EC workshop on phasing out animal testing for chemical safety
European Commission hosts workshop on the roadmap towards phasing out animal testing for chemical safety
On 11-12 December 2023, the ‘Workshop on the Commission roadmap towards phasing out animal testing for chemical safety assessments‘ was hosted by the Directorate-General for Internal Market, Industry and Entrepreneurship (DG-GROW) of the European Commission (EC).
The main objective of the workshop was to continue engagement with stakeholders (including members of the chemicals industry, regulators and NGOs) on the ongoing mandate of the Commission to prepare and finalise the roadmap in accordance with the landmark EU Parliamentary Resolution of September 2021 on ‘plans and actions to accelerate the transition to innovation without the use of animals in research, regulatory testing and education’.
During the opening sessions, DG-GROW explained that the workshop was being held as described in the Commission’s official response to the European Citizen’s Initiative (ECI) ‘Save Cruelty Free Cosmetics’, which successfully collected over 1.2 million signatures following sustained lobbying by animal protection NGOs and other stakeholders.
Furthermore, DG-GROW emphasised that the workshop aimed to specifically address part 2 of the ECI (‘Transform EU chemicals legislation’) and to a lesser extent, part 3 (‘Modernise science in the EU’) but not Part 1 (‘Protect and strengthen the cosmetics animal testing ban’). The EC referred again to its response to the ECI that the finalised roadmap will “outline milestones and specific actions” and address all “relevant pieces of chemical legislation (e.g. REACH, Biocidal Product Regulation, Plant Protection Products Regulation and human and veterinary medicines)”, further reiterating that the roadmap will not cover animal use for research purposes, e.g. biomedical research.
The EC also stated it has been working to move away from animal testing for a long time, but was aware that the transition is not happening as fast as many had hoped and that the workshop should discuss how (and who) can drive change faster, what changes are needed to the current system and how to define those changes in order to meet milestones on the roadmap for human health and the environment.
The workshop was divided into six sessions over two days. The first five sessions, hosted by the Commission were:
- Introduction and setting the scene
- How to replace animal testing for the concern of systemic human health effects
- How to replace animal testing for the concern of long-term aquatic toxicity
- Enhancing the translation of non-animal methods into regulation
- Next steps and closing remarks
The sessions each contained many sub-themed and comprehensive presentations from experts to identify and discuss the critical requirements of how to accelerate transition away from animal testing, including gaps and research needs still to be met, especially with regard to complex endpoints; variation in stakeholder expectations on how long transition will take and how ‘ready’ things are; the validation process; data generation and how human health and environmental protection goals could be met – and in the opinion of many, improved – without using animals.
There was clear agreement that more work is needed to invest in, and develop further, non-animal methods, and that continued reliance on some of the most controversial tests – for example the two year long rodent bioassay to detect carcinogens (cancer causing chemicals) – are very animal intensive and take so long to obtain results that it will take decades to identify currently unknown carcinogens, therefore identifying better solutions is essential for the way forward. There also remains concern over the use of positive in-vitro test results to trigger new in-vivo (animal) tests.
Session 6 (on the second half of day 2) was organised and hosted by the Partnership for the Assessment of Risks from Chemicals (PARC) and entitled ‘Guiding principles for NGRAroute- a roadmap proposal for implementing Next Generation Risk Assessment (NGRA) framework in EU chemicals legislation’.
Sub-themes in session 6 provided focus across several priority areas for discussion, namely: scientific development; regulatory acceptance; policy implementation and change management.
This two day event follows and builds upon a workshop hosted earlier in 2023 by the European Chemicals Agency (ECHA) on ‘New approach methodologies: Towards an animal-free regulatory system for industrial chemicals’. The presentations and recordings from this workshop are also recommended.
A further workshop as part of the EC’s mandate is planned for the end of 2024 and the Commission confirmed that the roadmap will be finalised in the ‘first quarter of the mandate of the next Commission’, with a timeframe described as ‘end of 2025/beginning 2026’. Stakeholder feedback included recommendations on how work should continue from now to be ready, rather than waiting for the final deadline to be announced.
The two day workshop included a variety of presentations and panel discussions and was very comprehensive and informative. Full further details, including all slides and access to the event recordings are available here and are highly recommended for review.