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

EFSA JournalVolume 9, Issue 5 2140 GuidanceOpen Access Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain EFSA Scientific Committee, EFSA Scientific CommitteeSearch for more papers by this author EFSA Scientific Committee, EFSA Scientific CommitteeSearch for more papers by this author First published: 10 May 2011 https://doi.org/10.2903/j.efsa.2011.2140Citations: 204 Scientific committee members: Boris Antunović, Susan Barlow, Andrew Chesson, Albert Flynn, Anthony Hardy, Klaus-Dieter Jany, Michael-John Jeger, Ada Knaap, Harry Kuiper, John-Christian Larsen, David Lovell, Birgit Noerrung, Josef Schlatter, Vittorio Silano, Frans Smulders and Philippe Vannier Correspondence: scientific.committee@efsa.europa.eu Acknowledgement: The Scientific Committee wishes to thank the members of the Working Group on Nanotechnologies – Guidance for the preparatory work for this scientific opinion: Mona-Lise Binderup, Qasim Chaudhry, Wim De Jong, Corrado Galli (member until February 2011), David Gott, Rolf Hertel, Akihiko Hirose, Wolfgang Kreyling, Hermann Stamm and Stefan Weigel, and EFSA staff member David Carlander for the support provided to this scientific opinion. Adoption date: 6 April 2011 Published date: 10 May 2011 Question number: EFSA-Q-2009-00942 On request from: European Commission This output is superseded by a newer version: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5327 and https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6768 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract The European Food Safety Authority has developed a practical approach for assessing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. Guidance is provided on: (i) the physico-chemical characterisation requirements of engineered nanomaterials used e.g. as food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides and; (ii) testing approaches to identify and characterise hazards arising from the nanoproperties which, in general, should include information from in vitro genotoxicity, absorption, distribution, metabolism and excretion and repeated-dose 90-day oral toxicity studies in rodents. The guidance allows for reduced information to be provided when no exposure to the engineered nanomaterial is verified by data indicating no migration from food contact materials or when complete degradation/dissolution is demonstrated with no absorption of engineered nanomaterials as such. The guidance indicates uncertainties that should be considered to perform a risk assessment. As this sector is under fast development, this guidance document will be revised as appropriate. References Auffan M, Rose J, Bottero JY, Lowry GV, Jolivet JP and Wiesner MR, 2009. Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective. Nature Nanotechnology 4, 634– 641. Blanquet S, Zeijdner E, Beyssac E, Meunier JP, Denis S, Havenaar R and Alric M, 2004. A dynamic artificial gastrointestinal system studying the beha vior of orally administered drug dosage forms under various physiological conditions. Pharmaceutical Research, 21, 585– 591. 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