Feedback from ECHA’s workshop: Towards an animal-free regulatory system for industrial chemicals

Posted on: 21/07/2024

On the 31st of May and the 1st of June 2023, over 500 participants joined the European Chemicals Agency (ECHA) two-day workshop on New Approach Methodologies (NAMs) in Helsinki. The workshop aimed at collecting feedback and perspectives from different stakeholders on how to accelerate the transition towards an animal-free regulatory framework for industrial chemicals. Presentations were divided in four sessions.

 

Hazard assessment for industrial chemicals: regulatory landscape and identifying critical needs

The first session featured speakers from ECHA, the European Commission, OECD, CEFIC and PETA who gave their perspectives on the hazard assessment of chemicals. It was highlighted that the first steps for the acceptance of NAMs should be to agree on a framework and roadmap for the current application of NAMs. Stakeholders agreed that the international harmonization of NAMs and Mutual Acceptance of Data (MAD) are essential to ensure global acceptance of NAMs. All stakeholders across different sectors and geographical areas need to be involved in this dialogue.

 

Opportunities for increasing the use of New Approach Methodologies under the current chemical regulatory systems

The second session of the workshop welcomed speakers from the European Commission including the Joint Research Centre and DG Environment. They discussed, among other topics, the current requirements for the assessment of chemicals, challenges related to the current regulations and future opportunities for NAMs. Then, brief perspectives were given on the status of NAMs and future opportunities to study different endpoints including repeated dose toxicity, developmental and reproductive toxicity, carcinogenicity or endocrine disruption.

 

Looking beyond current regulatory settings for a completely animal-free system

During this session, the perspective from DG Grow on moving towards animal free regulations was given. It was followed by presentations on how to accelerate the transition and perspectives from the European Partnership for Alternative Methods to Animal testing (EPAA). During the workshop, EPAA officially launched its Designathon for human systemic toxicity. The aim is to discuss NAM-based solutions to develop a potential future classification system for human systemic toxicity. Participants are invited to propose case studies on how they would go about this classification. The recording of the information webinar is available here.

 

Conclusions & final outcomes of the workshop

All stakeholders present during the workshop (International science community, OECD, authorities, NGOs, industry and the EU) demonstrated a strong commitment to move towards animal-free chemical safety assessment even though they have different expectations on the rapidity of this transition. They also highlighted the importance of having a roadmap to agree on this transition. Building confidence in NAMs is key and can be done by using targeted case studies. A targeted investment will be essential to facilitate the validation and regulatory acceptance of NAMs.

Ofelia Bercaru, the Director for Prioritisation and Integration, said: “ECHA is committed to supporting the development of new methodologies to replace testing on animals. We also want to contribute to future EU chemicals regulation which would not rely on animal testing. This workshop gave us new views and a better understanding on how we can move forward, while implementing horizonal regulations such as REACH and CLP. Concerted efforts by all stakeholders are needed for faster progress, and we are ready to play our part.”

 

Sources

ECHA’s workshop 2023