Cosmetic Regulations of the United States, European Union, and Japan

Abstract

Globalization of the trade and manufacturing of consumer products, including drugs and cosmetics is becoming a common practice. therefore a review of the definitions, classifications and regulations of cosmetics in the three most dominating markets of the world; US, EU and Japan appear to be appropriate for the scope of this journal. According to US Food Drug and Cosmetics Act (FD&C) definitions, cosmetic products can not contain drugs or any substance that causes alterations of the structure and the function of the skin hair and nails. As a result, the regulations related to cosmetic manufacturing and sales are not as stringent as the ones that are related to drugs. the legal keyword in the production and sales of the cosmetic products is the intended use. If a cosmetic is claimed to cause any physical changes in the structure and the function of the skin, hair and nails, the degree and the nature of the changes that it causes should be substantiated. According to FD&C Regulations, presence of some materials, in any concentration, can classify a product as a drug. Presence of some others, at therapeutic concentrations may cause classification of a product as a “drug” and below the therapeutic concentrations as a cosmetic. therefore, some of the cosmetics with drug claims and some others that contain chemicals with potentials of altering the physiology and biochemistry of especially skin and nails may be considered Over the Counter (OTC) drugs. According to Cosmetic Directive of the EU, a product is either a cosmetic or a drug. In Europe, many products that are classified under OTC in the US are considered to be cosmetics. With new developments in the EU Cosmetic Regulations the cosmetics are regulated more stringently than that of the cosmetics in the US. the VI Amendment of the Cosmetic Directive requires similar labeling requirements to that of US Cosmetic Regulations. the Cosmetic Directive also demands preparation and availability of a “Dossier” for each product that will be on the market which will among others, include information on the assessment of safety and documentation of the effectiveness of the product. In the US, and EU the manufacture, distribution and importation of cosmetics are not licensed whereas in Japan they are. Cosmetics are regulated according to Pharmaceutical Affairs Law. they can be classified under drugs, quasi-drugs or cosmetics. Quasi-drugs are the ones that have “mild effect” on the body. Cosmetics are classified according to a product category and they are licensed accordingly. Although, labeling and dossiers requirements may still create problems, harmonization of the Cosmetic Regulations of the US, EU regulations may be possible. However, review of the harmonization steps taken by the US, EU and Japan indicates that Japan needs more serious commitment to achieve harmonization.