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. 2021 Mar 26;19(3):e06553. doi: 10.2903/j.efsa.2021.6553

General scientific guidance for stakeholders on health claim applications (Revision 1) 1

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2,✉
PMCID: PMC7996104  PMID: 33791037

Abstract

Endorsement date 21 January 2021
Implementation date 27 March 2021
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The general guidance for stakeholders on the evaluation of Article 13(1), 13(5) and 14 health claims was first published in March 2011. Since then, the Panel on Dietetic Products Nutrition and Allergies (NDA) has completed the scientific assessment of Article 13(1) claims except for claims put on hold by the European Commission, and has assessedadditional health claim applications submitted pursuant to Articles 13(5), 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need to be further clarified and addressed. This guidance document aims to explain the general scientific principles applied by the NDA Panel for the scientific assessmentof all health claims and outlines a series of steps for the compilation of applications. The general guidance document represents the views of the NDA Panel based on the experience gained to date with the scientific assessment of health claims, and it may be further updated, as appropriate, when additional issues are addressed.The document also aims to inform applicants of newprovisionsin the pre‐submission phase and in the application procedure set out in the General Food Law, as amended by the Transparency Regulation. These new provisions are applicable to all applications submitted as of 27 March 2021. The version of this guidance published in 2016 remains applicable for applications submitted before 27 March 2021.

Keywords: guidance, health claims, general principles, scientific aspects, applications

Suggested citation: EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens) , 2021. General scientific guidance for stakeholders on health claim applications (Revision 1). EFSA Journal 2021;19(3):6553, 44 pp. doi: 10.2903/j.efsa.2021.6553

Requestor: European Food Safety Authority (EFSA)

Question number: EFSA‐Q‐2020‐00586

Panel members in 2015: 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, GrażynaNowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.

Acknowledgements: The 2015 Panel wishes to thank the members of the Working Group on Claims: Jean‐Louis Bresson, Susan Fairweather‐Tait, Marina Heinonen, Ambroise Martin, Harry J McArdle, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Hendrik Van Loveren and Peter Willattsfor the preparatory work on this scientific output.EFSA wishes to thank the Panel on Nutrition, Novel Foodsand Food Allergens (NDA) that endorsed this output in 2021: Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, HelleKatrineKnutsen, AlexandreMaciuk, IngeMangelsdorf, Harry J McArdle, AndronikiNaska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti. EFSA staffmember Sara De Berardis,LengHeng, Daniela Maurici.

1

The guidance was adopted on 10 December 2015 by the former Panel on Dietetic products, Nutrition and Allergies. The revision only aims to inform stakeholders of the new provisions 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 them through 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 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, Androniki Naska, 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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