Over the Counter (OTC) products can be called some of the cosmetics with drug claims and some others that contain chemicals with the ability to change the physiology and biochemistry of in particular skin and nails. A product is either a cosmetic or a medicine, according to the Cosmetic Directive of the EU. In Europe, cosmetics are considered to be several products which are listed under OTC in the US. With the latest changes in the EU Cosmetic Legislation, the regulation of cosmetics is tighter than that of cosmetics in the USA. Similar labeling standards to those of the US Cosmetic Regulations are required by the VI Amendment to the Cosmetic Directive. The Cosmetic Directive also mandates that a ‘Dossier’ be prepared and made available for each product to be put on the market, including, but not limited to, details on the safety evaluation and evidence of the product’s effectiveness. The production, distribution and importation of cosmetics are not permitted in the US and the EU, although they are licensed in Japan. Under the Pharmaceutical Affairs Rule, cosmetics are regulated. They can be known as narcotics, quasi-drugs, or cosmetics. The ones that have a ”mild effect” on the body are quasi-drugs. Cosmetics are categorized into a group of goods and are approved accordingly. Although the criteria for labeling and dossiers could still cause problems, harmonization of the US Cosmetic Regulations may be possible with EU regulations. However, the analysis of the harmonization measures taken by the US, the EU and Japan shows that, in order to achieve harmonization, Japan needs a more serious commitment.
Keywords: Cosmetics, Over the Counter (OTC) Drugs, Cosmetic Directive, Quasi-Drugs, EU Regulations.