do not exist or have been this chapter and a pH control agent as waived. defined in § 170.3(o)(23) of this chapter. [48 FR 52439, Nov. 18, 1983] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1139 Ammonium hydroxide.

ufacturing practice. (a) Ammonium hydroxide (NH4 OH, (d) Prior sanctions for this ingredient CAS Reg. No. 1336–21–6) is produced by different from the uses established in passing ammonia gas into water.

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(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. 20, which is incor- turing practice conditions of use: porated by reference. Copies are avail- (1) The ingredient is used as a flavor able from the National Academy Press, enhancer as defined in § 170.3(o)(11) of 2101 Constitution Ave. NW., Wash- this chapter and as a pH control agent ington, DC 20418, or available for in- as defined in § 170.3(o)(23) of this chap- spection at the Office of the Federal ter. Register, 800 North Capitol Street, (2) The ingredient is used in non- NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), alcoholic beverages as defined in the ingredient is used in food with no § 170.3(n)(3) of this chapter and in limitation other than current good cheeses as defined in § 170.3(n)(5) of this manufacturing practice. The affirma- chapter at levels not to exceed current tion of this ingredient as generally rec- good manufacturing practice. ognized as safe (GRAS) as a direct (d) Prior sanctions for this ingredient human food ingredient is based upon different from the uses established in the following current good manufac- this section, or different from those set turing practice conditions of use: forth in part 181 of this chapter, do not (1) The ingredient is used as a leav- exist or have been waived. ening agent as defined in § 170.3(o)(17) of this chapter; a pH control agent as de- [59 FR 63896, Dec. 12, 1994] fined in § 170.3(o)(23) of this chapter; a surface-finishing agent as defined in § 184.1141a Ammonium phosphate, § 170.3(o)(30) of this chapter; and as a monobasic. boiler water additive complying with (a) Ammonium phosphate, monobasic § 173.310 of this chapter. (NH4H2PO4, CAS Reg. No. 7722–76–1) is (2) The ingredient is used in food at manufactured by reacting ammonia levels not to exceed current good man- with phosphoric acid at a pH below 5.8. ufacturing practice. The ingredient (b) The ingredient meets the speci- may also be used as a boiler water ad- fications of the Food Chemicals Codex, ditive at levels not to exceed current 3d Ed. (1981), p. 21, which is incor- good manufacturing practice. porated by reference. Copies are avail- (d) Prior sanctions for this ingredient able from the National Academy Press, different from the uses established in 2101 Constitution Ave. NW., Wash- this section do not exist or have been ington, DC 20418, or available for in- waived. spection at the Office of the Federal [48 FR 52440, Nov. 18, 1983, as amended at 59 Register, 800 North Capitol Street, FR 14551, Mar. 29, 1994] NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), § 184.1140 Ammonium citrate, dibasic. the ingredient is used in food with no (a) Ammonium citrate, dibasic limitation other than current good ((NH4)2HC6H5O7, CAS Reg. No. 3012–65–5) manufacturing practice. The affirma- is the diammonium salt of citric acid. tion of this ingredient as generally rec- It is prepared by partially neutralizing ognized as safe (GRAS) as a direct citric acid with ammonia. human food ingredient is based upon (b) The Food and Drug Administra- the following current good manufac- tion, in cooperation with the National turing practice conditions of use: Academy of Sciences, is developing food-grade specifications for ammo- (1) The ingredient is used as a dough nium citrate, dibasic. In the interim, strengthener as defined in § 170.3(o)(6) this ingredient must be of a purity of this chapter and a pH control agent suitable for its intended use. as defined in § 170.3(o)(23) of this chap- (c) In accordance with § 184.1(b)(1), ter. the ingredient is used in food with no (2) The ingredient is used in food at limitation other than current good levels not to exceed current good man- manufacturing practice. The affirma- ufacturing practice. 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

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this section do not exist or have been be obtained from the National Acad- waived. emy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- [48 FR 52440, Nov. 18, 1983] ined at the Office of the Federal Reg- § 184.1141b Ammonium phosphate, di- ister, 800 North Capitol Street, NW., basic. suite 700, Washington, DC 20408. (a) Ammonium phosphate, dibasic (c) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) ((NH4)2HPO4, CAS Reg. No. 7783–28–0) is manufactured by reacting ammonia of this chapter, firming agent as de- with phosphoric acid at a pH above 5.8. fined in § 170.3(o)(10) of this chapter, (b) The ingredient meets the speci- and processing aid as defined in fications of the Food Chemicals Codex, § 170.3(o)(24) of this chapter. 3d Ed. (1981), p. 21, which is incor- (d) The ingredient is used in food at porated by reference. Copies are avail- levels not to exceed good manufac- able from the National Academy Press, turing practice in accordance with 2101 Constitution Ave. NW., Wash- § 184.1(b)(1). Current good manufac- ington, DC 20418, or available for in- turing practice results in a maximum spection at the Office of the Federal level, as served, of 0.15 percent for Register, 800 North Capitol Street, baked goods as defined in § 170.3(n)(1) of NW., suite 700, Washington, DC 20408. this chapter and 0.1 percent for gela- (c) In accordance with § 184.1(b)(1), tins and puddings as defined in the ingredient is used in food with no § 170.1(n)(22) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, the following current good manufac- 1980, as amended at 49 FR 5611, Feb. 14, 1984] turing practice conditions of use: (1) The ingredient is used as a dough § 184.1148 Bacterially-derived strengthener as defined in § 170.3(o)(6) carbohydrase enzyme preparation. of this chapter; a firming agent as de- (a) Bacterially-derived carbohydrase fined in § 170.3(o)(10) of this chapter; a enzyme preparation is obtained from leavening agent as defined in the culture filtrate resulting from a § 170.3(o)(17) of this chapter; a pH con- pure culture fermentation of a non- trol agent as defined in § 170.3(o)(23) of pathogenic and nontoxigenic strain of this chapter; and a processing aid as Bacillus subtilis or B. amyloliquefaciens. defined in § 170.3(o)(24) of this chapter. The preparation is characterized by the (2) The ingredient is used in food at presence of the enzymes a-amylase (EC levels not to exceed current good man- 3.2.1.1) and b-glucanase (EC 3.2.1.6), ufacturing practice. which catalyze the hydrolysis of O- (d) Prior sanctions for this ingredient glycosyl bonds in carbohydrates. different from the uses established in this section do not exist or have been (b) The ingredient meets the general waived. requirements and additional requirements in the monograph on enzyme [48 FR 52440, Nov. 18, 1983] preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128–135, which § 184.1143 Ammonium sulfate. is incorporated by reference in accord- (a) Ammonium sulfate ((NH4)2SO4, ance with 5 U.S.C. 552(a) and 1 CFR CAS Reg. No. 7783–20–2) occurs natu- part 51. Copies are available from the rally and consists of colorless or white, National Academy Press, 2101 Constitu- odorless crystals or granules. It is pre- tion Ave. NW., Washington, DC 20418, pared by the neutralization of sulfuric or may be examined at the Center for acid with ammonium hydroxide. Food Safety and Applied Nutrition’s (b) The ingredient meets the speci- Library, 200 C St. SW., Washington, fications of the ‘‘Food Chemicals DC, or at the Office of the Federal Reg- Codex,’’ 3d Ed. (1981), pp. 22–23, which is ister, 800 North Capitol Street, NW., incorporated by reference. Copies may Suite 700, Washington, DC. In addition,

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antibiotic activity is absent in the en- or may be examined at the Center for zyme preparation when determined by Food Safety and Applied Nutrition’s an appropriate validated method such Library, 200 C St. SW., Washington, as the method ‘‘Determination of anti- DC, or at the Office of the Federal Reg- biotic activity’’ in the Compendium of ister, 800 North Capitol Street, NW., Food Additive Specifications, vol. 2, Suite 700 Washington, DC. In addition, Joint FAO/WHO Expert Committee on antibiotic activity is absent in the en- Food Additives (JECFA), Food and Ag- zyme preparation when determined by riculture Organization of the United an appropriate validated method such Nations, Rome, 1992. Copies are avail- as the method ‘‘Determination of anti- able from Bernan Associates, 4611–F biotic activity’’ in the Compendium of Assembly Dr., Lanham, MD 20706, or Food Additive Specifications, vol. 2, from The United Nations Bookshop, Joint FAO/WHO Expert Committee on General Assembly Bldg., rm. 32, New Food Additives (JECFA), Food and Ag- York, NY 10017, or by inquiries sent to riculture Organization of the United ‘‘http://www.fao.org’’. Copies may be Nations, Rome, 1992. Copies are avail- examined at the Center for Food Safety able from Bernan Associates, 4611–F and Applied Nutrition’s Library, 200 C Assembly Dr., Lanham, MD 20706, or St. SW., Washington, DC. from The United Nations Bookshop, (c) In accordance with § 184.1(b)(1), General Assembly Bldg., rm. 32, New the ingredient is used in food with no York, NY 10017, or by inquiries sent to limitation other than current good ‘‘http://www.fao.org’’. Copies may be manufacturing practice. The affirma- examined at the Center for Food Safety tion of this ingredient as GRAS as a di- and Applied Nutrition’s Library, 200 C rect food ingredient is based upon the St. SW., Washington, DC. following current good manufacturing (c) In accordance with § 184.1(b)(1), practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as an en- limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. The affirma- chapter to hydrolyze polysaccharides tion of this ingredient as GRAS as a di- (e.g., starch). rect food ingredient is based upon the (2) The ingredient is used in food at following current good manufacturing levels not to exceed current good man- practice conditions of use: ufacturing practice. (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this [64 FR 19894, Apr. 23, 1999] chapter to hydrolyze proteins or § 184.1150 Bacterially-derived protease polypeptides. enzyme preparation. (2) The ingredient is used in food at levels not to exceed current good man- (a) Bacterially-derived protease en- ufacturing practice. zyme preparation is obtained from the culture filtrate resulting from a pure [64 FR 19895, Apr. 23, 1999] culture fermentation of a nonpathogenic and nontoxigenic strain of Bacil- § 184.1155 Bentonite. lus subtilis or B. amyloliquefaciens. The (a) Bentonite (Al2O34SiO2nH2O, CAS preparation is characterized by the Reg. No. 1302–0978–099) is principally a presence of the enzymes subtilisin (EC colloidal hydrated aluminum silicate. 3.4.21.62) and neutral proteinase (EC Bentonite contains varying quantities 3.4.24.28), which catalyze the hydrolysis of iron, alkalies, and alkaline earths in of peptide bonds in proteins. the commercial products. Depending on (b) The ingredient meets the general the cations present, natural deposits of requirements and additional require- bentonite range in color from white to ments in the monograph on enzyme gray, yellow, green, or blue. preparations in the Food Chemicals Bentonite’s fine particles provide large Codex, 4th ed. (1996), pp. 128–135, which total surface area and, hence, pro- is incorporated by reference in accord- nounced adsorptive capability. ance with 5 U.S.C. 552(a) and 1 CFR (b) FDA is developing food-grade part 51. Copies are available from the specifications for bentonite in coopera- National Academy Press, 2101 Constitu- tion with the National Academy of tion Ave. NW., Washington, DC 20418, Sciences. In the interim, the ingredient

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must be of a suitable purity for its in- (§ 133.103), Asiago old cheese (§ 133.104), tended use. Blue cheese (§ 133.106), Caciocavallo (c) In accordance with § 184.1(b)(1), siciliano chesse (§ 133.111), Gorgonzola the ingredient is used in food with no cheese (§ 133.141), Parmesan and limitation other than current good reggiano cheese (§ 133.165), Provolone manufacturing practice. The affirma- cheese (§ 133.181), Romano cheese tion of this ingredient as generally rec- (§ 133.183), and Swiss and emmentaler ognized as safe (GRAS) as a direct cheese (§ 133.195) in part 133 of this human food ingredient is based upon chapter; and annatto-colored whey, the following current good manufac- such that the final bleached product turing practice conditions of use: conforms to the descriptions and speci- (1) The ingredient is used as a proc- fications for whey, concentrated whey, essing aid as defined in § 170.3(o)(24) of or dried whey in § 184.1979(a) (1), (2), or this chapter. (3), respectively. (2) The ingredient is used in food at levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. Current good man- different from the uses established in ufacturing practice results in no sig- this section do not exist or have been nificant residue in foods. waived. (d) Prior sanctions for this ingredient [51 FR 27173, July 30, 1986] different from the uses established in this section do not exist or have been § 184.1165 n-Butane and iso-butane. waived. (a) n-Butane and iso-butane (empir- [47 FR 43367, Oct. 1, 1982] ical formula C4H10, CAS Reg. Nos. 106– 97–8 and 75–28–5, respectively) are color- § 184.1157 Benzoyl peroxide. less, odorless, flammable gases at nor- (a) Benzoyl peroxide ((C6H5CO)2O2, mal temperatures and pressures. They CAS Reg. No. 94–36–0) is a colorless, are easily liquefied under pressure at rhombic crystalline solid. It is pre- room temperature and are stored and pared by reaction of benzoyl chloride, shipped in the liquid state. The butanes sodium hydroxide, and hydrogen per- are obtained from natural gas by frac- oxide. tionation following absorption in oil, (b) The ingredient meets the speci- adsorption to surface-active agents, or fications of the Food Chemicals Codex, refrigeration. 3d Ed. (1981), p. 35, which is incor- (b) The Food and Drug Administra- porated by reference. Copies are avail- tion is developing food-grade specifica- able from the National Academy Press, tions for n-butane and iso-butane in co- 2101 Constitution Ave. NW., Wash- operation with the National Academy ington, DC 20418, or available for in- of Sciences. In the interim, the ingredi- spection at the Office of the Federal ents must be of a purity suitable for Register, 800 North Capitol Street, their intended use. NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no these ingredients are used in food with limitation other than current good no limitations other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally rection of these ingredients as generally ognized as safe (GRAS) as a direct recognized as safe (GRAS) as direct human food ingredient is based upon human food ingredients 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 bleach- (1) The ingredients are used as pro- ing agent in food. pellants, aerating agents, and gases as (2) The ingredient is used in the fol- defined in § 170.3(o)(25) of this chapter. lowing foods at levels not to exceed (2) The ingredients are used in food current good manufacturing practice: at levels not to exceed current good flour; milk used for production of manufacturing practice. Asiago fresh and Asiago soft cheese (d) Prior sanctions for these ingredi- (§ 133.102), Asiago medium cheese ents different from the uses established

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in this section do not exist or have acid, a natural polyuronide constituent been waived. of certain brown algae. Calcium algi- [48 FR 57270, Dec. 29, 1983] nate is prepared by the neutralization of purified alginic acid with appro- § 184.1185 Calcium acetate. priate pH control agents, or from sodium alginate by metathesis with ap- (a) Calcium acetate (Ca (C2H3O2)2, CAS Reg. No. 62–54–4), also known as propriate calcium salts. acetate of lime or vinegar salts, is the (b) The ingredient meets the speci- calcium salt of acetic acid. It may be fications of the Food Chemicals Codex, produced by the calcium hydroxide 3d Ed. (1981), p. 45, which is incor- neutralization of acetic acid. 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. 44, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the Office of the Federal able from the National Academy Press, Register, 800 North Capitol Street, 2101 Constitution Ave. NW., Wash- NW., suite 700, Washington, DC 20408. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(2), spection at the Office of the Federal the ingredient is used in food only Register, 800 North Capitol Street, within the following specific limita- NW., suite 700, Washington, DC 20408. tions: (c) The ingredient is used as a firming agent as defined in § 170.3(o)(10) of Maximum level of this chapter; pH control agent as de- Category of food use in Functional use fined in § 170.3(o)(23) of this chapter; food (as served) processing aid as defined in § 170.3(o)(24) (percent) of this chapter; sequestrant as defined in § 170.3(o)(26) of this chapter; sta- Baked goods, 0.002 Stabilizer, thickener, ¤ 170.3(n)(1) of this ¤ 170.3(o)(28) of this bilizer and thickener as defined in chapter . chapter. § 170.3(o)(28) of this chapter; and Alcoholic beverages, 0.4 Do. texturizer as defined in § 170.3(o)(32) of ¤ 170.3(n)(2) of this this chapter. chapter . Confections and 0.4 Do. (d) The ingredient is used in food at frostings, levels not to exceed current good man- ¤ 170.3(n)(9) of this ufacturing practices in accordance chapter . with § 184.1(b)(1). Current good manu- Egg products, 0.6 Do. ¤ 170.3(n)(11) of this facturing practices result in a max- chapter . imum level, as served, of 0.2 percent for Fats and oils, 0.5 Do. baked goods as defined in § 170.3(n)(1) of ¤ 170.3(n)(12) of this this chapter; 0.02 percent for cheese as chapter . Gelatins, puddings, 0.25 Do. defined in § 170.3(n)(5) of this chapter; ¤ 170.3(n)(22) of this 0.2 percent for gelatins, puddings, and chapter . fillings as defined in § 170.3(n)(22) of Gravies and sauces, 0.4 Do. this chapter; 0.15 percent for sweet ¤ 170.3(n)(24) of this sauces, toppings, and syrups as defined chapter . Jams and jellies, 0.5 Do. in § 170.3(n)(43) of this chapter; and ¤ 170.3(n)(28) of this 0.0001 percent for all other food cat- chapter . egories. Sweet sauces, 0.5 Do. ¤ 170.3(n)(43) of this (e) Prior sanctions for this ingredient chapter . different from the uses established in All other food cat- 0.3 Do. this section or in part 181 of this chap- egories . ter do not exist or have been waived. (d) Prior sanctions for calcium algi- [47 FR 27807, June 25, 1982] nate different from the uses established § 184.1187 Calcium alginate. in this section do not exist or have been waived. (a) Calcium alginate (CAS Reg. No. 9005–35–0) is the calcium salt of alginic [47 FR 29951, July 9, 1982]

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§ 184.1191 Calcium carbonate. § 170.3(o)(2) of this chapter; curing or pickling agent as defined in § 170.3(o)(5) (a) Calcium carbonate (CaCO3, CAS Reg. No. 471–34–1) is prepared by three of this chapter; firming agent as de- common methods of manufacture: fined in § 170.3(o)(10) of this chapter; (1) As a byproduct in the ‘‘Lime soda flavor enhancer as defined in process’’; § 170.3(o)(11) of this chapter; humectant (2) By precipitation of calcium car- as defined in § 170.3(o)(16) of this chap- bonate from calcium hydroxide in the ter; nutrient supplement as defined in ‘‘Carbonation process’’; or § 170.3(o)(20) of this chapter; pH control (3) By precipitation of calcium car- agent as defined in § 170.3(o)(23) of this bonate from calcium chloride in the chapter; processing aid as defined in ‘‘Calcium chloride process’’. § 170.3(o)(24) of this chapter; stabilizer (b) The ingredient meets the speci- and thickener as defined in § 170.3(o)(28) fications of the Food Chemicals Codex, of this chapter; surface-active agent as 3d Ed. (1981), p. 46, which is incor- defined in § 170.3(o)(29) of this chapter; porated by reference. Copies are avail- synergist as defined in § 170.3(o)(31) of able from the National Academy Press, this chapter; and texturizer as defined 2101 Constitution Ave. NW., Wash- in § 170.3(o)(32) of this chapter. ington, DC 20418, or available for in- (d) The ingredient is used in foods at spection at the Office of the Federal levels not to exceed current good man- Register, 800 North Capitol Street, ufacturing practices in accordance NW., suite 700, Washington, DC 20408. with § 184.1(b)(1). Current good manu- (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no facturing practices result in a max- limitation other than current good imum level, as served, of 0.3 percent for manufacturing practice. baked goods as defined in § 170.3(n)(1) of (d) Prior sanctions for this ingredient this chapter and for dairy product different from the uses established in analogs as defined in § 170.3(n)(10) of this section, or different from that set this chapter; 0.22 percent for non- forth in part 181 of this chapter, do not alcoholic beverages and beverage bases exist or have been waived. as defined in § 170.3(n)(3) of this chapter; 0.2 percent for cheese as defined in [48 FR 52441, Nov. 18, 1983] § 170.3(n)(5) of this chapter and for proc- § 184.1193 Calcium chloride. essed fruit and fruit juices as defined in § 170.3(n)(35) of this chapter; 0.32 per- (a) Calcium chloride (CaCl ·2H O, 2 2 cent for coffee and tea as defined in CAS Reg. No. 10035–04–8) or anhydrous § 170.3(n)(7) of this chapter; 0.4 percent calcium chloride (CaCl2, CAS Reg. No. 10043–52–4) may be commercially ob- for condiments and relishes as defined tained as a byproduct in the ammonia- in § 170.3(n)(8) of this chapter; 0.2 per- soda (Solvay) process and as a joint cent for gravies and sauces as defined product from natural salt brines, or it in § 170.3(n)(24) of this chapter; 0.1 per- may be prepared by substitution reac- cent for commercial jams and jellies as tions with other calcium and chloride defined in § 170.3(n)(28) of this chapter; salts. 0.25 percent for meat products as de- (b) The ingredient meets the speci- fined in § 170.3(n)(29) of this chapter; 2.0 fications of the Food Chemicals Codex, percent for plant protein products as 3d Ed. (1981), p. 47, which is incor- defined in § 170.3(n)(33) of this chapter; porated by reference. Copies are avail- 0.4 percent for processed vegetables and able from the National Academy Press, vegetable juices as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(36) of this chapter; and 0.05 ington, DC 20418, or available for in- percent for all other food categories. spection at the Office of the Federal (e) Prior sanctions for this ingredient Register, 800 North Capitol Street, different from the uses established in NW., suite 700, Washington, DC 20408. this section do not exist or have been (c) The ingredient is used as an waived. anticaking agent as defined in § 170.3(o)(1) of this chapter; anti- [47 FR 27808, June 25, 1982, as amended at 61 microbial agent as defined in FR 14247, Apr. 1, 1996]

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§ 184.1195 Calcium citrate. this chapter; formulation aid as defined (a) Calcium citrate in § 170.3(o)(14) of this chapter; sequestrant as defined in § 170.3(o)(26) of (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– 0994–095) is the calcium salt of citric this chapter; stabilizer or thickener as acid. It is prepared by neutralizing cit- defined in § 170.3(o)(28) of this chapter; ric acid with calcium hydroxide or cal- and texturizer as defined in § 170.3(o)(32) cium carbonate. It occurs as a fine of this chapter. white, odorless powder and usually (d) The ingredient is used in foods at contains four moles of water per mole levels not to exceed current good man- of calcium citrate. ufacturing practices in accordance (b) The ingredient meets the speci- with § 184.1(b)(1). Current good manu- fications of the Food Chemicals Codex, facturing practices result in a max- 3d ed. (1981), pp. 49 and 50, which is in- imum level, as served, of 1.75 percent corporated by reference in accordance for baked goods as defined in with 5 U.S.C. 552(a) and 1 CFR part 51. § 170.3(n)(1) of this chapter; 0.4 percent Copies are available from the National for dairy product analogs as defined in Academy Press, 2101 Constitution Ave. § 170.3(n)(10) of this chapter; 4.5 percent NW., Washington, DC 20418, and the for gelatins and puddings as defined in Center for Food Safety and Applied Nu- § 170.3(n)(22) of this chapter; and 0.01 trition (HFS–200), 5100 Paint Branch percent for sugar substitutes as defined Pkwy., College Park, MD 20740, or may in § 170.3(n)(42) of this chapter. be examined at the Office of the Fed- (e) Prior sanctions for this ingredient eral Register, 800 North Capitol St. different from the uses established in NW., suite 700, Washington, DC. 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 [47 FR 27808, June 25, 1982] limitation other than current good manufacturing practice. Calcium cit- § 184.1201 Calcium glycerophosphate. rate may also be used in infant formula (a) Calcium glycerophosphate in accordance with section 412(g) of the (C3H7CaO6P, CAS Reg. No. 27214–00–2) is Federal Food, Drug, and Cosmetic Act a fine, white, odorless, almost taste- (the act) or with regulations promul- less, slightly hygroscopic powder. It is gated under section 412(a)(2) of the act. prepared by neutralizing glycero- (d) Prior sanctions for this ingredient phosphoric acid with calcium hydrox- different from the uses established in ide or calcium carbonate. The commer- this section do not exist or have been cial product is a mixture of calcium b- waived. , and D-, and L-a-glycerophosphate. [59 FR 63896, Dec. 12, 1994] (b) The ingredient meets the specifications of the ‘‘Food Chemicals § 184.1199 Calcium gluconate. Codex,’’ 3d Ed. (1981), pp. 51–52, which is (a) Calcium gluconate incorporated by reference in accord- ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. ance with 5 U.S.C. 552(a) and 1 CFR 299–28–5) is the calcium salt of gluconic part 51. Copies may be obtained from acid which may be produced by neu- the National Academy Press, 2101 Con- tralization of gluconic acid with lime stitution Ave. NW., Washington, DC or calcium carbonate. 20418, or may be examined at the Office (b) The ingredient meets the speci- of the Federal Register, 800 North Cap- fications of the Food Chemicals Codex, itol Street, NW., suite 700, Washington, 3d Ed. (1981), p. 51, which is incor- DC. 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 Ave. NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. The affirma- spection at the Office of the Federal tion of this ingredient as generally rec- Register, 800 North Capitol Street, ognized as safe (GRAS) as a direct NW., suite 700, Washington, DC 20408. human food ingredient is based upon (c) The ingredient is used as a firm- the following current good manufac- ing agent as defined in § 170.3(o)(10) of turing practice conditions of use:

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(1) The ingredient is used as a nutri- (d) The ingredient is used in the man- ent supplement as defined in ufacture of bread in accordance with § 170.3(o)(20) of this chapter. § 184.1(b)(2) of this chapter in an (2) The ingredient is used in gelatins, amount not to exceed 0.0075 percent puddings, and fillings as defined in based on the weight of the flour. § 170.3(n)(22) of this chapter. (e) 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 or different from that as waived. set forth in part 181 of this chapter, do [43 FR 11699, Mar. 21, 1978, as amended at 49 not exist or have been waived. FR 5611, Feb. 14, 1984] [57 FR 10813, Mar. 31, 1992] § 184.1207 Calcium lactate. § 184.1205 Calcium hydroxide. (a) Calcium lactate (C6H10CaO6.xH2O, (a) Calcium hydroxide (Ca(OH)2, CAS where x is any integer up to 5, CAS Reg. No. 1305–62–0) is also known as Reg. No. 814–80–2) is prepared commer- slaked lime or calcium hydrate. It is cially by the neutralization of lactic produced by the hydration of lime. acid with calcium carbonate or cal- (b) The ingredient meets the speci- cium hydroxide. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 52, which is incor- fications of the Food Chemicals Codex, porated by reference. Copies are avail- 3d Ed. (1981), p. 53, which is incor- able from the National Academy Press, porated by reference. Copies are avail- 2101 Constitution Ave. NW., Wash- able from the National Academy Press, ington, DC 20418, or available for in- 2101 Constitution Avenue NW., Wash- spection at the Office of the Federal ington, DC 20418, or available for in- Register, 800 North Capitol Street, spection at the Office of the Federal NW., suite 700, Washington, DC 20408. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(1), NW., suite 700, Washington, DC 20408. 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. limitation other than current good (d) Prior sanctions for this ingredient manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon [49 FR 26714, June 29, 1984] the following current good manufacturing practice conditions of use: § 184.1206 Calcium iodate. (1) The ingredient is used as a firming agent as defined in § 170.3(o)(10) of (a) Calcium iodate [Ca(IO ) ·H O, CAS 3 2 2 this chapter; a flavor enhancer as de- Reg. No. 7789–80–2], also referred to as fined in § 170.3(o)(11) of this chapter; a lautarite, does not occur naturally but flavoring agent or adjuvant as defined can be prepared by passing chlorine in § 170.3(o)(12) of this chapter; a leav- into a hot solution of lime (CaCO ) in 3 ening agent as defined in § 170.3(o)(17) of which iodine has been dissolved. this chapter; a nutrient supplement as (b) The ingredient meets the speci- defined in § 170.3(o)(20) of this chapter; fications of the ‘‘Food Chemicals and a stabilizer and thickener as de- Codex,’’ 3d Ed. (1981), p. 53, which is in- fined in § 170.3(o)(28) of this chapter. corporated by reference. Copies may be (2) The ingredient is used in food, ex- obtained from the National Academy cept in infant foods and infant for- Press, 2101 Constitution Ave. NW., mulas, at levels not to exceed current Washington, DC 20418, or may be exam- good manufacturing practice. ined at the Office of the Federal Reg- (d) Prior sanctions for this ingredient ister, 800 North Capitol Street, NW., different from the uses established in suite 700, Washington, DC 20408. this section do not exist or have been (c) The ingredient is used as a dough waived. strengthener as defined in § 170.3(o)(6) of this chapter. [49 FR 35367, Sept. 7, 1984]

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§ 184.1210 Calcium oxide. human food ingredient is based upon the following current good manufac- (a) Calcium oxide (CaO, CAS Reg. No. turing practice conditions of use: 1305–78–8) is also known as lime, quick (1) The ingredient is used as a nutri- lime, burnt lime, or calx. It is produced ent supplement as defined in from calcium carbonate, limestone, or § 170.3(o)(20) of this chapter. oyster shells by calcination at tem- (2) The ingredient is used in foods at peratures of 1,700–2,450 °F. levels not to exceed current good man- (b) The ingredient meets the speci- ufacturing practice. Calcium panto- fications of the Food Chemicals Codex, thenate may be used in infant formula 3d Ed. (1981), p. 55, which is incor- in accordance with section 412(g) of the porated by reference. Copies are avail- Federal Food, Drug, and Cosmetic Act able from the National Academy Press, (the act) or with regulations promul- 2101 Constitution Ave. NW., Wash- gated under section 412(a)(2) of the Act. ington, DC 20418, or available for in- (d) Prior sanctions for this ingredient spection at the Office of the Federal different from the uses established in Register, 800 North Capitol Street, this section do not exist or have been NW., suite 700, Washington, DC 20408. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [48 FR 51908, Nov. 15, 1983] limitation other than current good manufacturing practice. § 184.1221 Calcium propionate. (d) Prior sanctions for this ingredient (a) Calcium propionate (C6H10CaO4, different from the uses established in CAS Reg. No. 4075–81–4) is the calcium this section do not exist or have been salt of propionic acid. It occurs as waived. white crystals or a crystalline solid, possessing not more than a faint odor [49 FR 26714, June 29, 1984] of propionic acid. It is prepared by neutralizing propionic acid with calcium § 184.1212 Calcium pantothenate. hydroxide. (a) Calcium pantothenate (b) The ingredient meets the speci- ((C9H16NO5)2Ca, CAS Reg. No. of the D- fications of the Food Chemicals Codex, isomer, 137–08–6) is a salt of panto- 3d Ed. (1981), p. 60, which is incor- thenic acid, one of the vitamins of the porated by reference. Copies are avail- B complex. Only the D-isomer of panto- able from the National Academy Press, thenic acid has vitamin activity, al- 2101 Constitution Ave. NW., Wash- though both the D-isomer and the DL- ington, DC 20418, or available for in- racemic mixture of calcium panto- spection at the Office of the Federal thenate are used in food. Commercial Register, 800 North Capitol Street, calcium pantothenate is prepared syn- NW., suite 700, Washington, DC 20408. thetically from isobutyraldehyde and (c) In accordance with § 184.1(b)(1), formaldehyde via 1,1-dimethyl-2-hy- the ingredient is used in food with no droxy-propionaldehyde and limitation other than current good pantolactone. manufacturing practice. The affirma- (b) Calcium pantothenate meets the tion of this ingredient as generally rec- specifications of the Food Chemicals ognized as safe (GRAS) as a direct Codex, 3d Ed. (1981), p. 56, which is in- human food ingredient is based upon corporated 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 an anti- Washington, DC 20418, or available for microbial agent as defined in inspection at the Office of the Federal § 170.3(o)(2) of this chapter. Register, 800 North Capitol Street, (2) The ingredient is used in the fol- NW., suite 700, Washington, DC 20408. lowing foods at levels not to exceed (c) In accordance with § 184.1(b)(1), current good manufacturing practice: the ingredient is used in food with no baked goods as defined in § 170.3(n)(1) of limitation other than current good this chapter; cheeses as defined in manufacturing practice. The affirma- § 170.3(n)(5) of this chapter; confections tion of this ingredient as generally rec- and frostings as defined in § 170.3(n)(9) ognized as safe (GRAS) as a direct of this chapter; gelatins, puddings, and

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fillings as defined in § 170.3(n)(22) of Paris, anhydrite, and gypsum, occurs this chapter; and jams and jellies as de- naturally and exists as a fine, white to fined in § 170.3(n)(28) of this chapter. slightly yellow-white odorless powder. (d) Prior sanctions for this ingredient The anhydrous form is prepared by different from the uses established in complete dehydration of gypsum, below this section do not exist or have been 300 °C, in an electric oven. waived. (b) The ingredient meets the speci- [49 FR 13141, Apr. 3, 1984] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), p. 66, which is in- § 184.1229 Calcium stearate. corporated by reference. Copies may be obtained from the National Academy (a) Calcium stearate (Ca(C17H35COO)2, CAS Reg. No. 1529–23–0) is the calcium Press, 2101 Constitution Ave. NW., salt of stearic acid derived from edible Washington, DC 20418, or may be exam- sources. It is prepared as a white pre- ined at the Office of the Federal Reg- cipitate by mixing calcium chloride ister, 800 North Capitol Street, NW., and sodium stearate in aqueous solu- suite 700, Washington, DC 20408. tion. (c) The ingredient is used as an (b) The ingredient meets the speci- anticaking agent as defined in fications of the Food Chemicals Codex, § 170.3(o)(1) of this chapter, color and 3d Ed. (1981), p. 64, which is incor- coloring adjunct as defined in porated by reference, and the require- § 170.3(o)(4) of this chapter, dough ments of § 172.860(b)(2) of this chapter. strengthener as defined in § 170.3(o)(6) Copies of the Food Chemicals Codex of this chapter, drying agent as defined are available from the National Acad- in § 170.3(o)(7) of this chapter, firming emy Press, 2101 Constitution Ave. NW., agent as defined in § 170.3(o)(10) of this Washington, DC 20418, or available for chapter, flour treating agent as defined inspection at the Office of the Federal in § 170.3(o)(13) of this chapter, formula- Register, 800 North Capitol Street, tion aid as defined in § 170.3(o)(14) of NW., suite 700, Washington, DC 20408. this chapter, leavening agent as de- (c) In accordance with § 184.1(b)(1), fined in § 170.3(o)(17) of this chapter, nu- the ingredient is used in food with no trient supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter, pH control manufacturing practice. The affirma- agent as defined in § 170.3(o)(23) of this tion of this ingredient as generally rec- chapter, processing aid as defined in ognized as safe (GRAS) as a direct § 170.3(o)(24) of this chapter, stabilizer human food ingredient is based upon and thickener as defined in § 170.3(o)(28) the following current good manufac- of this chapter, synergist as defined in turing practice conditions of use: § 170.3(o)(31) of this chapter, and (1) The ingredient is used as a fla- texturizer as defined in § 170.3(o)(32) of voring agent and adjuvant as defined in this chapter. § 170.3(o)(12) of this chapter; a lubricant (d) The ingredient is used in food at and release agent as defined in levels not to exceed good manufac- § 170.3(o)(18) of this chapter; and a sta- turing practice in accordance with bilizer and thickener as defined in § 184.1(b)(1). Current good manufac- § 170.3(o)(28) of this chapter. turing practice results in a maximum (2) The ingredient is used in foods at level, as served, of 1.3 percent for baked levels not to exceed current good man- goods as defined in § 170.3(n)(1) of this ufacturing practice. chapter, 3.0 percent for confections and (d) Prior sanctions for this ingredient frostings as defined in § 170.3(n)(9) of different from the uses established in this chapter, 0.5 percent for frozen this section do not exist or have been dairy desserts and mixes as defined in waived. § 170.3(n)(20) of this chapter, 0.4 percent [48 FR 52445, Nov. 18, 1983] for gelatins and puddings as defined in § 170.3(n)(22) of this chapter, 0.5 percent § 184.1230 Calcium sulfate. for grain products and pastas as de- (a) Calcium sulfate (CaSO4, CAS Reg. fined in § 170.3(n)(23) of this chapter, No. 7778–18–9 or CaSO4·2H2O, CAS Reg. 0.35 percent for processed vegetables as No. 10101–41–4), also known as plaster of defined in § 170.3(n)(36) of this chapter,

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and 0.07 percent or less for all other It is synthesized by saponification of food categories. vitamin A acetate. The resulting alco- (e) Prior sanctions for this ingredient hol is either reacted to form vitamin A different from the uses established in Wittig reagent or oxidized to vitamin A this section do not exist or have been aldehyde. Vitamin A Wittig reagent waived. and vitamin A aldehyde are reacted together to form beta-carotene. [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, (b) The ingredient meets the speci- 1980, as amended at 49 FR 5611, Feb. 14, 1984] fications of the Food Chemicals Codex, § 184.1240 Carbon dioxide. 3d Ed. (1981), p. 73, which is incorporated by reference. Copies are avail- (a) Carbon dioxide (empirical formula able from the National Academy Press, CO2, CAS Reg. No. 124–38–9) occurs as a 2101 Constitution Ave. NW., colorless, odorless, noncombustible gas Washingtion, DC 20418, or available for at normal temperatures and pressures. inspection at the Office of the Federal The solid form, dry ice, sublimes under Register, 800 North Capitol Street, atmospheric pressure at a temperature NW., suite 700, Washington, DC 20408. ¥ ° of 78.5 C. Carbon dioxide is prepared (c) In accordance with § 184.1(b)(1), as a byproduct of the manufacture of the ingredient is used in food with no lime during the ‘‘burning’’ of lime- limitation other than current good stone, from the combustion of carbo- manufacturing practice. The affirma- naceous material, from fermentation tion of this ingredient as generally rec- processes, and from gases found in cer- ognized as safe (GRAS) as a direct tain natural springs and wells. human food ingredient is based upon (b) The Food and Drug Administra- the following current good manufac- tion is developing food-grade specifica- turing practice conditions of use: tions for carbon dioxide in cooperation (1) The ingredient is used as a nutri- with the National Academy of ent supplement as defined in Sciences. In the interim, the ingredient § 170.3(o)(20) of this chapter. must be of purity suitable for its in- (2) The ingredient is used in the fol- tended use. lowing foods at levels not to exceed (c) In accordance with § 184.1(b)(1), current good manufacturing practice: the ingredient is used in food with no dairy product analogs as defined in limitations other than current good § 170.3(n)(10) of this chapter; fats and manufacturing practice. The affirma- oils as defined in § 170.3(n)(12) of this tion of this ingredient as generally rec- chapter; and processed fruits and fruit ognized as safe (GRAS) as a direct juices as defined in § 170.3(n)(35) of this human food ingredient is based upon chapter. Beta-carotene may be used in the following current good manufac- infant formula as a source of vitamin A turing practice conditions of use: in accordance with section 412(g) of the (1) The ingredient is used as a leav- Federal Food, Drug, and Cosmetic Act ening agent as defined in § 170.3(o)(17) of or with regulations promulgated under this chapter; a processing aid as de- section 412(g) of the act. fined in § 170.3(o)(24) of this chapter; (d) Prior sanctions for this ingredient and a propellant, aerating agent, and different from the uses established in gas as defined in § 170.3(o)(25) of this this section do not exist or have been chapter. waived. (2) The ingredient is used in food at levels not to exceed current good man- [52 FR 25211, July 6, 1987] ufacturing practice. § 184.1250 Cellulase enzyme prepara- (d) Prior sanctions for this ingredient tion derived from Trichoderma different from the uses established in longibrachiatum. this section do not exist or have been (a) Cellulase enzyme preparation is waived. derived from a nonpathogenic, [48 FR 57270, Dec. 29, 1983] nontoxicogenic strain of Trichoderma longibrachiatum (formerly T. reesei). The § 184.1245 Beta-carotene. enzyme, cellulase, catalyzes the (a) Beta-carotene (CAS Reg. No. 7235– endohydrolysis of 1,4-beta-glycosidic 40–7) has the molecular formula C40H56. linkages in cellulose. It is obtained 490

