For the purposes of this subchapter, the following definitions apply:

(a) Secretary means the Secretary of Health and Human Services.

(b) Department means the Department of Health and Human Services.

(c) Commissioner means the Commissioner of Food and Drugs.

(d) As used in this part, the term act means the Federal Food, Drug, and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392).

(e)(1) Food additives includes all substances not exempted by section 201(s) of the act, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food. A material used in the production of containers and packages is subject to the definition if it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food packed in the container. “Affecting the characteristics of food” does not include such physical effects, as protecting contents of packages, preserving shape, and preventing moisture loss. If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive. A substance that does not become a component of food, but that is used, for example, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.

(2) Uses of food additives not requiring a listing regulation. Use of a substance in a food contact article (e.g., food-packaging or food-processing equipment) whereby the substance migrates, or may reasonably be expected to migrate, into food at such levels that the use has been exempted from regulation as a food additive under § 170.39, and food contact substances used in accordance with a notification submitted under section 409(h) of the act that is effective.

(3) A food contact substance is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

(f) Common use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.

(g) The word substance in the definition of the term “food additive” includes a food or food component consisting of one or more ingredients.

(h) Scientific procedures include the application of scientific data (including, as appropriate, data from human, animal, analytical, or other scientific studies), information, and methods, whether published or unpublished, as well as the application of scientific principles, appropriate to establish the safety of a substance under the conditions of its intended use.

(i) Safe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety. In determining safety, the following factors shall be considered:

(1) The probable consumption of the substance and of any substance formed in or on food because of its use.

(2) The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.

(3) Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food and food ingredients, are generally recognized as appropriate.

(j) The term nonperishable processed food means any processed food not subject to rapid decay or deterioration that would render it unfit for consumption. Examples are flour, sugar, cereals, packaged cookies, and crackers. Not included are hermetically sealed foods or manufactured dairy products and other processed foods requiring refrigeration.

(k) General recognition of safety shall be in accordance with § 170.30.

(l) Prior sanction means an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food and Drug Administration or the United States Department of Agriculture pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act.

(m) Food includes human food, substances migrating to food from food-contact articles, pet food, and animal feed.

(n) The following general food categories are established to group specific related foods together for the purpose of establishing tolerances or limitations for the use of direct human food ingredients. Individual food products will be included within these categories according to the detailed classifications lists contained in Exhibit 33B of the report of the National Academy of Sciences/National Research Council report, “A Comprehensive Survey of Industry on the Use of Food Chemicals Generally Recognized as Safe” (September 1972), which is incorporated by reference. Copies are available from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Baked goods and baking mixes, including all ready-to-eat and ready-to-bake products, flours, and mixes requiring preparation before serving.

(2) Beverages, alcoholic, including malt beverages, wines, distilled liquors, and cocktail mix.

(3) Beverages and beverage bases, nonalcoholic, including only special or spiced teas, soft drinks, coffee substitutes, and fruit and vegetable flavored gelatin drinks.

(4) Breakfast cereals, including ready-to-eat and instant and regular hot cereals.

(5) Cheeses, including curd and whey cheeses, cream, natural, grating, processed, spread, dip, and miscellaneous cheeses.

(6) Chewing gum, including all forms.

(7) Coffee and tea, including regular, decaffeinated, and instant types.

(8) Condiments and relishes, including plain seasoning sauces and spreads, olives, pickles, and relishes, but not spices or herbs.

(9) Confections and frostings, including candy and flavored frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, powdered, and raw sugars.

(10) Dairy product analogs, including nondairy milk, frozen or liquid creamers, coffee whiteners, toppings, and other nondairy products.

(11) Egg products, including liquid, frozen, or dried eggs, and egg dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and frozen multicourse egg meals, but not fresh eggs.

(12) Fats and oils, including margarine, dressings for salads, butter, salad oils, shortenings and cooking oils.

(13) Fish products, including all prepared main dishes, salads, appetizers, frozen multicourse meals, and spreads containing fish, shellfish, and other aquatic animals, but not fresh fish.

(14) Fresh eggs, including cooked eggs and egg dishes made only from fresh shell eggs.

(15) Fresh fish, including only fresh and frozen fish, shellfish, and other aquatic animals.

(16) Fresh fruits and fruit juices, including only raw fruits, citrus, melons, and berries, and home-prepared “ades” and punches made therefrom.

(17) Fresh meats, including only fresh or home-frozen beef or veal, pork, lamb or mutton and home-prepared fresh meat-containing dishes, salads, appetizers, or sandwich spreads made therefrom.

(18) Fresh poultry, including only fresh or home-frozen poultry and game birds and home-prepared fresh poultry-containing dishes, salads, appetizers, or sandwich spreads made therefrom.

(19) Fresh vegetables, tomatoes, and potatoes, including only fresh and home-prepared vegetables.

(20) Frozen dairy desserts and mixes, including ice cream, ice milks, sherbets, and other frozen dairy desserts and specialties.

(21) Fruit and water ices, including all frozen fruit and water ices.

(22) Gelatins, puddings, and fillings, including flavored gelatin desserts, puddings, custards, parfaits, pie fillings, and gelatin base salads.

(23) Grain products and pastas, including macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables.

(24) Gravies and sauces, including all meat sauces and gravies, and tomato, milk, buttery, and specialty sauces.

(25) Hard candy and cough drops, including all hard type candies.

(26) Herbs, seeds, spices, seasonings, blends, extracts, and flavorings, including all natural and artificial spices, blends, and flavors.

(27) Jams and jellies, home-prepared, including only home-prepared jams, jellies, fruit butters, preserves, and sweet spreads.

(28) Jams and jellies, commercial, including only commercially processed jams, jellies, fruit butters, preserves, and sweet spreads.

(29) Meat products, including all meats and meat containing dishes, salads, appetizers, frozen multicourse meat meals, and sandwich ingredients prepared by commercial processing or using commercially processed meats with home preparation.

(30) Milk, whole and skim, including only whole, lowfat, and skim fluid milks.

(31) Milk products, including flavored milks and milk drinks, dry milks, toppings, snack dips, spreads, weight control milk beverages, and other milk origin products.

(32) Nuts and nut products, including whole or shelled tree nuts, peanuts, coconut, and nut and peanut spreads.

(33) Plant protein products, including the National Academy of Sciences/National Research Council “reconstituted vegetable protein” category, and meat, poultry, and fish substitutes, analogs, and extender products made from plant proteins.

(34) Poultry products, including all poultry and poultry-containing dishes, salads, appetizers, frozen multicourse poultry meals, and sandwich ingredients prepared by commercial processing or using commercially processed poultry with home preparation.

(35) Processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and mixtures; salads, juices and juice punches, concentrates, dilutions, “ades”, and drink substitutes made therefrom.

(36) Processed vegetables and vegetable juices, including all commercially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends.

(37) Snack foods, including chips, pretzels, and other novelty snacks.

(38) Soft candy, including candy bars, chocolates, fudge, mints, and other chewy or nougat candies.

(39) Soups, home-prepared, including meat, fish, poultry, vegetable, and combination home-prepared soups.

(40) Soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable, and combination soups and soup mixes.

(41) Sugar, white, granulated, including only white granulated sugar.

(42) Sugar substitutes, including granulated, liquid, and tablet sugar substitutes.

(43) Sweet sauces, toppings, and syrups, including chocolate, berry, fruit, corn syrup, and maple sweet sauces and toppings.

(o) The following terms describe the physical or technical functional effects for which direct human food ingredients may be added to foods. They are adopted from the National Academy of Sciences/National Research Council national survey of food industries, reported to the Food and Drug Administration under the contract title “A Comprehensive Survey of Industry on the Use of Food Chemicals Generally Recognized as Safe” (September 1972), which is incorporated by reference. Copies are available from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Anticaking agents and free-flow agents: Substances added to finely powdered or crystalline food products to prevent caking, lumping, or agglomeration.

(2) Antimicrobial agents: Substances used to preserve food by preventing growth of microorganisms and subsequent spoilage, including fungistats, mold and rope inhibitors, and the effects listed by the National Academy of Sciences/National Research Council under “preservatives.”

(3) Antioxidants: Substances used to preserve food by retarding deterioration, rancidity, or discoloration due to oxidation.

(4) Colors and coloring adjuncts: Substances used to impart, preserve, or enhance the color or shading of a food, including color stabilizers, color fixatives, color-retention agents, etc.

(5) Curing and pickling agents: Substances imparting a unique flavor and/or color to a food, usually producing an increase in shelf life stability.

(6) Dough strengtheners: Substances used to modify starch and gluten, thereby producing a more stable dough, including the applicable effects listed by the National Academy of Sciences/National Research Council under “dough conditioner.”

(7) Drying agents: Substances with moisture-absorbing ability, used to maintain an environment of low moisture.

(8) Emulsifiers and emulsifier salts: Substances which modify surface tension in the component phase of an emulsion to establish a uniform dispersion or emulsion.

(9) Enzymes: Enzymes used to improve food processing and the quality of the finished food.

(10) Firming agents: Substances added to precipitate residual pectin, thus strengthening the supporting tissue and preventing its collapse during processing.

(11) Flavor enhancers: Substances added to supplement, enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.

(12) Flavoring agents and adjuvants: Substances added to impart or help impart a taste or aroma in food.

(13) Flour treating agents: Substances added to milled flour, at the mill, to improve its color and/or baking qualities, including bleaching and maturing agents.

(14) Formulation aids: Substances used to promote or produce a desired physical state or texture in food, including carriers, binders, fillers, plasticizers, film-formers, and tableting aids, etc.

(15) Fumigants: Volatile substances used for controlling insects or pests.

(16) Humectants: Hygroscopic substances incorporated in food to promote retention of moisture, including moisture-retention agents and antidusting agents.

(17) Leavening agents: Substances used to produce or stimulate production of carbon dioxide in baked goods to impart a light texture, including yeast, yeast foods, and calcium salts listed by the National Academy of Sciences/National Research Council under “dough conditioners.”

(18) Lubricants and release agents: Substances added to food contact surfaces to prevent ingredients and finished products from sticking to them.

(19) Non-nutritive sweeteners: Substances having less than 2 percent of the caloric value of sucrose per equivalent unit of sweetening capacity.

(20) Nutrient supplements: Substances which are necessary for the body's nutritional and metabolic processes.

(21) Nutritive sweeteners: Substances having greater than 2 percent of the caloric value of sucrose per equivalent unit of sweetening capacity.

(22) Oxidizing and reducing agents: Substances which chemically oxidize or reduce another food ingredient, thereby producing a more stable product, including the applicable effect listed by the National Academy of Sciences/National Research Council under “dough conditioners.”

(23) pH control agents: Substances added to change or maintain active acidity or basicity, including buffers, acids, alkalies, and neutralizing agents.

(24) Processing aids: Substances used as manufacturing aids to enhance the appeal or utility of a food or food component, including clarifying agents, clouding agents, catalysts, flocculents, filter aids, and crystallization inhibitors, etc.

(25) Propellants, aerating agents, and gases: Gases used to supply force to expel a product or used to reduce the amount of oxygen in contact with the food in packaging.

(26) Sequestrants: Substances which combine with polyvalent metal ions to form a soluble metal complex, to improve the quality and stability of products.

(27) Solvents and vehicles: Substances used to extract or dissolve another substance.

(28) Stabilizers and thickeners: Substances used to produce viscous solutions or dispersions, to impart body, improve consistency, or stabilize emulsions, including suspending and bodying agents, setting agents, jellying agents, and bulking agents, etc.

(29) Surface-active agents: Substances used to modify surface properties of liquid food components for a variety of effects, other than emulsifiers, but including solubilizing agents, dispersants, detergents, wetting agents, rehydration enhancers, whipping agents, foaming agents, and defoaming agents, etc.

(30) Surface-finishing agents: Substances used to increase palatability, preserve gloss, and inhibit discoloration of foods, including glazes, polishes, waxes, and protective coatings.

(31) Synergists: Substances used to act or react with another food ingredient to produce a total effect different or greater than the sum of the effects produced by the individual ingredients.

(32) Texturizers: Substances which affect the appearance or feel of the food.

(a) Over the years the Food and Drug Administration has given informal written opinions to inquiries as to the safety of articles intended for use as components of, or in contact with, food. Prior to the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929; Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which reads in part: “A food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health”.

(b) Since enactment of the Food Additives Amendment, the Food and Drug Administration has advised such inquirers that an article:

(1) Is a food additive within the meaning of section 201(s) of the act; or

(2) Is generally recognized as safe (GRAS); or

(3) Has prior sanction or approval under that amendment; or

(4) Is not a food additive under the conditions of intended use.

(c) In the interest of the public health, such articles which have been considered in the past by the Food and Drug Administration to be safe under the provisions of section 402(a)(1), or to be generally recognized as safe for their intended use, or to have prior sanction or approval, or not to be food additives under the conditions of intended use, must be reexamined in the light of current scientific information and current principles for evaluating the safety of food additives if their use is to be continued.

(d) Because of the time span involved, copies of many of the letters in which the Food and Drug Administration has expressed an informal opinion concerning the status of such articles may no longer be in the file of the Food and Drug Administration. In the absence of information concerning the names and uses made of all the articles referred to in such letters, their safety of use cannot be reexamined. For this reason all food additive status opinions of the kind described in paragraph (c) of this section given by the Food and Drug Administration are hereby revoked.

(e) The prior opinions of the kind described in paragraph (c) of this section will be replaced by qualified and current opinions if the recipient of each such letter forwards a copy of each to the Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, along with a copy of his letter of inquiry, on or before July 23, 1970.

(f) This section does not apply to food additive status opinion letters pertaining to articles that were considered by the Food and Drug Administration to be food additives nor to articles included in regulations in parts 170 through 189 of this chapter if the articles are used in accordance with the requirements of such regulations.

(a) The inclusion of food ingredients in parts 170 through 189 of this chapter does not imply that these ingredients may be used in standardized foods unless they are recognized as optional ingredients in applicable food standards. Where a petition is received for the issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the Act, which proposes the inclusion of a food additive in such definition and standard of identity, the provisions of the regulations in this part shall apply with respect to the information that must be submitted with respect to the food additive. Since section 409(b)(5) of the Act requires that the Secretary publish notice of a petition for the establishment of a food-additive regulation within 30 days after filing, notice of a petition relating to a definition and standard of identity shall also be published within that time limitation if it includes a request, so designated, for the establishment of a regulation pertaining to a food additive.

(b) If a petition for a definition and standard of identity contains a proposal for a food-additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a food-additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in this part.

(c) A regulation will not be issued allowing the use of a food additive in a food for which a definition and standard of identity is established, unless its issuance is in conformity with section 401 of the Act or with the terms of a temporary permit issued under § 130.17 of this chapter. When the contemplated use of such additive complies with the terms of a temporary permit, the food additive regulation will be conditioned on such compliance and will expire with the expiration of the temporary permit.

(a) The Commissioner upon his own initiative may propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used. Notice of such proposal shall be published in the Federal Register and shall state the reasons for the proposal.

(b) Action upon a proposal made by the Commissioner shall proceed as provided in part 10 of this chapter.

A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the Act under the following conditions:

(a) If intended for investigational use in vitro or in laboratory research animals, it bears a label which states prominently, in addition to the other information required by the act, the warning:

(b) If intended for use in animals other than laboratory research animals and if the edible products of the animals are to be marketed as food, permission for the marketing of the edible products as food has been requested by the sponsor, and authorization has been granted by the Food and Drug Administration in accordance with § 511.1 of this chapter or by the Department of Agriculture in accordance with 9 CFR 309.17, and it bears a label which states prominently, in addition to the other information required by the Act, the warning:

(c) If intended for nonclinical laboratory studies in food-producing animals, the study is conducted in compliance with the regulations set forth in part 58 of this chapter.

(a) Food additives that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects and will be considered as related food additives.

(b) Tolerances established for such related food additives may limit the amount of a common component that may be present, or may limit the amount of biological activity (such as cholinesterase inhibition) that may be present or may limit the total amount of related food additives that may be present.

(c) Where food additives from two or more chemicals in the same class are present in or on a food, the tolerance for the total of such additives shall be the same as that for the additive having the lowest numerical tolerance in this class, unless there are available methods that permit quantitative determination of the amount of each food additive present or unless it is shown that a higher tolerance is reasonably required for the combined additives to accomplish the physical or technical effect for which such combined additives are intended and that the higher tolerance will be safe.

(d) Where residues from two or more additives in the same class are present in or on a food and there are available methods that permit quantitative determination of each residue, the quantity of combined residues that are within the tolerance may be determined as follows:

(1) Determine the quantity of each residue present.

(2) Divide the quantity of each residue by the tolerance that would apply if it occurred alone, and multiply by 100 to determine the percentage of the permitted amount of residue present.

(3) Add the percentages so obtained for all residues present.

(4) The sum of the percentage shall not exceed 100 percent.

When pesticide chemical residues occur in processed foods due to the use of raw agricultural commodities that bore or contained a pesticide chemical in conformity with an exemption granted or a tolerance prescribed under section 408 of the Act, the processed food will not be regarded as adulterated so long as good manufacturing practice has been followed in removing any residue from the raw agricultural commodity in the processing (such as by peeling or washing) and so long as the concentration of the residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity. But when the concentration of residue in the processed food when ready to eat is higher than the tolerance prescribed for the raw agricultural commodity, the processed food is adulterated unless the higher concentration is permitted by a tolerance obtained under section 409 of the Act. For example, if fruit bearing a residue of 7 parts per million of DDT permitted on the raw agricultural commodity is dried and a residue in excess of 7 parts per million of DDT results on the dried fruit, the dehydrated fruit is adulterated unless the higher tolerance for DDT is authorized by the regulations in this part. Food that is itself ready to eat, and which contains a higher residue than allowed for the raw agricultural commodity, may not be legalized by blending or mixing with other foods to reduce the residue in the mixed food below the tolerance prescribed for the raw agricultural commodity.

(a) In reaching a decision on any petition filed under section 409 of the Act, the Commissioner will give full consideration to the specific biological properties of the compound and the adequacy of the methods employed to demonstrate safety for the proposed use, and the Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council. A petition will not be denied, however, by reason of the petitioner's having followed procedures other than those outlined in the publications of the National Academy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the procedures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the outlined procedures. In reaching a decision, the Commissioner will give due weight to the anticipated levels and patterns of consumption of the additive specified or reasonably inferrable. For the purposes of this section, the principles for evaluating safety of additives set forth in the abovementioned publications will apply to any substance that may properly be classified as a food additive as defined in section 201(s) of the Act.

(b) Upon written request describing the proposed use of an additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive.

In accordance with section 409(c)(5)(C) of the Act, the following safety factors will be applied in determining whether the proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum amount demonstrated to be without harm to experimental animals.

(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. General recognition of safety requires common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the conditions of its intended use (see § 170.3(i)).

(b) General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive. General recognition of safety through scientific procedures shall be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.

(c)(1) General recognition of safety through experience based on common use in food prior to January 1, 1958, may be achieved without the quantity or quality of scientific procedures required for approval of a food additive. General recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information. An ingredient not in common use in food prior to January 1, 1958, may achieve general recognition of safety only through scientific procedures.

(2) A substance used in food prior to January 1, 1958, may be generally recognized as safe through experience based on its common use in food when that use occurred exclusively or primarily outside of the United States if the information about the experience establishes that the substance is safe under the conditions of its intended use within the meaning of section 201(u) of the Federal Food, Drug, and Cosmetic Act (see also § 170.3(i)). Common use in food prior to January 1, 1958, that occurred outside of the United States shall be documented by published or other information and shall be corroborated by information from a second, independent source that confirms the history and circumstances of use of the substance. The information used to document and to corroborate the history and circumstances of use of the substance must be generally available; that is, it must be widely available in the country in which the history of use has occurred and readily available to interested qualified experts in the United States. A person who concludes that a use of a substance is GRAS through experience based on its common use in food outside of the United States should notify FDA of that view in accordance with subpart E of this part.

(d) The food ingredients listed as GRAS in part 182 of this chapter or affirmed as GRAS in part 184 or part 186 of this chapter do not include all substances that are generally recognized as safe for their intended use in food. Because of the large number of substances the intended use of which results or may reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of food, it is impracticable to list all such substances that are GRAS. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to January 1, 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS without specific inclusion in part 182, part 184 or part 186 of this chapter.

(e) Food ingredients were listed as GRAS in part 182 of this chapter during 1958-1962 without a detailed scientific review of all available data and information relating to their safety. Beginning in 1969, the Food and Drug Administration has undertaken a systematic review of the status of all ingredients used in food based on the view that they are GRAS under the conditions of their intended use or subject to a prior sanction. All affirmations of GRAS status or determinations of food additive status or prior sanction status pursuant to this review shall be handled pursuant to §§ 170.35, 170.38, and 180.1 of this chapter. Affirmation of GRAS status shall be announced in part 184 or part 186 of this chapter.

(f) [Reserved]

(h) A food ingredient that is listed as GRAS in part 182 of this chapter or affirmed as GRAS in part 184 or part 186 of this chapter shall be regarded as GRAS only if, in addition to all the requirements in the applicable regulation, it also meets all of the following requirements:

(1) It complies with any applicable food grade specifications of the Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed. (1981), which are incorporated by reference, except that any substance used as a component of articles that contact food and affirmed as GRAS in part 186 of this chapter shall comply with the specifications therein, or in the absence of such specifications, shall be of a purity suitable for its intended use. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) It performs an appropriate function in the food or food-contact article in which it is used.

(3) It is used at a level no higher than necessary to achieve its intended purpose in that food or, if used as a component of a food-contact article, at a level no higher than necessary to achieve its intended purpose in that article.

(i) If a substance is affirmed as GRAS in part 184 or part 186 of this chapter with no limitation other than good manufacturing practice, it shall be regarded as GRAS if its conditions of use are not significantly different from those reported in the regulation as the basis on which the GRAS status of the substance was affirmed. If the conditions of use are significantly different, such use of the substance may not be GRAS. In such a case a manufacturer may not rely on the regulation as authorizing the use but must independently establish that the use is GRAS or must use the substance in accordance with a food additive regulation.

(j) If an ingredient is affirmed as GRAS in part 184 or part 186 of this chapter with specific limitation(s), it may be used in food only within such limitation(s) (including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use). Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation.

(k) Pursuant to § 170.35, a food ingredient may be affirmed as GRAS in part 184 or part 186 of this chapter for a specific use(s) without a general evaluation of use of the ingredient. In addition to the use(s) specified in the regulation, other uses of such an ingredient may also be GRAS. Any affirmation of GRAS status for a specific use(s), without a general evaluation of use of the ingredient, is subject to reconsideration upon such evaluation.

(l) New information may at any time require reconsideration of the GRAS status of a food ingredient. Any change to the GRAS status of a food ingredient in parts 182, 184, or 186 of this chapter shall be accomplished pursuant to § 170.38.

(a) The Commissioner, on his own initiative, may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use.

(b)(1) If the Commissioner proposes on his own initiative that a substance is entitled to affirmation as GRAS under the conditions of its intended use, he will place all of the data and information on which he relies on public file in the office of the Division of Dockets Management and will publish in the Federal Register a notice giving the name of the substance, its proposed uses, and any limitations proposed for purposes other than safety.

(2) The Federal Register notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Division of Dockets Management. Copies of all comments received shall be made available for examination in the Division of Dockets Management's office.

(3) The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS under the conditions of its intended use as described in § 170.30, he will publish a notice in the Federal Register listing the GRAS conditions of use of the substance in part 184 or part 186 of this chapter, as appropriate.

(4) If, after evaluation of the comments, the Commissioner concludes that there is a lack of convincing evidence that a substance is GRAS under the conditions of its intended use and that it should be considered a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act, he shall publish a notice thereof in the Federal Register in accordance with § 170.38.

(a) The Commissioner may, in accordance with § 170.35(b)(4), publish a notice in the Federal Register determining that a substance is not GRAS under the conditions of its intended use and is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act.

(b)(1) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may issue a notice in the Federal Register proposing to determine that a substance is not GRAS and is a food additive subject to section 409 of the Act. Any petition shall include all relevant data and information of the type described in § 171.130(b). The Commissioner will place all of the data and information on which he relies on public file in the office of the Division of Dockets Management and will include in the Federal Register notice the name of the substance, its known uses, and a summary of the basis for the determination.

(2) The Federal Register notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Division of Dockets Management. Copies of all comments shall be made available for examination in the Division of Dockets Management's office.

(3) The Commissioner will evaluate all comments received. If he concludes that there is a lack of convincing evidence that the substance is GRAS or is otherwise exempt from the definition of a food additive in section 201(s) of the Act, he will publish a notice thereof in the Federal Register. If he concludes that there is convincing evidence that the substance is GRAS, he will publish an order in the Federal Register listing the substance as GRAS in part 182, part 184, or part 186 of this chapter, as appropriate.

(c) A Federal Register notice determining that a substance is a food additive shall provide for the use of the additive in food or food contact surfaces as follows:

(1) It may promulgate a food additive regulation governing use of the additive.

(2) It may promulgate an interim food additive regulation governing use of the additive.

(3) It may require discontinuation of the use of the additive.

(4) It may adopt any combination of the above three approaches for different uses or levels of use of the additive.

(d) If the Commissioner of Food and Drugs is aware of any prior sanction for use of the substance, he will concurrently propose a separate regulation covering such use of the ingredient under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal.

(a) A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulation if:

(1) The substance has not been shown to be a carcinogen in humans or animals, and there is no reason, based on the chemical structure of the substance, to suspect that the substance is a carcinogen. The substance must also not contain a carcinogenic impurity or, if it does, must not contain a carcinogenic impurity with a TD50 value based on chronic feeding studies reported in the scientific literature or otherwise available to the Food and Drug Administration of less than 6.25 milligrams per kilogram bodyweight per day (The TD50, for the purposes of this section, is the feeding dose that causes cancer in 50 percent of the test animals when corrected for tumors found in control animals. If more than one TD50 value has been reported in the scientific literature for a substance, the Food and Drug Administration will use the lowest appropriate TD50 value in its review.);

(2) The substance presents no other health or safety concerns because:

(i) The use in question has been shown to result in or may be expected to result in dietary concentrations at or below 0.5 parts per billion, corresponding to dietary exposure levels at or below 1.5 micrograms/person/day (based on a diet of 1,500 grams of solid food and 1,500 grams of liquid food per person per day); or

(ii) The substance is currently regulated for direct addition into food, and the dietary exposure to the substance resulting from the proposed use is at or below 1 percent of the acceptable daily intake as determined by safety data in the Food and Drug Administration's files or from other appropriate sources;

(3) The substance has no technical effect in or on the food to which it migrates; and

(4) The substance use has no significant adverse impact on the environment.

(b) Notwithstanding paragraph (a) of this section, the Food and Drug Administration reserves the right to decline to grant an exemption in those cases in which available information establishes that the proposed use may pose a public health risk. The reasons for the agency's decision to decline to grant an exemption will be explained in the Food and Drug Administration's response to the requestor.

(c) A request for the Food and Drug Administration to exempt a use of a substance from regulation as a food additive shall include three copies of the following information (If part of the submitted material is in a foreign language, it must be accompanied by an English translation verified to be complete and accurate in accordance with § 10.20(c)(2) of this chapter):

(1) The chemical composition of the substance for which the request is made, including, whenever possible, the name of the chemical in accordance with current Chemical Abstract Service (CAS) nomenclature guidelines and a CAS registry number, if available;

(2) Detailed information on the conditions of use of the substance (e.g., temperature, type of food with which the substance will come into contact, the duration of the contact, and whether the food-contact article will be for repeated or single use applications);

(3) A clear statement as to whether the request for exemption from regulation as a food additive is based on the fact that the use of the substance in the food-contact article results in a dietary concentration at or below 0.5 parts per billion, or on the fact that it involves the use of a regulated direct food additive for which the dietary exposure is at or below 1 percent of the acceptable dietary intake (ADI);

(4) Data that will enable the Food and Drug Administration to estimate the daily dietary concentration resulting from the proposed use of the substance. These data should be in the form of:

(i) Validated migration data obtained under worst-case (time/temperature) intended use conditions utilizing appropriate food simulating solvents;

(ii) Information on the amount of the substance used in the manufacture of the food-contact article; or

(iii) Information on the residual level of the substance in the food-contact article. For repeat-use articles, an estimate of the amount of food that contacts a specific unit of surface area over the lifetime of the article should also be provided. (In cases where data are provided only in the form of manufacturing use levels or residual levels of the substance present in the food-contact article, the Food and Drug Administration will calculate a worst-case dietary concentration level assuming 100 percent migration.) A detailed description of the analytical method used to quantify the substance should also be submitted along with data used to validate the detection limit.

(iv) In cases where there is no detectable migration into food or food simulants, or when no residual level of a substance is detected in the food-contact article by a suitable analytical method, the Food and Drug Administration will, for the purposes of estimating the dietary concentration, consider the validated detection limit of the method used to analyze for the substance.

(5) The results of an analysis of existing toxicological information on the substance and its impurities. This information on the substance is needed to show whether an animal carcinogen bioassay has been carried out, or whether there is some other basis for suspecting that the substance is a carcinogen or potent toxin. This type of information on the impurities is needed to show whether any of them are carcinogenic, and, if carcinogenic, whether their TD50 values are greater than 6.25 milligrams per kilogram bodyweight per day in accordance with paragraph (a)(1) of this section.

(6) Information on the environmental impact that would result from the proposed use of the substance. The request should contain either a claim for categorical exclusion as specified in § 25.32 of this chapter or an environmental assessment as specified in § 25.40 of this chapter.

(d) Data to be reviewed under this section shall be submitted to the Food and Drug Administration's Office of Premarket Approval (HFS-200), 5001 Campus Dr., College Park, MD 20740.

(e) The Food and Drug Administration will inform the requestor by letter whether the specific food-contact application is exempt from regulation as a food additive or not. Although a substance that migrates to food at a level that results in a dietary concentration at or below the threshold of regulation will not be the subject of a regulation published in the Federal Register and will not appear in the Code of Federal Regulations, the Food and Drug Administration will maintain a list of substances exempted from regulation as food additives under this section on display at the Division of Dockets Management. This list will include the name of the company that made the request, the chemical name of the substance, the specific use for which it has received an exemption from regulation as a food additive, and any appropriate limitations on its use. The list will not include any trade names. This list will enable interested persons to see the types of uses of food-contact materials being exempted under the regulation. Interested persons may also obtain a copy of the list of exempted substances by contacting the Food and Drug Administration's Office of Premarket Approval (HFS-200), 5001 Campus Dr., College Park, MD 20740. For actions requiring an environmental assessment, the agency's finding of no significant impact and the evidence supporting that finding, contained in the petitioner's environmental assessment, also will be available for public inspection at the Division of Dockets Management in accordance with § 25.51(b)(2) of this chapter. Requests for copies of releasable information contained in submissions requesting exemptions from the food additive regulations will be handled in accordance with the Food and Drug Administration's Freedom of Information Act procedures, as described in part 20 of this chapter. In particular, data and information that fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure in accordance with § 20.61(c) of this chapter.

(f) If the request for an exemption from regulation as a food additive is not granted, the requestor may submit a petition to the Food and Drug Administration for reconsideration of the decision in accordance with the provisions of § 10.33 of this chapter.

