Using data supplied by France, EFSA estimates that a temporary increase in the levels of three mycotoxins – deoxynivalenol, fumonisins and zearalenone – in maize and maize products is unlikely to impact significantly on public health. However, for some consumers currently estimated total exposure from all sources (including other crops) is already close to what is considered a safe level.
France recently requested a temporary derogation to the maximum levels of these mycotoxins in maize and maize products for the 2013 harvest. The European Commission will consider EFSA’s scientific advice together with other factors when it decides whether or not to grant the French request.
Mycotoxins are chemical compounds produced naturally by fungi. They can cause adverse health effects in humans and animals and sometimes enter the food chain via cereal crops...
@ EFSA News in brief: Mycotoxins in maize – urgent scientific advice for the Commission:
H/T Wayne Parrott on Twitter.
Abstract
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 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, 2014
Summary
Following a request from the European Commission (EC), 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 (ML) of deoxynivalenol (DON), zearalenone (ZON) and fumonisins (FUMO) for maize and certain maize products.
DON is a plant pathogenic mycotoxin, mainly produced by Fusarium graminearum which grows on the crops in the field, and occurs frequently together with its acetyl-derivatives, 3-acetyl-deoxynivalenol (3-Ac-DON) and 15-acetyl-deoxynivalenol (15-Ac-DON). In 2010, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) established a group provisional tolerable daily intake (PMTDI) of 1 µg/kg body weight (b.w.) per day and a group ARfD of 8 µg/kg b.w. for DON, 3-Ac-DON and 15-Ac-DON which are considered in the present assessment.
FUMO are a group of structurally related plant pathogenic mycotoxins produced mainly by Fusarium verticillioides and Fusarium proliferatum growing on cereals, in particular on maize. The group PMTDI of 2 µg/kg b.w. per day for fumonisins established in 2011 by JECFA was considered in the present assessment.
ZON is a plant pathogenic mycotoxin produced by different Fusarium species, particularly Fusarium graminearum and also Fusarium culmorum, Fusarium equiseti and Fusarium verticillioides, found in cereals on the field (in particular maize) but also as a post-harvest contaminant. A TDI of 0.25 µg/kg b.w. per day set by EFSA in 2011 is used for the present assessment.
Occurrence data from the 2013 harvest originating from three different sources (FranceAgriMer collector survey, IRTAC Cereal Sanitary Monitoring Plan, and Euromaisiers) were provided with the request. Depending on the source, maize samples were taken at the maize collector and/or at maize milling factory. Data were mainly coming from France. DON, ZON and FUMO were analysed with enzyme-linked immunosorbent assays (ELISA) and high performance liquid chromatography (HPLC) (in total 2,637 analytical results). Occurrence data compiled in previous EFSA and JECFA risk assessments were also considered. These were mainly corresponding to results from official monitoring programmes, collected over a 5 - 10 years period between 2000 and 2012, and reported by up to 21 European countries (in total 39,202 analytical results). Mean levels in maize grains and maize milling products estimated from the datasets provided with the request appeared to be 1.3 to 6 times higher compared to mean levels considered in previous assessments.
The impact of a temporary derogation from the maximum levels was assessed considering the data from FranceAgriMer survey which was the most suitable source of information. This represented a total of 663 analytical results, 221 results for each mycotoxin. Transfer rates from grain to grain milling products were assumed to correspond to the ratio between the tML defined in the grain milling products and the tML defined for the unprocessed grains.
Compared to the current MLs, it was estimated that the tMLs would increase mean middle bound (MB) levels of DON, ZON and FUMO in unprocessed maize grains and milling fractions by 16 ‑ 18 %, 25 – 27 % and 7.6 – 23 % respectively. Depending on the kind of maize ingredient and its percentage content in final processed/composite products, the mean MB levels of DON and FUMO in final processed/composite products were increased by 12 – 58 %, whereas mean MB levels of ZON were increased by 25 - 99 %.
Chronic dietary exposure to DON of children age groups estimated with occurrence data reflecting current MLs ranged on average between 0.22 and 1.11 µg/kg b.w. per day (minimum lower bound (LB) to maximum upper bound (UB)) and at 95th percentile between 0.94 and 2.10 µg/kg b.w. per day. Chronic dietary exposure to DON of adult age groups ranged on average between 0.18 and 0.56 µg/kg b.w. per day and at 95th percentile between 0.38 and 1.01 µg/kg b.w. per day.
Depending on the survey and age group, mean and 95th percentile chronic dietary exposure to DON estimated with the occurrence data reflecting tML were up to 20 % higher than the levels estimated with the occurrence data reflecting current ML.
