Human and animal dietary exposure to T‐2 and HT‐2 toxin

European Food Safety Authority (EFSA); Davide Arcella; Petra Gergelova; Matteo Lorenzo Innocenti; Hans Steinkellner

doi:10.2903/j.efsa.2017.4972

. 2017 Aug 14;15(8):e04972. doi: 10.2903/j.efsa.2017.4972

Human and animal dietary exposure to T‐2 and HT‐2 toxin

European Food Safety Authority (EFSA), Davide Arcella, Petra Gergelova, Matteo Lorenzo Innocenti, Hans Steinkellner

PMCID: PMC7010047 PMID: 32625633

Abstract

T‐2 toxin (T2) and HT‐2 (HT2) toxin are trichothecenes, which form part of the group of Fusarium mycotoxins. Food and feed samples used to estimate human dietary and animal exposure were reported either as the individual results for T2 and/or, HT2, and/or as the sum of the two. The highest concentrations were reported in oats and oat‐containing commodities. Very high levels were reported in a small number of data on specific plant‐ and herb‐based dietary supplements. In humans, the mean chronic dietary exposure to the sum of T2 and HT2 was highest in ‘Toddlers’ and ‘Infants’, with maximum upper bound (UB) estimates of 64.8 and 62.9 ng/kg body weight (bw) per day, respectively. The 95th percentile dietary exposure was highest in ‘Infants’ with a maximum UB estimate of 146 ng/kg bw per day. UB estimations were on average fourfold higher than lower bound (LB) estimations. Average acute exposure ranged from a minimum of 13.4 ng/kg bw per day, estimated in ‘Elderly’, up to a maximum of 64.7 ng/kg bw per day estimated in ‘Toddlers’. The highest 95th percentile acute dietary exposure was estimated for a dietary survey within the age class ‘Infants’ (170 ng/kg bw per day). Overall, among processed foods the main contributors were cereal flakes, fine bakery wares and, for acute exposure, also bread and rolls. In the elderly and very elderly, dietary supplements made an important contribution. Exposure to the sum of T2 and HT2 in farm and companion animals varied according to the animal species. Exposures considering mean concentration scenarios varied between 0.03–0.08 (LB–UB) μg/kg bw per day in beef cattle and 1.13–1.47 μg/kg bw per day in milking goats. For high concentration scenarios, exposures varied between 0.12–0.16 μg/kg bw per day and 2.37–2.58μg/kg bw per day in the same species. In the absence of data, potential modified form were not included.

Keywords: T‐2, HT‐2, food, feed, dietary exposure

Summary

T‐2 toxin (T2) and HT‐2 toxin (HT2) belong to the group of compounds known as trichothecenes, which are part of the largest group of Fusarium mycotoxins comprising more than 150 compounds. In 2017, the European Food Safety Authority (EFSA) published a scientific opinion on the appropriateness to set a group health‐based guidance value (HBGV) for T2 and HT2 and its modified forms with objective of confirming or revising the previously established tolerable daily intake (TDI) of 0.1 μg/kg body weight (bw) and also to set, if appropriate, an acute reference dose (ARfD). Acute emetic events in mink following exposure to both T2 and HT2 observed in an in vivo acute toxicity study were identified as critical effects for setting an ARfD for T2 and HT2, and benchmark dose (BMD) calculations produced a BMDL₁₀ of 2.97 μg T2 or HT2/kg bw per day. Using an uncertainty factor (UF) of 10, a group ARfD of 0.3 μg T2 and HT2/kg bw was established. Based on an in vivo subchronic toxicity study with rats, a reduction of total leukocyte count was identified as the critical effect for setting a TDI. Using this endpoint, a BMDL₁₀ of 3.33 μg T2/kg bw per day was calculated and by using a UF of 200, a new group TDI for T2 and HT2 of 0.02 μg/kg bw was established.

Following an official request by the European Commission in September 2016, the EFSA Evidence Management Unit (DATA unit) has estimated chronic and acute dietary exposure to T2 and HT2 in humans and animals. A total of 93,335 analytical results reported either as the individual results for T2 (n = 41,922), HT2 (n = 40,236) or as the sum of two (n = 11,177), were submitted to EFSA. The data covered food, feed and unprocessed grains of undefined end‐use. The T2 and HT2 concentration levels on unprocessed grains did not show a robust consistency when compared to those reported as ‘Grains for human consumption’ or when compared to those reported as feed grains. Therefore, these data were not used in the present human or animal exposure assessment.

A total of 19,505 analytical results for food (8,502 results for T2, 6,877 results for HT2 and 4,126 results for the sum of T2 and HT2) and 6,411 analytical results for feed (2,735 results for T2, 2,429 results for HT2 and 1,247 results for the sum of T2 and HT2) were included in the final data set. In addition, more analytical results for the sum of T2 and HT2 were obtained by combining the individual concentrations of the T2 and HT2 for each sample, and consequently merged with those reported as the sum of T2 and HT2. For instances where either one of the individual T2 or HT2 values was not reported, an imputation method using the mean occurrence of the food group in concern was used to simulate the missing results. For food, this resulted in 9,551 analytical results for the sum of T2 and HT2 available for the human dietary exposure assessment. For feed, 3,007 analytical results for the sum of T2 and HT2 were available for the animal exposure assessment.

The food samples were collected between 2011 and 2016 in 20 different European countries, most of them in Germany (50%). The data set was characterised by a high proportion of left‐censored data (results below limit of detection (LOD)/limit of quantification (LOQ)) with 90% of left‐censored data reported for T2, and 87% of left‐censored data reported for HT2 and the sum of T2 and HT2 data. Within the food category ‘Grains and grain‐based products’, the highest levels of the sum of T2 and HT2 were reported in ‘Grains for human consumption’ and ‘Breakfast cereals’, in particular in oat‐containing commodities (e.g. oat grains, 127–128 μg/kg, lower bound–upper bound (LB–UB); oat cereal flakes, 13.9–16.5 μg/kg, LB–UB). Very high concentrations were reported for ‘Dietary supplements’ (592–594 μg/kg, LB–UB) with all high levels related to dietary supplements containing plant extracts and reported by one data provider. Quantified results were also found in other food categories covering grain‐based food products (e.g. snacks, food for infants and young children), while in other non‐grain‐based foods (e.g. legumes, fats and oils) the T2 and HT2 concentrations were quantified only occasionally.

For 34% of the food samples, no information was provided about the analytical methods used to analyse the toxins. In those where information was submitted, the separation method was mostly liquid chromatography (LC) with diverse detection methods. Low variability of the LOQs was observed across food categories as well as across the analytical methods. Although the majority of reported LOQs are in line with those described in recent literature, many of the analytical methods used for this dataset reported relatively high LOQs. This has a significant impact on the UB estimations when dealing with left‐censored data, even though this influence on the UB estimations was reduced by excluding those samples that reported LOQs above 10 μg/kg for the individual T2 and HT2 and above 20 μg/kg for the sum of T2 and HT2.

Also for feed, a high proportion of left‐censored data was observed for all three parameters (91% for T2, and 88% for HT2 and the sum of T2 and HT2). Only the sum of T2 and HT2 occurrence data were considered for the animal exposure. The feed samples were collected in 14 different European countries between 2011 and 2016. The data were mostly available for the feed category ‘Cereal grains, their products and by‐products’ and within that, the highest mean concentrations were observed for oats (LB mean=401 μg/kg; UB mean=405 μg/kg). For other feed categories, quantified values were available for cereal straw, mixed grains, sunflower seed, grass (field dried), maize silage, barley, maize, complementary feed, skimmed milk, rye, complete feed, cotton seed, toasted soya, wheat and triticale, with the mean concentrations being rather low (LB mean concentrations in the range of 0.7 μg/kg measured in triticale to 16.9 μg/kg measured for cereal straw). The most common analytical method reported for the analysis of T2 and HT2 in feed was LC‐tandem mass spectrometry (MS/MS) (69%). The highest sensitivity (median LOQ=3.0 μg/kg) was observed for results analysed by high‐performance liquid chromatography‐fluorescence detection (HPLC‐FD).

In humans, mean chronic dietary exposure to the sum of T2 and HT2 was highest in ‘Toddlers’ and ‘Infants’ with maximum UB estimates of 64.8 and 62.9 ng/kg bw per day, respectively. The 95th percentile dietary exposure was highest in ‘Infants’ with a maximum UB estimate of 146 ng/kg bw per day. Overall, chronic dietary exposure to the sum of T2 and HT2 in the young population (‘Infants’, ‘Toddlers’, and ‘Other children’) was 2–3 times higher than that estimated for the adult population (‘Adults’, ‘Elderly’, and ‘Very elderly’). UB estimations were on average fourfold higher than LB estimations. Overall, ‘Grains and grain‐based products’ made the largest contribution to the LB mean chronic dietary exposure to the sum of T2 and HT2 in all age classes, in particular ‘Cereal flakes’ and ‘Fine bakery wares’.

Average UB acute exposure to the sum of T2 and HT2 ranged from a minimum of 13.4 ng/kg bw per day, estimated in ‘Elderly’, up to a maximum of 64.7 ng/kg bw per day, estimated in ‘Toddlers’. The highest 95th percentile acute dietary exposure was estimated for a dietary survey within the age class ‘Infants’ (170 ng/kg bw per day). The food mostly contributing to the acute exposure to the sum of T2 and HT2 was ‘Bread and rolls’. Considering the 95th percentile acute exposure, for ‘Bread and rolls’ the exposure reached values of up to 72.8 ng/kg bw per day (95% CI = 71.0–74.6). The contribution of this food category resulted to be rather low for the chronic exposure to the sum of T2 and HT2. It is important to mention that different approaches for the chronic and acute exposure assessment were followed. For the chronic exposure, the main contributors to the mean exposure were based on the LB approach, which is considered to be less influenced by results below LOD/LOQ, while the acute exposure and the most relevant food contributing to that was based on the UB approach, which is considered more appropriate to capture an exposure to a maximum possible dose. This is likely a reason of discrepancy as for foods mainly contributing to the exposure observed between the chronic and acute exposures.

