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 H. Doak, Wouter Fransman, Agnieszka Gajewicz, 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 G. Oomen, Lisa Pizzol, Carlos Rumbo, Otmar Schmid, Neeraj Shandilya, Vicki Stone, Stella Stoycheva, Tobias Stoeger, Blanca Suarez Merino, Lang Tran, Georgia Tsiliki, Ulla Vogel, Wendel Wohlleben, Alex Zabeo
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.