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 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 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200. Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Federal Food, Drug, and Cosmetic 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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), 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200. Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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), 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 as identified in § 133.128 of this chapter, whereby the amount of the additive does not exceed .008 percent by weight of the finished product.

(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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 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 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 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 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 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 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 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 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 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 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 Official 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 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 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday 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.