(c) The additive is used as a halogen stabilizer in brominated soybean oil at a level not to exceed 1 percent.

[60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999]

§ 172.725 Gibberellic acid and its potassium salt.

The food additives gibberellic acid and its potassium salt may be used in the malting of barley in accordance with the following prescribed conditions:

(a) The additives meet the following specifications:

(1) The gibberellic acid is produced by deep-culture fermentation of a suitable nutrient medium by a strain of Fusarium moniliforme or a selection of this culture.

(2) The gibberellic acid produced is of 80 percent purity or better.

(3) The empirical formula of gibberellic acid is represented by C19H2206.

(4) Potassium gibberellate is the potassium salt of the specified gibberellic acid.

(5) The potassium gibberellate is of 80 percent purity or better.

(6) The gibberellic acid or potassium gibberellate may be diluted with substances generally recognized as safe in foods or with salts of fatty acids conforming to § 172.863.

(b) They are used or intended for use in the malting of barley under conditions whereby the amount of either or both additives present in the malt is not in excess of 2 parts per million expressed as gibberellic acid, and the treated malt is to be used in the production of fermented malt beverages or distilled spirits only, whereby the finished distilled spirits contain none and the finished malt beverage contains not more than 0.5 part per million of gibberellic acid.

(c) To insure the safe use of the food additives the label of the package shall bear, in addition to the other information required by the Act:

(1) The name of the additive, ‘gibberellic acid" or "potassium gibberellate", whichever is priate.

appro

(2) An accurate statement of the concentration of the additive contained in the package.

(3) Adequate use directions to provide not more than 2 parts per million of gibberellic acid in the finished malt.

(4) Adequate labeling directions to provide that the final malt is properly labeled as described in paragraph (d) of this section.

(d) To insure the safe use of the additive the label of the treated malt shall bear, in addition to the other information required by the Act, the statements:

(1) "Contains not more than 2 parts per million ", the blank being filled in with the words "gibberellic acid" or "potassium gibberellate”, whichever is appropriate; and

(2) "Brewer's malt-To be used in the production of fermented malt beverages only" or "Distiller's malt-To be used in the production of distilled spirits only", whichever is appropriate.

§ 172.730 Potassium bromate.

The food additive potassium bromate may be safely used in the malting of barley under the following prescribed conditions:

(a)(1) It is used or intended for use in the malting of barley under conditions whereby the amount of the additive present in the malt from the treatment does not exceed 75 parts per million of bromate (calculated as Br), and the treated malt is used only in the production of fermented malt beverages or distilled spirits.

(2) The total residue of inorganic bromides in fermented malt beverages, resulting from the use of the treated malt plus additional residues of inorganic bromides that may be present from uses in accordance with other regulations in this chapter promulgated under sections 408 and/or 409 of the act, does not exceed 25 parts per million of bromide (calculated as Br). No tolerance is established for bromide in distilled spirits because there is evidence that inorganic bromides do not pass over in the distillation process.

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

(1) The name of the additive.
(2) Adequate directions for use.

(c) To assure safe use of the additive, the label or labeling of the treated malt shall bear, in addition to other information required by the Act, the statement, "Brewer's Malt-To be used in the production of fermented malt beverages only", or "Distiller's MaltTo be used in the production of distilled spirits only", whichever is the

case.

§ 172.735 Glycerol ester of wood rosin.

Glycerol ester of wood rosin may be safely used in food in accordance with the following prescribed conditions:

(a) It has an acid number of 3 to 9, a drop-softening point of 88 °C-96 °C; and a color of N or paler as determined in accordance with Official Naval Stores Standards of the United States. It is purified by countercurrent steam distillation.

(b) It is used to adjust the density of citrus oils used in the preparation of beverages whereby the amount of the additive does not exceed 100 parts per million of the finished beverage.

with shortenings containing emulsifiers.

§ 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate). The food additive succistearin (stearoyl propylene glycol hydrogen succinate) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is the reaction product of succinic anhydride, fully hydrogenated vegetable oil (predominantly C16 or C18 fatty acid chain length), and propylene glycol.

(b) The additive meets the following specifications:

Acid number 50-150.
Hydroxyl number 15-50.

