Title 21 CFR reference

(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. Federal Register04(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…

Prior to the enactment of the food additives amendment to the Federal Food, Drug, and Cosmetic Act, sanctions were granted for the usage of the substances listed in §§ 181.23, 181.24, 181.25, 181.26, 181.27, 181.28, 181.29, and 181.30 in the manufacture of packaging materials. So used, these substances are not considered “food additives” within the meaning of section 201(s) of the Act, provided that they are of good commercial grade, are suitable for association with food, and are used in accordance with good manufacturing practice. For the purpose of this subpart, good manufacturing practice for food-packaging materials includes the restriction that the quantity of any of these substances which becomes a component of food as a result of use in food-packaging materials shall not be intended to accomplish any physical or technical effect in the food itself, shall be reduced to the least amount reasonably possible, and shall not exceed any limit specified in this subpart. [42 FR 56728, Oct. 28, 1977]

Substances classified as antimycotics, when migrating from food-packaging material shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

Substances classified as antioxidants, when migrating from food-packaging material (limit of addition to food, 0.005 percent) shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

Substances classified as driers, when migrating from food-packaging material shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

Substances classified as drying oils, when migrating from food-packaging material (as components of finished resins) shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

Substances classified as plasticizers, when migrating from food-packaging material shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 50 FR 49536, Dec. 3, 1985]

Substances classified as release agents, when migrating from food-packaging material shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

Substances classified as stabilizers, when migrating from food-packaging material shall include: [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

Substances used in the manufacture of paper and paperboard products used in food packaging shall include: *Under the conditions of normal use, these substances would not reasonably be expected to migrate to food, based on available scientific information and data.

(a) Acrylonitrile copolymers and resins listed in this section, containing less than 30 percent acrylonitrile and complying with the requirements of paragraph (b) of this section, may be safely used as follows: Films.(1) (i) Acrylonitrile/butadiene/styrene copolymers—no restrictions. (ii) Acrylonitrile/butadiene copolymers—no restrictions. (iii) Acrylonitrile/butadiene copolymer blended with vinyl chloride-vinyl acetate (optional at level up to 5 percent by weight of the vinyl chloride resin) resin—for use only in contact with oleomargarine. (iv) Acrylonitrile/styrene copolymer—no restrictions. Coatings.(2) (i) Acrylonitrile/butadiene copolymer blended with polyvinyl chloride resins—for use only on paper and paperboard in contact with meats and lard. (ii) Polyvinyl chloride resin blended with either acrylonitrile/butadiene copolymer or acrylonitrile/butadiene styrene copolymer mixed with neoprene, for use as components of conveyor belts to be used with fresh fruits, vegetables, and fish. (iii) Acrylonitrile/butadiene/styrene copolymer—no restrictions. (iv) Acrylonitrile/styrene copolymer—no restrictions. Rigid and semirigid containers.(3) (i)…

Sodium nitrate and potassium nitrate are subject to prior sanctions issued by the U.S. Department of Agriculture for use as sources of nitrite, with or without sodium or potassium nitrite, in the production of cured red meat products and cured poultry products. [48 FR 1705, Jan. 14, 1983]

Sodium nitrite and potassium nitrite are subject to prior sanctions issued by the U.S. Department of Agriculture for use as color fixatives and preservative agents, with or without sodium or potassium nitrate, in the curing of red meat and poultry products. [48 FR 1705, Jan. 14, 1983]

(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…