(g) If the Food and Drug Administration receives significant new information that raises questions about the dietary concentration or the safety of a substance that the agency has exempted from regulation, the Food and Drug Administration may reevaluate the substance. If the Food and Drug Administration tentatively concludes that the information that is available about the substance no longer supports an exemption for the use of the food-contact material from the food additive regulations, the agency will notify any persons that requested an exemption for the substance of its tentative decision. The requestors will be given an opportunity to show why the use of the substance should not be regulated under the food additive provisions of the act. If the requestors fail to adequately respond to the new evidence, the agency will notify them that further use of the substance in question for the particular use will require a food additive regulation. This notification will be placed on public display at the Division of Dockets Management as part of the file of uses of substances exempted from regulation as food additives. The Food and Drug Administration recognizes that manufacturers other than those that actually made a request for exemption may also be using exempted substances in food-contact articles under conditions of use (e.g., use levels, temperature, type of food contacted, etc.) that are similar to those for which the exemption was issued. Because only requestors will be notified as part of the revocation process described in this section, the Food and Drug Administration plans to notify other manufacturers by means of a notice published in the Federal Register of its decision to revoke an exemption issued for a specific use of a substance in a food contact article.

(h) Guidance documents to assist requestors in the preparation of submissions seeking exemptions from the food additive regulations are available from the Food and Drug Administration's Office of Premarket Approval (HFS-200), 5001 Campus Dr., College Park, MD 20740. Interested persons are encouraged to obtain specific guidance from the Food and Drug Administration on the appropriate protocols to be used for obtaining migration data, on the validation of the analytical methods used to quantify migration levels, on the procedures used to relate migration data to dietary exposures, and on any other issue not specifically covered in the Food and Drug Administration's guidance documents.

The Commissioner of Food and Drugs has concluded that it is in the interest of the public health to limit the addition of fluorine compounds to foods (a) to that resulting from the fluoridation of public water supplies, (b) to that resulting from the fluoridation of bottled water within the limitation established in § 165.110(d) of this chapter, and (c) to that authorized by regulations (40 CFR part 180) under section 408 of the Act.

(a) Heretofore, the Food and Drug Administration has expressed the opinion in trade correspondence that glycine is generally recognized as safe for certain technical effects in human food when used in accordance with good manufacturing practice; however:

(1) Reports in scientific literature indicate that adverse effects were found in cases where high levels of glycine were administered in diets of experimental animals.

(2) Current usage information indicates that the daily dietary intake of glycine by humans may be substantially increasing due to changing use patterns in food technology.

(b) The Commissioner of Food and Drugs concludes that by May 8, 1971, manufacturers:

(1) Shall reformulate food products for human use to eliminate added glycine and its salts; or

(2) Shall bring such products into compliance with an authorizing food additive regulation. A food additive petition supported by toxicity data is required to show that any proposed level of glycine or its salts added to foods for human consumption will be safe.

(c) The status of glycine as generally recognized as safe for use in animal feed, as prescribed in § 582.5049 of this chapter, remains unchanged because the additive is considered an essential nutrient in certain animal feeds and is safe for such use under conditions of good feeding practice.

(a) Nitrites and/or nitrates are food additives when combined in curing premixes with spices and/or other flavoring or seasoning ingredients that contain or constitute a source of secondary or tertiary amines, including but not limited to essential oils, disodium inosinate, disodium guanylate, hydrolysates of animal or plant origin (such as hydrolyzed vegetable protein), oleoresins of spices, soy products, and spice extractives. Such food additives may be used only after the establishment of an authorizing food additive regulation. A food additive petition submitted pursuant to §§ 171.1 and 171.100 of this chapter, supported by data demonstrating that nitrosamines are not formed in curing premixes containing such food additives, is required to establish safety.

(b) Nitrites and/or nitrates, when packaged separately from flavoring and seasoning in curing premixes, may continue to be used under prior sanctions in the commercial curing of meat and meat products and poultry products and in accordance with the provisions of §§ 172.170 and 172.175 of this chapter that apply to meat curing preparations for the home curing of meat and meat products, including poultry and wild game. To assure safe use of such ingredients the labeling of the premixes shall bear instructions to the user that such separately packaged ingredients are not to be combined until just prior to use. Encapsulating or coating some or all of the ingredients does not constitute separate packaging.

(a) An FCN is effective for the food contact substance manufactured or prepared by the manufacturer or supplier identified in the FCN submission. If another manufacturer or supplier wishes to market the same food contact substance for the same use, that manufacturer or supplier must also submit an FCN to FDA.

(1) An FCN must contain all of the information described in § 170.101.

(2) An FCN may incorporate by reference any information in FDA's files provided that the manufacturer or supplier is authorized to reference the information. The FCN must include information establishing that the manufacturer or supplier is authorized to reference information in FDA's files.

(3) Any material submitted in or referenced by an FCN that is in a foreign language must be accompanied by an English translation verified to be complete and accurate.

(b) FDA may choose not to accept an FCN for either of the following:

(1) A use of a food contact substance that is the subject of a regulation in parts 173 through 189 of this chapter; or

(2) A use of a food contact substance that is the subject of an exemption under the threshold of regulation process described in § 170.39.

(c) A petition must be submitted under § 171.1 of this chapter to authorize the safe use of a food contact substance in either of the following circumstances, unless FDA agrees to accept an FCN for the proposed use.

(1) The use of the food contact substance increases the cumulative dietary concentration to a certain level. For a substance that is a biocide (e.g., it is intended to exert microbial toxicity), this level is equal to or greater than 200 parts per billion in the daily diet (0.6 milligram (mg)/person/day). For a substance that is not a biocide, this level is equal to or greater than 1 part per million in the daily diet (3 mg/person/day); or

(2) There exists a bioassay on the food contact substance, FDA has not reviewed the bioassay, and the bioassay is not clearly negative for carcinogenic effects.

(d) A manufacturer or supplier for which a notification is effective must keep a current address on file with FDA.

(1) The current address may be either the manufacturer's (or supplier's) address or the address of the manufacturer's (or supplier's) agent.

(2) FDA will deliver correspondence to the manufacturer's or supplier's current address.

An FCN must contain the following:

(a) A comprehensive discussion of the basis for the manufacturer's or supplier's determination that the use of the food contact substance is safe. This discussion must:

(1) Discuss all information and data submitted in the notification; and

(2) Address any information and data that may appear to be inconsistent with the determination that the proposed use of the food contact substance is safe.

(b) All data and other information that form the basis of the determination that the food contact substance is safe under the intended conditions of use. Data must include primary biological data and chemical data.

(c) A good laboratory practice statement for each nonclinical laboratory study, as defined under § 58.3(d) of this chapter, that is submitted as part of the FCN, in the form of either:

(1) A signed statement that the study was conducted in compliance with the good laboratory practice regulations under part 58 of this chapter; or

(2) A brief signed statement listing the reason(s) that the study was not conducted in compliance with part 58 of this chapter.

(3) Data from any study conducted after 1978 but not conducted in compliance with part 58 of this chapter must be validated by an independent third party prior to submission to the Food and Drug Administration (FDA), and the report and signed certification of the validating party must be submitted as part of the notification.

(d) Information to address FDA's responsibility under the National Environmental Policy Act, in the form of either:

(1) A claim of categorical exclusion under § 25.30 or § 25.32 of this chapter; or

(2) An environmental assessment complying with § 25.40 of this chapter.

(e) A completed and signed FDA Form No. 3480.

(a) During the 120-day period of the Food and Drug Administration (FDA) review of an FCN, FDA will not disclose publicly any information in that FCN.

(b) FDA will not disclose publicly the information in an FCN that is withdrawn prior to the completion of FDA's review.

(c) Once FDA completes its review of an FCN, the agency will make its conclusion about the FCN publicly available. For example, if FDA objects to a notification 90 days after the date of receipt, the agency would make available its objection at that time.

(d) By submitting an FCN to FDA, the manufacturer or supplier waives any claim to confidentiality of the information required to adequately describe the food contact substance and the intended conditions of use that are the subject of that FCN.

(e) The following data and information in an FCN are available for public disclosure, unless extraordinary circumstances are shown, on the 121st day after receipt of the notification by FDA, except that no data or information are available for public disclosure if the FCN is withdrawn under § 170.103.

(1) All safety and functionality data and information submitted with or incorporated by reference into the notification. Safety and functionality data include all studies and tests of a food contact substance on animals and humans and all studies and tests on a food contact substance for establishing identity, stability, purity, potency, performance, and usefulness.

(2) A protocol for a test or study, unless it is exempt from disclosure under § 20.61 of this chapter.

(3) A list of all ingredients contained in a food contact substance, excluding information that is exempt from disclosure under § 20.61 of this chapter. Where applicable, an ingredient list will be identified as incomplete.

(4) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is exempt from disclosure under § 20.61 of this chapter.

(5) All correspondence and written summaries of oral discussions relating to the notification, except information that is exempt for disclosure under § 20.61 of this chapter.

(6) All other information not subject to an exemption from disclosure under subpart D of part 20 of this chapter.

A manufacturer or supplier may withdraw an FCN without prejudice to a future submission to the Food and Drug Administration (FDA) if FDA has not completed review of the FCN. For the purpose of this section, FDA's review is completed when FDA has allowed 120 days to pass without objecting to the FCN or FDA has issued an objection letter.

(a) If the Food and Drug Administration (FDA) does not object to an FCN within the 120-day period for FDA review, the FCN becomes effective.

(b) If an FCN is complete when received, the 120-day review period begins on the date FDA receives the FCN.

(1) If any element required under § 170.101 is missing from an FCN, then FDA will not accept that FCN and FDA will send an FCN nonacceptance letter to the manufacturer or supplier. If the manufacturer or supplier submits the missing information before FDA sends an FCN nonacceptance letter, the 120-day review period begins on the date of receipt of the missing information.

(2) If FDA accepts an FCN, then FDA will acknowledge in writing its receipt of that FCN.

(c) Objection to an FCN:

(1) If FDA objects to an FCN, then FDA will send an FCN objection letter. The date of the letter will be the date of FDA's objection for purposes of section 409(h)(2)(A) of the act.

(2) If FDA objects to an FCN within the 120-day period for FDA review, the FCN will not become effective.

(3) FDA may object to an FCN if any part of FDA's 120-day review occurs during a period when this program is not funded as required in section 409(h)(5) of the act.

(d) If FDA and a manufacturer or supplier agree that the notifier may submit a food additive petition proposing the approval of the food contact substance for the use in the manufacturer's or supplier's FCN, FDA will consider that FCN to be withdrawn by the manufacturer or supplier on the date the petition is received by FDA.

(a) If data or other information available to FDA, including data not submitted by the manufacturer or supplier, demonstrate that the intended use of the food contact substance is no longer safe, FDA may determine that the authorizing FCN is no longer effective.

(b) If FDA determines that an FCN is no longer effective, FDA will inform the manufacturer or supplier in writing of the basis for that determination. FDA will give the manufacturer or supplier an opportunity to show why the FCN should continue to be effective and will specify the time that the manufacturer or supplier will have to respond.

(c) If the manufacturer or supplier fails to respond adequately to the safety concerns regarding the notified use, FDA will publish a notice of its determination that the FCN is no longer effective. FDA will publish this notice in the Federal Register, stating that a detailed summary of the basis for FDA's determination that the FCN is no longer effective has been placed on public display and that copies are available upon request. The date that the notice publishes in the Federal Register is the date on which the notification is no longer effective.

(d) FDA's determination that an FCN is no longer effective is final agency action subject to judicial review.

(a) In order for the Food and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the formulation must be authorized for its intended use in that NFCSF.

(b) FDA may publish a notice in the Federal Register stating that the agency has insufficient resources to review NFCSFs. From the date that this notice publishes in the Federal Register, FDA will no longer accept NFCSFs.

(c) An NFCSF must contain the following:

(1) A completed and signed FDA Form No. 3479; and

(2) Any additional documentation required to establish that each component of the formulation already may be marketed legally for its intended use.

The definitions and interpretations of terms in § 170.3 apply to such terms when used in this subpart. The following definitions also apply:

Amendment means any data and information that you submit regarding a filed GRAS notice before we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).

GRAS means generally recognized as safe.

GRAS notice means a submission that informs us of your view that a substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the substance is GRAS under the conditions of its intended use in accordance with § 170.30.

Notified substance means the substance that is the subject of your GRAS notice.

Notifier means the person (e.g., an individual, partnership, corporation, association, or other legal entity) who is responsible for the GRAS notice, even if another person (such as an attorney, agent, or qualified expert) prepares or submits the notice or provides an opinion about the basis for a conclusion of GRAS status.

Qualified expert means an individual who is qualified by scientific training and experience to evaluate the safety of substances under the conditions of their intended use in food.

Supplement means any data and information that you submit regarding a filed GRAS notice after we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).

We, our, and us refer to the United States Food and Drug Administration (FDA).

You and your refer to a notifier.

Any person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act based on that person's conclusion that the substance is GRAS under the conditions of its intended use.

(a) Send your GRAS notice to the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

(b) When you submit your GRAS notice, you may do so either in an electronic format that is accessible for our evaluation or on paper. If you send your GRAS notice on paper, a single paper copy is sufficient.

You may incorporate into your GRAS notice either specifically identified data and information that you previously submitted to the Center for Food Safety and Applied Nutrition (CFSAN), or specifically identified publicly available data and information submitted by another party, when such data and information remain in CFSAN's records, such as data and information contained in a previous GRAS notice or a food additive petition.

(a) A GRAS notice has seven parts as required by §§ 170.225 through 170.255. You must submit the data and information specified in each of these parts on separate pages or sets of pages.

(b) You must include each of the seven parts in your GRAS notice. If you do not include a part, you must include with your GRAS notice an explanation of why that part does not apply to your GRAS notice.

(a) Part 1 of your GRAS notice must be dated and signed by a responsible official of your organization, or by your attorney or agent.

(b) Except as required by paragraph (c)(8) of this section, you must not include any information that is trade secret or confidential commercial information in Part 1 of your GRAS notice.

(c) In Part 1 of your GRAS notice, you must:

(1) Inform us that you are submitting a GRAS notice in accordance with this subpart;

(2) Provide the name and address of your organization;

(3) Provide the name of the notified substance, using an appropriately descriptive term;

(4) Describe the intended conditions of use of the notified substance, including the foods in which the substance will be used, the levels of use in such foods, and the purposes for which the substance will be used, including, when appropriate, a description of a subpopulation expected to consume the notified substance;

(5) Inform us of the statutory basis for your conclusion of GRAS status (i.e., through scientific procedures in accordance with § 170.30(a) and (b) or through experience based on common use in food in accordance with § 170.30(a) and (c));

(6) State your view that the notified substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the notified substance is GRAS under the conditions of its intended use;

(7) State that, if we ask to see the data and information that are the basis for your conclusion of GRAS status, either during or after our evaluation of your notice, you will:

(i) Agree to make the data and information available to us; and

(ii) Agree to both of the following procedures for making the data and information available to us:

(A) Upon our request, you will allow us to review and copy the data and information during customary business hours at the address you specify for where these data and information will be available to us; and

(B) Upon our request, you will provide us with a complete copy of the data and information either in an electronic format that is accessible for our evaluation or on paper;

(8) State your view as to whether any of the data and information in Parts 2 through 7 of your GRAS notice are exempt from disclosure under the Freedom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or as commercial or financial information that is privileged or confidential).

(9) Certify that, to the best of your knowledge, your GRAS notice is a complete, representative, and balanced submission that includes unfavorable information, as well as favorable information, known to you and pertinent to the evaluation of the safety and GRAS status of the use of the substance;

(10) State both the name and position or title of the person who signs the GRAS notice; and

(11) When applicable, state as required by § 170.270 whether you:

(i) Authorize us to send any trade secrets to the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture; or

(ii) Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS.

In Part 2 of your GRAS notice, you must include:

(a) Scientific data and information that identifies the notified substance.

(1) Examples of appropriate data and information include the chemical name, applicable registry numbers (such as a Chemical Abstracts Service (CAS) registry number or an Enzyme Commission (EC) number), empirical formula, structural formula, quantitative composition, and characteristic properties.

(2) When the source of a notified substance is a biological material, you must include data and information sufficient to identify:

(i) The taxonomic source (e.g., genus, species) including, as applicable, data and information at the sub-species level (e.g., variety, strain);

(ii) The part of any plant or animal used as the source; and

(iii) Any known toxicants that could be in the source;

(b) A description of the method of manufacture of the notified substance in sufficient detail to evaluate the safety of the notified substance as manufactured;

(c) Specifications for food-grade material; and

(d) When necessary to demonstrate safety, relevant data and information bearing on the physical or other technical effect the notified substance is intended to produce, including the quantity of the notified substance required to produce such effect.

In part 3 of your GRAS notice, you must provide data and information about dietary exposure (i.e., the amount of relevant substances that consumers are likely to eat or drink as part of a total diet), regardless of whether your conclusion of GRAS status is through scientific procedures or through experience based on common use in food, as follows:

(a) You must provide an estimate of dietary exposure to the notified substance that includes exposure from its intended use and all sources in the diet; and

(b) When applicable, you must provide an estimate of dietary exposure to any other substance that is expected to be formed in or on food because of the use of the notified substance (e.g., hydrolytic products or reaction products);

(c) When applicable, you must provide an estimate of dietary exposure to any other substance that is present with the notified substance either naturally or due to its manufacture (e.g., contaminants or by-products);

(d) You must describe the source of any food consumption data that you use to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section; and

(e) You must explain any assumptions you made to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section.

In circumstances where the amount of the notified substance that can be added to food is limited because food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical, in Part 4 of your GRAS notice you must include data and information on such self-limiting levels of use.

If the statutory basis for your conclusion of GRAS status is through experience based on common use in food, in Part 5 of your GRAS notice you must include evidence of a substantial history of consumption of the notified substance for food use by a significant number of consumers prior to January 1, 1958.

In Part 6 of your GRAS notice, you must include a narrative that provides the basis for your conclusion of GRAS status, in which:

(a)(1) You must explain why the data and information in your notice provide a basis for your view that the notified substance is safe under the conditions of its intended use. In your explanation, you must address the safety of the notified substance, considering all dietary sources and taking into account any chemically or pharmacologically related substances in such diet;

(2) In your explanation, you must identify what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are generally available, and what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are not generally available, by providing citations to the list of data and information that you include in Part 7 of your GRAS notice in accordance with § 170.255;

(b) You must explain how the generally available data and information that you rely on to establish safety in accordance with paragraph (a) of this section provide a basis for your conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use;

(c) You must either:

(1) Identify, discuss, and place in context, data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status, regardless of whether those data and information are generally available; or

(2) State that you have reviewed the available data and information and are not aware of any data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status;

(d) If you view any of the data and information in your notice as exempt from disclosure under the Freedom of Information Act, you must identify the specific data and information; and

(e) For non-public, safety-related data and information considered in reaching a conclusion of GRAS status, you must explain how there could be a basis for a conclusion of GRAS status if qualified experts do not have access to such data and information.

(a) In part 7 of your GRAS notice, you must include a list of all of the data and information that you discuss in Part 6 of your GRAS notice to provide a basis for your view that the notified substance is safe under the conditions of its intended use as described in accordance with § 170.250(a)(1).

(b) You must specify which data and information that you list in accordance with paragraph (a) of this section are generally available, and which data and information are not generally available.

(a) You may submit a timely amendment to your filed GRAS notice, to update your GRAS notice or in response to a question from us, before we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).

(b) At any time before we respond to your GRAS notice in accordance with § 170.265(b)(1), you may request in writing that we cease to evaluate your GRAS notice. Your request does not preclude you from submitting a future GRAS notice in accordance with this subpart with respect to the notified substance.

(a)(1) We will conduct an initial evaluation of your submission to determine whether to file it as a GRAS notice for evaluation of your view that the notified substance is GRAS under the conditions of its intended use.

(2) If we file your submission as a GRAS notice, we will send you a letter that informs you of the date of filing.

(3) If we do not file your submission as a GRAS notice, we will send you a letter that informs you of that fact and provides our reasons for not filing the submission as a GRAS notice.

(4) We will consider any timely amendment that you submit to a filed GRAS notice, to update your GRAS notice or in response to a question from us, before we respond to you by letter in accordance with paragraph (b)(1) of this section, if we deem that doing so is feasible within the timeframes established in paragraph (b) of this section. If we deem that considering your amendment is not feasible within the timeframes established in paragraph (b) of this section or if we have granted your request to cease to evaluate your notice, we will inform you that we are not considering your amendment.

(b)(1) Within 180 days of filing, we will respond to you by letter based on our evaluation of your notice. We may extend the 180 day timeframe by 90 days on an as needed basis.

(2) If we extend the timeframe, we will inform you in writing of the extension as soon as practicable but no later than within 180 days of filing.

(3) If you ask us to cease to evaluate your GRAS notice in accordance with § 170.260(b), we will send you a letter informing you of our decision regarding your request.

(c) If circumstances warrant, we will send you a subsequent letter about the notice.

If the intended conditions of use of the notified substance include use in a product or products subject to regulation by FSIS under statutes that it administers:

(a) When applicable, you must include in your GRAS notice a statement as to whether you:

(1) Authorize us to send any trade secrets to FSIS; or

(2) Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS.

(b)(1) We will forward a copy of a GRAS notice or relevant portions thereof to FSIS;

(2) We will exclude any trade secrets unless you have authorized us to do so in accordance with paragraph (a)(1) of this section; and

(c) We will ask FSIS to advise whether the intended conditions of use comply with applicable statutes and regulations, or, if not, whether the use of the substance would be permitted in products under FSIS' jurisdiction under specified conditions or restrictions.

(d) As appropriate, we will inform you of the advice we receive from FSIS in the letter we send you in accordance with § 170.265(b)(1).

(a) The data and information in a GRAS notice (including data and information submitted in any amendment or supplement to your GRAS notice or incorporated into your GRAS notice) are:

(1) Considered a mandatory, rather than voluntary, submission for purposes of their status under the Freedom of Information Act and our public information requirements in part 20 of this chapter; and

(2) Available for public disclosure in accordance with part 20 of this chapter as of the date that we receive your GRAS notice.

(b) We will make the following readily accessible to the public:

(1) A list of filed GRAS notices, including the information described in § 170.225(c)(2) through (c)(5);

(2) The text of any letter that we issue under § 170.265(b)(1) or (c); and

(3) The text of any letter that we issue under § 170.265(b)(3) if we grant your request that we cease to evaluate your notice.

(c) We will disclose all remaining data and information that are not exempt from public disclosure in accordance with part 20 of this chapter.

If circumstances warrant, you may submit a supplement to a filed GRAS notice after we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).

Because the procedure to submit a GRAS notice is replacing the former process to submit a GRAS affirmation petition, the following will happen to a filed GRAS affirmation petition that is pending on October 17, 2016.

(a) On October 17, 2016, we will close the docket for any GRAS affirmation petition that is still pending as of October 17, 2016.

(b) Any person who submitted a GRAS affirmation petition described in this section may submit a GRAS notice as described in this subpart and request that we incorporate the GRAS affirmation petition as described in § 170.215.

(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitioner's post office address to which published notices or orders issued or objections filed pursuant to section 409 of the Act may be sent.

(b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted it. Any reference to published information offered in support of a food additive petition should be accompanied by reprints or photostatic copies of such references.

(c) Petitions shall include the following data and be submitted in the following form:

(d) The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will usually be retained but not filed as a petition under section 409 of the Act. The petitioner will be notified in what respects his petition is incomplete.

(e) The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.

(f) The data specified under the several lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by specific reference to the earlier. If part of the data have been submitted by the manufacturer of the food additive as a master file, the petitioner may refer to the master file if and to the extent he obtains the manufacturer's written permission to do so. The manufacturer may authorize specific reference to the data without disclosure to the petitioner. Nothing herein shall prevent reference to published data.

(g) A petition shall be retained but shall not be filed if any of the data prescribed by section 409(b) of the Act are lacking or are not set forth so as to be readily understood.

(h)(1) The following data and information in a food additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved:

(i) All safety and functionality data and information submitted with or incorporated by reference in the petition.

(ii) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61 of this chapter.

(iii) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:

(a) Names and any information that would identify the person using the product.

(b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.

(iv) A list of all ingredients contained in a food additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within the exemption established in § 20.61 of this chapter, and a notation shall be made that any such ingredient list is incomplete.

(v) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in § 20.61 of this chapter.

(2) The following data and information in a food additive petition are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter:

(i) Manufacturing methods or processes, including quality control procedures.

(ii) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.

(iii) Quantitative or semiquantitative formulas.

(3) All correspondence and written summaries of oral discussions relating to a food additive petition are available for public disclosure in accordance with the provisions of part 20 of this chapter when the food additive regulation is published in the Federal Register.

(4) For purposes of this regulation, safety and functionality data include all studies and tests of a food additive on animals and humans and all studies and tests on a food additive for identity, stability, purity, potency, performance, and usefulness.

(i)(1)(i) Within 15 days after receipt, the Food and Drug Administration will notify the petitioner of the acceptance or nonacceptance of a petition, and if not accepted, the reasons therefor. If accepted, the petitioner will be sent a letter stating this and the date of the letter shall become the date of filing for the purposes of section 409(b)(5) of the act. In cases in which the Food and Drug Administration agrees that a premarket notification for a food contact substance (Food Contact Notification (FCN)) submitted under section 409(h) of the act may be converted to a petition, the withdrawal date for the FCN will be deemed the date of receipt for the petition.

(ii) If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, the petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified.

(iii) Notwithstanding paragraph (i)(1)(ii) of this section, the petition shall not be filed if the Food and Drug Administration determines that the use identified in the petition should be the subject of an FCN under section 409(h) of the act rather than a petition.

(2) The Commissioner will publish in the Federal Register within 30 days from the date of filing of such petition, a notice of the filing, the name of the petitioner, and a brief description of the proposal in general terms. In the case of a food additive which becomes a component of food by migration from packaging material, the notice shall include the name of the migratory substance, and where it is different from that of one of the original components, the name of the parent component, the maximum quantity of the migratory substance that is proposed for use in food, and the physical or other technical effect which the migratory substance or its parent component is intended to have in the packaging material. A copy of the notice will be mailed to the petitioner when the original is forwarded to the Federal Register for publication.

(j) The Commissioner may request a full description of the methods used in, and the facilities and controls used for, the production of the food additive, or a sample of the food additive, articles used as components thereof, or of the food in which the additive is proposed to be used, at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the food additive, or articles used as components thereof, or of the food in or on which the additive is proposed to be used, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the food additive present in foods for which it is intended to be used or adequate for any study or investigation reasonably required with respect to the safety of the food additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 409(c)(2) of the Act shall be moved forward 1 day for each day after the mailing date of the request taken by the petitioner to submit the sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice.

(k) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 409(b) of the act shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(l) [Reserved]

(m) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner under section 409(b) of the Act shall include statements regarding each such clinical investigation relied upon in the petition that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with § 56.104 or § 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.

(n)(1) If intended uses of the food additive include uses in meat, meat food product, or poultry product subject to regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward a copy of the petition or relevant portions thereof to the Food Safety and Inspection Service, USDA, for simultaneous review under the PPIA and FMIA.

(2) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA, or if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified conditions or restrictions.

After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amount to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(a) In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling.

(b) At any time before the order provided for in § 171.100(a) has been forwarded to the Federal Register for publication, the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling the time limitation will begin to run anew.

(c) Any petitioner who has a food additive petition pending before the agency and who subsequently submits a premarket notification for a food contact substance (FCN) for a use or uses described in such petition shall be deemed to have withdrawn the petition for such use or uses without prejudice to a future filing on the date the FCN is received by the Food and Drug Administration.

Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate or that may be expected to migrate into food at negligible levels may be reviewed under § 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in § 170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use.

(a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the Act), a regulation prescribing the conditions under which the food additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and prior to the forwarding of the order to the Federal Register for publication shall notify the petitioner of such order and the reasons for such action; or by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.

(b) The regulation shall describe the conditions under which the substance may be safely used in any meat product, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.).

(c) If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition.

A regulation published in accordance with § 171.100(a) shall become effective upon publication in the Federal Register.

Objections and hearings relating to food additive regulations under section 409 (c), (d), or (h) of the Act shall be governed by part 12 of this chapter.

(a) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive.

(b) Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data shall be furnished in the form specified in §§ 171.1 and 171.100 for submitting petitions.

(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this part, good manufacturing practice shall be defined to include the following restrictions.

(1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food.

(2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.

(b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the Act.

(c) The existence of any regulation prescribing safe conditions of use for a nutrient substance does not constitute a finding that the substance is useful or required as a supplement to the diet of humans.

Anoxomer as identified in this section may be safely used in accordance with the following conditions:

(a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4′-(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-57-2) prepared by condensation polymerization of divinylbenzene (m- and p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-cresol and 4,4′-isopropylidenediphenol.

(b) The polymeric antioxidant meets the following specifications:

(1) Polymer, not less than 98.0 percent as determined by an ultraviolet method entitled “Ultraviolet Assay, “1982, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Molecular weight: Total monomers, dimers and trimers below 500 not more than 1 percent as determined by a method entitled “Low Molecular Weight Anoxomer Analysis,” 1982, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Phenol content: Not less than 3.2 milliequivalent/gram and not more than 3.8 milliequivalent/gram as determined by a method entitled “Total Phenols,” 1982, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(4) Heavy metals as lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million.

(c) Anoxomer may be safely used as an antioxidant in food at a level of not more than 5,000 parts per million based on fat and oil content of the food.

The food additive BHA (butylated hydroxyanisole) alone or in combination with other antioxidants permitted in food for human consumption in this subpart B may be safely used in or on specified foods, as follows:

(a) The BHA meets the following specification:

(b) The BHA is used alone or in combination with BHT, as an antioxidant in foods, as follows:

(c) To assure safe use of the additive:

(1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive.

(2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture.

(3) The label or labeling of dry mixes for beverages and desserts shall bear adequate directions for use to provide that beverages and desserts prepared from the dry mixes contain no more than 2 parts per million BHA.

The food additive BHT (butylated hydroxytoluene), alone or in combination with other antioxidants permitted in this subpart B may be safely used in or on specified foods, as follows:

(a) The BHT meets the following specification: Assay (total BHT) 99 percent minimum.

(b) The BHT is used alone or in combination with BHA, as an antioxidant in foods, as follows:

(c) To assure safe use of the additive:

(1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive.

(2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture.

The food additive calcium disodium EDTA (calcium disodium ethylene-diaminetetraacetate) may be safely used in designated foods for the purposes and in accordance with the conditions prescribed, as follows:

(a) The additive contains a minimum of 99 percent by weight of either the dihydrate C10H12O8N2CaNa2·2H2O or the trihydrate C10H12O8N2CaNa2·3H2O, or any mixture of the two.

(b) It is used or intended for use as follows:

(1) Alone, in the following foods at not to exceed the levels prescribed, calculated as the anhydrous compound:

(2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C10H12O8N2CaNa2:

(c) To assure safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the Act, the name of the additive.

(2) The label or labeling of the additive container shall bear adequate use directions to provide a final food product that complies with the limitations provided in paragraph (b) of this section.

(d) In the standardized foods listed in paragraph (b) of this section, the additives are used only in compliance with the applicable standards of identity for such foods.

The food additive dehydroacetic acid and/or its sodium salt may be safely used in accordance with the following prescribed conditions:

(a) The food additive meets the following specifications:

(b) It is used or intended for use as a preservative for cut or peeled squash, and is so used that no more than 65 parts per million expressed as dehydroacetic acid remains in or on the prepared squash.

