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U.S. Department of Health and Human Services

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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.

Table of Contents


Color Additives Approved for Use in Human Food
Part 73, Subpart A: Color additives exempt from batch certification(1)
21 CFR SectionStraight ColorEEC#Year(2)ApprovedUses and Restrictions
§73.30Annatto extractE160b1963Foods generally.
§73.40Dehydrated beets (beet powder)E1621967Foods generally.
§73.75Canthaxanthin(3)E161g1969Foods 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.
§73.85CaramelE150a-d1963Foods generally.
§73.90β-Apo-8'-carotenalE160e1963Foods generally, NTE(7): 15 mg/lb solid, 15 mg/pt liquid.
§73.95β-CaroteneE160a1964Foods generally.
§73.100Cochineal extractE1201969Foods generally
2009Food label must use common or usual name "cochineal extract"; effective January 5, 2011
CarmineE1201967Foods generally
2009Food label must use common or usual name "carmine"; effective January 5, 2011
§73.125Sodium copper chlorophyllin(3)E1412002Citrus-based dry beverage mixes NTE(7) 0.2 percent in dry mix; extracted from alfalfa.
§73.140Toasted partially defatted cooked cottonseed flour----1964Foods generally.
§73.160Ferrous gluconate----1967Ripe olives.
§73.165Ferrous lactate----1996Ripe olives.
§73.169Grape color extract(3)E163?1981Nonbeverage food.
§73.170Grape skin extract (enocianina)E163?1966Still & carbonated drinks & ades; beverage bases; alcoholic beverages (restrict. 27 CFR Parts 4 & 5).
§73.200Synthetic iron oxide(3)E1721994Sausage casings NTE(7) 0.1 percent (by wt).
§73.250Fruit juice(3)----1966Foods generally.
1995Dried color additive.
§73.260Vegetable juice(3)----1966Foods generally.
1995Dried color additive, water infusion.
§73.300Carrot oil----1967Foods generally.
§73.340PaprikaE160c1966Foods generally.
§73.345Paprika oleoresinE160c1966Foods generally.
§73.350Mica-based pearlescent pigments(3)----2006Cereals, confections and frostings, gelatin desserts, hard and soft candies(including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum.
§73.450RiboflavinE1011967Foods generally.
§73.500SaffronE1641966Foods generally.
§73.575Titanium dioxideE1711966Foods generally; NTE(7) 1 percent (by wt).
§73.585Tomato lycopene extract; tomato lycopene concentrate(3)E1602006Foods generally.
§73.600TurmericE1001966Foods generally.
§73.615Turmeric oleoresinE1001966Foods generally.


 



 

Color Additives Approved for Use in Human Food
Part 74, Subpart A: Color additives subject to batch certification(4)
21 CFR SectionStraight ColorEEC#Year(2)ApprovedUses and Restrictions
§74.101FD&C Blue No. 1E1331969Foods generally.
1993Added Mn spec.
§74.102FD&C Blue No. 2E1321987Foods generally.
§74.203FD&C Green No. 3----1982Foods generally.
§74.250Orange B(3)----1966Casings or surfaces of frankfurters and sausages; NTE(7) 150 ppm (by wt).
§74.302Citrus Red No. 2----1963Skins of oranges not intended or used for processing; NTE(7) 2.0 ppm (by wt).
§74.303FD&C Red No. 3E1271969Foods generally.
§74.340FD&C Red No. 40(3)E1291971Foods generally.
§74.705FD&C Yellow No. 5E1021969Foods generally.
§74.706FD&C Yellow No. 6E1101986Foods generally.


