EU confirms lower red yeast rice monacolin levels for food

Tea regulations​ ​now dictates that individual portions of the product in question for daily consumption shall provide less than 3 milligrams (mg) of monacolins from red yeast rice.

Food labels will also provide the number of individual product portions for maximum daily consumption and a warning not to consume a daily amount of 3 mg of monacolins from red yeast rice or more.

The amendments are 12 years in the making when the European Food Safety Authority (EFSA) was asked to issue an opinion regarding the health claims for monacolin K.

From 2010 onwards, potential safety concerns related to the consumption of foods containing this component from red yeast rice were raised.

“Classic dosage has always been 10 mg to be able to use the claim (monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels) so most of the products do still contain 10 mg,”​ explains Dr Luis Gosálbez, Managing Director of consulting firm Sandwalk Bioventures.

“Since 2018 however some of the major, most risk-averse players have been formulating with 2.95 mg to avoid issues, or re-formulating to take down the original dose of 10 mg to below 3 mg.

“Rumors about a 3 mg limit have been there since 2018. In fact, Amazon started to flag products with 10 mg or even containing monacolin, acting a bit as a de facto regulator.”

Removal of health claim

The health claim is likely to be removed from the Union list of permitted health claims as the regulation states, “the use of monacolins from red yeast rice at levels of 3 mg and more per portion of the product recommended for daily consumption should be prohibited.


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