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Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health
Date Issued
2021-08-03
Date Available
2022-08-19T15:39:40Z
Abstract
The EFSA has updated the Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain, human and animal health. It covers the application areas within 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 on Nano-RA), has taken account of relevant scientific studies that provide insights to physico-chemical properties, exposure assessment and hazard characterisation of nanomaterials and areas of applicability. Together with the accompanying Guidance on Technical requirements for regulated food and 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-chemical characterisation, key parameters that should be measured, methods and techniques that can be used for characterisation of nanomaterials and their determination in complex matrices. The SC Guidance on Nano-RA also details aspects relating to exposure assessment and hazard identification and characterisation. In particular, nanospecific considerations relating to <i>in vitro/in vivo</i> toxicological studies are discussed and a tiered framework for toxicological testing is outlined. Furthermore, <i>in vitro</i> degradation, toxicokinetics, genotoxicity, local and systemic toxicity as well as general issues relating to testing of nanomaterials are described. Depending on the initial tier results, additional studies may be needed to investigate reproductive and developmental toxicity, chronic toxicity and carcinogenicity, immunotoxicity and allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity. The possible use of read-across to fill data gaps as well as the potential use of integrated testing strategies and the knowledge of modes or mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis.
Type of Material
Journal Article
Publisher
Wiley
Journal
EFSA Journal
Volume
19
Issue
8
Copyright (Published Version)
2021 European Food Safety Authority
Language
English
Status of Item
Peer reviewed
ISSN
1831-4732
This item is made available under a Creative Commons License
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Mar 28, 2024
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