Assessment of regulatory labeling compliance of red yeast rice supplements on the Bulgarian market

Introduction : Food supplements (FSs) containing monacolins derived from red yeast rice (RYR) have become increasingly prevalent on the European Union (EU) market and are classified under Regulation (EC) No 1925/2006 as “Restricted substances” and “Substances under Community scrutiny”. Aim : This study aims to assess EU regulatory requirements for FSs containing monacolins from RYR, evaluate labeling compliance of selected FSs on the Bulgarian market, and identify common ingredient combinations in registered products. Materials and methods : A documentary analysis of the regulatory requirements applicable to FSs containing monacolins from RYR was conducted, alongside a review of the Bulgarian register of FSs. In addition, 18 FSs containing these ingredients available on the Bulgarian market were selected, and the information provided on their packaging was compared with the relevant EU labeling requirements. Results and discussion : RYR is most frequently combined with plant extracts, coenzyme Q10, and B vitamins. Labelling of FSs containing monacolins from RYR is required to include specific mandatory warnings, including recommendations to avoid a daily intake of 3 mg or more of monacolins. Non-compliance with labeling requirements was identified in 11 of the 18 FSs examined due to the absence of mandatory information required by national legislation or warnings mandated by EU regulations for FSs containing monacolins from RYR. Conclusion : The results indicate that some FSs on the Bulgarian market do not comply with EU labeling requirements, highlighting the need for strengthened regulatory control.