Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.
Résumé
The EFSA has updated the Guidance on risk assessment of the application of nanoscience andnanotechnologies in the food and feed chain, human and animal health. It covers the application areaswithin EFSA’s remit, including novel foods, food contact materials, food/feed additives and pesticides.The updated guidance, now Scientific Committee Guidance on nano risk assessment (SC Guidance onNano-RA), has taken account of relevant scientific studies that provide insights to physico-chemicalproperties, exposure assessment and hazard characterisation of nanomaterials and areas ofapplicability. Together with the accompanying Guidance on Technical requirements for regulated foodand feed product applications to establish the presence of small particles including nanoparticles(Guidance on Particle-TR), the SC Guidance on Nano-RA specifically elaborates on physico-chemicalcharacterisation, key parameters that should be measured, methods and techniques that can be usedfor characterisation of nanomaterials and their determination in complex matrices. The SC Guidance onNano-RA also details aspects relating to exposure assessment and hazard identification andcharacterisation. In particular, nanospecific considerations relating toin vitro/in vivotoxicologicalstudies are discussed and a tiered framework for toxicological testing is outlined. Furthermore,in vitrodegradation, toxicokinetics, genotoxicity, local and systemic toxicity as well as general issues relating totesting of nanomaterials are described. Depending on the initial tier results, additional studies may beneeded to investigate reproductive and developmental toxicity, chronic toxicity and carcinogenicity,immunotoxicity and allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity. Thepossible use of read-across tofill data gaps as well as the potential use of integrated testing strategiesand the knowledge of modes or mechanisms of action are also discussed. The Guidance proposesapproaches to risk characterisation and uncertainty analysis.
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EFSA Journal - 2021 - - Guidance on risk assessment of nanomaterials to be applied in the food and feed chain human and.pdf (12.85 Mo)
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