[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR73.1] [Page 365-368] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents Subpart A_Foods Sec. 73.1 Diluents in color additive mixtures for food use exempt from certification. Subpart A_Foods Sec. 73.1 Diluents in color additive mixtures for food use exempt from certification. 73.30 Annatto extract. 73.35 Astaxanthin. 73.40 Dehydrated beets (beet powder). 73.50 Ultramarine blue. 73.75 Canthaxanthin. 73.85 Caramel. 73.90 [beta]-Apo-8'-carotenal. 73.95 [beta]-Carotene. 73.100 Cochineal extract; carmine. [[Page 366]] 73.125 Sodium copper chlorophyllin. 73.140 Toasted partially defatted cooked cottonseed flour. 73.160 Ferrous gluconate. 73.165 Ferrous lactate. 73.169 Grape color extract. 73.170 Grape skin extract (enocianina). 73.185 Haematococcus algae meal. 73.200 Synthetic iron oxide. 73.250 Fruit juice. 73.260 Vegetable juice. 73.275 Dried algae meal. 73.295 Tagetes (Aztec marigold) meal and extract. 73.300 Carrot oil. 73.315 Corn endosperm oil. 73.340 Paprika. 73.345 Paprika oleoresin. 73.355 Phaffia yeast. 73.450 Riboflavin. 73.500 Saffron. 73.575 Titanium dioxide. 73.600 Turmeric. 73.615 Turmeric oleoresin. Subpart B_Drugs 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 [beta]-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. 73.1400 Pyrophyllite. 73.1410 Logwood extract. 73.1496 Mica. 73.1550 Talc. 73.1575 Titanium dioxide. 73.1645 Aluminum powder. 73.1646 Bronze powder. 73.1647 Copper powder. 73.1991 Zinc oxide. Subpart C_Cosmetics 73.2030 Annatto. 73.2085 Caramel. 73.2087 Carmine. 73.2095 [beta]-Carotene. 73.2110 Bismuth citrate. 73.2120 Disodium EDTA-copper. 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex). 73.2150 Dihydroxyacetone. 73.2162 Bismuth oxychloride. 73.2180 Guaiazulene. 73.2190 Henna. 73.2250 Iron oxides. 73.2298 Ferric ammonium ferrocyanide. 73.2299 Ferric ferrocyanide. 73.2326 Chromium hydroxide green. 73.2327 Chromium oxide greens. 73.2329 Guanine. 73.2396 Lead acetate. 73.2400 Pyrophyllite. 73.2496 Mica. 73.2500 Silver. 73.2575 Titanium dioxide. 73.2645 Aluminum powder. 73.2646 Bronze powder. 73.2647 Copper powder. 73.2725 Ultramarines. 73.2775 Manganese violet. 73.2991 Zinc oxide. 73.2995 Luminescent zinc sulfide. Subpart D_Medical Devices 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2- propenoic)ester copolymers. 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. 73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. 73.3107 Carbazole violet. 73.3110 Chlorophyllin-copper complex, oil soluble. 73.3110a Chromium-cobalt-aluminum oxide. 73.3111 Chromium oxide greens. 73.3112 C.I. Vat Orange 1. 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5- benzenetriol. 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-1,5-anthracenediyl) bisbenzamide. 73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3',2',1'-lm] perylene-5,10- dione. 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers. 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-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. 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products. [[Page 367]] 73.3128 Mica-based pearlescent pigments. Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted. Editorial Note: Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001. The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification 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 Substances specifications Restrictions ------------------------------------------------------------------------ Calcium disodium EDTA Contains calcium May be used in (calcium disodium ethyl- disodium ethyl- aqueous solutions enediamine- tetraacetate). enediamine- and aqueous tetraacetate dispersions as a dihydrate (CAS preservative and Reg. No. 6766-87- sequestrant in 6) as set forth in color additive the Food Chemicals mixtures intended Codex, 3d ed., p. only for ingested 50, 1981. use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous calcium disodium ethyl-enediamine- tetraacetate). Castor oil................... As set forth in Not more than 500 U.S.P. XVI. 