The EC novel foods Regulation—a UK perspective

Abstract

On 15 May 1997 the EC novel foods Regulation came into effect introducing a statutory pre‐market approval system for novel foods across the whole of the European Union. A novel food is defined as a food which has not been consumed to a significant degree and includes foods containing or obtained from genetically modified organisms. The Regulation envisages an initial safety assessment at Member State level, although centralized procedures are available to resolve any objections between Member States. The most controversial aspect of the Regulation relates to the provisions for labelling genetically modified foods. Within the framework of the Regulation there is scope for labelling to be considered on a case by case basis, although the UK is pressing for all foods which may contain genetically modified material to be clearly labelled. To ensure that all Member States follow a consistent approach to the safety assessment of novel foods, the Commission has published a series of guidelines to accompany the regulation. The UK already has a well‐developed system for assessing the safety of novel foods dating back to the approval of the first novel food in the UK in 1983.

Keywords:

• genetically modified
• novel food
• safety assessment
• labelling
• substantial equivalence