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U.S. Department of Health and Human Services

Regulatory Status of Color Additives

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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:


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Records Found: 298 Show All Page 1 of 6
CAS Reg. No.
(or other ID code)
Color
(sorted A-Z)
Status Use
(Former use)
Restrictions
End Notes 21 CFR
977010-47-1 Algae Meal, Dried Permanently listed, exempt from certification Foods
Chicken feed, NTE 0.3% or 150 ppm ethoxyquin,
73.275
977000-19-3 Alkanet (Alkanna) Delisted, formerly exempt from certification None
(formerly Foods)
50-71-5 Alloxan Delisted, formerly exempt from certification None
(formerly Cosmetics)
1344-28-1 Alumina Permanently listed, exempt from certification Drugs
Drugs generally.
5 73.1010
555-32-8 Aluminum Benzoate Delisted, formerly exempt from certification None
(formerly Cosmetics)
21645-51-2 Aluminum Hydroxide Delisted, formerly exempt from certification None
(formerly Cosmetics)
7429-90-5 Aluminum Powder Permanently listed, exempt from certification Drugs, Cosmetics
Externally applied drugs including eye area use. Externally applied cosmetics including eye area use.
6 73.1645
73.2645
637-12-7 Aluminum Stearate Delisted, formerly exempt from certification None
(formerly Cosmetics)
1393-63-1 Annatto Extract / Annatto Permanently listed, exempt from certification Foods, Drugs, Cosmetics
Foods generally; ingested drugs generally, external drugs including eye area use; cosmetics generally including eye area use.
5, 6 73.1030
73.2030
73.30
Antarctic krill meal Permanently listed, exempt from certification Foods
Salmonid feed. NTE 4% by weight in freshwater salmonid feed and 12% by weight in marine salmonid feed. The quantity of astaxanthin in the finished feed, from Antarctic krill meal when used alone or in combination with other astaxanthin color additive sources listed in this part, must not exceed 80 mg/kg astaxanthin (72 grams/ton) in the finished feed.
1 73.32
472-61-7 Astaxanthin Permanently listed, exempt from certification Foods
Salmonid feed, NTE 80 mg/kg.
73.35
578006-46-9 Astaxanthin Dimethyldisuccinate Permanently listed, exempt from certification Foods
Salmonid feed, NTE 110 mg/kg, equivalent to 80 mg/kg astaxanthin.
73.37
7727-43-7 Barium Sulfate Delisted, formerly exempt from certification None
(formerly Cosmetics)
Beet Juice Permanently listed (as vegetable juice), exempt from certification Foods
Foods generally.
73.260
977010-48-2 Beet Powder and Dehydrated Beets Permanently listed, exempt from certification Foods
Foods generally.
73.40
1302-78-9 Bentonite Delisted, formerly exempt from certification None
(formerly Cosmetics)
1107-26-2 β-apo-8'-carotenal Permanently listed, exempt from certification Foods
Foods generally, NTE 15 mg/lb solid, 15 mg/pt liquid.
7 73.90
7235-40-7 β-carotene (Natural and Synthetic) Permanently listed, exempt from certification Foods, Drugs, Cosmetics
Foods generally. Ingested drugs generally. Externally applied drugs including eye area use. Cosmetics generally including eye area use.
5, 6 73.95
73.1095
73.2095
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
813-93-4 Bismuth Citrate Permanently listed, exempt from certification Cosmetics
Cosmetics intended for coloring hair on the scalp only NTE 0.5%. Cosmetics intended for color hair on the scalp only NTE 2.0%.
73.2110
7787-59-9 Bismuth Oxychloride Permanently listed, exempt from certification Drugs, Cosmetics
Externally applied drugs including eye area use. Cosmetics generally including eye area use.
5, 6 73.1162
73.2162
8021-99-6 Bone Black Delisted, formerly exempt from certification None
(formerly Drugs, Cosmetics)
12597-70-5 Bronze Powder Permanently listed, exempt from certification Drugs, Cosmetics
Externally applied drugs including eye area use. Cosmetics generally including eye area use.
5, 6 73.1646
73.2646
Butterfly pea flower extract Permanently listed, exempt from certification Foods
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
73.69
60-11-7 Butter Yellow Delisted prior to 1938 Food, Drug and Cosmetic Act None
(formerly Foods)
471-34-1 Calcium Carbonate Permanently listed, exempt from certification Foods, Drugs
