U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Food Ingredients and Packaging |
Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices
Notice: This document is not intended to be used as a substitute for the regulations that list color additives for use in the United States and the conditions imposed on their use in food, drugs, cosmetics, and medical devices, respectively. These regulations are located in Title 21 of the Code of Federal Regulations Parts 73, 74, 81 and 82. For approved conditions of use, the reader should refer to the regulation for the specific color additive of interest. Please note that color additives listed for use in drugs or cosmetics are not permitted for use in eye area products, injected products, or surgical sutures, unless the regulation for the color additive so states in the uses and restrictions paragraph. In this document, all color additives listed for suture use can be found in the table of color additives approved for use in medical devices. Additional information on color additives can be obtained from the Color Additive Status list. Important clarifications are detailed in the End Notes section.
Contact Information |
Table of Contents
Color Additives Approved for Use in Human Food Part 73, Subpart A: Color additives exempt from batch certification(1) |
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21 CFR Section | Straight Color | EEC# | Year(2)Approved | Uses and Restrictions |
73.30 | Annatto extract | E160b | 1963 | Foods generally. |
73.40 | Dehydrated beets (beet powder) | E162 | 1967 | Foods generally. |
73.75 | Canthaxanthin(3) | E161g | 1969 | Foods generally, NTE(7) 30 mg/lb of solid or semisolid food or per pint of liquid food; May also be used in broiler chicken feed. |
73.85 | Caramel | E150a-d | 1963 | Foods generally. |
73.90 | β-Apo-8'-carotenal | E160e | 1963 | Foods generally, NTE(7): 15 mg/lb solid, 15 mg/pt liquid. |
73.95 | β-Carotene | E160a | 1964 | Foods generally. |
73.100 | Cochineal extract | E120 | 1969 | Foods generally. |
Carmine | 1967 | |||
73.125 | Sodium copper chlorophyllin(3) | E141 | 2002 | Citrus-based dry beverage mixes NTE(7) 0.2 percent in dry mix; extracted from alfalfa. |
73.140 | Toasted partially defatted cooked cottonseed flour | ---- | 1964 | Foods generally. |
73.160 | Ferrous gluconate | ---- | 1967 | Ripe olives. |
73.165 | Ferrous lactate | ---- | 1996 | Ripe olives. |
73.169 | Grape color extract(3) | E163? | 1981 | Nonbeverage food. |
73.170 | Grape skin extract (enocianina) | E163? | 1966 | Still & carbonated drinks & ades; beverage bases; alcoholic beverages (restrict. 27 CFR Parts 4 & 5). |
73.200 | Synthetic iron oxide(3) | E172 | 1994 | Sausage casings NTE(7) 0.1 percent (by wt). |
73.250 | Fruit juice(3) | ---- | 1966 | Foods generally. |
1995 | Dried color additive. | |||
73.260 | Vegetable juice(3) | ---- | 1966 | Foods generally. |
1995 | Dried color additive, water infusion. | |||
73.300 | Carrot oil | ---- | 1967 | Foods generally. |
73.340 | Paprika | E160c | 1966 | Foods generally. |
73.345 | Paprika oleoresin | E160c | 1966 | Foods generally. |
73.350 | Mica-based pearlescent pigments(3) | ---- | 2006 | Cereals, confections and frostings, gelatin desserts, hard and soft candies(including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. |
73.450 | Riboflavin | E101 | 1967 | Foods generally. |
73.500 | Saffron | E164 | 1966 | Foods generally. |
