<
 
 
 
 
>
hide
You are viewing a Web site, archived on 06:30:09 Oct 31, 2004. It is now a Federal record managed by the National Archives and Records Administration.
External links, forms, and search boxes may not function within this collection.

U.S. Department of Health & Human Services
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 Foods, 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 foods, drugs, cosmetics, and medical devices. These regulations may be found in Title 21 of the Code of Federal Regulations Parts 73 and 74. This summary groups the color additives according to their categories of use and identifies the listing citation in Title 21 for each color additive. The reader should refer to the regulation for the specific color additive of interest. Any questions about the use of color additives may be referred to the following address:

Office of Food Additive Safety (HFS-200)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
202-418-3066

Table of Contents

Notes

  1. 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 foods (see 21 CFR 73.35,73.50, 73.75, 73.200, 73.275, 73.295, 73.315, respectively). Haematococcus algae meal (21 CFR 73.185) and Phaffia yeast (21 CFR 73.355) for use in fish feed to color salmoids were added in 7/6/2000.

  2. 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.

  3. Petitioned for use after the 1960 amendments; not provisionally listed.

  4. Lakes of certified straight color additives 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 2051 (external drugs and cosmetics).


Color Additives Approved for Use in Human Food
Part 73, Subpart A: Color additives exempt from batch certification(1)
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 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 beta-Apo-8'-carotenal E160e 1963 Foods generally, NTE: 15 mg/lb solid, 15 mg/pt liquid.
73.95 beta-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 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 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.
73.450 Riboflavin E101 1967 Foods generally.
73.500 Saffron E164 1966 Foods generally.
73.575 Titanium dioxide E171 1966 Foods generally; NTE 1 percent (by wt).
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)
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 150 ppm (by wt).
74.302 Citrus Red No. 2 ---- 1963 Skins of oranges not intended or used for processing; NTE 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
21 CFR Section Straight Color Year(2)Approved Uses and Restrictions
73.1010 Alumina (dried aluminum hydroxide) 1967 Drugs generally.
73.1030 Annatto extract 1963 Ingested drugs generally; external drugs including eye area use.
73.1070 Calcium Carbonate 1967 Drugs generally.
73.1075 Canthaxanthin(3) 1969 Ingested drugs generally.
73.1085 Caramel 1963 Ingested and topically applied drugs generally.
73.1095 beta-Carotene 1964 Ingested drugs generally.
1977 Externally applied drugs including eye area use.
73.1100 Cochineal Extract 1969 Ingested and externally applied drugs.
Carmine 1967
73.1125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex) 1969 Dentrifices that are drugs; NTE 0.1%
73.1150 Dihydroxyacetone 1973 Externally applied drugs intended solely or in part to impart a color to the human body
73.1162 Bismuth oxychloride 1977 Externally applied drugs including eye area use.
73.1200 Synthetic iron oxide 1966 Ingested or topically applied drugs ingested dosage by man NTE 5 mg/d (as Fe).
73.1298 Ferric ammonium ferrocyanide 1977 Externally applied drugs including eye area use.
73.1299 Ferric ferrocyanide 1977 Externally applied drugs including eye area use.
73.1326 Chromium hydroxide green 1977 Externally applied drugs including eye area use.
73.1327 Chromium oxide greens 1977 Externally applied drugs including eye area use.
73.1329 Guanine 1977 Externally applied drugs including eye area use.
73.1400 Pyrophillite 1966 Externally applied drugs.
73.1496 Mica 1977 Externally applied drugs including eye area use.
1987 Dentifrices.
73.1550 Talc 1967 Drugs generally.
73.1575 Titanium dioxide 1966 Drugs generally including eye area use;
73.1645 Aluminum powder 1977 Externally applied drugs including eye area use.
73.1646 Bronze powder 1977 Externally applied drugs including eye area use.
73.1647 Copper Powder 1977 Externally applied drugs including eye area use.
73.1991 Zinc oxide 1977 Externally applied drugs including eye area use.


