02879nas a2200373   4500000000100000008004100001260001500042653001300057653002400070653001200094653003100106653003600137653001700173653001900190653001100209100001800220700001700238700001500255700001700270700002500287700002200312700002400334700001500358700002000373700002400393700002100417700002000438245016900458856007200627300001100699490000800710520177300718022001402491       2025                            d  c2025-02-0110aBarriers10aChemical regulation10aDrivers10anew approach methodologies10aNext generation risk assessment10aPerspectives10aSocial science10asurvey1 aAngela Bearth1 aNicolas Roth1 aTom Jansen1 aLaura Holden1 aAleksandra Čavoški1 aEmma Di Consiglio1 aIngrid Hauzenberger1 aRobert Lee1 aEnrico Mombelli1 aOlga Tcheremenskaia1 aLina Wendt-Rasch1 aMartin F. Wilks00aNew approach methodologies in human health risk assessment across European regulatory frameworks: Status quo, barriers and drivers for regulatory acceptance and use  uhttps://www.sciencedirect.com/science/article/pii/S0160412025000303  a1092790 v1963 aThe traditional approaches to chemical risk assessment for human health are continuously challenged by their limitations, such as validity concerns, societal pressure to use animal-free methods, and resource constraints. New Approach Methodologies (NAMs) are considered a promising avenue toward modernisation of chemical risk assessment practices but their implementation in practice has been slow. This article aims to investigate the perspectives of human health risk assessors on the status quo, barriers and drivers of the acceptance and use of NAMs across different regulatory frameworks. A mixed method design was applied: qualitative interviews (N = 19) and an online survey with human health risk assessors from industry, regulatory agencies/institutions and academia (N = 222). The results show heterogeneity in familiarity and use of specific NAMs (e.g., QSARs as well-known and used vs. −omics approaches that are seldom used), the risk assessors’ background (e.g., industry vs. regulatory agencies and institutions vs. academia) and the application context (e.g., screening/prioritisation vs. hazard identification/characterisation). The identified barriers and drivers offer pointers for the future integration and acceptance of NAMs in regulatory risk assessment. For instance, guidance documents can facilitate the use of NAMs, showcasing successful examples that increase trust in the methods and thus, the risk assessors’ confidence in using these methods. Among other things, the article highlights the importance of considering human health risk assessors’ needs and prerequisites to foster bottom-up coordinated efforts and to ensure the success of top-down legal and institutional change to incorporate NAMs in regulatory risk assessment.  a0160-4120