Regulatory Requirements for Food Supplements in the European Union and Bulgaria

Abstract

Data provided by the European Commission show that public expenditures for food supplements have been constantly increasing over the last decade. The aim of the present study was to analyze the major food supplements regulations in the European Union and in Bulgaria. Relevant publications were searched and found in MEDLINE/PubMed, Scopus Database, Web of Knowledge, and in Internet-based search with predefined keywords. Numerous authors support the opinion that there is a real risk that low quality products may be distributed in countries with poor production control. Bulgarian national legislation have 6 regulations with different legal force for provision of healthy and safe food supplements on the market. Currently, the European Community is concerned about food products, including FS, launched on the market because the citizens require reliable protection of their health. This concern provoked the European Parliament and the Council to undertake a number of legislative initiatives in the field of production and control of food products. It is necessary to set more precise quality and safety criteria in future strategies associated with those products.

Dietary Supplements as Source of Unintentional Doping

“…Customers do not expect the presence of undeclared compounds in DS. For consumers with cardiovascular disease, the intake of products containing undeclared sibutramine could cause serious consequence [15]. Moreover, serious drug interactions are associated with sibutramine intake.…”

“…Regulation is mostly based on main integrities, and risk of adulterants is high [14]. There are no obligatory tests about the quality and quantity of the active compounds [15]. There are no obligatory tests about impurities, related compounds, and lead.…”

In-depth multidisciplinary review of the usage, manufacturing, regulations & market of dietary supplements

“…According to the European Union, food supplement regulation is the same way for food regulation, but a great deal of variation and expansion can be observed in the food supplements legislation among different countries. However, this legislation relies on native regulation [78].…”

Figure 1 from: Balkanska-Mitkova A, Yaneva A, Kondeva-Burdina M, Dimitrova M (2022) Pharmacists‘ attitudes to dispensing food supplements to chronically ill patients: a pilot survey among community pharmacies in Bulgaria. Pharmacia 69(3): 589-593. https://doi.org/10.3897/pharmacia.69.e85471

“…Food supplements (FS) placed on the market in a European Union (EU) Member State must comply with all relevant aspects of EU Food Law, ISO certification, and any specific national legislation of EU Member States with regard to their composition, manufacture, and control (Petkova et al 2019;GMP 2021).…”