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

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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Detalles Bibliográficos
Autores: Hristozov, Danail, Badetti, Elena, Bigini, Paolo, Brunelli, Andrea, Dekkers, Susan, Diomede, Luisa, Doak, Shareen H., Fransman, Wouter, Gajewicz-Skretna, Agnieszka, Giubilato, Elisa, Gómez Cuadrado, Laura, Grafström, Roland, Gutleb, Arno C., Halappanavar, Sabina, Hischier, Roland, Hunt, Neil, Katsumiti, Alberto, Kermanizadeh, Ali, Marcomini, Antonio, Moschini, Elisa, Oomen, Agnes, Pizzol, Lisa, Rumbo Lorenzo, Carlos, Schmid, Otmar, Shandilya, Neeraj, Stone, Vicki, Stoycheva, Stella, Stoeger, Tobias, Merino, Blanca Suarez, Tran, Lang, Tsiliki, Georgia, Vogel, Ulla Birgitte, Wohlleben, Wendel, Zabeo, Alex
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universidad de Burgos (UBU)
Repositorio:Repositorio Institucional de la Universidad de Burgos (RIUBU)
OAI Identifier:oai:riubu.ubu.es:10259/9803
Acceso en línea:http://hdl.handle.net/10259/9803
Access Level:acceso abierto
Palabra clave:Next 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
Nanotecnología
Química orgánica
Química
Nanotechnology
Chemistry, Organic
Chemistry
Descripción
Sumario: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.

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