(c) The label or labeling of any package of the additive intended for use in food shall bear adequate directions for use to insure compliance with this section.

Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive meets the following specifications:

(1) The additive has a purity of not less than 99.8 percent as determined by the following titration method:

(2) The additive contains not more than 2,000 ppm (0.2 percent) dimethyl carbonate as determined by a method entitled “Gas Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl Dicarbonate,” which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) The additive is used or intended for use as a microbial control agent in the following beverages under normal circumstances of bottling, canning, or other forms of final packaging, where the viable microbial load has been reduced to 500 microorganisms per milliliter or less by current good manufacturing practices such as heat treatment, filtration, or other technologies prior to the use of dimethyl dicarbonate:

(1) In wine, dealcoholized wine, and low alcohol wine in an amount not to exceed 200 parts per million.

(2) In ready-to-drink teas in an amount not to exceed 250 parts per million.

(3) In carbonated or noncarbonated, nonjuice-containing (less than or equal to 1 percent juice), flavored or unflavored beverages containing added electrolytes (5-20 milliequivalents/liter sodium ion (Na + ) and 3-7 milliequivalents/liter potassium ion (K + )) in an amount not to exceed 250 parts per million.

(4) In carbonated, dilute beverages containing juice, fruit flavor, or both, with juice content not to exceed 50 percent, in an amount not to exceed 250 parts per million.

(c) To ensure the safe use of the food additive, the label of the package containing the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act:

(1) The name of the additive “dimethyl dicarbonate.”

(2) The intended use of the additive.

(3) Adequate directions for use to ensure compliance with this section.

The food additive disodium EDTA (disodium ethylenediaminetetraacetate) may be safely used in designated foods for the purposes and in accordance with the following prescribed conditions:

(a) The additive contains a minimum of 99 percent disodium ethylenedia-minetetraacetate dihydrate (C10H14O8N2Na2·2H2O).

(b) It is used or intended for use as follows:

(1) Alone, in the following foods at not to exceed the levels prescribed, calculated as anhydrous calcium disodium EDTA:

(2) With calcium disodium EDTA (calcium disodium ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C10H12O8N2CaNa2:

(3) Alone, as a sequestrant in the nonnutritive sweeteners that are listed in § 180.37 of this chapter and that, in addition, are designed for aqueous solution: Provided, That the amount of the additive, calculated as anhydrous calcium disodium EDTA, does not exceed 0.1 percent by weight of the dry nonnutritive sweetener.

(c) To assure the safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the act, the name of the additive.

(2) The label or labeling of the additive container shall bear adequate use directions to provide a final food product that complies with the limitations provided in paragraph (b) of this section.

(d) In the standardized foods listed in paragraphs (b) (1) and (2) of this section the additives are used only in compliance with the applicable standards of identity for such foods.

(a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be safely used as an antioxidant for preservation of color in the production of chili powder, paprika, and ground chili at levels not in excess of 100 parts per million.

(b) In order to provide for the safe use of the additive in feed prepared in accordance with §§ 573.380 and 573.400 of this chapter, tolerances are established for residues of ethoxyquin in or on edible products of animals as follows:

(a) The food additive heptylparaben is the chemical n-heptyl p-hydroxybenzoate.

(b) It may be safely used to inhibit microbiological spoilage in accordance with the following prescribed conditions:

(1) In fermented malt beverages in amounts not to exceed 12 parts per million.

(2) In noncarbonated soft drinks and fruit-based beverages in amounts not to exceed 20 parts per million, when standards of identity established under section 401 of the Act (21 U.S.C. 341) do not preclude such use.

The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be safely used in food in accordance with the following prescribed conditions:

(a) The additive has a solidification point of 140 °C-141 °C.

(b) The additive is used as an antioxidant alone or in combination with other permitted antioxidants.

(c) The total amount of all antioxidants added to such food shall not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food.

(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an empirical formula of C33H47NO13 and a molecular weight of 665.7.

(b) The additive shall conform to the following specifications:

(c) The additive may be applied on cheese, as an antimycotic, in amounts not to exceed 20 milligrams per kilogram (20 parts per million) in the finished product as determined by International Dairy Federation (IDF) Standard 140A:1992, “Cheese and Cheese Rind-Determination of Natamycin Content-Method by Molecular Absorption Spectrometry and by High-Performance Liquid Chromatography,” which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Division of Product Policy (HFS-206), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

The food additive potassium nitrate may be safely used as a curing agent in the processing of cod roe, in an amount not to exceed 200 parts per million of the finished roe.

The food additive, quaternary ammonium chloride combination, may be safely used in food in accordance with the following conditions:

(a) The additive contains the following compounds: n-dodecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n-dodecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n-hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n-octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n-tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n-tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-29-4).

(b) The additive meets the following specifications: pH (5 percent active solution) 7.0-8.0; total amines, maximum 1 percent as combined free amines and amine hydrochlorides.

(c) The additive is used as an antimicrobial agent, as defined in § 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added prior to clarification when further processing of the sugar cane juice must be delayed.

(d) The additive is applied to the sugar juice in the following quantities, based on the weight of the raw cane:

An aqueous solution containing a mixture of silver nitrate and hydrogen peroxide may be safely used in accordance with the following prescribed conditions:

(a) The additive is used as an antimicrobial agent in bottled water.

(b) Hydrogen peroxide meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496-497, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) The amount of silver added will not exceed 17 micrograms per kilogram in the treated bottled water, and the amount of hydrogen peroxide will not exceed 23 milligrams per kilogram in the treated bottled water. Analyses for silver and hydrogen peroxide shall be conducted on samples of treated bottled water at the site of bottling, using samples of the water intended for treatment for the blank determination.

(d)(1) The amount of silver in the treated bottled water is determined using the method for silver designated in 21 CFR 165.110(b)(4)(iii)(G)(2)(i).

(2) The amount of hydrogen peroxide in the treated bottled water is determined using a Hydrogen Peroxide Test Kit from the HACH Co., or equivalent. The manual from the Hydrogen Peroxide Test Kit, Model HYP-1, Catalog Number 22917-00, 1991, is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of the test kit manual from the HACH Co., P.O. Box 389, Loveland CO, 80359 (1-800-227-4224), Model HYP-1, Catalog Number 22917-00. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 301-436-2163, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(e) Substances generally recognized as safe in or on food may be used to stabilize the additive to ensure that the additive will perform its intended technical effect.

(f) The additive may not be added to bottled water that has been filtered or is intended to be filtered through a silver-containing water filter.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

The food additive sodium nitrate may be safely used in or on specified foods in accordance with the following prescribed conditions:

(a) It is used or intended for use as follows:

(1) As a preservative and color fixative, with or without sodium nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked, cured shad, so that the level of sodium nitrate does not exceed 500 parts per million and the level of sodium nitrite does not exceed 200 parts per million in the finished product.

(2) As a preservative and color fixative, with or without sodium nitrite, in meat-curing preparations for the home curing of meat and meat products (including poultry and wild game), with directions for use which limit the amount of sodium nitrate to not more than 500 parts per million in the finished meat product and the amount of sodium nitrite to not more than 200 parts per million in the finished meat product.

(b) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of the additive or of a mixture containing the additive shall bear:

(i) The name of the additive.

(ii) A statement of the concentration of the additive in any mixture.

(2) If in a retail package intended for household use, the label and labeling of the additive, or of a mixture containing the additive, shall bear adequate directions for use to provide a final food product that complies with the limitations prescribed in paragraph (a) of this section.

(3) If in a retail package intended for household use, the label of the additive or of a mixture containing the additive, shall bear the statement “Keep out of the reach of children”.

The food additive sodium nitrite may be safely used in or on specified foods in accordance with the following prescribed conditions:

(a) It is used or intended for use as follows:

(1) As a color fixative in smoked cured tunafish products so that the level of sodium nitrite does not exceed 10 parts per million (0.001 percent) in the finished product.

(2) As a preservative and color fixative, with or without sodium nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked, cured shad so that the level of sodium nitrite does not exceed 200 parts per million and the level of sodium nitrate does not exceed 500 parts per million in the finished product.

(3) As a preservative and color fixative, with sodium nitrate, in meat-curing preparations for the home curing of meat and meat products (including poultry and wild game), with directions for use which limit the amount of sodium nitrite to not more than 200 parts per million in the finished meat product, and the amount of sodium nitrate to not more than 500 parts per million in the finished meat product.

(b) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of the additive or of a mixture containing the additive shall bear:

(i) The name of the additive.

(ii) A statement of the concentration of the additive in any mixture.

(2) If in a retail package intended for household use, the label and labeling of the additive, or of a mixture containing the additive, shall bear adequate directions for use to provide a final food product which complies with the limitations prescribed in paragraph (a) of this section.

(3) If in a retail package intended for household use, the label of the additive, or of a mixture containing the additive, shall bear the statement “Keep out of the reach of children”.

The food additive sodium nitrite may be safely used in combination with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation from Clostridium botulinum type E in the commercial processing of smoked chub in accordance with the following prescribed conditions:

(a) All fish in smoking establishments shall be clean and wholesome and shall be expeditiously processed, packed, and stored under adequate sanitary conditions in accordance with good manufacturing practice.

(b) The brining procedure is controlled in such a manner that the water phase portion of the edible portion of the finished smoked product has a salt (NaCl) content of not less than 3.5 percent, as measured in the loin muscle, and the sodium nitrite content of the edible portion of the finished smoked product is not less than 100 parts per million and not greater than 200 parts per million, as measured in the loin muscle.

(c) Smoked chub shall be heated by a controlled heat process which provides a monitoring system positioned in as many strategic locations in the smokehouse as necessary to assure a continuous temperature throughout each fish of at least 160 °F for a minimum of 30 minutes.

(d) The finished product shall be cooled to a temperature of 50 °F or below within 3 hours after smoking and further cooled to a temperature of 38 °F or below within 12 hours after smoking. A temperature of 38 °F or below shall be maintained during all subsequent storage and distribution. All shipping containers, retail packages, and shipping records shall indicate with appropriate notice the perishable nature of the product and specify that the product shall be held under refrigeration (38 °F or below) until consumed.

(e) To assure safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the Act, the name of the additive.

(2) The label or labeling of the additive container shall bear adequate directions to assure use in compliance with the provisions of this section.

The food additive stannous chloride may be safely used for color retention in asparagus packed in glass, with lids lined with an inert material, in an amount not to exceed 20 parts per million calculated as tin (Sn).

The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0), also known as tertiary butylhydroquinone, may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive has a melting point of not less than 126.5 °C.

(b) The percentage of TBHQ in the food additive is not less than 99.0 percent when tested by the assay described in the Food Chemicals Codex, 9th ed. (2014), pp. 1192-1194, which is incorporated by reference, or an equivalent method. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address: http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) It is used as an antioxidant alone or in combination with BHA and/or BHT.

(d) The total antioxidant content of a food containing the additive will not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food.

The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive has a melting point of 149 °C-153 °C.

(b) It is used as an antioxidant alone or in combination with other permitted antioxidants.

(c) The total antioxidant content of a food containing the additive will not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food.

Coatings may be applied to fresh citrus fruit for protection of the fruit in accordance with the following conditions:

(a) The coating is applied in the minimum amount required to accomplish the intended effect.

(b) The coating may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect:

(1) Substances generally recognized as safe for the purpose or previously sanctioned for the purpose.

(2) One or more of the following:

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

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

The food additive coumarone-indene resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and tangerines in accordance with the following prescribed conditions:

(a) The food additive is manufactured by the polymerization of a crude, heavy coal-tar solvent naphtha meeting the following specifications:

(1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and related compounds.

(2) It contains no more than 0.25 percent tar bases.

(3) 95 percent distills in the range 167 °C-184 °C.

(b) The food additive meets the following specifications:

(1) Softening point, ring and ball: 126 °C minimum as determined by ASTM method E28-67 (Reapproved 1982), “Standard Test Method for Softening Point by Ring-and-Ball Apparatus,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Refractive index (n 25/D) 1.63-1.64.

(c) It is used or intended for use as a protective coating for grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the maximum amount of the resin remaining on the fruit does not exceed 200 parts per million on a fresh-weight basis.

(d) To assure safe use of the additive:

(1) The label of the market package or any intermediate premix of the additive shall bear, in addition to the other information required by the act:

(i) The name of the additive, coumarone-indene resin.

(ii) A statement of the concentration of the additive therein.

(2) The label or accompanying labeling shall bear adequate directions that, if followed, will result in a finished food not in conflict with the requirements of this section.

Methyl esters and ethyl esters of fatty acids produced from edible fats and oils may be safely used in food, subject to the following prescribed conditions:

(a) The additive consists of a mixture of either methyl or ethyl esters of fatty acids produced from edible fats and oils and meets the following specifications:

(1) Not less than 90 percent methyl or ethyl esters of fatty acids.

(2) Not more than 1.5 percent unsaponifiable matter.

(b) The additive is used or intended for use at the level not to exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 200 parts per million.

Microcapsules may be safely used for encapsulating discrete particles of flavoring substances that are generally recognized as safe for their intended use or are regulated under this part, in accordance with the following conditions:

(a) The microcapsules may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect:

(1) Substances generally recognized as safe for the purpose.

(2) One or more of the following components:

(3) In lieu of the components listed in paragraph (a)(2) of this section, the following components:

(4) In lieu of the components listed in paragraphs (a)(2) and (3) of this section, the following component:

(b) The microcapsules produced from the components listed in paragraphs (a) (1), (2), and (3) of this section may be used for encapsulating authorized flavoring oils for use, in accordance with good manufacturing practice, in foods for which standards of identity established under section 401 of the Act do not preclude such use, except that microcapsules formulated from components listed in paragraph (a)(2) of this section may be used only for encapsulating lemon oil, distilled lime oil, orange oil, peppermint oil, and spearmint oil for use in dry mixes for puddings and gelatin desserts.

(c) The microcapsules produced from the components listed in paragraphs (a) (1) and (4) of this section may be used only for encapsulating authorized spice-flavoring substances for use, in accordance with good manufacturing practice, in frozen pizzas which are to be further processed by heat. Such pizzas shall bear labels or labeling including adequate directions for use to ensure heating to temperatures which will melt the wax to release the spice-flavoring substances.

Morpholine may be safely used as a component of food, subject to the following restrictions.

(a) It is used as the salt(s) of one or more of the fatty acids meeting the requirements of § 172.860, as a component of protective coatings applied to fresh fruits and vegetables.

(b) It is used at a level not in excess of that reasonably required to produce its intended effect.

Petroleum naphtha may be safely used in food in accordance with the following conditions:

(a) The additive is a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic in nature obtained from petroleum,

(b) The additive is refined to meet the following specifications when subjected to the procedures described in this paragraph.

(1) Boiling-point range: 175 °F-300 °F.

(2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.

(3) Ultraviolet absorbance limits, as follows:

(c) Petroleum naphtha containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. Petroleum naphtha may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended effect or to exceed any prescribed limitations.

(d) Petroleum naphtha is used or intended for use as a solvent in protective coatings on fresh citrus fruit in compliance with § 172.210.

Polyacrylamide containing not more than 0.2 percent of acrylamide monomer may be safely used as a film former in the imprinting of soft-shell gelatin capsules when the amount used is not in excess of the minimum required to produce the intended effect.

Oxidized polyethylene may be safely used as a component of food, subject to the following restrictions:

(a) Oxidized polyethylene is the basic resin produced by the mild air oxidation of polyethylene. The polyethylene used in the oxidation process conforms to the density, maximum n-hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed in item 2.3 of the table in § 177.1520(c) of this chapter. The oxidized polyethylene has a minimum number average molecular weight of 1,200, as determined by high temperature vapor pressure osmometry; contains a maximum of 5 percent by weight of total oxygen; and has an acid value of 9 to 19.

(b) The additive is used or intended for use as a protective coating or component of protective coatings for fresh avocados, bananas, beets, coconuts, eggplant, garlic, grapefruit, lemons, limes, mango, muskmelons, onions, oranges, papaya, peas (in pods), pineapple, plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines, turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, pecans, and walnuts (all nuts in shells).

(c) The additive is used in accordance with good manufacturing practice and in an amount not to exceed that required to produce the intended effect.

Sulfate butyl oleate may be safely used in food, subject to the following prescribed conditions:

(a) The additive is prepared by sulfation, using concentrated sulfuric acid, of a mixture of butyl esters produced by transesterification of an edible vegetable oil using 1-butanol. Following sulfation, the reaction mixture is washed with water and neutralized with aqueous sodium or potassium hydroxide. Prior to sulfation, the butyl oleate reaction mixture meets the following specifications:

(1) Not less than 90 percent butyl oleate.

(2) Not more than 1.5 percent unsaponifiable matter.

(b) The additive is used or intended for use at a level not to exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 100 parts per million.

Synthetic paraffin and succinic derivatives identified in this section may be safely used as a component of food, subject to the following restrictions:

(a) The additive is prepared with 50 percent Fischer-Tropsch process synthetic paraffin, meeting the definition and specifications of § 172.615, and 50 percent of such synthetic paraffin to which is bonded succinic anhydride and succinic acid derivatives of isopropyl alcohol, polyethylene glycol, and polypropylene glycol. It consists of a mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl succinic anhydride polyethylene glycol half ester, and dialkyl succinic anhydride polypropylene glycol half ester, where the alkane (alkyl) has a chain length of 30-70 carbon atoms and the polyethylene and polypropylene glycols have molecular weights of 600 and 260, respectively.

(b) The additive meets the following specifications: Molecular weight, 880-930; melting point, 215°-217 °F; acid number, 43-47; and saponification number, 75-78.

(c) It is used or intended for use as a protective coating or component of protective coatings for fresh grapefruit, lemons, limes, muskmelons, oranges, sweetpotatoes, and tangerines.

(d) It is used in an amount not to exceed that required to produce the intended effect.

The food additive terpene resin may be safely used in accordance with the following prescribed conditions:

(a) The food additive is the betapinene polymer obtained by polymerizing terpene hydrocarbons derived from wood. It has a softening point of 112 °C-118 °C, as determined by ASTM method E28-67 (Reapproved 1982), “Standard Test Method for Softening Point By Ring-and-Ball Apparatus,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) It is used or intended for use as follows:

(1) As a moisture barrier on soft gelatin capsules in an amount not to exceed 0.07 percent of the weight of the capsule.

(2) As a moisture barrier on powders of ascorbic acid or its salts in an amount not to exceed 7 percent of the weight of the powder.

Aluminum nicotinate may be safely used as a source of niacin in foods for special dietary use. A statement of the concentration of the additive, expressed as niacin, shall appear on the label of the food additive container or on that of any intermediate premix prepared therefrom.

Nicotinamide-ascorbic acid complex may be safely used in accordance with the following prescribed conditions:

(a) The additive is the product of the controlled reaction between ascorbic acid and nicotinamide, melting in the range 141 °C to 145 °C.

(b) It is used as a source of ascorbic acid and nicotinamide in multivitamin preparations.

The food additive amino acids may be safely used as nutrients added to foods in accordance with the following conditions:

(a) The food additive consists of one or more of the following individual amino acids in the free, hydrated, or anhydrous form, or as the hydrochloride, sodium, or potassium salts:

(b) The food additive meets the following specifications:

(1) As found in Food Chemicals Codex:

(2) As found in “Specifications and Criteria for Biochemical Compounds,” NAS/NRC Publication, for the following:

(c) The additive(s) is used or intended for use to significantly improve the biological quality of the total protein in a food containing naturally occurring primarily intact protein that is considered a significant dietary protein source, provided that:

(1) A reasonable daily adult intake of the finished food furnishes at least 6.5 grams of naturally occurring primarily intact protein (based upon 10 percent of the daily allowance for the “reference” adult male recommended by the National Academy of Sciences in “Recommended Dietary Allowances,” NAS Publication No. 1694.

(2) The additive(s) results in a protein efficiency ratio (PER) of protein in the finished ready-to-eat food equivalent to casein as determined by the method specified in paragraph (d) of this section.

(3) Each amino acid (or combination of the minimum number necessary to achieve a statistically significant increase) added results in a statistically significant increase in the PER as determined by the method described in paragraph (d) of this section. The minimum amount of the amino acid(s) to achieve the desired effect must be used and the increase in PER over the primarily intact naturally occurring protein in the food must be substantiated as a statistically significant difference with at least a probability (P) value of less than 0.05.

(4) The amount of the additive added for nutritive purposes plus the amount naturally present in free and combined (as protein) form does not exceed the following levels of amino acids expressed as percent by weight of the total protein of the finished food:

(d) Compliance with the limitations concerning PER under paragraph (c) of this section shall be determined by the method described in sections 43.212-43.216, “Official Methods of Analysis of the Association of Official Analytical Chemists.” Each manufacturer or person employing the additive(s) under the provisions of this section shall keep and maintain throughout the period of his use of the additive(s) and for a minimum of 3 years thereafter, records of the tests required by this paragraph and other records required to assure effectiveness and compliance with this regulation and shall make such records available upon request at all reasonable hours by any officer or employee of the Food and Drug Administration, or any other officer or employee acting on behalf of the Secretary of Health and Human Services and shall permit such officer or employee to conduct such inventories of raw and finished materials on hand as he deems necessary and otherwise to check the correctness of such records.

(e) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:

(1) The name of the amino acid(s) contained therein including the specific optical and chemical form.

(2) The amounts of each amino acid contained in any mixture.

(3) Adequate directions for use to provide a finished food meeting the limitations prescribed by paragraph (c) of this section.

(f) The food additive amino acids added as nutrients to special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions and comply with the requirements of part 105 of this chapter are exempt from the limitations in paragraphs (c) and (d) of this section and may be used in such foods at levels not to exceed good manufacturing practices.

(g) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877:

(i) Sections 43.212-43.216, “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980).

(ii) [Reserved]

(2) National Academy of Sciences, available from the FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:

(i) “Recommended Dietary Allowances,” NAS Publication No. 1694, 7th Ed. (1968).

(ii) “Specifications and Criteria for Biochemical Compounds,” NAS/NRC Publication, 3rd Ed. (1972).

(3) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org):

(i) Food Chemicals Codex, 7th ed. (2010), pages 28, 29, 69, 70, 71, 269, 270, 271, 440, 457, 458, 544, 545, 577, 578, 598, 599, 641, 642, 643, 697, 698, 794, 795, 864, 865, 915, 916, 1031, 1032, 1060, 1061, and 1072.

(ii) [Reserved]

Bakers yeast protein may be safely used in food in accordance with the following conditions:

(a) Bakers yeast protein is the insoluble proteinaceous material remaining after the mechanical rupture of yeast cells of Saccharomyces cerevisiae and removal of whole cell walls by centrifugation and separation of soluble cellular materials.

(b) The additive meets the following specifications on a dry weight basis:

(1) Zinc salts less than 500 parts per million (ppm) as zinc.

(2) Nucleic acid less than 2 percent.

(3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05 ppm mercury, and 0.3 ppm selenium.

(c) The viable microbial content of the finished ingredient is:

(1) Less than 10,000 organisms/gram by aerobic plate count.

(2) Less than 10 yeasts and molds/gram.

(3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium botulinum, or any other recognized microbial pathogen or any harmful microbial toxin.

(d) The ingredient is used in food as a nutrient supplement as defined in § 170.3(o)(20) of this chapter.

The food additive calcium chloride double salt of calcium pantothenate may be safely used in foods for special dietary uses in accordance with good manufacturing practice and under the following prescribed conditions:

(a) The food additive is of the d (dextrorotatory) or the dl (racemic) form.

(b) To assure safe use of the additive, the label and labeling of the food additive container, or that of any intermediate premixes prepared therefrom, shall bear, in addition to the other information required by the Act, the following:

(1) The name of the additive “calcium chloride double salt of d-calcium pantothenate” or “calcium chloride double salt of dl-calcium pantothenate”, whichever is appropriate.

(2) A statement of the appropriate concentration of the additive, expressed as pantothenic acid.

The food additive D-pantothenamide as a source of pantothenic acid activity, may be safely used in foods for special dietary use in an amount not in excess of that reasonably required to produce its intended effect.

(a) The food additive fish protein isolate may be safely used as a food supplement in accordance with the following prescribed conditions:

(1) The additive shall consist principally of dried fish protein prepared from the edible portions of fish after removal of the heads, fins, tails, bones, scales, viscera, and intestinal contents.

(2) The additive shall be derived only from species of bony fish that are generally recognized by qualified scientists as safe for human consumption and that can be processed as prescribed to meet the required specifications.

(3) Only wholesome fresh fish otherwise suitable for human consumption may be used. The fish shall be handled expeditiously under sanitary conditions. These conditions shall be in accordance with recognized good manufacturing practice for fish to be used as human food.

(4) The additive shall be prepared by extraction with hexane and food-grade ethanol to remove fat and moisture. Solvent residues shall be reduced by drying.

(b) The food additive meets the following specifications: (Where methods of determination are specified, they are Association of Official Analytical Chemists Methods, 13th ed., 1980, which are incorporated by reference). 1

(1) Protein content, as N × 6.25, shall not be less than 90 percent by weight of the final product, as determined by the method described in section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20) - Official Final Action.

(2) Moisture content shall not be more than 10 percent by weight of the final product, as determined by the method described in section 24.003, Air Drying (1) - Official First Action.

(3) Fat content shall not be more than 0.5 percent by weight of the final product, as determined by the method described in section 24.005, Crude Fat or Ether Extract - Official Final Action.

(4) Solvent residues in the final product shall not be more than 5 parts per million of hexane and 3.5 percent ethanol by weight.

Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, may be safely used in food as a nutrient in accordance with the following prescribed conditions:

(a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.

(b) Folic acid meets the specifications of the Food Chemicals Codex, 9th ed., updated through Third Supplement, effective December 1, 2015, pp. 495-496, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) Folic acid may be added to foods subject to a standard of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act (the act) when the standard of identity specifically provides for the addition of folic acid.

(d) Folic acid may be added, at levels not to exceed 400 micrograms (µg) per serving, to breakfast cereals, as defined under § 170.3(n)(4) of this chapter, and to corn grits at a level such that each pound of corn grits contains not more than 1.0 milligram of folic acid.

(e) Folic acid may be added to infant formula in accordance with section 412(i)(1) of the act or with regulations issued under section 412(i)(2) of the act which are codified in § 107.100 of this chapter.

(f) Folic acid may be added to a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to exceed the amount necessary to meet the distinctive nutritional requirements of the disease or condition for which the food is formulated.

(g) Folic acid may be added to food for special dietary use at levels not to exceed the amount necessary to meet the special dietary needs for which the food is formulated.

(h) Folic acid may be added to foods represented as meal-replacement products, in amounts not to exceed:

(1) Four hundred µg per serving if the food is a meal-replacement that is represented for use once per day; or

(2) Two hundred µg per serving if the food is a meal-replacement that is represented for use more than once per day.

(i) Folic acid may be added to corn masa flour at a level not to exceed 0.7 milligrams of folic acid per pound of corn masa flour.

Fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts may be safely used in food in accordance with the following prescribed conditions:

(a) The additives meet the following specifications:

(1) Fumaric acid contains a minimum of 99.5 percent by weight of fumaric acid, calculated on the anhydrous basis.

(2) The calcium, magnesium, potassium, and sodium salts contain a minimum of 99 percent by weight of the respective salt, calculated on the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent total iron and not more than 2 percent ferric iron.

(b) With the exception of ferrous fumarate, fumaric acid and the named salts are used singly or in combination in food at a level not in excess of the amount reasonably required to accomplish the intended effect.

(c) Ferrous fumarate is used as a source of iron in foods for special dietary use, when the use is consistent with good nutrition practice.

Kelp may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be consumed during a period of one day, or as directed for use in the case of a dietary supplement, will not result in daily ingestion of the additive so as to provide a total amount of iodine in excess of 225 micrograms for foods labeled without reference to age or physiological state; and when age or the conditions of pregnancy or lactation are specified, in excess of 45 micrograms for infants, 105 micrograms for children under 4 years of age, 225 micrograms for adults and children 4 or more years of age, and 300 micrograms for pregnant or lactating women. The food additive kelp is the dehydrated, ground product prepared from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and Laminaria cloustoni.

Iron-choline citrate complex made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and citric acid may be safely used as a source of iron in foods for special dietary use.

The food additive N-acetyl-L-methionine may be safely added to food (except infant foods and foods containing added nitrites/nitrates) as a source of L-methionine for use as a nutrient in accordance with the following conditions:

(a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No. 65-82-7) is the derivative of the amino acid methionine formed by addition of an acetyl group to the alpha-amino group of methionine. It may be in the free, hydrated or anhydrous form, or as the sodium or potassium salts.

(b) The additive meets the following specifications:

(1) Purity assay, on a dry basis: Minimum 99 percent.

(2) Residue on ignition: Maximum 0.1 percent.

(3) Specific optical rotation [alpha] 20D: Between −19° and −23°.

(4) The additive may contain residues of not more than 500 ppm ethyl acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm acetone, when used as processing solvents.

(c) The additive is used or intended for use as a source of L-methionine to improve significantly the biological quality of the total protein in a food containing naturally occurring primarily intact vegetable protein that is considered a significant dietary protein source, provided that:

(1) A reasonable daily adult intake of the finished food furnishes at least 6.5 grams of naturally occurring primarily intact vegetable protein.

(2) The additive results in a protein efficiency ratio (PER) of protein in the finished ready-to-eat food equivalent to casein as determined by the method specified in paragraph (d) of this section.

(3) The use of the additive results in a statistically significant increase in the PER as determined by the method described in paragraph (d) of this section. The minimum amount of the additive to achieve the desired effect must be used, and the increase in PER over the primarily intact naturally occurring vegetable protein in the food must be substantiated as a statistically significant difference with at least a probability (P) value of less than 0.05.

(4) The amount of the additive added for nutritive purpose shall not exceed the level that will provide a total of 3.1 percent L- and DL-methionine (expressed as the free amino acid) by weight of the total protein of the finished food, including the amount naturally present in free and combined (as protein) form.

(5) The additive shall not be added to infant foods or to foods containing added nitrites/nitrates.

(d) Compliance with the limitations concerning PER under paragraph (c) of the section shall be determined by the method described in sections 43.212-43.216, “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Each manufacturer or person employing the additive under the provisions of this section shall keep and maintain throughout the period of use of the additive and for a minimum of 3 years thereafter, records of the tests required by this paragraph and other records required to assure effectiveness and compliance with this regulation. Those records shall be made available upon request at all reasonable hours by any officer or employee acting on behalf of the Secretary of Health and Human Services. Those officers or employees shall be permitted to conduct inventories of raw and finished materials on hand as are deemed necessary to verify the records.

(e) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:

(1) The name of the additive contained therein.

(2) The amounts of additive and each amino acid contained in any mixture.

(3) Adequate directions for use to provide a finished food meeting the limitations prescribed by paragraph (c) of this section.

(f) When the food additive is added as a nutrient to special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions and these foods comply with the requirements of part 105 of this chapter, the food additive is exempt from the limitations in paragraphs (c)(1) through (4) and (d) of this section and may be used in those foods at levels not to exceed good manufacturing practices.

The food additive potassium iodide may be safely used in accordance with the following prescribed conditions:

(a) Potassium iodide may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be consumed during a period of one day, or as directed for use in the case of a dietary supplement, will not result in daily ingestion of the additive so as to provide a total amount of iodine in excess of 225 micrograms for foods labeled without reference to age or physiological state; and when age or the conditions of pregnancy or lactation are specified, in excess of 45 micrograms for infants, 105 micrograms for children under 4 years of age, 225 micrograms for adults and children 4 or more years of age, and 300 micrograms for pregnant or lactating women.

