EFSA Warns: Monacolins from Red Yeast Rice Unsafe Even in Low Amounts

# EFSA Warns: Monacolins from Red Yeast Rice Unsafe Even in Low Amounts

The European Food Safety Authority (EFSA) reaffirmed its safety concerns regarding monacolins from Red Yeast Rice (RYR) in March 2025. The authority warns that even low intake levels of these substances can pose significant health risks.

Background

Red Yeast Rice is produced by fermenting rice with the mold Monascus purpureus and naturally contains monacolins, especially monacolin K, which is chemically identical to the cholesterol-lowering drug lovastatin. RYR products are often marketed as a natural alternative to prescription statins.

Key Statements

• EFSA classifies monacolins from Red Yeast Rice as unsafe, even at low doses
• These substances can cause similar side effects as prescription statins
• Particularly affected are muscle damage, liver damage, and drug interactions
• The decision has significant implications for manufacturers and consumers
• No safe intake level could be established

Implications for Manufacturers

This EFSA assessment has far-reaching consequences for companies manufacturing or distributing RYR-containing products. It is expected that the EU Commission will take regulatory actions based on this scientific opinion, ranging from warning labels to sales bans.

Recommendations

• Immediately review your product portfolio for RYR-containing products
• Stay informed about national implementations of the EFSA recommendation
• Consider alternative formulations without monacolins
• Transparently inform your customers about the safety concerns
• Consult legal experts regarding potential liability risks
• Prepare for possible recall actions
• Document all safety information and warnings

Note: This article is for informational purposes only and does not constitute legal advice. Manufacturers should seek expert advice on product safety issues.

Source: [NutraIngredients - EFSA Declares Monacolins from Red Yeast Rice Unsafe](https://www.nutraingredients.com/Article/2025/03-13/efsa-declares-monacolins-from-red-yeast-rice-unsafe-at-any-dose/)