Scientific Documents

Scientific Opinion on the substantiation of a health claim related to OPC Premium^™ and the reduction of blood cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Summary (61 KB)

Opinion (167 KB)

Summary

Following an application from GP International Holding B.V. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on OPC Premium^™ and the reduction of blood cholesterol.

The scope of the application was proposed to fall under a health claim referring to reduction of a disease risk.

The food that is the subject of the health claim is OPC Premium^™, which contains 40 mg oligomeric procyanidins (OPC) and 400 mg berry-blend per capsule. The manufacturing process has been described. The Panel notes that no constituent relevant to the claimed effect has been identified in the berry-blend for standardisation purposes. The Panel considers that the food, OPC Premium^™, which is the subject of the health claim is not sufficiently characterised with respect to the berry blend, whereas the active constituent OPC extracted from grape (Vitis vinifera) seeds is sufficiently characterised.

The claimed effect is “reduces blood cholesterol and may therefore reduce the risk of cardiovascular disease”. The target population is males and females over 30 years of age. The Panel considers that lowering elevated blood LDL-cholesterol is beneficial to human health by decreasing the risk of coronary heart disease.

Among the 21 references provided, five report on animal and in vitro studies investigating outcomes unrelated to the claimed effect and 14 (four reviews) report on human studies on either substances unrelated to the food/component that is the subject of the health claim and/or on health outcomes unrelated to the claimed effect.

In a randomised, double-blind, placebo-controlled human intervention study, the effect of a daily dose of 100 mg of grape seed procyanidin extract (GSE) on serum total and LDL-cholesterol was investigated over two months in 20 hypercholesterolaemic subjects compared to placebo. No significant differences between the GSE group and the placebo group were observed.

One animal study reported on bioavailability and safety of a red grape seed extract. The Panel notes that this study did not report on blood LDL-cholesterol.

In weighing the evidence, the Panel has taken into account the lack of a significant effect of GSE intake on blood LDL-cholesterol when administered to hypercholesterolaemic subjects for two months, and the lack of studies conducted with OPC Premium^™ or with OPC contained in OPC Premium^™.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of OPC Premium^™ and the reduction of blood LDL-cholesterol concentrations.