[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.800]
[Page 78]
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
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 general-purpose sweetener and
flavor enhancer in foods generally, except in meat and poultry, in
accordance with current good manufacturing practice and in an amount not
to exceed that reasonably required to accomplish the intended technical
effect in foods for which standards of identity established under
section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude
such use, under the following conditions:
(a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-
oxathiazine-4(3H)-one-2,2-dioxide.
(b) The additive meets the following specifications:
(1) Purity is not less than 99 percent on a dry basis. The purity
shall be determined by a method titled ``Acesulfame Potassium Assay,''
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(2) Fluoride content is not more than 30 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 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) 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.
[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; 68 FR 75413, Dec. 31, 2003]
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