At the request of the European Commission, EFSA has reviewed the previous opinion of the Scientific Committee on Food (SCF, 1998)[1] on OTA in the light of more recent toxicological studies and exposure data. Specific attention has also been given to vulnerable groups such as infants and children and groups of consumers who are exposed to higher levels of OTA than the average consumer due to their dietary habits.

The Panel concluded that OTA is found to be a potent renal toxin in animals such as rodents and pigs. The extent of renal injury is dose-related and is associated with the duration of exposure. OTA accumulates in the kidney which has been identified as the most sensitive organ with respect to the toxicity of this mycotoxin. The Panel further concluded that there is increasing evidence that both OTA’s renal toxicity and its genotoxic effects (damaging DNA, the genetic material of cells) are most likely caused by the generation of free radicals harmful to cells (so called cellular oxidative stress). These effects may finally lead to kidney and liver tumours as observed in animal studies with rodents.

Taking into account all data available the Panel established a TWI of 120 ng/kg body weight for OTA. Current levels of exposure to OTA vary between 15 and 60 ng per kg bodyweight per week which is well below the established TWI. This evaluation takes into account both average and high consumers of foods that are the main contributors to OTA exposure. The Panel also recommended that more specific exposure data be collected for certain vulnerable groups, including infants and children and high consumers of certain regional food specialities containing OTA.