BUAV claims 18,000 animals saved through REACH testing proposals process

04/04/2014

The European Coalition to End Animal Experiments (ECEAE), for which the BUAV is Secretariat and UK the member group, has today announced that its efforts in commenting on REACH animal testing proposals has to date saved at least an estimated 18,000 animals.

The successes are detailed in a paper published this week in alternatives journal Altex which summarises the organization’s experiences with the testing proposals system.

In order to avoid animal testing under REACH some animal tests have to be proposed when companies register their chemicals with the agency responsible, European Chemical Agency (ECHA). The agency then publishes the details of the substance with the proposed test for 45 days. Third parties can submit information that can help companies avoid having to do the test. ECHA then comes to a decision on whether the information is suitable and whether the proposed test should go ahead.

The European Coalition to End Animal Experiments (ECEAE) is Europe’s leading alliance of animal protection groups campaigning on behalf of animals in laboratories. Since the start of the REACH process in 2009, the ECEAE has invested in toxicologists to systematically comment on testing proposals, including in–house scientists and external consultants TSGE Consulting Ltd. This week a summary of the ECEAE’s experiences of the testing proposals system for the first registration deadline (2010) is published in the alternatives journal Altex.

As a direct consequence of its comments, the ECEAE estimates that so far 17 animal tests, that would have involved over 18,000 animals, have been avoided. These tests include repeated dose tests in which rats are force fed the chemical every day for 90 days, prenatal developmental toxicity tests in which pregnant rats are force fed the chemical and then killed along with their unborn babies and two generation reproductive toxicity tests in which several generations of rats are force fed the substance to see if it alters their reproductive capacity.

The ECEAE believes that pressure on companies to avoid animal testing, for the 2010 deadline, has led to far fewer testing proposals being submitted than expected and many others were subsequently withdrawn. According to the ECEAE figures, only 21% of substances from the first registration deadline that were expected to have testing proposals actually had them. In addition to far fewer testing proposals being published, the ECHA report that 42% of these proposals were subsequently withdrawn. Therefore, a rough estimate is that 4,250,000 animals could have been used under the testing proposals system but that 493,000 are likely to have been (i.e. just over 10%)

Dr Katy Taylor, Chief Science Advisor to the BUAV and ECEAE and manager of the REACH project says;

“The ECEAE is pleased to have been able to help companies avoid some animal tests, and although the numbers are relatively small, any animal saved is a win for us. We would like to thank our members for funding the work and to their supporters for enabling them to do so. The ECEAE will continue to comment on proposals for the next deadline.”

However, despite its success, the ECEAE remains very disappointed with the way the testing proposal system works in practice. Dr Taylor says;

It has been a complete surprise to us to discover that the main reason animal testing has been avoided has been through companies withdrawing their testing proposals and not because the ECHA has reached a decision that the test can be avoided. The agency is failing to reject proposals for all but the narrowest legal reasons, mainly because it does not believe it should ‘do the registrant’s job for them’. It is because of this attitude that we believe, the agency has not taken the testing proposal system seriously. It has undermined the system by publishing proposals in large batches so we cannot comment and by forwarding our comments to companies at only the very last stage. We hope the EU officials will learn from our experiences and make sure there are mechanisms in place to ensure comments can be taken on board with any future consultations. “

The ECEAE is writing to the Commission and the agency to ask them to take these experiences and concerns on board. In the meantime, the ECEAE is pursuing an EU ombudsman complaint on the agency’s failure to follow its own guidance that said they had an obligation to evaluate whether tests on animals could be waived. (The agency has withdrawn the guidance in light of the complaint but has not changed its approach). 


Table of tests ECEAE has received advice from ECHA or the registrant that their comments directly helped and the reason why the test will not now occur

Test Number of animals Withdrawn Rejected Requested but
will not be
conducted
Total animals saved
90 day toxicity (rats) 100 3 0 0 300
Prenatal development toxicity (rats) 900 5 1 1 6300
Two generation reproductive toxicity (rats) 2200 2 2 0 8800
Bioaccumulation factor (fish) 280 1 0 0 280
Terrestrial toxicity (birds) 2832 1 0 0 2832
Mutagenicity (rats or mice) 50 0 0 1 50


We estimated in the paper that if all testing proposals published by July 2012 (includes all first registration deadline substances plus some new substances registered during this time) were accepted then approximately 850,000 animals would be used. According to ECHA Evaluation reports for 2009-2012, 42% of these proposals were subsequently withdrawn.