Scientific Opinion on the substantiation of health claims related to monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations (ID 1648, 1700) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

摘要

This opinion addresses the scientific substantiation of health claims in relation to monacolin K from red yeast rice and maintenance of normal blood LDL-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 that is the subject of the health claim is red yeast rice (i.e. rice fermented with the red yeast Monascus purpureus). The Panel considers that, whereas red yeast rice is not sufficiently characterised in relation to the claimed effect, the food constituent, monacolin K from red yeast rice, is sufficiently characterised. The claimed effects are “cholesterol” and “cholesterol management/heart health”. The target population is assumed to be adults in the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to maintenance of normal blood LDL-cholesterol concentrations. The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect. In weighing the evidence, the Panel took into account that two randomised controlled trials provided from which conclusions could be drawn for the scientific substantiation of the claim showed an effect of red yeast rice preparations providing a daily dose of about 10 mg monacolin K on LDL-cholesterol 1 On request from the European Commission, Question No EFSA-Q-2008-2384, EFSA-Q-2008-2436, adopted on 30 June 2011. Panel members: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus L?vik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuh?user-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen.