Abstract Icon

New approach methodologies: moving beyond animal testing

Chemical risk assessment has relied for over half a century almost exclusively on the data generated by animal testing. Yet, the approach of testing chemicals in rodents (and other animal species) for human safety purposes has been questioned repeatedly. In addition to ethical issues, the transferability of animal data across species is often problematic because of differences in physiology, metabolism and chemical susceptibilities. In this thematic session, we intend to explore the opportunities provided by new approach methodologies to shift the current paradigm from regulatory chemical risk assessment based on in vivo animal testing towards new generation risk assessment. This alternative will be supported by adverse outcome pathways and informed by mechanisms using integrated approaches based on in vitro testing in human-relevant cell models, alternative animal models (e.g., zebra fish, Caenorhabditis elegans) and in silico technologies.

Session Coordinator

Session coordinator
Georges Kass (EFSA)

Session Contributors

Session contributors
Marco Binaglia (EFSA)
Raffaella Corvi (JRC)
Antony Humphreys (EMA)
Anna Lanzoni (EFSA)
Annamaria Rossi (EFSA)
Rositsa Serafimova (EFSA)
Tomasz Sobanski (ECHA)
José Tarazona (EFSA)
Andrea Terron (EFSA)


Abstract Session Chairpersons
  • Maurice Whelan, Joint Research Centre (JRC)
Abstract Session Speakers
  • Katrin Schutte, Directorate-General for the Environment (European Commission) - NAMs in regulatory risk assessment – the REACH experience
  • Tomasz Sobanski, European Chemicals Agency (ECHA) - Experience of ECHA in developing and applying NAMs for regulatory applications
  • Russel Thomas, US Environmental Protection Agency (US UPA) - Developing NAMs for regulatory risk assessment at US EPA – experience, state-of-the-art and lessons learned
  • Bob Van der Water, University of Leiden - Developing NAMs for regulatory risk assessment – academia’s experience
  • Bob Diderich, Organisation for Economic Co-operation and Development (OECD) - Development and Implementation of NAMs at the OECD
  • Sylvia Escher, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) - EFSA's Roadmap
Abstract Session Moderators
  • Maurice Whelan, Joint Research Centre (JRC)
Abstract Session Panellists
  • Julia Baines, PETA/International Science Consortium Ltd
  • Michael Empl, European Medicines Agency (EMA)​
  • Suzanne Fitzpatrick, US Food and Drug Administration (US FDA)​
  • Marcel Leist, University of Konstanz
  • Anna Lennquist, ChemSec​
  • Carl Westmoreland, Unilever
Abstract Session Rapporteurs
  • Edoardo Carnesecchi, European Food Safety Authority (EFSA)
  • Georges Kass, European Food Safety Authority (EFSA)
  • Anna Lanzoni, European Food Safety Authority (EFSA)
  • Annamaria Rossi, European Food Safety Authority (EFSA)