[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR181.5]

[Page 462]
 
                        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 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.