Chronic dietary exposure to ZON of children age groups estimated with occurrence data reflecting current MLs ranged on average between 9.7 and 118 ng/kg b.w. per day (minimum LB-maximum UB) and at the 95th percentile between 47 and 303 ng/kg b.w. per day. The chronic dietary exposure to ZON of the adult age groups ranged on average between 4.4 and 64 ng/kg b.w. per day and at the 95th percentile between 11 and 117 ng/kg b.w. per day.
Depending on the survey and age group, the mean and 95th percentile chronic dietary exposure to ZON estimated with the occurrence data reflecting tML were up to 83 % higher than the levels estimated with the occurrence data reflecting current ML.
Chronic dietary exposure to FUMO of children age groups estimated with occurrence data reflecting current MLs ranged on average between 0.17 and 2.11 µg/kg b.w. per day (minimum LB to maximum UB) and at the 95th percentile between 0.54 and 4.39 µg/kg b.w. per day. Chronic dietary exposure to FUMO of adult age groups ranged on average between 0.03 and 1.19 µg/kg b.w. per day and at the 95th percentile between 0.08 and 2.30 µg/kg b.w. per day.
Depending on survey and age group, mean and 95th percentile chronic dietary exposure to FUMO estimated with the occurrence data reflecting tML were up to 17 % higher than the levels estimated with the occurrence data reflecting current ML.
Acute exposure scenarios were carried out for people who consume maize grains, maize milling products, maize-based breakfast cereals, maize-based snacks and maize-based pastries containing DON equal to the ML and resulted in a very low percentage of consumption days above the group ARfD (acute reference dose) (< 1 %) for all products except maize-based pastries, whatever the ML (current, tML) considered. For maize-based pastries, percentage of consumption days above the group ARfD estimated up to 1.2 % with current ML was increased up to 8.1 % considering the tML, with a maximum acute exposure level estimated at 20.8 µg/kg b.w.
Exceedance of the group PMTDI (provisional maximum tolerable daily intake) for DON is higher in the children than in the adults age groups, ranging between 2.7 and 52 % (minimum LB to maximum UB) considering the current MLs. Considering the tMLs, this is slightly increased and estimated to range between 4.2 and 54 %.
The results suggest a low impact of tMLs for chronic exposure levels of DON in all age groups owing to the fact that DON exposure is mainly driven by non maize-based foods. However, both application of current and increased MLs lead to exposures in the region of the group PMTDI of 1 µg/kg b.w. per day especially in the ‘toddlers’ age group.
Percentage of consumption days above the group ARfD of 8 µg/kg b.w. estimated up to 1.2 and 8.1 % with the current MLs and tMLs, respectively, indicates a potential concern resulting from the consumption of maize-based pastries containing high DON level for the children age groups.
Although the mandate concerns FB1 and FB2, based on the occurrence data available the assessment was based on total fumonisin occurrence. Based on the fact that toxicological assessments and also the group PMTDI are derived mainly from data with FB1 and the structural similarities of the different fumonisin derivatives of relevance, this is considered acceptable.
The exceedance of the group PMTDI defined for FUMO is higher in the children than in the adults age groups, ranging between 0 and 47 % (minimum LB to maximum UB) when considering current ML. When considering tML, this is slightly increased and estimated to range between less than 0.1 % and 48 %.
Results show that a temporary increase in MLs has only a very minor impact on exposure levels of FUMO and consequently on any risk estimates. However, when applying the current MLs, the exposure levels of FUMO are already in the region of the group PMTDI of 2 µg/kg b.w. per day in several age groups, being highest in ’other children’ age group.
Exceedance of the TDI for ZON is the higher in the children than in the adults age groups, ranging between 0 and 9.2 % (minimum LB to maximum UB) when considering the current MLs. With tMLs, this is slightly increased and estimated to range between 0 and 9.8 %.
Exposure levels for ZON both with current and tML levels are around or above the TDI of 0.25 µg/kg b.w. per day for the age groups of infants, toddlers and other children and thus might be considered as being of health concern. It is important to add here that although no acute reference value has been derived for ZON in a previous EFSA assessment, it was pointed out there that is possible that elevated circulating levels of oestrogens could lead to adverse effects also from short-term exposure during a sensitive stage of development. The impact of the increased ML for ZON need to be considered also in the light of these conclusions.
It was assumed that increased exposure of individuals suffering from celiac disease due to a temporary increase of MLs for DON, FUMO and ZON for maize and maize products were reflected in the high exposure levels (95th percentile) estimated for the general population.
There is a need to better assess the DON, ZON and FUMO levels in maize grains and maize milling products from the 2013 harvest coming from other countries than France and used for food processing at the European level.
Keywords
maximum level (ML), deoxynivalenol (DON), zearalenone (ZON), fumonisins (FUMO), maize products, occurrence, exposure
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