[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: 21CFR181.5]
[Page 463-464]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 181 PRIOR-SANCTIONED FOOD INGREDIENTS--Table of Contents
Subpart A General Provisions
Sec. 181.5 Prior sanctions.
(a) A prior sanction shall exist only for a specific use(s) of a
substance in food, i.e., the level(s), condition(s), product(s), etc.,
for which there was explicit approval by the Food and Drug
Administration or the United States Department of Agriculture prior to
September 6, 1958.
(b) The existence of a prior sanction exempts the sanctioned use(s)
from the food additive provisions of the Act but not from the other
adulteration or the misbranding provisions of the Act.
(c) All known prior sanctions shall be the subject of a regulation
published in this part. Any such regulation is subject to amendment to
impose whatever limitation(s) or condition(s) may be necessary for the
safe use of the ingredient, or revocation to prohibit use of the
ingredient, in order to prevent the adulteration of food in violation of
section 402 of the Act.
(d) In proposing, after a general evaluation of use of an
ingredient, regulations affirming the GRAS status of substances added
directly to human food in part 184 of this chapter or substances in
food-contact surfaces in part 186 of this chapter, or establishing a
food additive regulation for substances added directly to human food in
parts 172 and 173 of this chapter or food additives in food-contact
surfaces in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter, the Commissioner shall, if he is aware of any prior sanction
for use of the ingredient under conditions different from those proposed
in the regulation, concurrently propose a separate
[[Page 464]]
regulation covering such use of the ingredient under this part. 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 food additive or GRAS regulation promulgated after a
general evaluation of use of an ingredient 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 a
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 this part, 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.
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