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 |
---|---|---|---|---|---|
1344-28-1 | Alumina | Permanently listed, exempt from certification |
Drugs Drugs generally. |
5 | 73.1010 |
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 |
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 |
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 |
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 |
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 |
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 | |
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 |
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 |
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 |
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 |
D&C and Ext. D&C Lakes | Provisionally listed, certification required | External Drugs, External Cosmetics |
82.1051 82.2051 |
||
2650-18-2 | D&C Blue No. 4 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
74.1104 74.2104 82.1104 |
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 |
6358-69-6 | D&C Green No. 8 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs (NTE 0.01% (by weight)). Externally applied cosmetics NTE 0.01% (by wt) of finished cosmetic product). |
6 |
74.1208 74.2208 |
38577-97-8 | D&C Orange No. 10 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
74.1260 74.2260 81.10 81.30 82.1260 |
33239-19-9 | D&C Orange No. 11 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
74.1261 74.2261 81.10 81.30 82.1261 |
633-96-5 | D&C Orange No. 4 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Cosmetics generally. |
5, 6 |
74.1254 74.2254 81.30 82.1254 |
596-03-2 | D&C Orange No. 5 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs (NTE 5 mg/daily dose of drug). Externally applied cosmetics. Mouthwashes, dentrifices, lipsticks, and other lip cosmetics NTE 5%. |
6 |
74.1255 74.2255 82.1255 |
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 |
15086-94-9 | D&C Red No. 21 | Permanently listed, certification required |
Drugs, Cosmetics Drugs generally. Cosmetics generally. |
5 |
74.1321 74.2321 82.1321 |
17372-87-1 | D&C Red No. 22 | Permanently listed, certification required |
Drugs, Cosmetics Drugs generally. Cosmetics generally. |
5 |
74.1322 74.2322 82.1322 |
13473-26-2 | D&C Red No. 27 | Permanently listed, certification required |
Drugs, Cosmetics Drugs generally. Cosmetics generally. |
5 |
74.1327 74.2327 82.1327 |
18472-87-2 | D&C Red No. 28 | Permanently listed, certification required |
Drugs, Cosmetics Drugs generally. Cosmetics generally. |
5 |
74.1328 74.2328 82.1328 |
2379-74-0 | D&C Red No. 30 | Permanently listed, certification required |
Drugs, Cosmetics Drugs generally. Cosmetics generally. |
5 |
74.1330 74.2330 82.1330 |
6371-76-2 | D&C Red No. 31 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied cosmetics. |
6 |
74.1331 74.2331 81.30 82.1331 |
3567-66-6 | D&C Red No. 33 | Permanently listed, certification required |
Drugs, Cosmetics Ingested drugs, other than mouthwashes and dentrifices (NTE 0.75 mg/daily dose of drug); externally applied drugs, mouthwashes and dentrifices. Externally applied cosmetics; mouthwashes, dentrifices; cosmetic lip products (NTE) 3% (by wt) of finished cosmetic product.) |
6 |
74.1333 74.2333 82.1333 |
6417-83-0 | D&C Red No. 34 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
74.1334 74.2334 81.30 82.1334 |
2814-77-9 | D&C Red No. 36 | Permanently listed, certification required |
Drugs, Cosmetics Ingested drugs, other than mouthwashes and dentrifices, NTE 1.7 mg daily dose for drugs taken less than 1 yr; NTE 1.0 mg/daily dose for drugs taken more than 1 yr.mouthwashes and dentrifices. Externally applied drugs. Externally applied cosmetics; cosmetic lip products (NTE 3% (by wt) of finished cosmetic product). |
6 |
74.1336 74.2336 82.1336 |
6371-55-7 | D&C Red No. 39 | Permanently listed, certification required |
Drugs Quaternary ammonium type germicidal solutions for external application (NTE 0.1% (by wt) of finished drug product). |
74.1339 | |
5858-81-1 | D&C Red No. 6 | Permanently listed, certification required |
Drugs, Cosmetics Drugs such that total with D&C Red No. 7 NTE 5 mg/daily dose of drug. Ether soluble matter specification changed to1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. Cosmetics generally. |
5 |
74.1306 74.2306 82.1306 |
5281-04-9 | D&C Red No. 7 | Permanently listed, certification required |
Drugs, Cosmetics Drugs such that total with D&C Red No. 7 NTE 5 mg/daily dose of drug. Ether soluble matter specification changed to1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. Cosmetics generally in amounts consistent with GMP. |
4, 5, 6, 7 |
74.1307 74.2307 82.1307 |
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 |
8003-22-3 | D&C Yellow No. 11 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
4, 5, 6 |
74.1711 74.2711 81.30 |
2321-07-5 | D&C Yellow No. 7 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
4, 5, 6 |
74.1707 74.2707 82.1707 |
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 |
96-26-4 | Dihydroxyacetone | Permanently listed, exempt from certification |
Drugs, Cosmetics Externally applied drugs intended soley or in part to impart a color to the human body. Externally applied cosmetics intended solely or in part to impart color to the human body. |
3, 6 | 73.1150 |
139-33-3 | Disodium EDTA: Diluents for Color Additive Mixture | Permanently listed, exempt from certification |
Foods, Drugs May be used in aqueous solutions and aqueous dispersions in color additive mixtures. |
4, 5, 6, 7, 8 | 73.1 |
846-70-8 | Ext. D&C Yellow No. 7 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
74.1707a 74.2707a 82.2707a |
977105-05-7 | FD&C Lakes | Provisionally listed, certification required | Foods, Drugs, Cosmetics | 82.51 | |
3844-45-9 | FD&C Blue No. 1 | Permanently listed, certification required |
Foods, Drugs, Cosmetics Foods generally. Added Mn spec. Ingested drugs generally; externally applied drugs including eye area use (includes lakes). Cosmetics generally. Allows MnO2 in manufacture. Eye area use (includes lakes). |
5, 6 |
74.101 74.1101 74.2101 82.101 |
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 |
---|