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 |
---|---|---|---|---|---|
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 | |
977050-51-3 | Cornstarch | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
977043-77-8 | Cottonseed Flour, Toasted Partially Defatted Cooked | Permanently listed, exempt from certification |
Foods Foods generally. |
73.140 | |
1393-80-2 | Cudbear | Delisted, formerly exempt from certification |
None (formerly Foods) |
||
458-37-7 | Curcumin | Delisted, formerly exempt from certification |
None (formerly Foods) |
||
D&C and Ext. D&C Lakes | Provisionally listed, certification required | External Drugs, External Cosmetics |
82.1051 82.2051 |
||
1064-48-8 | D&C Black No. 1 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
1333-86-4 | D&C Black No. 2 | Permanently listed, certification required |
Cosmetics Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel. |
74.2052 | |
8021-99-6 | D&C Black No. 3 | Permanently listed, certification required |
Cosmetics Eyeliner, eye shadow, mascara, and face powder. |
3 | 74.2053 |
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 | |
81-48-1 | D&C Blue No. 3 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
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 |
6408-51-1 | D&C Blue No. 5 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
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 |
|
3374-30-9 | D&C Blue No. 7 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
3374-30-9 | D&C Blue No. 8 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
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 |
|
1320-07-6 | D&C Brown No. 1 | Permanently listed, certification required |
Cosmetics Externally applied cosmetics. |
6 | 74.2151 |
6546-18-5 | D&C Green No. 4 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
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 |
4857-81-2 | D&C Green No. 7 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 |
977140-41-2 | D&C Orange No. 12 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
10134-55-1 | D&C Orange No. 13 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
33014-42-5 | D&C Orange No. 14 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
72-48-0 | D&C Orange No. 15 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
31544-98-6 | D&C Orange No. 16 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
3468-63-1 | D&C Orange No. 17 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
1936-15-8 | D&C Orange No. 3 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 |
4372-02-5 | D&C Orange No. 6 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
6493-54-5 | D&C Orange No. 7 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
3474-67-7 | D&C Orange No. 8 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
977140-43-4 | D&C Orange No. 9 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
1248-18-6 | D&C Red No. 10 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
1103-39-5 | D&C Red No. 11 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
1103-38-4 | D&C Red No. 12 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
6371-67-1 | D&C Red No. 13 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
5850-76-0 | D&C Red No. 14 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
6372-81-2 | D&C Red No. 15 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
6373-04-2 | D&C Red No. 16 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
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 |
1320-06-5 | D&C Red No. 18 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
81-88-9 | D&C Red No. 19 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
64381-99-3 | D&C Red No. 20 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
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 |
56897-54-2 | D&C Red No. 23 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
2320-38-9 | D&C Red No. 24 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
2320-38-9 | D&C Red No. 25 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
2320-38-9 | D&C Red No. 26 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 |
6359-09-7 | D&C Red No. 29 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 |
2425-85-6 | D&C Red No. 35 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 |
6373-07-5 | D&C Red No. 37 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
3564-22-5 | D&C Red No. 38 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 | |
3761-53-3 | D&C Red No. 5 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.30 | |
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 |
2092-56-0 | D&C Red No. 8 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
5160-02-1 | D&C Red No. 9 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
1694-09-3 | D&C Violet No. 1 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
81.10 81.30 |
|
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 |
6417-85-2 | D&C Yellow No. 9 | Delisted, formerly subject to certification |
None (formerly Drugs, Cosmetics) |
||
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 |
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 |
14025-15-1 | Disodium EDTA-Copper (Copper Versenate) | Permanently listed, exempt from certification |
Cosmetics Coloring of shampoos that are cosmetics. |
3, 4 | 73.2120 |
3071-73-6 | Ext. D&C Black No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
61-73-4 | Ext. D&C Blue No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
6372-69-6 | Ext. D&C Blue No. 2 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
3486-30-4 | Ext. D&C Blue No. 3 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
2861-02-1 | Ext. D&C Blue No. 4 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
2646-15-3 | Ext. D&C Blue No. 5 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
19381-50-1 | Ext. D&C Green No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.10 81.30 |
|
6371-96-6 | Ext. D&C Orange No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
6359-06-4 | Ext. D&C Orange No. 2 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
523-44-4 | Ext. D&C Orange No. 3 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
2646-17-5 | Ext. D&C Orange No. 4 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
4321-69-1 | Ext. D&C Red No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
3567-69-9 | Ext. D&C Red No. 10 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