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from the culture filtrate resulting from Constitution Ave. NW., Washington, a pure culture fermentation process. DC 20055 (Internet address ‘‘http:// (b) The ingredient meets the general www.nap.edu’’), or may be examined at and additional requirements for en- the Center for Food Safety and Applied zyme preparations in the monograph Nutrition’s Library, Food and Drug Ad- specifications on enzyme preparations ministration, 200 C St. SW., Wash- in the ‘‘Food Chemicals Codex,’’ 4th ed. ington, DC, or at the Office of the Fed- (1996), pp. 129 to 134, which is incor- eral Register, 800 North Capitol St. porated by reference in accordance NW., suite 700, Washington, DC. As de- with 5 U.S.C. 552(a) and 1 CFR part 51. termined by analytical methods in the Copies are available from the National ‘‘Food Chemicals Codex,’’ clove oleo- Academy Press, 2101 Constitution Ave. resin or other natural extractives NW., Box 285, Washington, DC 20055 (other than clove oils) meet the ‘‘Food (Internet ‘‘http://www.nap.edu’’), or Chemicals Codex’’ specifications for may be examined at the Center for clove (clove bud) oil and the following Food Safety and Applied Nutrition’s modifications: Library, 200 C St. SW., Washington, (1) The assay for phenols, as eugenol, DC, or at the Office of the Federal Reg- by the ‘‘Food Chemicals Codex’’ test, ister, 800 North Capitol St. NW., suite 4th ed. (pp. 104–105), or the volatile oils 700, Washington, DC. content by the ‘‘Food Chemicals (c) In accordance with § 184.1(b)(1), Codex’’ test, 4th ed. (pp. 104–105) should the ingredient is used in food with no conform to the representation of the limitation other than current good vendor; manufacturing practice. The affirma- (2) Optical rotation of the volatile oil tion of this ingredient as generally rec- between ¥2° and 0°; ognized as safe (GRAS) as a direct (3) Refractive index of the volatile oil human food ingredient is based upon between 1.527 and 1.538 at 20 °C; the following current good manufac- (4) Specific gravity of the volatile oil turing practice conditions of use: between 1.036 and 1.060; and (1) The ingredient is used in food as (5) Residual solvent free, except those an enzyme as defined in § 170.3(o)(9) of solvents that are GRAS or within tol- this chapter for the breakdown of cel- erance levels as specified in part 173, lulose. subpart C, of this chapter. (2) The ingredient is used in food at (c) Clove and its derivatives are used levels not to exceed current good man- as flavoring agents and adjuvants as ufacturing practice. defined in § 170.3(0)(12) of this chapter. [64 FR 28361, May 26, 1999] (d) The ingredients are used in food at levels not to exceed good manufac- § 184.1257 Clove and its derivatives. turing practice in accordance with (a) Cloves are the dried unopened § 184.1(b)(1). flower buds and calyx tubes, harvested (e) Prior sanctions for these ingredi- before the flowers have opened, of the ents different from the uses established clove tree Eugenia caryophyllata in this section do not exist or have Thunberg, native to tropical Asia. been waived. Their derivatives include essential oils [44 FR 3964, Jan 19, 1979, as amended at 47 FR (cloves, CAS Reg. No. 8000–34–8; buds; 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; leaves, CAS Reg. No. 8015–97–2; stems, 64 FR 1759, Jan. 12, 1999] CAS Reg. No. 8015–98–3; and eugenol, CAS Reg. No. 97–53–0), oleoresins, and § 184.1259 Cocoa butter substitute. natural extractives obtained from (a) The common or usual name for clove buds, leaves, and stems. the triglyceride 1-palmitoyl-2-oleoyl-3- (b) Clove bud oil, clove leaf oil, clove stearin is ‘‘cocoa butter substitute pri- stem oil, and eugenol meet the speci- marily from palm oil.’’ The common or fications of the ‘‘Food Chemicals usual name for the triglyceride 1-3- Codex,’’ 4th ed. (1996), pp. 104–105, which distearoyl-2-olein is ‘‘cocoa butter sub- is incorporated by reference in accord- stitute primarily from high-oleic saf- ance with 5 U.S.C. 552(a) and 1 CFR flower or sunflower oil.’’ part 51. Copies are available from the (1) The ingredient 1-palmitoyl-2-ole- National Academy Press, Box 285, 2101 oyl-3-stearin is manufactured by:

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(i) Directed esterification of fully fluorine; limit of detection 0.2 part per saturated 1,3-diglycerides (derived from million F; multiply fluoride result by palm oil) with the anhydride of food- 2.63 to convert to residual catalyst. grade oleic acid in the presence of the Copies of the material incorporated by catalyst trifluoromethane sulfonic acid reference may be obtained from the As- (§ 173.395 of this chapter), or sociation of Official Analytical Chem- (ii) By interesterification of partially ists, P.O. Box 540, Benjamin Franklin saturated 1,2,3-triglycerides (derived Station, Washington, DC 20044, or may from palm oil) with ethyl stearate in be examined at the Office of the Fed- the presence of a suitable lipase en- eral Register, 800 North Capitol Street, zyme preparation that is either gen- NW., suite 700, Washington, DC 20408. erally recognized as safe (GRAS) or has The ingredient shall be washed three food additive approval for such use. times in batches with 0.5 percent so- (2) The ingredient 1-3-distearoyl-2- dium bicarbonate to remove catalyst olein is manufactured by residuals in accordance with good man- interesterification of partially unsatu- ufacturing practice. rated 1,2,3-triglycerides (derived from (7) Residual methanol—5 parts per high-oleic safflower or sunflower oil) million maximum. with ethyl stearate or stearic acid in (8) Residual fatty acid ethyl esters— the presence of a suitable lipase en- not more than 20 parts per million as zyme preparation that is either GRAS determined by a ‘‘Modification of or has food additive approval for such Japan Institute of Oils and Fats: Anal- use. ysis Method of Residual Ethyl Esters of (b) The ingredient meets the fol- Fatty Acids’’ issued by the Fuji Oil lowing specifications: Co., which is incorporated by reference. (1) Over 90 percent triglycerides, not Copies are available from the Division more than 7 percent diglycerides, not of Food and Color Additives, Center for more than 1 percent monoglycerides, Food Safety and Applied Nutrition and not more than 1 percent free fatty (HFS–200), Food and Drug Administra- acids. tion, 5100 Paint Branch Pkwy., College (2) Total glycerides—98 percent min- Park, MD 20740, or available for inspec- imum. (3) Heavy metals (as lead), not more tion at the Office of the Federal Reg- than 10 milligrams per kilogram, as de- ister, 800 North Capitol Street, NW., termined by the Heavy Metals Test of suite 700, Washington, DC 20408. the ‘‘Food Chemicals Codex,’’ 4th ed. (9) Hexane—not more than 5 parts per (1996), pp. 760–761, which is incorporated million as determined by the method of by reference in accordance with 5 Dupuy et al., ‘‘Rapid Quantitative De- U.S.C. 552(a) and 1 CFR part 51. Copies termination of Residual Hexane in Oils are available from the National Acad- by Direct Gas Chromatography,’’ pub- emy Press, Box 285, 2101 Constitution lished in the ‘‘Journal of the American Ave. NW., Washington, DC 20055 (Inter- Oil Chemists’ Society,’’ Vol. 52, p. 118– net address ‘‘http://www.nap.edu’’), or 120, 1975, which is incorporated by ref- may be examined at the Center for erence. Copies are available from the Food Safety and Applied Nutrition’s Division of Food and Color Additives, Library, Food and Drug Administra- Center for Food Safety and Applied Nu- tion, 200 C St. SW., Washington, DC, or trition (HFS–200), Food and Drug Ad- at the Office of the Federal Register, ministration, 5100 Paint Branch Pkwy., 800 North Capitol St. NW., suite 700, College Park, MD 20740, or available for Washington, DC. inspection at the Office of the Federal (4) Color—clear, bright, and free from Register, 800 North Capitol Street, suspended matter. NW., suite 700, Washington, DC 20408. (5) Odor and taste—free from foreign (c) In accordance with § 184.1(b)(1), and rancid odor and taste. the ingredient is used in the following (6) Residual catalyst (‘‘Official Meth- food categories at levels not to exceed ods of Analysis of the Association of current good manufacturing practice: Official Analytical Chemists,’’ 13th Ed. Confections and frostings as defined in (1980), sections 25.049–25.055, which is § 170.3(n)(9) of this chapter; coatings of incorporated by reference), residual soft candy as defined in §170.3(n)(38) of

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this chapter; and sweet sauces and top- this section do not exist or have been pings as defined in §170.3(n)(43) of this waived. chapter; except that the ingredient may not be used in a standardized food [49 FR 24119, June 12, 1984] unless permitted by the standard of § 184.1261 Copper sulfate. identity. (d) The ingredient is used in food in (a) Copper sulfate (cupric sulfate, accordance with § 184.1(b)(1) at levels CuSO4·5H2O, CAS Reg. No. 7758–98–7) not to exceed good manufacturing usually is used in the pentahydrate practice. form. This form occurs as large, deep blue or ultramarine, triclinic crystals; [43 FR 54239, Nov. 11, 1978, as amended at 47 as blue granules, or as a light blue pow- FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, der. The ingredient is prepared by the Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR reaction of sulfuric acid with cupric 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999] oxide or with copper metal. (b) FDA is developing food-grade § 184.1260 Copper gluconate. specifications for copper sulfate in co- (a) Copper gluconate (cupric gluco- operation with the National Academy nate (CH2OH(CHOH)4COO)2Cu, CAS of Sciences. In the interim, this ingre- Reg. No. 527–09–3) is a substance that dient must be of a purity suitable for occurs as light blue to bluish-green, its intended use. odorless crystals, or as a fine, light (c) In accordance with § 184.1(b)(1), blue powder. It is prepared by the reac- the ingredient is used in food with no tion of gluconic acid solutions with cu- limitation other than current good pric oxide or basic cupric carbonate. manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications of the Food Chemicals Codex, ognized as safe (GRAS) as a direct 3d Ed. (1981), p. 90, which is incor- human food ingredient is based upon porated by reference. Copies are avail- the following current good manufac- able from the National Academy Press, turing practice conditions of use: 2101 Constitution Ave. NW., Wash- (1) The ingredient is used as a nutri- ington, DC. 20418, or available for in- ent supplement as defined in spection at the Office of the Federal § 170.3(o)(20) of this chapter and as a Register, 800 North Capitol Street, processing aid as defined in § 170.3(o)(24) NW., suite 700, Washington, DC. 20408. of this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice. Copper sulfate manufacturing practice. The affirma- may be used in infant formula in action of this ingredient as generally rec- cordance with section 412(g) of the Fed- ognized as safe (GRAS) as a direct eral Food, Drug, and Cosmetic Act (the human food ingredient is based upon Act) or with regulations promulgated the following current good manufac- under section 412(a)(2) of the Act. turing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as a nutri- different from the uses established in ent supplement as defined in this section do not exist or have been § 170.3(o)(20) of this chapter and as a waived. synergist as defined in § 170.3(o)(31) of this chapter. [49 FR 24119, June 12, 1984] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1262 Corn silk and corn silk ex- ufacturing practice. Copper gluconate tract. may be used in infant formula in ac- (a) Corn silk is the fresh styles and cordance with section 412(g) of the Fed- stigmas of Zea mays L. collected when eral Food, Drug, and Cosmetic Act (the the corn is in milk. The filaments are Act) or with regulations promulgated extracted with dilute ethanol to under section 412(a)(2) of the Act. produce corn silk extract. The extract (d) Prior sanctions for this ingredient may be concentrated at a temperature different from the uses established in not exceeding 60 °C.

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(b) The Food and Drug Administra- (d) Prior sanctions for this ingredient tion, in cooperation with the National different from the uses established in Academy of Sciences, is developing this section do not exist or have been food-grade specifications for corn silk waived. and corn silk extract. In the interim, this ingredient must be of a suitable [49 FR 24119, June 12, 1984] purity for its intended use. § 184.1271 L-Cysteine. (c) In accordance with § 184.1(b)(2), the ingredients are used in food only (a) L-Cysteine is the chemical L-2- within the following specific limita- amino-3-mercaptopropanoic acid tions: (C3H7O2NS). (b) The ingredient meets the appro- Maximum level of priate part of the specification set Category of food use in Functional use forth in the ‘‘Food Chemicals Codex,’’ food (as served) 3d Ed. (1981), pp. 92–93, which is incorporated by reference. Copies may be Baked goods and bak- 30 Flavoring agent, obtained from the National Academy ing mixes, ¤ 170.3(o)(12) of this Press, 2101 Constitution Ave. NW., ¤ 170.3(n)(1) of this chapter. chapter . Washington, DC 20418, or may be exam- Nonalcoholic bev- 20 Do. ined at the Office of the Federal Reg- erages, ¤ 170.3(n)(3) ister, 800 North Capitol Street, NW., of this chapter . Frozen dairy desserts, 10 Do. suite 700, Washington, DC 20408. ¤ 170.3(n)(20) of this (c) The ingredient is used to supply chapter . up to 0.009 part of total L-cysteine per Soft candy, 20 Do. 100 parts of flour in dough as a dough ¤ 170.3(n)(38) of this chapter . strengthener as defined in § 170.3(o)(6) All other food cat- 4 Do. of this chapter in yeast-leavened baked egories . goods and baking mixes as defined in 1 Parts per million. § 170.3(n)(1) of this chapter. (d) Prior sanctions for this ingredient (d) This regulation is issued prior to different from the uses established in a general evaluation of use of this in- this section do not exist or have been gredient in order to affirm as GRAS waived. the specific use named. [47 FR 29953, July 9, 1982] [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984] § 184.1265 Cuprous iodide. § 184.1272 L-Cysteine (a) Cuprous iodide (copper (I) iodide, monohydrochloride. CuI, CAS Reg. No. 7681–65–4) is a pure white crystalline powder. It is prepared (a) L-Cysteine monohydrochloride is by the reaction of copper sulfate with the chemical L-2-amino-3- potassium iodide under slightly acidic mercaptopropanoic acid conditions. monohydrochloride monohydrate (b) FDA is developing food-grade (C3H7O2NS HCl H2O). specifications for cuprous iodide in co- (b) The ingredient meets the speci- operation with the National Academy fications of the ‘‘Food Chemicals of Sciences. In the interim, this ingre- Codex,’’ 3d Ed. (1981), pp. 92–93, which is dient must be of a purity suitable for incorporated by reference. Copies may its intended use. be obtained from the National Acad- (c) In accordance with § 184.1(b)(2), emy Press, 2101 Constitution Ave. NW., the ingredient is used in food only Washington, DC 20418, or may be exam- within the following specific limita- ined at the Office of the Federal Reg- tions: ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Cat- (c) The ingredient is used to supply egory Maximum treatment Functional use of food level in food up to 0.009 part of total L-cysteine per 100 parts of flour in dough as a dough Table 0.01 percent ...... Source of dietary iodine. strengthener as defined in § 170.3(o)(6) salt . of this chapter in yeast-leavened baked

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goods and baking mixes as defined in § 184.1278 Diacetyl. § 170.3(n)(1) of this chapter. (a) Diacetyl (C4H6O2, CAS Reg. No. (d) This regulation is issued prior to 431–03–8) is a clear yellow to yellowish a general evaluation of use of this in- green liquid with a strong pungent gredient in order to affirm as GRAS odor. It is also known as 2,3- the specific use named. butanedione and is chemically syn- [42 FR 14653, Mar. 15, 1977, as amended at 49 thesized from methyl ethyl ketone. It FR 5612, Feb. 14, 1984] is miscible in water, glycerin, alcohol, and ether, and in very dilute water so- § 184.1277 Dextrin. lution, it has a typical buttery odor and flavor. (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. (b) The ingredient meets the speci- No. 9004–53–9) is an incompletely fications of the Food Chemicals Codex, hydrolyzed starch. It is prepared by dry 3d Ed. (1981), p. 368, which is incor- heating corn, waxy maize, waxy milo, porated by reference. Copies are avail- potato, arrowroot, wheat, rice, tapioca, able from the National Academy Press, or sago starches, or by dry heating the 2101 Constitution Ave. NW., Wash- starches after: (1) Treatment with safe ington, DC 20418, or available for in- and suitable alkalis, acids, or pH con- spection at the Office of the Federal trol agents and (2) drying the acid or Register, 800 North Capitol Street, alkali treated starch. NW., suite 700, Washington, DC 20408. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fication of the Food Chemicals Codex, the ingredient is used in food with no 3d Ed. (1981), p. 96, 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 Office of the Federal the following current good manufac- Register, 800 North Capitol Street, turing practice conditions of use: (1) The ingredient is used as a fla- NW., suite 700, Washington, DC 20408. voring agent and adjuvant as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(12) of this chapter. the ingredient is used in food with no (2) The ingredient is used in food at limitation other than current good levels not to exceed current good man- manufacturing practice. The affirma- ufacturing practice. 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: [48 FR 51907, Nov. 15, 1983] (1) The ingredient is used as a formulation aid as defined in § 170.3(o)(14) of § 184.1282 Dill and its derivatives. this chapter; as a processing aid as de- (a) Dill (American or European) is fined in § 170.3(o)(24) of this chapter; as the herb and seeds from Anethum a stabilizer and thickener as defined in graveolens L., and dill (Indian) is the § 170.3(o)(28) of this chapter; and as a herb and seeds from Anethum sowa, surface-finishing agent as defined in D.C. Its derivatives include essential § 170.3(o)(30) of this chapter. oils, oleoresins, and natural extractives (2) The ingredient is used in food at obtained from these sources of dill. levels not to exceed current good man- (b) Dill oils meet the description and ufacturing practice. specifications of the ‘‘Food Chemicals (d) Prior sanctions for this ingredient Codex,’’ 4th ed. (1996), pp. 122–123, which different from the uses established in is incorporated by reference in accord- this section do not exist or have been ance with 5 U.S.C. 552(a) and 1 CFR waived. part 51. Copies are available from the National Academy Press, Box 285, 2101 [48 FR 51909, Nov. 15, 1983] Constitution Ave. NW., Washington,

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DC 20055 (Internet address ‘‘http:// (1) The ingredients are used as fla- www.nap.edu’’), or may be examined at voring agents and adjuvants as defined the Center for Food Safety and Applied in § 170.3(o)(12) of this chapter. Nutrition’s Library, Food and Drug Ad- (2) The ingredients are used in food ministration, 200 C St. SW., Wash- at levels not to exceed current good ington, DC, or at the Office of the Fed- manufacturing practice. eral Register, 800 North Capitol St. (d) Prior sanctions for these ingredi- NW., suite 700, Washington, DC. ents different from the uses established (c) Dill and its derivatives are used as in this section do not exist or have flavoring agents and adjuvants as de- been waived. fined in § 170.3(o)(12) of this chapter. (d) The ingredients are used in food [52 FR 25976, July 10, 1987] at levels not to exceed good manufac- § 184.1293 Ethyl alcohol. turing practice. (e) [Reserved] (a) Ethyl alcohol (ethanol) is the (f) Prior sanctions for these ingredi- chemical C2H5OH. ents different from the uses established (b) The ingredient meets the speci- in this section do not exist or have fications of the ‘‘Food Chemicals been waived. Codex,’’ 4th ed. (1996), p. 136, which is incorporated by reference in accord- [42 FR 14653, Mar. 15, 1977, as amended at 42 ance with 5 U.S.C. 552(a) and 1 CFR FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, 1999] part 51. Copies are available from the National Academy Press, Box 285, 2101 § 184.1287 Enzyme-modified fats. Constitution Ave. NW., Washington, DC 20055 (Internet address ‘‘http:// (a) Enzyme-modified refined beef fat, www.nap.edu’’), or may be examined at enzyme-modified butterfat, and en- the Center for Food Safety and Applied zyme-modified steam-rendered chicken Nutrition’s Library, Food and Drug Ad- fat are prepared from refined beef fat; ministration, 200 C St. SW., Wash- butterfat or milkfat; and steam-ren- ington, DC, or at the Office of the Fed- dered chicken fat, respectively, with eral Register, 800 North Capitol St. enzymes that are generally recognized NW., suite 700, Washington, DC. as safe (GRAS). Enzyme-modified milk (c) The ingredient is used as an anti- powder may be prepared with GRAS microbial agent as defined in enzymes from reconstituted milk pow- § 170.3(o)(2) of this chapter on pizza der, whole milk, condensed or con- crusts prior to final baking at levels centrated whole milk, evaporated not to exceed 2.0 percent by product milk, or milk powder. The lipolysis is weight. maintained at a temperature that is (d) This regulation is issued prior to optimal for the action of the enzyme general evaluation of use of this ingre- until appropriate acid development is dient in order to affirm as GRAS the attained. The enzymes are then inac- specific use named. tivated. The resulting product is concentrated or dried. [42 FR 14653, Mar. 15, 1977, as amended at 49 (b) FDA is developing food-grade FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, specifications for these enzyme-modi- 1999] fied ingredients in cooperation with the National Academy of Sciences. In § 184.1295 Ethyl formate. the interim, the ingredients must be of (a) Ethyl formate (C3H6O2, CAS Reg. purity suitable for their intended use. No. 109–94–4) is also referred to as ethyl (c) In accordance with § 184.1(b)(1), methanoate. It is an ester of formic the ingredients are used in food with acid and is prepared by esterification no limitation other than current good of formic acid with ethyl alcohol or by manufacturing practice. The affirma- distillation of ethyl acetate and formic tion of these ingredients as generally acid in the presence of concentrated recognized as safe (GRAS) as direct sulfuric acid. Ethyl formate occurs human food ingredients is based upon naturally in some plant oils, fruits, and the following current good manufac- juices but does not occur naturally in turing practice conditions of use: the animal kingdom.

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(b) The ingredient meets the speci- percent iron, approximately 7.5 percent fications of the ‘‘Food Chemicals ammonia, and 75 percent citric acid Codex,’’ 3d Ed. (1981), p. 376, which is in- and occurs as thin transparent green corporated by reference. Copies may be scales, as granules, as a powder, or as obtained from the National Academy transparent green crystals. Press, 2101 Constitution Ave. NW., (b) The ingredients meet the speci- Washington, DC 20418, or may be exam- fications of the Food Chemicals Codex, ined at the Office of the Federal Reg- 3d Ed. (1981), pp. 116–117 (Ferric ammo- ister, 800 North Capitol Street, NW., nium citrate, brown) and p. 117 (Ferric suite 700, Washington, DC 20408. ammonium citrate, green), which is in- (c) The ingredient is used as a fla- corporated by reference. Copies are voring agent and adjuvant as defined in available from the National Academy § 170.3(o)(12) of this chapter. Press, 2101 Constitution Ave. NW., (d) The ingredient is used in food at Washington, DC 20418, or available for levels not to exceed good manufac- inspection at the Office of the Federal turing practice in accordance with Register, 800 North Capitol Street, § 184.1(b)(1). Current good manufac- NW., suite 700, Washington, DC 20408. turing practice results in a maximum (c) In accordance with § 184.1(b)(1), level, as served, of 0.05 percent in baked the ingredients are used in food as nu- goods as defined in § 170.3(n)(1) of this trient supplements as defined in chapter; 0.04 percent in chewing gum as § 170.3(o)(20) of this chapter, with no defined in § 170.3(n)(6), hard candy as limitation other than current good defined in § 170.3(n)(25), and soft candy manufacturing practice. The ingredi- as defined in § 170.3(n)(38) of this chap- ents may also be used in infant formula ter; 0.02 percent in frozen dairy des- in accordance with section 412(g) of the serts as defined in § 170.3(n)(20) of this Federal Food, Drug, and Cosmetic Act chapter; 0.03 percent in gelatins, pud- (the act) (21 U.S.C. 350a(g)) or with reg- dings, and fillings as defined in ulations promulgated under section § 170.3(n)(22) of this chapter; and 0.01 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). percent in all other food categories. (d) Prior sanctions for these ingredi- (e) Prior sanctions for ethyl formate ents different from the uses established different from the uses established in in this section do not exist or have this section do not exist or have been been waived. waived. [53 FR 16864, May 12, 1988] [45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 1984] § 184.1297 Ferric chloride. (a) Ferric chloride (iron (III) chlo- § 184.1296 Ferric ammonium citrate. ride, FeC13, CAS Reg. No. 7705–08–0) (a) Ferric ammonium citrate (iron may be prepared from iron and chlorine (III) ammonium citrate) is prepared by or from ferric oxide and hydrogen chlo- the reaction of ferric hydroxide with ride. The pure material occurs as citric acid, followed by treatment with hydroscopic, hexagonal, dark crystals. ammonium hydroxide, evaporating, Ferric chloride hexahydrate (iron (III) and drying. The resulting product oc- chloride hexahydrate, FeC13. 6H20, CAS curs in two forms depending on the Reg. No. 10025–77–1) is readily formed stoichiometry of the initial reactants. when ferric chloride is exposed to mois- (1) Ferric ammonium citrate (iron ture. (III) ammonium citrate, CAS Reg. No. (b) The Food and Drug Administra- 1332–98–5) is a complex salt of undeter- tion is developing food-grade specifica- mined structure composed of 16.5 to tions for ferric chloride in cooperation 18.5 percent iron, approximately 9 per- with the National Academy of cent ammonia, and 65 percent citric Sciences. In the interim, this ingre- acid and occurs as reddish brown or dient must be of a purity suitable for garnet red scales or granules or as a its intended use. brownish-yellowish powder. (c) In accordance with § 184.1(b)(1) the (2) Ferric ammonium citrate (iron ingredient is used in food as a flavoring (III) ammonium citrate, CAS Reg. No. agent as defined in § 170.3(o)(12) of this 1333–00–2) is a complex salt of undeter- chapter, with no limitation other than mined structure composed of 14.5 to 16 current good manufacturing practice.

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(d) Prior sanctions for this ingredient Register, 800 North Capitol Street, different from the uses established in NW., suite 700, Washington, DC 20408. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food as nutrient supplement as defined in [53 FR 16864, May 12, 1988] § 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 Food and Drug Administra- 350a(a)(2)). tion is developing food-grade specifica- (d) Prior sanctions for this ingredient tions for ferric citrate in cooperation different from the uses established in with the National Academy of this section do not exist or have been Sciences. In the interim, this ingre- waived. dient must be of a purity suitable for its intended use. [53 FR 16865, May 12, 1988] (c) In accordance with § 184.1(b)(1), the ingredient is used in food as a nu- § 184.1304 Ferric pyrophosphate. trient supplement as defined in (a) Ferric pyrophosphate (iron (III) § 170.3(o)(20) of this chapter, with no pyrophosphate, Fe4(P207)3·xH2O, CAS limitation other than current good Reg. No. 10058–44–3) is a tan or yel- manufacturing practice. The ingre- lowish white colorless powder. It is pre- dient may also be used in infant for- pared by reacting sodium mula in accordance with section 412(g) pyrophosphate with ferric citrate. of the Federal Food, Drug, and Cos- (b) The ingredient meets the speci- metic Act (the act) (21 U.S.C. 350a(g)) fications of the Food Chemicals Codex, or with regulations promulgated under 3d Ed. (1981), p. 120, which is incor- section 412(a)(2) of the act (21 U.S.C. porated by reference. Copies are avail- 350a(a)(2)). able from the National Academy Press, (d) 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 do not exist or have been spection at the Office of the Federal waived. Register, 800 North Capitol Street, [53 FR 16865, May 12, 1988] NW., suite 700, Washington, DC 20408. (c) In accordance with § 184.1(b)(1), § 184.1301 Ferric phosphate. the ingredient is used in food as a nu- (a) Ferric phosphate (ferric trient supplement as defined in orthophosphate, iron (III) phosphate, § 170.3(o)(20) of this chapter, with no limitation other than current good FePO4·xH2O, CAS Reg. No. 10045–86–0) is an odorless, yellowish-white to buff- manufacturing practice. The ingre- colored powder and contains from one dient may also be used in infant for- to four molecules of water of hydra- mula in accordance with section 412(g) tion. It is prepared by reaction of so- of the Federal Food, Drug, and Cos- dium phosphate with ferric chloride or metic Act (the act) (21 U.S.C. 350a(g)) ferric citrate. or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. (b) The ingredient meets the speci- 350a(a)(2)). fications of the Food Chemicals Codex, 3d Ed. (1981), pp. 118–120, which is incor- (d) Prior sanctions for this ingredient porated by reference. Copies are avail- different from the uses established in able from the National Academy Press, this section do not exist or have been 2101 Constitution Ave. NW., Wash- waived. ington, DC 20418, or available for in- [53 FR 16865, May 12, 1988; 53 FR 20939, June spection at the Office of the Federal 7, 1988]

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§ 184.1307 Ferric sulfate. § 184.1307b Ferrous carbonate. (a) Ferric sulfate (iron (III) sulfate, (a) Ferrous carbonate (iron (II) car- Fe2(SO4)3, CAS Reg. No. 10028–22–5) is a bonate, FeCO3, CAS Reg. No. 563–71–3) yellow substance that may be prepared is an odorless, white solid prepared by by oxidizing iron (II) sulfate or by treating solutions of iron (II) salts with treating ferric oxide or ferric hydrox- alkali carbonate salts. ide with sulfuric acid. (b) The Food and Drug Administra- (b) The Food and Drug Administra- tion is developing food-grade specification is developing food-grade specifications for ferrous carbonate in coopera- tions for ferric sulfate in cooperation tion with the National Academy of with the National Academy of Sciences. In the interim, this ingre- Sciences. In the interim, this ingredient must be of a purity suitable for dient must be of a purity suitable for its intended use. its intended use. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food as a nu- the ingredient is used in food as a fla- trient supplement as defined in voring agent as defined in § 170.3(o)(12) § 170.3(o)(20) of this chapter, with no of this chapter, with no limitation other than current good manufacturing limitation other than current good practice. manufacturing practice. The ingre- (d) Prior sanctions for this ingredient dient may also be used in infant for- different from the uses established in mula in accordance with section 412(g) this section do not exist or have been of the Federal Foods, Drug, and Cos- waived. metic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under [53 FR 16865, May 12, 1988] section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). § 184.1307a Ferrous ascorbate. (d) Prior sanctions for this ingredient (a) Ferrous ascorbate (CAS Reg. No. different from the uses established in 14536–17–5) is a reaction product of fer- this section do not exist or have been rous hydroxide and ascorbic acid. It is waived. a blue-violet product containing 16 percent iron. [53 FR 16865, May 12, 1988] (b) The Food and Drug Administra- tion is developing food-grade specifica- § 184.1307c Ferrous citrate. tions for ferrous ascorbate in coopera- (a) Ferrous citrate (iron (II) citrate, tion with the National Academy of (C6H6FeO7), CAS Reg. No. 23383–11–1) is Sciences. In the interim, this ingre- a slightly colored powder or white dient must be of a purity suitable for crystals. It is prepared from the reac- its intended use. tion of sodium citrate with ferrous sul- (c) In accordance with § 184.1(b)(1), fate or by direct action of citric acid on the ingredient is used in food as a nu- iron filings. trient supplement as defined in (b) The Food and Drug Administra- § 170.3(o)(20) of this chapter, with no tion is developing food-grade specifica- limitation other than current good tions for ferrous citrate in cooperation manufacturing practice. The ingre- with the National Academy of dient may also be used in infant for- Sciences. In the interim, this ingre- mula in accordance with section 412(g) dient must be of a purity suitable for of the Federal Food, Drug, and Cos- its intended use. metic Act (the act) (21 U.S.C. 350a(g)) (c) In accordance with § 184.1(b)(1) the or with regulations promulgated under ingredient is used in food as a nutrient section 412(a)(2) of the act (21 U.S.C. supplement as defined in § 170.3(o)(20) of 350a(a)(2)). this chapter, with no limitation other (d) Prior sanctions for this ingredient than current good manufacturing prac- different from the uses established in tice. The ingredient may also be used this section do not exist or have been in infant formula in accordance with waived. section 412(g) of the Federal Food, [53 FR 16865, May 12, 1988] Drug, and Cosmetic Act (the act) (21

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U.S.C. 350a(g)) or with regulations pro- 3d Ed. (1981), pp. 122–123, which is incor- mulgated under section 412(a)(2) of the porated by reference. Copies are avail- act (21 U.S.C. 350a(a)(2)). able from the National Academy Press, (d) Prior sanctions for this ingredient 2101 Constitution Avenue NW., Wash- different from the uses established in ington, DC 20418, or available for in- this section do not exist or have been spection at the Office of the Federal waived. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [53 FR 16866, May 12, 1988] (c) In accordance with § 184.1(b)(1), § 184.1307d Ferrous fumarate. the ingredient is used in food as a nutrient supplement as defined in (a) Ferrous fumarate (iron (II) fuma- § 170.3(o)(20) of this chapter, with no rate, (C4H2FeO4), CAS Reg. No. 141–01–5) limitation other than current good is an odorless, reddish-orange to red- manufacturing practice. The ingre- dish-brown powder. It may contain soft dient may also be used in infant for- lumps that produce a yellow streak mula in accordance with section 412(g) when crushed. It is prepared by of the Federal Food, Drug, and Cos- admixing hot solutions of ferrous sul- metic Act (the act) (21 U.S.C. 350a(g)) fate and sodium fumarate. or with regulations promulgated under (b) The ingredient meets the speci- section 412(a)(2) of the act (21 U.S.C. fications of the Food Chemicals Codex, 350a(a)(2)). 3d Ed. (1981), pp. 120–122, which is incor- (d) Prior sanctions for this ingredient porated by reference. Copies are avail- different from the uses established in able from the National Academy Press, this section do not exist or have been 2101 Constitution Ave NW., Wash- waived. ington, DC 20418, or available for inspection at the Office of the Federal [53 FR 16866, May 12, 1988; 53 FR 20939, June 7, 1988] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1311 Ferrous lactate. (c) In accordance with § 184.1(b)(1) the ingredient is used in food as a nutrient (a) Ferrous lactate (iron (II) lactate, supplement as defined in § 170.3(o)(20) of C6H10FeO6, CAS Reg. No. 5905–52–2) in this chapter, with no limitation other the trihydrate form is a greenish-white powder or crystalline mass. It is pre- than current good manufacturing prac- pared by reacting calcium lactate or tice. The ingredient may also be used sodium lactate with ferrous sulfate, di- in infant formula in accordance with rect reaction of lactic acid with iron section 412(g) of the Federal Food, filings, reaction of ferrous chloride Drug, and Cosmetic Act (the act) (21 with sodium lactate, or reaction of fer- U.S.C. 350a(g)), or with regulations pro- rous sulfate with ammonium lactate. mulgated under section 412(a)(2) of the (b) The ingredient meets the speci- act (21 U.S.C. 350a(a)(2)). fications of the Food Chemicals Codex, (d) Prior sanctions for this ingredient 4th ed. (1996), pp. 154 to 155, which is in- different from the uses established in corporated by reference in accordance this section do not exist or have been with 5 U.S.C. 552(a) and 1 CFR part 51. waived. Copies are available from the National [53 FR 16866, May 12, 1988] Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be § 184.1308 Ferrous gluconate. examined at the Center for Food Safety (a) Ferrous gluconate (iron (II) gluco- and Applied Nutrition’s library, 200 C nate dihydrate, C12H22FeO14·2H2O, CAS St. SW., Washington, DC, or at the Of- Reg. No. 6047-12-7) is a fine yellowish- fice of the Federal Register, 800 North gray or pale greenish-yellow powder or Capitol St. NW., suite 700, Washington, granules. It is prepared by reacting hot DC. solutions of barium or calcium gluco- (c) In accordance with § 184.1(b)(1), nate with ferrous sulfate or by heating the ingredient is used in food as a nu- freshly prepared ferrous carbonate with trient supplement as defined in gluconic acid in aqueous solution. § 170.3(o)(20) of this chapter and as a (b) The ingredient meets the speci- color fixative for ripe olives, with no fications of the Food Chemcials Codex, other limitation other than current

