The European Commission held a significant workshop on 11-12 December 2023 in Brussels, focusing on "The Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments." The event attracted over 500 participants, including stakeholders from regulatory agencies, industry, academia, and non-governmental organisations. The workshop aimed to address the challenges and strategies for transitioning to non-animal methods in chemical safety testing. The workshop report was published in June 2024, providing comprehensive insights and detailed recommendations for the future.
Commitment to Animal-Free Testing
The workshop is part of the European Commission's response to the European Citizens' Initiative "Save cruelty-free cosmetics – Commit to a Europe without animal testing." The initiative gathered over one million statements of support, emphasising public demand for cruelty-free testing methods. The roadmap discussed at the workshop aims to outline milestones and specific actions needed to replace animal testing across various chemical regulations, with a target completion date by the end of 2025.
Diverse Stakeholder Perspectives
The workshop featured presentations and discussions from a wide range of stakeholders. Notable contributions included insights from the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA). Industry perspectives were also shared by the European Chemical Industry Council (CEFIC), while non-governmental organisations like Humane Society International (HSI) provided critical viewpoints on ethical and practical aspects of animal-free testing.
Key Recommendations and Challenges
1. Mapping and Gap Analysis:
A coordinated approach to mapping current information requirements and available non-animal methods (NAMs) is essential. This involves identifying existing alternatives, understanding regulatory needs, and pinpointing research gaps.
2. Validation and Regulatory Acceptance:
Participants highlighted the need for updating validation procedures to expedite the regulatory acceptance of NAMs. The current OECD Guidance Document 34 was deemed outdated, necessitating revisions to accommodate new technologies and scientific advancements.
3. Exposure and Toxicokinetics:
Improving the understanding of both internal and external exposure is crucial for implementing NAMs effectively. Strategies such as Exposure-Based Waiving (EBW) and the use of the Threshold of Toxicological Concern (TTC) were discussed as viable short-term measures.
4. Mechanistic Understanding:
A deep understanding of the mode and mechanism of action is vital for the adoption of NAMs. The use of Adverse Outcome Pathways (AOPs) and quantitative AOPs (qAOPs) was emphasised for their role in mechanistic hazard assessment.
5. Data Integration and Decision Making:
Frameworks for integrating data from various NAMs are needed to create a robust weight-of-evidence approach for decision making. Existing frameworks like Defined Approaches (DAs) and Integrated Approaches to Testing and Assessment (IATAs) were highlighted as models to build upon.
6. Safe Data Sharing Spaces:
The concept of "safe spaces" for data exchange was proposed to facilitate the sharing of NAM data between industry and regulatory bodies without regulatory consequences. This approach aims to build mutual confidence and trust in NAMs.
Future Outlook
The workshop concluded with a call for continued collaboration and stakeholder engagement to refine and implement the roadmap. A second workshop is planned for the second half of 2024 to review progress and update the roadmap. The ultimate goal is to achieve a regulatory system that relies entirely on non-animal methods for chemical safety assessments, ensuring the protection of human health and the environment.
The full report, published in June 2024, along with additional resources from the workshop, is available on the European Commission's website, providing comprehensive insights into the discussions and outcomes of this pivotal event.
