Scientific Opinion on the risks for public health related to the presence of zearalenone in food

Abstract

Zearalenone is a mycotoxin produced by several Fusarium species. It is commonly found in maize but can be found also in other crops such as wheat, barley, sorghum and rye. The European Commission asked the European Food Safety Authority to review the safety of zearalenone and the risk to consumers of a possible increase of the maximum level (ML) for zearalenone in breakfast cereals. A total of 13,075 analytical results obtained on food samples and 9,877 results on unprocessed grains sampled by 19 European countries in 2005-2010 were used in the evaluation. The highest concentrations of zearalenone were reported for wheat bran, corn and products thereof (e.g. corn flour, cornflakes). Grains and grain-based foods, in particular grains and grain milling products, bread and fine bakery wares, made the largest contribution to the estimated zearalenone exposures. Vegetable oils also made an important contribution to the zearalenone exposure. The critical effects of zearalenone result from its oestrogenic activity. Based on recent data in the most sensitive animal species, the pig, and taking into account comparisons between pigs and humans, the Panel on Contaminants in the Food Chain established a tolerable daily intake (TDI) for zearalenone of 0.25 μg/kg b.w. Estimates of chronic dietary exposure to zearalenone based on the available occurrence data are below or in the region of the TDI for all age groups and not a health concern. A potential increase in the ML for zearalenone in breakfast cereals from 50 µg/kg to 75, 100, 125 or 150 µg/kg is unlikely to result in a chronic dietary exposure exceeding the TDI. In a worst case scenario it is possible that an individual could consume the same batch of breakfast cereal containing zearalenone at the ML every day for 2 to 4 weeks, in which case exposures may exceed the TDI.

Endocrine Disrupters and the Safety of Food Chains

“…Refined models of dietary exposure assessment are being developed, taking into account age and gender differences in food consumption habits, as well as groups with enhanced intake (e.g., high seafood consumption) and/or vulnerability (e.g., low iodine status) [5,22,35,51,70]. The role of the metabolism and ecology of edible organisms as determinants of food contamination should be considered when appropriate [7,10,16,75].…”

“…Corn and wheat, major staple foods worldwide, are the major dietary sources of the potent estrogenic mycotoxin zearalenone; according to the EFSA assessment, the chronic dietary intake of zearalenone in Europe is below the tolerable intake in all age groups, whereas there may be a potential risk upon short-term exposure (e.g., through the consumption of breakfast cereals) in children [51]. Moreover, from soil and water cereals may accumulate the toxic heavy metal cadmium, which may have estrogen-like effects and specifically inhibits the production of the erythropoietin hormone and damages the renal proximal tubular cells, a rather peculiar ED effect [52].…”

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

“…The chemical structure of zearalenone (3,4,5,6,9,10-hexahydro-14,16-dihydroxy-3- The most recent comprehensive risk assessment available for zearalenone which is serving as a basis for the present evaluation is a scientific opinion on the risks for public health related to the presence of zearalenone in food issued by EFSA (EFSA CONTAM Panel, 2011). Zearalenone is readily absorbed through the gastrointestinal tract and extensively metabolised and distributed to various tissues (Shin et al, 2009).…”

“…Food consumption data were derived from the EFSA Comprehensive European Food Consumption Database (Comprehensive database) which was built in 2010 from existing national information on food consumption at the individual level (EFSA, 2011;Huybrechts et al, 2011;Merten et al, 2011).…”

“…It is also important to add, in the context of this statement, that although no acute reference value has been derived for ZON in a previous assessment (EFSA CONTAM Panel, 2011) it is possible that elevated circulating levels of oestrogens could lead to adverse effects either from long term exposure but also from short-term exposure during a sensitive stage of development. The impact of the increased ML for ZON needs to be considered in the light of these conclusions.…”