3734-67-6 | Ext. D&C Red No. 11 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
5850-85-1 | Ext. D&C Red No. 12 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
5413-75-2 | Ext. D&C Red No. 13 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
3118-97-6 | Ext. D&C Red No. 14 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
3564-09-8 | Ext. D&C Red No. 15 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
1836-22-2 | Ext. D&C Red No. 2 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
4548-53-2 | Ext. D&C Red No. 24 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
6252-76-2 | Ext. D&C Red No. 3 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
4370-09-6 | Ext. D&C Red No. 4 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
18265-55-9 | Ext. D&C Red No. 5 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
6372-92-5 | Ext. D&C Red No. 6 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
130-22-3 | Ext. D&C Red No. 7 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
1658-56-6 | Ext. D&C Red No. 8 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
6373-10-0 | Ext. D&C Red No. 9 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
6408-63-5 | Ext. D&C Violet No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
4430-18-6 | Ext. D&C Violet No. 2 | Permanently listed, certification required | Cosmetics | 74.2602a | |
587-98-4 | Ext. D&C Yellow No. 1 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.10 81.30 |
|
131-79-3 | Ext. D&C Yellow No. 10 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.10 81.30 |
|
4478-91-5 | Ext. D&C Yellow No. 2 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
6359-82-6 | Ext. D&C Yellow No. 3 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
6372-96-9 | Ext. D&C Yellow No. 4 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
2512-29-0 | Ext. D&C Yellow No. 5 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
6054-99-5 | Ext. D&C Yellow No. 6 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.30 | |
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 |
549-34-8 | Ext. D&C Yellow No. 8 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
||
85-84-7 | Ext. D&C Yellow No. 9 | Delisted, formerly subject to certification |
None (formerly External Drugs, External Cosmetics) |
81.10 81.30 |
|
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 |
16521-38-3 | FD&C Blue No. 2- Aluminum Lake on Alumina | Permanently listed, certification required |
Devices Bone cement NTE 0.1%. |
74.3102 | |
4680-78-8 | FD&C Green No. 1 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
81.30 | |
5141-20-8 | FD&C Green No. 2 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
81.30 | |
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 |
523-44-4 | FD&C Orange No.1 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
||
2646-17-5 | FD&C Orange No. 2 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
81.30 | |
3564-09-8 | FD&C Red No. 1 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
81.10 81.30 |
|
915-67-3 | FD&C Red No. 2 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
81.10 81.30 |
|
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 |
|
3118-97-6 | FD&C Red No. 32 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
81.30 | |
4548-53-2 | FD&C Red No. 4 | Permanently listed, certification required |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
74.1304 74.2304 81.10 81.30 82.304 |
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 |
1694-09-3 | FD&C Violet No. 1 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
4, 5 |
81.10 81.30 |
846-70-8 | FD&C Yellow No. 1 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
||
549-34-8 | FD&C Yellow No. 2 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
||
85-84-7 | FD&C Yellow No. 3 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
||
131-79-3 | FD&C Yellow No. 4 | Delisted, formerly subject to certification |
None (formerly Foods, Drugs, Cosmetics) |
||
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 |
1185-57-5 | Ferric Ammonium Citrate | Permanently listed, exempt from certification |
Drugs With pyrogallol for coloring plain or chromic catgut sutures; NTE 3% general and ophthalmic surgery. |
4, 5, 6 | 73.1025 |
25869-00-5 | Ferric Ammonium Ferrocyanide | Permanently listed, exempt from certification |
Drugs Externally applied drugs including eye area use. Externally applied cosmetics including eye area use. |
6 |
73.1298 73.2298 |
7705-08-0 | Ferric Chloride | Delisted |
None (formerly Drugs, Cosmetics) |
||
14038-43-8 | Ferric Ferrocyanide (Iron Blue) | Permanently listed, exempt from certification |
Drugs, Cosmetics Externally applied drugs including eye area use. Externally applied cosmetics including eye area use. |
6 |
73.1299 73.2299 |
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 |
7720-78-7 | Ferrous Sulfate | Delisted, formerly exempt from certification |
None (formerly Foods) |
||
977010-51-7 | Fruit Juice | Permanently listed, exempt from certification |
Foods Foods generally. Dried color additive |
3 | 73.250 |
8031-18-3 | Fuller's Earth | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
519-34-6 | Fustic | Delisted, formerly exempt from certification |
None (formerly Drugs) |
||
Gloss White | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
82.3 | ||
7440-57-5 | Gold | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
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 | |
7782-42-5 | Graphite | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
81.10 | |
489-84-9 | Guaiazulene | Permanently listed, exempt from certification |
Cosmetics Externally applied cosmetics. |
6 | 73.2180 |
73-40-5 | Guanine | Permanently listed, exempt from certification |
Drugs, Cosmetics Externally applied drugs including eye area use. Cosmetics generally including eye area use. |
5, 6 |
73.1329 73.2329 |
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 |
Henna | Permanently listed, exempt from certification |
Cosmetics Coloring hair but not eyelashes, eyebrows, or eye area. |
3 | 73.2190 | |
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 | ||
1332-58-7 | Kaolin | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
61790-53-2 | Kieselguhr (Diatomite) | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1302-83-6 | Lapis Lazuli (Lazurite) | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
301-04-2 | Lead Acetate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