Drugs generally. Hard and soft candy, mints, and chewing gum.
5 73.70
73.1070
62-33-9 Calcium Disodium EDTA: Diluents of Color Additive Mixture Permanently listed, exempt from certification Foods, Drugs
NTE 1% by weight as diluent in food color additive mixture and ingested drugs.
73.1
1344-95-2 Calcium Silicate Delisted, formerly exempt from certification None
(formerly Cosmetics)
1592-23-0 Calcium Stearate Delisted, formerly exempt from certification None
(formerly Cosmetics)
7778-18-9 Calcium Sulfate Delisted, formerly exempt from certification None
(formerly Cosmetics)
514-78-3 Canthaxanthin Permanently listed, exempt from certification Foods, Drugs
Foods generally, NTE 30 mg/lb of solid or semisolid food or per pint of liquid food; May also be used in broiler chicken feed; Ingested drugs generally; Approved for specific uses in animal food.
1, 3, 5 73.1075
73.75
8028-89-5 Caramel Permanently listed, exempt from certification Foods, Drugs, Cosmetics
Foods generally. Ingested and topically applied drugs generally. Cosmetics generally, including eye area use.
5, 6 73.1085
73.2085
73.85
6358-30-1 Carbazole Violet Permanently listed, exempt from certification Devices
Contact lenses use only.
3 73.3107
1333-86-4 Carbon Black (Channel or Impingement) Delisted, formerly exempt from certification None
(formerly Foods, Drugs, Cosmetics)
1390-65-4 Carmine Permanently listed, exempt from certification Foods, Drugs, Cosmetics
Foods generally. Ingested and externally applied drugs. Cosmetics generally including eye area use. Food and cosmetic labels must use common or usual name """"carmine.""""
5 73.100
73.1100
73.2087
8015-88-1 Carrot Oil Permanently listed, exempt from certification Foods
Foods generally.
73.300
16291-96-6 Charcoal Delisted, formerly exempt from certification None
(formerly Cosmetics)
16291-96-6 Charcoal (NFXI) Delisted, formerly exempt from certification None
(formerly Foods, Drugs)
1406-65-1 Chlorophyll Delisted, formerly exempt from certification None
(formerly Foods)
11006-34-1 Chlorophyllin-Copper Complex, Oil Soluble Permanently listed, exempt from certification Devices
Bone cement only NTE 0.003%
3 73.3110
977053-65-8 Chlorophyllin, Potasium Sodium Copper (Chlorophyllin copper complex) Permanently listed, exempt from certification Drugs, Cosmetics
Citrus-based dry beverage mixes NTE 0.2 percent in dry mix; extracted from alfalfa. Dentrifices that are drugs; NTE 0.1%. Coloring dentrifices that are cosmetics NTE 0.1% in combination with a list of substances.
3 73.1125
73.2125
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
12001-99-9 Chromium Hydroxide Green Permanently listed, exempt from certification Drugs, Cosmetics
Externally applied drugs including eye area use. Externally applied cosmetics including eye area use.
6 73.1326
73.2326
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
6358-53-8 Citrus Red No. 2 Permanently listed, certification required Foods
Mature oranges use only.
74.302
1333-88-6 Cobaltous Aluminate (Cobalt Blue) Delisted, formerly exempt from certification None
(formerly Cosmetics)
1343-78-8 Cochineal Delisted, formerly exempt from certification None
(formerly Foods, Drugs, Cosmetics)
1390-65-4 Cochineal Extract (Carminic Acid) Permanently listed, exempt from certification Foods, Drugs
Foods generally. Ingested and externally applied drugs. Cosmetics generally including eye area use. Food and cosmetic labels must use common or usual name """"cohineal extract.""""
6 73.100
73.1100
7440-50-8 Copper Metallic Powder Permanently listed, exempt from certification Drugs, Cosmetics
Externally applied drugs including eye area use. Cosmetics generally including eye area use.
5, 6 73.1647
73.2647
977010-50-6 Corn Endosperm Oil Permanently listed, exempt from certification Foods
Chicken feed use only
73.315

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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

  1. 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).
  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; never 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.
  8. 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
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