TY - JOUR

T1 - Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain

T2 - Part 1, human and animal health

AU - Hardy, Anthony

AU - Benford, Diane

AU - Halldorsson, Thorhallur

AU - Jeger, Michael John

AU - Knutsen, Helle Katrine

AU - More, Simon

AU - Naegeli, Hanspeter

AU - Noteborn, Hubert

AU - Ockleford, Colin

AU - Ricci, Antonia

AU - Rychen, Guido

AU - Schlatter, Josef R.

AU - Silano, Vittorio

AU - Solecki, Roland

AU - Turck, Dominique

AU - Younes, Maged

AU - Chaudhry, Qasim

AU - Cubadda, Francesco

AU - Gott, David

AU - Oomen, Agnes

AU - Weigel, Stefan

AU - Karamitrou, Melpo

AU - Schoonjans, Reinhilde

AU - Mortensen, Alicja

N1 - doi: 10.2903/j.efsa.2018.5327

PY - 2018/7

Y1 - 2018/7

N2 - Abstract The European Food Safety Authority has produced this Guidance on human and animal health aspects (Part 1) of the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. It covers the application areas within EFSA's remit, e.g. novel foods, food contact materials, food/feed additives and pesticides. The Guidance takes account of the new developments that have taken place since publication of the previous Guidance in 2011. Potential future developments are suggested in the scientific literature for nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides and food contact materials. Therefore, the Guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment and hazard characterisation of nanomaterials. It specifically elaborates on physicochemical characterisation of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterisation of nanomaterials and their determination in complex matrices. It also details the aspects relating to exposure assessment and hazard identification and characterisation. In particular, nanospecific considerations relating to in vivo/in vitro toxicological studies are discussed and a tiered framework for toxicological testing is outlined. It describes in vitro degradation, toxicokinetics, genotoxicity as well as general issues relating to testing of nanomaterials. Depending on the initial tier results, studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, 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/mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis, and provides recommendations for further research in this area.

AB - Abstract The European Food Safety Authority has produced this Guidance on human and animal health aspects (Part 1) of the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. It covers the application areas within EFSA's remit, e.g. novel foods, food contact materials, food/feed additives and pesticides. The Guidance takes account of the new developments that have taken place since publication of the previous Guidance in 2011. Potential future developments are suggested in the scientific literature for nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides and food contact materials. Therefore, the Guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment and hazard characterisation of nanomaterials. It specifically elaborates on physicochemical characterisation of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterisation of nanomaterials and their determination in complex matrices. It also details the aspects relating to exposure assessment and hazard identification and characterisation. In particular, nanospecific considerations relating to in vivo/in vitro toxicological studies are discussed and a tiered framework for toxicological testing is outlined. It describes in vitro degradation, toxicokinetics, genotoxicity as well as general issues relating to testing of nanomaterials. Depending on the initial tier results, studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, 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/mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis, and provides recommendations for further research in this area.

KW - Nanomaterial

KW - food

KW - feed

KW - guidance

KW - nanoscience

KW - nanotechnology

KW - risk assessment

KW - testing strategy

U2 - 10.2903/j.efsa.2018.5327

DO - 10.2903/j.efsa.2018.5327

M3 - Journal article

VL - 16

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

IS - 7

M1 - 05327

ER -