OPINION OF THE SCIENTIFIC PANEL ON CONTAMINANTS IN THE FOOD CHAIN ON A REQUEST FROM THE COMMISSION RELATED TO OCHRATOXIN A IN FOOD

Ochratoxin A (OTA) is a mycotoxin produced by several fungal species of the genera Penicillium and Aspergillus. Contamination of food commodities, including cereals and cereal products, pulses, coffee, beer, grape juice, dry vine fruits and wine as well as cacao products, nuts and spices, has been reported from all over the world. In addition, contamination of animal feeds with OTA may result in the presence of residues in edible offal and blood serum, whereas the OTA contamination in meat, milk and eggs is negligible. Despite efforts to reduce the amount of this mycotoxin in foods as consumed, a certain degree of contamination seems unavoidable at present. Some early epidemiological data had suggested that OTA might be involved in the pathogenesis of distinct renal diseases and otherwise rare tumours of the kidneys in certain endemic regions of the Balkan Peninsula. However, these epidemiological data are incomplete and do not justify the classification of OTA as a human renal carcinogen. OTA has been found to be a potent renal toxin in all of the animal species tested. It induces a typical karyomegaly and a progressive nephropathy. The extent of renal injury is dose-dependent, but also associated with the duration of exposure, as OTA accumulates in renal tissue. Previous National Toxicology Program (NTP) studies in United States showed that OTA can induce renal tumours in rodents at high dosages. Recent scientific evidence indicates that the site-specific renal toxicity as well as the DNA damage and genotoxic effects of OTA, measured in various in vivo and in vitro studies, are most likely attributable to cellular oxidative damage. Furthermore, advanced chemical analytical procedures failed to demonstrate the existence of specific OTA-DNA adducts. Considering the lack of evidence for the existence of OTA-DNA adducts, the Panel used a threshold-based approach in its risk assessment of OTA. On the basis of the lowest observed adverse effect level (LOAEL) of 8 mu g/kg body weight (b.w.) per day for early markers of renal toxicity in pigs (the most sensitive animal species), and applying a composite uncertainty factor of 450 for the uncertainties in the extrapolation of experimental data derived from animals to humans as well as for intra-species variability, a Tolerable Weekly Intake (TWI) of 120 ng/kg b.w. was derived for OTA. Recent analyses of the dietary exposure of adult European consumers to OTA revealed that at present the weekly exposure ranges from 15 to 60 ng OTA per kg bodyweight per week, including high consumers of foods containing OTA. This rate of exposure is below the TWI value of 120 ng/kg b.w. as derived by the Panel. However, as current EFSA consumption databases do not include infants and children, the CONTAM Panel concluded that more data would be needed to assess exposure rates of this segment of consumers, taking into account their dietary preferences.