(b) To assure safe use of the additive, in addition to the other information required by the Act, the label of the additive shall bear:

(1) The name of the additive.

(2) A statement of the concentration of the additive in any mixture.

Vitamin D2 may be used safely in foods as a nutrient supplement defined under § 170.3(o)(20) of this chapter in accordance with the following prescribed conditions:

(a) Vitamin D2, also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin D2 is produced by ultraviolet irradiation of ergosterol isolated from yeast and is purified by crystallization.

(b) Vitamin D2 meets the specifications of the 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1260-1261, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) The additive may be used as follows:

Vitamin D3 may be used safely in foods as a nutrient supplement defined under § 170.3(o)(20) of this chapter in accordance with the following prescribed conditions:

(a) Vitamin D3, also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in and is isolated from fish liver oils. It also is manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol and is purified by crystallization.

(b) Vitamin D3 meets the specifications of “Vitamin D3,”, Food Chemicals Codex, 11th ed., copyright 2018, pp. 1243-1244, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) The additive may be used as follows:

(1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants.

(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 100 mg of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants.

(3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in soy-protein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 of this chapter.

(4) At levels not to exceed 100 IU per 40 grams in meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 of this chapter.

(5) At levels not to exceed 81 IU per 30 grams in cheese and cheese products as defined under § 170.3(n)(5) of this chapter, excluding cottage cheese, ricotta cheese, and hard grating cheeses such as Parmesan and Romano as defined in §§ 133.165 and 133.183 of this chapter, and those defined by standard of identity in § 133.148 of this chapter.

(6) At levels not to exceed 500 IU per 240 mL (prepared beverage) in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that the total amount of Vitamin D3 provided by the product does not exceed 1,000 IU per day.

(7) At levels not to exceed 1.0 IU per kilocalorie in foods represented for use as a sole source of nutrition for enteral feeding.

(8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and that meets the requirements for foods named by use of a nutrient content claim and a standardized term in accordance with § 130.10 of this chapter.

Vitamin D2 bakers yeast may be used safely in foods as a source of vitamin D2 and as a leavening agent in accordance with the following prescribed conditions:

(a) Vitamin D2 bakers yeast is the substance produced by exposing bakers yeast (Saccharomyces cerevisiae) to ultraviolet light, resulting in the photochemical conversion of endogenous ergosterol in bakers yeast to vitamin D2 (also known as ergocalciferol or (9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol)).

(b) Vitamin D2 bakers yeast may be used alone as an active dry yeast concentrate or in combination with conventional bakers yeast.

(c) The additive may be used in yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods at levels not to exceed 400 International Units of vitamin D2 per 100 grams in the finished food.

(d) To assure safe use of the additive, the label or labeling of the food additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

(e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive, “vitamin D2 bakers yeast,” in the proper order of decreasing predominance in the finished food.

The food additive whole fish protein concentrate may be safely used as a food supplement in accordance with the following prescribed conditions:

(a) The additive is derived from whole, wholesome hake and hakelike fish, herring of the genera Clupea, menhaden, and anchovy of the species Engraulis mordax, handled expeditiously and under sanitary conditions in accordance with good manufacturing practices recognized as proper for fish that are used in other forms for human food.

(b) The additive consists essentially of a dried fish protein processed from the whole fish without removal of heads, fins, tails, viscera, or intestinal contents. It is prepared by solvent extraction of fat and moisture with isopropyl alcohol or with ethylene dichloride followed by isopropyl alcohol, except that the additive derived from herring, menhaden and anchovy is prepared by solvent extraction with isopropyl alcohol alone. Solvent residues are reduced by conventional heat drying and/or microwave radiation and there is a partial removal of bone.

(c) The food additive meets the following specifications:

(1) Protein content (N × 6.25) shall not be less than 75 percent by weight of the final product, as determined by the method described in section 2.057 in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980). Protein quality shall not be less than 100, as determined by the method described in sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by reference, and copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Moisture content shall not exceed 10 percent by weight of the final product, as determined by the method described in section 24.003 of the AOAC. See paragraph (c)(1) of this section for availability of the material incorporated by reference.

(3) Fat content shall not exceed 0.5 percent by weight of the final product, as determined by the method described in section 24.005 of the AOAC. See paragraph (c)(1) of the this section for availability of the material incorporated by reference.

(4) The additive may contain residues of isopropyl alcohol and ethylene dichloride not in excess of 250 parts per million and 5 parts per million, respectively, when used as solvents in the extraction process.

(5) Microwave radiation meeting the requirements of § 179.30 of this chapter may be used to reduce residues of the solvents used in the extraction process.

(6) The additive shall contain not in excess of 100 parts per million fluorides (expressed as F).

(7) The additive shall be free of Escherichia coli and pathogenic organisms, including Salmonella, and shall have a total bacterial plate count of not more than 10,000 per gram.

(8) The additive shall have no more than a faint characteristic fish odor and taste.

(d) When the additive is used or intended for use in the household as a protein supplement in food for regular consumption by children up to 8 years of age, the amount of the additive from this source shall not exceed 20 grams per day (about one heaping tablespoon).

(e) When the additive is used as a protein supplement in manufactured food, the total fluoride content (expressed as F) of the finished food shall not exceed 8 ppm based on the dry weight of the food product.

(f) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of consumer-sized or bulk containers of the additive shall bear the name “whole fish protein concentrate”.

(2) The label or labeling of containers of the additive shall bear adequate directions for use to comply with the limitations prescribed by paragraphs (d) and (e) of this section.

(3) Labels of manufactured foods containing the additive shall bear, in the ingredient statement, the name of the additive, “whole fish protein concentrate” in the proper order of decreasing predominance in the finished food.

Xylitol may be safely used in foods for special dietary uses, provided the amount used is not greater than that required to produce its intended effect.

Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used in accordance with the following prescribed conditions:

(a) The additive is the product of the reaction between equimolar amounts of zinc sulfate and DL-methionine in purified water.

(b) The additive meets the following specifications:

(c) The additive is used in tablet form as a source of dietary zinc.

Calcium silicate, including synthetic calcium silicate, may be safely used in food in accordance with the following prescribed conditions:

(a) It is used as an anticaking agent in food in an amount not in excess of that reasonably required to produce its intended effect.

(b) It will not exceed 2 percent by weight of the food, except that it may be present up to 5 percent by weight of baking powder.

Iron ammonium citrate may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is the chemical green ferric ammonium citrate.

(b) The additive is used, or intended for use as an anticaking agent in salt for human consumption so that the level of iron ammonium citrate does not exceed 25 parts per million (0.0025 percent) in the finished salt.

(c) To assure safe use of the additive the label or labeling of the additive shall bear, in addition to the other information required by the Act:

(1) The name of the additive.

(2) Adequate directions to provide a final product that complies with the limitations prescribed in paragraph (b) of this section.

The food additive silicon dioxide may be safely used in food in accordance with the following conditions:

(a) The food additive is manufactured by vapor phase hydrolysis or by other means whereby the particle size is such as to accomplish the intended effect.

(b) It is used as an anticaking agent, subject to the following conditions:

(1) It is used in only those foods in which the additive has been demonstrated to have an anticaking effect.

(2) It is used in an amount not in excess of that reasonably required to produce its intended effect.

(3) [Reserved]

(4) It is used in an amount not to exceed 2 percent by weight of the food.

(c) It is used or intended for use as a stabilizer in the production of beer, and is removed from the beer by filtration prior to final processing.

(d) It is used or intended for use as an adsorbent for dl-a-tocopheryl acetate and pantothenyl alcohol in tableted foods for special dietary use, in an amount not greater than that required to accomplish the intended physical or technical effect.

(a) The food additive yellow prussiate of soda (sodium ferrocyanide decahydrate; Na4Fe(CN)6·10H2O contains a minimum of 99 percent by weight of sodium ferrocyanide decahydrate.

(b) The additive is used or intended for use as an anticaking agent in salt and as an adjuvant in the production of dendritic crystals of salt in an amount needed to produce its intended effect but not in excess of 13 parts per million calculated as anhydrous sodium ferrocyanide.

Natural flavoring substances and natural adjuvants may be safely used in food in accordance with the following conditions.

(a) They are used in the minimum quantity required to produce their intended physical or technical effect and in accordance with all the principles of good manufacturing practice.

(b) In the appropriate forms (plant parts, fluid and solid extracts, concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates) they consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, previously sanctioned for such use, or regulated in any section of this part.

Synthetic flavoring substances and adjuvants may be safely used in food in accordance with the following conditions.

(a) They are used in the minimum quantity required to produce their intended effect, and otherwise in accordance with all the principles of good manufacturing practice.

(b) They consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, prior-sanctioned for such use, or regulated by an appropriate section in this part.

(c) Δ-Decalactone and Δ-dodecalactone when used separately or in combination in oleomargarine are used at levels not to exceed 10 parts per million and 20 parts per million, respectively, in accordance with § 166.110 of this chapter.

(d) BHA (butylated hydroxyanisole) may be used as an antioxidant in flavoring substances whereby the additive does not exceed 0.5 percent of the essential (volatile) oil content of the flavoring substance.

The food additive “cocoa with dioctyl sodium sulfosuccinate for manufacturing,” conforming to § 163.117 of this chapter and § 172.810, is used or intended for use as a flavoring substance in dry beverage mixes whereby the amount of dioctyl sodium sulfosuccinate does not exceed 75 parts per million of the finished beverage. The labeling of the dry beverage mix shall bear adequate directions to assure use in compliance with this section.

Disodium guanylate may be safely used as a flavor enhancer in foods, at a level not in excess of that reasonably required to produce the intended effect.

The food additive disodium inosinate may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is the disodium salt of inosinic acid, manufactured and purified so as to contain no more than 150 parts per million of soluble barium in the compound disodium inosinate with seven and one-half molecules of water of crystallization.

(b) The food additive is used as a flavoring adjuvant in food.

DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-72-7) may be safely used as a flavor enhancer for sweeteners in pickling mixtures at a level not to exceed 1 percent of the pickling spice that is added to the pickling brine.

The food additive modified hop extract may be safely used in beer in accordance with the following prescribed conditions:

(a) The food additive is used or intended for use as a flavoring agent in the brewing of beer.

(b) The food additive is manufactured by one of the following processes:

(1) The additive is manufactured from a hexane extract of hops by simultaneous isomerization and selective reduction in an alkaline aqueous medium with sodium borohydride, whereby the additive meets the following specifications:

(i) A solution of the food additive solids is made up in approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This absorbance is obtained by approximately 0.03 milligram solids permilliliter.) The ultraviolet absorption spectrum of this solution exhibits the following characteristics: An absorption peak at 253 millimicrons; no absorption peak at 325 to 330 millimicrons; the absorbance at 268 millimicrons does not exceed the absorbance at 272 millimicrons.

(ii) The boron content of the food additive does not exceed 310 parts per million (0.0310 percent), calculated as boron.

(2) The additive is manufactured from hops by a sequence of extractions and fractionations, using benzene, light petroleum spirits, and methyl alcohol as solvents, followed by isomerization by potassium carbonate treatment. Residues of solvents in the modified hop extract shall not exceed 1.0 part per million of benzene, 1.0 part per million of light petroleum spirits, and 250 parts per million of methyl alcohol. The light petroleum spirits and benzene solvents shall comply with the specifications in § 172.250 except that the boiling point range for light petroleum spirits is 150 °F-300 °F.

(3) The additive is manufactured from hops by a sequence of extractions and fractionations, using methylene chloride, hexane, and methyl alcohol as solvents, followed by isomerization by sodium hydroxide treatment. Residues of the solvents in the modified hop extract shall not exceed 5 parts per million of methylene chloride, 25 parts per million of hexane, and 100 parts per million of methyl alcohol.

(4) The additive is manufactured from hops by a sequence of extractions and fractionations, using benzene, light petroleum spirits, methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed by isomerization by potassium carbonate treatment. Residues of solvents in the modified hop extract shall not exceed 1.0 part per million of benzene, 1.0 part per million of light petroleum spirits, 50 parts per million of methyl alcohol, 50 parts per million of n-butyl alcohol, and 1 part per million of ethyl acetate. The light petroleum spirits and benzene solvents shall comply with the specifications in § 172.250 except that the boiling point range for light petroleum spirits is 150 °F to 300 °F.

(5) The additive is manufactured from hops by an initial extraction and fractionation using one or more of the following solvents: Ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene, and water; followed by isomerization by calcium chloride or magnesium chloride treatment in ethylene dichloride, methylene chloride, or trichloroethylene and a further sequence of extractions and fractionations using one or more of the solvents set forth in this paragraph. Residues of the solvents in the modified hop extract shall not exceed 125 parts per million of hexane; 150 parts per million of ethylene dichloride, methylene chloride, or trichloroethylene; or 250 parts per million of isopropyl alcohol or methyl alcohol.

(6) The additive is manufactured from hops by an initial extraction and fractionation using one or more of the solvents listed in paragraph (b)(5) of this section followed by: Hydrogenation using palladium as a catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol acidified with hydrochloric or sulfuric acid; oxidation with peracetic acid; isomerization by calcium chloride or magnesium chloride treatment in ethylene dichloride, methylene chloride, or trichloroethylene (alternatively, the hydrogenation and isomerization steps may be performed in reverse order); and a further sequence of extractions and fractionations using one or more of the solvents listed in paragraph (b)(5) of this section. The additive shall meet the residue limitations as prescribed in paragraph (b)(5) of this section.

(7) The additive is manufactured from hops as set forth in paragraph (b)(6) of this section followed by reduction with sodium borohydride in aqueous alkaline methyl alcohol, and a sequence of extractions and fractionations using one or more of the solvents listed in paragraph (b)(5) of this section. The additive shall meet the residue limitations as prescribed in paragraph (b)(5) of this section, and a boron content level not in excess of 300 parts per million (0.0300 percent), calculated as boron.

(8) The additive is manufactured from hops as a nonisomerizable nonvolatile hop resin by an initial extraction and fractionation using one or more of the solvents listed in paragraph (b)(5) of this section followed by a sequence of aqueous extractions and removal of nonaqueous solvents to less than 0.5 percent. The additive is added to the wort before or during cooking in the manufacture of beer.

Quinine, as the hydrochloride salt or sulfate salt, may be safely used in food in accordance with the following conditions:

The food additive safrole-free extract of sassafras may be safely used in accordance with the following prescribed conditions:

(a) The additive is the aqueous extract obtained from the root bark of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).

(b) It is obtained by extracting the bark with dilute alcohol, first concentrating the alcoholic solution by vacuum distillation, then diluting the concentrate with water and discarding the oily fraction.

(c) The purified aqueous extract is safrole-free.

(d) It is used as a flavoring in food.

Sugar beet extract flavor base may be safely used in food in accordance with the provisions of this section.

(a) Sugar beet extract flavor base is the concentrated residue of soluble sugar beet extractives from which sugar and glutamic acid have been recovered, and which has been subjected to ion exchange to minimize the concentration of naturally occurring trace minerals.

(b) It is used as a flavor in food.

Yeast-malt sprout extract, as described in this section, may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is produced by partial hydrolysis of yeast extract (derived from Saccharomyces cereviseae, Saccharomyces fragilis, or Candida utilis) using the sprout portion of malt barley as the source of enzymes. The additive contains a maximum of 6 percent 5′ nucleotides by weight.

(b) The additive may be used as a flavor enhancer in food at a level not in excess of that reasonably required to produce the intended effect.

Arabinogalactan may be safely used in food in accordance with the following conditions:

(a) Arabinogalactan is a polysaccharide extracted by water from Western larch wood, having galactose units and arabinose units in the approximate ratio of six to one.

(b) It is used in the following foods in the minimum quantity required to produce its intended effect as an emulsifier, stabilizer, binder, or bodying agent: Essential oils, nonnutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes.

The food additive chewing gum base may be safely used in the manufacture of chewing gum in accordance with the following prescribed conditions:

(a) The food additive consists of one or more of the following substances that meet the specifications and limitations prescribed in this paragraph, used in amounts not to exceed those required to produce the intended physical or other technical effect.

(b) In addition to the substances listed in paragraph (a) of this section, chewing gum base may also include substances generally recognized as safe in food.

(c) To assure safe use of the additive, in addition to the other information required by the act, the label and labeling of the food additive shall bear the name of the additive, “chewing gum base.” As used in this paragraph, the term “chewing gum base” means the manufactured or partially manufactured nonnutritive masticatory substance comprised of one or more of the ingredients named and so defined in paragraph (a) of this section.

The food additive carrageenan may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is the refined hydrocolloid prepared by aqueous extraction from the following members of the families Gigartinaceae and Solieriaceae of the class Rodophyceae (red seaweed):

(b) The food additive conforms to the following conditions:

(1) It is a sulfated polysaccharide the dominant hexose units of which are galactose and anhydrogalactose.

(2) Range of sulfate content: 20 percent to 40 percent on a dry-weight basis.

(c) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the additive, carrageenan.

Carrageenan otherwise meeting the definition and specifications of § 172.620 (a) and (b) and salts of carrageenan otherwise meeting the definition of § 172.626(a) may be safely produced with the use of polysorbate 80 meeting the specifications and requirements of § 172.840 (a) and (b) in accordance with the following prescribed conditions:

(a) The polysorbate 80 is used only to facilitate separation of sheeted carrageenan and salts of carrageenan from drying rolls.

(b) The carrageenan and salts of carrageenan contain not more than 5 percent by weight of polysorbate 80, and the final food containing the additives contains polysorbate 80 in an amount not to exceed 500 parts per million.

(c) The carrageenan and salts of carrageenan so produced are used only in producing foods in gel form and only for the purposes defined in §§ 172.620(c) and 172.626(b), respectively.

(d) The carrageenan and salts of carrageenan so produced are not used in foods for which standards of identity exist unless the standards provide for the use of carrageenan, or salts of carrageenan, combined with polysorbate 80.

(e) The carrageenan and salts of carrageenan produced in accordance with this section, and foods containing the same, in addition to the other requirements of the Act, are labeled to show the presence of polysorbate 80, and the label or labeling of the carrageenan and salts of carrageenan so produced bear adequate directions for use.

The food additive salts of carrageenan may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive consists of carrageenan, meeting the provisions of § 172.620, modified by increasing the concentration of one of the naturally occurring salts (ammonium, calcium, potassium, or sodium) of carrageenan to the level that it is the dominant salt in the additive.

(b) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the salt of carrageenan that dominates the mixture by reason of the modification, e.g., “sodium carrageenan”, “potassium carrageenan”, etc.

The food additive furcelleran may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is the refined hydrocolloid prepared by aqueous extraction of furcellaria fastigiata of the class Rodophyceae (red seaweed).

(b) The food additive conforms to the following:

(1) It is a sulfated polysaccharide the dominant hexose units of which are galactose and anhydrogalactose.

(2) Range of sulfate content: 8 percent to 19 percent, on a dry-weight basis.

(c) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the additive, furcelleran.

The food additive salts of furcelleran may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive consists of furcelleran, meeting the provisions of § 172.655, modified by increasing the concentration of one of the naturally occurring salts (ammonium, calcium, potassium, or sodium) of furcelleran to the level that it is the dominant salt in the additive.

(b) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the salt of furcelleran that dominates the mixture by reason of the modification, e.g., “sodium furcelleran”, “potassium furcelleran”, etc.

The food additive gellan gum may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a high molecular weight polysaccharide gum produced from Pseudomonas elodea by a pure culture fermentation process and purified by recovery with isopropyl alcohol. It is composed of tetrasaccharide repeat units, each containing one molecule of rhamnose and glucuronic acid, and two molecules of glucose. The glucuronic acid is neutralized to a mixed potassium, sodium, calcium, and magnesium salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters.

(b) The strain of P. elodea is nonpathogenic and nontoxic in man and animals.

(c) The additive is produced by a process that renders it free of viable cells of P. elodea.

(d) The additive meets the following specifications:

(1) Positive for gellan gum when subjected to the following identification tests:

(i) A 1-percent solution is made by hydrating 1 gram of gellan gum in 99 milliliters of distilled water. The mixture is stirred for about 2 hours, using a motorized stirrer and a propeller-type stirring blade. A small amount of the above solution is drawn into a wide bore pipet and transferred into a solution of 10-percent calcium chloride. A tough worm-like gel will form instantly.

(ii) To the 1-percent distilled water solution prepared for identification test (i), 0.50 gram of sodium chloride is added. The solution is heated to 80 °C with stirring, held at 80 °C for 1 minute, and allowed to cool to room temperature without stirring. A firm gel will form.

(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as determined by the procedure described in the “Gellan gum” monograph in the Food Chemicals Codex, 7th ed. (2010), pp. 425-426, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(e) The additive is used or intended for use in accordance with current good manufacturing practice as a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter. The additive may be used in foods where standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use.

(f) To assure safe use of the additive:

(1) The label of its container shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the name of the additive and the designation “food grade”.

(2) The label or labeling of the food additive container shall bear adequate directions for use.

The food additive xanthan gum may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a polysaccharide gum derived from Xanthomonas campestris by a pure-culture fermentation process and purified by recovery with isopropyl alcohol. It contains D-glucose, D-mannose, and D-glucuronic acid as the dominant hexose units and is manufactured as the sodium, potassium, or calcium salt.

(b) The strain of Xanthomonas campestris is nonpathogenic and nontoxic in man or other animals.

(c) The additive is produced by a process that renders it free of viable cells of Xanthomonas campestris.

(d) The additive meets the following specifications:

(1) Residual isopropyl alcohol not to exceed 750 parts per million.

(2) An aqueous solution containing 1 percent of the additive and 1 percent of potassium chloride stirred for 2 hours has a minimum viscosity of 600 centipoises at 75 °F, as determined by Brookfield Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60 r.p.m., and the ratio of viscosities at 75 °F and 150 °F is in the range of 1.02 to 1.45.

(3) Positive for xanthan gum when subjected to the following procedure:

(4) Positive for xanthan gum when subjected to the following procedure:

(e) The additive is used or intended for use in accordance with good manufacturing practice as a stabilizer, emulsifier, thickener, suspending agent, bodying agent, or foam enhancer in foods for which standards of identity established under section 401 of the Act do not preclude such use.

(f) To assure safe use of the additive:

(1) The label of its container shall bear, in addition to other information required by the Act, the name of the additive and the designation “food grade”.

(2) The label or labeling of the food additive container shall bear adequate directions for use.

The following surfactants and related adjuvants may be safely added to pesticide use dilutions by a grower or applicant prior to application to the growing crop:

The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be safely used in food in accordance with the following prescribed conditions:

(a) It is prepared by the aldol condensation of acetaldehyde followed by catalytic hydrogenation.

(b) The food additive shall conform to the identity and specifications of the Food Chemicals Codex, 7th ed. (2010), p. 126, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) It is used in the manufacture of sausage casings as a formulation aid as defined in § 170.3(o)(14) of this chapter and as a processing aid as defined in § 170.3(o)(24) of this chapter.

Calcium lignosulfonate may be safely used in or on food, subject to the provisions of this section.

(a) Calcium lignosulfonate consists of sulfonated lignin, primarily as calcium and sodium salts.

(b) It is used in an amount not to exceed that reasonably required to accomplish the intended physical or technical effect when added as a dispersing agent and stabilizer in pesticides for preharvest or postharvest application to bananas.

The food additive calcium lactobionate may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is the calcium salt of lactobionic acid (4-(β,D-galactosido)-D-gluconic acid) produced by the oxidation of lactose.

(b) It is used or intended for use as a firming agent in dry pudding mixes at a level not greater than that required to accomplish the intended effect.

Epoxidized soybean oil may be safely used in accordance with the following prescribed conditions:

(a) The additive is prepared by reacting soybean oil in toluene with hydrogen peroxide and formic acid.

(b) It meets the following specifications:

(1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 8.0 percent, as determined by the American Oil Chemists' Society (A.O.C.S.) method Cd 9-57, “Oxirane Oxygen,” reapproved 1989, which is incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR part 51. Copies are available from the American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) The maximum iodine value is 3.0, as determined by A.O.C.S. method Cd 1-25, “Iodine Value of Fats and Oils Wijs Method,” revised 1993, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.

(3) The heavy metals (as Pb) content cannot be more than 10 parts per million, as determined by the “Heavy Metals Test,” of the “Food Chemicals Codex,” 4th ed. (1996), pp. 760-761, Method II (with a 2-gram sample and 20 microgram of lead ion in the control), 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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The additive is used as a halogen stabilizer in brominated soybean oil at a level not to exceed 1 percent.

The food additives gibberellic acid and its potassium salt may be used in the malting of barley in accordance with the following prescribed conditions:

(a) The additives meet the following specifications:

(1) The gibberellic acid is produced by deep-culture fermentation of a suitable nutrient medium by a strain of Fusarium moniliforme or a selection of this culture.

(2) The gibberellic acid produced is of 80 percent purity or better.

(3) The empirical formula of gibberellic acid is represented by C19H22O6.

(4) Potassium gibberellate is the potassium salt of the specified gibberellic acid.

(5) The potassium gibberellate is of 80 percent purity or better.

(6) The gibberellic acid or potassium gibberellate may be diluted with substances generally recognized as safe in foods or with salts of fatty acids conforming to § 172.863.

(b) They are used or intended for use in the malting of barley under conditions whereby the amount of either or both additives present in the malt is not in excess of 2 parts per million expressed as gibberellic acid, and the treated malt is to be used in the production of fermented malt beverages or distilled spirits only, whereby the finished distilled spirits contain none and the finished malt beverage contains not more than 0.5 part per million of gibberellic acid.

(c) To insure the safe use of the food additives the label of the package shall bear, in addition to the other information required by the Act:

(1) The name of the additive, “gibberellic acid” or “potassium gibberellate”, whichever is appropriate.

(2) An accurate statement of the concentration of the additive contained in the package.

(3) Adequate use directions to provide not more than 2 parts per million of gibberellic acid in the finished malt.

(4) Adequate labeling directions to provide that the final malt is properly labeled as described in paragraph (d) of this section.

(d) To insure the safe use of the additive the label of the treated malt shall bear, in addition to the other information required by the Act, the statements:

(1) “Contains not more than 2 parts per million ___”, the blank being filled in with the words “gibberellic acid” or “potassium gibberellate”, whichever is appropriate; and

(2) “Brewer's malt - To be used in the production of fermented malt beverages only” or “Distiller's malt - To be used in the production of distilled spirits only”, whichever is appropriate.

The food additive potassium bromate may be safely used in the malting of barley under the following prescribed conditions:

(a)(1) It is used or intended for use in the malting of barley under conditions whereby the amount of the additive present in the malt from the treatment does not exceed 75 parts per million of bromate (calculated as Br), and the treated malt is used only in the production of fermented malt beverages or distilled spirits.

(2) The total residue of inorganic bromides in fermented malt beverages, resulting from the use of the treated malt plus additional residues of inorganic bromides that may be present from uses in accordance with other regulations in this chapter promulgated under sections 408 and/or 409 of the act, does not exceed 25 parts per million of bromide (calculated as Br). No tolerance is established for bromide in distilled spirits because there is evidence that inorganic bromides do not pass over in the distillation process.

(b) To assure safe use of the additive, the label or labeling of the food additive shall bear, in addition to the other information required by the Act, the following:

(1) The name of the additive.

(2) Adequate directions for use.

(c) To assure safe use of the additive, the label or labeling of the treated malt shall bear, in addition to other information required by the Act, the statement, “Brewer's Malt - To be used in the production of fermented malt beverages only”, or “Distiller's Malt - To be used in the production of distilled spirits only”, whichever is the case.

Glycerol ester of wood rosin, gum rosin, or tall oil rosin may be safely used in food in accordance with the following prescribed conditions:

(a) It has an acid number of 3 to 9, a drop-softening point of 88 to 96 °C; and a color of N or paler as determined in accordance with Official Naval Stores Standards of the United States. It is purified by countercurrent steam distillation or steam stripping.

(b) It is used to adjust the density of citrus oils used in the preparation of beverages whereby the amount of the additive does not exceed 100 parts per million of the finished beverage.

The food additive glycerides and polyglycides of hydrogenated vegetable oils may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is manufactured by heating a mixture of hydrogenated oils of vegetable origin and polyethylene glycol in the presence of an alkaline catalyst followed by neutralization with any acid that is approved or is generally recognized as safe for this use to yield the finished product.

(b) The additive consists of a mixture of mono-, di- and tri-glycerides and polyethylene glycol mono- and di-esters of fatty acids (polyglycides) of hydrogenated vegetable oils and meets the following specifications:

(1) Total ester content, greater than 90 percent as determined by a method entitled “Determination of Esterified Glycerides and Polyoxyethylene Glycols,” approved November 16, 2001, printed by Gattefosse S.A.S., and incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety, 5001 Campus Dr., College Park, MD 20740 or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Acid value, not greater than 2, and hydroxyl value, not greater than 56, as determined by the methods entitled “Acid Value,” p. 1220 and “Hydroxyl Value,” p. 1223, respectively, in the Food Chemicals Codex, 7th ed. (2010), which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(3) Lead, not greater than 0.1 mg/kg as determined by the American Oil Chemists' Society (A.O.C.S.) method Ca 18c-91, “Determination of Lead by Direct Graphite Furnace Atomic Absorption Spectrophotometry,” updated 1995, and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(4) 1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/kg), and ethylene oxide, not greater than 1 mg/kg, as determined by a gas chromatographic method entitled “Determination of Ethylene Oxide and 1,4-Dioxane by Headspace Gas Chromatography,” approved November 5, 1998, printed by Gattefosse S.A.S., and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51; see paragraph (b)(1) of this section for availability of the incorporation by reference.

(c) The additive is used or intended for use as an excipient in dietary supplement tablets, capsules, and liquid formulations that are intended for ingestion in daily quantities measured in drops or similar small units of measure.

The food additive stearyl monoglyceridyl citrate may be safely used in food in accordance with the following provisions:

(a) The additive is prepared by controlled chemical reaction of the following:

(b) The additive stearyl monoglyceridyl citrate, produced as described under paragraph (a) of this section, meets the following specifications:

(c) The additive is used or intended for use as an emulsion stabilizer in or with shortenings containing emulsifiers.

The food additive succistearin (stearoyl propylene glycol hydrogen succinate) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is the reaction product of succinic anhydride, fully hydrogenated vegetable oil (predominantly C16 or C18 fatty acid chain length), and propylene glycol.

(b) The additive meets the following specifications:

(c) The additive is used or intended for use as an emulsifier in or with shortenings and edible oils intended for use in cakes, cake mixes, fillings, icings, pastries, and toppings, in accordance with good manufacturing practice.

The polymer of ethylene oxide may be safely used as a foam stabilizer in fermented malt beverages in accordance with the following conditions.

(a) It is the polymer of ethylene oxide having a minimum viscosity of 1,500 centipoises in a 1 percent aqueous solution at 25 °C.

(b) It is used at a level not to exceed 300 parts per million by weight of the fermented malt beverage.

(c) The label of the additive bears directions for use to insure compliance with paragraph (b) of this section.

Methacrylic acid-divinylbenzene copolymer may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is produced by the polymerization of methacrylic acid and divinylbenzene. The divinylbenzene functions as a cross-linking agent and constitutes a minimum of 4 percent of the polymer.

