Additional information required for animal test proposals
As of mid-September 2015, the European Chemicals Agency (ECHA) has started sending requests to registrants that submit new testing proposals to inform the regulator whether and how alternative testing methods have been considered. The move follows a decision of the European Ombudsman, according to which ECHA should have taken a more prominent role in avoiding unnecessary animal testing.
Background to the new practice
Article 40 of the REACH Regulation provides that ECHA "shall examine any testing proposal set out in a registration or a downstream user report" submitted with respect to substances registered in the over 100 tonnes bands. At the same time, Article 25(1) of the REACH Regulation stipulates that any testing on vertebrate animals "shall be undertaken as a last resort" in the aim of avoiding unnecessary animal testing.
By a decision of 11 September 2015, the European Ombudsman found that ECHA had adopted an overly narrow position as regards its role in avoiding unnecessary animal testing. More specifically, the EU watchdog found that ECHA had taken an "excessively restrictive interpretation of its obligations in the context of evaluating testing proposals [which] was not compliant with the REACH Regulation". According to the EU Ombudsman, while the protection of human health is undoubtedly the most important objective of the REACH Regulation, it did not mean that the avoidance of animal testing, as the other objective, could "arbitrarily be disregarded". In fact, it was for ECHA to ensure that no animal testing "takes place if the protection of human health can be demonstrated without it". In the EU Ombudsman's view, it followed, for instance, that if an applicant fails to show that it has considered alternative testing methods to generate missing data, ECHA should reject a testing proposal.
The decision followed a complaint, treated as confidential, by a group of NGOs claiming that ECHA had misinterpreted its powers under the REACH Regulation. The complainants objected, in particular, to ECHA's stance that it could not reject testing proposals on grounds that the required data could be generated by alternative methods not involving animal testing.
The complaint was resolved through a so-called friendly solution, according to which ECHA accepted the EU watchdog's proposals to modify its practices. The EU Ombudsman proposed, on the one hand, that ECHA systematically requires all registrants to show that they have tried to avoid (unnecessary) animal testing. At the same time, ECHA should, according to the proposal, share all relevant information at its disposal that could allow registrants to avoid further animal testing. The EU Ombudsman shall review the progress made in March 2016.
The new practice
Following the decision of the EU Ombudsman, ECHA has started to request additional information from registrants that submit testing proposals that involve vertebrate animals. As of mid-September, such registrants are required to inform ECHA how alternative testing methods – that is methods not involving vertebrate animals – have been considered in the context of a new testing proposal.
According to ECHA, this information shall be published on the regulator's website, together with the actual testing proposal. The idea is that third parties can submit information on the substance from alternative methods, which may result in avoiding the conduct of animal testing. ECHA notes, however, that it is for the registrant to show that a high level of human health and environment protection can be achieved without the performance of a vertebrate animal test.
Alternative testing methods include, on the one hand, the specific adaptations to the general information requirements, which are defined separately for each tonnage band, and the general rules for adaptations contained in Annex XI to the REACH Regulation, on the other. The latter include various approaches seeking to establish or predict with sufficient certainty the effects of a substance, ranging from computer-based modelling to assumptions based on structural similarities, studies performed on cells or biological molecules outside their normal biological context, and the use of existing data. Further, a waiver applies where testing is not technically possible or it is not needed given the identified exposure scenarios (exposure-based waiving).