[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: 21CFR184.1]
[Page 482-483]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
Subpart A General Provisions
Sec. 184.1 Substances added directly to human food affirmed as
generally recognized as safe (GRAS).
(a) The direct human food ingredients listed in this part have been
reviewed by the Food and Drug Administration and determined to be
generally recognized as safe (GRAS) for the purposes and under the
conditions prescribed. The regulations in this part shall sufficiently
describe each ingredient to identify the characteristics of the
ingredient that has been affirmed as GRAS and to differentiate it from
other possible versions of the ingredient that have not been affirmed as
GRAS. Ingredients affirmed as GRAS in this part are also GRAS as
indirect human food ingredients, subject to any limitations prescribed
in parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter or in
part 186 of this chapter. The purity specifications in this part do not
apply when the ingredient is used in indirect applications. However,
when used in indirect applications, the ingredient must be of a purity
suitable for its intended use in accordance with Sec. 170.30(h)(1) of
this chapter.
(b) Any ingredient affirmed as GRAS in this part shall be used in
accordance with current good manufacturing practice. For the purpose of
this part, current good manufacturing practice includes the requirements
that a direct human food ingredient be of appropriate food grade; that
it be prepared and handled as a food ingredient; and that the quantity
of the ingredient added to food does not exceed the amount reasonably
required to accomplish the intended physical, nutritional, or other
technical effect in food.
(1) If the ingredient is affirmed as GRAS with no limitations on its
conditions of use other than current good manufacturing practice, it
shall be regarded as GRAS if its conditions of use are consistent with
the requirements of paragraph (b), (c), and (d) of this section. When
the Food and Drug Administration (FDA) determines that it is
appropriate, the agency will describe one or more current good
manufacturing practice conditions of use in the regulation that affirms
the GRAS status of the ingredient. For example, when the safety of an
ingredient has been evaluated on the basis of limited conditions of use,
the agency will describe in the regulation that affirms the GRAS status
of the ingredient, one or more of these limited conditions of use, which
may include the category of food(s), the technical effect(s) or
functional use(s) of the ingredient, and the
[[Page 483]]
level(s) of use. If the ingredient is used under conditions that are
significantly different from those described in the regulation, that use
of the ingredient may not be GRAS. In such a case, a manufacturer may
not rely on the regulation as authorizing that use but shall
independently establish that that use is GRAS or shall use the
ingredient in accordance with a food additive regulation. Persons
seeking FDA approval of an independent determination that a use of an
ingredient is GRAS may submit a GRAS petition in accordance with Sec.
170.35 of this chapter.
(2) If the ingredient is affirmed as GRAS with specific
limitation(s), it shall be used in food only within such limitation(s),
including the category of food(s), the functional use(s) of the
ingredient, and the level(s) of use. Any use of such an ingredient not
in full compliance with each such established limitation shall require a
food additive regulation.
(3) If the ingredient is affirmed as GRAS for a specific use,
without a general evaluation of use of the ingredient, other uses may
also be GRAS.
(c) The listing of a food ingredient in this part does not authorize
the use of such substance in a manner that may lead to deception of the
consumer or to any other violation of the Federal Food, Drug, and
Cosmetic Act (the Act).
(d) The listing of more than one ingredient to produce the same
technological effect does not authorize use of a combination of two or
more ingredients to accomplish the same technological effect in any one
food at a combined level greater than the highest level permitted for
one of the ingredients.
(e) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of an ingredient under conditions different from those
proposed to be affirmed as GRAS, he will concurrently propose a separate
regulation covering such use of the ingredient under part 181 of this
chapter. If the Commissioner is unaware of any such applicable prior
sanction, the proposed regulation will so state and will require any
person who intends to assert or rely on such sanction to submit proof of
its existence. Any regulation promulgated pursuant to this section
constitutes a determination that excluded uses would result in
adulteration of the food in violation of section 402 of the Act, and the
failure of any person to come forward with proof of such an applicable
prior sanction in response to the proposal will constitute a waiver of
the right to assert or rely on such sanction at any later time. The
notice will also constitute a proposal to establish a regulation under
part 181 of this chapter, incorporating the same provisions, in the
event that such a regulation is determined to be appropriate as a result
of submission of proof of such an applicable prior sanction in response
to the proposal.
(f) The label and labeling of the ingredient and any intermediate
mix of the ingredient for use in finished food shall bear, in addition
to the other labeling required by the Act:
(1) The name of the ingredient, except where exempted from such
labeling in part 101 of this chapter.
(2) A statement of concentration of the ingredient in any
intermediate mix; or other information to permit a food processor
independently to determine that use of the ingredients will be in
accordance with any limitations and good manufacturing practice
gudelines prescribed.
(3) Adequate directions for use to provide a final food product that
complies with any limitations prescribed for the ingredient(s).
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977;
48 FR 48457, 48459, Oct. 19, 1983; 62 FR 15110, Mar. 31, 1997]
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