Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283

The European Commission requested EFSA to update the scientific guidance forthe preparation of notifications for authorisation of traditional foods, previouslydeveloped following the adoption of Regulation (EU) 2015/2283 on novel foods.This guidance document provides advice on the scientific information neededto be submitted by applicants when submitting traditional food notificationspursuant to Article 14 and traditional food applications pursuant to Article 16 ofRegulation (EU) 2015/2283. The safety of a traditional food should be substanti-ated by data on its composition, its experience of continued use and its proposedconditions of use. Its normal consumption should not be nutritionally disadvanta-geous. The applicant should integrate the information on the composition andthe experience of continued use and provide a concise overall consideration onhow this substantiates the history of safe use of the traditional food and how thisrelates to the proposed conditions of use for the EU. Potential health hazards iden-tified on the basis of compositional data and/or data from the experience of con-tinued use should be discussed. On the basis of the information provided, EFSAwill assess the safety related to the consumption of the traditional food under theproposed conditions of use