For Industry

Summary of Color Additives 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 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.

Color Additives Approved for Use in Human Food
- Part 73, Subpart A: Color additives exempt from batch certification
- Part 74, Subpart A: Color additives subject to batch certification
Color Additives Approved for Use in Drugs
- Part 73, Subpart B: Color additives exempt from batch certification
- Part 74, Subpart B: Color additives subject to batch certification
Color Additives Approved for Use in Cosmetics
- Part 73, Subpart C: Color additives exempt from batch certification
- Part 74, Subpart C: Color additives subject to batch certification
Color Additives Approved for Use in Medical Devices
- Part 73, Subpart D: Color additives exempt from batch certification
- Part 74, Subpart D: Color additives subject to batch certification

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⁽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.
§73.100	Carmine	E120	1967	Foods generally.
§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.
§73.250	Fruit juice⁽³⁾	----	1995	Dried color additive.
§73.260	Vegetable juice⁽³⁾	----	1966	Foods generally.
§73.260	Vegetable juice⁽³⁾	----	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⁾
21 CFR Section	Straight Color	EEC#	Year⁽²⁾Approved	Uses and Restrictions
§74.101	FD&C Blue No. 1	E133	1969	Foods generally.
§74.101	FD&C Blue No. 1	E133	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
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⁾.
§73.1095	β-Carotene	1977	Externally applied drugs⁽⁶⁾ including eye area use.
§73.1100	Cochineal extract	1969	Ingested and externally applied drugs⁽⁶⁾.
§73.1100	Carmine	1967	Ingested and externally applied drugs⁽⁶⁾.
§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.
§73.1496	Mica	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
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⁾.
§74.1205	D&C Green No. 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).
§74.1255	D&C Orange No. 5	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.
§74.1336	D&C Red No. 36	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⁾.
§74.1340	FD&C Red No. 40⁽³⁾	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⁾.
§74.1710	D&C Yellow No. 10	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
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	ß-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⁾
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⁾.
§74.2205	D&C Green No. 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⁾ .
§74.2255	D&C Orange No. 5	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⁾.
§74.2340	FD&C Red No. 40⁽³⁾	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⁾.
§74.2705	FD&C Yellow No. 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⁾.
§74.2710	D&C Yellow No. 10	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
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
§73.3129	Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (Reactive Blue 69)⁽³⁾	2011	Contact lenses

Color Additives Approved for Use in Medical Devices Part 74, Subpart D: Color additives subject to batch certification⁽⁴⁾
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.
§74.1205	D&C Green No. 5	1977	Nylon 6 same conditions.
§74.3045	[Phthalocyaninato(2-)] copper	1969	Polypropylene sutures NTE⁽⁷⁾ 0.5%.
		1983⁽³⁾, 1986⁽³⁾	Contact lenses.
		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
§74.3102	FD&C Blue No. 2	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.
§74.3710	D&C Yellow No. 10	1987⁽³⁾	Contact lenses.

End Notes

The color additives Astaxanthin, Astaxanthin dimethyldisuccinate, Ultramarine blue, Canthaxanthin, Haematococcus algae meal, Synthetic iron oxide, Dried algae meal, Tagetes (Aztec marigold) meal and extract, Corn endosperm oil, Paracoccus pigment, and Phaffia yeast are approved for specific uses in animal food (see 21 CFR 73.35, 73.37, 73.50, 73.75, 73.185, 73.200, 73.275, 73.295, 73.315, 73.352, and 73.355, respectively).
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.
NTE - not to exceed.

To access regulations from the Government Printing Office Website, click on the hyperlinks below. This opens the Electronic Code of Federal Regulations . Select the desired section below.

Part	Sections	Titles
73	73.1-73-3128	Listing of Color Additives Exempt from Certification
74	74.101-74.3710	Listing of Color Additives Subject to Certification
81	81.1-81.32	General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
82	82.3-82.2707a	Listing of Certified Provisionally Listed Colors and Specifications

Content last updated on 2007-MAR-22

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Color Additives

Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices

Table of Contents

Color Additives Approved for Use in Human Food

Color Additives Approved for Use in Drugs

Color Additives Approved for Use in Cosmetics

Color Additives Approved for Use in Medical Devices

End Notes

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