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Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives.

Authors :
Hristozov D
Badetti E
Bigini P
Brunelli A
Dekkers S
Diomede L
Doak SH
Fransman W
Gajewicz-Skretna A
Giubilato E
Gómez-Cuadrado L
Grafström R
Gutleb AC
Halappanavar S
Hischier R
Hunt N
Katsumiti A
Kermanizadeh A
Marcomini A
Moschini E
Oomen A
Pizzol L
Rumbo C
Schmid O
Shandilya N
Stone V
Stoycheva S
Stoeger T
Merino BS
Tran L
Tsiliki G
Vogel UB
Wohlleben W
Zabeo A
Source :
NanoImpact [NanoImpact] 2024 Jul; Vol. 35, pp. 100523. Date of Electronic Publication: 2024 Jul 24.
Publication Year :
2024

Abstract

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.<br />Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br /> (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Details

Language :
English
ISSN :
2452-0748
Volume :
35
Database :
MEDLINE
Journal :
NanoImpact
Publication Type :
Academic Journal
Accession number :
39059749
Full Text :
https://doi.org/10.1016/j.impact.2024.100523