statement "Excess consumption may have a laxative effect". (f) In accordance with §180.1, adequate and appropriate feeding studies have been undertaken for this substance. Continued uses of this ingredient are contingent upon timely and adequate progress reports of such tests, and no indication of increased risk to public health during the test period. (g) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996] § 180.30 Brominated vegetable oil. The food additive brominated vegetable oil may be safely used in accordance with the following prescribed conditions: (a) The additive complies with specifications prescribed in the "Food Chemicals Codex," 3d Ed. (1981), pp. 4041, which is incorporated by reference, except that free fatty acids (as oleic) shall not exceed 2.5 percent and iodine value shall not exceed 16. Copies of the material incorporated by reference may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20418. (b) The additive is used on an interim basis as a stabilizer for flavoring oils used in fruit-flavored beverages, for which any applicable standards of identity do not preclude such use, in an amount not to exceed 15 parts per million in the finished beverage, pending the outcome of additional toxicological studies on which periodic reports at 6month intervals are to be furnished and final results submitted to the Food and Drug Administration promptly after completion of the studies. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984] § 180.37 Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin. The food additives saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin may be safely used as sweetening agents in food in accord ance with the following conditions, if the substitution for nutritive sweeteners is for a valid special dietary purpose and is in accord with current special dietary food regulations and policies or if the use or intended use is for an authorized technological purpose other than calorie reduction: (a) Saccharin is the chemical, 1,2benzisothiazolin-3-one - 1,1 dioxide (C7H5NOзS). The named salts of saccharin are produced by the additional neutralization of saccharin with the proper base to yield the desired salt. (b) The food additives meet the specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 22, 62, 266–267, 297-299, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) Authority for such use shall expire when the Commissioner receives the final reports on the ongoing studies in Canada and publishes an order on the safety of saccharin and its salts based on those reports and other available data. (d) The additives are used or intended for use as a sweetening agent only in special dietary foods, as follows: (1) In beverages, fruit juice drinks, and bases or mixes when prepared for consumption in accordance with directions, in amounts not to exceed 12 milligrams of the additive, calculated as saccharin, per fluid ounce. (2) As a sugar substitute for cooking or table use, in amounts not to exceed 20 milligrams of the additive, calculated as saccharin, for each expressed teaspoonful of sugar sweetening equivalency. (3) In processed foods, in amounts not to exceed 30 milligrams of the additive, calculated as saccharin, per serving of designated size. (e) The additives are used or intended for use only for the following technological purposes: (1) To reduce bulk and enhance flavors in chewable vitamin tablets, chewable mineral tablets, or combinations thereof. (2) To retain flavor and physical properties of chewing gum. (3) To enhance flavor of flavor chips used in nonstandardized bakery products. (f) To assure safe use of the additives, in addition to the other information required by the Act: (1) The label of the additive and any intermediate mixes of the additive for manufacturing purposes shall bear: (i) The name of the additive. (ii) A statement of the concentration of the additive, expressed as saccharin, in any intermediate mix. (iii) Adequate directions for use to provide a final food product that complies with the limitations prescribed in paragraphs (d) and (e) of this section. (2) The label of any finished food product containing the additive shall bear: (i) The name of the additive. (ii) The amount of the additive, calculated as saccharin, as follows: (a) For beverages, in milligrams per fluid ounce; (b) For cooking or table use products, in milligrams per dispensing unit; (c) For processed foods, in terms of the weight or size of a serving which shall be that quantity of the food containing 30 milligrams or less of the additive. (iii) When the additive is used for calorie reduction, such other labeling as is required by part 105 or $100.130 of this chapter. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984] (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 priorsanctioned 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. [42 FR 14638, Mar. 15, 1977, as amended at 42 FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, 1989] § 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 §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. Subpart B-Specific Prior- § 181.22 Certain substances employed in the manufacture of food-packaging materials. 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] Tall oil. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977] § 181.27 Plasticizers. Substances classified as plasticizers, when migrating from food-packaging material shall include: Acetyl tributyl citrate. Acetyl triethyl citrate. Butylphthalyl butyl glycolate. Dibutyl sebacate. Di-(2-ethylhexyl) phthalate (for foods of high water content only). Diethyl phthalate. Diisooctyl phthalate (for foods of high water content only). Diphenyl-2-ethylhexyl phosphate. Epoxidized soybean oil (iodine number maximum 6; and oxirane oxygen, minimum, 6.0 percent). Ethylphthalyl ethyl glycolate. Glycerol monooleate. Monoisopropyl citrate. Mono, di-, and tristearyl citrate. 3-(2-Xenolyl)-1,2-epoxypropane. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 50 FR 49536, Dec. 3, 1985] § 181.28 Release agents. Substances classified as release agents, when migrating from foodpackaging material shall include: Dimethylpolysiloxane (substantially free from hydrolyzable chloride and alkoxy groups, no more than 18 percent loss in weight after heating 4 hours at 200 °C.; viscosity 300 centisokes, 600 centisokes at 25 °C, specific gravity 0.96 to 0.97 at 25 °C, refractive index 1.400 to 1.404 at 25 °C). Linoleamide (linoleic acid amide). Oleamide (oleic acid amide). Palmitamide (palmitic acid amide). Stearamide (stearic acid amide). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977] § 181.29 Stabilizers. Substances classified as stabilizers, when migrating from food-packaging material shall include: Aluminum mono-, di-, and tristearate. Ammonium citrate. Ammonium potassium hydrogen phosphate. Calcium glycerophosphate. Calcium phosphate. Calcium hydrogen phosphate. Calcium acetate. Calcium carbonate. Disodium hydrogen phosphate. Magnesium hydrogen phosphate. Potassium stearate. Sodium pyrophosphate. Sodium tetrapyrophosphate. Stannous stearate (not to exceed 50 parts per million tin as a migrant in finished food). Zinc orthophosphate (not to exceed 50 parts per million zinc as a migrant in finished food). Zinc resinate (not to exceed 50 parts per million zinc as a migrant in finished food). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977] § 181.30 Substances used in the manufacture of paper and paperboard products used in food packaging. Substances used in the manufacture of paper and paperboard products used in food packaging shall include: Aliphatic polyoxyethylene ethers.* 1-Alkyl (C6-C18)3-amino-3-aminopropane Methyl ethers of mono-, di-, and tripropylene glycol.* Myristo chromic chloride complex. Polyethylene glycol 400. Potassium pentachlorophenate as a slime control agent.* Potassium trichlorophenate as a slime control agent.* Resins from high and low viscosity polyvinyl alcohol for fatty foods only. Rubber hydrochloride. Sodium pentachlorophenate as a slime control agent.* Sodium-trichlorophenate as a slime control agent.* Stearato-chromic chloride complex. Titanium dioxide.* Urea formaldehyde polymer. Vinylidine chlorides (polymerized). § 181.32 Acrylonitrile copolymers and resins. (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: (1) Films. (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. (2) Coatings. (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 mer-no restrictions. copoly |