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

Abstract

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 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. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. © European FoodThe food constituent that is the subject of the health claim is "protein-rich soybean component with limited quantities of macro-and micronutrients", which upon a request from EFSA was further defined by the applicant as ISP. The Panel considers that ISP (as defined by the applicant) is sufficiently characterised in relation to the claimed effect.The claimed effect is "reduction of total and LDL-cholesterol in healthy subjects with normal or mildly elevated blood cholesterol; a reduction of total and LDL cholesterol has been shown to reduce the risk of heart disease". The target population proposed by the applicant is healthy subjects with normal or mildly elevated blood cholesterol levels. The Panel considers that reduction of blood LDLcholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of CHD.The applicant identified 23 RCTs, which used ISP and one RCT which used the water insoluble fraction of a partially hydrolysed soy protein as interventions for the scientific substantiation of the claim, and presented an unpublished meta-analysis of 23 of these 24 RCTs. In addition, six RCTs, which used whole soy foods, and eight observational studies were provided as well as one animal a...

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