Evaluation of the increase of risk for public health related to a possible temporary derogation from the maximum level of deoxynivalenol, zearalenone and fumonisins for maize and maize products

maximum level (ML), deoxynivalenol (DON), zearalenone (ZON), fumonisins (FUMO), maize products, occurrence, exposure
First published in the EFSA Journal
22. Mai 2014
21. Mai 2014
Last Updated
30. Juni 2014. This version replaces the previous one/s.
Statement of EFSA


The European Food Safety Authority (EFSA) was asked to deliver a scientific statement on the increase of risk for public health related to a possible temporary derogation from the maximum level (tML) of deoxynivalenol (DON), fumonisins (FUMO) and zearalenone (ZON) in maize and maize products. EFSA relied on occurrence data reflecting levels of these mycotoxins in the 2013 maize harvest. Depending on the mycotoxin, mean levels estimated considering tMLs were increased by a factor comprised between 7.6 and 27 % in maize and maize milling fractions, and up to 99 % in some processed maize-based products, compared to levels estimated considering current ML. Chronic exposure levels estimated across the population groups – representing different age classes and countries – were increased by a factor up to 17 % for fumonisins, 20 % for deoxynivalenol and 83 % for zearalenone. The tolerable daily intake (TDI) for zearalenone set by EFSA at 0.25 µg/kg body weight (b.w.) per day, and the group provisional maximum tolerable daily intake (PMTDI) of 1 and 2 µg/kg b.w. per day set by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for deoxynivalenol and fumonisins, were used as chronic health based guidance values (HBGV). For all three mycotoxins these values were exceeded in at least one age group when considering the current ML, reflecting a health concern. When considering the tMLs, percentages of consumers in the age groups with the highest exposures exceeding chronic HBGVs increased from 9.2 to 9.8 % for zearalenone, from 47 to 48 % for fumonisins and from 52 to 54 % for deoxynivalenol. Acute exposure scenarios resulted in exceedance of the group acute reference dose (ARfD) of 8 µg/kg b.w. established by JECFA for DON, with up to 1.2 % of the consumption days above the group ARfD with the current ML, and up to 8.1 % with the tML. This assessment, mainly based on French data, may lack representativeness for the European situation.

European Food Safety Authority
contam [at] efsa.europa.eu
EFSA Journal 2014;12(5):3699
Question Number
On request from
European Commission