Risk assessment and risk management of novel plant foods:Concepts and principles

Novel food regulation is already in force in the European Community, Australia/New Zealand and in Canada. These regulations distinguish between traditional plant foods and novel plant foods, as the novel plant foods need to go through a premarket assessment procedure. This report focus on developing a proposal for definitions and criteria for determining if a plant food is traditional or novel and a proposal for an approach for the safety assessment of such plant foods with no or limited documented history of safe consumption. The report recommend to introduce a 2-step management procedure, first to establish the novelty and secondly to define and commit resources for the safety assessment, and recommend to generate and use a worldwide net of global, regional, local and ethnobotanical positive lists for food plants to guide both the decision on novelty and the safety assessment. The report recommends using the "history of use"-concept and if the data submitted can support the claim that a product has a history of safe use, the approval can be straightforward. In Europe around 300 food plants deliver near 100% of human daily intake of plant food calories while nearly 7,000 other food plant species are used in other parts of the world. This report focuses on the situation when novel food items from these 7,000 plants are to enter the European or other regional market