Compared to the 2011 EFSA opinion, the present data set contained a much higher proportion of left‐censored occurrence data, particularly in foods making the biggest contribution to dietary exposure (i.e. grain‐based food commodities). As a consequence, the chronic exposure estimates are at UB approximately threefold higher for ‘Infants’ and approximately 30% higher for other age classes (relative to the maximum UB exposure levels) in the present assessment when compared to that estimated in 2011.

Although in animal nutrition compound feeds (complementary or complete feeds) represent a very large proportion of the feed consumed by farm animals, the available data on the occurrence of the sum of T2 and HT2 in these feeds are difficult to use for exposure calculations due to the low number of samples available for each target species or category or feeds not sufficiently characterised to allow a proper utilisation in diet formulations. Therefore, only the occurrence data on cereal grains and on some forages and roughage were used to calculate animal exposure. Farm and companion animal dietary exposure to the sum of T2 and HT2 varied according to the animal species. The exposure for the mean concentration scenario varied between 0.03–0.08 (LB–UB) μg/kg bw per day in beef cattle and 1.13–1.47 μg/kg bw per day in milking goats, while for a high concentration scenario this varied between 0.12–0.16 μg/kg bw per day and 2.37–2.58 μg/kg bw per day for the same species. The exposure estimates are lower when compared to those reported in the previous scientific opinions of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) published in 2011 and 2014, which corresponds to the lower T2 and HT2 concentrations in feed reported in the last 5 years.

Dietary exposure estimates to T2 and HT2 have uncertainties relating to the representativeness of the food and feed samples across Europe. The large proportion of samples with left‐censored data introduced considerable uncertainties to the exposure assessment as the use of the LB tends to underestimate, while UB tends to overestimate the dietary exposure. Furthermore, by applying the imputation method, the real concentrations may have been under‐ or overestimated. Extremely high concentrations on very specific food products (i.e. plant extract formula), reported by only one data provider, may have led to overestimation. Due to lack of data, a potential presence of other modified forms of T2 and HT2 was not considered, which could have resulted in an underestimation of the exposure. The uncertainty related to the consumption data mainly concerns the eating occasions reported as raw agricultural or minimally processed commodities derived from consumption data on processed foods that were disaggregated (e.g. bread disaggregated into flour). Therefore, exposure estimations derived from using these commodities are most probably overestimates.

Overall, the chronic dietary exposure to T2 and HT2 presented in this report is likely to overestimate the exposure levels of the European population, in particular at the UB estimation. Acute exposure estimates based only on UB occurrence data are also likely to be overestimates. Both chronic and acute exposure estimates are affected by the high proportion of left‐censored data.

Efforts should continue to collect analytical data on T2 and HT2, including potential modified forms, in relevant food and feed commodities, with a particular focus on analysing both individual toxins within the same sample. Analytical methods with the appropriate sensitivity should be used allowing the reduction of the uncertainty associated to dietary exposure estimations, probably leading to a large overestimation when using UB scenarios. It would be desirable to encourage further research for the occurrence of T2 and HT2 in dietary supplements in order to evaluate a possible important source of exposure from these products.

1. Introduction

T‐2 toxin (T2) and HT‐2 toxin (HT2) (Figure 1) are trichothecenes, which are the largest group of Fusarium mycotoxins. They comprise of more than 150 compounds. The basic structure of all trichothecenes is a tetracyclic sesquiterpene with a spiro‐epoxide group at C‐12 and C‐13, and an olefinic double bond between C‐9 and C‐10. According to the substituents of the tetracyclic ring system, trichothecenes are grouped into different types (A–D). T2 and HT2 belong to the type A trichothecenes, which are characterised by an esterified or free hydroxyl group at C‐8, or an unsubstituted C‐8. Type B trichothecenes, e.g. nivalenol and deoxynivalenol, carry a keto group at C‐8. Type A and B compounds constitute the majority of trichothecene contaminants in food and feed.

The analytical methods for analysis of T2 and HT2 are well established and quantification is mainly carried out by liquid chromatography (LC) coupled with (multistage) mass spectrometry (MS) usually within a multianalyte approach. For rapid screening, immunochemical methods are used but have the disadvantage of cross‐reactivity. The existing immunochemical methods are not validated in interlaboratory studies.

In 2011, the European Food Safety Authority (EFSA) published a scientific opinion on the risks to human and animal health related to the presence of T‐2 toxin and HT‐2 toxin in food and feed (EFSA CONTAM Panel, 2011). In that risk assessment, the highest chronic human dietary exposure was estimated for toddlers, and was 12–43 ng/kg body weight (bw) per day for average consumers, and 23–91 ng/kg bw for 95th percentile consumers. Grains and grain‐based foods, in particular bread, fine bakery wares, grain milling products and breakfast cereals contributed most to the exposure. Based on the limited data available, no significant difference in exposures was found between vegetarians and the general population.

In their opinion of 2011, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that T2 inhibits protein, RNA and DNA synthesis and there are indications that T2 induces apoptosis, and in some cell types necrosis, as well as lipid peroxidation affecting cell membrane integrity. T2 induces haematotoxicity and myelotoxicity associated with impairment of haematopoiesis in bone marrow. A group tolerable daily intake (TDI) of 0.1 μg/kg bw was established for the sum of T2 and HT2 based on reduced antibody response to a specific antigen seen in a subchronic study with pigs.

All exposure estimates were below the group TDI of 0.1 μg/kg bw, and consequently, the Panel concluded that there was no health concern (EFSA CONTAM Panel, 2011).

Exposure of livestock and companion animals is mainly due to consumption of cereal grains and cereal by‐products, since levels in forages and oilseed meals were low. Species considered in the exposure assessment were dairy cows, beef cattle, sheep and goats, pigs and piglets, hens, broiler chickens, turkeys, ducks, rabbits, fish, dogs, cats and horses. The highest upper bound (UB) exposure estimates to the sum of T2 and HT2 was 3.3 μg/kg bw per day in milking goats, while the lowest was for farmed fish at 0.19 μg/kg bw per day.

For ruminants, a lowest observed adverse effect level (LOAEL) of 300 μg T2/kg bw per day was identified, based on findings of altered serum proteins and haematological and gastrointestinal parameter alterations. A no observed adverse effect level (NOAEL) could not be identified. For pigs, a LOAEL of 29 μg T2/kg bw per day was established based on observations of immunological and haematological effects from that dose onwards. No NOAEL could be established. In broiler chickens and turkeys, T2 caused mucosal oral damage (LOAELs of 40 and 48 μg/kg bw per day, respectively), while in ducks at 40 μg/kg bw per day reduced bw gain was observed. For laying hens, a LOAEL of 120 μg T2/kg bw per day was set based on infertility/reduced egg production at that dose. For rabbits, a NOAEL of 100 μg T2/kg bw per day was identified based on moderate haematological and hormonal effects seen at higher doses. For fish, a NOAEL of 13 μg T2/kg bw per day was identified (reduced feed intake, growth and increased mortality at higher doses). Due to the limited data and severity of effects observed (i.e. mortality), no reference points could be established for cats which are among the most sensitive species (EFSA CONTAM Panel, 2011). Due to absent/limited data, no NOAELs/LOAELs could be identified for dogs or horses.

The Panel concluded that the exposure of ruminants, fish and rabbits to the sum of T2 and HT2 is well below respective LOAELs and NOAELs and thus unlikely of health concern. For pigs, poultry, dogs and horses, the BMDL₀₅ for pigs (10 μg/kg bw per day) was used as the reference point in the absence of NOAELs/LOAELs for these species. When comparing estimated exposures to the sum of T2 and HT2 with this value, it was concluded that the health risk for these species was low. For cats, health risks could not be assessed.

In 2014, EFSA published a scientific opinion on the risks for human and animal health related to modified forms of zearalenone, nivalenol, T‐2 and HT‐2 toxins and fumonisins (EFSA CONTAM Panel, 2014). The Panel concluded that modified forms may add another 10% to the concentration of T2 and HT2 in food and feed. As a pragmatic approach it was assumed that modified forms of T2 and HT2 have equal toxicity as their parent compounds. To assess risks to T2 and HT2 and their modified forms, 10% was added to the exposures to the sum of T2 and HT2 for the different consumer groups as calculated in the previous opinion (EFSA CONTAM Panel, 2011) and EFSA compared these exposure levels with the TDI of 100 ng/kg bw established previously (EFSA CONTAM Panel, 2011). Exposure to the sum of T2 and HT2 and their modified forms was not of concern because lower bound (LB) and UB exposures across dietary surveys were lower than the TDI, except for the highest UB exposure for toddlers which was similar to the TDI. As in the previous opinion, exposure to T2 and HT2 of farm and companion animals were based on levels in feed ingredients. For risk characterisation, 10% was added to total UB exposures to T2 and HT2 and compared with NOAELs/LOAELs established in the previous opinion or indicative or guidance values where these were not available. Briefly, not only the mean but also the 95th percentile (P95) (not estimated in 2011) exposure to T2 and HT2 and their modified forms were lower than the respective effect/indicative/guidance levels and thus not of concern for pigs, ruminants, poultry, rabbits and dogs. For fish, the risk could not be characterised and for cats not ruled out, although for both this was considered unlikely.

In 2017, EFSA published a scientific opinion on the appropriateness to set a group health‐based guidance value (HBGV) for T2 and HT2 toxin and its modified forms (EFSA CONTAM Panel, 2017). For this opinion, the Panel reviewed new data on T2 and HT2 (published after the previous assessment) to confirm or revise the previously established TDI and also to set, if appropriate, an acute reference dose (ARfD). Any information on modified T2 and HT2 (i.e. metabolites of T2 and HT2) was evaluated to see if these could be included in a group HBGV with T2 and HT2.

