Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2)

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2017;15(1):4680 [31 pp.].
doi
10.2903/j.efsa.2017.4680
Panel Members
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

The Panel wishes to thank the following EFSA staff member for the support provided to this scientific opinion: Ariane Titz.

Contact
Type
Guidance of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2016-00285
Adopted
14 dicembre 2016
Published in the EFSA Journal
31 gennaio 2017
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim published in 2011. Since then, the NDA Panel has gained considerable experience in the evaluation of health claims. Lessons learnt from these experiences have been translated into a new General scientific guidance for stakeholders on health claim applications (published in January 2016). In this context, it is noted the need to adapt the existing guidance to the new scientific and technical developments in this area. 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.

Keywords
health claims, food/constituent, substantiation, comprehensive review, human pertinent data, application, guidance
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Number of Pages
31