Scientific Opinion on the substantiation of a health claim related to isolated soy protein and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006
Following an application from the European Natural Soyfood Manufacturers Association (ENSA), the European Vegetable Protein Federation (EUVEPRO) and the Soya Protein Association (SPA), 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 isolated soy protein (ISP) and reduction of blood LDL-cholesterol concentrations, referring to disease risk reduction. The food constituent that is the subject of the health claim, ISP (as defined by the applicant), is sufficiently characterised in relation to the claimed effect. A reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of CHD. In weighing the evidence, the Panel took into account that under similar conditions four randomised controlled trials (RCTs) reported an effect of ISP on blood LDL/non-HDL cholesterol concentrations, whereas 14 RCTs did not report such an effect, and another RCT showed no consistent effects. The Panel also took into account that most of these RCTs were at high risk of bias, that differences in the results obtained between trials appear unrelated to the dose of ISP used, to sample size or to study duration, and that the evidence provided in support of a possible mechanism was not convincing. A cause and effect relationship has not been established between the consumption of ISP (as defined by the applicant) and a reduction in blood LDL-cholesterol concentrations.