New European regulation on monacolins for red yeast rice food supplements


Last June 22, the new Commission Regulation (EU) 2022/860 came into force, which specifies that red yeast rice food supplements must have less than 3 mg of Monacolin K per daily dose.

What is monacolin K and what’s it for?

Monacolin K is present in red yeast rice, which results from the fermentation of white rice and a fungus known as Monascus purpureus. Monacolin K has a similar structure to lovastatin, which belongs to the same family of drugs used to lower cholesterol known as statins. As established by the European Food Safety Authority (EFSA) with Regulation (EU) 432/2012, “monacolin K from red yeast rice helps maintain normal cholesterol levels in the blood” as long as its daily intake reaches 10 mg.

So what happens from now on?

Food supplements may only be sold with a maximum of 3 mg of total monacolins per daily dose. This amount must be indicated on the packaging labels, and the following mandatory warnings must be added:

  • Do not exceed the recommended daily amount.
  • Not to be taken by pregnant or lactating women, children under 18 years of age, or adults over the age of 70.
  • Consult a GP regarding the intake of this product if you have any health problems.
  • Should not be taken if you are taking cholesterol-lowering medication.
  • Should not be taken if you are already taking other products containing red yeast rice.

Reformulated Red Yeast Rice

At Zenement, we have updated our product’s formula to comply with European regulations. As a result, we have reduced the total monacolins to 2.9 mg per serving. Coenzyme Q10 has also been reduced proportionally. We have also changed the format of our food supplement. We have swapped from capsules to tablets and the amount per pack will be higher. Here is a comparison table with the most relevant changes between the two products:

Original Red Yeast Rice Zenement New Red Yeast Rice Zenement
180 capsules 540 tablets
10 mg Monacolin K 2.9 mg Total monacolins
30 mg Coenzyme Q10 9 mg Coenzyme Q10

You may also be interested in our Berbelipid Complex

It is very complete and has the best formula to take care of your cardiovascular health. It combines the following ingredients:

  • 500 mg Berberine. This alkaloid helps lower blood sugar levels and promotes weight loss and heart health.
  • 2.9 mg Monacolin K. Provides the same cholesterol-lowering effect as satins do.
  • 10 mg Coenzyme Q10. Statins reduce Q10 in the body. By adding this ingredient, we compensate for this reduction.
  • 10 mg Policosanol. This is a molecule obtained from sugar cane that offers a lipid-lowering effect.
  • Vitamins B1 and B9. Which contributes to having a properly functioning heart.
  • Astaxanthin. A carotenoid that eradicates free radicals.

Important: Studies have shown that this composition has the same cholesterol-lowering effectiveness as 10 mg of Monacolin K.