outside the EU
In the USA cosmetics are regulated by the Food, Drug & Cosmetics Act, which prohibits the use of unsafe ingredients in a cosmetic product. The manufacturer has to verify if a cosmetic placed on the market presents any risk to consumer health using methods such as literature reviews, tests on animals or alternative methods, otherwise the cosmetic must bear the statement ‘the safety of this product has not been determined’. New active ingredients in Over-The-Counter products (anti-acne, anti caries/anti-plaque, anti-hair loss, anti-dandruff, anti-perspirant products, skin whiteners, sun protection products) must prove their safety on the basis of animal studies and clinical trials.
Whilst the USA does not prohibit animal testing, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was set up in 1997 with the aim to reduce animal testing. Once ICCVAM recommends that an alternative method has been adequately validated and the relevant test recommendations are accepted or endorsed by Federal regulatory agencies, the test becomes available for all toxicology purposes.
United States of America
A number of products that are qualified as cosmetics in the EU are qualified as quasi-drugs in Japan. This includes hair dyes and decolourants, anti-hair loss products, hair permanents/straighteners, depilatories, anti-perspirant, deodorant, anti-acne, skin whiteners, bath treatment products, and medicinal cosmetics such as anti-dandruff shampoos. These products are subject to the same regulations as pharmaceuticals and a toxicological dossier is required for approval of a new quasi-drug ingredient which includes animal tests when there are no alternatives available.
In China, the control of cosmetic products and new cosmetic ingredients is under the responsibility of the Chinese State Food and Drug Administration. For finished cosmetics, such as hair dye, sun protection products and for deodorants, a hygiene license or record-keeping certificate from the Health Administrative Department of the State Council is required and can only be obtained by the submission of animal data.