New in vivo acute toxicity studies showed that T2 and HT2 have anorectic effects upon short‐term exposure. Acute emetic events in mink upon exposure to both T2 and HT2 were identified as critical effects for setting an ARfD for T2 and HT2, and calculations for benchmark dose (BMD) resulted in a BMDL₁₀ of 2.97 μg T2 or HT2/kg bw per day. Using a uncertainity factor (UF) of 10, a group ARfD of 0.3 μg T2 and HT2/kg bw was established. An interspecies factor was not applied as it was assumed that humans are not more sensitive than mink towards this effect.

A new in vivo subchronic toxicity study with rats confirmed that that immune‐ and haematotoxicity are the critical effects of T2 upon repeated exposure. In this new study, a reduction of total leukocyte count was observed which was identified as the critical effect for setting a TDI. Using this endpoint a BMDL₁₀ of 3.33 T2/kg bw per day was calculated and by using a UF of 200 (adding to the standard UF an additional factor of 2 because a subchronic study was used and by noting that the toxic effect reached no plateau at the end of the study), a new group TDI for T2 and HT2 of 0.02 (rounded from 0.017) μg/kg bw was established.

Modified forms of T2 and HT2 arise from phase I and phase II metabolism of T2 and HT2 in fungi, plants and mammals. In order to include the modified forms in a group HBGV, the modified forms occurring in food and/or feed have been considered. Phase I metabolites identified as relevant were: 19‐HO‐T2, neosolaniol (NEO) and 19‐HO‐HT2, T2‐triol and T2‐tetraol. Phase II metabolites identified as relevant were: T2‐3‐glucose (T2‐3‐Glc), T2‐3‐diglucose (T2‐3‐diGlc), T2‐3‐sulfate (T2‐3‐Sulf), T2‐3‐glucuronic acid (T2‐3‐GlcA), 3‐acetyl‐T2 (3‐Ac‐T2), 3‐feruolyl‐T2 (3‐Fer‐T2), HT2‐3‐glusose (HT2‐3‐Glc), HT2‐diglucose (HT2‐diGlc), HT2‐glucuronic acid (HT2‐GlcA) and HT2‐malonylglucose (HT2‐MalGlc).

NEO showed equal emetic potency and was therefore included in a group ARfD with T2 and HT2 with the same molarity‐based relative potency factor (RPF) of 1. In the absence of toxicity data on phase II metabolites of T2, HT2 and NEO, the CONTAM Panel assumed that they are hydrolysed to their aglycones in the intestine and therefore included them in the group ARfD and used the same RPFs of 1 as for their parent compound/phase I metabolites.

Haematotoxicity, the underlying mode of action being protein synthesis inhibition, induction of ribotoxic stress and apoptosis, are the critical effects of T2. Since T2 is rapidly metabolised to HT2, the toxicity of T2 might partly be attributed to HT2. No in vivo studies on haematotoxicity of modified forms of T2 and HT2 have been identified, but the Panel assumed that their phase I metabolites work via a similar mode of action, as some have been shown to cause protein synthesis inhibition. The CONTAM Panel concluded that the phase I metabolites of NEO, T2‐triol and T2‐tetraol should be included in a group TDI with T2 and HT2. Because phase I metabolites show different potencies in inhibition of protein synthesis and other toxic effects, it was decided to assign molarity‐based relative potency factors (RPFs) for their inclusion in any risk assessment. These RPFs are 1 for T2 and HT2 and 19‐HO‐T2, 0.3 for NEO and 19‐HO‐HT2, and 0.1 for T2‐triol and T2‐tetraol. Since it was assumed that their phase II metabolites are hydrolysed to their aglycones after ingestion, they should also be included in a group TDI. Thus, T2‐3‐Glc, T2‐3‐diGlc, T2‐3‐Sulf, T2‐3‐GlcA, 3‐Ac‐T2, 3‐Fer‐T2, HT2‐3‐Glc, HT2‐diGlc, HT2‐GlcA and HT2‐MalGlc were included in the group TDI by applying an RPF of 1. NEO‐Glc was included by using a factor 0.3 and T2‐triol‐Glc and T2‐tetraol‐Glc by applying a factor of 0.1.

1.1. Background and Terms of Reference as provided by the requestor

Following the outcome of EFSA's scientific opinion on T‐2 and HT‐2 toxin in food and feed in 2011,1 the Commission adopted on 27 March 2013 Commission Recommendation 2013/165/EU on the presence of T‐2 and HT‐2 toxin in cereals and cereal products2 to collect more occurrence data on T‐2 and HT‐2 in cereals and cereal products, and more information on the effects of feed and food processing and agronomic factors on the presence of T‐2 and HT‐2 toxin. In view of the consideration of the need of further regulatory measures to prevent and reduce the presence of T‐2 and HT‐2 in feed and food to ensure a high level of animal and human protection, it is appropriate to perform an updated animal and human exposure assessment taking into account the new occurrence data. Furthermore, a scientific opinion on the appropriateness to set a group health based guidance value, including the assessment of a need to set an acute reference dose, for T‐2 and HT‐2 toxin is envisaged (EFSA‐Q‐2015‐02293).

TERMS OF REFERENCE

In accordance with Art. 31 (1) of Regulation (EC) No 178/2002, the Commission asks EFSA for an updated chronic and acute animal and human exposure assessment to T‐2 and HT‐2 toxin taking into account the occurrence data available in the EFSA database.

2. Data and methodologies

2.1. Data

2.1.1. Occurrence data (food and feed)

2.1.1.1. Data collection and validation

Following an European Commission mandate to EFSA, a call for an annual collection of chemical contaminant occurrence data in food and feed, including T‐2 and HT‐2 toxin, was issued in December 2010 with a closing date of 1 October of each year.4 European national authorities and similar bodies, research institutions, academia, food business operators and other stakeholders were invited to submit analytical data on T2 and HT2 in food and feed.

At the time of the closure of the data collection (January 2017), a total of 93,335 analytical results on T2 and HT2 were available in the EFSA database (analysed in 46,354 samples). Analytical results were reported either as individual analytical results for T2, HT2 and as the sum of two.

The data submission to EFSA followed the requirements of the EFSA Guidance on Standard Sample Description for Food and Feed (EFSA, 2010a); occurrence data were managed following the EFSA standard operational procedures (SOPs) on ‘Data collection and validation’ and on ‘Data analysis of food consumption and occurrence data’.

2.1.1.2. Data analysis

In line with the EFSA SOP on ‘Data analysis of food consumption and occurrence data’ to ensure an appropriate quality of the data used in the exposure assessment, the initial data set was evaluated by applying several data cleaning and validation steps. Special attention was paid to different parameters such as ‘Sampling strategy’, ‘Sampling year’, ‘Sampling country’, ‘Analytical methods’, ‘Reporting unit’, ‘Limit of detection’, and the codification of samples under FoodEx classification (EFSA, 2011a) and feed samples according to the catalogue of feed materials described in Commission Regulation 68/20135. The outcome of the data analysis is presented in Section 3.

The left‐censored data (results below limit of detection (LOD) or below limit of quantification (LOQ)) were treated by the substitution method as recommended in the ‘Principles and Methods for the Risk Assessment of Chemicals in Food’ (WHO/IPCS, 2009). The same method is indicated in the EFSA scientific report ‘Management of left‐censored data in dietary exposure assessment of chemical substances’ (EFSA, 2010b). The guidance suggests that the LB and UB approach should be used for chemicals likely to be present in the food (e.g. naturally occurring contaminants, nutrients and mycotoxins). The LB is obtained by assigning a value of zero (minimum possible value) to all samples reported as lower than the LOD (< LOD) or LOQ (< LOQ). The UB is obtained by assigning the numerical value of LOD to values reported as < LOD and LOQ to values reported as < LOQ (maximum possible value), depending on whether LOD or LOQ is reported by the laboratory.

2.1.2. Human consumption data

The EFSA Comprehensive European Food Consumption Database (hereinafter referred as Comprehensive Database) provides a compilation of existing national information on food consumption at the individual levels. It was first established in 2010 (EFSA, 2011b; Huybrechts et al., 2011; Merten et al., 2011). Details on how the Comprehensive Database is used are published in the Guidance of EFSA (2011b). The latest version of the Comprehensive Database, updated in 20156 contains results from a total of 51 different dietary surveys carried out in 23 different Member States covering 94,532 individuals.

Within the dietary studies, subjects are classified in different age classes as follows:

Infants: < 12 months old
Toddlers: ≥ 12 months to < 36 months old
Other children: ≥ 36 months to < 10 years old
Adolescents: ≥ 10 years to < 18 years old
Adults: ≥ 18 years to < 65 years old
Elderly: ≥ 65 years to < 75 years old
Very elderly: ≥ 75 years old

Two additional surveys provided information on specific population groups: ‘Pregnant women’ (≥ 15 years to ≤ 45 years old; Latvia) and ‘Lactating women’ (≥ 28 years to ≤ 39 years old; Greece).

Overall, the food consumption data gathered by EFSA in the Comprehensive Database are the most complete and detailed data currently available in the European Union (EU). Consumption data were collected using single or repeated 24‐ or 48‐h dietary recalls or dietary records covering from three to seven days per subject. Owing to the differences in the methods used for data collection, direct country‐to‐country comparisons can be misleading.

Detailed information on the different dietary surveys used in this report is shown in Appendix A, including the number of subjects and days available for each age class.

2.1.3. Animal consumption data

The feeds consumed (and the feed intake) by the most relevant farm livestock and companion animals can only be based on estimates, since no comprehensive feed consumption database exists covering the EU. The animal species and categories considered were: (i) ruminants (dairy cows (producing approximately 40 kg milk/day) for which non‐forage feeds accounted for 60% of the diet (on a dry matter basis) or different forage based diets, beef cattle (reared on silage and non‐forage feed or cereal based diets), lactating sheep, milking and fattening goats; (ii) pigs (piglets, fattening pigs and lactating sows); (iii) poultry (broilers, laying hens, turkeys for fattening and ducks for fattening); (iv) rabbits; (v) farmed fish; (vi) companion animals (dogs, cats) and (vii) horses.

