Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)1

Research output: Contribution to journalJournal articleCommissioned

  • Dominique Turck
  • Jean Louis Bresson
  • Barbara Burlingame
  • Tara Dean
  • Susan Fairweather-Tait
  • Marina Heinonen
  • Karen Ildico Hirsch-Ernst
  • Inge Mangelsdorf
  • Harry J. McArdle
  • Androniki Naska
  • Monika Neuhäuser-Berthold
  • Grazyna Nowicka
  • Kristina Pentieva
  • Yolanda Sanz
  • Alfonso Siani
  • Sjödin, Anders Mikael
  • Martin Stern
  • Daniel Tomé
  • Marco Vinceti
  • Peter Willatts
  • Karl Heinz Engel
  • Rosangela Marchelli
  • Annette Pöting
  • Morten Poulsen
  • Josef Schlatter
  • Wolfgang Gelbmann
  • Agnès de Sesmaisons-Lecarré
  • Hans Verhagen
  • Hendrik van Loveren
  • EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued 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 for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. It is applicable to all notifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.

Original languageEnglish
Article number6557
JournalE F S A Journal
Volume19
Issue number3
Number of pages21
ISSN1831-4732
DOIs
Publication statusPublished - 2021

    Research areas

  • Guidance, Novel foods, Primary production, Safety, Third country, Traditional foods

ID: 260239471