Monacolin K health claims could carry safety warnings
A spokesperson for the European Commission told us the possibility of introducing certain warning statements for the health claims was discussed in its last two working groups held in January and March.
“It was agreed with the member states that such an approach would also ensure better protection of the consumer.”
The spokesperson said it would be premature to give more details on the nature of the statements and a timeline could not yet be set.
Monacolin K is an active compound naturally present in red yeast rice, which is chemically identical to cholesterol statin drugs like lovastatin and has therefore been hailed as a food alternative to medication.
A general function article 13.1 health claim was authorised by the European Foods Safety Authority (EFSA) in 2011. It stated: “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol concentrations.”
A disease risk factor reduction article 14 health claim was authorised by EFSA in 2013. It stated: “A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease.”
However last year the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a warning against red yeast rice.
After calling for input on its safety back in 2013, it revealed there had been 25 cases of illness linked to the botanical since 2009, mostly related to muscle and liver health issues. In its warning it said: “The Agency considers that use of this kind of food supplement containing monacolins may expose consumers to a health risk – especially individuals who are particularly susceptible due to genetic predispositions, pathologies, ongoing treatments, etc. ANSES therefore recommends seeking medical advice before taking these products.”
It was highlighted that statin intake from all sources could be taken into account, as well as an individual’s tolerance.
The ingredient’s status as drug or supplement has also varied with monacolin traded in both the pharma and food spheres. This status often depends on the monacolin content, with this dosage distinction differing across member states.
Both ANSES and industry have called for greater clarity on an EU level.
