Statement on the risks for public health related to a possible increase of the maximum level of deoxynivalenol for certain semi-processed cereal products

The European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the risks for public health related to a possible increase of the maximum level (ML) of deoxynivalenol (DON) for certain semi-processed cereal products from 750 µg/kg to 1000 µg/kg. For this statement, EFSA relied on existing occurrence data on DON in food collected between 2007 and 2012 and reported by 21 European countries. Due to the lack of appropriate occurrence data from pre-market monitoring, the impact of increasing the ML was estimated using a simulation approach, resulting in an expected increase in mean levels of the respective food products by a factor of 1.14-1.16. Based on median chronic exposure in several age classes, the percentage of consumers exceeding the group provisional maximum tolerable daily intake (PMTDI) of 1 μg/kg body weight (b.w.) for the sum of DON and its 3- and 15-acetyl-derivatives, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2010, is approximately 2-fold higher with the suggested increased ML than with the current ML. Several acute exposure scenarios resulted in exceedance of the group acute reference dose (ARfD) of 8 µg/kg b.w. established by JECFA with up to 25.9 % of the consumption days above the group ARfD. The EFSA Scientific Panel on Contaminants in the Food Chain notes that the group health based guidance values (HBGVs) include 3-Ac-DON and 15-Ac-DON. The exposure from the acetyl-derivatives has not been covered in this statement, since the acetyl-derivatives are not included in the current or suggested increased ML and because only few occurrence data are available. An increase of the DON ML can be expected to be associated with an increase of the levels of DON and Ac-DONs, and can therefore increase the exposure and consequently the exceedances of the group HBGVs.