Last updated on November 7, 2025
No. Since July 2024, the European Commission has revoked the authorization for cholesterol-related health claims on Monacolin K from red yeast rice. Products containing Monacolin K may not be marketed using claims such as “contributes to the maintenance of normal blood LDL-cholesterol concentrations.”
A Rule That Changed the Game
The European Union once allowed a very specific health claim for red yeast rice: that Monacolin K, its active compound, could help maintain normal LDL cholesterol levels. This wasn’t a casual nod—it was backed by scientific opinion from the European Food Safety Authority (EFSA) and formally listed in the EU’s register of permitted health claims under Regulation (EU) No 432/2012. For years, supplement labels proudly displayed this claim, and consumers seeking natural cholesterol control embraced it.
But the story didn’t end there. Safety concerns began to surface. Monacolin K, chemically identical to lovastatin—a prescription drug—wasn’t just a benign plant compound. Reports of adverse effects, including muscle-related issues and liver problems, raised alarms. By 2018, EFSA concluded that even at levels as low as 3 mg per day, risks could not be ruled out. The Commission took note, and the clock started ticking toward regulatory change.
The Legal Pivot
Fast forward to July 2024: Commission Regulation (EU) 2024/2041 landed like a gavel strike. It amended the earlier framework and removed the health claim from the Union list. The reasoning was clear: scientific uncertainty and documented safety concerns outweighed the benefits. A companion regulation, Implementing Regulation (EU) 2024/2063, reinforced the prohibition, placing monacolins under scrutiny in Annex III of Regulation (EC) No 1925/2006. This means their use in food supplements remains under strict monitoring, and any future approval hinges on new safety data.
In practical terms, this isn’t just a tweak in wording. It’s a full stop. Marketing materials, product labels, and promotional campaigns across the EU had to strip away cholesterol-related claims. Non-compliance could trigger enforcement actions, from relabeling demands to market withdrawals.
Why It Matters Beyond Labels
This decision reflects a broader principle in EU food law: health claims must be scientifically substantiated and safe for all consumers. The Nutrition and Health Claims Regulation (EC) No 1924/2006 sets the tone—claims are not marketing poetry; they are regulated promises. When evidence shifts, so does the law. And in this case, the shift was seismic.
For businesses, the implications are significant. Red yeast rice supplements can still be sold, but without the cholesterol-lowering halo. For consumers, it’s a reminder that “natural” doesn’t always mean risk-free. And for regulators, it’s a showcase of vigilance in balancing innovation with public health.
A Cultural Footnote
Interestingly, red yeast rice has a long history in traditional Chinese cuisine and medicine, prized for its color and digestive benefits. Its journey into European supplement aisles was a modern twist on an ancient ingredient. But once it crossed into the realm of health claims, it entered a legal landscape where tradition bows to evidence and safety.
What’s Next?
The story isn’t entirely closed. The Commission has left the door ajar for future reassessment. Manufacturers can submit new data to EFSA to prove safety. Until then, the rule stands firm: no cholesterol-lowering claims for Monacolin K in the EU.
See more on EU
Sources
Commission Regulation (EU) 2024/2041 amending Regulation (EU) No 432/2012 as regards the health claim on monacolin K from red yeast rice
https://eur-lex.europa.eu/eli/reg/2024/2041/oj/eng
30 July 2024