New approach methodologies in human regulatory toxicology – not if, but how and when!
The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, demanding a change of paradigm. At the same time, the scientific toolbox used for risk assessment is continuously enriched by the development of “New Approach Methodologies” (NAMs). In addition to promising faster and more efficient toxicity testing, NAMs have the potential to fundamentally transform today’s regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Yet, several obstacles hamper a broader application of NAMs in current regulatory risk assessment. The conceptual perspective presented here has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021. It intends to provide further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free “Next Generation Risk Assessment” (NGRA).
SCHMEISSER Sebastian;
MICCOLI Andrea;
VON BERGEN Martin;
BERGGREN Elisabet;
BRAEUNING Albert;
BUSCH Wibke;
DESAINTES Christian;
GOURMELON Anne;
GRAFSTRÖM Roland;
HARRILL Joshua A.;
HARTUNG Thomas;
HERZLER Matthias;
KASS George;
KLEINSTREUER Nicole;
LEIST Marcel;
LUIJTEN Mirjam;
MARX-STOELTING Philip;
POETZ Oliver;
VAN RAVENZWAAY Bennard;
ROGGEBAND Rob;
ROGIERS Vera;
ROTH Adrian;
SANDERS Pascal;
THOMAS Russel;
VINGGAARD Anne Marie;
VINKEN Mathieu;
VAN DE WATER Bob;
LUCH Andreas;
TRALAU Tewes;
2023-07-13
PERGAMON-ELSEVIER SCIENCE LTD
JRC133128
0160-4120 (online),
https://www.sciencedirect.com/science/article/pii/S0160412023003550,
https://publications.jrc.ec.europa.eu/repository/handle/JRC133128,
10.1016/j.envint.2023.108082 (online),
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