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good manufacturing practice. The in- in this section do not exist or have gredient may also be used in infant for- been waived. mula in accordance with section 412(g) [53 FR 16866, May 12, 1988] of the Federal Food, Drug, and Cos- metic Act (the act) (21 U.S.C. 350a(g)) § 184.1316 Ficin. or with regulations promulgated under (a) Ficin (CAS Reg. No. 9001–33–6) is section 412(a)(2) of the act (21 U.S.C. an enzyme preparation obtained from 350a(a)(2)). the latex of species of the genus Ficus, (d) Prior sanctions for this ingredient which include a variety of tropical fig different from the uses established in trees. It is a white to off-white powder. this section do not exist or have been Its characterizing enzyme activity is waived. that of a peptide hydrolase (EC [53 FR 16866, May 12, 1988, as amended at 61 3.4.22.3). FR 40319, Aug. 2, 1996] (b) The ingredient meets the general requirements and additional require- § 184.1315 Ferrous sulfate. ments for enzyme preparations in the (a) Ferrous sulfate heptahydrate Food Chemicals Codex, 3d ed. (1981), p. (iron (II) sulfate heptahydrate, 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 FeSO4·7H2O, CAS Reg. No. 7782–63–0) is prepared by the action of sulfuric acid CFR part 51. Copies are available from on iron. It occurs as pale, bluish-green the National Academy Press, 2101 Con- crystals or granules. Progressive heat- stitution Ave., NW., Washington, DC ing of ferrous sulfate heptahydrate pro- 20418, or may be examined at the Office duces ferrous sulfate (dried). Ferrous of Premarket Approval (HFS–200), Food sulfate (dried) consists primarily of fer- and Drug Administration, 200 C St., rous sulfate monohydrate (CAS Reg. SW., Washington, DC, and the Office of No. 17375–41–6) with varying amounts of the Federal Register, 800 North Capitol ferrous sulfate tetrahydrate (CAS Reg. St., NW., suite 700, Washington, DC. No. 20908–72–9) and occurs as a grayish- (c) In accordance with § 184.1(b)(1), white to buff-colored powder. the ingredient is used in food with no (b) The ingredients meet the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d Ed. (1981), p. 123 (Ferrous sulfate tion of this ingredient as GRAS as a di- heptahydrate) and p. 124 (ferrous sul- rect food ingredient is based upon the fate, dried), which is incorporated by following current good manufacturing reference. Copies are available from practice conditions of use: the National Academy Press, 2101 Con- (1) The ingredient is used as an en- stitution Ave., NW., Washington, DC zyme as defined in § 170.3(o)(9) of this 20418, or available for inspection at the chapter to hydrolyze proteins or Office of Federal Register, 800 North polypeptides. Capitol Street, NW., suite 700, Wash- (2) The ingredient is used in food at ington, DC 20408. levels not to exceed current good manufacturing practice. (c) In accordance with § 184.1(b)(1), the ingredients are used in food as nu- [60 FR 32910, June 26, 1995] trient supplements as defined in § 170.3(o)(20) of this chapter and as a § 184.1317 Garlic and its derivatives. processing aid as defined in § 170.3(o)(24) (a) Garlic is the fresh or dehydrated of this chapter, with no limitation bulb or cloves obtained from Allium other than current good manufacturing sativum, a genus of the lily family. Its practice. The ingredients may also be derivatives include essential oils, oleo- used in infant formula in accordance resins, and natural extractives ob- with section 412(g) of the Federal Food, tained from garlic. Drug, and Cosmetic Act (the act) (21 (b) Garlic oil meets the specifications U.S.C. 350a(g)) or with regulations proof the ‘‘Food Chemicals Codex,’’ 3d Ed. mulgated under section 412(a)(2) of the (1981), p. 132, which is incorporated by act (21 U.S.C. 350a(a)(2)). reference. Copies may be obtained from (d) Prior sanctions for these ingredi- the National Academy Press, 2101 Con- ents different from the uses established stitution Ave. NW., Washington, DC

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20418, or may be examined at the Office § 170.3(o)(23) of this chapter; and of the Federal Register, 800 North Cap- sequestrant as defined in § 170.3(o)(26) of itol Street, NW., suite 700, Washington, this chapter. DC 20408. (2) The ingredient is used at levels (c) Garlic and its derivatives are used not to exceed current good manufac- as flavoring agents and adjuvants as turing practice. defined in § 170.3(o)(12) of this chapter. (d) Prior sanctions for this ingredient (d) The ingredients are used in food different from the uses established in at levels not to exceed good manufac- this section do not exist or have been turing practice. waived. (e) [Reserved] (f) Prior sanctions for this ingredient [51 FR 33896, Sept. 24, 1986] different from the uses established in § 184.1321 Corn gluten. this section do not exist or have been waived. (a) Corn gluten (CAS Reg. No. 66071– 96–3), also known as corn gluten meal, [42 FR 14653, Mar. 15, 1977, as amended at 42 is the principal protein component of FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, corn endosperm. It consists mainly of 1984] zein and glutelin. Corn gluten is a by- § 184.1318 Glucono delta-lactone. product of the wet milling of corn for starch. The gluten fraction is washed (a) Glucono delta-lactone (C6H10O6, to remove residual water soluble pro- CAS Reg. No. 90–80–2), also called D- teins. Corn gluten is also produced as a gluconic acid delta-lactone or D- byproduct during the conversion of the glucono-1,5-lactone, is the cyclic 1,5- starch in whole or various fractions of intramolecular ester of D-gluconic dry milled corn to corn syrups. acid. It is prepared by direct crys- (b) FDA is developing food-grade tallization from the aqueous solution specifications for corn gluten in co- of gluconic acid. Gluconic acid may be operation with the National Academy produced by the oxidation of D-glucose of Sciences. In the interim, the ingre- with bromine water, by the oxidation dient must be of a purity suitable for of D-glucose by microorganisms that its intended use. are nonpathogenic and nontoxicogenic (c) In accordance with § 184.1(b)(1), to man or other animals, or by the oxi- the ingredient is used in food with no dation of D-glucose with enzymes de- limitation other than current good rived from these microorganisms. manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications of the Food Chemicals Codex, ognized as safe (GRAS) as a direct 3d Ed. (1981), p. 134, which is incor- human food ingredient is based upon porated by reference. Copies are avail- the following current good manufac- able from the National Academy Press, turing practice conditions of use: 2101 Constitution Ave. NW., Wash- (1) The ingredient is used as a nutri- ington, DC 20418, or available for in- ent supplement as defined in spection at the Office of the Federal § 170.3(o)(20) of this chapter and a Register, 800 North Capitol Street, texturizer as defined in § 170.3(o)(32) of NW., suite 700, Washington, DC 20408. this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice. 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] (1) The ingredient is used as a curing and pickling agent as defined in § 184.1322 Wheat gluten. § 170.3(o)(5) of this chapter, leavening (a) Wheat gluten (CAS Reg. No. 8002– agent as defined in § 170.3(o)(17) of this 80–0) is the principal protein compo- chapter; pH control agent as defined in nent of wheat and consists mainly of

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gliadin and glutenin. Wheat gluten is ingredient must be of a purity suitable obtained by hydrating wheat flour and for its intended use. mechanically working the sticky mass (c) In accordance with § 184.1(b)(1), to separate the wheat gluten from the the ingredient is used in food with no starch and other flour components. limitation other than current good Vital gluten is dried gluten that has re- manufacturing practice. The affirma- tained its elastic properties. tion of this ingredient as generally rec- (b) FDA is developing food-grade ognized as safe (GRAS) as a direct specifications for wheat gluten in co- human food ingredient is based upon operation with the National Academy the following current good manufac- of Sciences. In the interim, the ingre- turing practice conditions of use: dient must be of a purity suitable for (1) The ingredient is used as a fla- its intended use. voring agent and adjuvant as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(12) of this chapter and as a the ingredient is used in food with no solvent and vehicle as defined in limitation other than current good § 170.3(o)(27) 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 baked goods and baking mixes as de- the following current good manufac- fined in § 170.3(n)(1) of this chapter; turing practice conditions of use: nonalcoholic beverages and beverage (1) The ingredient is used as a dough bases as defined in § 170.3(n)(3) of this strengthener as defined in § 170.3(o)(6) chapter; chewing gum as defined in of this chapter; a formulation aid as § 170.3(n)(6) of this chapter; and meat defined in § 170.3(o)(14) of this chapter; products as defined in § 170.3(n)(29) of a nutrient supplement as defined in this chapter. § 170.3(o)(20) of this chapter; a proc- (d) Prior sanctions for this ingredient essing aid as defined in § 170.3(o)(24) of different from the use established in this chapter; a stabilizer and thickener this section do not exist or have been as defined in § 170.3(o)(28) of this chap- waived. ter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and a [54 FR 7403 Feb. 21, 1989] texturizing agent as defined in § 184.1324 Glyceryl monostearate. § 170.3(o)(32) of this chapter. (2) The ingredient is used in food at (a) Glyceryl monostearate, also levels not to exceed current good man- known as monostearin, is a mixture of ufacturing practice. variable proportions of glyceryl mono- (d) Prior sanctions for this ingredient stearate (C21H42O4, CAS Reg. No. 31566– different from the uses established in 31–1), glyceryl monopalmitate this section do not exist or have been (C19H38O4, CAS Reg. No. 26657–96–5) and waived. glyceryl esters of fatty acids present in commercial stearic acid. Glyceryl [50 FR 8998, Mar. 6, 1985] monostearate is prepared by glycerolysis of certain fats or oils that § 184.1323 Glyceryl monooleate. are derived from edible sources or by (a) Glyceryl monooleate is prepared esterification, with glycerin, of stearic by esterification of commerical oleic acid that is derived from edible acid that is derived either from edible sources. sources or from tall oil fatty acids (b) FDA is developing food-grade meeting the requirements of § 172.862 of specifications for glyceryl monostea- this chapter. It contains glyceryl rate in cooperation with the National monooleate (C21H40O4, CAS Reg. No. Academy of Sciences. In the interim, 25496–72–4) and glyceryl esters of fatty this ingredient must be of a purity acids present in commercial oleic acid. suitable for its intended use. (b) FDA is developing food-grade (c) In accordance with § 184.1(b)(1), specifications for glyceryl monooleate the ingredient is used in food with no in cooperation with the National Acad- limitation other than current good emy of Sciences. In the interim, this manufacturing practice.

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(d) Prior sanctions for this ingredient esters of palmitic and stearic acids different from the uses established in made from glycerin, palmitic acid, and this section do not not exist or have stearic acid. been waived. (b) The ingredient meets the fol- [54 FR 7403 Feb. 21, 1989] lowing specifications: (1) The substance is a mixture of § 184.1328 Glyceryl behenate. mono-, di-, and triglycerides of pal- (a) Glyceryl behenate is a mixture of mitic acid and stearic acid. glyceryl esters of behenic acid made (2) Heavy metals (as lead): Not more from glycerin and behenic acid (a satu- than 10 parts per million. rated C22 fatty acid). The mixture con- (c) In accordance with § 184.1(b)(1), tains predominately glyceryl the ingredient is used in food with no dibehenate. limitation other than current good (b) The ingredient meets the fol- manufacturing practice. The affirma- lowing specifications: tion of this ingredient as generally rec- (1) 10 to 20 percent monoglyceride, 47 ognized as safe (GRAS) as a direct to 59 percent diglyceride, 26 to 38 percent triglyceride, and not more than human food ingredient is based upon 2.5 percent free fatty acids. the following current good manufac- (2) Behenic acid. Between 80 and 90 turing practice conditions of use: percent of the total fatty acid content. (1) The ingredient is used as a formu- (3) Acid value. Not more than 4. lation aid, as defined in § 170.3(o)(14) of (4) Saponification value. Between 145 this chapter. and 165. (2) The ingredient is used in excipient (5) Iodine number. Not more than 3. formulations for use in tablets at levels (6) Heavy metals (as Pb). Not more not to exceed good manufacturing than 10 parts per million. practice. (c) In accordance with § 184.1(b)(1) of this chapter, the ingredient is used in [60 FR 63621, Dec. 12, 1995] food with no limitation other than current good manufacturing practice. The § 184.1330 Acacia (gum arabic). affirmation of this ingredient is gen- (a) Acacia (gum arabic) is the dried erally recognized as safe (GRAS) as a gummy exudate from stems and direct human food ingredient is based branches of trees of various species of upon the following current good manu- the genus Acacia, family Leguminosae. facturing practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as a formu- fications of the ‘‘Food Chemicals lation aid, as defined in § 170.3(o)(14) of Codex,’’ 3d Ed. (1981), p. 7, which is in- this chapter. (2) The ingredient is used in excipient corporated by reference. Copies may be formulations for use in tablets at levels obtained from the National Academy not to exceed good manufacturing Press, 2101 Constitution Ave. NW., practice. Washington, DC 20418, or may be examined at the Office of the Federal Reg- [52 FR 42430, Nov. 5, 1987] ister, 800 North Capitol Street, NW., § 184.1329 Glyceryl palmitostearate. suite 700, Washington, DC 20408. (c) The ingredient is used in food (a) Glyceryl palmitostearate is a under the following conditions: mixture of mono-, di-, and triglyceryl

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, ¤ 170.3(n)(3) of this 2.0 Emulsifier and emulsifier salt, ¤ 170.3(o)(8) of this chapter; 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.

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

Confections and frostings, ¤ 170.3(n)(9) of this chap- 12.4 Formulation aid, ¤ 170.3(o)(14) of this chapter; stabilizer and ter . 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 2.5 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. Hard candy and cough drops, ¤ 170.3(n)(25) of this 46.5 Flavoring agent and adjuvant, ¤ 170.3(o)(12) of this chapter; 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] (iv) Heavy metals (as Pb). Not more (e) Prior sanctions for this ingredient than 40 parts per million (0.004 per- different from the uses established in cent); and this section do not exist or have been (v) Lead. Not more than 10 parts per waived. million (0.001 percent). (3) Loss on drying. Not more than 14 [42 FR 14653, Mar. 15, 1977, as amended at 42 ° FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, percent dried at 105 C for 5 hours. 1983; 53 FR 5766, Feb. 26, 1988] (4) Identification test. Add 0.2 ml of diluted lead acetate as outlined in ‘‘Offi- § 184.1333 Gum ghatti. cial Methods of Analysis of the Asso- ciation of Official Analytical Chem- (a) Gum ghatti (Indian gum) is an ists,’’ 13th Ed. (1980), section 31.178(b), exudate from wounds in the bark of p. 529, under ‘‘Dilute Basic Lead Ace- Anogeissus latifolia, a large tree found tate Standard Solution,’’ which is in- in the dry deciduous forests of India corporated by reference (copies are and Ceylon. available from the Association of Offi- (b) The ingredient complies with the cial Analytical Chemists, P.O. Box 540, following specifications: Benjamin Franklin Station, Wash- (1) Viscosity of a 1-percent solution. ington, DC 20044, or may be examined Not less than the minimum or within at the Office of the Federal Register, the range claimed by the vendor. 800 North Capitol Street, NW., suite (2) Limits of impurities—(i) Arsenic (as 700, Washington, DC 20408), to 5 ml of a AL). Not more than 3 parts per million cold 1-in-100 aqueous solution of the (0.0003 percent); gum. An immediate, voluminous, (ii) Ash (acid-insoluble). Not more opaque precipitate indicates acacia. A than 1.75 percent; small precipitate or clear solution (iii) Ash (total). Not more than 6.0 which produces an opaque flocculent percent; precipitate upon the additon of 1 ml of

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3 N ammonimum hydroxide indicates (c) The ingredient is used in food gum ghatti. 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 (b) The ingredient meets the speci- different from the uses established in fications of the ‘‘Food Chemicals this section do not exist or have been Codex,’’ 3d Ed. (1981), p. 141, which is in- waived. corporated by reference. Copies may be [42 FR 14653, Mar. 15, 1977, as amended at 49 obtained from the National Academy FR 5612, Feb. 14, 1984] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1339 Guar gum. ined at the Office of the Federal Reg- (a) Guar gum is the natural sub- ister, 800 North Capitol Street, NW., stance obtained from the maceration of suite 700, Washington, DC 20408. the seed of the guar plant, Cyamopsis (c) The ingredient is used in food tetragonoloba (Linne) Taub., or under the following conditions: Cyamopsis psoraloides (Lam.) D.C.

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, ¤ 170.3(n)(1) of this 0.35 Emulsifier and emulsifier salts, ¤ 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. 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 chap- 1.0 Firming agent, ¤ 170.3(o)(10) of this chapter; formulation ter . 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 1.0 Do. chapter . Milk products, ¤ 170.3(n)(31) of this chapter ...... 6 Do. Processed vegetables and vegetable juices, 2.0 Formulation aid, ¤ 170.3(o)(14) of this chapter; stabilizer and ¤ 170.3(n)(36) of this chapter . thickener, ¤ 170.3(o)(28) of this chapter. Soups and soup mixes, ¤ 170.3(n)(40) of this chap- .8 Do. ter . Sweet sauces, toppings and syrups, ¤ 170.3(n)(43) 1.0 Do. of this 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] § 184.1343 Locust (carob) bean gum. (e) Prior sanctions for this ingredient (a) Locust (carob) bean gum is pri- different from the uses established in marily the macerated endosperm of the this section do not exist or have been seed of the locust (carob) bean tree, waived. Ceratonia siliqua (Linne), a leguminous [42 FR 14653, Mar. 15, 1977, as amended at 42 evergreen tree, with lesser quantities FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, of seed coat and germ. 1984] (b) The ingredient meets the specifications of the ‘‘Food Chemicals

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Codex,’’ 3d Ed. (1981), pp. 174–175, which Register, 800 North Capitol Street, is incorporated by reference. Copies NW., suite 700, Washington, DC 20408. may be obtained from the National (c) The ingredient is used at levels Academy Press, 2101 Constitution Ave. not to exceed the following maximum NW., Washington, DC 20418, or may be levels: examined at the Office of the Federal

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] of trees of various species of the genus (e) Prior sanctions for this ingredient Sterculia. different from the uses established in (b) The ingredient meets the speci- this regulation do not exist or have fications of the ‘‘Food Chemicals been waived. Codex,’’ 3d Ed. (1981), p. 157, which is incorporated by reference. Copies may be [42 FR 14653, Mar. 15, 1977, as amended at 42 obtained from the National Academy FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Press, 2101 Constitution Ave. NW., 1984] Washington, DC 20418, or may be examined at the Office of the Federal Reg- § 184.1349 Karaya gum (sterculia gum). ister, 800 North Capitol Street, NW., (a) Karaya gum (sterculia gum) is the suite 700, Washington, DC 20408. dried gummy exudate from the trunk (c) The ingredient is used in food under the following conditions:

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] that grows wild in mountainous re- (e) Prior sanctions for this ingredient gions of the Middle East. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), p. 337, which is in- [42 FR 14653, Mar. 15, 1977, as amended at 42 corporated by reference. Copies may be FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, obtained from the National Academy 1984] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1351 Gum tragacanth. ined at the Office of the Federal Reg- (a) Gum tragacanth is the exudate ister, 800 North Capitol Street, NW., from one of several species of Astrag- suite 700, Washington, DC 20408. alus gummifier Labillardiere, a shrub

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

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

(d) [Reserved] (2) The ingredient is used in food at (e) 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 this section do not exist or have been [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, waived. 1984] [48 FR 57270, Dec. 29, 1983]

§ 184.1355 Helium. § 184.1366 Hydrogen peroxide.

(a) Helium (empirical formula He, (a) Hydrogen peroxide (H2O2, CAS CAS Reg. No. 7440–59–7) is a colorless, Reg. No. 7722–84–1) is also referred to as odorless, flavorless, nonflammable, hydrogen dioxide. It is made by the inert gas. It is lighter than air and is electrolytic oxidation of sulfuric acid produced by the liquefaction and puri- or a sulfate to persulfuric acid or a fication of natural gas. persulfuric acid salt with subsequent (b) The Food and Drug Administra- hydrolysis and distillation of the hy- tion is developing food-grade specifica- drogen peroxide formed; by decomposi- tions for helium in cooperation with tion of barium peroxide with sulfuric the National Academy of Sciences. In or phosphoric acid; by hydrogen reduc- the interim, the ingredient must be of tion of 2-ethylanthraquinone, followed a purity suitable for its intended use. by oxidation with air, to regenerate (c) In accordance with § 184.1(b)(1), the quinone and produce hydrogen per- the ingredient is used in food with no oxide; or by electrical discharge limitations other than current good through a mixture of hydrogen, oxy- manufacturing practice. The affirma- gen, and water vapor. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications of the Food Chemicals Codex, human food ingredient is based upon 3d ed. (1981), pp. 146–147, 1 which is in- the following current good manufac- corporated by reference. turing practice conditions of use: (c) In accordance with § 184.1(b)(2), (1) The ingredient is used as a proc- the ingredient is used to treat food essing aid as defined in § 170.3(o)(24) of only within the following specific limi- this chapter. tations:

1 Copies may be obtained from the National the Office of the Federal Register, 800 North Academy of Sciences, 2101 Constitution Ave. Capitol Street, NW., suite 700, Washington, NW, Washington, DC 20037, or examined at DC 20408.

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Maximum treatment Food level in food (percent) Functional use

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

(d) Residual hydrogen peroxide is re- ington, DC 20418, or available for in- moved by appropriate physical and spection at the Office of the Federal chemical means during the processing Register, 800 North Capitol Street, of food where it has been used accord- NW., suite 700, Washington, DC 20408. ing to paragraph (c) of this section. (c) In accordance with § 184.1(b)(1), (e) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitations other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [46 FR 44439, Sept. 4, 1981, as amended at 51 ognized as safe (GRAS) as a direct FR 27172, July 30, 1986] human food ingredient is based upon the following current good manufac- § 184.1370 Inositol. turing practice conditions of use: (1) The ingredient is used as a nutri- (a) Inositol, or myo-inositol (C6H12O6, CAS Reg. No. 87–89–8), is cis-1,2,3,5- ent supplement as defined in trans-4,6-cyclohexanehexol. It occurs § 170.3(o)(20) of this chapter. naturally and is prepared from an (2) The ingredient is used in special aqueous (0.2 percent sulfur dioxide) ex- dietary foods as defined in part 105 of tract of corn kernels by precipitation this chapter at levels not to exceed and hydrolysis of crude phytate. current good manufacturing practice. (b) The ingredient meets the speci- It may also be used in infant formula fications of the Food Chemicals Codex, in accordance with section 412(g) of the 3d Ed. (1981), p. 150, which is incor- Act, or with regulations promulgated porated by reference. Copies are avail- under section 412(a)(2) of the Act. able from the National Academy Press, (d) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash- different from the uses established by

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this section do not exist or have been any of the following processes: reduced waived. iron, electrolytic iron, and carbonyl iron. [47 FR 38278, Aug. 31, 1982] (1) Reduced iron is prepared by react- § 184.1372 Insoluble glucose isomerase ing ground ferric oxide with hydrogen enzyme preparations. or carbon monoxide at an elevated temperature. The process results in a (a) Insoluble glucose isomerase en- grayish-black powder, all of which zyme preparations are used in the pro- should pass through a 100-mesh sieve. duction of high fructose corn syrup de- It is lusterless or has not more than a scribed in § 184.1866. They are derived slight luster. When viewed under a mi- from recognized species of precisely croscope, it appears as an amorphous classified nonpathogenic and powder free from particles having a nontoxicogenic microorganisms, in- crystalline structure. It is stable in dry cluding Streptomyces rubiginosus, air. Actinoplanes missouriensis, Streptomyces (2) Electrolytic iron is prepared by olivaceus, Streptomyces olivochromogenes, electrodeposition. It is an amorphous, and Bacillus coagulans, that have been lusterless, grayish-black powder. It is grown in a pure culture fermentation stable in dry air. that produces no antibiotics. They are (3) Carbonyl iron is prepared by the fixed (rendered insoluble) for batch decomposition of iron pentacarbonyl. production with GRAS ingredients or It occurs as a dark gray powder. When may be fixed for further immobiliza- viewed under a microscope, it appears tion with either GRAS ingredients or as spheres built up with concentric materials approved under § 173.357 of shells. It is stable in dry air. this chapter. (b) Iron, elemental (carbonyl, elec- (b) The ingredient meets the general trolytic, or reduced) meets the speci- and additional requirements for en- fications of the Food Chemicals Codex, zyme preparations in the Food Chemi- 3d Ed. (1981) (iron, carbonyl, p. 151; cals Codex, 3d Ed. (1981), p. 107, which is iron, electrolytic, pp. 151–152; iron, re- incorporated by reference. Copies are duced; pp. 152–153), which is incor- available from the National Academy porated by reference. Copies are avail- Press, 2101 Constitution Ave. NW., able from the National Academy Press, Washington, DC 20418, or available for 2101 Constitution Ave. NW., Wash- inspection at the Office of the Federal ington, DC 20418, or available for in- Register, 800 North Capitol Street, spection at the Office of the Federal NW., suite 700, Washington, DC 20408. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(1), NW., suite 700, Washington, DC 20408. 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 as a nu- manufacturing practice. The affirma- trient supplement as defined in tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter, with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The ingre- the following current good manufac- dient may also be used in accordance turing practice conditions of use: with section 412(g) of the Federal Food, (1) The ingredient is used as an en- Drug, and Cosmetic Act (the act) (21 zyme, as defined in § 170.3(o)(9) of this U.S.C. 350a(g)) or with regulations pro- chapter, to convert glucose to fructose. mulgated under section 412(a)(2) of the (2) The ingredient is used in high act (21 U.S.C. 350a(2)). fructose corn syrup, at levels not to ex- (d) Prior sanctions for this ingredient ceed current good manufacturing prac- different from the uses established in tice. this section do not exist or have been waived. [48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 1996] [53 FR 16867, May 12, 1988]

§ 184.1375 Iron, elemental. § 184.1386 Isopropyl citrate. (a) Iron, elemental (CAS Reg. No. (a) Isopropyl citrate is a mixture of 7439–89–6) is metallic iron obtained by the mono-, di-, and triisopropyl esters

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of citric acid. It is prepared by available from the National Academy esterifying citric acid with Press, 2101 Constitution Ave. NW., isopropanol. Washington, DC 20418, or may be exam- (b) The Food and Drug Administra- ined at the Center for Food Safety and tion, in cooperation with the National Applied Nutrition’s Library, 200 C St. Academy of Sciences, is developing SW., Washington, DC, or at the Office food-grade specifications for isopropyl of the Federal Register, 800 North Cap- citrate. In the interim, this ingredient itol St. NW., suite 700, Washington, DC. must be of a purity suitable for its in- (c) In accordance with § 184.1(b)(1), tended use. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitations other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe as a direct human food tion of this ingredient as generally rec- ingredient is based upon the following ognized as safe (GRAS) as a direct current good manufacturing practice human food ingredient is based upon conditions of use: the following current good manufac- (1) The ingredient is used as an en- turing practice conditions of use: zyme, as defined in § 170.3(o)(9) of this (1) The ingredient is used as an anti- chapter, to convert lactose to glucose oxidant as defined in § 170.3(o)(3) of this and galactose. chapter; a sequestrant as defined in (2) The ingredient is used in food at § 170.3(o)(26) of this chapter; and a sol- levels not to exceed current good man- vent and vehicle as defined in ufacturing practice. Current good man- § 170.3(o)(27) of this chapter. ufacturing practice is limited to use of (2) The ingredient is used in mar- this ingredient to reduce the lactose garine in accordance with § 166.110 of content in milk and milk-derived food this chapter; in nonalcoholic beverages products where food standards do not as defined in § 170.3(n)(3) of this chap- preclude such use. ter; and in fats and oils as defined in [61 FR 7704, Feb. 29, 1996] § 170.3(n)(12) of this chapter at levels not to exceed current good manufac- § 184.1388 Lactase enzyme preparation turing practice. from Kluyveromyces lactis. (d) Prior sanctions for this ingredient (a) This enzyme preparation is de- different from the uses established in rived from the nonpathogenic, this section, or different from those set nontoxicogenic yeast Kluyveromyces forth in part 181 of this chapter, do not lactis (previously named Saccharomyces exist or have been waived. lactis). It contains the enzyme Β- [59 FR 63896, Dec. 12, 1994] galactoside galactohydrase (CAS Reg. No. CBS 683), which converts lactose to § 184.1387 Lactase enzyme preparation glucose and galactose. It is prepared from Candida pseudotropicalis. from yeast that has been grown in a (a) This enzyme preparation is de- pure culture fermentation and by using rived from the nonpathogenic, materials that are generally recognized nontoxicogenic yeast C. as safe or are food additives that have pseudotropicalis. It contains the enzyme been approved for this use by the Food lactase (b-D-galactoside and Drug Administration. galactohydrolase, EC 3.2.1.23), which (b) The ingredient meets the general converts lactose to glucose and galac- and additional requirements for en- tose. It is prepared from yeast that has zyme preparations in the Food Chemi- been grown by a pure culture fermenta- cals Codex, 3d Ed. (1981), p. 107–110, tion process. which is incorporated by reference. (b) The ingredient meets the general Copies are available from the National requirements and additional require- Academy Press, 2101 Constitution Ave. ments for enzyme preparations in the NW., Washington, DC 20418, or avail- Food Chemicals Codex, 3d ed. (1981), pp. able for inspection at the Office of the 107–110, which are incorporated by ref- Federal Register, 800 North Capitol erence in accordance with 5 U.S.C. Street, NW., suite 700, Washington, DC 552(a) and 1 CFR part 51. Copies are 20408.

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(c) In accordance with § 184.1(b)(1), § 184.1408 Licorice and licorice deriva- the ingredient is used in food with no tives. limitation other than current good (a)(1) Licorice (glycyrrhiza) root is manufacturing practice. The affirma- the dried and ground rhizome and root tion of this ingredient as generally rec- portions of Glycyrrhiza glabra or other ognized as safe as a direct human food species of Glycyrrhiza. Licorice extract ingredient is based upon the following is that portion of the licorice root that current good manufacturing practice is, after maceration, extracted by boil- conditions of use: ing water. The extract can be further (1) The ingredient is used as an en- purified by filtration and by treatment zyme as defined in §170.3(o)(9) of this with acids and ethyl alcohol. Licorice chapter to convert lactose to glucose extract is sold as a liquid, paste and galactose. (‘‘block’’), or spray-dried powder. (2) The ingredient is used in food at (2) Ammoniated glycyrrhizin is pre- levels not to exceed current good man- pared from the water extract of lico- ufacturing practice. Current good man- rice root by acid precipitation followed ufacturing practice is to use this ingre- by neutralization with dilute ammonia. dient in milk to produce lactase-treat- Monoammonium glycyrrhizinate ed milk, which contains less lactose (C42H61O16NH45H2O, CAS Reg. No. 1407– than regular milk, or lactose-reduced 03–0) is prepared from ammoniated glycyrrhizin by solvent extraction and milk, which contains at least 70 per- separation techniques. cent less lactose than regular milk. (b) The ingredients shall meet the [49 FR 47387, Dec. 4, 1984] following specifications when analyzed: (1) Assay. The glycyrrhizin content of § 184.1400 Lecithin. each flavoring ingredient shall be de- (a) Commercial lecithin is a natu- termined by the method in the Official rally occurring mixture of the Methods of Analysis of the Association phosphatides of choline, ethanolamine, of Official Analytical Chemists, 13th and inositol, with smaller amounts of Ed., §§ 19.136–19.140, which is incor- othe lipids. It is isolated as a gum fol- porated by reference, or by methods lowing hydration of solvent-extracted 19.CO1 through 19.CO4 in the Journal of the Association of Official Analytical soy, safflower, or corn oils. Lecithin is Chemists, 65:471–472 (1982), which are bleached, if desired, by hydrogen per- also incorporated by reference. Copies oxide and benzoyl peroxide and dried of all of these methods are available by heating. from the Association of Official Ana- (b) The ingredient meets the speci- lytical Chemists, 2200 Wilson Blvd., fications of the Food Chemicals Codex, Suite 400, Arlington, VA 22201–3301, or 3d Ed. (1981), pp. 166–167, which is incor- available for inspection at the Office of porated by reference. Copies are avail- the Federal Register, 800 North Capitol able from the National Academy Press, Street, NW., suite 700, Washington, DC 2101 Constitution Ave. NW., Wash- 20408. ington, DC 20418, or available for in- (2) Ash. Not more than 9.5 percent for spection at the Office of the Federal licorice, 2.5 percent for ammoniated Register, 800 North Capitol Street, glycyrrhizin, and 0.5 percent for NW., suite 700, Washington, DC 20408. monoammonium glycyrrhizinate on an (c) In accordance with § 184.1(b)(1), anhydrous basis as determined by the the ingredient is used in food with no method in the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), p. 466, which is incor- manufacturing practice. porated by reference. Copies are avail- (d) Prior sanctions for this ingredient able from the National Academy Press, different from the uses established in 2101 Constitution Ave. NW., Wash- this section do not exist or have been ington, DC 20418, or available for inspection at the Office of the Federal waived. Register, 800 North Capitol Street, [48 FR 51150, Nov. 7, 1983] NW., suite 700, Washington, DC 20408.

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(3) Acid unsoluble ash. Not more than (5) Arsenic (As). Not more than 3 parts 2.5 percent for licorice on an anhydrous per million as determined by the meth- basis as determined by the method in od in the Food Chemicals Codex. 3d Ed. the Food Chemicals Codex, 3d Ed. (1981), p. 464, which is incorporated by (1981), p. 466, which is incorporated by reference. reference. (c) In accordance with § 184.1(b)(2), (4) Heavy metals (as Pb). Not more these ingredients are used in food only than 40 parts per million as determined within the following specific limita- by method II in the Food Chemicals tions: Codex, 3d Ed. (1981), p. 512, which is incorporated by reference.

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 limitation other than current good different from the uses established in manufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in this section do not exist or have been [50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989] waived. [48 FR 52442, Nov. 18, 1983] § 184.1409 Ground limestone. (a) Ground limestone consists essen- § 184.1415 Animal lipase. tially (not less than 94 percent) of cal- (a) Animal lipase (CAS Reg. No. 9001– cium carbonate (CaCO3) and is prepared 62–1) is an enzyme preparation obtained by the crushing, grinding, and from edible forestomach tissue of classifying of naturally occurring lime- calves, kids, or lambs, or from animal stone. pancreatic tissue. The enzyme prepara- (b) The ingredient meets the speci- tion may be produced as a tissue prepa- fications of the Food Chemicals Codex, ration or as an aqueous extract. Its 3d Ed. (1981), p. 173, which is incor- characterizing enzyme activity is that porated by reference. Copies are avail- of a triacylglycerol hydrolase (EC able from the National Academy Press, 3.1.1.3). 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the general ington, DC 20418, or available for in- requirements and additional require- spection at the Office of the Federal ments for enzyme preparations in the Register, 800 North Capitol Street, Food Chemicals Codex, 3d ed. (1981), p. NW., suite 700, Washington, DC 20408. 110, which is incorporated by reference (c) In accordance with § 184.1(b)(1), in accordance with 5 U.S.C. 552(a) and 1 the ingredient is used in food with no CFR part 51. Copies are available from

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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 Office ognized as safe as a direct human food of Premarket Approval (HFS–200), Food ingredient is based upon the following and Drug Administration, 200 C St., current good manufacturing practice SW., Washington, DC, and the Office of conditions of use: the Federal Register, 800 North Capitol (1) The ingredient is used as an en- St., NW., suite 700, Washington, DC. zyme as defined in § 170.3(o)(9) of this (c) In accordance with § 184.1(b)(1), chapter for the interesterification of the ingredient is used in food with no fats and oils. limitation other than current good (2) The ingredient is used in food at manufacturing practice. The affirma- levels not to exceed current good man- tion of this ingredient as GRAS as a di- ufacturing practice. rect food ingredient is based upon the [63 FR 24419, May 4, 1998] following current good manufacturing practice conditions of use: § 184.1425 Magnesium carbonate. (1) The ingredient is used as an en- (a) Magnesium carbonate (molecular zyme as defined in § 170.3(o)(9) of this formula approximately chapter to hydrolyze fatty acid (MgCO ) ·Mg(OH) ·5H O, CAS Reg. No. glycerides. 3 4 2 2 39409–82–0) is also known as magnesium (2) The ingredient is used in food at carbonate hydroxide. It is a white pow- levels not to exceed current good man- der formed either by adding an alkaline ufacturing practice. carbonate (such as sodium carbonate) [60 FR 32911, June 26, 1995] to a solution of magnesium sulfate or by carbonation of a slurry of magne- § 184.1420 Lipase enzyme preparation sium hydroxide followed by boiling of derived from Rhizopus niveus. the resulting magnesium carbonate. (a) Lipase enzyme preparation con- (b) The ingredient meets the speci- tains lipase enzyme (CAS Reg. No. fications of the Food Chemicals Codex, 9001–62–1), which is obtained from the 3d Ed. (1981), p. 177, which is incor- culture filtrate resulting from a pure porated by reference. Copies are avail- culture fermentation of a nonpatho- able from the National Academy Press, genic and nontoxigenic strain of 2101 Constitution Ave. NW., Wash- Rhizopus niveus. The enzyme prepara- ington, DC 20418, or available for in- tion also contains diatomaceous earth spection at the Office of the Federal as a carrier. The characterizing activ- Register, 800 North Capitol Street, ity of the enzyme, which catalyzes the NW., suite 700, Washington, DC 20408. interesterification of fats and oils at (c) In accordance with § 184.1(b)(1), the 1- and 3-positions of triglycerides, the ingredient is used in food with no is triacylglycerol lipase (EC 3.1.1.3). limitation other than current good (b) The ingredient meets the general manufacturing practice. The affirma- requirements and additional require- tion of this ingredient as generally rec- ments for enzyme preparations in the ognized as safe (GRAS) as a direct monograph on Enzyme Preparations in human food ingredient is based upon the ‘‘Food Chemicals Codex,’’ 4th ed. the following current good manufac- (1996), pp. 133 and 134, which is incor- turing practice conditions of use: porated by reference in accordance (1) The ingredient is used as an with 5 U.S.C. 552(a) and 1 CFR part 51. anticaking and free-flow agent as de- Copies are available from the National fined in § 170.3(o)(1) of this chapter; a Academy Press, 2101 Constitution Ave. flour treating agent as defined in NW., Washington, DC 20418, or may be § 170.3(o)(13) of this chapter; a lubricant examined at the Center for Food Safety and release agent as defined in and Applied Nutrition’s Library, 200 C § 170.3(o)(18) of this chapter; a nutrient St. SW., Washington, DC, or the Office supplement as defined in § 170.3(o)(20) of of the Federal Register, 800 North Cap- this chapter; a pH control agent as de- itol St. NW., suite 700, Washington, DC. fined in § 170.3(o)(23) of this chapter; a (c) In accordance with § 184.1(b)(1), processing aid as defined in § 170.3(o)(24) the ingredient is used in food with no of this chapter; and a synergist as de- limitation other than current good fined in § 170.3(o)(31) of this chapter.

