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

Danail Hristozov, Elena Badetti, Paolo Bigini, Andrea Brunelli, Susan Dekkers, Luisa Diomede, Shareen Doak Orcid Logo, Wouter Fransman, Agnieszka Gajewicz-Skretna, Elisa Giubilato, Laura Gómez-Cuadrado, Roland Grafström, Arno C. Gutleb, Sabina Halappanavar, Roland Hischier, Neil Hunt, Alberto Katsumiti, Ali Kermanizadeh, Antonio Marcomini, Elisa Moschini, Agnes Oomen, Lisa Pizzol, Carlos Rumbo, Otmar Schmid, Neeraj Shandilya, Vicki Stone, Stella Stoycheva, Tobias Stoeger, Blanca Suarez Merino, Lang Tran, Georgia Tsiliki, Ulla Birgitte Vogel, Wendel Wohlleben, Alex Zabeo

NanoImpact, Volume: 35, Start page: 100523

Swansea University Author: Shareen Doak Orcid Logo

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DOI (Published version): 10.1016/j.impact.2024.100523

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...

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Published in: NanoImpact
ISSN: 2452-0748
Published: Elsevier BV 2024
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa67277
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.
Keywords: Next Generation Risk Assessment (NGRA); New Approach Methodologies (NAMs); Advanced materials; Nanomaterials; Regulatory readiness; GroupingIn vitro approaches; In vitro-in vivo extrapolation (IVIVE); In silico approachesIn chemico approaches
College: Faculty of Medicine, Health and Life Sciences
Funders: 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).
Start Page: 100523

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