Guidance for risk assessment of engineered nanomaterials

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Article
Engineered Nanomaterials, Food, Feed, Guidance, Nanoscience, Nanotechnology, Risk Assessment
First published in the EFSA Journal
10 May 2011
Adopted
6 April 2011
Type
Guidance
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.

Panel members at the time of adoption
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
Contact
scientific.committee [at] efsa.europa.eu
doi
10.2903/j.efsa.2011.2140
EFSA Journal 2011;9(5):2140 [36 pp.].
Question Number
On request from
European Commission
Print on demand
ISBN number
978-92-9199-465-6
Catalogue number
TM-30-12-980-EN-C
Number of Pages
36