食品伙伴網(wǎng)訊 據(jù)歐盟食品安全局(EFSA)消息,近日,歐盟食品安全局就紅曲米中莫納可林(monacolins)用作食品添加劑的安全性發(fā)布意見。
內(nèi)酯形式的莫納可林K與洛伐他?。╨ovastatin)相同,洛伐他汀是歐盟授權(quán)用于治療高膽固醇血癥幾種藥品中的活性成分。食品添加劑和營養(yǎng)源專家組(ANS)經(jīng)過評估認(rèn)為,當(dāng)紅曲米中的莫納可林用作食品補(bǔ)充劑時(shí),在10mg /天的使用水平下,具有顯著的安全性問題。
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.
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