21 Food and Drugs 3 2001-04-01 2001-04-01 false Acesulfame potassium. 172.800 Section 172.800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 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-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide.

(b) The additive meets the following specifications:

(1) Purity is not less than 99 percent on a dry basis. The purity shall be determined by a method titled “Acesulfame Potassium Assay,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 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, liquid, and tablet form.

(2) [Reserved]

(3) Chewing gum.

(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]