 



 

Color Additives Approved for Use in Drugs
Part 73, Subpart B: Color additives exempt from batch certification
21 CFR SectionStraight ColorYear(2)ApprovedUses and Restrictions
§73.1010Alumina (dried aluminum hydroxide)1967Drugs generally (5).
§73.1030Annatto extract1963Ingested drugs generally(5); external drugs(6) including eye area use.
§73.1070Calcium carbonate1967Drugs generally (5).
§73.1075Canthaxanthin(3)1969Ingested drugs generally (5).
§73.1085Caramel1963Ingested and topically applied drugs generally (5),(6).
§73.1095β-Carotene1964Ingested drugs generally(5).
1977Externally applied drugs(6) including eye area use.
§73.1100Cochineal extract1969Ingested and externally applied drugs(6).
Carmine1967
§73.1125Potassium sodium copper chlorophyllin (chlorophyllin-copper complex)1969Dentrifices that are drugs; NTE(7) 0.1%
§73.1150Dihydroxyacetone1973Externally applied drugs(6) intended solely or in part to impart a color to the human body
§73.1162Bismuth oxychloride1977Externally applied drugs (6) including eye area use.
§73.1200Synthetic iron oxide1966Ingested or topically applied drugs(6) ingested dosage by man NTE(7) 5 mg/d (as Fe).
§73.1298Ferric ammonium ferrocyanide1977Externally applied drugs(6) including eye area use.
§73.1299Ferric ferrocyanide1977Externally applied drugs including(6) eye area use.
§73.1326Chromium hydroxide green1977Externally applied drugs(6) including eye area use.
§73.1327Chromium oxide greens1977Externally applied drugs(6) including eye area use.
§73.1329Guanine1977Externally applied drugs(6) including eye area use.
§73.1350Mica-based pearlescent pigments (3)2006Ingested drugs NTE(7) 3%. Iron NTE(7)55 wt %.
§73.1400Pyrophyllite1966Externally applied drugs(6).
§73.1496Mica1977Externally applied drugs(6) including eye area use.
1987Dentifrices.
§73.1550Talc1967Drugs generally (5).
§73.1575Titanium dioxide1966Drugs generally(5) including eye area use .
§73.1645Aluminum powder1977Externally applied drugs(6) including eye area use.
§73.1646Bronze powder1977Externally applied drugs(6) including eye area use.
§73.1647Copper powder1977Externally applied drugs(6) including eye area use.
§73.1991Zinc oxide1977Externally 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 SectionStraight ColorYear(2)ApprovedUses and Restrictions
§74.1101FD&C Blue No. 11969Ingested drugs generally(5).
1982Externally applied drugs(6) .
1994Eye area use (includes lake).
§74.1102FD&C Blue No. 21987Ingested drugs.
§74.1104D&C Blue No. 41977Externally applied drugs(6) .
§74.1203FD&C Green No. 31982Drugs generally (5).
§74.1205D&C Green No. 51982Drugs generally(5).
1994Eye area use.
§74.1206D&C Green No. 61982Externally applied drugs(6) .
§74.1208D&C Green No. 81976Externally applied drugs(6) (NTE(7) 0.01% (by weight)).
§74.1254D&C Orange No. 41977Externally applied drugs (6) .
§74.1255D&C Orange No. 51984Externally applied drugs (6) (NTE(7) 5 mg/daily dose of drug).
1982Mouthwashes and dentifrices.
§74.1260D&C Orange No. 101981Externally applied drugs (6) .
§74.1261D&C Orange No. 111981Externally applied drugs (6) .
§74.1303FD&C Red No. 31969Ingested drugs.
§74.1304FD&C Red No. 41976Externally applied drugs (6) .
§74.1306D&C Red No. 61983Drugs such that total with D&C Red No. 7 NTE(7) 5 mg/daily dose of drug.
2012Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.1307D&C Red No. 71983Drugs such that total with D&C Red No. 6 NTE(7) 5 mg/daily dose of drug.
2012Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.1317D&C Red No. 171976Externally applied drugs(6) .
§74.1321D&C Red No. 211983Drugs generally (5).
§74.1322D&C Red No. 221983Drugs generally (5).
§74.1327D&C Red No. 271982Drugs generally (5).
§74.1328D&C Red No. 281982Drugs generally (5).
§74.1330D&C Red No. 301982Drugs generally (5).
§74.1331D&C Red No. 311976Externally applied drugs(6) .
§74.1333D&C Red No. 331988Ingested drugs, other than mouthwashes and dentifrices (NTE(7) 0.75 mg/daily dose of drug); externally applied drugs(6) mouthwashes and dentifrices.
§74.1334D&C Red No. 341976Externally applied drugs(6) .
§74.1336D&C Red No. 361989Ingested 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.
1988Externally applied drugs(6) .
§74.1339D&C Red No. 391966Quaternary ammonium type germicidal solutions for external application (NTE(7) 0.1% (by wt) of finished drug product).
§74.1340FD&C Red No. 40(3)1971Drugs generally(5).
1994Eye area use (includes lake).
§74.1602D&C Violet No. 21976Externally applied drugs(6) .
§74.1705FD&C Yellow No. 51969Ingested drugs generally(5).
1985Externally applied drugs(6) .
1994Eye area use (includes lake).
§74.1706FD&C Yellow No. 61986Drugs generally (5).
§74.1707D&C Yellow No. 71976Externally applied drugs(6) .
§74.1707aExt. D&C Yellow No. 71976Externally applied drugs(6) .
§74.1708D&C Yellow No. 81976Externally applied drugs(6) .
§74.1710D&C Yellow No. 101983Drugs generally (5).
1984Modification of uses and restrictions.
§74.1711D&C Yellow No. 111976Externally applied drugs(6) .


 



 

Color Additives Approved for Use in Cosmetics
Part 73, Subpart C: Color additives exempt from batch certification
21 CFR SectionStraight ColorYear(2)ApprovedUses and Restrictions
§73.2030Annatto1977Cosmetics generally(5) including eye area use.
§73.2085Caramel1981Cosmetics generally(5) including eye area use.
§73.2087Carmine1977Cosmetics generally(5) including eye area use.
§73.2095ß-Carotene1977Cosmetics generally(5) including eye area use.
§73.2110Bismuth citrate(3)1978Cosmetics intended for coloring hair on the scalp only NTE(7) 0.5 percent.
2010Cosmetics intended for coloring hair on the scalp only NTE(7) 2.0 percent.
§73.2120Disodium EDTA-copper1974Coloring of shampoos that are cosmetics.
§73.2125Potassium sodium copper chlorophyllin (chlorophyllin copper-complex)1969Coloring dentifrices that are cosmetics NTE(7) 0.1% in combination with a list of substances.
§73.2150Dihydroxyacetone1973Externally applied cosmetics(6) intended solely or in part to impart color to the human body.
§73.2162Bismuth oxychloride1977Cosmetics generally(5) including eye area use.
§73.2180Guaiazulene1977Externally applied cosmetics(6).
§73.2190Henna(3)1965Coloring hair but not eyelashes, eyebrows, or eye area.
§73.2250Iron oxides1977Cosmetics generally(5) including eye area use.
§73.2298Ferric ammonium ferrocyanide1977Externally applied cosmetics(6) including eye area use.
§73.2299Ferric ferrocyanide1978Externally applied cosmetics(6) including eye area use.
§73.2326Chromium hydroxide green1977Externally applied cosmetics(6) including eye area use.
§73.2327Chromium oxide greens1977Externally applied cosmetics(6) including eye area use.
§73.2329Guanine1977Cosmetics generally(5) including eye area use.
§73.2396Lead acetate(3)1981Cosmetics intended for coloring hair on the scalp only, NTE(7) 0.6 percent Pb (weight/volume).
§73.2400Pyrophyllite1973Externally applied cosmetics(6).
§73.2496Mica1977Cosmetics generally(5) including eye area use.
§73.2500Silver (3)1979Coloring fingernail polish NTE(7) 1% of final product.
§73.2575Titanium dioxide1973Cosmetics including eye area use.
§73.2645Aluminum powder1977Externally applied cosmetics(6) including eye area use.
§73.2646Bronze powder1977Cosmetics generally(5) including eye area use.
§73.2647Copper powder1977Cosmetics generally(5) including eye area use.
§73.2725Ultramarines1976Externally applied cosmetics(6) including eye area use.
§73.2775Manganese violet1976Cosmetics generally(5) including eye area use.
§73.2991Zinc oxide1977Cosmetics including eye area use.
§73.2995Luminescent zinc sulfide (3)2000Nail 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 SectionStraight ColorYear(2)ApprovedUses and Restrictions
§74.2052D&C Black No. 22004Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.
