22/02/2016

Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for notifications for Traditional Foods from third countries.

This Guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in the preparation of a well-structured notification dossier. The history of safe use of a Traditiona Food should be substantiated by data on its composition and its experience of use. The proposed conditions of use in the EU market should not raise safety concern. The normal consumption of the  traditional food should not be nutritionally disadvantageous. To that end, information is requested on the description, production process, compositional data, specifications, experience of use, and  proposed conditions of use of the Traditional Food for the EU market. The application should be comprehensive and complete. Where potential health hazards have been identified on the basis of the  composition and/or data from the experience of use, they should be presented, discussed and adequately addressed in the proposed conditions of use to ensure that the consumption of the Traditional Food is safe for the target population. The applicant should integrate the information on the composition and the experience of use, and provide a concise overall consideration on how this substantiates the history of safe use of the Traditional Food and how this relates to the proposed conditions of use in the EU. On the basis of the information provided, EFSA will assess whether there are reasoned safety