Risk assessment of ochratoxin A in food

Area of Science:

• Food safety and toxicology
• Mycotoxin analysis
• Risk assessment of food contaminants

Background:

• Ochratoxin A (OTA) is a mycotoxin produced by fungi, found in various foods, and known to cause kidney toxicity and tumors in animals.
• Recent studies have introduced uncertainty regarding the mode of action for OTA's kidney carcinogenicity.
• The European Food Safety Authority (EFSA) was requested to update its 2006 opinion on OTA in food.

Purpose of the Study:

• To update the 2006 opinion on Ochratoxin A (OTA) in food.
• To assess the health risks associated with OTA exposure in various consumer groups, including infants.
• To apply a margin of exposure (MOE) approach due to uncertainties in OTA's mode of action.

Main Methods:

• Utilized a benchmark dose lower confidence limit (BMDL 10) approach for both non-neoplastic (kidney lesions in pigs) and neoplastic (kidney tumors in rats) effects.
• Estimated chronic dietary exposure to OTA across different consumer groups and age ranges.
• Calculated MOE values by comparing estimated OTA exposures with the derived BMDL 10 values.

Main Results:

• BMDL 10 values were 4.73 μg/kg bw/day for non-neoplastic effects and 14.5 μg/kg bw/day for neoplastic effects.
• Estimated mean and 95th percentile chronic dietary exposures ranged from 0.6 to 17.8 and 2.4 to 51.7 ng/kg bw/day, respectively.
• MOEs were >200 for most consumers (low concern), but lower for high consumers in younger age groups (possible concern). MOEs were <10,000 for nearly all scenarios when compared to the neoplastic endpoint (possible concern if genotoxicity is direct).

Conclusions:

• A health-based guidance value (HBGV) was deemed inappropriate due to uncertainties in OTA's mode of action.
• The MOE approach suggests a possible health concern for specific consumer groups, particularly high consumers in younger age brackets and infants, depending on OTA's genotoxic mechanism.
• High uncertainty exists in the assessment, and the estimated risk may be overestimated.