EFSA scientific opinion on the safety of monacolins in red yeast rice

On 3 August 2018, EFSA published its scientific opinion on the safety of monacolins from red yeast rice. The Panel on Food Additives and Nutrient Sources Added to Foods (NSA) was invited to provide scientific opinion on monacolin dietary intake that does not raise health concerns based on available and received datas from a public call for data. EFSA concludes that the consumption of monacolin K of red rice yeast at 10 mg / day in food supplements poses a significant risk to the health of the consumer. In addition, the Panel emphasizes that cases of serious side effects have been reported from a dose of 3 mg / day.

On the basis of available data and uncertainties, EFSA is unable to set a daily dose of monacolin K of red rice yeast with no adverse health effects for the general population and vulnerable populations.

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