[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.800]

[Page 70-71]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION--Table of Contents
 
                    Subpart I--Multipurpose Additives
 
Sec. 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

[[Page 71]]

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]