(b) Aqueous extractives from the additive do not exceed 2 percent (dry basis) after 24 hours at 25 °C.

(c) The additive is used as a carrier of vitamin B12 in foods for special dietary use.

The food additive may be safely used in food in accordance with the following prescribed conditions:

(a) Acacia (gum arabic) is the dried gummy exudate from stems and branches of trees of various species of the genus Acacia, family Leguminosae.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 8th ed. (2012), p. 516, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address: http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) The ingredient is used in food in accordance with good manufacturing practices under the following conditions:

The additive may be safely used as an antimicrobial agent specific for Listeria monocytogenes (L. monocytogenes) in accordance with the following conditions:

(a) Identity. (1) The additive consists of a mixture of equal proportions of six different individually purified lytic-type (lacking lysogenic activity) bacteriophages (phages) specific against L. monocytogenes.

(2) Each phage is deposited at, and assigned an identifying code by, a scientifically-recognized culture collection center, and is made available to FDA upon request.

(3) The additive is produced from one or more cell cultures of L. monocytogenes in a safe and suitable nutrient medium.

(b) Specifications. (1) The additive achieves a positive lytic result (OD600 ≤0.06) when tested against any of the following L. monocytogenes isolates available from American Type Culture Collection (ATCC): ATCC 35152 (serogroup 1/2a), ATCC 19118 (serogroup 4b), and ATCC 15313 (serogroup 1/2b). The analytical method for determining the potency of the additive entitled “Determination of Potency of LMP-102 TM,” dated October 9, 2003, and printed by Intralytix, Inc., is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) The mean phage titer of each monophage in the additive is 1 × 10 9 plaque forming units (PFU)/ml. The analytical method for determining phage titer entitled “Method to Determine Lytic Activity/Phage Titer,” dated November 6, 2001, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section.

(3) The phages present in the preparation must not contain a functional portion of any of the toxin-encoding sequences described in 40 CFR 725.421(d). No sequences derived from genes encoding bacterial 16S ribosomal RNA are present in the complete genomic sequence of the phages.

(4) L. monocytogenes toxin, listeriolysin O (LLO), is not greater than 5 hemolytic units (HU)/ml. The analytical method for determining LLO entitled “Quantitation of Listeriolysin O Levels in LMP-102 TM,” dated September 27, 2004, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section.

(5) The additive is negative for L. monocytogenes. The modified version of the U.S. Department of Agriculture's method for determining L. monocytogenes entitled “LMP-102 TM Listeria monocytogenes Sterility Testing,” dated May 24, 2004, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section.

(6) The additive is negative for gram-positive and gram-negative bacteria capable of growing in commonly used microbiological media (e.g., Luria-Bertani (LB) medium), including Escherichia coli, Salmonella species and coagulase-positive Staphylococci, as determined by the “Method to Determine Microbial Contamination,” dated July 11, 2003, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section.

(7) Total organic carbon (TOC) is less than or equal to 36 mg/kg. The analytical method for determining TOC entitled “Determination of Total Organic Carbon by Automated Analyzer,” dated March 30, 2001, and printed by Intralytix, Inc., is incorporated by reference. Copies are available at locations cited in paragraph (b)(1) of this section.

(c) Conditions of use. The additive is used in accordance with current good manufacturing practice to control L. monocytogenes by direct application to meat and poultry products that comply with the ready-to-eat definition in 9 CFR 430.1. Current good manufacturing practice is consistent with direct spray application of the additive at a rate of approximately 1 mL of the additive per 500 cm 2 product surface area.

Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as acesulfame K, may be safely used as a general-purpose sweetener and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended technical effect in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use, under the following conditions:

(a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide.

(b) The additive meets the following specifications:

(1) Purity is not less than 99 percent on a dry basis. The purity shall be determined by a method titled “Acesulfame Potassium Assay,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Fluoride content is not more than 30 milligrams per kilogram, as determined by method III of the Fluoride Limit Test of the Food Chemicals Codex, 7th ed. (2010), p. 1151, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) If the food containing the additive is represented to be for special dietary uses, it shall be labeled in compliance with part 105 of this chapter.

The food additive acetone peroxides may be safely used in flour, and in bread and rolls where standards of identity do not preclude its use, in accordance with the following prescribed conditions:

(a) The additive is a mixture of monomeric and linear dimeric acetone peroxide, with minor proportions of higher polymers, manufactured by reaction of hydrogen peroxide and acetone.

(b) The additive may be mixed with an edible carrier to give a concentration of: (1) 3 grams to 10 grams of hydrogen peroxide equivalent per 100 grams of the additive, plus carrier, for use in flour maturing and bleaching; or (2) approximately 0.75 gram of hydrogen peroxide equivalent per 100 grams of the additive, plus carrier, for use in dough conditioning.

(c) It is used or intended for use: (1) In maturing and bleaching of flour in a quantity not more than sufficient for such effect; and (2) as a dough-conditioning agent in bread and roll production at not to exceed the quantity of hydrogen peroxide equivalent necessary for the artificial maturing effect.

(d) To insure safe use of the additive, the label of the food additive container and any intermediate premix thereof shall bear, in addition to the other information required by the act:

(1) The name of the additive, “acetone peroxides”.

(2) The concentration of the additive expressed in hydrogen peroxide equivalents per 100 grams.

(3) Adequate use directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

(a) Advantame is the chemical N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (CAS Reg. No. 714229-20-6).

(b) Advantame meets the following specifications when it is tested according to the methods described or referenced in the document entitled “Specifications and Analytical Methods for Advantame” dated April 1, 2009, by the Ajinomoto Co. Inc., Sweetener Department 15-1, Kyobashi 1-chome, Chuo-ku, Tokyo 104-8315, Japan. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) Assay for advantame, not less than 97.0 percent and not more than 102.0 percent on a dry basis.

(2) Free N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-α-aspartyl]-L-phenylalanine, not more than 1.0 percent.

(3) Total other related substances, not more than 1.5 percent.

(4) Lead, not more than 1.0 milligram per kilogram.

(5) Water, not more than 5.0 percent.

(6) Residue on ignition, not more than 0.2 percent.

(7) Specific rotation, determined at20 °C [α]D: −45.0 to −38.0° calculated on a dry basis.

(c) The food additive advantame may be safely used as a sweetening agent and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice, in an amount not to exceed that reasonably required to achieve the intended technical effect, in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use.

(d) If the food containing the additive purports to be or is represented to be for special dietary use, it must be labeled in compliance with part 105 of this chapter.

The food additive aspartame may be safely used in food in accordance with good manufacturing practice as a sweetening agent and a flavor enhancer in foods for which standards of identity established under section 401 of the act do not preclude such use under the following conditions:

(a) Aspartame is the chemical 1-methyl N-l-α-aspartyl-l-phenylalanine (C14H18N2O5).

(b) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 73-74, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c)(1) When aspartame is used as a sugar substitute tablet for sweetening hot beverages, including coffee and tea, L-leucine may be used as a lubricant in the manufacture of such tablets at a level not to exceed 3.5 percent of the weight of the tablet.

(2) When aspartame is used in baked goods and baking mixes, the amount of the additive is not to exceed 0.5 percent by weight of ready-to-bake products or of finished formulations prior to baking. Generally recognized as safe (GRAS) ingredients or food additives approved for use in baked goods shall be used in combination with aspartame to ensure its functionality as a sweetener in the final baked product. The level of aspartame used in these products is determined by an analytical method entitled “Analytical Method for the Determination of Aspartame and Diketopiperazine in Baked Goods and Baking Mixes,” October 8, 1992, which was developed by the Nutrasweet Co. Copies are available from the Office of Premarket Approval (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or are available for inspection at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The principal display panel of any intermediate mix of the additive for manufacturing purposes shall bear a statement of the concentration of the additive contained therein;

(2) The label of any food containing the additive shall bear, either on the principal display panel or on the information panel, the following statement:

(3) When the additive is used in a sugar substitute for table use, its label shall bear instructions not to use in cooking or baking.

(4) Packages of the dry, free-flowing additive shall prominently display the sweetening equivalence in teaspoons of sugar.

(e) If the food containing the additive purports to be or is represented for special dietary uses, it shall be labeled in compliance with part 105 of this chapter.

The food additive azodicarbonamide may be safely used in food in accordance with the following prescribed conditions:

(a) It is used or intended for use:

(1) As an aging and bleaching ingredient in cereal flour in an amount not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent; 45 parts per million).

(2) As a dough conditioner in bread baking in a total amount not to exceed 0.0045 percent (45 parts per million) by weight of the flour used, including any quantity of azodicarbonamide added to flour in accordance with paragraph (a)(1) of this section.

(b) To assure safe use of the additive:

(1) The label and labeling of the additive and any intermediate premix prepared therefrom shall bear, in addition to the other information required by the Act, the following:

(i) The name of the additive.

(ii) A statement of the concentration or the strength of the additive in any intermediate premixes.

(2) The label or labeling of the food additive shall also bear adequate directions for use.

Copolymer condensates of ethylene oxide and propylene oxide may be safely used in food under the following prescribed conditions:

(a) The additive consists of one of the following:

(1) α-Hydro-omega-hydroxy-poly (oxyethylene) poly(oxypropylene)-(55-61 moles)poly(oxyethylene) block copolymer, having a molecular weight range of 9,760-13,200 and a cloud point above 100 °C in 1 percent aqueous solution.

(2) α-Hydro-omega-hydroxy-poly (oxyethylene)poly(oxypropylene)-(53-59 moles)poly(oxyethylene)(14-16 moles) block copolymer, having a molecular weight range of 3,500-4,125 and a cloud point of 9 °C-12 °C in 10 percent aqueous solution.

(3) α-Hydro-omega-hydroxy-poly(ox-yethylene)/poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer, having a minimum average molecular weight of 1900 and a minimum cloud point of 9 °C-12 °C in 10 percent aqueous solution.

(4) α-Hydro-omega-hydroxy-poly(ox-yethylene) poly (oxypropylene)-(51-57 moles) poly(oxyethylene) block copolymer, having an average molecular weight of 14,000 and a cloud point above 100 °C in 1 percent aqueous solution.

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

(1) The additive identified in paragraph (a)(1) of this section is used in practice as a solubilizing and stabilizing agent in flavor concentrates (containing authorized flavoring oils) for use in foods for which standards of identity established under section 401 of the Act do not preclude such use, provided that the weight of the additive does not exceed the weight of the flavoring oils in the flavor concentrate.

(2) The additive identified in paragraph (a)(2) of this section is used as a processing aid and wetting agent in combination with dioctyl sodium sulfosuccinate for fumaric acid as prescribed in § 172.810.

(3) The additive identified in paragraph (a)(3) of this section is used:

(i) As a surfactant and defoaming agent, at levels not to exceed 0.05 percent by weight, in scald baths for poultry defeathering, followed by potable water rinse. The temperatures of the scald baths shall be not less than 125 °F.

(ii) As a foam control and rinse adjuvant in hog dehairing machines at a use level of not more than 5 grams per hog.

(4) The additive identified in paragraph (a)(4) of this section is used as a dough conditioner in yeast-leavened bakery products for which standards of identity established under section 401 of the Act do not preclude such use, provided that the amount of the additive dose not exceed 0.5 percent by weight of the flour used.

Curdlan may be safely used in accordance with the following conditions:

(a) Curdlan is a high molecular weight polymer of glucose (β-1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure culture fermentation from the nonpathogenic and nontoxicogenic bacterium Alcaligenes faecalis var. myxogenes.

(b) Curdlan meets the following specifications when it is tested according to the methods described or referenced in the document entitled “Analytical Methods for Specification Tests for Curdlan,” by Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku, Tokyo, 103, Japan, 1996, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-402-1200, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Positive for curdlan.

(2) Assay for curdlan (calculated as anhydrous glucose), not less than 80 percent.

(3) pH of 1 percent aqueous suspension, 6.0-7.5.

(4) Lead, not more than 0.5 mg/kg.

(5) Heavy metals (as Pb), not more than 0.002 percent.

(6) Total nitrogen, not more than 0.2 percent.

(7) Loss on drying, not more than 10 percent.

(8) Residue on ignition, not more than 6 percent.

(9) Gel strength of 2 percent aqueous suspension, not less than 600 × 10 3 dyne per square centimeter.

(10) Aerobic plate count, not more than 10 3 per gram.

(11) Coliform bacteria, not more than 3 per gram.

(c) Curdlan is used or intended for use in accordance with good manufacturing practice as a formulation aid, processing aid, stabilizer and thickener, and texturizer in foods for which standards of identity established under section 401 of the act do not preclude such use.

The food additive, dioctyl sodium sulfosuccinate, meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 313-314, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html). The food additive, dioctyl sodium sulfosuccinate, may be safely used in food in accordance with the following prescribed conditions:

(a) As a wetting agent in the following fumaric acid-acidulated foods: Dry gelatin dessert, dry beverage base, and fruit juice drinks, when standards of identity do not preclude such use. The labeling of the dry gelatin dessert and dry beverage base shall bear adequate directions for use, and the additive shall be used in such an amount that the finished gelatin dessert will contain not in excess of 15 parts per million of the additive and the finished beverage or fruit juice drink will contain not in excess of 10 parts per million of the additive.

(b) As a processing aid in sugar factories in the production of unrefined cane sugar, in an amount not in excess of 0.5 part per million of the additive per percentage point of sucrose in the juice, syrup, or massecuite being processed, and so used that the final molasses will contain no more than 25 parts per million of the additive.

(c) As a solubilizing agent on gums and hydrophilic colloids to be used in food as stabilizing and thickening agents, when standards of identity do not preclude such use. The additive is used in an amount not to exceed 0.5 percent by weight of the gums or hydrophilic colloids.

(d) As an emulsifying agent for cocoa fat in noncarbonated beverages containing cocoa, whereby the amount of the additive does not exceed 25 parts per million of the finished beverage.

(e) As a dispersing agent in “cocoa with dioctyl sodium sulfosuccinate for manufacturing” that conforms to the provisions of § 163.117 of this chapter and the use limitations prescribed in § 172.520, in an amount not to exceed 0.4 percent by weight thereof.

(f) As a processing aid and wetting agent in combination with α-hydro-omega -hydroxy - poly(oxyethylene) - poly-(oxypropylene) (53-59 moles) poly(oxyethylene) (14-16 moles) block copolymer, having a molecular weight range of 3,500-4,125 and a cloud point of 9 °C-12 °C in 10 percent aqueous solution, for fumaric acid used in fumaric acid-acidulated dry beverage base and in fumaric acid-acidulated fruit juice drinks, when standards of identity do not preclude such use. The labeling of the dry beverage base shall bear adequate directions for use, and the additives shall be used in such an amount that the finished beverage or fruit juice drink will contain not in excess of a total of 10 parts per million of the dioctyl sodium sulfosuccinate-block copolymer combination.

The food additive glyceryl tristearate may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive (CAS Reg. No. 555-43-1) is prepared by reacting stearic acid with glycerol in the presence of a suitable catalyst.

(b) The food additive meets the following specifications:

(c) The additive is used or intended for use as follows when standards of identity established under section 401 of the Act do not preclude such use:

(d) To assure safe use of the additive:

(1) In addition to the other information required by the act, the label or labeling of the additive shall bear the name of the additive.

(2) The label of the additive shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

The food additive glycine may be safely used for technological purposes in food in accordance with the following prescribed conditions:

(a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 457-458, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

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

(c) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The labeling of the additive shall bear adequate directions for use of the additive in compliance with the provisions of this section.

(2) The labeling of beverage bases containing the additive shall bear adequate directions for use to provide that beverages prepared therefrom shall contain no more than 0.2 percent glycine.

The food additive hydroxylated lecithin may be safely used as an emulsifier in foods in accordance with the following conditions:

(a) The additive is obtained by the treatment of lecithin in one of the following ways, under controlled conditions whereby the separated fatty acid fraction of the resultant product has an acetyl value of 30 to 38:

(1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and sodium hydroxide.

(2) With hydrogen peroxide, acetic acid, and sodium hydroxide.

(b) It is used or intended for use, in accordance with good manufacturing practice, as an emulsifier in foods, except for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive, the label of the food additive container shall bear, in addition to the other information required by the Act:

(1) The name of the additive, “hydroxylated lecithin”.

(2) Adequate directions for its use.

Methyl glucoside-coconut oil ester may be safely used in food in accordance with the following conditions:

(a) It is the methyl glucoside-coconut oil ester having the following specifications:

(b) It is used or intended for use as follows:

(1) As an aid in crystallization of sucrose and dextrose at a level not to exceed the minimum quantity required to produce its intended effect.

(2) As a surfactant in molasses at a level not to exceed 320 parts per million in the molasses.

The food additive oxystearin may be safely used in foods, when such use is not precluded by standards of identity in accordance with the following conditions:

(a) The additive is a mixture of the glycerides of partially oxidized stearic and other fatty acids obtained by heating hydrogenated cottonseed or soybean oil under controlled conditions, in the presence of air and a suitable catalyst which is not a food additive as so defined. The resultant product meets the following specifications:

(b) It is used or intended for use as a crystallization inhibitor in vegetable oils and as a release agent in vegetable oils and vegetable shortenings, whereby the additive does not exceed 0.125 percent of the combined weight of the oil or shortening.

(c) To insure safe use of the additive, the label and labeling of the additive container shall bear, in addition to the other information required by the Act:

(1) The name of the additive.

(2) Adequate directions to provide an oil or shortening that complies with the limitations prescribed in paragraph (b) of this section.

Polyethylene glycol identified in this section may be safely used in food in accordance with the following prescribed conditions:

(a) Identity. (1) The additive is an addition polymer of ethylene oxide and water with a mean molecular weight of 200 to 9,500.

(2) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols when tested by the analytical methods prescribed in paragraph (b) of this section.

(b) Analytical method. (1) The analytical method prescribed in the National Formulary XV (1980), page 1244, for polyethylene glycol 400 shall be used to determine the total ethylene and diethylene glycol content of polyethylene glycols having mean molecular weights of 450 or higher.

(2) The following analytical method shall be used to determine the total ethylene and diethylene glycol content of polyethylene glycols having mean molecular weights below 450.

(c) Uses. It may be used, except in milk or preparations intended for addition to milk, as follows:

(1) As a coating, binder, plasticizing agent, and/or lubricant in tablets used for food.

(2) As an adjuvant to improve flavor and as a bodying agent in nonnutritive sweeteners identified in § 180.37 of this chapter.

(3) As an adjuvant in dispersing vitamin and/or mineral preparations.

(4) As a coating on sodium nitrite to inhibit hygroscopic properties.

(d) Limitations. (1) It is used in an amount not greater than that required to produce the intended physical or technical effect.

(2) A tolerance of zero is established for residues of polyethylene glycol in milk.

The food additive sodium lauryl sulfate may be safely used in food in accordance with the following conditions:

(a) The additive meets the following specifications:

(1) It is a mixture of sodium alkyl sulfates consisting chiefly of sodium lauryl sulfate [CH2(CH2)10CH2OSO2Na].

(2) It has a minimum content of 90 percent sodium alkyl sulfates.

(b) It is used or intended for use:

(1) As an emulsifier in or with egg whites whereby the additive does not exceed the following limits:

(2) As a whipping agent at a level not to exceed 0.5 percent by weight of gelatine used in the preparation of marshmallows.

(3) As a surfactant in:

(i) Fumaric acid-acidulated dry beverage base whereby the additive does not exceed 25 parts per million of the finished beverage and such beverage base is not for use in a food for which a standard of identity established under section 401 of the Act precludes such use.

(ii) Fumaric acid-acidulated fruit juice drinks whereby the additive does not exceed 25 parts per million of the finished fruit juice drink and it is not used in a fruit juice drink for which a standard of identity established under section 401 of the Act precludes such use.

(4) As a wetting agent at a level not to exceed 10 parts per million in the partition of high and low melting fractions of crude vegetable oils and animal fats, provided that the partition step is followed by a conventional refining process that includes alkali neutralization and deodorization of the fats and oils.

(c) To insure the safe use of the additive, the label of the food additive container shall bear, in addition to the other information required by the Act:

(1) The name of the additive, sodium lauryl sulfate.

(2) Adequate use directions to provide a final product that complies with the limitations prescribed in paragraph (b) of this section.

The food additive sodium mono- and dimethyl naphthalene sulfonates may be safely used in accordance with the following prescribed conditions:

(a) The additive has a molecular weight range of 245-260.

(b) The additive is used or intended for use:

(1) In the crystallization of sodium carbonate in an amount not to exceed 250 parts per million of the sodium carbonate. Such sodium carbonate is used or intended for use in potable water systems to reduce hardness and aid in sedimentation and coagulation by raising the pH for the efficient utilization of other coagulation materials.

(2) As an anticaking agent in sodium nitrite at a level not in excess of 0.1 percent by weight thereof for authorized uses in cured fish and meat.

(c) In addition to the general labeling requirements of the Act:

(1) Sodium carbonate produced in accordance with paragraph (b)(1) of this section shall be labeled to show the presence of the additive and its label or labeling shall bear adequate directions for use.

(2) Sodium nitrite produced in accordance with paragraph (b)(2) of this section shall bear the labeling required by § 172.175 and a statement declaring the presence of sodium mono- and dimethyl naphthalene sulfonates.

Sodium stearyl fumarate may be safely used in food in accordance with the following conditions:

(a) It contains not less than 99 percent sodium stearyl fumarate calculated on the anhydrous basis, and not more than 0.25 percent sodium stearyl maleate.

(b) The additive is used or intended for use:

(1) As a dough conditioner in yeast-leavened bakery products in an amount not to exceed 0.5 percent by weight of the flour used.

(2) As a conditioning agent in dehydrated potatoes in an amount not to exceed 1 percent by weight thereof.

(3) As a stabilizing agent in nonyeast-leavened bakery products in an amount not to exceed 1 percent by weight of the flour used.

(4) As a conditioning agent in processed cereals for cooking in an amount not to exceed 1 percent by weight of the dry cereal, except for foods for which standards of identity preclude such use.

(5) As a conditioning agent in starch-thickened or flour-thickened foods in an amount not to exceed 0.2 percent by weight of the food.

The food additive acetylated monoglycerides may be safely used in or on food in accordance with the following prescribed conditions:

(a) The additive is manufactured by:

(1) The interesterification of edible fats with triacetin and in the presence of catalytic agents that are not food additives or are authorized by regulation, followed by a molecular distillation or by steam stripping; or

(2) The direct acetylation of edible monoglycerides with acetic anhydride without the use of catalyst or molecular distillation, and with the removal by vacuum distillation, if necessary, of the acetic acid, acetic anhydride, and triacetin.

(b) The food additive has a Reichert-Meissl value of 75-200 and an acid value of less than 6.

(c) The food additive is used at a level not in excess of the amount reasonably required to produce its intended effect in food, or in food-processing, food-packing, or food-storage equipment.

(a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9).

(b) Neotame meets the following specifications when it is tested according to the methods described or referenced in the document entitled “Specifications and Analytical Methods for Neotame” dated April 3, 2001, by the NutraSweet Co., 699 North Wheeling Rd., Mount Prospect, IL 60056. The Director of the Office of the Federal Register has approved the incorporation by reference of this material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., rm. 1C-100, College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Assay for neotame, not less than 97.0 percent and not more than 102.0 percent on a dry basis.

(2) Free dipeptide acid (N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine), not more than 1.5 percent.

(3) Other related substances, not more than 2.0 percent.

(4) Lead, not more than 2.0 milligrams per kilogram.

(5) Water, not more than 5.0 percent.

(6) Residue on ignition, not more than 0.2 percent

(7) Specific rotation, determined at 20 °C [α]D: −40.0° to 43.4° calculated on a dry basis.

(c) The food additive neotame may be safely used as a sweetening agent and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice, in an amount not to exceed that reasonably required to accomplish the intended technical effect, in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use.

(d) When neotame is used as a sugar substitute tablet, L-leucine may be used as a lubricant in the manufacture of tablets at a level not to exceed 3.5 percent of the weight of the tablet.

(e) If the food containing the additive purports to be or is represented to be for special dietary use, it shall be labeled in compliance with part 105 of this chapter.

The food additive succinylated monoglycerides may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a mixture of semi-and neutral succinic acid esters of mono- and diglycerides produced by the succinylation of a product obtained by the glycerolysis of edible fats and oils, or by the direct esterification of glycerol with edible fat-forming fatty acids.

(b) The additive meets the following specifications:

(c) The additive is used or intended for use in the following foods:

(1) As an emulsifier in liquid and plastic shortenings at a level not to exceed 3 percent by weight of the shortening.

(2) As a dough conditioner in bread baking, when such use is permitted by an appropriate food standard, at a level not to exceed 0.5 percent by weight of the flour used.

(a) Sucralose is the chemical 1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside (CAS Reg. No. 56038-13-2).

(b) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 993-995, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) The additive may be used as a sweetener in foods generally, in accordance with current good manufacturing practice in an amount not to exceed that reasonably required to accomplish the intended effect.

(d) If the food containing the additive purports to be or is represented to be for special dietary use, it shall be labeled in compliance with part 105 of this chapter.

A food additive that is a mixture of glyceryl monooleate and its citric acid monoester manufactured by the reaction of glyceryl monooleate with citric acid under controlled conditions may be safely used as a synergist and solubilizer for antioxidants in oils and fats, when used in accordance with the conditions prescribed in this section.

(a) The food additive meets the following specifications:

(b) It is used, or intended for use, in antioxidant formulations for addition to oils and fats whereby the additive does not exceed 200 parts per million of the combined weight of the oil or fat and the additive.

(c) To assure safe use of the additive:

(1) The container label shall bear, in addition to the other information required by the Act, the name of the additive.

(2) The label or accompanying labeling shall bear adequate directions for the use of the additive which, if followed, will result in a food that complies with the requirements of this section.

Sucrose acetate isobutyrate may be safely used in foods in accordance with the following prescribed conditions:

(a) Sucrose acetate isobutyrate (CAS Reg. No. 27216-37-1), or SAIB, is the chemical alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-oxopropyl)-beta-D-fructofuranosyl, acetate tris(2-methyl propanoate).

(b) SAIB, a pale, straw-colored liquid, meets the following specifications: (1) Assay: Not less than 98.8 percent and not more than 101.9 percent, based on the following formula:

(2) Saponification value: 524-540 determined using 1 gram of sample by the “Guide to Specifications for General Notices, General Analytical Techniques, Identification Tests, Test Solutions, and Other Reference Materials,” in the “Compendium of Food Additive Specifications, Addendum 4, Food and Agriculture Organization of the United Nations (FAO), Food and Nutrition Paper 5, Revision 2” (1991), pp. 203 and 204, which is incorporated by reference, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-402-1200, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Acid value: Not to exceed 0.20 determined using 50 grams of sample by the “Guide to Specifications for General Notices, General Analytical Techniques, Identification Tests, Test Solutions, and Other Reference Materials,” in the “Compendium of Food Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 2,” p. 189 (1991), which is incorporated by reference; see paragraph (b)(2) of this section for availability of the incorporation by reference.

(4) Lead: Not to exceed 1.0 milligrams/kilogram determined by the “Atomic Absorption Spectrophotometric Graphite Furnace Method, Method I,” in the “Food Chemicals Codex,” 4th ed. (1996), pp. 763 and 764, with an attached modification to the sample digestion section in Appendix III.B (July 1996), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(5) Triacetin: Not to exceed 0.10 percent determined by gas chromatography as described in the “Guide to Specifications for General Notices, General Analytical Techniques, Identification Tests, Test Solutions, and Other Reference Materials,” in the “Compendium of Food Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 2,” (1991), pp. 13-26, which is incorporated by reference; see paragraph (b)(2) of this section for availability of the incorporation by reference.

(c) The food additive is used as a stabilizer (as defined in § 170.3(o)(28) of this chapter) of emulsions of flavoring oils in nonalcoholic beverages.

(d) The total SAIB content of a beverage containing the additive does not exceed 300 milligrams/kilogram of the finished beverage.

The food additive ethoxylated mono-and diglycerides (polyoxyethylene (20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by:

(1) Glycerolysis of edible fats primarily composed of stearic, palmitic, and myristic acids; or

(2) Direct esterification of glycerol with a mixture of primarily stearic, palmitic, and myristic acids;

(b) The additive meets the following specifications:

(c) The additive is used or intended for use in the following foods when standards of identity established under section 401 of the Act do not preclude such use:

(d) When the name “polyglycerate 60” is used in labeling it shall be followed by either “polyoxyethylene (20) mono-and diglycerides of fatty acids” or “ethoxylated mono- and diglycerides” in parentheses.

The food additive polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) which is a mixture of polyoxyethylene ethers of mixed partial stearic and palmitic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 10 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.

(b) The food additive meets the following specifications:

(c) It is used or intended for use as follows:

(1) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:

(i) Sorbitan monostearate;

(ii) Polysorbate 65;

(iii) Polysorbate 80;

(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

(i) Polysorbate 65.

(ii) Sorbitan monostearate.

(3) As an emulsifier, alone or in combination with sorbitan monostearate, in nonstandardized confectionery coatings and standardized cacao products specified in §§ 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150 of this chapter, as follows:

(i) It is used alone in an amount not to exceed 0.5 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.

(ii) It is used with sorbitan monostearate in any combination of up to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan monostearate: Provided, That the total combination does not exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.

(4) [Reserved]

(5) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:

(i) Polysorbate 65.

(ii) Sorbitan monostearate.

(6) To impart greater opacity to sugar-type confection coatings whereby the maximum amount of the additive does not exceed 0.2 percent of the weight of the finished sugar coating.

(7) As an emulsifier in nonstandardized dressings whereby the maximum amount of the additive does not exceed 0.3 percent of the weight of the finished dressings.

(8) As an emulsifier, alone or in combination with polysorbate 80, in shortenings and edible oils intended for use in foods as follows, when standards of identity established under section 401 of the act do not preclude such use:

(i) It is used alone in an amount not to exceed 1 percent of the weight of the finished shortening or oil.

(ii) It is used with polysorbate 80 in any combination providing no more than 1 percent of polysorbate 60 and no more than 1 percent of polysorbate 80, provided that the total combination does not exceed 1 percent of the finished shortening or oil.

(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and (ii) of this section may be exceeded in premix concentrates of shortening or edible oil if the labeling complies with the requirements of paragraph (d) of this section.

(9) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:

(i) Polysorbate 65.

(ii) Sorbitan monostearate.

(10) As a foaming agent in nonalcoholic mixes, to be added to alcoholic beverages in the preparation of mixed alcoholic drinks, at a level not to exceed 4.5 percent by weight of the nonalcoholic mix.

(11) As a dough conditioner in yeast-leavened bakery products in an amount not to exceed 0.5 percent by weight of the flour used.

(12) As an emulsifier, alone or in combination with sorbitan monostearate, in the minimum quantity required to accomplish the intended effect, in formulations of white mineral oil conforming with § 172.878 and/or petroleum wax conforming with § 172.886 for use as protective coatings on raw fruits and vegetables.

(13) As a dispersing agent in artificially sweetened gelatin desserts and in artificially sweetened gelatin dessert mixes, whereby the amount of the additive does not exceed 0.5 percent on a dry-weight basis.

(14) As an emulsifier in chocolate flavored syrups, whereby the maximum amount of the additive does not exceed 0.05 percent in the finished product.

(15) As a surfactant and wetting agent for natural and artificial colors in food as follows:

(i) In powdered soft drink mixes in an amount not to exceed 4.5 percent by weight of the mix.