73.575 | Titanium dioxide | E171 | 1966 | Foods generally; NTE(7) 1 percent (by wt). |
73.585 | Tomato lycopene extract; tomato lycopene concentrate(3) | E160 | 2006 | Foods generally. |
73.600 | Turmeric | E100 | 1966 | Foods generally. |
73.615 | Turmeric oleoresin | E100 | 1966 | Foods generally. |
Color Additives Approved for Use in Human Food Part 74, Subpart A: Color additives subject to batch certification(4) |
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21 CFR Section | Straight Color | EEC# | Year(2)Approved | Uses and Restrictions |
74.101 | FD&C Blue No. 1 | E133 | 1969 | Foods generally. |
1993 | Added Mn spec. | |||
74.102 | FD&C Blue No. 2 | E132 | 1987 | Foods generally. |
74.203 | FD&C Green No. 3 | ---- | 1982 | Foods generally. |
74.250 | Orange B(3) | ---- | 1966 | Casings or surfaces of frankfurters and sausages; NTE(7) 150 ppm (by wt). |
74.302 | Citrus Red No. 2 | ---- | 1963 | Skins of oranges not intended or used for processing; NTE(7) 2.0 ppm (by wt). |
74.303 | FD&C Red No. 3 | E127 | 1969 | Foods generally. |
74.340 | FD&C Red No. 40(3) | E129 | 1971 | Foods generally. |
74.705 | FD&C Yellow No. 5 | E102 | 1969 | Foods generally. |
74.706 | FD&C Yellow No. 6 | E110 | 1986 | Foods generally. |
Color Additives Approved for Use in Drugs Part 73, Subpart B: Color additives exempt from batch certification |
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21 CFR Section | Straight Color | Year(2)Approved | Uses and Restrictions |
73.1010 | Alumina (dried aluminum hydroxide) | 1967 | Drugs generally (5). |
73.1030 | Annatto extract | 1963 | Ingested drugs generally(5); external drugs(6) including eye area use. |
73.1070 | Calcium carbonate | 1967 | Drugs generally (5). |
73.1075 | Canthaxanthin(3) | 1969 | Ingested drugs generally (5). |
73.1085 | Caramel | 1963 | Ingested and topically applied drugs generally (5),(6). |
73.1095 | β-Carotene | 1964 | Ingested drugs generally(5). |
1977 | Externally applied drugs(6) including eye area use. | ||
73.1100 | Cochineal extract | 1969 | Ingested and externally applied drugs(6). |
Carmine | 1967 | ||
73.1125 | Potassium sodium copper chlorophyllin (chlorophyllin-copper complex) | 1969 | Dentrifices that are drugs; NTE(7) 0.1% |
73.1150 | Dihydroxyacetone | 1973 | Externally applied drugs(6) intended solely or in part to impart a color to the human body |
73.1162 | Bismuth oxychloride | 1977 | Externally applied drugs (6) including eye area use. |
73.1200 | Synthetic iron oxide | 1966 | Ingested or topically applied drugs(6) ingested dosage by man NTE(7) 5 mg/d (as Fe). |
73.1298 | Ferric ammonium ferrocyanide | 1977 | Externally applied drugs(6) including eye area use. |
73.1299 | Ferric ferrocyanide | 1977 | Externally applied drugs including(6) eye area use. |
73.1326 | Chromium hydroxide green | 1977 | Externally applied drugs(6) including eye area use. |
73.1327 | Chromium oxide greens | 1977 | Externally applied drugs(6) including eye area use. |
73.1329 | Guanine | 1977 | Externally applied drugs(6) including eye area use. |
73.1350 | Mica-based pearlescent pigments (3) | 2006 | Ingested drugs NTE(7) 3%. Iron NTE(7) 55 wt %. |
73.1400 | Pyrophyllite | 1966 | Externally applied drugs(6). |
73.1496 | Mica | 1977 | Externally applied drugs(6) including eye area use. |
1987 | Dentifrices. | ||
73.1550 | Talc | 1967 | Drugs generally (5). |
73.1575 | Titanium dioxide | 1966 | Drugs generally(5) including eye area use. |
