EFSA UPDATE ON THE SCIENTIFIC REQUIREMENTS FOR HEALTH CLAIMS RELATED TO THE IMMUNE SYSTEM, THE GASTROINTESTINAL TRACT AND DEFENCE AGAINST PATHOGENIC MICROORGANISMS
van Loveren H.
Panel on Dietetic Products, Nutrition and Allergies (NDA Panel)
European Food Safety Authority (EFSA), Parma, Italy
Maastricht University, Maastricht, the Netherlands
The guidance on the scientific requirements for the substantiation of health claims made on foods related to gut and immune function published in 2011 has been recently updated by the EFSA NDA Panel and published in January 2016. Since Regulation (EC) No 1924/2006 entered into force, 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.
The updated guidance document reflects the views of the NDA Panel based on the experience gained to date with the evaluation of new health claim applications, and captures additional issues gathered during the consultation process with experts and stakeholders.
The guidance document has been structured to avoid overlapping with the general scientific guidance for stakeholders on health claim applications.
It is subdivided into two major sections that address: (1) function claims related to the role of a food in maintenance/improvement of a physiological function and (ii) disease risk reduction claims related to the role of a food in reducing a risk factor for disease. Specific claims addressed in the guidance include those on functions of the immune system (based or not on the essentiality of nutrients), functions of the gastro-intestinal tract (e.g. discomfort, gas accumulation, normal defecation and digestion and/or absorption of nutrients), defence against pathogens, and reduction of a risk factor for infections. Claims evaluated by the Panel with a favourable opinion have been used to provide guidance to applicants on the scientific requirements for their substantiation, whereas those evaluated with an unfavourable opinion have been used to illustrate the shortcomings that prevented their substantiation.
This presentation will give an overview of the way the EFSA guidance has been re-structured in the light of the new scientific evidence available to the NDA Panel, including the outcomes of public consultations, in an attempt to provide further assistance in preparing applications for the authorisation of health claims in this area.
Keywords: Health claims, Food, Disease risk reduction, Probiotic
Van Loveren H. (2016). EFSA update on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. Conference Proceedings of IPC2016. Paper presented at the International Scientific Conference on Probiotics and Prebiotics, Budapest (p. 45.). IPC2016