EFSA Issues Opinion on Red Yeast Rice Monacolins Safety

# EFSA Issues Opinion on Red Yeast Rice Monacolins Safety

EFSA's NDA Panel conducted scientific opinion on additional data related to safety of monacolins from red yeast rice, addressing uncertainties in establishing Health-Based Guidance Value.

This development has far-reaching implications for manufacturers, retailers, and consumers of food supplements in Europe. Below, we analyze the details and consequences of this important news.

Scientific Background and Methodology

The European Food Safety Authority (EFSA) conducts comprehensive scientific assessments of ingredients in food supplements. These opinions are based on a systematic evaluation of available scientific literature, studies, and data.

The assessment process includes: - Systematic literature search in scientific databases - Evaluation of study quality and relevance - Analysis of safety data from animal and human studies - Consideration of consumption data from various EU countries - Assessment of possible interactions with other substances

Importance for Product Safety

The scientific assessment is a central component of the European safety system for food supplements. It serves to:

Consumer Protection: Identify and evaluate potential health risks before products enter the market or while they are already available.

Evidence-Based Regulation: Regulatory decisions are made based on scientific evidence, not on assumptions or economic interests.

Harmonization: Uniform safety standards across all EU member states create equal competitive conditions and facilitate internal trade.

Impact on Manufacturers

For manufacturers of food supplements, scientific opinions result in concrete action requirements:

Product Formulation: Adjustment of dosages and combinations based on new safety findings. This may mean reducing maximum levels or avoiding certain combinations.

Documentation: Provision of comprehensive safety data and scientific evidence for the used ingredients. Documentation requirements are continuously increasing.

Labeling: Updating product information, warnings, and consumption recommendations according to new scientific findings.

Quality Assurance: Implementation of robust quality assurance systems to ensure products meet scientific requirements.

Practical Recommendations

For companies in the supplement sector, the following recommendations apply:

1. Immediate Assessment: Check immediately whether and how your products are affected 2. Compliance Check: Conduct a comprehensive compliance check 3. Documentation: Ensure all required documents are complete and up to date 4. Expert Advice: Consult compliance experts or legal counsel if uncertain 5. Proactive Communication: Inform customers and partners transparently about changes 6. Continuous Monitoring: Stay informed about further developments

Further Information and Sources

Detailed information on this development can be found at the original source: [EFSA](https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9276)

For questions regarding the compliance of your products, the Supplement-Check.eu team is available. Our tools and consulting services help you meet regulatory requirements and bring your products safely to market.

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*This article was created by the Supplement-Check.eu news team and is based on official sources from regulatory authorities. Last updated: 12.01.2026*

*Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific legal questions, please consult a qualified attorney.*