73.1645 | Aluminum powder | 1977 | Externally applied drugs(6) including eye area use. |
73.1646 | Bronze powder | 1977 | Externally applied drugs(6) including eye area use. |
73.1647 | Copper powder | 1977 | Externally applied drugs(6) including eye area use. |
73.1991 | Zinc oxide | 1977 | Externally applied drugs(6) including eye area use. |
Color Additives Approved for Use in Drugs Part 74, Subpart B: Color additives subject to batch certification |
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21 CFR Section | Straight Color | Year(2)Approved | Uses and Restrictions |
74.1101 | FD&C Blue No. 1 | 1969 | Ingested drugs generally(5). |
1982 | Externally applied drugs(6) . | ||
1994 | Eye area use (includes lake). | ||
74.1102 | FD&C Blue No. 2 | 1987 | Ingested drugs. |
74.1104 | D&C Blue No. 4 | 1977 | Externally applied drugs(6) . |
74.1203 | FD&C Green No. 3 | 1982 | Drugs generally (5). |
74.1205 | D&C Green No. 5 | 1982 | Drugs generally(5). |
1994 | Eye area use. | ||
74.1206 | D&C Green No. 6 | 1982 | Externally applied drugs(6) . |
74.1208 | D&C Green No. 8 | 1976 | Externally applied drugs(6) (NTE(7) 0.01% (by weight)). |
74.1254 | D&C Orange No. 4 | 1977 | Externally applied drugs (6) . |
74.1255 | D&C Orange No. 5 | 1984 | Externally applied drugs (6) (NTE(7) 5 mg/daily dose of drug). |
1982 | Mouthwashes and dentifrices. | ||
74.1260 | D&C Orange No. 10 | 1981 | Externally applied drugs (6) . |
74.1261 | D&C Orange No. 11 | 1981 | Externally applied drugs (6) . |
74.1303 | FD&C Red No. 3 | 1969 | Ingested drugs. |
74.1304 | FD&C Red No. 4 | 1976 | Externally applied drugs (6) . |
74.1306 | D&C Red No. 6 | 1983 | Drugs such that total with D&C Red No. 7 NTE(7) 5 mg/daily dose of drug. |
74.1307 | D&C Red No. 7 | 1983 | Drugs such that total with D&C Red No. 6 NTE(7) 5 mg/daily dose of drug. |
74.1317 | D&C Red No. 17 | 1976 | Externally applied drugs(6) . |
74.1321 | D&C Red No. 21 | 1983 | Drugs generally (5). |
74.1322 | D&C Red No. 22 | 1983 | Drugs generally (5). |
74.1327 | D&C Red No. 27 | 1982 | Drugs generally (5). |
74.1328 | D&C Red No. 28 | 1982 | Drugs generally (5). |
74.1330 | D&C Red No. 30 | 1982 | Drugs generally (5). |
74.1331 | D&C Red No. 31 | 1976 | Externally applied drugs(6) . |
74.1333 | D&C Red No. 33 | 1988 | Ingested drugs, other than mouthwashes and dentifrices (NTE(7) 0.75 mg/daily dose of drug); externally applied drugs(6) mouthwashes and dentifrices. |
74.1334 | D&C Red No. 34 | 1976 | Externally applied drugs(6) . |
74.1336 | D&C Red No. 36 | 1989 | Ingested drugs, other than mouthwashes and dentifrices, NTE(7) 1.7 mg/daily dose for drugs taken less than 1 yr; NTE(7) 1.0 mg/daily dose for drugs taken more than 1 yr. |
1988 | Externally applied drugs(6) . | ||
74.1339 | D&C Red No. 39 | 1966 | Quaternary ammonium type germicidal solutions for external application (NTE(7) 0.1% (by wt) of finished drug product). |
74.1340 | FD&C Red No. 40(3) | 1971 | Drugs generally(5). |
1994 | Eye area use (includes lake). | ||
74.1602 | D&C Violet No. 2 | 1976 | Externally applied drugs(6) . |
74.1705 | FD&C Yellow No. 5 | 1969 | Ingested drugs generally(5). |
1985 | Externally applied drugs(6) . | ||
1994 | Eye area use (includes lake). | ||
74.1706 | FD&C Yellow No. 6 | 1986 | Drugs generally (5). |
74.1707 | D&C Yellow No. 7 | 1976 | Externally applied drugs(6) . |
74.1707a | Ext. D&C Yellow No. 7 | 1976 | Externally applied drugs(6) . |
74.1708 | D&C Yellow No. 8 | 1976 | Externally applied drugs(6) . |