The average feed intakes used to calculate animals’ exposure to T2 and HT2 are described in Appendix B. They were derived from information extensively described by the CONTAM Panel in its Scientific Opinion on the risks for animal and public health related to the presence of T2 and HT2 toxin in food and feed (EFSA CONTAM Panel, 2011). The estimated feed intakes are based on published guidelines on nutrition and feeding (AFRC, 1993; Carabano and Piquer, 1998; NRC, 2006, 2007a,b; Leeson and Summers, 2008; EFSA, 2009).

2.1.4. Food classification

Consumption data were classified according to the FoodEx classification system (EFSA, 2011a). FoodEx is a food classification system developed by EFSA in 2009 with the objective of simplifying the linkage between occurrence and food consumption data when assessing the exposure to hazardous substances. It contains 20 main food categories (first level), which are further divided into subgroups having 140 items at the second level, 1,261 items at the third level and reaching about 1,800 end‐points (food names or generic food names) at the fourth level.

2.1.5. Feed classification

Feed samples were classified according to the Catalogue of feed materials as described in Commission Regulation No 68/20137 and recorded according to the FoodEx classification system.

2.2. Methodologies

2.2.1. Human dietary exposure assessment

In the EFSA 2011 CONTAM opinion (EFSA CONTAM Panel, 2011), only chronic dietary exposure to the individual T2 and HT2 and to the sum of T2 and HT2 was assessed. In the present scientific report, in addition to the chronic also acute dietary exposure to the individual T2 and HT2 and to the sum of T2 and HT2 is assessed. In Appendix A, the number of available days for each age class used in the acute exposure assessment is described, together with the number of subjects available for the chronic exposure assessment.

As suggested by the EFSA Working Group on Food Consumption and Exposure, dietary surveys with only 1 day per subject were considered only for acute exposure as they are not adequate to assess repeated exposure (EFSA, 2011b). Similarly, subjects who participated for only 1 day in the dietary studies, when the protocol prescribed more reporting days per individual, were also excluded for the chronic exposure assessment. Thus, for chronic exposure assessment, food consumption data were used from 35 different – and the most recent – dietary surveys carried out in 19 different European countries present in the latest version of the Comprehensive Database. Not all countries provided consumption information for all age classes, and in some cases, the same country provided more than one consumption survey.

For calculating chronic dietary exposure to the individual T2 and HT2 and to the sum of T2 and HT2, food consumption and body weight data at the individual level were accessed in the Comprehensive Database. Occurrence data and consumption data were linked at the lowest (most detailed) FoodEx level possible. In addition, the different food commodities were grouped within each food category to better explain their contribution to the total dietary exposure. The mean and the high (95th percentile) chronic dietary exposures were calculated by combining the LB and UB mean occurrence values of the individual T2 and HT2 and the sum of T2 and HT2 for food samples collected in different countries (pooled European occurrence data) with the average daily consumption for each food at individual level in each dietary survey and age class. Consequently, individual average exposures per day and body weight were obtained for all individuals. On the basis of distributions of individual exposures, the mean and 95th percentile exposures were calculated per survey and per age class.

Acute dietary exposure to the individual T2 and HT2 and the sum of T2 and HT2 was estimated using a probabilistic approach. A total of 41 most recent dietary surveys carried out in 23 different European countries were used (Appendix A). Acute exposure was assessed for each reporting day by multiplying the total consumption amount for each food category by one occurrence level randomly drawn among the individual results available for that food category. Respective intakes of the foods consumed that day were then summed and finally divided by the individual's body weight. This process was iterated 1,000 times for each reporting day. For the calculations, occurrence data estimated using the UB approach were used. For each of these endpoints, the 95% confidence interval was defined as the 2.5th and 97.5th percentiles obtained from the 1,000 iterations.

All analyses were run using the SAS Statistical Software (SAS enterprise guide 5.1), including the modelling of the probabilistic acute exposure.

2.2.2. Animal dietary exposure assessment

Estimated example diets for each animal species and category were used to calculate the exposure to the sum of T2 and HT2. The diets, already presented and extensively described by the CONTAM Panel in the Scientific Opinion on T‐2 and HT‐2 toxin in food and feed (EFSA CONTAM Panel, 2011), are summarised in the Appendix B. Different scenarios were proposed for ruminant animals: high yielding dairy cows are represented by animals with a daily milk production of 40 kg, fed either a diet based on non‐forage feeds (accounting for 60% of the dry matter intake, corresponding to about 12 kg), or different forage‐based diets diet. Regarding beef cattle, two feeding systems were used, one based on cereals and one on forages. For non‐ruminant livestock and companion animals, the assumed inclusion rates of different feed materials are given in Appendix B.

3. Assessment

3.1. Occurrence data on T‐2 and HT‐2 toxin

An initial number of 93,335 analytical results on T2 and HT2 (46,354 samples analysed) from 25 European countries were available for the assessment. The major contributor of the data was Germany which reported 35% of data, followed by the UK and France. Results were reported on samples collected between the years 2001 and 2016 with the majority of the data collected after 2006. The data covered food and feed, but also included unprocessed grains of undefined end‐use (hereinafter referred as ‘Unprocessed grains’).

Analytical results were reported either as the individual results for T2 (n = 41,922), HT2 (n = 40,236) and as the sum of two (n = 11,177).

The occurrence data were carefully evaluated and a list of validation steps was applied before being used to estimate dietary exposure.

As a first step, the data set was checked for duplicates (analytical results transmitted twice) and all duplicates (n = 107) were excluded.

Outdated results may not reflect the current levels of contamination. In order to select the most recent data, only the data sampled since the beginning of 2011 were retained for the further analysis. Consequently, 45,595 analytical results collected between 2001 and 2010 were excluded. The loss of these data did not compromise the availability of (quantified) data for the food categories mainly contributing to the dietary exposure to T2 and HT2 (i.e. grain‐based food/feed products). Particular attention was paid to data reported as suspect samples. Suspect samples are the samples taken repeatedly from the same site as a consequence of evidence or suspicion of contamination, and are often taken as a follow‐up of demonstrated non‐compliance with legislation. As they may lead to an overestimation of the contamination levels, results reported as ‘Suspect sampling’ (n = 7,216) were excluded from further analysis.

The LODs/LOQs of the T2 and HT2 data reported to EFSA varied between laboratories, between food matrices and substances, with higher LODs/LOQs for grain‐based food/feed products as compared to other food/feed categories. Considering the large amount of left‐censored data present in the dataset (91% for food, 90% for feed and 95% for unprocessed grains), the presence of relatively high LODs/LOQs may have a significant influence on the UB scenario. In order to reduce this impact, but without compromising the number of data available on food/feed categories contributing to the exposure to T2 and HT2, a careful evaluation of LOQs was performed. To identify the most appropriate LOQ cut‐off values, the distributions of quantified values (values above LOQ) as well as the reported LOQs were evaluated. A percentile (50th or 75th) derived from the quantified values was selected as a cut‐off value and subsequently applied to the LOQs reported. For food, a value of 10 μg/kg was selected as LOQ cut‐off for the individual T2 and HT2 data and a value of 20 μg/kg as LOQ cut‐off for the sum of T2 and HT2 data. For feed, a value of 50 μg/kg was selected as LOQ cut‐off for the individual T2 and HT2 data and a value of 100 μg/kg as LOQ cut‐off for the sum of T2 and HT2 data. In total, 12,298 analytical results on food (398 quantified, ~ 3%) and 552 data on feed (7 quantified, ~ 1%) were excluded following this criterion. Appendix C shows the effect of these cut‐offs on the occurrence values for the main selected food categories.

In addition, a total of 501 analytical results for which neither LOQ nor LOD were reported, were also excluded from the final data set.

A total of 66,269 analytical results were excluded from the final data set as described in Appendix D.

The majority of the remaining T2 and HT2 data (96%) were obtained for samples collected within official EU or national monitoring programmes, while the remaining samples were collected within other programmes types (e.g. surveys). Some of the analytical results (3%) were obtained from pooled samples, meaning that the result represented an average of a number of samples taken in equal parts from different consignments/batches and pooled together for the laboratory analysis. Since the level of aggregation for pooled samples matched the level of classification of the individual samples (only similar food matrices were pooled together), results from pooled samples were retained for further evaluation. To ensure a proportionate representation of the individual samples and thus an accurate use of occurrence data in assessing the dietary exposure, the mean concentrations per food category were calculated by weighting the reported analytical results for the number of samples pooled.

Based on the commodity classification provided, separate data sets were extracted for each of the three categories: food, feed and unprocessed grains. The final data set available for dietary exposure assessment included 19,505 analytical results on food (corresponding to a total of 9,035 samples), 6,411 analytical data on feed (corresponding to a total of 2,972 samples) and 1,150 analytical data on unprocessed grains (corresponding to a total of 562 samples). As explained later in Section 3.1.2, the data on unprocessed grains were treated separately and were not considered for the exposure assessment.

3.1.1. Occurrence data on food

The analytical results included in the final data set (n = 19,505 analytical results analysed in 9,035 samples) and considered for the dietary exposure of the present scientific report were collected in 20 different European countries, most of them in Germany (n = 9,712), Austria (n = 2,786) and the UK (n = 2,758) (Figure 2). It should be noted that the origin of the data was not always the European country reporting the data, i.e. the data set also contained samples originating from North and South America, Africa, Asia and Australia. The samples were collected between 2011 and 2016 (Figure 3).

Distribution of the food analytical results for the individual T2, HT2 and the sum of T2 and HT2 across the European countries (after excluding non‐qualifying data)
AT, Austria; BE, Belgium; BG, Bulgaria; CZ, the Czech Republic; DE, Germany; DK, Denmark; EE, Estonia; ES, Spain; FI, Finland; FR, France; HR, Croatia; HU, Hungary; IE, Ireland; LT, Lithuania; PO, Poland; RO, Romania; SE, Sweden; SI, Slovenia; SK, Slovakia; UK, the United Kingdom.

Distribution of the food analytical results for the individual T2, HT2 and the sum of T2 and HT2 over the sampling years (after excluding non‐qualifying data)

Table 1 summarises the number of analytical results and the percentage of left‐censored data per toxin and food category at FoodEx Level 1.