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(2) The ingredient is used in foods at § 184.1428 Magnesium hydroxide. levels not to exceed current good man- (a) Magnesium hydroxide (Mg(OH) ufacturing practice. 2, CAS Reg. No. 1309–42–8) occurs natu- (d) Prior sanctions for this ingredient rally as the colorless, crystalline min- different from the uses established in eral brucite. It is prepared as a white this section do not exist or have been precipitate by the addition of sodium waived. hydroxide to a water soluble magne- [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, sium salt or by hydration of reactive 1985] grades of magnesium oxide. (b) The ingredient meets the speci- § 184.1426 Magnesium chloride. fications of the Food Chemicals Codex, (a) Magnesium chloride (MgC12·6H2O, 3d Ed. (1981), p. 178, which is incor- CAS Reg. No. 7786–30–3) is a colorless, porated by reference. Copies are avail- deliquescent, crystalline material that able from the National Academy Press, occurs naturally as the mineral 2101 Constitution Ave. NW., Wash- bischofite. It is prepared by dissolving ington, DC 20418, or available for in- magnesium oxide, hydroxide, or car- spection at the Office of the Federal bonate in aqueous hydrochloric acid so- Register, 800 North Capitol Street, lution and crystallizing out magnesium NW., suite 700, Washington, DC 20408. chloride hexahydrate. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fications of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), p. 177, which is incor- manufacturing practice. The affirma- porated by reference. Copies are avail- tion of this ingredient as generally rec- able from the National Academy Press, ognized as safe (GRAS) as a direct 2101 Constitution Ave. NW., Wash- human food ingredient is based upon ington, DC 20418, or available for in- the following current good manufac- spection at the Office of the Federal turing practice conditions of use: Register, 800 North Capitol Street, (1) The ingredient is used as a nutri- NW., suite 700, Washington, DC 20408. ent supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter; a pH con- the ingredient is used in food with no trol agent as defined in § 170.3(o)(23) of limitation other than current good this chapter; and a processing aid as manufacturing practice. The affirma- defined in § 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 fla- this section do not exist or have been voring agent and adjuvant as defined in waived. § 170.3(o)(12) of this chapter and a nutri- [50 FR 13559, Apr. 5, 1985, as amended at 64 ent supplement as defined in FR 405, Jan. 5, 1999] § 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at § 184.1431 Magnesium oxide. levels not to exceed current good man- (a) Magnesium oxide (MgO, CAS Reg. ufacturing practice. The ingredient No. 1309–48–4) occurs naturally as the also may be used in infant formula in colorless, crystalline mineral periclase. accordance with section 412(g) of the It is produced either as a bulky white Federal Food, Drug, and Cosmetic Act powder (light) or a relatively dense (the act) or with regulations promul- white powder (heavy) by heating mag- gated under section 412(a)(2) of the act. nesium hydroxide or carbonate. Heat- (d) Prior sanctions for this ingredient ing these magnesium salts under mod- different from the uses established in erate conditions (400° to 900 °C for a few this section do not exist or have been hours) produces light magnesium waived. oxide. Heating the salts under more [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, rigorous conditions (1200 °C for 12 1985] hours) produces heavy magnesium

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oxide. Light magnesium oxide is con- Magnesium phosphate, tribasic verted to heavy magnesium oxide by (Mg3(PO4)2·xH2O, CAS Reg. No. 7727– sustained heating at high tempera- 0987–091) may contain 4, 5, or 8 mol- tures. ecules of water of hydration. It is pro- (b) The ingredient meets the speci- duced as a precipitate from a solution fications of the Food Chemicals Codex, of magnesite with phosphoric acid. 3d Ed. (1981), p. 178, which is incor- (b) Magnesium phosphate, dibasic, porated by reference. Copies are avail- meets the specifications of the Food able from the National Academy Press, Chemicals Codex, 3d Ed. (1981), p. 179, 2101 Constitution Ave. NW., Wash- which is incorporated by reference. ington, DC 20418, or available for in- Magnesium phosphate, tribasic, meets spection at the Office of the Federal the specifications of the Food Chemi- Register, 800 North Capitol Street, cals Codex, 3d Ed. (1981), p. 180, which is NW., suite 700, Washington, DC 20408. incorporated by reference. Copies are (c) In accordance with § 184.1(b)(1), available from the National Academy the ingredient is used in food with no Press, 2101 Constitution Ave. NW., limitation other than current good Washington, DC 20418, or available for manufacturing practice. The affirma- inspection at the Office of the Federal tion of this ingredient as generally rec- Register, 800 North Capitol Street, ognized as safe (GRAS) as a direct NW., suite 700, Washington, DC 20408. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as an manufacturing practice. The affirma- anticaking and free-flow agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(1) of this chapter; a ognized as safe (GRAS) as a direct firming agent as defined in § 170.3(o)(10) human food ingredient is based upon of this chapter; a lubricant and release the following current good manufac- agent as defined in § 170.3(o)(18) of this turing practice conditions of use: chapter; a nutrient supplement as de- (1) The ingredient is used as a nutri- fined in § 170.3(o)(20) of this chapter; ent supplement as defined in and a pH control agent as defined in § 170.3(o)(23) of this chapter. § 170.3(o)(20) of this chapter and a pH (2) The ingredient is used in foods at control agent as defined in § 170.3(o)(23) levels not be exceed current good man- of this chapter. ufacturing practice. The ingredient (2) The ingredient is used in foods at also may be used in infant formula in levels not to exceed current good man- accordance with section 412(g) of the ufacturing practice. The ingredient Federal Food, Drug, and Cosmetic Act also may be used in infant formula in (the act) or with regulations promul- accordance with section 412(g) of the gated under section 412(a)(2) of the act. Federal Food, Drug, and Cosmetic Act (d) Prior sanctions for this ingredient (the act) or with regulations promul- different from the uses established in gated under section 412(a)(2) of the Act. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in this section do not exist or have been [50 FR 13559, Apr. 5, 1985] waived. § 184.1434 Magnesium phosphate. [50 FR 13560, Apr. 5, 1985] (a) Magnesium phosphate includes both magnesium phosphate, dibasic, § 184.1440 Magnesium stearate. and magnesium phosphate, tribasic. (a) Magnesium stearate Magnesium phosphate, dibasic (Mg(C17H34COO)2, CAS Reg. No. 557–04–0) (MgHPO4·3H2O, CAS Reg. No. 7782–0975– is the magnesium salt of stearic acid. 094) occurs naturally as the white, It is produced as a white precipitate by crystalline mineral newberyite. It is the addition of an aqueous solution of prepared commercially as a precipitate magnesium chloride to an aqueous so- formed by treating a solution of mag- lution of sodium stearate derived from nesium sulfate with disodium phos- stearic acid that is obtained from edi- phate under controlled conditions. ble sources and that conforms to the

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requirements of § 172.860(b)(2) of this ognized as safe (GRAS) as a direct chapter. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 182, which is incor- (1) The ingredient is used as a flavor porated by reference. Copies are avail- enhancer as defined in § 170.3(o)(11) of able from the National Academy Press, this chapter; a nutrient supplement as 2101 Constitution Ave. NW., Wash- defined in § 170.3(o)(20) of this chapter; ington, DC 20418, or available for in- and a processing aid as defined in spection at the Office of the Federal Register, 800 North Capitol Street, § 170.3(o)(24) of this chapter. NW., suite 700, Washington, DC 20408. (2) The ingredient is used in foods 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 (d) Prior sanctions for this ingredient manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon the following current good manufac- [50 FR 13560, Apr. 5, 1985] turing practice conditions of use: (1) The ingredient is used as a lubri- § 184.1443a Malt. cant and release agent as defined in (a) Malt is an enzyme preparation ob- § 170.3(o)(18) of this chapter; a nutrient tained from barley which has been soft- supplement as defined in § 170.3(o)(20) of ened by a series of steeping operations this chapter; and a processing aid as and germinated under controlled condi- defined in § 170.3(o)(24) of this chapter. tions. It is a brown, sweet, and viscous (2) The ingredient is used in foods at liquid or a white to tan powder. Its levels not to exceed current good man- characterizing enzyme activities are a- ufacturing practice. amylase (EC 3.2.1.1.) and b-amylase (EC (d) Prior sanctions for this ingredient 3.2.1.2). 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 for enzyme preparations in the [50 FR 13560, Apr. 5, 1985] Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference § 184.1443 Magnesium sulfate. in accordance with 5 U.S.C. 552(a) and 1 (a) Magnesium sulfate (MgSO4·7H2O, CFR part 51. Copies are available from CAS Reg. No. 10034–99–8) occurs natu- the National Academy Press, 2101 Con- rally as the mineral epsomite. It is pre- stitution Ave., NW., Washington, DC pared by neutralization of magnesium 20418, or may be examined at the Office oxide, hydroxide, or carbonate with of Premarket Approval (HFS–200), Food sulfuric acid and evaporating the solu- and Drug Administration, 200 C St., tion to crystallization. SW., Washington, DC, and the Office of (b) The ingredient meets the speci- the Federal Register, 800 North Capitol fications of the Food Chemicals Codex, St., NW., suite 700, Washington, DC. 3d Ed. (1981), p. 183, which is incorporated 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 Ave. NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. The affirma- spection at the Office of the Federal tion of this ingredient as GRAS as a di- Register, 800 North Capitol Street, rect food ingredient is based upon the NW., suite 700, Washington, DC 20408. following current good manufacturing (c) In accordance with § 184.1(b)(1), practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as an en- limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. The affirma- chapter to hydrolyze starch or starch- tion of this ingredient as generally rec- derived polysaccharides.

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(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. [48 FR 51911, Nov. 15, 1983; as amended at 60 [60 FR 32911, June 26, 1995] FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, 1998] § 184.1444 Maltodextrin. § 184.1445 Malt syrup (malt extract). (a) Maltodextrin ((C H O ) CAS 6 10 5 n, (a) Malt is the product of barley Reg. No. 9050–36–6) is a nonsweet nutri- (Hordeum vulgare L.) germinated under tive saccharide polymer that consists controlled conditions. Malt syrup and of D-glucose units linked primarily by malt extract are interchangeable terms a-1-4 bonds and that has a dextrose for a viscous concentrate of water ex- equivalent (D.E.) of less than 20. It is tract of germinated barley grain, with prepared as a white powder or con- or without added safe preservative. centrated solution by partial hydrol- Malt syrup is usually a brown, sweet, ysis of corn starch, potato starch, or and viscous liquid containing varying rice starch with safe and suitable acids amounts of amylolytic enzymes and and enzymes. plant constituents. Barley is first soft- (b)(1) Maltodextrin derived from corn ened after cleaning by steeping oper- starch must be of a purity suitable for ations and then allowed to germinate its intended use. under controlled conditions. The ger- (2) Maltodextrin derived from potato minated grain then undergoes proc- starch meets the specifications of the essing, such as drying, grinding, ex- Food Chemicals Codex, 3d ed., 3d supp. tracting, filtering, and evaporating, to (1992), p. 125, which are incorporated by produce malt syrup (malt extract) with reference in accordance with 5 U.S.C. 75 to 80 percent solids or dried malt 552(a) and 1 CFR part 51. Copies are syrup with higher solids content. available from the National Academy (b) FDA is developing food-grade Press, 2101 Constitution Ave., NW., specifications for malt syrup (malt ex- Washington, DC 20418, or may be exam- tract) in cooperation with the National ined at the Office of the Federal Reg- Academy of Sciences. In the interim, ister, 800 North Capital St. NW., suite the ingredient must be of a purity suit- 700, Washington, DC 20408, or at the Di- able for its intended use. vision of Petition Control (HFS–217), (c) In accordance with § 184.1(b)(1), Center for Food Safety and Applied Nu- the ingredient is used in food with no trition, Food and Drug Administration, limitation other than current good 5100 Paint Branch Pkwy., College Park, manufacturing practice. The affirma- MD 20740. tion of this ingredient as generally rec- (3) Maltodextrin derived from rice ognized as safe (GRAS) as a direct starch meets the specifications of the human food ingredient is based upon Food Chemicals Codex, 4th ed. (1996), the following current good manufac- pp. 239 and 240, which is incorporated turing practice conditions of use: by reference in accordance with 5 (1) The ingredient is used as a fla- U.S.C. 552(a) and 1 CFR part 51. Copies voring agent and adjuvant as defined in are available from the National Acad- § 170.3(o)(12) of this chapter. emy Press, 2101 Constitution Ave. NW., (2) The ingredient is used in food at Washington, DC 20418, or may be exam- levels not to exceed current good man- ined at the Center for Food Safety and ufacturing practice. Applied Nutrition’s Library, 200 C St. (d) Prior sanctions for this ingredient SW., Washington, DC, or at the Office different from the uses established in of the Federal Register, 800 North Cap- this section do not exist or have been itol St. NW., suite 700, Washington, DC. waived. (c) In accordance with § 184.1(b)(1), [48 FR 51613, Nov. 10, 1983] the ingredient is used in food with no limitation other than current good § 184.1446 Manganese chloride.

manufacturing practice. (a) Manganese chloride (MnCl2·4H2O, (d) Prior sanctions for this ingredient CAS Reg. No. 7773–01–5) is a pink, different from the uses established in translucent, crystalline product. It is

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also known as manganese dichloride. It (c) In accordance with § 184.1(b)(1), is prepared by dissolving manganous the ingredient is used in food with no oxide, pyrolusite ore (MnO2), or re- limitation other than current good duced manganese ore in hydrochloric manufacturing practice. The affirma- acid. The resulting solution is neutral- tion of this ingredient as generally rec- ized to precipitate heavy metals, fil- ognized as safe (GRAS) as a direct tered, concentrated, and crystallized. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 186, which is incor- (1) The ingredient is used as a nutri- porated by reference. Copies are avail- ent supplement as defined in able from the National Academy Press, § 170.3(o)(20) of this chapter. 2101 Constitution Ave. NW., Wash- (2) The ingredient is used in the fol- ington, DC 20418, or available for in- lowing foods at levels not to exceed spection at the Office of the Federal current good manufacturing practice: Register, 800 North Capitol Street, baked goods as defined in § 170.3(n)(1) of NW., suite 700, Washington, DC 20408. this chapter; nonalcoholic beverages as (c) In accordance with § 184.1(b)(1), defined in § 170.3(n)(3) of this chapter; the ingredient is used in food with no dairy product analogs as defined in limitation other than current good § 170.3(n)(10) of this chapter; fish prod- manufacturing practice. The affirma- ucts as defined in § 170.3(n)(13) of this tion of this ingredient as generally rec- chapter; meat products as defined in ognized as safe (GRAS) as a direct § 170.3(n)(29) of this chapter; milk prod- human food ingredient is based upon ucts as defined in § 170.3(n)(31) of this the following current good manufac- chapter; and poultry products as de- turing practice conditions of use: fined in § 170.3(n)(34) of this chapter. (1) The ingredient is used as a nutri- The ingredient may be used in infant ent supplement as defined in formulas in accordance with section § 170.3(o)(20) of this chapter. 412(g) of the Federal Food, Drug, and (2) The ingredient may be used in in- Cosmetic Act (the act) or with regula- fant formulas in accordance with sections promulgated under section tion 412(g) of the Federal Food, Drug, 412(a)(2) of the act. and Cosmetic Act (the act) or with reg- (d) Prior sanctions for this ingredient ulations promulgated under section different from the uses established in 412(a)(2) of the act. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [50 FR 19166, May 7, 1985] this section do not exist or have been waived. § 184.1452 Manganese gluconate. [50 FR 19165, May 7, 1985] (a) Manganese gluconate (C12H22MnO14·2H2O, CAS Reg. No. 648– § 184.1449 Manganese citrate. 0953–0998) is a slightly pink colored (a) Manganese citrate (Mn3(C6H5O7)2, powder. It is obtained by reacting man- CAS Reg. No. 1002–46–65) is a pale or- ganese carbonate with gluconic acid in ange or pinkish white powder. It is ob- aqueous medium and then crystallizing tained by precipitating manganese car- the product. bonate from manganese sulfate and so- (b) The ingredient meets the speci- dium carbonate solutions. The filtered fications of the Food Chemicals Codex, and washed precipitate is digested first 3d Ed. (1981), p. 186, which is incor- with sufficient citric acid solution to porated by reference. Copies are avail- form manganous citrate and then with able from the National Academy Press, sodium citrate to complete the reac- 2101 Constitution Ave. NW., Wash- tion. ington, DC 20418, or available for in- (b) FDA is developing food-grade spection at the Office of the Federal specifications for manganese citrate in Register, 800 North Capitol Street, cooperation with the National Acad- NW., suite 700, Washington, DC 20408. emy of Sciences. In the interim, this (c) In accordance with § 184.1(b)(1), ingredient must be of purity suitable the ingredient is used in food with no for its intended use. limitation other than current good

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manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The affirma- the following current good manufac- tion of this ingredient as generally rec- turing practice conditions of use: ognized as safe (GRAS) as a direct (1) The ingredient is used as a nutri- human food ingredient is based upon ent supplement as defined in the following current good manufac- § 170.3(o)(20) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used as a nutri- lowing foods at levels not to exceed ent supplement as defined in current good manufacturing practice: § 170.3(o)(20) of this chapter. baked goods as defined in § 170.3(n)(1) of (2) The ingredient is used in the fol- this chapter; nonalcoholic beverages as lowing foods at levels not to exceed defined in § 170.3(n)(3) of this chapter; current good manufacturing practice: 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 chapter; meat products as defined in defined in § 170.3(n)(3) of this chapter; § 170.3(n)(29) of this chapter; milk prod- dairy product analogs as defined in ucts as defined in § 170.3(n)(31) of this § 170.3(n)(10) of this chapter; fish prod- chapter; and poultry products as de- ucts as defined in § 170.3(n(13) of this fined in § 170.3(n)(34) of this chapter. chapter; meat products as defined in The ingredient may be used in infant § 170.3(n)(29) of this chapter; milk prod- formulas in accordance with section ucts as defined in § 170.3(n)(31) of this 412(g) of the Federal Food, Drug, and chapter; and poultry products as de- Cosmetic Act (the act) or with regula- fined in § 170.3(n)(34) of this chapter. tions promulgated under section The ingredient may be used in infant 412(a)(2) of the act. formulas in accordance with section (d) Prior sanctions for this ingredient 412(g) of the Federal Food, Drug, and different from the uses established in Cosmetic Act (the act) or with regula- this section do not exist or have been tions promulgated under section waived. 412(a)(2) of the act. [50 FR 19166, May 7, 1985] (d) Prior sanctions for this ingredient different from the uses established in § 184.1461 Manganese sulfate. this section do not exist or have been waived. (a) Manganese sulfate (MnSO4·H2O, CAS Reg. No. 7785–0987–097) is a pale [50 FR 19166, May 7, 1985] pink, granular, odorless powder. It is obtained by reacting manganese com- § 184.1472 Menhaden oil. pounds with sulfuric acid. It is also obtained as a byproduct in the manufac- (a) Menhaden oil. (1) Menhaden oil is ture of hydroquinone. Other manufac- prepared from fish of the genus turing processes include the action of Brevoortia, commonly known as menha- sulfur dioxide on a slurry of manganese den, by cooking and pressing. The re- dioxide in sulfuric acid, and the roast- sulting crude oil is then refined using the following steps: Storage (winteriza- ing of pyrolusite (MnO2) ore with solid ferrous sulfate and coal, followed by tion), degumming (optional), neutral- leaching and crystallization. ization, bleaching, and deodorization. (b) The ingredient meets the speci- Winterization may separate the oil and fications of the Food Chemicals Codex, produce a solid fraction. 3d Ed. (1981), p. 188, which is incor- (2) Menhaden oil meets the following porated by reference. Copies are avail- specifications: able from the National Academy Press, (i) Color and state. Yellow liquid to 2101 Constitution Ave. NW., Wash- white solid. ington, DC 20418, or available for in- (ii) Odor. Odorless to slightly fishy. spection at the Office of the Federal (iii) Saponification value. Between 180 Register, 800 North Capitol Street, and 200 as determined by the American NW., suite 700, Washington, DC 20408. Oil Chemists’ Society Official Method

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Cd 3–25—‘‘Saponification Value’’ (re- The availability of this incorporation approved 1989), which is incorporated by reference is given in paragraph by reference in accordance with 5 (a)(2)(iii) of this section. U.S.C. 552(a) and 1 CFR part 51. Copies (viii) Lead. Not more than 0.1 part of this publication are available from per million as determined by the Amer- the Office of Premarket Approval, Cen- ican Oil Chemists’ Society Official ter for Food Safety and Applied Nutri- Method Ca 18c–91—‘‘Determination of tion (HFS–200), Food and Drug Admin- Lead by Direct Graphite Furnace istration, 5100 Paint Branch Pkwy., Atomic Absorption Spectrometry’’ (re- College Park, MD 20740, or available for vised 1992), which is incorporated by inspection at the Center for Food Safe- reference in accordance with 5 U.S.C. ty and Applied Nutrition’s Library, 552(a) and 1 CFR part 51. The avail- Food and Drug Administration, 200 C ability of this incorporation by ref- St. SW., Washington DC, or at the Of- erence is given in paragraph (a)(2)(iii) fice of the Federal Register, 800 North of this section. Capitol St. NW., suite 700, Washington, (ix) Mercury. Not more than 0.5 part DC. per million as determined by the meth- (iv) Iodine number. Not less than 120 od entitled ‘‘Biomedical Test Materials as determined by the American Oil Program: Analytical Methods for the Chemists’ Society Recommended Prac- Quality Assurance of Fish Oil,’’ pub- tice Cd 1d–92—‘‘Iodine Value of Fats lished in the ‘‘NOAA Technical Memo- and Oils, Cyclohexane—Acetic Acid randum NMFS–SEFC–211,’’ F. M. Van Method,’’ which is incorporated by ref- Dolah and S. B. Galloway, editors, Na- erence in accordance with 5 U.S.C. tional Marine Fisheries Service, U. S. 552(a) and 1 CFR part 51. The avail- Department of Commerce, pages 71–88, ability of this incorporation by ref- November, 1988, which is incorporated erence is given in paragraph (a)(2)(iii) by reference in accordance with 5 of this section. U.S.C. 552(a) and 1 CFR part 51. The (v) Unsaponifiable matter. Not more availability of this incorporation by than 1.5 percent as determined by the reference is given in paragraph American Oil Chemists’ Society Offi- (a)(2)(iii) of this section. cial Method Ca 6b–53—‘‘Unsaponifiable (3) In accordance with § 184.1(b)(2), Matter’’ (reapproved 1989), which is in- the ingredient may be used in food only corporated by reference in accordance within the following specific limita- with 5 U.S.C. 552(a) and 1 CFR part 51. tions: The availability of this incorporation Maximum level of use by reference is given in paragraph Category of food in food (as served) (a)(2)(iii) of this section. (vi) Free fatty acids. Not more than 0.1 Cookies, crackers, ¤ 170.3(n)(1) of 5.0 percent this chapter . percent as determined by the American Breads, rolls (white & dark), 1.0 percent Oil Chemists’ Society Official Method ¤ 170.3(n)(1) of this chapter . Ca 5a–40—‘‘Free Fatty Acids’’ (re- Fruit pies, custard pies, ¤ 170.3(n)(1) 7.0 percent approved 1989), which is incorporated of this chapter . Cakes, ¤ 170.3(n)(1) of this chapter .. 10.0 percent by reference in accordance with 5 Cereals, ¤ 170.3(n)(4) of this chapter 4.0 percent U.S.C. 552(a) and 1 CFR part 51. The Fats, oils, ¤ 170.3(n)(12) of this chap- 20.0 percent availability of this incorporation by ter, but not in infant formula . Yogurt, ¤ 170.3(n)(31) of this chapter 4.0 percent reference is given in paragraph Cheese products, ¤ 170.3(n)(5) of 5.0 percent (a)(2)(iii) of this section. this chapter . (vii) Peroxide value. Not more than 5 Frozen dairy products, ¤ 170.3(n)(20) 5.0 percent milliequivalents per kilogram of oil as of this chapter . Meat products, ¤ 170.3(n)(29) of this 10.0 percent determined by the American Oil Chem- chapter . ists’ Society Official Method Cd 8–53— Egg products, ¤ 170.3(n)(11) of this 5.0 percent ‘‘Peroxide Value, Acetic Acid—Chloro- chapter . Fish products, ¤ 170.3(n)(13) of this 20.0 percent form Method’’ (updated 1992) or Rec- chapter . ommended Practice Cd 8b–90—‘‘Per- Condiments, ¤ 170.3(n)(8) of this 5.0 percent oxide Value, Acetic Acid—Isooctane chapter . Method’’ (updated 1992), which are in- Soup mixes, ¤ 170.3(n)(40) of this 3.0 percent chapter . corporated by reference in accordance Snack foods, ¤ 170.3(n)(37) of this 5.0 percent with 5 U.S.C. 552(a) and 1 CFR part 51. chapter .

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Maximum level of use § 184.1490 Methylparaben. Category of food in food (as served) (a) Methylparaben is the chemical Nut products, ¤ 170.3(n)(32) of this 5.0 percent methyl p-hydroxybenzoate. It is pro- chapter . Gravies, sauces, ¤ 170.3(n)(24) of 5.0 percent duced by the methanol esterification of this chapter . p-hydroxybenzoic acid in the presence of sulfuric acid, with subsequent dis- (b) Hydrogenated and partially hydro- tillation. genated menhaden oils. (1) Partially hy- (b) The ingredient meets the speci- drogenated and hydrogenated menha- fications of the ‘‘Food Chemicals den oils are prepared by feeding hydro- Codex,’’ 3d Ed. (1981), p. 199, which is in- gen gas under pressure to a converter corporated by reference. Copies may be containing crude menhaden oil and a obtained from the National Academy nickel catalyst. The reaction is begun Press, 2101 Constitution Ave. NW., at 150 to 160 cC and after 1 hour the Washington, DC 20418, or may be exam- temperature is raised to 180 cC until ined at the Office of the Federal Reg- the desired degree of hydrogenation is ister, 800 North Capitol Street, NW., reached. Hydrogenated menhaden oil is suite 700, Washington, DC 20408. fully hydrogenated. (c) The ingredient is used as an anti- (2) Partially hydrogenated and hy- microbial agent as defined in drogenated menhaden oils meet the fol- § 170.3(o)(2) of this chapter. lowing specifications: (d) The ingredient is used in food at (i) Color. Opaque white solid. levels not to exceed good manufac- (ii) Odor. Odorless. turing practices. Current good manu- (iii) Saponification value. Between 180 facturing practice results in a max- and 200. imum level of 0.1 percent in food. (iv) Iodine number. Not more than 119 (e) Prior sanctions for this ingredient for partially hydrogenated menhaden different from the uses established in oil and not more than 10 for fully hy- this regulation do not exist or have drogenated menhaden oil. been waived. (v) Unsaponifiable matter. Not more than 1.5 percent.– [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984] (vi) Free fatty acids. Not more than 0.1 percent. § 184.1498 Microparticulated protein (vii) Peroxide value. Not more than 5 product. milliequivalents per kilogram of oil. (a) Microparticulated protein product (viii) Nickel. Not more than 0.5 part is prepared from egg whites or milk per million. protein or a combination of egg whites (ix) Mercury. Not more than 0.5 part and milk protein. These protein per million. sources may be used alone or in com- (x) Arsenic (as As). Not more than 0.1 bination with other safe and suitable part per million. ingredients to form the (xi) Lead. Not more than 0.1 part per microparticulated product. The mix- million. ture of ingredients is high-shear heat (3) Partially hydrogenated and hy- processed to achieve a smooth and drogenated menhaden oils are used as creamy texture similar to that of fat. edible fats or oils, as defined in Safe and suitable ingredients used in § 170.3(n)(12) of this chapter, in food at the preparation of the levels not to exceed current good man- microparticulated protein product ufacturing practice. must be used in compliance with the (4) If the fat or oil is fully hydro- limitations of the appropriate regula- genated, the name to be used on the tions in parts 172, 182, and 184 of this label of a product containing it shall chapter. include the term ‘‘hydrogenated,’’ or if (b) The ingredient is used in food in it is partially hydrogenated, the name accordance with § 184.1(b)(2) at levels shall include the term ‘‘partially hy- not to exceed current good manufac- drogenated,’’ in accordance with turing practice. The affirmation of the § 101.4(b)(14) of this chapter. use of this ingredient as generally rec- [62 FR 30756, June 5, 1997] ognized as safe (GRAS) as a direct

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human food ingredient is based upon limitation other than current good the following conditions of use: manufacturing practice. The affirma- (1) The ingredient is used in food as a tion of this ingredient as generally rec- thickener as defined in § 170.3(o)(28) of ognized as safe (GRAS) as a direct this chapter or as a texturizer as de- human food ingredient is based upon fined in § 170.3(o)(32) of this chapter. the following current good manufac- (2) The ingredient is used in frozen turing practice conditions of use: dessert-type products except that the (1) The ingredient is used in food as a ingredient may not be used to replace dough strengthener as defined in the milk fat required in standardized § 170.3(o)(6) of this chapter; an emulsi- frozen desserts. fier and emulsifier salt as defined in (3) The name of the ingredient used § 170.3(o)(8) of this chapter; a flavoring in the ingredient statement on both agent and adjuvant as defined in bulk and packaged food must include § 170.3(o)(12) of this chapter; a formula- the source of the protein (e.g., tion aid as defined in § 170.3(o)(14) of ‘‘microparticulated egg white pro- this chapter; a lubricant and release tein’’), followed by a parenthetical list- agent as defined in § 170.3(o)(18) of this ing of each of the ingredients in the chapter; a solvent and vehicle as de- microparticulated protein product, in fined in § 170.3(o)(27) of this chapter; a descending order of predominance. stabilizer and thickener as defined in Microparticulated protein product § 170.3(o)(28) of this chapter; a surface- must be used in accordance with this active agent as defined in §170.3(o)(29) requirement or its addition to food will of this chapter; a surface-finishing be considered by FDA to constitute the agent as defined in § 170.3(o)(30) of this use of an unapproved food additive (see chapter; and a texturizer as defined in § 184.1(b)(2)). § 170.3(o)(32) of this chapter. [55 FR 6391, Feb. 23, 1990] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1505 Mono- and diglycerides. ufacturing practice. (a) Mono- and diglycerides consist of (d) Prior sanctions for this ingredient a mixture of glyceryl mono- and different from the uses established in diesters, and minor amounts of this section do not exist or have been triesters, that are prepared from fats waived. or oils or fat-forming acids that are de- [54 FR 7403, Feb. 21, 1989, as amended at 57 rived from edible sources. The most FR 10616, Mar.27, 1992] prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic, and § 184.1521 Monosodium phosphate de- stearic. Mono- and diglycerides are rivatives of mono- and diglycerides. manufactured by the reaction of glyc- (a) Monosodium phophate derivatives erin with fatty acids or the reaction of of mono- and diglycerides are com- glycerin with triglycerides in the pres- posed of glyceride derivatives formed ence of an alkaline catalyst. The prod- by reacting mono- and diglycerides ucts are further purified to obtain a that are derived from edible sources mixture of glycerides, free fatty acids, with phosphorus pentoxide and free glycerin that contains at least (tetraphosphorus decoxide) followed by 90 percent-by-weight glycerides. neutralization with sodium carbonate. (b) The ingredient meets the speci- (b) FDA is developing food-grade fications of the Food Chemicals Codex, specifications for monosodium phos- 3d Ed. (1981), p. 201, which is incor- phate mono- and diglycerides in co- porated by reference in accordance operation with the National Academy with 5 U.S.C. 552(a). Copies are avail- of Sciences. In the interim, this ingre- able from the National Academy Press, dient must be of a purity suitable for 2101 Constitution Ave. NW., Wash- its intended use. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the Office of the Federal the ingredient is used in food with no Register, 800 North Capitol Street, limitation other than current good NW., suite 700, Washington, DC 20005. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe (GRAS) as a direct

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human food ingredient is based upon (1) The ingredient is used as a nutri- the following current good manufac- ent supplement as defined in turing practice conditions of use: § 170.3(o)(20) of this chapter. (1) The ingredient is used in food as (2) The ingredient is used in foods at an emulsifier and emulsifier salt as de- levels not to exceed current good man- fined in § 170.3(o)(8) of this chapter, a ufacturing practice. The ingredient lubricant and release agent as defined may also be used in infant formula in in § 170.3(o)(18) of this chapter, and as a accordance with section 412(g) of the surface-active agent as defined in Federal Food, Drug, and Cosmetic Act § 170.3(o)(29) of this chapter. (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (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 dairy product analogs as defined in waived. § 170.3(n)(10) of this chapter and soft candy as defined in § 170.3(n)(38) of this [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. chapter. 2, 1983, as amended at 64 FR 1760, Jan. 12, 1999] (d) Prior sanctions for this ingredient different from the uses established in § 184.1535 Niacinamide. this section do not exist or have been (a) Niacinamide (C H N O, CAS Reg. waived. 6 6 2 No. 98–92–0) is the chemical 3- [54 FR 7404, Feb. 21, 1989] pyridinecarboxylic acid amide (nicotinamide). It is a white crystalline powder § 184.1530 Niacin. that is soluble in water, alcohol, ether, ° (a) Niacin (C H NO CAS Reg. No. 59– and glycerol. It melts between 128 and 6 5 2, ° 67–6) is the chemical 3- 131 C. pyridinecarboxylic acid (nicotinic (b) The ingredient meets the speci- acid). It is a non-hygroscopic, stable, fications of the Food Chemicals Codex, white, crystalline solid that sublimes 3d Ed. (1981), p. 205, which is incorporated by reference. Copies are avail- without decomposition at about 230 °C. able from the National Academy Press, It is soluble in water and alcohol. It is 2101 Constitution Ave. NW., Wash- insoluble in ether. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the Office of the Federal fications of the ‘‘Food Chemicals Register, 800 North Capitol Street, Codex,’’ 4th ed. (1996), p. 264, which is NW., suite 700, Washington, DC 20408. incorporated by reference in accord- (c) In accordance with § 184.1(b)(1), ance with 5 U.S.C. 552(a) and 1 CFR the ingredient is used in food with no part 51. Copies are available from the limitation other than current good National Academy Press, Box 285, 2101 manufacturing practice. The affirma- Constitution Ave. NW., Washington, tion of this ingredient as generally rec- DC 20055 (Internet address ‘‘http:// ognized as safe (GRAS) as a direct www.nap.edu’’), or may be examined at human food ingredient is based upon the Center for Food Safety and Applied the following current good manufac- Nutrition’s Library, Food and Drug Ad- turing practice conditions of use: ministration, 200 C St. SW., Wash- (1) The ingredient is used as a nutri- ington, DC, or at the Office of the Fed- ent supplement as defined in eral Register, 800 North Capitol St. § 170.3(o)(20) of this chapter. NW., suite 700, Washington, DC. (2) The ingredient is used in foods 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. The ingredient limitation other than current good may also be used in infant formula in manufacturing practice. The affirma- accordance with section 412(g) of the tion of this ingredient as generally rec- Federal Food, Drug, and Cosmetic Act ognized as safe (GRAS) as direct (the act) or with regulations promul- human food ingredient is based upon gated under section 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

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this section do not exist or have been World Health Organization, FAO Nutri- waived. tion Meeting Report Series, No. 45A, 1969, which is incorporated by ref- [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983] erence. Copies are available from the Dockets Management Branch (HFA– § 184.1537 Nickel. 305), Food and Drug Administration, (a) Elemental nickel (CAS Reg. No. rm. 1–23, 12420 Parklawn Dr., Rockville, 7440–02–0) is obtained from nickel ore MD 20857, or available for inspection at by transforming it to nickel sulfide the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, (Ni3S2). The sulfide is roasted in air to give nickel oxide (NiO). The oxide is Washington, DC 20408. then reduced with carbon to give ele- (1) Nisin content, not less than 900 mental nickel. international units per milligram. (b) The Food and Drug Administra- (2) Arsenic, not more than 1 part per tion is developing food-grade specifica- million. tions for nickel in cooperation with the (3) Lead, not more than 2 parts per National Academy of Sciences. In the million. interim, this ingredient must be of a (4) Zinc, not more than 25 parts per purity suitable for its intended use. million. (c) In accordance with § 184.1(b)(1), (5) Copper, zinc plus copper not more the ingredient is used in food with no than 50 parts per million. limitation other than current good (6) Total plate count, not more than manufacturing practice. The affirma- 10 per gram. tion of this ingredient as generally rec- (7) Escherichia coli, absent in 10 ognized as safe (GRAS) as a direct grams. human food ingredient is based upon (8) Salmonella, absent in 10 grams. the following current good manufac- (9) Coagulase positive staphylococci, turing practice conditions of use: absent in 10 grams. (1) The ingredient is used as a cata- (c) The ingredient is used as an anti- lyst as defined in § 170.3(o)(24) of this microbial agent as defined in chapter. § 170.3(o)(2) of this chapter to inhibit (2) The ingredient is used in the hy- the outgrowth of Clostridium botulinum drogenation of fats and oils as defined spores and toxin formation in pasteur- in § 170.3(n)(12) of this chapter at levels ized cheese spreads and pasteurized not to exceed current good manufac- process cheese spreads listed in turing practice. Current good manufac- § 133.175; pasteurized cheese spread with turing practice includes the removal of fruits, vegetables, or meats as defined nickel from fats and oils following hy- in § 133.176; pasteurized process cheese drogenation. spread as defined in § 133.179; pasteur- (d) Prior sanctions for this ingredient ized process cheese spread with fruits, different from the uses established in vegetables, or meats as defined in this section do not exist or have been § 133.180 of this chapter. waived. (d) The ingredient is used at levels not to exceed good manufacturing [48 FR 51618, Nov. 10, 1983] practice in accordance with § 184.1(b)(1) of this chapter. The current good man- § 184.1538 Nisin preparation. ufacturing practice level is the quan- (a) Nisin preparation is derived from tity of the ingredient that delivers a pure culture fermentations of certain maximum of 250 parts per million of strains of Streptococcus lactis nisin in the finished product as deter- Lancefield Group N. Nisin preparation mined by the British Standards Insti- contains nisin (CAS Reg. No. 1414–45–5), tution Methods, ‘‘Methods for the Esti- a group of related peptides with anti- mation and Differentiation of Nisin in biotic activity. Processed Cheese,’’ BS 4020 (1974), (b) The ingredient is a concentrate or which is incorporated by reference. dry material that meets the specifica- Copies are available from the Dockets tions that follow when it is tested as Management Branch (HFA–305), Food described in ‘‘Specifications for Iden- and Drug Administration, rm. 1–23, tity and Purity of Some Antibiotics,’’ 12420 Parklawn Dr., Rockville, MD

