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January 14, 2011

EFSA Begins Public Consultation on Draft Guidance on Risk Assessment for Nanoscience and Nanotechnologies

Lynn L. Bergeson

On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011.