Experiences of the REACH Testing Proposals System to Reduce Animal Testing

In order to reduce animal testing, companies registering chemical substances under the EU REACH legislation must propose rather than conduct certain tests on animals. Third parties can submit "scientifically valid information" relevant to these proposals to the Agency responsible, the European Chemicals Agency (ECHA), who are obliged to take the information into account. The European Coalition to End Animal Experiments (ECEAE) provided comments on nearly half of the 817 proposals for vertebrate tests on 480 substances published for comment for the first REACH deadline (between August 1, 2009 and July 31, 2012). This paper summarizes the response by registrants and the Agency to third party comments and highlights issues with the use of read-across, in vitro tests, QSAR, and weight of evidence approaches. Use of existing data and evidence that testing is legally or scientifically unjustified remain the most successful comments for third parties to submit. There is a worrying conservatism within the Agency regarding the acceptance of alternative approaches and examples of where registrants have also failed to maximize opportunities to avoid testing.