Scientific Opinion on the substantiation of health claims related to cocoa flavanols and protection of lipids from oxidative damage (ID 652, 1372, 1506, 3143), and maintenance of normal blood pressure (ID 1507) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to cocoa flavanols and protection of lipids from oxidative damage, and maintenance of normal blood pressure. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is cocoa flavanols. The Panel considers that cocoa flavanols is sufficiently characterised. Protection of lipids from oxidative damage The claimed effects are antioxidant properties and oxidative stress reduction. The target population is assumed to be the general population. In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effect relates to the protection of lipids against oxidative damage. The Panel considers that the protection of lipids from oxidative damage may be a beneficial physiological effect. In weighing the evidence, the Panel took into account that, although one acute study reported significant changes in plasma concentrations of total F2-isoprostanes after a single administration of cocoa flavanols, this effect was not confirmed when cocoa flavanols were consumed daily for 3-6 weeks, and that no effect of cocoa flavanols was observed on plasma concentrations of oxidised LDL particles. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of cocoa flavanols and protection of lipids from oxidative damage. Maintenance of normal blood pressure The claimed effect is vascular health. The target population is assumed to be the general population. In the context of the proposed wording, the Panel assumes that the claimed effect refers to the maintenance of a normal blood pressure. The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect. In weighing the evidence the Panel took into account that evidence from ten randomised controlled trials for a blood pressure-lowering effect of cocoa flavanols was inconsistent, that evidence from small and un-blinded studies with lower doses in favour of an effect was in conflict with evidence from adequately powered and well controlled studies with higher doses, and that evidence from blinded studies with lower doses was conflicting. On the basis of the data presented, the Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of cocoa flavanols and maintenance of normal blood pressure.