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Hristozov, D.* ; Badetti, E.* ; Bigini, P.* ; Brunelli, A.* ; Dekkers, S.* ; Diomede, L.* ; Doak, S.H.* ; Fransman, W.* ; Gajewicz-Skretna, A.* ; Giubilato, E.* ; Gómez-Cuadrado, L.* ; Grafström, R.C.* ; Gutleb, A.C.* ; Halappanavar, S.* ; Hischier, R.* ; Hunt, N.* ; Katsumiti, A.* ; Kermanizadeh, A.* ; Marcomini, A.* ; Moschini, E.* ; Oomen, A.G.* ; Pizzol, L.* ; Rumbo, C.* ; Schmid, O. ; Shandilya, N.* ; Stone, V.* ; Stoycheva, S.* ; Stöger, T. ; Merino, B.S.* ; Tran, L.* ; Tsiliki, G.* ; Vogel, U.B.* ; Wohlleben, W.* ; Zabeo, A.*

Next generation risk assessment approaches for advanced nanomaterials: current status and future perspectives.

NanoImpact 35:100523 (2024)
Publ. Version/Full Text DOI PMC
Open Access Hybrid
Creative Commons Lizenzvertrag
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 an 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 relevance for AdNMs are 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.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Advanced Materials ; Grouping ; In Chemico Approaches ; In Silico Approaches ; In Vitro Approaches ; In Vitro-in Vivo Extrapolation (ivive) ; Nanomaterials ; New Approach Methodologies (nams) ; Next Generation Risk Assessment (ngra) ; Regulatory Readiness; Engineered Nanoparticles; Toxicity; Exposure; Limitations; Particles; Quality; Model
Language english
Publication Year 2024
HGF-reported in Year 2024
ISSN (print) / ISBN 2452-0748
e-ISSN 2452-0748
Journal NanoImpact
Quellenangaben Volume: 35, Issue: , Pages: , Article Number: 100523 Supplement: ,
Publisher Elsevier
Publishing Place Amsterdam
Reviewing status Peer reviewed
Institute(s) Institute of Lung Health and Immunity (LHI)
POF-Topic(s) 30202 - Environmental Health
Research field(s) Lung Research
PSP Element(s) G-505000-008
G-505000-001
Grants European Union
DOI 10.1016/j.impact.2024.100523
WOS ID 001292742900001
Scopus ID 85199916437
PubMed ID 39059749
Erfassungsdatum 2024-08-01
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