Abstract
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 1 August 2009 and 31 July 2012). The paper summarises 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 maximise opportunities to avoid testing.
Highlights
1.1 REACH and animal testingREACH (Regulation 1907/2006/EC) is the EU’s new legislation governing the registration, evaluation, authorization, and restriction of chemicals
MSC – Member State Committee, an ECHA committee formed of Member State representatives that make the final decision on testing proposal and compliance checks as well as other tasks related to substance evaluation
We made this comment in two of the four cases and were credited with this in the decision letters. In another case ECHA rejected a testing proposal for a reproductive toxicity screening study but asked the registrant to submit testing proposals for prenatal developmental toxicity and 90-day tests as these were the standard requirements at their tonnage level (EC 915-673-4). For another substance ECHA rejected the testing proposal for a two-generation test as the data was already available from another registrant who had been requested to do the tests under the previous legislation (EC 425220-8); confusingly, in an earlier decision on a testing proposal for a 90-day test for the same substance, ECHA had technically accepted the testing proposal but insisted in the letter that the data be obtained through the same data-share
Summary
In order to reduce animal testing, companies registering chemical substances under the EU REACH legislation must propose rather than conduct certain tests on animals. 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. MSC – Member State Committee, an ECHA committee formed of Member State representatives that make the final decision on testing proposal and compliance checks as well as other tasks related to substance evaluation. An international organization made up of member countries from around the world Amongst other tasks they harmonize the evaluation of chemicals, produce guidance on the assessment of hazardous chemicals, and produce test guidelines for the testing of chemicals that are used by member countries. Registrant – any company that registers their substance under the REACH legislation.
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