ECHA comes under fire on REACH

C&I Issue 14, 2011

The European Chemicals Agency (ECHA) has looked at the impact of the Registration, Evaluation and Authorisation of Chemicals (REACH) regulations on animal testing and concluded that it is working well in promoting the use of alternatives. While animal rights groups say the agency should do more to prevent unnecessary animal tests, it is unclear whether penalties for breaching REACH are effectual. One key principle of REACH is that testing on vertebrate animals should be a last resort, and alternatives must be used wherever possible.

The ECHA analysed 1862 dossiers submitted between 1 June 2008 and 28 February 2011 and found 90% of registrations were joint submissions between companies, indicating extensive data sharing instead of independent animal testing. Companies also made use of existing studies, in vitro methods and computer modelling to predict properties of substances and, as required, submitted proposals to test substances on animals before conducting those tests.

However, animal rights groups, such as the European Coalition to End Animal Experiments (ECEAE), assert that a shocking proportion of this animal testing is not required under REACH. According to ECEAE, the ECHA’s report shows 87% of new animal tests should never have been done; hundreds should have first been subjected to public consultation or replaced by in vitro tests.

The ECHA counters that there may have been legitimate reasons for carrying out such studies – perhaps to fulfil regulatory requirements in other countries, for example. It is currently evaluating dossiers, but says it is too early to conclude whether testing complied with REACH requirements. Norbert Fedtke, ECHA’s head of evaluation unit, admits that such checks so far have shown dossier quality to be variable, and the ECHA is urging companies to improve their quality, especially the justifications for waiving testing.

Nevertheless, critics say the ECHA simply must do more to prevent animal testing. It is ‘scandalous that the ECHA hasn’t compelled companies to use mechanisms available for avoiding animal tests, says People for the Ethical Treatment of Animals’ policy advisor Alistair Currie.

‘We also need a promise from them that they will facilitate action against registrants that have definitely breached the EU law on animal experiments,‘ says Katy Taylor, senior science advisor, secretariat to the International Council for Animal Protection in Pharmaceutical Programs.

The ECHA points out that REACH enforcement is a national responsibility and that it is not in its remit to compel companies to use alternative tests. But the agency says it informs member states of breaches and also hosts the Forum for Exchange for Information on Enforcement, which works to coordinate enforcement in EU member states.

The penalties set out in national legislation for breaches of REACH obligations vary significantly from one country to another, according to a 2010 report for the EU Environment Directorate by Milieu consultant Nathy Rass-Masson. This, says Rass- Masson, could lead to a risk of some companies avoiding countries with a more stringent compliance system or provide insufficient incentive for companies to comply.

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