Scientific Opinion on the substantiation of health claims related to glucomannan and maintenance of normal blood cholesterol concentrations (ID 836, 1560) pursuant to Article 13(1) of Regulation (EC) No 1924/20061

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 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to glucomannan (Konjac mannan) and the maintenance of normal blood cholesterol concentrations. 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 component that is the subject of the health claims is glucomannan (Konjac mannan). Glucomannan is a water-soluble type of fibre with high molecular weight and high viscosity in water solution. Glucomannan does not occur naturally in foods. The Panel considers that the food constituent, glucomannan, is sufficiently characterised. The claimed effects are "cholesterol" and " cholesterol level". The Panel assumes that the target population is the general population. The Panel considers that maintaining normal blood (LDL) cholesterol concentrations is beneficial to human health. Eight randomised controlled trials, which investigated the effects of glucomannan on LDL and/or total cholesterol at daily doses of 3-15 g/d in either healthy, hypercholesterolaemic or diabetic adult human subjects were provided. In weighing the evidence, the Panel took into account that a statistically significant effect on either total or LDL-cholesterol was not observed following the consumption of glucomannan in all of these studies, that reduction in total and/or LDL-cholesterol concentrations did not always lead to significant reductions in the total/HDL cholesterol ratio, that the vast majority of these studies had small sample sizes, and that no clear dose-response relationship was established between the consumption of glucomannan and the claimed effect. However, the Panel considers that most studies showed a consistent effect in the reduction of serum total and LDL-cholesterol concentrations at doses of about 4g/d of glucomannan, that the effect has been observed not only in hypercholesterolaemic subjects but also in healthy individuals, and that the mechanisms by which the consumption of the food may exert the claimed effect (biological plausibility) are established. On the basis of the data available, the Panel concludes that a cause and effect relationship has been established between the consumption of glucomannan and the reduction of blood cholesterol concentrations. The following wording reflects the scientific evidence: "Regular consumption of glucomannan helps maintain normal blood cholesterol concentrations". In order to bear the claim, a food should provide at least 4 g/d of glucomannan in one or more servings. The target population is the general population.