The BUAV along with our colleagues in the European Coalition to End Animal Experiments (ECEAE) warmly welcome the decision on 29 April 2013 of the Board of Appeal (BoA) of the European Chemicals Agency (ECHA), allowing the appeal by chemicals giant Honeywell against ECHA’s decision that it should carry out a 90-day inhalation experiment on rabbits for a refrigerant for its car air conditioner system. The ECEAE was allowed to intervene in the appeal, along with DuPont, which also makes the refrigerant. This is the first decision by the BoA on REACH testing requirements.
In a landmark ruling, the BoA has decided that ECHA breached the key REACH principle that animals should only be used as a last resort. ECHA had argued that the principle was limited to data-sharing and therefore irrelevant in the present context. The BoA also decided that the ECHA decision was disproportionate (a key principle of EU law), in that it failed to: identify properly what the aim of the experiment was; take account of the unprecedented nature of the experiment or whether rabbits were the appropriate species; consider whether the results would in fact be useful in the first place; or consider whether the experiment would be permitted in the EU or even whether anyone could carry it out. As the ECEAE had argued, ECHA should have adopted a ‘stepwise’ approach, looking first at whether non-animal approaches could allay the concern it identified.
Honeywell was instructed to conduct the test following a compliance check by the ECHA in 2010. The company had fulfilled all the standard requirements required by REACH but the Agency was concerned about the result of one experiment in rabbits in which some of the rabbits died. They asked for 90-day inhalation experiment to investigate this. The company appealed because (amongst other reasons) the test is virtually unprecedented (in fact the Agency found only 7 studies that were all done more than 20 years ago). 90-day tests are rarely done in rabbits especially by the inhalation route which is very cruel; the rabbits could be subjected to the refrigerant gas for several hours per day, and even be forced into tubes to ensure they cannot avoid breathing in the gas.
Dr Katy Taylor, BUAV Head of Science, commented:
‘We are delighted that the Board of Appeal has accepted all our main arguments. We have long maintained that ECHA pays scant regard to the last resort principle. This decision is important in recognising the high degree of suffering which the rabbits would experience in the relevant experiment and the poor scientific analysis underpinning the ECHA decision. But it has far wider implications than that, for ECHA’s decision-making in other cases. The need to avoid animal tests wherever possible should now assume a far greater priority for ECHA’
The ECEAE successfully applied to intervene in the case in 2011 and submitted our own arguments on the inappropriateness of the test. We took part at the oral hearing in Helsinki, the last stage in a very comprehensive appeals process, in December 2012. We believe the intervention made by the ECEAE was central in providing comprehensive legal and scientific the arguments about the ‘last resort principle’, the unprecedented nature of the test, the availability of an alternative (toxicokinetic) approach, animal welfare concerns and proportionality that formed the basis by which the Board rejected the rabbit test.
The substance will be considered again by the Agency, in light of the BoA’s detailed ruling. However, the BoA gave a strong steer about the obstacles in the path of the rabbit inhalation experiment. At least 120 rabbits have thus far been spared a very cruel experiment and death. But the implications of the case could go much further than that.