Impact of legislation related to animal issues

Resulting problems exist for the safety assessment of new ingredients for cosmetics, and therefore, for their market introduction. The ban may also cause issues for existing ingredients when further testing requirements from other regulatory regimes, e.g. from REACH, appear; a court case is pending for further clarification in this environment. Precise documentation of animal tests performed is required for the PIF and the product’s responsible persons must ensure compliance with the animal testing ban requirements which is verified by EU Member State authorities. New in silico and in chemico tools provide support for the safety assessment of ingredients.

The European Union’s legislation on cosmetic products, Regulation (EC) 1223/2009,¹ represents worldwide one of the most forceful and comprehensive regulatory frameworks for this consumer product group. In 2013, the Regulation replaced its predecessor legislation, Council Directive 76/768/EEC,¹ in a so-called recasting process and, hereby, general clarifications, amendments and updates to state-of-the-art science were made to the law. Taken over in full from the Directive and implemented within Chapter V, Article 18 of the Regulation were the provisions related to non-animal testing. Primarily, these provisions had been introduced in 2003 with Directive 2003/15/EC,² which is known as the 7th Amendment to the Cosmetics Directive. Foreseen, with a deadline in 1998, was the animal testing ban even earlier with the 6th Amendment to Directive 76/768/EEC, with Directive 93/35/EEC.³

The EU’s animal testing ban