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 in vitro/in vivo toxicological studies are discussed and a tiered framework for toxicological testing is outlined. Furthermore, in vitro 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.
Bibliographical noteFunding Information:
Nanogenotox was a Joint Action of European Commission and a consortium of national institutions of Member States which was funded by European Commission’s health programme (46%), while partners and some ministries of the participating Member States (Belgium, France, Germany and the Netherlands) provide the remaining. www.nanogenotox.eu
The Scientific Committee and the cross-cutting Working Group on Nanotechnologies wish to thank the experts: Jonathan Powell (until March 2017), Andrea Zijno (April-June 2017), Barbara Drasler (June 2017-March 2018), Shareen Doak (as from 2020) and EFSA staff members: Hermine Reich, Renata Leuschner, Maria Vittoria Vettori, Melpo Karamitrou (in 2018), Berrak Eryasa (in 2019), Irene Cattaneo, and Maria Chiara Astuto for the support provided to this scientific output. The Scientific Committee and the cross-cutting Working Group on Nanotechnologies wish to acknowledge JRC, ECHA and the Member States delegates of the EFSA Scientific Network of risk assessment of nanotechnologies in food and feed that provided feedback for this scientific output.
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
- Dietary exposure
- Physico-chemical characterisation
- Safety assessment
- Testing strategy