Color Additives Approved for Use in Drugs(4)
Part 74, Subpart B: Color additives subject to batch certification
21 CFR Section Straight Color Year(2)Approved Uses and Restrictions
74.1101 FD&C Blue No. 1 1969 Ingested drugs generally.
1982 Externally applied drugs.
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.
74.1203 FD&C Green No. 3 1982 Drugs generally.
74.1205 D&C Green No. 5 1982 Drugs generally.
1994 Eye area use.
74.1206 D&C Green No. 6 1982 Externally applied drugs.
74.1208 D&C Green No. 8 1976 Externally applied drugs (NTE 0.01% (by weight).
74.1254 D&C Orange No. 4 1977 Externally applied drugs.
74.1255 D&C Orange No. 5 1984 Externally applied drugs (NTE 5 mg/daily dose of drug).
1982 Mouthwashes and dentifrices.
74.1260 D&C Orange No. 10 1981 Externally applied drugs.
74.1261 D&C Orange No. 11 1981 Externally applied drugs.
74.1303 FD&C Red No. 3 1969 Ingested drugs.
74.1304 FD&C Red No. 4 1976 Externally applied drugs.
74.1306 D&C Red No. 6 1983 Drugs such that total with D&C Red No. 7 NTE 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 5 mg/daily dose of drug.
74.1317 D&C Red No. 17 1976 Externally applied drugs.
74.1321 D&C Red No. 21 1983 Drugs generally.
74.1322 D&C Red No. 22 1983 Drugs generally.
74.1327 D&C Red No. 27 1982 Drugs generally.
74.1328 D&C Red No. 28 1982 Drugs generally.
74.1330 D&C Red No. 30 1982 Drugs generally.
74.1331 D&C Red No. 31 1976 Externally applied drugs.
74.1333 D&C Red No. 33 1988 Ingested drugs, other than mouthwashes and dentifrices (NTE 0.75 mg/daily dose of drug); externally applied drugs, mouthwashes and dentifrices.
74.1334 D&C Red No. 34 1976 Externally applied drugs.
74.1336 D&C Red No. 36 1989 Ingested drugs, other than mouthwashes and dentifrices, NTE 1.7 mg/daily dose for drugs taken less than 1 yr; NTE 1.0 mg/daily dose for drugs taken more than 1 yr.
1988 Externally applied drugs.
74.1339 D&C Red No. 39 1966 Quaternary ammonium type germicidal solutions for external application (NTE 0.1% (by wt) of finished drug product).
74.1340 FD&C Red No. 40(3) 1971 Drugs generally.
1994 Eye area use (includes lake).
74.1602 D&C Violet No. 2 1976 Externally applied drugs.
74.1705 FD&C Yellow No. 5 1969 Ingested drugs generally.
1985 Externally applied drugs.
1994 Eye area use (includes lake).
74.1706 FD&C Yellow No. 6 1986 Drugs generally.
74.1707 D&C Yellow No. 7 1976 Externally applied drugs.
74.1707a Ext. D&C Yellow No. 7 1976 Externally applied drugs.
74.1708 D&C Yellow No. 8 1976 Externally applied drugs.
74.1710 D&C Yellow No. 10 1983 Drugs generally.
1984 Modification of uses and restrictions.
74.1711 D&C Yellow No. 11 1976 Externally applied drugs.


Color Additives Approved for Use in Cosmetics
Part 73, Subpart C: Color additives exempt from batch certification
21 CFR Section Straight Color Year(2)Approved Uses and Restrictions
73.2030 Annatto 1977 Cosmetics generally including eye area use.
73.2085 Caramel 1981 Cosmetics generally including eye area use.
73.2087 Carmine 1977 Cosmetics generally including eye area use.
73.2095 beta-Carotene 1977 Cosmetics generally including eye area use.
73.2110 Bismuth citrate(3) 1978 Cosmetics intended for coloring hair on the scalp only NTE 0.1 percent in combination with a list of substances.
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 (w/restrictions).
73.2150 Dihydroxyacetone 1973 Externally applied cosmetics intended solely or in part to impart color to the human body.
73.2162 Bismuth oxychloride 1977 Cosmetics generally including eye area use.
73.2180 Guaiazulene 1977 Externally applied cosmetics.
73.2190 Henna(3) 1965 Coloring hair but not for eye lashes, eyebrows, or eye area.
73.2250 Iron oxides 1977 Cosmetics generally including eye area use.
73.2298 Ferric ammonium ferrocyanide 1977 Externally applied cosmetics including eye area use.
73.2299 Ferric ferrocyanide 1978 Externally applied cosmetics including eye area use.
73.2326 Chromium hydroxide green 1977 Externally applied cosmetics including eye area use.
73.2327 Chromium oxide greens 1977 Externally applied cosmetics including eye area use.
73.2329 Guanine 1977 Cosmetics generally including eye area use.
73.2396 Lead acetate(3) 1981 Cosmetics intended for coloring hair on the scalp only, NTE 0.6 percent (weight/volume).
73.2400 Pyrophyllite 1973 Externally applied cosmetics.
73.2496 Mica 1977 Cosmetics generally including eye area use.
73.2500 Silver (3) 1979 Coloring fingernail polish NTE 1% of final product.
73.2575 Titanium dioxide 1973 Cosmetics including eye area use.
73.2645 Aluminum powder 1977 Externally applied cosmetics including eye area use.
73.2646 Bronze powder 1977 Cosmetics generally including eye area use.
73.2647 Copper powder 1977 Cosmetics generally including eye area use.
73.2725 Ultramarines 1976 Externally applied cosmetics including eye area use.
73.2775 Manganese violet 1976 Cosmetics generally 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 NTE 10% of final product for limited, occasional use.


