Regulatory Status of Color Additives
This database lists the status of color additives for use in foods, drugs, cosmetics, and some medical devices in the U.S. The list includes color additives permanently listed and those that once were provisionally listed, but then removed from the list (“delisted”) and are no longer permitted for use. This database will be updated periodically as amendments are made to the color additive regulations.
Whether a color additive is permanently listed, provisionally listed, or delisted is indicated under the “status” heading in the database. Only those color additives identified as permanently or provisionally listed are permitted for the indicated use. Delisted color additives are not permitted for any use. The database does not contain colorants permitted for use in food contact/packaging materials.
See additional Background Information.
For color additive petitions under review or held in abeyance, see Food Additive and Color Additive Petitions Under Review or Held in Abeyance.
Filter on current uses:
- Color additives in foods
- Color additives in cosmetics
- Color additives in drugs
- Color additives in devices
- No current uses
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CAS Reg. No. (or other ID code) |
Color
(sorted A-Z) |
Status |
Use (Former use) Restrictions |
End Notes | 21 CFR |
---|---|---|---|---|---|
6737-68-4 | 1,4-bis[(2-methylphenyl)amino]-9,10-anthracenedione | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 |
73.3105 74.2206 74.3206 |
6358-30-1 | Carbazole Violet | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3 | 73.3107 |
11006-34-1 | Chlorophyllin-Copper Complex, Oil Soluble | Permanently listed, exempt from certification |
Devices Bone cement only NTE 0.003% |
3 | 73.3110 |
68187-11-1 | Chromium-Cobalt-Aluminum Oxide | Permanently listed, exempt from certification |
Drugs, Devices Linear polyethylene surgical sutures NTE 2% general surgery. Contact lenses. |
3 |
73.1015 73.3110a |
1308-38-9 | Chromium Oxide Greens | Permanently listed, exempt from certification |
Drugs, Cosmetics, Devices Externally applied drugs and cosmetics, including eye area use. Contact lenses. |
3 |
73.1327 73.2327 73.3111 |
D&C Black No. 4 | Permanently listed, certification required |
Devices Ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery. |
4 | 74.3054 | |
482-89-3 | D&C Blue No. 6 | Permanently listed, certification required |
Devices Polyethylene terephthalate sutures NTE 0.2%, plain or chromic collagen absorbable sutures NTE 0.25%, polypropylene sutures NTE 0.5%, general surgicial use; plain or chromic collagen absorbable sutures NTE 0.5%, ophthalmic surgical use; polydioxanone synthetic absorbably sutures NTE 0.5% ophthalmic and general surgical use |
74.3106 81.10 81.30 |
|
130-20-1 | D&C Blue No. 9 | Permanently listed, certification required |
Drugs, Devices Cotton and silk surgical sutures; NTE 2.5% general and ophthalmic use. |
73.3119 74.1109 |
|
4403-90-1 | D&C Green No. 5 | Permanently listed, certification required |
Drugs, Cosmetics, Devices Drugs generally. Eye area use. Cosmetics generally. Eye area use. Nylon 66 nonabsorbable sutures; NTE 0.6% general surgery. Nylon 6; NTE 0.6% general surgery. |
5 |
74.1205 74.2205 82.1205 |
128-80-3 | D&C Green No. 6 | Permanently listed, certification required |
Drugs, Cosmetics, Devices Externally applied drugs. Externally applied cosmetics. Various sutures NTE specified levels; contact lenses NTE 0.03%; Haptics of intraocular lenses NTE 0.1%. |
3, 6 |
74.1206 74.2206 74.3206 81.10 81.30 82.1206 |
85-86-9 | D&C Red No. 17 | Permanently listed, certification required |
Drugs, Cosmetics, Devices Externally applied drugs. Externally applied cosmetics. Contact lenses. |
3, 6 |
74.1317 74.2317 74.3230 81.30 82.1317 |
81-48-1 | D&C Violet No. 2 | Permanently listed, certification required |
Drugs, Cosmetics, Devices Externally applied drugs. Externally applied cosmetics. NTE 0.2% by wt in glycolic-lactic acid polyester absorbable sutures; NTE 0.3% in polydioxanone synthetic absorbable sutures: 0.25% in ε-caprolactone/glycolide copolymer absorbable sutures; NTE 0.1% in poly(ε-caprolactone) absorbable sutures; NTE 0.2% in glycolide/dioxanone/triethylene carbonate tripolymer absorbable sutures; NTE 0.2% in absorbable sutures from homopolymers of glycolide; contact lenses; NTE 0.2% of intraocular lens haptics; NTE 0.15% by wt of meniscal tacks. |
4, 6 |
74.1602 74.2602 74.3602 81.30 82.1602 |
8004-92-0 | D&C Yellow No. 10 | Permanently listed, certification required |
Drugs, Cosmetics, Devices Drugs generally. Modification of uses and restrictions. Cosmetics generally. Contact lenses. |
3, 4, 5, 6, 7 |
74.1710 74.2710 74.3710 82.1710 |
518-47-8 | D&C Yellow No. 8 | Permanently listed, certification required |
Drugs, Cosmetics, Devices Externally applied drugs. Externally applied cosmetics. Contact lens solution; NTE 0.044% by weight. |
4, 5, 6 |
74.1708 74.2708 74.3708 82.1708 |
130-20-1 | 7,16-dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 |
73.3119 74.1109 |
86316-86-1 | 2-[[2,5-diethoxy-4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5- benzenetriol | Permanently listed, exempt from certification |
Devices Formed in situ in soft contact lenses to mark L and R NTE 1.1x10-7 g/lens. |
