European Ombudsman Ruling on PETA UK Complaint a Victory for Animals Used in EU Chemical Tests

Official Finds European Agency Overseeing Chemical Testing on Animals Is Failing to Minimise Animal Use; As Many as 100,000 Animals Killed Who Could Have Been Spared

The worldꞌs largest animal testing programme – the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH) – requires chemical companies to provide information about the health and environmental hazards of almost every chemical in use in Europe. Official reports from 2011 and 2014 show that, so far, more than 800,000 animals have been used in painful chemical tests under REACH with millions more expected to be used in the coming years.

However, European legislators also established a clear principle that is at the heart of the REACH Regulation: tests on animals should only be conducted as a last resort. Article 25 of the Regulation states this principle explicitly, while Article 13 mandates that “information shall be generated whenever possible by means other than vertebrate animal tests”. Furthermore, when conducting compliance checks on dossiers submitted by registrants, the European Chemicals Agency (ECHA) as the administrator of REACH is mandated with the responsibility of ensuring that any new information has been generated using non-animal methods wherever possible – the basis on which Members of the European Parliament passed the legislation.

In 2011, the People for the Ethical Treatment of Animals UK (PETA UK) learned that tens of thousands of animals were being poisoned and killed in potentially avoidable tests, contrary to the REACH Regulation. It appears from ECHAꞌs report on The Use of Alternatives to Testing on Animals for the REACH Regulation 2011 that companies registering chemicals have repeatedly failed to adhere to the last-resort principle. Among other significant concerns, the report revealed the following:

  • Up to 1,000 animals were used in painful skin and eye irritation tests even though validated non-animal methods exist, some of which are even written into the European Test Methods Regulation.
  • Tests on animals were conducted despite the requirement for submission of a proposal to test that must be subject to public review and approved in advance. An estimated 58,000 animals suffered and died in those tests.*
  • Despite advice from ECHA that certain screening tests could be omitted if proposals were made for more extensive testing, a number of companies conducted the tests regardless. An estimated 140,000 animals died in these tests.*
  • Critical mechanisms specified in Annex XI to avoid animal tests have been underused or completely ignored. It is not possible with the information available to estimate how many animals died as a result.

In combination with other evidence, this report demonstrated that ECHA had not accepted its responsibility to evaluate whether animal tests that are conducted for REACH could be avoided, and, according to statements made to PETA UK, that ECHA would not evaluate animal tests against the Article 13 criteria, despite Article 41 of REACH issuing a clear obligation upon them to do so.

PETA UK repeatedly contacted ECHA about this unconscionable use of animals, yet ECHA continued to shirk its duty to ensure that animal use is minimised. Therefore in 2012, PETA UK filed a detailed complaint with the European Ombudsman. Her decision, rendered at the end of 2014, which upholds the key argument in PETA UKꞌs complaint, has enormous implications for preventing the suffering of millions of animals and confirms that ECHA has failed to fully accept its mandate and use all tools at its disposal to minimise animal experiments. The European Ombudsman opined in her decision that “ECHAꞌs interpretation of its obligations was excessively restrictive”. She further expressed in her proposal for a friendly solution that the agencyꞌs refusal to ensure that dossiers comply with the principle of using animals only as a last resort is akin “to informally amending a piece of EU legislation without any involvement whatsoever of the legislator”. The Ombudsman has issued clear direction for ECHA to request information from registrants to demonstrate compliance when required and instructs ECHA to inform Member States of all possible instances of non-compliance, not just proven violations.

The latest triennial report published by ECHA on The Use of Alternatives to Testing on Animals for the REACH Regulation 2014 provides further documentation that corroborates our long-standing concerns that non-animal testing methods are not being used wherever possible. In light of this evidence that registrants are not fulfilling their legal requirement to test on animals only as a last resort and that ECHA is failing to meet its obligations to the last-resort principle, we request that MEPs urge the European Commission to: 

  1. Take immediate steps in accordance with the Ombudsmans decision to ensure that ECHA is fulfilling its legal requirement at compliance check to assess whether animal testing could have been avoided. Testing proposals must also be scrutinised with equal rigour.
  2. As directed by the Ombudsman, require ECHA to report all possible breaches of the last resort principle to Member States and ensure full public disclosure of information explaining why these breaches continue to occur.
  3. Require ECHA to remind registrants of their obligations to minimise animal testing and the consequences of non-compliance.
  4. Take immediate steps to ensure that suitable penalties for breaches of the REACH regulation regarding animal testing are implemented by Member States.
  5. Require ECHA to investigate the reasons for low uptake of alternative testing mechanisms and to ensure that such mechanisms are used to the fullest possible extent under the law.
  6. Require ECHA to update the guidance documents, including endpoint-specific guidance, in a timely fashion to reflect the recent developments in non-animal methods and testing strategies.

Registrants are already preparing and submitting dossiers in preparation for the next REACH deadline in 2018. Thus, it is imperative that the European Commission step in and take corrective action to ensure that the concerns outlined by the Ombudsman are addressed and that compliance with the spirit and content of REACH is assured from this point forward.

To aid registrants, the PETA Science Consortium International e.V., has published detailed guidance on how to minimise testing on animals under the REACH regulatory framework, and, in collaboration with Chemical Watch, the Science Consortium presents a series of webinars on alternative methods and testing strategies that can be used to meet REACH requirements.

As “guardian of the treaties”, the European Commission is responsible for the proper application of EU law and of ECHA’s founding regulations. In particular, the Directorate Generals for Internal Market, Industry, Entrepreneurship and SMEs and for the Environment are co-responsible for the REACH. Contact details for ECHA can be found here.

*European Coalition to End Animal Experiments