(ii) In sugar-based gelatin dessert mixes in an amount not to exceed 0.5 percent by weight of the mix.

(iii) In artificially sweetened gelatin dessert mixes in an amount not to exceed 3.6 percent by weight of the mix.

(iv) In sugar-based pudding mixes in an amount not to exceed 0.5 percent by weight of the mix.

(v) In artificially sweetened pudding mixes in an amount not to exceed 0.5 percent by weight of the mix.

(16) As an emulsifier in ice cream, frozen custard, fruit sherbet, and nonstandardized frozen desserts when used alone or in combination with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

(d) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of the additive and any intermediate premixes shall bear:

(i) The name of the additive.

(ii) A statement of the concentration or strength of the additive in any intermediate premixes.

(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

The food additive polysorbate 65 (polyoxyethylene (20) sorbitan tristearate), which is a mixture of polyoxyethylene ethers of mixed stearic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 15 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.

(b) The food additive meets the following specifications:

(c) The additive is used, or intended for use, as follows:

(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit sherbet and nonstandardized frozen desserts when used alone or in combination with polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

(i) Sorbitan monostearate.

(ii) Polysorbate 60.

(3) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:

(i) Sorbitan monostearate;

(ii) Polysorbate 60;

(iii) Polysorbate 80;

(4) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:

(i) Sorbitan monostearate.

(ii) Polysorbate 60.

(5) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:

(i) Sorbitan monostearate.

(ii) Polysorbate 60.

(d) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of the additive and any intermediate premixes shall bear:

(i) The name of the additive.

(ii) A statement of the concentration or strength of the additive in any intermediate premixes.

(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

The food additive polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), which is a mixture of polyoxyethylene ethers of mixed partial oleic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by reacting oleic acid (usually containing associated fatty acids) with sorbitol to yield a product with a maximum acid number of 7.5 and a maximum water content of 0.5 percent, which is then reacted with ethylene oxide.

(b) The food additive meets the following specifications:

(c) The additive is used or intended for use as follows:

(1) An emulsifier in ice cream, frozen custard, ice milk, fruit sherbet, and nonstandardized frozen desserts, when used alone or in combination with polysorbate 65 whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

(2) In yeast-defoamer formulations whereby the maximum amount of the additive does not exceed 4 percent of the finished yeast defoamer and the maximum amount of the additive in the yeast from such use does not exceed 4 parts per million.

(3) As a solubilizing and dispersing agent in pickles and pickle products, whereby the maximum amount of the additive does not exceed 500 parts per million.

(4) As a solubilizing and dispersing agent in:

(i) Vitamin-mineral preparations containing calcium caseinate in the absence of fat-soluble vitamins, whereby the maximum intake of polysorbate 80 shall not exceed 175 milligrams from the recommended daily dose of the preparations.

(ii) Fat-soluble vitamins in vitamin and vitamin-mineral preparations containing no calcium caseinate, whereby the maximum intake of polysorbate 80 shall not exceed 300 milligrams from the recommended daily dose of the preparations.

(iii) In vitamin-mineral preparations containing both calcium caseinate and fat-soluble vitamins, whereby the maximum intake of polysorbate 80 shall not exceed 475 milligrams from the recommended daily dose of the preparations.

(5) As a surfactant in the production of coarse crystal sodium chloride whereby the maximum amount of the additive in the finished sodium chloride does not exceed 10 parts per million.

(6) In special dietary foods, as an emulsifier for edible fats and oils, with directions for use which provide for the ingestion of not more than 360 milligrams of polysorbate 80 per day.

(7) As a solubilizing and dispersing agent for dill oil in canned spiced green beans, not to exceed 30 parts per million.

(8) As an emulsifier, alone or in combination with polysorbate 60, in shortenings and edible oils intended for use in foods as follows, when standards of identity established under section 401 of the act do not preclude such use:

(i) It is used alone in an amount not to exceed 1 percent of the weight of the finished shortening or oil.

(ii) It is used with polysorbate 60 in any combination providing no more than 1 percent of polysorbate 80 and no more than 1 percent of polysorbate 60, provided that the total combination does not exceed 1 percent of the finished shortening or oil.

(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and (ii) of this section may be exceeded in premix concentrates of shortening or edible oil if the labeling complies with the requirements of paragraph (d) of this section.

(9) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:

(i) Sorbitan monostearate;

(ii) Polysorbate 60;

(iii) Polysorbate 65;

(10) It is used as a wetting agent in scald water for poultry defeathering, followed by potable water rinse. The concentration of the additive in the scald water does not exceed 0.0175 percent.

(11) As a dispersing agent in gelatin desserts and in gelatin dessert mixes, whereby the amount of the additive does not exceed 0.082 percent on a dry-weight basis.

(12) As an adjuvant added to herbicide use and plant-growth regulator use dilutions by a grower or applicator prior to application of such dilutions to the growing crop. Residues resulting from such use are exempt from the requirement of a tolerance. When so used or intended for use, the additive shall be exempt from the requirements of paragraph (d)(1) of this section.

(13) As a defoaming agent in the preparation of the creaming mixture for cottage cheese and lowfat cottage cheese, as identified in §§ 133.128 and 133.131 of this chapter, respectively, whereby the amount of the additive does not exceed .008 percent by weight of the finished products.

(14) As a surfactant and wetting agent for natural and artificial colors for use in barbecue sauce where the level of the additive does not exceed 0.005 percent by weight of the barbecue sauce.

(d) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of the additive and any intermediate premixes shall bear:

(i) The name of the additive.

(ii) A statement of the concentration or strength of the additive in any intermediate premixes.

(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

Polydextrose as identified in this section may be safely used in food in accordance with the following prescribed conditions:

(a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially metabolizable water-soluble polymer prepared by the condensation of a melt which consists either of approximately 89 percent D-glucose, 10 percent sorbitol, and 1 percent citric acid or of approximately 90 percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric acid, on a weight basis.

(2) Polydextrose may be partially neutralized with potassium hydroxide, or partially reduced by transition metal catalytic hydrogenation in aqueous solution.

(b) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 811-814, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) When standards of identity established under section 401 of the act do not preclude such use, polydextrose may be used in accordance with current good manufacturing practices as a bulking agent, formulation aid, humectant, and texturizer in all foods, except meat and poultry, baby food, and infant formula.

(d) If the food containing the additive purports to be or is represented for special dietary uses, it shall be labeled in compliance with part 105 of this chapter.

(e) The label and labeling of food a single serving of which would be expected to exceed 15 grams of the additive shall bear the statement: “Sensitive individuals may experience a laxative effect from excessive consumption of this product”.

The food additive sorbitan monostearate, which is a mixture of partial stearic and palmitic acid esters of sorbitol anhydrides, may be safely used in or on food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield essentially a mixture of esters.

(b) The food additive meets the following specifications:

(c) It is used or intended for use, alone or in combination with polysorbate 60 as follows:

(1) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:

(i) Polysorbate 60;

(ii) Polysorbate 65;

(iii) Polysorbate 80;

(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

(i) Polysorbate 65.

(ii) Polysorbate 60.

(3) As an emulsifier, alone or in combination with polysorbate 60 in nonstandardized confectionery coatings and standardized cacao products specified in §§ 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150 of this chapter, as follows:

(i) It is used alone in an amount not to exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.

(ii) It is used with polysorbate 60 in any combination of up to 1 percent sorbitan monostearate and up to 0.5 percent polysorbate 60 provided that the total combination does not exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.

(4) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:

(i) Polysorbate 65.

(ii) Polysorbate 60.

(5) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:

(i) Polysorbate 60.

(ii) Polysorbate 65.

(6) It is used alone as a rehydration aid in the production of active dry yeast in an amount not to exceed 1 percent by weight of the dry yeast.

(7) As an emulsifier, alone or in combination with polysorbate 60, in the minimum quantity required to accomplish the intended effect, in formulations of white mineral oil conforming with § 172.878 and/or petroleum wax conforming with § 172.886 for use as protective coatings on raw fruits and vegetables.

(d) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of the additive and any intermediate premixes shall bear:

(i) The name of the additive.

(ii) A statement of the concentration or strength of the additive in any intermediate premixes.

(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

The food additive calcium stearoyl-2-lactylate may be safely used in or on food in accordance with the following prescribed conditions:

(a) The additive, which is a mixture of calcium salts of stearoyl lactylic acids and minor proportions of other calcium salts of related acids, is manufactured by the reaction of stearic acid and lactic acid and conversion to the calcium salts.

(b) The additive meets the following specifications:

(c) It is used or intended for use as follows:

(1) As a dough conditioner in yeast-leavened bakery products and prepared mixes for yeast-leavened bakery products in an amount not to exceed 0.5 part for each 100 parts by weight of flour used.

(2) As a whipping agent in:

(i) Liquid and frozen egg white at a level not to exceed 0.05 percent.

(ii) Dried egg white at a level not to exceed 0.5 percent.

(iii) Whipped vegetable oil topping at a level not to exceed 0.3 percent of the weight of the finished whipped vegetable oil topping.

(3) As a conditioning agent in dehydrated potatoes in an amount not to exceed 0.5 percent by weight thereof.

(d) To assure safe use of the additive:

(1) The label and labeling of the food additive and any intermediate premix prepared therefrom shall bear, in addition to the other information required by the act, the following:

(i) The name of the additive.

(ii) A statement of the concentration or strength of the additive in any intermediate premixes.

(2) The label or labeling of the food additive shall also bear adequate directions of use to provide a finished food that complies with the limitations prescribed in paragraph (c) of this section.

The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383-997) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive, which is a mixture of sodium salts of stearoyl lactylic acids and minor proportions of sodium salts of related acids, is manufactured by the reaction of stearic acid and lactic acid and conversion to the sodium salts.

(b) The additive meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 300-301, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) It is used or intended for use as follows when standards of identity established under section 401 of the Act do not preclude such use:

(1) As a dough strengthener, emulsifier, or processing aid in baked products, pancakes, and waffles, in an amount not to exceed 0.5 part for each 100 parts by weight of flour used.

(2) As a surface-active agent, emulsifier, or stabilizer in icings, fillings, puddings, and toppings, at a level not to exceed 0.2 percent by weight of the finished food.

(3) As an emulsifier or stabilizer in liquid and solid edible fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, at a level not to exceed 0.3 percent by weight of the finished edible fat-water emulsion.

(4) As a formulation aid, processing aid, or surface-active agent in dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry weight of the food.

(5) As an emulsifier, stabilizer, or texturizer in snack dips, at a level not to exceed 0.2 percent by weight of the finished product.

(6) As an emulsifier, stabilizer, or texturizer in cheese substitutes and imitations and cheese product substitutes and imitations, at a level not to exceed 0.2 percent by weight of the finished food.

(7) As an emulsifier, stabilizer, or texturizer in sauces or gravies, and the products containing the same, in an amount not to exceed 0.25 percent by weight of the finished food.

(8) In prepared mixes for each of the foods listed in paragraphs (c) (1) through (7) of this section, provided the additive is used only as specified in each of those paragraphs.

(9) As an emulsifier, stabilizer, or texturizer in cream liqueur drinks, at a level not to exceed 0.5 percent by weight of the finished product.

Lactylic esters of fatty acids may be safely used in food in accordance with the following prescribed conditions:

(a) They are prepared from lactic acid and fatty acids meeting the requirements of § 172.860(b) and/or oleic acid derived from tall oil fatty acids meeting the requirements of § 172.862.

(b) They are used as emulsifiers, plasticizers, or surface-active agents in the following foods, when standards of identity do not preclude their use:

(c) They are used in an amount not greater than required to produce the intended physical or technical effect, and they may be used with shortening and edible fats and oils when such are required in the foods identified in paragraph (b) of this section.

The food additive lactylated fatty acid esters of glycerol and propylene glycol may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a mixture of esters produced by the lactylation of a product obtained by reacting edible fats or oils with propylene glycol.

(b) The additive meets the following specifications: Water insoluble combined lactic acid, 14-18 percent; and acid number, 12 maximum.

(c) It is used in amounts not in excess of that reasonably required to produce the intended physical effect as an emulsifier, plasticizer, or surface-active agent in food.

Glyceryl-lacto esters of fatty acids (the lactic acid esters of mono- and diglycerides) may be safely used in food in accordance with the following prescribed conditions:

(a) They are manufactured from glycerin, lactic acid, and fatty acids conforming with § 172.860 and/or oleic acid derived from tall oil fatty acids conforming with § 172.862 and/or edible fats and oils.

(b) They are used in amounts not in excess of those reasonably required to accomplish their intended physical or technical effect as emulsifiers and plasticizers in food.

Polyglycerol esters of fatty acids, up to and including the decaglycerol esters, may be safely used in food in accordance with the following prescribed conditions:

(a) They are prepared from corn oil, cottonseed oil, lard, palm oil from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the fatty acids derived from these substances (hydrogenated and nonhydrogenated) meeting the requirements of § 172.860(b) and/or oleic acid derived from tall oil fatty acids meeting the requirements of § 172.862.

(b) They are used as emulsifiers in food, in amounts not greater than that required to produce the intended physical or technical effect.

(c) Polyglycerol esters of a mixture of stearic, oleic, and coconut fatty acids are used as a cloud inhibitor in vegetable and salad oils when use is not precluded by standards of identity. The fatty acids used in the production of the polyglycerol esters meet the requirements of § 172.860(b), and the polyglycerol esters are used at a level not in excess of the amount required to perform its cloud-inhibiting effect. Oleic acid derived from tall oil fatty acids conforming with § 172.862 may be used as a substitute for or together with the oleic acid permitted by this paragraph.

(d) Polyglycerol esters of butter oil fatty acids are used as emulsifiers in combination with other approved emulsifiers in dry, whipped topping base. The fatty acids used in the production of the polyglycerol esters meet the requirements of § 172.860(b), and the polyglycerol esters are used at a level not in excess of the amount required to perform their emulsifying effect.

Propylene glycol mono- and diesters of fats and fatty acids may be safely used in food, subject to the following prescribed conditions:

(a) They are produced from edible fats and/or fatty acids in compliance with § 172.860 and/or oleic acid derived from tall oil fatty acids in compliance with § 172.862.

(b) They are used in food in amounts not in excess of that reasonably required to produce their intended effect.

The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2) may be used as an emulsifier, flavoring adjuvant, formulation aid, stabilizer, surfactant, or thickener in foods in accordance with the following prescribed conditions:

(a) The additive meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 256, which is incorporated by reference (Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.), and the additional specification that it shall have up to 85 percent of the carboxylic acid groups esterified with the remaining groups either free or neutralized.

(b) The additive is used or intended for use in the following foods as defined in § 170.3(n) of this chapter, when standards of identity established under section 401 of the act do not preclude such use:

(1) As a stabilizer in frozen dairy desserts, in fruit and water ices, and in confections and frostings at a level not to exceed 0.5 percent by weight of the finished product.

(2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener in baked goods at a level not to exceed 0.5 percent by weight of the finished product.

(3) As an emulsifier, stabilizer, or thickener in cheeses at a level not to exceed 0.9 percent by weight of the finished product.

(4) As an emulsifier, stabilizer, or thickener in fats and oils at a level not to exceed 1.1 percent by weight of the finished product.

(5) As an emulsifier, stabilizer, or thickener in gelatins and puddings at a level not to exceed 0.6 percent by weight of the finished product.

(6) As a stabilizer or thickener in gravies and in sweet sauces at a level not to exceed 0.5 percent by weight of the finished product.

(7) As a stabilizer in jams and jellies at a level not to exceed 0.4 percent by weight of the finished product.

(8) As an emulsifier, stabilizer, or thickener in condiments and relishes at a level not to exceed 0.6 percent by weight of the finished product.

(9) As a flavoring adjunct or adjuvant in seasonings and flavors at a level not to exceed 1.7 percent by weight of the finished product.

(10) As an emulsifier, flavoring adjuvant, formulation aid, stabilizer or thickener, or surface active agent in other foods, where applicable, at a level not to exceed 0.3 percent by weight of the finished product.

(c) To ensure safe use of the additive, the label of the food additive container shall bear, in addition to the other information required by the act:

(1) The name of the additive, “propylene glycol alginate” or “propylene glycol ester of alginic acid”.

(2) Adequate directions for use.

Sucrose fatty acid esters identified in this section may be safely used in accordance with the following prescribed conditions:

(a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of sucrose with fatty acids and are derived from sucrose and edible tallow or hydrogenated edible tallow or edible vegetable oils. The only solvents which may be used in the preparation of sucrose fatty acid esters are those generally recognized as safe in food or regulated for such use by an appropriate section in this part. Ethyl acetate or methyl ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-propanol) may be used in the preparation of sucrose fatty acid esters.

(b) Sucrose fatty acid esters meet the following specifications:

(1) The total content of mono-, di-, and tri-esters is not less than 80 percent as determined by a method title “Sucrose Fatty Acid Esters, Method of Assay,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) The free sucrose content is not more than 5 percent as determined by Test S.2 in the method titled “Sucrose Fatty Acid Esters, Method of Assay,” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.

(3) The acid value is not more than 6.

(4) The residue on ignition (sulfated ash) is not more than 2 percent.

(5) The total ethyl acetate content is not more than 350 parts per million as determined by a method titled “Determination of Ethyl Acetate,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(6) Arsenic is not more than 3 parts per million.

(7) Total heavy metal content (as Pb) is not more than 50 parts per million.

(8) Lead is not more than 10 parts per million.

(9) The total content of methyl ethyl ketone or of methanol shall not be more than 10 parts per million as determined by a method titled “Methyl Ethyl Ketone Test; Methyl Alcohol Test,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(10) The total dimethyl sulfoxide content is not more than 2 parts per million as determined by a method entitled “Determination of Dimethyl Sulfoxide,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(11) The total isobuytl alcohol (2-methyl-1-propanol) content is not more than 10 parts per million as determined by a method entitled “Determination of Isobutyl Alcohol,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) Sucrose fatty acid esters may be used as follows when standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use:

(1) As emulsifiers as defined in § 170.3(o)(8) of this chapter, or as stabilizers as defined in § 170.3(o)(28) of this chapter, in baked goods and baking mixes as defined in § 170.3(n)(1) of this chapter, in chewing gum as defined in § 170.3(n)(6) of this chapter, in coffee and tea beverages with added dairy ingredients and/or dairy product analogues, in confections and frostings as defined in § 170.3(n)(9) of this chapter, in dairy product analogues as defined in § 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, and in whipped milk products.

(2) As texturizers as defined in § 170.3(o)(32) of this chapter in biscuit mixes, in chewing gum as defined in § 170.3(n)(6) of this chapter, in confections and frostings as defined in § 170.3(n)(9) of this chapter, and in surimi-based fabricated seafood products.

(3) As components of protective coatings applied to fresh apples, avocados, bananas, banana plantains, limes, melons (honeydew and cantaloupe), papaya, peaches, pears, pineapples, and plums to retard ripening and spoiling.

(d) Sucrose fatty acid esters are used in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended effect.

The food additive fatty acids may be safely used in food and in the manufacture of food components in accordance with the following prescribed conditions:

(a) The food additive consists of one or any mixture of the following straight-chain monobasic carboxylic acids and their associated fatty acids manufactured from fats and oils derived from edible sources: Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid, palmitic acid, and stearic acid.

(b) The food additive meets the following specifications:

(1) Unsaponifiable matter does not exceed 2 percent.

(2) It is free of chick-edema factor:

(i) As evidenced during the bioassay method for determining the chick-edema factor as prescribed in paragraph (c)(2) of this section; or

(ii) As evidenced by the absence of chromatographic peaks with a retention time relative to aldrin (RA) between 10 and 25, using the gas chromatographic-electron capture method prescribed in paragraph (c)(3) of this section. If chromatographic peaks are found with RA values between 10 and 25, the food additive shall meet the requirements of the bioassay method prescribed in paragraph (c)(2) of this section for determining chick-edema factor.

(c) For the purposes of this section:

(1) Unsaponifiable matter shall be determined by the method described in the 13th Ed. (1980) of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Chick-edema factor shall be determined by the bioassay method described in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 28.127-28.130, which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) The gas chromatographic-electron capture method for testing fatty acids for chick-edema shall be the method described in the “Journal of the Association of Official Analytical Chemists,” Volume 50 (No. 1), pages 216-218 (1967), or the modified method using a sulfuric acid clean-up procedure, as described in the “Journal of the Association of the Offical Analytical Chemists,” Volume 51 (No. 2), pages 489-490 (1968), which are incorporated by reference. See paragraph (c)(2) of this section for availability of these references.

(d) It is used or intended for use as follows:

(1) In foods as a lubricant, binder, and as a defoaming agent in accordance with good manufacturing practice.

(2) As a component in the manufacture of other food-grade additives.

(e) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the act, the following:

(1) The common or usual name of the acid or acids contained therein.

(2) The words “food grade,” in juxtaposition with and equally as prominent as the name of the acid.

The food additive, cocoa butter substitute from coconut oil, palm kernel oil, or both oils, may be safely used in food in accordance with the following conditions:

(a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is manufactured by esterification of glycerol with food-grade fatty acids (complying with § 172.860) derived from edible coconut oil, edible palm kernel oil, or both oils.

(b) The ingredient meets the following specifications:

(c) The ingredient is used or intended for use as follows:

(1) As coating material for sugar, table salt, vitamins, citric acid, succinic acid, and spices; and

(2) In compound coatings, cocoa creams, cocoa-based sweets, toffees, caramel masses, and chewing sweets as defined in § 170.3 (n)(9) and (n)(38) of this chapter, except that the ingredient may not be used in a standardized food unless permitted by the standard of identity.

(d) The ingredient is used in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended effect.

The food additive oleic acid derived from tall oil fatty acids may be safely used in food and as a component in the manufacture of food-grade additives in accordance with the following prescribed conditions:

(a) The additive consists of purified oleic acid separated from refined tall oil fatty acids.

(b) The additive meets the following specifications:

(1) Specifications for oleic acid prescribed in the Food Chemicals Codex, 7th ed. (2010), pp. 743-744, which is incorporated by reference, except that titer (solidification point) shall not exceed 13.5 °C and unsaponifiable matter shall not exceed 0.5 percent. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(2) The resin acid content does not exceed 0.01 as determined by ASTM method D1240-82, “Standard Test Method for Rosin Acids in Fatty Acids,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) The requirements for absence of chick-edema factor as prescribed in § 172.860.

(c) It is used or intended for use as follows:

(1) In foods as a lubricant, binder, and defoaming agent in accordance with good manufacturing practice.

(2) As a component in the manufacture of other food-grade additives.

(d) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:

(1) The common or usual name of the acid.

(2) The words “food grade” in juxtaposition with and equally as prominent as the name of the acid.

The food additive salts of fatty acids may be safely used in food and in the manufacture of food components in accordance with the following prescribed conditions:

(a) The additive consists of one or any mixture of two or more of the aluminum, calcium, magnesium, potassium, and sodium salts of the fatty acids conforming with § 172.860 and/or oleic acid derived from tall oil fatty acids conforming with § 172.862.

(b) The food additive is used or intended for use as a binder, emulsifier, and anticaking agent in food in accordance with good manufacturing practice.

(c) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:

(1) The common or usual name of the fatty acid salt or salts contained therein.

(2) The words “food grade,” in juxtaposition with and equally as prominent as the name of the salt.

Synthetic fatty alcohols may be safely used in food and in the synthesis of food components in accordance with the following prescribed conditions:

(a) The food additive consists of any one of the following fatty alcohols:

(1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl; manufactured by fractional distillation of alcohols obtained by a sequence of oxidation and hydrolysis of organo-aluminums generated by the controlled reaction of low molecular weight trialkylaluminum with purified ethylene (minimum 99 percent by volume C2H4), and utilizing the hydrocarbon solvent as defined in paragraph (b) of this section, such that:

(i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not less than 99 percent of total alcohols and not less than 96 percent of straight chain alcohols. Any nonalcoholic impurities are primarily paraffins.

(ii) Cetyl and stearyl alcohols contain not less than 98 percent of total alcohols and not less than 94 percent of straight chain alcohols. Any nonalcoholic impurities are primarily paraffins.

(iii) The synthetic fatty alcohols contain no more than 0.1 weight percent of total diols as determined by a method available upon request from the Commissioner of Food and Drugs.

(2) Hexyl, octyl, and decyl; manufactured by fractional distillation of alcohols obtained by a sequence of oxidation, hydrolysis, and catalytic hydrogenation (catalyst consists of copper, chromium, and nickel) of organo-aluminums generated by the controlled reaction of low molecular weight trialkylaluminum with purified ethylene (minimum 99 percent by volume C2H4), and utilizing an external coolant such that these alcohols meet the specifications prescribed in paragraph (a)(1) (i) and (iii) of this section.

(3) n-Octyl; manufactured by the hydrodimerization of 1,3-butadiene, followed by catalytic hydrogenation of the resulting dienol, and distillation to produce n-octyl alcohol with a minimum purity of 99 percent. The analytical method for n-octyl alcohol entitled “Test Method [Normal-octanol]” dated October 2003, and printed by Kuraray Co., Ltd., is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety, 5001 Campus Dr., College Park, MD 20740, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) The hydrocarbon solvent used in the process described in paragraph (a)(1) of this section is a mixture of liquid hydrocarbons essentially paraffinic in nature, derived from petroleum and refined to meet the specifications described in paragraph (b)(1) of this section when subjected to the procedures described in paragraph (b) (2) and (3) of this section.

(1) The hydrocarbon solvent meets the following specifications:

(i) Boiling-point range: 175 °C-275 °C.

(ii) Ultraviolet absorbance limits as follows:

(2) Use ASTM method D86-82, “Standard Method for Distillation of Petroleum Products,” which is incorporated by reference, to determine boiling point range. Copies of the material incorporated by reference may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) The analytical method for determining ultraviolet absorbance limits is as follows:

(c) Synthetic fatty alcohols may be used as follows:

(1) As substitutes for the corresponding naturally derived fatty alcohols permitted in food by existing regulations in this part or part 173 of this chapter provided that the use is in compliance with any prescribed limitations.

(2) As substitutes for the corresponding naturally derived fatty alcohols used as intermediates in the synthesis of food additives and other substances permitted in food.

Synthetic glycerin produced by the hydrogenolysis of carbohydrates may be safely used in food, subject to the provisions of this section:

(a) It shall contain not in excess of 0.2 percent by weight of a mixture of butanetriols.

(b) It is used or intended for use in an amount not to exceed that reasonably required to produce its intended effect.

Olestra, as identified in this section, may be safely used in accordance with the following conditions:

(a) Olestra is a mixture of octa-, hepta-, and hexa-esters of sucrose with fatty acids derived from edible fats and oils or fatty acid sources that are generally recognized as safe or approved for use as food ingredients. The chain lengths of the fatty acids are no less than 12 carbon atoms.

(b) Olestra meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 744-746, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) Olestra may be used in place of fats and oils in prepackaged ready-to-eat savory (i.e., salty or piquant but not sweet) snacks and prepackaged, unpopped popcorn kernels that are ready-to-heat. In such foods, the additive may be used in place of fats and oils for frying or baking, in dough conditioners, in sprays, in filling ingredients, or in flavors.

(d) To compensate for any interference with absorption of fat soluble vitamins, the following vitamins shall be added to foods containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 µg vitamin K1 per gram olestra.

(e)(1) Vitamins A, D, E, and K present in foods as a result of the requirement in paragraph (d) of this section shall be declared in the listing of ingredients. Such vitamins shall not be considered in determining nutrient content for the nutritional label or for any nutrient claims, express or implied.

(i) An asterisk shall follow vitamins A, D, E, and K in the listing of ingredients;

(ii) The asterisk shall appear as a superscript following each vitamin;

(iii) Immediately following the ingredient list an asterisk and statement, “Dietarily insignificant” shall appear prominently and conspicuously as specified in § 101.2(c) of this chapter;

(2) Olestra shall not be considered as a source of fat or calories for purposes of §§ 101.9 and 101.13 of this chapter.

The food additive ethyl cellulose may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is a cellulose ether containing ethoxy (OC2H5) groups attached by an ether linkage and containing on an anhydrous basis not more than 2.6 ethoxy groups per anhydroglucose unit.

(b) It is used or intended for use as follows:

(1) As a binder and filler in dry vitamin preparations.

(2) As a component of protective coatings for vitamin and mineral tablets.

(3) As a fixative in flavoring compounds.

Sucrose oligoesters, as identified in this section, may be safely used in accordance with the following conditions:

(a) Sucrose oligoesters consist of mixtures of sucrose fatty acid esters with an average degree of esterification ranging from four to seven. It is produced by interesterification of sucrose with methyl esters of fatty acids derived from edible fats and oils (including hydrogenated fats and oils). The only solvents which may be used in the preparation of sucrose oligoesters are dimethyl sulfoxide, isobutyl alcohol, and those solvents generally recognized as safe in food.

(b) Sucrose oligoesters meet the specifications in the methods listed in the table in this paragraph. The methods for determining compliance with each specification are incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. Copies of the methods are available from the sources listed in the table in this paragraph:

(c) The additive is used as an emulsifier (as defined in § 170.3(o)(8) of this chapter) or stabilizer (as defined in § 170.3(o)(28) of this chapter) in chocolate and in butter-substitute spreads, at a level not to exceed 2.0 percent; except that the additive may not be used in a standardized food unless permitted by the standard of identity.

The food additive hydroxypropyl cellulose may be safely used in food, except standardized foods that do not provide for such use, in accordance with the following prescribed conditions:

(a) The additive consists of one of the following:

(1) A cellulose ether containing propylene glycol groups attached by an ether linkage that contains, on an anhydrous basis, not more than 4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a minimum viscosity of 10 centipoises for a 10 percent by weight aqueous solution at 25 degrees C.

(2) A cellulose ether containing propylene glycol groups attached by an ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The common name for this form of the additive is low substituted hydroxypropyl cellulose.

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

(1) The additive identified in paragraph (a)(1) of this section is used or intended for use as an emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener in food, in accordance with good manufacturing practice. The additive also may be used as a binder in dietary supplements, in accordance with good manufacturing practice.

(2) The additive identified in paragraph (a)(2) of this section is used or intended for use as a binder and disintegrator in tablets or wafers containing dietary supplements of vitamins and/or minerals. The additive is used in accordance with good manufacturing practice.

The food additive methyl ethyl cellulose may be safely used in food in accordance with the following prescribed conditions.

(a) The additive is a cellulose ether having the general formula [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is the number of methyl groups and y is the number of ethyl groups. The average value of x is 0.3 and the average value of y is 0.7.

(b) The additive meets the following specifications:

(1) The methoxy content shall be not less than 3.5 percent and not more than 6.5 percent, calculated as OCH3, and the ethoxy content shall be not less than 14.5 percent and not more than 19 percent, calculated as OC2H5, both measured on the dry sample.

(2) The viscosity of an aqueous solution, 2.5 grams of the material in 100 milliliters of water, at 20 °C, is 20 to 60 centipoises.

(3) The ash content on a dry basis has a maximum of 0.6 percent.

(c) The food additive is used as an aerating, emulsifying, and foaming agent, in an amount not in excess of that reasonably required to produce its intended effect.

The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004-65-3) may be safely used in food, except in standardized foods which do not provide for such use if:

(a) The additive complies with the definition and specifications prescribed in the National Formulary, 12th edition.

(b) It is used or intended for use as an emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener, in accordance with good manufacturing practice.

