Europe: draft regulation on monacolins from red yeast rice voted by the Member States

The draft Commission Regulation (EU) amending Annex III to Regulation (EC) No 1925/2006 as regards monacolins from red yeast rice has been voted positively by the Member States by written procedure at the end of January 2022 and has been sent to the European Parliament for a 3-month period for scrutiny procedure.

Next step: The final text should be published in the Official Journal of the European Union in April or May 2022 (entry into force 20 days after, with no transition period).

This regulation will add monacolins from red yeast rice:

  • in Part B of Annex III to Regulation (EC) 1925/2006 (under restrictions):

Dose of monacolins < 3 mg / day (to be indicated on the label: content of monacolins per portion of the product and number of individual portions of the product for maximum daily consumption).

Mandatory warnings: Warning not to consume a daily amount of 3 mg or more of monacolins from yeast rice. “Should not be consumed by pregnant or lactating women, children below 18 years old and adults above 70 years old”. “Seek advice from a doctor on consumption of this product if you experience any health problems”; “Should not be consumed if you are taking cholesterol-lowering medication”; “Should not be consumed if you are already consuming other products containing red yeast rice”.

  • and in Part C of Annex III to Regulation (EC) 1925/2006, i.e. under Union scrutiny (under scrutiny because of scientific uncertainty: the industry will have 18 months to submit additional scientific data demonstrating the safety of the substances for a possible new assessment by EFSA; and the Commission should take a decision within four years).

Concretely, it corresponds to a ban of monacolins from red yeast rice for a daily dose greater than or equal to 3 mg/day and placing under restrictions (warnings) and under Union scrutiny for lower doses. Note that these restrictions apply to monacolins in general (and not only monacolin K).

For information, according to the SCPAFF summary report (meeting 5 October 2021):

  • The sum of the analysed contents of monacolin K (lacton) and monacolin K (hydroxy acid) can be used to quantify the total monacolin content in preparations from red yeast rice (practical methods that quantify all monacolins in red yeast rice preparations could not be identified).
  • The health claim authorized “monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels”, currently usable with an intake of 10 mg/day of monacolin K from red yeast rice, will be removed from the Union list of permitted health claims.