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) - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 2021

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)

Jean-Louis Bresson
  • Fonction : Auteur
Barbara Burlingame
  • Fonction : Auteur
Tara Dean
  • Fonction : Auteur
Susan Fairweather-Tait
  • Fonction : Auteur
Marina Heinonen
  • Fonction : Auteur
Karen Ildico Hirsch-Ernst
  • Fonction : Auteur
Inge Mangelsdorf
  • Fonction : Auteur
Harry J. Mcardle
  • Fonction : Auteur
Androniki Naska
  • Fonction : Auteur
Monika Neuhauser-Berthold
  • Fonction : Auteur
Grazyna Nowicka
  • Fonction : Auteur
Kristina Pentieva
  • Fonction : Auteur
Yolanda Sanz
  • Fonction : Auteur
Alfonso Siani
  • Fonction : Auteur
Anders Sjodin
  • Fonction : Auteur
Martin Stern
  • Fonction : Auteur
Daniel Tome
  • Fonction : Auteur
Marco Vinceti
  • Fonction : Auteur
Peter Willatts
  • Fonction : Auteur
Karl-Heinz Engel
  • Fonction : Auteur
Rosangela Marchelli
  • Fonction : Auteur
Annette Poting
  • Fonction : Auteur
Morten Poulsen
  • Fonction : Auteur
Josef Rudolf Schlatter
  • Fonction : Auteur
Wolfgang Gelbmann
  • Fonction : Auteur
Agnes de Sesmaisons-Lecarre
  • Fonction : Auteur
Hans Verhagen
  • Fonction : Auteur
Hendrik van Loveren
  • Fonction : Auteur

Résumé

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 allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.
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Dates et versions

hal-04441260 , version 1 (06-02-2024)

Identifiants

Citer

Dominique Turck, Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, et al.. 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). EFSA Journal, 2021, EFSA Journal, 19, pp.e06557. ⟨10.2903/j.efsa.2021.6557⟩. ⟨hal-04441260⟩

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