(c) To insure safe use of the additive, the container of the additive, in addition to being labeled as required by the general provisions of the act, shall be accompanied by labeling which contains adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (b) of this section.

The food additive castor oil may be safely used in accordance with the following conditions:

(a) The additive meets the specifications of the United States Pharmacopeia XX (1980).

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

White mineral oil may be safely used in food in accordance with the following conditions:

(a) White mineral oil is a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic in nature obtained from petroleum. It is refined to meet the following specifications:

(1) It meets the test requirements of the United States Pharmacopeia XX (1980) for readily carbonizable substances (page 532).

(2) It meets the test requirements of U.S.P. XVII for sulfur compounds (page 400).

(3) It meets the specifications prescribed in the “Journal of the Association of Official Analytical Chemists,” Volume 45, page 66 (1962), which is incorporated by reference, after correction of the ultraviolet absorbance for any absorbance due to added antioxidants. Copies of the material incorporated by reference are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) White mineral oil may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the Act, in an amount not greater than that required to produce its intended effect.

(c) White mineral oil is used or intended for use as follows:

Petrolatum may be safely used in food, subject to the provisions of this section.

(a) Petrolatum complies with the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for petrolatum.

(b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b):

(c) Petrolatum is used or intended for use as follows:

(d) Petrolatum may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the Act, in an amount not greater than that required to produce its intended effect.

Synthetic isoparaffinic petroleum hydrocarbons may be safely used in food, in accordance with the following conditions:

(a) They are produced by synthesis from petroleum gases and consist of a mixture of liquid hydrocarbons meeting the following specifications:

(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended technical effect nor to exceed any prescribed limitations.

(c) Synthetic isoparaffinic petroleum hydrocarbons are used or intended for use as follows:

Odorless light petroleum hydrocarbons may be safely used in food, in accordance with the following prescribed conditions:

(a) The additive is a mixture of liquid hydrocarbons derived from petroleum or synthesized from petroleum gases. The additive is chiefly paraffinic, isoparaffinic, or naphthenic in nature.

(b) The additive meets the following specifications:

(1) Odor is faint and not kerosenic.

(2) Initial boiling point is 300 °F minimum.

(3) Final boiling point is 650 °F maximum.

(4) Ultraviolet absorbance limits determined by method specified in § 178.3620(b)(1)(ii) of this chapter, as follows:

(c) The additive is used as follows:

Petroleum wax may be safely used in or on food, in accordance with the following conditions:

(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, derived from petroleum, and refined to meet the specifications prescribed by this section.

(b) Petroleum wax meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in this paragraph.

(c) Petroleum wax may contain one or more of the following adjuvants in amounts not greater than that required to produce their intended effect:

(1) Antioxidants permitted in food by regulations issued in accordance with section 409 of the act.

(2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long chain (C16-C22) alcohols and acrylic acid, or poly(alkylmethacrylate) (CAS Reg. No. 179529-36-3), made from long chain (C18-C22) methacrylate esters, having:

(i) A number average molecular weight between 40,000 and 100,000;

(ii) A weight average molecular weight (MWw) to number average molecular weight (MWn) ratio (MWw/MWn) of not less than 3; and

(iii) Unreacted alkylacrylate or alkylmethacrylate monomer content not in excess of 14 percent, as determined by a method entitled “Method for Determining Weight-Average and Number-Average Molecular Weight and for Determining Alkylacrylate Monomer Content of Poly(alkylacrylate) used as Processing Aid in Manufacture of Petroleum Wax,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Petroleum wax shall contain not more than 1,050 parts per million of poly(alkylacrylate) or poly(alkylmethacrylate) residues as determined by a method entitled “Method for Determining Residual Level of Poly(alkylacrylate) in Petroleum Wax,” which is incorporated by reference. Copies are available from the addresses cited in this paragraph.

(d) Petroleum wax is used or intended for use as follows:

Synthetic petroleum wax may be safely used in or on foods in accordance with the following conditions:

(a) Synthetic petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, prepared by either catalytic polymerization of ethylene or copolymerization of ethylene with linear (C3 to C12) alpha-olefins, and refined to meet the specifications prescribed in this section.

(b) Synthetic petroleum wax meets the ultraviolet absorbance limits of § 172.886(b) when subjected to the analytical procedure described therein.

(c) Synthetic petroleum wax has a number average molecular weight of not less than 500 nor greater than 1,200 as determined by vapor pressure osmometry.

(d) Synthetic petroleum wax may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the act, in an amount not greater than that required to produce its intended effect.

(e) Synthetic petroleum wax is used or intended for use as follows:

Rice bran wax may be safely used in food in accordance with the following conditions:

(a) It is the refined wax obtained from rice bran and meets the following specifications:

(b) It is used or intended for use as follows:

Food starch-modified as described in this section may be safely used in food. The quantity of any substance employed to effect such modification shall not exceed the amount reasonably required to accomplish the intended physical or technical effect, nor exceed any limitation prescribed. To insure safe use of the food starch-modified, the label of the food additive container shall bear the name of the additive “food starch-modified” in addition to other information required by the Act. Food starch may be modified by treatment prescribed as follows:

(a) Food starch may be acid-modified by treatment with hydrochloric acid or sulfuric acid or both.

(b) Food starch may be bleached by treatment with one or more of the following:

(c) Food starch may be oxidized by treatment with chlorine, as sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of dry starch.

(d) Food starch may be esterified by treatment with one of the following:

(e) Food starch may be etherified by treatment with one of the following:

(f) Food starch may be esterified and etherified by treatment with one of the following:

(g) Food starch may be modified by treatment with one of the following:

(h) Food starch may be modified by a combination of the treatments prescribed by paragraphs (a), (b), and/or (i) of this section and any one of the treatments prescribed by paragraph (c), (d), (e), (f), or (g) of this section, subject to any limitations prescribed by the paragraphs named.

(i) Food starch may be modified by treatment with the following enzymes:

The food additive modified cottonseed products may be used for human consumption in accordance with the following prescribed conditions:

(a) The additive is derived from:

(1) Decorticated, partially defatted, cooked, ground cottonseed kernels; or

(2) Decorticated, ground cottonseed kernels, in a process that utilizes n-hexane as an extracting solvent in such a way that no more than 60 parts per million of n-hexane residues and less than 1 percent fat by weight remain in the finished product; or

(3) Glandless cottonseed kernels roasted to attain a temperature of not less than 250 °F in the kernel for not less than 5 minutes for use as a snack food, or in baked goods, or in soft candy; or

(4) Raw glandless cottonseed kernels may be used in hard candy where the kernel temperature during cooking will exceed 250 °F for not less than 5 minutes.

(b) The additive is prepared to meet the following specifications:

(1) Free gossypol content not to exceed 450 parts per million.

(2) It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As.

(c) To assure safe use of the additive, the label of the food additive container shall bear, in addition to other information required by the act, the name of the additive as follows:

(1) The additive identified in paragraph (a)(1) of this section as “partially defatted, cooked cottonseed flour”.

(2) The additive identified in paragraph (a)(2) of this section as “defatted cottonseed flour”.

(3) The additive identified in paragraph (a)(3) of this section as “roasted glandless cottonseed kernels”.

(4) The additive identified in paragraph (a)(4) of this section as “raw glandless cottonseed kernels for use in cooked hard candy”.

(d) The Food and Drug Administration and the Environmental Protection Agency have determined that glandless cottonseed kernels permitted for use by this section are a distinct commodity from glanded cottonseed.

Dried yeast (Saccharomyces cerevisiae and Saccharomyces fragilis) and dried torula yeast (Candida utilis) may be safely used in food provided the total folic acid content of the yeast does not exceed 0.04 milligram per gram of yeast (approximately 0.008 milligram of pteroyglutamic acid per gram of yeast).

Bakers yeast glycan may be safely used in food in accordance with the following conditions:

(a) Bakers yeast glycan is the comminuted, washed, pasteurized, and dried cell walls of the yeast, Saccharomyces cerevisiae. It is composed principally of long chain carbohydrates, not less than 85 percent on a dry solids basis. The carbohydrate is composed of glycan and mannan units in approximately a 2:1 ratio.

(b) The additive meets the following specifications on a dry weight basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.

(c) The viable microbial content of the finished ingredient is:

(1) Less than 10,000 organisms/gram by aerobic plate count.

(2) Less than 10 yeasts and molds/gram.

(3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium botulinum, or any other recognized microbial pathogen or any harmful microbial toxin.

(d) The additive is used or intended for use in the following foods when standards of identity established under section 401 of the Act do not preclude such use:

(e) The label and labeling of the ingredient shall bear adequate directions to assure that use of the ingredient complies with this regulation.

Acrylate-acrylamide resins may be safely used in food under the following prescribed conditions:

(a) The additive consists of one of the following:

(1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is produced by the polymerization of acrylamide with partial hydrolysis, or by copolymerization of acrylamide and acrylic acid, with the greater part of the polymer being composed of acrylamide units.

(2) Sodium polyacrylate-acrylamide resin is produced by the polymerization and subsequent hydrolysis of acrylonitrile in a sodium silicate-sodium hydroxide aqueous solution, with the greater part of the polymer being composed of acrylate units.

(b) The additive contains not more than 0.05 percent of residual monomer calculated as acrylamide.

(c) The additive is used or intended for use as follows:

(1) The additive identified in paragraph (a) (1) of this section is used as a flocculent in the clarification of beet sugar juice and liquor or cane sugar juice and liquor or corn starch hydrolyzate in an amount not to exceed 5 parts per million by weight of the juice or 10 parts per million by weight of the liquor or the corn starch hydrolyzate.

(2) The additive identified in paragraph (a)(2) of this section is used to control organic and mineral scale in beet sugar juice and liquor or cane sugar juice and liquor in an amount not to exceed 2.5 parts per million by weight of the juice or liquor.

Modified polyacrylamide resin may be safely used in food in accordance with the following prescribed conditions:

(a) The modified polyacrylamide resin is produced by the copolymerization of acrylamide with not more than 5-mole percent β-methacrylyloxyethy-ltrimethylammonium methyl sulfate.

(b) The modified polyacrylamide resin contains not more than 0.05 percent residual acrylamide.

(c) The modified polyacrylamide resin is used as a flocculent in the clarification of beet or cane sugar juice in an amount not exceeding 5 parts per million by weight of the juice.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to the other information required by the act, adequate directions to assure use in compliance with paragraph (c) of this section.

Ion-exchange membranes may be safely used in the processing of food under the following prescribed conditions:

(a) The ion-exchange membrane is prepared by subjecting a polyethylene base conforming to § 177.1520 of this chapter to polymerization with styrene until the polystyrene phase of the base is not less than 16 percent nor more than 30 percent by weight. The base is then modified by reaction with chloromethyl methyl ether, and by subsequent amination with trimethylamine, dimethylamine, diethylenetriamine, or dimethylethanolamine.

(b) The ion-exchange membrane is manufactured so as to comply with the following extraction limitations when subjected to the described procedure: Separate square-foot samples of membrane weighing approximately 14 grams each are cut into small pieces and refluxed for 4 hours in 150 cubic centimeters of the following solvents: Distilled water, 5 percent acetic acid, and 50 percent alcohol. Extraction from each sample will not exceed 0.4 percent by weight of sample.

(c) The ion-exchange membrane will be used in the production of grapefruit juice to adjust the ratio of citric acid to total solids of the grapefruit juice produced.

Substances identified in paragraph (a) of this section may be safely used as ion exchange membranes intended for use in the treatment of bulk quantities of liquid food under the following prescribed conditions:

(a) Identity. The membrane is a copolymer of ethanesulfonyl fluoride, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, with tetrafluoroethylene that has been subsequently treated to hydrolyze the sulfonyl fluoride group to the sulfonic acid. The Chemical Abstracts Service name of this polymer is ethanesulfonic acid, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. 31175-20-9).

(b) Optional adjuvant substances. The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymer. These optional adjuvant substances may include substances used in accordance with § 174.5 of this chapter.

(c) Conditions of use. (1) Perfluorinated ion exchange membranes described in paragraph (a) of this section may be used in contact with all types of liquid foods at temperatures not exceeding 70° (158 °F).

(2) Maximum thickness of the copolymer membrane is 0.007 inch (0.017 centimeter).

(3) Perfluorinated ion exchange membranes shall be maintained in a sanitary manner in accordance with current good manufacturing practice so as to prevent microbial adulteration of food.

(4) To assure their safe use, perfluorinated ionomer membranes shall be thoroughly cleaned prior to their first use in accordance with current good manufacturing practice.

Ion-exchange resins may be safely used in the treatment of food under the following prescribed conditions:

(a) The ion-exchange resins are prepared in appropriate physical form, and consist of one or more of the following:

(1) Sulfonated copolymer of styrene and divinylbenzene.

(2) Sulfonated anthracite coal meeting the requirements of ASTM method D388-38, Class I, Group 2, “Standard Specifications for Classification of Coal by Rank,” which is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Sulfite-modified cross-linked phenol-formaldehyde, with modification resulting in sulfonic acid groups on side chains.

(4) Methacrylic acid-divinylbenzene copolymer.

(5) Cross-linked polystyrene, first chloromethylated then aminated with trimethylamine, dimethylamine, di-ethylenetriamine, or dimethylethanol-amine.

(6) Diethylenetriamine, triethylene-tetramine, or tetraethylenepentamine cross-linked with epichlorohydrin.

(7) Cross-linked phenol-formaldehyde activated with one or both of the following: Triethylene tetramine and tetraethylenepentamine.

(8) Reaction resin of formaldehyde, acetone, and tetraethylenepentamine.

(9) Completely hydrolyzed copolymers of methyl acrylate and divinylbenzene.

(10) Completely hydrolyzed terpolymers of methyl acrylate, divinylbenzene, and acrylonitrile.

(11) Sulfonated terpolymers of styrene, divinylbenzene, and acrylonitrile or methyl acrylate.

(12) Methyl acrylate-divinylbenzene copolymer containing not less than 2 percent by weight of divinylbenzene, aminolyzed with dimethylaminopro-pylamine.

(13) Methyl acrylate-divinylbenzene copolymer containing not less than 3.5 percent by weight of divinylbenzene, aminolyzed with dimethylaminopro-pylamine.

(14) Epichlorohydrin cross-linked with ammonia.

(15) Sulfonated tetrapolymer of styrene, divinylbenzene, acrylonitrile, and methyl acrylate derived from a mixture of monomers containing not more than a total of 2 percent by weight of acrylonitrile and methyl acrylate.

(16) Methyl acrylate-divinylbenzenediethylene glycol divinyl ether terpolymer containing not less than 3.5 percent by weight of divinylbenzene and not more than 0.6 percent by weight of diethylene glycol divinyl ether, aminolyzed with dimethylaminopropylamine.

(17) Styrene-divinylbenzene cross-linked copolymer, first chloromethylated then aminated with dimethylamine and oxidized with hydrogen peroxide whereby the resin contains not more than 15 percent by weight of vinyl N,N-dimethylbenzylamine-N-oxide and not more than 6.5 percent by weight of nitrogen.

(18) Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether terpolymer containing not less than 7 percent by weight of divinylbenzene and not more than 2.3 percent by weight of diethylene glycol divinyl ether, aminolyzed with dimethylaminopropylamine and quaternized with methyl chloride.

(19) Epichlorohydrin cross-linked with ammonia and then quaternized with methyl chloride to contain not more than 18 percent strong base capacity by weight of total exchange capacity [Chemical Abstracts Service name: Oxirane (chloromethyl)-, polymer with ammonia, reaction product with chloromethane; CAS Reg. No. 68036-99-7].

(20) Regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then sulfonated whereby the amount of epichlorohydrin plus propylene oxide employed does not exceed 250 percent by weight of the starting quantity of cellulose.

(b) Ion-exchange resins are used in the purification of foods, including potable water, to remove undesirable ions or to replace less desirable ions with one or more of the following: bicarbonate, calcium, carbonate, chloride, hydrogen, hydroxyl, magnesium, potassium, sodium, and sulfate except that: The ion-exchange resin identified in paragraph (a)(12) of this section is used only in accordance with paragraph (b)(1) of this section, the ion-exchange resin identified in paragraph (a)(13) of this section is used only in accordance with paragraph (b)(2) of this section, the resin identified in paragraph (a)(16) of this section is used only in accordance with paragraph (b)(1) or (b)(2) of this section, the ion-exchange resin identified in paragraph (a)(17) of this section is used only in accordance with paragraph (b)(3) of this section, the ion-exchange resin identified in paragraph (a)(18) of this section is used only in accordance with paragraph (b)(4) of this section, and the ion-exchange resin identified in paragraph (a)(20) of this section is used only in accordance with paragraphs (b)(5) and (d) of this section.

(1) The ion-exchange resins identified in paragraphs (a) (12) and (16) of this section are used to treat water for use in the manufacture of distilled alcoholic beverages, subject to the following conditions:

(i) The water is subjected to treatment through a mixed bed consisting of one of the resins identified in paragraph (a) (12) or (16) of this section and one of the strongly acidic cation-exchange resins in the hydrogen form identified in paragraphs (a) (1), (2), and (11) of this section; or

(ii) The water is first subjected to one of the resins identified in paragraph (a) (12) or (16) of this section and is subsequently subjected to treatment through a bed of activated carbon or one of the strongly acidic cation-exchange resins in the hydrogen form identified in paragraphs (a) (1), (2), and (11) of this section.

(iii) The temperature of the water passing through the resin beds identified in paragraphs (b)(1) (i) and (ii) of this section is maintained at 30 °C or less, and the flow rate of the water passing through the beds is not less than 2 gallons per cubic foot per minute.

(iv) The ion-exchange resins identified in paragraph (a) (12) or (16) of this section are exempted from the requirements of paragraph (c)(4) of this section, but the strongly acidic cation-exchange resins referred to in paragraphs (b)(1) (i) and (ii) of this section used in the process meet the requirements of paragraph (c)(4) of this section, except for the exemption described in paragraph (d) of this section.

(2) The ion-exchange resins identified in paragraphs (a) (13) and (16) of this section are used to treat water and aqueous food only of the types identified under Categories I, II, and VI-B in table 1 of § 176.170(c) of this chapter: Provided, That the temperature of the water or food passing through the resin beds is maintained at 50 °C or less and the flow rate of the water or food passing through the beds is not less than 0.5 gallon per cubic foot per minute.

(i) The ion-exchange resin identified in paragraph (a)(13) of this section is used to treat water and aqueous food only of the types identified under categories I, II, and VI-B in Table 1 of § 176.170(c) of this chapter: Provided, That the temperature of the water or food passing through the resin bed is maintained at 50 °C or less and the flow rate of the water or food passing through the bed is not less than 0.5 gallon per cubic foot per minute.

(ii) The ion-exchange resin identified in paragraph (a)(16) of this section is used to treat water and aqueous food only of the types identified under categories I, II, and VI-B in Table 1 of § 176.170(c) of this chapter, Provided, that either:

(A) The temperature of the water or food passing through the resin bed is maintained at 50 °C or less and the flow rate of the water or food passing through the bed is not less than 0.5 gallon per cubic foot per minute; or

(B) Extracts of the resin will be found to contain no more than 1 milligram/kilogram dimethylaminopropylamine in each of the food simulants, distilled water and 10 percent ethanol, when, following washing and pretreatment of the resin in accordance with § 173.25(c)(1), the resin is subjected to the following test under conditions simulating the actual temperature and flow rate of use: “The Determination of 3-Dimethylaminopropylamine in Food Simulating Extracts of Ion Exchange Resins,” February 4, 1998, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) The ion-exchange resin identified in paragraph (a)(17) of this section is used only for industrial application to treat bulk quantities of aqueous food, including potable water, or for treatment of municipal water supplies, subject to the condition that the temperature of the food or water passing through the resin bed is maintained at 25 °C or less and the flow rate of the food or water passing through the bed is not less than 2 gallons per cubic foot per minute.

(4) The ion-exchange resin identified in paragraph (a)(18) of this section is used to treat aqueous sugar solutions subject to the condition that the temperature of the sugar solution passing through the resin bed is maintained at 82 °C (179.6 °F) or less and the flow rate of the sugar solution passing through the bed is not less than 46.8 liters per cubic meter (0.35 gallon per cubic foot) of resin bed volume per minute.

(5) The ion-exchange resin identified in paragraph (a)(20) of this section is limited to use in aqueous process streams for the isolation and purification of protein concentrates and isolates under the following conditions:

(i) For resins that comply with the requirements in paragraph (d)(2)(i) of this section, the pH range for the resin shall be no less than 3.5 and no more than 9, and the temperatures of water and food passing through the resin bed shall not exceed 25 °C.

(ii) For resins that comply with the requirements in paragraph (d)(2)(ii) of this section, the pH range for the resin shall be no less than 2 and no more than 10, and the temperatures of water and food passing through the resin shall not exceed 50 °C.

(c) To insure safe use of ion-exchange resins, each ion-exchange resin will be:

(1) Subjected to pre-use treatment by the manufacturer and/or the user in accordance with the manufacturer's directions prescribed on the label or labeling accompanying the resins, to guarantee a food-grade purity of ion-exchange resins, in accordance with good manufacturing practice.

(2) Accompanied by label or labeling to include directions for use consistent with the intended functional purpose of the resin.

(3) Used in compliance with the label or labeling required by paragraph (c)(2) of this section.

(4) Found to result in no more than 1 part per million of organic extractives obtained with each of the named solvents, distilled water, 15 percent alcohol, and 5 percent acetic acid when, having been washed and otherwise treated in accordance with the manufacturer's directions for preparing them for use with food, the ion-exchange resin is subjected to the following test: Using a separate ion-exchange column for each solvent, prepare columns using 50 milliliters of the ready to use ion-exchange resin that is to be tested. While maintaining the highest temperature that will be encountered in use pass through these beds at the rate of 350-450 milliliters per hour the three test solvents distilled water, 15 percent (by volume) ethyl alcohol, and 5 percent (by weight) acetic acid. The first liter of effluent from each solvent is discarded, then the next 2 liters are used to determine organic extractives. The 2-liter sample is carefully evaporated to constant weight at 105 °C; this is total extractives. This residue is fired in a muffle furnace at 850 °C to constant weight; this is ash. Total extractives, minus ash equals the organic extractives. If the organic extractives are greater than 1 part per million of the solvent used, a blank should be run on the solvent and a correction should be made by subtracting the total extractives obtained with the blank from the total extractives obtained in the resin test. The solvents used are to be made as follows:

(d)(1) The ion-exchange resins identified in paragraphs (a)(1), (a)(2), (a)(11), and (a)(15) of this section are exempted from the acetic acid extraction requirement of paragraph (c)(4) of this section.

(2) The ion-exchange resin identified in paragraph (a)(20) of this section shall comply either with:

(i) The extraction requirement in paragraph (c)(4) of this section by using dilute sulfuric acid, pH 3.5 as a substitute for acetic acid; or

(ii) The extraction requirement in paragraph (c)(4) of this section by using reagent grade hydrochloric acid, diluted to pH 2, as a substitute for acetic acid. The resin shall be found to result in no more than 25 parts per million of organic extractives obtained with each of the following solvents: Distilled water; 15 percent alcohol; and hydrochloric acid, pH 2. Blanks should be run for each of the solvents, and corrections should be made by subtracting the total extractives obtained with the blank from the total extractives obtained in the resin test.

(e) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter.

Molecular sieve resins may be safely used in the processing of food under the following prescribed conditions:

(a) The molecular sieve resins consist of purified dextran having an average molecular weight of 40,000, cross-linked with epichlorohydrin in a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a stable three dimensional structure. The resins have a pore size of 2.0 to 3.0 milliliters per gram of dry resin (expressed in terms of water regain), and a particle size of 10 to 300 microns.

(b) The molecular sieve resins are thoroughly washed with potable water prior to their first use in contact with food.

(c) Molecular sieve resins are used as the gel filtration media in the final purification of partially delactosed whey. The gel bed shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent microbial build-up on the bed and adulteration of the product.

Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS Reg. No. 70247-90-4) may be safely used in food in accordance with the following prescribed conditions:

(a) The additives have a weight-average molecular weight in the range of 540 to 850 and a number-average molecular weight in the range of 520 to 650, calculated as the acid. Molecular weights shall be determined by a method entitled “Determination of Molecular Weight Distribution of Poly(Maleic) Acid,” March 17, 1992, produced by Ciba-Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or are available for inspection at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) The additives may be used, individually or together, in the processing of beet sugar juice and liquor or of cane sugar juice and liquor to control mineral scale.

(c) The additives are to be used so that the amount of either or both additives does not exceed 4 parts per million (calculated as the acid) by weight of the beet or cane sugar juice or liquor process stream.

The food additive polyvinylpolypyrrolidone may be safely used in accordance with the following prescribed conditions:

(a) The additive is a homopolymer of purified vinylpyrrolidone catalytically produced under conditions producing polymerization and cross-linking such that an insoluble polymer is produced.

(b) The food additive is so processed that when the finished polymer is refluxed for 3 hours with water, 5 percent acetic acid, and 50 percent alcohol, no more than 50 parts per million of extractables is obtained with each solvent.

(c) It is used or intended for use as a clarifying agent in beverages and vinegar, followed by removal with filtration.

The food additive polyvinylpyrroli-done may be safely used in accordance with the following prescribed conditions:

(a) The additive is a polymer of purified vinylpyrrolidone catalytically produced, having an average molecular weight of 40,000 and a maximum unsaturation of 1 percent, calculated as the monomer, except that the polyvinylpyrrolidone used in beer is that having an average molecular weight of 360,000 and a maximum unsaturation of 1 percent, calculated as the monomer.

(b) The additive is used or intended for use in foods as follows:

Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is produced by copolymerization of dimethylamine and epichlorohydrin in which not more than 5 mole-percent of dimethylamine may be replaced by an equimolar amount of ethylenediamine, and in which the mole ratio of total amine to epichlorohydrin is approximately 1:1.

(b) The additive meets the following specifications:

(1) The nitrogen content of the copolymer is 9.4 to 10.8 weight percent on a dry basis.

(2) A 50-percent-by-weight aqueous solution of the copolymer has a minimum viscosity of 175 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by another equivalent method).

(3) The additive contains not more than 1,000 parts per million of 1,3-dichloro-2-propanol and not more than 10 parts per million epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content is determined by an analytical method entitled “The Determination of Epichlorohydrin and 1,3-Dichloro-2-Propanol in Dimethylamine-Epichlorohydrin Copolymer,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(4) Heavy metals (as Pb), 2 parts per million maximum.

(5) Arsenic (as As), 2 parts per million maximum.

(c) The food additive is used as a decolorizing agent and/or flocculant in the clarification of refinery sugar liquors and juices. It is added only at the defecation/clarification stage of sugar liquor refining at a concentration not to exceed 150 parts per million of copolymer by weight of sugar solids.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other information required by the Act, adequate directions to assure use in compliance with paragraph (c) of this section.

Divinylbenzene copolymer may be used for the removal of organic substances from aqueous foods under the following prescribed conditions:

(a) The copolymer is prepared in appropriate physical form and is derived by the polymerization of a grade of divinylbenzene which comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-percent ethylvinylbenzene, and no more than 4 weight-percent nonpolymerizable impurities.

(b) In accordance with the manufacturer's directions, the copolymer described in paragraph (a) of this section is subjected to pre-use extraction with a water soluble alcohol until the level of divinylbenzene in the extract is less than 50 parts per billion as determined by a method titled, “The Determination of Divinylbenzene in Alcohol Extracts of Amberlite XAD-4,” which is incorporated by reference. Copies of this method are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The copolymer is then treated with water according to the manufacturer's recommendation to remove the extraction solvent to guarantee a food-grade purity of the resin at the time of use, in accordance with current good manufacturing practice.

(c) The temperature of the aqueous food stream contacting the polymer is maintained at 79.4 °C (175 °F) or less.

(d) The copolymer may be used in contact with food only of Types I, II, and VI-B (excluding carbonated beverages) described in table 1 of paragraph (c) of § 176.170 of this chapter.

Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg. No. 60177-39-1) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is an aqueous dispersion of styrene-divinylbenzene copolymers, first chloromethylated then aminated with trimethylamine, having an average particle size of not more than 2.0 microns.

(b) The additive shall contain no more than 3.0 percent nonvolatile, soluble extractives when tested as follows: One hundred grams of the additive is centrifuged at 17,000 r/min for 2 hours. The resulting clear supernatant is removed from the compacted solids and concentrated to approximately 10 grams on a steam bath. The 10-gram sample is again centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble material. The supernatant from the second centrifugation is then removed from any compacted solids and dried to constant residual weight using a steam bath. The percent nonvolatile solubles is obtained by dividing the weight of the dried residue by the weight of the solids in the original resin dispersion.

(c) The additive is used as a decolorizing and clarification agent for treatment of refinery sugar liquors and juices at levels not to exceed 500 parts of additive solids per million parts of sugar solids.

Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is produced by the polymerization of acrylic acid and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium hydroxide solution. As determined by a method entitled “Determination of Weight Average and Number Average Molecular Weight of Sodium Polyacrylate,” which is incorporated by reference in accordance with 5 U.S.C. 552(a), the additive has -

(1) A weight average molecular weight of 2,000 to 2,300; and

(2) A weight average molecular weight to number average molecular weight ratio of not more than 1.3. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) The additive is used to control mineral scale during the evaporation of beet sugar juice or cane sugar juice in the production of sugar in an amount not to exceed 3.6 parts per million by weight of the raw juice.

Sorbitan monooleate may be safely used in accordance with the following prescribed conditions:

(a) The additive is produced by the esterification of sorbitol with commercial oleic acid.

(b) It meets the following specifications:

(1) Saponification number, 145-160.

(2) Hydroxyl number, 193-210.

(c) The additive is used or intended for use as follows:

(1) As an emulsifier in polymer dispersions that are used in the clarification of cane or beet sugar juice or liquor in an amount not to exceed 7.5 percent by weight in the final polymer dispersion.

(2) The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor.

Amyloglucosidase enzyme product, consisting of enzyme derived from Rhizopus niveus, and diatomaceous silica as a carrier, may be safely used in food in accordance with the following conditions:

(a) Rhizopus niveus is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, niveus.

(b) The strain of Rhizopus niveus is nonpathogenic and nontoxic in man or other animals.

(c) The enzyme is produced by a process which completely removes the organism Rhizopus niveus from the amyloglucosidase.

(d) The additive is used or intended for use for degrading gelatinized starch into constituent sugars, in the production of distilled spirits and vinegar.

(e) The additive is used at a level not to exceed 0.1 percent by weight of the gelatinized starch.

The food additive alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation, may be safely used in accordance with the following conditions:

(a) The food additive is the enzyme preparation derived from a modified Bacillus subtilis strain that contains the gene coding for α-ALDC from Bacillus brevis.

(b)(1) The manufacturer produces the additive from a pure culture fermentation of a strain of Bacillus subtilis that is nonpathogenic and nontoxigenic in man or other animals.

(2) The manufacturer may stabilize the enzyme preparation with glutaraldehyde or with other suitable approved food additives or generally recognized as safe substances.

(3) The enzyme preparation must meet the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 4th ed., 1996, pp. 133-134, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at the Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The additive is used in an amount not in excess of the minimum required to produce its intended effect as a processing aid in the production of alcoholic malt beverages and distilled liquors.

Carbohydrase and cellulase enzyme preparation derived from Aspergillus niger may be safely used in food in accordance with the following prescribed conditions:

(a) Aspergillus niger is classified as follows: Class, Deuteromycetes; order, Moniliales; family, Moniliaceae; genus, Aspergillus; species, niger.

