Risk evaluation of the Alternaria mycotoxin tenuazonic acid in foods for adults and infants and subsequent risk management

Since the first risk evaluation of Alternaria toxins by the European Food Safety Authority (EFSA) in 2011, new stable isotope dilution assays for tenuazonic acid (TA) broadened and deepened the data for exposure assessment. Moreover, recently unraveled high contents of TA in infant food based on sorghum/millet required an updated risk assessment. With the new data, the risk evaluation still revealed a low risk for adults as the maximum upper-bound data of the 95th percentile dietary exposure of TA can be estimated to be below the threshold of toxicological concern of 1500 ng/kgb.w. d. However, the evaluation of infant cereals based on sorghum/millet revealed a risk for the health of children consuming these foods, when two complementary approaches were applied. On the one hand, the maximum value of 1200 μg/kg TA in sorghum/millet-based infant food results in an intake of 3670 ng TA/kg b.w. d, which exceeds the threshold of toxicological concern by a factor of 2.4. On the other hand, this intake only leaves a margin of safety of 340 to the lowest dose showing subacute adverse effects in animals (1.25 mg/kgb.w. d), However, a safety factor of at least 1000 would be required. Therefore, infant cereals based on sorghum/millet with high content of TA cannot be regarded as safe. Based on toxicological considerations a limit of 500 μg TA per kg of sorghum/millet-based infant food is suggested. In these foods, other relevant Alternaria toxins such as alternariol or its methyl ether were not detected and obviously do not impose a risk for the consumers.