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Appropriate human health risk assessment (HHRA) is desire in modern regulatory toxicology, especially for elemental impurity studies. The aim of this article is the comprehensive HHRA of two heavy metals impurities—Cd and Pb in herbal medicinal products (HMP) as Menthae piperitae tinctura (Mentha × piperita L., folium) available in Polish pharmacies. These phytopharmaceuticals registered in EU are very common and usually applied OTC products by adults and also children/adolescents. For this purpose, we applied double regulatory approach, including: (1) requirements of ICH Q3D R1 guideline about elemental impurities and (2) additionally margin of exposure (MoE)-based concept to cover also specific population groups. Raw results shows that Cd and Pb were present in all analyzed HMP with Mentha × piperita L., folium (PTM1–PTM10) available in Polish pharmacies. In all samples, Cd impurities (in the range: 0.305–0.506 µg/L) were greatly lower than Pb impurities (in the range: 1.122–4.4921 µg/L). The HHRA of Cd and Pb impurities considering ICH Q3D R1 guideline-based approach made it possible to conclude that all results were below the permissible limit set by FAO/WHO for medicinal herbs and plants in different countries (300 µg/kg for Cd and 10,000 µg/kg for Pb). Additionally, the estimated daily intake of investigated elemental impurities compared to the PDE value confirm all samples safety. The second approach, an MoE-based strategy, indicated that the obtained values of MoE for Cd and Pb in daily dose for each samples were above 10,000; hence, exposure to these elemental impurities would not cause a health risk for all investigated population groups (children, adolescents, and adults). To the best our knowledge, this article is the first study about heavy metals impurities level in final HMPs as Menthae piperitae tinctura (Mentha × piperita L., folium) available in Polish pharmacies. |
