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. 2021 Mar 26;19(3):e06557. doi: 10.2903/j.efsa.2021.6557

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

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2,✉, 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, Josef Schlatter, Wolfgang Gelbmann, Agnès de Sesmaisons‐Lecarré, Hans Verhagen, Hendrik van Loveren
PMCID: PMC7996108  PMID: 33791041

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 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.

Keywords: guidance, novel foods, traditional foods, third country, primary production, safety

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, Schlatter J, Gelbmann W, de Sesmaisons‐Lecarré A, Verhagen H and van Loveren H. 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;19(3):6557, 21 pp. doi: 10.2903/j.efsa.2021.6557

Requestor: European Commission

Question number: EFSA‐Q‐2020‐00591

Correspondence: nda@efsa.europa.eu

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 member Sara De Berardis, Leng Heng, Daniela Maurici and Emanuela Turla.

1

The revision aims to inform applicants of the new requirements set out in 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 requirements. 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 2021 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

References

  1. EFSA (European Food Safety Authority) ,2021. Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA Journal 2010;8(6):1637, 90 pp. 10.2903/j.efsa.2010.1637 [DOI] [Google Scholar]
  2. EFSA (European Food Safety Authority) , 2011. Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database. EFSA Journal 2011;9(3):1970, 27 pp. 10.2903/j.efsa.2011.1970 [DOI] [Google Scholar]
  3. EFSA (European Food Safety Authority) , 2012. Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements. EFSA Journal 2012;10(5):2663, 60 pp. 10.2903/j.efsa.2012.2663 [DOI] [Google Scholar]
  4. EFSA (European Food Safety Authority) , 2021a. Administrative guidance for the processing of applications for regulated products. EFSA supporting publication2021:EN‐6471. 10.2903/sp.efsa.2021.EN-6471 [DOI] [Google Scholar]
  5. EFSA (European Food Safety Authority) , 2021b. EFSA's Catalogue of support initiatives during the life‐cycle of applications for regulated products. EFSA supporting publication2021:EN‐6472. 10.2903/sp.efsa.2021.EN-6472 [DOI] [Google Scholar]
  6. EFSA (European Food Safety Authority) , 2021c. Decision of the Executive Director of the European Food Safety Authority laying down the Practical Arrangements on pre‐submission phase and public consultations. Available online: https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/210111-PAs-pre-submission-phase-and-public-consultations.pdf
  7. EFSA (European Food Safety Authority) , 2021d. Decision of the Executive Director of the European Food Safety Authority laying down practical arrangements concerning transparency and confidentiality. Available online: https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/210111-PAs-transparency-and-confidentiality.pdf
  8. EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms) , 2011. Scientific Opinion on guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use. EFSA Journal 2011;9(6):2193, 54 pp. 10.2903/j.efsa.2011.2193 [DOI] [Google Scholar]
  9. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2021a. General scientific guidance for stakeholders on health claim applications (Revision 1). [DOI] [PMC free article] [PubMed]
  10. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2021b. Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1). [DOI] [PMC free article] [PubMed]
  11. EFSA Scientific Committee , 2009. Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, on request of EFSA. EFSA Journal 2009;7(9):1249, 19 pp. 10.2093/j.efsa.2009.1249 [DOI] [Google Scholar]
  12. EFSA Scientific Committee , 2011. Guidance on conducting repeated‐dose 90‐day oral toxicity study in rodents on whole food/feed. EFSA Journal 2011;9(12):2438, 21 pp. 10.2903/j.efsa.2011.2438 [DOI] [Google Scholar]
  13. S‐IN (Soluzioni Informatiche) , 2015. Further development and update of EFSA's Chemical Hazards Database NP/EFSA/EMRISK/2012/01. EFSA supporting publication2014:EN‐654, 103 pp. Available online: doi.org/10.2903/sp.efsa.2015.EN‐823 [Google Scholar]

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