New regulation on novel foods in the European Union

* This record is given in both English and Spanish

The new Regulation (EU) 2015/2283 on novel foods has included new categories in the concept of novel food. These include engineered nanomaterials, whole animals (including insects) and food from material of mineral origin. However, the definition of novel food as such has not undergone any significant changes with respect to the previous definition, keeping the date from which it is con­sidered that a food product that has not been used for human consumption to a significant degree must be subject to assessment.

The application of Regulation (EU) 2015/2283 implies a significant change in the regulation and authorization procedure for novel foods. The new criteria applicable from 2018 include the requi­rement that the assessment should no longer be conducted by the Member States but should be carried out by the European Food Safety Authority (EFSA), the establishment of a specific procedure for traditional foods from third countries when a history of safe food use has been demonstrated for at least 25 years, and the establishment of time periods for consultation, assessment and autho­rization. In addition, data protection is offered when the scientific evidence or data on which the application is based are essential for the assessment of the safety of the novel food such that the data shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorization of the novel food without the agreement of the initial applicant.

In any case, and in spite of the changes introduced, experience obtained to date will be essential for improving the authorization procedures for novel foods, making the authorization process more efficient, and stimulating innovation in the food sector and, at the same time, guaranteeing the safe­ty of European consumers and increasing the variety of available food products