[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.804]
[Page 78-79]
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. 172.804 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 1-methyl N-l-[alpha]-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, 5100
Paint Branch Pkwy., College Park, MD 20740, 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.
(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,
[[Page 79]]
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, 5100 Paint Branch
Pkwy., College Park, MD 20740, 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:
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 chapter.
[39 FR 27319, July 26, 1974]
Editorial Note: For Federal Register citations affecting Sec.
172.804, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Additives that reference this regulation: |