(b) The strain of Aspergillus niger is nonpathogenic and nontoxic in man or other animals.

(c) The additive is produced by a process that completely removes the organism Aspergillus niger from the carbohydrase and cellulase enzyme product.

(d) The additive is used or intended for use as follows:

(1) For removal of visceral mass (bellies) in clam processing.

(2) As an aid in the removal of the shell from the edible tissue in shrimp processing.

(e) The additive is used in an amount not in excess of the minimum required to produce its intended effect.

Carbohydrase from Rhizopus oryzae may be safely used in the production of dextrose from starch in accordance with the following prescribed conditions:

(a) Rhizopus oryzae is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, Rhizopus oryzae.

(b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic.

(c) The carbohydrase is produced under controlled conditions to maintain nonpathogenicity and nontoxicity, including the absence of aflatoxin.

(d) The carbohydrase is produced by a process which completely removes the organism Rhizopus oryzae from the carbohydrase product.

(e) The carbohydrase is maintained under refrigeration from production to use and is labeled to include the necessity of refrigerated storage.

Bacterial catalase derived from Micrococcus lysodeikticus by a pure culture fermentation process may be safely used in destroying and removing hydrogen peroxide used in the manufacture of cheese, in accordance with the following conditions.

(a) The organism Micrococcus lysodeikticus from which the bacterial catalase is to be derived is demonstrated to be nontoxic and nonpathogenic.

(b) The organism Micrococcus lysodeikticus is removed from the bacterial catalase prior to use of the bacterial catalase.

(c) The bacterial catalase is used in an amount not in excess of the minimum required to produce its intended effect.

Esterase-lipase enzyme, consisting of enzyme derived from Mucor miehei var. Cooney et Emerson by a pure culture fermentation process, with maltodextrin or sweet whey as a carrier, may be safely used in food in accordance with the following conditions:

(a) Mucor miehei var. Cooney et Emerson is classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, Mucor; species, miehei; variety Cooney et Emerson.

(b) The strain of Mucor miehei var. Cooney et Emerson is nonpathogenic and nontoxic in man or other animals.

(c) The enzyme is produced by a process which completely removes the organism Mucor miehei var. Cooney et Emerson from the esterase-lipase.

(d) The enzyme is used as a flavor enhancer as defined in § 170.3(o)(12).

(e) The enzyme is used at levels not to exceed current good manufacturing practice in the following food categories: cheeses as defined in § 170.3(n)(5) of this chapter; fat and oils as defined in § 170.(3)(n)(12) of this chapter; and milk products as defined in § 170.(3)(n)(31) of this chapter. Use of this food ingredient is limited to nonstandarized foods and those foods for which the relevant standards of identity permit such use.

(f) The enzyme is used in the minimum amount required to produce its limited technical effect.

The food additive alpha-galactosidase and parent mycelial microorganism Mortierella vinaceae var. raffinoseutilizer may be safely used in food in accordance with the following conditions:

(a) The food additive is the enzyme alpha-galactosidase and the mycelia of the microorganism Mortierella vinaceae var. raffinoseutilizer which produces the enzyme.

(b) The nonpathogenic microorganism matches American Type Culture Collection (ATCC) No. 20034, 1 and is classified as follows:

(c) The additive is used or intended for use in the production of sugar (sucrose) from sugar beets by addition as mycelial pellets to the molasses to increase the yield of sucrose, followed by removal of the spent mycelial pellets by filtration.

(d) The enzyme removal is such that there are no enzyme or mycelial residues remaining in the finished sucrose.

Milk-clotting enzyme produced by pure-culture fermentation process may be safely used in the production of cheese in accordance with the following prescribed conditions:

(a) Milk-clotting enzyme is derived from one of the following organisms by a pure-culture fermentation process:

(1) Endothia parasitica classified as follows: Class, Ascomycetes; order, Sphaeriales; family, Diaporthacesae; genus, Endothia; species, parasitica.

(2) Bacillus cereus classified as follows: Class, Schizomycetes; order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species, cereus (Frankland and Frankland).

(3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, Mucor; species, pusillus; variety, Lindt.

(4) Mucor miehei Cooney et Emerson classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et Emerson.

(5) Aspergillus oryzae modified by recombinant deoxyribonucleic (DNA) techniques to contain the gene coding for aspartic proteinase from Rhizomucor miehei var. Cooney et Emerson as defined in paragraph (a)(4) of this section, and classified as follows: Class, Blastodeuteromycetes (Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus; species oryzae.

(b) The strains of organism identified in paragraph (a) of this section are nonpathogenic and nontoxic in man or other animals.

(c) The additive is produced by a process that completely removes the generating organism from the milk-clotting enzyme product.

(d) The additive is used in an amount not in excess of the minimum required to produce its intended effect in the production of those cheeses for which it is permitted by standards of identity established pursuant to section 401 of the Act.

The food additive Candida guilliermondii may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions:

(a) The food additive is the enzyme system of the viable organism Candida guilliermondii and its concomitant metabolites produced during the fermentation process.

(b)(1) The nonpathogenic and nontoxicogenic organism descending from strain, American Type Culture Collection (ATCC) No. 20474, 1 is classified as follows:

(2) The toxonomic characteristics of the reference culture strain ATCC No. 20474 agree in the essentials with the standard description for Candida guilliermondii variety guilliermondii listed in “The Yeasts - A Toxonomic Study;” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c)(1) The additive is used or intended for use as a pure culture in the fermentation process for the production of citric acid using an acceptable aqueous carbohydrate substrate.

(2) The organism Candida quilliermondii is made nonviable and is completely removed from the citric acid during the recovery and purification process.

(d) The additive is so used that the citric acid produced conforms to the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

The food additive Candida lipolytica may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions:

(a) The food additive is the enzyme system of the organism Candida lipolytica and its concimitant metabolites produced during the fermentation process.

(b)(1) The nonpathogenic organism is classified as follows:

(2) The taxonomic characteristics of the culture agree in essential with the standard description for Candida lipolytica variety lipolytica listed in “The Yeasts - A Toxonomic Study,” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The additive is used or intended for use as a pure culture in the fermentation process for the production of citric acid from purified normal alkanes.

(d) The additive is so used that the citric acid produced conforms to the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. The additive meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in this paragraph:

The food additive aminoglycoside 3′-phosphotransferase II may be safely used in the development of genetically modified cotton, oilseed rape, and tomatoes in accordance with the following prescribed conditions:

(a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the phosphorylation of certain aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin.

(b) Aminoglycoside 3′-phosphotransferase II is encoded by the kan r gene originally isolated from transposon Tn5 of the bacterium Escherichia coli.

(c) The level of the additive does not exceed the amount reasonably required for selection of plant cells carrying the kan r gene along with the genetic material of interest.

A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from the extraction of spice.

1,3-Butylene glycol (1,3-butanediol) may be safely used in food in accordance with the following prescribed conditions:

(a) The substance meets the following specifications:

(1) 1,3-Butylene glycol content: Not less than 99 percent.

(2) Specific gravity at 20/20 °C: 1.004 to 1.006.

(3) Distillation range: 200°-215 °C.

(b) It is used in the minimum amount required to perform its intended effect.

(c) It is used as a solvent for natural and synthetic flavoring substances except where standards of identity issued under section 401 of the act preclude such use.

Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in accordance with the following conditions:

(a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 343-344, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(b) The additive is used in accordance with current good manufacturing practice as a solvent in the decaffeination of coffee and tea.

A tolerance of 30 parts per million is established for ethylene dichloride in spice oleoresins when present therein as a residue from the extraction of spice; Provided, however, That if residues of other chlorinated solvents are also present the total of all residues of such solvents shall not exceed 30 parts per million.

Isopropyl alcohol may be present in the following foods under the conditions specified:

(a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million.

(b) In lemon oil as a residue in production of the oil, at a level not to exceed 6 parts per million.

(c) In hops extract as a residue from the extraction of hops at a level not to exceed 2.0 percent by weight: Provided, That,

(1) The hops extract is added to the wort before or during cooking in the manufacture of beer.

(2) The label of the hops extract specifies the presence of the isopropyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (c)(1) of this section.

Methyl alcohol may be present in the following foods under the conditions specified:

(a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million.

(b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, That:

(1) The hops extract is added to the wort before or during cooking in the manufacture of beer.

(2) The label of the hops extract specifies the presence of methyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section.

Methylene chloride may be present in food under the following conditions:

(a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 30 parts per million; Provided, That, if residues of other chlorinated solvents are also present, the total of all residues of such solvents shall not exceed 30 parts per million.

(b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent, Provided, That:

(1) The hops extract is added to the wort before or during cooking in the manufacture of beer.

(2) The label of the hops extract identifies the presence of the methylene chloride and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section.

(c) In coffee as a residue from its use as a solvent in the extraction of caffeine from green coffee beans, at a level not to exceed 10 parts per million (0.001 percent) in decaffeinated roasted coffee and in decaffeinated soluble coffee extract (instant coffee).

Hexane may be present in the following foods under the conditions specified:

(a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 25 parts per million.

(b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; Provided, That:

(1) The hops extract is added to the wort before or during cooking in the manufacture of beer.

(2) The label of the hops extract specifies the presence of the hexane and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section.

The food additive hydrogenated sperm oil may be safely used in accordance with the following prescribed conditions:

(a) The sperm oil is derived from rendering the fatty tissue of the sperm whale or is prepared by synthesis of fatty acids and fatty alcohols derived from the sperm whale. The sperm oil obtained by rendering is refined. The oil is hydrogenated.

(b) It is used alone or as a component of a release agent or lubricant in bakery pans.

(c) The amount used does not exceed that reasonably required to accomplish the intended lubricating effect.

A solvent extraction process for recovery of citric acid from conventional Aspergillus niger fermentation liquor may be safely used to produce food-grade citric acid in accordance with the following conditions:

(a) The solvent used in the process consists of a mixture of n-octyl alcohol meeting the requirements of § 172.864 of this chapter, synthetic isoparaffinic petroleum hydrocarbons meeting the requirements of § 172.882 of this chapter, and tridodecyl amine.

(b) The component substances are used solely as a solvent mixture and in a manner that does not result in formation of products not present in conventionally produced citric acid.

(c) The citric acid so produced meets the polynuclear aromatic hydrocarbon specifications of § 173.165 and the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(d) Residues of n-octyl alcohol and synthetic isoparaffinic petroleum hydrocarbons are removed in accordance with good manufacturing practice. Current good manufacturing practice results in residues not exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm synthetic isoparaffinic petroleum hydrocarbons in citric acid.

(e) Tridodecyl amine may be present as a residue in citric acid at a level not to exceed 100 parts per billion.

Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods as follows:

Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in food in accordance with the following prescribed conditions:

(a)(1) The additive is generated by one of the following methods:

(i) Treating an aqueous solution of sodium chlorite with either chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid.

(ii) Treating an aqueous solution of sodium chlorate with hydrogen peroxide in the presence of sulfuric acid.

(iii) Treating an aqueous solution of sodium chlorite by electrolysis.

(2) The generator effluent contains at least 90 percent (by weight) of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO2 E in the “Standard Methods for the Examination of Water and Wastewater,” 20th ed., 1998, or an equivalent method. Method 4500-ClO2 E (“Amperometric Method II”) is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or the American Public Health Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b)(1) The additive may be used as an antimicrobial agent in water used in poultry processing in an amount not to exceed 3 parts per million (ppm) residual chlorine dioxide as determined by Method 4500-ClO2 E, referenced in paragraph (a)(2) of this section, or an equivalent method.

(2) The additive may be used as an antimicrobial agent in water used to wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO2 E, referenced in paragraph (a)(2) of this section, or an equivalent method. Treatment of the fruits and vegetables with chlorine dioxide shall be followed by a potable water rinse or by blanching, cooking, or canning.

Boiler water additives may be safely used in the preparation of steam that will contact food, under the following conditions:

(a) The amount of additive is not in excess of that required for its functional purpose, and the amount of steam in contact with food does not exceed that required to produce the intended effect in or on the food.

(b) The compounds are prepared from substances identified in paragraphs (c) and (d) of this section, and are subject to the limitations, if any, prescribed:

(c) List of substances:

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

(e) To assure safe use of the additive, in addition to the other information required by the Act, the label or labeling shall bear:

(1) The common or chemical name or names of the additive or additives.

(2) Adequate directions for use to assure compliance with all the provisions of this section.

(f) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:

(i) “Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS” (October 23, 1987).

(ii) [Reserved]

(2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org):

(i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129.

(ii) Food Chemicals Codex, 7th ed. (2010), pp. 825-827.

Chemicals may be safely used to wash or to assist in the peeling of fruits and vegetables in accordance with the following conditions:

(a) The chemicals consist of one or more of the following:

(1) Substances generally recognized as safe in food or covered by prior sanctions for use in washing fruits and vegetables.

(2) Substances identified in this subparagraph and subject to such limitations as are provided:

(3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-260) may be used in the steam/scald vacuum peeling of tomatoes at a level not to exceed 0.2 percent in the condensate or scald water.

(4) Substances identified in this paragraph (a)(4) for use in flume water for washing sugar beets prior to the slicing operation and subject to the limitations as are provided for the level of the substances in the flume water:

(5) Substances identified in this paragraph (a)(5) for use on fruits and vegetables that are not raw agricultural commodities and subject to the limitations provided:

(b) The chemicals are used in amounts not in excess of the minimum required to accomplish their intended effect.

(c) The use of the chemicals listed under paragraphs (a)(1), (a)(2), and (a)(4) is followed by rinsing with potable water to remove, to the extent possible, residues of the chemicals.

(d) To assure safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the act, the name of the additive or a statement of its composition.

(2) The label or labeling of the additive container shall bear adequate use directions to assure use in compliance with all provisions of this section.

Agents for controlling microorganisms in cane-sugar and beet-sugar mills may be safely used in accordance with the following conditions:

(a) They are used in the control of microorganisms in cane-sugar and/or beet-sugar mills as specified in paragraph (b) of this section.

(b) They are applied to the sugar mill grinding, crusher, and/or diffuser systems in one of the combinations listed in paragraph (b) (1), (2), (3), or (5) of this section or as a single agent listed in paragraph (b) (4) or (6) of this section. Quantities of the individual additives in parts per million are expressed in terms of the weight of the raw cane or raw beets.

(1) Combination for cane-sugar mills:

(2) Combination for cane-sugar mills:

(3) Combinations for cane-sugar mills and beet-sugar mills:

(4) Single additive for cane-sugar mills and beet-sugar mills.

(5) Combination for cane-sugar mills:

(6) Single additive for beet-sugar mills:

(c) To assure safe use of the additives, their label and labeling shall conform to that registered with the Environmental Protection Agency.

Chemicals may be safely used to assist in the delinting of cottonseed in accordance with the following conditions:

(a) The chemicals consist of one or more of the following:

(1) Substances generally recognized as safe for direct addition to food.

(2) Substances identified in this paragraph and subject to such limitations as are provided:

Acidified sodium chlorite solutions may be safely used in accordance with the following prescribed conditions:

(a) The additive is produced by mixing an aqueous solution of sodium chlorite (CAS Reg. No. 7758-19-2) with any generally recognized as safe (GRAS) acid.

(b)(1) The additive is used as an antimicrobial agent in poultry processing water in accordance with current industry practice under the following conditions:

(i) As a component of a carcass spray or dip solution prior to immersion of the intact carcass in a prechiller or chiller tank;

(ii) In a prechiller or chiller solution for application to the intact carcass;

(iii) As a component of a spray or dip solution for application to poultry carcass parts;

(iv) In a prechiller or chiller solution for application to poultry carcass parts; or

(v) As a component of a post-chill carcass spray or dip solution when applied to poultry meat, organs, or related parts or trim.

(2) When used in a spray or dip solution, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 parts per million (ppm), in combination with any GRAS acid at a level sufficient to achieve a solution pH of 2.3 to 2.9.

(3) When used in a prechiller or chiller solution, the additive is used at levels that result in sodium chlorite concentrations between 50 and 150 ppm, in combination with any GRAS acid at levels sufficient to achieve a solution pH of 2.8 to 3.2.

(c) The additive is used as an antimicrobial agent in accordance with current industry practice in the processing of red meat, red meat parts, and organs as a component of a spray or in the processing of red meat parts and organs as a component of a dip. Applied as a dip or spray, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 ppm in combination with any GRAS acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.

(d)(1) The additive is used as an antimicrobial agent in water and ice that are used to rinse, wash, thaw, transport, or store seafood in accordance with current industry standards of good manufacturing practice. The additive is produced by mixing an aqueous solution of sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5 to 2.9 and diluting this solution with water to achieve an actual use concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption.

(2) The additive is used as a single application in processing facilities as an antimicrobial agent to reduce pathogenic bacteria due to cross-contamination during the harvesting, handling, heading, evisceration, butchering, storing, holding, packing, or packaging of finfish and crustaceans; or following the filleting of finfish; in accordance with current industry standards of good manufacturing practice. Applied as a dip or spray, the additive is used at levels that result in a sodium chlorite concentration of 1,200 ppm, in combination with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. Treated seafood shall be cooked prior to consumption.

(e) The additive is used as an antimicrobial agent on raw agricultural commodities in the preparing, packing, or holding of the food for commercial purposes, consistent with section 201(q)(1)(B)(i) of the act, and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with current industry standards of good manufacturing practice. Applied as a dip or a spray, the additive is used at levels that result in chlorite concentrations of 500 to 1200 parts per million (ppm), in combination with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. Treatment of the raw agricultural commodities with acidified sodium chlorite solutions shall be followed by a potable water rinse, or by blanching, cooking, or canning.

(f) The additive is used as an antimicrobial agent on processed, comminuted or formed meat food products (unless precluded by standards of identity in 9 CFR part 319) prior to packaging of the food for commercial purposes, in accordance with current industry standards of good manufacturing practice. Applied as a dip or spray, the additive is used at levels that result in sodium chlorite concentrations of 500 to 1200 ppm, in combination with any GRAS acid at levels sufficient to achieve a pH of 2.5 to 2.9.

(g) The additive is used as an antimicrobial agent in the water applied to processed fruits and processed root, tuber, bulb, legume, fruiting (i.e., eggplant, groundcherry, pepino, pepper, tomatillo, and tomato), and cucurbit vegetables in accordance with current industry standards of good manufacturing practices, as a component of a spray or dip solution, provided that such application be followed by a potable water rinse and a 24-hour holding period prior to consumption. However, for processed leafy vegetables (i.e., vegetables other than root, tuber, bulb, legume, fruiting, and cucurbit vegetables) and vegetables in the Brassica [Cole] family, application must be by dip treatment only, and must be preceded by a potable water rinse and followed by a potable water rinse and a 24-hour holding period prior to consumption. When used in a spray or dip solution, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 ppm, in combination with any GRAS acid at a level sufficient to achieve a solution pH of 2.3 to 2.9.

(h) The concentration of sodium chlorite is determined by a method entitled “Determination of Sodium Chlorite: 50 ppm to 1500 ppm Concentration,” September 13, 1995, developed by Alcide Corp., Redmond, WA, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Defoaming agents may be safely used in processing foods, in accordance with the following conditions:

(a) They consist of one or more of the following:

(1) Substances generally recognized by qualified experts as safe in food or covered by prior sanctions for the use prescribed by this section.

(2) Substances listed in this paragraph (a)(2) of this section, subject to any limitations imposed:

(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:

(4) The substances listed in this paragraph (a)(4), provided they are components of defoaming agents limited to use in processing beet sugar only, and subject to the limitations imposed:

(b) They are added in an amount not in excess of that reasonably required to inhibit foaming.

A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also known as fluorocarbon 113, CFC 113 and FC 113) and 1 percent perfluorohexane (CAS Reg. No. 355-42-0) may be safely used in accordance with the following prescribed conditions:

(a) The additive chlorofluorocarbon 113 has a purity of not less than 99.99 percent.

(b) The additive mixture is intended for use to quickly cool or crust-freeze chickens sealed in intact bags composed of substances regulated in parts 174, 175, 177, 178, and § 179.45 of this chapter and conforming to any limitations or specifications in such regulations.

The food additive chloropentafluoroethane may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive has a purity of not less than 99.97 percent, and contains not more than 200 parts per million saturated fluoro compounds and 10 parts per million unsaturated fluoro compounds as impurities.

(b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, propane, and octafluorocyclobutane complying with § 173.360, as an aerating agent for foamed or sprayed food products, with any propellant effect being incidental and no more than is minimally necessary to achieve the aerating function, except that use is not permitted for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive

(1) The label of the food additive container shall bear, in addition to the other information required by the act, the following:

(i) The name of the additive, chloropentafluoroethane.

(ii) The percentage of the additive present in the case of a mixture.

(iii) The designation “food grade”.

(2) The label or labeling of the food additive container shall bear adequate directions for use.

The food additive combustion product gas may be safely used in the processing and packaging of the foods designated in paragraph (c) of this section for the purpose of removing and displacing oxygen in accordance with the following prescribed conditions:

(a) The food additive is manufactured by the controlled combustion in air of butane, propane, or natural gas. The combustion equipment shall be provided with an absorption-type filter capable of removing possible toxic impurities, through which all gas used in the treatment of food shall pass; and with suitable controls to insure that any combustion products failing to meet the specifications provided in this section will be prevented from reaching the food being treated.

(b) The food additive meets the following specifications:

(1) Carbon monoxide content not to exceed 4.5 percent by volume.

(2) The ultraviolet absorbance in isooctane solution in the range 255 millimicrons to 310 millimicrons not to exceed one-third of the standard reference absorbance when tested as described in paragraph (e) of this section.

(c) It is used or intended for use to displace or remove oxygen in the processing, storage, or packaging of beverage products and other food, except fresh meats.

(d) To assure safe use of the additive in addition to the other information required by the act, the label or labeling of the combustion device shall bear adequate directions for use to provide a combustion product gas that complies with the limitations prescribed in paragraph (b) of this section, including instructions to assure proper filtration.

(e) The food additive is tested for compliance with paragraph (b)(2) by the following empirical method:

The food additive dichlorodifluoromethane may be safely used in food in accordance with the following prescribed conditions:

(a) The additive has a purity of not less than 99.97 percent.

(b) It is used or intended for use, in accordance with good manufacturing practice, as a direct-contact freezing agent for foods.

(c) To assure safe use of the additive:

(1) The label of its container shall bear, in addition to the other information required by the act, the following:

(i) The name of the additive, dichlorodifluoromethane, with or without the parenthetical name “Food Freezant 12”.

(ii) The designation “food grade”.

(2) The label or labeling of the food additive container shall bear adequate directions for use.

Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to treat food in accordance with the following conditions:

(a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496 and 497, which is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) The additive is used as an antimicrobial agent in the production of modified whey (including, but not limited to, whey protein concentrates and whey protein isolates) by ultrafiltration methods, at a level not to exceed 0.001 percent by weight of the whey, providing that residual hydrogen peroxide is removed by appropriate chemical or physical means during the processing of the modified whey.

Fixing agents may be safely used in the immobilization of enzyme preparations in accordance with the following conditions:

(a) The materials consist of one or more of the following:

(1) Substances generally recognized as safe in food.

(2) Substances identified in this subparagraph and subject to such limitations as are provided:

(b) The fixed enzyme preparation is washed to remove residues of the fixing materials.

The food additive octafluorocyclo-butane may be safely used as a propellant and aerating agent in foamed or sprayed food products in accordance with the following conditions:

(a) The food additive meets the following specifications:

(b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, and propane, as a propellant and aerating agent for foamed or sprayed food products, except for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive:

(1) The label of the food additive container shall bear, in addition to the other information required by the act, the following:

(i) The name of the additive, octafluorocyclobutane.

(ii) The percentage of the additive present in the case of a mixture.

(iii) The designation “food grade”.

(2) The label or labeling of the food additive container shall bear adequate directions for use.

Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319), in accordance with the following prescribed conditions:

(a) The additive is an unstable, colorless gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen.

(b) The additive is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter.

(c) The additive meets the specifications for ozone in the Food Chemicals Codex, 7th ed. (2010), pp. 754-755, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(d) The additive is used in contact with food, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase in accordance with current industry standards of good manufacturing practice.

(e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

Peroxyacids may be safely used in accordance with the following prescribed conditions:

(a) The additive is a mixture of peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1,1-diphosphonic acid.

(b)(1) The additive is used as an antimicrobial agent on meat carcasses, parts, trim, and organs in accordance with current industry practice where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, and the maximum concentration of hydrogen peroxide is 75 ppm.

(2) The additive is used as an antimicrobial agent on poultry carcasses, poultry parts, and organs in accordance with current industry standards of good manufacturing practice (unless precluded by the U.S. Department of Agriculture's standards of identity in 9 CFR part 381, subpart P) where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, the maximum concentration of hydrogen peroxide is 110 ppm, and the maximum concentration of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 ppm.

(c) The concentrations of peroxyacids and hydrogen peroxide in the additive are determined by a method entitled “Hydrogen Peroxide and Peracid (as Peracetic Acid) Content,” July 26, 2000, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The concentration of 1-hydroxyethylidene-1,1-diphosphonic acid is determined by a method entitled “Determination of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) Peroxyacid/Peroxide-Containing Solutions,” August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The Director of the Office of the Federal Register approves these incorporations by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods from the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions:

(a) The additive meets the specifications of the United States Pharmacopeia (USP)/National Formulary (NF) described in USP 30/NF 25, May 1, 2007, pp. 1700-1701, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(b) The additive is used in food as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter to treat the surface of raw poultry carcasses. The solution in which the additive is used to treat raw poultry carcasses shall also contain propylene glycol (CAS Reg. No. 57-55-6) complying with § 184.1666 of this chapter, at a concentration of 1.5 times that of cetylpyridinium chloride.

(c) The additive is used as follows:

(1) As a fine mist spray of an ambient temperature aqueous solution applied to raw poultry carcasses prior to immersion in a chiller, at a level not to exceed 0.3 gram cetylpyridinium chloride per pound of raw poultry carcass, provided that the additive is used in systems that collect and recycle solution that is not carried out of the system with the treated poultry carcasses; or

(2) As a liquid aqueous solution applied to raw poultry carcasses either prior to or after chilling at an amount not to exceed 5 gallons of solution per carcass, provided that the additive is used in systems that recapture at least 99 percent of the solution that is applied to the poultry carcasses. The concentration of cetylpyridinium chloride in the solution applied to the carcasses shall not exceed 0.8 percent by weight. When application of the additive is not followed by immersion in a chiller, the treatment will be followed by a potable water rinse of the carcass.

Sodium methyl sulfate may be present in pectin in accordance with the following conditions.

(a) It is present as the result of methylation of pectin by sulfuric acid and methyl alcohol and subsequent treatment with sodium bicarbonate.

(b) It does not exceed 0.1 percent by weight of the pectin.

Trifluoromethane sulfonic acid has the empirical formula CF3SO3H (CAS Reg. No. 1493-13-6). The catalyst (Trifluoromethane sulfonic acid) may safely be used in the production of cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) (see § 184.1259 of this chapter) in accordance with the following conditions:

(a) The catalyst meets the following specifications:

(b) It is used at levels not to exceed 0.2 percent of the reaction mixture to catalyze the directed esterification.

(c) The esterification reaction is quenched with steam and water and the catalyst is removed with the aqueous phase. Final traces of catalyst are removed by washing batches of the product three times with an aqueous solution of 0.5 percent sodium bicarbonate.

(d) No residual catalyst may remain in the product at a detection limit of 0.2 part per million fluoride as determined by the method described in “Official Methods of Analysis of the Association of Official Analytical Chemists,” sections 25.049-25.055, 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Dimethyldialkylammonium chloride may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is produced by one of the following methods:

(1) Ammonolysis of natural tallow fatty acids to form amines that are subsequently reacted with methyl chloride to form the quaternary ammonium compounds consisting primarily of dimethyldioctadecylammonium chloride and dimethyldihexadecylammonium chloride. The additive may contain residues of isopropyl alcohol not in excess of 18 percent by weight when used as a processing solvent.

(2) Ammonolysis of natural tallow fatty acids to form amines that are then reacted with 2-ethylhexanal, reduced, methylated, and subsequently reacted with methyl chloride to form the quaternary ammonium compound known as dimethyl(2-ethylhexyl) hydrogenated tallow ammonium chloride and consisting primarily of dimethyl(2-ethylhexyl)octadecylammonium chloride and dimethyl(2-ethylhexyl)hexadecylammonium chloride.

(b) The food additive described in paragraph (a)(1) of this section contains not more than a total of 2 percent by weight of free amine and amine hydrochloride. The food additive described in paragraph (a)(2) of this section contains not more than 3 percent by weight, each, of free amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, “Acid Value and Free Amine Value of Fatty Quaternary Ammonium Chlorides,” 2d printing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and from the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The food additive is used as a decolorizing agent in the clarification of refinery sugar liquors under the following limitations:

(1) The food additive described in paragraph (a)(1) of this section is added only at the defecation/clarification stage of sugar liquor refining in an amount not to exceed 700 parts per million by weight of sugar solids.

(2) The food additive described in paragraph (a)(2) of this section is used under the following conditions:

(i) The additive is adsorbed onto a support column composed of suitable polymers that are regulated for contact with aqueous food. Excess nonadsorbed additive shall be rinsed away with potable water prior to passage of sugar liquor through the column.

(ii) The residue of the additive in the decolorized sugar liquor prior to crystallization shall not exceed 1 part per million of sugar as determined by a method entitled “Colorimetric Determination of Residual Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar Solutions,” June 13, 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with paragraph (c) of this section.

Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely used in accordance with the following prescribed conditions:

(a) The additive is an antimicrobial agent used in wash water for fruits and vegetables. The additive may be used at a level not to exceed 111 milligrams per kilogram in the wash water. Fruits and vegetables treated by the additive do not require a potable water rinse.

(b) The additive is limited to use in commissaries, cafeterias, restaurants, retail food establishments, nonprofit food establishments, and other food service operations in which food is prepared for or served directly to the consumer.

(c) To assure safe use of the additive, the label or labeling of the additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section.

(a) Adhesives may be safely used as components of articles intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions:

(1) The adhesive is prepared from one or more of the optional substances named in paragraph (c) of this section, subject to any prescribed limitations.

(2) The adhesive is either separated from the food by a functional barrier or used subject to the following additional limitations:

(i) In dry foods. The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice.

(ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice.

(b) Under normal conditions of use the packaging seams or laminates will remain firmly bonded without visible separation.

(b) To assure safe usage of adhesives, the label of the finished adhesive container shall bear the statement “food-packaging adhesive”.

(c) Subject to any limitation prescribed in this section and in any other regulation promulgated under section 409 of the Act which prescribes safe conditions of use for substances that may be employed as constituents of adhesives, the optional substances used in the formulation of adhesives may include the following:

(1) Substances generally recognized as safe for use in food or food packaging.

(2) Substances permitted for use in adhesives by prior sanction or approval and employed under the specific conditions of use prescribed by such sanction or approval.

(3) Flavoring substances permitted for use in food by regulations in this part, provided that such flavoring substances are volatilized from the adhesives during the packaging fabrication process.

(4) Color additives approved for use in food.

(5) Substances permitted for use in adhesives by other regulations in this subchapter and substances named in this subparagraph: Provided, however, That any substance named in this paragraph and covered by a specific regulation in this subchapter, must meet any specifications in such regulation.