[Code of Federal Regulations]

[Title 21, Volume 3, Parts 170 to 199]

[Revised as of April 1, 1998]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR181.5]

(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 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.