The conditions of the animal testing ban in the EU were finally clarified last 27th October 2014, in a communication concerning this conflictive contact point between the REACH Regulation 1907/2006 and the EU Cosmetics Regulation 1223/2009, issued by the European Commission and ECHA (European Chemicals Agency).
The conflict
In the EU there is a total ban on animal testing for cosmetic products and its raw materials, which the Cosmetics Regulation 1223/2009 reflects in its provisions.
This ban affects two aspects of cosmetic products:
- Testing Ban: any animal testing in cosmetic products or cosmetic raw materials cannot be conducted in the EU as of 11th September 2014 – following the ban on testing ingredients and their combinations in force since 11th March 2009
- Marketing Ban: cosmetics tested in animals, or whose ingredients have been tested on animals, cannot be placed in the EU market as of 11th March 2013 – following a previous almost total ban in force since 11th March 2009
However, the REACH Regulation requires animal testing for certain chemicals, some of which are used as cosmetics raw materials. This requirement is in conflict with the animal testing ban on cosmetic raw materials.
In March 2013, the European Commission published a Communication on the Cosmetics Regulation. It explained that the testing and marketing bans in the Cosmetics Regulation apply only where animal testing is carried out to meet the requirements of that legislation. However, the practical meaning of this statement remained unclear.
Clarification: when may animal testing be performed?
ECHA clarifies the following points in regards to animal testing in chemicals affected by REACH:
- Substances exclusively used in cosmetics animal testing is banned, except if any testing is required to assess the risks from exposure to workers according to REACH
- Substances used as well for non-cosmetic purposes animal testing can be performed, as a last resort, for all human health endpoints
- Animal testing can be performed, as a last resort, for all environmental endpoints established by REACH (whether or not they the substance is only used for cosmetic purposes)
In the case the substance is only used for cosmetic purposes, there is the option to “waive” (adapt) the human health endpoints in order to avoid animal testing. This is provided that the registrant does not need to assess the risks arising from exposure to workers.
The below is the decision tree indicated when animal testing may or may not take place according to the EU regulatory framework:
The clarification by ECHA and the European Commission is to be strongly taken into account by the EU Responsible Person, since one of his obligations according to Article 5 of the Cosmetics Regulation is to ensure that cosmetic products placed in the EU market properly comply with the animal testing ban provisions.
The Responsible Person should make sure that the marketing ban on animal testing is respected, both for finished products and for raw materials.
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