Citation:

Dent, M., E. Vaillancourt, R. Thomas, P. Carmichael, G. Ouedraogo, H. Kojima, J. Barroso, J. Anseil, T. Barton-Maclaren, S. Bennekou, K. Boekelheide, J. Ezendam, J. Field, S. Fitzpatrick, M. Hatao, R. Kreiling, M. Lorencini, C. Mahony, B. Montemayor, R. Mazaro-Costa, J. Oliveira, V. Rogiers, D. Smegal, R. Taalman, Y. Tokura, R. Verma, C. Willett, AND C. Yang. Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 125:105026, (2021). https://doi.org/10.1016/j.yrtph.2021.105026

Impact/Purpose:

This is a report from the International Cooperation on Cosmetics Regulation (ICCR) workshop held in Montreal Canada in 2019. Workshop participants explored whether next generation risk assessment (NGRA) for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. Seven areas were identified to help progress application of NGRA, including significant further investments in case studies that elaborate on scenarios/problem formulations frequently encountered by industry and regulatory safety assessors 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 concern or risk. Furthermore, frameworks to guide performance and reporting of the assessment and its strengths and limitations should be developed. These steps will help to make NGRA a day-to-day reality for cosmetic ingredients.

Description:

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.

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