74.1710 | D&C Yellow No. 10 | 1983 | Drugs generally (5). |
1984 | Modification of uses and restrictions. | ||
74.1711 | D&C Yellow No. 11 | 1976 | Externally applied drugs(6) . |
Color Additives Approved for Use in Cosmetics Part 73, Subpart C: Color additives exempt from batch certification |
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21 CFR Section | Straight Color | Year(2)Approved | Uses and Restrictions |
73.2030 | Annatto | 1977 | Cosmetics generally(5) including eye area use. |
73.2085 | Caramel | 1981 | Cosmetics generally(5) including eye area use. |
73.2087 | Carmine | 1977 | Cosmetics generally(5) including eye area use. |
73.2095 | β-Carotene | 1977 | Cosmetics generally(5) including eye area use. |
73.2110 | Bismuth citrate(3) | 1978 | Cosmetics intended for coloring hair on the scalp only NTE(7) 0.5 percent. |
73.2120 | Disodium EDTA-copper | 1974 | Coloring of shampoos that are cosmetics. |
73.2125 | Potassium sodium copper chlorophyllin (chlorophyllin copper-complex) | 1969 | Coloring dentifrices that are cosmetics NTE(7) 0.1% in combination with a list of substances. |
73.2150 | Dihydroxyacetone | 1973 | Externally applied cosmetics(6) intended solely or in part to impart color to the human body. |
73.2162 | Bismuth oxychloride | 1977 | Cosmetics generally(5) including eye area use. |
73.2180 | Guaiazulene | 1977 | Externally applied cosmetics(6). |
73.2190 | Henna(3) | 1965 | Coloring hair but not eyelashes, eyebrows, or eye area. |
73.2250 | Iron oxides | 1977 | Cosmetics generally(5) including eye area use. |
73.2298 | Ferric ammonium ferrocyanide | 1977 | Externally applied cosmetics(6) including eye area use. |
73.2299 | Ferric ferrocyanide | 1978 | Externally applied cosmetics(6) including eye area use. |
73.2326 | Chromium hydroxide green | 1977 | Externally applied cosmetics(6) including eye area use. |
73.2327 | Chromium oxide greens | 1977 | Externally applied cosmetics(6) including eye area use. |
73.2329 | Guanine | 1977 | Cosmetics generally(5) including eye area use. |
73.2396 | Lead acetate(3) | 1981 | Cosmetics intended for coloring hair on the scalp only, NTE(7) 0.6 percent Pb (weight/volume). |
73.2400 | Pyrophyllite | 1973 | Externally applied cosmetics(6). |
73.2496 | Mica | 1977 | Cosmetics generally(5) including eye area use. |
73.2500 | Silver (3) | 1979 | Coloring fingernail polish NTE(7) 1% of final product. |
73.2575 | Titanium dioxide | 1973 | Cosmetics including eye area use. |
73.2645 | Aluminum powder | 1977 | Externally applied cosmetics(6) including eye area use. |
73.2646 | Bronze powder | 1977 | Cosmetics generally(5) including eye area use. |
73.2647 | Copper powder | 1977 | Cosmetics generally(5) including eye area use. |
73.2725 | Ultramarines | 1976 | Externally applied cosmetics(6) including eye area use. |
73.2775 | Manganese violet | 1976 | Cosmetics generally(5) including eye area use. |
73.2991 | Zinc oxide | 1977 | Cosmetics including eye area use. |
73.2995 | Luminescent zinc sulfide (3) | 2000 | Nail polish and externally applied facial makeup(6) NTE(7) 10% of final product for limited, occasional use. |
Color Additives Approved for Use in Cosmetics Part 74, Subpart C: Color additives subject to batch certification(4) |
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21 CFR Section | Straight Color | Year(2)Approved | Uses and Restrictions |
74.2052 | D&C Black No. 2 | 2004 | Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel. |
