[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: 21CFR186.1]
[Page 586-587]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 186 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
Subpart A General Provisions
Sec. 186.1 Substances added indirectly to human food affirmed as
generally recognized as safe (GRAS).
(a) The indirect 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, providing they comply with the purity
specifications listed in this part or, in the absence of purity
specifications, are of a purity suitable for their intended use in
accordance with Sec. 170.30(h)(1) of this chapter. Certain ingredients
in this part may also be used in food-contact surfaces in accordance
with parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter.
Ingredients affirmed as GRAS for direct use in part 184 of this chapter
are also GRAS as indirect human food ingredients in accordance with
Sec. 184.1(a) of this chapter.
(b) The regulations in this part do not authorize direct addition of
any food ingredient to a food. They authorize only the use of these
ingredients as indirect ingredients of food, through migration from
their immediate wrapper, container, or other food-contact surface. 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 an
indirect human food ingredient be of a purity suitable for its intended
use, and that it be used at a level no higher than reasonably required
to achieve its intended technical effect in the food-contact article.
(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 paragraphs (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 indirect 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 indirect ingredient, one or more of these limited
conditions of use, which may include the category of food-contact
surface(s), technical effect(s) or functional use(s) of the indirect
ingredient, and the level(s) of use. If the ingredient is used under
conditions that are significantly different from those described in the
regulation, such use of a substance 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 the 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-contact surfaces
[[Page 587]]
only within such limitation(s), including the category of food-contact
surface(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, prior
to 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 for the purpose of adding the ingredient to
the food through extraction from the food-contact surface.
(d) 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 to the
consumer or to any other violation of the Federal Food, Drug, and
Cosmetic Act (the Act).
(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.
[42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19,
1983]
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