EFSA evaluates ochratoxin A in food and derives a Tolerable Weekly Intake

The Panel on Contaminants in the Food Chain (CONTAM) of the European Food Safety Authority (EFSA) published today an opinion on ochratoxin A (OTA), a mycotoxin naturally produced by certain fungi such as the Penicillium and Aspergillus species. The Panel concluded that, when consumed, OTA accumulates in the kidney and is particularly toxic to this organ. Taking into account all data currently available the Panel derived a Tolerable Weekly Intake (TWI) of 120 ng per kg body weight for OTA. Currently, the weekly exposure of the general population to OTA varies between 15 and 60 ng per kg bodyweight and is therefore well below this value. The experts recommended that all efforts be made to continue to reduce OTA levels in food and that a monitoring programme be established to gather more specific exposure data for certain vulnerable groups.

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.

Notes to editors
  • Occurrence of OTA

    Ochratoxin A is a mycotoxin produced by several fungal species in the Penicillium and Aspergillus genera which widely occur in nature. Mycotoxins such as OTA are formed as crops grow or more commonly develop later during storage and have been reported as contaminants in food commodities. Human exposure to OTA has been confirmed through the detection of this mycotoxin in the blood, urine and milk samples of healthy subjects. The main sources are cereals and cereal products, pulses, coffee, beer, grape juice, dry vine fruits and wine, cacao products, nuts as well as spices. OTA is also found in animal feed from across the world but OTA in meat, milk and eggs was considered to be a negligible source for human exposure. However, higher concentrations of OTA may occur in certain local specialties such as blood puddings and sausages prepared with pig blood serum.
     

  • Previous evaluations considered by the CONTAM Panel for the evaluation of OTA

    OTA in food has been previously evaluated by the Scientific Committee on Food (SCF)1 and the Joint FAO/WHO Expert Committee on Food Additives (JECFA)[2] . The CONTAM Panel evaluated the results of these opinions in the light of more recent toxicological studies, in particular the findings of an EU-research project on the mechanism of carcinogenicity induced by OTA[3] and recent analytical findings on the occurrence of OTA in food and exposure assessments.

[1] Opinion of the Scientific Committee for Food on OTA (expressed on 17 September 1998)
[2] Evaluation of certain food additives and contaminants. Thirty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). WHO Technical Report Series, No 806, 1991, and corrigenda.
Evaluation of certain food additives and contaminants. Forty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). WHO Technical Report Series, No 859, 1995.
Safety evaluation of certain mycotoxins in food. Fifty-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) - WHO Food Additives series 47 – FAO Food and Nutrition Paper – IPCS – International Programme on Chemical Safety, World Health Organisation, Geneva, 2001.
[3] Ochratoxin A - risk assessment. Project No.: QLK1-2001-01614.

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