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20857, or available for inspection at the must be of a purity suitable for its in- Office of the Federal Register, 800 tended use. North Capitol Street, NW., suite 700, (c) In accordance with § 184.1(b)(1), Washington, DC 20408. the ingredient is used in food with no limitations other than current good [53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994] manufacturing practice. The affirmation of this ingredient as generally rec- § 184.1540 Nitrogen. ognized as safe (GRAS) as a direct human food ingredient is based upon (a) Nitrogen (empirical formula N2, the following current good manufac- CAS Reg. No. 7727–37–9) is a colorless, turing practice conditions of use: odorless, flavorless gas that is pro- (1) The ingredient is used as a propel- duced commercially by the fraction- lant, aerating agent, and gas as defined ation of liquid air. in § 170.3(o)(25) of this chapter. (b) The Food and Drug Administra- (2) The ingredient is used in dairy tion is developing food-grade specifica- product analogs as defined in tions for nitrogen in cooperation with § 170.3(n)(10) of this chapter at levels the National Academy of Sciences. In not to exceed current good manufac- the interim, the ingredient must be of turing practice. a purity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitations other than current good waived. manufacturing practice. The affirmation of this ingredient as generally rec- [48 FR 57270, Dec. 29, 1983] ognized as safe (GRAS) as a direct § 184.1553 Peptones. human food ingredient is based upon the following current good manufac- (a) Peptones are a variable mixture turing practice conditions of use: of polypeptides, oligopeptides, and (1) The ingredient is used as a propel- amino acids that are produced by par- lant, aerating agent, and gas as defined tial hydrolysis of casein, animal tissue, in § 170.3(o)(25) of this chapter. soy protein isolate, gelatin, defatted (2) The ingredient is used in food at fatty tissue, egg albumin, or lactal- levels not to exceed current good man- bumin (whey protein). Peptones are ufacturing practice. produced from these proteins using (d) Prior sanctions for this ingredient proteolytic enzymes that either are different from the uses established in considered to be generally recognized this section do not exist or have been as safe (GRAS) or are regulated as food waived. additives. Peptones are also produced by denaturing any of the proteins list- [48 FR 57270, Dec. 29, 1983] ed in this paragraph with safe and suitable acids or heat. § 184.1545 Nitrous oxide. (b) FDA is developing food-grade (a) Nitrous oxide (empirical formula specifications for peptones in coopera- N2O, CAS Reg. No. 10024–97–2) is also tion with the National Academy of known as dinitrogen monoxide or Sciences. In the interim, these ingredi- laughing gas. It is a colorless gas, ents must be of a purity suitable for about 50 percent heavier than air, with their intended use. a slightly sweet smell. It does not burn (c) In accordance with § 184.1(b)(1), but will support combustion. Nitrous these ingredients are used in food with oxide is manufactured by the thermal no limitation other than current good decomposition of ammonium nitrate. manufacturing practice. The affirma- Higher oxides of nitrogen are removed tion of these ingredients as GRAS as by passing the dry gas through a series direct human food ingredients is based of scrubbing towers. upon the following current good manu- (b) The Food and Drug Administra- facturing practice conditions of use: tion is developing food-grade specifica- (1) These ingredients are used as nu- tions for nitrous oxide in cooperation trient supplements as defined in with the National Academy of § 170.3(o)(20) of this chapter; as proc- Sciences. In the interim, the ingredient essing aids as defined in § 170.3(o)(24) of

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this chapter; and as surface-active cess glycerol to the fully hydrogenated agents as defined in § 170.3(o)(29) of this rapeseed oil and heating, in the pres- chapter. ence of a sodium hydroxide catalyst, to (2) These ingredients are used in food 330 °F under partial vacuum and steam at levels not to exceed current good sparging agitation. manufacturing practice. (2) The ingredient meets the speci- (d) Prior sanctions for these ingredi- fications of the ‘‘Food Chemicals ents different from the uses established Codex,’’ 3d Ed. (1981), p. 201, relating to in this section do not exist or have mono- and diglycerides, which is incor- been waived. porated by reference. Copies may be [49 FR 25430, June 21, 1984, as amended at 50 obtained from the National Academy FR 49536, Dec. 3, 1985] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1555 Rapeseed oil. ined at the Office of the Federal Reg- (a) Fully hydrogenated rapeseed oil. (1) ister, 800 North Capitol Street, NW., Fully hydrogenated rapeseed oil is a suite 700, Washington, DC 20408. An ad- mixture of triglycerides in which the ditional specification requires the io- fatty acid composition is a mixture of dine number to be 4 or less. saturated fatty acids. The fatty acids (3) The ingredient is used as an emul- are present in the same porportions sifier as defined in § 170.3(o)(8) of this which result from the full hydro- chapter in shortenings for cake mixes. genation of fatty acids occurring in The use level of the ingredient is lim- natural rapeseed oil. The rapeseed oil ited by good manufacturing practice is obtained from the napus and (GMP) to the minimum amount re- campestris varieties of Brassica of the quired to produce the intended effect. family Cruciferae. It is prepared by Current good manufacturing practices fully hydrogenating refined and result in a maximum level, as served, bleached rapeseed oil at 310–375 °F, of 4 percent of the shortening or 0.5 using a catalyst such as nickel, until percent of the total weight of the cake the iodine number is 4 or less. mix. (2) The ingredient meets the fol- (c) Low erucic acid rapeseed oil. (1) lowing specifications: Acid value not Low erucic acid rapeseed oil, also more than 6, arsenic not more than 3 known as canola oil, is the fully re- parts per million, free glycerin not fined, bleached, and deodorized edible more than 7 percent, heavy metals (as oil obtained from certain varieties of Pb) not more than 10 parts per million, Brassica Napus or B. Campestris of the iodine number not more than 4, residue family Cruciferae. The plant varieties on ignition not more than 0.5 percent. are those producing oil-bearing seeds (3) The ingredient is used as a sta- with a low erucic acid content. Chemi- bilizer and thickener as defined in cally, low erucic acid rapeseed oil is a § 170.3(o)(28) of this chapter in peanut mixture of triglycerides, composed of butter. The use level of the ingredient both saturated and unsaturated fatty is limited by good manufacturing prac- acids, with an erucic acid content of no tice (GMP) to the minimum amount re- more than 2 percent of the component quired to produce the intended effect. fatty acids. Current good manufacturing practices (2) Low erucic acid rapeseed oil as de- result in a maximum level of 2 percent fined in paragraph (c)(1) of this section in peanut butter. may be partially hydrogenated to re- (b) Superglycerinated fully hydro- duce the proportion of unsaturated genated rapeseed oil. (1) fatty acids. When the partially hydro- Superglycerinated fully hydrogenated genated low erucic acid rapeseed oil is rapeseed oil is a mixture of mono- and used, it shall be referred to as partially diglycerides with triglycerides as a hydrogenated low erucic acid rapeseed minor component. The fatty acid com- oil. position is a mixture of saturated fatty (3) In addition to limiting the con- acids present in the same proportions tent of erucic acid to a level not ex- as those resulting from the full hydro- ceeding 2 percent of the component genation of fatty acids in natural fatty acids, FDA is developing other rapeseed oil. It is made by adding ex- food-grade specifications for low erucic

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acid rapeseed oil and partially hydro- cordance with § 170.30(h)(1) of this chap- genated low erucic acid rapeseed oil in ter. cooperation with the National Acad- (c) In accordance with § 184.1(b)(2), emy of Sciences. In the interim, the in- the ingredient is used to treat food gredients must be of a purity suitable only within the following specific limi- for their intended use. tations: (4) Low erucic acid rapeseed oil and partially hydrogenated low erucic acid Category of food Maximum treat- Functional use rapeseed oil are used as edible fats and ment level in food oils in food, except in infant formula, Bottled water that Not to exceed cur- Antimicrobial at levels not to exceed current good prior to ozonation rent good man- agent, ¤ 170.3 manufacturing practice. meets the micro- ufacturing prac- (o)(2) of this biological, phys- tice. Current chapter. [42 FR 48336, Sept. 23, 1977, as amended at 49 ical, chemical, good manufac- FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, and radiological turing practice 1985; 53 FR 52682, Dec. 29, 1988] quality standards results in a of ¤ 165.110 maximum resid- (b)(2) through ual level at the § 184.1560 Ox bile extract. (b)(5) of this time of bottling (a) Ox bile extract (CAS Reg. No. chapter . of 0.4 milligram of ozone per 8008–63–7), also known as purified liter of bottled oxgall or sodium choleate, is a yel- water . lowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste. [47 FR 50210, Nov. 5, 1982, as amended at 60 It is the purified portion of the bile of FR 57130, Nov. 13, 1995] an ox obtained by evaporating the alcohol extract of concentrated bile. § 184.1583 Pancreatin. (b) Food-grade ox bile extract shall meet the specifications of the U.S. (a) Pancreatin (CAS Reg. No. 8049–47– Pharmacopeia (USP), XIV, 1950, p. 410. 1 6) is an enzyme preparation obtained (c) The ingredient is used as a surfac- from porcine or bovine pancreatic tis- tant as defined in § 170.3 (o)(29) of this sue. It is a white to tan powder. Its chapter. characterizing enzyme activity that of (d) The ingredient is used in food in a peptide hydrolase (EC 3.4.21.36). accordance with § 184.1(b)(1) at levels (b) The ingredient meets the general not to exceed good manufacturing requirements and additional require- practice. Current good manufacturing ments in the Food Chemicals Codex, 3d practice results in a maximum level, as ed. (1981), p. 110, which is incorporated served, of 0.002 percent for cheese as de- by reference in accordance with 5 fined in § 170.3(n)(5) of this chapter. U.S.C. 552(a) and 1 CFR part 51. Copies (e) Prior sanctions for this ingredient are available from the National Acad- different from the uses established in emy Press, 2101 Constitution Ave. NW., this section do not exist or have been Washington, DC 20418, or may be exam- waived. ined at the Office of Premarket Ap- proval (HFS–200), Food and Drug Ad- [43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985] ministration, 200 C St. SW., Wash- ington, DC, and the Office of the Fed- § 184.1563 Ozone. eral Register, 800 North Capitol St. NW., suite 700, Washington, DC. (a) Ozone (O3, CAS Reg. No. 10028–15– 6) is an unstable blue gas with a pun- (c) In accordance with § 184.1(b)(1), gent, characteristic odor, which occurs the ingredient is used in food with no freely in nature, It is produced com- limitation other than current good mercially by passing electrical dis- manufacturing practice. The affirma- charges or ionizing radiation through tion of this ingredient as GRAS as a di- air or oxygen. rect food ingredient is based upon the (b) The ingredient must be of a pu- following current good manufacturing rity suitable for its intended use in ac- practice conditions of use: (1) The ingredient is used as an en- 1 Copies may be obtained from: U.S. zyme as defined in § 170.3(o)(9) of this 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 group occur as methyl esters, and the levels not to exceed current good man- remaining carboxyl groups exist in the ufacturing practice. form of the free acid or as its ammonium, potassium, or sodium (CAS Reg. [60 FR 32911, June 26, 1995] No. 9000–59–8) salts, and in some types § 184.1585 Papain. as the acid amide. Thus, the pectins regulated in this section are the high- (a) Papain (CAS Reg. No. 9001–73–4) is ester pectins, low-ester pectins, a proteolytic enzyme derived from amidated pectins, pectinic acids, and Carica papaya L. Crude latex con- pectinates. Pectin is produced commer- taining the enzyme is collected from cially by extracting citrus peel, apple slashed unripe papaya. The food-grade pomace, or beet pulp with hot dilute product is obtained by repeated filtra- acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- tion of the crude latex or an aqueous tract is filtered, and pectin is then pre- solution of latex or by precipitation cipitated from the clear extract with from an aqueous solution of latex. The ethanol or isopropanol, or as the cop- resulting enzyme preparation may be per or aluminum salt. The acid extract used in a liquid or dry form. is sometimes spray- or roller-dried, or (b) The ingredient meets the speci- it is concentrated to be sold as liquid fications of the Food Chemicals Codex, pectin. 3d Ed. (1981), pp. 107–110, which is incor- (b) The ingredients meet the speci- porated by reference. Copies are avail- fications of the Food Chemical Codex, able from the National Academy Press, 3d Ed. (1981), p. 215, which is incor- 2101 Constitution Ave. NW., Wash- porated by reference. Copies are avail- ington, DC 20418, or available for in- able from the National Academy Press, spection at the Office of the Federal 2101 Constitution Ave. NW., Wash- Register, 800 North Capitol Street, ington, DC 20418, or available for in- NW., suite 700, Washington, DC 20408. spection at the Office of the Federal (c) In accordance with § 184.1(b)(1), Register 800 North Capitol Street, NW., the ingredient is used in food with no suite 700, Washington, DC 20408. limitation other than currect good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredients are used in food with tion of this ingredient as generally rec- no limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of these ingredients as generally the following current good manufac- recognized as safe (GRAS) as direct turing conditions of use: human food ingredients is based upon (1) The ingredient is used as an en- the following current good manufac- zyme as defined in § 170.3(o)(9) of this turing practice conditions of use: chapter; processing aid as defined in (1) The ingredients are used as emul- § 170.3(o)(24) of this chapter; and sifiers as defined in § 170.3(o)(8) of this texturizer as defined in § 170.3(o)(32) of chapter and as stabilizers and thick- this chapter. eners as defined in § 170.3(o)(28) of this (2) The ingredient is used in food at chapter. levels not to exceed current good man- (2) The ingredients are used in food ufacturing practice. at levels not to exceed current good (d) Prior sanctions for this ingredient manufacturing practice. different from the uses established in (d) Prior sanctions for these ingredi- this section do not exist or have been ents different from the uses established waived. in this section do not exist or have [48 FR 48806, Oct. 21, 1983] been waived. [48 FR 51149, Nov. 7, 1983] § 184.1588 Pectins. (a) The pectins (CAS Reg. No. 9000– § 184.1595 Pepsin. 69–5) are a group of complex, high mo- (a) Pepsin (CAS Reg. No. 9001–75–6) is lecular weight polysaccharides found an enzyme preparation obtained from in plants and composed chiefly of par- the glandular layer of hog stomach. It tially methylated polygalacturonic is a white to light tan powder, amber acid units. Portions of the carboxly paste, or clear amber to brown liquid.

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Its characterizing enzyme activity is Maximum level of that of a peptide hydrolase (EC use in 3.4.23.1). Category of food food (as Functional use served) (b) The ingredient meets the general (percent) requirements and additional requirements for enzyme preparations in the Confections and 0.1 Stabilizer, thickener, frostings, ¤ 170.3(o)(28) of this Food Chemicals Codex, 3d ed. (1981), p. ¤ 170.3(n)(9) of this chapter 110, which is incorporated by reference chapter . in accordance with 5 U.S.C. 552(a) and 1 Gelatins and puddings, 0.7 Do. CFR part 51. Copies are available from ¤ 170.3(n)(22) of this chapter . the National Academy Press, 2101 Con- Processed fruits and 0.25 Do. stitution Ave. NW., Washington, DC fruit juices, 20418, or may be examined at the Office ¤ 170.3(n)(35) of this of Premarket Approval (HFS–200), Food chapter . All other food cat- 0.01 Do. and Drug Administration, 200 C St. egories . SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol (d) Prior sanctions for potassium al- St. NW., suite 700, Washington, DC. ginate different from the uses estab- (c) In accordance with § 184.1(b)(1), lished in this section do not exist or the ingredient is used in food with no have been waived. limitation other than current good manufacturing practice. The affirma- [47 FR 29951, July 9, 1982] tion of this ingredient as GRAS as a di- § 184.1613 Potassium bicarbonate. rect food ingredient is based upon the following current good manufacturing (a) Potassium bicarbonate (KHCO3, practice conditions of use: CAS Reg. No. 298–14–6) is made by the (1) The ingredient is used as an en- following processes: zyme as defined in § 170.3(o)(9) of this (1) By treating a solution of potas- chapter to hydrolyze proteins or sium hydroxide with carbon dioxide; polypeptides. (2) By treating a solution of potas- (2) The ingredient is used in food at sium carbonate with carbon dioxide. levels not to exceed current good man- (b) The ingredient meets the speci- ufacturing practice. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incor- [60 FR 32911, June 26, 1995] porated by reference. Copies are available from the National Academy Press, § 184.1610 Potassium alginate. 2101 Constitution Ave. NW., Wash- (a) Potassium alginate (CAS Reg. No. ington, DC 20418, or available for in- 9005–36–1) is the potassium salt of al- spection at the Office of the Federal ginic acid, a natural polyuronide con- Register, 800 North Capitol Street, stituent of certain brown algae. Potas- NW., suite 700, Washington, DC 20408. sium alginate is prepared by the neu- (c) In accordance with § 184.1(b)(1), tralization of purified alginic acid with the ingredient is used in food with no appropriate pH control agents. 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. 239, 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 formu- spection at the Office of the Federal lation aid as defined in § 170.3(o)(14) of Register, 800 North Capitol Street, this chapter; nutrient supplemlent as NW., suite 700, Washington, DC 20408. defined in § 170.3(o)(20) of this chapter; (c) In accordance with § 184.1(b)(2), pH control agent as defined in the ingredient is used in food only § 170.3(o)(23) of this chapter; and proc- within the following specific limita- essing aid as defined in § 170.3(o)(24) of tions: this chapter.

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(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. [48 FR 52442, Nov. 18, 1983] (d) Prior sanctions for this ingredient different from the uses established in § 184.1622 Potassium chloride. this section do not exist or have been waived. (a) Potassium chloride (KCl, CAS Reg. No. 7447–40–7) is a white, odorless [48 FR 52442, Nov. 18, 1983] solid prepared from source minerals by fractional crystallization or flotation. § 184.1619 Potassium carbonate. It is soluble in water and glycerol and (a) Potassium carbonate (K2CO3, CAS has a saline taste at low concentration Reg. No. 584–08–7) is produced by the levels. following methods of manufacture: (b) The ingredient meets the speci- (1) By electrolysis of potassium chlo- fications of the Food Chemicals Codex, ride followed by exposing the resultant 3d Ed. (1981), p. 241, which is incor- potassium to carbon dioxide; porated by reference. Copies are avail- (2) By treating a solution of potas- able from the National Academy Press, sium hydroxide with excess carbon di- 2101 Constitution Ave. NW., Wash- oxide to produce potassium carbonate; ington, DC 20418, or available for in- (3) By treating a solution of potas- spection at the Office of the Federal sium hydroxide with carbon dioxide to Register, 800 North Capitol Street, produce potassium bicarbonate, which NW., suite 700, Washington, DC 20408. is then heated to yield potassium car- (c) In accordance with § 184.1(b)(1), bonate. 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), p. 240, which is incor- tion of this ingredient as generally rec- porated by reference. Copies are avail- ognized as safe (GRAS) as a direct able from the National Academy Press, human food ingredient is based upon 2101 Constitution Ave. NW., Wash- the following current good manufac- ington, D.C. 20418, or available for in- turing practice conditions of use: spection at the Office of the Federal (1) The ingredient is used as a flavor Register, 800 North Capitol Street, enhancer as defined in § 170.3(o)(11) of NW., suite 700, Washington, DC 20408. this chapter; as a flavoring agent as de- (c) In accordance with § 184.1(b)(1), fined in § 170.3(o)(12) of this chapter; as the ingredient is used in food with no a nutrient supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter; as a pH manufacturing practice. the affirma- control agent as defined in §170.3(o)(23) tion of this ingredient as generally rec- of this chapter; and as a stabilizer or ognized as safe (GRAS) as a direct human food ingredient is based upon thickener as defined in § 170.3(o)(28) of the following current good manufac- this chapter. turing practice conditions of use: (2) The ingredient is used in food at (1) The ingredient is used in food as a levels not to exceed current good man- flavoring agent and adjuvant as defined ufacturing practice. Potassium chlo- in § 170.3(o)(12) of this chapter; nutrient ride may be used in infant formula in supplement as defined in § 170.3(o)(20) of accordance with section 412(g) of the this chapter; pH control agent as de- Federal Food, Drug, and Cosmetic Act fined in § 170.3(o)(23) of this chapter; (the Act) or with regulations promul- and processing aid as defined in gated under section 412(a)(2) of the Act. § 170.3(o)(24) 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 51614, Nov. 10, 1983] different from the uses established in

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§ 184.1625 Potassium citrate. North Capitol Street, NW., suite 700, Washington, DC 20408. (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- (c) In accordance with § 184.1(b)(1), tassium salt of citric acid. It is pre- the ingredient is used in food with no pared by neutralizing citric acid with limitation other than current good potassium hydroxide or potassium car- manufacturing practice. The affirma- bonate. It occurs as transparent crys- tion of this ingredient as generally rec- tals or a white granular powder, is ognized as safe (GRAS) as a direct odorless and deliquescent, and contains human food ingredient is based upon one mole of water per mole of potas- the following current good manufac- sium citrate. turing practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as a formu- fications of the Food Chemicals Codex, lation aid as defined in § 170.3(o)(14) of 3d ed. (1981), p. 242, which is incor- this chapter; a pH control agent as de- porated by reference in accordance fined in § 170.3(o)(23) of the chapter; a with 5 U.S.C. 552(a) and 1 CFR part 51. processing aid as defined in § 170.3(o)(24) Copies are available from the National of this chapter; and a stabilizer and Academy Press, 2101 Constitution Ave. thickener as defined in § 170.3(o)(28) of NW., Washington, DC 20418, and the this chapter. Center for Food Safety and Applied Nu- (2) The ingredient is used in food at trition (HFS–200), 5100 Paint Branch levels not to exceed current good man- Pkwy., College Park, MD 20740, or may ufacturing practice. be examined at the Office of the Fed- (d) Prior sanctions for this ingredient eral Register, 800 North Capitol St. different from the uses established in NW., suite 700, Washington, DC. 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 [48 FR 52444, Nov. 18, 1983] manufacturing practice. § 184.1634 Potassium iodide. (d) Prior sanctions for this ingredient different from the uses established in (a) Potassium iodide (KI, CAS Reg. this section, or different from those set No. 7681–11–0) is the potassium salt of forth in part 181 of this chapter, do not hydriodic acid. It occurs naturally in exist or have been waived. sea water and in salt deposits, but can be prepared by reacting hydriodic acid [59 FR 63896, Dec. 12, 1994] (HI) with potassium bicarbonate § 184.1631 Potassium hydroxide. (KHCO3). (b) The ingredient meets the speci- (a) Potassium hydroxide (KOH, CAS fications of the ‘‘Food Chemicals Reg. No. 1310–58–3) is also known as Codex,’’ 3d Ed. (1981), pp. 246–247, which caustic potash, potash lye, and potassa. is incorporated by reference. Copies The empirical formula is KOH. It is a may be obtained from the National white, highly deliquescent caustic Academy Press, 2101 Constitution Ave. solid, which is marketed in several NW., Washington, DC 20418, or may be forms, including pellets, flakes, sticks, examined at the Office of the Federal lumps, and powders. Potassium hydroxide is obtained commercially from the Register, 800 North Capitol Street, electrolysis of potassium chloride solu- NW., suite 700, Washington, DC 20408. tion in the presence of a porous dia- (c) The ingredient is used as a nutri- phragm. ent supplement as defined in (b) The ingredient meets the speci- § 170.3(o)(20) of this chapter. fications of the Food Chemicals Codex, (d) The ingredient is used in table 3d Ed. (1981), which is incorporated by salt in accordance with § 184.1(b)(2) of reference. Copies are available from this chapter as a source of dietary io- the National Academy Press, 2101 Con- dine at a maximum level of 0.01 per- stitution Ave. NW., Washington, DC cent. 20418, or available from inspection at (e) Prior sanctions for this ingredient the Office of the Federal Register, 800 different from the uses established in

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this section do not exist or have been upon the following current good manu- waived. facturing practice conditions of use: [43 FR 11699, Mar. 21, 1978, as amended at 49 (1) The ingredient is used as a flavor FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, enhancer as defined in § 170.3(o)(11) of 1996] this chapter; a flavoring agent or adjuvant as defined in § 170.3(o)(12) of this § 184.1635 Potassium iodate. chapter; a humectant as defined in (a) Potassium iodate (KIO3, CAS Reg. § 170.3(o)(16) of this chapter; and a pH No. 7758–05–6) does not occur naturally control agent as defined in § 170.3(o)(23) but can be prepared by reacting iodine of this chapter. with potassium hydroxide. (2) The ingredient is used in food at (b) The ingredient meets the speci- levels not to exceed current good man- fications of the ‘‘Food Chemicals ufacturing practice. Codex,’’ 3d Ed. (1981), pp. 245–246, which (d) Prior sanctions for this ingredient is incorporated by reference. Copies different from the uses established in may be obtained from the National this section do not exist or have been Academy Press, 2101 Constitution Ave. waived. NW., Washington, DC 20418, or may be examined at the Office of the Federal [52 FR 10886, Apr. 6, 1987] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1643 Potassium sulfate.

(c) The ingredient is used as a dough (a) Potassium sulfate (K2SO4, CAS strengthener as defined in § 170.3(o)(6) Reg. No. 7778–80–5) occurs naturally and of this chapter. consists of colorless or white crystals (d) The ingredient is used in the man- or crystalline powder having a bitter, ufacture of bread in accordance with saline taste. It is prepared by the neu- § 184.1(b)(2) of this chapter in an tralization of sulfuric acid with potas- amount not to exceed 0.0075 percent sium hydroxide or potassium car- based on the weight of the flour. bonate. (e) Prior sanctions for this ingredient different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), p. 252, which is incorporated by reference. Copies may be [43 FR 11699, Mar. 21, 1978, as amended at 49 obtained from the National Academy FR 5613, Feb. 14, 1984] Press, 2101 Constitution Ave. NW., § 184.1639 Potassium lactate. Washington, DC 20418, or may be examined at the Office of the Federal Reg- H O K, CAS (a) Potassium lactate (C3 5 3 ister, 800 North Capitol Street, NW., Reg. No. 996–31–6) is the potassium salt suite 700, Washington, DC 20408. of lactic acid. It is a hydroscopic, white, odorless solid and is prepared (c) The ingredient is used as a fla- commercially by the neutralization of voring agent and adjuvant as defined in lactic acid with potassium hydroxide. § 170.3(o)(12) of this chapter. (b) FDA is developing food-grade (d) The ingredient is used in food at specifications for potassium lactate in levels not to exceed good manufac- cooperation with the National Acad- turing practice in accordance with emy of Sciences. In the interim, this § 184.1(b)(1). Current good manufac- ingredient must be of a purity suitable turing practice results in a maximum for its intended use. level, as served, of 0.015 percent for (c) In accordance with § 184.1(b)(1), nonalcoholic beverages as defined in the ingredient is used in food with no § 170.3(n)(3) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. This regula- different from the uses established in tion does not authorize its use in in- this section do not exist or have been fant foods and infant formulas. The af- waived. firmation of this ingredient as generally recognized as safe (GRAS) as a [45 FR 6086, Jan. 25, 1980, as amended at 49 direct human food ingredient is based FR 5613, Feb. 14, 1984]

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§ 184.1655 Propane. Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (a) Propane (empirical formula C3H8, (c) The ingredient is used as an anti- CAS Reg. No. 74–98–6) is also known as oxidant as defined in § 170.3(o)(3) of this dimethylmethane or propyl hydrid. It chapter. is a colorless, odorless, flammable gas (d) The ingredient is used in food at at normal temperatures and pressures. levels not to exceed good manufac- It is easily liquefied under pressure at turing practice in accordance with room temperature and is stored and § 184.1(b)(1). Good manufacturing prac- shipped in the liquid state. Propane is tice results in a maximum total con- obtained from natural gas by fraction- tent of antioxidants of 0.02 percent of ation following absorption in oil, ad- the fat or oil content, including the es- sorption to surface-active agents, or re- sential (volatile) oil content, of the frigeration. food. (b) The Food and Drug Administra- (e) Prior sanctions for this ingredient tion is developing food-grade specifica- different from the uses established in tions for propane in cooperation with this section, or different from that the National Academy of Sciences. In stated in part 181 of this chapter, do the interim, the ingredient must be of not exist or have been waived. a purity suitable for its intended use. [42 FR 14653, Mar. 15, 1977, as amended at 44 (c) In accordance with § 184.1(b)(1), FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, the ingredient is used in food with no 1984] limitations other than current good manufacturing practice. The affirma- § 184.1666 Propylene glycol.

tion of this ingredient as generally rec- (a) Propylene glycol (C3H8O2, CAS ognized as safe (GRAS) as a direct Reg. No. 57–55–6) is known as 1,2- human food ingredient is based upon propanediol. It does not occur in na- the following current good manufacture. Propylene glycol is manufactured turing practice conditions of use: by treating propylene with chlorinated (1) The ingredient is used as a propel- water to form the chlorohydrin which lant, aerating agent, and gas as defined is converted to the glycol by treatment in § 170.3(o)(25) of this chapter. with sodium carbonate solution. It is (2) The ingredient is used in food at also prepared by heating glyercol with levels not to exceed current good man- sodium hydroxide. ufacturing 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. 255, which is incor- this section do not exist or have been porated by reference. Copies may be waived. obtained from the National Academy Press, 2101 Constitution Ave. NW., [48 FR 57271, Dec. 29, 1983] Washington, DC 20418. It is also available for inspection at the Office of the § 184.1660 Propyl gallate. Federal Register, 800 North Capitol (a) Propyl gallate is the n- Street, NW., suite 700, Washington, DC propylester of 3,4,5-trihydroxybenzoic 20408. acid (C10H12O5). Natural occurrence of (c) The ingredient is used as an propyl gallate has not been reported. It anticaking agent as defined in is commercially prepared by § 170.3(o)(1) of this chapter; antioxidant esterification of gallic acid with propyl as defined in § 170.3(o)(3) of this chap- alcohol followed by distillation to re- ter; dough strengthener as defined in move excess alcohol. § 170.3(o)(6) of this chapter; emulsifier (b) The ingredient meets the speci- as defined in § 170.3(o)(8) of this chap- fications of the ‘‘Food Chemicals ter; flavor agent as defined in Codex,’’ 3d Ed. (1981), pp. 257–258, which § 170.3(o)(12) of this chapter; formula- is incorporated by reference. Copies tion aid as defined in § 170.3(o)(14) of may be obtained from the National this chapter; humectant as defined in Academy Press, 2101 Constitution Ave. § 170.3(o)(16) of this chapter; processing NW., Washington, DC 20418, or may be aid as defined in § 170.3(o)(24) of this examined at the Office of the Federal chapter; solvent and vehicle as defined

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in § 170.3(o)(27) of this chapter; sta- this regulation do not exist or have bilizer and thickener as defined in been waived. § 170.3(o)(28) of this chapter; surface-ac- [42 FR 14653, Mar. 15, 1977, as amended at 49 tive agent as defined in § 170.3(o)(29) of FR 5613, Feb. 14, 1984] this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter. § 184.1676 Pyridoxine hydrochloride. (d) The ingredient is used in foods at (a) Pyridoxine hydrochloride levels not to exceed current good man- (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is ufacturing practice in accordance with the chemical 3-hydroxy–4,5- § 184.1(b)(1). Current good manufac- dihydroxymethy–2-methylpyridine hy- turing practice results in maximum drochloride that is prepared by chem- levels, as served, of 5 percent for alco- ical synthesis. holic beverages, as defined in (b) The ingredient meets the speci- § 170.3(n)(2) of this chapter; 24 percent fications of the Food Chemicals Codex, for confections and frostings as defined 3d Ed. (1981), p. 260, which is incor- in § 170.3(n)(9) of this chapter; 2.5 per- porated by reference. Copies are avail- cent for frozen dairy products as de- able from the National Academy Press, fined in § 170.3(n)(20) of this chapter; 97 2101 Constitution Ave. NW., Wash- percent for seasonings and flavorings ington, DC 20418, or available for in- as defined in § 170.3(n)(26) of this chap- spection at the Office of the Federal ter; 5 percent for nuts and nut products Register, 800 North Capitol Street, as defined in § 170.3(n)(32) of this chap- NW., suite 700, Washington, DC 20408. ter; and 2.0 percent for all other food (c) In accordance with § 184.1(b)(1), categories. the ingredient is used in food with no (e) Prior sanctions for this ingredient limitation other than current good manufacturing practice. The affirma- different from the uses established in tion of this ingredient as generally rec- this section do not exist or have been ognized as safe (GRAS) as a direct waived. human food ingredient is based upon [47 FR 27812, June 25, 1982] the following current good manufacturing practice conditions of use: § 184.1670 Propylparaben. (1) The ingredient is used as a nutri- (a) Propylparaben is the chemical ent supplement as defined in propyl p-hydroxybenzoate. It is pro- § 170.3(o)(20) of this chapter. duced by the n-propanol esterification (2) The ingredient is used in the fol- of p-hydroxybenzoic acid in the pres- lowing foods at levels not to exceed ence of sulfuric acid, with subsequent current good manufacturing practice: distillation. baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages (b) The ingredient meets the speci- and beverage bases as defined in fications of the ‘‘Food Chemicals § 170.3(n)(3) of this chapter; breakfast Codex,’’ 3d Ed. (1981), p. 258, which is in- cereals as defined in § 170.3(n)(4) of this corporated by reference. Copies may be chapter; dairy product analogs as de- obtained from the National Academy fined in § 170.3(n)(10) of this chapter; Press, 2101 Constitution Ave. NW., meat products as defined in Washington, DC 20418, or may be exam- § 170.3(n)(29) of this chapter; milk prod- ined at the Office of the Federal Reg- ucts as defined in § 170.3(n)(31) of this ister, 800 North Capitol Street, NW., chapter; plant protein products as de- suite 700, Washington, DC 20408. fined in § 170.3(n)(33) of this chapter; (c) The ingredient is used as an anti- and snack foods as defined in microbial agent as defined in § 170.3(n)(37) of this chapter. Pyridoxine § 170.3(o)(2) of this chapter. hydrochloride may be used in infant (d) The ingredient is used in food at formula in accordance with section levels not to exceed good manufac- 412(g) of the Federal Food, Drug, and turing practices. Current good manu- Cosmetic Act (the Act) or with regula- facturing practice results in a max- tions promulgated under section imum level of 0.1 percent in food. 412(a)(2) of the Act. (e) 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 gillus niger van Tieghem variety waived. awamori (Nakazawa) Al-Musallam (syn- [48 FR 51615, Nov. 10, 1983] onym A. awamori Nakazawa) containing the prochymosin gene. § 184.1685 Rennet (animal-derived) Chymosin is recovered from the fer- and chymosin preparation (fermentation broth after acid treatment. mentation-derived). All materials used in the processing (a)(1) Rennet and bovine rennet are and formulating of chymosin prepara- commercial extracts containing the action must be either generally recog- tive enzyme rennin (CAS Reg. No. 9001– nized as safe (GRAS) or be food addi- 98–3), also known as chymosin (Inter- tives that have been approved by the national Union of Biochemistry En- Food and Drug Administration for this zyme Commission (E.C.) 3.4.23.4). use. Rennet is the aqueous extract prepared (b) Rennet and chymosin preparation from cleaned, frozen, salted, or dried meet the general and additional re- fourth stomachs (abomasa) of calves, quirements for enzyme preparations of kids, or lambs. Bovine rennet is the the ‘‘Food Chemicals Codex,’’ 3d Ed. product from adults of the animals list- (1981), pp. 107–110, which is incorporated ed above. Both products are called by reference in accordance with 5 rennet and are clear amber to dark U.S.C. 552(a). Copies are available from brown liquid preparations or white to the National Academy Press, 2101 Con- tan powders. stitution Avenue NW., Washington, DC (2) Chymosin preparation is a clear 20418, or are available for inspection at solution containing the active enzyme the Office of the Federal Register, 800 chymosin (E.C. 3.4.23.4). It is derived, North Capitol Street, NW., suite 700, via fermentation, from a nonpatho- Washington, DC. genic and nontoxigenic strain of Esch- (c) In accordance with § 184.1(b)(1), erichia coli K–12 containing the the ingredient is used in food with no prochymosin gene. The prochymosin is limitation other than current good isolated as an insoluble aggregate that manufacturing practice. The affirma- is acid-treated to destroy residual cel- tion of this ingredient as generally rec- lular material and, after solubilization, ognized as safe as a direct human food is acid-treated to form chymosin. It ingredient is based upon the following must be processed with materials that current good manufacturing practice are generally recognized as safe, or are conditions of use: food additives that have been approved (1) The ingredient is used as an en- by the Food and Drug Administration zyme as defined in § 170.3(o)(9) of this for this use. chapter; a processing aid as defined in (3) Chymosin preparation is a clear § 170.3(o)(24) of this chapter; and a sta- solution containing the active enzyme bilizer and thickener as defined in chymosin (E.C. 3.4.23.4). It is derived, § 170.3(o)(28) of this chapter. via fermentation, from a nonpathogenic and nontoxigenic strain of (2) The ingredient is used in the fol- Kluyveromyces marxianus variety lactis, lowing foods at levels not to exceed containing the prochymosin gene. The current good manufacturing practice: prochymosin is secreted by cells into In cheeses as defined in § 170.3(n)(5) of fermentation broth and converted to this chapter; frozen dairy desserts and chymosin by acid treatment. All mate- mixes as defined in § 170.3(n)(20) of this rials used in the processing and formu- chapter; gelatins, puddings, and fillings lating of chymosin must be either gen- as defined in § 170.3(n)(22) of this chap- erally recognized as safe (GRAS), or be ter; and milk products as defined in food additives that have been approved § 170.3(n)(31) of this chapter. by the Food and Drug Administration (d) Prior sanctions for this ingredient for this use. different from the uses established in (4) Chymosin preparation is a clear this section do not exist or have been solution containing the active enzyme waived. chymosin (E.C. 3.4.23.4). It is derived, [55 FR 10935, Mar. 23, 1990, as amended at 57 via fermentation, from a nonpatho- FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, genic and nontoxigenic strain of Asper- 1993]

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§ 184.1695 Riboflavin. porated by reference. Copies are available from the National Academy Press, (a) Riboflavin (C H N O CAS Reg. 17 20 4 6, 2101 Constitution Ave. NW., Wash- No. 83–88–5) occurs as yellow to orange- ington DC 20418, or available for inspec- yellow needles that are crystallized tion at the Office of the Federal Reg- from 2N acetic acid, alcohol, water, or ister, 800 North Capitol Street, NW., pyridine. It may be prepared by chem- suite 700, Washington, DC 20408. ical synthesis, biosynthetically by the (c) In accordance with § 184.1(b)(1), organism Eremothecium ashbyii, or iso- the ingredient is used in food with no lated from natural sources. 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. 262, 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 Office of the Federal ent supplement as defined in Register, 800 North Capitol Street, § 170.3(o)(20) of this chapter. NW., suite 700, Washington, DC 20408. (2) The ingredient is used in milk (c) In accordance with § 184.1(b)(1), products, as defined in § 170.3(n)(31) of the ingredient is used in food with no this chapter, at levels not to exceed limitation other than current good current good manufacturing practice. manufacturing practice. The affirma- The ingredient may also be used in in- tion of this ingredient as generally rec- fant formulas in accordance with sec- ognized as safe (GRAS) as a direct tion 412(g) of the Federal Food, Drug, human food ingredient is based upon and Cosmetic Act (the Act) or with reg- the following current good manufac- ulations promulgated under section turing practice conditions of use: 412(a)(2) of the Act. (1) The ingredient is used as a nutri- (d) Prior sanctions for this ingredient ent 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 manufacturing practice. The ingredient [48 FR 51148, Nov. 7, 1983] may also be used in infant formula in accordance with section 412(g) of the § 184.1698 Rue. Federal Food, Drug, and Cosmetic Act (a) Rue is the perennial herb of sev- (the Act) or with regulations promul- eral species of Ruta (Ruta montana L., gated under section 412(a)(2) of the Act. Ruta graveolens L., Ruta bracteosa L., (d) Prior sanctions for this ingredient and Ruta calepensis L.). The leaves, different from the uses established in buds, and stems from the top of the this section do not exist or have been plant are gathered, dried, and then waived. crushed in preparation for use, or left whole. [48 FR 51148, Nov. 7, 1983] (b) The ingredient is used in all cat- § 184.1697 Riboflavin–5′-phosphate (so- egories of food in accordance with dium). § 184.1(b)(2) of this chapter at concentrations not to exceed 2 parts per (a) Riboflavin-5′-phosphate (sodium) million. (C H N O PNa·2H O, CAS Reg. No 130– 17 20 4 9 2 (c) Prior sanctions for this ingredient 40–5) occurs as the dihydrate in yellow different from the uses established in to orange-yellow crystals. It is pre- this section do not exist or have been pared by phosphorylation of riboflavin waived. with chlorophosphoric acid, pyrophosphoric acid, metaphosphoric [43 FR 3705, Jan. 27, 1978] acid, or pyrocatechol cyclic phosphate. (b) The ingredient meets the speci- § 184.1699 Oil of rue. fications of the Food Chemicals Codex, (a) Oil of rue is the natural substance 3d Ed. (1981), p. 263, which is incor- obtained by steam distillation of the

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fresh blossoming plants of rue, the pe- Ave. NW., Washington, DC 20055 (Inter- rennial herb of several species of net address ‘‘http://www.nap.edu’’), or Ruta—Ruta montana L., Ruta graveolens may be examined at the Center for L., Ruta bracteosa L., and Ruta Food Safety and Applied Nutrition’s calepensis L. Library, Food and Drug Administra- (b) Oil of rue meets the specifications tion, 200 C St. SW., Washington, DC, or of the ‘‘Food Chemicals Codex,’’ 4th ed. at the Office of the Federal Register, (1996), pp. 342–343, which is incorporated 800 North Capitol St. NW., suite 700, by reference in accordance with 5 Washington, DC. U.S.C. 552(a) and 1 CFR part 51. Copies (c) The ingredient is used in food are available from the National Acad- emy Press, Box 285, 2101 Constitution under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Parts per Food (as served) million Function

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

(d) Prior sanctions for this ingredient current good manufacturing practice, different from the uses established in except that the ingredient may not be this section do not exist or have been used in a standardized food unless per- waived. mitted by the standard of identity: Confections and frostings as defined in [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, § 170.3(n)(9) of this chapter, coatings of 1999] soft candy as defined in § 170.3(n)(38) of this chapter, and sweet sauces and top- § 184.1702 Sheanut oil. pings as defined in § 170.3(n)(43) of this (a) Sheanut oil is produced from chapter. sheanuts derived from the Shea tree [63 FR 28895, May 27, 1998] Butyrospermum parkii and is composed principally of triglycerides containing § 184.1721 Sodium acetate.

an oleic acid moiety at the 2-position (a) Sodium acetate (C2H3O2Na, CAS and saturated fatty acids, usually ste- Reg. No. 127–09–3 or C2H3O2Na·3H2O, aric or palmitic acids, at the 1- and 3- CAS Reg. No. 6131–90–4) is the sodium positions. salt of acetic acid and occurs naturally (b) The ingredient meets the fol- in plant and animal tissues. Sodium ac- lowing specifications when tested using etate may occur in either the anhy- any appropriate validated method- drous or trihydrated form. It is pro- ology: duced synthetically by the neutraliza- (1) Saponification value of 185 to 195, tion of acetic acid with sodium car- (2) Iodine value of 28 to 43, bonate or by treating calcium acetate (3) Unsaponifiable matter not to ex- with sodium sulfate and sodium bicar- ceed 1.5 percent, bonate. (4) Free fatty acids not more than 0.1 (b) The ingredient meets the speci- percent as oleic acid, fications of the Food Chemicals Codex, (5) Peroxide value not more than 10 3d Ed. (1981), pp. 272, 273 which is incor- milliequivalents/equivalent (meq/eq), porated by reference. Copies are avail- (6) Lead not more than 0.1 part per able from the National Academy Press, million (ppm), 2101 Constitution Ave. NW., Wash- (7) Copper not more than 0.1 ppm. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(3), spection at the Office of the Federal the ingredient is used in the following Register, 800 North Capitol Street, food categories at levels not to exceed NW., suite 700, Washington, DC 20408.