Table 1.

Distribution of analytical results per toxin and food category

FoodEx Level 1 food category	T‐2 toxin		HT‐2 toxin		Sum of T‐2 and HT‐2 toxins (as reported)
FoodEx Level 1 food category	N	%LC	N	%LC	N	%LC
Grains and grain‐based products	7,126	90	5,711	85	3,488	86
Vegetables and vegetable products	42	100	4	100	39	100
Starchy roots and tubers	5	100	–	–	5	100
Legumes, nuts and oilseeds	109	95	31	100	104	95
Fruit and fruit products	32	100	–	–	33	100
Meat and meat products	4	25	4	0	4	0
Sugar and confectionary	10	100	–	–	10	100
Animal and vegetable fats and oils	45	73	45	100	44	73
Non‐alcoholic beverages	2	100	2	100	–	–
Alcoholic beverages	604	100	604	99	101	100
Herbs, spices and condiments	13	100	–	–	14	93
Food for infants and small children	448	97	437	96	254	95
Products for special nutritional use	25	72	10	30	18	67
Composite food	3	100	2	100	–	–
Snacks, desserts, and other foods	34	71	27	70	12	100
Total	8,502	90	6,877	87	4,126	87

	N	Percentiles (μg/kg)
	N	Min	P5	P25	P50	P75	P95	Max
T‐2 toxin
Grains and grain‐based products, unspecified	24	4.0	4.0	5.0	5.0	10.0	10.0	10.0
Grains for human consumption	3,025	0.01	0.7	5.0	5.0	5.0	10.0	10.0
Grain milling products	1,888	0.01	0.4	4.5	5.0	5.0	10.0	10.0
Bread and rolls	451	0.4	4.5	5.0	5.0	9.0	10.0	10.0
Pasta (Raw)	312	0.4	0.4	4.5	4.5	5.0	10.0	10.0
Breakfast cereals	1,161	0.2	0.4	2.0	5.0	5.0	10.0	10.0
Fine bakery wares	265	0.4	0.4	1.0	5.0	5.0	10.0	10.0
Oilseeds	76	0.4	5.0	5.0	5.0	5.0	5.0	10.0
Beer and beer‐like beverage	604	2.5	3.0	3.3	3.3	3.3	10.0	10.0
Food for infants and small children, unspecified	11	4.5	4.5	4.5	5.0	5.0	5.0	5.0
Cereal‐based food for infants and young children	382	0.03	0.7	5.0	5.0	5.0	6.0	10.0
Dietary supplements	15	2.0	2.0	5.0	5.0	10.0	10.0	10.0
Snack food	33	0.4	0.4	5.0	6.0	8.0	10.0	10.0
HT‐2 toxin
Grains and grain‐based products, unspecified	22	5.0	5.0	5.0	6.0	10.0	10.0	10.0
Grains for human consumption	2,511	1.0	2.0	5.0	5.0	8.0	10.0	10.0
Grain milling products	1,507	0.01	2.0	4.5	5.0	5.0	10.0	10.0
Bread and rolls	293	1.0	4.5	4.5	6.7	10.0	10.0	10.0
Pasta (Raw)	256	4.5	4.5	4.5	4.5	10.0	10.0	10.0
Breakfast cereals	933	0.2	0.4	2.0	5.0	5.0	10.0	10.0
Fine bakery wares	189	1.0	1.0	1.1	5.0	10.0	10.0	10.0
Beer and beer‐like beverage	604	2.5	3.3	3.3	3.3	6.4	10.0	10.0
Food for infants and small children, unspecified	11	4.5	4.5	4.5	5.0	5.0	5.0	5.0
Cereal‐based food for infants and young children	372	0.09	1.1	5.0	5.0	5.0	8.0	10.0
Dietary supplements	7	2.0	2.0	5.0	5.0	5.0	5.0	5.0
Snack food	26	2.0	2.0	6.0	8.0	10.0	10.0	10.0
Sum of T‐2 and HT‐2 toxins (as reported)
Grains for human consumption	1,476	0.7	4.0	5.0	10.0	10.0	20.0	20.0
Grain milling products	968	1.1	4.0	5.0	5.0	10.0	20.0	20.0
Bread and rolls	172	2.0	5.0	5.0	10.0	20.0	20.0	20.0
Pasta (Raw)	132	5.0	5.0	5.0	10.0	17.5	20.0	20.0
Breakfast cereals	542	0.4	0.4	2.0	5.0	10.0	20.0	20.0
Fine bakery wares	196	1.1	1.1	2.0	10.0	15.0	20.0	20.0
Oilseeds	73	5.0	5.0	5.0	5.0	5.0	20.0	20.0
Beer and beer‐like beverage	101	3.0	3.0	3.0	3.0	10.0	10.0	10.0
Food for infants and small children, unspecified	8	10.0	10.0	10.0	10.0	10.0	10.0	10.0
Cereal‐based food for infants and young children	239	0.1	1.1	5.0	5.0	5.0	10.0	20.0
Dietary supplements	12	10.0	10.0	10.0	10.0	10.0	10.0	10.0
Snack food	12	10.0	10.0	15.0	15.5	16.0	20.0	20.0

Commodity	N	%LC	Concentration range (LB – UB) (μg/kg)
Commodity	N	%LC	Mean	Median	P75	P95a
T‐2 toxin
Grains as crops, unspecified	1	100	0.00–19.0	0–19.0	0–19.0	–
Wheat grain crop	85	98	0.32–19.8	0–25.0	0–25.0	0–25.0
Barley grain (Crop)	63	98	0.70–80.8	0–100	0–100	0–100
Corn grain (Crop)	17	76	8.92–20.3	0–6.40	0–24.6	–
Rye grain (Crop)	17	100	0.00–91.2	0–100	0–100	–
Spelt grain (Crop)	3	100	0.00–2.00	0–2.00	0–2.00	–
Buckwheat grain (Crop)	4	100	0.00–87.5	0–100	0–100	–
Millet grain (Crop)	2	100	0.00–75.0	0–75.0	0–100	–
Oats, grain (Crop)	91	87	1.52–33.7	0–50.0	0–50.0	10.4–150
Rice (Crop)	191	100	0.00–93.2	0–100	0–100	0–100
HT‐2 toxin
Grains as crops, unspecified	1	100	0.00–47.5	0–47.5	0–47.5	–
Wheat grain crop	68	99.5	0.13–20.2	0–25.0	0–25.0	0–25.0
Barley grain (Crop)	61	98	0.89–95.6	0–100	0–100	0–100
Corn grain (Crop)	7	100	0.00–8.29	0–7.60	0–10.0	–
Rye grain (Crop)	17	100	0.00–100	0–100	0–100	–
Spelt grain (Crop)	3	100	0.00–0.00	0.00–0.00	0.00–0.00	–
Buckwheat grain (Crop)	4	100	0.00–100	0–100	0–100	–
Millet grain (Crop)	2	100	0.00–100	0–100	0–100	–
Oats, grain (Crop)	91	74	11.1–65.4	0–70.0	2.8–100	90–250
Rice (Crop)	191	100	0.00–100	0–100	0–100	0–100
Sum of T‐2 and HT‐2 toxins
Grains as crops, unspecified	1	100	0.00–19.0	0–19.0	0–19.0	–
Wheat grain crop	150	98	1.32–35.8	0–50.0	0–50.0	0–50.0
Barley grain (Crop)	14	100	0.00–113	0–22.8	0–75.0	–
Corn grain (Crop)	14	64	40.3–52.5	0–25.0	35.0–35.0	–
Spelt grain (Crop)	3	100	0.00–0.00	0.00–0.00	0.00–0.00	–
Oats, grain (Crop)	49	90	13.4–109	0–75.0	0–75.0	–

Feed category Level 1	T‐2 toxin		HT‐2 toxin		Sum of T‐2 and HT‐2 toxins (as reported)
Feed category Level 1	N	%LC	N	%LC	N	%LC
Feed terms (unspecified)	8	88	–	–	8	88
Cereal grains, their products and by‐products	1,381	89	1,298	85	596	82
Minerals and products derived thereof	1	100	1	100	–	–
Fermentation (by‐)products from microorganisms the cells of which have been inactivated or killed	1	100	1	100	–	–
Miscellaneous	5	100	1	100	1	100
Oil seeds, oil fruits, and products derived thereof	159	94	36	94	119	98
Legume seeds and products derived thereof	8	100	8	100	1	100
Tubers, roots, and products derived thereof	1	100	1	100	–	–
Other seeds and fruits, and products derived thereof	2	100	2	100	–	–
Forages and roughage, and products derived thereof	162	90	160	83	58	69
Milk products and products derived thereof	1	0	1	0	–	–
Land animal products and products derived thereof	2	100	2	100	–	–
Compound feed	1004	94	918	92	464	96
Total	2,735	91	2,429	88	1,247	88

Age class	Minimum		Median		Maximum
Age class	LB	UB	LB	UB	LB	UB
	Mean dietary exposure in total population (ng/kg bw per day)
Infants	4.41	19.3	14.9	31.1	18.3	62.9
Toddlers	8.99	49.8	15.3	55.6	29.0	64.8
Other children	8.50	35.1	11.1	45.4	18.0	62.1
Adolescents	4.37	15.4	6.59	27.9	11.3	38.9
Adults	2.54	14.3	3.62	19.8	8.82	26.4
Elderly	2.27	13.4	2.94	17.5	10.2	23.4
Very elderly	1.82	14.5	3.05	18.4	8.23	20.7
Pregnant womenb	5.72	–	–	–	–	20.5
Lactating womenb	4.60	–	–	–	–	15.9
	95 ^th percentile dietary exposure in total population (ng/kg bw per day)
Infantsa	18.0	50.5	45.1	89.6	53.9	146
Toddlersa	23.8	95.0	43.3	107	67.3	109
Other children	20.3	60.9	28.1	81.5	37.2	112
Adolescents	11.4	26.1	17.1	53.2	29.9	71.5
Adults	6.37	27.6	9.11	37.7	16.7	54.1
Elderly	5.41	26.8	7.32	33.6	20.9	41.8
Very elderlya	4.22	29.1	7.61	32.2	20.3	41.2
Pregnant womenb	14.0	–	–	–	–	38.5
Lactating womenb	13.4	–	–	–	–	33.3

