Safety assessment of selected polyphenolic marker compounds in plant-derived Korean health functional food ingredients and regulatory considerations

Abstract As of 2025, the South Korean health functional food (HFF) market has grown into a KRW 6.5 trillion industry, characterized by the diversification of consumer demands aligned with individual health statuses and interests. This trend has accelerated the launch of various HFF products featuring enhanced bioavailability or high contents of bioactive ingredients, while simultaneously fostering a consumer environment susceptible to overlapping or multiple intakes. To comprehensively diagnose the current status of HFF safety management in South Korea, this review investigated all 68 notified ingredients registered with the Ministry of Food and Drug Safety (MFDS) and the top 50 individually recognized ingredients based on sales volume, which collectively account for over 90% of the domestic HFF market. Our analysis revealed that approximately 21% of these major ingredients utilize polyphenolic substances as marker compounds to guarantee consistent quality and safety. While polyphenolic substances have garnered significant attention due to their well-documented health benefits—including antioxidant, anti-inflammatory, and drug-modulating activities—they also pose potential safety risks when consumed in excess or under various intake conditions. Therefore, this study closely examines the specific safety management frameworks of EGCG, curcumin, and quercetin, for which relatively abundant scientific data are available, as representative case studies. Based on these findings, we propose proactive regulatory considerations and policy guidelines, emphasizing that future safety regulations must incorporate factors such as enhanced bioavailability from advanced formulation technologies, potential drug-HFF interactions during multiple concomitant ingestions, and the distinct pharmacogenetic polymorphisms and dietary profiles of the Korean population.