74.2053 | D&C Black No. 3 (3) | 2007 | Eyeliner, eye shadow, mascara, and face powder. |
74.2101 | FD&C Blue No. 1 | 1982 | Cosmetics generally(5). |
1993 | Allows MnO2 in manufacture. | ||
1994 | Eye area use (includes lake). | ||
74.2104 | D&C Blue No. 4 | 1977 | Externally applied cosmetics(6) . |
74.2151 | D&C Brown No. 1 | 1976 | Externally applied cosmetics(6) . |
74.2203 | FD&C Green No. 3 | 1982 | Cosmetics generally (5). |
74.2205 | D&C Green No. 5 | 1982 | Cosmetics generally(5). |
1994 | Eye area use. | ||
74.2206 | D&C Green No. 6 | 1982 | Externally applied cosmetics(6) . |
74.2208 | D&C Green No. 8 | 1976 | Externally applied cosmetics(6) (NTE(7) 0.01% (by wt) of finished cosmetic product). |
74.2254 | D&C Orange No. 4 | 1977 | Externally applied cosmetics(6) . |
74.2255 | D&C Orange No. 5 | 1984 | Externally applied cosmetics(6) . |
1982 | Mouthwashes, dentifrices, lipsticks, and other lip cosmetics NTE(7) 5 percent. | ||
74.2260 | D&C Orange No. 10 | 1981 | Externally applied cosmetics(6) . |
74.2261 | D&C Orange No. 11 | 1981 | Externally applied cosmetics(6) . |
74.2304 | FD&C Red No. 4 | 1976 | Externally applied cosmetics(6) . |
74.2306 | D&C Red No. 6 | 1983 | Cosmetics generally (5). |
74.2307 | D&C Red No. 7 | 1983 | Cosmetics generally (5). |
74.2317 | D&C Red No. 17 | 1976 | Externally applied cosmetics(6) . |
74.2321 | D&C Red No. 21 | 1982 | Cosmetics generally (5). |
74.2322 | D&C Red No. 22 | 1982 | Cosmetics generally (5). |
74.2327 | D&C Red No. 27 | 1982 | Cosmetics generally (5). |
74.2328 | D&C Red No. 28 | 1982 | Cosmetics generally (5). |
74.2330 | D&C Red No. 30 | 1982 | Cosmetics generally (5). |
74.2331 | D&C Red No. 31 | 1976 | Externally applied cosmetics(6) . |
74.2333 | D&C Red No. 33 | 1988 | Externally applied cosmetics(6) ; mouthwashes, dentifrices; cosmetic lip products (NTE(7) 3% (by wt) of finished cosmetic product). |
74.2334 | D&C Red No. 34 | 1976 | Externally applied cosmetics(6) . |
74.2336 | D&C Red No. 36 | 1988 | Externally applied cosmetics(6); cosmetic lip products (NTE(7) 3% (by wt) of finished cosmetic product). |
74.2340 | FD&C Red No. 40(3) | 1975 | Cosmetics generally(5). |
1994 | Eye area use (includes Al lake). No oxidizing or reducing agents that may affect integrity. | ||
74.2602 | D&C Violet No. 2 | 1976 | Externally applied cosmetics(6) . |
74.2602a | Ext. D&C Violet No. 2 | 1976 | Externally applied cosmetics(6) . |
74.2705 | FD&C Yellow No. 5 | 1985 | Cosmetics generally(5). |
1994 | Eye area use (includes Al lake). | ||
74.2706 | FD&C Yellow No. 6 | 1986 | Cosmetics generally (5). |
74.2707 | D&C Yellow No. 7 | 1976 | Externally applied cosmetics(6). |
74.2707a | Ext. D&C Yellow No. 7 | 1976 | Externally applied cosmetics(6). |
74.2708 | D&C Yellow No. 8 | 1976 | Externally applied cosmetics(6). |
74.2710 | D&C Yellow No. 10 | 1983 | Cosmetics generally (5). |
1984 | Modification of uses and restrictions. | ||
74.2711 | D&C Yellow No. 11 | 1976 | Externally applied cosmetics(6). |
Color Additives Approved for Use in Medical Devices Part 73, Subpart D: Color additives exempt from batch certification |
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21 CFR Section | Straight Color | Year(2)Approved | Uses and Restrictions |
73.1015 | Chromium-cobalt-aluminum oxide | 1974 | Linear polyethylene surgical sutures NTE(7) 2% general surgery. |
