欧盟就红曲米中莫纳可林的安全性发布意见

 

    内酯形式的莫纳可林K与洛伐他汀（lovastatin）相同，洛伐他汀是欧盟授权用于治疗高胆固醇血症几种药品中的活性成分。食品添加剂和营养源专家组（ANS）经过评估认为，当红曲米中的莫纳可林用作食品补充剂时，在10mg /天的使用水平下，具有显著的安全性问题。

 

    部分原文如下：

 

    The Panel on Food Additives and Nutrient Sources added to Food （ANS） was asked to deliver a scientific opinion on the safety of monacolins in red yeast rice （RYR） and to provide advice on a dietary intake of monacolins that does not give rise to concerns about harmful effects to health. The Panel reviewed the scientific evidences available as well as the information provided by interested parties in response of a public 'Call for data' launched by EFSA. The Panel considered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolaemia in the EU. On the basis of the information available, the Panel concluded that intake of monacolins from RYR via food supplements, could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin. The Panel considered that the available information on the adverse effects reported in humans were judged to be sufficient to conclude that monacolins from RYR when used as food supplements were of significant safety concern at the use level of 10 mg/day.