3 | 73.3115 |
82-18-8 | N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl)bisbenzamide | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3118 |
860-22-0 | FD&C Blue No. 2 | Permanently listed, certification required |
Foods, Drugs, Cosmetics, Devices Foods generally. Ingested drugs. Nylon surgical sutures NTE 1% general surgery; suture listing moved from 74.1102 to 74.3102. Bone cement (Al lake) NTE 0.1%. |
3 |
74.102 74.1102 74.3102 82.102 |
16521-38-3 | FD&C Blue No. 2- Aluminum Lake on Alumina | Permanently listed, certification required |
Devices Bone cement NTE 0.1%. |
74.3102 | |
1332-37-2 | Synthetic Iron Oxides / Iron Oxides | Permanently listed, exempt from certification |
Foods, Drugs, Cosmetics, Devices Sausage casings NTE 0.1 percent (by wt). Hard and soft candy, mints, and chewing gum. Dietary supplement tablets and capsules. For all human food uses, lead (as Pb) content NTE 5 mg/kg (5 ppm). Ingested or topically applied drugs ingested dosage by man NTE 5 mg/d (as Fe). Cosmetics generally including eye area use. Contact lenses. |
1, 3, 6 |
73.1200 73.200 73.2250 73.3125 |
Mica-Based Pearlescent Pigments | Permanently listed, exempt from certification |
Foods, Drugs, Devices Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. 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. Ingested drugs NTE 3%. Iron NTE 55 wt%. Contact lenses. |
3 |
73.350 73.3128 |
|
1328-53-6 | Phthalocyanine Green | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3124 |
147-14-8 | [phthalocyaninato(2-)] copper | Permanently listed, exempt from certification |
Devices Polypropylene sutures NTE 0.5%; contact lenses; polybutester sutures NTE 0.5%; haptics for intraocular lens NTE 0.5%; poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene)nonabsorbable sutures. To color orientation marks for intraocular lenses (IOLs). |
74.3045 | |
977171-98-4 | Poly(Hydroxyethyl Methacrylate)-C.I. Reactive Red 180 Copolymer | Permanently listed, exempt from certification |
Devices Contact lenses |
73.3121 | |
Poly(Hydroxyethyl Methacrylate)- Dye Polymers | Permanently listed, exempt from certification |
Devices Contact lenses |
73.3121 | ||
17095-24-8 | C.I. Reactive Black 5 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3, 8 | 73.3127 |
2580-78-1 | C.I. Reactive Blue 19 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3, 8 |
73.3121 73.3127 |
73049-92-0 | C.I. Reactive Blue 21 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3, 8 | 73.3127 |
121888-69-5 | 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) copolymers | Permanently listed, exempt from certification |
Devices Contact lenses. |
3, 8 | 73.3106 |
109561-07-1 | 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic) ester copolymers | Permanently listed, exempt from certification |
Devices Contact lenses. |
8 | 73.3100 |
70209-99-3 | Reactive Blue 69 | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3129 |
68189-39-9 | C.I. Reactive Orange 78 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3, 8 | 73.3127 |
98114-32-0 | C.I. Reactive Red 180 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3, 8 | 73.3127 |
60958-41-0 | C.I. Reactive Yellow 15 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3, 8 | 73.3127 |
6407-78-9 | 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3122 |
13463-67-7 | Titanium Dioxide | Permanently listed, exempt from certification |
Foods, Drugs, Cosmetics, Devices Foods generally, NTE 1 percent (by wt.) Drugs generally including eye area use. Cosmetics including eye area use. Contact lenses. To color orientation marks for intraocular lenses (IOLs). |
73.1575 73.2575 73.3126 73.575 |
|
2475-33-4 | 16,23-Dihydrodinaphtho[2,3-a:2',3'-i]naphtho[2',3':6,7]indolo[2,3-c]carbazole-5,10,15,17,22,24-hexone | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3117 |
128-58-5 | 16,17-Dimethoxydinaphtho[1,2,3-cd:3',2',1'-lm]perylene-5,10-dione | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3120 |
1324-11-4 | C.I. Vat Orange 1 | Permanently listed, exempt from certification |
Devices Contact lenses use only. |
3 | 73.3112 |
3263-31-8 | 6-ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene)benzo[b]thiophen-3(2H)-one | Permanently listed, exempt from certification |
Devices Contact lenses. |
3 | 73.3123 |
Definitions of Terms Used
- FID
Food Inspection Decision (issued by USDA prior to 1927) -
CAS Reg. No. or other ID
Chemical Abstract Service (CAS) Registry® Number for the substance or a numerical code assigned by CFSAN (977nnn-nn-n-series) to those substances that do not have a CAS Reg. No. - Other names
Recognized synonyms for color additives - Lakes
Insoluble pigments formed by chemically reacting water-soluble straight colors with precipitants and substrata.
End Notes
- The color additives Antarctic krill meal, 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 73.32. 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; never 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.
- The listed color additives are the reaction products produced by copolymerizing the reactive dyes with various monomers such that the dyes are chemically bound in the resulting polymer matrix.
CAS Reg. No. (or other ID code) |
Color
(sorted A-Z) |
Status |
Use (Former use) Restrictions |
End Notes | 21 CFR |
---|