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:
- 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 |
|---|---|---|---|---|---|
| 977010-47-1 | Algae Meal, Dried | Permanently listed, exempt from certification |
Foods Chicken feed, NTE 0.3% or 150 ppm ethoxyquin, |
73.275 | |
| 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 | |
| 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 | |
| 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 |
| 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 | ||
| 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 |
| 8015-88-1 | Carrot Oil | Permanently listed, exempt from certification |
Foods Foods generally. |
73.300 | |
| 6358-53-8 | Citrus Red No. 2 | Permanently listed, certification required |
Foods Mature oranges use only. |
74.302 | |
| 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 |
| 977010-50-6 | Corn Endosperm Oil | Permanently listed, exempt from certification |
Foods Chicken feed use only |
73.315 | |
| 977043-77-8 | Cottonseed Flour, Toasted Partially Defatted Cooked | Permanently listed, exempt from certification |
Foods Foods generally. |
73.140 | |
| 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 |
| 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 |
| 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 |
| 2353-45-9 | FD&C Green No. 3 | Permanently listed, certification required |
Foods, Drugs, Cosmetics Foods generally. Drugs generally. Cosmetics generally. |
5 |
74.1203 74.203 74.2203 82.203 |
| 16423-68-0 | FD&C Red No. 3 | Permanently listed, certification required |
Foods, Drugs, Cosmetics Foods generally. Ingested drugs. |
74.1303 74.303 81.10 81.30 |
|
| 25956-17-6 | FD&C Red No. 40 | Permanently listed, certification required |
Foods, Drugs, Cosmetics Foods generally. Drugs generally. Cosmetics generally (includes lakes). Eye area use (includes aluminum lake). No oxidizing or reducing agents that may affect integrity. |
4, 5, 6 |
74.1340 74.2340 74.340 |
| 1934-21-0 | FD&C Yellow No. 5 | Permanently listed, certification required |
Foods, Drugs, Cosmetics Foods generally. Ingested drugs generally. Externally applied drugs. Eye area use (includes lakes). Cosmetics generally. Eye area use (includes Al lake). |
4, 5, 6, 7, 8 |
74.1705 74.2705 74.705 82.705 |
| 2783-94-0 | FD&C Yellow No. 6 | Permanently listed, certification required |
Foods, Drugs, Cosmetics Foods generally. Drugs generally. Cosmetics generally. |
4, 5, 6, 7, 8 |
74.1706 74.2706 74.706 82.706 |
| 6047-12-7 | Ferrous Gluconate | Permanently listed, exempt from certification |
Foods Ripe olives |
5 | 73.160 |
| 92542-68-2 | Ferrous Lactate | Permanently listed, exempt from certification |
Foods Ripe olives |
5 | 73.165 |
| 977010-51-7 | Fruit Juice | Permanently listed, exempt from certification |
Foods Foods generally. Dried color additive |
3 | 73.250 |
| 977091-57-8 | Grape Color Extract | Permanently listed, exempt from certification |
Foods Nonbeverage food. |
3 | 73.169 |
| 11029-12-2 | Grape Skin Extract (Enocianina) | Permanently listed, exempt from certification |
Foods Still & carbonated drinks &ades; beverage bases; alcoholic beverages (restr. 27 CFR Parts 4 & 5) |
73.170 | |
| 977176-72-9 | Haematococcus Algae Meal | Permanently listed, exempt from certification |
Foods Salmonid feed, NTE 80 mg/kg (72 g/ton) astaxanthin in finished feed. |
1 | 73.185 |
| 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 |
| Jagua (genipin-glycine) blue | Permanently listed, exempt from certification |
Foods Foods generally. |
73.225 | ||
| 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 |
|
| 15139-76-1 | Orange B | Permanently listed, certification required |
Foods Casings or surfaces of frankfurthers and sausages; NTE 150 ppm (by wt). |
74.250 | |
| 977006-45-3; 68917-78-2 | Paprika and Paprika Oleoresin | Permanently listed, exempt from certification |
Foods Foods generally. |
73.340 73.345 |
|
| 977188-18-3 | Paracoccus Pigment | Permanently listed, exempt from certification |
Foods Salmonid feed, NTE 80 mg/kg (72 g/ton) astaxanthin in finished feed. |
73.352 | |
| 977165-85-7 | Phaffia Yeast | Permanently listed, exempt from certification |
Foods Salmonid feed, NTE 80 mg/kg (72 g/ton) astaxanthin in finished feed. |
73.355 | |
| 83-88-5 | Riboflavin | Permanently listed, exempt from certification |
Foods Foods generally. |
73.450 | |
| 977051-90-3 | Saffron (Crocus Sativus L.) | Permanently listed, exempt from certification |
Foods Foods generally. |
73.500 | |
| 28302-36-5 | Sodium Copper Chlorophyllin | Permanently listed, exempt from certification |
Foods Citrus-based dry beverages mixes NTE 0.2 percent in the dry mix. |
3, 7 | 73.125 |
| 1673586-07-6 | Soy leghemoglobin | Permanently listed, exempt from certification |
Foods Ground beef analogue products; NTE 0.8% by weight. |
73.520 | |
| 977091-09-0 | Spirulina Extract | Permanently listed, exempt from certification |
Foods, Drugs Candy and chewing gum; Coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded cereals), and coating formulation for dietary supplements, drug tablets, capsules. Hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). Alcoholic beverages with less than 20% alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated). |
73.530 73.1530 |
|
| 977010-56-2 | Tagetes (Aztec Marigold) Extract | Permanently listed, exempt from certification |
Foods Chicken feed. |
1 | 73.295 |
| 977010-56-2 | Tagetes Meal | Permanently listed, exempt from certification |
Foods Chicken feed. |
1 | 73.295 |
| 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 |
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 |
|---|
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