Probabilistic reference dose derivation and risk assessment of mycotoxin citrinin for red yeast rice-related foods

Red yeast rice (RYR), a traditional food and health supplement widely consumed in East Asian, has been associated with contamination by citrinin (CTN)-a nephrotoxic and potentially reproductive-toxic mycotoxin produced during fermentation. Taiwan's food surveillance program has reported high detection rates and concentrations of CTN in RYR-related products. However, the dietary risks posed to the Taiwanese population remain poorly characterized, largely due to uncertainties in exposure assessment and limited toxicological data. This study aimed to assess the dietary risk of CTN exposure through the consumption of RYR-related food products using a Bayesian-based probabilistic framework that integrates uncertainty and variability in food consumption, CTN concentration, and dose-response modeling of point of departure values. Estimated CTN exposure ranged from 0.0023 ± 0.36 to 0.0059 ± 1.28 μg/kg bw/day, with the majority of the population reporting no consumption of RYR-containing foods. A reference dose (pRfD) was derived at 0.08 μg/kg bw/day to protect 99 % of the population from experiencing a 5 % adverse response using a probabilistic framework. At this regulatory goal, most of the Taiwanese population showed no appreciable risk but about 0.1 % of the population was found to be at risk. Although uncertainties remain regarding food consumption patterns and CTN concentrations in foods, the findings raise potential health concerns for subpopulations with regular RYR consumption and support the need for targeted risk management in Taiwan.