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Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health

on the Wiley Online Library


Panel members at the time of adoption

Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Michael John Jeger, Helle Katrine Knutsen, Simon More, Maged Younes, Hanspeter Naegeli, Hubert Noteborn, Colin Ockleford, Antonia Ricci, Guido Rychen, Josef R. Schlatter, Vittorio Silano, Roland Solecki and Dominique Turck.

The Panel wishes to thank the members of the Working Group on nanoscience and nanotechnology in food/feed: Qasim Chaudhry, Francesco Cubadda, David Gott, Agnes Oomen, Stefan Weigel, Roland Franz, Jonathan Powell (until March 2017), Andrea Zijno (April ‐ June 2017), Barbara Drasler (June 2017 – March 2018) and Alicja Mortensen (Chair), and EFSA staff members: Marcella De Maglie, Dimitra Kardassi, Emanuela Tiramani, Maria Vittoria Vettori, Melpo Karamitrou, Berrak Eryasa and Reinhilde Schoonjans for the support provided to this scientific output. The Scientific Committee wishes to acknowledge the JRC 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.


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 vitrodegradation, 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.