EFSA: Guidance on the scientific requirements for health claims related to the gastro-intestinal tract, the immune system, and defence against pathogenic microorganisms EFSA Panel on Dietetic Products, Nutrition and Allergies

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, which was published in 2011. The revision takes into account the outcome of a public consultation on a discussion paper together with new scientific evidence available to the NDA Panel and the experience gained to date with the evaluation of health claim applications in the areas of the gastrointestinal tract, the immune system, and defence against pathogenic microorganisms. The guidance presents examples drawn from evaluations to illustrate the approach of the NDA Panel in the evaluation of health relationships and outcome variables which may be acceptable in these areas, as well as the conditions under which they may be acceptable. It is not intended to include in the document an exhaustive list of beneficial effects and studies/outcome variables which could be acceptable. The reason is that defining the conditions under which health relationships and outcome variables for claimed effects may be acceptable is generally possible only in the context of specific applications, which are often unique and technically complex. A better understanding of the approach of the NDA Panel could help applicants in preparing applications on health relationships and related outcome variables. This draft guidance was discussed and endorsed by the NDA Panel on 10 December 2014 for release for public consultation before finalisation.