Following EFSA’s scientific safety evaluation on monacolins in red yeast rice published in 2018, the decision of the European Commission is now official. The EC is limiting the use of monacolin K from red yeast rice to a maximum of 3 mg/d in foods and food supplements.
Monacolins from red yeast rice are added as a restricted substance in Annex III of Regulation (EC) No. 1925/2006. The food label should include a warning for people who should not use products containing monacolins, e.g. pregnant women or persons taking cholesterol-lowering medication.
Additionally, the use of monacolins has been put under a scrutiny period of 18 months with the option to restrict or prohibit its use within four years. As a result of this decision, the approved health claim for Monacolin K to maintain normal blood cholesterol levels, which requires a minimum amount of 10 mg/d, can no longer be used. Consequently, the claim will be removed from the Union list as the requirement can’t be met with the new restriction.