Succinated ester content 45-75 percent.

(c) The additive is used or intended for use as an emulsifier in or with shortenings and edible oils intended for use in cakes, cake mixes, fillings, icings, pastries, and toppings, in accordance with good manufacturing practice.

§ 172.770 Ethylene oxide polymer.

The polymer of ethylene oxide may be safely used as a foam stabilizer in fermented malt beverages in accordance with the following conditions.

(a) It is the polymer of ethylene oxide having a minimum viscosity of 1,500 centipoises in a 1 percent aqueous solution at 25 °C.

(b) It is used at a level not to exceed 300 parts per million by weight of the fermented malt beverage.

(c) The label of the additive bears directions for use to insure compliance with paragraph (b) of this section.

(c) The additive is used as a carrier of vitamin B12 in foods for special dietary

use.

Subpart I-Multipurpose Additives

§ 172.800 Acesulfame potassium.

Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as acesulfame K, may be safely used as a sweetening agent in food in accordance with the following prescribed conditions:

(a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3oxathiazine-4(3H)-one-2,2-dioxide.

(b) The additive meets the following specifications:

by

(1) Purity is not less than 99 percent on a dry basis. The purity shall be determined method a titled "Acesulfame Potassium Assay," which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(2) Fluoride content is not more than 30 parts per million, as determined by method III of the Fluoride Limit Test of the Food Chemicals Codex, 3d Ed. (1981), p. 511, 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 Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(c) The additive may be used in the following foods when standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use:

(1) Sugar substitute, including granulated, powdered, and tablet form.

(2) [Reserved]

(3) Chewing gum.

liquid,

(4) Dry bases for beverages, instant coffee, and instant tea.

(5) Dry bases for gelatins, puddings, and pudding desserts.

(6) Dry bases for dairy product analogs.

(7) Confections, hard candy, and soft candy.

(8) Baked goods and baking mixes, including frostings, icings, toppings, and fillings for baked goods.

(9) Yogurt and yogurt-type products. (10) Frozen and refrigerated desserts. (11) Sweet sauces, toppings, and syrups.

(12) Alcoholic beverages.

(13) Nonalcoholic beverages, including beverage bases.

(d) 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.

(e) The additive shall be used in accordance with current good manufacturing practice in an amount not to exceed that reasonably required to accomplish the intended effect.

[53 FR 28382, July 28, 1988, as amended at 57 FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 36362, July 6, 1998]

§ 172.802 Acetone peroxides.

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.

§ 172.804 Aspartame.

The food additive aspartame may be safely used in food in accordance with good manufacturing practice as a sweetening agent and a flavor enhancer in foods for which standards of identity established under section 401 of the act do not preclude such use under the following conditions:

(a) Aspartame is the chemical 1methyl N-L-a-aspartyl-L-phenylalanine (C14H18N2O5).

(b) The additive meets the specifications of the "Food Chemicals Codex," 3d Ed. (1981) pp. 28–29 and First Supplement p. 5, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food And Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(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 sweet

ener in the final baked product. The level of aspartame used in these products is determined by an analytical method entitled "Analytical Method for the Determination of Aspartame and Diketopiperazine in Baked Goods and Baking Mixes," October 8, 1992, which was developed by the Nutrasweet Co. Copies are available from the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or are available for inspection at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(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: PHENYLKETONURICS: CONTAINS PHENYLALANINE

The statement shall appear in the labeling prominently and conspicuously as compared to other words, statements, designs or devices and in bold type and on clear contrasting background in order to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(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 chap

ter.

EDITORIAL NOTE: For FEDERAL REGISTER Citations affecting § 172.804, see the List of CFR

Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 172.806 Azodicarbonamide.

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.

ethylene oxide and propylene oxide. 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) a-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.

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) 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.

a-Hydro-omega-hydroxy-poly(ox

(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.

[42 FR 14491, Mar. 15, 1977, as amended at 46 FR 57476, Nov. 24, 1981]

§ 172.809 Curdlan.

Curdlan may be safely used in accordance with the following conditions: (a) Curdlan is a high molecular weight polymer of glucose (B-1,3