Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms
health claims, immune system, gastrointestinal tract, pathogens, microorganisms, applications, guidance
First published in the EFSA Journal:
18 January 2016
10 December 2015
The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to gut and immune function published in 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 and 14, which are in the area covered by this guidance. In addition, the NDA Panel has developed the general scientific guidance for stakeholders for health claims applications which addresses general issues that are common to all health claims. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. Examples of claims evaluated favourably by the Panel will be used to provide guidance to applicants on the scientific requirements for the substantiation of health claims in specific areas, whereas examples of claims evaluated unfavourably by the Panel will be used to illustrate the shortcomings that prevented the substantiation of these claims. The general 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, in the light of experiences gained from the evaluation of additional health claim applications.
© European Food Safety Authority, 2016
Panel members at the time of adoption:
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.
Panel on Dietetic Products, Nutrition and Allergies
nda [at] efsa.europa.eu
EFSA Journal 2016;14(1):4369 [23 pp.].
On request from: