RT info:eu-repo/semantics/article
T1 Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
A1 Hristozov, Danail
A1 Badetti, Elena
A1 Bigini, Paolo
A1 Brunelli, Andrea
A1 Dekkers, Susan
A1 Diomede, Luisa
A1 Doak, Shareen H.
A1 Fransman, Wouter
A1 Gajewicz-Skretna, Agnieszka
A1 Giubilato, Elisa
A1 Gómez Cuadrado, Laura
A1 Grafström, Roland
A1 Gutleb, Arno C.
A1 Halappanavar, Sabina
A1 Hischier, Roland
A1 Hunt, Neil
A1 Katsumiti, Alberto
A1 Kermanizadeh, Ali
A1 Marcomini, Antonio
A1 Moschini, Elisa
A1 Oomen, Agnes
A1 Pizzol, Lisa
A1 Rumbo Lorenzo, Carlos
A1 Schmid, Otmar
A1 Shandilya, Neeraj
A1 Stone, Vicki
A1 Stoycheva, Stella
A1 Stoeger, Tobias
A1 Merino, Blanca Suarez
A1 Tran, Lang
A1 Tsiliki, Georgia
A1 Vogel, Ulla Birgitte
A1 Wohlleben, Wendel
A1 Zabeo, Alex
K1 Next Generation Risk Assessment (NGRA)
K1 New Approach Methodologies (NAMs)
K1 Advanced materials
K1 Nanomaterials
K1 Regulatory readiness
K1 Grouping
K1 In vitro approaches
K1 In vitro-in vivo extrapolation (IVIVE)
K1 In silico approaches
K1 In chemico approaches
K1 Nanotecnología
K1 Nanotechnology
K1 Química orgánica
K1 Chemistry, Organic
K1 Química
K1 Chemistry
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.
PB Elsevier
SN 2452-0748
YR 2024
FD 2024-07
LK http://hdl.handle.net/10259/9803
UL http://hdl.handle.net/10259/9803
LA eng
NO This work was supported by the European Union's Horizon 2020 Programme under grant agreements 952924 (SUNSHINE project), 953183 (HARMLESS project) and 953152 (DIAGONAL project), and by the European Union's Horizon Europe Programme under grant agreements 101092901 (POTENTIAL project) and 101137324 (SUNRISE project).
DS Repositorio Institucional de la Universidad de Burgos
RD 22-dic-2024