Color Additives Approved for Use in Cosmetics(4)
Part 74, Subpart C: Color additives subject to batch certification
21 CFR Section Straight Color Year(2)Approved Uses and Restrictions
74.2052 D&C Black No. 2(3) 2004 Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.
74.2101 FD&C Blue No. 1 1982 Cosmetics generally.
1993 Allows MnO2 in manufacture.
1994 Eye area use (includes lake).
74.2104 D&C Blue No. 4 1977 Externally applied cosmetics.
74.2151 D&C Brown No. 1 1976 Externally applied cosmetics.
74.2203 FD&C Green No. 3 1982 Cosmetics generally.
74.2205 D&C Green No. 5 1982 Cosmetics generally.
1994 Eye area use.
74.2206 D&C Green No. 6 1982 Externally applied cosmetics.
74.2208 D&C Green No. 8 1976 Externally applied cosmetics (NTE 0.01% (by wt) of finished cosmetic product).
74.2254 D&C Orange No. 4 1977 Externally applied cosmetics.
74.2255 D&C Orange No. 5 1984 Externally applied cosmetics.
1982 Mouthwashes, dentifrices, lipsticks, and other lip cosmetics NTE 5 percent.
74.2260 D&C Orange No. 10 1981 Externally applied cosmetics.
74.2261 D&C Orange No. 11 1981 Externally applied cosmetics.
74.2304 FD&C Red No. 4 1976 Externally applied cosmetics.
74.2306 D&C Red No. 6 1983 Cosmetics generally.
74.2307 D&C Red No. 7 1983 Cosmetics generally.
74.2317 D&C Red No. 17 1976 Externally applied cosmetics.
74.2321 D&C Red No. 21 1982 Cosmetics generally.
74.2322 D&C Red No. 22 1982 Cosmetics generally.
74.2327 D&C Red No. 27 1982 Cosmetics generally.
74.2328 D&C Red No. 28 1982 Cosmetics generally.
74.2330 D&C Red No. 30 1982 Cosmetics generally.
74.2331 D&C Red No. 31 1976 Externally applied cosmetics.
74.2333 D&C Red No. 33 1988 Externally applied cosmetics; mouthwashes, dentifrices; cosmetic lip products (NTE 3% (by wt) of finished cosmetic product).
74.2334 D&C Red No. 34 1976 Externally applied cosmetics.
74.2336 D&C Red No. 36 1988 Externally applied cosmetics; cosmetic lip products (NTE 3% (by wt) of finished cosmetic product).
74.2340 FD&C Red No. 40(3) 1975 Cosmetics generally.
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.
74.2602a Ext. D&C Violet No. 2 1976 Externally applied cosmetics.
74.2705 FD&C Yellow No. 5 1985 Cosmetics generally.
1994 Eye area use (includes Aluminum lake).
74.2706 FD&C Yellow No. 6 1986 Cosmetics generally.
74.2707 D&C Yellow No. 7 1976 Externally applied cosmetics.
74.2707a Ext. D&C Yellow No. 7 1976 Externally applied cosmetics.
74.2708 D&C Yellow No. 8 1976 Externally applied cosmetics.
74.2710 D&C Yellow No. 10 1983 Cosmetics generally.
1984 Modification of uses and restrictions.
74.2711 D&C Yellow No. 11 1976 Externally applied cosmetics.


Color Additives Approved for Use in Medical Devices
Part 73, Subpart D: Color additives exempt from batch certification
21 CFR Section Straight Color Year(2)Approved Uses and Restrictions
73.1015 Chromium-cobalt-aluminum oxide 1974 Linear polyethylene surgical sutures NTE 2% general surgery.
73.1025 Ferric ammonium citrate 1973 With pyrogallol for coloring plain or chromic catgut sutures; NTE 3% general and ophthalmic surgery.
73.1375 Pyrogallol: C.I. Oxidation base 32 1973 With ferric ammonium citrate for coloring plain or chromic catgut sutures; NTE 3% general and ophthalmic surgery.
73.1410 Logwood extract; C.I. Natural black 1 1977 For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE 1% general and ophthalmic surgery.
73.3100 1,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers 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 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 1.1x10-7 g/lens.
73.3117 C.I. Vat brown 1: 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 C.I. Vat yellow 3: N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl) bisbenzamide(3) 1983 Contact lenses.
73.3119 C.I. Vat blue 6: 7,16-Dichloro- 6,15-dihydro- 5,9,14,18-anthrazinetetrone(3) 1983 Contact lenses.
73.3120 C.I. Vat green 1: 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) C.I. Reactive black 5 1984 Contact lenses.
(2) C.I. Reactive blue 21 1984
(3) C.I. Reactive orange 78 1984
(4) C.I. Reactive yellow 15 1984
(5) C.I. Reactive blue 19 1985
(6) C.I. Reactive blue 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 C.I. Solvent Yellow 18: 4-[(2,4-dimethylphenyl)azo]- 2,4-dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one(3) 1986 Contact lenses.
73.3123 C.I. Vat orange 5: 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 19
(6) C.I. Reactive blue 21
73.3128 Mica-based pearlescent pigments(3) 2002 Contact lens


Color Additives Approved for Use in Medical Devices
Part 74, Subpart D: Color additives subject to batch certification
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 2.5% general and ophthalmic use.
74.1205 D&C Green No. 5 1973 Nylon 66 nonabsorbable sutures; NTE 0.6% general surgery.
1977 Nylon 6 same conditions.
74.3045 (Phthalocyaninato(2-)) copper 1969 Polypropylene sutures NTE 0.5%.
1983(3), 1986(3) Contact lenses.

1985(3) Polybutester sutures NTE 0.5%.
1986(3) Increased chlorine spec.
1987(3) Haptics for intraocular lens NTE 0.5%.
1990(3) Polybutylene terephthalate sutures NTE 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 1% general surgery.
Suture listing moved from 74.1102 to 74.3102
1999(3) Bone cement
74.3106 D&C Blue No. 6 1978,
1985(3)
Various sutures NTE specified levels.
74.3206 D&C Green No. 6 1963, 1975 Various sutures NTE specified levels.
1983(3) Contact lenses NTE 0.03%.
1986(3) Uniform specifications.
1993(3) Haptics of intraocular lenses NTE 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 0.2 percent by wt in glycolic-lactic acid polyester absorbable sutures
NTE 0.3 percent in polydioxanone synthetic absorbable sutures
NTE 0.25 percent in epsilon caprolactone/glycolide copolymer absorbable sutures
NTE 0.1 percent in poly epsilon caprolactone absorbable sutures
NTE 0.2 percent in glycolide/dioxanone/ triethylene carbonate tripolymer absorbable sutures
NTE 0.2 percent in absorbable sutures from homopolymers of glycolide.
1987(3) Contact lenses.
1990(3)
1999 (3)
NTE 0.2 percent of intraocular lens haptics.
NTE 0.15 percent by weight of meniscal tacks.
74.3710 D&C Yellow No. 10 1987(3) Contact lenses.



Food Ingredients and Packaging
Foods Home   |   FDA Home   |   Search/Subject Index   |   Disclaimers & Privacy Policy   |   Accessibility/Help

Content last updated by emw/axl/msl on 2004-OCT-15
Hypertext updated by kwg/dms/cjm/emw/msl on 2004-OCT-15