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(c) The ingredient is used as a fla- (e) Prior sanctions for this ingredient voring agent and adjuvant as defined in different from the uses established in § 170.3(o)(12) of this chapter; and as a pH this section do not exist or have been control agent as defined in § 170.3(o)(23) waived. of this chapter. (d) The ingredient is used in food at [47 FR 27815, June 25, 1982] levels not to exceed current good man- § 184.1724 Sodium alginate. ufacturing practice in accordance with 184.1(b)(1). Current good manufacturing (a) Sodium alginate (CAS Reg. No. practice results in a maximum level, as 9005–38–3) is the sodium salt of alginic served, of 0.007 percent for breakfast acid, a natural polyuronide constituent cereals as defined in § 170.3(n)(4) of this of certain brown algae. Sodium algi- chapter; 0.5 percent for fats and oils as nate is prepared by the neutralization defined in § 170.3(n)(12) of this chapter; of purified alginic acid with appro- 0.6 percent for grain products and pas- priate pH control agents. tas as defined in § 170.3(n)(23) of this (b) The ingredient meets the speci- chapter and snack foods as defined in fications of the Food Chemicals Codex, § 170.3(n)(37) of this chapter; 0.15 per- 3d Ed. (1981), p. 274, which is incor- cent for hard candy as defined in porated by reference. Copies are avail- § 170.3(n)(25) of this chapter; 0.12 per- able from the National Academy Press, cent for jams and jellies as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(28) of this chapter and meat ington, DC 20418, or available for in- products as defined in § 170.3(n)(29) of spection at the Office of the Federal this chapter; 0.2 percent for soft candy Register, 800 North Capitol Street, as defined in § 170.3(n)(38) of this chap- NW., suite 700, Washington, DC 20408. ter; 0.05 percent for soups and soup (c) In accordance with § 184.1(b)(2), mixes as defined in § 170.3(n)(40) of this the ingredient is used in food only chapter and sweet sauces as defined in within the following specific limita- § 170.3(n)(43) of this chapter. 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- § 184.1733 Sodium benzoate. nate different from the uses established (a) Sodium benzoate is the chemical in this section do not exist or have benzoate of soda (C H NaO ), produced been waived. 7 5 2 by the neutralization of benzoic acid [47 FR 29951, July 9, 1982, as amended at 48 with sodium bicarbonate, sodium car- FR 52448, Nov. 18, 1983] bonate, or sodium hydroxide. The salt is not found to occur naturally.

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(b) The ingredient meets the speci- this section do not exist or have been fications of the ‘‘Food Chemicals waived. Codex,’’ 3d Ed. (1981), p. 278, which is in- [48 FR 52442, Nov. 18, 1983] corporated by reference. Copies may be obtained from the National Academy § 184.1742 Sodium carbonate. Press, 2101 Constitution Ave. NW., (a) Sodium carbonate (Na2CO3, CAS Washington, DC 20418, or may be exam- Reg. No. 497–19–8) is produced (1) from ined at the Office of the Federal Reg- purified trona ore that has been ister, 800 North Capitol Street, NW., calcined to soda ash; (2) from trona ore suite 700, Washington, DC 20408. calcined to impure soda ash and then (c) The ingredient is used as an anti- purified; or (3) synthesized from lime- microbial agent as defined in stone by the Solvay process. § 170.3(o)(2) of this chapter, and as a fla- (b) The ingredient meets the speci- voring agent and adjuvant as defined in fications of the Food Chemicals Codex, § 170.3(o)(12) of this chapter. 3d Ed. (1981), p. 280, which is incor- (d) The ingredient is used in food at porated by reference. Copies are avail- levels not to exceed good manufac- able from the National Academy Press, turing practice. Current usage results 2101 Constitution Ave. NW., Wash- in a maximum level of 0.1 percent in ington, DC 20418, or available for in- food. (The Food and Drug Administra- spection at the Office of the Federal tion has not determined whether Register, 800 North Capitol Street, significally different conditions of use NW., suite 700, Washington, DC 20408. would be GRAS.) (c) In accordance with § 184.1(b)(1), (e) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section, or different from that set manufacturing practice. The affirma- forth in part 181 of this chapter, do not tion of this ingredient as generally rec- exist or have been waived. ognized as safe (GRAS) as a direct human food ingredient is based upon [42 FR 14653, Mar. 15, 1977, as amended at 49 the following current good manufac- FR 5613, Feb. 14, 1984] turing practice conditions of use: (1) The ingredient is used in food as § 184.1736 Sodium bicarbonate. an antioxidant as defined in § 170.3(o)(3) (a) Sodium bicarbonate (NaHCO3, of this chapter; curing and pickling CAS Reg. No. 144–55–8) is prepared by agent as defined in § 170.3(o)(5) of this treating a sodium carbonate or a so- chapter; flavoring agent and adjuvant dium carbonate and sodium bicarbon- as defined in § 170.3(o)(12) of this chap- ate solution with carbon dioxide. As ter; pH control agent as defined in carbon dioxide is absorbed, a suspen- § 170.3(o)(23) of this chapter; and proc- sion of sodium bicarbonate forms. The essing aid as defined in § 170.3(o)(24) of slurry is filtered, forming a cake which this chapter. is washed and dried. (2) The ingredient is used in food at (b) The ingredient meets the speci- levels not to exceed current good man- fications of the Food Chemicals Codex, ufacturing practice. 3d Ed. (1981), p. 278, which is incor- (d) Prior sanctions for this ingredient porated by reference. Copies are avail- different from the uses established in able from the National Academy Press, this section do not exist or have been 2101 Constitution Ave. NW., Wash- waived. ington, DC 20418, or available for in- [48 FR 52442, Nov. 18, 1983, as amended at 50 spection at the Office of the Federal FR 49536, Dec. 3, 1985] Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. § 184.1751 Sodium citrate.

(c) In accordance with § 184.1(b)(1), (a) Sodium citrate (C6H5Na3O7·2H2O, the ingredient is used in food with no CAS Reg. No. 68–0904–092) is the sodium limitation other than current good salt of citric acid. It is prepared by manufacturing practice. neutralizing citric acid with sodium (d) Prior sanctions for this ingredient hydroxide or sodium carbonate. The different from the uses established in product occurs as colorless crystals or

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a white crystalline powder. It may be § 184.1(b)(1). Current good manufac- prepared in an anhydrous state or may turing practice results in a maximum contain two moles of water per mole of level, as served, 0.4 percent for baked sodium citrate. goods as defined in § 170.3(n)(1) of this (b) The ingredient meets the speci- chapter; 0.1 percent for fats and oils as fications of the Food Chemicals Codex, defined in § 170.3(n)(12) of this chapter, 3d ed. (1981), pp. 283–284, which is incor- meat products as defined in porated by reference in accordance § 170.3(n)(29) of this chapter and soft with 5 U.S.C. 552(a) and 1 CFR part 51. candy as defined in § 170.3(n)(38) of this Copies are available from the National chapter; 0.25 percent for gravies and Academy Press, 2101 Constitution Ave. sauces as defined in § 170.3(n)(24) of this NW., Washington, DC 20418, and the chapter; and 0.05 percent for snack Center for Food Safety and Applied Nu- foods as defined in § 170.3(n)(37) of this trition (HFS–200), 5100 Paint Branch chapter and soups and soup mixes as Pkwy., College Park, MD 20740, or may defined in § 170.3(n)(40) of this chapter. be examined at the Office of the Fed- (e) Prior sanctions for this ingredient eral Register, 800 North Capitol St. different from the uses established in NW., suite 700, Washington, DC. 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 [47 FR 27815, June 25, 1982] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1763 Sodium hydroxide. different from the uses established in (a) Sodium hydroxide (NaOH, CAS this section, or different from those set Reg. No. 1310–73–2) is also known as so- forth in part 181 of this chapter, do not dium hydrate, soda lye, caustic soda, exist or have been waived. white caustic, and lye. The empirical [59 FR 63896, Dec. 12, 1994] formula is NaOH. Sodium hydroxide is prepared commercially by the elec- § 184.1754 Sodium diacetate. trolysis of sodium chloride solution and also by reacting calcium hydroxide (a) Sodium diacetate (C4H7O4Na·xH2O, CAS Reg. No. 126–96–5) is a molecular with sodium carbonate. compound of acetic acid, sodium ace- (b) The ingredient meets the speci- tate, and water of hydration. The tech- fications of the Food Chemicals Codex, nical grade is prepared synthetically 3d Ed. (1981), which is incorporated by by reacting sodium carbonate with ace- reference. Copies are available from tic acid. Special grades are produced by the National Academy Press, 2101 Con- reacting anhydrous sodium acetate and stitution Ave. NW., Washington, DC acetic acid. 20418, or available for inspection at the (b) The ingredient meets the speci- Office of the Federal Register, 800 fications of the Food Chemicals Codex, North Capitol Street, NW., suite 700, 3d Ed. (1981), p. 284, which is incor- Washington, DC 20408. 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 Ave. NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. The affirma- spection at the Office of the Federal tion of this ingredient as generally rec- Register, 800 North Capitol Street, ognized as safe (GRAS) as a direct NW., suite 700, Washington, DC 20408. human food ingredient is based upon (c) The ingredient is used as an anti- the following current good manufac- microbial agent as defined in turing practice conditions of use: § 170.3(o)(2) of this chapter; flavoring (1) The ingredient is used as a pH agent and adjuvant as defined in control agent as defined in § 170.3(o)(23) § 170.3(o)(12) of this chapter; and pH of this chapter and as a processing aid control agent as defined in § 170.3(o)(23) as defined in § 170.3(o)(24) of this chap- of this chapter. ter. (d) The ingredient is used in food at (2) The ingredient is used in foods at levels not to exceed current good man- levels not to exceed current good manufacturing practice in accordance with ufacturing practice.

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

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(2) The ingredient is used to treat the cheeses as defined in § 170.3(n)(5) of this following foods at levels not to exceed chapter; confections and frostings as current good manufacturing practice: defined in § 170.3(n)(9) of this chapter; for use in washing and lye peeling of gelatins, puddings, and fillings as de- fruits, vegetables, and nuts when used fined in § 170.3(n)(22) of this chapter; in accordance with § 173.315 of this jams and jellies as defined in chapter; for use as a denuding agent in § 170.3(n)(28) of this chapter; meat prod- tripe; for use as a hog scald agent in re- ucts as defined in § 170.3(n)(29) of this moving hair; and for use as a corrosion chapter; and soft candy as defined in preventative in canned and bottled § 170.3(n)(38) of this chapter. water when used in accordance with § 103.35 of this chapter. (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [49 FR 13142, Apr. 3, 1984] [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 1985] § 184.1792 Sodium sesquicarbonate. (a) Sodium sesquicarbonate § 184.1784 Sodium propionate. (Na2CO3·NaHCO3·2H2O, CAS Reg. No. (a) Sodium propionate (C3H5NaO2, 533–96–0) is prepared by: (1) Partial CAS Reg. No. 137–40–6) is the sodium carbonation of soda ash solution fol- salt of propionic acid. It occurs as lowed by crystallization, centrifuga- colorless, transparent crystals or a tion, and drying; (2) double refining of granular crystalline powder. It is odor- trona ore, a naturally occurring im- less, or has a faint acetic-butyric acid odor, and is deliquescent. It is prepared pure sodium sesquicarbonate. by neutralizing propionic acid with so- (b) The ingredient meets the speci- dium hydroxide. fications of the Food Chemicals Codex, (b) The ingredients meets the speci- 3d Ed. (1981), p. 299, which is incor- fications of the Food Chemicals Codex, porated by reference. Copies are avail- 3d Ed. (1981), p. 296, which is incor- able from the National Academy Press, porated by reference. Copies are avail- 2101 Constitution Ave. NW., Wash- able from the the National Academy ington, DC 20418, or available for in- Press, 2101 Constitution Ave. NW., spection at the Office of the Federal Washington DC 20418, or available for Register, 800 North Capitol Street, inspection at the Office of the Federal NW., suite 700, Washington, DC 20408. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(1), NW., suite 700, Washington, DC 20408. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used as a pH turing practice conditions of use: control agent as defined in § 170.3(o)(23) (1) The ingredient is used as an antimicrobial agent as defined in of this chapter. § 170.3(o)(2) of this chapter and a fla- (2) The ingredient is used in cream at voring agent as defined in § 170.3(o)(12) levels not to exceed current good man- of this chapter. ufacturing practice. Current good man- (2) The ingredient is used in the fol- ufacturing practice utilizes a level of lowing foods at levels not to exceed the ingredient sufficient to control lac- current good manufacturing practice: tic acid prior to pasteurization and baked goods as defined in § 170.3(n)(1) of churning of cream into butter. this chapter; nonalcoholic beverages as (d) Prior sanctions for this ingredient defined in § 170.3(n)(3) of this chapter; different from the uses established in

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this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 296, which is incor- [48 FR 52443, Nov. 18, 1983] porated by reference. Copies are avail- § 184.1801 Sodium tartrate. able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (a) Sodium tartrate (C H Na O ·2H O, 4 4 2 6 2 ington, DC 20418, or available for in- CAS Reg. No. 868–18–8) is the disodium spection at the Office of the Federal salt of L¥(+)¥tartaric acid. It occurs Register, 800 North Capitol Street, as transparent, colorless, and odorless NW., suite 700, Washington, DC 20408. crystals. It is obtained as a byproduct (c) In accordance with § 184.1(b)(1), of wine manufacture. 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), p. 303, which is incor- tion of this ingredient as generally rec- porated by reference. Copies are avail- ognized as safe (GRAS) as a direct able from the National Academy Press, human food ingredient is based upon 2101 Constitution Ave. NW., Wash- the following current good manufac- ington, DC 20418, or available for in- turing practice conditions of use: spection at the Office of the Federal Register, 800 North Capitol Street, (1) The ingredient is used as an emul- NW., suite 700, Washington, DC 20408. sifier as defined in § 170.3(o)(8) of this (c) In accordance with § 184.1(b)(1), chapter and as a pH control agent as the ingredient is used in food with no defined in § 170.3(o)(23) 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 cheeses as defined in § 170.3(n)(5) of this human food ingredient is based upon chapter and jams and jellies as defined the following current good manufac- in § 170.3(n)(28) of this chapter. turing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as an emul- different from the uses established in sifier as defined in § 170.3(o)(8) of this this section do not exist or have been chapter and as a pH control agent as waived. defined in § 170.3(o)(23) of this chapter. [48 FR 52447, Nov. 18, 1983] (2) The ingredient is used in the following foods at levels not to exceed § 184.1807 Sodium thiosulfate. current good manufacturing practice: (a) Sodium thiosulfate (Na2S2O3·5H2O, cheeses as defined in§ 170.3(n)(5) of this CAS Reg. No. 010102–0917–097) is also chapter; fats and oils as defined in known as sodium hyposulfite. It is pre- § 170.3(n)(12) of this chapter; and jams pared synthetically by the reaction of and jellies as defined in § 170.3(n)(28) of sulfides and sulfur dioxide (SO2), the this chapter. reaction of sulfur and sulfite, or the ox- (d) Prior sanctions for this ingredient idation of metal sulfides and different from the uses established in hydrosulfides. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the ‘‘Food Chemicals [48 FR 52447, Nov. 18, 1983] Codex,’’ 3d Ed. (1981), p. 304, which is incorporated by reference. Copies may be § 184.1804 Sodium potassium tartrate. obtained from the National Academy (a) Sodium potassium tartrate Press, 2101 Constitution Ave. NW., (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– Washington, DC 20418, or may be exam- 6) is the sodium potassium salt of ined at the Office of the Federal Reg- L¥(+)¥tartaric acid and is also called ister, 800 North Capitol Street, NW., the Rochelle salt. It occurs as colorless suite 700, Washington, DC 20408. crystals or as a white, crystalline pow- (c) The ingredient is used as a formu- der and has a cooling saline taste. It is lation aid as defined in § 170.3(o)(14) of obtained as a byproduct of wine manu- this chapter and reducing agent as de- facture. fined in § 170.3(o)(22) of this chapter.

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(d) The ingredient is used in alco- as defined in § 170.3(o)(30) of this chap- holic beverages and table salt in ac- ter, and texturizer as defined in cordance with § 184.1(b)(1) at levels not § 170.3(o)(32) of this chapter. to exceed good manufacturing practice. (d) The ingredient is used in food at Current good manufacturing practice levels not to exceed good manufac- results in a maximum level, as served, turing practices. Current good manu- of 0.00005 percent for alcoholic bev- facturing practice in the use of sorbitol erages as defined in § 170.3(n)(2) of this results in a maximum level of 99 per- chapter and 0.1 percent for table salt as cent in hard candy and cough drops as defined in § 170.3(n)(26) of this chapter. defined in § 170.3(n)(25) of this chapter, (e) Prior sanctions for this ingredient 75 percent in chewing gum as defined in different from the uses established in § 170.3(n)(6) of this chapter, 98 percent this section do not exist or have been in soft candy as defined in § 170.3(n)(38) waived. of this chapter, 30 percent in nonstandardized jams and jellies, commer- [43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984] cial, as defined in § 170.3(n)(28) of this chapter, 30 percent in baked goods and § 184.1835 Sorbitol. baking mixes as defined in § 170.3(n)(1) (a) Sorbitol is the chemical 1,2,3,4,5,6- of this chapter, 17 percent in frozen dairy desserts and mixes as defined in hexanehexol (C6H14O6), a hexahydric alcohol, differing from mannitol prin- § 170.3(n)(20) of this chapter, and 12 per- cipally by having a different optical ro- cent in all other foods. tation. Sorbitol is produced by the (e) The label and labeling of food electrolytic reduction, or the transi- whose reasonably foreseeable consumption metal catalytic hydrogenation of tion may result in a daily ingestion of sugar solutions containing glucose or 50 grams of sorbitol shall bear the fructose. statement: ‘‘Excess consumption may (b) The ingredient meets the speci- have a laxative effect.’’ fications of the ‘‘Food Chemicals (f) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), p. 308, which is in- different from the uses established in corporated by reference. Copies may be this regulation do not exist or have obtained from the National Academy been waived. Press, 2101 Constitution Ave. NW., [42 FR 14653, Mar. 15, 1977, as amended at 49 Washington, DC 20418, or may be exam- FR 5613, Feb. 14, 1984] ined at the Office of the Federal Reg- ister, 800 North Capitol Street, NW., § 184.1845 Stannous chloride (anhy- suite 700, Washington, DC 20408. drous and dihydrated). (c) The ingredient is used as an (a) Stannous chloride is anhydrous or anticaking agent and free-flow agent as contains two molecules of water of hy- defined in § 170.3(o)(1) of this chapter, dration. Anhydrous stannous chloride curing and pickling agent as defined in (SnCl2, CAS Reg. No. 7772–99–8) is the § 170.3(o)(5) of this chapter, drying chloride salt of metallic tin. It is pre- agent as defined in § 170.3(o)(7) of this pared by reacting molten tin with ei- chapter, emulsifier and emulsifier salt ther chlorine or gaseous tin tetra- as defined in § 170.3(o)(8) of this chap- chloride. Dihydrated stannous chloride ter, firming agent as defined in (SnCl2·2H2O, CAS Reg. No. 10025–0969– § 170.3(o)(10) of this chapter, flavoring 091) is the chloride salt of metallic tin agent and adjuvant as defined in that contains two molecules of water. § 170.3(o)(12) of this chapter, formula- It is prepared from granulated tin sus- tion aid as defined in § 170.3(o)(14) of pended in water and hydrochloric acid this chapter, humectant as defined in or chlorine. § 170.3(o)(16) of this chapter, lubricant (b) Both forms of the ingredient meet and release agent as defined in the specifications of the Food Chemi- § 170.3(o)(18) of this chapter, nutritive cals Codex, 3d Ed. (1981), p. 312, which is sweetener as defined in § 170.3(o)(21) of incorporated by reference. Copies are this chapter, sequestrant as defined in available from the National Academy § 170.3(o)(26) of this chapter, stabilizer Press, 2101 Constitution Ave. NW., and thickener as defined in § 170.3(o)(28) Washington, DC 20418, or available for of this chapter, surface-finishing agent inspection at the Office of the Federal

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Register, 800 North Capitol Street, (2) The ingredient is used in food at NW., suite 700, Washington, DC 20408. levels not to exceed current good man- (c) The ingredient is used as an anti- ufacturing practice. oxidant as defined in § 170.3(o)(3) of this (d) Prior sanctions for this ingredient chapter. different from the uses established in (d) 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 in accordance with [48 FR 51907, Nov. 15, 1983] § 184.(b)(1). Current good manufacturing practice results in a maximum level, as § 184.1851 Stearyl citrate. served, of 0.0015 percent or less; cal- (a) Stearyl citrate is a mixture of the culated as tin, for all food categories. mono-, di-, and tristearyl esters of cit- (e) Prior sanctions for this ingredient ric acid. It is prepared by esterifying different from those uses established in citric acid with stearyl alcohol. this section do not exist or have been (b) The Food and Drug Administra- waived. tion, in cooperation with the National Academy of Sciences, is developing [47 FR 27816, June 25, 1982] food-grade specifications for stearyl citrate. In the interim, this ingredient § 184.1848 Starter distillate. must be of a purity suitable for its in- (a) Starter distillate (butter starter tended use. distillate) is a steam distillate of the (c) In accordance with § 184.1(b)(1), culture of any or all of the following the ingredient is used in food with no species of bacteria grown on a medium limitation other than current good consisting of skim milk usually for- manufacturing practice. The affirma- tified with about 0.1 percent citric acid: tion of this ingredient as generally rec- Streptococcus lactis, S. cremoris, S. lactis ognized as safe (GRAS) as a direct subsp. diacetylactis, Leuconostoc human food ingredient is based upon citrovorum, and L. dextranicum. The in- the following current good manufac- gredient contains more than 98 percent turing practice conditions of use: water, and the remainder is a mixture (1) The ingredient is used as an anti- of butterlike flavor compounds. Diace- oxidant as defined in § 170.3(o)(3) of this tyl is the major flavor component, con- chapter; an emulsifier and emulsifier stituting as much as 80 to 90 percent of salt as defined in § 170.3(o)(8) of this the mixture of organic flavor com- chapter; a sequestrant as defined in pounds. Besides diacetyl, starter dis- § 170.3(o)(26) of this chapter; and a sur- tillate contains minor amounts of acet- face-active agent as defined in aldehyde, ethyl formate, ethyl acetate, § 170.3(o)(29) of this chapter. acetone, ethyl alcohol, 2-butanone, (2) The ingredient is used in mar- acetic acid, and acetoin. garine in accordance with § 166.110 of (b) FDA is developing food-grade this chapter; in nonalcoholic beverages specifications for starter distillate in as defined in § 170.3(n)(3) of this chap- cooperation with the National Acad- ter; and in fats and oils as defined in emy of Sciences. In the interim, this § 170.3(n)(12) of this chapter at levels ingredient must be of a purity suitable not to exceed current good manufac- for its intended use. turing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section, or different from those set manufacturing practice. The affirma- forth in part 181 of this chapter, do not tion of this ingredient as generally rec- exist or have been waived. ognized as safe (GRAS) as a direct [59 FR 63897, Dec. 12, 1994] human food ingredient is based upon the following current good manufac- § 184.1854 Sucrose.

turing practice conditions of use: (a) Sucrose (C12H22O11, CAS Reg. No. (1) The ingredient is used as a fla- 57–50–11–1) sugar, cane sugar, or beet voring agent and adjuvant as defined in sugar is the chemical b-D- § 170.3(o)(12) of this chapter. fructofuranosyl-a-D-glucopyranoside. 546

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Sucrose is obtained by crystallization or partly inverted, refined or partly re- from sugar cane or sugar beet juice fined sucrose, the solids of which con- that has been extracted by pressing or tain not more than 0.3 percent by diffusion, then clarified and evapo- weight of ash. The solution is colorless, rated. odorless, and flavorless, except for (b) FDA is developing food-grade sweetness. It is produced by the hydrol- specifications for sucrose in coopera- ysis or partial hydrolysis of sucrose tion with the National Academy of with safe and suitable acids or en- Sciences. In the interim, this ingre- zymes. dient must be of a purity suitable for its intended use. (b) FDA is developing food-grade (c) In accordance with § 184.1(b)(1), specifications for invert sugar in co- the ingredient is used in food with no operation with the National Academy limitation other than current good of Sciences. In the interim, this ingre- manufacturing practice. dient must be of a purity suitable for (d) Prior sanctions for this ingredient 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 [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, manufacturing practice. 1989] (d) Prior sanctions for this ingredient different from the uses established in § 184.1857 Corn sugar. this section do not exist or have been

(a) Corn sugar (C6H12O6, CAS Reg. No. waived. 50–99–7), commonly called D-glucose or dextrose, is the chemical -D- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, a 1989] glucopyranose. It occurs as the anhydrous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of corn starch with safe and suitable acids (a) Corn syrup, commonly called or enzymes, followed by refinement and ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is crystallization from the resulting hy- obtained by partial hydrolysis of corn drolysate. starch with safe and suitable acids or (b) The ingredient meets the speci- enzymes. It may also occur in the de- fications of the Food Chemicals Codex, hydrated form (dried glucose sirup). 3d Ed. (1981), pp. 97–98 under the head- Depending on the degree of hydrolysis, ing ‘‘Dextrose,’’ which is incorporated corn syrup may contain, in addition to by reference in accordance with 5 glucose, maltose and higher U.S.C. 552(a) and 1 CFR part 1. Copies saccharides. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave., NW., fications as defined and determined in Washington, DC 20418, or available for § 168.120(b) or § 168.121(a) of this chapter, inspection at the Office of the Federal Register, 800 North Capitol Street, as appropriate. FDA, in cooperation NW., suite 700, Washington, DC 20408. with the National Academy of (c) In accordance with § 184.1(b)(1), Sciences, is undertaking a study to de- the ingredient is used in food with no termine if additional food-grade speci- limitation other than current good fications for corn syrup are necessary. 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. waived. (d) Prior sanctions for this ingredient [53 FR 44876, Nov. 7, 1988] different from the uses established in this section do not exist or have been § 184.1859 Invert sugar. waived. (a) Invert sugar (CAS Reg. No. 8013– [53 FR 44876, Nov. 7, 1988] 17–0) is an aqueous solution of inverted

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§ 184.1866 High fructose corn syrup. spection at the Office of the Federal Register, 800 North Capitol Street, (a) High fructose corn syrup, a sweet, NW., suite 700, Washington, DC 20408. nutritive saccharide mixture con- (c) In accordance with § 184.1(b)(1), taining either approximately 42 or 55 the ingredient is used in food with no percent fructose, is prepared as a clear limitation other than current good aqueous solution from high dextrose- manufacturing practice. The affirma- equivalent corn starch hydrolysate by tion of this ingredient as generally rec- partial enzymatic conversion of glu- ognized as safe (GRAS) as a direct cose (dextrose) to fructose using an in- human food ingredient is based upon soluble glucose isomerase enzyme prep- the following current good manufac- aration described in § 184.1372. The turing practice conditions of use: product containing more than 50 per- (1) The ingredient is used as a fla- cent fructose (dry weight) is prepared voring agent and adjuvant as defined in through concentration of the fructose § 170.3(o)(12) of this chapter or as a nu- portion of the mixture containing less trient supplement as defined in than 50 percent fructose. § 170.3(o)(20) of this chapter. (b) The ingredient shall conform to (2) The ingredient is used in food at the identity and specifications listed in levels not to exceed current good man- the monograph entitled ‘‘High-Fruc- ufacturing practice. Thiamine hydro- tose Corn Syrup’’ in the Food Chemi- chloride may be used in infant formula cals Codex, 4th ed. (1996), pp. 191–192, in accordance with section 412(g) of the which is incorporated by reference in Federal Food, Drug, and Cosmetic Act accordance with 5 U.S.C. 552(a) and 1 (the Act) or with regulations promul- CFR part 51. Copies are available from gated under section 412(a)(2) of the Act. the Office of Premarket Approval, Cen- (d) Prior sanctions for this ingredient ter for Food Safety and Applied Nutri- different from the uses established in tion (HFS–200), Food and Drug Admin- this section do not exist or have been istration, 5100 Paint Branch Pkwy., waived. College Park, MD 20740, or may be examined at the Center for Food Safety [48 FR 55124, Dec. 9, 1983] and Applied Nutrition’s Library, 200 C § 184.1878 Thiamine mononitrate. St. SW., Washington, DC, or at the Of- fice of the Federal Register, 800 North (a) Thiamine mononitrate Capitol St. NW., suite 700, Washington, (C12H17N5O4S, CAS Reg. No. 532–43–4) is DC. the mononitrate salt of thiamine. It (c) In accordance with § 184.1(b)(1), occurs as white crystals or a white the ingredient is used in food with no crystalline powder and is prepared limitation other than current good from thiamine hydrochloride by dis- manufacturing practice. solving the hydrochloride salt in alkaline solution followed by precipitation [61 FR 43450, Aug.23, 1996] of the nitrate half-salt with a stoichio- metric amount of nitric acid. § 184.1875 Thiamine hydrochloride. (b) The ingredient meets the speci- (a) Thiamine hydrochloride fications of the Food Chemicals Codex, (C12H17C1N4OS·HCl, CAS Reg. No. 67–03– 3d Ed. (1981), p. 325, which is incor- 8) is the chloride-hydrochloride salt of porated by reference. Copies are avail- thiamine. It occurs as hygroscopic able from the National Academy Press, white crystals or a white crystalline 2101 Constitution Ave. NW., Wash- powder. The usual method of preparing ington, DC 20418, or available for in- this substance is by linking the spection at the Office of the Federal preformed thiazole and pyrimidine ring Register, 800 North Capitol Street, systems. NW., suite 700, Washington, DC 20408. (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. 324, 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

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the following current good manufac- (2) The ingredients are used in pump- turing practice conditions of use: cured bacon at levels not to exceed cur- (1) The ingredient is used as a nutri- rent good manufacturing practice. ent supplement as defined in [49 FR 13348, Apr. 4, 1984] § 170.3(o)(20) of this chapter. (2) The ingredient is used in food at § 184.1901 Triacetin. levels not to exceed current good man- (a) Triacetin (C8 H14O6, CAS Reg. No. ufacturing practice. Thiamine mono- 102–76–1), also known as 1,2,3,- nitrate may be used in infant formula propanetriol triacetate or glyceryl in accordance with section 412(g) of the triacetate, is the triester of glycerin Federal Food, Drug, and Cosmetic Act and acetic acid. Triacetin can be pre- (the Act) or with regulations promul- pared by heating glycerin with acetic gated under section 412(a)(2) of the Act. anhydride alone or in the presence of (d) Prior sanctions for this ingredient finely divided potassium hydrogen sul- different from the uses established in fate. It can also be prepared by the re- this section do not exist or have been action of oxygen with a liquid-phase waived. mixture of allyl acetate and acetic acid [48 FR 55124, Dec. 9, 1983] using a bromide salt as a catalyst. (b) The ingredient meets the speci- § 184.1890 α-Tocopherols. fications of the Food Chemicals Codex, 3d Ed. (1981), pp. 337–338, as revised by (a) The -tocopherols that are the a the First Supplement to the 3d Ed., subject of this GRAS affirmation regu- which is incorporated by reference in lation are limited to the following: accordance with 5 U.S.C. 552(a). Copies (1) d-a-Tocopherol (CAS Reg. No. 59– are available from the National Acad- ′ 02–9) is the chemical [2R,4 R,8prime;R]- emy Press, 2102 Constitution Ave., NW., ′ ′ ′ 2,5,7,8-tetramethyl-2-(4 ,8 ,12 -trimethyl- Washington, DC 20418, or available for tridecyl)-6-chromanol. It occurs com- inspection at the Office of the Federal mercially as a concentrate and is a red, Register, 800 North Capitol Street, nearly odorless, viscous oil. It is ob- NW., suite 700, Washington, DC 20005. tained by vacuum steam distillation of (c) In accordance with § 184.1(b)(1), edible vegetable oil products. the ingredient is used in food with no (2) dl-a-Tocopherol (CAS Reg. No. limitation other than current good 10191–41–0) is a mixture of manufacturing practice. The affirma- stereoisomers of 2,5,7,8-tetramethyl-2- tion of this ingredient as generally rec- (4′,8′,12′-trimethyl-tridecyl)-6- ognized as safe (GRAS) as a direct chromanol. It is chemically syn- human food ingredient is based upon thesized by condensing racemic the following current good manufac- isophytol with trimethyl hydro- turing practice conditions of use: quinone. It is a pale yellow viscous oil (1) The ingredient is used in food as a at room temperature. flavoring agent and adjuvant as defined (b) The ingredients meet the speci- in § 170.3(o)(12) of this chapter; a formu- fications of the Food Chemicals Codex, lation aid as defined in § 170.3(o)(14) of 3d Ed. (1981), pp. 330–331, which is incor- this chapter; and humectant as defined porated by reference. Copies are avail- in § 170.3(o)(16) of this chapter; and a able from the National Academy Press, solvent and vehicle as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(27) of this chapter. ington, DC 20418, or available for in- (2) The ingredient is used in the fol- spection at the Office of the Federal lowing foods at levels not to exceed Register, 800 North Capitol Street, current good manufacturing practice: NW., suite 700, Washington, DC 20408. baked goods and baking mixes as de- (c) In accordance with § 184.1(b)(3), fined in § 170.3(n)(1) of this chapter, al- the affirmation of the ingredients as coholic beverages as defined in generally recognized as safe is limited § 170.3(n)(2) of this chapter; non- to the following conditions of use while alcoholic beverages and beverage bases the agency concludes the general eval- as defined in § 170.3(n)(3) of this chap- uation of all food uses of tocopherols: ter; chewing gum as defined in (1) The ingredients are used as inhibi- § 170.3(n)(6) of this chapter; confections tors of nitrosamine formation. and frostings as defined in § 170.3(n)(9)

