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                Color Additive Inventories

Color Additive Inventories

                        Color Additive Status List Home
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          Color Additives
          Color Additive Inventories
          Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical DevicesColor Additive Inventories Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
  
  	
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    PrintNotice: 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.

Table of Contents

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 certificationColor 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 certificationColor 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 certificationColor 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 certificationColor Additives Approved for Use in Human FoodPart 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.§73.69
			Butterfly pea flower extract
			----
			2021
			Alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, and soft candy.§73.70
			Calcium carbonate
			E170
			2017
			Hard and soft candies and mints, inks used on the surface of chewing gum.§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
			1967
			Foods generally§73.100
			Carmine
			E120
			2009
			Food label must use common or usual name "carmine"; effective January 5, 2011§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).§73.200
			Synthetic iron oxide(3)
			E172
			2015
			Hard and soft candy, mints and chewing gum.§73.200
			Synthetic iron oxide(3)
			E172
			2015
			For allowed human food uses, reduce lead from ≤ 20 ppm to ≤ 5 ppm.§73.200
			Synthetic iron oxide
			
			2018
			Dietary supplement tablets and capsules, including coatings and printing inks.§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
			----
			2006
			Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum.§73.350
			Mica-based pearlescent pigments
			----
			2013
			Distilled spirits containing not less than 18 % and not more than 23 % alcohol by volume but not including distilled spirits mixtures containing more than 5 % wine on a proof gallon basis.§73.350
			Mica-based pearlescent pigments
			----
			2015
			Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, nonalcoholic cocktail mixers and mixes and in egg decorating kits.§73.450
			Riboflavin
			E101
			1967
			Foods generally.§73.500
			Saffron
			E164
			1966
			Foods generally.§73.520
			Soy leghemoglobin
			----
			2019
			Ground beef analogue products, NTE 0.8% by weight of uncooked ground beef analogue product.§73.530
			Spirulina extract
			----
			2013
			Candy and chewing gum.§73.530
			Spirulina extract
			----
			2014
			Coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals (excluding extruded cereals).§73.530
			Spirulina extract
			----
			2017
			Seasonally color the shells of hard-boiled eggs.§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 FoodPart 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 DrugsPart 73, Subpart B: Color additives exempt from batch certification21 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 DrugsPart 74, Subpart B: Color additives subject to batch certification21 CFR Section
			Straight Color
			Year(2)Approved
			Uses and Restrictions§74.1101
			FD&C Blue No. 1
			1969
			Ingested drugs generally(5).§74.1101
			FD&C Blue No. 1
			1982
			Externally applied drugs(6) .§74.1101
			FD&C Blue No. 1
			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.§74.1306
			D&C Red No. 6
			2012
			Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.§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.§74.1307
			D&C Red No. 7
			2012
			Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.§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).§74.1705
			FD&C Yellow No. 5
			1985
			Externally applied drugs(6) .§74.1705
			FD&C Yellow No. 5
			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 CosmeticsPart 73, Subpart C: Color additives exempt from batch certification21 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.§73.2110
			Bismuth citrate(3)
			2010
			Cosmetics intended for coloring hair on the scalp only NTE(7) 2.0 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
			2021 (repeal of listing)
			No longer permitted for coloring hair on the scalp.§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.§73.2550
			Silver nitrate
			2021
			Externally applied professional-use only cosmetics intended to impart color to the eyebrows and eyelashes, NTE 4% by weight, additional restrictions.§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 CosmeticsPart 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).§74.2101
			FD&C Blue No. 1
