European stakeholders' workshop on new approach methodologies (NAMs) for developmental neurotoxicity (DNT) and their use in the regulatory risk assessment of chemicals

Summary

On 7-9 March a European stakeholder workshop on developmental neurotoxicity (DNT) was attended by 170 representatives of the European Chemicals Agency (ECHA), the European Commission, industry, EU Member States, and academia.

The aim of the workshop was to define the next steps for using new alternative methodologies (NAMs) in the context of an integrated approach for testing and assessment (IATA) framework. The ultimate goal, in line with the European Commission’s Chemicals Strategy for Sustainability, is to be able to assess any regulated chemical for DNT using an IATA approach and minimise the need for DNT in vivo guideline studies.

The breakout sessions focused on three main questions:

• What is needed in the short term to reach the goal?
• What level of uncertainty are regulators and assessors ready to accept by changing paradigm, against the non-testing alternative?
• What are the critical scientific and legislative regulatory hurdles to including the DNT-IVB in regulatory chemical risk assessment?

The group unanimously agreed that NAMs can be used immediately as available evidence in the weight of evidence analysis, read across and screening priority for DNT but that more work is necessary to substantiate inter-laboratory reproducibility, laboratory accessibility and development of specific test guideline for method descriptions. The group also supported the finalisation of the OECD DNT guidance on the use of DNT in vitro testing battery as a general guidance and inspirational document for further work on jurisdiction specific tiered approaches.