Regulatory Safety Assessment of Nanomaterials for the Food Chain in Europe

The risk assessment of small particles (including nanoparticles) used in the food chain in the EU falls within the remit of EFSA and has been under thorough scientific considerations for over a decade. Now that more experience is gained with evaluating novel foods, food contact materials, food/feed additives and pesticides, the outlines for regulatory assessments and data requirements are established. The principles underlying safety testing of small particles are reviewed, based on recent EFSA guidance. Observations from assessing existing materials are provided to facilitate adequate implementation of the regulatory requirements. The primary aspect for safety testing is the physico-chemical characterisation of the pristine material. Key parameters and threshold values for establishing the presence of small particles, the techniques and methods for determining and characterising in complex matrices, as well as systematic approaches for dietary exposure assessment are outlined. Where there is the likelihood of small particles remaining after gastrointestinal digestion, hazard identification and hazard characterisation are required with special provisions. In particular, certain nanospecific considerations are highlighted that have to be considered during toxicological testing with the aim to demonstrate consumer safety of products to be used in the food chain in Europe.

SCHOONJANS Reinhilde;  CASTENMILLER Jacqueline;  CHAUDHRY Qasim;  CUBADDA Francesco;  DASKALEROS Takis;  FRANZ Roland;  GOTT David;  MAST Jan;  MORTENSEN Alicja;  OOMEN Agnes;  RAUSCHER Hubert;  WEIGEL Stefan;  ASTUTO Maria;  CATTANEO Irene;  BARTHELEMY Eric;  RINCON Ana;  TARAZONA Jose; 

2023-03-13

ELSEVIER SCIENCE LONDON

JRC130657

0924-2244 (online),   

https://www.sciencedirect.com/science/article/pii/S0924224423000171,    https://publications.jrc.ec.europa.eu/repository/handle/JRC130657,   

10.1016/j.tifs.2023.01.017 (online),