Document M4rxon2197wB35mkaDBOxzVBx

Cruelty Free EUROPE Ref. ARreesf(.2A0r2e1s)(722042035)43366-62648/161-/22062/015/2023 FRANS TIMMERMANS Executive Vice President for the European Green Deal VIRGINIJUS SINKEVICIUS EU Commissioner for Environment, Oceans and Fisheries THIERRY BRETON EU Commissioner for Internal Market MARIYA GABRIEL EU Commissioner for Innovation, Research, Culture, Education and Youth European Commission Rue de la Loi / Wetstraat 200 B-1049 Brussels 22 November 2021 SUBJECT: ANIMAL TESTING AND THE CHEMICALS STRATEGY FOR SUSTAINABILITY Dear Commissioners, We, representatives from the European Parliament, civil society and industry, are writing to bring to your attention the issue of animal testing in the context of the Chemicals Strategy for Sustainability (CSS). The Strategy is an important pillar of the European Green Deal, that we all fully support. We understand that the Commission is committed to the ultimate goal of replacing, reducing and refining animal testing, as set out in the Directive 2010/63/EU on the protection of animals used for scientific purposes. The European Parliament's Resolution on the CSS underlined the need to minimise and progressively replace animal testing through an expanded use of New Approach Methodologies (NAMs), as well as to increase efforts and funding for establishing fast, reliable and robust non-animal-based safety assessments. However, with the lack of a clear Action Plan to support this ambition, it is becoming increasingly difficult to envisage how the CSS will serve to minimise animal testing, promote alternative methods, reflect latest scientific advances, further accelerate research on alternatives, and uphold the REACH principle of animal testing as a last resort. We want to see the CSS fulfil its commitment of ensuring the highest levels of protection of human health and the environment. We call on the Commission to modernise the legislative framework, particularly REACH, to reflect scientific advances in the area of NAMs, where reliable and predictive alternatives are available, and to include and measure animal testing in the upcoming REACH impact assessment. We are concerned by the proposed and future increase in information requirements, particularly under REACH, and Cruelty Free Europe has estimated that, without a change in approach, this will likely lead to millions more animals used in testing. The CSS is ambitious in its intent to accelerate regulation of chemicals. It should be equally ambitious in the area of modern chemical safety assessment. The general public joins us in favouring the use of animal-free methods: in a 2020 poll conducted by Savanta ComRes for Cruelty Free Europe, 70% of adults agree that replacing animal tests with NAMs should be an EU priority.  Cruelty Free EUROPE trefc There is an urgent need for increased regulatory acceptance of fit-for-purpose alternative testing methods and more investment in next generation animal-free approaches and any amendment to REACH, now or in the future, should be taken as an opportunity to reflect scientific advances in alternative methods and enhance regulatory acceptance. Legislation ensuing from the proposals must stimulate the prioritisation of the use of robust and fit-for-purpose animal-free NAMs as well as their development and rapid adoption. This must include: Proper evaluation of the impacts on animal testing (volumes and types required) in the Impact Assessments for all legislation ensuing from the Chemicals Strategy for Sustainability Ongoing monitoring of the animal testing required as the CSS implementation is rolled out and Key Performance Indicators (KPIs) tracking the reduction in the number of animals used for testing A modernised regulatory framework that is flexible enough to reflect fast-evolving scientific advances in the area of NAMs and that truly prioritises predictive NAMs and intelligent assessment strategies for the generation of safety information under REACH. Clear mandate for ECHA to systematically and transparently assess whether data requirements can be met through NAMs Greater efforts to increase regulatory acceptance and implementation of those NAMs in which the EU and industry have already invested, including transparent comparison of the uncertainties associated with animal studies and NAMs for the respective type of toxicity. Continuation of dedicated funding at Commission and Member State level Acceleration of the development of fit-for-purpose NAMs at international (OECD) level Continuing to rely on animal tests rather than cutting-edge scientific advances, where possible, will hold back achievement of the aims of the CSS and the overarching goals of the EU Green Deal to better protect people and the environment and to accelerate innovations in safe and sustainable alternatives. We look forward to hearing from you about the next steps that the European Commission plans to take for all these matters. Sincerely yours,