Age class	Number dietary surveys	Minimum	Median	Maximum
		Range of average acute exposure (ng/kg bw per day)
Infants	6	15.2 (10.1–29.2)	27.7	54.6 (48.5–69.3)
Toddlers	11	47.9 (46.1–50.3)	55.7	64.7 (62.3–69.8)
Other children	20	35.1 (33.9–36.7)	46.3	62.1 (59.9–64.7)
Adolescents	20	15.3 (14.7–16.1)	28.1	39.5 (38.0–41.2)
Adults	22	14.4 (14.1–14.7)	19.9	26.5 (25.6–27.6)
Elderly	16	13.4 (13.0–13.9)	17.8	23.5 (21.2–26.5)
Very elderly	14	14.5 (13.6–15.8)	18.7	20.7 (19.3–22.4)
Pregnant women	1	–c	–c	25.7 (24.7–27.0)
Lactating women	1	–c	–c	17.3 (16.1–19.0)
		Range of 95th percentile acute exposure (ng/kg bw per day)
Infants	5	73.0 (65.3–81.1)	–d	170 (152–193)
Toddlers	10	110 (101–121)	142	154 (116–222)
Other children	20	84.4 (79.1–89.8)	116	140 (130–151)
Adolescents	20	36.2 (33.5–39.4)	73.2	100 (92.1–109)
Adults	22	38.0 (36.7–39.3)	49.8	68.4 (63.0–75.0)
Elderly	16	34.3 (31.8–37.1)	43.1	55.4 (46.7–66.9)
Very elderly	14	37.2 (32.4–42.7)	43.4	55.3 (43.9–69.5)
Pregnant women	1	–c	–c	72.0 (66.1–78.7)
Lactating women	1	–c	–c	50.2 (43.1–57.6)

	Number dietary surveys	Minimum	Maximum
		Percentage of subjects above the ARfD b
Infants	6	< 0.01 (0–< 0.01)	0.07 (0.04–0.10)
Toddlers	11	< 0.01 (0–0.01)	0.05 (0.03–0.07)
Other children	20	< 0.01 (0–< 0.01)	0.03 (0.01–0.05)
Adolescents	20	< 0.01 (0–0.01)	0.01 (< 0.01–0.01)
Adults	22	< 0.01 (0–< 0.01)	< 0.01 (< 0.01–0.01)
Elderly	16	< 0.01 (0–< 0.01)	< 0.01 (0–0.02)
Very elderly	14	< 0.01 (0–< 0.01)	< 0.01 (0–0.02)
Pregnant women	1	–c	< 0.01 (0–< 0.01)
Lactating women	1	–c	< 0.01 (0–0.02)

Sources of uncertainty	Directiona
Extrapolation of occurrence data few Member States to whole Europe	+/−
Large proportion of left‐censored data in the final data set	+/−
Using the substitution method at the lower bound (LB) scenario	−
Using the substitution method at the upper bound (UB) scenario	+
Using imputation method	+/−
Lack of data on modified forms	−
Limited occurrence data from several food groups/limited consumption data for certain population groups	+/−
Very high occurrence data for one product reported by only one data provider	+
Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard	+/−
Reporting of consumption data on raw agricultural commodities derived from consumption of processed foods	+
High variability of feedstuffs used and feeding systems for livestock	+/−

	Live weight (kg)	Growth rate or productivity	Dry matter intake (kg/day)	% of diet as non‐forage feed	Reference
Dairy cows, lactatinga	650	40 kg milk/day	20.7	60	AFRC (1993)
Beef: fatteningb	400	1 kg/day	9.6	20	AFRC (1993)
Beef: cereal	400	1.4 kg/day	8.4	85	AFRC (1993)
Sheep: lactating	80	Feeding twin lambs	2.8	35	AFRC (1993)
Goats: milkingc	60	6 kg milk/day	3.4	75	NRC (2007a)
Goats: fattening	40	0.2 kg/day	1.5	40	NRC (2007a)
Horses	450	–	9	50	NRC (2007b)

Type of forage	Quantities of feed consumed (kg dry matter/day)
Type of forage	Forage	Maize grain	Soybean meal
Maize silage	15.0	9.5	2.8
Grass silage	16.8	9.2	0.8
Hay	16.3	12.6	0.73
Grazed grass	18.8	7.2	0

	Live weight (kg)	Feed intake (kg/day)	Reference
Pigs: piglets	20	1.0	EFSA (2009)
Pigs: fattening pigs	100	3.0	EFSA (2009)
Pigs: lactating sows	200	6.0	EFSA (2009)
Poultry: broilers	2	0.12	EFSA (2009)
Poultry: laying hens	2	0.12	EFSA (2009)
Turkeys: fattening turkeys	12	0.40	EFSA (2009)
Ducks: fattening ducks	3	0.14	Leeson and Summers (2008)
Salmonids	2	0.04	EFSA (2009)
Rabbits	2	0.15	Carabano and Piquer (1998)

Feeds	Dairy cow	Beef cattle	Beef cattle	Sheep	Goats	Goats	Horses
Feeds	Dairy cow	Cereal beef	Fattening	Lactating	Dairy	Fattening	Horses
Wheat (%)	15			14
Barley (%)	20	60	40	18	25	20
Oats (%)					35	40	40
Soybean meal (%)	5			5	10	10
Rapeseed meal (%)	20	5	20	10	10	10
Sunflower meal (%)		5		5
Beans (%)	5			10			10
Maize gluten feed (%)	10	10	11
Wheat feed (%)	10	4	10	15	10	10	30
Oat feed (%)							12
Sugar beet pulp (%)	8	10	12	15		2
Molasses (%)	3	2	3	4	4	3	5
Vegetable oils (%)	1	1	1	1	2	2
Minerals and vitamins (%)	3	3	3	3	4	3	3
T‐2 and HT‐2 toxins a
Mean lower bound (μg/kg)	3.2	7.8	4.9	3.5	26.6	29.3	116
Mean upper bound (μg/kg)	12.9	17.1	14.8	10.6	34.5	37.3	126
High lower bound (μg/kg)	12.6	32.2	22.0	10.2	55.8	59.5	240
High upper bound (μg/kg)	24.6	38.5	30.3	20.9	60.7	64.2	250

Age class	Minimum		Median		Maximum
Age class	LB	UB	LB	UB	LB	UB
	Mean dietary exposure in total population (ng/kg bw per day)
Infants	0.74	12.5	4.17	19.6	5.46	47.0
Toddlers	2.94	26.8	5.56	35.6	8.00	43.8
Other children	2.89	20.7	4.04	29.5	6.10	41.9
Adolescents	1.35	9.8	2.42	17.7	3.73	24.4
Adults	0.96	9.6	1.28	13.5	3.55	18.3
Elderly	0.77	9.1	1.04	12.1	4.55	16.2
Very elderly	0.63	9.8	1.10	12.8	2.96	14.2
Pregnant womenb	1.62	–	–	–	–	13.1
Lactating womenb	1.67	–	–	–	–	9.98
	95 ^th percentile dietary exposure in total population (ng/kg bw per day)
Infantsa	6.33	26.7	12.2	52.1	17.2	108
Toddlersa	9.14	47.3	15.5	63.6	19.3	71.7
Other children	7.06	33.2	9.73	51.1	15.1	72.9
Adolescents	3.82	16.0	6.62	35.9	10.7	43.5
Adults	2.41	18.4	3.68	26.5	6.49	39.8
Elderly	2.04	17.3	2.72	23.9	10.2	32.8
Very elderlya	1.61	19.4	2.61	21.5	9.32	26.8
Pregnant womenb	4.07	–	–	–	–	24.7
Lactating womenb	4.10	–	–	–	–	21.4

Age class	Minimum		Median		Maximum
Age class	LB	UB	LB	UB	LB	UB
	Mean dietary exposure in total population (ng/kg bw per day)
Infants	2.32	16.7	10.2	26.4	13.2	58.7
Toddlers	5.42	40.4	9.02	47.8	20.2	54.9
Other children	5.06	28.5	7.20	38.9	11.8	52.6
Adolescents	2.81	12.9	3.94	23.9	7.26	33.2
Adults	1.16	12.5	2.10	17.0	5.32	23.3
Elderly	1.03	11.9	1.80	15.2	6.22	20.3
Very elderly	1.03	12.9	2.05	16.5	5.62	18.4
Pregnant womenb	3.59	–	–	–	–	17.6
Lactating womenb	2.94	–	–	–	–	13.3
	95 ^th percentile dietary exposure in total population (ng/kg bw per day)
Infantsa	9.79	38.4	32.8	76.5	37.3	130
Toddlersa	14.5	75.2	31.6	87.2	48.7	95.5
Other children	11.5	47.7	17.9	68.5	25.8	95.5
Adolescents	6.78	21.6	10.6	46.1	19.8	57.3
Adults	3.01	23.9	5.73	33.7	11.5	48.9
Elderly	2.88	23.8	5.06	30.1	13.3	42.6
Very elderlya	2.36	26.0	5.26	27.5	11.7	34.8
Pregnant womenb	9.22	–	–	–	–	32.6
Lactating womenb	8.42	–	–	–	–	29.0

