A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication

Derek J Knight, Hubert Deluyker, Qasim Chaudhry, Jean-Marc Vidal, Alie de Boer*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Safety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a longstanding ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources.

This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.

Original languageEnglish
Article number104837
Number of pages7
JournalRegulatory Toxicology and Pharmacology
Early online date2020
Publication statusPublished - Feb 2021


  • Risk assessment
  • Toxicology
  • Non-animal-based testing
  • Animal welfare
  • 3Rs
  • New approach methods
  • Medicines
  • Cosmetics
  • Food safety
  • Next generation risk assessment
  • FOOD

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