(a) An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201(s)(4) of the Act is exempt from classification as a food additive. The Commissioner will publish in this part all known prior sanctions. Any interested person may submit to the Commissioner a request for publication of a prior sanction, supported by evidence to show that it falls within section 201(s)(4) of the Act.

(b) Based upon scientific data or information that shows that use of a prior-sanctioned food ingredient may be injurious to health, and thus in violation of section 402 of the Act, the Commissioner will establish or amend an applicable prior sanction regulation to impose whatever limitations or conditions are necessary for the safe use of the ingredient, or to prohibit use of the ingredient.

(c) Where appropriate, an emergency action level may be issued for a prior-sanctioned substance, pending the issuance of a final regulation in accordance with paragraph (b) of this section. Such an action level shall be issued pursuant to section 402(a) of the Act to identify, based upon available data, conditions of use of the substance that may be injurious to health. Such an action level shall be issued in a notice published in the Federal Register and shall be followed as soon as practicable by a proposed regulation in accordance with paragraph (b) of this section. Where the available data demonstrate that the substance may be injurious at any level, use of the substance may be prohibited. The identification of a prohibited substance may be made in part 189 of this chapter when appropriate.

(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 § 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.