The use of colors in drugs and cosmetics is regulated to ensure safety and consistency. The permitted colors are often classified as either synthetic or natural, and regulations vary by country. Below is an overview of permitted colors commonly allowed in the United States by the FDA, the European Union by the EMA, and other major regulatory bodies.
United States (FDA)
In the United States, the FDA regulates color additives through the Color Additive Amendments of 1960. The colors are categorized as follows:
FD&C Colors (Food, Drugs, and Cosmetics):
1. FD&C Blue No. 1: Brilliant Blue FCF
2. FD&C Blue No. 2: Indigotine
3. FD&C Green No. 3: Fast Green FCF
4. FD&C Red No. 3: Erythrosine
5. FD&C Red No. 40: Allura Red AC
6. FD&C Yellow No. 5: Tartrazine
7. FD&C Yellow No. 6: Sunset Yellow FCF
D&C Colors (Drugs and Cosmetics):
1. D&C Blue No. 4
2. D&C Green No. 5
3. D&C Red No. 6
4. D&C Red No. 7
5. D&C Red No. 17
6. D&C Red No. 19
7. D&C Red No. 21
8. D&C Red No. 22
9. D&C Red No. 27
10. D&C Red No. 30
11. D&C Red No. 33
12. D&C Yellow No. 7
External D&C Colors (External Drugs and Cosmetics):
1. External D&C Violet No. 2
European Union (EMA)
In the European Union, color additives are regulated by the European Medicines Agency (EMA) and are listed in Annex IV of the Cosmetics Regulation (EC) No 1223/2009.
Permitted Colors:
1. E100: Curcumin
2. E101: Riboflavin
3. E102: Tartrazine
4. E104: Quinoline Yellow
5. E110: Sunset Yellow FCF
6. E120: Cochineal, Carminic Acid, Carmines
7. E122: Azorubine, Carmoisine
8. E123: Amaranth
9. E124: Ponceau 4R, Cochineal Red A
10. E127: Erythrosine
11. E129: Allura Red AC
12. E131: Patent Blue V
13. E132: Indigotine, Indigo Carmine
14. E133: Brilliant Blue FCF
15. E140: Chlorophylls and Chlorophyllins
16. E141: Copper Complexes of Chlorophylls and Chlorophyllins
17. E142: Green S
18. E150a: Plain Caramel
19. E150d: Sulphite Ammonia Caramel
20. E151: Brilliant Black BN, Black PN
21. E153: Vegetable Carbon
22. E160a: Carotenes
23. E160e: Beta-apo-8′-Carotenal (C 30)
24. E161b: Lutein
25. E161g: Canthaxanthin
26. E162: Beetroot Red, Betanin
27. E170: Calcium Carbonate
28. E171: Titanium Dioxide
29. E172: Iron Oxides and Hydroxides
 Other Regulatory Bodies
Different countries have their own regulations, but many follow similar guidelines. For example, India’s Central Drugs Standard Control Organization (CDSCO) and Japan’s Ministry of Health, Labour, and Welfare (MHLW) have lists that often overlap with those of the FDA and EMA.
Summary
The permitted colors for drugs and cosmetics are strictly regulated to ensure safety and effectiveness. Compliance with these regulations is crucial for manufacturers to avoid adverse health effects and ensure product quality. Always refer to the specific regulatory guidelines applicable to the country where the product is being marketed.
