TY - JOUR

T1 - Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health

AU - EFSA Scientific Committee, null

AU - More, Simon

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Bragard, Claude

AU - Halldorsson, Thorhallur

AU - Hernández-Jerez, Antonio

AU - Hougaard Bennekou, Susanne

AU - Koutsoumanis, Kostas

AU - Lambré, Claude

AU - Machera, Kyriaki

AU - Naegeli, Hanspeter

AU - Nielsen, Søren

AU - Schlatter, Josef

AU - Schrenk, Dieter

AU - Silano (deceased), Vittorio

AU - Turck, Dominique

AU - Younes, Maged

AU - Castenmiller, Jacqueline

AU - Chaudhry, Qasim

AU - Cubadda, Francesco

AU - Franz, Roland

AU - Gott, David

AU - Mast, Jan

AU - Mortensen, Alicja

AU - Oomen, Agnes G.

AU - Weigel, Stefan

AU - Barthelemy, Eric

AU - Rincon, Ana

AU - Tarazona, José

AU - Schoonjans, Reinhilde

PY - 2021

Y1 - 2021

N2 - 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 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.

AB - 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 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.

KW - nanoparticle

KW - physico-chemical characterisation

KW - dietary exposure

KW - nanotoxicology

KW - safety assessment

KW - testing strategy

U2 - 10.2903/j.efsa.2021.6768

DO - 10.2903/j.efsa.2021.6768

M3 - Journal article

C2 - 34377190

VL - 19

SP - 1

EP - 111

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 8

M1 - e06768

ER -