Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop

Carl Westmoreland, Hans J. Bender, John E. Doe, Miriam N. Jacobs, George E.N. Kass, Federica Madia, Catherine Mahony, Irene Manou, Gavin Maxwell, Pilar Prieto, Rob Roggeband, Tomasz Sobanski, Katrin Schütte, Andrew P. Worth, Zvonimir Zvonar, Mark T.D. Cronin*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


New Approach Methodologies (NAMs) are considered to include any in vitro, in silico or chemistry-based method, as well as the strategies to implement them, that may provide information that could inform chemical safety assessment. Current chemical legislation in the European Union is limited in its acceptance of the widespread use of NAMs. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a ‘Deep Dive Workshop’ to explore the use of NAMs in chemical safety assessment, the aim of which was to support regulatory decisions, whilst intending to protect human health. The workshop recognised that NAMs are currently used in many industrial sectors, with some considered as fit for regulatory purpose. Moreover, the workshop identified key discussion points that can be addressed to increase the use and regulatory acceptance of NAMs. These are based on the changes needed in frameworks for regulatory requirements and the essential needs in education, training and greater stakeholder engagement as well the gaps in the scientific basis of NAMs.

Original languageEnglish
Article number105261
JournalRegulatory Toxicology and Pharmacology
Publication statusPublished - Nov 2022

Bibliographical note

Funding Information:
Dr Hans Bender received funding from EPAA for funding to moderate the workshop. Dr John Doe received funding from ECETOC for financial support to prepare his presentation.

Publisher Copyright:
© 2022 The Authors


  • Chemicals legislation
  • Exposure
  • Hazard
  • In silico
  • In vitro
  • New approach methodology
  • Safety assessment


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