442 Address all correspondence to Yoonjung Kim at yoonjungkim@amorepacific.com. J. Cosmet. Sci., 72, 442–498 (July/August 2021) Cosmetic Coloration: A Review YOONJUNG KIM and JUNGJA LEE AMOREPACIFIC Research and Development Center, 1920, Yonggu-daero, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea (Y.K., J.L.) Accepted for publication July 6, 2021. Synopsis Colorants for cosmetics appear to be more strictly regulated than any other cosmetic ingredients. Most countries have adopted a positive regulatory system for colorants used in cosmetics. Although there have been many reports on colorants that are used in food products from regulatory perspectives, reports on colorants used in cosmetic products have been limited. The objective of this report is to provide different countries’ regulatory requirements and to encourage the cosmetic industry to export products in compli- ance with global regulations through a comparative analysis of cosmetic colorant regulatory systems in major countries. We first provide an overview of cosmetic colorant regulatory frameworks of the European Union, the United States, China, and Korea. Then the cosmetic colorants were divided into three sectors: synthetic, inorganic, and natural. Each chapter describes the colorants’ general characteristics and explains the regulatory differences. Additionally, synthetic colorant labeling with a different nomenclature system is discussed. INTRODUCTION Colorants have been used since prehistoric times in cosmetics, foods, and fabrics (1). Colors influence people’s moods and feeling as well as the appearance of the products to others. It has been reported that when people have their first interaction with a person or a product, 62–90% of their assessments are based on colors alone (2). When consumers select cosmetic products, color is a decisive factor in their purchases (3). Recently, the cosmetic industry in Korea has developed at a very fast speed, and increased its global exports. Thanks to the growing popularity of K-beauty around the world, Korea has become the world’s fourth largest cosmetic exporter after France, the United States, and Germany (4). When exporting products to various countries, understanding the differences in cosmetic regulatory systems between countries is crucial. Specially, cosmetic colorants follow a positive system in most countries. Because all countries have ­ different approaches to these regulations, they are perceived as the biggest barrier to exports to the international market. Therefore, we have compared Korea’s cosmetic regu- lations with those of other world leaders.
443 COSMETIC COLORATION: A REVIEW There have been many reports (5–10) on colorants used in food products from regulatory perspectives, but reports (11,12) on colorants used in cosmetic products have been some- what limited. In addition, the general properties of cosmetic colorants have not been dis- cussed before. To use cosmetic colorants properly, it is essential to completely understand their regulation, which are based on the colorants’ chemical properties. The objective of this report is to provide the general properties of cosmetic colorants and describe different countries’ regulatory requirements. Ultimately, it is hoped that this report will serve as a useful reference document for those exporting cosmetics. The research described in this report was conducted using the following steps. First, we targeted the European Union (EU), United States, which have the world’s leading markets and regulatory initiatives on cosmetics, and China, as it is the one of the fastest growing markets in the world. Japan was excluded because its regulatory system is similar to Korea’s system. Second, the col- orants were categorized as synthetic, inorganic, and natural according to their chemical characteristics. Then, we determined the colorants’ general features and compared the key features of regulatory systems between countries. Third, the cosmetic labeling regu- lations for synthetic colorants in each country were studied. OVERVIEW OF COSMETIC COLORANT REGULATORY FRAMEWORKS In the EU, cosmetic products must comply with the requirements of European Regula- tion (EC) No 1223/2009, which replaced Council Directive 76/768/EEC (13). It defines colorants as substances that are exclusively or mainly intended to color the cosmetic product, the body as a whole, or certain parts thereof, by absorption or reflection of visible light (13). It does not include colorants colored through photoluminescence, interference, or chemical reactions. Substances intended to be used as a colorant should be listed in Annex IV of European Regulation (EC) No 1223/2009. Annex IV includes substance identification, product type and body parts to which it is applied, and maximum con- centrations. Colorants assigned with an E number have been proven safe for use in food by the member states. Each E number has a separate specification for purity criteria that are defined in Commission Regulation (EU) No 231/2012, and cosmetic colorants follow the same specifications. Colorants labeling is determined according to the nomenclature listed in Annex IV of the European Regulation. In the United States, cosmetic products are regulated by the US Food and Drug Admin- istration (FDA) under the Federal Food, Drugs, and Cosmetic (FD&C) Act and its imple- menting regulations (14). The FD&C Act defines a colorant as any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body (14). Colorants approved for use are named in the US Code of Federal Regulation (CFR) Title 21, Parts 70–82. Colorants derived from petroleum and synthetically produced organic colorants are subject to certification. If a manufacturer sends a sample, FDA personnel evaluate the purity, impurities, heavy metals, and so on, and assign a certified lot num- ber. Colorants obtained from minerals, plants, or animal sources are not subject to batch certification requirements. However, they must comply with the identity, specifications, uses, and restrictions in Regulation 21 CFR 73. If the colorant subject to batch certifi- cation requirements is not certified, the cosmetics including that colorant are considered adulterated. Colorant labeling is determined according to the nomenclature listed in 21 CFR Parts 73, 74, and 82, and it is acceptable to use a colorant name with a Color Index (CI) number in parentheses.
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