§74.2053D&C Black No. 3 (3)2007Eyeliner, eye shadow, mascara, and face powder.
§74.2101FD&C Blue No. 11982Cosmetics generally(5).
1993Allows MnO2 in manufacture.
1994Eye area use (includes lake).
§74.2104D&C Blue No. 41977Externally applied cosmetics(6) .
§74.2151D&C Brown No. 11976Externally applied cosmetics(6) .
§74.2203FD&C Green No. 31982Cosmetics generally (5).
§74.2205D&C Green No. 51982Cosmetics generally(5).
1994Eye area use.
§74.2206D&C Green No. 61982Externally applied cosmetics(6) .
§74.2208D&C Green No. 81976Externally applied cosmetics(6) (NTE(7) 0.01% (by wt) of finished cosmetic product).
§74.2254D&C Orange No. 41977Externally applied cosmetics(6) .
§74.2255D&C Orange No. 51984Externally applied cosmetics(6) .
1982Mouthwashes, dentifrices, lipsticks, and other lip cosmetics NTE(7) 5 percent.
§74.2260D&C Orange No. 101981Externally applied cosmetics(6) .
§74.2261D&C Orange No. 111981Externally applied cosmetics(6) .
§74.2304FD&C Red No. 41976Externally applied cosmetics(6) .
§74.2306D&C Red No. 61983Cosmetics generally (5).
2012Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.2307D&C Red No. 71983Cosmetics generally (5).
2012Ether-soluble matter specification changed to 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
§74.2317D&C Red No. 171976Externally applied cosmetics(6) .
§74.2321D&C Red No. 211982Cosmetics generally (5).
§74.2322D&C Red No. 221982Cosmetics generally (5).
§74.2327D&C Red No. 271982Cosmetics generally (5).
§74.2328D&C Red No. 281982Cosmetics generally (5).
§74.2330D&C Red No. 301982Cosmetics generally (5).
§74.2331D&C Red No. 311976Externally applied cosmetics(6) .
§74.2333D&C Red No. 331988Externally applied cosmetics(6) ; mouthwashes, dentifrices; cosmetic lip products (NTE(7) 3% (by wt) of finished cosmetic product).
§74.2334D&C Red No. 341976Externally applied cosmetics(6) .
§74.2336D&C Red No. 361988Externally applied cosmetics(6); cosmetic lip products (NTE(7) 3% (by wt) of finished cosmetic product).
§74.2340FD&C Red No. 40(3)1975Cosmetics generally(5).
1994Eye area use (includes Al lake). No oxidizing or reducing agents that may affect integrity.
§74.2602D&C Violet No. 21976Externally applied cosmetics(6) .
§74.2602aExt. D&C Violet No. 21976Externally applied cosmetics(6) .
§74.2705FD&C Yellow No. 51985Cosmetics generally(5).
1994Eye area use (includes Al lake).
§74.2706FD&C Yellow No. 61986Cosmetics generally (5).
§74.2707D&C Yellow No. 71976Externally applied cosmetics(6).
§74.2707aExt. D&C Yellow No. 71976Externally applied cosmetics(6).
§74.2708D&C Yellow No. 81976Externally applied cosmetics(6).
§74.2710D&C Yellow No. 101983Cosmetics generally (5).
1984Modification of uses and restrictions.
§74.2711D&C Yellow No. 111976Externally applied cosmetics(6).


