Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients

M. P. Dent, E. Vaillancourt*, R. S. Thomas, P L Carmichael, G. Ouedraogo, H Kojima, J. Barroso, J. Ansell, T. S. Barton-Maclaren, Susanne Hougaard Bennekou, K. Boekelheide, J. Ezendam, J. Field, S. Fitzpatrick, M. Hatao, R. Kreiling, M. Lorencini, C. Mahony, B. Montemayor, R. Mazaro-CostaJ. Oliveira, V. Rogiers, D. Smegal, R. Taalman, Y. Tokura, R. Verma, C. Willett, C. Yang

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

154 Downloads (Pure)


Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.

Original languageEnglish
Article number105026
JournalRegulatory Toxicology and Pharmacology
Number of pages12
Publication statusPublished - 10 Aug 2021

Bibliographical note

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.


  • Non-animal approaches
  • In vitro


Dive into the research topics of 'Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients'. Together they form a unique fingerprint.

Cite this