The Red Yeast Rice (RYR) is a natural ingredient traditionally used in Chinese medicine for its lipid-lowering properties.

This effect is due to the presence of monacolin K, a compound chemically identical to lovastatin, a widely used synthetic statin in the pharmacological treatment of hypercholesterolemia.

Thanks to its ability to reduce LDL cholesterol levels (the so-called “bad cholesterol”), RYR has become one of the most common ingredients in dietary supplements aimed at cholesterol control, representing a natural alternative to lipid-lowering drugs.

In recent years, however, the growing popularity of Red Yeast Rice-based supplements has attracted the attention of European regulatory authorities, leading to further investigations into the safety of monacolins.

This is because, although natural, monacolins act similarly to synthetic statins and may present similar side effects, such as muscle pain, liver disorders, and drug interactions.

In light of these considerations, the EFSA (European Food Safety Authority) has released new scientific assessments that could lead to a revision of the regulations on the use of RYR in dietary supplements.

EFSA’s Concerns About Health Risks from Monacolin Consumption

On February 28, 2025, the EFSA’s Panel on Nutrition, Novel Foods, and Food Allergens (NDA) published an updated scientific opinion on the safety of monacolins found in Red Yeast Rice, confirming concerns already raised in 2018 by the ANS Panel (Additives and Nutrient Sources added to Food).

The document highlights significant health risks, even at doses previously considered relatively low, raising questions about the future commercialization of RYR-based supplements within the European Union.

Red Yeast Rice: An Ingredient Under Surveillance

Under Article 8(4) of Regulation (EC) No. 1925/2006, monacolins from RYR have been included in Part C of Annex III under Union surveillance, requiring an in-depth scientific safety assessment.

The NDA Panel analyzed updated data provided by industry operators and scientific literature, including:

• Compositional analyses of RYR supplements available on the market;• Assessment of monacolin exposure from other dietary sources;
• Studies on the bioavailability and cytotoxicity of monacolins compared to other statins;
• Nutri-vigilance data and post-marketing reports;
• Clinical reports and studies on adverse effects.

Regulatory Implications of RYR Use in Dietary Supplements

One of the most critical aspects highlighted by the EFSA review concerns the safety threshold of monacolin K. The NDA Panel confirmed that a daily intake of just 3 mg can cause severe adverse effects, including:

• Muscle damage: Cases of rhabdomyolysis have been reported, a severe condition characterized by muscle fiber necrosis and the release of myoglobin into the bloodstream, potentially leading to kidney failure.
• Hepatotoxicity: The use of RYR has been associated with impaired liver function, elevated transaminases, and the risk of drug-induced hepatitis.
• Adverse cardiovascular and gastrointestinal effects: Including muscle pain, weakness, cramps, digestive disorders, and possible interactions with other medications.

EFSA concludes that, based on available data, it is not possible to establish a safe dose of monacolins from RYR in dietary supplements, nor to identify an intake threshold that poses no risk to the general population or vulnerable groups (elderly individuals, patients with liver or kidney diseases, and those taking medications that interact with statins).

Consequences for the Red Yeast Rice Supplement Market

EFSA’s scientific opinion will have a significant impact on European regulations regarding Red Yeast Rice. Potential consequences include:

1. Restriction or prohibition of commercialization: Supplements containing monacolins from RYR may be banned or limited to levels below 3 mg, leading to a downsized market.
2. Revision of labels and health claims: The new EFSA opinion may result in the revocation of health claims regarding monacolin’s effects.
3. Increased monitoring and regulation: Health authorities may tighten controls on RYR-containing products, imposing stricter safety and transparency requirements for consumer information.
4. Development of nutraceutical alternatives: With the potential withdrawal of RYR from the market.

Final Considerations

EFSA’s opinion on February 28, 2025, marks a turning point for the future of Red Yeast Rice in Europe. The growing body of evidence on the adverse effects of monacolins, even at low doses, raises concerns about the safety of these supplements and may lead to stricter regulations or even their removal from the market. This scenario poses a challenge for the nutraceutical industry, which must reconsider formulations and commercial strategies to comply with the new safety standards set by regulatory authorities.

However, this regulatory evolution could also be an opportunity for innovation. Technological advancements in the pharmaceutical and nutraceutical sectors are paving the way for new ingredients and alternative formulations for cholesterol control, offering benefits comparable to Red Yeast Rice but with an improved safety profile. Plant extracts, bioactive peptides, phytosterols, and other natural substances are at the forefront of research aimed at developing effective supplements with fewer side effects.

As the European Commission and Member States deliberate, the dietary supplement sector must adapt to an ever-changing regulatory environment, exploring new solutions for cholesterol management that ensure both efficacy and safety for consumers.

The focus on safer and more sustainable ingredients could drive a paradigm shift in cardiovascular health approaches, promoting greater consumer awareness and encouraging the adoption of supplements with a more favorable risk profile.

In this context, regulation should not be seen merely as an obstacle but as a driver of progress, fostering research and the development of new solutions that meet the needs of an increasingly safety-conscious and quality-oriented market.