Clarity on interface between REACH and the Cosmetics Regulation
(Note: ECHA and the European Commission have concluded that there is no need to revise this information as a result of the judgment of the European Court of Justice of 21 September 2016 in Case C-592/14 concerning the marketing of cosmetics products that may contain ingredients that have been tested on animals.)
Substances used in cosmetic products may need to be registered under REACH but, under certain circumstances registrants may not have to carry out new tests on animals. Answers to questions on the interface between REACH and the Cosmetics Regulation are available on ECHA's website.
Helsinki, 27 October 2014 – To meet the requirements of the new Cosmetics Regulation (Regulation (EC) No 1223/2009) cosmetic products are prohibited to be placed on the market where the final formulation, ingredients in a final formulation or a finished product, have been subject to animal testing. Those same chemical ingredients may, however, also need to be registered under REACH. This has created some uncertainty about whether testing on animals can take place in order to comply with REACH, or whether it should not, in order to comply with the Cosmetics Regulation.
The European Commission, in cooperation with ECHA, has now clarified the relationship between the marketing ban and the REACH information requirements as follows:
- Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance. Workers in this context, refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g. hairdressers).
- Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints.
- Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints.
Therefore, 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.
Registrants of substances registered exclusively for cosmetic use will still have to provide the required information under REACH wherever possible, by using alternatives to animal testing (such as computer modelling, read-across, weight of evidence etc.).