Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2016;14(1):4369 [23 pp.].
doi
10.2903/j.efsa.2016.4369
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.
Acknowledgements

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. 

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2014-00353
Adopted
10 dicembre 2015
Published
18 gennaio 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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. 

Summary

The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to revise 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.

The guidance document has been structured to avoid overlapping with the general scientific guidance for stakeholders on health claim applications. 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 are 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 are used to illustrate the shortcomings that prevented the substantiation of these claims.

The guidance does not intend to provide an exhaustive list of beneficial physiological effects and studies/outcome variables which could be acceptable, or address potential health relationships and related outcome measures which have not yet been considered by the Panel in the context of a particular application.

This guidance supersedes the guidance on the scientific requirements for health claims related to gut and immune function published in 2011.

The guidance has been subject to public consultations, first on a discussion paper (from 18 June to 10 September 2014) and subsequently on an updated version of the guidance (from 9 February to 23 March 2015). This 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 updated in the future following the evaluation of additional health claim applications.

Keywords
health claims, immune system, gastrointestinal tract, pathogens, microorganisms, applications, guidance
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Number of Pages
23