Cosmetic Regulation in the European Union

Cosmetic Regulation in the European Union

The European Union Cosmetics Directive defines a cosmetic as "any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition."The European Union requires that cosmetic products placed on the EU market be safe; that is, they "must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use."As in the U.S., manufacturers are responsible for ensuring that cosmetic products comply with the law before they are marketed. The manufacturer or importer of cosmetics is responsible for demonstrating that the product is safe for its intended use. Regulations are enforced at the national level, and each country in the EU has an authoritative body that is responsible for upholding compliance.

Cosmetic Regulation in Japan

The Japanese government regulates the cosmetics industry through its Ministry of Health, Labor and Welfare according to the Pharmaceutical Affairs Law (Law No. 145) established August 10, 1960. Japan has adopted a list of prohibited ingredients, a list of restricted ingredients, a positive list of UV filters and a positive list of preservatives.Other than these restrictions, the burden of ensuring product safety has been shifted to cosmetic manufacturers. As such, any ingredient that can be shown to be safe may be used in a cosmetic product. Until recently, a manufacturer or importer of cosmetics was required to obtain a pre-market approval and license from the Ministry of Health, Labor and Welfare. Since 2001, however, Japanese cosmetics companies are required only to provide notification of the product's brand prior to manufacturing or importing.Japan is an excellent example of a nation where costly pre-market registration procedures were replaced with manufacturer responsibility for product safety and with post-market surveillance (similar to the systems in the U.S. and EU) without compromising consumer safety.

Cosmetic Regulation in Canada

The Canadian government regulates the cosmetics industry through Health Canada's Cosmetics Program. The basis for the regulatory authority for the Cosmetics Program comes from the Food and Drugs Act and Cosmetic Regulations. Cosmetics are defined as "any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes." This definition also includes cosmetics used by professional esthetic services, as well as bulk institutional products (e.g. hand soap in school restrooms).

Health Canada's Cosmetics Program has the mandate to protect the health of Canadians by minimizing the risk associated with the use of cosmetics marketed in Canada. The program defines and communicates requirements for the manufacture, labelling, distribution and sale of cosmetics, and evaluates compliance.

As in the U.S., manufacturers are responsible for ensuring that products comply with the law before they are marketed. The manufacturer or importer of cosmetics is responsible for demonstrating that the product is safe for its intended use. Regulations are enforced by Health Canada and is overseen by Product Safety Officers who manage inspections, investigations, seizures, recalls and prosecutions from regional offices.