73.1001 Diluents in color additive mixtures for drug use exempt from certification. 73.1010 Alumina (dried aluminum hydroxide). 73.1015 Chromium-cobalt-aluminum oxide. 73.1025 Ferric ammonium citrate. 73.1030 Annatto extract. 73.1070 Calcium carbonate. 73.1075 Canthaxanthin. 73.1085 Caramel. 73.1095 B-Carotene. 73.1100 Cochineal extract; carmine. 73.1125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex). 73.1150 Dihydroxyacetone. 73.1162 Bismuth oxychloride. 73.1200 Synthetic iron oxide. 73.1298 Ferric ammonium ferrocyanide. 73.1299 Ferric ferrocyanide. 73.1326 Chromium hydroxide green. 73.1327 Chromium oxide greens. 73.1329 Guanine. 73.1375 Pyrogallol. 73.3117 16,23-Dihydrodinaphtho[2,3-a:2',3'i] naphth [2',3':6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone. 73.3118 N,N'-(9,10-Dihydro-9,10-dioxo-1,5anthracenediyl) bisbenzamide. 73.3119 7,16-Dichloro-6,15-dihydro 5,9,14,18-anthrazinetetrone. 73.3120 16,17-Dimethoxydinaphtho [1,2,3cd:3',2',1'-lm] perylene-5,10-dione. 73.3121 Poly(hydroxyethyl methacrylate)dye copolymers. 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4dihydro-5-methyl-2-phenyl-3H-pyrazol-3 one. 73.3123 6-Ethoxy-2-(6-ethoxy-3 oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one. 73.3124 Phthalocyanine green. 73.3125 Iron oxides. 73.3126 Titanium dioxide. AUTHORITY: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601, 602, 701, 706 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 376). SOURCE: 42 FR 15643, Mar. 22, 1977, unless otherwise noted. Castor oil. Substances Dioctylsodium sulfosuccinate.. cation for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use. (a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201(s) of the act. (2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations. (3) The following: Definitions and specifications As set forth in U.S.P. XVI Restrictions Not more than 500 p.p.m. in the finished food. Labeling of color additive mixtures containing castor oil shall bear adequate directions for use that will result in a food meeting this restriction. As set forth in sec. 172.810 of this Not more than 9 p.p.m. in the finished chapter. food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. (b) Special use-(1) Diluents in color additive mixtures for marking food—(i) Inks for marking food supplements in tablet form, gum, and confectionery. Items listed in paragraph (a) of this section and the following: Polyoxyethylene sorbitan monooleate (poly- As set forth in sec. 172.840 of this Shellac, purified. Molecular weight, minimum 2,000 As set forth in sec. 173.55 of this As set forth in sec. 172.615 of this Food grade (ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following: § 73.30 Annatto extract. (a) Identity. (1) The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., using any one or an appropriate combination of the food-grade extractants listed in paragraph (a)(1) (i) and (ii) of this section: (i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrys tallization, using the solvents listed under paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity. (ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene. (2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications: (1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million. (2) When solvents listed under paragraph (a)(1)(ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter. (c) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. Labels shall bear information showing that the color is derived from annatto seed. The requirements of § 70.25(a) of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in paragraph (a)(1)(ii) of this section. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. § 73.40 Dehydrated beets (beet powder). (a) Identity. (1) The color additive dehydrated beets is a dark red powder prepared by dehydrating sound, mature, good quality, edible beets. (2) Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. The color additive shall conform to the following specifications: Volatile matter, not more than 4 percent. Acid insoluble ash, not more than 0.5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. Dehydrated beets may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (a) Identity. The color additive ultramarine blue is a blue pigment obtained by calcining a mixture of kaolin, sulfur, sodium carbonate, and carbon at temperatures above 700° C. Sodium sulfate and silica may also be incorporated in the mixture in order to vary the shade. The pigment is a complex sodium aluminum sulfo-silicate having the approximate formula Na,Ai.SiO2 S3. (b) Specifications. Ultramarine blue shall conform to the following specifications: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. The color additive ultramarine blue may be safely used for coloring salt intended for animal feed subject to the restriction that the quantity of ultramarine blue does not exceed 0.5 percent by weight of the salt. 1 percent solution in chloroform, complete and clear. Melting range (decomposition), 207° C. to 212° C. (corrected). Loss on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Total carotenoids other than trans-canthax- (c) Use and restrictions. (1) The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions: (i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food. (ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (2) Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of the canthaxanthin incorporated in feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985] |