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 Cargill Incorporated submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 16 references as being pertinent to the health claim. These references comprised three meta-analyses, 10 human intervention studies, two animal studies and one mechanistic study. 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 the mechanism by which barley beta-glucans could exert the claimed effect is biologically plausible and supported by the animal studies provided. The Panel concludes that a cause and effect relationship has been established between the consumption of barley beta-glucans and the 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.