73.1025 | Ferric ammonium citrate | 1973 | With pyrogallol for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery. |
73.1375 | Pyrogallol | 1973 | With ferric ammonium citrate for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery. |
73.1410 | Logwood extract | 1977 | For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE(7) 1% general and ophthalmic surgery. |
73.3100 | 1,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers(3) | 1996 | Contact lenses |
73.3105 | 1,4-Bis [(2-methylphenyl)amino] -9,10-anthracenedione(3) | 1984 | Contact lenses. |
73.3106 | 1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3) | 1990 | Contact lenses. |
1993 | Added copolymer, renamed. | ||
1995 | Additional copolymer. | ||
73.3107 | Carbazole violet(3) | 1988 | Contact lenses. |
73.3110 | Chlorophyllin-copper complex, oil soluble(3) | 1984 | Bone cement only NTE(7) 0.003%. |
73.3110a | Chromium-cobalt-aluminum oxide(3) | 1988 | Contact lenses. |
73.3111 | Chromium oxide greens(3) | 1986 | Contact lenses. |
73.3112 | C.I. Vat Orange 1(3) | 1985 | Contact lenses. |
73.3115 | 2-[[2,5-Diethoxy- 4-[(4-methylphenyl)thiol] phenyl]azo] -1,3,5-benzenetriol(3) | 1983 | Formed in situ in soft contact lenses to mark L and R NTE(7) 1.1x10-7 g/lens. |
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(3) | 1983 | Contact lenses. |
73.3118 | N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl) bisbenzamide(3) | 1983 | Contact lenses. |
73.3119 | 7,16-Dichloro- 6,15-dihydro- 5,9,14,18-anthrazinetetrone(3) | 1983 | Contact lenses. |
73.3120 | 16,17-Dimethoxydinaphtho (1,2,3-cd:3',2',1'-lm) perylene-5,10-dione(3) | 1983 | Contact lenses. |
73.3121 | Poly(hydroxyethyl methacrylate) -dye copolymers(3): one or more of (1) Reactive Black 5 | 1984 | Contact lenses. |
(2) Reactive Blue 21 | 1984 | ||
(3) Reactive Orange 78 | 1984 | ||
(4) Reactive Yellow 15 | 1984 | ||
(5) Reactive Blue No. 19 | 1985 | ||
(6) Reactive Blue No. 4 | 1985 | ||
(7) C.I. Reactive Red 11 | 1985 | ||
(8) C.I. Reactive Yellow 86 | 1985 | ||
(9) C.I. Reactive Blue 163 | 1985 | ||
(10) C.I. Reactive Red 180 | 1993 | ||
73.3122 | 4-[(2,4-dimethylphenyl)azo]- 2,4-dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one(3) | 1986 | Contact lenses. |
73.3123 | 6-Ethoxy-2- (6-ethoxy-3-oxobenzo[b] thien-2(3H)- ylidene) benzo[b]thiophen- 3(2H)-one(3) | 1986 | Contact lenses. |
73.3124 | Phthalocyanine green(3) | 1986 | Contact lenses. |
73.3125 | Iron oxides(3) | 1986 | Contact lenses. |
73.3126 | Titanium dioxide(3) | 1986 | Contact lenses. |
73.3127 | Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (1) C.I. Reactive Red 180 | 1993 | Contact lenses. |
(2) C.I. Reactive Black 5 | |||
(3) C.I. Reactive Orange 78 | |||
(4) C.I. Reactive Yellow 15 | |||
(5) C.I. Reactive Blue No. 19 | |||
(6) C.I. Reactive Blue 21 | |||
73.3128 | Mica-based pearlescent pigments(3) | 2002 | Contact lenses |
Color Additives Approved for Use in Medical Devices Part 74, Subpart D: Color additives subject to batch certification(4) |
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21 CFR Section | Straight Color | Year(2)Approved | Uses and Restrictions |
74.1109 | D&C Blue No. 9 | 1974 | Cotton and silk surgical sutures; NTE(7) 2.5% general and ophthalmic use. |
74.1205 | D&C Green No. 5 | 1973 | Nylon 66 nonabsorbable sutures; NTE(7) 0.6% general surgery. |
1977 | Nylon 6 same conditions. | ||
74.3045 | [Phthalocyaninato(2-)] copper | 1969 | Polypropylene sutures NTE(7) 0.5%. |
1983(3), 1986(3) | Contact lenses.
