Regulatory Process

Novel Food

Any food not significantly consumed in the EU before 15 May 1997.

Under Regulation (EU) 2015/2283, a novel food is any food that was not used for human consumption to a significant degree within the European Union before 15 May 1997. The regulation defines ten categories of novel food, including food with a new or intentionally modified molecular structure, food from cell or tissue cultures derived from animals or plants, food produced using new production processes not previously used for food in the EU, and food consisting of or derived from engineered nanomaterials.

The regulation replaced the earlier Novel Foods Regulation (EC) No 258/97. It introduced a centralised EU-level authorisation procedure managed by the European Commission, with safety assessments carried out by EFSA's NDA Panel. Once authorised, a novel food is added to the Union List (Regulation (EU) 2017/2470), which specifies the conditions of use, labelling requirements, and any restrictions.

A substance's novel food status can be checked in the European Commission's Novel Food Catalogue, which lists whether a food or food ingredient has a history of significant consumption in the EU before the cut-off date.

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