			1993
			Allows MnO2 in manufacture.§74.2101
			FD&C Blue No. 1
			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).§74.2306
			D&C Red No. 6
			2012
			Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.§74.2307
			D&C Red No. 7
			1983
			Cosmetics generally (5).§74.2307
			D&C Red No. 7
			2012
			Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.§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 DevicesPart 73, Subpart D: Color additives exempt from batch certification21 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.§73.3106
			1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3)
			1993
			Added copolymer, renamed.§73.3106
			1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3)
			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.§73.3127
			Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (2) C.I. Reactive Black 5
			1993
			Contact lenses.§73.3127
			Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (3) C.I. Reactive Orange 78
			1993
			Contact lenses.§73.3127
			Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (4) C.I. Reactive Yellow 15
			1993
			Contact lenses.§73.3127
			Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (5) C.I. Reactive Blue No. 19
			1993
			Contact lenses.§73.3127
			Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (6) C.I. Reactive Blue 21
			1993
			Contact lenses.§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 DevicesPart 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.1977
			Nylon 6 same conditions.§74.3045
			[Phthalocyaninato(2-)] copper
			1969
			Polypropylene sutures NTE(7) 0.5%.§74.3045
			[Phthalocyaninato(2-)] copper
			1983(3)
			Contact lenses.§74.3045
			[Phthalocyaninato(2-)] copper
			1986(3)
			Contact lenses.§74.3045
			[Phthalocyaninato(2-)] copper
			1985(3)
			Polybutester sutures NTE(7) 0.5%.§74.3045
			[Phthalocyaninato(2-)] copper
			1986(3)
			Increased chlorine spec.§74.3045
			[Phthalocyaninato(2-)] copper
			1987(3)
			Haptics for intraocular lens NTE(7) 0.5%.§74.3045
			[Phthalocyaninato(2-)] copper
			1990(3)
			Polybutylene terephthalate sutures NTE(7) 0.5%.§74.3045
			[Phthalocyaninato(2-)] copper
			1999(3)
			Poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene) nonabsorbable sutures.§74.3054
			D&C Black No. 4
			2018
			Ultra-high molecular weight polyethylene non-absorbable sutures, NTE 1.0% by weight.§74.3102
			FD&C Blue No. 2
			1971
			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
			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
			Various sutures NTE(7) specified levels.§74.3106
			D&C Blue No. 6
			1985(3)
			Various sutures NTE(7) specified levels.§74.3206
			D&C Green No. 6
			1963
			Various sutures NTE(7) specified levels.§74.3206
			D&C Green No. 6
			1975
			Various sutures NTE(7) specified levels.§74.3206
			D&C Green No. 6
			1983(3)
			Contact lenses NTE(7) 0.03%.§74.3206
			D&C Green No. 6
			1986(3)
			Uniform specifications.§74.3206
			D&C Green No. 6
			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
			NTE(7) 0.2 percent by wt in glycolic-lactic acid polyester absorbable sutures§74.3602
			D&C Violet No. 2
			1980 (3)
			NTE(7) 0.3 percent in polydioxanone synthetic absorbable sutures§74.3602
			D&C Violet No. 2
			1993 (3)
			NTE(7) 0.25 percent in epsilon caprolactone/glycolide copolymer absorbable sutures§74.3602
			D&C Violet No. 2
			1994 (3)
			NTE(7) 0.1 percent in poly epsilon caprolactone absorbable sutures§74.3602
			D&C Violet No. 2
			1998(3)
			NTE(7) 0.2 percent in glycolide/dioxanone/ triethylene carbonate tripolymer absorbable sutures§74.3602
			D&C Violet No. 2
			2000 (3)
			NTE(7) 0.2 percent in absorbable sutures from homopolymers of glycolide.§74.3602
			D&C Violet No. 2
			1987(3)
			Contact lenses.§74.3602
			D&C Violet No. 2
			1990(3)
			NTE(7) 0.2 percent of intraocular lens haptics.§74.3602
			D&C Violet No. 2
			1999 (3)
			NTE(7) 0.15 percent by weight of meniscal tacks.§74.3708
			D&C Yellow No. 8
			2018
			Contact lens solution for coloring disposable daily-wear hydrogel-based soft (hydrophilic). contact lenses, NTE 0.044% by weight.§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
			Titles73
			73.1-73-3128
			Listing of Color Additives Exempt from Certification74
			74.101-74.3710
			Listing of Color Additives Subject to Certification81
			81.1-81.32
			General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics82
			82.3-82.2707a
			Listing of Certified Provisionally Listed Colors and Specifications

Content last updated on May 2015

                                                                                  Content current as of:
      03/04/2022
              
              
Regulated Product(s)
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