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

Journal article

Hristozov, D., Badetti, E., Bigini, P., Brunelli, A., Dekkers, S., Diomede, L., Doak, S. K., Fransman, W., Gajewicz-Skretna, A., Giubilato, E., Gómez-Cuadrado, L., Grafström, R., Gutleb, R. C., Halappanavar, S., Hischier, R., Hunt, N., Katsumiti, A., Kermanizadeh, A., Marcomini, A., Moschini, E., Oomen, E., Pizzol, L., Rumbo, C., Schmid, O., Shandilya, N., Stone, V., Stoycheva, S, Stoeger, T., Merino, B. S., Tran, L., Tsiliki, G., Vogel, U. B., Wohlleben, W. and Zabeo, A. 2024. Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives. NanoImpact. pp. 1-48. https://doi.org/10.1016/j.impact.2024.100523
AuthorsHristozov, D., Badetti, E., Bigini, P., Brunelli, A., Dekkers, S., Diomede, L., Doak, S. K., Fransman, W., Gajewicz-Skretna, A., Giubilato, E., Gómez-Cuadrado, L., Grafström, R., Gutleb, R. C., Halappanavar, S., Hischier, R., Hunt, N., Katsumiti, A., Kermanizadeh, A., Marcomini, A., Moschini, E., Oomen, E., Pizzol, L., Rumbo, C., Schmid, O., Shandilya, N., Stone, V., Stoycheva, S, Stoeger, T., Merino, B. S., Tran, L., Tsiliki, G., Vogel, U. B., Wohlleben, W. and Zabeo, A.
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 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.

KeywordsNext Generation Risk Assessment (NGRA); New Approach Methodologies (NAMs); Advanced materials; Nanomaterials; Regulatory readiness; Grouping; In vitro approaches; In vitro-in vivo extrapolation (IVIVE); In silico approaches; In chemico approaches
Year2024
JournalNanoImpact
Journal citationpp. 1-48
PublisherElsevier
ISSN2452-0748
Digital Object Identifier (DOI)https://doi.org/10.1016/j.impact.2024.100523
Web address (URL)https://www.sciencedirect.com/science/article/pii/S2452074824000338?via%3Dihub
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Online24 Jul 2024
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Accepted17 Jul 2024
Deposited29 Jul 2024
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