Scientific Opinion on the substantiation of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Barry Callebaut Belgium nv, 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 cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. Cocoa flavanols are sufficiently characterised. The claimed effect is "help maintain endothelium-dependent vasodilation which contributes to healthy blood flow". The target population proposed by the applicant is the general healthy adult population. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. In weighing the evidence, the Panel took into account that cocoa flavanols consumed for 12 weeks have been shown to increase fasting ED-FMD significantly in the target population in one human intervention study, that in another study the effect was dose-dependent and occurred after one week of consumption, that the effect was supported by two additional studies, and that it was also observed in two out of three studies in patients under pharmacological treatment for coronary artery disease, although the mechanisms by which regular consumption of cocoa flavanols may induce a sustained effect on fasting ED-FMD are unknown. The Panel concludes that a cause and effect relationship has been established between the consumption of cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. The following wording reflects the scientific evidence: "Cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow". In order to obtain the claimed effect, 200 mg of cocoa flavanols should be consumed daily. This amount could be provided by 2.5 g of high-flavanol cocoa powder or 10 g of high-flavanol dark chocolate, both of which can be consumed in the context of a balanced diet. The target population is the general population.