Safety in using red-yeast rice

EFSA (European Food Safety Agency) has recently presented its opinion regarding Monacolin K based on the scientific evidence available currently, after the European Commission asked for the safe usage of this ingredient in food supplements.

Monacolin K comes from the rice fermentation with a mixture of fungus from the Monascus genus, mainly Monascus purpureus, which confers rice the characteristic red colour. Monacolin K structure is equivalent to lovastatin, a drug of the statin group. It is used in food supplements and after an efficacy inform performed by EFSA, the Regulation (EU) 432/2012 approved the health claim: “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels”, as long as the daily intake is 10 mg of monacolin K.

Even though its efficacy has been proved, its safety has been studied and adverse effects similar to statins have been reported, such as musculoskeletal and connective tissue effects, or nervous system, even at 3 mg/day doses. Therefore, the EFSA panel was unable to determine a daily intake that guarantees a safe use in the red yeast rice.

Some countries have updated their regulation, like Italy that has established a maximum dosage of 10 mg, or France or Belgium that over 10 mg/day categorize monacolin K as a drug. In Spain we are awaiting on a verdict and so far there hasn’t been changes in the regulations.

From Lleó, we will follow the matter to inform you of any changes in legislation.