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BUAV urges ECHA to revise process for testing proposals for second REACH deadline as the fate of half a million animals will be decided

04/06/2013

The BUAV, together with our partners in the European Coalition to End Animal Experiments (ECEAE), the leading organisation within the EU campaigning on the issue of animal testing, have announced its commitment to allocating further resources to support the ‘testing proposals’ scheme under EU chemicals legislation REACH. However, it has stated that it will not be able to cope with the task unless the Agency responsible for REACH (the European Chemicals Agency) improves the process by staggering the publication of animal testing proposals.

REACH, the EU's legislation relating to the Registration, Evaluation, Authorisation and Restriction of Chemicals came into force in 2007.  It requires all chemicals manufactured or imported into the EU to be registered with the European Chemical’s Agency (ECHA) based in Helsinki. To reduce the impact on the industry there are deadlines by which all chemicals have to be registered. The next (the second) deadline was the 1 June 2013 for substances produced in quantities of 100 tonnes per year or more. ECHA announced yesterday (3 June) that 2,923 substances were registered under this deadline. The ECEAE estimate that over half a million animals will be killed if testing proposals on just 25% of these substances are agreed.

As a measure to try to avoid animal testing, REACH stipulates that new animal tests for these high tonnage chemicals are ‘proposed’ but not immediately conducted. Instead, chemicals are registered with proposals for animal tests which ECHA posts on its website for 45 days. This is to enable third parties to submit information that could prevent the tests from being carried out. Such information may be existing data on the chemical, or its constituents, or other data waiving arguments. 

The ECEAE committed considerable resources in 2009 to provide a small team of scientific experts to comment on animal testing proposals, under the first REACH deadline which was in December 2010, for substances produced in quantities of 1000 tonnes per year or more. Submissions were made on nearly 50% of the 480 substances with testing proposals published between 2009 and 2012. The ECEAE were assisted by independent toxicologists and TSGE LLP, an independent European regulatory consultancy company based in the UK.

Unfortunately ECHA itself very rarely rejects testing proposals, so the main mechanism by which the animal test does not occur is by the company withdrawing the initial proposal. The last ECHA Evaluation report (2012) found that 42% of registrants withdrew their testing proposals before a decision could be made. However, companies do not immediately receive any third party comments, instead receiving them with the draft decision asking for the animal test to be conducted. The ECEAE is asking the ECHA to change this process so that companies have longer to consider alternatives to testing on animals before the decision becomes binding.

The ECEAE’s efforts have been further compromised by the Agency publishing 62% of the substances for comment between just 6 months over the summer of 2011. The ECEAE argues that, despite the deadlines imposed by the regulation, the ECHA could have staggered the publication over an 18 month period and is asking the Agency to consider these aspects for this next deadline to prevent the same issues from occurring.

Despite the failure of the Agency to consider alternative approaches to animal testing under the testing proposal evaluation, the ECEAE believes its efforts have been worthwhile. It is, therefore, contributing similar funds to support the scientific team for a further two years to cover this second wave of testing proposals. It will continue to be assisted by TSGE LLP. 

It is estimated that there may be over 700 testing proposals published between June 2013 and June 2015. The animal tests are likely to include tests for reproductive and repeated dose toxicity which involve force feeding high doses of the substance to rats and rabbits and long term toxicity tests in which fish are forced to swim in water polluted with the substance. The ECEAE estimate a further half a million animals could be involved in tests like this if all proposed tests go ahead.

Dr Katy Taylor, Scientific Co-ordinator for BUAV & ECEAE says:

The testing proposal system is designed as a mechanism to prevent some of the largest animal-consuming toxicity tests. However, if the process is to be at all effective, the European Chemicals Agency must ensure not only that the publication of proposals is a more staggered process thus enabling the ECEAE to comment, but also ensure that registrants receive these comments as soon as the consultation has ended.”