2026-04-20T21:38:17Zhttps://riubu.ubu.es/oai/request

oai:riubu.ubu.es:10259/98032024-12-19T01:05:23Zcom_10259_6168com_10259_5086com_10259_2604col_10259_6169

00925njm 22002777a 4500 dc Hristozov, Danail author Badetti, Elena author Bigini, Paolo author Brunelli, Andrea author Dekkers, Susan author Diomede, Luisa author Doak, Shareen H. author Fransman, Wouter author Gajewicz-Skretna, Agnieszka author Giubilato, Elisa author Gómez Cuadrado, Laura author Grafström, Roland author Gutleb, Arno C. author Halappanavar, Sabina author Hischier, Roland author Hunt, Neil author Katsumiti, Alberto author Kermanizadeh, Ali author Marcomini, Antonio author Moschini, Elisa author Oomen, Agnes author Pizzol, Lisa author Rumbo Lorenzo, Carlos author Schmid, Otmar author Shandilya, Neeraj author Stone, Vicki author Stoycheva, Stella author Stoeger, Tobias author Merino, Blanca Suarez author Tran, Lang author Tsiliki, Georgia author Vogel, Ulla Birgitte author Wohlleben, Wendel author Zabeo, Alex author 2024-07 This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas. 2452-0748 http://hdl.handle.net/10259/9803 10.1016/j.impact.2024.100523 Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives