Cosmetics Legislation

All cosmetic ingredients must be demonstrated to be safe for application to humans. Currently there are two distinct channels in the safety evaluation of cosmetic ingredients:

  • colorants, preservatives, UV filters and other (banned or restricted) substances appearing in the annexes of the Cosmetics Products Directive are formally reviewed by the Scientific Committee on Consumer Safety (SCCS; former SCC(NF)P).
  • the safety evaluation of all other ingredients in finished cosmetic products is carried out by a qualified safety assessor in industry.

There is a requirement to assess the effects of repeated doses of cosmetic ingredients. However, the 7th Amendment to the Cosmetics Directive and the new Cosmetic Products EU Regulation has banned the marketing of cosmetics tested for this endpoint in animals.

In general, the Cosmetics Directive puts an end to animal testing by banning:

  • testing of finished cosmetic products (since 11 September 2004) and ingredients on animals (since 11 March 2009)
  • marketing of finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals, since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics. For products tested for these specific health effects, the deadline was 11 March 2013 (press release announcing the Commission Communication, "Full EU ban on animal testing for cosmetics enters into force").

Animal tests should be replaced by alternative safety assessment methods.

However, currently no validated alternatives exist for the prediction of repeated dose toxicity. In addition, there is an increasing concern that animal testing and the existing alternatives are not adequately protective of human health. Therefore, as part of the Seurat-1 cluster of alternatives projects, COSMOS has developed a suite of computational prediction models and approaches to assist in the assessment of the safety of cosmetic ingredients.

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This is European Comission Project. Seventh Framework Programme. Cosmetics Europe, The Personal Care Association. COLIPA, The European trade association for the cosmetic, toiletry and perfumery industry.