Abstract
| Endorsement date | 21 January 2021 |
| Implementation date | 27 March 2021 |
Upon request from the European Commission, the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim initially published in 2007 and subsequently revised in 2011 and 2016 has been updated. This guidance document presents a common format for the organisation of information for the preparation of a well‐structured application for authorisation of health claims which fall under Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim. This guidance has been revised in 2020 to inform applicants of new provisions in the pre‐submission phase and in the application procedure set out in 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, that are applicable to all applications submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.
Keywords: health claims, food/constituent, substantiation, comprehensive review, human pertinent data, application, guidance
Suggested citation: EFSA NDA Panel in 2016 (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, Sjödin A, Stern M, Tomé D, van Loveren H, Vinceti M, Willatts P, Martin A, Strain JJ, Heng L, Valtueña Martínez S, and Siani A, 2021. Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3). EFSA Journal 2021;19(3):6554, 35 pp. doi: 10.2903/j.efsa.2021.6554
Requestor: European Commission
Question number: EFSA‐Q‐2020‐00588
Panel members in 2016: 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, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Henk 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, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti. EFSA staff members: Sara De Berardis, Leng Heng and Daniela Maurici for the support provided to this output.
The guidance was adopted on 14 December 2016 by the former Panel on Dietetic products, Nutrition and Allergies. The present revision only 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 3) 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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