 



 

Color Additives Approved for Use in Medical Devices
Part 73, Subpart D: Color additives exempt from batch certification
21 CFR SectionStraight ColorYear(2)ApprovedUses and Restrictions
§73.1015Chromium-cobalt-aluminum oxide1974Linear polyethylene surgical sutures NTE(7) 2% general surgery.
§73.1025Ferric ammonium citrate1973With pyrogallol for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery.
§73.1375Pyrogallol1973With ferric ammonium citrate for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery.
§73.1410Logwood extract1977For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE(7) 1% general and ophthalmic surgery.
§73.31001,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers(3)1996Contact lenses
§73.31051,4-Bis [(2-methylphenyl)amino] -9,10-anthracenedione(3)1984Contact lenses.
§73.31061,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3)1990Contact lenses.
1993Added copolymer, renamed.
1995Additional copolymer.
§73.3107Carbazole violet(3)1988Contact lenses.
§73.3110Chlorophyllin-copper complex, oil soluble(3)1984Bone cement only NTE(7) 0.003%.
§73.3110aChromium-cobalt-aluminum oxide(3)1988Contact lenses.
§73.3111Chromium oxide greens(3)1986Contact lenses.
§73.3112C.I. Vat Orange 1(3)1985Contact lenses.
§73.31152-[[2,5-Diethoxy- 4-[(4-methylphenyl)thiol] phenyl]azo] -1,3,5-benzenetriol(3)1983Formed in situ in soft contact lenses to mark L and R NTE(7) 1.1x10-7 g/lens.
§73.311716,23-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)1983Contact lenses.
§73.3118N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl) bisbenzamide(3)1983Contact lenses.
§73.31197,16-Dichloro- 6,15-dihydro- 5,9,14,18-anthrazinetetrone(3)1983Contact lenses.
§73.312016,17-Dimethoxydinaphtho (1,2,3-cd:3',2',1'-lm) perylene-5,10-dione(3)1983Contact lenses.
§73.3121Poly(hydroxyethyl methacrylate) -dye copolymers(3): one or more of (1) Reactive Black 51984Contact lenses.
(2) Reactive Blue 211984
(3) Reactive Orange 781984
(4) Reactive Yellow 151984
(5) Reactive Blue No. 191985
(6) Reactive Blue No. 41985
(7) C.I. Reactive Red 111985
(8) C.I. Reactive Yellow 861985
(9) C.I. Reactive Blue 1631985
(10) C.I. Reactive Red 1801993
§73.31224-[(2,4-dimethylphenyl)azo]- 2,4-dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one(3)1986Contact lenses.
§73.31236-Ethoxy-2- (6-ethoxy-3-oxobenzo[b] thien-2(3H)- ylidene) benzo[b]thiophen- 3(2H)-one(3)1986Contact lenses.
§73.3124Phthalocyanine green(3)1986Contact lenses.
§73.3125Iron oxides(3)1986Contact lenses.
§73.3126Titanium dioxide(3)1986Contact lenses.
§73.3127Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (1) C.I. Reactive Red 1801993Contact 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
§73.3128Mica-based pearlescent pigments(3)2002Contact lenses
§73.3129Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (Reactive Blue 69)(3)2011Contact lenses


 



 

Color Additives Approved for Use in Medical Devices
Part 74, Subpart D: Color additives subject to batch certification(4)
21 CFR SectionStraight ColorYear(2)ApprovedUses and Restrictions
§74.1109D&C Blue No. 91974Cotton and silk surgical sutures; NTE(7) 2.5% general and ophthalmic use.
§74.1205D&C Green No. 51973Nylon 66 nonabsorbable sutures; NTE(7) 0.6% general surgery.
1977Nylon 6 same conditions.
§74.3045[Phthalocyaninato(2-)] copper1969Polypropylene 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.
§74.3102FD&C Blue No. 21971
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%
§74.3106D&C Blue No. 61978,
1985(3)
Various sutures NTE(7) specified levels.
§74.3206D&C Green No. 61963, 1975Various 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%.
§74.3230D&C Red No. 171990(3)Contact lenses.
§74.3602D&C Violet No. 21974

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.
§74.3710D&C Yellow No. 101987(3)Contact lenses.


 


 

End Notes

 

  1. 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).
     
  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.  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.
     
  5.   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).
     
  6.   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.
     
  7.  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.

 

PartSectionsTitles
7373.1-73-3128Listing of Color Additives Exempt from Certification
7474.101-74.3710Listing of Color Additives Subject to Certification
8181.1-81.32General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
8282.3-82.2707aListing of Certified Provisionally Listed Colors and Specifications

Content last updated on 2013-FEB-11