Food supplement safety and market entry in Germany, Bulgaria, North Macedonia and China

Abstract

Objective: To compare market entry controls for food supplements in Germany, Bulgaria, and North Macedonia with the health food framework of mainland China, and assess their relationship to scientific safety evaluation. Methods: A functional comparative legal review of legislation, judgments, and regulatory guidance was combined with a targeted medical literature review. Sources were checked through September 24, 2026. Vitamin B6, green tea extracts, and red yeast rice illustrate dose-related toxicity and regulatory responses. Results: Germany uses notification, Bulgaria requires prior registration, and North Macedonia uses a compliance opinion followed by registration. China distinguishes registration involving assessment of safety, health function, and quality controllability from catalog-based filing supported by technical documentation. Chinese health foods and European food supplements are not identical legal categories. The examples demonstrate the importance of total exposure, preparation-specific toxicity, and continued reassessment after market entry. An administrative status or regulatory dose ceiling cannot establish universal safety or therapeutic efficacy. Conclusion: Good practice combines transparent classification, proportionate evidence requirements, prominent warnings, controlled product changes, and post-market surveillance. Chinese functional assessment adds a distinct comparator but does not establish superiority in health outcomes. The review supports cooperation between legal, toxicological, nutritional, and clinical expertise, while identifying limits arising from documentary access and the absence of comparative outcome data.

Keywords: Food supplement; Food safety; Toxicology; Registration; China