Scientific Opinion on the risks for public and animal health related to the presence of citrinin in food and feed

The European Food Safety Authority (EFSA) was asked by the European Commission to deliver a scientific opinion on the health risks from citrinin in food and feed. Citrinin is a mycotoxin produced by several species of the genera Aspergillus, Penicillium and Monascus and occurs mainly in stored grains. The available occurrence data were not adequate to carry out a dietary exposure assessment. Citrinin is nephrotoxic and a no-observed-adverse-effect level (NOAEL) of 20 µg/kg body weight (b.w.) per day was identified from a 90-day study in rats. Due to the limitations and uncertainties in the database, the derivation of a health-based guidance value was not considered appropriate but a level of no concern for nephrotoxicity of 0.2 µg/kg b.w. per day was determined. Based on the available data a concern for genotoxicity and carcinogenicity could not be excluded at the level of no concern for nephrotoxicity. In the absence of adequate exposure data, characterisation of the risk of citrinin as a food contaminant was based on the estimate of the citrinin concentrations in grains and grain-based products that would result in an exposure equal to the level of no concern for nephrotoxicity. For high consuming toddlers, other children and adults this citrinin concentration is between 9 and 53 µg citrinin/kg and between 19 and 100 µg citrinin/kg for average consumers, respectively. For animals, risk characterisation was based on the estimate of the citrinin concentration in grains that would result in exceedance of the NOAEL of 20 µg/kg b.w. per day for pigs, which ranged between 640 and 1 173 µg/kg. The CONTAM Panel concluded that the impact of uncertainties on the risk assessment is large, and more data regarding the toxicity and the occurrence of citrinin in food and feed in Europe are needed to enable refinement of the risk assessment.