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of this chapter; frozen dairy dessert (d) Prior sanctions for this ingredient and mixes as defined in § 170.3(n)(20) of different from the uses established in this chapter; gelatins, puddings, and this section do not exist or have been fillngs as defined in § 170.3(n)(22) of this waived. chapter; hard candy as defined in [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, § 170.3(n)(25) of this chapter; and soft 1989] candy as defined in § 170.3(n)(38) of this chapter. § 184.1911 Triethyl citrate. (d) Prior sanctions for this ingredient different from the uses established in (a) Triethyl citrate (C12H20O7, CAS this section do not exist or have been Reg. No. 77–93–0) is the triethyl ester of waived. citric acid. It is prepared by esterifying citric acid with ethyl alcohol and oc- [54 FR 7404, Feb. 21, 1989] curs as an odorless, practically colorless, oily liquid. § 184.1903 Tributyrin. (b) The ingredient meets the speci- (a) Tributyrin (C15H26O6, CAS Reg. fications of the Food Chemicals Codex, No. 60–01–5), also known as butyrin or 3d ed. (1981), p. 339, which is incor- glyceryl tributyrate, is the triester of porated by reference in accordance glycerin and butyric acid. It is pre- with 5 U.S.C. 552(a) and 1 CFR part 51. pared by esterification of glycerin with Copies are available from the National excess butyric acid. Academy Press, 2101 Constitution Ave. (b) The ingredient meets the speci- NW., Washington, DC 20418, and the fication of the Food Chemicals Codex, Center for Food Safety and Applied Nu- 3d Ed. (1981), p. 416, which is incor- trition (HFS–200), 5100 Paint Branch porated by reference in accordance Pkwy., College Park, MD 20740, or may with 5 U.S.C. 552(a). Copies are avail- be examined at the Office of the Fed- able from the National Academy Press, eral Register, 800 North Capitol St. 2101 Constitution Ave. NW., Wash- NW., suite 700, Washington, DC. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the Office of the Federal the ingredient is used in food with no Register, 800 North Capitol Street, limitation other than current good NW., suite 700, Washington, DC 20005. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The affirma- the following current good manufac- tion of this ingredient as generaly rec- turing practice conditions of use: ognized as safe (GRAS) as a direct (1) The ingredient is used as a fla- human food ingredient is based upon voring agent as defined in § 170.3(o)(12) the following current good manufac- of this chapter; a solvent and vehicle as turing practice conditions of use: defined in § 170.3(o)(27) of this chapter; (1) The ingredient is used in food as a and a surface-active agent as defined in flavoring agent and adjuvant as defined § 170.3(o)(29) of this chapter. in § 170.3(o)(12) 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; alcoholic beverages as de- this section, or different from those set fined in § 170.3(n)(2) of this chapter; forth in part 181 of this chapter, do not nonalcoholic beverages as defined in exist or have been waived. § 170.3(n)(3) of this chapter; fats and oils as defined in § 170.3(n)(12) of this chap- [59 FR 63897, Dec. 12, 1994] ter; frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter; § 184.1914 Trypsin. gelatins, puddings and fillngs as de- (a) Trypsin (CAS Reg. No. 9002–07–7) fined in § 170.3(n)(22) of this chapter; is an enzyme preparation obtained and soft candy as defined in from purified extracts of porcine or bo- § 170.3(n)(38) of this chapter. vine pancreas. It is a white to tan

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amorphous powder. Its characterizing (1) The ingredient is used as a formu- enzyme activity is that of a peptide hy- lation aid as defined in § 170.3(o)(14) of drolase (EC 3.4.21.4). this chapter and as a fermentation aid. (b) The ingredient meets the general (2) The ingredient is used in yeast- requirements and additional require- raised bakery products; in alcoholic ments for enzyme preparations in the beverages as defined in § 170.3(n)(2) of Food Chemicals Codex, 3d ed. (1981), p. this chapter; and in gelatin products. 110, which is incorporated by reference (d) Prior sanctions for this ingredient in accordance with 5 U.S.C. 552(a) and 1 different from the uses established in CFR part 51. Copies are available from this section do not exist or have been the National Academy Press, 2101 Con- waived. stitution Ave. NW., Washington, DC [48 FR 51616, Nov. 10, 1983, as amended at 49 20418, or may be examined at the Office FR 19816, May 10, 1984] of Premarket Approval (HFS–200), Food and Drug Administration, 200 C St. § 184.1924 Urease enzyme preparation from Lactobacillus fermentum. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol (a) This enzyme preparation is de- St. NW., suite 700, Washington, DC. rived from the nonpathogenic, (c) In accordance with § 184.1(b)(1), nontoxicogenic bacterium Lactobacillus the ingredient is used in food with no fermentum. It contains the enzyme limitation other than current good urease (CAS Reg. No. 9002–13–5), which manufacturing practice. The affirma- facilitates the hydrolysis of urea to ammonia and carbon dioxide. It is pro- tion of this ingredient as GRAS as a di- duced by a pure culture fermentation rect food ingredient is based upon the process and by using materials that are following current good manufacturing generally recognized as safe (GRAS) or practice conditions of use: are food additives that have been ap- (1) The ingredient is used as an en- proved for this use by the Food and zyme as defined in § 170.3(o)(9) of this Drug Administration (FDA). chapter to hydrolyze proteins or (b) The ingredient meets the general polypeptides. and additional requirements for en- (2) The ingredient is used in food at zyme preparations in the ‘‘Food Chemi- levels not to exceed current good man- cals Codex,’’ 3d ed. (1981), pp. 107–110, ufacturing practice. which is incorporated by reference in [60 FR 32911, June 26, 1995] accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from § 184.1923 Urea. the National Academy Press, 2101 Con- stitution Ave. NW., Washington, DC (a) Urea (CO(NH ) CAS Reg. No. 57– 2 2, 20418, or available for inspection at the 13–6) is the diamide of carbonic acid Office of the Federal Register, 800 and is also known as carbamide. It is a North Capitol St. NW., suite 700, Wash- white, odorless solid and is commonly ington, DC. produced from CO2 by ammonolysis or (c) In accordance with § 184.1(b)(1), from cyanamide by hydrolysis. the ingredient is used in food with no (b) FDA is developing food-grade limitation other than current good specifications for urea in cooperation manufacturing practice. The affirma- with the National Academy of tion of this ingredient as GRAS as a di- Sciences. In the interim, this ingre- rect human food ingredient is based dient must be of a purity suitable for upon the following current good manu- its intended use. facturing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used in wine, as the ingredient is used in food with no defined in 27 CFR 2.5 and 4.10, as an en- limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. The affirma- chapter to convert urea to ammonia tion of this ingredient as generally rec- and carbon dioxide. ognized as safe as a direct human food (2) The ingredient is used in food at ingredient is based upon the following levels not to exceed current good man- current good manufacturing practice ufacturing practice. Current good man- conditions of use: ufacturing practice is limited to use of

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this ingredient in wine to inhibit for- this section do not exist or have been mation of ethyl carbamate. waived. [57 FR 60473, Dec. 21, 1992] [48 FR 51610, Nov. 10, 1983]

§ 184.1930 Vitamin A. § 184.1945 Vitamin B12. (a)(1) Vitamin A (retinol; CAS Reg. (a) Vitamin B12, also known as cyano- No. 68–26–8) is the alcohol 9,13-di- cobalamin (C63H88CoN14O14P, CAS Reg. methyl-7-(1,1,5-trimethyl-6-cyclohexen- No. 68–0919–099), is produced commercially from cultures of Streptomyces 5-yl)-7,9,11,13-nonatetraen-15-ol. It may griseus. be nearly odorless or have a mild fishy (b) The ingredient meets the speci- odor. Vitamin A is extracted from fish fications of the Food Chemicals Codex, liver oils or produced by total syn- 3d Ed. (1981), p. 343, which is incor- thesis from b-ionone and a propargyl porated by reference. Copies are avail- halide. able from the National Academy Press, (2) Vitamin A acetate (retinyl ace- 2101 Constitution Ave. NW., Wash- tate; CAS Reg. No. 127–47–9) is the ace- ington, DC 20418, or available for in- tate ester of retinol. It is prepared by spection at the Office of the Federal esterifying retinol with acetic acid. Register, 800 North Capitol Street, (3) Vitamin A palmitate (retinyl NW., suite 700, Washington, DC 20408. palmitate; CAS Reg. No. 79–81–2) is the (c) In accordance with § 184.1(b)(1), palmitate ester of retinol. It is pre- the ingredient is used in food with no pared by esterifying retinol with pal- limitation other than current good mitic acid. manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications for vitamin A in the Food ognized as safe (GRAS) as a direct Chemicals Codex, 3d Ed. (1981), p. 342, human food ingredient is based upon which is incorporated by reference. the following current good manufac- Copies are available from the National turing practice conditions of use: Academy Press, 2101 Constitution Ave. (1) The ingredient is used as a nutri- NW., Washington, DC 20418, or avail- ent supplement as defined in § 170.3(o)(20) of this chapter. able for inspection at the Office of the (2) The ingredient is used in food at Federal Register, 800 North Capitol levels not to exceed current good man- Street, NW., suite 700, Washington, DC ufacturing practice. Vitamin B12 also 20408. 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: [50 FR 6341, Feb. 15, 1985] (1) The ingredient is used in food as a nutrient supplement as defined in § 184.1950 Vitamin D. § 170.3(o)(20) of this chapter. (a) Vitamin D is added to food as the (2) The ingredient is used in foods at following food ingredients: levels not to exceed current good man- (1) Crystalline vitamin D2 (C28H44O, ufacturing practice. Vitamin A may be CAS Reg. No. 50–14–6), also known as used in infant formula in accordance ergocalciferol, is the chemical 9,10- with section 412(g) of the Federal Food, seco(5Z,7E,22E)-5,7,10(19),22- Drug, and Cosmetic Act (the act) or ergostatetraen-3-ol. The ingredient is with regulations promulgated under produced by ultraviolet irradiation of section 412(a)(2) of the Act. ergosterol isolated from yeast and re- (d) Prior sanctions for this ingredient lated fungi and is purified by crys- different from the uses established in tallization.

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(2) Crystalline vitamin D3 (C27H44O, (2) Vitamin D may be used in infant CAS Reg. No. 67–97–0), also known as formula in accordance with section cholecalciferol, is the chemical 9,10- 412(g) of the Federal Food, Drug, and seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- Cosmetic Act (the act) or with regula- ol. Vitamin D3 occurs in, and is iso- tions promulgated under section lated from, fish liver oils. It is also 412(a)(2) of the act. manufactured by ultraviolet irradia- (3) Vitamin D may be used in mar- tion of 7-dehydrocholesterol produced garine in accordance with § 166.110 of from cholesterol. It is purified by crys- this chapter. (d) Prior sanctions for these ingredi- tallization. Vitamin D3 is the vitamin D form that is produced endogenously ents different from the uses established in humans through sunlight activation in this section do not exist or have of 7-dehydrocholesterol in the skin. been waived.

(3) Vitamin D2 resin and vitamin D3 [50 FR 30152, July 24, 1985] resin are the concentrated forms of ir- § 184.1973 Beeswax (yellow and white). radiated ergosterol (D2) and irradiated 7-dehydrocholesterol (D3) that are sepa- (a) Beeswax (CAS Reg. No. 8012–89–3) rated from the reacting materials in is a secretory product of honey bees paragraphs (a) (1) and (2) of this sec- used as a structural material in honey- tion. The resulting products are sold as combs. Beeswax is prepared from hon- food sources of vitamin D without fur- eycombs after removal of the honey by ther purification. draining or centrifuging. The combs are melted in hot water or steam or (b) Vitamin D2 and vitamin D3 as crystals meet the specifications of the with solar heat, and strained. The wax Food Chemicals Codex, 3d Ed. (1981), is refined by melting in hot water to which sulfuric acid or alkali may be pp. 344 and 345, which is incorporated added to extract impurities. The re- by reference. Copies are available from sulting wax is referred to as yellow the National Academy Press, 2101 Con- beeswax. White beeswax is produced by stitution Ave. NW., Washington, DC bleaching the constituent pigments of 20418, or available for inspection at the yellow beeswax with peroxides, or pref- Office of the Federal Register, 800 erably it is bleached by sun light. North Capitol Street, NW., suite 700, (b) The ingredient meets the speci- Washington, DC 20408. FDA is devel- fications of the ‘‘Food Chemicals oping food-grade specifications for vi- Codex,’’ 3d Ed. (1981), pp. 34–35, which is tamin D2 resin and vitamin D3 resin in incorporated by reference. Copies may cooperation with the National Acad- be obtained from the National Acad- emy of Sciences. In the interim, these emy Press, 2101 Constitution Ave. NW., resins must be of a purity suitable for Washington, DC 20418, or may be exam- their intended use. ined at the Office of the Federal Reg- (c)(1) In accordance with § 184.1(b)(2), ister, 800 North Capitol Street, NW., the ingredients are used in food as the suite 700, Washington, DC 20408. sole source of added vitamin D only (c) The ingredient is used as a fla- within the following specific limita- voring agent and adjuvant as defined in tions: § 170.3(o)(12) of this chapter, as a lubricant as defined in § 170.3(o)(18) of this Maximum levels in Category of food food (as served) Functional use chapter, and as a surface-finishing agent as defined in § 170.3(o)(30) of this Breakfast cereals, 350 (IU/100 Nutrient supple- chapter. ¤ 170.3(n)(4) of grams) . ment, (d) The ingredient is used in food, in this chapter . ¤ 170.3(o)(20) of this chapter. accordance with § 184.1(b)(1) of this Grain products and 90(IU/100 grams) Do. chapter, at levels not to exceed good pastas, manufacturing practice. Current good ¤ 170.3(n)(23) of manufacturing practice results in a this chapter . Milk, ¤ 170.3(n)(30) 42 (IU/100 grams) Do. maximum level, as served, of: 0.065 per- of this chapter . cent for chewing gum as defined in Milk products, 89 (IU/100 grams) Do. § 170.3(n)(6) of this chapter; 0.005 per- ¤ 170.3(n)(31) of cent for confections and frostings as this chapter . defined in § 170.3(n)(9) of this chapter;

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0.04 percent for hard candy as defined § 184.1978 Carnauba wax. in § 170.3(n)(25) of this chapter; 0.1 per- (a) Carnauba wax (CAS Reg. No. 008– cent for soft candy as defined in 015–869) is obtained from the leaves and § 170.3(n)(38) of this chapter; and 0.002 buds of the Brazilian wax palm percent or less for all other food cat- Copernicia cerifera Martius. The wax is egories. hard, brittle, sparingly soluble in cold [43 FR 14644, Apr. 7, 1978, as amended at 49 organic solvents and insoluble in FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, water. It is marketed in five grades 1985] designated No. 1 through No. 5. Grades No. 4 and No. 5 represent the bulk of § 184.1976 Candelilla wax. the commercial trade volume. These (a) Candelilla wax (CAS Reg. No. commercial grades consist chiefly of 8006–44–8) is obtained from the can- C24 to C32 normal saturated delilla plant. It is a hard, yellowish- monofunctional fatty acids and normal brown, opaque-to-translucent wax. saturated monofunctional primary al- Candelilla wax is prepared by immers- cohols. ing the plants in boiling water con- (b) The ingredient meets the speci- taining sulfuric acid and skimming off fications of the Food Chemicals Codex, the wax that rises to the surface. It is 3d Ed. (1981), p. 73, which is incor- composed of about 50 percent hydro- porated by reference. Copies are avail- carbons with smaller amounts of esters able from the National Academy Press, and free acids. 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 Office of the Federal 3d Ed. (1981), p. 67, which is incor- Register, 800 North Capitol Street, porated by reference. Copies are avail- NW., suite 700, Washington, DC 20408. 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 Office of the Federal manufacturing practice. The affirma- Register, 800 North Capitol Street, tion of this ingredient as generally rec- NW., suite 700, Washington, DC 20408. 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: (1) The ingredient is used as an manufacturing practice. The affirma- anticaking agent as defined § 170.3(o)(1) tion of this ingredient as generally rec- of this chapter; as a formulation aid as ognized as safe (GRAS) as a direct defined in § 170.3(o)(14) of this chapter; human food ingredient is based upon as a lubricant and release agent as de- the following current good manufac- fined in § 170.3(o)(18) of this chapter; turing practice conditions of use: and as a surface-finishing agent as de- (1) The ingredient is used as a lubri- fined in § 170.3(o)(30) of this chapter. cant as defined in § 170.3(o)(18) of this (2) The ingredient is used in the fol- chapter and as a surface-finishing lowing foods at levels not to exceed agent as defined in § 170.3(o)(30) of this current good manufacturing practice: 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; lowing foods at levels not to exceed chewing gun as defined in § 170.3(n)(6) of current good manufacturing practice: this chapter; confections and frostings in chewing gum as defined in as defined in § 170.3(n)(9) of this chap- § 170.3(n)(6) of this chapter and in hard ter; fresh fruits and fruit juices as de- candy as defined in § 170.3(n)(25) of this fined in § 170.3(n)(16) of this chapter; chapter. gravies and sauces as defined in (d) Prior sanctions for this ingredient § 170.3(n)(24) of this chapter; processed different from the uses established in fruits and fruit juices as defined in this section do not exist or have been § 170.3(n)(35) of this chapter; and soft waived. candy as defined in § 170.3(n)(38) of this [48 FR 51617, Nov. 10, 1983] chapter.

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(d) Prior sanctions for this ingredient istration, 200 C St. SW., Washington, different from the uses established in DC, or at the Office of the Federal Reg- this section do not exist or have been ister, 800 North Capitol St. NW., suite waived. 700, Washington, DC. [48 FR 51147, Nov. 7, 1983] (i) Protein content, 10 to 15 percent— as determined by the methods pre- § 184.1979 Whey. scribed in section 16.036 (liquid sample), entitled ‘‘Total Nitrogen—Official (a)(1) Whey. Whey is the liquid sub- Final Action’’ under the heading stance obtained by separating the co- agulum from milk, cream, or skim ‘‘Total Solids,’’ or in section 16.193 (dry milk in cheesemaking. Whey obtained sample), entitled ‘‘Kjeldahl Method’’ from a procedure, in which a signifi- under the heading ‘‘Protein—Official cant amount of lactose is converted to Final Action.’’ lactic acid, or from the curd formation (ii) Fat content, 0.2 to 2.0 percent—as by direct acidification of milk, is determined by the methods prescribed known as acid whey. Whey obtained in section 16.059 (liquid sample), from a procedure in which there is in- ‘‘Reese-Gottlieb Method [Reference significant conversion of lactose to lac- Method] (11)—Official Final Action’’ tic acid is known as sweet whey. Sweet under the heading ‘‘Fat,’’ or in section whey has a maximum titratable acid- 16.199 (dry sample), entitled ‘‘Fat in ity of not more than 0.16 percent, cal- Dried Milk (45)—Official Final Action.’’ culated as lactic acid, and an alka- (iii) Ash content, 7 to 14 percent—as linity of ash of not more than 225 milli- determined by the methods prescribed liters of 0.1N hydrochloric acid per 100 in section 16.035 (liquid sample), enti- grams. The acidity of whey, sweet or tled ‘‘Ash (5)—Official Final Action’’ acid, may be adjusted by the addition under the heading ‘‘Total Solids,’’ or in of safe and suitable pH-adjusting ingre- section 16.196 (dry sample), entitled dients. ‘‘Ash—Official Final Action’’ under the (2) Concentrated whey. Concentrated heading ‘‘Dried Milk, Nonfat Dry Milk, whey is the liquid substance obtained and Malted Milk.’’ by the partial removal of water from (iv) Lactose content, 61 to 75 per- whey, while leaving all other constitu- cent—as determined by the methods ents in the same relative proportions prescribed in section 16.057 (liquid sam- as in whey. ple), entitled ‘‘Gravimetric Method— (3) Dry or dried whey. Dry or dried Official Final Action’’ under the head- whey is the dry substance obtained by ing ‘‘Lactose,’’ or in section 31.061 (dry the removal of water from whey, while sample), entitled ‘‘Lane-Eynon General leaving all other constituents in the Volumetric Method’’ under the heading same relative proportions as in whey. ‘‘Lactose—Chemical Methods—Official (b) The ingredients meet the fol- Final Action.’’ lowing specifications: (v) Moisture content, 1 to 8 percent— (1) The analysis of whey, con- as determined by the methods pre- centrated whey, and dry (dried) whey, scribed in section 16.192, entitled on a dry product basis, based on ana- ‘‘Moisture (41)—Official Final Action’’ lytical methods in the referenced sec- under the heading ‘‘Dried Milk, Nonfat tions of ‘‘Official Methods of Analysis Dry Milk, and Malted Milk.’’ of the Association of Official Analyt- (vi) Solids content, variable—as de- ical Chemists,’’ 13th ed. (1980), which is termined by the methods prescribed in incorporated by reference in accord- section 16.032, entitled ‘‘Method I—Offi- ance with 5 U.S.C. 552(a) and 1 CFR cial Final Action’’ under the heading part 51, is given in paragraphs (b)(1)(i) ‘‘Total Solids.’’ through (b)(1)(vii) of this section. Cop- (vii) Titratable Acidity, variable—as ies may be obtained from the Associa- determined by the methods prescribed tion of Official Analytical Chemists in section 16.023, entitled ‘‘Acidity (2)— International, 481 North Frederick Official Final Action’’ under the head- Ave., suite 500, Gaithersburg, MD 20877– ing ‘‘Milk,’’ or by an equivalent poten- 2504, or may be examined at the Center tiometric method. for Food Safety and Applied Nutri- (2) Limits of impurities are: Heavy tion’s Library, Food and Drug Admin- metals (as lead). Not more than 10

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parts per million (0.001 percent) as de- may be adjusted by the addition of safe termined by the method described in and suitable pH-adjusting ingredients. the ‘‘Food Chemicals Codex,’’ 4th ed. (b) The reduced lactose whey meets (1996), pp. 760–761, which is incorporated the following specifications: by reference in accordance with 5 (1) The analysis of reduced lactose U.S.C. 552(a) and 1 CFR part 51. Copies whey, on a dry product basis, based on are available from the National Acad- analytical methods in the referenced emy Press, Box 285, 2101 Constitution sections of ‘‘Official Methods of Anal- Ave. NW., Washington, DC 20055 (Inter- ysis of the Association of Official Ana- net address ‘‘http://www.nap.edu’’), or lytical Chemists,’’ 13th ed. (1980), which may be examined at the Center for is incorporated by reference in accord- Food Safety and Applied Nutrition’s ance with 5 U.S.C. 552(a) and 1 CFR Library, Food and Drug Administra- part 51, is given in paragraphs (b)(1)(i) tion, 200 C St. SW., Washington, DC, or through (b)(1)(vii) of this section. Cop- at the Office of the Federal Register, ies may be obtained from the Associa- 800 North Capitol St. NW., suite 700, tion of Official Analytical Chemists Washington, DC. International, 481 North Frederick (3) The whey must be derived from Ave., suite 500, Gaithersburg, MD 20877– milk that has been pasteurized, or the 2504, or may be examined at the Center whey and modified whey product must for Food Safety and Applied Nutri- be subjected to pasteurization tech- tion’s Library, Food and Drug Admin- niques or its equivalent before use in istration, 200 C St. SW., Washington, food. DC, or at the Office of the Federal Reg- (c) Whey, concentrated whey, and dry ister, 800 North Capitol St. NW., suite (dried) whey may be used in food in ac- 700, Washington, DC. cordance with good manufacturing (i) Protein content, 16 to 24 percent— practice as indicated in § 184.1(b)(1). as determined by the methods pre- (d) The label on the whey form sold scribed in section 16.036 (liquid sample), to food manufacturers shall read as fol- entitled ‘‘Total Nitrogen—Official lows: Final Action’’ under the heading (1) For whey: ‘‘(Sweet or acid) whey’’ ‘‘Total Solids,’’ or in section 16.193 (dry or ‘‘whey (ll% titratable acidity). sample), entitled ‘‘Kjeldahl Method’’ (2) For concentrated whey: ‘‘Con- under the heading ‘‘Protein—Official centrated (sweet or acid) whey, ll% Final Action.’’ solids’’ or ‘‘Concentrated whey (ll% (ii) Fat content, 1 to 4 percent—as de- titratable acidity), ll% solids’’. termined by the methods prescribed in (3) For dry (dried) whey: ‘‘Dry (dried) section 16.059 (liquid sample), ‘‘Reese- (sweet or acid) whey’’ or ‘‘dry (dried) Gottlieb Method [Reference Method] whey, (ll% titratable acidity)’’. (11)—Official Final Action’’ under the heading ‘‘Fat,’’ or in section 16.199 (dry (e) Whey, concentrated whey, or dry sample), entitled ‘‘Fat in Dried Milk (dried) whey in a finished food product (45)—Official Final Action.’’ shall be listed as ‘‘whey.’’ (iii) Ash content, 11 to 27 percent—as [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, determined by the methods prescribed 1982, as amended at 54 FR 24899, June 12, 1989; in section 16.035 (liquid sample), enti- 64 FR 1760, Jan. 12, 1999] tled ‘‘Ash (5)—Official Final Action’’ under the heading ‘‘Total Solids,’’ or in § 184.1979a Reduced lactose whey. section 16.196 (dry sample), entitled (a) Reduced lactose whey is the sub- ‘‘Ash—Official Final Action’’ under the stance obtained by the removal of lac- heading ‘‘Dried Milk, Nonfat Dry Milk, tose from whey. The lactose content of and Malted Milk.’’ the finished dry product shall not ex- (iv) Lactose content, not more than ceed 60 percent. Removal of the lactose 60 percent—as determined by the meth- is accomplished by physical separation ods prescribed in section 16.057 (liquid techniques such as precipitation, filtra- sample), entitled ‘‘Gravimetric Meth- tion, or dialysis. As with whey, reduced od—Official Final Action’’ under the lactose whey can be used as a fluid, heading ‘‘Lactose,’’ or in section 31.061 concentrate, or a dry product form. (dry sample), entitled ‘‘Lane–Eynon The acidity of reduced lactose whey General Volumetric Method’’ under the

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heading ‘‘Lactose—Chemical Meth- actual percentage is based is supplied ods—Official Final Action.’’ to the food manufacturer. (v) Moisture content, 1 to 6 percent— (e) The presence of reduced lactose as determined by the method pre- whey in a finished food product shall be scribed in section 16.192, entitled listed as ‘‘reduced lactose whey.’’ ‘‘Moisture (41)—Official Final Action’’ [46 FR 44440, Sept. 4, 1981, as amended at 54 under the heading ‘‘Dried Milk, Nonfat FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, Dry Milk, and Malted Milk.’’ 1999] (vi) Solids content, variable—as determined by the methods prescribed in § 184.1979b Reduced minerals whey. section 16.032, entitled ‘‘Method I—Offi- (a) Reduced minerals whey is the sub- cial Final Action’’ under the heading stance obtained by the removal of a ‘‘Total Solids.’’ portion of the minerals from whey. The (vii) Titratable Acidity, variable—as dry product shall not contain more determined by the methods prescribed than 7 percent ash. Reduced minerals in section 16.023, entitled ‘‘Acidity (2)— whey is produced by physical separa- Official Final Action’’ under the head- tion techniques such as precipitation, ing ‘‘Milk,’’ or by an equivalent poten- filtration, or dialysis. As with whey, tiometric method. reduced minerals whey can be used as a (2) Limits of impurities are: Heavy fluid, concentrate, or a dry product metals (as lead). Not more than 10 form. The acidity of reduced minerals parts per million (0.001 percent), as de- whey may be adjusted by the addi- termined by the method described in tional of safe and suitable pH-adjusting the ‘‘Food Chemicals Codex,’’ 4th ed. ingredients. (1996), pp. 760–761, which is incorporated (b) The reduced minerals whey meets by reference in accordance with 5 the following specifications: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The analysis of reduced minerals are available from the National Acad- whey, on a dry product basis, based on emy Press, Box 285, 2101 Constitution analytical methods in the referenced Ave. NW., Washington, DC 20055 (Inter- sections of ‘‘Official Methods of Anal- net address ‘‘http://www.nap.edu’’), or ysis of the Association of Official Ana- may be examined at the Center for lytical Chemists,’’ 13th ed. (1980), which Food Safety and Applied Nutrition’s is incorporated by reference in accord- Library, Food and Drug Administra- ance with 5 U.S.C. 552(a) and 1 CFR tion, 200 C St. SW., Washington, DC, or part 51, is given in paragraphs (b)(1)(i) at the Office of the Federal Register, through (b)(1)(vii) of this section. Cop- 800 North Capitol St. NW., suite 700, ies may be obtained from the Associa- Washington, DC. tion of Official Analytical Chemists (3) The reduced lactose whey shall be International, 481 North Frederick derived from milk that has been pas- Ave., suite 500, Gaithersburg, MD 20877– teurized, or the reduced lactose whey 2504, or may be examined at the Center shall be subjected to pasteurization for Food Safety and Applied Nutri- techniques or its equivalent before use tion’s Library, Food and Drug Admin- in food. istration, 200 C St. SW., Washington, (c) Reduced lactose whey may be DC, or at the Office of the Federal Reg- used in food in accordance with good ister, 800 North Capitol St. NW., suite manufacturing practice as indicated in 700, Washington, DC. § 184.1(b)(1). (i) Protein content, 10 to 24 percent— (d) The percent of lactose present on as determined by the methods pre- a dry product basis, i.e., ‘‘reduced lac- scribed in section 16.036 (liquid sample), tose whey (ll% lactose),’’ shall be de- entitled ‘‘Total Nitrogen—Official clared on the label of the package sold Final Action’’ under the heading to food manufacturers. The percent of ‘‘Total Solids,’’ or in section 16.193 (dry lactose may be declared in 5-percent sample), entitled ‘‘Kjeldahl Method’’ increments, expressed as a multiple of under the heading ‘‘Protein—Official 5, not greater than the actual percent- Final Action.’’ age of lactose in the product, or as a (ii) Fat content, 1 to 4 percent—as de- actual percentage provided that an termined by the methods prescribed in analysis of the product on which the section 16.059 (liquid sample), ‘‘Reese-

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Gottlieb Method [Reference Method] 800 North Capitol St. NW., suite 700, (11)—Official Final Action’’ under the Washington, DC. heading ‘‘Fat,’’ or in section 16.199 (dry (3) The reduced minerals whey shall sample), entitled ‘‘Fat in Dried Milk be derived from milk that has been pas- (45)—Official Final Action.’’ teurized, or the reduced minerals whey (iii) Ash content, maximum 7 per- shall be subjected to pasteurization cent—as determined by the methods techniques or its equivalent before use prescribed in section 16.035 (liquid sam- in food. ple), entitled ‘‘Ash (5)—Official Final (c) The reduced minerals whey may Action’’ under the heading ‘‘Total Sol- be used in food in accordance with good ids,’’ or in section 16.196 (dry sample), manufacturing practice as indicated in entitled ‘‘Ash—Official Final Action’’ § 184.1(b)(1). under the heading ‘‘Dried Milk, Nonfat (d) The percent of minerals present Dry Milk, and Malted Milk.’’ on a dry product basis, i.e., ‘‘reduced minerals whey (ll% minerals),’’ shall (iv) Lactose content, maximum 85 be declared on the label of the package percent—as determined by the methods sold to food manufacturers. The per- prescribed in section 16.057 (liquid sam- cent of minerals may be declared in 2- ple), entitled ‘‘Gravimetric Method— percent increments expressed as a mul- Official Final Action’’ under the head- tiple of 2, not greater than the actual ing ‘‘Lactose,’’ or in section 31.061 (dry percentage of minerals in the product, sample), entitled ‘‘Lane-Eynon General or as an actual percentage provided Volumetric Method’’ under the heading that an analysis of the product on ‘‘Lactose—Chemical Methods—Official which the actual percentage is based is Final Action.’’ supplied to the food manufacturer. (v) Moisture content, 1 to 6 percent— (e) The presence of reduced minerals as determined by the methods pre- whey in a finished food product shall be scribed in section 16.192, entitled listed as ‘‘reduced minerals whey’’. ‘‘Moisture (41)—Official Final Action’’ under the heading ‘‘Dried Milk, Nonfat [46 FR 44441, Sept. 4, 1981, as amended at 54 Dry Milk, and Malted Milk.’’ FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, 1999] (vi) Solids content, variable—as determined by the methods prescribed in § 184.1979c Whey protein concentrate. section 16.032, entitled ‘‘Method I—Offi- (a) Whey protein concentrate is the cial Final Action’’ under the heading substance obtained by the removal of ‘‘Total Solid.’’ sufficient nonprotein constituents from (vii) Titratable Acidity, variable—as whey so that the finished dry product determined by the methods prescribed contains not less than 25 percent pro- in section 16.023, entitled ‘‘Acidity (2)— tein. Whey protein concentrate is pro- Official Final Action’’ under the head- duced by physical separation tech- ing ‘‘Milk,’’ or by an equivalent poten- niques such as precipitation, filtration, tiometric method. or dialysis. As with whey, whey protein (2) Limits of impurities are: Heavy concentrate can be used as a fluid, con- metals (as lead). Not more than 10 centrate, or dry product form. The parts per million (0.001 percent), as de- acidity of whey protein concentrate termined by the method described in may be adjusted by the addition of safe the ‘‘Food Chemicals Codex,’’ 4th ed. and suitable pH-adjusting ingredients. (1996), pp. 760–761, which is incorporated (b) The whey protein concentrate by reference in accordance with 5 meets the following specifications: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The analysis of whey protein con- are available from the National Acad- centrate, on a dry product basis, based emy Press, Box 285, 2101 Constitution on analytical methods in the ref- Ave. NW., Washington, DC 20055 (Inter- erenced sections of ‘‘Official Methods net address ‘‘http://www.nap.edu’’), or of Analysis of the Association of Offi- may be examined at the Center for cial Analytical Chemists,’’ 13th ed. Food Safety and Applied Nutrition’s (1980), which is incorporated by ref- Library, Food and Drug Administra- erence in accordance with 5 U.S.C. tion, 200 C St. SW., Washington, DC, or 552(a) and 1 CFR part 51, is given in at the Office of the Federal Register, paragraphs (b)(1)(i) through (b)(1)(vii)

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of this section. Copies may be obtained (vii) Titratable Acidity, variable—as from the Association of Official Ana- determined by the methods prescribed lytical Chemists International, 481 in section 16.023, entitled ‘‘Acidity (2)— North Frederick Ave., suite 500, Gai- Official Final Action’’ under the head- thersburg, MD 20877–2504, or may be ex- ing ‘‘Milk,’’ or by an equivalent poten- amined at the Center for Food Safety tiometric method. and Applied Nutrition’s Library, Food (2) Limits of impurities are: Heavy and Drug Administration, 200 C St. metals (as lead). Not more than 10 SW., Washington, DC, or at the Office parts per million (0.001 percent), as de- of the Federal Register, 800 North Cap- termined by the method described in itol St. NW., suite 700, Washington, DC. 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 ‘‘Total Solids,’’ or in section 16.193 (dry Ave. NW., Washington, DC 20055 (Inter- sample), entitled ‘‘Kjeldahl Method’’ net address ‘‘http://www.nap.edu’’), or under the heading ‘‘Protein—Official Final Action.’’ may be examined at the Center for Food Safety and Applied Nutrition’s (ii) Fat content, 1 to 10 percent—as Library, Food and Drug Administra- determined by the methods prescribed in section 16.059 (liquid sample), tion, 200 C St. SW., Washington, DC, or ‘‘Reese-Gottlieb Method [Reference at the Office of the Federal Register, Method] (11)—Official Final Action’’ 800 North Capitol St. NW., suite 700, under the heading ‘‘Fat,’’ or in section Washington, DC. 16.199 (dry sample), entitled ‘‘Fat in (3) The whey protein concentrate Dried Milk (45)—Official Final Action.’’ shall be derived from milk that has (iii) Ash content, 2 to 15 percent—as been pasteurized, or the whey protein determined by the methods prescribed concentrate shall be subjected to pas- in section 16.035 (liquid sample), enti- teurization techniques or its equiva- tled ‘‘Ash (5)—Official Final Action’’ lent before use in food. under the heading ‘‘Total Solids,’’ or in (c) The whey protein concentrate section 16.196 (dry sample), entitled may be used in food in accordance with ‘‘Ash—Official Final Action’’ under the good manufacturing practice as indi- heading ‘‘Dried Milk, Nonfat Dry Milk, cated in § 184.1(b)(1). and Malted Milk.’’ (d) The percent of protein present on (iv) Lactose content, maximum 60 a dry product basis, i.e., ‘‘whey protein percent—as determined by the methods concentrate (ll% protein),’’ shall be prescribed in section 16.057 (liquid sam- declared on the label of the package ple), entitled ‘‘Gravimetric Method— sold to food manufacturers. The per- Official Final Action’’ under the head- cent of protein may be declared in 5- ing ‘‘Lactose,’’ or in section 31.061 (dry percent increments, expressed as a sample), entitled ‘‘Lane-Eynon General multiple of 5, not greater than the ac- Volumetric Method’’ under the heading tual percentage of protein in the prod- ‘‘Lactose—Chemical Methods—Official uct, or as an actual percentage pro- Final Action.’’ vided that an analysis of the product (v) Moisture content, 1 to 6 percent— on which the actual percentage is as determined by the methods pre- based is supplied to the food manufac- scribed in section 16.192, entitled turer. ‘‘Moisture (41)—Official Final Action’’ (e) The presence of whey protein con- under the heading ‘‘Dried Milk, Nonfat centrate in a finished food product Dry Milk, and Malted Milk.’’ shall be listed as ‘‘whey protein con- (vi) Solids content, variable—as de- centrate’’. termined by the methods prescribed in section 16.032, entitled ‘‘Method I—Offi- [46 FR 44441, Sept. 4, 1981, as amended at 54 cial Final Action’’ under the heading FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, ‘‘Total Solids.’’ 1999]

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§ 184.1983 Bakers yeast extract. (1) The ingredient is used as a sur- (a) Bakers yeast extract is the food face-finishing agent as defined in ingredient resulting from concentra- § 170.3(o)(30) of this chapter. tion of the solubles of mechanically (2) The ingredient is used in food at ruptured cells of a selected strain of levels not to exceed current good man- yeast, Saccharomyces cerevisiae. It may ufacturing practice. be concentrated or dried. (d) Prior sanctions for this ingredient (b) The ingredient meets the fol- different from the uses established in lowing specifications on a dry weight this section do not exist or have been basis: Less than 0.4 part per million waived. (ppm) arsenic, 0.13 ppm cadmium, 0.2 [50 FR 8999, Mar. 6, 1985] ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc. § 184.1985 Aminopeptidase enzyme (c) The viable microbial content of preparation derived from the finished ingredient as a con- lactococcus lactis. centrate or dry material is: (a) Aminopeptidase enzyme prepara- (1) Less than 10,000 organisms/gram by aerobic plate count. tion is derived from the nonpathogenic (2) Less than 10 yeasts and molds/ and nontoxicogenic bacterium gram. Lactococcus lactis (previously named (3) Negative for Salmonella, E. coli, Streptococcus lactis). The preparation coagulase positive Staphylococci, Clos- contains the enzyme aminopeptidase tridium perfringens, Clostridium botu- (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and linum, or any other recognized micro- other peptidases that hydrolyze milk bial pathogen or any harmful microbial proteins. The preparation is produced toxin. by pure culture fermentation. (d) The ingredient is used as a fla- (b) The ingredient meets the speci- voring agent and adjuvant as defined in fications for enzyme preparations in § 170.3(o)(12) of this chapter at a level the Food Chemicals Codex, 3d ed. (1981), not to exceed 5 percent in food. pp. 107–110, which are incorporated by (e) This regulation is issued prior to reference in accordance with 5 U.S.C. general evaluation of use of this ingre- 552(a) and 1 CFR part 51. Copies are dient in order to affirm as GRAS the available from the National Academy specific use named. Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1984 Zein. ined at the Division of Petition Control (a) Zein (CAS Reg. No. 9010–66–6) is (HFS–215), Center for Food Safety and one of the components of corn gluten. Applied Nutrition, Food and Drug Ad- It is produced commercially by extrac- ministration, 1110 Vermont Ave. NW., tion from corn gluten with alkaline suite 1200, Washington, DC, or at the aqueous isopropyl alcohol containing Office of the Federal Register, 800 sodium hydroxide. The extract is then North Capitol St. NW., suite 700, Wash- cooled, which causes the zein to pre- ington, DC. cipitate. (c) In accordance with § 184.1(b)(1), (b) FDA is developing food-grade the ingredient is used in food with no specifications for zein in cooperation limitations other than current good with the National Academy of manufacturing practice. The affirma- Sciences. In the interim, the igredient tion of this ingredient as generally rec- must be of a purity suitable for its in- ognized as safe as a direct human food tended use. ingredient is based upon the following (c) In accordance with § 184.1(b)(1), current good manufacturing practice the ingredient is used in food with no conditions of use: limitation other than current good (1) The ingredient is used as an en- manufacturing practice. The affirma- zyme, as defined in § 170.3(o)(9) of this tion of this ingredient as generally rec- chapter, as an optional ingredient for ognized as safe (GRAS) as a direct flavor development in the manufacture human food ingredient is based upon of cheddar cheese, in accordance with the following current good manufac- § 133.113 of this chapter, and in the turing practice conditions of use: preparation of protein hydrolysates.

