Scientific Opinion on the substantiation of a health claim related to Vitis vinifera L. seeds extract and “helps to decrease swollen legs” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vitis vinifera L. seeds extract and “helps to decrease swollen legs”. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. Upon EFSA's request for clarification, the applicant stated that the claimed effect was “helps to decrease swollen legs”, and that the beneficial physiological effect could be related to “helps to refine legs”. In the context of the references provided for the scientific substantiation of the claim, and in particular of the human intervention study which was conducted with the food constituent that is the subject of the health claim, the Panel notes that the claim refers to the reduction of peripheral oedema in the context of chronic clinical conditions (e.g. chronic venous insufficiency) where the reduction of peripheral oedema is a therapeutic target for the treatment of the condition. The Panel considers that the reduction of peripheral oedema in the context of chronic clinical conditions is a therapeutic target for the treatment of the condition and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.