EU Commission Enacts Alternative Testing Methods

The EU Commission has amended Annex VII of the REACH Regulation. According to the change, in vitro testing is to replace in vivo (animal) testing whenever possible in testing the effectiveness of substances used for skin sensitization.

REACH Regulation (EC) No. 1907/2006 has so far supported only in vivo experiments. However, such testing no longer corresponds to the state of science. Since the original Regulation was written, in chemico and in vitro testing methods have been internationally recognized by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM) and the Organization for Economic Co-Operation and Development (OECD).

Furthermore, sensitization testing will no longer be required for substances that are:

  • Classified as skin corrosion (category 1)
  • Classified as a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5)
  • Spontaneously flammable in air or in contact with water or moisture at room temperature.

A good overview can be found in the Report from the Commission to the European Parliament and the Council on the development, validation, and legal acceptance of methods alternative to animal testing in the field of cosmetics (2013-2015).

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