TY - JOUR
T1 - 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)
AU - Turck, Dominique
AU - Bresson, Jean-Louis
AU - Burlingame, Barbara
AU - Dean, Tara
AU - Fairweather-Tait, Susan
AU - Heinonen, Marina
AU - Hirsch-Ernst, Karen Ildico
AU - Mangelsdorf, Inge
AU - McArdle, Harry J
AU - Naska, Androniki
AU - Neuhäuser-Berthold, Monika
AU - Nowicka, Grazyna
AU - Pentieva, Kristina
AU - Sanz, Yolanda
AU - Siani, Alfonso
AU - Sjödin, Anders
AU - Stern, Martin
AU - Tomé, Daniel
AU - Vinceti, Marco
AU - Willatts, Peter
AU - Engel, Karl-Heinz
AU - Marchelli, Rosangela
AU - Pöting, Annette
AU - Poulsen, Morten
AU - Schlatter, Josef
AU - Gelbmann, Wolfgang
AU - de Sesmaisons-Lecarré, Agnès
AU - Verhagen, Hans
AU - van Loveren, Hendrik
N1 - Funding Information:
EFSA wishes to thank the Panel on Nutrition, Novel Foods and Food Allergens (NDA) that endorsed this output in 2021: Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, AndronikiNaska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti. EFSA staff member Sara De Berardis, Leng Heng, Daniela Maurici and Emanuela Turla.
Publisher Copyright:
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3
Y1 - 2021/3
N2 - [Table: see text] 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.
AB - [Table: see text] 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.
KW - guidance
KW - novel foods
KW - primary production
KW - safety
KW - third country
KW - traditional foods
UR - http://www.scopus.com/inward/record.url?scp=85103599473&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2021.6557
DO - 10.2903/j.efsa.2021.6557
M3 - Article
C2 - 33791041
SN - 1831-4732
VL - 19
SP - e06557
JO - EFSA Journal
JF - EFSA Journal
IS - 3
M1 - e06557
ER -