Category Research project
  • Analytik

Integration of New Approach Methodologies results in chemical risk assessments: Case studies addressing nanoscale considerations. - LOT 1: Review of tools and developing a ‘Qualification System for NAMs’

Project status
In Progress
Project start
Apr 2023
Project end
Mar 2027
Acronym
NAMS4NANO LOT1
Department
Chemikalien- und Produktsicherheit

Description and Objective

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 1) will firstly review existing NAMs for NMs. Secondly, a qualification system will be developed to assess their regulatory maturity. Finally, an implementation plan will be worked out to integrate NAMs in future in a more coherent manner in risk assessments. This project interacts closely with two other EFSAshort forEuropean Food Safety Authority-funded projects. In a second project (Lot 2) risk assessment case studies for five selected materials are conducted and in a third project (Lot 3) five methodological case studies are ongoing. To reach its ambitious goals this project regularly exchanges with relevant stakeholders such as EFSAshort forEuropean Food Safety Authority, ECHAshort forEuropean Chemicals Agency, EMA and OECD.
Type of project

Third-party funded project

BFR research focus

Nanotechnologie: Nachweis, Toxikologie, Risikobewertung und Risikowahrnehmung

Organisational units and partners

Lead specialist group: Faser- und Nanotoxikologie (76)
Contact persons: PDshort foroutside lecturer Dr. Andrea Haase
Involved BfR partners: Exposition, Sicherheit in der Nahrungskette, Lebensmittelsicherheit, Sicherheit von Pestiziden, Chemikalien- und Produktsicherheit
External partner: Italian National Institute of Health, Sciensano, French Agency for Food, Environmental and Occupational Health & Safety , National Institute For Public Health and The Environment, Luxembourg Institute of Science and Technology, Wageningen University & Research, European Commission’s Joint Research Centre, Singapore Food Agency

Funding body and grant number

Europäische Behörde für Lebensmittelsicherheit
GP/EFSAshort forEuropean Food Safety Authority/MESE/2022/01

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