RT Journal Article
T1 Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.
A1 EFSA Scientific Committee, 
A1 More, Simon
A1 Bampidis, Vasileios
A1 Benford, Diane
A1 Bragard, Claude
A1 Halldorsson, Thorhallur
A1 Hernández-Jerez, Antonio
A1 Hougaard Bennekou, Susanne
A1 Koutsoumanis, Kostas
A1 Lambré, Claude
A1 Machera, Kyriaki
A1 Naegeli, Hanspeter
A1 Nielsen, Søren
A1 Schlatter, Josef
A1 Schrenk, Dieter
A1 Silano Deceased, Vittorio
A1 Turck, Dominique
A1 Younes, Maged
A1 Castenmiller, Jacqueline
A1 Chaudhry, Qasim
A1 Cubadda, Francesco
A1 Franz, Roland
A1 Gott, David
A1 Mast, Jan
A1 Mortensen, Alicja
A1 Oomen, Agnes G
A1 Weigel, Stefan
A1 Barthelemy, Eric
A1 Rincon, Ana
A1 Tarazona, José
A1 Schoonjans, Reinhilde
K1 dietary exposure
K1 nanoparticle
K1 nanotoxicology
K1 physico‐chemical characterisation
K1 safety assessment
K1 testing strategy
AB 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.
YR 2021
FD 2021-08-03
LK https://hdl.handle.net/10668/26740
UL https://hdl.handle.net/10668/26740
LA en
DS RISalud
RD Apr 8, 2025