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. Dioctylsodium sulfosuccinate. As set forth in Not more than 9 sec. 172.810 of p.p.m. in the this chapter. finished food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. Disodium EDTA (disodium ethyl- Contains disodium May be used in enediamine- tetraacetate). ethyl- enediamine- aqueous solutions tetraacetate and aqueous dihydrate (CAS dispersions as a Reg. No. 6381-92- preservative and 6) as set forth in sequestrant in the Food Chemicals color additive Codex, 3d ed., p. mixtures intended 104, 1981. only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous disodium ethyl- enediamine- tetraacetate). ------------------------------------------------------------------------ (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: ------------------------------------------------------------------------ Definitions and Substances specifications Restrictions ------------------------------------------------------------------------ Alcohol, SDA-3A.............. As set forth in 26 No residue. CFR pt. 212. n-Butyl alcohol.............. ................... Do. Cetyl alcohol................ As set forth in Do. N.F. XI. Cyclohexane.................. ................... Do. Ethyl cellulose.............. As set forth in sec. 172.868 of this chapter. Ethylene glycol monoethyl ................... Do. ether. Isobutyl alcohol............. ................... Do. Isopropyl alcohol............ ................... Do. Polyoxyethylene sorbitan As set forth in monooleate (polysorbate 80). sec. 172.840 of this chapter. [[Page 368]] Polyvinyl acetate............ Molecular weight, minimum 2,000. Polyvinylpyrrolidone......... As set forth in sec. 173.55 of this chapter. Rosin and rosin derivatives.. As set forth in sec. 172.615 of this chapter. Shellac, purified............ Food grade......... ------------------------------------------------------------------------ (ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following: ------------------------------------------------------------------------ Definitions and Substances specifications Restrictions ------------------------------------------------------------------------ Acetone...................... As set forth in No residue. N.F. XI. Alcohol, SDA-3A.............. As set forth in 26 Do. CFR pt. 212. Benzoin...................... As set forth in U.S.P. XVI. Copal, Manila................ ................... Ethyl acetate................ As set forth in Do. N.F. XI. Ethyl cellulose.............. As set forth in sec. 172.868 of this chapter. Methylene chloride........... ................... Do. Polyvinylpyrrolidone......... As set forth in sec. 173.55 of this chapter. Rosin and rosin derivatives.. As set forth in sec. 172.615 of this chapter. Silicon dioxide.............. As set forth in Not more than 2 pct sec. 172.480 of of the ink solids. this chapter. Terpene resins, natural...... As set forth in sec. 172.615 of this chapter. Terpene resins, synthetic.... Polymers of [alpha]- and [beta]-pinene. ------------------------------------------------------------------------ (2) Diluents in color additive mixtures for coloring shell eggs. Items listed in paragraph (a) of this section and the following, subject to the condition that there is no penetration of the color additive mixture or any of its components through the eggshell into the egg: Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service. Damar gum (resin). Diethylene glycol distearate. Dioctyl sodium sulfosuccinate. Ethyl cellulose (as identified in Sec. 172.868 of this chapter). Ethylene glycol distearate. Japan wax. Limed rosin. Naphtha. Pentaerythritol ester of fumaric acid-rosin adduct. Polyethylene glycol 6000 (as identified in Sec. 172.820 of this chapter). Polyvinyl alcohol. Rosin and rosin derivatives (as identified in Sec. 172.820 of this chapter). (3) Miscellaneous special uses. Items listed in paragraph (a) of this section and the following: ------------------------------------------------------------------------ Definitions and Substances specifications Restrictions ------------------------------------------------------------------------ Polyvinylpyrrolidone......... As set forth in In or as food-tablet sec. 173.55 of coatings; limit, this chapter. not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidon e shall bear adequate directions for use that will result in a food meeting this restriction. ------------------------------------------------------------------------ [42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992]