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

Pharmacia 73: e193045 DOI 10.3897/pharmacia.73.e193045 Research Article Assessment of regulatory labeling compliance of red yeast rice supplements on the Bulgarian market Katerina Slavcheva1 , Radiana Staynova1 , Daniela Kafalova1 1 Department of Organisation and Economics of Pharmacy, Faculty of Pharmacy, Medical University of Plovdiv, Plovdiv, Bulgaria Corresponding author: Daniela Kafalova () Received 25 March 2026 ♦ Accepted 14 April 2026 ♦ Published 8 May 2026 Citation: Slavcheva K, Staynova R, Kafalova D (2026) Assessment of regulatory labeling compliance of red yeast rice supplements on the Bulgarian market. Pharmacia 73: e193045. https://doi.org/10.3897/pharmacia.73.e193045 Abstract 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. Keywords Food supplements, label, monacolins, red yeast rice, regulatory framework Introduction In the European Union (EU), food supplements (FSs) are legally defined as foodstuffs, and their regulation is established under Directive 2002/46/EC of the European Parliament and the Council. This directive establishes a formal legal definition of FSs, provides harmonized lists of vitamins and minerals allowed for use in their manufacture, and specifies mandatory labeling requirements to ensure Copyright Slavcheva K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 2 Slavcheva K et al.: Regulatory Labelling Compliance of RYR FSs consistency and consumer protection across Member States (European Food Safety Authority 2018; Hadzhieva 2023). In Bulgaria, the regulation of FSs is implemented under the Food Act, with the Bulgarian Food Safety Agency (BFSA) serving as the competent authority (Petkova 2014; Tsvetkova 2014; Republic of Bulgaria 2020). Following amendments to the Food Act in 2020, FSs may be placed on the Bulgarian market only after registration with the BFSA and inclusion in a public national register. Labeling, presentation, and advertising of FSs must comply with harmonized EU legislation, including Regulation (EU) No 1169/2011. Since 30 December 2021, the national Ordinance on Food Supplements has been in force, requiring specific information to be provided on the labeling of these products placed on the Bulgarian market (Republic of Bulgaria 2021): (Cicero 2021), resulting in the formation of several bioactive compounds collectively known as monacolins. Among these, monacolin K is the principal active compound. Monacolin K in its lactone form has been shown to be chemically identical to lovastatin, the active pharmaceutical ingredient used in medicinal products for the treatment of hypercholesterolemia (European Commission 2022). A meta-analysis has demonstrated that FSs containing RYR significantly reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglyceride levels, while increasing high-density lipoprotein cholesterol (HDL-C) (Rahmani 2023). On 25 June 2018, the European Food Safety Authority (EFSA) adopted a scientific opinion on the safety of monacolins present in RYR (EFSA Panel on Food Additives and Nutrient Sources added to Food 2018). EFSA concluded that the intake of monacolins from RYR-containing FSs may lead to exposure to monacolin K comparable to the therapeutic doses of lovastatin. Furthermore, it was established that the adverse effect profile of RYR is similar to that observed for lovastatin. According to published reports, adverse reactions have been identified affecting the musculoskeletal and connective tissue (including rhabdomyolysis), the liver, the nervous system, and the gastrointestinal tract, as well as the skin and subcutaneous tissue (European Commission 2022). EFSA has considered that the available evidence on adverse effects in humans is sufficient to determine that monacolins present in RYR, when used in FSs, pose a health risk at a daily intake of 10 mg. Moreover, individual cases of severe adverse reactions, including rhabdomyolysis, hepatitis, and dermatological disorders leading to hospitalization, have been reported at intake levels as low as 3 mg/day of monacolins from RYR. In light of the significant adverse health effects associated with the consumption of monacolins from RYR, regulatory measures have been introduced to restrict their use at daily intake levels of 3 mg or higher (European Commission 2022). Consequently, monacolins from RYR were included in Part B, “restricted substances,” of Annex III to Regulation (EC) No 1925/2006 (European Parliament 2006). In addition, Part B concerning monacolins from rice fermented with red yeast establishes specific conditions of use and labeling requirements for FSs, requiring that the daily portion of the product provide less than 3 mg of monacolins (European Commission 2022). Given the potential for adverse health effects associated with monacolin intake and the persistence of scientific uncertainty, EFSA has placed the use of monacolins from RYR in FSs under scrutiny. Consequently, these substances have been included in Part C (“substances under Community scrutiny”) of Annex III to Regulation (EC) No 1925/2006 (European Commission 2022). The present study aimed to analyze the regulatory requirements applicable at the European level to FSs containing monacoli (...truncated)