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
Search and display hints
- Select the Substance name below to view the additional information about the substance.
- To sort by a specific field, click on the column header for that field.
- To browse the records, use the Show All, First/Previous/Next/Last, and Jump To options at the bottom of the data table.
- To search for a specific term (or phrase or partial word), enter that term in the Search box and select Show Items to display only those records that contain the selected term.
- The search results may include terms not shown on the results pages, but included in the full record descriptions. For example, a search for “natural orange 4” will find the substance “Annatto” and "Annatto Extract".
- The search results will return hits of records containing words that include the search term. For example, a search for the color red will return results that include terms such as reducing, ingredient, and denatured. To limit results to only the searched term, place a space before and after the word in the basic search or in the advanced search “this exact phrase” field. You may also do a Field Search, to limit occurrence to a specific data field type (such as "color" names).
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 |
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 |
---|