EFSA Begins Public Consultation on Draft Guidance on the Preparation and Presentation of an Application for Authorization of a Novel Food

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Courtesy of Bergeson & Campbell, P.C.

The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food. As reported in our December 22, 2015, blog item, the European Commission (EC) promulgated a final novel foods regulation in December 2015. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. EFSA intends the draft document to provide guidance on the data needed to carry out the safety assessments of novel foods. The draft guidance states that, for foods consisting of “engineered nanomaterials,” the parameters for characterization and identification of engineered nanomaterials outlined in the EFSA Scientific Committee Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain should be provided. According to the draft guidance, where the novel food contains or consists of “engineered nanomaterials,” the applicant should consider the Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain from EFSA’s Scientific Committee. Comments are due April 21, 2016.

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