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Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006

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Abstract

Following a request from the European Commission, EFSA was asked to review the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from Johnson & Johnson on behalf of the applicants and Intertek Cantox. The comments received were related to need of a reference group to quantify the effect of a diet low in saturated fat. EFSA has reviewed the comments and shared them with the chair of the NDA Panel and the chair of the NDA Working Group on Claims. In its opinion adopted on 21 March 2013, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that the evidence provided by the applicant does not establish that the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat results in a two-fold greater reduction in LDL-cholesterol concentrations compared with consuming a diet low in saturated fat alone. The comments received do not change the conclusions of the NDA Panel.