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 journal › Journal article › Commissioned

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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

Harvard

Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather-Tait, S, Heinonen, M, Hirsch-Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Neuhäuser-Berthold, M, Nowicka, G, Pentieva, K, Sanz, Y, Siani, A, Sjödin, A, Stern, M, Tomé, D, Vinceti, M, Willatts, P, Engel, KH, Marchelli, R, Pöting, A, Poulsen, M, Schlatter, J, Gelbmann, W, de Sesmaisons-Lecarré, A, Verhagen, H, van Loveren, H & EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 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)1', E F S A Journal, vol. 19, no. 3, 6557. https://doi.org/10.2903/j.efsa.2021.6557

APA

Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., Heinonen, M., Hirsch-Ernst, K. I., Mangelsdorf, I., McArdle, H. J., Naska, A., Neuhäuser-Berthold, M., Nowicka, G., Pentieva, K., Sanz, Y., Siani, A., Sjödin, A., Stern, M., Tomé, D., Vinceti, M., ... EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) (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)1. E F S A Journal, 19(3), [6557]. https://doi.org/10.2903/j.efsa.2021.6557

Vancouver

Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M 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)1. E F S A Journal. 2021;19(3). 6557. https://doi.org/10.2903/j.efsa.2021.6557

Author

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). / 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. In: E F S A Journal. 2021 ; Vol. 19, No. 3.

Bibtex

@article{18e2426b76d0490fad0e522dd362b92c,
title = "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",
abstract = "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.",
keywords = "Guidance, Novel foods, Primary production, Safety, Third country, Traditional foods",
author = "Dominique Turck and Bresson, {Jean Louis} and Barbara Burlingame and Tara Dean and Susan Fairweather-Tait and Marina Heinonen and Hirsch-Ernst, {Karen Ildico} and Inge Mangelsdorf and McArdle, {Harry J.} and Androniki Naska and Monika Neuh{\"a}user-Berthold and Grazyna Nowicka and Kristina Pentieva and Yolanda Sanz and Alfonso Siani and Anders Sj{\"o}din and Martin Stern and Daniel Tom{\'e} and Marco Vinceti and Peter Willatts and Engel, {Karl Heinz} and Rosangela Marchelli and Annette P{\"o}ting and Morten Poulsen and Josef Schlatter and Wolfgang Gelbmann and {de Sesmaisons-Lecarr{\'e}}, Agn{\`e}s and Hans Verhagen and {van Loveren}, Hendrik and {EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)}",
note = "CURIS 2021 NEXS 145",
year = "2021",
doi = "10.2903/j.efsa.2021.6557",
language = "English",
volume = "19",
journal = "E F S A Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (E F S A)",
number = "3",

}

RIS

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