Scientific Opinion on the substantiation of a health claim related to soy protein and reduction of blood cholesterol concentrations pursuant to Article 14 of the Regulation (EC) No 1924/2006

Following an application from HarlandHall Ltd. on behalf of the Soya Protein Association (SPA), the European Vegetable Protein Federation (EUVEPRO), and the European Natural Soyfood Manufacturers Association (ENSA) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on soy protein and reduction of blood cholesterol concentrations. The scope of the application was proposed to fall under a health claim referring to reduction of a disease risk. The food constituent that is the subject of the health claim is soy protein, i.e. the protein component of the soybean Glycine max. The Panel considers that soy protein is sufficiently characterised. The claimed effect is “reduces blood cholesterol and may therefore reduce the risk of (coronary) heart disease”. The target population is healthy adults. The Panel considers that lowering LDL-cholesterol is a beneficial physiological effect by reducing the risk of coronary heart disease. In weighing the evidence, the Panel took into account that the results from the four human intervention studies identified by the applicant as being controlled for the macronutrient composition of the test products do not support an effect of the protein component of soy on LDL-cholesterol concentrations, and that the proposed mechanism by which the protein component of soy would exert the claimed effect is not supported by available scientific evidence. The Panel concludes that a cause and effect relationship has not been established between the consumption of soy protein and the reduction of LDL-cholesterol concentrations