Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges

New Approach Methodologies (NAMs), broadly understood to include in silico, in chemico, in vitro and ex vivo methods, show great potential in advancing risk assessment (RA) albeit their regulatory implementation is lagging. The EFSA Guidance on RA of nanomaterials (EFSA Guidance on Nano-RA) suggests nano-specific RA is best achieved through Integrated Approaches to Testing and Assessment (IATA) with NAMs as the first choice to generate new information. Integrating NAMs in RA promises several advantages such as a better human focus, a stronger emphasis on molecular mechanisms and a higher efficacy. Applying NAMs to NMs also poses considerable challenges such as issues related to dispersion stability, dosimetry, agglomeration, dissolution, transformations or assay interferences. Significant efforts are being undertaken by standardization organizations and research projects to establish various nano-specific NAMs. Here a thorough review is provided covering NAMs that will be potentially useful for RA of NMs in the food and feed sector. It follows the structure of the EFSA Guidance on Nano-RA and expands it, where needed, beginning with an overview on nano-specific NAM-frameworks, followed by a description of individual NAMs including those relevant to NM physicochemical characterization, toxicodynamics and toxicokinetics. The focus is on NAMs concerning NM degradation/dissolution, genotoxicity, cytotoxicity, oxidative stress, inflammation, and barrier integrity as those are important endpoints for initial screening according to the EFSA framework. As a result, in total 242 individual NAMs mostly “not validated” (with a few notable exceptions) were included in this review. Validation notwithstanding, NAMs could already prove relevant and reliable for RA, especially in integrated approaches.

USMANI Shirin M.;  BREMER-HOFFMANN Susanne;  CHEYNS Karlien;  CUBADDA Francesco;  DUMIT Verónica I. Dumit;  ESCHER Sylvia E.;  FESSARD Valerie;  GUTLEB Arno;  LÉGER Thibaut;  LIU Yuk-Chien;  MAST Jan;  MCVEY Emily;  MERTENS Birgit;  MONTALVO Daniela;  OOMEN Agnes;  RITZ Vera;  SERCHI Tommaso;  SIEG Holger;  SIEWERT Katherina;  STANCO Deborah;  VERLEYSEN Eveline;  VINCENTINI Olimpia;  YEO Calvin W. S. Yeo;  YU Dingyi;  VAN DER ZANDE Meike;  HAASE Andrea; 

2024-11-19

WILEY

JRC136858

1831-4732 (online),   

https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2024.EN-8826,    https://publications.jrc.ec.europa.eu/repository/handle/JRC136858,   

10.2903/sp.efsa.2024.EN-8826 (online),