Age class	Number dietary surveys	Minimum	Median	Maximum
		Range of average acute exposure (ng/kg bw per day)
Infants	6	10.2 (7.55–13.0)	16.9	40.6 (38.4–42.7)
Toddlers	11	26.8 (25.9–27.9)	36.2	43.8 (42.4–45.6)
Other children	20	20.7 (20.2–21.4)	30.0	41.9 (40.7–43.4)
Adolescents	20	9.76 (9.47–10.1)	18.2	26.4 (25.5–27.4)
Adults	22	9.58 (9.44–9.74)	13.4	18.4 (17.8–19.0)
Elderly	16	9.06 (8.80–9.35)	12.2	16.3 (14.9–18.0)
Very elderly	14	9.77 (9.26–10.4)	13.0	14.2 (12.8–16.1)
Pregnant women	1	–b	–b	15.3 (14.9–15.7)
Lactating women	1	–b	–b	11.0 (10.3–11.8)
		Range of 95th percentile acute exposure (ng/kg bw per day)
Infants	5	34.2 (31.5–37.1)	–c	137 (125–151)
Toddlers	10	59.5 (55.8–63.8)	83.6	96.3 (90.8–103)
Other children	20	44.3 (42.2–46.6)	70.9	90.9 (85.4–96.6)
Adolescents	20	21.8 (20.6–23.0)	45.7	60.4 (55.5–65.6)
Adults	22	24.7 (23.9–25.4)	33.6	46.4 (44.7–48.3)
Elderly	16	22.4 (20.9–24.0)	28.9	38.9 (36.1–42.0)
Very elderly	14	24.7 (21.7–28.6)	28.5	36.5 (32.6–41.4)
Pregnant women	1	–b	–b	37.7 (36.0–39.6)
Lactating women	1	–b	–b	30.3 (27.0–34.9)

Feeds	Piglets	Pigs for fattening	Lactating sow	Broilers	Laying hens	Turkeys for fattening	Ducks for fattening
Wheat (%)	48	48	50	38	30	30	45
Barley (%)	20	20	11			35	15
Maize (%)				38	35
Soybean meal (%)	22	11	16	15	22	15	28
Rapeseed meal (%)	3	4
Lucerne meal (%)					4	9	5
Wheat feed (%)		9	14	1			7
Molasses (%)	3	4	4	3	3	3
Vegetable oils (%)	1	1	2	1	2	4
Minerals and vitamins (%)	3	3	3	4	4	4
T‐2 and HT‐2 toxins a
Mean lower bound (μg/kg)	4.3	3.6	3.1	5.0	5.1	5.3	4.3
Mean upper bound (μg/kg)	11.7	12.7	12.7	15.3	14.2	11.6	12.5
High lower bound (μg/kg)	11.8	11.1	7.2	19.0	18.1	18.4	9.9
High upper bound (μg/kg)	27.9	29.7	27.7	34.0	30.3	29.2	27.2

Feeds	Rabbit
Sunflower meal (%)	20
Dried lucerne (%)	19
Wheat bran (%)	19
Barley (%)	18
Sugar beet pulp (%)	12
Beans (%)	11
Minerals and vitamins (%)	1
T‐2 and HT‐2 toxins a
Mean lower bound (μg/kg)	5.3
Mean upper bound (μg/kg)	13.6
High lower bound (μg/kg)	12.1
High upper bound (μg/kg)	19.9

Feeds	Salmonids
Fishmeal (%)	30.5
Wheat (%)	13.2
Soybean meal (%)	12.3
Maize gluten feed (%)	11.5
Fish and vegetable oils (%)	31.9
Mineral vitamins premix (%)	0.6
T‐2 and HT‐2 toxins a
Mean lower bound (μg/kg)	1.5
Mean upper bound (μg/kg)	6.9
High lower bound (μg/kg)	3.6
High upper bound (μg/kg)	10.7

Food category (FoodEx Level 1)	Number of data before applying cut‐off	LC %	Mean occurrence values before application of cut‐offs (μg/kg)		Cut‐off applied on LOQ (μg/kg)	Number of data excluded	Number samples after applying cut‐off	Mean occurrence values after application of cut‐offs (μg/kg)
Food category (FoodEx Level 1)	Number of data before applying cut‐off	LC %	LB	UB	Cut‐off applied on LOQ (μg/kg)	Number of data excluded	Number samples after applying cut‐off	LB	UB
T‐2 toxin
Grains and grain‐based products	9,306	91	2.17	12.3	10	2,180	7,126	2.46	6.02
Vegetables and vegetable products	120	100	0.00	60.2		78	42	0.00	3.19
Starchy roots and tubers	7	100	0.00	30.7		2	5	0.00	3.00
Legumes, nuts and oilseeds	1,031	99.5	0.11	53.9		922	109	1.01	3.45
Fruit and fruit products	513	100	0.00	47.7		481	32	0.00	3.00
Meat and meat products (including edible offal)	5	40	2.55	12.8		1	4	3.18	3.43
Sugar and confectionary	39	100	0.00	32.2		29	10	0.00	3.00
Animal and vegetable fats and oils	84	86	0.31	23.8		39	45	0.58	1.03
Fruit and vegetable juices	74	100	0.00	77.0		74	0	–	–
Non‐alcoholic beverages	2	100	0.00	5.00		0	2	0.00	5.00
Alcoholic beverages	829	99.6	0.03	26.0		225	604	0.05	1.74
Herbs, spices and condiments	41	100	0.00	38.8		28	13	0.00	3.00
Food for infants and small children	528	97	0.14	4.96		80	448	0.11	3.09
Products for special nutritional use	26	73	127	132		1	25	133	135
Composite food	3	100	0.00	4.33		0	3	0.00	4.33
Snacks, desserts, and other foods	82	88	1.89	18.7		48	34	4.56	8.37
HT‐2 toxin
Grains and grain‐based products	9,224	87	4.44	16.7	10	3,513	5,711	5.67	9.55
Vegetables and vegetable products (including fungi)	120	100	0.00	63.5		116	4	0.00	4.67
Starchy roots and tubers	7	100	0.00	35.7		7	0	–	–
Legumes, nuts and oilseeds	1,034	99.9	0.09	85.8		1,003	31	0.00	2.72
Fruit and fruit products	513	100	0.00	91.6		513	0	–	–
Meat and meat products	5	20	3.14	23.1		1	4	3.93	3.93
Sugar and confectionary	21	100	0.00	11.2		21	0	–	–
Animal and vegetable fats and oils	84	100	0.00	47.1		39	45	0.00	1.24
Fruit and vegetable juices	74	100	0.00	100		74	0	–	–
Non‐alcoholic beverages	2	100	0.00	5.00		0	2	0.00	5.00
Alcoholic beverages	829	99	0.04	26.2		225	604	0.06	2.07
Herbs, spices and condiments	41	98	0.49	72.0		41	0	–	–
Food for infants and small children	528	96	0.75	6.04		91	437	0.48	3.70
Products for special nutritional use	19	63	139	155		9	10	264	265
Composite food	3	100	0.00	5.00		1	2	0.00	5.00
Snacks, desserts, and other foods	77	90	1.56	21.1		50	27	4.45	9.76
Sum of T‐2 and HT‐2 toxins
Grains and grain‐based products	5,795	87	8.35	19.02	20	2,307	3,488	9.12	14.9
Vegetables and vegetable products (including fungi)	40	100	0.00	5.50		1	39	0.00	5.18
Starchy roots and tubers	5	100	0.00	5.80		0	5	0.00	5.80
Legumes, nuts and oilseeds	108	95	1.86	7.02		4	104	1.93	5.94
Fruit and fruit products	33	100	0.00	8.15		0	33	0.00	8.15
Meat and meat products (including edible offal)	4	0.0	7.11	7.11		0	4	7.11	7.11
Sugar and confectionary	11	100	0.00	8.31		1	10	0.00	7.20
Animal and vegetable fats and oils	44	73	0.64	0.88		0	44	0.64	0.88
Alcoholic beverages	101	100	0.00	3.16		0	101	0.00	3.16
Herbs, spices and condiments	18	83	9.76	20.2		4	14	1.43	11.3
Food for infants and small children	327	94	1.43	9.36		73	254	0.65	4.63
Products for special nutritional use	20	70	295	306		2	18	328	333
Composite food (including frozen products)	1	100	0.00	8.00		1	0	–	–
Snacks, desserts, and other foods	25	88	4.74	20.3		13	12	0.00	13.5

Feed category (Level 1)	Number of data before applying cut‐off	LC %	Mean occurrence values before application of cut‐offs (μg/kg)		Cut‐off applied on LOQ (μg/kg)	Number of data excluded	Number samples after applying cut‐off	Mean occurrence values after application of cut‐offs (μg/kg)
Feed category (Level 1)	Number of data before applying cut‐off	LC %	LB	UB	Cut‐off applied on LOQ (μg/kg)	Number of data excluded	Number samples after applying cut‐off	LB	UB
T‐2 toxin
Feed terms	9	89	3.07	24.3	50	1	8	3.46	21.1
Cereal grains, their products and by‐products	1,488	89	7.53	25.7		107	1,381	7.89	19.2
Fish, other aquatic animals and products derived thereof	1	100	0.00	53.5		1	0	–	–
Minerals and products derived thereof	1	100	0.00	7.00		0	1	0.00	7.00
Fermentation (by‐)products from microorganisms the cells of which have been inactivated or killed	1	100	0.00	5.00		0	1	0.00	5.00
Miscellaneous	8	100	0.00	26.2		3	5	0.00	11.0
Oil seeds, oil fruits, and products derived thereof	174	95	0.10	19.2		15	159	0.11	15.9
Legume seeds and products derived thereof	8	100	0.00	7.50		0	8	0.00	7.50
Tubers, roots, and products derived thereof	2	100	0.00	53.0		1	1	0.00	5.00
Other seeds and fruits, and products derived thereof	2	100	0.00	5.00		0	2	0.00	5.00
Forages and roughage, and products derived thereof	169	91	4.78	13.6		7	162	4.99	12.6
Milk products and products derived thereof	1	0	3.00	3.00		0	1	3.00	3.00
Land animal products and products derived thereof	2	100	0.00	7.50		0	2	0.00	7.50
Compound feed	1,125	95	1.62	24.2		121	1,004	1.67	16.3
HT‐2 toxin
Feed terms	9	78	27.9	67.1	50	9	0	–	–
Cereal grains, their products and by‐products	1,394	86	19.6	49.0		96	1,298	20.9	41.3
Fish, other aquatic animals and products derived thereof	1	100	0.00	53.5		1	0	–	–
Minerals and products derived thereof	1	100	0.00	10.0		0	1	0.00	10.00
Fermentation (by‐)products from microorganisms the cells of which have been inactivated or killed	1	100	0.00	5.00		0	1	0.00	5.00
Miscellaneous	3	100	0.00	39.2		2	1	0.00	38.0
Oil seeds, oil fruits, and products derived thereof	167	99	0.29	41.5		131	36	1.35	6.33
Legume seeds and products derived thereof	8	100	0.00	11.5		0	8	0.00	11.5
Tubers, roots, and products derived thereof	2	100	0.00	53.0		1	1	0.00	5.00
Other seeds and fruits, and products derived thereof	2	100	0.00	5.00		0	2	0.00	5.00
Forages and roughage, and products derived thereof	167	83	6.79	21.9		7	160	7.09	21.1
Milk products and products derived thereof	1	0	3.40	3.40		0	1	3.40	3.40
Land animal products and products derived thereof	2	100	0.00	7.50		0	2	0.00	7.50
Compound feed	964	93	2.19	35.0		46	918	2.30	28.9
Sum of T‐2 and HT‐2 toxins
Feed terms	8	88	18.5	36.1	100	0	8	18.5	36.1
Cereal grains, their products and by‐products	598	82	39.8	81.0		2	596	39.9	54.5
Miscellaneous	1	100	0.00	15.2		0	1	0.00	15.2
Oil seeds, oil fruits, and products derived thereof	119	98	0.66	20.4		0	119	0.66	20.4
Legume seeds and products derived thereof	1	100	0.00	18.8		0	1	0.00	18.8
Forages and roughage, and products derived thereof	58	69	14.2	22.4		0	58	14.2	22.4
Compound feed	465	96	1.44	36.5		1	464	1.44	19.3

