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
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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. / Turck, Dominique; Bresson, Jean Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; McArdle, Harry J.; Naska, Androniki; Neuhäuser-Berthold, Monika; Nowicka, Grazyna; Pentieva, Kristina; Sanz, Yolanda; Siani, Alfonso; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Vinceti, Marco; Willatts, Peter; Engel, Karl Heinz; Marchelli, Rosangela; Pöting, Annette; Poulsen, Morten; Schlatter, Josef; Gelbmann, Wolfgang; de Sesmaisons-Lecarré, Agnès; Verhagen, Hans; van Loveren, Hendrik; EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
In: E F S A Journal, Vol. 19, No. 3, 6557, 2021.Research output: Contribution to journal › Journal article › Commissioned
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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)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
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
N1 - CURIS 2021 NEXS 145
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
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 - Journal article
C2 - 33791041
AN - SCOPUS:85103599473
VL - 19
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 3
M1 - 6557
ER -
ID: 260239471