Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

The European Commission requested EFSA to update the scientific guidance forthe preparation of applications for authorisation of novel foods, previously devel-oped following the adoption of Regulation (EU) 2015/2283 on novel foods. Thisguidance document provides advice on the scientific information needed to besubmitted by the applicant towards demonstrating the safety of the novel food.Requirements pertain to the description of the novel food, production process,compositional data, specifications, proposed uses and use levels and anticipatedintake of the novel food. Furthermore, information needed in sections on the his-tory of use of the novel food and/or its source, absorption, distribution, metabo-lism, excretion, toxicological information, nutritional information and allergenicityis also described. The applicant should integrate and interpret the data presentedin the different sections to provide their overall considerations on how the infor-mation supports the safety of the novel food under the proposed conditions ofuse. Where potential health hazards have been identified, they are to be discussedin relation to the anticipated intake of the novel food and the proposed targetpopulations. On the basis of the information provided, EFSA will assess the safetyof the novel food under the proposed conditions of use.