Criteria for exclusion	Number of samples excluded
Duplicates	107
Outdated data (data sampled before 2011)	45,595
Reported as suspect samples (not random sampling)	7,216
LOD/LOQ not reported	501
Food data eliminated due to application of LOQ cut‐offs	12,298
Feed data eliminated due to application of LOQ cut‐offs	552
Total	66,269

Age class	Number dietary surveys	Minimum	Median	Maximum
		Range of average acute exposure (ng/kg bw per day)
Infants	6	12.9 (8.66–23.7)	23.1	50.9 (46.8–60.9)
Toddlers	11	40.4 (38.6–42.2)	47.7	54.8 (53.0–58.1)
Other children	20	28.5 (27.6–29.6)	39.8	52.6 (50.9–55.0)
Adolescents	20	12.8 (12.4–13.3)	24.3	34.3 (33.1–35.6)
Adults	22	12.5 (12.3–12.8)	17.1	23.4 (22.7–24.0)
Elderly	16	11.9 (11.6–12.3)	15.3	20.3 (19.6–21.1)
Very elderly	14	12.9 (12.2–13.7)	16.7	18.4 (16.5–20.6)
Pregnant women	1	– b	– b	21.6 (20.8–22.5)
Lactating women	1	– b	– b	14.6 (13.7–15.6)
		Range of 95th percentile acute exposure (ng/kg bw per day)
Infants	5	55.5 (50.1–61.1)	– c	165 (151–181)
Toddlers	10	97.0 (89.6–105)	119	133 (125–141)
Other children	20	65.4 (62.1–69.2)	96.4	117 (110–125)
Adolescents	20	29.3 (27.4–31.3)	61.1	81.1 (75.5–87.4)
Adults	22	33.2 (32.1–34.3)	44.9	59.3 (56.9–61.9)
Elderly	16	30.1 (28.1–32.4)	38.9	51.6 (47.5–56.2)
Very elderly	14	32.8 (30.5–35.4)	38.0	49.9 (38.1–63.4)
Pregnant women	1	– b	– b	57.9 (53.8–62.6)
Lactating women	1	– b	– b	41.0 (36.2–47.3)

	Exposure
	Milk Yield: 40 kg non‐forage feed consumed: 12 kg dry matter/day
	μg/day
Lower bound	39
Upper bound	155
	μg/kg bw per day
Lower bound	0.06
Upper bound	0.24

	Exposure
	Forage type
	Maize silage	Grass silage	Hay	Pasture grass
	μg/day
Lower bound	364	90	120	66
Upper bound	742	229	310	173
	μg/kg bw per day
Lower bound	0.56	0.14	0.19	0.10
Upper bound	1.14	0.35	0.48	0.27

	Exposure
	Fattening beef	Cereal beef
	Non‐forage feeds consumed (kg dry matter/day)
	1.9	7.1
	μg/day
Lower bound	11	64
Upper bound	32	139
	μg/kg bw per day
Lower bound	0.03	0.16
Upper bound	0.08	0.35

PERMALINK

Human and animal dietary exposure to T‐2 and HT‐2 toxin

Davide Arcella

Petra Gergelova

Matteo Lorenzo Innocenti

Hans Steinkellner

Abstract

Summary

1. Introduction

Figure 1.

1.1. Background and Terms of Reference as provided by the requestor

2. Data and methodologies

2.1. Data

2.1.1. Occurrence data (food and feed)

2.1.1.1. Data collection and validation

2.1.1.2. Data analysis

2.1.2. Human consumption data

2.1.3. Animal consumption data

2.1.4. Food classification

2.1.5. Feed classification

2.2. Methodologies

2.2.1. Human dietary exposure assessment

2.2.2. Animal dietary exposure assessment

3. Assessment

3.1. Occurrence data on T‐2 and HT‐2 toxin

3.1.1. Occurrence data on food

Figure 2.

Figure 3.

Table 1.

Figure 4.

Table 2.

3.1.1.1. Occurrence data on the individual T2 and HT2

3.1.1.2. Occurrence data on the sum of the T2 and HT2

3.1.2. Occurrence data on unprocessed grains

Figure 5.

Figure 6.

Table 3.

3.1.3. Occurrence data on feed

Figure 7.

Figure 8.

Table 4.

3.2. Human dietary exposure to T‐2 and HT‐2 toxin

3.2.1. Chronic dietary exposure to the sum of T2 and HT2

Table 5.

3.2.2. Acute dietary exposure

Table 6.

3.3. Animal exposure

4. Uncertainties

Table 7.

5. Conclusions

6. Recommendations

Abbreviations

Appendix A – Dietary surveys used for the estimation of chronic and acute dietary exposure to T2 and HT2

1.

Appendix B – Intakes and composition of diets used estimating animal exposure to T2 and HT2

1.

B.1. Feed intake

B.1.1. Cattle, sheep, goats and horses

B.1.1.1. Live weights, growth rate/productivity, dry matter intake for cattle, sheep, goats and horses, and the proportions of the diet as non‐forage

B.1.2. Dairy cows fed different forages and non‐forage feeds

B.1.2.1. Feed intake of dairy cows producing 40 kg milk/day and fed diets based on different forages and non‐forage feeds (From AFSSA, 2009, modified)

B.1.3. Pigs, poultry, fish and rabbit

B.1.3.1. Live weights and feed intake for pigs, poultry, fish and rabbits

B.1.4. Dogs and cats

B.1.4.1. Live weights and feed intake for dogs and cats

B.2. Diets composition and T‐2 and HT‐2 toxins concentration estimates

B.2.1. Cattle sheep, goats and horses

B.2.1.1. Diet compositions of non‐forage feed for cattle, sheep and goats, and calculated mean and high lower bound and upper bound levels of T‐2 and HT‐2 toxins in these diets

B.2.2. Pigs and poultry

B.2.2.1. Diet compositions of feed for pigs and poultry, and calculated mean and high lower bound and upper bound levels of T‐2 and HT‐2 toxins in these diets

B.2.3. Rabbits

B.2.3.1. Diet composition for rabbits and calculated mean and high lower bound and upper bound levels of T‐2 and HT‐2 toxins

B.2.4. Fish

B.2.4.1. Diet composition for salmonids and calculated mean and high lower bound and upper bound levels of T‐2 and HT‐2 toxins

B.2.5. Dogs and cats

B.2.5.1. Diet compositions for dogs and cats, and calculated mean and high lower bound and upper bound levels of T‐2 and HT‐2 toxins

Appendix C – Use of cut‐offs for the LOQs and its effect on the final occurrence values

C.1. Use of cut‐offs for the LOQs and its effect on the final food occurrence values

C.2. Use of cut‐offs for the LOQs and its effect on the final feed occurrence values

Appendix D – Food samples excluded from the final data set used to estimate dietary exposure and the criteria applied for exclusion

	Exposure
	80‐kg lactating sheep	60‐kg milking goat	40‐kg fattening goat
	μg/day
Lower bound	4	68	18
Upper bound	12	88	22
	μg/kg bw per day
Lower bound	0.05	1.13	0.44
Upper bound	0.15	1.47	0.56

	Exposure
	Piglets	Fattening pigs	Lactating sows
	μg/day
Lower bound	4.3	10.8	18.5
Upper bound	11.7	38.0	76.1
	μg/kg bw per day
Lower bound	0.22	0.11	0.09
Upper bound	0.59	0.38	0.38

	Exposure
	Rabbit
	μg/day
Lower bound	0.79
Upper bound	2.05
	μg/kg bw per day
Lower bound	0.40
Upper bound	1.02

	Exposure
	Salmon
	μg/day
Lower bound	0.06
Upper bound	0.27
	μg/kg bw per day
Lower bound	0.03
Upper bound	0.14

	Exposure
	Dogs	Cats
	μg/day
Lower bound	0.96	0.16
Upper bound	3.54	0.59
	μg/kg bw per day
Lower bound	0.04	0.04
Upper bound	0.14	0.15

	Exposure
	Milk Yield: 40 kg non‐forage feed consumed: 12 kg dry matter/day
	μg/day
Lower bound	151
Upper bound	295
	μg/kg bw per day
Lower bound	0.23
Upper bound	0.45