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Nov 10

COREXNAT COMMUNICATION BEFORE THE IMMINENT REGULATORY UPDATE ON MONACOLINAS

Dear customers

As happened recently with the botanical species containing derivatives of hydroxyanthracene, the latest actualization at european level points to an immediate update of Annex III of Reg. 1925/2006 about substances subjected to restrictions and about substances subjected to surveillance by the European Community .

On the 20th of  May 2021, the European Commission launched a query on a draft regulation regarding monacolins in red yeast rice, according to Article 8 of Regulation (EC) 1925/2006 and following the opinion of the EFSA in 2018.

 

This draft regulation would add:

– Monacolin dose <3 mg / day (it will be indicated on the label: total monacolin content and number of individual servings of the product for maximum daily consumption)

– Mandatory warnings: Warning not to exceed the daily amount of less than 3 mg. “It should not be consumed by pregnant or lactating women, children under 18 years of age and adults over 70 years of age.” “Consult a doctor about the consumption of this product if you have any health problems”; “It should not be consumed if you are taking a cholesterol-lowering medication”; “It should not be consumed if other products containing red yeast rice are already being consumed.”

Specifically, it corresponds to a prohibition on monacolins in red yeast rice for a daily dose higher than or equal to 3 mg / day and the placement on the label of warnings.

Note that these restrictions apply to total monacolins (and not just monacolin K).

 

The final text could be published in the European Union Official Journal in early 2022 (without a transition period).

Until now, some Member States have already taken action in this regard. While some have decided to ban it, others have chosen to restrict its use under specific conditions.

 

From Corexnat, we will pay attention to updates or changes in the regulations in order to keep you informed.