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(2) The ingredient is used at levels 184 of this chapter are also GRAS as in- not to exceed current good manufac- direct human food ingredients in ac- turing practice. cordance with § 184.1(a) of this chapter. [60 FR 54193, Oct. 20, 1995] (b) The regulations in this part do not authorize direct addition of any PART 186—INDIRECT FOOD SUB- food ingredient to a food. They authorize only the use of these ingredients as STANCES AFFIRMED AS GEN- indirect ingredients of food, through ERALLY RECOGNIZED AS SAFE migration from their immediate wrap- per, container, or other food-contact Subpart A—General Provisions surface. Any ingredient affirmed as Sec. GRAS in this part shall be used in ac- 186.1 Substances added indirectly to human cordance with current good manufac- food affirmed as generally recognized as turing practice. For the purpose of this safe (GRAS). part, current good manufacturing prac- Subpart B—Listing of Specific Substances tice includes the requirements that an Affirmed as GRAS indirect human food ingredient be of a purity suitable for its intended use, 186.1093 Sulfamic acid. and that it be used at a level no higher 186.1256 Clay (kaolin). than reasonably required to achieve its 186.1275 Dextrans. 186.1300 Ferric oxide. intended technical effect in the food- 186.1316 Formic acid. contact article. 186.1374 Iron oxides. (1) If the ingredient is affirmed as 186.1551 Hydrogenated fish oil. GRAS with no limitations on its condi- 186.1555 Japan wax. tions of use other than current good 186.1557 Tall oil. manufacturing practice, it shall be re- 186.1673 Pulp. 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 AUTHORITY: 21 U.S.C. 321, 342, 348, 371. one or more current good manufac- SOURCE: 42 FR 14658, Mar. 15, 1977, unless turing practice conditions of use in the otherwise noted. regulation that affirms the GRAS status of the indirect ingredient. For ex- Subpart A—General Provisions ample, when the safety of an ingredient has been evaluated on the basis of lim- § 186.1 Substances added indirectly to ited conditions of use, the agency will human food affirmed as generally describe in the regulation that affirms recognized as safe (GRAS). the GRAS status of the indirect ingre- (a) The indirect human food ingredi- dient, one or more of these limited con- ents listed in this part have been re- ditions of use, which may include the viewed by the Food and Drug Adminis- category of food-contact surface(s), tration and determined to be generally technical effect(s) or functional use(s) recognized as safe (GRAS) for the pur- of the indirect ingredient, and the poses and under the conditions pre- level(s) of use. If the ingredient is used scribed, providing they comply with under conditions that are significantly the purity specifications listed in this different from those described in the part or, in the absence of purity speci- regulation, such use of a substance fications, are of a purity suitable for may not be GRAS. In such a case, a their intended use in accordance with manufacturer may not rely on the reg- § 170.30(h)(1) of this chapter. Certain in- ulation as authorizing that use but gredients in this part may also be used shall independently establish that the in food-contact surfaces in accordance use is GRAS or shall use the ingredient with parts 174, 175, 176, 177, 178 or in accordance with a food additive reg- § 179.45 of this chapter. Ingredients af- ulation. Persons seeking FDA approval firmed as GRAS for direct use in part of an independent determination that a

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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 surface(s), the functional use(s) of the in- Subpart B—Listing of Specific gredient, and the level(s) of use. Any Substances Affirmed as GRAS use of such an ingredient not in full compliance with each such established § 186.1093 Sulfamic acid. limitation shall require a food additive (a) Sulfamic acid (H3NO3S, CAS Reg. regulation. No. 5329–14–6) is a white crystalline (3) If the ingredient is affirmed as solid manufactured from urea, sulfur GRAS for a specific use, prior to gen- trioxide, and sulfuric acid. It is soluble eral evaluation of use of the ingredient, and highly ionized in water. other uses may also be GRAS. (b) In accordance with § 186.1(b)(1), (c) The listing of a food ingredient in the ingredient is used as an indirect this part does not authorize the use of food ingredient with no limitations such substance for the purpose of add- other than current good manufacturing ing the ingredient to the food through practice. The affirmation of this ingre- extraction from the food-contact sur- dient as generally recognized as safe face. (GRAS) as an indirect human food in- (d) The listing of a food ingredient in gredient is based upon the current good this part does not authorize the use of manufacturing practice of using this such substance in a manner that may ingredient in the manufacture of paper lead to deception to the consumer or to and paperboard that contact food. any other violation of the Federal (c) Prior sanctions for this ingredient Food, Drug, and Cosmetic Act (the different from the uses established in Act). this section do not exist or have been (e) If the Commissioner of Food and waived. Drugs is aware of any prior sanction for use of an ingredient under condi- [47 FR 29954, July 9, 1982] tions different from those proposed to be affirmed as GRAS, he will concur- § 186.1256 Clay (kaolin). rently propose a separate regulation (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas covering such use of the ingredient Reg. No. 1332–58–7) consists of hydrated under part 181 of this chapter. If the aluminum silicate. The commercial Commissioner is unaware of any such products of clay (kaolin) contain vary- applicable prior sanction, the proposed ing quantities of alkalies and alkaline regulation will so state and will re- earths. Clay (kaolin) is a white to yel- quire any person who intends to assert lowish or grayish fine powder. There or rely on such sanction to submit are at least three different minerals, proof of its existence. Any regulation kaolinite, dickite, and nacrite, classi- promulgated pursuant to this section fied as kaolin. Kaolinite or china clay constitutes a determination that ex- is whiter, less contaminated with excluded uses would result in adultera- traneous minerals, and less plastic in tion of the food in violation of section water. 402 of the Act, and the failure of any (b) In accordance with § 186.1(b)(1), person to come forward with proof of the ingredient is used as an indirect such an applicable prior sanction in re- human food ingredient with no limita- sponse to the proposal will constitute a tion other than current good manufac- waiver of the right to assert or rely on turing practice. The affirmation of this such sanction at any later time. The ingredient as generally recognized as notice will also constitute a proposal safe (GRAS) as an indirect human food to establish a regulation under part 181 ingredient is based upon the following of this chapter, incorporating the same current good manufacturing practice provisions, in the event that such a conditions of use:

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(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 (CH O CAS Reg. No. § 186.1275 Dextrans. 2 2, 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 for- from sucrose by Leuconostoc mate with sulfuric acid and is isolated mesenteroides strain NRRL B–512(F). by distillation. Partial depolymerization and purifi- (b) Formic acid is used as a con- cation of the fermented mixture shall stituent of paper and paperboard used produce a product that is free of viable for food packaging. microorganisms. (c) The ingredient is used at levels (b) The ingredient is used or intended not to exceed good manufacturing for use as a constituent of food-contact practice in accordance with § 186.1(b)(1). surfaces. (d) Prior sanctions for formic acid (c) The ingredient is used at levels different from the uses established in not to exceed good manufacturing this section do not exist or have been practice. waived. (d) Prior sanctions for this ingredient different from the uses established in [45 FR 22915, Apr. 4, 1980] this section do not exist or have been waived. § 186.1374 Iron oxides. [43 FR 29288, July 7, 1978, as amended at 48 (a) Iron oxides (oxides of iron, CAS FR 48457, Oct. 19, 1983] Reg. No. 97705–33–85) are undefined mixtures of iron (II) oxide (CAS Reg. No. § 186.1300 Ferric oxide. 1345–25–1, black cubic crystals) and iron (a) Ferric oxide (iron (III) oxide, (III) oxide (CAS Reg. No. 1309–37–1, red- brown to black trigonal crystals). Fe2O3, CAS Reg. No. 1309–37–1) occurs naturally as the mineral hematite. It (b) In accordance with § 186.1(b)(1), may be prepared synthetically by heat- the ingredient is used as an indirect ing brown iron hydroxide oxide. The human food ingredient with no limita- product is red-brown to black trigonal tion other than current good manufac- crystals. turing practice. The affirmation of this (b) In accordance with § 186.1(b)(1), ingredient as generally recognized as the ingredient is used as an indirect safe (GRAS) as an indirect human food human food ingredient with no limita- ingredient is based upon the following tion other than current good manufac- current good manufacturing practice turing practice. The affirmation of this conditions of use: ingredient as generally recognized as (1) The ingredient is used as a con- safe (GRAS) as an indirect human food stituent of paper and paperboard used ingredient is based upon the following for food packaging. current good manufacturing practice (2) The ingredient is used at levels conditions of use: not to exceed current good manufac- (1) The ingredient is used as a con- turing practice. stituent of paper and paperboard used (c) Prior sanctions for this ingredient for food packaging. different from the uses established in

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this section do not exist or have been of tripalmitin. It is prepared from the waived. mesocarp by hot pressing of immature fruits of the oriental sumac, Rhus [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988] succedanea (Japan, Taiwan, and Indo- China), R. vernicifera (Japan), and R. § 186.1551 Hydrogenated fish oil. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot (a) Hydrogenated fish oil (CAS Reg. alcohol, benzene, and naphtha, and in- No. 91078–95–4) is a class of oils pro- soluble in water and in cold alcohol. duced by partial hydrogenation of oils (b) In accordance with paragraph expressed from fish, primarily menha- (b)(1) of this section, the ingredient is den, and secondarily herring or tuna. used as an indirect human food ingre- Hydrogenation of fish oils uses cata- dient with no limitation other than lysts composed of either elemental current good manufacturing practice. nickel, elemental copper, or a mixture The affirmation of this ingredient as of these elements. The crude hydro- generally recognized as safe (GRAS) as genated fish oil is further processed by an indirect human food ingredient is alkali refining, bleaching, and deodori- based on the following current good zation by steam stripping. manufacturing practice conditions of (b) Hydrogenation of fish oils results use: in a final product with a melting point 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 [60 FR 62208, Dec. 5, 1995] polyenoic fatty acids. The approximate percentages of total fatty acids by car- § 186.1557 Tall oil. bon chain length are 15 to 30 percent (a) Tall oil (CAS Reg. No. 8002–26–4) is each of C16, C18, C20, C22, less than 10 per- essentially the sap of the pine tree. It cent C14 or lower carbon chain length, is obtained commercially from the and less than 1 percent C24 or higher waste liquors of pinewood pulp mills carbon chain length fatty acids. and consists mainly of tall oil resin (c) The ingredient is used as a con- acids and tall oil fatty acids. 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 on the following waived. current good manufacturing practice [44 FR 28323, May 15, 1979, as amended at 49 conditions of use: FR 5614, Feb. 14. 1984; 58 FR 17099, Apr. 1, (1) The ingredient is used as a con- 1993] stituent of cotton and cotton fabrics used for dry food packaging. § 186.1555 Japan wax. (2) The ingredient is used at levels (a) Japan wax (CAS Reg. No. 8001–39– not to exceed current good manufac- 6), also known as Japan tallow or turing practice. sumac wax, is a pale yellow vegetable (c) Prior sanctions for this ingredient tallow, containing glycerides of the different from the uses established in C19–C23 dibasic acids and a high content this section, or from those listed in

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part 181 of this chapter, do not exist or mercially, sodium oleate is made by have been waived. mixing and heating flaked sodium hydroxide and oleic acid. [51 FR 16830, May 7, 1986] (b) In accordance with § 186.1(b)(1), § 186.1673 Pulp. the ingredient is used as a constituent of paper and paperboard for food pack- (a) Pulp is the soft, spongy pith inside 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. [51 FR 39372, Oct. 28, 1986] (d) Prior sanctions for this ingredient different from the uses established in § 186.1771 Sodium palmitate. this section do not exist or have been (a) Sodium palmitate (C16H31O2Na, waived. CAS Reg. No. 408–35–5) is the sodium § 186.1750 Sodium chlorite. salt of palmitic acid (hexadecanoic acid). It exists as a white to yellow (a) Sodium chlorite (NaCLO2, CAS powder. Commercially, sodium Reg. No. 7758–19–2) exists as slightly palmitate is made by mixing and heat- hygroscopic white crystals or flakes. It ing flaked sodium hydroxide and pal- is manufactured by passing chlorine di- mitic acid. oxide into a solution of sodium hydrox- (b) In accordance with § 186.1(b)(1), ide and hydrogen peroxide. the ingredient is used as a constituent (b) the ingredient is used at levels of paper and paperboard for food pack- from 125 to 250 parts per million as a aging with no limitation other than slimicide in the manufacture of paper current good manufacturing practice. and paperboard that contact food. (c) Prior sanctions for this ingredient [45 FR 16470, Mar. 14, 1980] different from the uses established in this section do not exist or have been § 186.1756 Sodium formate. waived. (a) Sodium formate (CHNaO2, CAS Reg. No. 141–53–7) is the sodium salt of [51 FR 39372, Oct. 28, 1986] formic acid. It is produced by the reac- § 186.1797 Sodium sulfate. tion of carbon monoxide with sodium hydroxide. (a) Sodium sulfate (Na2SO4, CAS Reg. (b) The ingredient is used as a con- No. 7757–82–6), also known as Glauber’s stituent of paper and paperboard used salt, occurs naturally and exists as for food packaging. colorless crystals or as a fine, white (c) The ingredient is used at levels crystalline powder. It is prepared by not to exceed good manufacturing the neutralization of sulfuric acid with practice in accordance with § 186.1(b)(1). sodium hydroxide. (d) Prior sanctions for sodium for- (b) The ingredient is used as a con- mate different from the uses estab- stituent of paper and paperboard used lished in this section do not exist or for food packaging, and cotton and cot- have been waived. ton fabric used for dry food packaging. (c) The ingredient is used at levels [45 FR 22915, Apr. 4, 1980] not to exceed good manufacturing § 186.1770 Sodium oleate. practice in accordance with § 186.1(b)(1). (d) Prior sanctions for this ingredient (a) Sodium oleate (C H O Na, CAS 18 33 2 different from the uses established in Reg. No. 143–19–1) is the sodium salt of this section do not exist or have been oleic acid (cis-9-octadecenoic acid). It waived. exists as a white to yellowish powder with a slight tallow-like odor. Com- [45 FR 6086, Jan. 25, 1980]

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§ 186.1839 Sorbose. Subpart C—Substances Prohibited From In- direct Addition to Human Food (a) Sorbose (L-sorbose, sorbinose) Through Food-Contact Surfaces (C6H12O6, CAS Reg. No. 87–79–6) is an orthorhombic, bisphenoidal crystalline 189.220 Flectol H. ketohexose. It was originally identifed 189.240 Lead solders. in the juice of mature berries from the 189.250 Mercaptoimidazoline and 2- mountain ash (Sorbus aucuparia) where mercaptoimidazoline. it occurs as the result of microbial oxi- 189.280 4,4′-Methylenebis (2-chloroanaline). dation of sorbitol. It also occurs natu- 189.300 Hydrogenated 4,4′-isopropylidene- rally in other plants. Sorbose can be diphenolphosphite ester resins. 189.301 Tin–coated lead foil capsules for synthesized by the catalytic hydro- wine bottles. genation of glucose to D-sorbitol. The resulting sorbitol can be oxidized by AUTHORITY: 21 U.S.C. 321, 342, 348, 371. Acetobacter xylinum or by Acetobacter SOURCE: 42 FR 14659, Mar. 15, 1977, unless suboxydans. otherwise noted.

(b) The ingredient is used or intended EDITORIAL NOTE: Nomenclature changes to for indirect food use as a constituent of part 189 appear at 61 FR 14482, Apr. 2, 1996, cotton, cotton fabrics, paper, and pa- and 66 FR 56035, Nov. 6, 2001. perboard in contact with dry food. (c) The ingredient migrates to food at Subpart A—General Provisions levels not to exceed good manufacturing practice. § 189.1 Substances prohibited from use (d) Prior sanctions for this ingredient in human food. different from the uses established in (a) The food ingredients listed in this this section do not exist or have been section have been prohibited from use waived. in human food by the Food and Drug [43 FR 11698, Mar. 21, 1978, as amended at 48 Administration because of a deter- FR 48457, Oct. 19, 1983] mination that they present a potential risk to the public health or have not PART 189—SUBSTANCES PROHIB- been shown by adequate scientific data ITED FROM USE IN HUMAN FOOD to be safe for use in human food. Use of any of these substances in violation of this section causes the food involved to Subpart A—General Provisions be adulterated in violation of the act. Sec. (b) This section includes only a par- 189.1 Substances prohibited from use in tial list of substances prohibited from human food. use in human food, for easy reference purposes, and is not a complete list of Subpart B—Substances Generally Prohib- substances that may not lawfully be ited From Direct Addition or Use as used in human food. No substance may Human Food be used in human food unless it meets 189.110 Calamus and its derivatives. all applicable requirements of the act. 189.113 Cinnamyl anthranilate. (c) The Commissioner of Food and 189.120 Cobaltous salts and its derivatives. Drugs, either on his own initiative or 189.130 Coumarin. on behalf of any interested person who 189.135 Cyclamate and its derivatives. has submitted a petition, may publish 189.140 Diethylpyrocarbonate (DEPC). a proposal to establish, amend, or re- 189.145 Dulcin. peal a regulation under this section on 189.155 Monochloroacetic acid. the basis of new scientific evaluation 189.165 Nordihydroguaiaretic acid (NDGA). or information. Any such petition shall 189.175 P–4000. 189.180 Safrole. include an adequate scientific basis to 189.190 Thiourea. support the petition, pursuant to part 189.191 Chlorofluorocarbon propellants. 10 of this chapter, and will be published

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for comment if it contains reasonable based upon an order published in the grounds. FEDERAL REGISTER of October 23, 1985. [42 FR 14659, Mar. 15, 1977, as amended at 54 [50 FR 42932, Oct. 23, 1985] FR 24899, June 12, 1989] § 189.120 Cobaltous salts and its de- Subpart B—Substances Generally rivatives. Prohibited From Direct Addi- (a) Cobaltous salts are the chemicals, CoC4H6O4, CoCl2, and CoSO4.They have tion or Use as Human Food been used in fermented malt beverages as a foam stabilizer and to prevent § 189.110 Calamus and its derivatives. ‘‘gushing.’’ (a) Calamus is the dried rhizome of (b) Food containing any added cobal- Acorus calamus L. It has been used as a tous salts is deemed to be adulterated flavoring compound, especially as the in violation of the act based upon an oil or extract. order published in the FEDERAL REG- (b) Food containing any added ISTER of August 12, 1966 (31 FR 8788). calamus, oil of calamus, or extract of calamus is deemed to be adulterated in § 189.130 Coumarin. violation of the act based upon an (a) Coumarin is the chemical 1,2- order published in the FEDERAL REG- benzopyrone, C9H6O2. It is found in ISTER of May 9, 1968 (33 FR 6967). tonka beans and extract of tonka (c) The analytical method used for beans, among other natural sources, detecting oil of calamus (b-asarone) is and is also synthesized. It has been in the ‘‘Journal of the Association of used as a flavoring compound. Official Analytical Chemists,’’ Volume (b) Food containing any added cou- 56, (Number 5), pages 1281 to 1283, Sep- marin as such or as a constituent of tember 1973, which is incorporated by tonka beans or tonka extract is deemed reference. Copies are available from to be adulterated under the act, based the Association of Official Analytical upon an order published in the FED- Chemists International, 481 North ERAL REGISTER of March 5, 1954 (19 FR Frederick Ave., suite 500, Gaithersburg, 1239). MD 20877–2504, also from the Division of (c) The analytical methods used for Food and Color Additives, Center for detecting coumarin in food are in sec- Food Safety and Applied Nutrition tions 19.016–19.024 of the ‘‘Official Meth- (HFS–200), Food and Drug Administra- ods of Analysis of the Association of tion, 5100 Paint Branch Pkwy., College Official Analytical Chemists,’’ 13th Ed. Park, MD 20740, or available for inspec- (1980), which is incorporated by ref- tion at the Office of the Federal Reg- erence. Copies may be obtained from ister, 800 North Capitol Street, NW., the Association of Official Analytical suite 700, Washington, DC 20408. Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, [42 FR 14659, Mar. 15, 1977, as amended at 47 MD 20877–2504, or may be examined at FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, the Office of the Federal Register, 800 1989] North Capitol Street, NW., suite 700, Washington, DC 20408. § 189.113 Cinnamyl anthranilate. [42 FR 14659, Mar. 15, 1977, as amended at 49 (a) The food additive cinnamyl an- FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, thranilate (C16H15NO2, CAS Reg. No. 87– 1989] 29–6) is the ester of cinnamyl alcohol and anthranilic acid. Cinnamyl an- § 189.135 Cyclamate and its deriva- thranilate is a synthetic chemical that tives. has not been identified in natural prod- (a) Calcium, sodium, magnesium and ucts at levels detectable by available potassium salts of cyclohexane sul- methodology. It has been used as a fla- famic acid, (C6H12NO3S)2Ca, voring agent in food. (C6H12NO3S)Na, (C6H12NO3S)2Mg, and (b) Food containing any added (C6H12NO3S)K. Cyclamates are syn- cinnamyl anthranilate is deemed to be thetic chemicals having a sweet taste adulterated in violation of the act 30 to 40 times that of sucrose, are not

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found in natural products at levels de- FEDERAL REGISTER of January 19, 1950 tectable by the official methodology, (15 FR 321). and have been used as artificial sweet- (c) The analytical methods used for eners. detecting dulcin in food are in sections (b) Food containing any added or de- 20.173–20.176 of the ‘‘Official Methods of tectable level of cyclamate is deemed Analysis of the Association of Official to be adulterated in violation of the Analytical Chemists,’’ 13th Ed. (1980), act based upon an order published in which is incorporated by reference. the FEDERAL REGISTER of October 21, Copies may be obtained from the Asso- 1969 (34 FR 17063). ciation of Official Analytical Chemists (c) The analytical methods used for International, 481 North Frederick detecting cyclamate in food are in sec- Ave., suite 500, Gaithersburg, MD 20877– tions 20.162–20.172 of the ‘‘Official Meth- 2504, or may be examined at the Office ods of Analysis of the Association of of the Federal Register, 800 North Cap- Official Analytical Chemists,’’ 13th Ed. itol Street, NW., suite 700, Washington, (1980), which is incorporated by ref- DC 20408. erence. Copies may be obtained from the Association of Official Analytical [42 FR 14659, Mar. 15, 1977, as amended at 49 Chemists International, 481 North FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, Frederick Ave., suite 500, Gaithersburg, 1989] MD 20877–2504, or may be examined at § 189.155 Monochloroacetic acid. the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, (a) Monochloroacetic acid is the Washington, DC 20408. chemical chloroacetic acid, C2H3C1O2. It is a synthetic chemical not found in [42 FR 14659, Mar. 15, 1977, as amended at 49 natural products, and has been pro- FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] posed as a preservative in alcoholic and nonalcoholic beverages. § 189.140 Diethylpyrocarbonate Monochloroacetic acid is permitted in (DEPC). food package adhesives with an accept- (a) Diethylpyrocarbonate is the ed migration level up to 10 parts per chemical pyrocarbonic acid diethyl billion (ppb) under § 175.105 of this chapter. The official methods do not detect ester, C6H10O5. It is a synthetic chemical not found in natural products at monochloroacetic acid at the 10 ppb levels detectable by available method- level. ology and has been used as a ferment (b) Food containing any added or de- inhibitor in alcoholic and nonalcoholic tectable level of monochloroacetic acid beverages. is deemed to be adulterated in viola- (b) Food containing any added or de- tion of the act based upon trade cor- tectable level of DEPC is deemed to be respondence dated December 29, 1941 adulterated in violation of the act (TC–377). based upon an order published in the (c) The analytical methods used for FEDERAL REGISTER of August 2, 1972 (37 detecting monochloroacetic acid in FR 15426). food are in sections 20.067–20.072 of the ‘‘Official Methods of Analysis of the § 189.145 Dulcin. Association of Official Analytical (a) Dulcin is the chemical 4- Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be ethoxyphenylurea, C9H12N2O2. It is a synthetic chemical having a sweet obtained from the Association of Offi- taste about 250 times that of sucrose, is cial Analytical Chemists International, not found in natural products at levels 481 North Frederick Ave., suite 500, detectable by the official methodology, Gaithersburg, MD 20877–2504, or may be and has been proposed for use as an ar- examined at the Office of the Federal tificial sweetener. Register, 800 North Capitol Street, (b) Food containing any added or de- NW., suite 700, Washington, DC 20408. tectable level of dulcin is deemed to be [42 FR 14659, Mar. 15, 1977, as amended at 49 adulterated in violation of the act, FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, based upon an order published in the 1989]

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§ 189.165 Nordihydroguaiaretic acid of the Federal Register, 800 North Cap- (NDGA). itol Street, NW., suite 700, Washington, (a) Nordihydroguaiaretic acid is the DC 20408. ′ chemical 4,4 -(2,3-dimethyltetrame- [42 FR 14659, Mar. 15, 1977, as amended at 49 thylene) dipyrocatechol, C18H22O4. It FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, occurs naturally in the resinous 1989] exudates of certain plants. The commercial product, which is synthesized, § 189.180 Safrole. has been used as an antioxidant in (a) Safrole is the chemical 4-allyl-1,2- foods. methylenedioxy-benzene, C H O It is (b) Food containing any added NDGA 10 10 2. a natural constituent of the sassafras is deemed to be adulterated in violation of the act based upon an order plant. Oil of sassafras is about 80 percent safrole. Isosafrole and published in the FEDERAL REGISTER of April 11, 1968 (33 FR 5619). dihydrosafrole are derivatives of saf- (c) The analytical method used for role, and have been used as flavoring detecting NDGA in food is in section compounds. 20.008(b) of the ‘‘Official Methods of (b) Food containing any added saf- Analysis of the Association of Official role, oil of sassafras, isosafrole, or Analytical Chemists International,’’ dihydrosafrole, as such, or food con- 13th Ed. (1980), which is incorporated taining any safrole, oil of sassafras, by reference. Copies may be obtained isosafrole, or dihydrosafrole, e.g., sas- from the Association of Official Ana- safras bark, which is intended solely or lytical Chemists International, 481 primarily as a vehicle for imparting North Frederick Ave., suite 500, Gai- such substances to another food, e.g., thersburg, MD 20877–2504, or may be ex- sassafras tea, is deemed to be adulter- amined at the Office of the Federal ated in violation of the act based upon Register, 800 North Capitol Street, an order published in the FEDERAL NW., suite 700, Washington, DC 20408. REGISTER of December 3, 1960 (25 FR [42 FR 14659, Mar. 15, 1977, as amended at 49 12412). FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, (c) The analytical method used for 1989] detecting safrole, isosafrole and dihydrosafrole is in the ‘‘Journal of the § 189.175 P–4000. Association of Official Analytical (a) P–4000 is the chemical 5-nitro-2-n- Chemists,’’ Volume 54 (Number 4), propoxyaniline, C9H12N2O3. It is a syn- pages 900 to 902, July 1971, which is in- thetic chemical having a sweet taste corporated by reference. Copies are about 4000 times that of sucrose, is not available from the Division of Food found in natural products at levels de- and Color Additives, Center for Food tectable by the official methodology, Safety and Applied Nutrition (HFS– and has been proposed for use as an ar- 200), Food and Drug Administration, tificial sweetener. 5100 Paint Branch Pkwy., College Park, (b) Food containing any added or de- MD 20740, or available for inspection at tectable level of P–4000 is deemed to be the Office of the Federal Register, 800 adulterated in violation of the act North Capitol Street, NW., suite 700, based upon an order published in the Washington, DC 20408. FEDERAL REGISTER of January 19, 1950 (15 FR 321). [42 FR 14659, Mar. 15, 1977, as amended at 42 (c) The analytical methods used for FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, detecting P–4000 in food are in sections 1982; 54 FR 24900, June 12, 1989] 20.177–20.181 of the ‘‘Official Methods of § 189.190 Thiourea. Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), (a) Thiourea is the chemical which is incorporated by reference. thiocarbamide, CH4N2S. It is a syn- Copies may be obtained from the Asso- thetic chemical, is not found in natural ciation of Official Analytical Chemists products at levels detectable by the of- International, 481 North Frederick ficial methodology, and has been pro- Ave., suite 500, Gaithersburg, MD 20877– posed as an antimycotic for use in dip- 2504, or may be examined at the Office ping citrus.

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(b) Food containing any added or de- of the Federal Food, Drug, and Cos- tectable level of thiourea is deemed to metic Act, based upon an order pub- be adulterated under the act. lished in the FEDERAL REGISTER of (c) The analytical methods used for June 27, 1995. detecting thiourea are in sections [60 FR 33109, June 27, 1995] 20.115–20.126 of the ‘‘Official Methods of Analysis of the Association of Official § 189.250 Mercaptoimidazoline and 2- Analytical Chemists,’’ 13th Ed. (1980), mercaptoimidazoline. which is incorporated by reference. (a) Mercaptoimidazoline and 2- Copies may be obtained from the Asso- mercaptoimidazoline both have the ciation of Official Analytical Chemists molecular formula C3H6N2S. They are International, 481 North Frederick synthetic chemicals not found in nat- Ave., suite 500, Gaithersburg, MD 20877– ural products and have been used in the 2504, or may be examined at the Office production of rubber articles that may of the Federal Register, 800 North Cap- come into contact with food. itol Street, NW., suite 700, Washington, (b) Food containing any added or de- DC 20408. lectable levels of these substances is [42 FR 14659, Mar. 15, 1977, as amended at 49 deemed to be adulterated in violation FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, of the act based upon an order pub- 1989] lished in the FEDERAL REGISTER of No- vember 30, 1973 (38 FR 33072). § 189.191 Chlorofluorocarbon propellants. § 189.280 4,4′-Methylenebis (2-chloro- The use of chlorofluorocarbons in analine). human food as propellants in self-pres- (a) 4,4′-Methylenebis (2- surized containers is prohibited as pro- chloroanaline) has the molecular for- vided by § 2.125 of this chapter. mula, C13H12Cl2N2. It is a synthetic chemical not found in natural products [43 FR 11317, Mar. 17, 1978] and has been used as a polyurethane curing agent and as a component of Subpart C—Substances Prohibited food packaging adhesives and poly- From Indirect Addition to urethane resins. Human Food Through Food- (b) Food containing any added or de- Contact Surfaces tectable level of this substance is deemed to be adulterated in violation § 189.220 Flectol H. of the act based upon an order pub- (a) Flectol H is the chemical 1,2- lished in the FEDERAL REGISTER of De- dihydro-2,2,4-trimethylquinoline, po- cember 2, 1969 (34 FR 19073). lymerized, C H N. It is a synthetic 12 15 § 189.300 Hydrogenated 4,4′-isopropyl- chemical not found in natural prod- idene-diphenolphosphite ester res- ucts, and has been used as a component ins. of food packaging adhesives. (a) Hydrogenated 4,4′-isopropylidene- (b) Food containing any added or de- diphenolphosphite ester resins are the tectable level of this substance is condensation product of 1 mole of deemed to be adulterated in violation triphenyl phosphite and 1.5 moles of of the act based upon an order pub- hydrogenated 4,4′-isopropylidene- lished in the FEDERAL REGISTER of diphenol such that the finished resins April 7, 1967 (32 FR 5675). have a molecular weight in the range [42 FR 14659, Mar.15, 1977, as amended at 58 of 2,400 to 3,000. They are synthetic FR 17099, Apr. 1, 1993] chemicals not found in natural products and have been used as anti- § 189.240 Lead solders. oxidants and as stabilizers in vinyl (a) Lead solders are alloys of metals chloride polymer resins when such that include lead and are used in the polymer resins are used in the manu- construction of metal food cans. facture of rigid vinyl chloride polymer (b) Food packaged in any container bottles. that makes use of lead in can solder is (b) Food containing any added or de- deemed to be adulterated in violation tectable levels of these substances is

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deemed to be adulterated and in viola- Subpart B—New Dietary tion of the Federal Food, Drug, and Ingredient Notification Cosmetic Act, based upon an order published in the FEDERAL REGISTER of Sep- § 190.6 Requirement for premarket no- tember 9, 1987 (52 FR 33929). tification. [54 FR 7188, Feb. 17, 1989] (a) At least 75 days before intro- ducing or delivering for introduction § 189.301 Tin-coated lead foil capsules into interstate commerce a dietary for wine bottles. supplement that contains a new die- (a) Tin-coated lead foil is composed tary ingredient that has not been present in the food supply as an article of a lead foil coated on one or both used for food in a form in which the sides with a thin layer of tin. Tin-coat- food has not been chemically altered, ed lead foil has been used as a capsule the manufacturer or distributor of that (i.e., as a covering applied over the supplement, or of the new dietary in- cork and neck areas) on wine bottles to gredient, shall submit to the Office of prevent insect infestation, as a barrier Nutritional Products, Labeling and Di- to oxygen, and for decorative purposes. etary Supplements (HFS–820), Center Information received by the Food and for Food Safety and Applied Nutrition, Drug Administration establishes that Food and Drug Administration, 5100 the use of such a capsule on wine bot- Paint Branch Pkwy., College Park, MD tles may reasonably be expected to re- 20740, information including any cita- sult in lead becoming a component of tion to published articles that is the the wine. basis on which the manufacturer or (b) The capping of any bottles of wine distributor has concluded that a die- after February 8, 1996, with a tin-coat- tary supplement containing such die- ed lead foil capsule renders the wine tary ingredient will reasonably be ex- adulterated and in violation of section pected to be safe. An original and two 402(a)(2)(C) of the Federal Food, Drug, copies of this notification shall be sub- and Cosmetic Act because lead from mitted. the capsule, which is an unsafe food ad- (b) The notification required by para- ditive within the meaning of section graph (a) of this section shall include: 409 of the act, may reasonably be ex- (1) The name and complete address of pected to become a component of the the manufacturer or distributor of the wine. dietary supplement that contains a new dietary ingredient, or of the new [61 FR 4820, Feb. 8, 1996] dietary ingredient; (2) The name of the new dietary in- PART 190—DIETARY SUPPLEMENTS gredient that is the subject of the premarket notification, including the Subpart A [Reserved] Latin binomial name (including the author) of any herb or other botanical; Subpart B—New Dietary Ingredient (3) A description of the dietary sup- Notification plement or dietary supplements that contain the new dietary ingredient in- Sec. cluding: 190.6 Requirement for premarket notifica- (i) The level of the new dietary ingre- tion. dient in the dietary supplement; and AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of (ii) The conditions of use rec- the Federal Food, Drug, and Cosmetic Act ommended or suggested in the labeling (21 U.S.C. 321(ff), 331, 342, 350b, 371). of the dietary supplement, or if no con- SOURCE: 62 FR 49891, Sept. 23, 1997, unless ditions of use are recommended or sug- otherwise noted. gested in the labeling of the dietary supplement, the ordinary conditions of EDITORIAL NOTE: Nomenclature changes to use of the supplement; part 170 appear at 66 FR 56035, Nov. 6, 2001. (4) The history of use or other evidence of safety establishing that the Subpart A [Reserved] dietary ingredient, when used under

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the conditions recommended or sug- new dietary ingredient, or of the new gested in the labeling of the dietary dietary ingredient, provides additional supplement, will reasonably be ex- information in support of the new die- pected to be safe, including any cita- tary ingredient notification, the agen- tion to published articles or other evi- cy will review all submissions per- dence that is the basis on which the taining to that notification, including distributor or manufacturer of the die- responses made to inquiries from the tary supplement that contains the new agency, to determine whether they are dietary ingredient has concluded that substantive and whether they require the new dietary supplement will rea- that the 75-day period be reset. If the sonably be expected to be safe. Any ref- agency determines that the new sub- erence to published information offered mission is a substantive amendment, in support of the notification shall be FDA will assign a new filing date. FDA accompanied by reprints or photostatic will acknowledge receipt of the addi- copies of such references. If any part of tional information and, when applica- the material submitted is in a foreign ble, notify the manufacturer of the new language, it shall be accompanied by filing date, which is the date of receipt an accurate and complete English by FDA of the information that con- translation; and stitutes the substantive amendment. (5) The signature of the person des- (e) FDA will not disclose the exist- ignated by the manufacturer or dis- ence of, or the information contained tributor of the dietary supplement that in, the new dietary ingredient notifica- contains a new dietary ingredient. tion for 90 days after the filing date of (c) FDA will acknowledge its receipt the notification. After the 90th day, all of a notification made under section information in the notification will be 413 of the Federal Food, Drug, and Cos- placed on public display, except for any metic Act (the act) and will notify the information that is trade secret or oth- submitter of the date of receipt of such erwise confidential commercial infor- a notification. The date that the agen- mation. cy receives the notification submitted (f) Failure of the agency to respond under paragraph (a) of this section is to a notification does not constitute a the filing date for the notification. For finding by the agency that the new die- 75 days after the filing date, the manu- tary ingredient or the dietary supple- facturer or distributor of a dietary sup- ment that contains the new dietary in- plement that contains a new dietary gredient is safe or is not adulterated ingredient shall not introduce, or de- under section 402 of the act. liver for introduction, into interstate commerce the dietary supplement that [62 FR 49891, Sept. 23, 1997, as amended at 66 contains the new dietary ingredient. FR 17359, Mar. 30, 2001] (d) If the manufacturer or distributor of a dietary supplement that contains a PARTS 191–199 [RESERVED]

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