Risk assessment of intake of pyrrolizidine alkaloids from herbal teas and medicines following realistic exposure scenarios.

In this study five types of herbal teas were used to quantify the effect of comminution of the leaves on resulting PA exposure. Results show that PA levels extracted from intact leaves were consistently lower than from comminuted tea leaves. The Margin of Exposure (MOE) approach was applied to evaluate the consequences of this difference for the associated risks in the scenario of lifetime exposure. Furthermore, we considered medicinal use of these teas for shorter-than-lifetime exposure scenarios, and also analysed the risks of shorter-than-lifetime use of eight herbal medicines and 19 previously analysed plant food supplements. This analysis revealed that shorter-than-lifetime use resulted in MOE values < 10,000 upon use for 40-3450 weeks during a lifetime, with for only a limited number of herbal teas and medicines use of two weeks a year (150 weeks during a 75 year lifetime) would still raise a concern. It is concluded that taking more realistic conditions into account markedly reduces the concerns raised for these herbal preparations. These results also illustrate the need for development of a generally accepted method for taking short term exposure into account in risk assessment of compounds that are genotoxic and carcinogenic.

Levels of methyleugenol and eugenol in instant herbal beverages available on the Indonesian market and related risk assessment.

The presence and accompanying risks of methyleugenol and eugenol in herbal beverages available on the Indonesian market were evaluated. Methyleugenol was detected in 49 out of 114 samples, at levels amounting to 2.6-443.7 µg/g, while 4 samples contained eugenol at 21.4-101.2 µg/g. The EDI resulting from drinking these preparations amounted to 0.1-51.2 µg/kg bw/day and 1.1-3.3 µg/kg bw/day, respectively for samples targeted at adults and children. A BMDL10 value of 22.2 mg/kg bw/day for methyleugenol was defined using literature data and model averaging. MOE values were below 10,000 for 46 samples (40.4%), indicating a priority for risk management when assuming daily lifelong consumption, while the EDI for 4 samples containing eugenol did not exceed the ADI of 2.5 mg/kg bw thus did not raise a concern for human health. Using Haber's rule to correct for less than lifetime exposure, consumption of methyleugenol via these beverages would be of low concern when consumed for less than 2 weeks/year during a lifetime. This conclusion holds for herbal beverages collected by targeted sampling, not for all herbal beverages on the Indonesian market. The study provides data that can support establishment of a maximum permitted level (MPL) for methyleugenol in herbal beverages in Indonesia.

Risk assessment for pyrrolizidine alkaloids detected in (herbal) teas and plant food supplements.

Pyrrolizidine alkaloids (PAs) are plant metabolites present in some botanical preparations, with especially 1,2-unsaturated PAs being of concern because they are genotoxic carcinogens. This study presents an overview of tumour data on PAs and points of departure (PODs) derived from them, corroborating that the BMDL10 for lasiocarpine represents a conservative POD for risk assessment. A risk assessment using this BMDL10 and mean levels of PAs reported in literature for (herbal) teas, indicates that consumption of one cup of tea a day would result in MOE values lower than 10 000 for several types of (herbal) teas, indicating a priority for risk management for these products A refined risk assessment using interim relative potency (REP) factors showed that based on the mean PA levels, 7(54%) of 13 types of (herbal) teas and 1 (14%) of 7 types of plant food supplements (PFS) resulted in MOE values lower than 10 000, indicating a priority for risk management also for these products in particular. This includes both preparations containing PA-producing and non-PA-producing plants. Our study provides insight in the current state-of-the art and limitations in the risk assessment of PA-containing food products, especially (herbal) teas and PFS, indicating that PAs in food presents a field of interest for current and future risk management.