444 JOURNAL OF COSMETIC SCIENCE In China, the cosmetic regulatory system is founded on Regulations Concerning the Hygiene Supervision Over Cosmetics (1989) supervised by the National Medicinal Prod- ucts Administration, previously called the China Food and Drug Administration. Cos- metic ingredients should be listed in the Inventory of Existing Cosmetic Ingredients in China (15) and comply with the Safety and Technical Standard for Cosmetics-2015 regulation (16). Ingredients not listed in the Inventory of Existing Cosmetic Ingredi- ents in China are required to undergo a registration procedure. The Safety and Technical Standards for Cosmetics regulation includes the lists of banned, allowed, and restricted ingredients. It defines a coloring agent as an ingredient added to cosmetics to create certain colors by absorbing and reflecting light (16). The list of colorants approved for use in cosmetic products can be found in Table 6 of the regulation along with the field of application, limitations, and requirements. The Chinese regulatory framework is similar to that of the EU. For this paper, we compared cosmetic color regulations in China to those of the other entities but did not analyze them in depth. In Korea, cosmetic products are regulated by the Ministry of Food and Drug Safety under the Cosmetics Act and its amendments (17). A colorant is defined as an ingredient for which the main purpose is to make the color appear in cosmetic products or on skin (17). The Ministry of Food and Drug Safety’s Colorant Specifications and Test methods notice laid out the types of colorants permitted in cosmetic products, their specifications, and the test methods. The types, usage areas, and usage of permitted colorants are specified in Annex 1. The particular specification and test method for each colorant are described in Annex 2. Although the acceptable criteria may be equivalent to those of other countries, it is mandatory to verify that manufacturer is using the same method detailed in Annex 2 of the regulation. Korean cosmetic regulations are similar to the Japanese cosmetic regu- lations, which have considerable differences from those of the EU and the United States. In the next section, cosmetic colorants as mentioned before were grouped into three categories (synthetic, inorganic, and natural), and comparative studies are conducted. Although the regulations of each country are constantly changing, the current number of colorants permitted in cosmetics in each country is shown in Table I, as are provided the permitted number of colorants in the three categories. The numbers were tabulated based on the numbers in Appendix 1. Colorants used as hair dyes or cosmetic soaps are not dis- cussed in this report. Throughout the paper, colorants will be referred to by the common names. The nomenclature for colorants from each country can be found in Appendix 1. Table I Comparison of the Number of Permitted Colorants in Cosmetics Total Synthetic Colorants Inorganic Colorants Natural Colorants EUa 153 110 29 14 United Statesb 65 37 20 8 Chinac 157 110 31 16 Koread 102 59 30 13 a FDA 21 CFR Parts 73 and 74. b Annex IV, Regulation (EC) No 1223/2009. c Table 6, Chap.3, Safety and Technical Standards for Cosmetics 2015.’ d Annex 1, MFDS Notification ‘Colorants specification and test methods.’

445 COSMETIC COLORATION: A REVIEW COMPARISONS OF COSMETIC COLORANT REGULATIONS SYNTHETIC COLORANTS Synthetic colorants provide superior technical properties in tinctorial strength, hue, and stability compared to natural colorants (18). The use of synthetic colorants in cosmetic products has dominated the market globally because of the limitations of current tech- nologies regarding natural colorants. Synthetic colorants present uniform quality and stability. Synthetic colorants do not appear in nature, are produced only by a chemi- cal synthesis, and can be categorized based on their solubility and chemical structure. Depending on the solubility in the medium in which it is dispersed, one is soluble as a dye and the other is insoluble as a pigment (19). Additionally, synthetic colorants can be classified according to their common chemical structural features (Table II) (20–22). Table II Classification of Synthetic Colorants (US permitted colorants) by Structure Classification Chromophore Examples [Common Name (CI No, US Name)] Azo dye Permaton Red (CI 12085, D&C Red No. 36), Ponceau SX (CI 14700, FD&C Red No. 4),Orange II (CI 15510, D&C Orange No. 4), Brilliant Lake Red R (CI 15800, D&C Red No. 31), Lithol Rubine B (CI 15850, D&C Red No. 6), Lithol Rubine BCA (CI 15850, D&C Red No. 7), Deep Maroon (CI 15880, D&C Red No. 34), Sunset Yellow FCF (CI 15985, FD&C Yellow No. 6), Allura Red AC (CI 16035, FD&C Red No. 40), Fast Acid Magenta (CI 17200, D&C Red No. 33), Tartrazine (CI 19140, FD&C Yellow No. 5), Resorcin Brown (CI 20170, D&C Brown No. 1), Sudan III (CI 26100, D&C Red No. 17) Triarylcarbonium dye Fast Green FCF (CI 42053, FD&C Green No. 3), Brilliant Blue FCF (CI 42090, FD&C Blue No. 1), Alphazurine FG (CI 42090, D&C Blue No. 4) Xanthene dye Uranine (CI 45350, D&C Yellow No. 8), Fluorescein (CI 45350, D&C Yellow No. 7), Dibromofluorescein (CI 45370, D&C Orange No. 5), Eosine YS (CI 45380, D&C Red No. 22), Tetrabromoflu- orescein (CI 45380, D&C Red No. 21), Tetrachlorotetrabromo- fluorescein (CI 45410, D&C Red No. 27), Phloxine B (CI 45410, D&C Red No. 28), Diiodofluorescein (CI 45425, D&C Orange No. 10), Erythrosine Yellowish NA (CI 45425, D&C Orange No. 11) Anthraquinone dye Pyranine Conc (CI 59040, D&C Green No. 8), Alizurine Purple SS (CI 60725, D&C Violet No. 2), Alizurol Purple (CI 60730, Ext. D&C Violet No. 2), Quinizarine Green SS (CI 61565, D&C Green No. 6), Alizarine Cyanine Green F (CI 61570, D&C Green No. 5) Quinophthalone dye (Quonoline) Quinoline Yellow SS (CI 47000, D&C Yellow No. 11), Quinoline Yellow WS (CI 47005, D&C Yellow No. 10) Thioindigo dye (Indigos) Helindone Pink CN (CI 73360, D&C Red No. 30) Nitro dye Naphthol Yellow S (CI 10316, Ext. D&C Yellow No. 7) Ar stands for Aryl group