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NAMS4NANO: Integration of New Approach Methodologies results in chemical risk assessments: Case studies addressing nanoscale considerations. - LOT 3: Methodological and generic case studies (NAMS4NANO LOT3)

04/2023-03/2027

Funding programme / funding institution: Europäische Behörde für Lebensmittelsicherheit (EFSA) - Italien

Grant number: GP/EFSA/MESE/2022/01

Project homepage: -

Project description:

New Approach Methodologies (NAMs), which can be broadly understood to include in silico, in chemico and in vitro methods including new testing tools such as “high-throughput screening” and “high-content methods” like the various omics approaches bear great potential to advance chemical risk assessment. NAMs allow for higher throughput, use human-relevant models and allow for important insights into underlying toxicity mechanisms. However, their regularory implementation remains challenging, in particular for higher tier toxicological endpoints. Major obstacles are the lacking standardization of methods, reporting templates and data interpretation. This project specifically aims to advance risk assessment of nanomaterials (NM) in the food and feed sectors by the implementation of NAMs. The application of NAMs for NMs is in particular promising as NMs easily can be manufactured in plenty of variants. However, the particulate nature raises additional issues that have to be properly adressed.

This project (Lot 3) conducts five methodological case studies. The case studies adresses questions such as the development of integrated approaches to testing and assessment for nanocarriers (case study 1), nanofibres such as nanocellulose (case study 2), the consideration of particle aging and other transformations in in vitro studies (case study 3), the use of disease models to represent more vulnerable populations (case study 4) and the application of simple in vivo models such as C. elegans or zebrafish to generate human relevant data (case study 5).

There is a close interaction with the risk assessment case studies ongoing in Lot 2 and with the overarching work being conducted in Lot 1.

Coordination

• Italian National Institute of Health

Project partners

• Italian National Institute of Health (ISS) - Italien
• National Institute For Public Health and The Environment (RIVM) - Niederlande
• Wageningen University & Research (WUR) - Niederlande
• French Agency for Food, Environmental and Occupational Health & Safety (ANSES) - Frankreich
• Sciensano (Sciensano) - Belgien
• Luxembourg Institute of Science and Technology (LIST) Diekirch - Luxemburg
• European Commission’s Joint Research Centre (JRC) - Belgien

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