Science Consortium Achievements Regarding REACH

The Science Consortium applies a broad approach to reducing and replacing tests on animals under REACH. For example, we promote ways to minimise testing for chemicals registered for 1 to 100 tonnes per year, work to reduce duplicative testing, and engage extensively with the European Chemicals Agency (ECHA), EU member states, and the European Commission. Key milestones are described below.

• Minimising Animal Testing for Annex VII and VIII REACH Dossiers
  The Science Consortium provided registrants with advice on minimising testing on animals for Annex VII and VIII REACH dossiers in a Chemical Watch article and with practical information on incorporating non-animal methods into testing strategies via two free webinar series. The Science Consortium also wrote to the European Commission with detailed recommendations for updating the Test Methods Regulation (TMR).

• Reducing Duplicative Animal Testing
  Science Consortium members spearheaded a coalition effort of animal protection organisations to address duplicative testing under REACH. As a result, in 2009, ECHA clarified the REACH information requirements for manufacturers and importers of chemical substances. The clarification that short-term or screening studies are not required when long-term toxicity studies are available or proposed has the potential to prevent millions of animals from being used in redundant testing.

• Guidance on Avoiding Animal Tests
  After meeting with two Science Consortium members, PETA US and PETA UK, ECHA published the practical guide titled “How to Avoid Unnecessary Animal Testing” in 2010. It emphasised the explicit requirement that tests on animals be conducted only as a last resort and contained information on approaches to avoiding animal tests. These included sharing existing data among companies to prevent the duplication of tests, the use of read-across data from similar chemicals, and the use of other mechanisms, such as computer models and in vitro methods, to help manufacturers avoid tests on animals while satisfying REACH requirements. ECHA has since replaced the 2010 publication with an updated practical guide titled “How to Use Alternatives to Animal Testing to Fulfil Your Information Requirements for REACH Registration“.

• Extended One-Generation Reproductive Toxicity Study
  The Extended One-Generation Reproductive Toxicity Study (EOGRTS; OECD Test Guideline 443) has the potential to reduce animal use for REACH by 50% to 70% per chemical requiring reproductive toxicity testing, compared to the two-generation reproduction toxicity test. The Science Consortium lobbied the EU member states, ECHA, and the European Commission to ensure the acceptance of the EOGRTS in place of the Two-Generation Reproduction Toxicity Study to meet REACH information requirements. It has since been validated and accepted by the OECD and is included in the TMR, Biocidal Products Regulation, and REACH. Additional cohorts, including a second generation, can be triggered in the EOGRTS, but this should be avoided wherever possible.

• Providing Companies with Resources
  The Science Consortium has produced a number of resources for companies, including a series of factsheets on the use of in vitro methods instead of tests on animals.

• Intervening in ECHA Board of Appeal Cases
  As an intervener in Board of Appeal cases, the Science Consortium supports companies in their appeals against requests by ECHA for them to conduct tests on animals. These cases can set precedents and influence the way the agency assesses animal testing requirements thereafter. In 2014, the Science Consortium intervened in a case brought by CINIC Chemicals Europe Sàrl in which the Board of Appeal annulled a decision by ECHA that required the company to conduct an EOGRTS in which approximately 1,300 animals would have been used. ECHA had claimed that considering new information after a self-imposed deadline would be too burdensome. The Science Consortium presented written and oral observations calling for changes to ECHA’s strict administrative processes in order to ensure that all data are assessed prior to requiring tests on animals. The Board decided that ECHA must reopen the case and assess the new information and, in doing so, ensured that all relevant data are considered prior to requiring the animal test.In 2017, the Science Consortium successfully intervened in another Board of Appeal case, brought by BASF Personal Care and Nutrition GmbH, in which the Board rejected a decision by ECHA that would have required the use of hundreds of pregnant rats or rabbits in a prenatal developmental toxicity test for a cosmetics ingredient. The Science Consortium argued successfully that ECHA had failed to consider the implications of the EU Cosmetics Regulation, which prevents companies from relying on animal testing data to demonstrate the safety of cosmetics.In an additional case launched in 2020, the Science Consortium intervened to demonstrate that information requested by ECHA was disproportionate and not in keeping with the regulator’s responsibility to ensure that animals be tested on only as a last resort. The subject of the case centered on the tonnage category being downgraded during a compliance check process, yet ECHA maintained that it was unable to take such new information into account and accordingly amend its data requirements. By providing additional evidence for the correct interpretation of the regulation, PETA scientists helped win the appeal and thus annul the compliance check decision. The appeal outcome also means that ECHA will need to change its future working practices to ensure that it takes into account new and substantial information that can have an impact on animal testing.

  The Science Consortium’s work on ECHA Board of Appeal cases raises awareness of non-animal testing approaches. By intervening and holding ECHA accountable, the Science Consortium also encourages the agency to think carefully before requesting or proposing more animal tests in the future.

• European Ombudsman Cases
  Science Consortium member PETA UK filed a complaint in 2012 with the European Ombudsman regarding ECHA’s failure to ensure compliance with the requirement that animals be used in tests only as a last resort. The Ombudsman ruled that ECHA’s interpretation of its obligations was excessively restrictive and that its practices amounted to informally amending a piece of EU legislation without having the right to do so. The ruling confirmed that ECHA has a responsibility to assess whether registrants have used alternatives to animal testing wherever possible. Further information is available here. ECHA conducted a pilot study to find out why tests on animals were conducted when non-animal methods were available, and the agency notified member states of detected cases of potential non-compliance. This change to its compliance-checking process, if adopted routinely, has enormous implications for reducing testing on animals under REACH. Registrants will be deterred from conducting avoidable tests on animals, because their registration dossiers will be scrutinised for potentially avoidable tests. If such tests are identified, member state competent authorities will be informed, and registrants could face penalties.In 2016, PETA UK filed a further complaint with the Ombudsman alleging that, through the publication of a joint statement, the European Commission and ECHA were enabling cosmetics manufacturers to violate the EU’s ban on animal testing for cosmetics by permitting cosmetics ingredients to be tested on animals under REACH. The Ombudsman’s opinion considered that the joint statement applies only to REACH and does not provide clarity on the relationship between the Cosmetics Regulation and REACH. As the Ombudsman noted, the data generated by tests on animals cannot be relied upon for safety assessment under the Cosmetics Regulation. Furthermore, the Ombudsman agreed with PETA UK that the joint statement is not legally binding, stating that “the fact that the Commission and ECHA may issue such guidance does not prejudge the issue of whether their guidance is correct”. The Ombudsman’s opinion is available here.

• Participation in Working Groups
  Consortium scientists are actively involved in subgroups of the Competent Authorities for REACH and CLP (CARACAL) expert group dedicated to updating the REACH information requirements, the possible registration of some polymers under REACH, and the adaptation of REACH to regulate chemicals with endocrine-disrupting properties. Through this involvement, Consortium scientists work with ECHA, member states, and the European Commission to shape REACH, embedding strategies for reducing and replacing tests on animals.

Further information on minimising testing on animals for REACH can be found here.