ECHA, REACH and Animal Testing

Testing and marketing bans in the EU

Back in 2004, the EU prohibited animal testing on cosmetic products. In 2009, and then in 2013, the EU Cosmetics Regulation 1223/2009 sequentially introduced the ‘testing ban’ on cosmetic ingredients and the ‘marketing ban’, prohibiting placing on the EU market of cosmetics containing ingredients tested on animals. However, according to the Cosmetics Regulation, historic data on animal testing performed before the ban in 2004 can continue to be relied on. Moreover, later on , data on animal testing can be used when it is proved the tests were not carried out for the purpose of compliance with the Cosmetics Regulation. In cases where it is not possible to carry out a conclusive safety assessment because data is missing and because new animal data cannot be created for the purposes of cosmetics use, the respective ingredient should not be used (European Commission, 2013).

Nevertheless, while the Cosmetics Regulation restricted testing on vertebrate animals on substances used in cosmetic products and on finished cosmetic products, animal tests are still run in the scope of other regulatory frameworks, such as the European Chemicals Legislation REACH (EC 1907/2006).

REACH and animal testing

Some of the chemical ingredients used also in formulas of cosmetics may be, at the same time, registered under REACH, to assure that they are not hazardous to health and to the environment. This means that, in order to provide data proving whether ingredients are safe for human health and the environment, animal testing must be carried out. This rule was confirmed by the ECHA Board of Appeal in its decisions on two substances: homosalate (CAS# 118-56-9) and 2-ethylhexyl salicylate (CAS# 118-60-5). The ECHA agreed that the Cosmetics Regulation was not applicable, as the substances were considered hazardous for workers who participate in the production process, or for those who handle chemical substances on an industrial side and required registrants to carry out tests on animals.

This interface between the Cosmetics Regulation and REACH has already been clarified back in 2014 by the European Commission and the European Chemicals Agency (ECHA). It was concluded that the testing and marketing bans in the Cosmetics Regulation do not apply to testing required for environmental endpoints, exposure of workers and non-cosmetic uses of substances under REACH(ECHA, 2014).

Kamila Swiatek

Regulatory Affairs Department


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