Risk management and risk assessment of novel plant foods: concepts and principles.

Worldwide 30 food plants deliver 95% of human daily intake of plant food calories and around 300 other plant species are delivering the last 5%. These some 300 food plants are likely to be considered traditional in Europe, while the nearly 7000 other plant species traditionally used in the human food supply in other parts of the world may be considered novel in Europe. Novel food regulation is already in force in the European Community, Australia/New Zealand and in Canada where the novel plant foods need to go through a premarket assessment procedure. This paper propose criteria and definitions to be used in determining novelty of a plant food and also propose a safety assessment approach for novel plant food with no or limited documented history of safe consumption. A 2-step management procedure is recommended for a smooth introduction of fruits and vegetables; first to establish the novelty and second to define and commit resources for the safety assessment. The procedure builds upon the use of a worldwide network of global, regional, local and ethnobotanical positive lists for food plants to guide the decision on novelty at the first step and to enable the safety assessment at the second step.