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. 2021 Mar 26;19(3):e06555. doi: 10.2903/j.efsa.2021.6555

Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 1 (Revision 1)2

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Products3,✉, Nutrition, Allergies (NDA), 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, Anders Sjödin, Martin Stern, Daniel Tomé, Marco Vinceti, Peter Willatts, Karl‐Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Davide Arcella, Wolfgang Gelbmann, Agnès de Sesmaisons‐Lecarré, Hans Verhagen, Hendrik van Loveren
PMCID: PMC7996107  PMID: 33791039

Abstract

Endorsement date 21 January 2021
Implementation date 27 March 2021
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Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well‐structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use.

This guidance was originally adopted in 2016.It has beenrevised to informapplicants 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.This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.

Keywords: guidance, novel foods, traditional foods, authorisation, safety, toxicity

Suggested citation: EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , Turck D, Bresson J‐L, 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 K‐H, Marchelli R, Pöting A, Poulsen M, Salminen S, Schlatter J, Arcella D, Gelbmann W, de Sesmaisons‐Lecarré A, Verhagen H and van Loveren H, 2021. Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1). EFSA Journal 2021;19(3):6555, 27 pp. 10.2903/j.efsa.2021.6555

Requestor: European Commission

Question number: EFSA‐Q‐2020‐00590

Panel membersin 2016: Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J McArdle, AndronikiNaska, Monika Neuhäuser‐Berthold, Grazyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.

Acknowledgements: 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 members: Sara De Berardis, Andrea Germini, Leng Heng, Daniela Mauriciand Emanuela Turlafor the support provided to this scientific output.

1

The guidance was adopted on 21 September 2016 by the former Panel on Dietetic products, Nutrition and Allergies. This revision only aims to inform applicants of the new provisions introduced by the General Food Law (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), and to guide to EFSA's practical arrangements implementing these new provisions. For this purpose, the revision concerns only the administrative part.The scientific content remains unchanged. The present guidance (revision 1) was endorsed on 21 January 2020 by the Panel on Nutrition, Novel Foods and Food Allergens (NDA): 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.

This Guidance is applicable for applications submitted as of 27 March 2021

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