Aflatoxin B1 (AFB1) is a mycotoxin produced by several species of Aspergillus fungi which can cause liver cancer in animals and humans. This study aims to perform the risk assessment of AFB1 in herbal medicines and plant food supplements (PFS) in Malaysian market. A total of 31 herbal medicines and PFS were purchased through online platforms and over the counter using a targeted sampling strategy. Of 31 samples analysed using the ELISA method, 25 (80.6%) were contaminated with AFB1 at levels ranged from 0.275 to 13.941 μg/kg. The Benchmark Dose Lower Confidence level of 10 (BMDL10) of 63.46 ng/kg bw/day and the estimated dietary intake of the adult population ranged from 0.006 to 10.456 ng/kg bw/day were used to calculate the Margin of Exposure (MOE). The MOEs for 24 (96%) out of the 25 positive samples were lower than 10,000. The RISK21 matrix revealed that AFB1 exposure levels from herbal medicines and PFS differed greatly over the world. The calculated population risk of acquiring liver cancer from AFB1 exposure ranged from 0 to 0.261 cancers/100,000 populations/year and accounted for an estimated percentage of liver cancer incidence ranged from 0.002 to 4.149%. This study revealed a moderate risk of liver cancer attributable to AFB1 from herbal medicine and PFS among Malaysian populations and emphasised an urgency for risk management actions.
Mycotoxins are toxic secondary metabolites produced by fungi, pose significant health risks when present in plant-based supplements (PBS), necessitating thorough risk assessment to ensure consumer safety. This study evaluates the health risks associated with mycotoxins, specifically aflatoxins (AFB1, AFB2) and ochratoxin A (OTA), in PBS sold in Malaysia. Contamination levels of AFB1, AFB2, and OTA were quantified in 14 PBS samples using Liquid Chromatography-Mass Spectrometry. All samples tested positive for AFB2, while 28.57% and 42.86% tested positive for AFB1 and OTA, respectively with some levels exceeding the regulatory limits set by the Malaysian Food Act 1983 and European regulations. The estimated daily intake of these mycotoxins was calculated based on the recommended daily intake of each supplement. To assess risk, Margin of Exposure (MOE) values were determined, showing that all AFB2-positive samples had MOE values below the critical threshold of 10,000, indicating an urgent need for risk management. A quantitative cancer risk assessment also estimated the percentage of hepatocellular carcinoma and kidney cancer attributable to mycotoxin exposure. The findings emphasize the significant public health risks posed by mycotoxins, particularly in samples B2 and B10, where all three mycotoxins studied were present at concerning levels. This study highlights the urgent need for stricter regulations and better monitoring of mycotoxin levels in PBS to protect consumer's health.