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December 22, 2015

EC Promulgates Final Novel Foods Regulation

Lynn L. Bergeson Carla N. Hutton

The European Commission (EC) published the final novel foods regulation in the December 11, 2015, issue of the Official Journal of the European Union. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. Engineered nanomaterial means “any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.” Properties that are characteristic of the nanoscale include those related to the large specific surface area of the materials considered; and/or specific physico-chemical properties that are different from those of the non-nanoform of the same material. The regulation states that the European Food Safety Authority (EFSA) should verify that, where a novel food consists of engineered nanomaterials, “the most up-to-date test methods are used to assess their safety.” When test methods are applied to engineered nanomaterials, applicants must provide an explanation of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made to respond to the specific characteristics of those materials.