TY - JOUR
T1 - Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
AU - Hristozov, Danail
AU - Badetti, Elena
AU - Bigini, Paolo
AU - Brunelli, Andrea
AU - Dekkers, Susan
AU - Diomede, Luisa
AU - Doak, Shareen H.
AU - Fransman, Wouter
AU - Gajewicz-Skretna, Agnieszka
AU - Giubilato, Elisa
AU - Gómez-Cuadrado, Laura
AU - Grafström, Roland
AU - Gutleb, Arno C.
AU - Halappanavar, Sabina
AU - Hischier, Roland
AU - Hunt, Neil
AU - Katsumiti, Alberto
AU - Kermanizadeh, Ali
AU - Marcomini, Antonio
AU - Moschini, Elisa
AU - Oomen, Agnes
AU - Pizzol, Lisa
AU - Rumbo, Carlos
AU - Schmid, Otmar
AU - Shandilya, Neeraj
AU - Stone, Vicki
AU - Stoycheva, Stella
AU - Stoeger, Tobias
AU - Suarez Merino, Blanca
AU - Tran, Lang
AU - Tsiliki, Georgia
AU - Vogel, Ulla Birgitte
AU - Wohlleben, Wendel
AU - Zabeo, Alex
PY - 2024/7
Y1 - 2024/7
N2 - 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.
AB - 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.
KW - Advanced materials
KW - Grouping
KW - In chemico approaches
KW - In silico approaches
KW - In vitro approaches
KW - In vitro-in vivo extrapolation (IVIVE)
KW - Nanomaterials
KW - New Approach Methodologies (NAMs)
KW - Next Generation Risk Assessment (NGRA)
KW - Regulatory readiness
UR - http://www.scopus.com/inward/record.url?scp=85199916437&partnerID=8YFLogxK
U2 - 10.1016/j.impact.2024.100523
DO - 10.1016/j.impact.2024.100523
M3 - Article
C2 - 39059749
SN - 2452-0748
VL - 35
JO - NanoImpact
JF - NanoImpact
M1 - 100523
ER -