Table 20.

Summary of major uncertainties in the risk assessment of OTA in food

Sources of uncertainty	Directiona
Assumption that OTA‐induced mutations result from direct genotoxicity	+
Assumption that OTA‐induced mutations result from indirect genotoxicity	–
Use of kidney lesion incidences for non‐neoplastic effect characterisation	+
Use of an uncertainty factor of 2 for extrapolation from a 3‐month study in pigs to chronic effects	–
Small sample size in human study where raised protein concentrations were seen	+/–
Extrapolation of the occurrence data submitted mainly by two countries to the whole of Europe	+/–
Methodology used to estimate 95th percentile chronic exposure based on consumption surveys only covering a few days	+
Consideration of all cheese with equal contamination level	+
Extrapolation of occurrence data from one study used for exposure assessment for breastfed infants to the whole of Europe	+/–

^a+ = uncertainty with potential to cause overestimation of exposure/risk; – = uncertainty with potential to cause underestimation of exposure/risk. Extent of potential over/underestimation might differ in direction.