4485-12-5 | Lithium Stearate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1345-05-7 | Lithopone | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
8005-33-2 | Logwood | Permanently listed, exempt from certification |
Drugs For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE 1% general and ophthalmic surgery. |
73.1410 | |
8005-33-2 | Logwood (Bluewood, Campeche Wood) | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
977140-94-5; 8005-33-2 | Logwood Chips and Extracts | Delisted, formerly exempt from certification |
None (formerly Foods) |
||
Luminescent Zinc Sulfide | Permanently listed, exempt from certification |
Cosmetics Nail polish and externally applied facial makeup NTE 10% of final product for limited, occasional use. |
6 | 73.2995 | |
41855 | Magnesium Aluminum Silicate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
546-93-0 | Magnesium Carbonate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
557-04-0 | Magnesium Stearate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
14987-04-3 | Magnesium Trisilicate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1309-48-4 | Magnesium Oxide | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
Metallic Salts | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
|||
91-44-1 | 4-Methyl-7-Diethylaminocoumarin | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
90-33-5 | β-methylumbelliferone | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
12001-26-2 | Mica | Permanently listed, exempt from certification |
Drugs, Cosmetics Externally applied drugs including eye area use. Dentrifices. Cosmetics generally including eye area use. |
5, 6 |
73.1496 73.2496 73.350 73.3128 |
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 | |
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 | ||
13943-58-3 | Potassium Ferrocyanide | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
87-66-1 | Pyrogallol | Permanently listed, exempt from certification |
Drugs With ferric ammonium citrate for coloring plain or chromic catgut sutures: NTE 3% general and ophthalmic surgery. |
73.1375 | |
12269-78-2 | Pyrophyllite (aluminum silicate) | Permanently listed, exempt from certification |
Drugs, Cosmetics Externally applied drugs. Externally applied cosmetics. |
6 |
73.1400 73.2400 |
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 |
83-88-5 | Riboflavin | Permanently listed, exempt from certification |
Foods Foods generally. |
73.450 | |
977134-91-0 | Safflower (American Saffron, Florets of Tinctorious L.) | Delisted, formerly exempt from certification |
None (formerly Foods) |
||
977051-90-3 | Saffron (Crocus Sativus L.) | Permanently listed, exempt from certification |
Foods Foods generally. |
73.500 | |
977115-45-9 | Saffron Oleoresin | Delisted, formerly exempt from certification |
None (formerly Foods) |
||
12769-50-5 | Sienna | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1343-98-2 | Silicic Acid | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
7631-86-9 | Silicon Dioxide | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
73.1 73.575 |
|
9009-99-8 | Silk Powder | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
7440-22-4 | Silver | Permanently listed, exempt from certification |
Cosmetics Coloring fingernail polish NTE 1% of final product. |
3, 7 | 73.2500 |
7761-88-8 | Silver nitrate | Permanently listed, exempt from certification |
Cosmetics Externally applied professional-use only cosmetics intended to impart color to the eyebrows and eyelashes; NTE 4% by weight |
73.2550 | |
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 |
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 |
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 |
|
842-07-9 | Sudan I | Delisted prior to 1938 Food, Drug and Cosmetic Act |
None (formerly Foods) |
||
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 |
14807-96-6 | Talc | Permanently listed, exempt from certification |
Drugs Drugs generally. |
5 | 73.1550 |
18282-10-5 | Tin Oxide | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
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 |
|
502-65-8 | Tomato Lycopene Extract and Concentrate | Permanently listed, exempt from certification |
Foods Foods generally. |
3 | 73.585 |
977052-44-0 | Turmeric | Permanently listed, exempt from certification |
Foods Foods generally. |
73.600 | |
129828-29-1 | Turmeric Oleoresin | Permanently listed, exempt from certification |
Foods Foods generally. |
73.615 | |
57455-37-5 | Ultramarine Blue | Permanently listed, exempt from certification |
Foods, Cosmetics Animal feed. Externally applied cosmetics including eye area use. |
1, 5, 7 |
73.2725 73.50 |
1345-00-2 | Ultramarine Green | Permanently listed, exempt from certification |
Cosmetics Externally applied cosmetics including eye area use. |
5 | 73.2725 |
977058-55-1 | Ultramarine Pink | Permanently listed, exempt from certification |
Cosmetics Externally applied cosmetics including eye area use. |
5 | 73.2725 |
977058-56-2 | Ultramarine Red | Permanently listed, exempt from certification |
Cosmetics Externally applied cosmetics including eye area use. |
5 | 73.2725 |
12769-96-9 | Ultramarine Violet | Permanently listed, exempt from certification |
Cosmetics Externally applied cosmetics including eye area use. |
5 | 73.2725 |
12713-03-0 | Umber | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
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 |
977010-58-4 | Vegetable Juice | Permanently listed, exempt from certification |
Foods Foods generally. |
73.260 | |
977141-34-6 | Vegetable Substances | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1318-00-9 | Vermiculite | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
127-40-2 | Xanthophyll | Permanently listed, exempt from certification | Foods | 1 |
73.275 73.295 73.315 |
3486-35-9 | Zinc Carbonate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1314-13-2 | Zinc Oxide | Permanently listed, exempt from certification |
Drugs, Cosmetics Externally applied drugs including eye area use. Cosmetics generally including eye area use. |
6 |
73.1991 73.2991 |
557-05-1 | Zinc Stearate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
1314-23-4 | Zirconium Oxide | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
||
14940-68-2 | Zirconium Silicate | Delisted, formerly exempt from certification |
None (formerly Cosmetics) |
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 |
---|