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1985(3) | Polybutester sutures NTE(7) 0.5%. | ||
1986(3) | Increased chlorine spec. | ||
1987(3) | Haptics for intraocular lens NTE(7) 0.5%. | ||
1990(3) | Polybutylene terephthalate sutures NTE(7) 0.5%. | ||
1999(3) | Poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene) nonabsorbable sutures. | ||
74.3102 | FD&C Blue No. 2 | 1971 1999 |
Nylon surgical sutures; NTE(7) 1% general surgery. Suture listing moved from 74.1102 to 74.3102 |
1999(3) | Bone cement (Al lake) NTE(7) 0.1% | ||
74.3106 | D&C Blue No. 6 | 1978, 1985(3) |
Various sutures NTE(7) specified levels. |
74.3206 | D&C Green No. 6 | 1963, 1975 | Various sutures NTE(7) specified levels. |
1983(3) | Contact lenses NTE(7) 0.03%. | ||
1986(3) | Uniform specifications. | ||
1993(3) | Haptics of intraocular lenses NTE(7) 0.1%. | ||
74.3230 | D&C Red No. 17 | 1990(3) | Contact lenses. |
74.3602 | D&C Violet No. 2 | 1974 1980 (3) 1993 (3) 1994 (3) 1998 (3) 2000 (3) |
NTE(7) 0.2 percent by wt in glycolic-lactic acid polyester absorbable sutures NTE(7) 0.3 percent in polydioxanone synthetic absorbable sutures NTE(7) 0.25 percent in epsilon caprolactone/glycolide copolymer absorbable sutures NTE(7) 0.1 percent in poly epsilon caprolactone absorbable sutures NTE(7) 0.2 percent in glycolide/dioxanone/ triethylene carbonate tripolymer absorbable sutures NTE(7) 0.2 percent in absorbable sutures from homopolymers of glycolide. |
1987(3) | Contact lenses. | ||
1990(3) 1999 (3) |
NTE(7) 0.2 percent of intraocular lens haptics. NTE(7) 0.15 percent by weight of meniscal tacks. |
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74.3710 | D&C Yellow No. 10 | 1987(3) | Contact lenses. |
End Notes
The color additives Astaxanthin, Ultramarine blue, Canthaxanthin, Synthetic iron oxide, Dried algae meal, Tagetes (Aztec marigold) meal and extract, and Corn endosperm oil are approved for specific uses in animal food (see 21 CFR 73.35,73.50, 73.75, 73.200, 73.275, 73.295, and 73.315, respectively). Haematococcus algae meal (21 CFR 73.185) and Phaffia yeast (21 CFR 73.355) for use in fish feed to color salmonids were added in 7/6/2000.
The year approved is based on the date listed in the "Confirmation of Effective Date" notice for the action as published in the Federal Register.
Petitioned for use after the 1960 amendments; not provisionally listed.
Color additives listed in 21 CFR Parts 74 and 82 must be analyzed and batch certified by FDA before they can be used in any FDA-regulated product marketed in the U.S. This requirement applies to products imported into this country as well as those manufactured domestically. Manufacturers of certified color additives must include on the label the name of the certified color additive, a statement indicating general use limitations, any quantitative limitations in products, and the certification lot number assigned to the batch. Straight colors required to be certified are listed in 21 CFR Part 74. Most lakes are provisionally listed under 21 CFR 81.1 for use as listed in 21 CFR 82.51 (food, drugs, and cosmetics), 21 CFR 82.1051 (drugs and cosmetics), or 21 CFR 82.2051 (externally applied drugs and cosmetics). All FD&C Red No. 40 lakes are permanently listed under 21 CFR 74.340 (food), 74.1340 (drugs), and 74.2340 (cosmetics). FD&C Blue No. 1 and FD&C Yellow No. 5 aluminum lakes for drug and cosmetic use are permanently listed in 21 CFR sections 74.1101, 74.1705, 74.2101, and 74.2705.
Color additives that are permitted for general use may not be used in the area of the eye, in injections, or in surgical sutures unless such use is specified in the color additive listing regulation. Currently no color additives are listed for use in injected products (such as tattoos or permanent makeup).
Color additives that are permitted for external application may not be used in the area of the eye, in injections, or in surgical sutures unless such use is specified in the color additive listing regulation. Currently no color additives are listed for use in injected products (such as tattoos or permanent makeup). Some color additives that are permitted for external application also may be permitted in mouthwashes, dentifrices, or lipsticks in limited amounts specified in the color additive listing regulations.