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.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.
The food constituent that is the subject of the health claim is cocoa flavanols. Flavanols are flavonoids and belong to a larger group of polyphenols. The flavanols in cocoa (Theobroma cacao L.) consist of monomeric catechins (mainly epicatechin) and oligomeric flavanols (procyanidins) ranging from dimers to decamers. The Panel considers that 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 capacity of blood vessels to respond to an increase in blood flow by dilating is designated as flow-mediated dilation (FMD). Endothelium-dependent vasodilation contributes to the maintenance of an adequate blood flow to body cells and tissues. The Panel considers that a sustained increase of endothelium-dependent vasodilation in fasting conditions in response to an intervention (e.g. regular consumption of a food/constituent) is a beneficial physiological effect. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect.
The human intervention studies identified by the applicant as being strictly pertinent to the claim (five published and one unpublished randomised controlled trials) were aimed at assessing the effects of cocoa flavanols on ED-FMD in fasting conditions during regular consumption of the food constituent (1-12 months) in non-diseased populations. One of the studies also assessed the acute effects of cocoa flavanol consumption on ED-FMD. The Panel considered that no conclusions could be drawn from two of these studies for the scientific substantiation of the claim due to important methodological limitations. One intervention study showed an effect of cocoa flavanols consumed for 12 weeks on fasting ED-FMD, another intervention study showed a dose-dependent effect of cocoa flavanols on fasting ED-FMD after one week of consumption, and the effect was observed under the conditions of use proposed by the applicant, and two additional intervention studies which may not have been adequately controlled for other food constituents in cocoa also supported an effect of cocoa flavanols on ED-FMD.
In addition, the applicant provided three human intervention studies as supportive evidence for the scientific substantiation of the claim which investigated the effects of cocoa flavanols on ED-FMD in fasting conditions during repeated consumption of the food constituent (for 30 days to 6 weeks) in subjects with coronary artery disease (CAD) under pharmacological treatment for this condition. Two out of the three studies showed an effect of cocoa flavanols consumed for 30 days on fasting ED-FMD in subjects with CAD who were under pharmacological treatment, and the effect occurred after seven days of consumption of cocoa flavanols.
A number of human intervention studies conducted in different population subgroups (e.g. smokers, older adults, obese subjects, subjects with type 2 diabetes and CAD) and which addressed the acute effects of cocoa flavanols when consumed on a single occasion on ED-FMD were also provided by the applicant as supportive evidence for the scientific substantiation of the claim. One of the studies also assessed the acute effects of cocoa flavanols on ED-FMD during repeated consumption (for seven days) of the food/constituent. Consumption of cocoa flavanols on a single occasion induced an acute, dose-dependent increase in ED-FMD which was maximal two hours after consumption of the food constituent, parallels blood concentrations of the flavanol metabolites, returns to baseline six hours after ingestion, and is sustained with repeated consumption of cocoa flavanols.
The evidence provided in support of mechanisms by which repeated consumption of cocoa flavanols may induce longer-term effects on fasting ED-FMD was weak. Cocoa flavanols (mostly epicatechins) may exert an acute effect on ED-FMD by enhancing nitric oxide (NO) production in the endothelium each time they are consumed.
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 human intervention study the effect was dose-dependent and occurred after one week of consumption under the conditions of use proposed by the applicant, that the effect was supported by two additional intervention studies, and that it was also observed in two out of three studies in patients under pharmacological treatment for CAD, whereas the mechanisms by which regular consumption of cocoa flavanols may induce a sustained effect on fasting ED-FMD are unknown. The Panel also took into account that consumption of cocoa flavanols on a single occasion induces an acute and dose-dependent increase in ED-FMD which is sustained with regular consumption of the food/constituent, and that this acute effect may be mediated by the enhancement of NO production in the endothelium each time cocoa flavanols are consumed.
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 Panel considers that 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. These amounts of cocoa powder or dark chocolate can be consumed in the context of a balanced diet. The target population is the general population.