General scientific guidance for stakeholders on health claim applications


Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2016;14(1):4367 [38 pp.].
Panel Members
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
The Panel wishes to thank the members of the Working Group on Claims: Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Harry McArdle, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Hendrik Van Loveren and Peter Willatts for the preparatory work on this scientific output and EFSA staff members: Leng Heng and Silvia Valtueña Martínez for the support provided to this scientific output.
Opinion of the Scientific Committee/Scientific Panel
On request from
Question Number
10 dicembre 2015
Published in the EFSA Journal
18 gennaio 2016
European Food Safety Authority (EFSA), Parma, Italy
The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional 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 evaluation of 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 evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed.
guidance, health claims, general principles, scientific aspects, applications
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