Scientific Opinion on the substantiation of a health claim related to barley beta-glucans and lowering of blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Valens Int. d.o.o. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Slovenia, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to barley beta-glucans and lowering of blood cholesterol and reduced risk of (coronary) heart disease, referring to disease risk reduction and including a request for the protection of proprietary data. The food constituent that is the subject of the health claim, barley beta-glucans, is sufficiently characterised. Lowering blood LDL-cholesterol concentration is a beneficial physiological effect by decreasing the risk of coronary heart disease. The applicant identified a total of eight references as being pertinent to the health claim. These references included two meta-analyses and six human studies. In weighing the evidence, the Panel took into account that one meta-analysis including 11 RCTs, and one additional RCT, which investigated the effects of barley beta-glucans at doses of at least 3 g/day showed a decrease in total and LDL-cholesterol concentrations in both normo- and hypercholesterolaemic subjects, and that there is evidence supporting the biological plausibility of the mechanism of the effect. The Panel concludes that a cause and effect relationship has been established between the consumption of barley beta-glucans and lowering of blood LDL-cholesterol concentrations. The following wording reflects the scientific evidence: “Barley beta-glucans have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease”. At least 3 g of barley beta-glucans should be consumed per day in order to obtain the claimed effect. The target population is adults who want to lower their blood cholesterol concentrations.